| # | Vaccine | Age | Onset Interval | VAERS ID | Adverse Event Description | | | 1 | COVID19 (COVID19 (JANSSEN)) | 18-29 years | 0 days | 1183063-1 | He mentioned feeling lightheaded in the car & severe arm pain at the injection site. 5 minutes later experienced cramping sensation in his facial cheeks on both sides. Within 10 more min encountered numbness in his face & his arms began to have sensation of, ""dead weight"" along w/nausea & unable to move rt. hand. VERY lightheaded all along. We had to travel due to limited supply. His symptoms mimiced a stroke; however, it was determined that it was a severe nuerological reaction & not a stroke. After arrival at the hospital his face felt fully numb & he was unable to smile, like normal. Lower extremities were fine. 102.5 fever next a.m. w/headaches, fatigure and aches that week."" | | 2 | COVID19 (COVID19 (JANSSEN)) | 18-29 years | 4 days | 1096548-1 | First three days 102 fever, legs were in so much pain I could not walk or get up. The fourth and fifth day my lips and face would become tingly/numb and my left arm would get weak and I would feel a little disoriented, my sleep has been pretty disturbed. It felt like I was having a stroke. I did not have a stroke, I continue to occasionally feel the above symptoms, a little less potent than they were, they might be going away, I can't tell. I will be calling my doctor if it continues. | | 3 | COVID19 (COVID19 (JANSSEN)) | 18-29 years | 4 days | 1202290-1 | Patient presented to hospital on 4/9/21 - 4 days post vaccination - with new onset left sided weakness. Brain CTA showed a M1 branch occlusion. Patient was given TPA and transferred to Medical Center for further management and mechanical thrombectomy. Successful thrombectomy done. Etiology of stroke cryptogenic but suspect emoblic event. Questionable moyamoya disease - notes state ""if moyamoya suspect, patietn will get neurosurgery survice on board/appreciate neuro recommendations"""" | | 4 | COVID19 (COVID19 (JANSSEN)) | 18-29 years | 6 days | 1106370-1 | About 7-8 minutes later I started feeling pressure in the right side of my head. It went away a bit. I was walking after the 15 minutes and started feeling weird in my face, I just sat in my car and waited because I had to drive. I started feeling numbness under my eye and down the rest of my face. The thing that worried me the most I had so much pressure under my eye like it was inside my brain. The numbness and pain caused me to freak out. I went to back to the convention center to let them know, they brought the Paramedic to me they started checking me and doing a work up. They told me I wasn't a life threatening emergency and my vitals were ok. They offered to take me to the ER and I declined and I decided to leave because I have been there for 1hr 45mins. I felt like my symptoms were at 70%. When I got home I freaked out again because the numbness didn't go away and my face looked like it was a little lower and had a panic attack and went to the ER. They checked on me and told me I didn't have a stroke. They told me It was a side effect to the vaccine. They told me to follow up with the Neurologist if I have any more symptoms, I have an appointment with them in a couple weeks. I'm a little concerned because there is a minor pain that I didn't have before on my right side and it worries me. | | 5 | COVID19 (COVID19 (JANSSEN)) | 30-39 years | 10-14 days | 1178023-1 | Admitted with ischemic stroke and multiple thrombi in extremities | | 6 | COVID19 (COVID19 (JANSSEN)) | 30-39 years | 15-30 days | 1201967-1 | 36 y.o. female referred for the above chief complaint. She has no significant medical history and presented with a headache that became severe 3 days ago. She received the Johnson and Johnson COVID vaccine on March 25th and had a mild headache following that which she attributed to the vaccine. 3 days ago the pain became excruciating and was associated with vomiting. This prompted presentation to the ED where she was treated with Dilaudid. She was discharged home and has been using her mom's headache cocktail with some transient relief. She presented back to the ED today with continued symptoms. MRV revealed a venous sinus thrombosis and neurology was therefore consulted. She has no history of clots personally or in the family. Her dad did have a stroke in his 50s. Patient otherwise denies any other associated speech change, vision change, extremity numbness, extremity weakness, coordination difficulty, or dizziness. Patient admitted to the neurology ICU and started on anticoagulation. | | 7 | COVID19 (COVID19 (JANSSEN)) | 40-49 years | 0 days | 1139453-1 | 3/11/21 Left side of face went numb, jaw pain, felt like electric bolts through head, involuntary muscle contacting in face (both sides), Jittery, Eye twitching, headache. Ear pain. 3/12 -3/13/21 Face numbness got worse, left side started to droop. Muscle soreness in left arm, headache, tired. 3/14/21 ER visit to rule out Stroke. Diagnosed with Bells Palsey. 3/15-3/17/21 Left side of face still numb, pain/muscle spasms come and go. 3/18/21 Woke up with skin hypersensitive- feels like I have a severe sun burn from my neck to waist area, swollen glands, eye twitching, lips, tongue and throat swelled up. Severe jaw and ear pain, trouble breathing. Face still tingly/numb. Legs became extremely sore and heavy feeling, hard to walk. Called Dr- put on Prednisone (60mg and decreasing) and an anti-viral. 3/19/21 Same symptoms as previous day plus stomach area began to hurt/burning sensation- like all my organs were inflammed. Uncomfortable pain in my right side. Took first dose of meds this am. 3/20/21 Extreme jaw/ear pain, clenching feeling, loss of strength on the left side of my face Symptoms tapered off fir a few days, face numbness decreased and swelling seemed to improve. 3/25/21 Woke up with Skin burning again and glands in neck swollen. Called Dr- placed back on a higher dose of Predisone . At night, throat and tongue swelled up 3/26/21 Tongue and throat swelling, still facial tingling and numbness | | 8 | COVID19 (COVID19 (JANSSEN)) | 40-49 years | 0 days | 1149738-1 | Patient presented to Medical center with right sided MCA stroke (proximal M1) occlusion. She underwent tPA therapy and is recovering. She has a history of breast cancer that was treated in 2017. It?s unclear to us whether or not these events are related. However, given the thrombosis occurred on the same day as the vaccine was administered, we felt it was a reportable event | | 9 | COVID19 (COVID19 (JANSSEN)) | 40-49 years | 1 day | 1084789-1 | FEVER OVER 100, SEVERE HEADACHE, BODY ACHES, CHILLS, RIGORS, SHARP PAINS, CAUSED MY NERVE PAIN FROM THE STROKE TO BE VERY BAD, TINGLING ON MY AFFECTED SIDE, NAUSEA, DIZZINESS, DEHYDRATION, FATIGUE. I WAS GIVEN TYLENOL, IBUPROFEN, ZOFRAN, ATIVAN, AND 2 BAGS OF FLUIDS. | | 10 | COVID19 (COVID19 (JANSSEN)) | 40-49 years | 3 days | 1106846-1 | Was in his USOH until this morning whilst he was at work. He noticed that he was having difficulty finding his words and that he felt spaced out. Decided to schedule appointment see his PCP early afternoon. He was brought to the emergency room for further evaluation due to concern of an underlying stroke. On further questioning, he has a history of atrial fibrillation for which he has been on Cardizem. Not placed on any anti-platelet or anticoagulants. Does mention that he has a family history of this. Recently had the COVID-19 vaccine. Notes that he did have some body aches and fatigue. The symptoms cleared up by yesterday was went to work. He was feeling normal today until he began to develop the above symptoms. He denies any weakness today however he does recollect that last week, as he was walking the dog, he fell. He was able to get up unassisted. About a year ago in August, he had a similar episode of falling, came to the emergency room the following day and was found to be in atrial fibrillation with a rapid ventricular rate. States he has been diagnosed with atrial fibrillation since his early 20s. He is unaware of any history of hypertension. He states that he is on Cardizem for treatment of atrial fibrillation | | 11 | COVID19 (COVID19 (JANSSEN)) | 40-49 years | 3 days | 1201378-1 | Approximately three days after vaccine, I experienced a blood clot. This caused an acute ischemic stroke in my left frontal lobe, resulting in muscle weakness and partial loss of use in my right leg. | | 12 | COVID19 (COVID19 (JANSSEN)) | 40-49 years | 5 days | 1186290-1 | Stroke | | 13 | COVID19 (COVID19 (JANSSEN)) | 40-49 years | 15-30 days | 1170056-1 | The patient received the Janssen Covid 19 vaccine (lot 1805022) on 3/17/21. Today (4/5/21) the patient called to report several adverse reactions. She stated that she had body aches and chills the day after the vaccine. The aches went away but the patient reports that the chills in her hands, legs, and feet have persisted. The patient also said that she started to have facial paralysis on 4/3/21. Also on 4/3/21 she reported developing multiple skin rashes on different areas of the body. She also said she went to the ER and had multiple tests run, including an MRI to rule out stroke. She did report to her primary care doctor who advised her to see a Neurologist. I offered to reach out to her primary care but she did not provide the information. I advised the patient that she would need to seek care from a provider who could assess and treat her as needed. I called Janssen and they said the facial paralysis is a very rare possibility but did not have any additional information to provide me. They advised me to tell the patient to seek medical care as necessary. I spoke with the patient multiple times this evening and provided her with the information to VAERS and Vsafe. I also let her know that I contacted Janssen and gave her the information they gave me. I expressed to her that I understood that she was concerned and she could reach out to me if needed. I also will follow up with her later in the week. | | 14 | COVID19 (COVID19 (JANSSEN)) | 40-49 years | 15-30 days | 1202401-1 | Janssen COVID-19 Vaccine EUA: patient presents to emergency department with altered mental status and confusion three days after being discharged from a different hospital for COVID-19 infection. In emergency department diagnosed with stroke, left ventricular thrombus, subacute anterior myocardial inferction with totally occluded mid LAD, and COVID-19 infection. Underwent cardiac catheterization and transferred to current facility for higher level of care and testing- currently remains hospitalized on anticoagulation and oxygen. | | 15 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 0 days | 1092507-1 | Vax Clinic note: Approximately 10 minutes after receiving J&J vaccine c/o lips tingling and tongue feeling thick. Medicated with 10 MG cetirizine. VS o2Sat 97%, Pulse 84, BP 146/74. Pt states has had allergic reactions to IV contrast that involved tongue swelling. staets this feels similar but not as bad. o2Sat continues at 97%, Pulse 58, BP 128/68, pt trying to relax, c/o slight headache. Swellig has spread to her lips, and cheeks feeling heavy, O2Sat 97%, Pulse 75, medicated with 50mg benadryl. 911 called to transfer pt to ED for further eval. States throat is feeling tighter. And unable to swallow Epi given 11:18, daughter aware and will meet her at ED. BP 148/82, PUlse 75, O2Stat 97% swelling in tongue decreasing, throat n o longer tight, tongue still feels thick, has some hives between her eyes, and forehead. Pt transported via EMS to ED Intake ED note: 51 y.o. F here after getting J&J vaccine and 10 min. After she c/o her tongue feeling thick and lips tingling Pt given zertec Then 15 min later pt felt lips swelling and had hives around eyes and forehead Pt c/o difficulty swallowing and was rx'd with epi pen Pt has no stridor, or resp issues on arrival, able to speak in full sentences. Pt denies COVID sx 2nd ED note: Pt arrived to ED via EMS from community health center S/P Covid vaccination. About 15 minutes after receiving vaccine - felt nausea and smelled ""medicine"" followed with upper lip swelling and numbness to tongue associated with difficulty swallowing and redness to forehead. Pt alert and oriented at this time. Speaking in full sentence, drinking bottled water without any difficulty. No drooling noted. Denies SOB, chills or fever. Emergency Department Attending Attestation Note See resident/PA/student note for further details of HPI, history, exam, ED course, and diagnoses. Briefly, this is a 51 y.o. female with PMH reviewed in chart and w/ patient notable for insulin dependent diabetes, depression, prothrombin mutation, migraine, p/w concern for allergic reaction. Emesis or change in Covid vaccine today. 10 minutes after receiving the vaccine, patient reports feeling thick in her tongue with tingling in her lips. Patient was given Zertec. The minutes later, her lips began to swell up and was also noted to have new erythematous rash between her eyes and forehead. Patient was given 50 mg of Benadryl. Patient felt like she could not swallow with worsening lip swelling. She was given EpiPen and 911 was called. No stridors. No wheezing. Reports continued tingling and the numbness in her mouth but no lip swelling or tongue swelling. Denies any difficulty swallowing at this time. No wheezing. No abdominal pain or nausea. No rash at this time. Of note, patient also notes left-sided facial, arm, and leg numbness starting about 10 minutes prior to arrival to the emergency department. She reports that she has had recurrent numbness on the left side in the past, which was thought to be due to migraine versus TIA. She has had extensive work-up and multiple hospitalization for this symptom. She reports that she is allergic to iodine and gadolinium containing contrast. Denies any headache at this time though she had a mild headache after receiving the vaccine. Denies any blurry vision. Denies any weakness in her bilateral upper and lower extremities. Assessment and Plan: Vital signs notable for O2 sat of 96 to 98% on room air without tachypnea. Patient is mildly hypertensive. Patient is well-appearing speaking full sentences without any dysarthria. Pupils are equal and reactive to light. Extraocular movement intact. She notes diminished sensation to her left face, left upper extremity, and left lower extremity. Tongue is midline. Hearing is intact bilaterally. No facial droop. She has 5 out of 5 strength in bilateral upper and lower extremities. No pronator drift. Normal gait. No tongue swelling or lip swelling. No stridors. No uvula swelling. No pharyngeal or erythema. Lungs are clear to auscultation bilaterally without wheezing or rhonchi. Cardiac exam without murmurs rubs or gallops. Regular rhythm. No abdominal distention or tenderness on palpation. No CVA tenderness. 51-year-old female who is presenting to the emergency department with improving lip swelling and numbness in her mouth, raising a concern for anaphylaxis related to her Covid vaccine. Reassuringly, status post EpiPen, her symptoms are improving. However, she has new onset left-sided numbness, with without any headache. She reports that she has had this numbness in the past the last time she had the numbness on the left side was approximately 10 years ago. Her neurologic exam is only notable for diffuse numbness on her left side including her face. Differential diagnosis include migraine headache and TIA. Stroke is possible though less likely given the patient has had the same symptoms in the past with negative work-up. Will defer code stroke at this time but will emergently consult neurology. Will get labs including BMP and CBC. We will continue to monitor her from the anaphylaxis perspective. We will also give her a dose of steroid. Prednisone 60 mg by mouth given 12:29 PM NEUROLOGY CONSULT NOTE Assessment: Formulation- Diagnosis is guarded. Localization structurally would suggest subcortical (thalamic) or small brain-stem in a sensory territory on the right. Etiologies could be stroke given her vascular risk factors but seems unlikely given there is stereotypy of earlier symptomatology. Demyelinating would be another possibility as well, but again, the stereotype. Seizure unlikely because of the timing of rush from toes to body was minutes and duration of some occasions being days. Complicated migraine possible, has some risk factors, but should be treated as dx of exclusion. She does make complaint of headache, which could support. Some FND elaboration on her anxiety-ridden allergic reaction is also possible, but no objective non-structural signs to support."" | | 16 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 0 days | 1115152-1 | Approximately 10 hours after the injection (about 2 weeks prior to this ER visit) the patient started experience paresthesias of the right arm and face. Evaluation in the ER on today's date did not show objective findings of the paresthesias, nor identified cause, including evaluation for stroke. | | 17 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 0 days | 1138178-1 | I got a really bad migraine within 10 minutes and they transported you to the ER. I have had a Stroke in the past so migraines do scare me a bit. In the ER they gave me numerous medications and nothing worked, I was there for about 5 hours before they discharged me. When I got home I went straight to sleep and when I woke up in the morning I was feeling better. | | 18 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 1 day | 1085779-1 | Pt presented with AMS. History provided by father at bedside. For 2 days after vaccine pt reported not knowing what he was doing and where he was. Father brought him to ED after having breakfast together and son didn't know how to pay or what foods he liked. Was unable to recall his father's name. Treatment: DAPT with ASA and plavix x21 days and then transition to plavix 75mg daily, atorvastatin 80mg (stroke treatment) Outcome: TBD | | 19 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 1 day | 1108465-1 | Heart was in A-fib, blood clot formed and had a Left Posterior Parietal Stroke | | 20 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 1 day | 1127077-1 | pt presented to ER 0230 3-17-21 pt c/o right sided weakness and numbness, tried to get out of bed and use bathroom and couldn't bear weight or move his right leg. NIH stroke scale score-2, Glasgow coma score =15 183/105, HR 103, RR 18, 02 saturation 95% RA 98.7 oral temp 0/10 pain. clonidine po tablet 0.1mg. EKG=tachycardia 106 normal P waves, normal PRI, normal QRS complex, normal ST and T waves. labs=SARSCoV2 RNA negative, CT head WO=no acute intracranial abnormality by CT criteria. UA=negative, glucose 359 | | 21 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 2 days | 1154739-1 | Ischemic stroke right cerebellar, left thalamic | | 22 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 2 days | 1203360-1 | PATIENT CALLED Hospital 04-13-21 AND REPORTED HE HAD A STROKE 2 DAYS AFTER VACCINATION AND WENT TO another HOSPITAL. HE VERBALLY STATES IS HAVING PHYSICAL THERAPY FOR THIS STROKE. ENCOURGAED PATIENT TO SELF REPORT THIS EVENT. PATIETN WAS CALLING Due to THE TV NEWS NOTIFICATION OF THE J&J VACCINE PLACED ON HOLD DUE to IT CAUSING STROKES AND BLOOD CLOTS. PATIENT NOR DID HOSPITAL NOTIFY original HOSPITAL ON THIS PATIENT STROKE EVENT. | | 23 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 4 days | 1148591-1 | Was reported by the patients primary care provider that the patient experienced a stroke approximately 4 days post vaccination. | | 24 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 7 days | 1199143-1 | Headache and vomiting starting one week later (4/3/2021); seizure due to hemorrhagic stroke 04/ 5/2021; continued bleeds 04/06/2021, 04/07/2021; life support removed 04/08/2021. | | 25 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 7 days | 1201835-1 | Low grade fever, aches & chills on 3/13/21 & 3/14/21. Felt better 3/15/21 through 3/18/21. Side effects ( fever, aches, chills ) returned on 3/19/21 & 3/20/21. Suffered stroke on 3/21/21 at 3:30 AM due to blood clots. Passed away on 3/22/21. | | 26 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 7 days | 1202017-1 | Received vaccine on 3/9/21. Started experiencing facial numbness , difficulty with speech and swallowing on 3/16/21 around 11pm. Had facial drooping of the mouth and eye on my left side of face. Went to Hospital ER around 5:30 am on 3/17/21 as symptoms did not subside. I was later placed in stroke observation unit. I had 2 MRI's, CT scan and Echo tests ran. i was diagnosed with TIA. All test were negative for a cause. I sent a total of about 26 hours hospitalized. | | 27 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 8 days | 1202639-1 | Develop a blood clot lost vision in left eye due to stroke. I?m still in the hospital. I am 50 and had a stroke a week at getting that vaccine TPA shot. Given. Clot buster | | 28 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 10-14 days | 1182506-1 | 4/6/21 I awoke with symptoms of numbness/paralysis on left side of face limited to upper lip and cheek area and both eyes would not stop watering. Movements to drink or make facial expressions were limited due to the numbness. Because I have sensitive skin I thought I may have had some type of reaction to something. So I waited to see if it would clear up through the day. I was not experiencing any other symptoms. By that evening it was apparent that I was not getting better and possibly getting worse because I began to experience some noticeable drooping in my cheek area. I decided to call my doctor in the morning. Because I am currently out of town, my home doctor suggested I see a local ER to rule out a stroke and determine if I was experiencing Bell's Palsy. I went to an ER clinic on 4/7/21 | | 29 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 10-14 days | 1205309-1 | Got very dizzy, confused, could not speak. 911 was called and was transported to hospitol for stroke sysmptons | | 30 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 10-14 days | 1205684-1 | Blood Clot blocked oxygen to the brain. Suffered a severe stroke Was hospitalized Suffered brain swelling Lost brain function Died. | | 31 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 15-30 days | 1202607-1 | minor stroke 4/10/2021 | | 32 | COVID19 (COVID19 (JANSSEN)) | 50-59 years | 15-30 days | 1203802-1 | Janssen: Patient's son reports his mother woke up the morning of 4/7/2021 and c/o a severe headache and neck pain; around 10:45 a.m. patient collapsed and was taken to Hospital by paramedics and then later was airlifted due to a massive stroke. Patient remains hospitalized in the Neuro ICU. | | 33 | COVID19 (COVID19 (JANSSEN)) | 60-64 years | 0 days | 1091996-1 | 61 y.o. right handed male who the Program is consulted for possible stroke. Patient reports that he got his COVID vaccination (Johnson & Johnson) today (3/11/2021) at about 10:30 AM. While waiting after the vaccination, at about 11 AM he became dizzy and felt like he was ""loaded"" (""stoned from smoking weed"") and the started shaking ""as though he has a fever but without a fever."" and left side sensory loss which is non-disabling. He was taking to a CT scan which was negative for stroke and was discharged home."" | | 34 | COVID19 (COVID19 (JANSSEN)) | 60-64 years | 0 days | 1112109-1 | @1247 once client?s 15 minutes of observation was completed, she stood up to leave and felt dizzy. LPN assisted client to sit down and notified site managers. Client than reported feeling nauseated and dry heaved. RN and Site Supervisor and EMT arrived to | | 35 | COVID19 (COVID19 (JANSSEN)) | 60-64 years | 1 day | 1105301-1 | Within 12 hours I became to have severe muscle aches and joint aches. All my joint felt hot, it was bad enough I wasn't able to sleep. I took Ibuprofen to help sleep. I slept most of Friday I has extreme fatigue. On Saturday I has muscle weakness and tingly in my hands, the muscle aches have gone away. I couldn't knit ot fine motor skills, It bothered me. I woke up on Sunday where I had extremes muscle weakness in both my legs. I called my PCP, they were surprised by how the reaction was delayed. They wanted me to get a test for the strength in my legs and sent me to the ER. I wen to the Er they tested for stroke, blood work, scans, they were worried about Guillain Barre Syndrome. I stayed there about 5 hours. Yesterday afternoon the tingly went away from my hands but my legs are still kinda goofy. The muscle in my forearm and thigh feel like my muscle are really sore, like they have been tense | | 36 | COVID19 (COVID19 (JANSSEN)) | 60-64 years | 1 day | 1202570-1 | Good morning, I have the patient in the hospital. We have had to give her 2 transfusion in the last 2 weeks and 2 days. The patient also had a more pronounced stroke system. We read today that people with the systems of low platelets and stoke system need to report. I have called everyone and have had no help. I believe it has to be the health department. | | 37 | COVID19 (COVID19 (JANSSEN)) | 60-64 years | 3 days | 1091497-1 | 64 y.o. female who is consulted for possible stroke. Patient reports that she awoke this morning (3/10/2021) at about 4:30 PM with severe spinning dizziness. She reports associated nausea, diaphoresis, blurred vision and bilateral hand numbness and tingling. She denies speech or language problems or weakness. She reports she got a COVID vaccine (Johnson & Johnson) Sunday 93/7/2021) and felt a little ""woozy"" Monday (3/8/2021)."" | | 38 | COVID19 (COVID19 (JANSSEN)) | 60-64 years | 3 days | 1134651-1 | The patient had a hemorrhagic stroke approximately 3 days after receiving the vaccine and died. | | 39 | COVID19 (COVID19 (JANSSEN)) | 60-64 years | 6 days | 1139200-1 | Six days after receiving Janssen vaccine at approximately 4:00 pm, left hand experienced numbness. As the evening wore on, weakness spread through the left side of body and speech began slurring. The next day, after no improvement, went to hospital to find from CT scan that he had suffered a stroke. He had no precursors that would lead to being prone to strokes. | | 40 | COVID19 (COVID19 (JANSSEN)) | 60-64 years | 10-14 days | 1205627-1 | Janssen shot on Mar 12, 2021. On Mar 25,2021 at 10 AM, I woke up with a headache, sore joints, nausea. Also blurry vision and inability to read words on a page. Sensing something wrong, my sister drove me to emergency room at Hospital where I was admitted. I was later told I suffered a stroke. I was in the hospital for 5 days, receiving various tests. (Hospital has all info on record). I am awaiting surgery to remove blockage from carotid artery. Doctor has all my information and should be reporting the event also to VAERS. | | 41 | COVID19 (COVID19 (JANSSEN)) | 60-64 years | 15-30 days | 1198043-1 | Developed right facial droop in the hospital, lead to a new diagnosis of Bell's Palsy (MRI no evidence for stroke, CT no acute abnormality) She has Johnson and Johnson Vaccine and she is currently hospitalized after a fall at home | | 42 | COVID19 (COVID19 (JANSSEN)) | 60-64 years | 15-30 days | 1201532-1 | Numbness entire left side of body and face. Treatment for stroke | | 43 | COVID19 (COVID19 (JANSSEN)) | 60-64 years | 15-30 days | 1203326-1 | Stroke | | 44 | COVID19 (COVID19 (JANSSEN)) | 60-64 years | 15-30 days | 1206024-1 | stroke caused by 2 cerebral blood clots | | 45 | COVID19 (COVID19 (JANSSEN)) | 60-64 years | Unknown | 1168903-1 | RIB PAIN; VOMITING; HEADACHE; NAUSEA; INJECTION SITE PAIN; NIGHTMARES/VIVID DREAMS; FEELING COLD; FEELS AWFUL; INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; ARM PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included stroke, alcohol use 1-2 glasses per week, non smoker, depression, and sleeping problem. The patient experienced drug allergy when treated with povidone-iodine, and codeine for drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:30 in left arm for prophylactic vaccination. Concomitant medications included fluoxetine for depression, zolpidem for occasion sleeping problems, acetylsalicylic acid for stroke, and atorvastatin for stroke. On 12-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 12-MAR-2021, the subject experienced off label use. On 12-MAR-2021, the subject experienced arm pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021 18:30, the subject experienced feels awful. On 12-MAR-2021 19:00, the subject experienced feeling cold. On 13-MAR-2021, the subject experienced nightmares/vivid dreams. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares/vivid dreams, rib pain, vomiting, feels awful, feeling cold, arm pain, chills, fever, headache, nausea, injection site pain, and fatigue on 15-MAR-2021, and the outcome of off label use and inappropriate route of vaccine administration was not reported. This report was non-serious. Additional follow up information received on 26-Mar-2021.The following information was updated and incorporated into the case: age, medical history, demographics, concomitant medication, route of administration for suspect product, events (inappropriate route of vaccine administration and off label use) concomitant medications and outcome was updated.; Sender's Comments: V1: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious. | | 46 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 0 days | 1105748-1 | Thursday, March 11, 2021 (approximately 8:30 am) Patient experienced blurred vision, unbalance, and slurred speech and had an irregular heartbeat. March 11, 2021 (approximately 11:30 am) Patient was admitted to Hospital administered CT scan, MRI and multiple blood tests. Diagnosis - Ischemic Stroke | | 47 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 0 days | 1117550-1 | Stroke | | 48 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 0 days | 1200615-1 | Johnson and Johnson Covid-19 vaccine - patient had ischemic stroke approximately 4 hours after vaccination given and was admitted to hospital. | | 49 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 1 day | 1105572-1 | Initially had chills, fatigue for two days, then on 3/15 awoke with severe weakness in the right lower extremity. Presented to ER, MRI showed acute stroke ( Small acute infarction within the posterior left corona radiata). Admitted for stroke stabilization and rehab evaluation. Will be discharged to home with outpatient PT and OT | | 50 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 1 day | 1115946-1 | resident began to experience stroke like symptoms at approximately 0300, resident noted with slurred speech, left arm and leg flacid, facial drooping to left side of face. B/P 193/116. transferred to ER for evaluation | | 51 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 1 day | 1204548-1 | On 4/7/21 patient administered Janssen vaccine. On 4/8/21 at 7:00 am patient had stroke symptoms and advised to call 911 after conversation with AARP nurse hotline. Patient had difficult speaking and right side weakness. Transported via ambulance and admitted to hospital until discharge on 4/11 at 1:00 pm. Per patient diagnosis was Hypertensive Crisis, Acute Stroke with High suspicion for cardioembolic stroke. | | 52 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 2 days | 1202072-1 | PATIENT WOKE UP AT 12 AM THROWING UP BLOOD AND FEELINGS OF PASSING OUT, 911 WAS CALLED AND AMBULANCE TOOK HER TO HOSPITAL, WHERE THEY DETERMINED IT WAS A STROKE AND MOVED HER TO ANOTHER HOSPITAL, WHERE CURRENTLEY BEING TREATED DETERMINED BLOOD CLOT IN BRAIN. MOST LIKELEY DUE TO VACCINE SHOT. | | 53 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 3 days | 1116598-1 | Occipital stroke involving vision on 3/14/21, was seen at ophthalmologist and sent to Hospital and stroke confirmed on MRI. | | 54 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 3 days | 1132777-1 | They found her unconscious and rushed to ER and MRI showed mild stroke | | 55 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 3 days | 1171746-1 | Patient vaccinated by EMS on 3/29/21, EMS notified clinic that patient was taken to the Hospital for a stroke on 4/1/21 | | 56 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 4 days | 1126402-1 | on 3/22/2021 pt developed altered mental status, right sided weakness, right sided gaze, aphasic. Patient was administered 65 mg IVPB alteplase 3/22 1245 with last known well 3/22 1000. Received Covid vaccine 3/18/21. Pt was usual state of health prior to stroke with no illnesses. initial NIH score was 18. post tpa NIH of 12 am of 3/23. | | 57 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 4 days | 1155956-1 | not an adverse event, but we thought someone should know about this, as it was 3-4 days after he received his vaccine, that he had an embolic stroke | | 58 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 4 days | 1212390-1 | Within 4 days of the vaccine she became weak, nauseous, body pain and developed a fever. She was unable to get out of bed at all. One week after vaccine she suffered a stroke. | | 59 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 5 days | 1116053-1 | Exceptionally healthy Patient suffered a stroke within 5-6 days after receiving the J & J vaccine. | | 60 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 5 days | 1118691-1 | On Thursday, March 18, I had some slight dizziness during the day. After going to bed that night I woke up and the night light in the smoke alarm on the ceiling appeared to be spinning. I sat, then stood, grabbling walls for support and attempted to reach my recliner. At that point I was severely dizzy, completely lost any sense of balance and collapsed into the chair. I could not stand or walk. After 20 minutes, I asked my wife to call an ambulance. I did not think she would be able to get me into our car. The paramedics ran an EKG and tested me for a stroke. Both were normal. I was transported to the ER. The doctor gave me Meclizine. Had a CT scan of my brain, and blood work. All results normal. Dizziness resolved. They tested my balance and then released me at 3:30 a.m. on March 19. I was tired that day, but did not need further medication. During that night, as I turned over in bed, the vertigo returned. I took a Meclizine and went to the recliner for the remainder of the night. I am feeling somewhat fuzzy today, March 20. Not sure how long this will continue, or if it is related to my Covid vaccination. However, I am reporting it in the event that others may be experiencing this problem as well. | | 61 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 5 days | 1128150-1 | STROKE 4 days after | | 62 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 8 days | 1201907-1 | Had a stroke | | 63 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 10-14 days | 1198147-1 | pt with a history of eosinophilia treated with xeljanz 5 bid presented 9 days after covid vaccine with symptoms of acute LCMA ischemic stroke and was treated with tPA. | | 64 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 10-14 days | 1205282-1 | Patient had a stroke 11 days later(on 4/6/21) and expired | | 65 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 10-14 days | 1213138-1 | The day after vaccination had a terrible headache. Stroke on 4/6/21. Died on 4/11/21 | | 66 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 15-30 days | 1163599-1 | 4/2/2021 - pain in right arm starting at injection site. Over next 18 hours pain ran along arm to shoulder to upper back. Pain starts as sharp, then burning. Patient had difficulty sleeping. Started on ibuprofen (1000mg) at 8am on 4/3/2021 and heating pad. Pain dulled a bit. Additional info: on 3/27/2021 Patient woke up with a droopy eyelid that was diagnosed as Horner?s Syndrome on 3/31/2021 . Sent to ER at Hospital for MRI/MRA/CT, scans showed nothing conclusive - no evidence of stroke, aneurysm, clot, cancer, or anything pressing on optical nerve. Have followup with Dr at Hospital Neurology. Blood work ordered to check for evidence of other conditions that could deteriorate the myelin sheath. | | 67 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 15-30 days | 1201645-1 | PATIENT SUFFERED AN ISCHEMIC OCCIPITAL LOBE STROKE, CONFIRMED BY CT SCAN, ON 4/2/2021. PATIENT WAS TRANSFERRED TO AND ADDMITTED TO HOSPITAL. PATIENT WAS NOT ADMITTED TO THE ICU PER HIS WIFE. PATIENT WAS RECENTLY TRANSFERED TO REHAB WHERE IS HE IS CURRENTLY AS OF 4/13/2021. PATIENT LOST VISION IN LEFT EYE AS WELL AS FUNCTION IN HIS LEFT ARM PER THE PATIENTS WIFE. PATIENT IS REGAINING SIGHT AND STRENGTH IN BOTH HIS LEFT EYE AND ARM BUT PROGRESS IS SLOW, PER HIS WIFE. | | 68 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 15-30 days | 1204231-1 | Suffered from a stroke on 4/3/21 from a blood clot in his brain stem. Prior to vaccine he was healthy and 100% independent, still drove, did grocery shopping, yard work, etc. Now he cannot move his left side and was placed on hospice as he has lost his will to eat, drink, or live. | | 69 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 15-30 days | 1208082-1 | Pt had AFIB and was on ELIQUIS 2.5 mg BID. He began to bleed, a lot. We stopped DOAC, disussed possibility pt might die form blood clot without the DOAC. He had vaccine after stopping DOAC (stopped DOAC 2/24/21). On 3/8 he had the Janssen Vaccine. On 3/15 he awoke w weakness, inability to speak. Transferred to hospital where he was diagnosed w having major stroke, admitted to hospital. They decided NOT to use anticoagulant because he had too great a risk of bleeding. | | 70 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 15-30 days | 1211052-1 | My father received his shot on March 13, 2021. He drove to move home and on March 28th started having his right arm go numb but did not tell us. He asked to go the ER March 29th at 6:45am saying his chest hurt and was having a hard time breathing, this has happened before since having Covid in September. I called 911 after he became dizzy and could not walk. While at the ER suffered a massive stroke that paralyzed him from his nose down over a course of 3 days. His brain stem was affected and he lost the ability to swallow. After being on a ventilator for 72 hours he was removed from it and died less then 30 mins later from drowning in his own saliva on April 1, 2021. | | 71 | COVID19 (COVID19 (JANSSEN)) | 65+ years | 15-30 days | 1216240-1 | Massive stroke Death 4 Days later | | 72 | COVID19 (COVID19 (JANSSEN)) | 65+ years | Unknown | 1153102-1 | STROKE; This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, non alcoholic, and cigarette smoker (one pack per day). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose was not reported, administered on 03-MAR-2021,13:36 right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAR-2021, Patient experienced a stroke. Patient was sent to the ER. The patient was treated per stroke treatment guidelines, The patient was hospitalized for two days. The patient returned to hospital a week later. Professionals at the hospital found reason for blood loss, but could not find reason for the stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke on 06-MAR-2021. The reporter causality assessment for stroke was not related. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20210340063-Covid-19 vaccine ad26.cov2.s-Stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY | | 73 | COVID19 (COVID19 (JANSSEN)) | 65+ years | Unknown | 1161955-1 | ARRHYTHMIA; COMPLEX MIGRAINE; BP BOUNCING HIGH AND LOW; TROUBLE MOVING LEGS AND NO STRENGTH; TIRED; EXTREMELY WEAK; TEMPERATURE ELEVATED; ELEVATED BLOOD PRESSURE; TROUBLE WITH ARM HARDLY USE ARM; GROIN PAIN; MUSCLE ACHE; COULDN'T SLEEP; UNABLE TO WALK; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's past medical history included bulbar polio diagnosed at age 15, and concurrent conditions included seasonal allergy, non-smoker, and high blood pressure. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at right arm. No concomitant medications were reported. On 12-MAR-2021, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) NEGATIVE. On 13-MAR-2021, the patient experienced temperature elevated. On 14-MAR-2021 (Sunday) and 15-MAR-2021 (Monday), she felt bad and had elevated blood pressure (BP) and temperature. On 16-MAR-2021 (Tuesday), she felt lot better but by afternoon, she experienced loss of sight in right saw round circle with black triangle and her BP was 130/111 (77- heart rate (HR)). She developed arrhythmias. Her daughter and husband took her to the hospital. The hospital staff was concern about stroke. Her magnetic resonance imaging (MRI) and two computerized axial tomography (CAT) scans, one with iodine was performed and confirmed that she did not had stroke. Her BP was bouncing around high and low. She had trouble in moving legs were not working no strength. At one point her heavy muscle couldn't move. She reported that her BP was erratic, she was conscious but not mentally functioning, which was hard to explain. She was sent back to do scan with iodine, as health care professional was concern with blockage. Later, her MRI was performed. She started getting better and on the same day she was released from hospital after about 7 -8 hours. After coming home, she felt tired. She was diagnosed with complex migraine. On 26-MAR-2021, she started having trouble with arm and leg and she could not sleep. On 27-MAR-2021, her last muscle ache. Her BP elevated again and can hardly use her right arm. On 28-MAR-2021, her left leg was not in shape, trouble using right arm, groin area muscle is giving out with sharp pains. Treatment medications (dates unspecified) included: amlodipine, acetylsalicylic acid, and metoprolol. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arrhythmia on 16-MAR-2021, and temperature elevated, and unable to walk, had not recovered from elevated blood pressure, trouble moving legs and no strength, complex migraine, muscle ache, groin pain, and BP bouncing high and low, and the outcome of extremely weak, trouble with arm hardly use arm, tired and couldn't sleep was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arrhythmia, Complex migraine, Temperature elevated, Trouble moving legs and no strength, Tired. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Elevated Blood pressure, BP bouncing high and low. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY of High blood pressure. V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Extremely Weak. This event(s) is labeled and is therefore considered potentially related. | | 74 | COVID19 (COVID19 (JANSSEN)) | 65+ years | Unknown | 1177862-1 | HIVES ON EAR AND HEAD; FEVER; This spontaneous report received from a consumer concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke, and heart problems, and concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced hives on ear and head. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives on ear and head on 28-MAR-2021, and fever on 27-MAR-2021. This report was non-serious. | | 75 | COVID19 (COVID19 (JANSSEN)) | Unknown | 0 days | 1176567-1 | TIRED; SORE ARM; FELT LIKE A BIG PIECE OF LEAD GOING IN WHEN VACCINE WAS INJECTED FOR ABOUT 15 MINUTES; This spontaneous report received from a patient concerned an 80 year old female patient. The patient's height, and weight were not reported. The patient's past medical history included previous diphtheria infection during childhood, and 2 episodes of potential mini-stroke, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1803070, expiry: UNKNOWN) 1 total dose, administered on 22-MAR-2021 at 13:30 in left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced sore arm. On 22-MAR-2021, the subject experienced felt like a big piece of lead going in when vaccine was injected for about 15 minutes. On 23-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and tired on 24-MAR-2021, and felt like a big piece of lead going in when vaccine was injected for about 15 minutes on 22-MAR-2021. This report was non-serious. | | 76 | COVID19 (COVID19 (JANSSEN)) | Unknown | Over 120 days | 1147809-1 | We have a patient that received his Janssen vaccination 3/29/21 at 2016 hours. He had no complaints during the remainder of his dialysis. He left without problems. His wife called the unit around 0700 this morning. RN answered the phone and the wife stated that the patient woke up not being able to speak. He was out of sorts and that he had difficulty breathing. Nurse told the wife to call ambulance in case of possible stroke. The wife verbalized understanding. Ongoing discovery. | | 77 | COVID19 (COVID19 (JANSSEN)) | Unknown | Unknown | 1153081-1 | STROKE; ALWAYS RINGING IN THE EARS; This spontaneous report received from a patient concerned an 87 year old female. The patient's weight was 153 pounds, and height was 67 inches. The patient's past medical history included strokes but the last one was a long time ago. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter state that, the patient was taking two vaccine shots and was halfway between the two vaccines (2 weeks) second one would be on 29-MAR-2021. On 09-Mar-2021, the patient experienced TIA symptoms (feeling fuzzy, batch of color lights in her left eye, very slurred speech, difficulty understanding and difficulty in communication) and stated she was having a stroke. Patient also informed that she already had this a lot of time before, and her doctor told her to lay down, take an aspirin. Treatment medications (dates unspecified) included: acetylsalicylic acid. On 2021, the subject experienced always ringing in the ears. The reporter stated that, the patient had severe hearing impairment as patient continuously complained that her ears were ""always ringing an patient was unable to answer all the questions as she stated that she had to go for some physical therapy exercise and could not continue the discussion. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The patient had not recovered from stroke, and the outcome of always ringing in the ears was not reported. This report was serious (Other Medically Important Condition). Additional information was received on 18-Mar-2021. The following information was updated and incorporated into the narrative: The patient's demographics details (age and age group),event (Always ringing in the ears), reporter address details and other reference number.; Sender's Comments: V1: The following information updates addition of event (always ringing in the ears), patient's demographics details (age and age group), reporter details and other reference number. This updated information does not alter prior causality assessment of reported event. 20210316871-Covid-19 vaccine ad26.cov2.s-Stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY"" | | 78 | COVID19 (COVID19 (JANSSEN)) | Unknown | Unknown | 1153892-1 | BLIND; STROKE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose and therapy start date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in MAR-2021 (reported as last week), the patient had a stroke and made her blind. There was no other information known about the patient or vaccine administration site. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blind and stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210333599- Covid-19 vaccine ad26.cov2.s-Blind, Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). | | 79 | COVID19 (COVID19 (JANSSEN)) | Unknown | Unknown | 1157499-1 | BELL'S PALSY EXACERBATED; TINGLING IN PALMS OF HANDS; HOT IN PALMS; PAIN IN BETWEEN SHOULDER BLADES; EXTREME WEAKNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included bells palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination on right arm. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 19-MAR-2021, the patient stated that she experienced extreme weakness and pain in between shoulder blades within 48 hours of vaccination and ambulance took her to the emergency room where she got tested for stroke but confirmed bell's palsy diagnosis. She has bell's palsy seven years ago and it was reported that vaccine seemed to exacerbated the condition. Patient also experienced tingling and hotness in palms of hands within 48 hours of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme weakness, and had not recovered from bell's palsy exacerbated, pain in between shoulder blades, tingling in palms of hands, and hotness in palms of hands. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 23/Mar/2021. Upon review, the following information was amended: Age group updated as unknown, Reporter causality updated as possible, narrative updated.; Sender's Comments: V1: Version created to amend age group, reporter causality and narrative. This updated information does not alter the causality of previously reported event. 20210345589-Covid-19 vaccine ad26.cov2.s-Bell's palsy exacerbated. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE | | 80 | COVID19 (COVID19 (JANSSEN)) | Unknown | Unknown | 1157526-1 | STROKE AS A RESULT OF RECEIVING THE J&J VACCINE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received JNJ78436735 (Ad26.COV2.S) (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination at unknown site. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced stroke as a result of receiving the j&j vaccine. The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The outcome of stroke as a result of receiving the j&j vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210353970 - COVID-19 VACCINE AD26.COV2.S - Stroke. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. | | 81 | COVID19 (COVID19 (JANSSEN)) | Unknown | Unknown | 1161937-1 | SEIZURE; FLU LIKE SYMPTOMS (CHILLS, HIGH TEMPERATURE, FEELS HOT,STUFFY NOSE); This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. No concomitant medications were reported. On MAR-2021,On an unspecified date, the patient experienced seizure, shaking, chills, high temperature, feels hot, and stuffy nose. patient daughter report she was suffering from seizure symptoms include extremely stiff ,extreme dizziness, shaking, and eyes rolling in back of head, also reported her mother did not lost consciousness and has been coherent .Daughter stated symptoms seem almost like a stroke ,upon follow call she clarify about seizure which is subsided. seizure occurred 3 times over past 5 days prior to call (first night of vaccine, next morning, and reporting day.) Daughter also reported mother had flu-like symptoms for the first 3 days after vaccine, including chills, high temperature, feels hot, and stuffy nose, but these have resolved. Daughter reports mother has not had symptoms like these prior to vaccine. she also report pharmacist who gave vaccine is aware of symptoms. patient body temperature was high, patient not performed covid 19 test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms ( chills, high temperature, feels hot ,stuffy nose.), and the outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0: 20210322863-Covid-19 Vaccine Ad26.Cov2.S-Seizure. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. | | 82 | COVID19 (COVID19 (JANSSEN)) | Unknown | Unknown | 1161947-1 | STROKE; BLINDNESS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested On MAR-2021, the subject experienced stroke. On MAR-2021, the subject experienced blindness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and blindness was not reported. The reporter did not report causality between covid-19 vaccine ad26.cov2.s and stroke ,blindness .Company causality between covid-19 vaccine ad26.cov2.s and stroke and blindness was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210331088-Covid-19 vaccine ad26.cov2.s-Stroke , Blindness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). | | 83 | COVID19 (COVID19 (JANSSEN)) | Unknown | Unknown | 1182377-1 | RED SPOT ON INJECTION SITE; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 150 pounds, and height was 167.64 centimeters. The patient's concurrent conditions included non smoker, wine-one glass with dinner, and short term memory stroke, and other pre-existing medical conditions included the patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on right arm with 2"" length of needle on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included apixaban for due to stroke. On 14-MAR-2021, the subject experienced red spot on injection site. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red spot on injection site on 15-MAR-2021. This report was non-serious."" | | 84 | COVID19 (COVID19 (JANSSEN)) | Unknown | Unknown | 1203033-1 | STROKE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The reporter obtained the information from news/media. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210414698- Covid-19 vaccine ad26.cov2.s -Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). | | 85 | COVID19 (COVID19 (MODERNA)) | 18-29 years | 0 days | 1017076-1 | Paralyzed on the right side down to her foot; Numbness in her hands and feet; Slurred speech; Felt really heavy in her face area, hurt really bad; Shooting pain; Feels tingly; Felt really heavy in her neck, hurt really bad; unable to walk; A spontaneous report was received from a consumer who was also a 25-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings. The patient's medical history was not provided. Concomitant product use was not provided. On 21 Jan 2021, approximately two hours prior to the start of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. Approximately two hours after receiving the vaccine at 12:30 pm, the patient experienced heavy feeling in her neck and face area that hurt really bad. Later, she noticed numbness in her hands and feet. Slurred speech was reported from a bystander. By 3:30pm, the patient was completely paralyzed on her right side. She was taken to the hospital, and a code stroke was initiated; however, all labs were normal. On 26 Jan 2021, the patient was still paralyzed on her right side, unable to walk, had shooting pain feeling, and two fingers on her right hand were able to move but still felt tingly. The doctors planned to discharge her on the next day to a rehab center because she could not function alone. Treatment for the event included pain medication and hospitalization. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, developed heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly, unable to walk and shooting pain feelings were considered unknown.; Reporter's Comments: A spontaneous report concerns a 25-year-old, female, patient, who experienced heaviness in her face and neck, numbness in hands and feet, slurred speech, completely paralyzed on her right side, right fingers tingly and shooting pain feelings. The events of heavy feeling in her neck and face area, numbness in her hands and feet, slurred speech, completely paralyzed on her right side occurred on the same day after the administration of the first dose of mRNA-1273 (Lot number 032L20A, expiration date unknown). The events of inability to walk, had shooting pain feeling and two fingers on her right hand were able to move but still felt tingly occurred the following day after the vaccine administration. Treatment included pain medication and outcome is unknown. Based on the information provided, which indicates a strong temporal association between the reported events and administration of mRNA-1273 vaccine (onset latency of 2 hours), a causal association cannot be excluded. | | 86 | COVID19 (COVID19 (MODERNA)) | 18-29 years | 0 days | 1049231-1 | Patient assessed via virtual visit on 2/21 Got 2nd dose of Moderna vaccine on 2/20. On way home was having tongue swelling. Sharp CP radiating to diaphragm and throat swelling since last night. +wheezing. Walking from bed to bathroom gets SOB SOB gradually worsened as time passed Dizziness since difficulty breathing paresthesia in hands diaphoresis - pt attributes to fever/chills she has been getting since having the vaccine Denies n/v, abdominal pain, syncope Dyspnea, oral swelling, CP began s/p Moderna vaccine 2 of 2 and gradually worsening Advised ER via ambulance. Pt prefers to wait for her dad to take her to the ER Counseled pt on risk of death due to airway cut off due to worsening sx: bronchial inflammation/throat swelling or decreased oxygen to heart/brain with dizziness (MI/stroke). Advised tools EMS would be able to administer life saving medications to support her in these emergent situations and quickly get pt to ER vs having her die in car with dad bearing guilt of losing daughter. Pt expresses understanding, will wait for her dad. Suggested pt have a code word to say so if things getting worse her dad pulls over to call 911. Pt agreeable. | | 87 | COVID19 (COVID19 (MODERNA)) | 18-29 years | 0 days | 1122253-1 | Stroke (blood clot in vein in left side of brain), occurred Wednesday March 17 at 5:15 pm. Immediately admitted to emergency room/stroke unit and given blood thinner IV and anti-seizure medicine | | 88 | COVID19 (COVID19 (MODERNA)) | 18-29 years | 5 days | 1109302-1 | Swollen lymph nodes under both arms, urgent care, referred to ultrasound tech, mammogram, referred to general surgeon (awaiting appointment). Lymph nodes stayed swollen after first dose, got worse after second dose, and have been swollen since. Swollen lymph nodes in neck, hard to breathe, went to hospital, told it was just the vaccine and to wait it out. Lymph nodes in neck went down in swelling after 2-3 days. Irregular menstrual cycle, started approximately 2 weeks after first dose. Have had a menstrual cycle for 5 days every 9-12 days since first dose. Hospitalized for stroke-like symptoms (lost vision, couldn't form sentences) on 5 Feb 21. Discharged after CT scan and MRI came back fine. | | 89 | COVID19 (COVID19 (MODERNA)) | 18-29 years | 15-30 days | 1023668-1 | Headache started on 1/26. Woke up from a nap on 1/30 at 1:30pm and was having difficulty with speech. I could not say the words I wanted to and words that I could get out sounded very slurry. I went to the Emergency Room where I was stroke-activated. I was admitted to the hospital 1/30 and discharged 1/31. | | 90 | COVID19 (COVID19 (MODERNA)) | 30-39 years | 0 days | 0922174-1 | About 5-10 minutes later patient began to have metallic taste in her mouth. She began to feel warm. Also began to feel some burning in her upper chest. Patient denies any swelling in her throat. She denied any difficulty swallowing or breathing. Patient does have history of a mini stroke in the past. Patient states since then she is become hypersensitive to phalanx. She denies any known allergies. She denies any allergies to any injectables or any vaccines. No known food allergies. No medication allergies. Patient denies any known history of panic attacks. Patient was questioning if this may be a panic attack. | | 91 | COVID19 (COVID19 (MODERNA)) | 30-39 years | 0 days | 0928240-1 | Less than 5 minutes after vaccine, nose drained, weird taste in mouth, tingle in nose and on tongue. Throat and tongue swelled, couldn?t speak. Dizzy and slurring speech. Was taken to ambulance outside, BP was 191/101. Given beta blockade. Confused and dizzy for next 2 hours in ER. Evaluated for stroke and given a 12-lead ECG. Given benedryl and prednisone. Felt better after 3 1/2 hours. Continued steroids for 5 days and had to take benedryl every 4 hours for 3 days or swelling/itching/bad taste in mouth would return. Sore arm on day 3. | | 92 | COVID19 (COVID19 (MODERNA)) | 30-39 years | 0 days | 0952489-1 | Patient is 39-year-old male with no significant past medical history who works at long-term care facility. He received COVID-19 vaccine on 1/13/2021 and immediately developed numbness and tingling in the area of injection which was the left shoulder. Over the next 15 to 30 minutes numbness and tingling expanded to the left side of his body including face arm and leg and the left side of his trunk. He began to feel foggy and had some slurred speech. He presented to the Emergency Room and tests were performed to rule out a stroke. The patient denies any other symptoms such as fever chills myalgias. He did not have any weakness of the extremities. He did not have any speech disturbances or visual disturbances. This morning on examination he states his symptoms are much better. He still has some residual numbness in his leg and arm. Facial numbness is almost all gone. As of 1/18/2021, residual numbness and tingling is only in his left ring and pinky finger. | | 93 | COVID19 (COVID19 (MODERNA)) | 30-39 years | 0 days | 1062336-1 | 200/100 high blood pressure; stammering problems; uncontrolled shaking at my right hand; cold feet; dry mouth; Headaches; body aches; A spontaneous report was received from a 31-year old, female patient who experienced headaches, body aches, dry mouth, cold feet, uncontrolled shaking in right hand, stammering problems, and 200/100 high blood pressure. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided). On 21 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 028L20A) for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient was taken to the emergency room (ER) approximately four hours after receiving the second dose of the Moderna COVID vaccine. She was experiencing headaches, body aches, dry mouth, cold feet, uncontrollable shaking in her right hand, speech impairment, and her blood pressure was 200/100. The patient tested negative for all stroke tests performed in the ER.. The patient reported she received a medication that ""knocked me out"" and relieved the symptoms. Treatment information was not provided. On 23 Jan 2021, the patient still had shaking and stammering problems. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events headaches, body aches, dry mouth, cold feet, and 200/100 high blood pressure were unknown. The outcome of events uncontrolled shaking in right hand and stammering problems were not recovered/ not resolved. Follow up: Follow-up received on 29 Jan 2021 included the patient's report that her adverse events have been sustained and not improved. On 27 Jan 2021, the patient received an MRI that showed brain lesions existed as diagnosed by a neurologist.; Reporter's Comments: The follow-up received reports that on 27Jan 2021, the patient received an MRI that showed brain lesions existed as diagnosed by a neurologist. Based on this information, the event of hypertensive crisis, dysphemia, tremors, is assessed as unlikely related to mRNA-1273."" | | 94 | COVID19 (COVID19 (MODERNA)) | 30-39 years | 0 days | 1097867-1 | Headache, nausea, and vomiting starting about 2 hours after vaccine and got worse overnight. Patient reported intractable vomiting the next morning an feeling week so she called EMS in the evening. She developed sudden onset of right lower extremity paralysis and numbness. In ED, stroke was called and Alteplase was given on 3/13/21 | | 95 | COVID19 (COVID19 (MODERNA)) | 30-39 years | 1 day | 0914521-1 | Patient presents with ? Altered Mental Status ? Headache ß ß HPI Patient presents to ER by EMS ambulance after family called 911 as patient was incomprehensible with slurred speech and moaning on the phone this evening. On arrival of EMS patient was asleep in bed and reportedly unresponsive other that to localize to pain. EMS transferred patient to ER. On arrival to ER patient had GCS 7. Reportedly patient is locum nurse who works in a Nursing Home and patient reportedly received COVID vaccination 2 days ago and that night reportedly began complaining to family on the phone of headache, nasal congestion, sore throat, cough, fever, chills, nausea, emesis, myalgias, and lethargy. Per the medical record patient has history of seizures, migraines, and sciatica. No other information is known on patient arrival to ER. 1. Peripheral IV right dorsal hand placed by EMS in route to ER. 2. On arrival to ER GCS 7 (E1M5V1) and roving eye movements with episodic lateral conjugate and at times disconjugate gaze concerning for seizure activity. Arms and legs with moderately increased tone but no clonic movements and patient able to localize bilaterally. 3. Ativan 1 mg IVP for seizure, then further 2 mg IVP for persistent seizure. 4. Fosphenytoin 1,000 mg IVPB in ER for loading dose of antiseizure medication. 5. Patient had significant improvement following completion of Ativan 3 mg IVP and GCS improved to 14 (E3M6V5) from GCS of 7 (E1M5V1). 6. Patient able to communicate after improvement as above and reports she has had headache or migraine for past several days as well as dysuria with bilateral CVA pain and has significant pain on percussion of bilateral CVA and moderate pain on palpation of bilateral flanks. No nuchal rigidity or pain with ROM of neck. Additionally, she complains of severe headache and diffuse pain of back and abdomen/pelvis. She reports a history of seizures in the past and reports she had one last month and was treated at a hospital in her home state. She denies antiseizure medications. Additionally, patient reports nonproductive cough, sore throat, nasal congestion, fever, chills, myalgias, lethargy, nausea, and episodic emesis over the past 2 days. She has anterograde amnesia following seizure and does not recall events. 7. Normal saline 1,000 mL IV bolus, then 100 mL/hour in ER. 8. CT of head with and without contrast performed and negative for intracranial hemorrhage, lesions, stroke, or other acute pathology. 9. CT of chest/abdomen/pelvis with IV contrast shows no acute pathology or notable abnormalities. 10. Lactic acid drawn and normal. 11. UA and urine microscopy collected by straight catheterization and culture collected and pending. 12. Blood cultures x 2 collected and pending. 12. Rocephin 2 mg IVPB in ER after blood cultures collected. 13. Vancomycin 20 mg/kg (1,500 mg) IVPB following Rocephin. 14. Dexamethasone 10 mg IVP in ER. 15. Duoneb nebulizer in ER. 16. Called to discuss with patient's daughter and the family's preferred contact who is 23 years old. She reports patient had COVID vaccination 2 days ago and beginning that night patient has complained of headache, fever, chills, nonproductive cough, sore throat, nasal congestion, myalgias, and lethargy. Additionally, she reports patient has history of seizures on at least 1 occasion in the past a few months ago but is not on antiseizure medications. She reports patient had MRI and MRA of her brain at that time and reportedly and intracranial aneurysm was identified at that time. 17. Called to request transfer to another facility and spoke with hospitalist who states there is no neurologist there and suggests transfer to larger tertiary care facility with neurology. 18. Called to request transfer and accepted by ER provider. 19. Transfer by ALS ground ambulance with telemetry, pulse oximetry, O2 to keep > 02%, vitals every 30 minutes, normal saline at 100 mL/hour, Rocephin 2 grams IVPB, vancomycin 20 mg/kg (1,500 mg) IVPB in ER. ß DISPOSITION Patient Stabilized and Transferred Data Unavailable Wed Dec 30, 2020 2:12 AM CST | | 96 | COVID19 (COVID19 (MODERNA)) | 30-39 years | 1 day | 1061906-1 | Atrial fibrillation; Hard to breathe; A spontaneous report was received from a consumer (patient's wife), regarding a 37 years-old white male patient, unknown ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, atrial fibrillation, uncomfortable (discomfort), and hard to breathe (dyspnoea). Current medical conditions reported as controlled atrial fibrillation and cardiomyopathy. Past medical history includes atrial fibrillation diagnosis (May 2018) and stroke (May2018/hospitalized). Weight reported as 180 lbs.The patient's medication allergy included albuterol inhaler. Concomitant medications reported included are rivaroxaban, levetiracetam, bisoprolol and flecainide. On 15 JAN 2021, one day prior to the onset of events, the patient received their first of planned doses of mRNA-1273 (batch number: 029L20A), at a dose of 0.5 ml, intramuscular in the left arm for the prophylaxis of COVID-19 infection. The consumer reported that the patient became uncomfortable and it was hard to breathe on 16 JAN 2021. On 17 JAN 2021, in the morning, the patient went into atrial fibrillation. The patient received treatment medication with a double dose of flecainide and went back into normal sinus rhythm about 2 hours later. On 18 JAN 2021, in the morning, the patient had a second occurrence of atrial fibrillation, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. On 21 JAN 2021, the patient again developed atrial fibrillation third occurrence, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. On 27 JAN 2021, the patient had a fourth occurrence of atrial fibrillation, for which he received treatment with a double dose of flecainide and went back into normal sinus rhythm. These adverse events were reported to his physician. The consumer stated that she can be further contacted if the safety department follows up for any additional information. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of the events, atrial fibrillation, uncomfortable, and hard to breathe, were reported as not recovered.; Reporter's Comments: Very limited information regarding this event has been provided at this time. The patient's medical history of atrial fibrillation and cardiomyopathy remains a confounding factor. Further information has been requested. | | 97 | COVID19 (COVID19 (MODERNA)) | 30-39 years | 2 days | 0968026-1 | Patient states he started having sudden onset of left facial droop, left-sided arm and leg 15 minutes prior to arrival on 1/23 while driving. Pt got the Moderna vaccine second dose 2 days ago (1/21). Patient denies any history of stroke, DVT, PE. tPA was administered. Found to have clot in the Right MCA territory and taken for mechanical thrombectomy to remove the clot. Patient remains hospitalized and further workup is going. | | 98 | COVID19 (COVID19 (MODERNA)) | 30-39 years | 3 days | 1089100-1 | Woke up on Friday morning (3/5) with severe neck pain and vertigo. Tried to walk to bathroom and was falling over to the right side and felt very nauseous. Starting throwing up. Arrived at ER around9:30AM and was diagnosed with vertigo and discharged a few hours later. He slept most of the day but woke up for a few minutes to take medicine on Friday evening and told me his vision was blurry. He went back to sleep and slept until Saturday (3/6) morning around 9:30. He told me his vision was still really blurry so we went back to the ER. They did an MRI and MRA and saw that he had two strokes. The strokes have affected his vision and he still has blurry vision and is not able to see well peripherally. | | 99 | COVID19 (COVID19 (MODERNA)) | 30-39 years | 15-30 days | 1033056-1 | Patient developed sudden onset vertigo with recurrent vomiting. He was brought to the emergency department and was evaluated under the stroke protocol and underwent CT, CTA, and MRI of the brain which did not reveal an etiology of his symptoms. He had a neurology consultation and the most likely cause was thought to be vestibular neuritis on the left side. He was treated with Zofran, Reglan, Meclizine, IV fluids, and Valium with partial relief and was discharged home with outpatient follow-up. Symptoms are unresolved at the time of this report. | | 100 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 0 days | 0941476-1 | Patient received vaccine in afternoon of 12/28. She works in ER as housekeeper 7pm-7am. The day she received the vaccine she became ill with fever chills and nausea and left work at 2am. On 12/31 she developed hemianopia. She went to ER and they did CT scan. She was told it was complex migraine. She left and came Home. On 1/1/21 her vision was back to normal. On 1/3 she suffered bilateral cerebellum ischemic stroke. She is currently in medical center. In Trauma. | | 101 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 0 days | 0948410-1 | This facility staff member received her first dose of the MODERNA COVID-19 vaccine (Lot037K20A/EXP 6/22/21) at clinic at approximately 9:15AM on 1/14/21. She initially answered ""no"" to any allergies on the VAR but revealed to the pharmacist reviewing the VAR that she had experienced an allergy to food and contrast dye that required an epi-pen and hospital attention. She did not offer additional details and explained that she had tolerated other shots (including the 2020 flu shot) without incident. I advised patient to remain for a 30 minute monitoring period post-vaccination due to history of allergic reaction. Patient presented with some anxiety before the shot and immediately started to complain of feeling ""sick"" and said she was having trouble breathing due to chest pressure. We advised patient to remove her mask and provided her with water and a trash can though no vomiting occurred. After 15-20 minutes, patient still complained of chest pressure and difficulty breathing. When asked if she was experiencing any itchiness or throat swelling, patient said she did feel some throat swelling so she was given 25MG of Benadryl. After an additional 15 minutes, patient's condition seemed unchanged (not worsening, not improving) so the facility's nursing team was called to evaluate patient. Patient said she was still experiencing difficulty breathing and throat swelling so nursing advised use of EPI-PEN and patient consented. I administered a dose of 0.3MG (LOT0FM4066/EXP 02/2022) to the right lateral thigh and nurse called for EMS. Immediately after injection, patient's eyes fluttered and she seemed to be on the verge of fainting. Nursing checked her oxygen saturation which was 100%. Patient reported no improvement after 5 minutes so another EPI-PEN 0.3MG was administered to the left lateral thigh. Nursing also gave the patient 81MG chewable aspirin due to the patient experiencing a stroke last month. EMS arrived a few minutes after the second EPI-PEN dose and patient was transported to the hospital for evaluation. Facility reported that patient went home that afternoon but did not provide details. Based on my assessment of patient's symptoms and behavior, I feel it is likely that she experienced either an acute panic attack or anaphylaxis due to vaccine administration. I called the patient today (the day after the incident) and she confirms that she received treatment for an anaphylactic reaction to the Moderna COVID shot and is doing well without any lasting adverse effects."" | | 102 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 0 days | 0958921-1 | This may be a duplicate report, as primary care notes state the process has been initiated. However, out of an abundance of caution, and as the facility the event was reported to, I wanted to enter this report for completeness due to the unusual events. Patient received 1st dose of moderna covid vaccine at an outside facility and (per patient) had a seizure at that site immediately following the injection (history of seizures due to past meningitis, no seizures in past 3 months per patient). No medications were given, 911 was not called, patient not instructed to go to ED (per patient). Patient went home. Once home, patient reported ""stroke like symptoms"" on her right side (weakness and inability to close right eye for 30 minutes, numbness in R thigh and heel). Then weakness moved to left side (numbness/tingling in L hand and eye, numbness in L lower leg) along with some swelling to face/tongue. Had back pain but no chest pain or difficulty breathing. Extreme dizziness. No additional seizures. The next day she called our nursing line to report these symptoms and was instructed to go to the ED and also scheduled a visit with primary care provider the next morning. Patient stated she was feeling better and apparently did not go to the ED, instead choosing to see PCP next morning. On presentation to PCP, injection site was red and swollen, itching and swelling in hands, itching in bottom of feet, widespread joint pain. No visible rash, no dysphagia, no difficulty breathing. Other symptoms had largely resolved. Patient was prescribed benadryl (no steroids due to allergy to prednisone), cold compresses for injection site and sent home with instructions to go to ED if symptoms reappeared. Also recommended making an appointment with a neurologist for additional follow up as patient currently does not see a neurologist for seizures and is treating with CBD/THC only."" | | 103 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 0 days | 1030023-1 | couldn't move her face and all the left side of her body/ Drooping Face/ Bell's Palsy; couldn't move her face and all the left side of her body; palm went numb; hip pain; lower leg pain; heart racing; really low blood pressure; arm was itching, her whole body was itching; Tongue and roof of the mouth numb; really bad headache; rash on both arms; nausea; vomiting; freezing; chills; Severe allergic reaction/Allergic symptoms; diarrhea; low grade fever; A spontaneous report was received from a healthcare professional who is a 43-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, arm pain, arm itched, whole body itching, rash on both arms, nausea, really bad headache, vomiting, freezing, low blood pressure, hip pain and lower leg pain and a bad headache. The patient's medical history included helicobacter pylori, two cervical spinal fusions, allergies to shellfish, strawberry leaves and dust. No concomitant product use was reported. On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-A) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) in the right arm intramuscularly for prophylaxis of COVID-19 infection. On 26 Dec 2020, approximately 20 minutes after receiving the Moderna COVID-19 vaccine, the patient reported she experienced a headache, body aches, chills, had a low-grade fever, diarrhea and arm pain. The headache and arm pain resolved after 4 days. On 23 Jan 2021, after the patient received her second dose of the Moderna COVID-19 vaccine, she reported her arm itched, then had whole body itched, a rash on both arms, was nauseated with a bad headache and vomiting. She stated she went to the emergency care unit and was given diphenhydramine 50 milligrams intramuscularly, a steroid injection and intravenous fluids. She stated, her legs and arms were shaking, she was freezing, and her teeth were chattering. Everything disappeared 2 hours later. The patient stated she went home but continued to vomit, had fevers, headaches, chills and body aches for two more days. On 30 Jan 2021, the patient reported she had a rash, was nauseated and her heart was racing. She road in an ambulance to the emergency room. She stated her palm went numb, she could not mover her face or the left side of her body. She stated, ""they thought I was having a stroke"". She also reported her blood pressure was low. The patient reported, they gave her Tissue Plasminogen Activator (TPA) and diphenhydramine. She reported she was able to mover her arm a little better. On unknown date, the patient reported that she was in the Coronary Care Unit (CCU) on bed rest with monitors. The patient reported she had hip pain and lower leg pain that was making her limp and a bad headache. On unknown date, the patient reported she had a magnetic resonance imaging (MRI) and computed tomography scan (CT) and stated, ""it only showed a narrow spine"". The patient stated she had a spinal fusion (date not provided). Treatment for the event included diphenhydramine, a steroid injection, intravenous fluids, and Tissue Plasminogen Activator (TPA). Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, headache and arm pain, were considered resolved on 30 Dec 2020. The outcome of the events, arm itched, whole body itching, freezing, rash on both arms, were considered resolved on 23 Jan 2021. The outcome of the events, couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, rash, nausea, really bad headache, vomiting, low blood pressure, hip pain and lower leg pain, were considered unknown.; Reporter's Comments: This case concerns a 43-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and couldn't move her face and all the left side of her body, her palm went numb, headache, body aches, chills, had a low-grade fever, diarrhea, arm pain, arm itched, whole body itching, rash on both arms, nausea, really bad headache, vomiting, freezing, low blood pressure, hip pain and lower leg pain and a bad headache.Very limited information regarding these events has been provided at this time. Further information has been requested."" | | 104 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 1 day | 0908917-1 | Patient is a 47 y.o. female who arrived by Car presented to the emergency department for Stroke symptoms. Patient awoke at 6:15 this morning, some difficulty seeing out of the right eye and also was stumbling towards the left and to table. Concerned about things not being right so brought to the emergency department. Patient feels her speaking and swallowing are okay. She did drink a bit of coffee earlier. She denies headache or significant vision problems presently. Continues to not feel normal on her left side. No history of stroke and parents or siblings. She does give personal history of an occipital migraine many years ago at which time she did not have a headache but had some vision troubles. Physical Exam Vitals signs and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: She is not ill-appearing or diaphoretic. HENT: Head: Normocephalic and atraumatic. Right Ear: Tympanic membrane normal. Left Ear: Tympanic membrane normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: No oropharyngeal exudate or posterior oropharyngeal erythema. Eyes: Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Comments: Patient displays absence of left lateral movement Neck: Musculoskeletal: Normal range of motion. No muscular tenderness. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: No murmur. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Bowel sounds are normal. There is no distension. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. Musculoskeletal: Right lower leg: No edema. Left lower leg: No edema. Lymphadenopathy: Cervical: No cervical adenopathy. Skin: Findings: No rash. Neurological: Mental Status: She is alert. Cranial Nerves: Cranial nerve deficit (left facial droop, dysarthria) present. Comments: Patient's speech seems a bit slurred to me. Absence of ocular movements towards left noted as well as upward movements. Tongue is midline. Patient is unable to shrug the left shoulder or lift the left arm off the bed. Grip strength is 4 out of 5 on the left. Left leg strength is 3 out of 5. Extremity strength on right arm and leg is 5 out of 5. After consultation with a neurologist, the patient is being transferred from the ED. | | 105 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 1 day | 0959750-1 | 24 hours after vaccination I had tingling and numbness on right side of face, heavy eyelids, ""pulling sensation"" in neck. Unable to lay flat. Tingling and numbness would switch from right side to entire face but mostly on right side. Headaches and noticed increased heart rate two days after vaccine. One week after vaccine numbness and weakness extended down right arm and leg, able to move leg just felt ""weak"". I thought I was having a stroke or TIA. Made an appt. with the NP and she did full neuro exam and everything came back normal. Also, made an appt. with my PCP. Still continued to have headaches and weakness improved. Did get a COVID test since was still having headaches and it so long since vaccine, received test 1/12/2021 and it was negative. This past weekend was the 1st time I felt ""pre vaccine"" 17 days post vaccination. I am truly hesitant to take my 2nd dose scheduled on 1/26/2021."" | | 106 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 1 day | 1020320-1 | After the first vaccine next day at 9:00am I have shooting headache,severe pounding in my ear. I told my wife (physician) what happened she recommended me to go toER. I went to ER they thought I had a stroke,CT scan diagnosed with subarachnoid bleeding. I was transferred to another hospital 1 day had another CT scan, MRI Scan and was seen by a Neurosurgeon. I was told I have a revolving bleeding in my brain, loss sensation right side and double vision. I'm scheduled for Cerebral Angiogram in Feb. | | 107 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 2 days | 1005616-1 | Stroke two days after vaccination, CVA hemorrhage, aneurysm (hospitalized ICU 08 January 2021, currently requires daily physical therapy and has walker to ambulate). | | 108 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 3 days | 0935338-1 | Patient reported stroke-like symptoms as he was driving to work: started ""feeling funny"" with dizziness; progressed to feeling weakness in left side of face with facial drooping; tingling in left hand progressed to numbness and weakness in left arm and leg; difficultly coordinating motor movement in right arm; difficulty/ diminished speech ""tongue felt fat."" Symptoms resolved within appx 1+ hour from onset. Per patient, he was given an injection at the hospital (unsure for what?) and was discharged with a prescription for chlorthalidone 25mg daily, blood pressure was elevated."" | | 109 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 4 days | 0967529-1 | At 6:45AM on 1/19/21 patient developed numbness and tingling on right side of body which progressed to right hemiparesis and right-sided facial droop. Brought to ED by EMS and worked up for stroke. Found to have acute infarct on MRI and treated with dual antiplatelet therapy. | | 110 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 6 days | 1083241-1 | 1/20/20 extreme fatigue at work and got lost/confused on drive home, weakness, uncoordinated, admitted to hospital 1/26 with stroke like symptoms, still to date 3/8 ongoing neurological issues, weak tingling limbs, memory/focus, speech, balance, extreme fatigue, unable to drive or work, unsteady if on feet for more than short amount of time, spacial awareness off sometimes run into objects and miscalculating placing items back on shelves | | 111 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 10-14 days | 1065909-1 | Stroke; A spontaneous report was received from a consumer concerning a 48-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke (cerebrovascular accident). The patient's medical history was not provided by the reporter. Concomitant product use was not reported. On 30 Dec 2020, approximately 11 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot #: 037K20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. The reporter stated that on 10 Jan 2021, the onset of symptoms of stroke began. The patient reports that he was discharged from the hospital on 20 Jan 2021 and was later discharged from patient rehabilitation on 26 Jan 2021. Treatment for the event included apixaban, acetylsalicyclic acid, and atorvastatin as advised by patient's HCP (health care provider). Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, stroke, was unknown.; Reporter's Comments: This case concerns a 48 year old male who experienced stroke 11 days after the vaccine was administered. Very limited information regarding this event has been provided at this time. Further information has been requested. | | 112 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 15-30 days | 1115342-1 | Dizzy; short term memory sucks and it's frustrating; Can't see well; Fibromyalgia; bone pain; Neuropathy; Feeling aches in the body; Bells palsy-paralysis on the left side of the face/ pressure on the left side of the face and neck; headache; Ringing in the ears; Pressure in the ears; A spontaneous report was received from consumer concerning a 41-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pressure in ears/ear discomfort, ringing in ears/tinnitus, pressure on the left side of the face and neck which was found to be Bell's Palsy/facial paralysis, Headache, neuropathy peripheral, fibromyalgia, memory impairment, couldn't see well/visual decrease, feeling aches in the body/myalgia, and dizziness. The patient's medical history included neuropathy and fibromyalgia and past cancer. No relevant concomitant medications were reported. On 03 Feb 2021, the patient received the first of two doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 24FEB2021 the patient began experiencing pressure and a ringing in the ears and then started like a pressure on the left side of the face and neck. On 25FEB2021, the patient started having a headache and on 26FEB2021 the paralysis on the left side of the face began. The patient said that it worsened, couldn't eat, couldn't speak, and went to the hospital. The patient said that they had a CT Scan, and the result was that it wasn't a stroke. Vitals were taken and blood work came back normal. The conclusion was Bell's Palsy. The patient stated that they couldn't see well and were dizzy. The patient said that they were experiencing fibromyalgia and neuropathy that they had when they had cancer. The patient also mentioned that they were experiencing some bone pain and that their short term memory was not good and was frustrating. Treatment of these events were not reported. The outcome of the events, ear discomfort, tinnitus, facial paralysis, headache, neuropathy peripheral, fibromyalgia, memory impairment, visual decrease, myalgia and dizziness were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's medical history of neuropathy, fibromyalgia and past history of cancer remains the contributing factors. Further information has been requested. | | 113 | COVID19 (COVID19 (MODERNA)) | 40-49 years | 15-30 days | 1124712-1 | Volunteered on March 1st to help with vaccines- I filled syringes with the Moderna vaccine. On 3/6/2021 at 11:24 AM I presented with dizziness, slurred speech, a feeling of my lip dropping to the right, and weakness in left upper extremity. Called my daughter whom arrived within 10 minutes. After asking me some questions and exercises she said my strength in the left upper extremity was weak compared to the right. My daughter took me to ER, at check in I said I think I had a stroke. I was admitted, and neurology was consulted. In the ER they called it a TIA, and after imaging a diagnosis of stroke was made. Acute frontoparietal infarct, ASA/plavix, lipitor, PT/OT, Neurologist follow up. After discharge I have been meeting with PT/OT following exercises. Met with my PCP and continued medications Aspirin 81 mg, atorvastatin 80 mg, clopidogrel 75 mg. Still have muscle aches, and pain in the left upper extremity- especially 3rd and 5th digits. | | 114 | COVID19 (COVID19 (MODERNA)) | 40-49 years | Over 120 days | 0919633-1 | Presented to the ED with cc of left sided facial and LUE numbness and weakness x 1 days. Patient received her COVID-19 vaccination on 12/30/2020 around 1PM. Immediately after the injection in her left shoulder, she began to feel warmth and numbness in her left shoulder, arm, neck, face, and chest. She reports later experiencing nausea, palpitations, and left arm weakness. Her symptoms persisted, and her family noted a left sided facial droop which prompted her ED visit. In the ED, patient was noted to have some left sided facial droop and left arm and leg weakness. CT head and CTA showed no acute abnormalities. Tele-neurology was consulted who recommended admission to rule out acute stroke. Ultimately, work up was negative and symptoms resolved. Symptoms appear to be related to the vaccine. | | 115 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 0917961-1 | I suffer from lingering SOB with exertion after COVID infection. On the night of 12/31/2020 I began to feel more SOB than usual and was unable to correct my SOB with rescue inhaler. Became more SOB with exacerbated tachycardia and tachypnea, My family had to call 911 because I became aphasic and showing signs of possible stroke. I was taken to the ER and admitted for respiratory recovery and to role out stroke. The stroke was ruled out and I recovered with IV prednisone therapy, twice daily and supplemental oxygen. Released after HR, BP, & respiratory effort returned to normal: 01/03/2021 | | 116 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 0919452-1 | Its been 30 min now and she is doing much better. Felt tingling in her arm and leg on side that vaccine was given. Felt nauseous. Also had headache. Pt has had a severe ischemic stroke in past and has an intellectual disability. Pt seems to be doing fine otherwise and is slowly improving. | | 117 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 0927184-1 | Approximately 45 minutes later on my drive home my face on the left side started to feel numb. It started on my cheek and gradually ran up to right under my left eye and down to under my chin. It lasted for about an hour then gradually started to disappear. I got a little nervous but checked all signs that I was not having a stroke.. I ate dinner and calmed down. I also took a Tylenol 500 mg and drank a lot of water It?s gone now. It?s now 8:29 pm. Just feeling tired now. | | 118 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 0929955-1 | Rapid palpations, Peripheral numbness, Nasal and lip numbness, Throat "" Fullness"", noted posturing. Timeline of Events 1425 Vaccine Administered, Left Deltoid 1429 Symptoms Onset 1430 20mL Benadryl Administered; BP (132/84), HR 88, check lung sounds: WNL 1433 BP second check (BP 134/84) 1438 Pt noted lips, and toes felt tingly 1439 second HR check (HR 80) 1445 third BP check (132/82); pt claims past hx of stroke (x2) and SVT 1446 EMS was called 1449 Pt reports feeling of tightness in tongue and lips; pt reports similar symptoms to red wine and Novocain 1455 EMS arrived 1458 Pt was loaded into gurney and ambulance 1500 Pt depart in ambulance to the hospital"" | | 119 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 0946135-1 | Was taking Plavix for prevention of stroke. Initial examination lungs CTA, flushed, edema of lips and tongue. Uvula not deviated. Pt moved to observation area. Initial vitals: BP: 136/89, HR 99, 87% O2 on initial read, but when repositioned it was 91% at 14:42 EMS notified and first injection 3mg Epi pen injection given at 14:45; 911 called. Symptoms improved, but shortly after returned. Second epi injection at 14:56. BP: 136/89, HR 104, RR 18, 98% O2 at 14:55. Second epinephrine 3mg injection given at 15:00. BP 148/85, HR 91 at 15:00. EMS arrived and she was taken to Hospital at 15:03 | | 120 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 0951574-1 | I had numbness of the left side of my face with a heaviness over the left eye. I was evaluated for a stroke-NEG result I had a bad headache. The numbness resolved after 10 days . I went to an Urgent Care I also followed up with my PCP who put me on a steroid taper and an antiviral. | | 121 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 0972363-1 | 1/6/21 5:30 pm Client was as her patients house and stood up to leave and was ""walking like I was drunk."" Felt like her leg was asleep. Got to her car and drove to next patients house. Noticed Rt. sided weakness and knee buckling. Drove herself home and went to bed. 1/7/21 Woke up to increased symptoms, Rt hand and Rt. leg weak, slurring speech. hospital by rescue. Admitted X 7 days. CT SCAN with and without contrast showed no bleed. Telemed Visit, MD ordered MRI to rule out Cerebellum Stroke. MRI showed cerebellum stroke. Transferred to A Rehabilitation X 7 days. Has regained most of her normal functions, continues outpatient therapy."" | | 122 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 0985716-1 | That evening my heart was pounding very hard throughout my entire body that's all I could hear laying down I thought that I was going to either have a heart attack or a stroke. I got up and took one of my blood pressure medications. It's slowed down but I was unable to sleep due to feeling jittery and my heart pounding hard. The next day I felt exhausted my stomach hurt. I have had a sore throat the worst being on the Thursday following. Today Friday things seem to be subsiding. However my concern is not to get the second dose if I had such a bad reaction the first time I definitely will have a heart attack the second time. | | 123 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 1012893-1 | that evening i started to get a cold feeling down my arm and pain at injection site. later that night i had headache, nausea, body ache no fever very weak.. The next day i had body ache and all the same symptoms again. Then on the on the morning of the 29th woke up at 5:00 woke up to my head was killing me. Felt like my head was going to explode and i was disoriented. and i couldn't speak. couldn't even see to dial 911 or get my husband and after about 20 minutes or so i was able to get to my husband and he took me to the ER. There they gave me meds to get my blood pressure down and ended up admitting me to make sure i was not having a stroke. was in the hospital until that Sunday afternoon. | | 124 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 1026005-1 | Facial paralysis; Bradycardia; Weakness on his right arm and right leg; Difficulty talking; Canªt close eyes; Right leg is numb; Severe headache; Some eye issues, sees blurry; A spontaneous report was received from a paramedic, who was also a 59-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia. The patient's medical history was not provided. Concomitant product use reported included, insulin, statin, losartan, and metformin. On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 07 Jan 2021, after receiving the vaccine, the patient experienced eye issues and would see blurry and had a severe headache. On 23 Jan 2021, the patient was hospitalized for 36 hours because he thought he was having a stroke. Test results showed the patient did not have a stroke. The patient did, however, experience facial paralysis, couldn't close his eyes, bradycardia, weakness in the right arm and right leg, difficulty talking, and his right leg felt numb. Treatment for the events included prednisone, valaciclovir, and unspecified calming medication while at the hospital. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right am and right leg, right leg is numb, can't close eyes, and bradycardia, was considered not resolved.; Reporter's Comments: This case concerns a 59 year old male was hospitalized with a serious events of some eye issues, sees blurry, severe headache, facial paralysis, difficulty in talking, weakness in the right arm and right leg, right leg is numb, can't close eyes, and bradycardia after first dose to mRNA-1273 in the left arm. Comcomitant medications include insulin, metformin, atorvastatin, losartan. Hospital work-up showed ne did not have a stroke, and he was treated with prednisone, valaciclovir and a ""calming medicine"". b) Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. + b) Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded."" | | 125 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 1041321-1 | Flu-like symptoms, face going numb, right side weakness, double vision in right eye, migraine headache. Stroke like symptoms | | 126 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 1042801-1 | "Moderna COVID-19 Vaccine EUA"" Hypersensitivity & fleeting / flowing pains spread throughout left side of body from tip of nose across face, up and down neck and left side of head out through fingers of left hand, down left side of back, down left thigh / leg and out through toes of left foot. It was as if the left side of my body was in a different time zone than the right side. I called the nurse line; they suggested a visit to the ER. My BP was way up, and I panicked just a little; but, tried to use my mindfulness practice to observe the unfolding events, rather than being consumed by them. There was a CT of my skull wherein they found indications of ""an old"" stroke; so, they decided that it was possible I had a stroke. I was transferred from the Medical Center to the Stroke Center at the Medical Center under the care of Dr. Another CT with contrast and a MRI confirmed ""OLD"" stroke, but nothing new. I was assured the vaccine had nothing to do do with my symptoms, and that I most likely experienced a Trans Ischemic Attack (TIA), and that the situation was merely a coincidence as they believe the vaccine had nothing to do with the TIA. However, based on my personal experience of the events as they unfolded, it is my sincere belief that the vaccine was incidental to the effects as I experienced them. I was kept overnight for further observation, released the next day, and had a follow-up with my primary care physician at the Med Center. I am now taking an 81 mg aspirin, Plavix, and 80 MG Clopidogrel as a precaution, and my symptoms have been gradually fading away."" | | 127 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 1049191-1 | After patient received vaccine she had a rash and raised area around the injection site on 1/28/2021. Patient continued to have this and then on 2/17/2021 patient went to the ER with stroke like symptoms ie facial dropping , left sided weakness and slurred speech | | 128 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 1069632-1 | Presented to ED for evaluation of generalized lower extremity weakness, falls. The patient states that he carries a diagnosis of MS and typically is fully functioning without assistance of a cane or walker. The patient states that yesterday morning around 0900 he received the second dose of his Moderna COVID-19 vaccine and was otherwise feeling fine but by last night (12 hours after the vaccine) the patient states he tried to get out of bed and was transferring when he felt his bilateral legs give out, causing him to slide to the ground. His wife then came to help and states that the patient was completely weak in the legs, and was unable to even lift his legs up to get back into bed. They then tried to walk him again a short time later and he again stumbled with weakness in his legs. Since that time, the patient states he has been minimally ambulatory and has been using a cane, but still needs large assistance to get around his home. The patient states he has baseline foot drop but feels this is worse in his legs today. He went to clinic this morning for his symptoms where he was noted to have an elevated temperature and was diffusely weak in his lower extremities. Given this, the patient was referred to the ED for further evaluation. The patient denies any weakness in his upper extremities or facial asymmetry. He denies sensation change in his extremities nor any recent illness such as cough, shortness of breath, chest pain, sore throat, nausea, vomiting, urinary symptoms, or leg pain. He has no history of stroke. He denies any injuries or head injury, syncope from his falls. He was admitted to the hospital where he will receive further symptomatic treatment as necessary. No treatment provided in emergency department for weakness. | | 129 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 1086024-1 | bell's palsy or could of had a stroke; mouth drooping; speech was a little slurred; could not smile, could not open mouth to eat; right eye started tearing up and was watery; A spontaneous report was received from a consumer concerning a 55 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Facial paralysis, Lacrimation increased, Dysarthria and Facial discomfort. The patient's medical history was not provided. Relevant concomitant medications were not reported. On 05-FEB-2021, prior to the onset of the events, the patient received their first dose of two planned dose of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection. On 05-FEB-2021, the patient experienced Lacrimation increased. On 06-FEB-2021, the patient experienced Facial paralysis (mouth drooping), Facial discomfort. On 08-FEB-2021, the patient experienced Facial paralysis. The patient reported that he went to the doctor who said it could be bell's palsy or could had a stroke, and recommend he go to hospital to have it checked. The Patient reported that he has not gone to the hospital at the time of this report. No Laboratory details were provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. At the time of this report, the outcome of the event's Facial paralysis, Lacrimation increased, Dysarthria and Facial discomfort was considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. | | 130 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 0 days | 1127730-1 | A stroke occurred approximately 3 hrs after receiving vaccine. He was flown by helicopter to Medical Center. He had dysphasia which did resolve by the time he was admitted into the ER. He has since had CHF and Afib and is now on anticoagulation and diuretics. He continues to have problems with CHF, SOB, weakness and is undergoing treatment as outpatient. He is now followed by Cardiology, Neurology. | | 131 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 1 day | 0951442-1 | Vaccine given at work left arm on Friday 1:45 pm and felt like tight Blood Pressure cuff on my arm within 30 mins. This was constant pressure that lasted until I slept that night. went home after work, ate dinner, then sleep with my CPAP. Slept late, woke up 1:40pm with entire left arm numb, but still able to move it. (sleeping on right side) and numb tongue that felt swollen. Stroke? I got up and as time progressed over next 30 mins or so, I started coughing more, felt like sore throat, itchy, having trouble clearing my throat, some trouble breathing, tongue didn't look swollen, but it felt like scotch tape underneath my tongue with someone slowly pulling tape off. with top of tongue swollen and heavy. 2:25pm I took 25 mg Benadryl oral tablet and called 24/7 RN hotline and was told to go to ER and take another 25 mg Benadryl tablet which I did. I arrived at ER and was really coughing hacking repeatedly. Short of breath, kept trying to clear my throat. Seen in triage. No meds given, this was? <20 from time I took Benadryl. About an hour later I did have about 15 mins of feeling like I was wearing a very snug neck turtleneck with 2 brief cool sensations going down the middle of my throat and down both sides of my upper chest. I felt better when I kept my neck very straight versus looking down. I was later seen again and felt 75% better, given Dexamethasone and Pepcid. Discharged home. around 6:30pm. Took Benadryl 50 mg again 10 pm same night. | | 132 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 1 day | 0959422-1 | sever bruising, swelling starting1/15, followed by bilateral transient severe head ache 1/16,17, and 18, followed by crushing headache and BLURRED VISION and DOUBLE VISION 1/19/21 upon waking. Went to ER - ruled out stroke and tumor. Given Dilauded, prenizone and Benydryl. Today, 1/20 headache and double vision was crushing upon waking for several hours. After taking a Dilauded and 2 prednizone pills, pain subsided. As of 5:09 pm, hadache nearly gone, blurred vision resolved, but double vision still present. Brusing and sweeling still visible. | | 133 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 1 day | 1031033-1 | Narrative: Patient evaluated for stroke. No bleeding. Maybe ischemia - Further testing results still pending at the time of this initial report | | 134 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 1 day | 1034613-1 | For two days after receiving the first vaccination for Covid-19 I ran a temperature of 101.9 and was not able to go to work. When I returned to work on Friday February 12, 2021 at approximately 8:40am I had a stroke and was rushed by ambulance to the hospital. | | 135 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 1 day | 1039506-1 | Patient suffered a stroke the next day. She was hospitalized at Hospital. | | 136 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 1 day | 1116723-1 | COVID and stroke December 2020. Patient's mother talked to him at 4:30 and he said he was not feeling well. Driving to work when coworkers found pt after he curbed his vehicle with AMS. Right side deficit with aphasia, unknown last normal. Pt had sz upon EMS arrival and 2.5mg versed given. was initially unresponsive while going into the CT suite and apparently had a seizure as soon as he arrived to the ED. but alert by the time he was done with CT head, CTA and CTP. He was followed to the ED assigned room and he was more alert but aphasic and only say 'yep' and did not follow commands. He was able to move his left side initially but not to command. about 2 minutes later he was able to move his right lower extremity to pain followed by right upper extremity. He is febrile with temp >103F. Diagnosed with seizure and Left acute arterial ischemic stroke, MCA. | | 137 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 1 day | 1126900-1 | Moderna COVID-19 Vaccine EUA Patient received Moderna Vaccine - first dose on 3/15/21 around 3 pm. Patient returned to the vaccine clinic to speak with doctor (reporter of event) on Wednesday 3/17 to inquire on the left-sided facial numbness and droopiness the patient was experiencing. Pt stated the left-sided facial reactions started on Tuesday, 3/16 in the morning. Doctor assessed for further signs of other neurodeficit (i.e. stroke) and patient denied. Doctor encouraged patient to contact PCP. Patient contacted PCP that day (3/17), and then saw her PCP on Thursday 3/18. From phone follow up with patient on Monday, 3/22, patient stated her PCP diagnosed her with Bells Palsy, and initiated her on a 10 day course of prednisone along with valacyclovir. Pt since last Thursday, 3/18 has taken a leave of absence from work. Pt has upcoming physical therapy scheduled for Wednesday, 3/24. Follow up still in progress. | | 138 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 2 days | 0914748-1 | Patient received the vaccine at 9am on 12/24/2020. Later on 12/24 he had a ""bad headache"" which did not impede him from participating in his planned activities on that day. When he woke on 12/25 the headache had resolved but he began having significant injection site pain that persisted until 12/26 at 6pm when it resolved and again the pain did not impede him from participating in his planned activities on 12/25 or 12/26. at about 6pm when the injection site pain resolved he began experiencing a feeling of ""being unwell"". He described this as a panic attack with feelings of impending doom, worries that he was having a stroke such that he told his wife that he felt he should go to the ED (he did not go to the ED), feeling shaky but whit no visible evidence of tremor or restlessness, and an out of body experience (specifically depersonalization). He had no physical signs of a stroke or TIA. He reports that this lasted one hour then he fell asleep at 7p on 12/26 and slept until 8am on 12/27. When he woke on 12/27 he was back to baseline without any persistent feelings of being unwell or panic. He does not have a history of panic attacks and he does not use any mood altering substances. He is not a somatically focused individual so this experience was atypical for him."" | | 139 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 2 days | 0959598-1 | 1/16/2021. Large swollen lymph nodes under high jaw and down front of neck. Very tender to touch and painful to swallow and move neck. 1/17/2021: woke up with worse neck pain and palpable lymph nodes in neck. Headache. 1/18/2021: woke up at 3AM with weakness on left arm and left leg. Continued pain in neck. Tingling on lips. Intermittent tingling and warmth on face. Went to Urgent Care. Released after EKG and stroke discussion with assurance I would go to ER with any changes. 1/19/2021: woke at 3:30AM with facial tingling/numbness and worsening left side weakness and tingling. Went to ER. EKG - normal. Brain MRI for stroke - normal. Blood work - normal. Released with assumption of vaccine reaction. Referred to neurologist. | | 140 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 2 days | 0974313-1 | Patient vaccinated on 1/22. The next morning (1/23), patient experienced diminished sensory and motor function in left arm and leg, as well as facial numbness. Presented to the hospital on 1/24, and was found to have a small stroke in pontine medullary junction. Discharged on 1/25. There is some suspicion that her COVID infection in December may have precipitated this, and patient is currently being evaluated for coagulation disorders, primarily antiphospholipid antibody testing. It is unlikely that the vaccine contributed to this, but given close timeline between the two, filing this report. | | 141 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 2 days | 1028597-1 | R thalamic stroke 2 days after 2nd dose of Moderna vaccine with L sided numbness acute in onset | | 142 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 3 days | 0919546-1 | thrombotic stroke -necessitating hospitalization; and craniotomy; required mechanical ventilator for 2 days. Patient now extubated, breathing on her own. Patient remains hospitalized with marked deficits (aphasic) | | 143 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 3 days | 0977362-1 | Moderna COVID-19 Vaccine EUA On 1/9/2021 I suffered a lacunar stroke, Symptoms of left sided paralysis . The symptoms came and went. I was life flighted to Hospital. Underwent several test . CT,MRI,ECHO and labs among other test I was in patient ICU for 3 days. Discharged home. The longest event lasted 4 hours . My BP was extremely elevated. I had borderline HTN in past but never that high. Fortunately I have regained the use of my left side and minimal side effects remain. Unsure if the vaccine could have elevated my BP | | 144 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 3 days | 1050111-1 | I had the expected flu-like symptoms for a couple of days, and then on Day 3 got nauseous and started feeling tingling on my face (below the nose and around my mouth. It felt like pins and needles. When it went on for several hours I called Hospital and they advised to contact them if it worsened of I began having symptoms of Bells Palsey or a stroke (not concerning at all!) I took tylenol then ibuprofen and it went away. It's come back two more days (up to today) but has not worsened. Just thought I should report it. | | 145 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 4 days | 1013249-1 | Stroke like symptoms like Loss of balance, loss of words, mixing up words, headache, nausea, distance in vision off, muscle aches | | 146 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 4 days | 1020077-1 | Stroke symptoms. Complete loss of function of left side of body, slurred speech, confusion. Outside of window for treatment. Partially resolved. Still having some trouble with speech, left hand still ""tingly."" Able to walk now."" | | 147 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 5 days | 1124370-1 | nonocclusive left sigmoid venous sinus thrombosis without ischemic stroke | | 148 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 5 days | 1143895-1 | 13th of January received first Moderna shot. 18-19th began to have headaches 22nd headaches worsened 25th at the doctor's (tested negative nose swab) home till 28th (28th tested positive for corona after having her first shot at Advent) stroke symptoms at school 28th Advent did CT scan MRI venous thrombosis diagnosis, from front to back, hemorrage in the northern hemisphere 29th blood thinner administered to attempt to drain clot, seizures 31st passed away | | 149 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 6 days | 1047133-1 | TPA aborted Stroke on day 5 post vaccine. Probably not related but was told I needed to report it. | | 150 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 7 days | 1040633-1 | Death due to hemorrhagic stroke. | | 151 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 9 days | 1058950-1 | I woke up at 2:00 am and was dizzy and rolled over and was dizzier with Vertigo - couldn't sit up I couldn't stand up or walk. Son took me to ER - Medical Center - and they put me on an IV and gave me Meclizine. Kept me for obsevation for 36 hours as it was not subsiding (the vertigo). Ruled out stroke with CT scan. They sent me home with Meclizine and I'm still taking it. I get Vertigo every day still. | | 152 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 10-14 days | 0991722-1 | Went to my doctor thinking it was a very very bad sinus infection. My doctor didn't think it was with the way my headaches were. It hurt on the back right and above the right ear. It hurt to touch. My tongue is not functjioning now. I had to get a MRI because they thought it could of been a mini stroke. MRI came back negative the doctors told me Bell Palsy. They advise me not to get my second dose on 2/3/21. | | 153 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 10-14 days | 0998753-1 | Patient came to the emergency department on 02/02/2020 at 2:30 pm to be evaluated for possible stroke due to sudden acute numbness, weakness in right wrist and arm, but no pain. Patient has no prior history of sudden acute numbness in arm and did not report any recent injury to his arm. Neurologist evaluated patient for possible stroke and patient was unable to lift right wrist and hand. Patient was able to lift both arms overhead, lift both legs, smile normal, open and close mouth and move tongue. Both CT Scan and MRI were normal. Neurologist and emergency medical specialist determined that patient did not have a stroke and diagnosed acute brachial plexus palsy possibly due to patient sleeping in an awkward position. Emergency specialist said it was unlikely but could not rule out the possibility of an adverse reaction to the Moderna vaccine, which patient had received 10 days earlier (second dose, see details above.) | | 154 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 15-30 days | 0981249-1 | I had covid nov 23 2020. On jan 25 I had a stroke Couldn't talk. Couldn't move my left arm or leg. I received TPA. | | 155 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 15-30 days | 1141968-1 | My husband died of a sudden massive heart attack. He was one of two teachers who died after the moderna vaccine, second dose. A third teacher had a stroke. | | 156 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 15-30 days | 1163428-1 | Began with weakness of March 24th and stroke- like symptoms despite a clear CT Scan and EKG. Trouble walking or staying awake. Heart stopped on March 28th. Deceased. | | 157 | COVID19 (COVID19 (MODERNA)) | 50-59 years | 31-60 days | 1041485-1 | Patient suffered from a stroke 4 days after the second vaccination | | 158 | COVID19 (COVID19 (MODERNA)) | 50-59 years | Unknown | 0997531-1 | Narrative: Patient is a 49 year old man with past medical history of hypertension and kidney stones who presented with a chief complaint of word finding difficulties and slurred speech. Patient was last seen normal at 1230 pm on 1/21/2021. He got his covid vaccine and shortly after he developed a headache that was on both sides of his head. Felt like 8/10 pain. He then had difficulty with speaking - he didn't know what word to say so he would make a noise. He was on the phone, and that person recommended that he come to the ED to get evaluated.In the ED, a stroke code was called. BP 169/97. NIHSS 0. A CT non con did not show any acute bleed or any signs of a stroke. After the stoke code was ended, the patient has a headache severity 1/10 and did not have any word finding difficulties. Patient was non focal by the time that the stroke code was ended. In the setting of hypertension, a blood pressure of 169/97 on admission and fluctuating symptoms, most concerning on the differential is a TIA. Given his risk factors and episodic presentation, he will need to be worked up for a stroke. The differential also includes post-vaccination reaction vs complex migraine. | | 159 | COVID19 (COVID19 (MODERNA)) | 50-59 years | Unknown | 1067936-1 | acute adrenal crisis; A spontaneous report was received from a Physician regarding his son who received second dose of Moderna Covid-19 vaccine and have experienced acute adrenal crisis. The patient's medical history was not provided. His concomitant medications were not provided. No information on allergies. On 11-FEB-2021, prior to the onset of events, the patient received second of two planned doses of Covid-19 vaccine for the prophylaxis of Covid-19 infection. Patient lives in a group home. On an unspecified date, he seemed to be confused, disoriented and unable to talk. Father met him at Emergency department where the patient had an acute adrenal crisis , and after ruling out stroke ,he was diagnosed with Addison's disease(loss of adrenal function). He was admitted and discharged after two days. Post discharge, he seemed totally normal. Action taken with the vaccine is not applicable as the patient received both the doses. The outcome of the event acute adrenal crisis is considered recovered at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. | | 160 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 0 days | 0932051-1 | Neuropathy left cheek, radiating up and down my face. It started in the late afternoon after I received the vaccination. It would get more intense throughout the day. I thought I was having a stroke. After sleeping it wasn't as intense, the more active I was it would intensify. I went to clinic on 1-07-2021 because I still have neuropathy on my left side of my face. The Provider tested me to see if I had Bells Palsy. He said I didn't, he recommended I see a Dentist, he thought I probably had a tooth infection. I went to the Dentist at 3 p.m. on 1-07-21. They took a panoramic x-ray of my teeth. The dentist adivsed me that I did not have a infected tooth. I limited my activity for the jrest of the day on 1-7-21. I still have the neuropathy. | | 161 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 0 days | 0977379-1 | the right side of my head, face, neck, and right arm to the fingers went numb - I had the shot on my left arm, but have a metal plate on the right side of my head. it is just a very little bit numb still on my face and my head still hurts on and off My doctor thinks it may have been a mini stroke , but my tests have all come back negative i am in pretty good shape - good blood pressure etc., so I think it was a reaction to the shot, maybe because of the metal plate??? Going to the specialist for a consult per my primary care physician - | | 162 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 0 days | 1002849-1 | Arrived to the hospital with questionable stroke, 2 seizures in route to hospital (witnessed by EMS personnel) approximately 8 hours after injection. | | 163 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 0 days | 1036498-1 | According to the information I have gathered, she became dizzy, nauseated, vomiting later in the day. This continued for nearly two weeks. She then presented to an emergency room and was diagnosed with a cerebellar stroke that likely started on the same day as her vaccine per that physicians report. | | 164 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 0 days | 1080075-1 | Hemorrhagic stroke. = Death | | 165 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 0 days | 1090186-1 | blood pressure was 286/89/blood pressure was so high; rapid heartbeat; severe inflammatory reaction; fever; headaches; body was in a weakened state; pain in arm; swelling up her arm/swelling in hands; had a severe reaction; swelling at injection site; hot; A spontaneous report was received from a consumer who was also a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe reaction (vaccination site reaction), swelling and warmth at vaccination site, pain in the arm, swelling up her arm/left hand swelling (peripheral swelling), inflammation, rapid heartbeat (heart rate increased), blood pressure was 286/89/blood pressure was so high (hypertension), fever (pyrexia), headache and weakened body state (asthenia). The patient's medical history, as provided by the reporter, pneumonia (had from Dec 2020 to Feb 2021 and had ""compromised lungs""), allergies to penicillin and sulfa drugs, vitamin D deficiency, pseudobulbar effect, and traumatic brain injury (with swelling on back of brain stem, memory loss, problems with speech). Concomitant medications included levothyroxine sodium, vitamin C, vitamin D, fish oil, tizanidine, and fluvoxamine. On 18 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:029L20A) in the left arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, after receiving mRNA-1273 the patient reported to have a severe reaction to the vaccination. The patient had swelling at injection site which looked like a bee sting and felt hot. On 19 Feb 2021, the patient reported to experience swelling and very bad pain in left hand. The patient took Benadryl as a treatment. On 20 Feb 2021, terrible pain in arm was reported along with swelling. She went urgent care and they sent her to the hospital, where she stayed for about 8 hours. Test showed a severe inflammatory reaction. She also had headaches, her body was in a weakened state, pain went up her arm, she had a rapid heartbeat and a fever. The patient's blood pressure was 289/89 and they ""thought she was going to have a stroke or a heart attack"" because her blood pressure was so high. Treatment for the events included steroids and unspecified painkillers. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events peripheral swelling was considered to be not resolved at the time of reporting. The outcome of the events of severe reaction, swelling and warmth at vaccination site, pain in the arm, inflammation, rapid heartbeat, blood pressure was 286/89/blood pressure was so high, fever, headache, and weakened body state was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded."" | | 166 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 0 days | 1114267-1 | Bell's Palsy; A spontaneous report was received from a consumer concerning a 64-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy (facial paralysis). The patient's medical history was not provided. No relevant concomitant medications were reported. On 4 Mar 2021, at 13:00, four hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 4 Mar 2021, the patient had had Bell's palsy and had to go to the emergency room (ER). They went to the emergency room (ER) because they though the patient was having a stroke. Treatment details included IV (intravenous) medication. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event of Bell's palsy was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. | | 167 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 0 days | 1117198-1 | Patient received 1st dose of Moderna vaccine on 01/30/2021. Patient received second dose on 2/27/2021 and within an hour noticed slurred speech and drooped face. Patient went to ER and was transferred to another Hospital on 2/27/21 due to stroke. Now patient believes stoke may have started 2/26/21, as she was somewhat confused that day, but didn't realize stroke until after vaccine. | | 168 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 0 days | 1124585-1 | Determined she had a mild stroke yesterday, March 21. Had slurred speech, could not form words, couldn't cook. Symptoms actually started on March 17th, one week after having the vaccine. She is currently hospitalized at hospital where she received her vaccination. | | 169 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 1 day | 0974848-1 | Woke up the next morning with slurred speech, right side weakness, illegible writing, balance issues. Next day all symptoms worse. Went to Urgent Care, was transferred to Hospital. Diagnosed with stroke. | | 170 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 1 day | 1049432-1 | right parietal stroke--transient left-sided hemiplegia, dysarthia, agnosia, denial | | 171 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 1 day | 1080481-1 | Had normal reaction to covid shot,fever,body aches and fatigue. Jan 29 dizzy and unable to focus, no appointments available with pcp, went to urgent care and sent to er for possible stroke, stroke ruled out and sent to physical therapy for vertigo then not spinning and regaining balance. Feb 17 vertigo returned on right and left sides, treated. Feb 19 left sided vertigo treated,Feb 22 left sided vertigo treated, March 1 right sided vertigo treated, March 5 negative for vertigo but still dizzy and off balance, vestibular exercises required to regain balance.. Positive for covid in July. | | 172 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 1 day | 1093043-1 | The second shot was on February 19. On February 20 and 21, patient experienced a sore arm and flu-like symptoms. On Febuary 28, he had a stroke. Hospital where the ambulance took him initially diagnosed it as Bells Palsy and prescribed prednisone and an anti-viral. After an MRI the next day on Monday, he was diagnosed correctly as a stroke. On Tuesday, he was airlifted to another hospital and was in the ICU for more than 2 days. Patient spent the next 7 days in the neuro-trauma step-down unit with the results of the debilitating stroke. He is unable to swallow and his entire left side is affected as well as vision and hearing. | | 173 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 1 day | 1108914-1 | Patient awoke the day after the vaccine and noticed her left ear swollen and trouble moving parts of her face, the symptoms progressed over the course of the next few days until she was unable to move the entirety of the left side of her face and head. At this moment in the fear of a stroke she went to a local Emergency Department where she was given the diagnosis of Bell's Palsy secondary to the vaccine | | 174 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 2 days | 0934967-1 | Facial swelling along the left side of the face along jawline leading up to ear. Pain when closing mouth resulting in some drooling from keeping mouth open. Also some nasal drainage and feeling of unwell. Telehealth appointment occurred on 1/8/21. Both corners of his mouth would raise when smiling so a stroke was ruled out. Could possibly be a coincidence with the vaccine timing but healthcare professional advised us to report it here. | | 175 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 2 days | 1123370-1 | On March 16th at roughly 1:30pm, the patient received his first dose of the COVID19 Moderna vaccine. Afterward, the patient experienced no adverse side effects. About 48 hours later, however, at 2pm on March 18th, the patient's spouse attempted to wake him from a nap. The patient seemed much groggier than normal and his expression appeared vacant. When pressed by his spouse, the patient could not say who he was, or who his wife was. He agreed to travel with his wife to the hospital. At the hospital, a healthcare professional asked the patient who he was. He answered with his correct name. He also correctly identified his spouse by name. But when asked where he was, the patient gave a long and incoherent response. After this initial screening, doctors at the hospital evaluated the patient for a stroke. They ruled this out as a possibility. Next, they suspected the patient's MS lesions may have contributed to his ""cognitive event."" However, after comparing his 2018 scan to a current scan, they determined this was unlikely the cause. After about 24 hours at the hospital, a neurologist hypothesized that the patient had experienced a seizure. Another doctor at the facility concurred with this assessment. By late Friday (more than 24 hours after the episode), the patient had regained most of their cognitive functioning, though he still experienced mild confusion around the week's events (even preceding the ""cognitive event""). Prior to now, the patient has never had a seizure before."" | | 176 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 2 days | 1126469-1 | Patient presented to the ER with complaints of tingling and numbness in the left upper and lower extremities along with the left side of her face. She said this lasted 5 minutes the first time and then it happened again when she laid down to go to sleep, lasting about 3 minutes. She noted these same symptoms last month approximately 2 weeks after her first covid vaccine. She was admitted for observation to the facility to rule out stroke/TIA and had negative tests across the board. Physician attributes symptoms to covid vaccine. Pt was discharged in stable condition. | | 177 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 3 days | 1036832-1 | Achy sore/heavy muscles (current to date) , fatigue that grew worse daily ( and current to date) , whole body chills that lasted 2-3 hours (until 1/25 and now on occasion) , night sweats ( 1/12-1/25) , diarrhea (1/23 - 1/25), headache (1/25 to current date), dizziness (1/25). On Jan. 25: Went to bathroom around 3:15 p.m. with diarrhea and became woozy so decided to get off of the toilet and sit down on the floor. Husband found me semi conscious on the floor with drool at about 4:10 p.m. He tried to awaken me and found me not lucid, speech was garbled, fragmented responsiveness and could not keep upright position, could not give details to the situation. Husband called 911. Ambulance transported to hospital ER during hospital exams and tests patient was not lucid and this continued for the next 32 hours. EKG, EEG, CT scan, MRI, Blood/Lab work; all tests were negative indicating no seizure , healthy heart, clear brain scan, no stroke, white blood count normal, dehydrated. All tests negative with all doctors unable to find a reason for this situation other than the Moderna vaccine considered highly for the situation. Advised patient not to take the second dose of Moderna. | | 178 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 4 days | 0934758-1 | PATIENT PRESENTED TO ER ON 1/8/21 @ 6AM WITH STROKE SYMPTOMS INCLUDING (R) SIDE WEAKNESS | | 179 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 5 days | 0971665-1 | Left side of face paralysis, primarily noted in mouth and left eye. Can not blink left eye, continues to tear up. Left side of mouth does not move while trying to smile/eat/talk. Emergency Room visited 1/24/20. MRI, CT Scans run to determine if stroke occurred. Diagnosis is Bells Palsy with seven days of steroids prescribed (Prednisone 20mg - two tabs once per day). | | 180 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 6 days | 1070978-1 | report of patient being admitted for a stroke after about a week after first dose of moderna vaccine | | 181 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 10-14 days | 0973044-1 | Morning of 1/24/21 (Sunday), patient saw that the right side of her face was drooping, her right eye was swollen and excessively tearing. Patient noted drooling out of the right side of mouth when drinking fluids or eating food. Patient was unable to chew on the right side, had difficulty speaking due to the drooping of the right side of her mouth. Symptoms persisted into the next day. Patient was seen by her PCP and was diagnosed with Facial Palsy (Bell's Palsy). Patient's neurological assessment was negative for stroke symptoms. | | 182 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 10-14 days | 1054353-1 | 10 daya after receiving Moderna vaccine: 60 year old right handed woman with migraine + chronic headaches, nephrolithiasis, who presented to the hospital with expressive aphasia and right facial weakness and was found to have at least to distal left MCA occlusions for which she received IV tPA. ßMRI brain shows a small left frontal cortical acute ischemic stroke. ßPost tPA ICU course has been notable for angioedema of the tongue now improved. TTE showed PFO. LDL 111, new diagnosis HLD. ß | | 183 | COVID19 (COVID19 (MODERNA)) | 60-64 years | 10-14 days | 1179255-1 | Had a stroke Mar 16, 2021. 12 days after shot. This is nonsense adding all this data. It is as though you don't want to hear. Mistakes on pages are mot clear and easy to figure out. Such as no months if over 2 years of age. Idiotic. | | 184 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 0948222-1 | Patient presented to ER department with s/s of stroke. He was transferred from Hospital to another hospital | | 185 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 0967214-1 | Within 1/2 hour of vaccination the patient was dizzy and was having a hard time remaining upright, additionally the patient was less alert and oriented. Patient was observed for a few minutes and then ambulance was called. Patient was transported via EMS within an hour of being vaccinated to local hospital. Patient was found to have has had major stroke and is presently in ICU and not expected to make it. | | 186 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 0968326-1 | Patient was dizzy and slight disorientation after getting vaccine and was observed on site until 1/22 then she was sent to hospital for stroke like symptoms and is scheduled to return to facility on 1/23. | | 187 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 0974040-1 | high fever, severe pain, dizziness, vomitting, internal bleeding, stroke, sepsis | | 188 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 0976541-1 | Collapsed; Unable to walk on her own; Muscle pain; Nausea; Vomiting; Headache at the base of her head and neck; A spontaneous report was received from a consumer concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, collapsed, unable to walk on her own, muscle pain, nausea, vomiting, and headache at the base of her head and neck. The patient's medical history, as provided by the reporter, included stroke. No relevant concomitant medications were reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 026L20A) in the left deltoid for prophylaxis of COVID-19 infection. On 30 Dec 2020, after vaccine administration, the patient experienced a headache at the base of her head and neck. On 03 Jan 2021, the patient collapsed and was unable to walk on her own. She was hospitalized from 04 Jan 2021 to 05 Jan 2021. She also experienced muscle pain, nausea, and vomiting. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, collapsed, unable to walk on her own, muscle pain, nausea, vomiting, and headache at the base of her head and neck, was unknown.; Reporter's Comments: This case concerns a 72 year old, female patient with a history of stroke, who experienced a serious unexpected event of fall, gait inability and non-serious expected event of myalgia, nausea, vomiting and headache. The event of headache occurred same day after first dose mRNA-1273 (Lot# 026L20A) administration. The event of fall and gait inability occurred 5 days after first dose of mRNA-1273. The event of myalgia, nausea, vomiting occurred on an unspecified date after mRNA-1273 (Lot# 026L20A) administration. The treatment medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. | | 189 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 0986910-1 | L MCA stroke | | 190 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 0987301-1 | My Mother was given the Covid Vaccine (1st Dose) on 12/28/2020. Later that night we received a call from the nursing facility that my Mother was having uncontrollable seizures and had to be transported to the nearby hospital. The ER doctor confirmed that my Mother had tested positive to Covid. She was treated for Covid and was on life support. A few days later we received a call that my Mother had a major stroke. She passed away on January 4, 2021 | | 191 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 0987400-1 | Patient left the pharmacy and was at his table eating. He dropped his bowl and appeared to be shaking and his eyes rolled back. He was unresponsive so his wife called 911 and an ambulance came and transported him to the Hospital. Concern at the time was either a seizure or stroke. | | 192 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 0987423-1 | Patient received COVID vaccine #1 at 5pm. At around 9pm, she went to bathroom and noticed that she felt dizzy, shortly thereafter she noticed that her speech was slurred. Her daughter saw that her mouth was droopy and called 911. Pt took 3 baby ASA at that time as well. Patient evaluated in ED for stroke, CT/CTA normal, TPA not given. Admission diagnosis CVA vs Bell's palsy (mild). MRI consistent with changes suspect acute infarct. No arrhytmias noted. ECHO unremarkable. | | 193 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 0992977-1 | spoke with patient husband on Saturday 1/23 and he said that she had been in the hospital. that she had had a stroke, the MD's at the hospital told him that it was not contributed to the vaccine and that they were unsure even if the stroke had occurred prior to the vaccine or after. spoke with him again on 1-29 and he stated that she had passed away on 1/25/21 | | 194 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1002073-1 | Extreme pain in L arm injection site immediately after injection, followed by extreme fatigue, constant L arm pain, ache in body, on Tuesday-Friday, Saturday felt weak and extremely nauseous, at 2:00 pm experienced a embolic stroke on the right side of the brain and paralysis on the left side of body, rushed to ER, administered TPA clot buster and had a removal of the clots by Dr. | | 195 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1025481-1 | After receiving the vaccination her husband met with his son. He reported that his dad did not know anything. His wife told the son to bring him to Hospital. They brought him to the hospital and got there and his son said that he had called the daughter and he did not know the day, month, his grandson's name, like he wasn't there. He had a funny look on his face that he was ""out of it"". Asked simple questions about pet at home, favorite and could not remember the name of the cat. He then came out and said that he was fine. They ran tests for a mini-stroke, CT scan, blood work. They had a consult with Neurology, virtual. The neurologist did some questioning, and by 3:00 they felt that it was like a mini-stroke, and she said that she felt it was from the vaccination as it occurred right after the vaccine. She took him home, and told him to take a nap. By 4:30 PM she woke him up and said that they were going to eat, she was getting things ready. He was sitting on the couch about 5:00 PM and had that blank stare again. He went walking through the house walking aimlessly and started fumbling through papers . She called 9-1-1 and within 10 minutes they took him to the ER. It took her an hour to get to the hospital, his daughter met them at the ER. He told them that he was fine, and they knew that he was not. By 7:00 PM they were going to do an MRI and wanted to admit him to the hospital. All of a sudden at 9:00 he was having another episode. She got the nurse and they watched him and decided that he was having a seizure, (agitation, not making sense.). The entire episode lasts for about 30 minutes. They did an MRI and an EEG, which she does not have the results of. On 2/11/21 she talked to the neurologist who insisted it was due to the vaccine. He has now settled down and has not had another seizure since 9:00 PM the night before. He was discharged yesterday at around 1:00 PM, he slept, got up and is fine this morning. He was diagnosed with seizures, and to FU with Dr. in Epilepsy clinic, and prescribed Keppra, which he has not taken as he feels it was due to the vaccination.. He does not remember the events that took place."" | | 196 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1031466-1 | Minor stroke; Weak muscles; Terible pain in neck and lower back; Terible pain in neck and lower back; Nerve pain; Achy; Injection site reaction; A spontaneous report was received from a consumer who was also a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced C, injection site reaction, and achy. The patient's medical history was not provided. Concomitant medications were not reported. On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, after vaccine administration, the patient experienced injection site reaction. On 22 Jan 2021, she was feeling achy. On 23 Jan 2021, she had nerve pain that felt like cutting on the back, legs, and arms. On 24 Jan 2021, the patient's muscles were weak and were not working or responsive on both sides. On 25 Jan 2021, the patient could not control her left hand and weakness was more predominant on left side. The patient went to the doctor and was hospitalized with minor stroke for 24 hours. The patient stated that she was still experiencing terrible pain in neck and lower back. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, minor stroke, weak muscles, nerve pain, injection site reaction, and achy, was unknown. The outcome of event, terrible pain in neck and lower back, was considered not resolved.; Reporter's Comments: Based on the current available information and evidence of a temporal association between mRNA-1273 use and the onset of injection site reaction and achy, a causal relationship cannot be excluded. There is limited information to asses causality for the events of injection site reaction, and achy. Additional information has been requested. | | 197 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1044497-1 | Massive headache for 24 hours following the 2nd dose Mini stroke (TIA) | | 198 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1047181-1 | Hospitalized for possible TIA or stroke or maybe Guillain Barre syndrome | | 199 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1051267-1 | Passed away; Slight soreness in arm; A regulatory report was received from a pharmacist concerning a 72-year-old male patient who received Moderna covid-19 vaccine and death occurred 4 days after the vaccine and also experienced soreness in his arm after the vaccine administration. The patient's medical history includes diabetes mellitus, Hypertension, Hypercholesterolemia, CVD, previous stroke and Depression. No relevant concomitant medications were reported. No information on allergies. On 4-FEB-2021 at 10:43 am, prior to the onset of events, the patient received his first of two planned doses of covid-19 vaccine for the prophylaxis of covid-19 infection. He had soreness in his arm the day following the shot, but he had no other symptoms. He passed away on 08-FEB-2021 at 10 am. As per his wife, they never made it to the hospital, and he had poor health prior to vaccination. Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable. The outcome of the event death is fatal.; Reporter's Comments: This is a 72 year old male with hx of diabetes mellitus, hypertension, hypercholesterolemia, and CVD who died 4 days after the vaccine was administered. No autopsy report provided. No further information is expected in this regulatory report case.; Reported Cause(s) of Death: Unknown cause of death | | 200 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1052774-1 | The patient has developed an acute ischemic stroke on the evening of receiving the COVID vaccine #1 dose. She is in the hospital with left sided weakness, facial droop and speech changes. She is receiving blood thinner and therapies. | | 201 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1053346-1 | Hemorrhagic Stroke | | 202 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1053692-1 | My mother received her vaccine at 12:40 on 2/2. She waited longer than the fifteen minutes and she seemed fine. We left the facility and on the way home, approximately 45 after she received the vaccine, she began slurring her words ands was confused. The slurring lasted for 2-3 minutes The confusion continued. I brought her the ER where she was immediately taken in for a CT Scan. She later had an MRI, and met with a Cardiologist. She later had an EEG at the request of a Neurologist. She spent three nights in the hospital. All tests showed no acute signs of stroke, etc. | | 203 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1060879-1 | stroke spent 3 days in ICU and saw a neurologist | | 204 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1061909-1 | Massive stroke; A spontaneous report was received from a consumer (patient's daughter), concerning an 85-year-old female patient, who received Moderna COVID-19 vaccine and death occurred in two days. The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies. She states that her mother was physically and mentally healthy before vaccination. On 29-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of covid-19 vaccine for the prophylaxis of Covid-19 infection. There were no complaints on any side effects from the patient for 6 hours after vaccination. Next day, she was found unresponsive on her bed by her neighbor after they were sent to check on her by her daughter. Her heart was beating, and she was breathing at that time, but did not have consciousness. According to her daughter, the patient had a massive stroke in her sleep sometime between 8:pm on 29-JAN-2021 and 9:30 am on 30-JAN-2021. Her life saving measures were taken out at 1:15 am on 31-JAN-2021 and she died approximately at 1:45am. No information available on hospitalization and treatment received with this event. It is not known whether autopsy was done. Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable. The outcome of the event stroke is fatal.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stoke, a causal relationship cannot be excluded. Patient's elderly age is considered a risk factor.; Reported Cause(s) of Death: Massive stroke | | 205 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1063574-1 | STROKE LIKE SYSTEMS /FATIGUE/ WEAKNESS IN LEG AND ARM JOINTS/LOS OF BALANCE/ DELIRIUM. | | 206 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1069978-1 | Patient has a debilitating headache on the Friday, Saturday, and Sunday after the second dose. He still had the headache but not as bad on Monday, Tuesday, and Wednesday after the second dose. On Wednesday morning, he passed out three times while in the shower and bathroom. He has been admitted to the hospital. They have ruled out a heart attack and most likely ruled out a stroke. He is still undergoing tests. | | 207 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1070583-1 | He complained of dizziness the evening of the shot. He went to bed and when he woke up the next morning he was having double vision. Is eye drifted off to the side and he was too dizzy to get up. He was taken to the hospital. They did a CT scan which didn't give a diagnosis, and they were unable to do a MRI scan due to a medical reason, so they could not determine for sure if he had a stroke. They are assuming that he did have a stroke and he has oculomotor nerve paralysis on the right side. The nurse practitioner saw him today and she reports he is doing very well now. He had been staying in a assisted living type facility when this occurred, but he is expected to return home tomorrow. | | 208 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1075922-1 | Felt bad after vaccine, had arm paint that went up my neck to my head, on 2nd day after shot I collapsed with a stroke. Blood Pressure was sky high. I was taken by Ambulance to Hospital, as I was at work at the time of the stroke. I have perfect bmi, never had high blood pressure, no health problems at all. No heart problems. | | 209 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1076108-1 | Patient received first dose of vaccine on 2/8/2021. Was monitored properly with no adverse reaction, but had a stroke a few hours later after leaving facility. Patient is still hospitalized. | | 210 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1080485-1 | Within 10 minutes of my dad receiving his COVID-19 vaccine he suffered a major stroke. | | 211 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1093414-1 | Patient received 2nd dose of Moderna COVID vaccine at approx. 10am on 03/10/21. At approx. 5pm on 03/10/21, he developed typical side effects including fever, chills, and lethargy. Additionally, he became confused. The next morning, he remained lethargic and minimally responsive. He was febrile to 106 F per daughter and somewhat hypotensive with SBP into the 80s. The afternoon of 03/11/21, he also developed right facial droop and weakness. EMS was called and he was found to have suffered a left MCA stroke. He was admitted to the hospital for this and underwent thrombectomy. Of note, he was febrile and hypotensive on admission. | | 212 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1094285-1 | Had a stroke. | | 213 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1107881-1 | pt started slurring his words and his face started drooping about 8 hours after taking the covid vax. pts wife took him to ER. They did a CT which did not show a hemorrhage. He was admitted to the floor but had a 'Stroke Code' so was transferred to ICU. Next day he had an MRI which showed he had a stroke. The following day he was given another MRI since his symptoms were getting worse and it showed additional bleeding. Pt is awake and starting to move around some but unable to communicate which speech at this time. | | 214 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1114750-1 | Stroke, fall, nerve damage, left arm (vaccine arm) | | 215 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1115035-1 | Stroke; Sleeps all the time; Extemely Tired; A spontaneous report was received from a consumer concerning, 81-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced stroke, was extremely tired and slept all the time. The patient's medical history was not provided. No concomitant product was reported. On 11-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. As per reporter patient had been extremely tired and slept most of the day since injection. On 17-Feb-2021, patient experienced stroke. Magnetic resonance imaging confirmed stroke. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events experienced stroke, was extremely tired and slept all the time were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. | | 216 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1116460-1 | Patient called today to report her adverse event. Patient reports several hours after getting her vaccines being at the ER for stroke like symptoms. Patient reports that after several test were performed they confirmed she had sustained a stroke. Patient was hospitalized for 9 days including rehab. | | 217 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1116994-1 | About 20 minutes after the vaccine was administered my Mother's speech became garbled and she was unable to speak understandably. I thought she was having a stroke so rushed her to the emergency room. They examined her and her speech returned to normal in about an hour. They kept her overnight for tests and after an MRI they said she had a TIA. We wanted to report it in case there were others who had a similar adverse affect. No one can say for sure if the vaccine caused it or not but we wanted to let you know what happened to her. | | 218 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1121305-1 | ON 3-20-2021 PATIENT SPOUSE REPORTED THAT PATIENT HAD SUFFERED A STROKE APPROXIMATELY 2 HOURS AFTER THE SECOND DOSE ON 3-18-21. SHE STATED THAT HE WAS CURRENTLY HOSPITALIZED. | | 219 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1145479-1 | Patient received vaccine at 10:18am and then went home with no reaction in the vaccination POD. EMS was called to the patients home shortly before 2:30 that afternoon. When EMS arrived patient was posturing with lower extremities extended in plantar flexion. Last seen normal 30 minutes prior. she was also tachycardic and in respiratory distress with sonorous respirations. Cranial nerve deficit present GCS 3.She was unresponsive and intubated. Airlifted after CT to hospital. She died at 1647 at Hospital from hemorrhagic stroke. | | 220 | COVID19 (COVID19 (MODERNA)) | 65+ years | 0 days | 1191979-1 | Started with intense headaches right after the 2nd dose of the Moderna vaccine on 03/06/2021. Had the headache for over two weeks, and eventually went to the hospital with loss of speech and movement on her left side of her body. They at first said it was strokes, then after the CT scan results came back they found multiple abscess in her brain. She does not have a history of strokes or brain abscess. Speech and motor functions never returned, and one abscess was so large that it caused a brain shift ( the two hemispheres separated) they performed brain surgery and it was not successful. She passed away on 3/31/2021 at 431 am. | | 221 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0917026-1 | 12/28/2020, Pharmacy staff administered Moderna COVID Vaccine. 12/29/2020, he had not eaten breakfast or lunch but did consume fluids and take his medications. BP =150/70, Temp. = 101.6, Pulse= 102, Respirations= 18 and Oxygen saturation= 97%. Tylenol 650 mg given. It was difficult for him to swallow. Also had no use of right upper extremity and unable to move lower extremity, mouth was drooping and was drooling. Physician in attendance and ordered to send to ER. 1/1/2021, received information from nurse at hospital that patient received a Peg Tube this afternoon and Clinical indication of a stroke. | | 222 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0935079-1 | Day 2 after vaccination I experienced severe headache, dizziness on standing, and stroke like movement in my right leg being unable to advance it normally when walking and my right foot turning so that I stood on the outside border of my foot. After sitting down I experienced visual disturbance in my right eye of blurred vision and corona of bright lines that zigzagged. These symptoms slowly resolved over the next hour, but left with extreme fatigue. | | 223 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0941412-1 | On 01/11/2021, within a few hours of my grandmother getting the shot her injection area became red, swollen and hot to the touch. At around midnight the day her shot she started to experience tingling on both sides of my tounge. She an unusually restless night and on 1/12/2021 woke up feeling very tired and over all worn down. Around 10:45a my I called to check on her she said she had just checked her temp and it was 99.6. She was complaining of being very cold and had the shivers. While on the phone she started to develop a stutter. At first it was one word every 14-20 word but it quickly got worse to the point where she couldn't get a full word out and just sounds. I immediately left work and went to her house. On my way we contacted 911. It took me about 10 mins to get to her house and when I got there she was semi- unresponsive on the couch making moaning noises and shaking. She was having severe muscle spasms throughout her body. You could see her muscles tighten and release. EMS got there within a few minutes after me. They checked her temp and it had increased to 101.00 she was a bit responsive and they were able to take her vitals however, it was difficult due to her shaking and convulsing. They transported her to the hospital and by they time they arrived (within 15 mins) her temp was then 102.6. She was still shaking, not lucid and stuttering her words. They hospital ran several tests to rule out stroke and other possible reasons for her symptoms- they said she had to be having a delayed reaction to the shot. She was extremely dehydrated, they hooked her up to an IV, she had an extremely elevated white blood count and was overall ""out of it"". She was given IV antibiotics and observed."" | | 224 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0941561-1 | Staff walked into resident's room around 10:00am and noted resident's left side of his face was flaccid. Nurse was called and upon assessment resident noted to have an unequal hand grasp with left worse. He was able to talk but was mumbled and hard to understand. Physician, hospice, and family were notified. Resident had a stroke at 10:06 am on 1/8/2020. He lost all ability to use his left side. Resident passed away on 1/11/2020. | | 225 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0942392-1 | chills ...fever....extreme weakness, not even able to get himself up from a chair NO strength what so ever, feeling he was going to faint at any minute , slurred speech. Sounded as if he was having a stroke and extreme dizziness.So we to him to ER. Once there they did CBC with Differential...Comprehensive Metabolic Panel ..Protime-Inr....Ptt....Sugar Ck....Urinalysis with Reflex Culture ....Then they did a CT Head W/O Contrast Stoke Protocol & an EKG 12- lead The report with all this information was printed out on 01/05/2021 03:03 PM | | 226 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0955247-1 | About 22 hours after the shot, I had a mini stroke that required going to the emergency room by ambulance. I was transported that evening to the stroke division that same evening for further evaluation, tests and care. I have never had a mini stroke before this.The doctors said it may have been from the vaccination, or it may not have been precipitated by it. They said they don't have enough information on the Moderna vaccine to make that call. | | 227 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0958971-1 | Hemorrhagic Stroke, Right Basal Ganglion | | 228 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0959620-1 | Eleven hours after receiving COVID vaccine, client started experiencing stroke-like symptoms legs/arm weakness, couldn't speak, shortness of breath, and throat swelling. Hospital ruled out acute stroke but could not entirely exclude a cerebellar stroke due to her dizziness with vertigo and nystagmus (per hospital report). Client was in hospital 2.5 days, per hospitalist. note-all work up including MRI and tte were negative for acute findings- symptoms have resolved. Hospitalist noted symptoms may be worse following second shot. Spoke with client 1/19/21 and she reported feeling weak and tired only. | | 229 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0960025-1 | Pt presented to ED with Left facial numbness and concern for stroke. Observed over night. MRI brain negative for acute process. Stable at baseline neuro status 1/10/21, discharged home. | | 230 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0964460-1 | Sometime within 12 hours from receiving vaccine he had a stroke. He was taken to the emergency room on January 16, 2021 and tests were performed and he was transferred to Hospital on January 17, 2021. A MRI was performed on January 17, 2021 and showed that he had suffered a stroke. He was put on blood thinners and sent home on January 18, 2021. He had an appointment with MD on January 19, 2021. He has appointments with speech therapist, cardiologist and neurologist. | | 231 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0964666-1 | Patient suffered stroke morning after vaccine. | | 232 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0964750-1 | Pt well until approximately 2:55am when she passed out in bathroom according to her husband. Pt was diaphoretic. Denied dyspnea, chest pain, fever, redness, or difficulty breathing. Patient: Age: 76 Years Additional information for Item 18: Date/Time: 01/22/21 03:19 Time of my initial contact with patient: 0319 Mode of Arrival: Ambulance Private Medical Doctor: Triage Narrative: Pt. bib medics from home after near syncopal event in bathroom, lowered herself ot the ground, no LOC/trauma. BP on medic arrival was 86/50 HR in 50s, improved to 100/68 w/ lying down and 250ml bolus. Received 1st covid vax today, has felt weak w/ diarrhea since then. Denies pain, skin pale/w/d, AxOx3, resp e/u. Chief Complaint: Syncope/Near syncope History of Present Illness: This is a 76-year-old female with history of CAD status post remote PCI, previous CVA on Plavix, hysterectomy, migraines who presents ER today for a syncopal event. Patient was given her first dose of Covid vaccine earlier today, per patient's primary doctor found in prior to arrival she had been very hesitant because she was concerned for triggering migraines, this was clear with her neurologist that she was pretreated with Benadryl, she states that she initially felt fine after vaccine administration, she states however later in the evening she developed 4 episodes of loose watery bowel movements and crampy abdominal pain, she states she was feeling tired and so she laid down to go to bed, she states that she woke up feeling as if she had to have another diarrheal episode, she reports that when she stood up and went to the bathroom she was not feeling well, she reports feeling very lightheaded while on the toilet and trying to have a bowel movement, she attempted to stand up however felt acutely lightheaded, she states that she sat back down the toilet and slumped down and woke up on the ground. She denies any pain other than her abdominal pain and a sensation that she has had further bowel movements. Per EMS patient was noted to be hypotensive on arrival 86/50 with heart rate in the 50s, this improved with laying flat on the gurney and given a 250 cc bolus. Patient has been seen in the past for syncopal events with postural changing. She denies any new medication changes, she states that she had been drinking water throughout the day but has had a poor appetite no dysuria frequency urgency no headache head injury neck pain back pain new numbness tingling or weakness in arms or legs no difficulty with speech Problem List & Past Medical/Surgical History: CAD (coronary artery disease) Dysuria Hysterectomy Migraine Potential stroke Stent Family History: No related illness Social History: The patient does not smoke tobacco or abuse alcohol. Allergies: Imitrex morphine (Nausea) shellfish traMADol Medications: Available Med List Reviewed Review of Systems: All other systems reviewed and are negative except per HPI Physical Exam: Vital Signs BP: 151/93 mmHg Temp (Oral): 36.4 DegC ( 97.5 DegF) HR: 73 bpm Resp: 18 br/min SpO2: 97 % GENERAL: Patient appears well developed, well nourished. HEENT: Normocephalic and atraumatic. EOMI. No scleral icterus. Airway is patent NECK: Supple Trachea is midline. No midline tenderness full range of motion without pain or discomfort RESP: Lungs are clear to auscultation bilaterally. No wheezing, rhonchi, rales CARDIOVASCULAR: Regular rate and rhythm 2+ radial and DP pulses symmetric bilaterally GASTROINTESTINAL: Abdomen is soft, mild diffuse tenderness and nondistended. No rebound, no guarding. No pulsatile mass appreciated. BACK: No CVA or spinal midline tenderness to palpation MUSCULOSKELETAL: No clubbing, cyanosis, or edema. No calf tenderness to palpation. SKIN: Warm and dry. No external evidence of trauma NEURO: The patient is alert and oriented x3, not confused. Speech not slurred. Normal facial symmetry. No subjective facial numbness. No vision changes. EOMI. Upper and lower extremitites with 5/5 strength globally. Normal sensation noted over all extremities. No subjective dizziness. Finger-to-nose testing normal. Normal gait. PSYCHIATRIC: Alert and appropriate. Test Results: Labs Results 01/22/21 03:38 134 L 102 9 109 4.2 23 0.6 01/22/21 03:38 12.9 9.6 355 37.8 01/22/21 05:20 Cardiac Studies Troponin-HS <2.0 01/22/21 03:38 Hematology WBC 9.6 HGB 12.9 HCT 37.8 PLT 355 MCV 94 RBC 4.03 MCH 32 MCHC 34.2 RDW 13.1 MPV 6.1 L Neutrophils 55 Lymphocytes 34 Monocytes 8 Eosinophils 2 Basophils 1 Neut Absolute 5.2 Lymph Absolute 3.3 Mono Absolute 0.8 Eos Absolute 0.2 Baso Absolute 0.1 Cardiac Studies Troponin-HS <2.0 Chemistry Calcium Lvl 8.1 L Anion Gap 9 Sodium Lvl 134 L Potassium Lvl 4.2 Chloride 102 CO2 23 Glucose Lvl 109 BUN 9 Creatinine 0.6 Alk Phos 75 ALT 13 AST 15 Bili Total 0.4 Total Protein 5.8 L Albumin Lvl 3.5 LAB >60 LAB >60 01/22/21 03:17 Chemistry Gluc POC 106 Gluc POC 106 (01/22/21 03:17) Diagnostic Results Preliminary CT head reveals no acute intracranial abnormality Preliminary CT abdomen pelvis revealed no acute intracranial abnormality other than hiatal hernia Chest x-ray is negative for acute pulmonary pathology EKG Results EKG obtained at 0323 interpreted by me reveals normal sinus rhythm, patient has diffuse T wave flattening which appears similar to previous no STEMI, no ectopy no heart block no WPW Brugada prolonged QTC Emergency Department Course and Procedures: Medications, IV's and Blood Products Ordered Sodium Chloride 0.9% (Sodium Chloride 0.9% Bolus) 1,000 mL once IV Bolus, Reason for Infusion = Abnormal fluid losses Other Orders Nursing to Initiate Saline lock Insertion Careset (Stat) Oxygen Therapy (Titrate for SaO2 > 95%) Reexamination/Reevaluation: Critical Care Note The high probability of sudden, clinically significant deterioration in the patient's condition required the highest level of my preparedness to intervene urgently. Critical care was necessary to treat or prevent imminent or life-threatening deterioration of the following conditions: cardiac failure, circulatory failure, CNS failure or compromise, dehydration, hepatic failure, endocrine crisis, metabolic crisis, renal failure, sepsis, respiratory failure, shock, toxidrome and trauma. I provided critical care services requiring my management in the following manner: chart data review, documentation time, medication orders and management, re-evaluations, vital signs assessments and reviewing monitor data, and ordering and reviewing lab tests. Aggregate Critical care time was 30 minutes. My time did not include minutes spent treating any other patient simultaneously or on activities that did not directly contribute to the patient's treatment. It did not include time spent performing other reported procedures. Medical Decision Making: This is a 76-year-old female who presented ER today for evaluation of syncope. Patient was reportedly mildly hypotensive which improved with IV fluids. I suspect that patient had dehydration given 4 episodes of large watery stools. Patient had no recent antibiotic use and has no C. difficile risk factors, suspect this may be related to her Covid vaccine, she had no evidence to suggest anaphylactic shock, patient felt better after IV fluid bolus was able to ambulate around the emergency department without lightheadedness or near syncope. She had troponins x2 which were negative, her EKG was nonischemic and there was no evidence of ectopy or arrhythmia. Patient did have syncope and fell onto her side, she denies discrete head injury although patient is anticoagulated, CT head was obtained to rule out intracranial hemorrhage given the syncopal event. Patient CT abd/pelvix was negative for obvious cause of patient's abdominal tenderness may be related to her diarrheal illness patient will be prescribed Bentyl. She will call her primary care doctor in the morning to arrange close follow-up. She understands need for aggressive oral hydration at home. She will have low threshold to return should she develop lightheadedness syncope chest pain shortness of breath palpitations worsening abdominal pain bloody or dark stools any new or concerning symptoms. The patient presented to the emergency department with potentially life or limb-threatening symptoms. After my history, examination, and workup have decided that the patient is stable. My impression is that they are safe to go home at this time. I have reviewed ED return precautions with the patient. They understand to return if they are concerned for any reason. They will follow-up with their PCP in 1-2 days. Impression: Syncope, hypotension√improved, dehydration Plan: Discharge Follow Up Within: 1-2 days Comments: Please call your doctor in the morning to arrange follow-up with your primary care doctor in the next 24 hours. Please stay well-hydrated and eat regular meals. Please take Bentyl as needed for abdominal cramping with diarrhea. Please return to the ER if you develop worsening abdominal pain, feelings of lightheadedness passing out any new or concerning symptoms. Patient Education Syncope, Easy-to-Read Diarrhea, Adult Discharge Meds dicyclomine 10 mg 1 cap, PO, QID, 20 cap Referral for suspected pre-hypertension or hypertension was given. Please note: Unless specifically stated, all procedures mentioned, tests done and medications given were performed/interpreted by the emergency physician, or were under the direct supervision of the emergency physician. This ED Note was completed using voice-recognition transcription and may contain inadvertent errors. Additional information for Item 9: | | 233 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0965323-1 | Sudden onset of expressive aphasia the next morning (0915) after vaccination. Went to emergency room and diagnosed with stroke. | | 234 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0968972-1 | Right eye Central Retinal Artery Occlusion resulting in blindness in right eye. Sight lost suddenly. Hospitalized for stroke assessment. | | 235 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0971989-1 | Following are my symptoms and severe side effects and events after receiving the COVID-19 Vaccine. 1- Receive COVID 19 vaccine at 4.00 PM on 01/15/21. 2- Stay about 20 minutes after Vaccination and observe no reactions and symptoms. Dive back home. take dinner and sleep well whole night. 3- Next day morning when I wake up feel till bit of Nausea/Vomiting. 4- Take breakfast at about 10.00 AM and after that feeling of Nausea got increased and i also start feeling weakness. These symptoms remains all day. 5- At about 5.15 PM I went to take Shower. After about 2 minutes during shower, i feel shortness of Breath,pressure on chest and Dizziness 6- These Symptoms was for about 4 to 5 second and goes off. 7- After about one minute I feel second time shortness of Breath, pressure on chest and Dizziness. It was bit intensive and for a longer period for about 10 second. 8- At this point I realized that this is something serious happening to me. 9- I came out from the Vertical Shower and called my wife that I am not feeling well. She was at this time at first floor. 10- I think it is about 1 minute after when I came from shower, I feel third time shortness of Breath, pressure on chest and Dizziness. I was very severe and within a second or so I passed out and fell down into the Jacuzzi which is beside the Vertical Shower. 11- Within a minute, my wife and my son came to the scene. At this time my wife finds me unconscious with my eyes open. 12- She shouted my name and then I came into my senses and told them to get me out of Jacuzzi. 12- My wife and my son get me out and carried over to the bedroom. I was feeling no shortness of Breath and Dizziness but mild pressure on chest, shivering and chill. 13- Thanks GOD I did not get any body injury except little bit of hit at my Neck and back of the Head. 14- My wife immediately called to my Primary Care Nurse and then I talk to her explain the whole situation and then asking for advise. 15- She advise me to go to any near Hospital Emergency for any urgent Medical care. 16-A about 6.00 PM I went to Emergency. At this time I was feeling Nausea and Shortness of breath. 17- The Nurse immediately check my blood pressure, temperature, oxygen and pulse. These all was normal. Nurse also provide me IV medicine for Nausea. 18- During my stay at Emergency, I again feeling mild tightness/pressure in chest beside shortness of breath and shivering, therefore Emergency Doctor advise me that will admit to the hospital and do the complete check of any stroke and heart attack. 19- I was in the Hospital for 2 nights. During this stay I was under care of: -Attending Physicism: -Cardiology Physician 20- They have carried out Multiple Blood and Radiology Test as stated below. As per Doctors, all of my Test results are Normal, and they did not find any sign of Stoke and Heart Attack. -Multiple Blood Lab test. -XR CHEST 1 V -CT C-SPINE WO CONT. -CT HEAD-BRAIN WO CONT. -CT ANGIO HEAD W&WO CONT. -CT ANGIO NECK W&WO CONT. -CTA CHEST FOR PE -MRI BRAIN WO CONTRAST . -STRESS TEST. 21- I was discharge from the Hospital on 01/18/21 at 17.34. | | 236 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0974584-1 | Stroke like symptoms; Water in lungs; A spontaneous report was received from a consumer concerning an 83-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke like symptoms and water in lungs. The patient's medical history was not provided. Concomitant products known to have been used by the patient included, insulin aspart, insulin glargine, ticagrelor, sacubitril valsartan sodium hydrate, furosemide, carvedilol, omeprazole, and sertraline. On 04 Jan 2021, one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Jan 2021, the patient began experiencing stroke-like symptoms and had water in his lungs. On 06 Jan 2021, the patient was hospitalized and had a computed tomography (CT) scan and magnetic imaging resonance (MRI) scan of the brain. On 09 Jan 2021, the patient was discharged from the hospital. Treatment information for the events was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, stroke like symptoms and water in lungs , was not reported.; Reporter's Comments: This case concerns an 83 year old male patient who experienced serious unexpected events of Cerebrovascular accident and Pulmonary oedema. The events occurred the next day of their first dose of their first of two planned doses of mRNA-1273. Concomitant medications included, insulin aspart, insulin glargine, ticagrelor, sacubitril valsartan sodium hydrate, furosemide, carvedilol, omeprazole, and sertraline. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. | | 237 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0987374-1 | Patient was in distress and had a Stroke ( per his wife). Ambulance called and pt was admitted to hospital. | | 238 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0998725-1 | Patient daughter reported that patient was admitted to Neurology with a stroke. She has cognitive and speech impairment as well as motor impairment. She was admitted either 2-2-21 or 2-3-21. She is still in the hospital. | | 239 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 0999192-1 | According to the staff at the Hospital, the patient was treated in their emergency room for a stroke this morning at approximately 730AM | | 240 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1004209-1 | Stroke like symptoms; Couldn't speak; Shortness of breath; Legs and arm weakness; Dizziness with Nystagmus; Throat swelling; Dizziness with vertigo; Dizziness with vertigo; A spontaneous report was received from a nurse concerning a 79-year-old, white, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. The patient's medical history, as provided by the reporter included anemia, overactive bladder, fibroid cystic disease, allergy to fluoroquinolone, ciprofloxacin, povidone iodine, morphine and adhesive tape. The concomitant medications reported included atorvastatin, calcium, colecalciferol, metoprolol succinate, pramipexole hcl and prasugrel hcl for unspecified indications. On 07 Jan 2021, 11 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient experienced stroke like symptoms, couldn't speak, shortness of breath and throat swelling. It was reported that the patient was hospitalized for acute stroke. On an unknown date, while still being hospitalized, the patient developed, dizziness with nystagmus and dizziness with vertigo. The lab findings included, magnetic resonance imaging (MRI) and computed tomography (CT) scans as negative for acute findings, electrocardiography (EKG), complete blood count (CBC), X-ray and chemistries were reported as within normal limits. The patient remained hospitalized for 2.5 days while the symptoms improved. On 09 Jan 2021, the patient was discharged. On 20 Jan 2021, the reporter stated that the patient felt weak and tired without other symptoms. It was also noted that the patient's discharge summary stated the patient's symptoms may be worse following a second dose of mRNA-1273 vaccine. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. were considered as resolved on an unknown date.; Reporter's Comments: This case concerns a 79-year-old, white, female patient with medical history of anemia, overactive bladder, fibroid cystic disease, who experienced the serious, unexpected event of stroke, Aphasia, dyspnea and non-serious, unexpected events of , dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness. The events of stroke, Aphasia, Dyspnea and pharyngeal swelling occurred 11 hours after the first dose of mRNA-1273 (Lot number: 025J20-2A) administration and the events of dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness occurred on an unknown date while the patient was still hospitalized. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. | | 241 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1009866-1 | pt was given vaccine on the afternoon of 01-29-2021. Pt was administered the moderna covid-19 shot into the deltoid muscle of this pt. Pt was observed and left pharmacy. on 2-6, pts daughter calls pharmacy, and says the night of 1-29, after recieveing the vaccine, her mother had a hemmorhagic stroke and passed away | | 242 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1013235-1 | Patient was transported to a local hospital, She experienced a stroke. | | 243 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1020873-1 | Cerebral stroke. Symptoms onset was documented by nursing home staff on 1/13/21. Second dose of vaccine was received on 1/12/21. I am unsure at this time if it was the Pfizer or Moderna vaccine. Patient has severe defecits at this time but the brain is still healing. Several weeks in the hospital, patient now has peg tube and picc line. Flaccid right side and speech severely impacted. | | 244 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1022513-1 | Arrived to ED with slurred speech, potential stroke, was transferred to Hospital for higher level of care. | | 245 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1025585-1 | Lost all muscle control. couls not sit up stand or walk: stroke likwe symptoms hospitalized 3 days Cat scan, EKG, MRI, heart monitor | | 246 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1031790-1 | Received influenza vaccine 1/29 at PCP clinic. Received Moderna vaccine on 2/6 by pharmacist at her place of residence. She was taken to the ER on 2/9, unresponsive. Staff reported she wasn't acting normally since 2/7. During her hospital course (2/9-2/13) she was only able to open her eyes. Unable to follow any commands. MRI showed large right MCA stroke. She was discharged from the hospital on hospice. | | 247 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1032865-1 | 4am (1/29/2021) extreme sweating to the point of soaking the hair on head; extreme dizziness with vertigo and inability to stand up or walk straight leading to nausea and vomiting 11am( out of bed) needed assistance to chair bc of vertigo and vision impairment; spent most of day seated; cont to require assistance with any walking 9pm to bed 8am(1/30/2021) Wake up and all symptoms worse. Unable to walk without assistance and had a severe body lean to left. Husband called doc and they suggested calling 911 to get to ER ASAP 1130 Arrived at hospital ER and was subsequently diagnosed and admitted with a cerebellar stroke | | 248 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1040535-1 | Stroke (blood in the brain); heavy legs; not feeling himself; difficulty walking secondary to stroke; Bad Headache; A spontaneous report was received from a consumer concerning a 65-years-old, male patient who experienced bad headache, stroke (blood in the brain), difficulty walking secondary to stroke, heavy legs, and not feeling himself. The patient's medical history included atrial fibrillation (A-Fib) four years ago. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included blood thinners. On 10 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient experienced a headache. On 28 Jan 2021, he reported having a bad headache, heavy legs and was not feeling himself. On 29 Jan 2021, the patient was admitted to the hospital and was told he had a stroke (blood in the brain). Patient was discharged on 02 Feb 2021. He now has difficulty walking and is trying to walk with a walker and has to go to rehab. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events bad headache, stroke (blood in the brain), difficulty walking secondary to stroke, heavy legs, not feeling himself and headache were resolved on 02 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Of note, patient's medical history of atrial fibrillation and concomitant use of blood thinners may have been contributory for hemorrhagic stroke. | | 249 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1044692-1 | Right hemisphere stroke. Currently hospitalized. Stable condition. | | 250 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1047033-1 | Had vaccine on 2/15 , then on 2/16 evening had stroke like symptoms trying to turn the TV channel and could not find numbers on remote. then her friend called and could not formulate words to her on the phone and could not say the words that she was thinking. Then she called her brother who is a doctor and he told her to go to Cardiologist and get in. She was talking normal by the time she talked to him. Adverse reaction was TIA. TIA symptoms lasted 5-10 minutes max per patient. | | 251 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1047596-1 | Stroke and seizure ( In the past he had a stroke and seizure ) So this is not his first time and we are not sure if this is related to the vaccine. | | 252 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1049146-1 | Loss of control of my bladder. Couldnt walk. Taken to urgent care. Cardiogram was done. BP was over 300. Taken to Hospital, CAT scan confirmed that I was NOT having a stroke. after 4 days I was fine | | 253 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1049814-1 | Stroke confirmed on MRI. | | 254 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1051703-1 | Patient had sore arm the first day, the second day patient had slurred speech, couldn?t remember or say words, went to the hospital, CT scan and it showed a stroke, AFib came back that had been resolved, he had to be bagged for 2 minutes because he stopped breathing, MD told him the covid shot may have reacted negatively with his previous heart surgery | | 255 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1052478-1 | Patient presented to the emergency department after being found down in her home and presented with right upper and lower extremity weakness and a right-sided facial droop. Patient's presentation was consistent with an acute ischemic stroke which was confirmed on MRI. | | 256 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1052496-1 | Numbness and tingling on right side of body, onset < 24 hours after vaccine was administered. Equilibrium affected. Treated at hospital ER and admitted. Acute ischemic VBA thalamic stroke. | | 257 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1055691-1 | Massive ischemic stroke with aspiration, unable to arouse on the morning of 1/21/2021 and placed on Hospice with death 1/24/2021 | | 258 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1055819-1 | On January 1, 2021, patient was admitted to Medical Center with COVID. Tested positive on January 2, 2021. Spent 10 days in hospital. Once recovered from pneumonia and fever gone, on January 10, 2021, she was transferred to Rehabilitation Center for continued treatment. She spent 16 days there. She developed UTI and CDIF infections and was on/off oxygen. She started physical therapy. She was scheduled to be released to go home on January 27, 2021. On January 26, 2021, the day before going home, Rehabilitation Center gave her the Moderna vaccine. On January 27, the day she went home, she started feeling very weak and couldn't walk. My dad tried lifting her and they both fell to the ground. My dad called 911 and she was taken to Medical Center, with high fever and possible stroke symptoms (which later was negative). Two days later, she had difficulty breathing and was put on a ventilator. She was on a ventilator for about three days. They took it off and she slowly started recovering. The doctors did all kinds of tests (blood clot in lung, heart, etc.) and all was negative. The only thing they could trace it to was an adverse reaction to the vaccine. After spending 11 days at hospital and treating her for various infections, her heart stopped and she passed away suddenly. | | 259 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1056452-1 | left sided weakness; Stroke like symptoms; Slurred speech; Pneumonia; spontaneous report received from a Consumer concerning, 79-year-old female patient who received the first dose of Moderna COVID-19 vaccine and woke up the next morning not feeling well. /PT: [Not Feeling Well]. The patient's medical history included COPD, hypertension and hyperlipidemia. Patient allergies included sleep medications. Patient's concomitant included Gabapentin, Simvastatin, Advair, Spiriva and Proventil. On 04-FEB-2021, the patient received their first of two planned doses of mRNA-1273 in left arm (Batch #: 016M20A) intramuscularly for prophylaxis of COVID-19 infection. Patient daughter called on behalf of her mother. Patient daughter stated that her mother received the Moderna COVID-19 vaccine on 04FEB2021 and on 05Feb2021 her mother woke up and wasn't feeling well. She stated her mother had weakness on her left side. The daughter stated that ambulance took her mother to hospital. The daughter stated that her mother had stroke like symptoms. The daughter stated her mother had difficulty speaking and slurred speech. The daughter stated the doctor Called it ""Neglect for sensation"". The daughter stated her mother was treated like she had a stroke. The daughter stated that the doctor gave her mother a ""Clot buster"" treatment and it started to normalize. The daughter stated the MRI was negative. She daughter that her mother was still hospitalized and now has pneumonia. Wanted to know if this has been previously reported. Treatment that was given in the hospital was a ""Clot Buster"" Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: The events developed on same day after first dose of mRNA-1372. Hemiparesis, dysarthria, and pneumonia were consistent with increased risk of cerebrovascular accidents related to high blood pressure confounded by elderly age of patient. Very limited information regarding this event/s has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded."" | | 260 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1058214-1 | The day following Moderna #2 (on 2/17/21) she had sudden onset of confusion. She thought the remote control was the telephone and speech was confused. No motor deficits. Was taken to ER and then admitted to Medical Center for stroke-like symptoms. Admitted 2/18/21, discharged 2/20/21 with diagnosis of Acute Encephalopathy (possible TIA) and Accelerated hypertension. | | 261 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1060146-1 | unresponsiveness, left hemiplegia, no evidence of stroke on imaging | | 262 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1061907-1 | Double vision; Chills; Low graded fever (99.8); A spontaneous report was received from a consumer, concerning a 75-year-old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced double vision, chills and low graded fever (99.8). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 30 JAN 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 31JAN2021, after the vaccine administration, the patient developed chills and low-grade fever of 99.8, hence he was given with acetaminophen to alleviate these symptoms. On 01 FEB 2021, the patient started experiencing double vision, hence, on 05 FEB 2021, the patient went to their eye doctor who instructed the patient to go to the emergency room (ER). The ER doctor admitted the patient to the hospital to run some tests and labs. The patient was tested for stroke, tumor, and bell palsy and all these tests were negative. The hospital conducted several CT and MRI and they were all negative. The neurologists did not know what was going on with the patient. Hence, he was discharged from the hospital on 07 FEB 2021. The patient was still having symptoms. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable. The outcome of the events double vision, chills and low graded fever (99.8) were considered not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. | | 263 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1073412-1 | Initial flulike symptoms with fever Tues -Friday. Had a right side stroke 6 AM Saturday morning . Rushed to hospital and had a procedure involving a catheter through the body to the clot in the brain. Came out of that with a weekend left side and was medicated through Sunday night. At 10:30 PM Sunday night had a second stroke on the right side. Did not wake from that. Now I?m not expected to survive. | | 264 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1078464-1 | My birthfather had an adverse reaction after he got his 1st Moderna COVID vaccine. He lives alone and was doing well with some underlying conditions. The day of the shot was fine. The next AM, he had vision changes and sudden numbness in his R arm/leg and fell after getting up. ?The numbness went away pretty quickly, but the visual changes remained. He refused to go to the ER/Dr. The next week and a half, he was weak, tired, and couldn?t think as clearly. ?He was brought to the ER? on Wed, 3/3/21 at Hospital. He was found to have a low oxygen level, possible a-fib, fluid retention, emphysema, and aortic stenosis, in addition to his other health issues. ?The Dr said his symptoms the day after the vaccine were a mini-stroke.. He was released from the hospital on Friday, 3/5/21. On Saturday, Hospice came to see him, since nothing can be done for his medical conditions; however, they decided not to sign him up yet, since he I was told they didn't feel he needed to, at this time. One of my sisters is staying with him during the day until he builds his strength back up. Do you think his Mini stroke and health changes had anything to do with the vaccine? He will not be getting the second COVID shot. ?We?re all caught between a rock and a hard place as far as what to do, esp for older folks. | | 265 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1090674-1 | Acute ischemic lacunar stroke in left ligament resulting in mild left leg weakness | | 266 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1091828-1 | As reported by son and by DON of Medical Center: 02.06.2021 Son reports that patient had spoken with her daughter the morning of 02.06 via phone and that patient sounded fine. Patient's son tried to call her around 3:30 or 4 and there was no answer. Son called the facility where patient resided and staff went to check on her, where they found patient on the floor, conscious. Patient was communicating fine when they found her. It is unclear if she bumped her head when she fell, but patient deteriorated and was taken to ER where a CT was done and it was determined patient had a brain bleed as well as a UTI. Patient was admitted to hospital. Patient subsequently had a stroke while in hospital. Patient was discharged to rehab facility on 02.23.2021 and while she has regained the ability to walk with a walker and some use of her right hand, she remains unable to speak. | | 267 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1094879-1 | 69 year old male with a PMH of hypertension and T2DM who was admitted on 3/12/2021 for lactic acidosis, hyperglycemia (to 580s), RUE weakness/dysarthria/weakness (now resolved), and septic shock of unknown etiology. Outside Hospital: Seen at ED where a stroke code was called for headache, RUE weakness, dysarthria with a CT and CTA that were negative for any acute changes. He he was febrile to 102.2, tachycardic to 130s, hypotensive with pressures in the 80s systolic unresponsive to fluids, leukocytosis to 15 and lactate of 3.5. He was started on vancomycin, ceftriaxone, ampicillin, acyclovir, and dexamethasone. Additional workup including an LP, UA, and CXR were all unremarkable. He was transferred here due to a lack of beds. Of note, the patient received his second COVID-19 vaccine dose on 3/10 and had been febrile since the morning of 3/11. Hospital ICU: Patient is hemodynamically stable and has been fully weaned off pressor support. His hyperglycemia is decreasing satisfactorily to insulin and is receiving IVF. Repeat lactate for PM of 3/12 and workup for TIA initiated. Assessment and plan : 69 year old male with a PMH of hypertension and T2DM who was admitted on 3/12/2021 for lactic acidosis, hyperglycemia (to 580s), RUE weakness/dysarthria/weakness (now resolved), and septic shock of unknown etiology requiring vasopressors, antibiotics, and TIA workup. I have personally reviewed the daily labs, imaging studies, cultures and discussed the case with referring physician and consulting physicians. My assessment and plan by system for this patient is as follows: Neurology/Psychiatry: # RUE Weakness, headache, dysarthria Presented to Hospital with RUE, headache, and dysarthria with negative CT and CTA. The patient has a known hx of diabetes and hypertension with a recent elevated A1c. His hypotension as a result of sepsis may have revealed territories in his cerebrum particularly affected by his likely vascular disease. Will initiate TIA workup. Pending results, will consider Neurology Consult. Plan: - ASA 81 mg PO daily - Echocardiogram - Fasting lipid panel - Bilateral carotid artery ultrasound Cardiovascular: # Hemodynamics, Rhythm, Ischemia # Septic Shock Weaned off NE, still on Vasopressin 2.4. Monitor shows NSR in the 70s. Has now been weaned off vasopressors. Plan: - Weaned off pressors # History of hypertension Plan: - HOLD PTA lisinopril Pulmonary/Ventilator Management: # Airway, Oxygenation, Ventilation, Mechanics: No airway in place. Unlabored breathing on room air without assistance with sats in mid-90s. Plan: - Monitor GI and Nutrition : # BMs/Gas/Feedings: Reports having diarrhea. No enteral feeds. Plan - Monitor electrolytes Renal/Fluids/Electrolytes: # Electrolytes, Acid/Base, Volume Patient is septic and requiring pressors. He is also having diarrhea, so monitor electrolytes, creatinine, UOP. Glucose responding to insulin, most recently 159. If this afternoon's lactate and creatinine normalize this afternoon 3/12/21 and the patient continues to eat/drink ok (which he has been), then we can turn off his IVF. Plan: - HOLD Metformin given elevated creatinine and risk of metabolic acidosis - Lactated Ringers at 75 mL/hr continuous - Trend BMP - Monitor UOP - Venous Blood Gas - Electrolyte replacement per ICU protocols - Generally avoid nephrotoxic agents such as NSAID, IV contrast unless specifically required - Adjust medications as needed for renal clearance - Follow I/O's as appropriate Infectious Disease: # Septic Shock # Leukocytosis # Lactic Acidosis # Recent Covid-19 Vaccine Patient was tachycardic to the 130s, hypotensive with systolic pressures in the 80s, and febrile to 102.2 F. Worked up extensively at outside hospital with the following perfomed: Negative CT/CTA, unremarkable lumbar puncture, unremarkable CXR, and unremarkable UA. His pressures were not fluid responsive at that time, so we will continue some further workup here as below. In addition, there remains the possibility that this patient's current status may be a result of the Covid-19 vaccine and cannot be ruled out given its temporal relationship to his presentation. Will document this potential reaction with the Department of Health. Patient's most recent lactate returned at 6.5 and likely reflects his critical illness in combination with decreased clearance (given that his creatinine was 1.7, unclear baseline). Plan: - MRSA Swab, nares - Stool Ova and Parasite - CSF Culture - CSF HSV (from outside hospital, pending) - Continue piperacillin-taxobactam - Trend procalcitonin - Trend lactate - Report possible Covid-19 reaction with DH Endocrine: # Hyperglycemia # Recent Diagnosis of T2 DM not on Insulin Was found to be hyperglycemic in the high-500s on arrival. At least part of his hyperglycemia is a result of receiving dexamethasone at the hospital. However, his most recent A1c on 3/12 was 8.8 and his diagnosis of T2DM is recent. Plan - Diabetic diet - Nutrition consult - Insulin bolus 5 U - ICU insulin protocol with goal of BG <180 - HOLD PTA metformin Hematology/Oncology: # Hgb, Platelets Within normal limits. - Monitor as appropriate # Leukocytosis Leukocytosis to 15.4 here. Plan as above. Plan - Trend CBC MSKL/Rheum: # Right Shoulder Pain Reports having some right shoulder pain over the last few weeks, exacerbated by shoveling snow. Pain with right arm abduction. Pain is greater in arm and forearm than shoulder itself. Plan: - Tylenol PRN for pain - Outpatient f/u as needed. IV/Access: 1. Venous access - Left brachial PICC, left wrist PIV 2. Arterial access - None ICU Prophylaxis: 1. DVT: Hep Subq/ LMWH/mechanical 2. VAP: Not applicable 3. Stress Ulcer: Not indicated 4. Restraints: Not indicated at this time 5. Wound care - per unit routine 6. Feeding - Diabetic Diet 7. Family Update: Updated wife who was at bedside on AM 3/12/21. 8. Disposition - ICU pending further workup, treatment, and continuation of vasopressors. | | 268 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1095848-1 | Hours after receiving the 1st Moderna Vaccine patient realized left arm would not move at all and left leg was weak and dragging. Called ambulance and was transported to Hospital. No other signs of a stroke, other than paralyzed left arm and weak leg. Initial scans did not show a stroke. Patient could talk fine, smile, etc. Ran tests in ER, then admitted patient. Treated with muscle relaxers given arm was bent and stiff and would not move. After admitted, the next day an MRI was performed and indicated a stroke in the part of the brain which affects the left side. Began treatment for stroke with blood thinners, etc. Patient moved to Rehab after 4 days in hospital. Remained in Rehab until Monday, March 15th then discharged with weakness in arm and leg remaining. | | 269 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1104469-1 | Excrutiating leg pain from knee to groin began on day after first shot 1/28/2021 then after 2nd dose was given on 2/24//2021 a massive stroke occured within 8 hours. | | 270 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1107218-1 | seizures; small stroke; A spontaneous report was received from a consumer (wife of patient) concerning a 78- year-old, male patient who developed seizure and a small stroke. The patient's medical history included seizure 4 years ago, stroke long time ago. Products known to have been used by the patient, within two weeks prior to the event, Cholesterol medicines, Blood pressure medicines and Aspirin. On 18 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 031M20A) intramuscularly in the Right arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, the patient developed seizure, small stroke . Treatment for the event was not reported. Doctors are not sure about the causality, but want to report it. They spoke to his doctor about not getting the second vaccine. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event's, seizure, stroke was considered unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with history of seizure confounded by elderly age of patient. Company assessed the events to be unlikely related to company product. | | 271 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1108656-1 | The next day, I had short term memory loss. I went to the hospital, and they said I had some type of heart episode. I was taken by ambulance to the hospital and was told I had a blood clot in my brain and had suffered a mini stroke. I was hospitalized for 4 nights. I was given blood thinner and I improved. | | 272 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1109667-1 | The day after the vaccine the patient had facial swelling and rash. Two days after the vaccine she awoke with aphasia. MRI of the brain was negative for stroke or obvious encephalitis. Then lumbar puncture was done which showed an eosinophilic pleocytosis | | 273 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1110453-1 | Around 11:35 PM on Thursday March 12, my father dropped his dish and drinking glass. Awokened by the noise, we rushed to him and noticed that his speech was slurred and he was not walking well. His SpO2 was 94 and his heart rate was in the 140's. His blood pressue was elevated. He has suffered a stroke in November 2020 and he was acting like he did on that day. Once he sat down, he could not get himself up. The paramedics and my brother had to help him into the ambulance where they administered oxygen. The paramedics took him to the hospital, where he was admitted to the ICU. An MRI did not reveal any damage to the brain. He was diagnosed with a TIA and discharged from the hospital on Sunday, March 14. I am not sure if the vaccine had anything to do with this episode, but I thought it should be reported just in case. | | 274 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1111266-1 | No longer has vision in that eye; Stroke; Sneezing; A spontaneous report was received from a consumer concerning a 75-years-old, male patient who experienced stroke, lost vision in one eye and Sneezing. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medicines. On 31 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 039K20A] intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 01 Jan 2021, the patient reported sneezing and had vision issues. He was told that it appeared he had a stroke. Treatment for the event included eye drops. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events stroke, lost vision in one eye and Sneezing were unknown.; Reporter's Comments: This case concerns a 75 year old, male patient, who experienced a serious unexpected event of blindness and cerebrovascular accident. Concomitant medication included blood pressure medication. Very limited information regarding this event has been provided at this time. Further information has been requested. | | 275 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1123839-1 | seizure / hospitalized for having seizure; trouble talking; biting her lips and as a result was bleeding all over.; feel sluggish.; Fatigue; runny nose; sneezing; A spontaneous report was received from a consumer concerning a 75-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced was Seizure, trouble talking, runny nose, sneezing, biting her lips and as a result was bleeding all over, Very upset / frustration, feel sluggish, and fatigue. The patient's medical history was not provided by the reporter. Current history includes stroke. Concomitant medications were carvedilol 12.5 bid, losartan 100mg, rovastatin 20mg, ezetimibe 10mg, levothyroxine 75 mcg, aspirin 81mg On 28-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the unknown location for prophylaxis of COVID-19 infection. On 25-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26-Feb-2021, the patient experienced seizure which occurred less than 24 hours after receiving the 2nd dose of the Moderna vaccine. At approximately 10:00 am, the patient wasn't able to formulate a sentence, similar to when she had a stroke. Husband drove her to the ER and she had a seizure in the car. CT Scan showed no stroke, showed a seizure. Patient was admitted, kept overnight, intubated and administered anti-seizure medicine. On 27-Feb-2021, the patient was discharged and developed flu-like symptoms (runny nose, sneezing, fatigue). Flu-like symptoms have cleared. The reporter feels the seizures are related to the prior stroke history. On 10-Mar-2021, a follow-up was received. Patient feel huge disappointment and frustration on reporting serious adverse reaction. New information about the event include that on 26-Feb-2021, her husband noticed she was biting her lips and as a result was bleeding all over. Patient stated she has never had history of seizure but after this incident neurologists put her on high dose anti-seizure medications twice daily. These medications make her feel sluggish. Treatment details provided was Keppra, anti -seizure medications. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event seizure, fatigue, runny nose, sneezing were recovered on 27-Feb-2021 and 01-Mar-2021 respectively. The outcome of the events trouble talking, biting her lips, feeling upset and frustrated and feeling sluggish were unknown.; Reporter's Comments: Based on reporter's causality and the described prior history of stroke, the event is assessed as unlikely related to mRNA-1273. | | 276 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1124024-1 | I lost vision in my right eye. The Doctor tested my eye and told me I had a eye stroke. He said he did not think it was related to the vaccine. | | 277 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1124826-1 | Patient had a mini stroke (TIA) approximately 14 hours after the 1st Moderna COVID vaccine which is when the doctors put him on Plavix, the blood thinner and an aspirin. The patient had a massive stroke with brain hemorrhage within 24 hours of the 2nd Moderna COVID vaccine which resulted in his death. | | 278 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1126882-1 | Patient's wife states that he reported a bad headache about 3 hours after vaccination, that had improved by the next morning. The afternoon of 1/27/21, within 24 hours of receiving the vaccine, patient suffered from a stroke. | | 279 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1127650-1 | I had a full stroke the day after | | 280 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1143613-1 | He was going to be discharged from Hospice on Monday 2/15/2021. The patient was in Hospice due to a stroke. The nurse indicates after the vaccine she started with stomach pain and vomiting. Hospice evaluated her, she was given Pedialyte and then she died on 2/19/2021 | | 281 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1170851-1 | suffered a Stroke within 24 hours of 1st dosage received | | 282 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1179009-1 | Blood clot (brain)/ stroke | | 283 | COVID19 (COVID19 (MODERNA)) | 65+ years | 1 day | 1212251-1 | Fall and stroke | | 284 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 0917185-1 | Severe dizziness to the point I was unable to walk or even sit without fear of passing out or falling and had to lay on the floor. Rapid heart rate, nausea, felt like blood pressure was going up a lot. Afraid I was on the verge of having a stroke. Symptoms hit abruptly with no warning. Were severe for about an hour and then started subsiding. Gradually felt better over the course of a couple of hours. After about 6 hours, symptoms completely gone and I felt fine. | | 285 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 0920769-1 | ( I am a physician )First 24-36 hours noted minimal site discomfort. On 1/1/21 @ 6 PM with dinner noted some difficulty chewing food and minor sensation on right lower lip. As evening progressed it was noticeable a small right facial droop and distorted smile. By 1/2/21 5 AM, facial droop was more noticeable as well as distorted smile. So I decided to to ED to be checked out.ED MD was contemplating between unusual presentation of Bell's Palsy, small stroke or COVID 19 presentation. Vitals except for slightly elevated BP (145/85) were NLas well as lab ( see below). PEx: tender area posterior to R Jaw. So left with Right madibular trigeminal inflammation ( limited Bell's Palsy) and consideration for steroids. I opted NO steroids since I wanted to COVID vaccine response. Since it was a holiday weekend, I finally got to talk to my PCP on 1/4/21 ( Dr, from Internal Medicine at Hospital) who agree with me n no steroids. Also no vaccine until we see course and newer recommendations over next few weeks from CDC. I am being monitored with CDC text messaging but have not received a call from them yet. since 1/1/2021 there has been improvement in that there tenderness behind the right jaw is gone. There are no new symptoms but he weakness of right lower lip and eating issues persists. When a move water around in my mouth with closed lips , it tends to leak on right side. I am hoping for full recovery but time will tell. Summary of ED physician assessment from 1/2/21 Medical Decision Making Patient seen by me on: 1/2/2021 Assessment: 72 year old male presenting with right sided facial weakness. No paralysis on exam but mildly notably weaker on R side. Otherwise, neurologically intact on exam. Differential diagnosis: Bell's Palsy, Incomplete Bell's Palsy, CNS lesion, vaccine adverse effect, lymphadenopathy Considered CVA, not a TPA candidate based on timing and minor deficits. May need to obtain MRI to evaluate. Plan: EKG, basic labs Discussed with patient, who is a physician, given risk factors and not classic Bell's Palsy, will proceed with MRI brain. ED Course and Disposition: MRI unremarkable. I feel this adequately rules out stroke and CNS lesion as a cause of facial weakness. CBC, CMP unremarkable. Patient's exam remains stable. We discussed risks/benefits of steroids. Concerns being his diabetes as well as blunting immune response to vaccine. He has mild facial asymmetry but not complete and will hold off on steroids unless worsening symptoms. COVID testing sent as discussed with patient. He will return to ED or see PCP if symptoms worsen. Dx- Bell's Palsy 01/02/21 1231 | | 286 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 0985015-1 | There were no signs of adverse affects from vaccine. She was admitted to hospital due to stroke. | | 287 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 0997081-1 | Pt suffered stroke on 1-23-21, 2 days after getting vaccine. | | 288 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1002039-1 | on 1/31/2021 she had a small stroke and she is still getting therepy. | | 289 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1009821-1 | Ischemic stroke 2 days following vaccine administration resulting in hospitalization. Symptoms began with left lower extremity weakness. The patient also reported a low-grade fever as well as fatigue and generalized weakness following vaccine. | | 290 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1026534-1 | resident had a stroke, sent to the hospital and died 4 days later | | 291 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1031925-1 | On 2/9/2021 experienced headache, chills, and sore arm 0n 2/10/2021 still experiencing similar side effects but know light headed On 2/11/2-12: 930AM experienced a TIA . I totally believed it was a by product of the Covid shot - 1st dose. Had to go to ER and go through series of tests. Now on blood thinner. Since this occurred i know of 2 people that had similar results and experienced a stroke with 2 of them experiencing major stroke and died. people had similar results Now I don't think I will take second dose - very scared NOTE: I was in great shape prior to this vaccine | | 292 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1038147-1 | Patient went into new-onset atrial fibrillation, resulting in a catastrophic stroke. Patient passed away on 2/11 as a result of the stroke. | | 293 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1040541-1 | Debilitating Stroke; Affecting the left side of her body; A spontaneous report was received from a consumer concerning an 85-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced debilitating stroke (cerebrovascular accident), affecting the left side of her body (hemiplegia). The patient's medical history was not provided. No concomitant medications were reported. On 23 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient experienced debilitating stroke, affecting the left side of her body. Treatment information was not provided. The reporter stated that the patient was now in hospice care. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, debilitating stroke, affecting the left side of her body, was unknown.; Reporter's Comments: This case concerns a 85-year-old, female patient who experienced debilitating cerebrovascular accident and hemiplegia 3 days after the first dose of mRNA-1273 (Lot number: 029L20A). Very limited information regarding this event has been provided at this time. Further information regarding patient's medical history and comorbidities has been requested. | | 294 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1049792-1 | Developed stroke like symptoms with hypertension on 2/19/2021. treated on 2/22/2021 for bells palsy with left sided facial droop and severe hypertension at dr office. | | 295 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1083159-1 | Extreme fatigue for two weeks, change in gait and hand tremors over that time - culminated into - inability to walk, hand tremors, drooping face and slurred, garbled speech - I thought he was having a stroke and called 911 | | 296 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1105125-1 | Patient had a hemorrhagic stroke | | 297 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1106505-1 | Ocular stroke. A black curtain dropped down over right eye. Went to ER on the 28th, and was admitted. Had a blood clot in the right eye. Carotid artery right side did not have stenosis, they do not know why she had a stroke. Doctor can't say that it was caused by the vaccine. She now has a permanent blind spot in right eye. | | 298 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1111710-1 | Became dizzy and left leg feeling full. Stroke, Hospitalized in ICU, regular room, then rehab, now home health care | | 299 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1116828-1 | I had a painful nodule on the left side of my neck, I applied pressure to it and I had complete loss of sensation and paralysis in my right arm that lasts 5-7 hours. MRI confirmed I had a small stroke. 85% recovered. fatigue and loss of energy. | | 300 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1117222-1 | Stroke - CVA - craniotomy & evacuation of IHC hematoma. | | 301 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1118197-1 | 2 days after receiving the second moderna vaccine my father experienced a stroke. He was transported to the emergency room medical center where he went thru a procedure to remove a clot in his left side brain. Prior to this vaccine my father was in good health and was very active and still works and owns and operates a restaurant. He has never had any problems like this before the vaccine. One day after the vaccine he was complaining about a pain on the left side of his neck area. He was doing paperwork at approx 7:40pm when he experienced the stroke. I had to call 911. My father is currently at the medical center recovering from the incident. | | 302 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1124292-1 | March 6th noticed right hand going numb but cleared up within 10 minutes. March 7th right hand went numb again and had vision problems with right eye, cleared up in about 15 minutes. March 9th right hand and right side of face went numb. Went to hospital and was examined and told I was having a stroke. I was admitted to hospital for two days. MRI showed that I had a stroke and now have some brain tissue damage. I and now going to occupational therapy to regain use of right hand. The Doctors thought that it was pretty coincidental that my first stroke symptom (transient numb right hand on the 6th) started just a couple days after I got the second dose of the moderna vaccine. | | 303 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1127860-1 | Not sure if covid vaccine caused this, but this is what happened - Received covid vaccine. two days later had violent shakes in the night. Immediately went to get a covid test out of precaution. Tested negative for covid, but positive for ""flu b"". Went home to treat flu with fluids and rest. Got no better. Went to heart doctor out of precaution, full work up...everything checked out great. Went home, got no better. Went to primary care physician, full work up...found a ""spot"" on left lung. Was given antibiotics and steroids, go home and in a few days will be getting better. 3 days later became incapacitated and had to be rushed to ER. Was admitted into hospital for 6 days to treat ""pneumonia"". Also possible UTI and sepsis. Also while in hospital found out that a mini stroke had happened. Treatment went well, oxygen levels were good. Was released with glowing reports. 24 hours later at home had to be rushed to ER again after becoming incapacitated.. Was admitted again 7 more days. During this time everything took a nose dive in succession. Lungs were failing, multiple unexplained strokes were happening (while on blood thinners, had been on blood thinner 15 years...after first stroke they changed to another blood thinner...only more strokes). After so many strokes and compounding of strokes, his neuro function started failing. He was put on life support. While on life support his organs started failing. He had to be put on comfort mode and was dead within 8 hours. A perfectly healthy 77 year old man who had never been sick a day in his life (literally) got his 2nd covid shot, two days later he fell ill. From that point on his health spiraled out of control until his death on March 19th. Every doctor (pulmonologist, cardiologist, neurologist, and all attending doctors said that it was ""atypical and abnormal"" what was happening. It should not have happened. 180 degrees from normal."" | | 304 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1128609-1 | pt had a headache and some dizziness. Next day he had gargled speech and unsteady on his feet so 911 was called. He was transported by EMT to ER . They started TPA protocol upon arrival in the ER. He had CT, MRI, Doppler study of heart and carotid, blood work. He was diagnosed w/ a stroke and then admitted to ICU where he was kept overnight. He saw a cardiologist, Internist, and Neuro doctors. He speech was clear by 3/21/2021 and was released to FU w/ his physicians. | | 305 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1137122-1 | Left side stroke, paralyzed left side | | 306 | COVID19 (COVID19 (MODERNA)) | 65+ years | 2 days | 1145251-1 | Ppt collapsed at home on 3/27/2021 late morning. Presented to ED on 3/27/21 from home around 11am with altered mental status. Was found to have a hyper acute stroke per CT head (intracranial hemorrhage). Ppt was pronounced on 3/28/2021 at 1:45pm. UNSURE IF DEATH RELATED TO VACCINE. | | 307 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 0926433-1 | Hemmoragic Stroke. Began with vision difficulty in the morning. Then I noticed she had left sided neglect. Went to ER. Treated with Andresxa (to counteract Elaquis). In SICU for 2 nights then telemetry unit for 3 nights. CUrrently in Rehab. | | 308 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 0951757-1 | evening of 1/15 mild sore throat and mild malaise morning of 1/16 awoke with extreme dizziness and true vertigo (room was spinning to the right), persisted over 40 min, followed by nausea and vomiting. Several bouts of emesis and dry heaves. Remained dizzy with continued nausea and attacks of dry heaves. Went to emergency room to rule out stroke (onset of severe dizziness , vertigo and vomiting. No prior history of vertigo). ER workup had negative brain CT scan. Was discharged after 6 hrs. Dizziness and nausea and vomiting were controlled with Zofran and Meclizine. Other than being very sleepy symptoms had resolved prior to discharge from the Emergency Room. | | 309 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 0964540-1 | Possible Todd's Paralysis. h/o L craniotomy for meningioma. s/sx stroke ruled out, aphasia and R hemiparesis. Started on Keppra | | 310 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 0969093-1 | Pt received vaccine and within 72 hrs developed a stroke. Low platelet count. Endocarditis. Emboli to liver, spleen, kidney. | | 311 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 0981406-1 | Stroke, death | | 312 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 0985751-1 | Started on 1/16/21, noticed droopiness and slurring on the left side of her mouth, and the eyelid did not want to shut properly, could not raise the eyebrow on that side. Stayed that way until yesterday, 1/28/21, was able to raise the left eyebrow and her lip was starting to normalize, but still having some droopiness from it. Called her provider and looked it up on the internet, and was told she had Bell's Palsy. Told her to keep an eye on it, and if anything else happened to go into the hospital to see if it was a stroke. It did not affect her limbs or have any other stroke symptoms, just the left side of her face. | | 313 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 0996956-1 | Positive Covid case investigation with the PA DOH. Spoke with case's daughter. States her mother recieved vaccine at clinic on 01/27/21. Had no complaints of illness or exposure to a positive case prior to vaccine. Daughter states she's independent and stays alone at night. Felt fine the day and the day after of the vaccine. Per daughter, case's last known well time was Friday 1/29/21 at 730pm. Daughter states they found her Saturday morning with stroke like symptoms and was admitted to Hospital step down unit. She was also informed by the doctor that her heart was irregular with atrial fibrillation. | | 314 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 1033426-1 | Stroke with right upper extremity weakness. Weakness improved, has mild residual weakness at this time. That still may improve in the coming months. | | 315 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 1040343-1 | 2/9: Received vaccine 2/12: Brain fog - actions disassociated from thoughts 2/14: Altered mental status - in a ""fog""; transported to ER via ambulance; neuro exam , diagnostics (CT with & w/o contrast, CTA, CT perfusion, MRI, EEG), COVID -19 PCR, blood work/urine - all negative for intracranial bleed/stroke/tumor, ischemic changes, perfusion issues, seizures, COVID, etc. Diagnosis: Transient Global Amnesia (TGA). Admitted overnight. Amnesia event lasted 7hrs from onset and mental status returned to baseline with no residual effects. The 7hr amnesia period is unable to be recalled."" | | 316 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 1056011-1 | My grandpa had a stroke on the 15th of February. He claimed he had been feeling ""off"" for a few days, but didn't say anything. A blood clot had formed in his brain. He was doing better and about to go to rehab to strength his right side of his body. On the 22nd he took a turn for the worst. He was having trouble breathing and they sedated and partially paralyzed him to put a tube in his mouth. I believe another blood clot had formed and oxygen wasn't properly going through his body. They could not stabilize him, and he passed away the same day."" | | 317 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 1102403-1 | 74 years old female (09/04/1946) got her moderna vaccine on 03/03/2021 @1300. patient reported that on 03/06/2021 @0400 she woke up with cloudy vision on both eyes. patient reported on 03/06/2021 she went to the eye doctor to check on her eyes. Patient reported 03/07/2021 she developed a black plaque on her left eye lead to vision loss in the left eye. patient was send to the hospital stayed there for 3 days she was diagnosed with stroke in the eye. patient reported penicillin allergies. patient reported no medical history. patient reported no current medications. patient called, because she wants help to get all her paperwork and the labs she have done during her stay at the hospital, to provide it to her ophthalmologist during her appointment on Monday. patient was instructed to call the hospital or to call the department of health to get the lab results. | | 318 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 1108959-1 | Stroke resulting in death. Admitted to hospital 2/21/21 as transfer from first Hospital after found collapsed in his hotel room. Left M1 occlusion, thrombectomy performed, then had hemorrhagic trnasformation. Developed worsening respiratory status after extubation, was reintubated. Given poor neurologic status, was extubated and started on palliative morphine drip. Pt died 0100 3/1/21. | | 319 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 1110537-1 | Pt was found to be having stroke like symptoms 3/15 in the morning at nursing home. he was evaluated and was transported by ambulance from one hospital to another hospital as the CT scanner was down. patient had an injury on march 1 with a cabinet falling on him breaking his femur and family not sure if at that time he had hit his head. Patient was intubated in the ER CT scan showed a massive cerebral bleed with midline shift and transtentorial herniation | | 320 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 1114896-1 | one side of his face was paralyzed/ had bell's palsy; A spontaneous report was received from a consumer concerning an 85-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and one side of his face was paralyzed (Bell's palsy). The patient's medical history as not reported. Concomitant use was not reported. On 08-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 11-Feb -2021, three days after receiving vaccine, one side of his face was paralyzed. They called the nurse line and was unsure if he was having a stroke. They were instructed that he needed to go the emergency room and to call 911. After several hours in emergency department, the healthcare professionals said he had Bell's Palsy. He was given antiviral medication, prednisone, and eye drops as a treatment. Action taken with mrna-1273 in response to the event was not reported. The outcome of event was not reported.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded. | | 321 | COVID19 (COVID19 (MODERNA)) | 65+ years | 3 days | 1125863-1 | loss of balance, inabilty to walk or stand up. stroke ?? | | 322 | COVID19 (COVID19 (MODERNA)) | 65+ years | 4 days | 0979044-1 | When I woke up to use the bathroom I was ataxic and had nystagmus. A while later I became nauseous. I took a baby aspirin because I was afraid I was having a stroke. This lasted about 5 hours. Then I developed a head ache just behind my nose. The headache subsided in the mid afternoon, but I was wiped out and slept most of the day. Today (the next morning) I feel fine, just a little tired. | | 323 | COVID19 (COVID19 (MODERNA)) | 65+ years | 4 days | 0992073-1 | Haven?t been able to stabilize his BP since vaccination. It?s been at 160/85 even with medication. He has suffered 2 strokes so this is concerning. Today he woke up with his BP 176/87. | | 324 | COVID19 (COVID19 (MODERNA)) | 65+ years | 4 days | 1056842-1 | The medical facility did not treat patient as her primary care, but were informed that she passed away on 15 February 2021 of a stroke. I do not have further information on the medical aspect of this as we were not her treating provider but did administer the vaccine on 12 February. | | 325 | COVID19 (COVID19 (MODERNA)) | 65+ years | 4 days | 1061434-1 | I am the patient's daughter as well as an RN-BSN. My mother was given the Moderna vaccine on Feb 11, 2021 and on Feb 15, 2021 she had a CVA and MI. She was found on her apt. floor unconscious. She was transferred to the Hospital by ambulance where a CT scan and other tests were done. It was determined she had a stroke and heart attack. My mother was in great health, took no medications, and lived alone in her apt. before this incident. The medical professionals determined she would not recover so she was admitted to hospice and died on Feb. 21, 2021. I believe there is a relationship between the vaccine and the CVA and MI. | | 326 | COVID19 (COVID19 (MODERNA)) | 65+ years | 4 days | 1063835-1 | Pt. received her 1st Moderna Covid vaccine on 1/28/2021 with lot number of 010M20-A at 0906 am. Family reports since the first vaccine pt. has had weakness and has fallen. Pt. received her 2nd Moderna vaccine on 2/24/2021; see information above for lot, etc. Pt. was brought into ER with c/o falls, weakness and confusion. Pt. had fallen on 2/27 and 2/28. With one of the falls pt. fx. her right radius and ulna. PCP due to altered mental status, right sided weakness and aphasia at times is r/o stroke. | | 327 | COVID19 (COVID19 (MODERNA)) | 65+ years | 4 days | 1078895-1 | Began feeling very weak with a constant headache that later led to blurry vision on March, 2, 2021. On the morning of March 4, 2021, I was still experiencing a right sided headache as well as double vision. I was no longer able to drive at that point. I took my blood pressure digitally at the local pharmacy twice where it was 200/104. I went home to call my physician and also have my wife take my blood pressure manually. My blood pressure at that time was 214/106. I went to the hospital where they examined me and then discharged me with a General Headache without a know cause. I contacted my PCP and he advised me to quadruple my Lisinopril until my BP came down to normal range and see him the morning. My visit the next day showed an elevated blood pressure, double vision, and a continuing headache. My meds were adjusted to Lisinopril 10 mg qd and an addition of Norvasc 5 mg qd. Later that day my blood pressure was down, but still not in the normal range. The following day, March 6, 2021, I was still having the same issues despite the changes in medication. I took my blood pressure at 6 pm and it was 199/104. I immediately went to another hospital where I was admitted as a ""stroke alert"" patient in hypertensive emergency. I am presently being followed as an inpatient in order to get these issues under control."" | | 328 | COVID19 (COVID19 (MODERNA)) | 65+ years | 4 days | 1084387-1 | Stroke/ TIA | | 329 | COVID19 (COVID19 (MODERNA)) | 65+ years | 4 days | 1105045-1 | Acute stroke. Left facial droop with dysarthria. Admitted to the hospital and received tPA. | | 330 | COVID19 (COVID19 (MODERNA)) | 65+ years | 4 days | 1111889-1 | The patient reported feeling tired and diziness beginning February 20, 2021 and had a stroke later that day. She was treated in the hospital for 4 days and later released. She did not get her second dose. | | 331 | COVID19 (COVID19 (MODERNA)) | 65+ years | 4 days | 1123167-1 | Stroke | | 332 | COVID19 (COVID19 (MODERNA)) | 65+ years | 5 days | 1011517-1 | Patient reported left arm numbness. Went to the hospital for full stroke evaluation all tests returned negative. (CT scan, MRI, etc.). Patient was observed overnight and released from hospital with resolved symptoms and negative report of any stroke or mini-stroke. Patient has had follow-up appointments with PCP and Cardiologist. Received ok from PCP prior to second dose vaccination of COVID. | | 333 | COVID19 (COVID19 (MODERNA)) | 65+ years | 5 days | 1018448-1 | 2/6/2021 stroke. 2/8/2021 he died | | 334 | COVID19 (COVID19 (MODERNA)) | 65+ years | 5 days | 1027967-1 | Patient received vaccination on 1/15/2021. Hemorrhagic Stroke on 1/20 , then diagnosed with complicated idiopathic coagulopathy | | 335 | COVID19 (COVID19 (MODERNA)) | 65+ years | 5 days | 1042766-1 | First fever and body aches day 2. On day 5 developed a stroke and later developed Bell's Palsy. Hospitalized because of this. Currently moved to a rehab hospital. | | 336 | COVID19 (COVID19 (MODERNA)) | 65+ years | 5 days | 1042967-1 | Patient called son around 6:30am on 2/18/21. When son tried to contact patient around 8:30am, he was not able to get a hold of patient. Son sent someone over to check on patient. They found patient on the floor. He was coherent at first but then lost consciousness. It believed he experienced a stroke sometime around 8:30-9:00am of 2/18/21. Patient was taken to hospital and then transferred to another hospital. He was put in a medically induced coma. He passed between 4:00 and 4:30 pm on 02/19/21. | | 337 | COVID19 (COVID19 (MODERNA)) | 65+ years | 5 days | 1055656-1 | On Day 5 (February 21st) after receiving her 2nd COVID vaccine injection, the patient suffered a massive stroke. She was rushed to an ED, arriving within 45 minutes, immediately received TPA treatment and thrombectomy from the right side of her brain. She continues to receive acute treatment inpatient. | | 338 | COVID19 (COVID19 (MODERNA)) | 65+ years | 5 days | 1091544-1 | On the morning of 2/22/21 Patient was found by care staff to have signs of stroke as evidence by left sided facial drooping. EMS were called and he was taken to a local hospital where he was admitted. He then was discharge to a skilled nursing facility for rehabilitation. He is still there as of today, 3/11/2021. | | 339 | COVID19 (COVID19 (MODERNA)) | 65+ years | 5 days | 1094363-1 | Patient presented to the ED on 3/9/2021 with chest pain, headache, and brief blurred vision. There was no signs of stroke or MI event. Reason for admission: chest pain. | | 340 | COVID19 (COVID19 (MODERNA)) | 65+ years | 5 days | 1102633-1 | Client claims she had a stroke d/t covid vaccination. She developed symptoms of weakness, nausea/vomiting 5 days after receiving first dose of Moderna (February 4, 2021). On Feb. 5th client fell 3 times while at home and on Feb. 6th her daughter took her to the ED where she was diagnosed with having a CVA. Client was hospitalized 2/6/2021 thru 2/16/21. On 2/16 she was transfered to another hospital where she had another stroke and was discharged 2/23/2021. Please note client received her second covid vaccine on 02/27/2021. Writer called client's PCP office and spoke with RN. RN verified client was prescribed medications listed in box 9 prior to stroke. RN also stated client had diagnosis of hypertension prior to stroke but did not have any record of medications to treat hypertension on file prior to stroke. | | 341 | COVID19 (COVID19 (MODERNA)) | 65+ years | 5 days | 1116425-1 | Major stroke that required surgery and 18 days in the hospital. | | 342 | COVID19 (COVID19 (MODERNA)) | 65+ years | 5 days | 1199543-1 | Facility manager informed us that patient had a seizure on 3/17/21, which was 2 days after the vaccine was given (3/15/21) which then lead to a stroke. Patient passed died on 3/17/21. | | 343 | COVID19 (COVID19 (MODERNA)) | 65+ years | 6 days | 1019653-1 | 6 days following vaccination patient had a left sided stroke-numbness in face arm and hand. went to ER. and stroke was confirmed | | 344 | COVID19 (COVID19 (MODERNA)) | 65+ years | 6 days | 1048961-1 | Stroke; A spontaneous report was received on 09 FEB 2021 from a consumer concerning an 81-year-old, male patient who received Moderna's COVID-19 vaccine and experienced stroke. The patient's medical history provided were, Alzheimer and Parkinson's disease. No relevant concomitant medications were reported. On 28 JAN 2021, patient received their first of two planned doses of mRNA-1273(Batch number 027L20A) injection for the prophylaxis of COVID-19 infection. On 03 FEB 2021, within 7 days of receiving vaccine, patient experienced a stroke. On 03 FEB 2021, patient was admitted to hospital. Patient was due for his second shot of Moderna's COVID-19 vaccine on 26 Feb 2021. Patient's hospital can only provide Pfizer's vaccine and not Moderna's COVID-19 vaccine. But patient wanted to get Moderna's COVID-19 vaccine. Patient's wife wanted to know the way she could arrange the administration of the Moderna's COVID-19 vaccine in the hospital for her husband. Treatment for the event was not provided. ß Action taken the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, stroke, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, patient's elderly age is considered a risk factor. | | 345 | COVID19 (COVID19 (MODERNA)) | 65+ years | 6 days | 1057844-1 | Stroke in left occipital lobe Feb 1 & Feb 2 Right peripheral vision effected in both eyes 2 heart stops on Feb 10, 2021 Pacemaker implanted after heart stops | | 346 | COVID19 (COVID19 (MODERNA)) | 65+ years | 6 days | 1180896-1 | Narrative: Patient received second dose of Moderna COVID vaccine on 3/11. per caregiver, was diagnosed with a stroke at hospital ~ 3/17/21. He was transitioned to hospice and expired last week. | | 347 | COVID19 (COVID19 (MODERNA)) | 65+ years | 7 days | 0961179-1 | Seizure like episode on 1/12/21, one week after vaccine, last 1.5 hours, consisting of both eyes twitching and clenching/spasm of right hand and arm. EMS called. BP normal. Continuing weakness of right arm and right leg, which was side weakened by stroke. Could no longer stand or walk on right leg. Some slurring of speech. Some confusion. Went to hospital 1/14. No evidence of stroke or current seizure. Considered problem to be mild UTI, started antiobiotics, rapid improvement. Discharged 1/17. Woke up 1/18 with aphasia. Went to urgent care, sent immediately to hospital. Doctors found no evidence of stroke or seizure. Consider problem to be due to inflammation, caused by mild UTI (which was cleared by antibiotics) or perhaps due to inflammation caused by Covid vaccination. The inflammation reinitiated the symptoms of her stroke, although she never had expressive aphasia prior to this, only word-finding problems, which had been resolved. | | 348 | COVID19 (COVID19 (MODERNA)) | 65+ years | 7 days | 1038609-1 | Atrial fibrillation, ischemic stroke right internal capsule, ER, tpa, recovered much of neurologic deficit | | 349 | COVID19 (COVID19 (MODERNA)) | 65+ years | 7 days | 1050333-1 | Ever since having her first Covid shot by Moderna, my mother is coherent, interactive, and engaged. She had a stroke in March 2015 and has had dementia ever since, slowly declining annually, and now she still has dementia, but is much more aware. Moderna may be on to something for dementia/alzheimers medication help. | | 350 | COVID19 (COVID19 (MODERNA)) | 65+ years | 7 days | 1053682-1 | Stroke. I do not know if the vaccine was related or not, but the patient had a stroke and falls on 2/17/2021 and 2/18/2021 and was found to have two strokes. He does have atrial fibrillation, but with the proximity to the second vaccine, I cannot tell if they are just related temporally or if there is a true risk. Another patient at this facility had a stroke within same time frame post second Moderna vaccine, but not my patient, so I do not know if that was reported. Due to new nature of this vaccine, I felt it important to report this event for further investigation. Again, I am not sure if it is a true adverse reaction of the vaccine or not. | | 351 | COVID19 (COVID19 (MODERNA)) | 65+ years | 7 days | 1062457-1 | Patient admitted for fatigue, dry throat, generalized weakness, dyspnea on exertion. Durion hospitalization was identified to have an acute ischemic CVA -- unclear time of symptom onset, possibly evening of 2/9 or morning of 2/10. Time course suspicious for possible COVID vaccine adverse event. He received his first Moderna COVID vaccine on 2/2/21 per WIR. Per PCP note on 2/9/21: Patient is here today accompanied by his wife with concerns for fatigue, headaches, head pressure and tremors. Received vaccine last Tuesday. Around 10 PM that evening he developed pressured in the head. On Wednesday morning, he states he got out of bed and was in a cold sweat - he states he pajamas were soaked in sweat and he felt chilled. He experienced brief numbness of the left arm down to his fingers. On Thursday, he felt fine - he went out to snow blow. Friday he developed headaches and head pressure. At night, he felt his breathing was labored as he was ""gasping for air."" On Saturday and Sunday, he sat and laid around all day. On Monday, he wakes up at 125 AM and his blood pressure was 165/104 and it remained elevated for 3 separate readings. Patient was then admitted on 2/10/21 with weakness and confusion, then on 2/11 MD noted ?word finding difficulty, slurred speech, possible subtle right upper lip droop, and possibly some mild right hemineglect? with MRI showing likely embolic source of infarcts and cerebral MRA with possible acute thrombus. His symptoms the day after the vaccine seem a bit suspicious for TIA. Per Drug Policy Manager call to Moderna, no current reports of TIA/stroke secondary to COVID vaccine, so time course may be incidental. Patient had echocardiogram without right to left shunt or clot identified, no known history of atrial fibrillation. Was monitored on telemetry for the duration of his hospitalization without any noted arrhythmias, discharged on e patch for 14-day outpatient monitoring."" | | 352 | COVID19 (COVID19 (MODERNA)) | 65+ years | 7 days | 1101286-1 | Large Stroke | | 353 | COVID19 (COVID19 (MODERNA)) | 65+ years | 7 days | 1104222-1 | Client suffered a stroke on 02/11/21 which caused client to fall while getting into shower. Client hit his head during fall causing a brain bleed and also broke his left shoulder. Client was transferred to hospital via ambulance and admitted to hospital. | | 354 | COVID19 (COVID19 (MODERNA)) | 65+ years | 8 days | 1048812-1 | 8 days after vaccination - stroke/full right side of body paralyzed - clot buster drug at ER | | 355 | COVID19 (COVID19 (MODERNA)) | 65+ years | 8 days | 1051268-1 | Possible Stroke; Increase pressure and numbness in fingers; Headache; A spontaneous report was received from a pharmacist concerning an 81-year old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced possible stroke, face numbness, startled speech, increase pressure and numbness in fingers and headache. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included alprazolam and hydroxyzine. On 02 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of Covid-19 infection. On unknown date, days after the vaccine was administered, the patient reported that he started having a headache, increased pressure and numbness in fingers. Patient had been having intermittent symptoms for 9 days. Patient was admitted to hospital on 10 Feb 2021 due to possible stroke. On 11 Feb 2021, the patient began to have startled speech and face numbness. Patient was evaluated by Neurology and an MRI was done. No further information was provided. Treatment for headache included Excedrin Migraine, ibuprofen and acetaminophen. Action taken with mRNA-1273 in response to the events were not reported. The outcome for the events possible stroke, face numbness, startled speech, headache, increase pressure and numbness in fingers, were considered as unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. | | 356 | COVID19 (COVID19 (MODERNA)) | 65+ years | 8 days | 1091269-1 | A home dialysis patient who received his first COVID-19 (Moderna) vaccine on 2/4/2021. He was screened prior to admission into the clinic and reported no signs of symptom of COVID-19. This patient was diagnosed with COVID-19 on 2/12/2021 and hospitalized on 2/16/2021 with COVID pneumonia. The patient's spouse and son (who lives with them) also tested positive for COVID-19. This patient developed COVID-19 complications while inpatient including stroke and mechanical ventilation was required. The patient was made a DNR by family and removed from mechanical ventilation and expired on 2/26/2021. | | 357 | COVID19 (COVID19 (MODERNA)) | 65+ years | 8 days | 1180388-1 | Suffered a mild stroke | | 358 | COVID19 (COVID19 (MODERNA)) | 65+ years | 9 days | 1055418-1 | Patient suffered a stroke and passed away | | 359 | COVID19 (COVID19 (MODERNA)) | 65+ years | 9 days | 1073487-1 | Had a stroke; A spontaneous report was received from a caregiver concerning an 81-years-old female patient who received Moderna's Covid-19 vaccine and had a stroke. Patient's medical history included a mini stroke (5-6 years ago). Concomitant medication included blood thinners. On 02 Feb 2021 at 4:30 pm, ten days prior to onset of the event stroke, the patient received the first of two planned doses of mRNA-1273 vaccine (Lot/batch: unknown) for prophylaxis of Covid-19 infection. On 11 Feb 2021, the patient had an event of stroke for which was hospitalized. The patient was on a lot of medications (not specified). Action taken with second dose of mRNA-1273 in response to the event was not recorded. The outcome of the event stroke was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stroke, a causal relationship cannot be excluded. However, patient's elderly age and prior history of TIA are considered as risk factors. | | 360 | COVID19 (COVID19 (MODERNA)) | 65+ years | 9 days | 1079768-1 | Hemorrhagic Stroke | | 361 | COVID19 (COVID19 (MODERNA)) | 65+ years | 9 days | 1102281-1 | ER visit for stroke like symptoms, aphasia, weakness. Transferred to long term inpatient acute rehabilitation | | 362 | COVID19 (COVID19 (MODERNA)) | 65+ years | 9 days | 1203204-1 | Patient is a 69yo w history of mitral valve and aortic valve replacement with recent admissions to outside hospitals transferred from Hospital on 3/25/21 for new onset L sided weakness and possible brain abscesses. On chart review, she had second COVID vaccination on 3/6/21 and was lethargic afterwards. She was admitted to hospital 3/15 - 3/20 and had imaging showing multiple embolic strokes thought to be cardioembolic. She did have TEE on 3/19/21 w leaflet calcifications involving bioprosthetic aortic valve w/o vegetations or thrombosis. CTA neck negative. Blood culture was negative. No atrial fibrillation on telemetry. There was note of calcifications involving one of the areas concerning for possible embolic calcification from her valve. She complained of posterior head and neck pain treated conservatively. She was discharged on aspirin to home w her daughter. She does have a history of endocarditis in 2007 necessitating repair of MV and AV bioprosthetic valve. She now presents to hospital on 3/24 w acute onset of confusion and fever to 101.5F. she had LP showing 52 RBC, 34 WBC (80% mono, 20% poly), gluc 57, protein 82. She was started on empiric antibiotics for possible meningoencephalitis. MRI showed multiple enhancing lesions in L cerebral hemisphere and L cerebellum; consetllation was noted to be concern for multiple infarcts and possible abscesses w larges at L temporal-parietal junction. She had eConsult noted and there was concern for possible meningitis or vasculitis and possible mass lesion w evolving stroke or abscess. She could not be transferred back to previous hospital so was transferred to different hospital yesterday. She had repeat MRI brain showing large parenchymal hemorrhage w fluid level in R frontal lobe w possible mass and vasogenic edema, multiple areas of restricted diffusion throughout the brain, L parietal lesion w hemorrhage with component of leptomeningeal enhancement. Neurosurgery was consulted and she underwent right sided craniotomy w large intracerebral hemorrhage w both liquid and solid clot concerning for AV malformation. Tissue was not sent for culture. It does not appear that CSF from outside hospital was sent for culture. On interview w daughter, her mom has been very functional up until recently. She had a history of endocarditis in 2007 due to infected teeth. She had surgery involving her aortic and mitral valve. Has been very up to date w dental visits. Not on any anticoagulation. She got her first dose of Moderna on 2/13/21 and second dose on 3/6/21. She slept for 14.5hrs afterwards. Started getting nausea and headache. Then declined w issues w balance and walking. She was taken to the hospital and admitted for further work up. She lives w her daughter. Has dogs at home. No history of TB and no travel to central valley. She did move back in August | | 363 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 0978635-1 | Patient is a 96 year old MALE with pmh colon cancer s/p resection 25 years ago, chronic urinary retention in the setting of prostate cancer with chronic foley, CKD 3b, HTN, HLD, hypothyroidism, left frontal lobe stroke on plavix here for hemoglobin of 5.9 on labs. Pt reports that he was drawing some bloodwork for renal follow up in 2 weeks and was told to come into the ED for evaluation due to low hemoglobin levels. Patient smear also contains schistocytes, more concerning for hemolytic process at play. | | 364 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1013051-1 | On 2/6/21 at 6:00PM, resident experienced sudden left facial droop, left arm and left leg weakness. She was sent to hospital and they confirmed she had an acute ischemic stroke. | | 365 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1060543-1 | Began walking on treadmill at 5:30 a.m. and left foot felt heavy and dragging, L hand tingling, and facial/neck numbness. Arrived at hospital at 8:15. Vitals, EKG, CT scan, and MRI conducted. MRI showed an acute mild stroke on R side of brain. Over-night stay was recommended. Echocardiogram was performed the following day and nothing was abnormal. I am now on a heart monitor for 30 days. Upon departure of hospital the symptoms in L leg and arm have nearly resolved but face is still numb/decreased sensation. Plan to contact PCP tomorrow. | | 366 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1066556-1 | Stroke, Pulmonary embolism, kidney failure | | 367 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1071051-1 | she had TIA (a mini stroke) on 2/15/2021 put in the hospital and got released the next day, doctor said is ok to get 2nd covid 19 shot. | | 368 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1104554-1 | I had quite an adverse reaction to the second MODERNA vaccine. That afternoon and evening I developed symptoms. I was experiencing chills, fever, body aches, headache, sore throat, shaking and nausea. As the week went on, my reaction became worse. I was sweating profusely and had shortness of breath accompanied with burning pain on the top of my hands and feet and a rash. On Friday morning, 5 days after the vaccine, I collapsed and had a stroke. I was rushed to hospital and was admitted. It was confirmed that I had a stroke. through a Cat Scan and MRI. On Saturday, I had another stroke. This time I was transferred to hospital. I had a huge blood clot on the left side of my brain which has effected my speech and walking. My entire life has been effected and changed. I had a plethora of tests done, MRI, CAT SCAN, EKG, BLOOD WORK etc. I also have to have speech therapy, physical therapy and occupation therapy. I spent about weeks in the hospital. The doctors think it is a possibility that the 2 Moderna vaccine caused my two strokes. What can be done about this? I will have problems for the rest of my life. | | 369 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1105218-1 | Stroke 11 days (2-27) after first dose (2-16), discharged the following day (2-28). Spoke to PCP's office (nurse) who states stroke was likely due to patient's own decision to discontinue his blood pressure medications without doctor's approval. Stroke unlikely related to vaccination and determined patient should receive second dose on 3-16. | | 370 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1109535-1 | My Father had a hemorrhagic stroke. He passed away 13 days after receiving the second Modern?s vaccine. | | 371 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1117510-1 | my grandfather suffered a stroke affecting his left side. it took us over a day to conceive him to see a Dr. he was finally taken by ambulance to our local hospital and transferred to another hospital about an hour away. they did multiple tests to make sure he wasn't in further danger and released him to the care of my mother. it didn't damage his ability to think. he struggles to speak, swallow, and walk, and can't move his arm at all. | | 372 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1122133-1 | pt states that a couple of weeks after taking the vax she ended up in the Hospital ER on 3/18/2021 for symptoms of having a stroke and blurred vision. On 3/18/2021 Pt was transferred to Hospital in. They ran ECHO, EKG, CT and MRI. Blood Work. No findings of clogged arteries. DX was w/ TIA possible cause due to AFIB. Pt states that she no longer has any symptoms. | | 373 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1127809-1 | 12 days following vaccine, stroke occurred. | | 374 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1139302-1 | Stroke Medication to thin my blood Good recovery | | 375 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1151679-1 | Patient received 2nd Moderna Covid-19 vaccine on 3/4/21. Patient was admitted to hospital on 3/14/21 with a stroke. The patient fell the night before and laid on the floor until family found him and then was taken to the ER. Prior to falling he experienced left arm weakness. | | 376 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1151700-1 | Narrative: Patient received dose 1 of Moderna COVID-19 vaccine on 3/11/21 from clinic. Vaccine was administered to patient without complications and patient was observed for 15 minutes post-vaccination without any adverse effects. No documentation as to any adverse effects following the 15 minutes post-vaccination. 11 days later on 3/22/21, EMS was dispatched to patient's home and patient was found lying supine, unconscious, and unresponsive to stimuli. Patient was noted to have shallow breathing per EMS staff, and was subsequently brought to the hospital. Per family, patient lives alone and was feeling well - they had spoken to her two days prior to the event. Per family patient did not have recent fevers, vomiting, diarrhea, or cough. Also no recent medication changes or trauma. PMH includes stroke approx. 8 years ago, gout, HLD, HTN, and RLS. BP upon admission was 126/93, HR 123, temp 37.1 degrees Celcius, RR 28. Patient noted to smell of urine. CT showed large completed right sided infarct consistent with MCA stroke. Per neurology the lesion was not recoverable and patient would be unlikely to regain any function. Family was notified and poor prognosis was discussed. Patient has been very clear in the past that she would prefer ""to go when her time came"". She had a DNR And DNI as well. Daughter requested to pursue comfort measures for patient, therefore she was transferred to hospice care. Patient passed away the following day on 3/23/21. Death very unlikely due to COVID-19 vaccination since CT imaging clearly showed cerebral infarct and patient had a PMH of stroke."" | | 377 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1159900-1 | CVA (stroke) around 2:00 p.m., was immediately transported to hospital. Meds were given (I believe Alteplase, but would need to confirm.) 3 brain bleeds after medications. Patient passed away at 5:40 p.m. | | 378 | COVID19 (COVID19 (MODERNA)) | 65+ years | 10-14 days | 1215091-1 | Stroke Pulmonary Embolism Liver failure Kidney Failure | | 379 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 0977961-1 | january 19th during lunch, experienced a slurring of speech, left eye and left side of mouth droop. unable to hold in fluids. went to ED, stated all the tests were normal. air flighted to higher level of care facility for neurology. MRI/ CT negative. work up for stroke unfounded. 1/26 ENT visit- no definitive diagnosis. treatment with levaquin and steroids. | | 380 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 0998598-1 | On 1/15/21, resident fell during the night while getting up without assistance and hit her head. She did not have any neurological impairment after fall and remained at facility to be monitored. 1/26/21, resident had sudden loss of consciousness with hypotension and tachycardia. This resolved slowly after resident was put in trendelenberg position. She has not had similar events in the past. She was sent to ED without a distinct underlying cause of the event identified, differential included cardiac arrhythmia, ? orthostatic hypotension, vasovagal syncope, stroke She had a similar event occur on 1/27 after she had returned to the facility from the ED. The family elected not to pursue further evaluation for second event and she was placed on hospice as she had been experiencing some gradual decline before these events occurred. | | 381 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1025460-1 | Patient went to bed totally fine and woke up saying he could not see in one eye. I rushed him to the emergency hospital they ran cat scans, MRI, heart tests etc. He stayed overnight while they checked. The next day we went to eye doctor who told him he had a eye stroke. He would regain some of his site not all of it. Something to do with blood clot or loss of blood to the eye. I was not satisfied with that so made another drs appointment for the next day with a different eye doctor. The first eye doctor gave us some blood test to do so we did it then. Later that evening we got an emergency call form the first eye doctor to get back to the hospital right away he could lose sight in the other eye.. They found some high c-reactive protein. Normal is 8 his was over 40. They put him on heavy steroids and did biopsy on both temples of his eyes. This started last Wednesday morning. He was released from the hospital Monday Morning to see his regular doctor that afternoon. Test results for the eye would be Tuesday and all other vital tests came back fine thank goodness. On Tuesday the biopsy tests also came back negative so they are stopping steroids. I think they were looking for auto immune issues. Today we are going to Rheumatologist | | 382 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1039402-1 | Left arm and left leg weakness following administration of the vaccine. She had similar symptoms with a stroke one year ago, but MRI reveals no new acute stroke symptoms. Her symptoms had improved over the course of the last year and worsened after the COVID vaccine. | | 383 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1042458-1 | Patient admitted with acute stroke, no prior history of same. Mild hyperlipidemia, but otherwise no clear risk factors for stroke. Unclear if anything to do with COVID vaccine. | | 384 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1047176-1 | On Friday morning, February 19 around 9 am, patient felt like he was biting his lip but didn't say/do anything about it. He got up and got dressed, went about his day. Around 12:30 his nephew saw him and commented that his left eye was puffy and red, his face was swollen and drooped and he looked like he was having an allergic reaction of some kind. At that time, his speech became slurred. They got a neighbor, who is a nurse, to come over. She recommended medical attention. They went to an urgent care center and were immediately sent to the hospital.. Left side of his face was drooping and his speech was slurred. There were no cognitive issues. Arrived at hospital around 1:30. He was assessed immediately for a stroke and it was determined that he had not had a stroke. Bell's Palsy was diagnosed. He was given a steroid injection at the hospital and given a Medrol dosepak to begin on Saturday, Feb. 20 and sent home. As of today, Monday, February 22, his symptoms are improving. | | 385 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1049648-1 | I was notified on 2/22/21 that this patient passed away over the weekend. I do not know the details, nor can I confirm anything beyond what I was told. I believe the death occurred on 2/20/21 due to a massive stroke. | | 386 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1051677-1 | I noticed that the left side of my mouth was a little droopy around 10:00am on 2/14/2021 but didn?t think anything of it. Then around 4pm my daughter saw me and noticed it as well. We went to the ED immediately and got a stroke rule out work up. There were no other deficits besides the left sided facial palsy. | | 387 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1056476-1 | Seizures; Mini stroke; Tired; A spontaneous report was received from a consumer concerning a 73-year-old male who received Moderna Covid-19 vaccine and experienced seizures, mini stroke, confused, agitated, eyes were abnormal, memory impairment, and tired. The patient's medical history included heart attack and stent placement in 2011. His relevant concomitant medications include acetylsalicylic acid, candesartan cilexetil, clopidogrel bisulfate, diltiazem hydrochloride, ezetimibe, adenosine, gabapentin, metoprolol tartrate and rosuvastatin calcium. The patient received their first of two planned doses of mRNA-1273 on 14 Jan 2021. On 10 Feb 2021, 30 minutes prior to the onset of the events, the patient received his second of two planned doses of mRNA-1273 (Lot#010M20A) intramuscularly in left deltoid for the prophylaxis of COVID-19 infection. On 10 Feb 2021, With in 30 minutes of receiving the vaccination, the patient had a seizure. They took him to the hospital, where he had a computerized tomography (CT) scan, blood work and had a consult. After consult, they said, it's a mini stroke. They released him and told her if it happens again call 911. He felt so tired and went to sleep at home. Around 17:00 dinner time, he woke up looked very blankly, and his wife reported knowing he had another seizure. She reported he ran to his keys saying, ""I have to go"", seemed confused, agitated and didn't know where he was. She called 911 andhe was transported to the hospital in an ambulance. Around 19:00 the same day, he was admitted to do scans overnight. Around 21:00, patient's eyes were abnormal, he became agitated again and nurses confirmed he was having another seizure. 30 minutes later, he was talking to his wife and daughter as if he didn't remember anything. He mentioned some metallic taste in his mouth. On 11 Feb 2021, they did an electroencephalogram (EEG) and confirmed that he was having seizure. He was prescribed seizure medication and released him from hospital. However, the patient and his wife reported not wanting him to take the medication as they believe the events were due to the vaccine. Treatment information was not provided. Action taken with vaccine is not applicable as the patient received both the doses. The outcomes of the events, seizures, mini stroke, and tired, were recovered.; Reporter's Comments: Very limited information regarding this event has been provided at this time. The patient's medical history of heart attack and concomitant medication use can be confounding factor. Further information has been requested."" | | 388 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1066166-1 | Patient is an 80-year-old male that is admitted for observation status for recent TIA symptoms and bradycardia. He was seen in the emergency room this morning at approximately for complaints of posterior head and neck pressure, right arm numbness and tingling as well as a mild blurry vision in his right eye. Patient states that the symptoms from the right arm and eye blurriness lasted less than 1 hour. And has completely resolved at this time. Patient states that he still does have some posterior neck tightness. But most of this is on the left side at this point. Patient denies any increase in physical activity that he could attribute to the onset of the neck pain. Patient states that it does feel tight when he turns his head from side to side. Patient states that he no longer has a headache. He does have a history of a possible mini stroke approximately 10 years ago. He has had no other recent cardiac problems, or any other strokelike symptoms since that time. Patient takes medications for his cholesterol and a baby aspirin daily. Patient is fairly active and continues to drive a semi-5 days a week. TIA Neurochecks every 4 hours Carotid Dopplers 3/2 Bradycardia Echocardiogram 3/2 Last echo 1/4/2019, EF 60% Discharged home 3/2/21. | | 389 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1071945-1 | Massive stroke causing Left hemiplegia | | 390 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1086021-1 | Possible Stroke; Unable to speak/Lack of pronunciations; Fatigue; A spontaneous report was received from a health care professional concerning 75-years old male patient who experienced stroke (Cerebrovascular accident), unable to speak/ lack of pronunciations (Speech disorder) and fatigue (Fatigue). The patient's medical history included heart attack. Concomitant medications included included Metoprolol, HCTZ, Irbesartan, and Aspirin. On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L201A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 05 Feb 2021, approximately four days prior to the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 06 Feb 2021, the patient experienced fatigue. On 09 Feb 2021, the patient experienced the events stroke and unable to speak/ lack of pronunciations. The events resulted in hospitalisation as seriousness criteria. The patient was admitted to the hospital on 09 Feb 2021. The patient was moved to ICU for 24 hours, and was the patient was discharged from Hospital on 11 Feb 2021. Treatment for the event included Eliquis and 80 mg chewable aspirin. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events is not applicable. The events stroke, unable to speak/ lack of pronunciations and fatigue were considered as recovered/resolved.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Of note, the patient has a pre-existing history of heart attack which is a strong confounder for the reported CVA and speech disorder. Fatigue is consistent with the known safety profile of the vaccine. | | 391 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1093969-1 | New onset Myasthenia gravis. Patient initially presented in the ED on 2/23/2021 with complaint of left facial droop, slurred speech and double vision. His stroke score was 2, for left facial droop. nAChR antibody test this test has come back positive, making it likely that this patients symptoms are due to acute myasthenia gravis. The patient continued to experience double vision and eye weakness associated with trouble swallowing that has continued to worsen and was brought the hospital for re-assessment at the request of his wife. | | 392 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1094160-1 | On 3/9/2021 the patient presented to the ED with leg weakness and was unable to walk that morning secondary to pain in her right hip. She reported falling the night prior. Upon admission, she was found to have a developing pneumonia infection. Reason for admission: possible stroke. | | 393 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1095299-1 | Patient presented to ER with complaints of facial droop that began on 3/8/2021. Work up for stroke negative. Dx with Bells Palsy | | 394 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1095943-1 | Extreme fatigue began on 3/3/21 (3 weeks post vaccine). Left sided facial drop and left sided weakness began on 3/6/21. 2 days later, symptoms were communicated to doctor and patient admitted to hospital, where CT scan and MRI confirmed right-sided stroke. No predisposing factors (no preceding HTN, non- smoker, normal carotid arteries, no congenital heart defects, not on OCP, no history of blood clots or abnormal clotting factors.) | | 395 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1108903-1 | Pharmacy staff tried to contact patient to confirm appointment for second dose. Patient's sister answered the phone and stated that the patient had a stroke on 03-16-2021, that he was in the hospital. She could not discuss it further because the patient's mother was next to her, and did not know that her son went to hospital. Patient's mother received vaccine the same day. | | 396 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1111862-1 | 5 days after vaccination patient admitted to hospital with acute ischemic stroke. she was ""dragging"" her left leg"" | | 397 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1123876-1 | Stroke; A spontaneous report was received from a consumer concerning her husband, a 75 years old, male patient who received Moderna (mRNA-1273) vaccine and experienced Stroke (Cerebrovascular accident). The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included: prefervifion. On 14-Feb-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031M20A)intramuscularly for prophylaxis of COVID-19 infection. On 1-Mar-2021, the patient had a stroke and was hospitalized on the same day. The patient is still hospitalized. No laboratory details were provided. On 14 Mar 2021, the patient has their second shot scheduled. Treatment information provided by the reporter included: Aspirin, prolix, cleft, lovenox. Action taken with mRNA-1273 in response to the event was unknown The outcome of the event, Stroke was considered Not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. | | 398 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1126925-1 | Massive Stroke | | 399 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1127653-1 | Death by Hemorrhagic Stroke | | 400 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1136657-1 | NA 74 y/o several comorbidities. Stroke | | 401 | COVID19 (COVID19 (MODERNA)) | 65+ years | 15-30 days | 1156284-1 | Cerebral stroke on 3/23/21 | | 402 | COVID19 (COVID19 (MODERNA)) | 65+ years | 31-60 days | 1049547-1 | Woke up with severe dizziness, nausea/vomiting and increased while at work(denies palpitations). In ER 1/2/2021-CT of head(WNL), MRI (saw lesion and physician thought she had a stroke). Neurologist consult on 1/3 and felt it was not a stroke and unsure the reason of dizziness.. 1/3 no arm or leg weakness. Order to see a cardiologist d/t residual dizziness and advised against 2nd moderna covid 19 vaccine. | | 403 | COVID19 (COVID19 (MODERNA)) | 65+ years | 31-60 days | 1101154-1 | Husband experienced seizure lasting 30min. after taking 2nd vaccine. 1st vaccine on 26/01/21 LOT# 00TM20A. 2nd on 23/02/21 LOT# 024M20A,5 Days after; the Ambulance took husband to hospital & Dr put the patient on a seizure med Levetiracitam 500mg; A spontaneous report was received from a consumer, concerning 87-year-old male patient, who received his second dose of Moderna's COVID-19 vaccine and experienced seizure that lasted about a half an hour. Medical history included: seizure 37 years ago during a stroke. There were no concomitant medications reported. On 26-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: LOT# 00TM20A) and on 23-Feb-2021, he received the second dose of mRNA-1273 (LOT# 024M20A), intramuscularly for prophylaxis of COVID-19 infection. On 28-Feb-2021, five days post receive the vaccine, the patient experienced a seizure which lasted about a half an hour. The patient was taken to hospital and was treated with Levetiracitam 500mg. Action taken with the dose of mRNA-1273 in response to the event was not reported. The outcome for the event was considered as resolved on 28-Feb-2021.; Reporter's Comments: Based on the current available information which show a temporal association between the use of the product and excluding all other etiologies as reported (subject experienced seizure 37 years ago), a causal relationship with the event cannot be excluded. | | 404 | COVID19 (COVID19 (MODERNA)) | 65+ years | 31-60 days | 1107342-1 | Blod clot, stroke | | 405 | COVID19 (COVID19 (MODERNA)) | 65+ years | 31-60 days | 1118235-1 | Thalamic Stroke., Left sided | | 406 | COVID19 (COVID19 (MODERNA)) | 65+ years | 31-60 days | 1123841-1 | On March 13, I developed double vision, dizziness and nystagmus. I was transferred by ambulance to a hospital due to stroke symptoms. Admitted overnight. Diagnosis: Transient Ischemic Attack. This occurred one month after second Covid injection. | | 407 | COVID19 (COVID19 (MODERNA)) | 65+ years | 31-60 days | 1126370-1 | No adverse symptoms at time of shots. After second Moderna shot February 23, 2021 I suffered a stroke seven day later on March 2, 2021. | | 408 | COVID19 (COVID19 (MODERNA)) | 65+ years | Unknown | 0991434-1 | The patient developed an acute right posterior frontal stroke with weakness, dysarthria and hemineglect at 1015pm on 1/26. He had received the Moderna vaccine second dose on 1/25. He received tPA and is now in the ICU for monitoring. Also found to have atrial fibrillation on EKG which seems to be a new finding. | | 409 | COVID19 (COVID19 (MODERNA)) | 65+ years | Unknown | 1122713-1 | Stroke; Diabetic Ketoacidosis; A spontaneous report was received from a consumer concerning a 77-years old, male patient who experienced the events cerebrovascular accident and diabetic ketoacidosis. The patient's medical history included hypertension. Concomitant product use was not provided by the reporter. On 06 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced stroke and diabetic ketoacidosis. which caused hospitalization. On 13 Feb 2021, the patient was admitted to the hospital. On 04 Mar 2021, the patient was discharged. Treatment details was not provided. Action taken with mRNA-1273 in response to the events was not unknown. The outcome of the events cerebrovascular accident and diabetic ketoacidosis was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. However, the patient's advance age, diabetes, Hypertension, may remain contributing factor for this event.Further information has been requested | | 410 | COVID19 (COVID19 (MODERNA)) | 65+ years | Unknown | 1123119-1 | Bell's palsy; A spontaneous report was received from a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Three to four days after receiving the vaccine, the left side of the patient's face was frozen. The patient was rushed to the emergency room because he thought it was a stroke. The physician confirmed that was not a stroke, and diagnosed Bells' palsy. The patient reported that he spent 6 hours in the hospital and the doctor prescribed him prednisone and valacyclovir. The patient reported feeling better now. Action taken with mRNA-1273 in response to the event was unknown. The outcome of event, Bell's palsy, was considered recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. | | 411 | COVID19 (COVID19 (MODERNA)) | Unknown | 0 days | 0950067-1 | She did not have any problems immediately after the shot or waiting period. She went back to work and all was normal until she went to meeting. It was a little less than 4 hours after the shot. She asked to have her temperature checked, then fell on the floor and collapsed. Her BP was 190/110, and her HR was very high, beating out of her throat and throat swelled up √ she could barely breathe. Normally, her BP is 120/80 and HR is usually around 68 BPM. She could not move her legs or arms, but she could move fingers. This is an anaphylactic seizure that acts like a stroke √ severe slurring of speech, cannot close eyes (but vision blurred), throat swells up and constricts airway, and she yells out uncontrollably. She shivered like she was very cold, but she did not have any convulsions. It lasted around 20 minutes. EMT who took care of her. She could hear everything going on, but her vision was very blurry (could not see). She was taken to Hospital. They checked her for stroke, did a CAT scan, and took her blood. Everything came out normal. She felt fine after it was over. She was released at 8 pm to go home, and she walked out on her own. She feels that the 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC] in the vaccine may be what triggered her reaction as she thinks it may be closely related to steroids. She will NOT take the 2nd shot on advice of doctor. Dr. has been her physician for 10 years. Previous History: Seizure reaction to steroids √ happened 4 hours after took the steroid √ this same anaphylactic like seizure happened with the steroid, exactly. Present at that event were several people. Patient says that this is the exact same reaction she had both when she took the steroid and following the COVID vaccine. | | 412 | COVID19 (COVID19 (MODERNA)) | Unknown | 0 days | 0990361-1 | blindness in left eye; stroke in back of the eye; blood clot; A spontaneous report was received from a consumer concerning an 83-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced blindness in left eye, blood clot, and stroke in back of the eye. The patient's medical history was not provided. Concomitant medications reported included comerdol, losartan, hydrocortisone, meloxicam, and unspecified stomach pills. On 14 Jan 2021 at 10:15 am, approximately 3 hours and 45 minutes prior to the onset of the events, the patient received a dose of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 14 Jan 2021 around 2:00 pm, the patient lost sight in her left eye as a result of a blood clot and stroke in the back of her eye. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, blindness in left eye, blood clot, and stroke in back of eye, was unknown.; Reporter's Comments: This case concerns an 83-years-old female patient, who experienced a serious unexpected event of blindness unilateral, retinal artery occlusion, and thrombosis. The event of blindness unilateral and retinal artery occlusion occurred 3 hrs. after first dose of mRNA-1273, lot # 013L20A. The event of thrombosis occurred on an unspecified date after first dose of mRNA-1273, lot # 013L20A. Treatment included details were not provided. Concomitant medications included Comerdol, Losartan for blood pressure, Hydrocortisone, Meloxicam and stomach pills. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. | | 413 | COVID19 (COVID19 (MODERNA)) | Unknown | 0 days | 1004199-1 | possible stroke; face is drooping a little; had numbness and tingling on the left side of my face; had numbness and tingling on the left side of my face; red splotches about the size of a small leaf from injection site to elbow; had a rash opposite the injection site; a vein protruded out; bone chilling chills; deep pain in my arm that feel like someone was beating me; arm sore to touch; my arm was sore to touch from injection site to elbow; had a fever of 103 F/low grade (~99 F); I was shaking; blood pressure went up to 149/89; my heart rate was elevated to over 110; dull headache off and on since receiving the vaccine; A spontaneous report was received from a nurse who was also a 66-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced possible stroke, face is drooping a little, a vein protruded out, blood pressure went up to 149/89, my heart rate was elevated to over 110, deep pain in my arm that feel like someone was beating me; arm sore to touch; my arm was sore to touch from injection site to elbow, I was shaking, had numbness and tingling on the left side of my face, red splotches about the size of a small leaf from injection site to elbow, dull headache off and on since receiving the vaccine, had a rash opposite the injection site, my arm was sore to touch from injection site to elbow, bone chilling chills, and had a fever of 103 degrees Fahrenheit (F)/low grade (~99 F). The patient's medical history was not provided. There were no concomitant medications provided. On 08 Jan 2021 the patient received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly, in her right arm, for prophylaxis of COVID-19 infection. On 08 Jan 2021 at 3:00 pm, the patient received her first injection. Right after the injection, her blood pressure went up to 149/89 and her heart rate was elevated to over 110 and both came down to normal by 4 pm. A dull headache started on the same day. About midnight on 09 Jan 2021, the patient was awakened by deep vein in her arm that felt like someone was beating her. About 11 am the same day she had a fever of 103 degrees Fahrenheit, bone chilling chills., and she was shaking. Treatment included a hot shower, ibuprofen, paracetamol, and acetylsalicylic acid. The chills and shaking stopped after treatment. It was noted that fever lowered to about 99 degrees. On 11 Jan 2021, the patient had red splotches about the size of a small leaf and her arm was sore to touch from injection site to elbow. A vein protruded out and she had a rash opposite the injection site. On 12 Jan 2021, the fever had resolved. The patient noted that all right arm reaction lasted until Saturday, 16 Jan 2021. On 19 Jan 2021 in the evening, the patient had numbness on the left side of her face. It appeared as if her face was drooping a little, but there was nothing wrong with her smile or her speech. She noted she called the clinic and they wanted her to come in to determine if she had a possible stroke. Additionally, she reported she had a dull headache off and on since she got the vaccine. Action taken with mRNA-1273 in response to the event was not provided. The event of dull headache off and on since receiving the vaccine was not recovered/not resolved. The outcome for the events, possible stroke, face is drooping a little, had numbness and tingling on the left side of my face, was unknown. The outcome of the events, a vein protruded out, blood pressure went up to 149/89, my heart rate was elevated to over 110, deep pain in my arm that feel like someone was beating me; arm sore to touch; my arm was sore to touch from injection site to elbow, I was shaking, red splotches about the size of a small leaf from injection site to elbow, had a rash opposite the injection site, bone chilling chills, and had a fever of 103 F/low grade (~99 F) were resolved at the time of this report.; Reporter's Comments: This spontaneous report concerns a 66-years old female patient who experienced possible stroke, face is drooping a little, a vein protruded out, blood pressure went up to 149/89, my heart rate was elevated to over 110, deep pain in my arm that feel like someone was beating me; arm sore to touch; my arm was sore to touch from injection site to elbow, I was shaking, had numbness and tingling on the left side of my face, red splotches about the size of a small leaf from injection site to elbow, dull headache off and on since receiving the vaccine, had a rash opposite the injection site, my arm was sore to touch from injection site to elbow, bone chilling chills, and had a fever of 103 degrees Fahrenheit (F)/low grade (~99 F). The events of blood pressure went up, heart rate elevated and dull headache occurred on the same day after the administration of the first dose of mRNA-1273 ((lot number unknown) and events of deep vein in her arm that felt like someone was beating her, fever of 103 degrees Fahrenheit, bone chilling chills., shaking occurred 1 day after. The events of red splotches, arm was sore to touch from injection site to elbow, a vein protruded out, rash opposite the injection site developed 3 days after the vaccine dose and numbness on the left side of her face and possible stroke occurred 11 days after the vaccine dose. Treatment provided, fever and dull headache are resolved, and outcome of other events are unknown. He events of injection site redness and pain, fever, rash chills and headaches are consistent with the safety profile of the vaccine. Based on the current available information and temporal association between the use of the product and onset of the reported events a causal relationship cannot be excluded | | 414 | COVID19 (COVID19 (MODERNA)) | Unknown | 0 days | 1057765-1 | Completely out/eyes were closed; looked like he wasn't breathing; Began to shake, patient's head and arm shocked; Weak; little confused; A spontaneous report was received from a consumer concerning a 69 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced began to shake (MedDRA PT: tremor), head and arm shocked (MedDRA PT: tremor), completely out/eyes were closed (MedDRA PT: loss of consciousness), looked like he wasn't breathing (MedDRA PT: respiratory arrest), weak (MedDRA PT: asthenia), and little confused (MedDRA PT: confusional state). The patient's medical history included stroke. Concomitant product use included unspecified blood pressure pills, cholesterol pills, vitamins, and a drug for the patient's brain due to the stroke. On 17 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot #: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 17 Feb 2021, ten minutes after receiving the vaccination, the patient began to shake, patient's head and arm shocked and patient was completely out with eyes closed. The reporter stated it looked like the patient wasn't breathing. Seven minutes later, the patient was given an epi shot and oxygen. The patient was transported via ambulance to the emergency room (ER). At that time, a scan was performed - nothing was detected in patient's brain. Patient remained in ER from 0830 to 1500. Patient subsequently left ER very weak and a little confused. It was recommended for patient not to receive second vaccination dose. Treatment information included epi shot and oxygen. Action taken with mRNA-1273 in response to the events was not reported. The events began to shake, head and arm shocked, completely out/eyes were closed, and looked like he wasn't breathing were considered resolved on 17 Feb 2021. The events very weak and little confused were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. | | 415 | COVID19 (COVID19 (MODERNA)) | Unknown | 0 days | 1074925-1 | stroke; vertigo attack; severe headaches; severe dizziness; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced severe headaches / headache, severe dizziness / dizziness, vertigo attack / vertigo, and stroke / cerebrovascular accident. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Feb 2021, prior to the onset of the events, the patient received their second dose of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 13 Feb 2021, about 12 hours after receiving the vaccine, the patient experienced severe dizziness and severe headaches which lasted for about 4 days. On 17 Feb 2021, while driving, the patient thought he was having a vertigo attack and went to the emergency room. He had a cat scan (results not provided) and was treated with TPA (tissue plasminogen activator). After three days in the hospital, they determined he had a stroke. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, severe headaches, severe dizziness, vertigo attack, and stroke, was not provided.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of cerebrovascular accident among others, 5 days after receiving 2nd dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested. | | 416 | COVID19 (COVID19 (MODERNA)) | Unknown | 0 days | 1086859-1 | difficulty talking; unable to move his arm or leg; Massively sick; body pain; Nausea; headaches; fatigue; muscle aches and pains; chills; A spontaneous report was received from a 79-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ""unable to move his arm or leg"", massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills. The patient's medical history included Covid-19 positive on 17-OCT-2020. Concomitant product included metformin, metoprolol and rivaroxaban. On 04-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly for prophylaxis of COVID-19 infection. On 04-FEB-2021, one day after receiving the vaccine, the patient felt ""crummy"", ""massively sick"", nausea, headaches, fatigue, chills, muscle aches and pains and other pains. On 05-FEB-2021, the patient reported that he believed he was having a stroke. The patient was unable to move his arm or leg and had difficulty talking. The patient was taken to the emergency room for treatment. Computerized tomogram (CT) scan and magnetic resonance imaging (MRI) were taken. Later that night, after receiving treatment all his side effects subsided and none were present at the time of this report. The patient would like to know if he should get the second dose of vaccine. Treatment information included heparin, acetaminophen and magnesium. Action taken with mRNA-1273 was unknown. The outcome of the events, unable to move his arm or leg, massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills, was resolved. The reporter did not provide the assessment for the events unable to move his arm or leg, massively sick, nausea, headache, body pains, difficulty talking, fatigue, muscle aches and pains and chills.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded."" | | 417 | COVID19 (COVID19 (MODERNA)) | Unknown | 0 days | 1090174-1 | Does not feel good; Face is cold; Headache; Muscles hurt; Got confused, lost/disorientation; Left side of face and body went numb; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of got confused, lost, disoriented, left side of body went numb, left side of face was still numb, does not feel good, headache, muscles hurt, face is numb and cold. The patient's medical history was not provided. No concomitant medications were reported. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown). On 29 Dec 2021, the same day following vaccination, the patient experienced events, got confused, lost, disoriented, and left side of body went numb. She was taken to the emergency room (ER) and observed for a potential stroke. The reporter stated, all labs came out fine and she was discharged the same day. On 30 Dec 2020, the patient experienced events, left side of face was still numb, does not feel good, headache, muscles hurt, and face is numb and cold. The treatment information reported included diphenhydramine. The action taken with mRNA-1273 in response to the events was unknown. The outcome for the events, got confused, lost, disoriented, was considered as unknown. The outcome for the events, left side of body went numb, left side of face was still numb, does not feel good, headache, muscles hurt, and face is numb and cold, was considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. | | 418 | COVID19 (COVID19 (MODERNA)) | Unknown | 0 days | 1100255-1 | out of sorts; dry heaving; so dizzy couldn't see; sweating to death; so dizzy couldn't see; A spontaneous report was received from a consumer who was a 76-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced sweating to death, so dizzy could not see, dry heaving, blood pressure was 127/108 and out of sorts. The patient's medical history included stroke and hypertension. Concomitant products included hydrazine and meclizine. On 01-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection. On 01-Mar-2021, the same day of vaccine administration, the patient experienced sweating to death and so dizzy that she could not see. Her husband took her to the emergency room on 02-Mar-2021 and on the way, she was dry heaving. Her blood pressure at the hospital was 127/108. She stayed in the emergency room for 12 hours and took blood pressure medication hydrazine and Meclizine, which helped. On 03-Mar2021, she reported that she was still out of sorts and lightheaded. Treatment information for the events was not reported. Action taken with mRNA-1273 with respect to the events was not reported. The outcomes of the events, sweating to death, so dizzy could not see, dry heaving, blood pressure was 127/108 and out of sorts, were considered unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Patient has a history of stroke and hypertension. | | 419 | COVID19 (COVID19 (MODERNA)) | Unknown | 0 days | 1114893-1 | Stroke; recall/memory problems; could no longer speak; A spontaneous report was received from consumer (patient's husband) for a 90-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke and could no longer speak, stroke and recall/memory problems The patient's medical history was not provided. Concomitant product use included enalapril maleate, hydrochlorothiazide, furosemide, potassium chloride extended release, clopidogrel and apixaban. On 04-Feb- 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 020M20A) intramuscularly on left non dominant deltoid for prophylaxis of COVID-19 infection. After receiving the vaccine on an unspecified date in 2021 in the middle of the night, the patient woke up and could no longer speak. The patient was taken to the hospital and had a stroke. The patient was admitted for 2 days and 2 nights. The patient was not able to recall and have memory problems at the time of this report. Treatment information was not provided. Action taken with mRNA-1273 was unknown. The outcome of the events, could no longer speak and stroke were unknown and outcome for recall/memory problems was not recovered.; Reporter's Comments: Although a temporal association exist, based on the lack of critical details such as the patient's medical history and other relevnt information for accurate assessment is lacking. Concomitant medications is suggestive of underlying cardiac disease. Additional information have been requested. | | 420 | COVID19 (COVID19 (MODERNA)) | Unknown | 1 day | 1067942-1 | Stroke; A spontaneous report was received from a Consumer and Other HCP concerning a 84Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event like Stroke. The patient's medical history provided no adverse event. Relevant concomitant medications were reported like atorvastatin calcium, ezetimibe, niacin, metoprolol, acetylsalicylic acid, levothyroxine sodium, and iron supplement. On 4th Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038k20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On date 5th Feb 2021, The patient experienced the event like Stroke, which required hospitalization. It was noted the patient's speech was getting better, but the left side of his body was still paralyzed. There was no treatment information provided There were no laboratory details provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event is unknown.; Reporter's Comments: Although a temporal association exit, provided information is not adequate to assess the causal association between the event and mRNA-1273. Critical details such as the medical history and diagnostic report is lacking. Causality is also confounded by the patient's advanced age and suspected cardiac related condition (patient is on antihypertensive noted in conmed) | | 421 | COVID19 (COVID19 (MODERNA)) | Unknown | 1 day | 1086869-1 | Stroke; A spontaneous report was received from a consumer who was also a 66-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced stroke. The patient's medical history was not provided by the reporter. Concomitant medications included Lisinopril, Rosuvastatin, Montelukast, Hydrochlorothiazide, Sertraline, Metoprolol, and Zyrtec. The patient received their first of two planned doses of mRNA-1273 (Batch number: 029L201A) on 12 Feb 2021, approximately one day prior to the onset of the symptoms in the left non-dominant arm for prophylaxis of COVID-19 infection. The patient experienced a stroke on the night of 13 Feb 2021- 14 Feb 2021. The patient could not speak properly due to being drowsy. On unspecified date the patient was hospitalized for the event of stroke and released on 16 Feb 2021. Treatment for the event included double cholesterol med (from 10 to 20 mg) and baby aspirin. No relevant laboratory details were included. Action taken with the drug in response to the event was not reported. Outcome of the event was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stroke, a causal relationship cannot be excluded. | | 422 | COVID19 (COVID19 (MODERNA)) | Unknown | 3 days | 1025002-1 | Wobbly; Sees double; BP dropped; Fluid behind ears; Lower back pain; Ear infection; Severe Vertigo; Dizziness; A spontaneous report was received from a consumer who was also a 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe vertigo (vertigo), dizziness, ear infection, fluid behind her ears (middle ear efflusion), being wobbly (gait disturbance), seeing double (diplopia), lower back pain (back pain), and blood pressure dropped (blood pressure decreased). The patient's medical history included arthritis and migraine. Products known to have been used by the patient included fluticasone propionate/ salmeterol xinafoate, botulinum type A, duloxetine hydrochloride, hydrochlorothiazide (HCTZ), umeclidinium bromide, atorvastatin calcium, gabapentin, raloxifene, sumatriptan, telmisartan, cetirizine hydrochloride, cholecalciferol, calcium, zinc, probiotics, apoaequorin, and galcanezumab-gnlm. On 14 Jan 2021, the patient saw an ear doctor for ear pain. Treatment included steroids and eardrops that were antibiotics. On 23 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, approximately 3 days after the mRNA-1273 vaccine was given, the patient noted she started getting severe vertigo or dizziness. On 28 Jan 2021, she saw her physician who attributed the dizziness to an ear infection that went undiagnosed. She also had fluid behind her ears. On 28 Jan 2021, a different doctor informed her that her eardrops were not going to touch the ear infection she had and prescribed amoxicillin. She reported that she still has dizziness. She stated that she was still wobbly and sees double. She then saw an ophthalmologist for her double vision and his concern was that it was not an eye issue more of a head issue and should be checked for a transient ischemic attack (TIA) or stroke. She then went to the emergency room (ER) to get it checked out and left the ER after waiting over 2 hours. The triage nurse at the ER told her that she was beyond any help since it was after 90 minute window if she had a stroke. She was attempting to get a CT scan of her head done. She was given pain medication as well for lower back pain. She was taken off the HCTZ because blood pressure dropped after getting the vaccine. Consent to contact was obtained. Treatment information included amoxicillin, meclizine and pain medication. Action taken with mRNA-1273 was not reported. The outcome of the events, severe vertigo, and/or dizziness, ear infection, fluid behind her ears, being wobbly and seeing double, lower back pain and blood pressure dropped, was not resolved.; Reporter's Comments: Based on the information provided the event of ear infection is unlikely related to the vaccine administration as event was pre-existing , Although a temporal association exist between the other events and mRNA-1273, critical details is lacking as patient is of an advanced age and has an undisclosed cardiac condition (on treatment with HCTZ ). . Hence, there is not enough information to adequately assess association with mRNA-1273 at this time. | | 423 | COVID19 (COVID19 (MODERNA)) | Unknown | 3 days | 1037722-1 | Paralysis legs intermittent; Disoriented; Malaise; Fatigue; Fever; A spontaneous report was received from a consumer concerning an 85-year-old, Asian, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever (pyrexia), malaise, fatigue, disorientation, and intermittent leg paralysis (diplegia). The patient's medical history included stroke and hypertension. No relevant concomitant medications were reported. On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K202A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced symptoms of fever, malaise, fatigue, disorientation, and intermittent leg paralysis. Treatment for the event included acetaminophen. Action taken with mRNA-1273 in response to the events was unknown. The outcome for the event fever and disorientation was reported resolved on 20 Jan 2021.The outcome for the event paralysis legs intermittent was reported resolved on 22 Jan 2021. The outcome for the event fatigue and malaise was reported as resolved on 23 Jan 2021.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. | | 424 | COVID19 (COVID19 (MODERNA)) | Unknown | 4 days | 1056481-1 | Bell's Palsy; A spontaneous report received from a Healthcare Professional concerning, 81-year-old female patient who received the first dose of Moderna COVID-19 vaccine and was hospitalized for Bell's Palsy. The patient's medical history was not included/ unknown. There were no concomitant medications provided. On 15-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient was hospitalized on 19Jan2021 because developed Bell's palsy. Patient was observed because it was thought that she had a stroke. It was not a stroke. On 22Jan2021 the patient left the hospital. Second dose of Moderna COVID-19 vaccine is scheduled on 12Feb2021. Reporter wanted to know if patient should get second dose of Moderna COVID-19 vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported events, a causal relationship cannot be excluded. | | 425 | COVID19 (COVID19 (MODERNA)) | Unknown | 5 days | 1045543-1 | Mini stroke; Tingling sensation; Numbness at the right side of the body from face down to foot; A spontaneous report was received from a HCP concerning a male patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced tingling sensation and numbness at the right side of the body from face down to the foot. The patient's medical history was reported as diabetic and was taking medications for diabetes but did not provide exact name of the medication. No relevant concomitant medications were reported. 24 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 29 Dec 2020, 5 days after the dose of injection, the patient experienced and experienced tingling sensation and numbness at the right side of the body from face down to the foot. The patient was taken to ER and patient was diagnosed with mini stroke at the ER. No Laboratory details provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events experienced tingling sensation and numbness at the right side of the body from face down to the foot was Unknown.; Reporter's Comments: The events developed on five day after first dose of mRNA-1372. Paresthesia, and hypoesthesia were consistent with increased risk of cerebrovascular accidents associated with history of diabetes. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. | | 426 | COVID19 (COVID19 (MODERNA)) | Unknown | 6 days | 1024999-1 | Admitted to the hospital with multiple small strokes; Feeling fatigue; Headache; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being admitted to the hospital for multiple small strokes, fatigue and headache. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 21 Jan 2021, prior to the onset of the events, the patient received the first of planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On an unknown date, Shortly after the mRNA-1273 vaccine was given, the patient experienced fatigue and headache which was attributed to vaccine side effect. On 27 Jan 2021, the patient was admitted to the hospital with multiple small strokes. No other treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, fatigue, headache and being hospitalized with multiple small strokes, is unknown.; Reporter's Comments: This case concerns a 79 year-old, female patient, who experienced events of multiple small strokes, fatigue and headache. The events of fatigue and headache occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. The event of stroke occurred approximately 6 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available limited information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related. | | 427 | COVID19 (COVID19 (MODERNA)) | Unknown | 10-14 days | 1100272-1 | Stroke; A spontaneous report was received from a consumer who was also a 76-years-old female patient, who received Moderna's covid-19 vaccine (mRNA-1273) and who experienced stroke (stroke). The patient's medical history was not provided. Concomitant medications were not reported. On 13 FEB 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection. On 23 FEB 2021, the patient had a stroke leading to hospitalization. Treatment details were not provided. Action taken with mRNA-1273 in response to the events was unknown. At the time of this report, the outcome of the event stroke was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. | | 428 | COVID19 (COVID19 (MODERNA)) | Unknown | 15-30 days | 1056507-1 | Bells Palsy; A spontaneous report was received from a consumer concerning a 65 year old male patient who experienced Bells Palsy/Facial Paralysis, Slurred speech/.Dysarthria, Facial droop/Facial droop, Numbness on Facial right side/ Facial Paresthesia, Thumb numbness/ Thumb Paresthesia, Right paralysis/Right Paralysis, Right eye lid will not close/Right Eyelid Paralysis The patient's medical history was not provided. Products known to have been used by the patient, within in two weeks prior to the events, included Insulin Zinc Suspension, Insulin Aspart, Clopidogrel bisulfate, Gabapentin, Mesalamine, and Atorvastatin. On 18-Jan-2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 ( Batch number: 09L20A) intramuscularly into the right arm for prophylaxis of Covid-19 infection. On 15-Feb-2021 the patient received the second of two planned doses of mRNA-1273 ( Batch number: 024M20A) intramuscularly (site not provided) for prophylaxis of Covid-19 infection. On 15 Feb-2021, the patient left a voicemail message to safety and stated ""got right paralysis, thought I had stroke, spent 4 days in the hospital and diagnosed me with Bells Palsy"". Hospital admission, treatment information, and discharge dates were not provided. On 16-Feb-2021 Safety agent reached the patient to clarify the information provided in his first report (15-Feb-2021). The patient reported his symptoms began on 08-Feb-2021, 21 days following the first dose of mRNA-1273, the patient experienced slurred speech, facial droop , numbness on facial right side, thumb numbness, right paralysis, right eye lid will not close and blurred vision of the right eye. He was hospitalized (date not provided). Treatment information included a CT scan which was reported as normal . He reported seeing a speech therapist to help with his speech and improve swallowing. He reported no treatment was given to him. A physician diagnosed him with Bells Palsy on 10-Feb-2021. Hospital discharge date was not provided. The second dose of mRNA-1273 was temporarily withheld in response to the events rechallenge date 15-Feb-2021 was reported as negative. The outcome of the events, Bells Palsy,slurred speech, facial droop , numbness on facial right side, thumb numbness, right paralysis, right eye lid will not close and blurred vision of the right eye were considered Not recovered/Not resolved. Company Comment: the reported event Bells Palsy was considered possibly related to mRNA-1273.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded."" | | 429 | COVID19 (COVID19 (MODERNA)) | Unknown | 15-30 days | 1086926-1 | thought that it might be a stroke; Lip is dripping at the right side; A spontaneous report was received from a Healthcare professional which concerns 37-year-old male nurse patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced a situation where his right lip is dripping and thought that it might be a stroke. The patient's medical history was not provided. The concomitant medication included Tizanidine. On 23-Dec-2021, approximately 27 days prior to the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly for prophylaxis of COVID-19 infection. On 18-Jan-2021, Patient experienced a situation where his right lip are is dripping and thought that it might be a stroke. Treatment information was not provided. Action taken with mrna-1273 in response to the events was unknown. The outcome of the event(s) where his right lip is dripping and thought that it might be a stroke was unknown.; Reporter's Comments: Limited information regarding these events has been provided at this time. Further information has been requested. | | 430 | COVID19 (COVID19 (MODERNA)) | Unknown | 15-30 days | 1119813-1 | Suffered 2 strokes; kidney stone surgery; A spontaneous report was received from a consumer concerning a 62 year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cerebrovascular accident,and renal stone surgery. The patient's medical history was not provided., included allergy to cefaclor and hereditary hemorrhagic telangiectasia.Concomitant medications reported included Atrovastin, Aspirin, Clopidogrel, Olicolic oil. On 21 Jan 2021 , approximately 28 days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 032120A) via unknown route in an unknown site for prophylaxis of COVID-19 infection. Before the scheduled second dose of Moderna Vaccination patient developed adverse events. On 16 Feb 2021, patient had surgery for kidney stone. On 17 Feb 2021 she developed a stroke and again on 26 Feb 2021 she developed second stroke.The event stroke was considered serious and medically significant. The treatment taken for the events was reported as unknown. Action taken with mRNA-1273 in response to the events was unknown.. The outcomes of the events were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. | | 431 | COVID19 (COVID19 (MODERNA)) | Unknown | 15-30 days | 1197611-1 | Massive heart attack; Death; vomiting; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Massive heart attack), CEREBROVASCULAR ACCIDENT (Stroke) and DEATH (Death) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011m20a and 013a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included LOSARTAN POTASSIUM (COZAAR) for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DEATH (Death) (seriousness criterion death) and VOMITING (vomiting). In March 2021, the patient experienced MYOCARDIAL INFARCTION (Massive heart attack) (seriousness criteria hospitalization and life threatening) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). On 11-Mar-2021, MYOCARDIAL INFARCTION (Massive heart attack), CEREBROVASCULAR ACCIDENT (Stroke) and VOMITING (vomiting) had resolved. The patient died on 11-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Echocardiogram: unknown (Inconclusive) unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information also included inhalers, non specified and eye drops non specified. No treatment information was reported. Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death | | 432 | COVID19 (COVID19 (MODERNA)) | Unknown | Unknown | 0971034-1 | ON Jan 16 complained of lightheadedness then felt better after supper and nap. Next day ok On Jan 22 did not get up, had stroke, taken by ambulance to hospital and transferred to medical facility. | | 433 | COVID19 (COVID19 (MODERNA)) | Unknown | Unknown | 1057709-1 | stroke; A spontaneous report was received from a consumer concerning a male patient who experienced a stroke/cerebrovascular accident. The patient's medical history was not provided. Concomitant medications were not provided. On an unspecified date, the patient received one of two planned doses of mRNA-1273 intramuscularly for the prophylaxis of COVID-19 infection. On an unspecified date, the patient reported that he had a stroke. Treatment information was not provided. Action taken with mRNA-1273 was not reported. The outcome of the event, stroke, was not reported/unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. No further information is expected | | 434 | COVID19 (COVID19 (MODERNA)) | Unknown | Unknown | 1076717-1 | Thrombocytopenia (diffuse petechiae, easy bruising, bleeding gums); Polychromasia; Petechiae; Easy bruising; Mild headache; Anisocytosis; A spontaneous report was received from a literature article concerning a 36, year old, female patient who experienced thrombocytopenia, headache, polychromasia, anisocytosis, petechiae and easy bruising. The patient's medical history included thrombocytopenia and allergy to acetaminophen. Products known to have been used by the patient, within one week prior to the event, included ibuprofen and sumatriptan. A vaginal ring containing etonogestrel-ethinyl estradiol, was place one week prior to hospitalization Approximately one week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on unknown date, intramuscularly in the for prophylaxis of COVID-19 infection. The patient presented to the hospital on unknown date with diffuse petechiae, easy bruising, bleeding gums and mild headache. Vital signs were within normal limits upon arrival at hospital. Physical exam was notable for diffuse petechiae of the extremities and trunk along with oral ecchymosis of 1-2 cm: no focal neurological deficits were observed, and no hepatic or splenic enlargement was noted. Blood work was significant for white blood count of 13.1 L/uL, hemoglobin 13.6 g/dL, heamatocrit of 42.1%, and platelet count of 3000/uL. Prothrombin time and activated partial thromboplastin time were within normal limits. SARS-CoV2 swab was negative but the SARS-CoV2 IgG antibodies were reactive. Peripheral smear showed thrombocytopenia without clumping along with polychromasia and anisocytosis appreciated with some mature neutrophils. A CT scan of the head did not show acute infarction or hemorrhage. Treatment for the event included, dexamethasone 40 mg intravenously daily for four days, intravenous immunoglobulin (IVIG) 1 mg/Kg for three days and was place on the Health Stroke Scale monitoring. Platelet count improved to 28000/uL within 3 days and oral lesions disappeared through some petechiae remained. The patient's contraception ring was not removed. The patient was discharged with outpatient hematology follow up. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the event(s) was not reported. According to the abstract, the temporal sequence of the events suggests an exacerbation of the patient's chronic thrombocytopenia related to the receipt of the mRNA-1273 Covid-19 vaccine. The abstract also stated that it is possible based on reviews of reported side effects unlikely, that the patient's headache medications and contraception were triggers for this event. Follow up: No follow up provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time. | | 435 | COVID19 (COVID19 (MODERNA)) | Unknown | Unknown | 1115607-1 | Suffer a stroke a few weeks after the vaccine; 42 days pasted since his first dose; A spontaneous report was received from a son, concerning a 92 year old male patient, his father, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke a few weeks after the vaccine and it was known that missed the second date, 42 days passed since the first dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced a stroke and went to nursing home. Th patient had missed the second vaccine dose which was scheduled for 19-Feb-2021. It was known that 42 days have passed since the patient had the initial dose administered. No treatment information was provided. The outcome of event, 42 days passed since his first dose was recovered. The outcome of the event, suffer a stroke a few weeks after the vaccine, was unknown.; Reporter's Comments: This report refers to a case of 92- year-old male patient who experienced serious unexpected event of stroke a few weeks after the vaccine and missed the second date (Product dose omission issue) for mRNA-1273. Limited information regarding the event of stroke has been provided at this time. Patients medical history, onset date, clinical details and diagnostic results of the event are lacking. Further information has been requested. The event of product dose omission issue is considered not applicable. | | 436 | COVID19 (COVID19 (MODERNA)) | Unknown | Unknown | 1170757-1 | Mild stroke; Sore arm; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild stroke/ transient ischaemic attack and sore arm/pain in extremity. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (Batch Number: unknown) via unspecified route for prophylaxis of COVID-19 infection. On an unspecified date, after the vaccination, the patient experienced sore arm and mild stroke. Treatment information for the events was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, mild stroke and sore arm, was unknown at the time of this report.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities | | 437 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 18-29 years | 0 days | 0915649-1 | On 12/30 Immediately 1 hr post vaccination employee could not speak correctly. 2.5 hours after vaccine experienced severe headache and called 911. Vital signs were stable and did not go with EMS. 3 hours after 911 was called went to ED. MD in ED wrote up summary as ""severe migraine with trouble speaking"". ED MD said ""trouble speaking is a symptom of migraine"". No evidence of stroke. Employee still has Headache as of 12/31/20. Employee was COVID positive on 12/1/2020."" | | 438 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 18-29 years | 0 days | 0918783-1 | left sided weakness; it has weakened his heart; stutter; severe stroke like symptoms; Ventricular tachycardia/help keep his heart rate at bay; Loss of balance; extreme numbness and tingling in left hand and foot; tingling in left hand and foot; oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily; Issues finding words and trouble speaking; Issues finding words and trouble speaking; Ejection fraction down to 25%; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 28Dec2020, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other healthcare professional (HCP). A 29-years-old male patient received bnt162b2 (lot number: EJ1685), intramuscular (deltoid left) on 21Dec2020 at 05:30 at 0.3 mL single (first dose) for Covid. Medical history was reported as ""none"". Concomitant medications were not reported. The patient previously received Flu vaccine in Oct2020 for immunization. The patient is an Occupational Therapist, and he called to report an adverse event that he experienced with the first dose of the COVID Vaccine. He received the vaccine last Monday, 21Dec2020 at 5:30AM before his shift at work, then 20 minutes later, he was having severe stroke like symptoms. He experienced severe left sided weakness, loss of balance, extreme numbness and tingling in his left hand and foot, he had issues finding his words and he couldn't speak, and he had an oral motor impairment where his mouth was weak and not coordinated. The staff at the hospital did a neurological exam on him, and he failed, so he had to go to the emergency room (ER). The patient added that he was already in the hospital when this happened, and the ER doctors suspected that he had a CVA, and they gave him TPA to prevent any permanent brain damage and it worked. The patient then added that due to the shock of this whole event, from everything that happened, it has weakened his heart. Reportedly, he is a healthy 29 year old man, with no preexisting conditions, and he works out, and he has no heart conditions, but he had to get a cardiology follow up a few days after he got the vaccine, because he started going in to Ventricular Tachycardia, which he had never had in his life. So, the doctors at the hospital went ahead and did an Echocardiogram and an EKG, and he was told that his Ejection Fraction is down to 25%. He stated his heart is so weak, that he cannot work right now, but the structure of his heart is fine and has not had any damage. The hospital staff thought that maybe the patient had a chronic heart issue that he just did not know about, and that the stress of this event maybe made it kick into overdrive, but he states that the cardiologist said that was not the case, because the structure of his heart is fine, and the only thing they can see is that the heart is pumping weak. One physician even suggested that due to the shock of the event, he might have Takotsubo Cardiomyopathy, which is a broken heart, but because the structure of his heart is okay, it should be reversible. He stated that he is hoping he will heal up good, because he is young and has no pre-existing conditions. He added that his heart is in such a state right now; he has to wear an external defibrillator. The patient stated that all these happened about 20 minutes after he received the vaccine, and he was admitted to the hospital from 21Dec2020 to 25Dec2020. His neurological symptoms have resolved except that he has a stutter that he did not have before and his mouth is fatigued easily, so he has to slow down when he is eating, but now he can eat regular for the most part. The patient confirmed that he was not specifically prescribed the product; it was administered to him at his place of work, but it was optional. He stated he considered how he is working with COVID patients every day, and given the circumstance, he thought that it would be a best practice for him to get the vaccine. He had not gone to his primary care doctor in a while because he had been fine and healthy, but he called them and found out that his primary care had retired, so he has to find a new one now. Regarding the issues finding words and trouble speaking, he stated that he has improved, but it is still ongoing, he is just stuck in a plateau zone. With the Ventricular Tachycardia, he stated that this is an ongoing issue, as he has to wear the life vest even though he has no need to activate it yet. He did have one minor bought of the VTach, but because he is a therapist, he knows how to take care of it with relaxation techniques, he knows how to manage it. He had one bought of VTach the evening prior, but he was able to get it under control. The doctors have him on medication to help keep his heart rate at bay. He has never had to use medication before and is on the following medications to help keep his heart rate at bay: Metoprolol 25mg one tablet once daily by mouth and Lisinopril 5mg one tablet once daily by mouth. The VTach has improved, it was good enough he was able to discharge home, but it is still a concern. His cardiologist said that, basically his hope, is that once his body recover from the whole shock of everything, then his ejection fraction will heal, and his heart will heal. He again stated that the doctor told him that the structure of his heart is perfectly fine; he has thick walls in his heart, no leaking valves, and the heart was not conducting any abnormal signals. The doctor just said that right now, his heart is super weak and that it is an acute problem. With the Takotsubo Cardiomyopathy, he states that two doctors mentioned this diagnosis, but he confirmed that he was not actually diagnosed with this issue, he was just diagnosed with Ventricular Tachycardia. The outcome of the ejection fraction down to 25% was unknown to the patient at this time as he has not had another EKG or echocardiogram, but the cardiologist told him that the cardiologist expects that this will not be resolved quickly anyway. The patient confirmed that he did not receive any other vaccines on the same day he received the COVID vaccine. The only other vaccine he had this year was the flu vaccine which he got back in Oct2020. He has gone on to his online portal and there are the bloodwork results and all the imaging results on there from his CTs and MRIs, but he did not see the EKG or Echocardiogram results yet. He does not have this pulled up at this time, but he does have access to this stuff and can provide it later, if requested. He is curious about the next steps from here to how his case is processed. He is also curious if this information would help Pfizer make modifications to the vaccine if it is found that a lot of people are having the same reaction as he did. He is also wondering, given his situation, that probably he is not going to get the second dose, for his safety, but he is wondering what percentage of effectiveness the first dose does having just covered. The events left sided weakness, loss of balance, extreme numbness and tingling in left hand and foot resolved on 25Dec2020; severe stroke like symptoms and oral motor impairment; mouth weakness and not coordinated/mouth is fatigued easily resolved in 2020. The events ventricular tachycardia/help keep his heart rate at bay and issues finding words and trouble speaking were resolving, stutter had not resolved while the outcome of the events it has weakened his heart, and ejection fraction down to 25% was unknown.; Sender's Comments: The reported information is unclear and does not allowa meaningful assessment of the case. It will be reassessed upon receipt of follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate."" | | 439 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 18-29 years | 0 days | 0921633-1 | The night after the covid vaccine, the patient started experiencing left-side facial numbness and tingling of the V2 and V3. Patient also started experiencing ear pain. Patient also had uncontrollable drooling and dry eye. The next day, the patient went to work and there the adverse events started worsening. Patient went to the ER and did a full workup. CT scan to rule out stroke and full blood work. As per the neurologist (MD), patient is developing mild Bell's Palsy. No course of treatment was given. | | 440 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 18-29 years | 0 days | 0964487-1 | 26 y/o woman w/ no sig pmhx, c/o left sided facial numbness/tingling s/o covid vaccine. Pt states she received her vaccine at 3pm, approx 1-2 hrs later started to notice left sided lip numbness that radiated to her left ear and left side of head. No difficulty speaking, no facial heaviness, no changes in vision or hearing. No n/v, no fevers. No previous similar episodes. ED states low suspicion for any stroke, states may be an early bell's palsy vs a pre-rash zoster. Unlikely to be reaction to vaccine. Some slight improvement during ED stay. | | 441 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 18-29 years | 0 days | 1010598-1 | mental confusion; inability to speak/tried to say things and it was a jumbled, meaningless string of words; felt very cold; tingling around the mouth; aura like a bad migraine; bright spotty vision in the peripheral right field; bright spotty vision in the peripheral right field; thought she was having a stroke; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; likely a severe migraine; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231, expiration date was unknown), intramuscularly on the left arm on 30Dec2020 at 14:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. Relevant medical history included COVID-19, which was diagnosed prior to vaccination and migraines (before). The patient had no allergies to medications, food, or other products. Concomitant medication included melatonin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 15:45 or 1 hour after the vaccine injection, the patient had an aura like a bad migraine and she had bright spotty vision in the peripheral right field for 15-20 minutes; the patient has had migraines before, but they're not common for her. Two hours after the vaccine, on 30Dec2020 at 16:45, the patient had mental confusion and an inability to speak; she tried to say things to her husband and it was a jumbled, meaningless string of words. She also felt very cold and she had tingling around the mouth. Her husband thought she was having a stroke and called 911 on 30Dec2020. All her vitals were stable, and within 10 minutes she could speak again. On 30Dec2020, the patient's electrocardiogram (EKG) showed peaked T waves, common with dehydration and high potassium. She was encouraged to go to the emergency room (ER). Instead of taking the ambulance, she drove herself several hours later. The patient wanted someone to tell her it wasn't a stroke. After a brief neurological exam on 30Dec2020, the doctor said it was likely a severe migraine and wrote the reason for her visit as a vaccine reaction. This took place in the late evening to early morning, and she missed one day of work. The events did result in an emergency room/department or urgent care visit. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered from all the events on 31Dec2020.; Sender's Comments: Based on the close temporal relationship, the association between the event stroke with BNt162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. | | 442 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 18-29 years | 6 days | 1035544-1 | stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day three of a coma on life support from a brain aneurysm; Mood swings; irate; Body aches; This is a spontaneous report from a Contactable Consumer, the patient. This 28-year-old non-pregnant female consumer (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 as a single dose, for COVID-19 vaccination. Historical vaccination includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1. The facility in which the second vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. No Medical history reported ('No health issues, At all'). The patient has no known allergies. There were no concomitant medications. On an unspecified The Patient Experienced became irate. Mood swings. Body aches for couple days; On 07Feb2021 at 13:45, The patient experienced Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm (hospitalization, disability, life threatening), Treatment was given for the events of stroke, a thunder clap headache, limbs stiffened up, eyes crossed, lost speech, and brain aneurysm. The Adverse Event resulted in an Emergency Room Visit. Treatment was given for the events. 'Patient on Life support still'. The Clinical Outcome of the events Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm not recovered, while Mood Swings, Anger and Pain was unknown. Information on Lot has been requested. | | 443 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 0903318-1 | 10:00 am received vaccine @ medical center right side of mouth felt strange on the way home. 13:00 pm right side of mouth continued to feel strange. Looked in mirror and noticed uneven smile, right side of mouth drooping. 13:35 pm messaged my primary care MD. And called Nurse triage. 14:00 pm Nurse triage advised me to go the emergency room ASAP. 15:00 pm @ Emergency room. Stroke code called, labs, CT, MRI completed. Diagnosis Bell's palsy. Went home with steroid and anti-viral. Symptoms are improving. | | 444 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 0918049-1 | For her hours after vaccine administration, experienced 10 to 15 minutes of left lower quadrant visual field defect. Was not associated with headache or other neurologic (sensory or motor) deficits. Patient with history of headaches and remote history of migraines but never migraine with aura. No personal or family history of cardiovascular disease or stroke. Visual field defect resolved completely and has not been experienced sense. | | 445 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 0923506-1 | he had some facial drooping then resolving and his hand released an object he was holding, limbs going numb and he felt like he was having a stroke. This occurred about an hour after his vaccine. in the next few days he experienced severe headaches. All adverse experiences have resolved as of 1/6 | | 446 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 0924817-1 | As soon as I received my shot it was like an electric shot from the injection shot, up the back of my neck, into my brain. I was instantly woozy and disoriented. They moved me to observation. My hemiplegic migraine started within 10 minutes of the vaccine. I take a preventative every day, and to be honest after the vaccine it was like I had never, ever taken my preventatives. The migraine I got that day is the worst one I have experienced since the first one I ever got. Now on top of the migraines, the vaccine gave me waves of new symptoms. I was having spells of intense heat flashes, with wooziness, and nausea. So the new symptoms were paired with the hemiplegic migraines that, if you aren?t familiar with, mimic strokes because my whole left side tends to go limp, and I struggle with speech, and cognitive issues. So it really wasn?t all too long before the nurse kindly suggested that I didn?t look great and we should head to the ED. They treated the migraine, gave me a CT, everything came back fine. They reached out to my neurologist, gave me some fluids, really they wanted to keep me a little longer, but I know the migraine drill and just wanted to go home and sleep and eat. I promised to follow up with my neurologist and fill out my CDC form. Over the next week the migraine and extra symptoms seemed to slowly but surely let up. The only note worthy thing was really that my left side would get extra tender at times. Not just my injection site, but it was almost like all my nerve endings all over my left side were on fire at times and a pinch on the thigh may as well have been a stab, or a pat on the back a punch. It was pretty intense at times. And just when I thought it was all over my menses started, you see my hormones trigger my migraines. And once again it was like I wasn?t on a preventative. I had an intense Migraine start. I was able to take my bail out medication (sumatriptan) though and get to work. I moved forward with my day, and just when I thought all was normal, I got one of those brutal heat flashes, the room started moving, and I was nauseous. Unfortunately I was in full PPE, I almost passed out, I had to get a coworker to help, they had to get my supervisor. It was a big, unnecessary-necessary, pride-wounding scene. Now I am not a scientist or a doctor, but I might speculate that people with neurological deficits, like myself, are going to have a harder time with this inactive Covid strand. I would much rather be immune to Covid then catch it though, so whatever I can do to help, and protect myself and family and friends and neighbors, I will absolutely do... But I imagine there is probably an adjustment to be made here for the neurologically impaired. Thanks for your time, and let me know if you have any questions. | | 447 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 0931432-1 | At around 11:45pm tingling started in my left eyebrow. I thought there was something in my eyebrow and after time of wiping it a few times I went to look into the mirror and realized that nothing was there. about and hour later I got a drink and a snack to eat and I realized I had a numb sensation in the left corner of my lip. As a nurse I went though the signs of a stroke with 2 other nurses I called. Everything was normal other than that sensation. Thinking I was just overly tired I went to bed. When I woke up the next day I felt okay until I went to drink some coffee and the numb sensation in my corner lip was still there. Now I was concerned and called employee health and was instructed to go to the ER to role out a stoke. I followed employee health's instructions and went to the ER. I was diagnosed with facial paresthesia and discharged with instructions to come back if symptoms got worse. Symptoms persisted all day and around 7 I called my mom on video chat to show a visual facial twitch on the left side of my face. right after I got off the phone with her the left side of my face drooped and my fiance immediately drove me to the closest ER. I was seen immediately and they decided to admit me. The did labs and head CT. They admitted me to labor and delivery because there were no other rooms. The next day I was seen by a neurologist and many doctors. | | 448 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 0932287-1 | Potential Bell's Palsy 8 days post Pfizer BioNtech COVID19 Vaccine Dose #1 Per documentation from emergency department provider: 32 y/o M who comes in from home for a new onset facial droop. Pt states that this is sudden onset today. he is unsure if it is related to the recent covid vaccine but has otherwise been well. He has no recent viral sx. He has no other neuro sx. He did have some pain in the jaw at the onset but that has since resolved. CT head obtained more for the jaw pain and to ensure no mass etc. It is normal. I discussed at length with the pt that I suspect this is bells palsy as he has very minimal movement of the forehead, cannot fully blink the L eye closed and has no risk factors for stroke. I did offer him further imaging to make 100% sure this is not a stroke but he agrees that he feels he has bells palsy and declined further labs or imaging. i will have him f/u with ENT as an OP. Given return precautions and f/u with them in the office. Given first dose of steroids and valacyclovir here. He will use artificial tears and tape the eye at night. . | | 449 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 0942081-1 | Had Vaccine on 12/24. Since then she has had daily episodic full-body itchiness and rash or redness; light-headedness, migraines, irregular heartbeat. She has also noted episodic throat tightness and SOB in the 10 days since the vaccine. She has a history of anaphylaxis w/ morphine. She has an autoimmune condition currently being evaluated by rheumatology. Has Von Willibrands and Hx stroke due to BCP. Will need Allergy Consultation with MD prior to 2nd dose. | | 450 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 0944084-1 | Vaccinated Thursday morning, later in the evening felt achy and had a fever. Headache for 2 days. Sat morning 1/9/21 woke up with left arm weakness and numbness which went up to her face. Had an MRI completed which showed a new small right paritial ischemic stroke. | | 451 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 0959476-1 | Around 30 minutes after vaccine, I started to feel dizzy and light headed As the day went on, I started to get a headache and get very tired. Then around 5 I started to feel intense: Headache Chills/cold Dizzy/light headed/almost fell over several times Muscle weakness, could not carry anything or lift Muscles in face felt like they were melting down/stroke sensation Exhaustion Sore/achy everywhere Tender left arm where shot was Could not think/memory was gone/could not put together a sentence Tightness chest/hard to breath Could not keep eyes open Had to lay down and sleep with long pants long sweater, jacket and 3 blankets I woke up the next morning and some of my symptoms were gone except I still felt tired and had some achy ness, pain and left arm hurt and had shooting pain in joints Shooting severe pain in each joint, laster for 3 days, most severe in joints where I received vaccine but also in wrists, shoulder, elbows, hips, knees, ankles At day 5 my left arm is still sore including muscles around injection site | | 452 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 0978105-1 | Patient reports tingling/numbness in upper left arm at injection site down to left finger tips, likened to ""arm being asleep and waking up"". Writer performed stroke assessment due to patients reported symptoms. Assessment negative. Assessment of injection site negative. Patient remains A&O x4 (person, place, time, and situation). Patient reports improvement with continued movement with arm. Patient released to self to home after reported symptoms subsided - ~30 minutes from start to finish"" | | 453 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 1018910-1 | I am actually not certain which COVID vaccine she got but she came to our hospital having a stroke confirmed by CT | | 454 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 1024368-1 | Patient received her 1st dose of Pfizer vaccine around 1810 on 2/9. Approximately 10-15 mins later her arm was shaking uncontrollably, she felt that her throat was closing and had chest pressure. Medics noted hives and a rash on her chest and administered Epi and Benadryl. She began exhibiting stroke-like symptoms of expressive aphasia and dysarthria in the medic?s truck around 1850. She was crying and unable to speak. She had right sided facial droop, right sided grip weakness, and right sided arm drift. Patient was transferred to MC. Patient Update: Patient received tPA on 2/9 at 1949. CT revealed no hemorrhage or large territory stroke and no large vessel occlusion. NIHSS on admission to MC was a 3. Patient was also assessed by speech pathology. Patient appears to have been discharged home on 2/10. Patient to follow up with Outpatient Neuro PT Rehab as she is having some issues with mobility, gait, and overall functional mobility. She is using a 2 wheeled walker at this time. | | 455 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 1058150-1 | convulsing uncontrollably; stroke; rash; chest felt really heavy like someone was sitting on it; her throat felt like it was on fire; shaking uncontrollably/ arms and legs were shaking; Her speech was slurred, she could not communicate; Stuttering; dysphagia; tongue was falling to the side/mile was droopy on the right side/right arm- she would try to move it but it would not go/right leg was almost paralyzed; This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 09Feb2021 18:10 at a single dose for COVID-19 immunization. The patient had no relevant medical history. She was healthy and takes no medications. The patient got the vaccine Tuesday night at 6:10 PM. She waited in the parking lot where she got it, which was through (School Name). She had a severe reaction and had to receive an Epi Pen. This reaction occurred maybe 10 minutes after she got it. She had not left the parking lot yet, so it was prior to the 15 minutes. She broke out in a rash, her chest felt really heavy like someone was sitting on it, like an elephant, and her throat felt like it was on fire which is what is started as, then it went to her ears. From there, it escalated. She had gotten out of her car and took her sweatshirt off, she thought she was just hot. As soon as she got back in the car and as soon as she got in she started convulsing uncontrollably and shaking uncontrollably. Two ladies she works with had parked next two her on both sides and they noticed this and went to get the emergency squad. She did not lose consciousness. She could still hear everything but her arms and legs were shaking, and her right leg was shaking and stuck. The emergency squad had to help her out of the car. The ambulance gave her an Epi Pen injection and the squad took her to the hospital. Her speech was slurred, she could not communicate. She was stuttering the same thing over and over. She had a CAT scan with contrast and the stroke team decided she needed TPA - the stoke medication. They administered that and admitted her to the hospital Tuesday night. Wednesday she had an MRI, echocardiogram and another CAT scan and they released her to come home last night. She is still having lingering effects. Her speech is back. Her arm movement is back. The reason they treated her as a stroke patient, they said, is because when they told her to stick her tongue out, she had dysphagia - her tongue was falling to the side, and her smile was droopy on the right side. Her right arm- she would try to move it but it would not go. And her right leg too. She could do everything on her left side and nothing on her right side. She was conscious and could hear but could not get anything to work. After receiving the TPA, Wednesday when she woke up, she was being checked on every 30 minutes throughout the night, she was able to speak and communicate. She will still stutter and have slow words but it is way better and she can communicate. Her right arm is able to move and she can use it but her fine motor is hard. Like writing stuff is a challenge. She also has a walker. Her right leg is almost paralyzed, it drags beside her as she walks. She can move but has to really concentrate to get going. She has not reached out to her doctor yet. She was admitted to the hospital and had a bunch of tests done. The Epi Pen gave her stroke like symptoms. They were not sure in the hospital if it was actually a stroke based on her 2 MRI's and CAT scans. It did not look like a stroke from those but they think that the Epi Pen and the stress it puts into your body made her body shut down. Which the Epi Pen they said can cause stroke like symptoms. They were unsure as they have seen multiple things with the vaccine come in over the last few weeks. They told her she would need to work on the therapies out-patient. She will have to have PT/OT for lingering effects she was suffering from. Outcome of events was recovered with sequelae. | | 456 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 0 days | 1179304-1 | facial paralysis/facial drooping/facial palsy/eyes started drooping and then mouth started drooping; strange feelings in face; This is a spontaneous report received from a Pfizer sponsored program.This contactable consumer patient himself and a contactable physician psychologist, (parent of patient reported) that a 33-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm on 21Mar2021 16:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. On 21Mar2021 at 07:30 PM, after receiving his first dose, he began noticing facial drooping, which began to intensify, on the right side. He was advised by a medical professional to immediately call an ambulance and he was then taken to an emergency room where received a CT scan and full bloodwork on Mar2021. Luckily, the facial palsy began to subside and he was able to return home after the test results came back and a stroke was ruled out - it was stated that this was some kind of immuno-reaction to the vaccine. He still felt as though his face was still not 100% back to normal and still felt a bit droopy (noticeable in the mirror) yet it does feel better than on 21Mar2021 evening. Patient had a nasal swab on 22Mar2021 with negative result. One of the reporters is a psychologist and reported that her son received Pfizer-BioNTech COVID-19 Vaccine. Psychologist asking about risk of Bell's palsy, incidence, and outcomes and if these patients received their second dose of the Pfizer-BioNTech COVID-19 Vaccine. She read about 7 cases of Bell's palsy in a Dec2020 article in the [Redacted], 4 of them on the Pfizer vaccine. The reporter further clarified and described that at 6pm (2 hours after dose), patient reported he felt fine and was happy he got the vaccine; but then sometime after that, he reported ""strange feelings in face"" and then eyes started drooping and then mouth started drooping, all on right side of face. They called the university clinic and was instructed to go to ER. Brain scans and blood work were done; they ruled out stroke and said it was a possible reaction to the vaccine. He was discharged at midnight and by then, paralysis was 80-85% resolved. He is an otherwise very healthy young man. The psychologist wanted to know the efficacy after just one dose and stated that a friend suggested to perhaps not get second dose and consider getting a dose of the non mRNA vaccine like Johnson and Johnson. The outcome of the event was recovering. Information on Lot/Batch number has been requested."" | | 457 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 1 day | 0986036-1 | stroke; unresponsive; unable to move one side of her body; fell down the stairs; fever; felt groggy; This is a spontaneous report from a contactable consumer and a non-contactable consumer (patient's sister). A 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for an covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was an oncology nurse practitioner working received the Pfizer BioNtech vaccine on Thursday 14Jan2021. On Friday 15Jan2021, the patient visited her family members and told them she had a fever and felt groggy. She went to sleep around 8pm-9pm that evening (15Jan2021). Around 2am-3am in the morning Saturday 16Jan2021, the patient fell down the stairs and her family member found her - unresponsive and unable to move one side of her body. Her family member moved her to the couch. Around 7am-7:30am, the patient was still unresponsive and unable to move one side of her body. Her family dialed an ambulance took her to an hospital. At present - her family reported that the healthcare professional they spoke to said the patient had a stroke. She had received multiple scans (MRI, brain scan) in the hospital and was awaiting a Neuro consult. It was unknown if treatment received. The outcome of events was unknown. Information about lot/batch number has been requested. | | 458 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 2 days | 0913984-1 | his thighs are getting tossed to the right; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730, expiry date: unknown), via an unspecified route of administration at the right deltoid on 22Dec2020 18:40 at 0.3 mL, single for covid-19 immunization. Medical history included mini strokes and master strokes, connective tissue disorder from 2018 (diagnosed 2 years ago), seizure and brain issues. The patient experienced ""his thighs are getting tossed to the right"" on 24Dec2020 05:00. The morning of 24Dec2020, patient woke up and he felt like everything was getting switched to the right on his thighs. Below his calf and his torso are fine. He feels fine though, it was just his hips and thighs. His sister reminded him that this is how he felt when he had mini strokes and master strokes in the past. She reminded him that his left leg would go to the right. He was not falling or anything though. He feels fine, it just has that feeling. He would like to know if he should be seen for this. He was just asking because his sister is freaking out and asked if he should be seen. Patient takes epilepsy medication, blood thinners and thyroid medication. He will receive 2nd dose on 08Jan2020. Outcome of the event was not recovered."" | | 459 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 3 days | 0937436-1 | On 12/25 I was driving home and my left arm got numb, tingly and weak to the the point where I thought I was suffering from a stroke. I rushed to my moms and had her to drive me to the hospital where they did a neuro check to include a CT scan which ruled out the stroke but the symptoms lasted about 4 days which came and went with the pain and intensity varying each time which ended around 12/29. I suffered from body aches and night chills one night. Around the 12/29 I began to have pressure around the back of my head which felt as if I was laying on bricks when I laid down. It got to the point to where I couldnt sleep which caused me to go back to the ER on 1/1 where I was given toradol, decadron and sudafed which allowed me to sleep. I was released from the ER with Motrin 800 and contined to take that and Tylenol until the headaches ceased which was about 3 or 4 days later. The headache went away but the pressure still remained. My lymph glands were swollen so I was also given a prescription for amoloxicillin. | | 460 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 4 days | 0959919-1 | received the vaccine on 12/22/2020. Took a nap on 12/26/2020 around 1400 and woke up and noticed that left eye had blurry vision. He washed it and it was still blurry. After 1 hour, he decided to go to the ED- was worried about possible stroke in his eye or retinal detachment. No retinal detachment found in ED; was discharged from the ED, not admitted into the hospital. Followed up with ophthalmologist as instructed on 12/27/2020. Retinal scan done and found no retinal detachment but the doctor found fluid found behind the retina. MD recommends rest, less stress at work. Unknown if related to vaccine per MD - mentioned no data is available to compare. | | 461 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 4 days | 1085200-1 | Patient had 4 mm left frontal lobe stroke without any other known etiology on testing (heme, cardio, neuro consulting/workup); This is a spontaneous report from a contactable physician. A 35-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL9267), intramuscularly at site of left arm at 16:30 on 16Feb2021 at single dose for COVID-19 immunisation. Medical history included hypothyroidism and autism spectrum disorder (ASD) (closed 12 years ago with NO sequelae). Concomitant medication included levothyroxine and valacyclovir [valaciclovir], both received within two weeks of vaccine. The patient had 4 mm left frontal lobe stroke without any other known etiology on testing (heme, cardio, neuro consulting/workup) at 13:15 on 20Feb2021. The patient was hospitalized for this event for 2 days. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received treatment (Multiple MRI/MRI, TTE AND TEE, blood studies/holter study, new medicatinos) for adverse event. No covid prior vaccination. Covid was tested post vaccination. Covid test type post vaccination was blood test, covid test name post vaccination was Ig M/IgG with negative result on 24Feb2021. Covid test type post vaccination was Nasal Swab, covid test name post vaccination was Rapid with negative result on 24Feb2021. No known allergies. No other vaccine received in four weeks. The outcome of event was recovered/resolved with sequel.; Sender's Comments: Limited information does not allow a medically meaningful assessment for the event Stroke for BNT162B2. Details regarding the clinical symptoms, relevant test results, treatment medications and clinical course are not provided. At this time, the case is handled as related for reporting purposes. The case will be re-evaluated if more information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 462 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 5 days | 0948118-1 | Pfizer-BioNTech COVID- 19 Vaccine EUA Received communication that patient experienced a stroke and received alteplase at a non-facility (Medical Center) 5 days after receiving COVID-19 vaccination. | | 463 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 6 days | 0918980-1 | guillain barre syndrome; stroke; left thigh burning; Left b/l gluteal burning/bilateral gluteal burning; paresthesia; mid back burning; right side burning / right thigh burning; b/l hand numbness/bilateral hand numbness; left facial numbness; b/l foot numbness/bilateral foot numbness; This is a spontaneous report from a contactable physician (patient). A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 19Dec2020 at single dose for prevention. Medical history included none. There were no concomitant medications. Caller states, he received the covid vaccine 19Dec2020 and on 25Dec2020 he was experiencing left facial numbness, b/l foot numbness, b/l hand numbness on 26Dec2020, right side burning on 28Dec2020, Today (29Dec2020) he has had left thigh burning, and Left b/l gluteal burning and paresthesia. No motor issues and no tendon issues, all intact. Also had mid back burning on 28Dec2020 that comes and goes. He has heard that there is a described neuropathy with the virus and/or with the vaccine and wants more information on that. Curious if anyone has anything similar? and makes mention of possible Gillian Barre Syndrome. States that he has had a potential reaction. He had his dose on 19Dec2020. On 25Dec2020 he developed left facial numbness, then later that day he developed bilateral foot numbness. On 26Dec2020, he developed bilateral hand numbness, on 28Dec2020 he developed right thigh burning, and today (29Dec2020) he has developed left thigh burning, and bilateral gluteal burning and paresthesia. States that he has been kind of freaking out about it. He doesn't have any motor issues. States that he heard that there is a described neuropathy with the virus, but not with the vaccine, is that true? The left facial numbness resolved on either 26Dec2020 or 27Dec2020. States that the symptoms were concerning because it could have been a stroke. States his symptoms were moderate. States that due to the bilateral foot and hand numbness, he had a LP, brain and spine MRI, and blood work done on 26Dec2020. All came back completely normal. When asked about causality, caller states that it makes the most sense for his symptoms to be caused by the vaccine due to his age and the fact that all his testing was completely normal. Reporter seriousness for left facial numbness, bilateral foot numbness, bilateral hand numbness, right thigh burning, left thigh burning and bilateral gluteal burning and paresthesia: Medically significant. The outcome of the event left facial numbness was recovered in Dec2020. The outcome of the events guillain barre syndrome, stroke and mid back burning was unknown. The outcome of the other events was not recovered.; Sender's Comments: Based on the temporal relationship the association between the reported serious adverse events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. | | 464 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 9 days | 0984637-1 | Rught MCA Stroke; This is a spontaneous report from a contactable nurse (patient). A 39 years old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 16Dec2020 10:15 at the first single dose at right arm for covid-19 immunisation. Medical history included Hodgkin's disease. Concomitant medication included colecalciferol (VITAMIN D3 1000). The patient experienced rught MCA stroke on 25Dec2020 06:15. Seriousness criteria reported as hospitalization, life threatening. The patient was hospitalized for rught MCA stroke for 3 days. The patient underwent lab tests and procedures which included Nasal Swab: negative on 25Dec2020. The patient received unspecified treatment for rught MCA stroke. The outcome of event was recovered.; Sender's Comments: The subject had medical history included Hodgkin's disease. The reported stroke was more likely an intercurrent disease, and unlikely causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 465 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 9 days | 1044071-1 | I had a major stroke on 12/25/2020, 9 days after receiving the vaccine. I had a clot in my MCA. My left arm was completely flaccid, with left facial droop and garbled speech. Thankfully I was able to receive TPA that day, which resolved all of my symotoms. | | 466 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | 15-30 days | 0972019-1 | On Thursday 1/21/2021, around 10am: I felt my left lip and mouth had a numbing taste and effect, I was slowly throughout the day unable to drink out of a cup without dribbling, my right eye was constantly watering, around 4pm: my right arm started tingling and bothering me, around 9pm: I tasted a Novocain(numbing) like taste in my mouth, I showered and went to bed, while in bed around 10:30pm: I drank out of a water cup and immediately drooled water onto my shirt and my right arm was starting to tingle even more, I thought that was out of the ordinary and got up to look in the mirror, when I looked in the mirror, my first thought was to smile and the right side of my mouth drooped, my right eye was drooping and I was unable to smile or close my eye. At 12:30: I went to the ER for tingling on my face and right arm, I thought I was having a stroke. In between home and traveling to the ER, paralysis started on my right side of face | | 467 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 30-39 years | Unknown | 0934951-1 | Acute demyelinating encephalomyelitis; Slurring his speech; Stroke; This is a spontaneous report from a contactable physician. A 35-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in deltoid (unknown if right or left) on 17Dec2020 at 30 ug, single for 'Preventative'. Medical history included hypertension. There were no concomitant medications.(Physician) He is calling about the Pfizer Covid 19 vaccine. States what is going on with the patient may be associated as a side effect. The patient got the vaccine two to three weeks ago, he clarifies the patient received the vaccine on 17Dec2020 and the patient ended up acutely developing (states it is a presumptive diagnosis) Acute demyelinating encephalomyelitis, states it looks like a radiologic diagnosis. The patient is an employee at hospital. When querying seriousness states it is medically significant but could be disabling but he thinks the patient will recover. Reporter seriousness for acute demyelinating encephalomyelitis: Medically significant, Hospitalization. Patient was hospitalized on Sunday and he is still admitted at this time. Dates when patient was in hospital for acute demyelinating encephalomyelitis was from 03Jan2021 to ongoing. Caller thinks the patient was flown to (Place) yesterday. The patient's mother asked the caller if the caller thought the acute demyelinating encephalomyelitis was from the vaccine and the caller responded that he did not think it was from the vaccine. He confirms the patient is still admitted in the hospital and the patient's attending neurologist is doctor. The caller heard about the patient from doctor. When querying covid vaccine dose, the caller states the standard dose is 30 mcg. This was clarified and documented as provided. The patient has not received his second dose yet. He asks if the patient should receive the second dose. He asks a general question if a pregnant patient can be given the Pfizer covid vaccine. He heard the patient had a stroke then the CFO tried to talk to him and the patient was slurring his speech. Caller spoke to the patient's mother this morning and caller told the mother that he would try to find out what is going on with the patient. He asked that the patient get an HIV test even though he does not think the patient is at risk. Vaccination facility type was Hospital. Vaccine administered at military facility was No. None additional vaccines administered on same date of the PFIZER suspect. AE acute demyelinating encephalomyelitis require a visit to Emergency Room, not visit to physician office. Prior Vaccinations (within 4 weeks) was none. He has heard of acute demyelinating encephalomyelitis being associated with vaccines in the past and states that it is rare and usually in kids. States he saw patients that may have had acute demyelinating encephalomyelitis back in the 80s and 90s. Therapeutic measures were taken as a result of acute demyelinating encephalomyelitis (Patient will get steroids tonight pending the review of the x-ray). The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported stroke with speech slurred, and the presumptive diagnosis of acute demyelinating encephalomyelitis (looks like a radiologic diagnosis by the reporting physician), was most likely an intercurrent disease, and unlikely causally related to the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 468 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 0 days | 0905974-1 | Left sided weakness of face, arm and left leg, onset 15 minutes after receiving vaccination Brought immediately to ED, subjective feeling of closing of throat. Given IM epinephrine 0.3mg x 1. Upon evaluation in the ED by tele-neurology consult, she received 88.5mg of alteplase on 12/20/20 at 1721 She was admitted to the Intensive Care Unit on 12/20/20 at 2208 Seen by neurology on 12/21/20 at 1227. Evaluation showed weakness on the left side but is noted that it could be effort-related. Neurologist noted that patient was treated with alteplase; CT angiogram showed no significant blockage or stenosis. Noted that this is could be related to a vasovagal effect, psychogenic or an acute ischemic stroke. As of 12/21/20 at 1615, attending provider noted left-sided paresthesia, left-sided tics and possible transient ischemic attack | | 469 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 0 days | 0906552-1 | 12/16/2020 2:30 AFTER VACCINATION, STARTED TO FEEL INCREASE HR. STARTED TO FEEL WOOZY, UNABLE TO FOCUS. CHECKED VITALS IN ICU; HR 116. WENT TO ER, TRIAGE BP WAS 163/101; HR 115. GIVEN LITER SALINE, DREW LABS. BP AND HR CAME DOWN. TOLD TO REST COUPLE DAYS. WAS CONCERNED AS HX OF STROKE. F/UP WITH CARDIOLOGIST 'DOESN'T THINK THE SECOND VACCINE WOULD BE HARMFUL' BUT 'I JUST DON'T KNOW'. FAMILY HAS HX OF HEART DISEASE. I KNOW ANXIETY BUT NEVER HAD HR DO 'WHAT IT DID'. DON'T FEEL LIKE IT WAS ANXIETY. I KNOW MY BODY. I HAD TAKEN CARE OF COVID PATIENTS THE WEEK BEFORE. I DON'T KNOW WHAT TO THINK. TRYING TO LOOK AT ALL FACTORS. 12/17/2020 HEADACHE; FOLLOWING DAY I WAS FINE | | 470 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 0 days | 0907586-1 | 2 hours after the vaccine felt like she was hit by a bus. Had facial droopiness. Has Migraines with the same facial droopiness. Left eye blurred vision. Stroke like symptoms. Fatigue, weakness. | | 471 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 0 days | 0911087-1 | Onset of tongue numbness a few hours after vaccination, which was gone the next day. Vaccinated on 12/16 - 10 days later on 12/26/20 tongue numbness recurred & he developed (R) facial droop - seen in ER on 12/17 had normal head CT, negative work up for stroke. Seen in clinic on 12/28 - diagnosed with Bells palsy, started on Valacyclovir. Patient will hold PrEP x7 days (precautionary), no sexual activity during that time. | | 472 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 0 days | 0938054-1 | joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; developing swollen, tender, and hard lymph nodes under the Left subclavian area/ swollen left subclavian lymph nodes; developing swollen, tender, and hard lymph nodes under the Left subclavian area; extreme fatigue; Runny nose; Headache; This is a spontaneous report from a contactable nurse (RN) reporting for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 23Dec2020 h 09:00 intramuscularly in left deltoid (left arm) lot number: EK5730 at single dose for COVID-19 immunization. Concomitant medications were not provided. Patient stated that she has had double mastectomy, and missing a lot of lymph nodes, states she got the first dose of Pfizer Covid vaccine on 23Dec2020, states it made her left subclavian lymph nodes swollen and hard. States that when she gets the flu vaccine at her hospital every year, she gets swollen lymph nodes ever since she had a double mastectomy and chemotherapy. She originally was wondering if she could get the vaccine in another large muscle group. States she even went as far as to cross reference flu shot ingredients with the Pfizer Covid ingredients to see if something in the vaccines were causing the swollen lymph nodes but was unable to come to any conclusion, the only think in common is the Sodium Chloride and she does not feel like that would cause any issue. States the swollen lymph nodes occurred after the Sanofi brand flu vaccine (no other information known or provided). Patient is on day 15 post vaccination and they are still swollen and hard, she is wondering if there is any data on how long this side effect can last. She made an appointment with her oncologist, she knows that the swollen lymph had the first dose, lymph nodes are still swollen and hard, knows it can cause swollen lymph nodes but wants to know what is the typically length of the event. Patient also experienced other side effects, on 30Dec2020 (last week), she developed vertigo that lasted through the weekend intermittently, states she at first thought she was having a stroke. States it seems to have subsided as of 05Jan2021 (yesterday). Patient also reported she had an itchy rash twice as part of her side effects reported from the COVID 19 vaccine. She noticed an itchy rash and it went away but she is unsure exactly the day or time. Stated she definitely remembered the rash on 28Dec2020 as she took pictures. It was gone in about three hours on the same day. She did not treat the rash because it was gone and not itching. The rash came and went and had not come back. It was mostly on the bends of the arms, bilateral arms. Patient reported developing swollen, tender, and hard lymph nodes under the Left subclavian area the day after the injection, on 24Dec2020. They were not as tender at the time of the report but were continuing and this was 15 days from her vaccination. Patient also experienced an itchy rash bilaterally on her arms that occurred twice and only lasted a few hours each time, onset date reported as 25Dec2020. She was advised to take diphenhydramine hydrochloride (BENADRYL) for it however she did not take it. On 23Dec2020 patient experienced headache. On 24Dec2020 patient experienced extreme fatigue, swollen left subclavian lymph nodes and runny nose. On 30Dec2020 patient experienced joint pain and muscle and vertigo. The events headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms were considered serious as medically significant events. Patient had not recovered from swollen left subclavian lymph nodes, joint pain and muscle, extreme fatigue and swollen, tender, and hard lymph nodes under the Left subclavian area, she was recovering from headache, runny nose and vertigo and recovered completely from an itchy rash bilaterally on her arms on 28Dec2020.; Sender's Comments: The Causality between the events, headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms, and the administration of the COVID 19 vaccine cannot be denied based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate. | | 473 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 0 days | 0959746-1 | Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything. | | 474 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 0 days | 0961281-1 | near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for Covid 19; lost weight; No sense of taste or smell; No sense of taste or smell; losing hair; heart rate started increasing; high blood pressure; Increased cough; Sleepy; tired; Headache; This is a spontaneous report from a contactable other healthcare professional (patient) through the Medical Information Team and Pfizer-sponsored program Pfizer First Connect. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly on the arm on 19Dec2020 11:15 at a single dose for COVID-19 immunization. Medical history included tachycardia and stroke from 2019 and diabetes mellitus diagnosed in summer of 2020 and ongoing. Family medical history included father had type 2 diabetes. Concomitant medication included metformin hydrochloride, sitagliptin (JANUMET) for diabetes. The patient previously took regular flu shot and had body aches; it did not happen at the year of report but in years past she did have it. The patient took the COVID vaccine for precaution as she was a healthcare worker/paramedic and stated there was no prescriber. She received the vaccination at a health department facility, not a military facility. She had no previous immunizations and no additional vaccines were administered on the same date as COVID-19 vaccine. The patient received her first dose of COVID-19 vaccine on 19Dec2020 and after nine days, she tested positive for COVID-19 on 30Dec2020 and had an inpatient hospital stay. She mentioned she was so happy that she did not have any symptoms for those days. She stated that she got the shot on the 19th and later that evening was when she started having symptoms. She tried to sleep and it woke her up, she felt sleepy, tired and experienced headache on 19Dec2020 20:00 to 21:00. On 28Dec2020 23:00, she had an increased cough. She initially had increased cough from wearing mask and was having post nasal drip, then she got wet cough and that was when she decided to get tested. She went back and forth on dates; stated she was confused with the dates because of being in the hospital, it had been a while and the dates were all meshing in together. Her specimen was collected and they did the test on 29Dec2020 then found out that she tested positive for COVID virus with a COVID test nasal swab on 30Dec2020 17:30. She mentioned she lost weight after she got COVID, had no sense of taste or smell on unspecified dates. She did not know if it was related to her thyroid but she started losing hair and her heart rate started increasing on Monday, so they took her off all her meds and said the COVID was doing crazy things to the body. She had to go on Carvedilol for the sinus tachycardia and had high blood pressure now. This was all new after she tested positive. She has had bouts of tachycardia before and did have a heart monitor as she had a stroke last year. So those have never been persistent or symptomatic. If she did have a high heart rate, it always went down. This one was symptomatic. She did fine the whole week after the shot, just had that little bit of sleepiness, was tired, and had a headache. The patient reported near syncope with sinus tachycardia due to COVID-19 and hypothyroidism on 08Jan2021 14:30 to 15:00, which required hospitalization from 08Jan2021 to 10Jan2021 (2 days). ER or physician's office was required. She never went to the ER for the vaccination, it was just for the near syncope with sinus tachycardia due to COVID-19 and hypothyroidism that she went and was then admitted to hospital. She just got out of the hospital the day before report (10Jan2021), was there for two days and was still recovering. She was supposed to receive her second vaccination on the day of report however her doctor did not know if she should get the second dose due to double antibodies. She did not ask if she still had the virus or it went away. She has not been to work in two weeks. Outcome of the events tested positive for COVID virus was not recovered; near syncope with sinus tachycardia due to COVID-19 and hypothyroidism was recovered with sequel; sleepy, tired and headache was recovering; while the remaining events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. | | 475 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 0 days | 0964376-1 | 8 minutes after the vaccine i satrt to experience some tingling to my left earlobe. It then radiated to my left jaw line where i felt an onset of numbness. the numbness hten radited to my left shoulder all the way down to my left extrremity digits. atthat time i waived over a nurse who waived a physician who check my radial pulse, pulse was noted in the 70's. At that time the physician asked a EMT perofrmed four evalautions of my BP and my BP was reading syttolically between was 140-150 and my datolics was reading 110-115. Throughout that time the numbness was still to my left side of my face and shoulder and arm and to myfingers. This was only localized to those two areas. At that time it was requested for me to go to the hospital to seek medical attention. I deferrred to going home to check my BP and at that time i was running 150/100. The numbness was still present and mu thought process my body was stressed out. I then took a nice cold shower with breathing techniques. I did orthastatics on myself. I then followed with my PCP the next day and she ordered bunch of labs, CRP, triponents, CBC, bubble study and chest x-ray and EKG. ALl the testes were deemed to be negative. My systolics were 120/80 when i saw my PCP, however i was recommedned to take the whole week off and was recommended to go back to work after the new year. After five days the numbness went away to my digits went away but not to my face. My grips were equal. I had no Bal palsy nor stroke. The numbness sill persisted up till day 9 and the umbness to the face went away. | | 476 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 0 days | 1082962-1 | thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; She lost her voice completely; coughing; itchy throat; very hoarse voice/her voice goes and comes; she got very dark in her face; She had an allergic reaction from the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer (patient's mother). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on the right arm on 17Feb2021 10:46 at a single dose for covid-19 immunization. The patient medical history included renal failure which she has had since 17Feb2020 and she was on dialysis which started on 04Dec2020. She had had a prior renal transplant before which was on 12Aug2004. Concomitant medications included prednisone, nifedipine (PROCARDIA [NIFEDIPINE]), clonidine, sevelamer, tacrolimus, carvedilol and repaglinide; all were taken from an unspecified date for an unspecified indication. She was on current medication for that for the renal failure. However, at the time of the vaccine her regular medication was on hold, she did not take it because she wanted to do the vaccine. The patient's mother reported that on 17Feb2021 her daughter has been having a lot of difficulty, she couldn't speak, she can't speak properly, unable to speak very clearly. She lost her voice completely/loss of voice, coughing, itchy throat, very hoarse voice, her voice goes and comes, and she got very dark in her face. The patient's mother thought that her daughter was having a stroke. The patient's mother also thought that the patient was going to die. She added that her daughter went to the ER and she still has problems and she could have died. She had an allergic reaction from the Pfizer COVID vaccine. She took the Pfizer vaccine at 10:46 AM. She can't speak now if she does it strains her voice then she was more hoarse. She said after the vaccine this occurred about 30 or 45 minutes. The patient was terrified, she was frightened because she wasn't able to speak. She had coughing, itchy throat, unable to speak clearly. The patient stated that she was dying. They had to get her to the hospital and she stayed over night for observation. She was discharged the next day, she stayed over night because they gave her medications they had to watch and take her vitals and blood work and they came back normal it was just the hoarseness but she had a bad allergic reaction. They gave her a lot of medications to go home on. She said that on 17Feb2021 she went to the hospital and she was discharged home 18 Feb2021. They were doing an EKG, a chest Xray, blood work, those test were being done to make sure her respiratory was okay. She had no swelling, no enlargement or they would have admitted her but all of that was normal and she was discharged home on 18Feb2021 on Solumedrol, Albuterol, Pepcid, Benadryl, Claritin. She had a terrible allergy. She said she was not admitted to the hospital they kept her for observation and she stayed in the emergency room for observation. They gave her an EpiPen. They discharged her home with an EpiPen and Prednisone 40 mg for 4 days. She said that the doctor said if you have an allergy, go to the nearest hospital and that was all being done. She asked what happens now because the patient was supposed to get a second dose but the patient's mother doesn't think so since the patient was terrified. The patient's mother said the vaccine was causing a lot of big allergies up there. She confirmed that it was her daughter experienced. Coughing itchy throat, loss of voice, unable to speak very clearly, and her face was very dark. She said hopefully someone will get back to her. She said the loss of voice after so many days, it has been 7 days now and her voice that way frightens the patient's mother. The outcome of the events was unknown. | | 477 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 0 days | 1086894-1 | tired; sore arm; Facial droop (left eye and mouth); This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at left arm 23Feb2021 08:00 at single dose for covid-19 immunisation. Medical history included Known allergies: Sulfa drugs, codeine, diastolic dysfunction type 1 from Jul2020, and anxiety depressive disorder (she took a medication for that and it had been diagnosed more than ten years). Concomitant medication included bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). The patient experienced facial droop (left eye and mouth) on 23Feb2021 14:30, tired and sore arm on an unspecified date. The clinical course was as following: She said her appointment for the vaccine was at 08:00AM, and around 02:30PM she was in a video meeting and her left side of her face started to droop and her coworker messaged her to ask if she was ok since she looked pretty funny with the eye and mouth droop. She said that this droop lasted about 4 hours and by 06:30PM it was mostly resolved, if she was not looking at it or trying to raise her eyebrows. She said that the only other side effects were she was tired and had a sore arm. She said doctor asked her to got to the emergency room (ER) to rule out a stroke or transient ischemic attack (TIA) so they did a couple of Computerised tomogram (CT) scans, one with contrast and one without, and a MRI and they did full blood lab work up, and did an Electrocardiogram (EKG) to rule out central nervous system events. She says that they didn't think it was a TIA, they felt it was a peripheral nervous event related to an autoimmune response and all the tests said that they did not thought she had TIA event. She said doctor said it was likely an auto immune response to receiving vaccine, since there were no intervening events between getting the vaccine and the droop, she has not been sick or had any dental events recently. the main reason she was calling was to see if she should get the second dose, since she wanted to get it but has heard the side effects can be stronger for the second dose. She says she would like to know can she or should she take it. The patient was tested was for a stroke but that test came back negative. The patient would like to know if it is contraindicated for her to receive the second dose after having this reaction. The outcome of the event Facial droop was recovering, and the outcome of the event tired and sore arm was unknown. | | 478 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 0 days | 1091424-1 | anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a spontaneous report from a contactable other HCP. This other HCP reported for herself that a 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 48-years, via an unspecified route of administration in left arm on 28Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included nerve damage; multiple surgeries from a wreck. Patient was not pregnant, was not pregnant at time of vaccination, there was no other vaccine in four weeks. No COVID-19 prior vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA); loratadine (CLARITIN); colecalciferol (VITAMIN D); ascorbic acid (VITAMIN C); probiotics nos. The patient previously took rofecoxib (VIOXX), miconazole nitrate (MONISTAT), gabapentin, flu shot, all experienced allergies. At 10:45 AM on 28Jan2021, the patient experienced shortness of breath (SOB), BP 209/109 within 15 minutes of the shot, clammy, major headache. Received diphenhydramine hydrochloride (BENADRYL) on site and transferred by ambulance to hospital where she received Epishot, dexamethasone and ketorolac tromethamine (TORADOL). Diagnosed with anaphylactic shock. Went home with elevated BP and major headache. Daughter called an ambulance that night because the headaches were so bad. Ambulance driver stated they couldn't do anything for patient at the hospital unless she exhibited stroke like symptoms. BP stayed elevated for 2 days and headaches continued. Started to feel better 5 days later. Followed up with her PCP and patient was put on steroids for 5 days to taper down. The adverse events resulted in doctor or other HCP office/clinic visit, emergency room/department or urgent care. Patient received BENADRYL, epinephrine, dexamethasone, TORADOL as treatment for AEs. Lab data included: patient was tested negative for COVID-19 virus test (nasal swab) on 23Feb2021. Outcome of the events was recovered in Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events anaphylactic shock, BP increased and headache with BNT162b2 use can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. | | 479 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 0 days | 1102935-1 | PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, ""My wife felt bad after the first shot, she complained of body soreness, weakness and headaches that did not go away until she had the stroke on 03/12/2021"". Patient is now hospitalized and unresponsive."" | | 480 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 1 day | 0932512-1 | Woke up in the morning with soreness in wrist and elbow and practically zero use of my left hand. Woke up on left side so just assumed hand was asleep. After 15 minutes of no improvement, I started to panic thinking I was having a stroke. Realizing I had no other symptoms and was feeling fine otherwise I knew that likely wasn't the case. Besides having zero strength (I did have feeling) my hand would curl inward toward my body. I could manipulate with my right hand by it would always curl back in. I was barely able to grip, would actually have to manipulate my fingers into a grasp, couldn't do it on it's own, and holding something as light as my cellphone would cause my hand to turn down towards the floor. Pain level I would only describe as soreness in my wrist and elbow. Annoying but not painful. It's now over 24 hours since symptoms first appeared and besides some slight weakness in the hand I would say I'm 95% better. | | 481 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 1 day | 0942217-1 | 1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted throughout the day. 1/9/21 - I woke up at 4am the follow day after receiving the vaccine and my left side of my face was numb, I could still taste metal in my mouth, I had a headache and pain in my right arm. I watch my symptoms and checked to see if I was having a stroke, but nothing pointed to that. 1/10/21 - I still was experiencing the same symptoms from 1/9/21 with not increased or decreasing of symptoms. Watched them throughout the day but nothing changed. 1/11/21 - I continued to have the same symptoms and reported to the ED after work for the symptoms listed above with no improvement. 1/12 & 1/13 - I continue to have the same symptoms with no changes. | | 482 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 1 day | 0978870-1 | Heart event stopped him from breathing; stroke; lack of air; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm on 13Jan2021 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included nut allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included zolpidem tartrate (AMBIEN) and doxepin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 13:00, the patient experienced heart event that stopped him from breathing and the lack of air caused a stroke; all reported as life-threatening. On 14Jan2021, the patient underwent lab tests and procedures which included COVID-19 test which was negative. The patient was treated for the events which included being put on a ventilator and sedation. The clinical outcomes of the heart event stopped him from breathing, lack of air, and stroke, were not recovered. | | 483 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 1 day | 1036403-1 | Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram after finding brain bleed. Once released home from brain bleed patient developed petechai, weakness, shortness of breath | | 484 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 2 days | 0904719-1 | Day 1: palpitations, dizziness Day 2: headache, redness, swelling, itching on vaccination site; GI disturbance Day 3: vaccination arm had paresthesia, heaviness, almost stroke-like symptoms; the symptoms started suddenly ** treated in the ER; IV steroids- for possible allergic reaction; tpa- for the stroke-like signs; halfway through the tpa, I felt an improvement with the arm | | 485 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 2 days | 0945691-1 | Severe axillary, supraclavicular, and ant cervical lymph node swelling on left. Left hand and facial numbness. Stroke w/u in ER with CT angio and perfusion and brain MRI with w/o gad all normal, labs normal. Sensory deficit resolved in 24hrs. Lymphadenopathy still severe at present. | | 486 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 2 days | 0954426-1 | Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment. | | 487 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 2 days | 0976837-1 | severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization. Medical history reported as none. The patient has no allergies to medications, food, or other products. There were no concomitant medications. 48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness. She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious. Information on the lot/batch number has been requested. | | 488 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 2 days | 1051870-1 | Woke up at 4 am on 01/31/2021 with muffled hearing and numbness on left side of body. BP increased to 150/100. Vomiting and diarrhea. Went to ER on 02/01/2021 and had MRI of the brain to check for stroke/TIA. Had an EKG and carotid artery scan. All tests came back normal. Continued to have neuropathy only on the left side of the body since 01/31/21. Pain travels from nerve to nerve. Occasional HA with pain only on the left side of the head. Cold tightness in chest. Seen PCP numerous times and had bloodwork done, Symptoms have continued since onset on 01/31/21 with no increase or decrease in severity. PCP has referred him to a neurologist. | | 489 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 2 days | 1054924-1 | Ischemic stroke | | 490 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 3 days | 0942107-1 | Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progressively worse over the course of the following day. I developed a persistent headache on Thursday that stuck around until Sunday. On Saturday morning I woke up feeling ok, still had the dull headache, but was ok enough to be up and around. At approximately 10:30 Saturday morning I was hit with stroke symptoms. I had weakness in my left hand, tunnel vision, couldn?t understand words that were spoke to me and was aphasic with garbled speech. Went to local ER and was worked up for stroke. Symptoms resolved Within approximately 45 minutes. All tests, lab results ok. | | 491 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 4 days | 0911765-1 | Drooping of the Right side of her face. Started 12/26/20. MRI to rule out Stroke negative. Diagnosed with Bell's Palsy. RX with a Prednisone taper and Valtrex. | | 492 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 5 days | 1033768-1 | Vaccine given 1-6-21, patient had a stroke left occluded carotid with dissection 1-11-21, no risk factors. 1-20-21 had second stroke, hospitalized for both episodes without residual symptoms. | | 493 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 6 days | 0961839-1 | tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female (no pregnant) patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 05Jan2021 10:15AM at Upper Left Arm for COVID-19 immunization. Medical history and concomitant drug were not reported. She said she got Botox injections in her forehead, as well as, a little bit by each eye, a little less than 3 weeks prior to receiving the COVID-19 Vaccine. She clarified she believes she was injected with only 50cc's of a Botox 100mg vial. She said she does not have the Botox NDC, Lot, and Expiration Date from the Botox that was injected into her forehead and eye areas approximately 3 weeks earlier. Patient got the 1st shot of covid vaccine on 05Jan2021. On Monday she had symptoms of bells palsy and wanted clinic trials result for it. Reported her Bell's Palsy symptoms started on Monday, 11Jan2021, and she was formally diagnosed with Bell's Palsy in the right side of her face in the Emergency Room on 12Jan2021 was reported as worsened. She said the doctor told her the Bells Palsy could worsen before it improves. She said the doctors ruled out a stroke and diagnosed her with Bells Palsy. Stated she has tingling in her right arm that comes and goes on 12Jan2021. She doesn't have the right arm tingling all the time. Event details: On Saturday, 09Jan and Sunday 10Jan my right eye began to twitch from time to time. I woke up on Monday very tired and my eyes were swollen and I had bags under my eyes. I felt a little off but went to work. In the middle of the day my right eye began hurting with a burning sensation. I thought I needed to change my contact lenses. The following day, Tuesday 12Jan. I woke up and noticed that I can't fully close my right eye. I felt tired again and my eyes had bags under them. I went to work and felt like not myself. Around 10am, I ate cereal and noticed that I was chewing funny. At 1:30 pm I felt tingling around my right lip and at 4pm I noticed that smile is off and that I was not able to smile fully with my right side. That was when I went to the Emergency Room. She said she was given 3 Prednisone 20mg pills while she was at the hospital yesterday, as well as, a prescription for Prednisone 20mg tablets. She said she is to take 3 Prednisone 20mg tablets per day for 6 days. She clarified once she finishes the Prednisone 20mg prescription, she will have taken 7 days of Prednisone 20mg tablets. She stated the Prednisone 20mg tablets were dispensed in a pharmacy vial, and she does not have the NDC, Lot and Expiration Date. She said she also received a prescription for Valacyclovir 1gm tablets. She said she is to take 1 Valacyclovir 1gm tablet, three times a day, for 7 days. She said the Valacyclovir 1gm tablets are dispensed in a pharmacy bottle, and she doesn't have the Valacyclovir 1gm NDC, Lot and Expiration Date. She said she doesn't want to get the second COVID-19 Vaccine dose now. No Covid prior vaccination. Covid tested post vaccination (Nasal Swab): Yes- Negative. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. Follow-up attempts are completed. No further information is expected. | | 494 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 6 days | 0981952-1 | on the evening of 1/11/21 pt started to talk to her children and she ""could not access the words."" Then she tried to text and couldn't figure out the vocabulary. She went to the ER where she was transported to hospital, under stroke protocol. She also c/o right hand numbness at the er. She was admitted and test run. No evidence of a stroke."" | | 495 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 8 days | 0994219-1 | Diagnosis of Bell's palsy/ getting peripheral nerve palsy/Left side partial facial paralysis/droopy face; difficulty with blinking; This is a spontaneous report from a non-contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3246), via an unspecified route of administration on 09Jan2021 14:30 at left arm at single dose for covid-19 immunisation. Medical history included type 2 diabetes, Hep B carrier. Concomitant medication included metformin, entecavir. On 17Jan2021 04:30 PM, the patient experienced left side partial facial paralysis, droopy face, difficulty with blinking...went to ER to rule out stroke, MRI and CAT scan normal. Diagnosis of Bell's palsy. First time getting peripheral nerve palsy. AE treatment: Prednisone, Valtrex, eye drops...IV steroids. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No known allergies. The patient underwent lab tests and procedures which included computerised tomogram: normal, magnetic resonance imaging: normal. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected. | | 496 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 10-14 days | 0944451-1 | Was working on a shower door and i got dizzy, called my wife (She's a RN) because i didn't feel good. She came in and said it looked like i had a stroke. She called 911 and i was taken to ER | | 497 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 10-14 days | 1012897-1 | Employee reports having a stroke 2 weeks after vaccination that required hospitalization. | | 498 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 10-14 days | 1054591-1 | Stroke on January 20th, 2021. Unknown cause for blood clot. | | 499 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 15-30 days | 0996053-1 | After first vaccine had LR rash after second vaccine had Bell?s palsy possible stroke | | 500 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | 15-30 days | 1094126-1 | About a week and a half after receiving the second Pfizer vaccine my husband had a stroke | | 501 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 40-49 years | Unknown | 0971548-1 | TIA/mini stroke; This is a spontaneous report from non-contactable consumer via Pfizer Sales Representative. A 5-decade-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included insulin dependent diabetic in mid 40s. The patient's concomitant medications were not reported. The patient experienced TIA (transient ischaemic attack) /mini stroke on same day he received COVID vaccine. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. | | 502 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 0 days | 0906662-1 | Soon after the shot I had a big headache, almost like a migraine headache; I am having tough time right now; Soon after the shot I had a big headache, almost like a migraine headache; I am having tough time right now; I have slight fever 99.6; Muscle ache; This is a spontaneous report from a contactable healthcare professional, the patient. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK55730), via an unspecified route of administration on 17Dec2020 at 13:00 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history included high blood pressure, lupus, stroke, and diabetes. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN). On 17Dec2020, soon after receiving the vaccine, the patient experienced a big headache, almost like a migraine headache; slight fever of 99.6 (no units provided), and muscle ache. The clinical outcomes of slight fever of 99.6 and muscle ache were unknown; while that of the big headache, like a migraine was not recovered. | | 503 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 0 days | 0913914-1 | blood pressure was super elevated, in the 190/110 range; It was getting close to stroke level; woke up and felt restlessness and agitation; Headache; felt really restless and anxious; felt really restless and anxious; was not able to sleep/ could not go back to sleep; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730, expiration date: Mar2021 intramuscularly in left deltoid from 17Dec2020 at single dose for COVID-19 immunization. Patient medical history included seasonal allergy. Concomitant medication included mometasone furoate (FLONASE) via nasal from 2018 (about 2 years ago) and ongoing at 1 spray each nostril, 1x/day for seasonal allergy. The patient previously received flu shot, on Oct2020 (2 months ago) for immunization. Patient was a firefighter and reported that he received the vaccination in the afternoon of 17Dec2020. On that afternoon, he was on duty and felt really restless and anxious and was not able to sleep. He did not sleep at all that night. He maybe got like an hour or 2 on Friday after his shift. Friday night he had the same kind of deal and it continued on into Saturday. He did crash and burn (pending clarification) on Saturday night. On Sunday, he got up and felt normal again. A few hours later on Sunday, it started up again and then it went away. He said that after dinner Sunday evening it started up again, but he was able to get some sleep. He said that Yesterday, 21Dec2020, he was fine. He took off yesterday. This morning on 22Dec2020 at 0200 he woke up and felt restlessness and agitation and he could not go back to sleep. He said that he had a headache and his blood pressure was super elevated, in the 190/110 range on 22Dec2020. It was getting close to stroke level. He said that he thought about going to the ER, but did not experience any stroke or cardiac symptom's, although his blood pressure is still high, but not as high as it was. He has not gotten any sleep since then. He said that he has an appointment to see his physician this afternoon at 1300 22Dec2020. It was reported that all events require physician office visit. Got his flu shot like 2 months ago and nothing like this happened. He said that he heard with the second round there are supposed to me more symptoms like flu like symptoms with the Covid vaccine like fever, muscle aches. Outcome of the events was reported as unknown. | | 504 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 0 days | 0920958-1 | felt like she had a stroke; fell down; Pain in leg; itchiness in her head; left leg not functioning normally; This is a spontaneous report from a contactable nurse (reporting for herself). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), via an unspecified route of administration in the left deltoid on 21Dec2020 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. There were no prior vaccinations within 4 weeks prior to the first administration of the suspect vaccine. On 21Dec2020, the patient experienced left leg not functioning normally, which was reported with the seriousness criteria of disability. On 21Dec2020, the patient had itchiness in her head. The patient felt like she had a stroke, fell down and pain in leg on 22Dec2020, which were all reported with the seriousness criteria of disability. The patient called the doctor office and spoke with the doctor on call and was told to use diphenhydramine hydrochloride (BENADRYL). No further details provided. The patient was sent home for 10 days and she was sent back to work. The patient underwent lab tests and procedures which included COVID: negative in Dec2020. The outcome of the events was not recovered. The reported assessed the events related to the suspect product, BNT162B2.; Sender's Comments: The reported events leg dragging, leg pain and fall and suspected stroke were possibly related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, stroke was not diagnosed. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 505 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 0 days | 0924320-1 | "EE reviewed contraindications and verbalized """"non"""" to all contraindications. Vaccine administrd at 1045. 1100 EE stated """"I feel weid"""". EE complained of SOB and dizziness. RN and LVN assisted EE to floor and elevated lower extremities. EE was taking deep breaths, pulse normal. RN, Called ED to notify them of EE situation. 1110 EE breathing normal and EE verbalized, """" no feeling of dizziness"""" and was assisted to sit in chair. 1113 RN escorted EE wo security golf cart and was transported to ED by Manager of security. EE was stable. ED Note 55-year-old male presenting with dizziness and anxiety after vaccination. This is a potentially seriously ill patient with significant medical complexity and risk who was assessed emergently on arrival given their concerning story. Differential includes but is not limited to orthostatic hypotension, cardiac dysrhythmia, atypical presentation of myocardial infarction, allergic reaction, adverse effect of medication. Fortunately, the patient denies any chest pain his troponin is not elevated with no ischemic findings on his EKG. He is nonfocal neurologically make me doubt stroke. He has no findings at this time to suggest an anaphylactic reaction and his vital signs are within normal limits. Orthostats were checked and negative. He has no anemia, leukocytosis or emergent electrolyte derangements that could be participating in his symptoms. Patient is tolerating oral intake and asymptomatic at this time. He was monitored and on serial reassessment developed no no recurrence of symptoms. He is safe for discharge at this time but ED read precautions were given and the patient was discharged from the emergency department in good condition. Impression: Acute dizziness anxiety, suspect adverse medication reaction"""" | | 506 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 0 days | 0924893-1 | Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in her neck; sick; She doesn't know if she had the flu bug or not; She also had very high blood pressure. It was through the roof/Blood pressure was high and she was concerned she would have a stroke; Muscle soreness; Arm soreness; This is a spontaneous report from a contactable healthcare professional (physical therapist). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 21Dec2020 08:15 at a single dose for COVID-19 immunisation; and sumatriptan from 25Dec2020 to an unspecified date at unknown dose and frequency (standard unknown dose/ She only gets 9 pills a month) for migraine. Medical history included ongoing migraine, obesity (She would say she was kind of obese), coeliac disease (She had Celiac disease and cannot eat gluten which was diagnosed since she was 4), chronic back pain (this was diagnosed a couple of years before she took the COVID vaccine), spinal stenosis (this was diagnosed a couple of years before she took the COVID vaccine), and pain (she took hydrocodone for pain but did not take any that day). Concomitant medication included hydrocodone for pain. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were none. The patient had the vaccine on 21Dec2020, and she got sick on Christmas day. She was vomiting at 14:00 and did not know if it was a side effect or not. She did have arm soreness muscle soreness at 15:00, that evening and the next day too. She normally gets a migraine once a month. She does not normally throw up with a headache though. The vomiting started when she threw up twice on 25Dec2020, then once on morning of 26Dec2020. She also had very high blood pressure. It was through the roof. She did not know if that was related to drug for migraine or vaccine. She also had the headache at 14:00 the whole time. She believed she threw up before she took Sumatriptan. The muscles got rigid and tight in her neck and she doesn't think she took it. She threw up and then she took it. She did not have a lot or expiration. There was no ER nor physician's office required. She would have it if her car was not buried in snow. Her blood pressure was high and she was concerned she would have a stroke. It was usually around 110/70 and was always very low usually. She did not know if it was accurate, but it was 165/124 at one point and she did know her pulse was accurate. She did not provide her pulse rate. She did not know if she was throwing up because her blood pressure was high and did not know if blood pressure was high because of Sumatriptan. She only gets 9 pills a month. She did not know if high blood pressure was one of the side effects. It was not a real safe medication to take once a day. She only took it once a month and only once that day. She had never thrown up with migraines before and was just concerned. She doesn't usually take her blood pressure and doesn't know if the Sumatriptan always makes it go up or not. She doesn't know if she had the flu bug or not. The action taken in response to the events for bnt162b2 was not applicable, while for sumatriptan was unknown. Clinical outcome of sickness and influenza was unknown, for headache was recovered on 27Dec2020, while for the other events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the elevated BP and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 507 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 0 days | 0928432-1 | From Patient: I received my shot on 12/30/20. When I got to my car I was having some face numbness and tingling. I went back to work I also had some weakness and being tired but that went away and weakness in my legs but that went away didn?t last long. The numbness and tingling in my face and neck did not go away. My arm is still sore. I did go to the er last night cause my blood pressure was high at home and face still numb and tingling. Just thought I better check things out. Dr wasn?t sure if it was a reaction from the covid shot he was checking for stroke issues all tests he ran were good. | | 508 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 0 days | 0934913-1 | Chills; Headache; Coughing; Tiredness; Nasal congested; Feels like her sinus were blocked; Body ache; feeling sick; Sneezing; This is a spontaneous report from a contactable nurse (patient, front line health care worker). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EH9899) via an unspecified route of administration in the left arm on 28Dec2020 (at 10:30 or 11:00 AM) at single dose for COVID-19 immunization. Medical history included hypertension, diabetes, and stroke, all reported as family history (her parent). There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional vaccines administered on same date of the Pfizer suspect. The patient did not have prior vaccinations within 4 weeks. The patient had body ache (reported as medically significant) on 01Jan2021 with outcome of recovering, had been sick for a week/ very ill on 28Dec2020 with outcome of unknown, sneezing on 28Dec2020 with outcome of not recovered, chills on 01Jan2021 with outcome of unknown, headache on 01Jan2021 with outcome of recovering, coughing on 01Jan2021 with outcome of not recovered, tiredness on 01Jan2021 with outcome of unknown, nasal congested on 01Jan2021 with outcome of not recovered, feels like her sinus were blocked on 01Jan2021 with outcome of unknown. Treatment was received for the events. Reported she had a lot of sickness, by evening that day (28Dec2020) she got sneezing and feeling sick. Then the next day was the same, then the third day. She became very ill with chills, body ache, headache, coughing, and tiredness on 01Jan2021 (also reported as 3 days later vaccination). And she had no fever, but stated she had been sick for a week. Added the headache and body ache were a little better but still she felt so congested. Clarified she had nasal congested that feels like her sinus were blocked. She treated herself with acetaminophen, once daily 500 mg by mouth starting 01Jan2021. Added the body ache pain was still on the back of her chest but her legs and arms were better. She used steam inhalation for the congestion. She was not scheduled for the next dose yet, she was just waiting. The patient was wondering if she should do a test for COVID 19. Mentioned she had been healthy all through this year and digging in the COVID 19 all the time but then after the vaccine she got so sick. This was the first day she could get up and did anything. Advised caller to consult her HCP.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the body ache. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 509 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 0 days | 0944270-1 | He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered. Unknown if any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension. Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 510 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 0 days | 0960714-1 | Pt received vaccine and developed HA with left hemianopsia, left upper ext and left lower ext weakness. Stroke Code activated at clinic where she works CT head neg TPA administered, transferred to ED for CTA and stroke care CTA neg MRI pending but clinically improved | | 511 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 0 days | 1030131-1 | Basal Ganglia sudden stroke; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 30Jan2021 at 13:00 (at the age of 55-years-old) at a single dose for COVID-19 immunization. The patient had no medical history and no blood pressure condition. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included an unspecified thyroid medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced basal ganglia sudden stroke on 30Jan2021 at 13:00, which prolonged hospitalization, caused disability, and was reported as life-threatening. The vaccine was received during existing hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 03Feb2021. Therapeutic measures were taken as a result of the event, which included intensive care unit (ICU) neurocare. The clinical outcome of basal ganglia sudden stroke was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. | | 512 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 0 days | 1058366-1 | 15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport to ER, Left side weakness, loss of speech. Er evaluated for sudden onset left sided weakness, facial droop.Code stroke was called CT angiography was unremarkable and patient admitted for bp control. Bp normalized with Clonidine , neurological exam is stable. Md felt that thus was a combination adverse reaction to vaccine in combination with Wellbutrin. Discharge after 24 hours | | 513 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 0 days | 1068382-1 | Joint aches (hips); tiredness; fever 102; patient is taking anastrazole for breast cancer; patient is taking anastrazole for breast cancer; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient, who was also 53-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number: EL3247, via an unspecified route of administration on left leg on 29Jan2021 14:45 as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer, stroke, migraines is situ melanoma, penicillin allergy, and COVID-19 prior vaccination. Concomitant medication included atorvastatin (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), anastrozole, and colecalciferol (VITAMIN D). On 30Jan2021 04:30, the patient experienced Joint aches (hips), tiredness, and fever 102 (unknown unit). The outcome of the events was recovering. No treatment given for the events. The patient has COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. | | 514 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 1 day | 0912317-1 | Urgency, repeated episodes of diarrhea; GI symptoms; Cramping; This is a spontaneous report from a contactable physician (patient). A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration at right arm on 19Dec2020 07:15 at single dose for COVID-19 immunization at a hospital. The patient's medical history included hypertension (HTN), obesity, had hx of stroke 2007 and COVID-19 (diagnosed prior to vaccination). No allergies to medications, food, or other products. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included hydrochlorothiazide, valsartan (VALSARTAN HCTZ), rosuvastatin calcium (CRESTOR), acetylsalicylic acid (ASA 81) and multivitamin. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 20Dec2020 09:00, the patient experienced gastrointestinal (GI) symptoms, cramping, and ""urgency, repeated episodes of diarrhea"". No fever. No treatment was taken as a result of the events. The outcome of the events was recovering."" | | 515 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 1 day | 0915640-1 | The next day around 2PM I felt lightheaded and overheated and I felt like I was going to pass out. Around 3PM I started with real bad chills. I was in front of the fireplace and could not get warm. Temp was 100.8F. I think I took a Tylenol. Struggled staying warm at night. Fatigue settled in and started with dry cough and it continued on Saturday. Sunday I just felt fatigue. Monday I felt a little better and Tuesday I had facial numbness so I was sent to the ER. 2-3 years ago I had bells palsy. At the ER they did a cat scan to rule out stroke and no problems there. I have been fine ever since. My arm was sore throughout everything. I had COVID in March/April. It was not confirmed with PCR but with antibody tests in May/June. The 2 things that concerned me was the cough and the facial numbness. I had a COVID test and was negative. | | 516 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 1 day | 0989988-1 | Diagnosed day after 2nd shot with opthalmic artery thrombus causing vision loss/change in left eye. I did get shot series on 12/22/2020 #1 and 1/10/2021 and was diagnosed with Covid-19 on 12/13/2020. My internist MD did not feel the vaccine caused the thrombus /Stroke but I wanted to report it as it was associated with the vaccine administration (symptoms of vision loss within 24 hours of the vaccine #2 administration). | | 517 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 1 day | 1053367-1 | day after vaccination suffered from a massive cerebellar stroke with ischemic infarct and suspected embolic stroke required emergency craniectomy with cerebellar resection | | 518 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 1 day | 1066835-1 | I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very bad headache. I took and Advil. My husband was making breakfast. I came downstairs, ate, had a cup of coffee, then got a glass of water and an ice pack and sat on a recliner in the living room. I don't remember much of the rest. It was like a dream. My husband said I let out a yell, my arms flailed and my eyes were very strange. I lost muscle strength in my lift side mimicking a stroke. He called 911. I was taken to Emergency facility where I gained consciousness. I was then transferred to Hospital. So far every test has come back negative. I have an EEG scheduled for this Thursday. | | 519 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 1 day | 1086900-1 | having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; Headache; having issues with her right hand being numb/1st 2 fingers on her right hand were numb; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 01Mar2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date was not reported) (at 59 years of age), via an unspecified route of administration in the right arm on 20Feb2021 15:49 at a single dose for COVID-19 immunisation. The patient's medical history and family medical history were none. The concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, 1st dose, lot number: EL9263, injection in right arm on 30Jan2021 (at 59 years of age). There was no other vaccines administered on same date with the Pfizer vaccine and there was no any other vaccinations within four weeks prior to the first administration date of the vaccine. The patient stated that she is not an HCP, but she does work in a mental health. She stated that she is concerned. She got her 2nd dose of the vaccine on Saturday and was having weakness in her right hand and arm. She asked if this was expected. She added that when she got up yesterday, her right arm was really sore, she was extremely tired, and she had a headache. She went to bed early that night at around 5:30pm, and she woke up around 8 or 9pm that night and tried to pick up her phone and couldn't. She stated that the 1st 2 fingers on her right hand were numb. When she got up today it was fine. They are working from home, so she was typing some notes and then it felt like her fingers went numb, it felt like her 1st finger was like rubber. She stated that the numbness comes and goes. She mentioned that she doesn't have a headache right now, but it felt like it could come back. The events did not require emergency room or physician visit. On 01Mar2021, it was reported that the patient was having issues with her right hand being numb and the representative that she spoke with recommended she follow up with her PCP, which she did, and they diagnosed her with having a small stroke and also referred her to a neurologist as well. She said that her primary care provider she saw was a nurse practitioner. She said that she also saw a neurologist. It was not reported if the patient received treatment for 'having a small stroke' while no treatment received for all other events. The outcome of having a small stroke was unknown; 'weakness in her right hand and arm' was not recovered; while 'Right arm was really sore' and 'really tired' was recovering. The outcome of Headache and 'having issues with her right hand being numb/1st 2 fingers on her right hand were numb' was recovered on an unknown date. | | 520 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 1 day | 1086954-1 | Chills; Fever; Tired; Rash; This is a spontaneous report from a contactable consumer reported for herself. A 50-year-old patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL9629 and Expiration Date unknown) via an unspecified route of administration on 04Feb2021 03:00 PM at age of 50-year-old (vaccine location: Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3249 and Expiration Date unknown) via an unspecified route of administration on 13Jan20210 3:15 PM at age of 50-year-old (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history was reported as stroke from Oct2019, no previous covid and no known allergy. There is no other vaccine in four weeks. The concomitant medications reported as acetylsalicylic acid (ASPIRIN) and metoprolol succinate (Toprol 25MG). Patient experienced Chills, then fever, tired, rash from 05Feb2021 06:00 PM. The outcome of events was recovering without treatment given. Information on the batch/Lot number has been requested. | | 521 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 2 days | 0940475-1 | Less than 2 days after having the 1st shot of the COVID-19 vaccine, I woke up at 2am and experienced Bell's palsy on the left side of my face...and had minor heart pain...was dizzy...had loss of balance...slurred speech, I had all of the symptoms of a stroke. Later in that same morning the swelling starting going down, so I waited to go to the emergency room...did not want to spend the money for all of the tests. I woke up the next morning and still had heart pain, so I decided to go to emergency room . | | 522 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 2 days | 1000626-1 | she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 with the symptoms she has now; was feeling bad; she lost her taste and her smell; she lost her taste and her smell; tired; sleeping all the time; she is sick; She still hasn't eaten a whole meal since Friday; not able to eat; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL0142, exp date not reported), intramuscular (by injection once left arm, below shoulder blade in muscle) on 13Jan2021 for COVID-19 immunization (because of job). Medical history included two stroked from 1998 and 2005. Concomitant medication included oral donepezil started taking 3 months ago (Oct2020) for something having to do with muscles because of stroke. She takes a blood thinner, as she had 2 strokes; and takes muscle relaxers too. By 15Jan2021 (Friday morning) the patient was feeling bad, she couldn't go to work, she lost her taste and her smell, part of smell. Part of taste was back at the time of reporting, but she was tired and sleeping all the time (onset date reported as 15Jan2021). She saw her neurologist because she had 2 strokes, they referred her to Pfizer, as they said she may have already had COVID 19 with the symptoms she has, but as far as she knows, she didn't have it, she took a test with the center a month before giving the vaccine, she took the vaccine because of her job, because of the kind of job she has, and they wanted her to let Pfizer know she was sick. She doesn't know if she wanted to get the other dose, as she was not feeling well at all. She was laying down sleeping every day. Her doctor said to tell Pfizer what was going on. She still doesn't feel good the day of reporting. She still hasn't eaten a whole meal since 15Jan2021. She thinks she was probably getting better, but was getting better slowly, she has no taste, she was not able to eat, no smell at all, which was really not a good thing. She can't tell the outcome of no smell she thinks. She can't smell nothing at all. She can't smell what she was cooking. It was the same as taste, she thought that is probably why she can't eat, she can't taste what she was eating. Taste was improved, but not well enough for her, it is hard to explain, you know how you enjoy food, like how it tastes, and if you can't taste, you can't eat. She sleeps all day, she was up now, but is probably going to go to sleep, she feels tired and needs to lay down. She told her doctor she will call and see what Pfizer says, they will go from there. She doesn't know if she will have to go see if she has COVID 19, or what was going on. No further investigation assessment was performed. The patient took a test a month before (results unknown). No taste was recovering (ongoing at the time of reporting) while outcome of other events was not recovered. | | 523 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 2 days | 1038403-1 | admitted to hospital for a stroke | | 524 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 2 days | 1109378-1 | I tested positive for Covid on November 11th 2020,and was asymptomatic. Within 48 hrs of getting the vaccine both my right hand and right leg started tingling and I had pins and needles sensation. I also woke up in the middle of the night with immense night sweating. My arm started becoming numb and cold. I talked to a doctor and she suggested I go to the ER right away as this could be indicative of a minor stroke. I was admitted in the hospital as they needed to run several tests. I spoke with other doctors who suggested not taking the 2nd shot as it could make matters worse. So I opted out of taking the 2nd jab. I wonder if there is any study about adverse reaction for former Covid positive people and if they are better of only taking the 1st jab. Another Covid positive friend also had a similar reaction after the 1st jab. His right side of face became numb. I am worried about lasting damage if any. Could somebody please get back with me on this. | | 525 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 2 days | 1112775-1 | blood clot leading to brain stem stroke, intubation, shortness of breath and chest pain | | 526 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 3 days | 0938118-1 | on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm | | 527 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 3 days | 0940753-1 | After getting out of the bathtub as I was reaching for my towel, A VERY SUDDEN ONSET of severe weakeness hit me and I had to sit on toilet. I was unable to move my arms or legs for 20 minutes, then was able to get up but walked VERY WOBBLY AND WEAK to my bed just a few feet away. I collapsed on my bed and turned my fan blowing on me directly. {Im NEVER hot, usually cold ALL the time}. I layed there so weak I could barely move for another 20 to 30 minutes. I thought I was having a stroke honestly and my thoughts were about my doors being locked so nobody could get in to help me and my phone was in the living room and for that time period I WAS TOTALLY UNABLE to go get it. THANKFULLY, after about 45 minutes total, all symptons went away and I returned to my baseline mobility. Im very grateful that this was not a stroke as I thought. but I do believe it may have been a reaction to the vaccine. I did not notify any physicians yet, and as of this writing Im perfectly fine, Thank the Lord. | | 528 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 3 days | 0943102-1 | Received COVID vaccine on 1/7/2021 on 1/10/2021 I had a sudden onset of right side facial numbness. I was worked up in the ER for a possible stroke but all testing was negative. The numbness lasted 3 days and has now resolved. My COVID shot was given in the right arm. | | 529 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 4 days | 1059679-1 | Stroke Bala Gangria catastrophic stroke | | 530 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 5 days | 0938471-1 | Date/time/when adverse event started: 12/31/20 noticed a white streak noted from R eyelid straight down to the R jaw. Numbness, tingling feeling from R mid cheek moving toward R ear. Swelling of the face at this site as well. Paresthesia feeling, abnormal sensations at this same area of the face. These issues continues even to today. Initially, I experienced a H/A on the R sided above my eye which has not been occurring lately. On 1/8/21 I was seen by the NP at and was dx. with Bell?s Palsy. The NP noticed that when I initially speak my mouth doesn?t move properly, but once I get my words started then my mouth moves properly. My smile is noticed to be abnormal. The NP then sent me to ER for evaluation with the dx. Of Bell?s Palsy and because of another potential medical condition there?s a high risk for a stroke. A CT scan and blood work were obtained. A f/u script for a MRI of the brain has been ordered as well. Discharge paperwork states: Bell?s Palsy. Currently, I am taking a tapering dose of Prednisone and Valtrex as prescribed. | | 531 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 5 days | 0993678-1 | Diagnosed with Bell's Palsy from Covid-19 injection (1st dose.)/left sided face droop; Stroke; Lower left pain under ear, sudden onset; This is a spontaneous report from two contactable consumers. A 50-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, Post-traumatic stress disorder (PTSD), elevated pressure increased (BP), elevated cholesterol, spondylosis with radiculopathy. Known allergies: NSAID's and augmentin. Concomitant medications included hydrochlorothiazide, venlafaxine hydrochloride (EFFEXOR), hydroxyzine, atorvastatin and ascorbic acid;betacarotene;biotin; calcium; chloride; chromium; copper; folic acid; iodine; iron; magnesium; manganese; molybdenum; nickel; nicotinic acid; pantothenic acid; phosphorus; potassium; pyridoxine hydrochloride; riboflavin; selenium; silicon; thiamine; vanadium; vitamin B12 NOS; vitamin D NOS; vitamin E NOS; vitamin K NOS; xantofyl; zinc (CENTRUM SILVER WOMEN 50+). On 05Jan2021 at 13:00, patient experienced lower left pain under ear, sudden onset. Then, noticed symptoms of a stroke. Left sided face droop. Patient went to ER (emergency room). Patient was diagnosed with Bell's Palsy from Covid-19 injection (1st dose). Patient received treatments for the events included prednisone, acyclovir, ointment to protect eye and eye patch for covering of left eye. Lab test included Nasal Swab: negative on 07Jan2021. Outcome of the events was resolving. Information on Lot/Batch number has been requested. | | 532 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 8 days | 0983883-1 | Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache that would not be relieved with tylenol. I took a plane and arrived at 1130 pm. I went to bed shortly after arriving at my daughters house. Friday morning, I was unable to be woken up and my daughter called 911. I was in a coma. I suffered cardiac arrest during a CT to check for clots. I was resuscitated and put on life support. CT scan for clots, strokes, heart attacks were all clear. I was admitted to the C-ICU and on life support, on the ventilator, and was on 3 different medications at max dosage to keep my blood pressure barely surviving. The doctors told my daughter not to expect me to survive because they had no idea why I was suddenly so ill. A doctor then told my daughter that my kidneys were failing, and my liver was damaged. I also developed a high fever and had a high white blood cell count. They gave me Vancomycin and another antibiotic, and then the next the day a kidney doctor gave me lasix to flush out all of the excess fluid. I woke up on Saturday not knowing what had happened and was completely terrified and confused. My daughter was allowed into the ICU to see me and keep me calm, thankfully. She explained to me what happened. I am still in the hospital, as they are keeping me for observation and trying to determine if my kidneys will start working properly again. Prior to this, I have only ever had a kidney infection, and I thought before I might have had the start of a UTI. I do have chronic high blood pressure as well, a long term side effect from open heart surgery 10 years prior for an aneurysm, but aside from that I am relatively healthy 50 year old. | | 533 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 8 days | 1017596-1 | 1/12/21: Pt presented to ED with L sided facial droop, L sided weakness to arm and leg, numbness to L face L arm and left leg. Presentation consistent with acute ischemic stroke. Risks and benefits discussed with the patient, who agreed to proceed with tPA. MRI brain 1/12: ""Acute infarct right MCA territory predominantly involving the right parietal/insular lobes. No acute hemorrhage or midline shift."" Started on aspirin 325 mg daily and rosuvastatin dose increased to 40 mg daily 24 hours post tPA. Patient reported a history of a-flutter many years ago for which she was on a beta-blocker, but the diagnosis remains unconfirmed. Tele reviewed during stay, no arrhythmias. ECHO, normal EF, NO PFO. Discharged to rehab on 1/15."" | | 534 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 10-14 days | 0964218-1 | Pt received dose 1 of Pfizer vaccine on 12/23/2020. Starting 1/4/2021, pt develped numbness and tingling of left arm, cheek, and tongue lasting 1.5-2 minutes. Numbness starts in elbow and radiates up and down arm. These episodes happen at various times thorughout the day. Sometimes her arm feels heavy. Has had an episode involving lip numbness that affected her seaking. Sometimes gets hot flashes lasting a few seconds. She contacted PCP to re-establish care on 1/11/21 after about 2 weeks of consistent, infrequent episodes. Never experienced this before. On 1/14 pt had an in person visit where she was evaluated by PCP. At ambulatory visit, BP 174/96. Other vital signs normal. Upper extremity exam: wrist (left, Phalen's test positive, Tinel test positive, no deformity, no crepitus), wrist (right, normal range of motion, Phalen's test negative, Tinel test negative), hand grips 5/5 bicep 5/5 tricep 5/5. Differential diagnosis: TIA, carpal tunnel syndrome, transient neurological event, shingles, hypertensive urgency. Anxiety could be component as well. Pt started ASA 81 mg QD and amodipine 5 mg QD. Plan to get carotid Dopplers to rule out TIA/stroke. Consider MRI in the future. 1/16/21: Pt developed left arm/leg numbness and tingling 0530 and reported to ED with stroke-like symptoms. During this encounter, pt states that she experiences these 1-3 minute episodes of tingling/numbness every hour or so (initially only had 1-2 per day, became more frequent in days immediately preceding 1/16). Pt reports not being able to stand that morning due to weakness in lower extremeties, though the symptoms resolved after sitting down. The patient denies any weakness to the right side, along with any family hx of stroke or headache. She takes omeprazole, amlodipine, and a baby aspirin daily. She does not currently follow up with a neurologist. The patient had lab work done yesterday and also recently had a US of her carotid artery which was unremarkable. She denies any weakness, numbness, or tingling currently. There are no other concerns at this time. The onset was 3 weeks ago. The course/duration of symptoms is worsening and episodic: lasting 3 minutes and with a frequency of every hour. Location: Left face, left upper extremity, left lower extremity. The character of symptoms is weakness, tingling and numbness. SBP 182/86. Temp 97.6 F. CT head ngative, bloodwork unremarkable, chest X-ray negative. Pt admitted for MRI of brain and C-spine. 1/17/21: Hospital notes note that symptoms apear to worsen when pt is stressed or she talks about it. MRI of brain w/ and w/o contrast completed and unremarkable. Pt declined C-spine MRI with and without contrast. Pt discharged. 1/19/21: Pt presented to outpt ambulatory appointment to follow up with worsening episodes of tingling in left arm/leg, numbness and tingling in mouth - is now effecting balance. Considering testing for other diseases such as syphilis, Lyme disease, multiple sclerosis, Guillaine-Barre. Priority status on referral to neurologist. | | 535 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 10-14 days | 0998412-1 | Patient is noticed to have generalized weakness, holding his head towards right side, mild right facial puffiness with mild left facial droop, and sent to ER, on 1/22/21. Patient also had mild fever for the last two days and was on Tylenol, blood pressure also remained elevated moderately than the usual readings. Patient was admitted through ER for 2 days and was discharged on 1/24/21, with a diagnosis of possible TIA, Todd's paresis post seizure. Patient's CT head and MRI of brain was negative for acute stroke. Patient's left facial droop and right side facial puffiness resolved over a week but noticed to have right sided pronounced weakness with moderate swelling on right arm. Patient used to eat by himself,but now not able to do so and not able to hold cup in the right hand. Patient was again sent to ER for repeat CAT scan of head, further evaluation and management. Not sure if patient had an adverse reaction to Covid-19 vaccination, but definitely these symptoms were developed after 2 weeks of receiving Pfizer vaccination, which may be coincidental. Patient was followed up by the neurologist a week after the discharge from hospital who couldn't rule out adverse reaction of vaccination. Patient is awaiting for an EEG, carotid ultrasound and Echo as an out patient. | | 536 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 10-14 days | 1021215-1 | On Saturday 2/6 unwitnessed fall without loss of consciousness. Gait was unstable, weakness on right side (RUE, RLE) slurred speech, difficulty with finding words. Transported by POV to ED for evaluation of stroke - same sx with onset of parasthesia in right upper arm. Stroke protocol done - received tPA with resolution of symptoms during infusion. Stayed in hospital until protocol completed. Symptoms resolved over the course of the hopsitalization. | | 537 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 10-14 days | 1038438-1 | episode of amnesia, occurring on 16 Feb 2021 for about 30 to 45 minutes, (no recall of memory to this time); mild confusion/sluggish thinking lasting about 24 - 36 hours afterwards.. No physical droopiness or paralysis; negative work-up for stroke done in ER, TIA could not be ruled out. | | 538 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 10-14 days | 1108885-1 | 12 hours after receiving a shot I woke up from a sleep and when I went to walk her right leg collapsed under her. She hit her head at that point. Her leg remained unable to bear weight and Monday morning we went to the emergency room where they diagnosed her with a stroke. Her right leg is paralyzed and her right side weak. | | 539 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 10-14 days | 1109279-1 | Dizziness the afternoon after the second shot on 23 Feb 2021 On 8 Mar 2021 experienced extreme dizziness. Call 911. Went to Hospital. Dr treated a brain stem stroke. | | 540 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 10-14 days | 1120013-1 | SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability to swallow properly, see without double vision, and walk again. | | 541 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 10-14 days | 1122895-1 | patient admitted with pontine Stroke | | 542 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 15-30 days | 1033542-1 | I experienced and embolic Stroke that is currently not determined a cause for at this time | | 543 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 15-30 days | 1039950-1 | Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose | | 544 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 15-30 days | 1209873-1 | The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her right eye that never went away. Then on Wednesday morning, March 31st (two weeks after receiving the first dose), she was found in bed by my mother, unable to walk or talk, her face was drooping, she was very sweaty, and had defecated on herself. My mother called the ambulance. She was transported to Hospital where it was determined she had suffered a massive hemorrhagic stroke. She was immediately transported by ambulance to another Hospital. She spent one day in ICU and then was put on palliative care. She died around 12/N on Friday, April 2nd, two days after the stroke. | | 545 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | 31-60 days | 1179688-1 | pt states on 4/1/2021 when he woke up his mouth was crooked and face was dropping. He thought he was having a stroke Pt went to Hospital ER. They gave him a CT, Blood test, X-RAYS. pt was transported to another hospital to have the MRI which showed no sign of stroke. He was brought back to hospital where he was admitted for observation. He was released after 3 days. His DX was Bells Palsy. He was prescribed valacyclovir 1mg bds and prednisone. He has to wear a patch of his left since he cant close it and he has no control of the tear ducts in this eye. The left side of this face is still drooping and he cant use the left side of his mouth and he bites his tongue when he is eating. He wishes he had not taken the shot. | | 546 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 50-59 years | Unknown | 0927751-1 | Severe body ache; it has reached to the back area on both sides; nausea; vomiting; pain below her ribs; Stomach upset; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received bnt162b2 (Covid Vaccine) lot no: EK5730, expiry date: 23Dec2020 (as reported), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history included pre-diabetes, hypertension, and flu all from unspecified dates. Concomitant medication included losartan and metoprolol succinate both for hypertension, and atorvastatin (LIPITOR) and acetylsalicylic acid (ASPIRIN) both for preventative for stroke. The patient received the Covid vaccine by Pfizer on 18Dec2020. Then on Saturday (unspecified date), the patient started having symptoms like Covid symptoms. She had severe body ache. She stated it has reached to the back area on both sides and she never had this before. She had nausea and vomiting but she only vomited once. At the time of report, she was still sick and stated that she felt like she was not getting well. Patient's causality for the events was yes and explained because she never had this kind of symptoms before. She always had the flu but the severity of it where it goes out below her ribs, she never had that. It was like her stomach was upset and she had the pain below her ribs. The patient had not recovered from the events. | | 547 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 0 days | 0932315-1 | Numb hands, numb face, lightheaded, almost passed out, spike in blood pressure, unsteady walk. Ambulance called, tested to rule out stroke and blood sugar issue but tested ok. Determined I had allergic reaction to vaccine. | | 548 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 0 days | 0971287-1 | forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most uncomfortable at this point; seemed like UTI symptoms were coming back; felt really wiped out and worn down/tired; anxiety; racing/ pounding in chest; potassium was a little low; elevated blood pressure; arm a little bit sore; 99.1 degrees Fahrenheit fever; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 28Dec2020 07:15 at single dose on deltoid left for COVID-19 immunisation. Medical history included hepatitis C which cleared in 2016, hysterectomy was done in 2004 or 2005, cyst removed from breast long ago, ongoing arthritis in left knee, urinary tract infection was treated in Nov2020. The patient's concomitant medications were not reported. She received the first vaccine on 28Dec2020. She did fine that day. She came home and laid down and rested. Her temperature went up to 99.1 degrees Fahrenheit but was resolved that same day/night. Early in the morning on 29Dec2020, around 3:30 a.m., she woke up and had a racing/pounding feeling in her chest. She took her blood pressure and it was 158/86, heart rate (HR) was 83. She felt really funny. She hadn't been diagnosed with high blood pressure before, so this was high for her. She took her blood pressure again about an hour later and it was 165/95, HR 73. She took it again about an hour later and her blood pressure read 180/98, HR 77. Her heart rate stayed in the normal range, but the force felt really strong. She did go to the emergency room around 5:00 am on 29Dec2020. She told them what she was experiencing and that she had received the COVID-19 vaccine. About the time she got to the hospital, her blood pressure was starting to come down. An EKG was done and they drew bloodwork. Her potassium came back a little low-they didn't tell her how low or what her level was. She was given 2 potassium tablets which did help. She confirms she doesn't have any NDC, Lot number or expiration date for the potassium she was given. It was given to her at the hospital. She was also given a sheet to monitor her salt intake, which she already does that. She confirmed she was not admitted into the hospital, she was discharged from the Emergency Room. She felt pretty good. She didn't go to work that Wednesday, 30Dec2020, but she went to work on Thursday, 31Dec2020. On 01Jan2021, the same thing happened to her again. She had elevated blood pressure, forceful beat. She went back to the ER early in the morning, around 5:00 am, on 01Jan2021. Her pulse stayed within normal range, but she had such a forceful beat. She informed them that she was really uncomfortable in her chest, the force was the most uncomfortable at this point. They wanted to make sure she wasn't have a stroke or heart attack, so they did their normal procedures to rule this out. They did 2 EKG's, 2 sets of labs, Chest X-ray, CAT scan and everything came back normal. She had a discussion with the physician that saw her about what she was experiencing and the physician was asking her about having anxiety. Caller explains she has never really had problems with anxiety before, but she can't say she hasn't had it. Being around COVID patients and getting the shot, sometimes anxiety can be there. The physician wanted her to try a low dose of Hydrochlorothiazide 12.5mg. She was to only to take a half dose by mouth, if her top number (systolic blood pressure) was between 140-160. Caller clarifies when she means half of a dose, the dose equals 12.5mg. She was instructed to take this 12.5mg dose until she saw her PCP. So, she did this and called her PCP and wasn't able to get an appointment to speak with a provider until the following Wednesday, 06Jan2021. She did a tele visit with her provider and let her know what had happened and that the half of the pill will only bring her top number (systolic blood pressure) to 130's-140's. Caller states she was used to her top number (systolic) being maybe in the 120's, low 130's. Her doctor increased her dose to 25mg. She was prescribed to take 25mg, tablet, by mouth, once a day. She confirmed she still checks her blood pressure before she takes the medicine. Caller verifies she has 2 bottles, one being the 12.5mg dose and the second being the 25mg dose. With the 12.5mg bottle, she sees refills and the date 05Jan2022. Caller clarifies both bottles are dispensed in pharmacy vials with no NDC, Lot number or expiry date. About a month prior to all of this and receiving the COVID-19 vaccine, clarified as Nov2020, she was treated for a UTI. During that time, her blood pressure went up a little and kind of bounced around a little bit, but came back down. Then, she got the COVID-19 shot. She initially felt fine but later on by the time she got a chance to do the tele visit with her PCP, she was telling her about her previous UTI, and the provider put her on Cipro because it seemed like her UTI symptoms were coming back. Caller verifies she doesn't have any NDC, Lot number or expiration for the Cipro. She already took of all of that. She went to the ER for the third time on 08Jan2021 because she again felt the forceful beat feeling in her chest. She explained she felt really wiped out and worn down and she was tired. An EKG was done and they did labs. She confirms she doesn't have any results with her at this time. She was taken off of work for a couple of weeks. She is currently getting in contact with a Cardiologist to make sure everything is alright. The cardiologist wants her to have a stress test. The caller states so this is where she is now. She is taking blood pressure medicine and getting set up to do a stress test. Sore arm outcome: Caller confirms she recovered from the arm soreness within that same day. Her arm didn't stay sore long at all. Racing/pounding in chest: This had improved. It's not like it was. She still has it a little bit of it now, but she is going to see her cardiologist and do a stress test. The blood pressure medicine has helped some. Elevated blood pressure: Today her blood pressure top number got to 161 and she had to take medication but her blood pressure has improved. Outcome of elevated blood pressure, racing/ pounding in chest was resolving; outcome of forceful beat feeling in her chest, UTI, potassium was a little low, felt really wiped out and worn down/tired, anxiety was unknown; outcome of arm a little bit sore, 99.1 degrees Fahrenheit fever was resolved on 28Dec2020.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. | | 549 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 0 days | 1012742-1 | 1/31/21 0730 am confused and low grade temp 99.5, 12 noon Temp 100.6 and sitting in recliner non responsive twitching. Sent to Hospital with EMS to rule out stroke. Admitted 1/31/21. | | 550 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 0 days | 1091063-1 | Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced chest pain radiating down left arm, shortness of breath, and nausea. Patient also endorses numbness to left upper arm and left lower leg. Denies any wheezing, throat swelling, facial swelling, diarrhea, urticaria. Vitals: BP 104/65, Pulse 78, SpO2. On chart review, she had similar symptoms in the past with full stroke workup that was ultimately determined to be conversion disorder. Admitted for observation to rule out ACS. EKG and serial troponin unremarkable. | | 551 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 1 day | 1138291-1 | Severe headache, fatigue, very sleepy about two hours after injection. Woke about 1:00 a.m. with severe headache. Gave two Tylenol and cold wash cloth for forehead. Started tossing and turning about five minutes later. Sat up in bed, fell over and struck bedside table. EMT said he suffered stroke around 1:30 am. He passed away on the 5th. | | 552 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 2 days | 1041365-1 | Patient got up from being in bed in the AM and noticed some numbness/tingling in bilateral extremities. There was concern for stroke so the patient came to the ER .The patient had received the second dose of the Pfizer vaccination 2 days prior. The patient received tPA and was treated in the ICU. After a short hospital course, the patient was discharged home. | | 553 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 2 days | 1100472-1 | I had a stroke; This is a spontaneous report from a non-contactable Nurse. A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3302), via an unspecified route of administration in left arm on 02Feb2021 at single dose for Covid-19 immunisation in hospital. Medical history included hypothyroid. Patient is not pregnant. Concomitant medication included levothyroxine, trazodone, famotidine (PEPCID), cyanocobalamin (VITAMIN B 12). The patient previously took codeine and experienced drug hypersensitivity. Historical vaccination included BNT162B2(lot number:EL3248) on 12Jan2021, in left arm, first dose. No other vaccine in four weeks. No Covid prior vaccination. The patient stated I don't know if it was a result of the Covid shot. But I don't have any comorbidities and I had a stroke on to four which was two days after the shot on 04Feb2021 09:30 with outcome of recovering (as reported). AE result in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (2 days), disability or permanent damage. The patient underwent lab tests and procedures which included Nasal Swab, Covid test result: negative. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Despite insufficient clinical information provided, by close temporal relationship and absence of factors which may provide an alternative cause, the company deems there is a reasonable possibility that the reported stroke is related to the suspect drug Comirnaty. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 554 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 2 days | 1126961-1 | Patient received the vaccine on Tuesday, and on Thursday morning he woke up and couldn't speak and was taken to the hospital and diagnosed with an ischemic stroke | | 555 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 5 days | 0940809-1 | left side will blur; Left side of face was sagging/ water leaking out of mouth/Progressive weakness on left side of face/ Swelling on lower left mandible/ diagnosed with Bell's Palsy.; Eye tearing; This is a spontaneous report from a contactable nurse who reported for himself. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK5780) in left arm on 26Dec2020 at 08:30 at single dose for covid-19 immunisation (worked in surgical ICU and was over 61 years old). Medical history included Pre-diabetic. Family history included: mother died; mother's side had colon cancer and grandparents and uncles had cardiovascular diseases.Concomitant medication included exenatide (BYDUREON), amlodipine besilate (NORVASC), omeprazole (PROTONIX), hydrochlorothiazide, lisinopril and pneumococcal vaccine on 08Dec2020 and tetanus vaccine on 08Dec2020. It was reported that on 31Dec2020 at 07:30, the patient had eye tearing and water leaking out of mouth, left side of face was sagging, swelling on lower left mandible (eye tearing was first, as reported); on 31Dec2020 he also experienced progressive weakness on left side of face; on 02Jan2021 the patient was diagnosed with Bell's Palsy. Then on an unknown date, left side will blur occurred. All events required emergency room visit and physician office visit. Diagnosis of Bell's Palsy and event eye tearing were serious per disability; left side will blur was non serious. Patient described the events as follows: on 31Dec2020 he was brushing teeth and noticed the water was going everywhere. Left side of face was sagging, noticed some swelling and thought it was from a bug bite. He wasn't sure if it was a stroke or not. In the morning of 01Jan2021 noticed it was progressively causing a problem. Days before noticed tearing of left eye (as reported). On 31Dec2020 before midnight, something felt wrong. He saw four cases on clinical trial with similar side effects (he clarified he had no patient information for the four patients mentioned with similar side effects from Pfizer Clinical trial. He saw this information from a article; stated four from Pfizer and Moderna). In the morning of 02Jan202, he went to Emergency Room (ER) and was diagnosed with Bells Palsy. He was given prednisone 20mg to take 3 times by mouth every day for 5 days, tetracycline 100mg, at 1 capsule by mouth twice a day for 10 days and methylprednisolone (SOLU MEDROL; Lot: 9945776;Exp: Nov2021) 4mg dose pack, started with 6 tablets first day. It was told by doctor it might cause tick problems. He was waiting for results. On 04Jan2021 went to family doctor and more blood work was taken. Because he was taking prednisone, noticed his sugar was up a little bit (date unspecified). It was prescribed Glitizide extended release, 2.5mg one tablet twice a day with breakfast. Patient was checking sugar every 6 hours. It was also prescribed Acyclovir 400mg one tablet orally five times per day for 10 days. 08Jan2021 is last day of prednisone 5 day dose and will follow up with methylprednisolone tablets. Patient had an appointment with a neurologist on 13Jan2021. Patient was still having symptoms. It was really hard for him. Not hard to swallow. Face was still drooping. Eyes were still tearing. Could not work with eyes tearing all of the time. Needed to be alert. When driving, had to focus on the right side because his left side will blur. He had to chew only on the right side because food will be left behind in between his cheeks and gums. If he drank through a straw, he had to cover the left side of his lips so he was able to suck out fluids. He thought symptoms were progressively getting worse, he didn't see much improvement. He clarified swelling was on lower part of mandible on left side. It was slightly bigger than right. When looking at face, the lines on his forehead on the left side were down. If he smiled he cannot raise his left eye brow, when before the COVID-19 vaccine he could. Noticed left side of nose was lower than the right. Cannot raise left side of lips. Outcome of the event Eyes tearing and Bell's Palsy was not recovered; outcome of the other event was unknown. Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Bell's palsy, Lacrimation increased and vision blurred due to temporal relationship. However, the Bell's palsy may likely possibly represent concurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and viral serologies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 556 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 5 days | 1068615-1 | stroke occurred five days after receiving vaccine. I was hospitalized overnight in General Hospital. Have had two MRI's. | | 557 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 8 days | 1048211-1 | a genitourinary infection (UTI)/diagnosed with a gram negative urinary tract infection; iron level was low at 21. He said a normal iron level for a male is 35; couldn't walk afterwards; Tiredness; another soft tissue injury; Headache; left eye was totally blurry/ one eye blurriness; has severe eye dryness; Injection site pain; Injection site redness; injection site puffiness; stated he noticed at around 2:30PM-3:00PM he had a rash on his hip and back; shingles/ shingles pain; a fever of 100.4 Degree F/Fever; This is a spontaneous report from a contactable pharmacist (patient) reported similar events for two patients. This is the first of two reports. A 64-year-old male patient receive first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), at same age intramuscular in arm left on 16Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included fallen at work and landed on his left side, hitting his head and left knee, a knot on the left side of his head, bleeding from above his left eyebrow, had a left black eye, all on Nov2020, subarachnoid hemorrhage, cataract surgery, using crutches when he walks, in the hospital from Nov2020 to 17Nov2020, pacemaker implanted while he was in the hospital on Nov2020, he couldn't walk on 19Nov2020, 6 stents, 3 cardiac stents on Oct2020, and chicken pox as a young adult. Concomitant medication included aspirin [acetylsalicylic acid], clopidogrel bisulfate (PLAVIX) from unspecified date to 27Jan2021 for 6 stents, paracetamol (TYLENOL, 500 mg, caplets, NDC Number: 5058044936, Lot Number: SJA066 and Expiration Date: Jul2024). The patient said he received his first COVID-19 Vaccine dose on 16Jan2021. He said at the time he pre-medicated with 2 paracetamol. He said he had read afterwards that it is not recommended to pre-medicate with Tylenol before receiving the COVID-19 Vaccine. On 24Jan2021 he developed a fever of 100.4 Degree F (body temperature). He stated his fever was 8 days after receiving his first COVID-19 Vaccine dose. On 27Jan2021, he was urinating blood/blood clots and was admitted to the hospital and treated for a UTI. He was diagnosed with a genitourinary infection (UTI). He clarified on the morning of 27Jan2021 his urine looked darker than normal. He said he went to physical therapy (PT) on 27Jan2021. He said when he came back from PT, and went to the bathroom, there was blood and blood clots in his urine. He said he called his urologist, and his urologist saw him on 27Jan2021. He said his urologist took a urine sample, and his urine sample was clear and negative for nitrites. He clarified his urologist did a digital prostate exam, and his prostate was fine. He said his urologist wanted him to make an appointment for a cystoscopy, and a CAT scan of his abdomen and pelvis. He said after he got home from the urologist, he went to the bathroom, and again had blood and blood clots in his urine. He went to emergency room. While he was in the Emergency Room, he was set-up on CBI (Continuous Bladder Irrigation). He said the urologist did not seem concerned about the amount of blood in his urine. He clarified he was admitted to the hospital, and had in place for approximately 16 hours. Next day (28Jan2021) he was diagnosed with a gram negative urinary tract infection. He said he was given a daily dose of IV Ceftriaxone 1gram on 29Jan2021 and 30Jan2021. He said he was also given a daily dose on 29Jan2021 and 30Jan2021 of IV Ferrlecit 125mg because his iron level was low at 21. He said a normal iron level for a male is 35. On 31Jan2021 he had injection site pain in his left arm, he said the COVID-19 Vaccine injection site was red and puffy. He said the COVID-19 Vaccine injection site pain, redness, and puffiness resolved on the same day, 31Jan2021. He said his second COVID-19 Vaccine dose was given in the same arm (left) on 06 Feb2021. He stated he asked that the second COVID-19 Vaccine dose be given in the same arm (left) because his left arm is his non-dominant arm. He was discharged from the hospital on 30Jan2021, and was given a prescription to take 1 Levaquin 250mg orally for 3 days starting on 31Jan2021. He said the Levaquin 250mg was dispensed in a pharmacy bottle, and did not have the NDC, Lot, and Expiration Date. He said he was also prescribed oral Feosol 325mg, twice a day, starting on 31Jan2021. He provided the Feosol 325mg, NDC Number: 12451-10-17 (unsure if he provided the correct NDC), Lot Number: 201167, and Expiration Date: Jul2022. At around 2:30-3:00PM on 31Jan2021, he developed a rash on his hip and back, saying the hip and back rash were along the same pathway. He said he spoke to a PA (physician assistant) about his rash. He said on 31Jan2021 he had taken 1 oral dose of the Levaquin 250mg. He said the PA discontinued the oral Levaquin 250mg, and changed his prescription to Macrobid 100mg, twice a day, for 5 days. He said he started the Macrobid 100mg, twice a day, on Monday, 01Feb2021. He said he completed the Macrobid 100mg prescription on Sunday, 07Feb2021, and did not have the Macrobid 100mg NDC, Lot and Expiration Date. He clarified his rash was raised, oozy, and looked weird, like a pimple that came to head. He said he spoke to his dermatologist on a video call Sunday, 31Jan2021. He said his dermatologist told him he had shingles and prescribed Valtrex 1gram, three times a day, for 7-10 days. He stated the Valtrex 1gram was dispensed in a pharmacy bottle. He said he took his first Valtrex 1gram dose on Sunday evening, 31Jan2021, and was still taking the Valtrex 1gram as of today (08Feb2021). He had an appointment to see his dermatologist in person on Wednesday, 03Feb2021, but woke up with a wicked headache that morning, so he took paracetamol and went back to sleep. He said when he woke, he still had headache, and his left eye was totally blurry. He said back in Nov2020 he had fallen at work and landed on his left side, hitting his head and left knee. He said his fall left him with a knot on the left side of his head, and he had bleeding from above his left eyebrow, and had a left black eye. He said he also had a subarachnoid hemorrhage. He said he had a CT scan of his head that showed the subarachnoid hemorrhage was contained, so the doctors wanted to just monitor him. He said he was on Effient at the time and the doctors changed him to Plavix. He said he also was taking Aspirin 81mg. He said he was taken off of Plavix on 27Jan2021 when he was admitted to the hospital for having blood and blood clots in his urine. He said he continues to take the Aspirin 81mg daily. He clarified he has been on compensation since his fall in Nov2020. He said he also had cataract surgery 2 years ago. He said he immediately called his eye doctor, and then went to the hospital Emergency Room because he thought he had a stroke. He said the Emergency room did a CAT scan and CTA of his head, which were both normal. He said a neurologist saw him in the Emergency Room, and said since it was a headache with one eye blurriness, he should see his eye doctor. He said the neurologist told him if he had a headache and both eyes were blurry, it would more likely have been a stroke. He stated when he was discharged from the Emergency Room on 03Feb2020, he went directly to his eye doctor. He said his eye doctor did several tests: field of vision, a sonogram, pictures of his left eye, and a dilation of his eyes. He said he had an eye test where he looked at a half circle and clicked a counter when he saw dots, and another eye test where he stared at something that looked like a hot air balloon, while the eye doctor took measurements. He said the eye doctor also measured his eye pressure, which was normal. He said he was at his eye doctor's office for a good couple of hours. He said his eye doctor told him that he has little white dots on the background area of his eyes that indicates he has severe eye dryness. He said his left eye is much worse than right eye. He said his eye doctor asked him if he took Crack, or Cocaine, or any kind of opioids in the last few weeks. He said he told his doctor he took 1 dose of an opioid on 31Jan2021 because of the shingles pain. He clarified he had a Percocet prescription leftover from his hospitalization in Nov2020. He said he took another dose of the Percocet the week before 31Jan2021 for pain in his knee from the fall he had in Nov2020. He said his eye doctor told him his dry eyes could be caused by the Percocet. He said his eye doctor prescribed lubricating eye drops (Refresh Optive Mega 3, UPC Number: 0023577330, Lot Number: T095, and Expiration Date: Aug2022), that he is to use in both eyes every hour, and an eye ointment in his left eye only at bedtime. He had been using crutches when he walks because of the problem with his right knee since he fell in Nov2020. He said on 06Feb2021, he took a shower, and when he went to get out of the shower, his right leg gave out. He said he didn't fall, but he couldn't walk afterwards. He said he went to the Emergency Room on 06Feb2021, and an x-ray and sonogram were done of his right knee. He said he was told he had another soft tissue injury like he had when he fell back in Nov2020. He said he was given a leg immobilizer to use. He said when he first fell in Nov2020, he originally fell on his left knee. He said he has had PT since being discharged from the hospital on 17Nov2020. He said he also had a pacemaker implanted while he was in the hospital in Nov2020. He said after his discharge from the hospital on 17Nov2020, he went to take shower at home on 18Nov2020 and his left knee gave out. He said he was able to lower himself to the floor in the shower stall, but he couldn't get out of the shower stall. He said he was left sitting on his left leg and he couldn't use his right leg. He said he finally got himself to bed, and iced his right knee because he sat on it for over an hour. He said the next day (19Nov2020), he couldn't walk and had to have an ambulance take him to Emergency Room. He said he hasn't had PT since 27Jan2021, and needs clearance from his doctor before he can restart PT. He said he has been without PT for 2 weeks now. He said on 06Feb2021 he was unable to get a MRI on his knee because he had too much swelling that would have made the MRI imaging cloudy. On 06Feb2021 he was due for his second COVID-19 Vaccine, so before he was discharged from the Emergency Room he was given his second COVID-19 Vaccine dose. He was using the Refresh Optive Mega 3 eye drops constantly now. He said he had no fever, but is more tired than in the past. He said the last couple of days he can sleep for hours, and wake up and feel like he can go right back to sleep. He said he and his cardiologist are concerned because since 27Jan2021, he has only been on Aspirin 81mg. He said he has 3 cardiac stents since Oct2020, and should be on dual therapy. He said he had a CT of his abdomen and pelvis while he was in the hospital. He said he has been off of Plavix since 27Jan2021, and can restart the Plavix until he has a cystoscopy. He wants to know if UTIs in men are common after getting the COVID-19 Vaccine, so he can decide if he should cancel the cystoscopy and restart his Plavix. The second COVID-19 Vaccine Lot number as EL9261 or EI9261. He stated the vaccine lot number was handwritten on his COVID-19 Vaccine immunization card and was difficult to read the handwritten vaccine lot number. The patient underwent lab tests and procedures which included bacterial sepsis: gram negative urinary tract infection on 28Jan2021. Clarified he had no pain, burning, or urgency with the UTI. He said he was told by the hospital he had gram negative rods in his urine, when he was started on the IV Ceftriaxone on 29Jan2021. He stated he has never had a UTI before. Clarified his body temperature is rarely 98.6 degrees, and is normally 98.2 degrees and he had never had shingles before. He said he had chicken pox as a young adult, and he only had 1 spot of chicken pox. He had never had dry eyes before. Reporter seriousness for fever, UTI, injection site pain, injection site redness, injection site puffiness, rash, shingles were medically significant. For other events were unspecified. The outcome of event injection site pain, injection site redness, injection site puffiness was recovered on 31Jan2021, dry eye, tiredness was not recovered, while the outcomes of other events were unknown.; Sender's Comments: Based on the temporal association and the known possible local reaction, a possible contributory role of BNT162B2 to the development of injection site pain, redness, and puffiness cannot be excluded. The other events are considered as due to underlying or intercurrent conditions and unrelated to the use of BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021134924 same reporter/drug, different patient, similar event | | 558 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 8 days | 1101755-1 | On 2/16/21 I suffered an occlusive stroke. No health problems. No prescriptions meds. BP was always around 120/70's. Height: 5'4"", Weight: 126 lbs. All blood work within normal range No high chlolestrol, etc. I was scheduled for 2nd vaccine on 3/1, I was advised to reschedule, which I did for 3/23. I spoke to a coule of health care professionals and asked them if they would proceed with the 2nd vaccine if it were them and was told ""no"". I am very afraid to get the 2nd vaccine. I would like to discuss this with someone."" | | 559 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 9 days | 0977620-1 | SUDDEN LOSS OF MOTION OF THE LEFT INDEX FINGER AND LEFT THUMB 9 DAYS AFTER RECEIVING VACCINE. WENT TO ER AND HAD A STAT CAT SCAN TO R/O STROKE AND A CHEST X RAY BOTH NEGATIVE. DISCHARGED FROM ER . SAW NEUROSURGEON FOLLOWING DAY, NECK X RAYS DONE. WAS PLACED ON PREDNISONE FOR 6 DAYS AND REFERRED TO NEUROLOGIST. EMG TO BE DONE IN THREE WEEKS FROM 1/22/21. | | 560 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 9 days | 1103742-1 | Beginning February 28, 2021 stroke, seizure, fever, headache and weakness. | | 561 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 60-64 years | 10-14 days | 0942237-1 | She got the vaccine on Dec 23, and then on Jan 4 she had a mild stroke with left sided arm and face weakness. She did recover fully. She already has known CAD and risk factors for CVD. It is possible, but by no means certain, that the vaccine was an indirect cause of the event. Since the vaccine provoked an immune response, as it was supposed to, it is possible that this inflammation may have set up a metabolic predisposition that may have contributed to the event, which was 12 days later. | | 562 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0929173-1 | Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), on 31Dec2020 11:00 AM via unknown route of administration at single dose for COVID-19 immunization. Medical history included high blood pressure, but went up and down and had to readjust. His BP was high and not sure how long it was that way. Concomitant medications included unspecified blood pressure medications. There were no known allergies. Patient went to ER left side of face sagging. They did MRI it showed he had stroke. It Happened before 4pm that same day as vaccine on 31Dec2020 02:00 PM. And it Happened between 2-4 pm. Patient received treatment. Patient had ER test blood, cat scan, MRI. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was recovering. This case was assessed non-serious by reporter. And the events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. | | 563 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0932145-1 | Patient came into the emergency department on 1/8/21 with an acute ischemic stroke with complete occlusion of her left MCA. She had acute and complete flaccid paresis of her right face, arm, and leg, complete aphasia, and neglect of the right side of her body. NIHSS of 27. Onset of deficit was between 6:30pm-7:10pm. She recieved her 1st COVID-19 vaccine dose that morning at 10:31am. | | 564 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0958389-1 | Stroke-like symptoms approximately 2-3 hours after receiving shot (aphasia), BP bottomed out, was transported by EMS and is currently on a ventilator in hospital. CT scan clear; MRI pending. | | 565 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0965108-1 | Pt got second dose of Pfizer after unremarkable first dose. 2 hours later at home developed garbled speech and confusion. Taken to ED and evaluated for acute stroke, TPA given. CT was not definitive. Weakness was R>L. Pt confusion worsened a bit into evening of day of event, but by the following morning pt had returned to baseline. Is an independent 89 yo who otherwise lives at home alone and is highly functioning. Pt did have a recent kyphoploasty and SI joint injection (perhaps with steroids/lidocaine). Currently patient hospitalized, expected discharge soon, only complaint is tingling in fingers.... we believe this may have been coincidental, but due to time course are reporting here. | | 566 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0968846-1 | Within 15 minutes of the injection, the individual became aphasia and stroke like symptoms. She was taken to the ER where she was later diagnosed with a cerebral hemorrhage and passed away. | | 567 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0970573-1 | Entire left side of my bod y, from head to foot, became numb and tingly very suddenly. I called 911 to make certain I was not experiencing a stroke. EMT assured me I was not. This was Saturday night. It is now Monday morning, January 25, and the numbness has not gone away. | | 568 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0970624-1 | Saturday evening 1/23/21 after vaccine, just all of a sudden from one moment to the next, left hand was very tingly and tight feeling and could not move very easily. A few minutes later her lip from the center left was also tingling, and then spread to entire left side of her body from head to feet, like her left side feel asleep that tingly feeling and numbness. Began to be worried, called 9-1-1 and the EMT reassured her that she was not having a stroke, and told her that they had heard of it before. Still today, Monday 1/25/21, particularly in her left hand which she is not able to use very much. Did take Ibuprofen but nothing else. | | 569 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0971736-1 | Vomit 30 minutes after administration. approx. 9 hours later, resident has Stroke-like symptoms. He was previously on Hospice before admitting to our facility and planned to be readmitted to hospice upon discharge. | | 570 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0972424-1 | Pfizer-BioNTech COVID- 19 Vaccine EUA:Patient with significant PMHx of alcoholism, AFIB, CHF, COPD, DM, GERD, MI, HTN, pacemaker placement stroke, and hyperlipidemia who presents to the ED with CC of dizziness. Pt states that two days prior he slipped and fell and hit his head, and was unable to ambulate after the fall. Pt denies any LOC, but states he is currently on Xarelto. Pt currently c/o back pain. Pt went for his first COVID-19 immunization 1/22/2021 when he became suddenly dizzy. Patient denies chest pain, shortness of breath, nausea, vomiting, diarrhea, abdominal pain, fever, chills, or any other acute complaints. Progress Note: ""Dizziness, near-syncope: Onset following injection of COVID-19 vaccination."" | | 571 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0978959-1 | Presented with stroke like symptoms at 10:30, right sided weakness and slurred speach. 911 was call, patient was transported to hospital. Per ED note, patient experienced TIA which resolved, actue exacerbation of CHF. Patient was admitted. Discharge summary on 1/22 indicates same diagnosis, plan was home with hospice. Family notified hospital on 1/25 that patient had expired on 1/23 at home. | | 572 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0993506-1 | the doctor was concerned that it might be a mini stroke; couldn't think of what he wanted to say; This is a spontaneous report from a contactable consumer reporting for the father. An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 08:45 at single dose in right arm because of his age group /mass senior vaccination order. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medications included blood pressure medicine since recent years. The patient previously had a flu shot (INFLUENZA VACCINE) but had that in early Nov2020. He kept saying it was the shot, but that he was fine. There were no additional vaccines administered on same date of the Pfizer Suspect. The patient got vaccinated with the Pfizer COVID vaccine on 14Jan2021. He was feeling great with no problems. He sat and waited 15 minutes, and felt fine. When they were driving home after breakfast, her mother said she was talking asking him a question, and he wouldn't respond. Her father could hear her mother asking the question, but he said he could not think of what he wanted to say. He told her he couldn't think of what he was thinking on 14Jan2021. It probably started 1 hour to 1 hour 15 minutes after vaccination, and lasted 15-20 minutes. He kept trying to think of stuff. He kept repeating this for a little bit. His wife thought he was just trying to think of something, but couldn't remember. He was 81. He was very healthy and in shape. He still rides his bike every day. He walks in the morning to play golf too. When they got home and woke up from the nap, and he felt fine. He did say it was the weirdest thing, and that it had to have come from the shot. Since then, he has felt perfectly fine. He had nothing more going on that would indicate any side effect. Her concern was that it sounded like possibly a mini stroke. Upon checking with an HCP (Healthcare professional), the doctor was concerned that it might be a mini stroke and scheduled him for a CAT (Computerised axial tomography) scan. He kept saying it had to be the shot because he has been fine ever since. He had no issues with soreness at site or anything. He didn't have a prescribing doctor. He was driving when it happened. He didn't have a slur or anything. His second appointment is on the 04Feb2021. The event did not require a visit to Emergency Room, but required a visit to Physician Office in the morning of 18Jan2021. The outcome of the event couldn't think of what he wanted to say was recovered, and of the other event was unknown. Information on lot/batch number has been requested. | | 573 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0993695-1 | Couldn't speak, slurring words, stuttering, couldn't formulate a sentence; stroke; This is a spontaneous report from a contactable consumer. A 97-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 14:15 at single dose for covid-19 immunization. Medical history included ongoing atrial fibrillation(A-flib), took medication for that. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), rosuvastatin calcium (CRESTOR). Additional vaccines administered on same date of pfizer suspect reported as no. Prior vaccinations within 4 weeks, AES follow prior vaccinations and family medical history all reported as no. The patient got her first dose on 16Jan2021 and that evening she began to have a stroke. The patient was on blood thinners (apixaban(ELIQUIS) and questor). Event reported as ""Couldn't speak, slurring words, stuttering, couldn't formulate a sentence"" with onset date 16Jan2021. Event was serious as hospitalization from 17Jan2021 to 18Jan2021. The outcome of the events was not recovered/not resolved. Patient was caller's mother. Four hours later, patient couldn't speak and was slurring words. Ambulance was called, vitals were checked, and patient was told she was ok. Next morning patient was the same. Ambulance was called again and patient had a stroke. Caller stated the stroke was very coincidental. Patient had the COVID-19 Vaccine at about 2PM. Patient had A-fib. Stroke affected patient's speech, but not terribly. Patient was on a blood thinner at the time of the report because of MRI and CT scan results. The patient was taking acetylsalicylic acid (BABY ASPIRIN), but that was taken away at time of the report. The patient was on rosuvastatin calcium (CRESTOR) 0.5 at time of the report. Next appointment for second COVID-19 Vaccine was 06Feb2021. Caller was concerned. Patient never had a stroke before. The reporter wanted to know if this had been previously reported. Saturday night was when patient's speech began slurring. The patient had the Pfizer COVID-19 Vaccine that afternoon. EMS didn't take patient to the hospital on Saturday night, just took vitals and left. Patient's speech was going in and out. Caller reached out to patient Sunday morning and patient was having the same speech issues. Patient was stuttering and couldn't formulate a sentence. Ambulance was called and patient was transported to (health center). CT scan and MRI showed patient had a stroke in the area of the brain that affect speech. Patient had an echocardiogram. Clarified patient's speech symptoms began on Saturday, 16Jan2021. ß Information of lot/batch number has been requested."" | | 574 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0994113-1 | Daughter contacted the clinical location for vaccination to inquire regarding if her mother was confused when at the location to receive her vaccine as she ended up in the ED 2 hours later with a diagnosis of stroke. completing VAERs due to how closely the vaccine was to the event. | | 575 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 0994265-1 | got the 2nd vaccine on Thursday and already had symptoms from 1st vaccine but became weaker, vomiting, diarrhea. headache went to the ER Sunday . She was coherent just weak. Did Xray of stomach found out she had colitis , started her on antibiotics and admitted her and by the next morning She started having delusions, almost like having a seizure. on blood work her magnesium was low. She started retaining fluid. Thought maybe she had stroke but CT showed nothing. Now she doesn't know who she is and just repeating numbers. Pt is currently in the ICU. She has a feeding tube now do to not eating. | | 576 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1005990-1 | irregular hearbeat; Belching; Gas; Stomach cramps; felt antsy; his blood pressure went up the day he hook the vaccine to 200/93; He was anxious feeling; sharp pains in his right eye; Ears Felt Funny; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiry date not reported), via an unspecified route of administration on 19Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included high cholesterol and blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication included propranolol hcl for blood pressure and an unspecified cholesterol pill. The patient previously received influenza (Flu shot) on an unspecified date (years) ago for immunization and experienced light headed. The patient reported that his blood pressure went up the day he hook the vaccine to 200/93 and he was real concerned about that. He took a blood pressure pill and was having some sharp pains in his right eye (he had 3-4 at different times). He was anxious feeling and could hear it blowing in his ears (which happens when his blood pressure is high). He stated he has never had his blood pressure that high and has never had any heart problems. The patient asked, whether he was in the danger zone, the danger zone of having a stroke and if they should take their second dose. The patient wondered if they could just take the first dose only. It was further reported that he took the vaccine yesterday or the day before (19Jan2021) at 11'o clock. He didn't have any problems, he just got home. Then 11'o clock at night he had fallen asleep during the day and woke up at that time, 11'o clock and he felt Antsy, his blood pressure was up, his ears puffed real high, he's on Blood Pressure medication. He Clarified further that his First Dose was on 19Jan2021 at 11 o clock during the day. Then 12 hours later that same day, he woke up, and that's when he felt antsy and the blood pressure being up. Normally he takes his Blood Pressure 2-3 times a week but that day it was like 190/80 something. When he saw it, he sat down, and thought if he relaxed it would go down. He went back over in 45 minutes or an hour later and it was 200/93, he thought he had sharp pain in the right eye during that time as well. He Never had that before, he had pain in eye before, but not like this. He then told himself maybe he should take a blood pressure pill, because he was concerned he didn't want to stroke out. He took a Blood pressure pill and then relaxed for an hour later he checked it was 189/82. He waited some more, and it kept coming down. He stayed in the recliner all night. Then on 20Jan2021 he checked and it slipped to 140/55 at about 5 o clock. The Blood pressure kept coming down 10 to 15 points every hour. The last one he took later that day was 118/65. He explains that his Blood pressure normally runs 120/65 to 140/70 normally. His blood pressure medication is only 10mg, its a low dose, he is a Healthy Person, he walks every day, his weight is good. The blood pressures provided were from 11AM to 11PM at night of 19Jan2021. It was the same day when he felt the ears feeling funny, and the sharp pain in the right eye, he has never had that before. He also forgot to mention that the next day he had a lot of stomach irregularities , he had cramping, it was uncomfortable, this was on 20Jan2021, he was also belching, and had gas. It went away that evening lasting 4-5 hours, it started in the morning 10 o clock went till 3 or 4PM. The BP value of 140/65 was from today, before lunch. The right eye sharp pain went away during the night, after he took his blood pressure pill, he didnt notice it anymore after. He doesn't know if the vaccine caused this. He couldn't tell any difference even with the pain. The ears feeling funny, he took his blood pressure a couple times a day. The monitor is showing an irregular heart beat, he didn't notice that before. He has had no positive COVID test or Antibody Test prior to the vaccine. The patient recovered from sharp pains in his right eye, ears felt funny on 19Jan2021, stomach cramps, belching, gas on 20Jan2021 while the outcome of the rest of the events was unknown. | | 577 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1010235-1 | Stroke. Massive brain bleed right side | | 578 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1011771-1 | Narrative: Patient with history advanced vascular dementia, hypertensive cerebrovascular disease and stroke, T2DM. Received her second dose of Pfizer COVID-19 vaccine at approximately 14:00 and was reported to have expired at home at 20:55. Dr. (Medical Director) spoke with patient's son/caregiver 2/4/21. Son reports that patient was in her usual health yesterday morning, deemed well enough by son to travel for vaccination. He reports she had no bothersome symptoms after either first or second vaccinations. Specifically denied rash, wheeze, and difficulty breathing. Son was with patient throughout the day. In the evening, when preparing for bed, he noted she became suddenly unresponsive in a similar fashion as she has done several times in past years. While in all previous such episodes she recovered within minutes, last evening she did not regain consciousness, experiences a brief period of labored breathing, and died. Patient's son called 911 and the patient's body was brought to the medical examiners. The medical examiner declined to proceed with autopsy. Patient's son is not interested in autopsy. Patient's son reports confidence that his mother's underlying hypertensive/diabetic cardiovascular disease is the natural cause of her death. Other Relevant Hx: Symptoms: & Death Treatment: | | 579 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1023361-1 | tingling of lip and face; tingling of lip and face; numbness on left side of face/numbness was not in her throat but it was on her neck behind her ear; blood pressure spiked; tired; she didn't sleep well; Chest pain; This is a spontaneous report from a contactable nurse (patient herself). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: lot number: E19262, via an unspecified route of administration, left arm, on 26Jan2021 10:00 at a single dose to not get Covid and to protect others around her. Medical history included mini stroke at least 8-10 years ago and neuropathy in face from ministroke. Concomitant medication included gabapentin for neuropathy in face from ministroke. The patient had no prior vaccinations (within 4 weeks). The patient previously took pregabalin (LYRICA): but was changed to gabapentin. On 26Jan2021, the patient experienced tingling of lip and face, numbness on left side of face, blood pressure spiked and chest pain. On 27Jan2021, the patient experienced tired. The events were described as: After getting the vaccine, she experienced tingling of the lip and left side of her face. She had numbness on the left side of her face. The numbness was not in her throat but it was on her neck behind her ear. Her blood pressure spiked. She drover herself to the emergency room. Her blood pressure was 160 something over 101. She was unable to specify the exact number. Then her blood pressure decreased to 104 over 80 something and it increased to 202 systolic. She was unable to specify the reading. She was tired on 27Jan2021 because she didn't sleep well in the hospital. She signed out against medical advice. The patient had a full work up to include a CT scan, MRI and doppler: results were not provided (unknown results). The patient wanted to know if recommendations were made in regard to taking the second dose if they have had adverse events. The patient was hospitalized from 26Jan2021 to 27Jan2021 (1 day) for tingling of lip and face, numbness on left side of face and blood pressure spiked. Chest pain was considered medically significant by the reporter. The outcome of she didn't sleep well was unknown. The patient was recovering from tingling of lip and face and tired. The patient has not recovered from numbness on left side of face. The patient recovered from blood pressure spiked and chest pain on 27Jan2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. | | 580 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1024099-1 | I am the discharging physician and did not admit her but based off the information at admit: the patient received her Pfizer vaccine and developed nausea during her observation time but it was not significant enough to cause concern for the family. They took her home in good spirits and she appeared to be doing well until the evening when she became unresponsive. She developed high fevers and came to the ER with low normal O2 saturations and evidence of sepsis. Blood work showed a markedly elevated white count and an elevated lactic acid of 8 along with an elevated renal function and cardiac enzymes without EKG changes (multiorgan failure). Her COVID test was negative. Blood and urine cultures were negative. A CT scan of the abdomen demonstrated no acute findings but likely chronic fecal impaction. CT Head was negative for bleed or stroke. At this time is is unclear as to what was the cause of her symptoms but we believe it was presumed bacterial sepsis but this diagnosis is in question as all her cultures were unremarkable. The family opted on comfort measures rather than aggressive intervention and she was sent home with hospice. Since it occurred so closely after receiving the vaccine I think it was worthwhile to bring it to your attention. | | 581 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1025300-1 | 75 year old M, worsening weakness for the past several weeks. Seems to have gotten worse since Monday when he had his first Covid vaccine here at the hospital. Denies any headaches or neck pain. No fevers or chills. No cough or shortness of breath. No abdominal pain. No vomiting or diarrhea. No black or bloody stools. No dizziness. Today he almost fell and the son had to catch him. He did not suffer any trauma. He offers no symptoms of pain. Here he is fully awake and alert. Nothing to clinically suspect a stroke. His vitals are stable. Chest x-ray shows nothing acute. Creatinine is better than baseline. Electrolytes are stable. Troponin reassuring. He had no chest pain or shortness of breath to suspect angina. Spoke to the wife via telephone, he is getting so weak that he was unable to walk. Paramedics report they had lift him as he could not take a step. He was unable to ambulate here in the emergency room. At this time it does not seem like I can safely discharge him home. | | 582 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1033573-1 | Patient is 102 years old history of hypertension hypothyroidism, patient presenting with altered mental status, hemoglobin of 4.6 with creatinine of 2.53, patient has lactic acidosis, anion gap metabolic acidosis. Stool Hemoccult is positive, platelet count of 23,000 noted. Patient is awake but confused, patient's son is by the bedside.Patient has diffuse oozing from multiple skin wounds,Patient has received 2 units of blood along with 2 units of platelets and 2 units of FFP. Fibrinogin of 209. Hematology service recommended starting dexamethasone for suspected ITP. Patient is a PMH of ßspontaneous subdural >ß20 years ago, surgically evacuated, HTN, Hypothyroidism ,pre-diabetes who presented to the ED with CC of AMS and slurred speech x 1 day. History obtained from son at bedside and chart review. At baseline patient is reportedly very independent and able to ambulate in the home without assistive devices. He handles his own ADLs. Patient reportedly received his 2nd dose of the COVID vaccine on Monday and since then has been experiencing fatigue and generalized weakness, in addition to decreased appetite. AMS started yesterday. He reportedly fell out of bed last night around 2 AM and family found him at 7 AM on the floor. Denied loss of consciousness. He was evaluated by Stroke team, CT of the head was un-revealing for an acute process and stable chronic changes, and CTA revealed some mild intracranial stenoses, Stroke team felt was unlikely to be an acute stroke. He was found to have Hb 4.6 on admission. Platelets were 23, He was transfused 1 unit of blood and 1 unit of platelets. Hematology was consulted and recommended dexamethasone 20 mg daily for 3 days. Rectal exam was done and he was found to be Guaiac positive was started on Protonix 40 BID. | | 583 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1033876-1 | EMS reported around 3:30 pm, patient started not feeling right. He had some tingling sensation in his left arm. Per family patient had slurred speech was not acting right. He did slide out of the chair he was sitting in. He was ambulatory on scene. Symptoms lasted approximately 5 minutes and then gradually resolved. Upon arrival to the emergency department symptoms had significantly improved. Patient reports he is feeling a lot better. Patient did receive his second covid vaccination 2 hours prior to arrival. His never had a stroke in the past. Patient was otherwise feeling at baseline earlier today. No chest pain shortness breath nausea vomiting diarrhea comes patient fever chills headache. | | 584 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1034234-1 | Eye Stroke / Retinal Occlusion Lost eyesight in left eye | | 585 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1035674-1 | Within 15-minutes, the patient reported a ""pulsating sharp pain"" behind their right eye. EMS evaluated the patient on-site and they were found to be hypertensive (173/88). The patient proceeded to a emergency department. In the ED, the patient remained hypertensive with a mild generalized headache. They reported that their eye pain is constant but comes in waves of higher intensity. Differential diagnosis was possible stroke due to right-sided hemianopsia and right-sided ptosis. Patient was admitted and evaluated. Aspirin was administered and blood pressure was monitored prior to discharge."" | | 586 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1042639-1 | Pt. recieved COVID vaccine on 6 Feb @0730 and presented to the hospital with chest pain & quesionable stroke. + CT and transferred to another hospital @ 1430, appears CVA (cerebral vascular accident); Cardioembolic stroke; Cerebrovascular accident (CVA), unspecified mechanism; TIA (transient ischemic attack). He was discharged on 10 Feb. Home course unknown | | 587 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1046413-1 | Experienced Primary Diagnosis of Stroke to left rear side of head (Also Mixed Hyperlipidemia, Coronary Artery Disease involving Native Coronary Artery of Native Heart without Angina Pectoris, Type 2 Diabetes) | | 588 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1050104-1 | client says she was in distress prior to taking the vaccine because she had stood for over an hour in line waiting to be seen and she had a double mask on. She says by then she was dehydrated and feeling faint. She has a history of atrial fib off and on, which she takes medication for. She says she feels like she almost had a stroke and Nurse Pract told her she had a full blown panic attack. She was allowed to sit down and rest and rehydrate and eat and she felt better. | | 589 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1051535-1 | My mother complained of a severe headache within 1 hour of receiving the injection. 18 hours later she was rushed to the the ER with a Hemorrhagic stroke. Hospitalized for 3.5 days, cognitive impairment remains, resulting in the need for rehabilitation therapy. | | 590 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1052491-1 | brain fog immediately after vaccination, 2 hours later blood pressure and heart were elevated. Around 11:00 pm went into extreme Atrial Fibrillation and risk of stroke for 10 hours. Heart rate went from 55 bpm before vaccine to 90 bpm after vaccine. Blood pressure went from 120/70 to 145/80. | | 591 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1056186-1 | delirium; fell in the night/fallen; extreme fatigue; memory loss/memory problem prior to getting the vaccine, however, now it was worse; memory loss/memory problem prior to getting the vaccine, however, now it was worse; This is a spontaneous report from contactable other healthcare professionals. An 87-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EN5318), via an unspecified route of administration in the left arm on 01Feb2021 14:00 at a single dose for covid-19 immunization. Medical history included blood pressure abnormal, glaucoma, thyroid problems, mild cognitive impairment and memory problem. Concomitant medication included amlodipine, atorvastatin and carvedilol for blood pressure, donepezil for mild cognitive impairment, ezetimibe, levothyroxine for thyroid problems and ongoing latanoprost for glaucoma. The patient previously received first dose of bnt162b2 (lot number: EL3246) on 11Jan2021 for covid-19 immunization. On an unspecified date in Feb2021, the patient had fallen, did not hit her head, but she has extreme fatigue, memory loss (she has seen some improvement now) unable to be by herself now and take her medications. The patient had a mild case of memory loss and had delirium. The reporter cannot say these events occurred from the vaccine of course. However, the work up that has been done has been negative and reporter was worried. It was reported that the patient had a little memory problem prior to getting the vaccine, however, now it was worse. It was like the patient cannot be alone now. The patient did not have a stroke. However, this like sent the patient over a cliff. This is a life changing event. If patient gets better it's all good, but if she does not they are in big trouble. Patient was previously able to care for self and now she was not able too. Patient underwent lab test (unknown result) in Feb2021. Patient was taken to Urgent Care, was seen by a physician and basic blood work was done and a urine test was done (unknown result). The outcome of event delirium was recovering; all other events was unknown. Information on Lot/Batch has been requested. | | 592 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1056626-1 | Vertigo last week that stayed for five days; pain at the injection site; 2 stroke like symptoms/ like she was having a TIA (Reporter confirmed TIA as Transient ischemic attack); Blood Pressure 170/130; Fatigue; Joint ache; Nausea; Vomiting; Fever 100.1; Stress; 2 stroke like symptoms/numbness in her lip; Pervasive aching; Momentary confusion; , like she was having a TIA; Not able to answer questions; she still has not recovered her strength; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old female patient (mother) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1283), via an unspecified route of administration on 23Jan2021 13:00 at a single dose for COVID-19 immunisation. The patient's medical history included ischaemic stroke, haemorrhagic stroke in Aug2019, pulmonary embolism, deep vein thrombosis (DVT), cholesterol, myalgia condition, blood pressure, thyroid, sleep and vertigo. The patient concomitant medications included amlodipine for blood pressure, calcium carbonate/colecalciferol (CALCIUM + VITAMIN D), rosuvastatin calcium (CRESTOR) for cholesterol, levothyroxine for thyroid, eszopiclone (LUNESTA) for sleep medication, ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2), prednisone for myalgia condition, and escitalopram. The patient experienced fatigue, joint ache, nausea, vomiting, blood pressure 170/130, fever 100.1, stress, stroke like symptoms, numbness in her lip, momentary confusion; like she was having a TIA; not able to answer questions, tired, pervasive aching, all on 23Jan2021 19:00. Events reported as follow: patient had the Pfizer vaccine on Saturday around 1 pm and Saturday (Clarified 23Jan2021) night she had severe side effects for about 4 hours. When probed for side effects, the reporter stated it increased gradually over time. So, first patient had joint achiness and then she experienced nausea and vomiting. The reporter took her blood pressure. It was 170/130 and so reporter called EMS and they came up and her blood pressure had gone back down to normal and they recorded she had a fever of 100.1. EMS believed that the combination of the 'violence' of the onset and the fever caused her blood pressure to spike but she had a history of ischemic and hemorrhagic stroke. So, the reporter was concerned that the stress and whatever that was going on the reaction, the reporter was concerned that it was going to cause her a stroke. Patient had 2 stroke like symptoms, one was that she had numbness in her lip and the second was that she had momentary confusion, like she was having a TIA (reporter confirmed TIA as Transient ischemic attack). The only symptom of that was when the reporter asked her the name of her children she gave the names of her grandchildren but that confusion cleared up quickly and she was fine for a while but not able to answer questions, sharply. By the time that EMS got there patient was sharp again, no problem. For treatment, the reporter gave patient aspirin. The reporter put some Salonpas patches on her joints. It was like the analgesic patch. It was an external patch that patient put on. Patient usually does not need them that was why she was taking the prednisone to treat that kind of pervasive aching. The reporter also gave her the fluids, Gatorade kind of stuff to replace her fluids from throwing up and that kind of stuff. One more thing, it all started with an extreme fatigue but that seem normal but it seemed to lead into the other symptoms. Like it was a big day to go out and get the vaccine. So, she was a little bit tired. This was a very deep fatigue that was part of it too. Reporter stated only 81 aspirin (later clarified as treatment) as she could not go back on blood thinners because she had the hemorrhagic stroke. As of 11Feb2021, it was reported that patient still has not recovered her strength since 23Jan2021 19:00 and was reported as ongoing but improved. On 03Feb2021, the patient had vertigo that stayed for five days and was now improved. The patient was scheduled for the second dose on 13Feb2021. The immediate effects her mother had after the first dose of the vaccine were pain at the injection site; fatigue; fever; nausea. Mentions she also had some confusion and they were worried that the patient might be having another stroke. But all of this cleared up; all of this in a violent episode that lasted about four hours. Today she wants to report that her it took her a week for her mother to recover. Adds her mother could walk for half an hour before the vaccine but since the vaccine she still has not recovered her strength. Adds her mother has only been able to walk about 15 minutes with a walker and resting a lot, for a couple time in three weeks and this was their main way of maintaining her health. Adds her mother also had some vertigo last week that stayed for five days but she has had that in the past. Adds actually she still has the vertigo a little and she can tell when her mother bends her head. Outcome of blood pressure 170/130, she still has not recovered her strength and vertigo was recovering, outcome of events pain at the injection site, fatigue, fever, nausea and confusion was recovered on 23Jan2021 23:00; other events was unknown. No investigation assessment. Follow-up (11Feb2021): New information received from the same contactable consumer (patient's daughter) includes: reporter details, medical history, reaction data and course of events. | | 593 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1056656-1 | blew a blood vessel under her eye lid; stroke; tasted rubber band taste in her mouth; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), in a clinic, intramuscularly in the right arm on 29Jan2021 at 14:00 at 65-years-old at a single dose for COVID-19 immunization. There were no prior vaccinations within four weeks of the bnt162b2. Medical history included ongoing fibromyalgia from an unknown date, reflex sympathetic dystrophy from an unknown date and unknown if ongoing, irregular heart beat from an unknown date and unknown if ongoing, ongoing hemangioma from an unknown date, thyroid problems from an unknown date and unknown if ongoing, low white blood cell counts from an unknown date and unknown if ongoing, ongoing pinched nerves in her neck and back from an unknown date, migraines from an unknown date and unknown if ongoing, diastolic heart failure from an unknown date and unknown if ongoing (diagnosed about 5 years ago.), abdominal pains from an unknown date and unknown if ongoing, numbness in her nose, foot from an unknown date and unknown if ongoing, nausea from an unknown date and unknown if ongoing, vomiting from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1283) for COVID-19 immunization on 08Jan2021 at 64-years-old and experienced metallic taste (Recovered), carbamazepine (TEGRETOL) from an unknown date to an unknown date and experienced white count was down to 1, influenza vaccine (MANUFACTURER UNKNOWN) in Jul2020 at 64-years-old for immunization. The patient experienced the following events and outcomes: stroke (medically significant) on 29Jan2021 at 14:10 with outcome of unknown, blew a blood vessel under her eye lid (medically significant) on 31Jan2021 with outcome of recovering, tasted rubber band taste in her mouth (non-serious) on 29Jan2021 with outcome of unknown. The clinical course was reported as follows: The patient reported a history of migraines/ weather migraines, that cause numbness in nose and foot as well as gastro-intestinal symptoms. The patient received her first dose of the Pfizer COVID vaccine on 08Jan2021 and felt a metallic taste in her mouth (said that the metallic taste lasted about three hours; ate to get rid of the metallic taste). On 29Jan2021, the patient received her second dose; after 10 minutes her face went numb; her nose, forehead, and under her eyes all the way up felt numb. Also, the patient's systolic blood pressure was at 150. The patient reported that she also tasted rubber band taste in her mouth. The patient's neighbor that was there with her getting the vaccine told the nurse and they called the paramedics. The paramedics stated that they thought she had a stroke. She said that her blood pressure was 150 systolic (usually 107-110/79). The patient had diastolic heart failure which was diagnosed about 5 years prior. The numbness stayed with her until about 22:00 on 29Jan2021. The patient had a history of ""migraines and gets abdominal pains, numbness in her nose, foot"", and she experienced ""nausea and vomiting and stuff with her migraines."" The patient thought the vaccine just gave her a big migraine. The patient took sumatriptan succinate (IMITREX) and it did nothing. The patient said that on 31Jan2021 her eye felt weird. The patient blew a blood vessel under her eye lid. The patient's eye looked like a blood clot in the corner of her eye then it dispersed throughout the eye and then now it was just below the pupil of her eye. The patient called the doctor on 01Feb2021, but they were out because of the snow. On 02Feb2021, the patient received a call from the doctor's office saying that the physician assistant would call her back, but the patient had not heard anything yet. The blood circulated around her eye and now it was just only under her pupil. The patient said that her daughter sent her something that said that some people have gotten Bell's palsy after getting the vaccine. The patient said that she was concerned about this with the facial numbness. The patient said that every once in a while, her face felt weird; her cheeks feel weird and her nose. The patient said that it comes and goes. The day after she got the second shot, she felt like she got run over by a truck and like someone beat her up. The patient's migraines were under control with magnesium. The migraine came on so quick it was like a boom. The patient said that was why she was concerned. The patient said that she declined going to the hospital; and there was no trip to the emergency room or physician office. The patient underwent lab tests and procedures which included blood pressure: 150 systolic on 29Jan2021 (usually 107-110/79). Therapeutic measures were taken as a result of stroke."" | | 594 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1056660-1 | Cardiac Event MI or Stroke; Cardiac Event MI or Stroke; This is a spontaneous report from a contactable consumer (Son in law). A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 17Feb2021 14:00 at single dose for covid-19 immunisation. Medical history included atrial fibrillation (AFib), prostate cancer Survivor. Concomitant medication included alirocumab (PRALUENT), escitalopram oxalate (LEXAPRO), apixaban (ELIQUIS), nitroglycerin and Ca channel blocker. The patient received the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient experienced cardiac event myocardial infarction (MI) or stroke on 17Feb2021. Adverse event result in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient died on 19Feb2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. The reporter didn't know if this was associated or not. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardiac Event MI or Stroke; Cardiac Event MI or Stroke | | 595 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1057550-1 | has sporadic a-fib (at baseline); She stated she was in real bad stroke territory; she felt like she was going to faint; Her blood pressure was 220/97; tingling in her hands and feet; felt like brain sizzling like it was frying/going to faint; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, first dose) solution for injection intramuscular in the left arm on 06Feb2021 at 09:30 (at the age of 79-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing sporadic A fib (atrial fibrillation) for 6 years know about; allergy to polyethylene glycol in 1985 (she had difficulty taking birth, control pills and they found out it was the coating PEG in); cerebrovascular accident prophylaxis; in 1985 She had difficulty taking birth control pills and they found out it was the coating PEG in it. She had an allergy to this where she broke out in bumps on her fingers and mouth and had itchy eyes, a full blown allergy; and when she was 45 going through menopause. Concomitant medication included apixaban (ELIQUIS) for A fib and cerebrovascular accident prophylaxis. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021, the patient had sporadic a-fib (at baseline) then put in a medical van requiring emergency room visit. The patient stated, She stated she was in real bad stroke territory, felt like she was going to faint (6 minutes after vaccination), blood pressure was 220/97, tingling in her hands (6 minutes after vaccination) and feet and felt like brain sizzling like it was frying/going to faint (6 minutes after vaccination) on 06Feb2021. Lab tests included blood pressure on an unknown date high 150s and never lower than 187, then on 06Feb2021 was 220/97, on 09Feb2021 was systolic blood pressure 180, then on 10Feb2021 had gone down. The outcome of the events atrial fibrillation and feeling unwell was recovered on 06Feb2021, after 3 hours. The outcome of the events stroke, faint and tingling of extremity was unknown. The outcome of the event blood pressure was 220/97 was recovered on 10Feb2021. | | 596 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1059644-1 | Pt had a stroke the night after receiving the vaccine. | | 597 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1062045-1 | irregular heart beat; congestion in the chest; dizzy/the dizziness she was having and feeling now after getting the vaccine was definitely more noticeable; This is a spontaneous report from a contactable consumer (the patient). A 73-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left deltoid/ left upper arm in the shoulder on 26Jan2021 around 14:00 (at the age of 73-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: stroke about 4-5 years ago in June, dizziness, blood pressure. The patient also had difficulty writing stuff down; besides having a number issue, she had issues writing numbers down. Concomitant medication included apixaban (ELIQUIS) from an unspecified date and ongoing as a blood thinner. The patient stated she was on ten different medications. These medications were added after the stroke. Before the stroke she was not on any medication. The patient did not have any vaccines administered on same date of the Pfizer COVID vaccine. The patient got the pneumonia vaccine (unspecified), but thinks it was longer than 4 weeks before. She did not remember, but she believed it had been a month and a half to 2 months (at the age of 73-years-old) since getting the pneumonia vaccine for immunization. The patient had the COVID shot on Tuesday of this week (26Jan2021), and she didn't seem to have much of a reaction other than what they expected except at 21:00 that night, she got pretty dizzy. She was still dizzy now. It was enough for her to have to walk with a cane in order to try and keep herself leveled. She could not move quickly. She did not know why she had this reaction. She called her doctor the next day, and he did not understand why. She mentioned she was reading material and saw this could be a severe side effect/situation. The doctor mentioned they were trying to find out if it was related to the blood pressure. She wanted to know if this is part of the side effect, dizziness? When the patient was attempting to provide the zip code, she stated her mind was going blank and could not remember the zip code. She later found something with it written on it and provided those details. She explained she had a stroke when trying to provide her current age. She stated numbers are hard for her. She stated she would be 74 in March, and questioned how old that would make her now, she later confirmed as 73. She read information today about the COVID vaccine, and she saw that one should be cautious about the vaccine if have a bleeding disorder, and she commented she was on a blood thinner. She went to the doctor last week and mentioned she was having dizziness. She clarified she had dizziness before getting the COVID-19 vaccine. When she went to the doctor, they thought it was due to blood pressure as the problem. They changed her blood pressure medication by placing on a higher dose. Then she started having more dizziness, and the dose was taken back down to the dose she was on before. She also added, she has an irregular heartbeat (unspecified date). She went to the doctor because of congestion in the chest (unspecified date); that was why she went to the doctor. The doctor asked about dizziness and she said she was having a little. However, the dizziness she was having and feeling now after getting the vaccine was definitely more noticeable. The clinical outcome of dizzy was recovering (as reported). The outcome of the other events was unknown. Information on Lot/Batch number has been requested. | | 598 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1062100-1 | Pt developed left lower lip paresthesia that radiated to L side of face.; Pt developed left lower lip paresthesia that radiated to L side of face.; This is a spontaneous report from a non-contactable pharmacist. A 75-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), intramuscular on 26Jan2021 at 10:00 at a single dose for covid-19 immunisation. Medical history included transient ischaemic attack (TIA), stroke and chronic kidney disease (CKD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took gabapentin for facial nerve pain. The patient developed left lower lip paresthesia that radiated to the left (L) side of face on 26Jan2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. | | 599 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1062106-1 | Lymph nodes hurting/burning pain on chest and breast area/ Her Lymph nodes are tender on the Left Side, it goes down the breast arm; This is a spontaneous report from a contactable consumer reporting for herself. A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration (arm right) on 26Jan2021 at SINGLE DOSE for COVID-19 immunization, at 92 years old. Medical history lung cancer 12 years before from 2009, breast cancer on an unspecified date, and a lump already on the breast from the surgery and she usually get pain there from an unspecified date. She is a cancer survivor. She had surgery for breast cancer on same side, that's where the pain was. She also had a stroke and speech is slurry from an unspecified date. The patient asked to bear with her as she had a stroke in the past and her speech is slurry. She lost the COVID card, she did not even know they gave a card, until somebody told her that they had their card. She lives in a Senior citizen facility, and she does not remember any card. They just gave her information sheets. It was reported that the patient had the vaccine and she was having a lot of pain on the left side, however she got the vaccine on the right side. She had surgery for breast cancer on same side, that's where the pain was, however the vaccine was on the other arm. Patient stated that she thinks it was the lymph nodes, she does not know what to do about it, since she is a Cancer survivor. The patient requested the call handler to talk slow, she is 92 years old. She cannot call the doctor because he is retired and so she does not have a doctor. The patient expressed that its especially in the Lymph nodes, she read the papers that she got, she thought this is common. Her First Dose was on 26Jan2021, probably around 9:30AM or 10AM. The Lymph nodes began hurting on 26Jan2021, it was a burning pain on chest and breast area. She took a Vicodin and it went away and did not bother her for the rest of the day, but it was bothering her this morning and it woke her up. She has a lump already on the breast from the surgery and she usually get pain there, but this is not the same pain today. As of reporting time, it was different, it was a stronger pain, it goes down the breast arm. Her Lymph nodes are tender on the Left Side which is the same side she had surgery on in the past. She got the vaccine on the right arm. Outcome of the event was not recovered. Information on the lot/batch number has been requested. | | 600 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1062260-1 | Developed acute facial droop and slurred speech 2h after 1st dose of the vaccine on 2/17, found with R MCA stroke. Then became unresponsive on 2/27 and was found with an acute L MCA stroke. Was transferred from another hospital, was not a candidate for intervention, and was made comfort and died on 2/28 | | 601 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1068274-1 | face and jawline went absolutely numb; Headache; Swelling arm; This is a spontaneous report from a contactable consumer reported for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 16Feb2021 10:15 (at the age of 67-year-old) from lot # EN6200 at single dose for COVID-19 immunization via intramuscular route at the left arm. The caller stated she had a half an hour of sitting afterwards and then they let her go. Concomitant medications included loratadine (CLARITIN) for sinusitis and insulin for Type 2 diabetes mellitus. Relevant medical history included type 2 diabetic (Diagnosed about 17 years ago), allergic to some food, allergic to sulfa, she had a number of allergies and she had an anaphylactic reactions in the past, asthma diagnosed around the age of 40, sinuses, high blood pressure after a D&C, she had a miscarriage, uterine dilation and curettage, one headache before this in her entire life. The patient had received Flu vaccine on unknown date. The patient, on 16Feb2021 had headache that lasted for 5 minutes. It was right after the first shot of the Pfizer COVID-19 vaccine, her face went numb and she couldn't breathe through her nose. She was only able to breathe through her mouth. Her jaw got really numb. It happened when she was driving home from the vaccination center and she had to pull over because she might go into an accident. She wasn't sure if she was having a stroke or not but she was scared since her sister had histories of multiple strokes. She wanted to know Pfizer's recommendations for the second dose considering her adverse events. He had a really short headache tonight, He stated ""it hit me out of the blue right in my temporal; I got on the floor it was so bad. 5 minutes after I left my face went totally numb"" She stated she also had the second headache she had ever had in her entire life. She also mentioned she had some swelling in her arm but she didn't think that was unusual. She clarified as she was driving home after receiving her shot, her entire face went numb and her jawline went numb. It scared her so bad. She thought she was having a stroke or something. She confirmed she recovered completely from this, the numbness cleared up in 10 minutes. The Outcome of the event swelling arm was unknown while the outcome of the other events was recovered on 16Feb2021."" | | 602 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1070965-1 | right sided embolic stroke, right retinal artery occlusion occurred 8 hours after vaccination, requiring hospitalization for 2 days, he is now left with right eye visual loss as the only sequelae to the stroke | | 603 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1072543-1 | Like I'm having a stroke; neck ache; nightmares; nervousness; Felt terrible with bad headache; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6200) via an unspecified route of administration on 15Feb2021 13:00 at single dose in left arm for COVID-19 immunisation. She received the first dose of BNT162B2 (lot number: EL9262) on 18Jan2021 13:00 in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was allergic to Formaldehyde, Coumadin. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021, the patient felt terrible with bad headache. On 18Feb2021 also felt terrible. On 17Feb2021 08:00, Like she was having a stroke. Headache, neck ache, nightmares, nervousness. Blood pressure was ok. Oxygen was ok. Pulse was ok. No treatment received for the adverse events. Events outcome was not recovered. | | 604 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1073652-1 | Vomitting; severe abdominal pain secondary to pancreatitis; severe abdominal pain secondary to pancreatitis; This is a spontaneous report from a contactable Consumer (patient). A 72-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 19Feb2021 10:15 at single dose at right arm for covid-19 immunisation. No pregnant at time of vaccination. Medical history included Diabetes, three prior strokes, cardiac stent, Seafood and pollen allergy. Concomitant medication included paracetamol (TYLENOL) and unspecified medication. The patient experienced Vomitting, severe abdominal pain secondary to pancreatitis for nonalcoholic patient with no history of abdominal pain or gallstone on 19Feb2021 18:00, which lead to Emergency room/department or urgent care, Hospitalization. Hospitalization lasted 4 days. Therapeutic measures were taken as a result of events included unspecified therapy. The outcome of events was recovering. information on the lot/batch number has been requested. | | 605 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1076017-1 | elderly diabetic man with AFib/RVR who presented with multiorgan failure few hours after receiving his 2nd COVID shot today and ultimately expired. he did well after the 1st COVID shot and subsequently developed this multiorgan failure after the 2nd shot. had his second COVID vaccine shot around 4 pm, went home and collapsed, lay on the floor for a few hours refusing to call paramedics, eventually wife called 911, he arrived to ED and was dead a few hours later. -on arrival the pH was 6.7, agonal breathing, low BP, lactate 18, but no MI, no stroke, no apparent infection/sepsis. important to note that he had a covid vaccine just a few hours from collapsing and dying. | | 606 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1085254-1 | Severe abdominal pain unable to eat or sleep for 36 hours. He went by ambulance to the Hospital emergency room. They tried to pump his stomach but he aspirated and and went into cardiac arrest. He was revived but never regained consciousness. (The ICU Dr said that he had blood clots in his abdomen from a recent stroke. We were unaware of him having a stroke other than in 2026. The same Dr. said that he had necrosis in his lungs from aspirating. The necrosis was from his bowel dying) He was put on a ventilator and given drugs to increase his heart rate. On 3-5-21 the heart drugs were reduced and he died. I was with him when he recieved the vaccination and he was healthy, just old. I think that the shot killed him. | | 607 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1103625-1 | dizzy; BP dropped to 117/79.; This is a spontaneous report from a consumer. A 75-years-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL9265, via an unspecified route of administration in left arm,from 03Feb2021 as a single doseE for COVID-19 immunization . Medical history included a stroke and high blood pressure . Concomitant medication included oral clopidogrel (CLOPIDOGREL), 75 mg once a day for a storkeand apixaban (ELIQUIS) 5 mg 2x/day oral for blood clots. On 03Feb2021Patient had a reaction with the first dose of the Pfizer vaccine. He got a little dizzy and his BP dropped to 117/79. He wants to know if it is safe to take the second dose.. Patient states that he had a mild reaction to the COVID shot on 03Feb2021. Patient states that he got kind of dizzy, and his blood pressure dropped to 117. Patient states that his reaction lasted about an hour, and he had no other problems. Patient is wondering if he should get the second dose, or if he should not take some of his blood thinning medications on the same day as his second dose. Patient got his first dose of the product on 03Feb2021, and the side effects occurred that same day, just after the patient left the clinic, about 15 minutes later. Patient reports that he got kind of dizzy and he checked his blood pressure which was 117/79. Patient states that the dizziness lasted about an hour, and he did not check his blood pressure again after that. The outcome of the events was not reported. | | 608 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1104658-1 | I am reporting the below as everything written has NEVER happened to me before in my 72 years of living. This has all taken place since I have had the Vaccine Injection on Wednesday, February 24th. I am attributing all of this as a possible reaction to the vaccine or maybe coincidence. I wanted to report what has taken place so you all can assess if this is a possible adverse reaction, a direct effect from the vaccine or just coincidence. Please let me know if anything like this has been reported and what your thoughts about the matter. Wednesday, February 24th 11:15am Pfizer Vaccine right arm ?about an hour later discomfort on shot side that went from the shoulder up the right side of the neck. Was gone by next day. Thursday, February 25th Day seemed to be normal. When I went to bed that evening a pressure and pounding on the left top side of the head, on the part line. Lasted 5-6 hours and then went away for that episode. Friday, February 26th Day started off OK, walked 2 miles and then ran some errands. *3:00pm I bent down to pick up something and when I came up I had extreme light headedness like I have never had before. I was able to get myself collected and then continued to get ready to go out. *6:00pm I just sat in a chair in the restaurant and BAM the room started spinning at about 500 miles (that is the speed that it felt like) an hour. My arms were flailing as I was trying to grab something to old onto. Just when I was about to fall off of the chair my husband walked up and grabbed me as he could see that something was going on and he said that I was white as a sheet. Once I got somewhat collected, I knew immediately that I had to throw up. My husband took me to the restroom. I had severe dry heaves that just would not stop. I wasn?t breathing properly so my hands and feet were numb, tingly and very white in color. Then I had to have a bowel movement. We phoned for the ambulance to take me to the hospital jus to make sure that I did not have a stroke, or it was my heart, or a vessel had burst in the head. The Paramedic tested me for a stroke and I passed the test. *8:00pm or so I had another episode with room going around at top speed and I started having dry heaves. Nurse gave me medicine in the IV for nausea. My Doctor said that everything was Benign. He said that the CT patient scan was negative and all other tests were OK. Saturday, February 27th I was released from the hospital and went home. I did very little that day. I slept that night from 10:00pm until 10:00am the next day. Sunday, February 28th I was lightheaded, had a headache, and ears ringing all day. I just did not feel myself at all. Tuesday, March 9th Around noon I had a severe lightheadedness/spinning episode, eyes felt like they were spinning. Laid down for about 2 hours and when I got up I was able to function and the spinning had gotten better. Headache all night long, ears ringing, feeling of lightheadedness. Wednesday, March 10th Not quite as dizzy, headache all day, back of neck and left side of head sore to touch. Pounding on left top side of head ? along the part line, where I had the same discomfort the 2nd day after the vaccine. Thursday, March 11th Having discomfort on left side of head. To the right of the left ear, going down to the neck. I can touch those areas and add to the discomfort. Friday, March 12th On Monday, March 7th I noticed a red spot on the right side behind where I was given the injection. I tried to treat it myself but my remedies were not helping. Contacted my Dermatologist on Thursday, March 11th. She saw me today, Friday, March 12th. She is not sure if it is a possible aftermath of the vaccine or something else. Had some bloodwork run to rule how Shingles. Prescribed some medication for Shingles to take until Monday when the bloodwork report is due for review. Blood work was negative for Shingles. Ever since the episode on February 26th I have NOT felt myself at all. Lightheaded, nausea, headache, pressure in head and feels heavy, not steady on my feet, discomfort in back of head near neckline, on/off discomfort in the top of the head with a pounding force. BLOOD PRESSURE IS NOW HIGHER THAN NORMAL ESPECIALLY WITH BOTTOM NUMBER BEING HIGH. I have never had a Blood Pressure problem, although as I have aged the top number has elevated but not enough to take medicine. However, the lower number is now elevated (high 80-?s, low mid range 90?s) and Cardiologist is going to make a decision on whether I should start on a low dose medicine. I am to take my 2nd Pfizer shot tomorrow ? Wednesday, March 17th at 11:00am. Thank You for reviewing the above writings. I look forward to the conclusion VAERS makes on my situation. | | 609 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1111271-1 | Stroke; Dose Number 1 on 08Jan2021/Dose Number 2 on 25Jan2021; This is a spontaneous report from a contactable nurse. A 70-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249 and expiry date unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. Patient has no medical history. Concomitant medication included tamsulosin hydrochloride (FLOMAX). Patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on 08Jan2021 on the left arm. The most recent COVID-19 vaccine was administered at the hospital. On 18Jan2021 06:00, the patient experienced right foot drop. Spine MRI on 18Jan2021 was negative. Stroke confirmed on brain MRI on 28Jan2021. Patient was sent to the ED at the hospital immediately after and was admitted from the ED to the hospital. Number of days of hospitalization was 2. Adverse event result: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient has not recovered from the event stroke. Event was reported as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has been tested for COVID-19 with test type: nasal swab on 28Jan2021 with result negative. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Sender's Comments: Based on current information available, the event stroke mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2. Relevant medical history and concurrent disease are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. | | 610 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1126105-1 | Hospital Discharge Summary Note: Patient is a 73-year-old female with a past medical history significant for hypertension, hyperlipidemia, hypothyroidism, and breast cancer. She presented to the emergency department with reports of possible allergic reaction to Pfizer vaccine. Patient received her first dose of: Vaccine earlier today and approximately 5 minutes later developed a cough, diaphoresis, and lightheadedness. She was given 50 mg oral Benadryl in the ED. Patient then complained of tingling sensation throughout her body and was continuously coughing. She was brought to the emergency department for evaluation. Patient noted she felt jittery and ""disconnected"". In the ED her cough and dizziness significantly improved. Upon examination, patient was noted to have right lower extremity weakness. She denied any weakness. CT of the head was performed to rule out stroke. Neurology was consulted. CT head brain was negative however patient was still having right-sided weakness. Emergency department physician confirmed the patient was able to get up without difficulty after receiving her vaccine at 1415 immediately following her vaccine. It was determined she was within the window for TPA. Patient was transferred to the ICU for further management."" | | 611 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1173972-1 | Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, her eyes are weak; Difficulty breathing; thought she was having a heart attack; dehydrated; fast heart beat that felt like her chest was full; fast heart beat that felt like her chest was full; Injection Site Pain; blood pressure fluctuated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 27Feb2021 12:00 (lot number: EN6202; expiration date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure and stroke from 2012 to an unknown date. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN) taken for stroke from 2012 and ongoing; clopidogrel bisulfate (CLOPIDA) and simvastatin both taken for high blood pressure from 2012 and ongoing; ongoing amlodipine, lisinopril, and metoprolol all taken for high blood pressure. On 27Feb2021, she took the first vaccine. From that day, for 2 days, she had injection site pain. On 07Mar2021, she started having tiredness, headaches, chills, fever, felt nauseated, had a fast heart beat that felt like her chest was full and thought she was having a heart attack, dizziness, weakness, felt sick, and difficulty breathing. The patient added that she can't see as good, her eyes are weak. She was going to make an appointment to get her eyes checked. For dizziness event, she has to sit on the side of her bed for 10 minutes and she was still dizzy. She has to hold on to something because she feels like she is going to fall. She was given meclizine three times a day for this event. For tiredness event, she stated that it fluctuates during day. After she takes a paracetamol (EXTRA STRENGTH TYLENOL) and lays down for a while, she feels ok and then she feels tired again. For fast heart beat that felt like her chest was full and thought she was having a heart attack event, it comes and goes, she had it yesterday (21Mar2021) but hasn't had it today (22Mar2021) but she doesn't know if it is gone. Her symptoms were usually in the morning when she first gets up. She has been to the emergency room (ER) on 07Mar2021 and on 13Mar2021 and they say that nothing is wrong. On 07Mar2021, they gave her an IV because they thought she was dehydrated. On 13Mar2021, she went back to another hospital ER. She felt worse and her son came and got her and took her to the ER. They did a whole workup MRI of her head, x rays, blood work and everything. They didn't know what was causing it because it had it been over a week since her vaccine and they sent her home. She has been laying down and staying hydrated. She couldn't hardly get up and they asked her what has she done different and the only thing different was the vaccine. Everything listed on the risk factors [side effects] is how she is feeling. She was not hospitalized, they gave her medicine and told her to stay hydrated and sent her home and was told to follow up with her physician. She finally got an appointment for tomorrow (23Mar2021) with her physician. She can't drive because of the dizziness. All of her tests came back normal. They said her blood pressure fluctuated on 2021 but that is normal. Outcome of the injection site pain was recovered on 01Mar2021, of the difficulty breathing was recovering, of the headache, chills, fever, dizziness, weakness, and felt sick was not recovered, while of the remaining events was unknown. | | 612 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1177384-1 | 4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, described as unusual pain; thought a migraine was coming on. 5-7:00pm headache continues to worsen; chills; research on line side effects of Pfizer vaccine and they coincide with symptoms; 7:05 gets up to urinate (no assistance needed); screams out in pain 3 times while on toilet; starts to vomit; right side of face (eye and cheek and mouth droop like a stroke; left hand starts to curl. Loses consciousness immediately thereafter. 911 call; paramedics on the way; airway was swept and clear; gurgled breathing. Rushed to Hospital and assessed as having massive brain bleed. Pronounced dead at 10:22pm. Acute Hemorrhagic Stroke on Death Certificate. | | 613 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 0 days | 1208484-1 | 3hrs after the patient's vaccination, she fell to the floor and was unable to get up, noted to have R sided facial droop, inability to speak, R sided weakness. Found to have a large stroke with left sided M2 MCA clot noted on CT angiogram. | | 614 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 0932623-1 | Acute ischemic stroke, basilar occlusion | | 615 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 0941401-1 | Patient is a 99yr old female who got a covid vaccine in the afternoon of 1/10/21 and woke up in the morning of 1/11/21 with altered mental status, weakness, and dysarthria. She was taken from her assisted living facility to the hospital and MRI showed a small stroke in the right medial thalamus. She was also found to have new onset atrial fibrillation. She was treated appropriately for both conditions and discharged to a skilled nursing facility on 1/13/21. | | 616 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 0944857-1 | Patient presented herself to LPN slurring words and 'not herself'. Upon evaluation, patient denied drinking alcohol, knew she was not able to speak correctly and visibly frustrated . With great difficulty she was able to communicate that she had a headache and was slightly dizzy. Failed FAST and does have a history of CVAs. EMS called and patient was taken to ER where they admitted her for observation post Stroke. Per the hosp nurse, patient received tPA treatment and will be moved to step-down unit when a bed is available. | | 617 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 0949555-1 | Received Pfizer vaccine, first dose on Wed. 01/13/21 between 12 and 1 P.M. Thurs. 01/14/21 in the afternoon he began to note that he had difficultly walking. Went to bed when he woke up at 5:48 A.M. he reported he had ataxia. Patient reported having to walk in tiny steps to stay upright. He went to the emergency room. Had CT scan of head and found blood clots. MRI performed. Stroke found in right PCA territory, but no loss in strength in left lower extremity. Sensation and vision intact. Strength in all four extremities is 5 out of 5. | | 618 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 0960018-1 | Pt reported difficulty in swallowing and wife noticed left-sided facial droop morning of 1/10. Patient admitted for concerns of TIA. Symptoms resolved prior to hospitalization. Patient had MRI brain without contrast of the find evidence of acute infarct. Neurology recommended treatment patient has TIA and having dual anti-platelet therapy for 21 days followed by monotherapy of Plavix for stroke prevention. Patient was stable discharge to home 1/12/21 | | 619 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 0960031-1 | Pt Rec'd Covid vaccine and injection in Lt eye for macular degeneration. Monday 1/11 slurring speech/jumbled words since dinner, went to bed, wife states improved from last night but still difficult clearly communicating. Also reports difficulty writing. Came to ED and admitted for stroke evaluation. Stable for discharge home 1/13 with neurology follow up visits. | | 620 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 0976011-1 | Began experiencing left sided weakness, Evaluated in ER, Medivac'd to other facility for stroke | | 621 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 0979257-1 | Notified by a secondary source the following information. Patient was admitted to the hospital for a stroke. The hospital discovered the patient had a stroke a week prior to vaccination. Patient pace maker had been faulty and patient INR may have been lower than therapeutic. Unable to speak directly to patient at this time to confirm these events. Actual progression unknown. Understood patient is improving. | | 622 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 0981535-1 | The next morning after receiving the vaccine I noticed that my mother she talking to me, as her primary giver she knows me and comfortable to me. She tells me the same story over the over with isn't abnormal. It was every 3-4 words she was jumbling her words. I didn't think anything of it at first. I just let it go. Early Wednesday morning 2:48am, I heard her in her bedroom. I went to check on her, I found at her dresser trying to put her watch on. She didn't know who was I or didn't know where she was. It took me about 40 minutes to calm her down. Now it was every 2 words that she was jumbling up. I finally got her back to bed. I went to send a message to her doctor. In the morning someone from the doctor's office called back I explained what was going on and they said get her to an ER. I took her to the hospital 01/27/2021. She was admitted to hospital for overnight observation. Still not been discharged. Patient was still confused when I had to left last night, did not understand where she was at or why she had to stay there. My mother was very angry when she woke up early Wednesday is not my mom she is very lovely. One year or two years she did have a TA or mini stroke. | | 623 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 0989918-1 | Stroke | | 624 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 0994698-1 | Embolic stroke involving left middle cerebral artery; Impaired mobility and ADLs; Stroke | | 625 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 0996739-1 | Approximately 22 hours after vaccination had a seizure. Felt fine up until the seizure occurred. Never had a seizure in past. No other illness or symptoms. No fever or change in blood sugar.; This is a spontaneous report from a contactable Physician. A 75-year-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular on 18Jan2021 19:30 at single dose on left arm for COVID-19 immunization. Medical history included Stroke, diabetes, hypertension, anaphylaxis to bee stings. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included sitagliptin phosphate (JANUVIA), hydrochlorothiazide, telmisartan, rivaroxaban (XARELTO), gabapentin and baclofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had allergy to Morphine and experienced Hives. Approximately 22 hours after vaccination the patient had a seizure on 19Jan2021 17:15. She felt fine up until the seizure occurred. She never had a seizure in past. No other illness or symptoms. No fever or change in blood sugar. No treatment was received for the event. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was resolved. Information on the lot/Batch number has been requested.; Sender's Comments: Based on the time association and previously allergic reactions to bee stings and other drugs, the possible contribution of suspect BNT162B2 to the event seizure cannot be excluded in this elderly patient with multiple medical histories including stroke, diabetes and hypertension. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 626 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 0997584-1 | STROKE, ABDOMINAL ANEURYSM, FATIGUE, VOMITING, FALL, HEADACHE, BODY ACHE | | 627 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1000658-1 | Stroke; leukemia; This is a spontaneous report from a contactable consumer. This consumer reported for a 68-year-old male (consumer's husband) received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EL0140, Expiry Date: Mar2021), via an unspecified route of administration on 31Dec2020 13:30 at single dose on right upper shoulder for COVID-19 prophylaxis. Medical history included smoker for 50 years, and blockage in his carotid artery. His grandma died of a stroke and his folks, his dad died of lung cancer and his mom died of uterine cancer. Both his parents had high blood pressure. His dad had a heart attack and his mom had Parkinson's because her hands would shak. There were no concomitant medications. On the 08Jan2021 at about 8PM he had a massive stroke and they had to life flight him to hospital from 08Jan2021 to 19Jan2021. He did have a blockage in his carotid artery but they have been told. She says her husband just had his second vaccine with lot is EL1283 and exp is Apr2021 and all of this could be a coincidence but he told her to call so that was why she was calling. Also he was diagnosed with, it is 4 words and then leukemia and he had an appointment with doctor to get his blood drawn every 2 weeks. The neurosurgeon that did surgery on him on 09Jan2021 at 4 am said that his carotid artery in his neck was plugged and he went in and cleaned it out and put in a stent and he said that his carotid artery was plugged all the way to his temple and he tried to get that out and couldn't. He had his stroke at 8PM on the 08Jan2021. They had dinner at 5 pm and at 6pm they were sitting on the couch and all of sudden he started slurring his words and he said his mouth felt like someone give him Novocain and then he had his arm around her and all of sudden it felt like he was choking her so she grabbed his hand and his fingers started rolling up, started closing up tight so she started playing with his fingers and then he went out in the kitchen and then he hit the floor and she called # and the paramedics came up there. When they got there he could squeeze both hands and lift both feet by that time it was 7:30, they had just brought in a chair, by time they got done bringing in the chair they realized his left side was becoming paralyzed and so they had to go back and get the stretcher so they were there for about 30 minutes, maybe 15 minutes then they headed up the hill toward the hospital at about 8pm and they came in and gave anti-blood clotting medicine and took him for a scan with dye, they found he still had a blockage on his brain so at 2AM on the 9th they came in with a medical helicopter and flew him to (institution name withheld) in (place name withheld) and they did an MRI on and seen his carotid blockage there so he had emergency surgery at from # that morning of the 09Jan2021 at (institution name withheld) and he was in ICU from Saturday until a week ago at 3 oclock 13Jan2021 he was placed in a regular room and on the 19Jan2021 at 7:30PM he was moved (hospital name) in (place name withheld) for 14 days having 15 hours per day of therapy for a week and then he will go to (place name withheld) (rehab name withheld) and he could be there 2-3 weeks. Wednesday right before they moved him he needed a therapist in the back and one in the front and a 6 inch belt to help him stand up. He started out 08Jan2021 and was put in (institution name withheld) on the 09Jan2021 and then he was discharged to rehab on the 19Jan2021 7:30 pm She has been told it may take up to year for recovery as much as he can. The week of his stroke they were adding on to his home and he was doing the electrical upstairs so it is not like he just sat around and ate bon bons, he was very active. The outcome of the events was unknown. | | 628 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1010846-1 | could not get her head around what day it was/ her brain was not working right; disoriented/disorientation; body not responding/she couldn't function; This is a spontaneous report from a contactable Other Health Professional (patient). An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 by injection once to right deltoid (Batch/lot number: EL0142), second dose of BNT162B2 via an unspecified route of administration on 18Jan2021, both at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Investigation Assessment: No. The patient had second her COVID shot, the vaccine, on 18Jan2021, and she is a very healthy 84 years old with no health problems, and she woke up on 19Jan2021, and was disoriented, she could not get her head around what day it was, this was so rare, she normally goes to the fitness center and excursuses, but her body was not responding, her brain was not working right, it was a strange ordeal, so she got in the shower, to get her circulation going, and she couldn't shower, she got all wet, and had to get out and lay on a towel, she couldn't function, it was very scary, and very atypical. Her disorientation went away by 10AM on 19Jan2021- she did not see anyone or go to a provider. Her body started not responding around 7:30 when she got up, and by 9 or 10AM, she was functioning again. The patient didn't think this was from vaccine, she had seen enough vaccine reactions to various vaccines, and this was not a vaccine reaction, she thought what is happening? Is this a stroke, or a vascular event, she has since recovered but was still very shook, anxious about what it was, what happened until an hour or so after, it was still under her. Causality: Unknown, she didn't think of the connection until someone else did, she was describing it and the other person said it was because of the vaccine, as this person was a skeptic and doesn't want the vaccine herself, and this was not a typical response, but then she got to thinking. The outcome of disoriented/disorientation and body not responding/she couldn't function was recovered on 19Jan2021, the other event was unknown. Seriousness: it was disabling at the time, she was concerned she had a stroke, she was checking her grasps and her face and legs, she was obsessing. Seriousness for disoriented/disorientation and body not responding/she couldn't function was disability. Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of serious events cannot be excluded, considering the plausible temporal relationship. The underlying medical conditions in the advanced old patient considered confounders. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate | | 629 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1019661-1 | Patient admitted to hospital evening of 2/7/21 with acute ischemic stroke and received tenectaplase. Diagnosis Left MCA stroke. Reporting event given was just over 24 hours after first COVID vaccine dose. | | 630 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1020437-1 | Patient is bedbound at home after multiple strokes. He also has dysarthria at baselin. Was in usual state of health. Received vaccine at medical facility on 1/29/21. Caregiver reported that he subsequently had behavioral change the following day and stopped oral nutrition intake. He was subsequently admitted to Hospital on 2/6/2021 with encephalopathy and severe dehydration. | | 631 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1022969-1 | This patient received his 2nd dose of Pfizer vaccine yesterday. Today, he had focal weakness and difficulty walking and was transferred for suspected stroke. | | 632 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1027071-1 | Adverse reaction to the vaccine started with variable weakness beginning 1/29/2021. On 1/30/21 around 8:30pm, he needed assistance in the bathroom related to weakness and had what was later identified as a stroke with left side weakness and slurred speech. In accordance with his wishes, he had care at home. Due to his advanced age and frailty, a CT scan was not pursued. The 325 mg of aspirin that he was previously taking daily was discontinued. After the stroke, he needed total care. Hospice was established at home. Nursing assistant care was delivered by daughter. Death followed 9 days later (2/9/2021). | | 633 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1028452-1 | The patient suffered embolic strokes and was admitted to the hospital the day after she received her first COVID-19 vaccination. She has a history of strokes, with atrial fibrillation, but was faithfully taking her Eliquis at the time she suffered these recurrent strokes. | | 634 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1029784-1 | Patient presented on 1/24 with acute onset weakness and numbness of the left leg so a stroke alert was activated. NIHSS 3. Head Ct and CTA head/neck were unremarkable. Not a candidate for tPA given on Eliquis. Initial exam was notable for weakness and sensory loss in the left leg, but a sensory level was also found to the umbilicus raising concern for a myelitis. Of note, the patient also reported that certain red colored things she looked at appeared black. Labs unrevealing- CBC, CMP unremarkable. ESR, CRP normal. UA and UCx positive for E. Coli UTI, she was treated with ceftriaxone. MRIs were done of her brain, cervical and thoracic spine which were unrevealing. On 1/25, her exam worsened including worsening weakness in the left leg and new numbness and paresthesias in the right leg. Reflexes were preserved. MRI L spine was done which was unrevealing. Lumbar puncture was done which showed 2 nucleated cells and mildly elevated protein at 50, but was otherwise unrevealing. IgG Index normal. No oligoclonal bands. She developed mild hyperreflexia in the left leg and continued to have a sensory level, now at around T5-6. Repeat imaging of her cervical and thoracic spine were completed on 1/28 which showed a contrast enhancing hyperintensity at T5. The patient was diagnosed with myelitis and she was started on IV methylprednisolone x5 days and sent to rehab. Patient is now significantly improved though continues to report some numbness in the left leg. | | 635 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1033683-1 | Chills and muscle weakness that started on 2/13 PM and then mom suffered a basal ganglia stroke on 2/14 PM. | | 636 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1035559-1 | Stroke; like he had a film over his eye, it was cloudy, like a cloudy day; This is a spontaneous report from a contactable consumer (patient). A 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283 and expiry date: 30Apr2021) solution for injection, intramuscular in left arm on 18Jan2021 13:10 at a single dose for Covid-19 immunization. Medical history included chicken pox, measles, and mumps (had chicken pox vaccine, measles, and mumps when he was younger, and he got the flu shot for flu). The patient's concomitant medications were not reported. The next day (19Jan2021) after receiving the injection, patient reported it was like he had a film over his eye, it was cloudy, like a cloudy day. This went on for a couple of days before it improved. There was still a little bit in his left eye, but he can read and it has improved. He can see now and his eyes were improving. He found out that he had a stroke on 28Jan2021. He did not go to the hospital. He does not think the stroke affected anything else. He was supposed to have an MRI sometime this week. He went to the eye doctor and the eye doctor was the one that discovered the stroke and his eye doctor sent the report over to his primary office. He had a vision field test which was how the stroke was diagnosed. He was taking a baby aspirin and he will be put on a blood thinner called Plavix. He has not started Plavix yet, he has to go pick it up. Outcome of the event stroke was unknown while the other events was recovering. No follow-up activities are needed. No further information is expected. | | 637 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1040422-1 | Morning following 2nd vaccination patient was confused and not able to keep herself upright in a char, stand or feed herself . All of which she could do the day before. She was sent to medical center for MRI and they found no evidence of stroke and sent her back. She was then sent to rehab where she continued to weaken and not be able to eat or drink . A week later she is now under Hospice care. | | 638 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1042342-1 | cold and clammy; kept clearing his throat; blood sugar was 245; blood pressure 175/111; Runny nose; it could have been a delayed allergic response; This is a spontaneous report from a contactable nurse reporting for husband. A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 10:15 right arm at single dose for protection from virus. Medical history included diabetes from 2005 and ongoing, partial gastrectomy from Jul2016, stroke from 2015, allergic to various things, dementia. Prior Vaccinations (within 4 weeks): None. Patient previously received Shingrix vaccine (first dose) and experienced a similar reaction (have to clear his throat), flu or hepatitis vaccines and not had a reaction. The patient experienced cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose on 04Feb2021 02:00. Clinical course reported as: Her husband had the vaccine at 10:15am. She gave him some Advil. Sixteen hours later at 2:00am her husband was cold, clammy and diaphoretic. He was having to clear his throat. He did have a little dementia and was diabetic. His blood sugar was 245. His blood pressure was 175/111 and he had a runny nose. He did not have any chest pain. He was unable to explain what was happening. She checked his blood pressure again manually and the results were the same. She gave him another blood pressure pill though it was out of the usual time. Gradually his blood pressure came down. The diastolic stayed over 100 for the evening. The systolic came down. She kept trying to read but was unable to find information. She thought it could have been a delayed allergic response. She was going to take him to the hospital but took care off him herself. She gave him a Benadryl and it calmed him down. He was feeling better and was able to fall asleep. Her husband had a Shingrix vaccine (first dose) this summer and had a similar reaction (have to clear his throat). He went to the hospital and they monitored him. They said it was not because of the vaccine. Her husband has not had a reaction in the past to vaccines. He has had every kind of vaccine with no reaction. He has not had a reaction to the flu or hepatitis vaccines. Outcome of events cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose was recovered on 04Feb2021. Events cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose were reported as serious medically significant. Events cold and clammy and kept clearing his throat was classified as related to suspect vaccine. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to reported events cannot totally be excluded. | | 639 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1046512-1 | Fever, Stroke like symptoms, Sent to hospital for evaluation, admitted. (In house hospice) | | 640 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1047170-1 | On January 28 around 9 am, I started feeling sick. About an hour later, I felt nauseated and then started vomiting. I vomited throughout the day, about 6 times. I assumed this was a fairly common reaction to the vaccine. The following day (Jan. 29) I felt very weak and noticed that when I signed my name, my hand felt numb and I couldn't control it very well. On Saturday, my left leg began to feel abnormal. I called a friend who is a retired doctor and he said that he had heard of some neurological reactions to the vaccine. By Sunday, I was having a difficult time walking so I called my GPs office and set up an appointment for Monday morning. As soon as she saw my face without a mask, she said that I had had a stroke. I had a slight droop on my left cheek and mouth which indicated to the doctor that a stroke had occurred. She scheduled me for a MRI the following morning, Feb. 3. As soon as the MRI was completed, my GP scheduled me with a neurosurgeon whom I was able to see the same afternoon. The diagnosis was a right medullary ischemic stroke. She ordered a number of tests to be run and scheduled me for March 9 to come back for the result of all the tests and blood work. Doctor referred me for physical therapy to help me regain the use of my left leg and hand. | | 641 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1048688-1 | My mother had a stroke on 28Jan2021 sometime after 9:30 AM the morning after getting the first dose of the Pfizer Covid vaccine; Cerebral infarction; This is a spontaneous report from a contactable consumer (reporting for mother). A 94-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown as not available or provided to reporter at the time of report completion) via an unspecified route of administration on 27Jan2021 in right arm at single dose for COVID-19 immunization. Medical history included coronary artery disease and hypertension. There were no concomitant medications. The patient was not pregnant. No other vaccine was received in four weeks. The patient did not have covid prior vaccination and not have covid tested post vaccination. The patient had a stroke on 28Jan2021 sometime after 9:30 AM the morning after getting the first dose of the Pfizer Covid vaccine and was hospitalized due to stroke for 6 days from Jan2021. The patient then experienced cerebral infarction in 2021 and died due to it on 04Feb2021. Treatment received for events stroke and cerebral infarction included tPA injection. The outcome of events stroke and cerebral infarction was fatal. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cerebral infarction | | 642 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1051522-1 | Patient brought to emergency department at 2210 with concern for stroke d/t left sided weakness. Upon arrival patient appeared to have seizure like activity and was given 2mg of ativan and keppra 1000mg. Patient remained able to converse with providers during episode. Seizure activity/muscle twitching resolved after ativan/keppra administration. At the time of filing this report the patient is being admitted to the hospital. | | 643 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1059421-1 | After the second vaccine dose she reported not feeling well with unspecified symptoms for a few days. On February 18th, 2021 she visited her doctor with numbness in her hand. They thought it may be carpal tunnel and sent her home. The morning or March 18th , 2021 she had a severe stroke and was transferred to Hospital and then to other hospital. She was in the hospital until Tuesday March 23rd when she was transferred back to her home for hospice care. She died on March 26th, 2021. | | 644 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1062877-1 | Stroke like symptoms and treated for CVA with Altapace | | 645 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1065921-1 | right middle cerebral stroke due to clot in brain; right middle cerebral stroke due to clot in brain; This is a spontaneous report from a contactable consumer or other non hcp. A 87-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9265), via an unspecified route of administration right arm single dose on 30Jan2021 15:00 for covid-19 immunisation. First dose was received on 09Jan2021 03:00 PM, right arm, lot # EK9231. Medical history included diabetes mellitus, hypertension, hyperthyroidism, glaucoma, drug allergy (to Sulfites). The patient's concomitant medications were not reported. The patient experienced right middle cerebral stroke due to clot in brain from 31Jan2021. The patient was hospitalized from 31Jan2021 to 01Feb2021. The events outcome was not recovered. | | 646 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1069796-1 | Right dorsal medullary stroke leading to dysphagia and left-sided sensation changes. First noticed symptoms on 2/25 but did not present to emergency room until 2/27/2021. Patient was hospitalized 2/27/2021; anticipate discharge 3/4 or 3/5 2021. Patient lost ability to swallow; requires tube feeding. | | 647 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1070711-1 | stroke; Joint pain; In the palm of my hand I might jump out of my skin; ; arm was hardly sore at all; right arm at the shoulder, elbow, and fingers is hurting at the joints; This is a spontaneous report from a contactable consumer. This 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9269) single dose, dose 1 via unknown route of administration in the left arm for COVID-19 vaccination on 12Feb2021 at 14:30. There were no additional vaccines administered on the same date as the COVID-19 vaccine. Medical history included pneumonia five times on an unknown date, septicemia one time, melanoma cancer in 2015, Factor V Leiden, high blood pressure and blood thinner. Prior Vaccinations (within 4 weeks): Concomitant medications included lisinopril from 2008 and ongoing for high blood pressure and warfarin 9.5 mg daily from 2008 and ongoing for blood thinner. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On an unknown date, the patient's arm was hardly sore at all and he had a stroke. On 13Feb2021, the patient experienced joint pain, in the palm of his hand if he presses right in the dead center he thinks he is going to jump out of the skin and right arm at the shoulder, elbow and fingers is hurting at the joints. When he first felt it in his right arm it wasn't horrible and it seemed like it got worse the next day. Then it seemed like it tapered off a little bit. On 16Feb2021, the pain woke him up in the middle of the night. The events did not require an emergency room or physician's office visit. He gets the flu shot every year and he has no symptoms whatsoever. The clinical outcome of stroke, joint pain, in the palm of my hand I might jump out of my skin, arm was hardly sore at all and right arm at the shoulder, elbow, and fingers is hurting at the joints were unknown. | | 648 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1072540-1 | 100% deaf, she couldn't hear a thing/ by 11 or 12 that same day, her hearing started to come back; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 78-year-old female patient received first dose of bnt162b2 (BNT162B2, Pfizer-Biontech Covid-19 Vaccine, Lot#: EL9266) via an unspecified route of administration on 14Feb2021 via injection into left arm at single dose for covid-19 immunization (COVID Protection for herself and so that she won't give COVID to anyone else). Medical history was none. There were no concomitant medications. The patient experienced 100% deaf, she couldn't hear a thing (medically significant) on 15Feb2021 with outcome of recovered. The patient underwent lab tests and procedures which included blood pressure measurement: good the consumer did not have a stroke , body height: 5'3- 5'4 states that she has been shrinking , body temperature: good the caller did not have a stroke, blood test: blood work done in the fall but it was all fine. The consumer says, ""I no problems with it. I came home, went to bed, I guess sometime during the night it happened. I got up at 6am- 100% deaf!"" The consumer says she was unable to couldn't hear gas stove turn on, couldn't hear the fridge shut, couldn't hear the microwave go off, couldn't head the phone ring. The consumer went to walk in-clinic. Hearing started coming back while being seen by the PA. The consumer was given ""5 prednisone pills to take if hearing doesn't come back, and was told to have them on hand in case you get the 2nd shot and it comes back"". The consumer says, ""I can hear perfect now"". ""It was a matters of hours"". The consumer ""searched it"" and read that this is very rare side effect, but temporary. The consumer asking if she should I get the 2nd shot in 2 weeks, because she heard the side effects with 2nd shot, could be worse. Caller asks, ""If I get the 2nd dose, will the hearing loss be temporary again or will it be permanent?"" The consumer states that last Sunday, she had her first dose of the COVID vaccine. The consumer states that she had no aches, no pains, no anything. The consumer states that sometime in the night, she got up, and was 100% deaf, she couldn't hear a thing, not one thing. The consumer states that in the morning she was standing in the kitchen and saw her phone blinking and she couldn't hear it ring. The consumer tested her hearing by putting half a cup of water in the microwave for 30 seconds, and she didn't hear the beep when it was done, she heard nothing, it was zero hearing at all. The consumer couldn't call anyone cause she knew she would not be able to hear them, and it was 6AM. The consumer states that she waited until she knew her daughter would be up, and the consumer texted her daughter and explained what happened, and the consumer's daughter tried to call, the caller's primary care doctor, but they put the consumer's daughter on hold and then hung up on her. The consumer states that her daughter texted someone at Pfizer, and they did not answer, so by that time it was 1030 or 11AM, and the caller drove herself to the walk in clinic. The consumer states that slowly but surely, her hearing came back. The consumer has some questions including, should she get the second dose of the product? Caller also states that she heard on TV that the second dose has stronger side effects than the first, and so she is wondering if that is true, and if she can expect this side effect to come back again with the second dose? Height: The consumer is 5'3- 5'4, and states that she has been shrinking. The consumer states that she read some of the side effects include, nausea and fatigue, she did not have any of those, and her arm was not even sore. But, caller states that this even scared her. The consumer states that by 11 or 12 that same day, her hearing started to come back. The consumer had driven to the walk in clinic, and at first could not hear what the staff said, but it started to come back while she was there, and she did not see a doctor, she saw a PA who gave the caller a prescription for 5 pills of Prednisone, and told the caller to not take them unless the deafness comes back, or gets worse. The consumer has not taken them because her hearing did come back. The consumer wants to say that she has recovered completely, but she does not know if it will come back with the second dose of the product, so she is unsure. The consumer states that she has not seen her grandkids in a year and a half, because they were afraid to come visit her because they did not want to give her COVID. The consumer confirms that she received no other vaccines on the same day. The consumer states that she did have a flu shot in the fall, but that is all. The consumer also had blood work done in the fall but it was all fine. The consumer states that when she went to the walk in clinic, the staff took her blood pressure and temperature and asked her to squeeze the PA's hands and stuff, and the PA said, good the consumer did not have a stroke."" | | 649 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1075755-1 | Fever, chills, communication difficulties similar to that related to a TIA or stroke | | 650 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1076909-1 | Blood pressure would drop and then go back up; feeling passed; he is not thinking well; he is not talking as clear or loud; sick; Very hot, flushed; Everything started spinning; Headache; Mind not clear/It is like he is kind of in a fog. It is not clear; Not being as focused with is eyes; Breathing difficulty/breathing harder; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL9262 and expiry date: 21May2021) solution for injection, via an unspecified route of administration in arm on 17Feb2021 15:00 at a single dose for Covid-19 immunization. Medical history included muscle relaxer/pain therapy, accident at work (stated he taught college for many years. However, he was in (enforcement type) for the office of (County Name). He worked as an admin assistant for the state attorney. He was injured on the job because someone did not like him. He was injured real bad and taking these medications for pain. Concomitant medications included ongoing gabapentin (NEURONTIN) for pain, oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for pain, ongoing tizanidine (TIZANIDINE) as muscle relaxer/for pain, and unspecified medications for pain. The first dose was administered on 27Jan2021 (Lot Number: EL1283, Expiry Date: 30Apr2021), in Left arm. The patient reported breathing difficulty/breathing harder, mind not clear/it was like he was kind of in a fog. It was not clear, not being as focused with his eyes, all on 18Feb2021. On 19Feb2021, the patient reported his blood pressure would drop and then go back up, very hot, flushed, everything started spinning, and had headache and was sick. The patient reported feeling passed, he was not thinking well, he was not talking as clear or loud on an unspecified date. On Friday around 1'clock he got very hot, flushed. He took off his shirt. He was washing dishes. He needed to cool down a bit. He went to the bathroom to shave and brush his teeth. However, things were getting out of focus. He sat down on the toilet for about 3-4 minutes and then the feeling passed. He got back up and walked into the family room. He made it in there and had to sit down. All of a sudden he felt like everything was started to spin. Everything was really spinning. He was standing and had to sit down for a few minutes. While sitting he felt all of a sudden a super wave of feeling bad. He was sick. Everything was spinning. He could not stand it for another minute. The patient was hospitalized from 19Feb2021 to 21Feb2021 due to blood pressure would drop and then go back up. The fire department came and one of the things they did was check his blood pressure. Initially stated it was low and then it jumped up 20points when he stood up. They then threw him in the ambulance to take to the ER. He was going to the hospital because they thought he was having a stroke. He was seen by two different neurologist and other hospital doctors. The patient underwent lab tests and procedures which included blood pressure abnormal: it was low and then it jumped up 20points (Initially stated it was low and then it jumped up 20points when he stood up), blood pressure abnormal: believes it was like 140 was the high (he was unable to provide a true blood pressure reading at the time event occurred. Stated he was messed up in the head. He believes it was like 140 was the high. His was usually lower than that to begin with. Then it would go to 110. It would bounce from 110 to 140. It would change from sitting to standing), chest X-ray and electrocardiogram: test came back negative (He was in the ER and had a Chest -X Ray. He had an electrocardiogram, EKG, he had a scan that was dry without contrast and second one with contrast/iodine. He had an MRI of the brain to check for brain bleed. They thought he was in the process of having a stroke. They could not find anything. He had two CTs. Test came back negative. Neurologist determined it was not a stroke. Decided it must be inner ear situation), computerised tomogram: test came back negative (he was in the ER and had a Chest -X Ray. He had an electrocardiogram , EKG, he had a scan that was dry without contrast and second one with contrast/iodine. He had an MRI of the brain to check for brain bleed. They thought he was in the process of having a stroke. They could not find anything. He had two CTs. Test came back negative. Neurologist determined it was not a stroke. Decided it must be inner ear situation); test done on his heart, MRI of the brain, and two different scans: everything was negative (he had all kinds of test done on his heart, two different scans, MRI of the brain to see if had a brain bleed all that stuff. He was in the hospital for three days. Yesterday he was sent home. They found nothing wrong. Everything was negative. Therefore, he was sent home. Outcome of the event Blood pressure would drop and then go back up, Breathing difficulty/breathing harder, Mind not clear/It is like he is kind of in a fog/It was not clear was recovering; everything started spinning was recovered 20Feb2021; not being as focused with his eyes, feeling passed, he was not thinking well, he was not talking as clear or loud, and sick was unknown; headache was not recovered. No follow-up activities are needed. No further information is expected. Information about lot/batch number has been obtained. | | 651 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1076972-1 | Monday morning I found my father lying on couch trying to tell me he couldn?t walk. His speech was slurred he fell and was unable to walk good his body was pulling to one side. His left arm was numb . I called ambulance he was taken to hospital diagnosed with a stroke. Now in rehab | | 652 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1082335-1 | Patient seen at the ER for symptoms of stroke. | | 653 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1100501-1 | started him on his oxygen; O2 went from 85 to 98; bp 155; notably shuffled; became non-responsive; looks like he is having a stroke; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Feb2021 13:45 (at 94-year-old) at single dose (Arm Right) for COVID-19 immunization. Vaccination facility type is clinic. Medical history included congestive heart failure, early stages dementia. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 04Feb2021 (at 93-year-old) on right arm for COVID-19 immunization. The patient had no covid prior vaccination. Patient has no known allergies. The patient (father) seemed to be doing fine until 19:45 on 26Feb2021 roughly 30 hours after vaccination. He has early stages dementia, so if he was feeling ill he didn't report anything, and they didn't notice anything. He got up from the table, notably shuffled the 10 feet to the bathroom, sat down on the toilet before we could ""pull down his pants"", and then became non-responsive. The reporter said to her son it looks like he is having a stroke. They got him onto the floor. started him on his oxygen concentrator (usually used only at night), O2 went from 85 to 98; bp 155 from an unspecified date. after a while he came to. he is dnr, dni, so they didn't call an ambulance. Eventually they got him up. no signs of stroke. He does have congestive heart failure. This has never happened before, and he has no history of falling. Daughter was reporting the next morning. He has not yet been awake since this occurred. it is now 8am 27Feb2021. Covid was not tested post vaccination. The outcome of the event o2 went from 85 to 98 was recovered, while for other events was unknown. Information on the lot/batch number has been requested."" | | 654 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1104545-1 | stroke | | 655 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1105716-1 | At 2 a.m.the following morning after the vaccine , my father got up to use the bathroom and realized his legs were so weak he could not stand from the bed. This happened again at 5 a.m.and 7 a.m. when he awakened to urinate. He called his doctor that morning who advised him to go to the ER to rule out a stroke. He was admitted overnight for observation. A CT scan of the head was negative for stroke. He had a follow up MRI head which was also negative for stroke. He will follow up with his neurologist. | | 656 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1109478-1 | 2/25 woke up at 7:30 a.m. with fever, chills, and severe body aches all day 2/26 same as previous day plus lethargy 2/27 woke up at 3:30 a.m. with SEVERE headache and partial loss of vision Went to ER and they diagnosed me with a moderate stroke and mild cognitive issues with right hemisphere vison loss in both eyes. | | 657 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1111291-1 | a specific disease where things in time-space was not adding up/something not right with time frame; having bouts, what the reporter thinks are slight hallucinations; ""floaty"" feeling/ feeling of being ""trapped"" as he was trying to exit the latrine; This is a spontaneous report from a contactable consumer reported for her husband. A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration at left arm on 27Jan2021 13:15 at single dose for COVID-19 immunization. Facility where the COVID-19 vaccine was administered: Other. The patient's medical history included stroke, blood pressure high (HBP), diabetes (Non-Insulin Dependent) and known allergies to medications, food, or other products: Lisinopril, Penicillin. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril and experienced drug allergy. The reporter's husband (for whom she was reporting) had been having bouts, what she thought are slight hallucinations, since receiving the vaccine. The first (onset of bouts) was twenty-four hours later (28Jan2021) when he described a ""floaty"" feeling in the morning and was not wanting to get out of bed. Second was forty-eight hours later, on the 29Jan2021, in the morning when he had (as with routine), left his empty water pitcher out for refill (which was per normal), he proceeded to question her about what happened to it and was stating that something was not right with the time frame of events. Thirdly, he had a feeling of being ""trapped"" as he was trying to exit the latrine on the 31Jan2021 (early hours of the morning). He at that point referenced a specific ""disease"" where things in time-space was not adding up. Before the vaccine, he was doing fine. After receiving this first dose, it seems to the reporter that he was suffering a reaction contrary to the general side effects. No treatment was received for the events. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination."" | | 658 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1112372-1 | Patient had a large stroke. Seizure on 01/30/2021 after first dose of Pfeizer vaccine on 01/29/2021. Patient was 74 years old at the time she received the vaccine. | | 659 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1113686-1 | Pfizer vaccine injected 3:00 PM 3/10/21. The next day, 27 hours post-vaccine injection, while in a store, patient noted at 6:06 PM onset of numbness/tingling Right foot/leg with difficulty standing/lifting foot. He needed support of shopping cart to make it to car. Once in car, numbness/tingling, heaviness/clumsiness of right hand/arm noted. Then right side of lips/mouth affected with dysarthria. Wife witnessed evolution and drove directly to Hospital ER/stroke center by which time patient was vomiting and required wheelchair to enter ER. Stroke team evaluation neurologist concluded ischemic stroke and administered TPA. During TPA infusion, all symptoms resolved remarkably so that dysarthria cleared, numbness resolved and dysmetria/fine motor incoordination/right hand/arm/leg/foot symptoms were markedly improved. Patient admitted to ICU for one day and then neurocare floor for one day. MRI showed 8 mm linear diffusion weighted lesion in right centrum semiovale which was deemed c/w acute/subacute infarct. Attending neurologist in ICU and neurofloor noted that location laterality of MRI lesion did not correlate well with the right-sided patient symptoms, but could not identify other left brain lesions on review of scans. EKG, TEE and echo studies showed no cardiac lesions. Carotid studies were negative. CT and CT angio were uninformative; no hemorrhagic lesions or large vessel blockage. At discharge on 3/14/2021 around 6 PM, patient could walk, talk, and use hands essentially normally to outside observer although patient could relate intermittent brief episodes of possible numbness in lips or hands/fingers or slight heaviness of foot which is slight and decreasing. Patient discharged on atorvastatin, amlodipine, fluticasone, Loratadine, 81 mg aspirin, Ibuprofen (for headaches) for further post-stroke follow-up. | | 660 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1113938-1 | woke wet from sweat; Nausea; neuropathy was elevated to an unbearable level /neuropathy flared up; body aches; severe muscle ache; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's daughter-in-law). An 82-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date) at 82-year-old vaccination age via an unspecified route of administration in the right arm on 11Feb2021 15:30 as a single dose for covid protection (covid-19 immunisation). Medical history included transient ischaemic attack (TIA) which she has had this happen twice, thyroid removal in 1970, stroke (last doctor screwed up her medications and could have caused a stroke), has been losing a lot of weight (prior to vaccination) and neuropathy. Concomitant medications included influenza vaccine (FLU) on an unspecified date for an unspecified indication, blood pressure medicine, and hormone medication since she had her thyroid removed in 1970. The patient did not receive vaccinations within 4 weeks prior. The reporter mentioned that the patient has experienced body aches on 12Feb2021, nausea on 13Feb2021 and she woke wet from sweat on 16Feb2021. It was mentioned that her neuropathy was elevated to an unbearable level on 12Feb2021. She didn't feel it the first day. When talking about the neuropathy, the reporter stated that it was like something stabbing her from the knees to the toes. She has to lay in bed. Her legs hurt so bad she is unable to stand and can't sit for long. She woke wet with sweat twice. The first time was on 16Feb2021 and again on 19 or 20Feb2021. She had a flu shot on an unspecified date when they came out. The events did not require emergency room or physician's office visit. The reporter mentioned that her mother in law who was due tomorrow for the second dose and wanted to cancel because their doctor advised them to wait for at least a month to receive the second dose. According to her, her mother in law was sick for almost 3 weeks after the first dose, her mother in law experienced severe muscle ache and her neuropathy flared up on an unspecified date in 2021. The outcome of the events sweaty was recovered on an unspecified date in 2021, as for the event nausea was recovered on 01Mar2021 while muscle ache was unknown. The outcome of the other events was recovering. The following information on the batch/lot number has been requested. | | 661 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1114375-1 | I suffered a stroke 24 hours after receiving vaccine; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Left arm on 20Feb2021 (at the age of 69-year-old) at 11:15 AM at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no Covid prior vaccination and patient had COVID tested post vaccination. The patient suffered a stroke about 24 hours after receiving vaccine on 21Feb2021 at 10:30. The event result in hospitalization for 2 days in Feb2021 and considered as life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included Nasal swab was negative on 23Feb2021. Treatment included blood thinner. The outcome of the event was not recovered. Information on lot number/batch number has been requested. | | 662 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1118702-1 | Had a stroke 36 hours after getting second vaccine. Lost ability to speak and see clearly, had word salad. Was identified quickly by my wife and was taken by ambulance to hospital where they gave me TPA clot buster infusion after identifying a clot in my left back side of brain and luckily I responded well and have all speech function back we believe so far. | | 663 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1122643-1 | Massive Hemorrhagic stroke 24 hours after receiving first Pfizer vaccination. Suffered bleeding of kidney 6 days later, followed more brain bleeds and blood in stomach area. Vessels are leaking blood, Dr's were could find no reason for the bleedings, have not seen this before. | | 664 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1123131-1 | hard of hearing; Headache and then I had muscle aches/Achy and headachy; Headache and then I had muscle aches/Achy and headachy; Little bit of discomfort; Kind of stiff; Trouble in seeing; Used to be 5'7"" but now I am 5'4""; she noticed bright red bleeding in her urine when she emptied her bladder; I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it; Skin dry; slept a lot; she felt tired and so rotten; mild low-grade fever; body aches and pains; This is a spontaneous report from a contactable consumer (patient herself). An 85-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810) via an unspecified route of administration on 25Feb2021, 11:00 am as a single dose for COVID-19 immunisation. Medical history included hypertension, stroke, heart attack, COVID-19 in Aug2020 (actually had COVID this summer in August, had the mild case), and emergency surgery in Aug2020. Concomitant medications included ajmaline (CARDIA), isosorbide, and levothyroxine sodium (SYNTHROID) taken for cardiac disorder; and losartan. The patient her first dose on 04Feb2021 and experienced headaches, muscle aches and pains, chills, other flu-like symptoms, heart conditions, and sensitivity to eggs. She mentioned that this was normal and nothing unusual. She received her second dose on 25Feb2021 at 11:00 am. She was still kind of stiff but was okay. The next day on 26Feb2021 at 11:00 am, she noticed bright red bleeding in her urine when she emptied her bladder. After a few hours it faded. On the next day on 27Feb2021, she experienced the bright red bleeding in the urine again. The red blood did not hurt and patient was achy and headachy, ""you know muscles."" So, that kind of happened and it just kind of eased off. She slept a lot because she felt tired and so rotten from Friday, Saturday, Sunday after getting the shot. She also had a mild low-grade fever, headaches, and body aches and pains which she considered normal. Patient was hard of hearing and did not have a bright red bleeding, just had a taint little bit till the day when she got it and then the next day, she went to the bathroom to empty her bladder again and had bright red bleeding again with some blood clots in it. Then she did not really have that much the rest of the day and since then it seems to be clear. She did have a little bit of discomfort and her skin was dry. She have never had that experience before so she was just not sure was that connected with that shot? She wanted to know if there were any other patients that have had that. Patient also stated, ""I have a bit trouble in seeing. So, I am going to have my magnifying glass"" when asked about the product details. She will be getting her annual check up on 24Mar2021 so she will also check with her doctor. She mentions that she doesn't take that much flu-shots because she is sensitive to eggs. Her urine seems to be clear as of the time of report. She wants to know if the bright red bleeding in the urine has been reported. Patient stated, ""I used to be 5'7"" but now I am 5'4"". I think I am weighing about 158 now. I am sorry like I said because of my hearing and with a language difference a little bit. I was having a trouble hearing you."" The patient did not have treatment for the events. Outcome of the events was unknown."" | | 665 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1126875-1 | Developed paresthesias, migraine headaches, and then was admitted on 3/20, three days after dose #2 with acute dysarthria thought to be due to complex migraine. MRI was negative for stroke. Additionally she had accelerated hypertension. She reports that migraines have not been a problem for 10 years prior. Hypertension has been an ongoing issue. | | 666 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1134252-1 | 1/15 through 1/19 Pt was hospitalized for COVID symptoms and diagnosed COVID +. received remdesivir and plasma on 1/15. 1/19 discharged home and doing well until 2/12 2/11 received pfizer vaccine 2/12 readmitted to hospital after being found unresponsive at home, sats 35%, rales, temp 103.8, CXR infiltrates, placed on PR mask then BIPAP- diagnosed with cytokine storm possibly from vaccine. 2/13 sats 78% on BIPAP, sweating, rapid response called and stabilized 2/16 pt found with left sided weakness, droop and left arm flaccid. CT scan revealed ischemic stroke 2/17 6L salter lab remain weak on left side 2/19 increased to 10L salter lab 2/20 possible aspiration - worsening sats 2/21 continues to have decreased sats PR mask at 15L. then back on BIPAP 2/22 discussion with family about poor prognosis. DNR comfort. 2/23 Pt passed away | | 667 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1173824-1 | I have excruciating hip pain which my Dr diagnosed as bursitis of the left hip; I have excruciating hip pain which my Dr diagnosed as bursitis of the left hip; I couldn't walk, sit, or lay on that side; I have had tremendous pain for two weeks only being able to hobble to the bathroom as needed; I'm unable to work at my physical part-time job, and have extreme difficulty sitting for 8 hours for my banking job; It hurts to stand too long; I'm miserable; This is a spontaneous report from a contactable consumer, the patient. A 70-years-old male patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 05Mar2021 at11:15 (at the age of 70 years old); (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included stroke, high blood pressure, overweight. The patient has no known allergies. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)), ; lisinopril (LISINOPRIL); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); atorvastatin (ATORVASTATIN). Facility in which the vaccine was a Public Health Clinic. No other vaccines were given. Since the vaccination the patient had not been tested for COVID-19. On 06Mar2021 at 18:00 The patient experienced Bursitis, Pain in hip, Unable to walk, Pain, Impaired work ability, Difficulty in standing and Feeling miserable. The events were reported as a disability. The clinical course is as follows The day before, the patient was totally healthy. Day after, I have excruciating hip pain in which the patient's doctor diagnosed as bursitis of the left hip. I couldn't walk, sit, or lay on that side. I have had tremendous pain for two weeks only being able to hobble to the bathroom as needed. Oxycod/Acetamin only barely takes the edge off. The patient was unable to work at his physical part-time job, and have extreme difficulty sitting for 8 hours for his job. It hurts to stand too long. In short, I'm miserable and need help. The adverse events resulted in Physician Office Visit . Treatment given for the events include alternate hot/cold packs, oxycodin/acetamin. The clinical outcome of the events was not recovered. Information on the lot/batch number has been requested. | | 668 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 1 day | 1202320-1 | Acute stroke | | 669 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 0930423-1 | I received a call from the pharmacist at the clinic at 10:30 am on 1/8/2021, to let me know that a staff member at the facility we were at on Tuesday 1/5/2021 developed Bell's Palsy on 1/7/2021. Half of his face went numb and they feared the patient had a stroke. They rushed the patient to urgent care where it was determined it was Bell's Palsy and NOT a stroke. The patient is back home and recovering well. | | 670 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 0959972-1 | Pt is alert and oriented with a GCS of 15. Pt able to answer questions appropriately, name, DOB and any complaints, which pt stated no complaints. Staff stated pt wasn't speaking to them prior to arrival and pt's strength and ability to move from her bed to her wheel chair and vice versa has been compromised since she received first dose of COVID vaccination on the 12th. 911 was called when it appeared she could not speak and noted her left eye was no longer staying open. Pt able to speak clearly with EMS, but noted left eye continued to stay shut. No recent trauma, no ocular hx and no changes to recent medications. Assessment documented above, stroke scale negative. Speech was excellent, symmetrical smile, negative on arm drift, good grip strength and good push and pull with feet. BG of 103. Pt is wheelchair bound but independent for transferring from chair to bed but has been on a steady decline in terms of independence and needed 1-2 person assist for a week. | | 671 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1003132-1 | Stroke within 48 hours of shot on 1/22/2021. L sided weakness, facial droop, slurred speech, confusion, . to this writing (2/4/2021), symptoms persist. | | 672 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1006823-1 | Patient received her vaccine on 01/25/2021. Two days later, she presented with an acute right MCA stroke with aphasia. | | 673 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1016880-1 | Pt was vaccinated on 1/21/21. Presented to ED on 1/23/21 after stroke like symptoms that started at 7:30am. Symptoms resolved over the morning, admitted to hospital for observation, MRI confirmed small infarct R central gyrus, consistent with symptoms. Started on plavix, continued on aspirin. | | 674 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1017681-1 | 94 yo F presented from assist living with slur speech for 1 day, last seen well on 1/30. Pt has a PMH of dementia (Baseline, she will keep saying, ""help me, help me"", AOX3, using walker, could go to bathroom by herself), hx breast cancer (s/p lumpectomy, chemo, Tamoxifen, currently not on tx), HTN, HLD, vaginal bleeding (no further work up by family), overactive bladder (on solifenacin), hx of MI (undocumented, no PCI or CABG), spine stimulator placed. According to patient's daughter, she saw her January 30, she was doing okay after the vaccine. On 1/31 when the daughter called her on the phone, she knows she has some slurred speech, when she saw patient in the facility, she noticed her gait becomes unsteady. She decided to bring her to the hospital. 1/30, she noticed the patient has spilled up some water, otherwise denies fever, chills, shortness of breath, pain, chronically, she has constipations taking laxative. In the ED, pt was afebrile, 36.1, heart rate 85, blood pressure 130/61, respiratory rate 18, saturations 98 on room air. Labs shows, sodium 134, potassium 3.6, bicarb 28, BUN 18, creatinine 0.97, glucose 119, WBC 12.5, hemoglobin 11.8, platelet 239. PT INR 1.09, COVID negative. CT head suggestive of subacute infarct. Possible including small vessel ischemic changes. Chest xray questionable patchy left retrocardiac atelectasis or pneumonia. EKG shows atrial fibrillation's heart rate 71, QTc 610. Case was discussed with neurology in the ED, patient was not a TPA or embolectomy candidate. CT head suggestive of acute/subacute cerebellar infarct. Patient does not have any residual or sensory deficit except expressive aphasia. Neuro saw patient, mentioned patient appears to have had a stroke that by the CAT scan criteria is already subacute. The patient was admitted on the stroke pathway. The patient has new onset atrial fibrillation and therefore should be considered for anticoagulation. The patient cannot have an MRI of the brain due to her spinal cord stimulator but given that the stroke is already subacute on the CT without any signs of hemorrhagic conversion she could be started on this at this point. If she gets started on anticoagulation the aspirin should be stopped. If the patient cannot go on anticoagulation or does not want to then she might be a candidate for dual antiplatelet therapy for secondary stroke prevention. 2D echo shows normal ejection fraction of the left ventricle estimated at 70 to 75%. Regional wall motion abnormality was not observed. Right ventricle systolic function is normal. Moderate aortic stenosis. Cardio was consulted for anticoagulation, From cardioembolic prevention standpoint, anticoagulation is recommended to prevent CVA. However, she has significant risks for bleeding given recent vaginal bleeding (investigation not pursued to spare her comfort), age, comorbidities, etc. Again, further discussion between family and primary team is required regarding risks vs benefits. Was evaluated by speech-language pathology present minimal oral dysphagia no overt clinical signs of aspiration, recommended to continue with NDD 2 diet/thin liquid. Patient was discharged to ECF."" | | 675 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1020284-1 | DIAGNOSIS: #1. CVA #2. Aphasia, acute Number 3. Change in mental status, acute ASSESSMENT/PLAN/DECISION MAKING: Spoke with radiologist informed me that patient had a deep ischemic or infarct change in his corona radiata area which is common in patients with covid 19 infection or vaccination, which patient had a day and a half ago after lengthy discussion with wife, she informed me that patient would not want CPR and he had a stroke in the past and does not want to go to another city as he is 91 years old and therefore not a candidate for thrombolysis and also this was a wakeup stroke and so we do not know his exact time of onset, and she states that they simply want to be treated here for comfort care. | | 676 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1023803-1 | Was contacted by the person's daughter on 2/5/21. Patient started vomiting 2 days after vaccination. She aspirated and passed away 1/16/21. Patient had history of stroke and swallowing problems. | | 677 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1024643-1 | 1/21/2021, 48 hours after 1st dose, collapsed at home. Possibly triggered A Fib and went to ER with BP 180/110. CVA verified by MRI of brain. Drs suggested that Pradaxa was not strong enough to prevent stroke when A Fib was triggered. Anticoagulant changed to Eliquis. | | 678 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1031977-1 | Patient started having fever 2 days after second dose of Pfizer mrna vaccine. First dose occurred January 19, 2021 and was uncomplicated. Fevers continued and she started to have delirium and increased neurologic symptoms that mimicked stroke 6 days after vaccination. She was admitted 6 days after vaccination with fever 102, delirium. | | 679 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1035850-1 | Patient woke up on the morning of 2/6 with symptoms of a stroke. Rushed to hospital where clot found in brain. Recovered from initial stroke but then had another major stroke on 2/8 and never recovered. | | 680 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1038447-1 | Ischemic stroke on Saturday morning following vaccine Thursday. Symptoms were muscle weakness and inability to speak | | 681 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1041784-1 | On the 25th he was home alone, he called 911 and let them know he thought he was having a stroke. EMS arrived and transported him to Hospital. It was massive stroke, he was not able to comprehend anything, he was put into Hospice the following day and passed away on the 27th. There was no autopsy preformed. | | 682 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1045944-1 | I HAD MY FIRST VACCINE ON 6 FEB 2021 AT FACILITY ABOUT 6:00PM. THAT WAS ON A SATURDAY. ON THE FOLLOWING TUESDAY, I HAD A PAIN IN MY LEFT ARM FROM THE INJECTION SITE DOWN THRU MY ELBOW JOINT AND CONTINUING ON TO MY LEFT WRIST. I HAVE HAD THE PAIN EVER SINCE. I DID NOT REALIZE THAT TIREDNESS, MUSCLE PAIN, JOINT PAIN AND FEELING UNWELL ALONG WITH DIZZINESS AND WEAKNESS WERE SYMPTOMS OF A POSSIBLE REACTION TO THE VACCINE. SOME OF THESE SYMPTOMS COULD BE FROM A PREVIOUS STROKE. | | 683 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1047410-1 | Acute stroke 2 days after receiving vaccine. Second stroke 7 days after that despite being started on aspirin and statin | | 684 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1053200-1 | Within 1-2 days of second COVID vaccine, patient developed ataxic gait. After ~7-10days of symptoms, she saw her primary care, who referred the patient to the ER for stroke work-up. MRI of the brain with and without gadolinium contrast showed sub-CM lesions. Pan-CT scan showed no evidence of malignancy. LP for CSF analysis shows lymphocytic pleocytosis. Complete axonal MRI of the spine (cervical, thoracic and lumbar) shows T2 cord signal abnormalities concerning for demyelinating process. Overall, highly concerning for COVID mRNA vaccine induced acute disseminated encephalomyelitis (ADEM). Treatment initiated with glucocorticoids. | | 685 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1058733-1 | On 02/09/2021, the patient received his first dose of the Pfizer COVID-19 vaccine. Two days later, the patient presented to ER at Hospital on 02/11/2021 after noticing right arm weakness, slurred speech and facial droop while in the shower at home. Patient was evaluated and determined to have an ischemic stroke, treated with tPA. Patient transferred to hospital ICU for monitoring on 02/12/2021. Patient transferred to step down care on 02/12/2021 and then was discharged home on 02/13/2021 with improvement in his right sided weakness and the ability to ambulate independantly. | | 686 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1068235-1 | fever; Patient was unable to go to work due to disorientation, confusion, headache, and chillsPatient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chillsPatient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chills; bronchitis; This is a spontaneous report from a contactable Pharmacist. A 67-year-old male patient received second dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 at 07:30 at single dose in left arm for COVID-19 immunisation at the age of 67-year-old. Lot number was EL3248. Medical history included Cerebrovascular accident (CVA), Hypertension, Coronary artery disease (CAD), Transient ischaemic attack, Myocardial infarction, migraine induced stroke like symptoms, seizures. Concomitant medications included acetylsalicylic acid, dipyridamole (AGGRENOX), atorvastatin calcium (ATORVASTATIN), cetirizine hydrochloride (CETIRIZINE), Clonazepam, Diclofenac sodium, valproate semisodium (Depakote), docusate sodium (COLACE), lansoprazole, lisinopril, metoprolol succinate (TOPROL XL), morniflumate (FLOMAX), tadalafil (CIALIS). The patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 12:30 at single dose in left arm for COVID-19 immunisation at the age of 67-year-old; lot number EL0140. Patient missed worked on 03Feb2021 due to effects from COVID vaccine. Patient was unable to go to work due to disorientation, confusion, headache, and chills on 04Feb2021. The patient's employee health department advised the patient's family to send patient to be seen by emergency department (ED). Per ED note patient had complaint of intermittent confusion and disorientation, and fever. Symptoms started after he received his second Covid vaccine. Patient was alert and oriented when seen by ED physician. Patient described symptoms as coming and going, have been worse when he first wakes up. Patient has a past history of seizures and transient ischemic attack (TIA). Provider admitted making sure he was not having further seizures or TIA. Patient was observed and discharged on 05Feb2021. Per discharging provider the patient had some mild low-grade fever with negative cultures on unknown date. On 03Feb2021, nasal swab resulted negative. Provider unsure if fever due to vaccine or mild case of bronchitis (04Feb2021), patient discharged on a ZITHROMAX pack, antibiotics-one dose of Zosyn, Vancomycin, Rocephin. The patient was treated for the events. The patient recovered from the events. The patient did not have covid-19 prior to vaccination; the patient was tested for covid-19 post vaccination (nasal swab, negative). No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 687 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1072535-1 | Could have died with a blood pressure with these numbers; Blood pressure had spiked up to 235/104; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN9581), via an unspecified route of administration in the left arm on 09Feb2021 at 13:00 at 67-years-old at a single dose for COVID-19 immunization. There were no additional vaccines administered on the same date of Pfizer suspect. The patient did not receive any prior vaccinations within 4 weeks of the Pfizer suspect vaccine. Medical history included blood pressure increased (BP raised) in Sep2020 (BP reading was 135/80). There were no concomitant medications. The patient experienced: ""could have died with a blood pressure with these numbers"" (medically significant, life threatening) on an unspecified date, and blood pressure had spiked up to 235/104 (medically significant, life threatening) on 11Feb2021 at 16:30. The clinical course was reported as follows: The patient reported that she was a healthy person; and she had never had blood pressure problems before (as reported). The patient also reported that she was ""on no medications whatsoever."" Five months ago (from the time of the report), the patient had a wellness exam. The patient's ""blood pressure was perfect."" It was reported that ""everything was perfect"" with her health exam five months ago. Five months prior, the patient's BP reading was 135/80. The patient thought that the COVID vaccine was very dangerous and she was unaware that hypertension could even be a side effect. The patient received the vaccine on 09Feb2021, and she ""got a long fine while waiting at the facility."" Two days later, on 11Feb2021, the patient took her blood pressure and she could not believe the reading. The patient then went to a pharmacy and had the pharmacist take it for her because she thought ""she was crazy""; and because she thought her machine was not right. The patient's blood pressure had spiked up to 235/104. When the pharmacist took her blood pressure, they told her she needed to go to the ER immediately. The patient was informed her blood pressure was beyond stroke level; therefore, she was rushed to the ER and was given IV BP medications to try and get her blood pressure down. The patient was released to home. The patient, after she went to the ER the first time, she was told to go see her primary care the following day. Two days later she was back in the ER with spiked blood pressure on 13Feb2021. The patient's blood pressure on 13Feb2021 was 224/84. The patient was again treated and released. The patient stated that she saw who she believed was a physician assistant (PA). The patient was started on a blood pressure medication as well; and her last and most recent blood pressure reading was 144/85. The patient reported that the she was prescribed hydrochlorothiazide. After the patient's first ER visit, she was prescribed 12.5mg once a day. However, after the second ER visit, she had a blood pressure spike and the dose was increased to 25mg once a day. The patient received the paper with side effects, and she had none of the side effects listed; ""none, whatsoever."" The patient read that the more severe side effects were difficulty breathing, fast heartbeat, rash, dizziness. The patient further stated that ""under that, it was list serious and unexpected side effects may occur""; this was where the patient felt like her situation come in. It was serious and unexpected. The patient reported that she was upset; and felt that she could have died with a blood pressure of those numbers. The patient reported that she was a healthy person and she was looking forward to getting the vaccine. The patient stated she would not be getting the second vaccine. The patient wished she just had the normal listed side effects such as arm soreness, joint pain, fever, headache; however, she did not experience any of those events. The patient felt that if she did not check her blood pressure at home on her own, she would not have known her blood pressure was that high. The patient then added she had spoken to a couple of doctors and they had a total of five cases that were very similar to hers and had to be treated. The patient underwent lab tests and procedures which included blood pressure: spike on an unspecified date, blood pressure: 135/80 in Sep2020, blood pressure: 235/104 on 11Feb2021, blood pressure: 224/84 on 13Feb2021, blood pressure: 144/85 in Feb2021, health exam: everything was perfect on an unspecified date. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was unknown. Adverse events following prior vaccinations: None. The patient did not remember getting any other vaccinations."" | | 688 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1072539-1 | Ischemic stroke; not hypertensive, but supposedly is now.; Visual disturbances; Headache; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EM9810, expiry: unknown), via an unspecified route of administration in the left deltoid on 01Feb2021 14:15 at a single dose for covid-19 immunization at a Physician office. Medical history included asthma, irritable bowel syndrome, pneumonia and borderline high cholesterol. The patient's concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The patient had her first COVID-19 vaccine on 01Feb2021 and second one is due on 22Feb2021. On 03Feb2021, the patient had a headache, but didn't think too much because it is a side effect. The headache lasted all through the weekend. Visual disturbances began 04Feb2021. She called her doctor on Monday and was seen by her doctor on Tuesday, 09Feb2021. The patient was referred to the eye center. Her headache was getting a little better. On 10Feb2021, the patient was seen at an institution, her retina and macula looked good, so she was referred to the ED. The patient was told she probably had a stroke. The patient was admitted to the hospital for an ischemic stroke. By looking at the MRI, the onset of the ischemic stroke would have been five to seven days prior, placing the onset on Wednesday, 03Feb2021, which was also the onset of her headache. There is no definitive cause of her ischemic stroke. The patient currently has an arrhythmia monitor on. MRI/MRA showed her vessels looked good. MRI showed evidence of the ischemic stroke. The patient has neurologists since being admitted to the hospital. It was thought that the headache was just because of the COVID-19 Vaccine. Causality was unknown, it was stated that they haven't found anything else as a cause. The patient's doctor stated she was borderline for high cholesterol. She was not hypertensive, but supposedly is now. The patient also had echocardiogram, EKG, manual neuro checks, and blood work but does not have the results. The outcome of the events was unknown. The has trouble reading now since the stroke.; Sender's Comments: Based on available information, the reported events are assessed as unrelated to the vaccine BNT162B2 and can be explained as intercurrent or underlying medical conditions in this elderly patient with excessive weight (BMI=29) and underlying elevated cholesterol. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 689 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1083501-1 | Patient has nausea, vomiting, severe headache and severely increased blood pressure. She reported to the ER where it was determined she had had a stroke. | | 690 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1086478-1 | TIA followed by mild stroke 10 hours later. Hospitalized for 2 days for tests and observation. | | 691 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1091446-1 | 74 y.o. female with a history of hypertension and hyperlipidemia who was admitted to this hospital on February 25, 2020 4 hours after the development of left-sided weakness. She was found to have an acute ischemic stroke. She has had slow progression with therapy but is now able to ambulate with a walker. She is in need of further rehab, hence the transition to swing bed. She denies any new complaints today, including headache, chest pain, shortness of breath, palpitations or feelings of tachyarrhythmias. The sensory deficits on the left side have improved in particular in her left upper extremity. She is noting some improvement as well and strength. No new focal neurological deficits | | 692 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1094566-1 | abrupt onset dysarthria, left facial droop and left hemiparesis on 03/10/2020 (2 days after vaccine admin) concerning for ischemic stroke. Found to have right ICA and M1 occlusions on imaging suggestive of large vessel occlusion as etiology of stroke. | | 693 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1099131-1 | Extreme exhaustion and weakness. Loss of appetite. Incontinence. Inability to participate in activities of daily living. Possible stroke. Amnesia. Delerium. Visited Dr on March 1st. Bloodwork taken. Bloodwork showed high white blood cell count. On 3/2/21, Doctor advised patient to go to ER but patient refused. Urine sample dropped off on 3/3/21. Urinalysis showed bacteria in urine. Doctor prescribed cephalexin for possible UTI and ordered brain MRI without contrast. Patient is still exhausted and sleeping a great deal. Appetite is improving. Additional information for Item 18: Patient cannot remember any events between February 24-March 9, 2021. MRI done on 3/12/21. Waiting on results of MRI. Switched primary care on 3/12/21. | | 694 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1102412-1 | Approximately 2.5 days following my mothers fist covid-19 vaccine dose, she had a stroke and was admitted to the emergency room. She survived the stroke and following a brief stay at a skilled nursing facility, is still undergoing physical, occupational, and speech therapy. | | 695 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1104570-1 | Patient presented to the emergency room with 5hrs of speech difficulty and right arm weakness ( contralateral to IM injection that occured two days prior to symptom onset). Currently being admitted for stroke workup. | | 696 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1111287-1 | stroke; Extensive FLAIR hyperintense signal signal in the cerebral white matter/ Mild hyperintense signal in the brain stem and medial cerebellum; This is a spontaneous report from a contactable consumer. This consumer reported for a 76-year-old female patient (reporter's mother) who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302) first dose via unspecified route of administration on 21Jan2021 at 12:00 PM in left arm at single dose for COVID-19 Immunization in the hospital. There was no other vaccine administered in four weeks. Medical history included COPD (Chronic obstructive pulmonary disease), Small Cell Lung Carcinoma with metastases to brain s/p surgery, chemotherapy and radiation in 2014, dementia. Concomitant medications included citalopram at 40mg, levothyroxine at 0.05 mg, salbutamol (ALBUTEROL). The patient previously took Codeine and experienced allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient had what appeared to be a stroke on Saturday, 23Jan2021 at 12:00 PM. A CT, MRI and an Echocardiogram were all performed on 23Jan2021 and there was no acute intracranial hemorrhage, mass effect, midline shift, or extra-axial fluid collection. Extensive FLAIR hyperintense signal signal in the cerebral white matter. Mild hyperintense signal in the brain stem and medial cerebellum. Following contrast administration there is no abnormal CNS enhancement. The adverse events resulted in Emergency room/department or urgent care and hospitalization for seven days from Jan2021. Treatment given was TPA to reverse adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was recovered/resolved with sequel. No follow-up attempts possible. No further information expected. | | 697 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1112779-1 | Just 38.5 hours after receiving my 2nd dose of the Pfizer Covid-19 Vaccine I suffered a Cerebral Vascular Accident, a CVA, a Stroke @ 5:05a.m. in our home. My entire right side was paralyzed & unable to speak. My husband alerted #911 & fortunately @ the hosp. I received immediate life saving care. I had a C.T. Scan which revealed #2 blood clots in the left side of my brain. Intravenous T.P.A. was administered & then a thrombectomy was performed. Hospitalized approx. 5:45a.m on Sun., Feb. 28th, 2021 till my discharge on Wed., March 3rd, 2021@ 5:30pm. | | 698 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1117431-1 | Found in chair lethargic less than 48 hours after her first civid vaccine by facility staff where she lives in an independent living facility. Nursing staff felt she had a stroke with right sided weakness. Slurred speech, weak, unable to walk without two person assistance. Patient was under hospice care so hospitalization was given. | | 699 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1119178-1 | Weakness (Mar 5 evening), not able to stand / walk (March 6) ending up in slurring of voice /lethargic , high BP (morning Mar.7). Called 911 and moved to ER @ Hospital. CT Scan did not show stroke, EEG showed slowness in brain activity, MRI showed minor stroke left side of brain. Low salt (124) at the time of admittance. Released from Hospital on Mar 10. | | 700 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1123129-1 | TIA- mini stroke; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 12:00 PM (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included lisinopril. On 27Feb2021 14:00, the patient experienced TIA- mini stroke. The AE resulted in Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Feb2021. Therapeutic measures were taken as a result of tia- mini stroke. The outcome of the event was recovered. | | 701 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1126561-1 | basal ganglionic hemorrhagic stroke; basal ganglionic hemorrhagic stroke; This is a spontaneous report from a contactable consumer. This 74-years-old male consumer (Patient) reported for himself that he received first dose of bnt162b2 (BNT162B2) (Batch/Lot Number: EN9581), via an unspecified route of administration in Arm Right on 03Feb2021 at single dose for covid-19 immunization. Medical history included asthma, atrial fibrillation (A-fib), hypertension (HTN), ischaemic stroke (Ischemic CVA). Concomitant medications included amlodipine; atorvastatin; doxazosin; apixaban (ELIQUIS); lisinopril (LISNOP). No other vaccine in four weeks. The patient experienced basal ganglionic hemorrhagic stroke (hospitalization, disability, life threatening) on 05Feb2021 08:00 with outcome of not recovered. The patient was hospitalized for basal ganglionic hemorrhagic stroke from 05Feb2021 to 21Feb2021. Clinical course reported as follow: Early in the morning hours of 05Feb2021, patient had a basal ganglionic hemorrhagic stroke. He was found 10+ hours later and airlifted from local emergency room to neuro ICU unit. He spent 16 days in hospital then was d/c home for hospice care. Treatment for event included factor ii (prothrombin);factor ix;factor vii (proconvertin);factor x (stuart prower factor);protein c (coagulation inhibitor);protein s (KCENTRA). No covid prior vaccination. No covid tested post vaccination. | | 702 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1140696-1 | Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021. An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage | | 703 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1152698-1 | stroke -venous thrombosis | | 704 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 2 days | 1156352-1 | Patient's wife returned for second Pfizer CoVid vaccine on 4/1/2021 she told the vaccinator, that her husband, died two days after he received the first Pfizer vaccine. Date of Death - 03/13/2021. Wife states that husband had a ""massive stroke."" EEG indicated no brain activity and it was decided to remove him from life support."" | | 705 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 0910750-1 | Patient was found slumped over in wheelchair, drooling and unable to respond/follow simple instructions; sent to ED for evaluation. CT scans and MRI NEGATIVE for new/recent stroke; resident slurred speech likely due to hypertensive urgency | | 706 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 0951101-1 | PATIENT GOT HER FIRST COVID PFIZER VACCINE AT 12/31 IN THE AM. HAD GOTTEN FLU LIKE SYMPTOMS AND HAD BEEN SICK FOR A COUPLE OF DAYS. HAD NAUSEA AND VOMITTING DURING THIS TIME AS WELL. ON 1/3 THE CARE GIVER WENT TO CHECK ON HER PT AT HER LTC FACILITY WHERE SHE LIVES AND SHE WASN'T ACTING RIGHT. SHE WAS UNABLE TO DO A STROKE EXAM. PT HAD NO MOVEMNET IN ARMS OR LEGS AND WAS UNABLE TO SPEAK. PT WAS VITALLY STABLE AT THE TIME. EMS RECORDED THAT THEY THOUGHT DIAGNOSIS WOULD BE STROKE, PNEUMONIA OR SEPSIS. AFTER ARRIVAL AT THE HOSPITIAL DETERMED THAT SHE HAD A STORKE, ACUTE KIDNEY INJURY, ABNORMAL LFTS. | | 707 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 0951412-1 | Vaccine was administered on 1/12/21 at Memory Care. On 1/15/21 at 12:30 he developed slurred speech at his facility and slumped to his left side. Out of concern for stroke he was sent by ambulance to Hospital. There he was found to have no evidence of stroke on MRI or CT angiogram. He was admitted to the hospital due to fever and elevated inflammatory markers (ferritin, CRP) and transaminases. He was found to have a positive SARS-CoV-2 PCR and IgG. His symptoms resolved the following morning and may have represented a TIA. He had many markers consistent with COVID-19 and his CT pulmonary angiogram did show ground glass opacities but no pulmonary embolism. It was difficult to assess if this was a reinfection with COVID-19, persistent PCR positivity from November, or an adverse event to the vaccine. | | 708 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 0973816-1 | right hand swelling, right knee swelling, right ankle swelling, facial swelling of left cheek Narrative: Following 1st COVID-19 vaccine dose on 12/17/20, patient seen at Emergency Department on 12/21/20- 12/22/20 for eval of new left cheek swelling and right hand/ankle swelling. Hand x-ray did not show signs of fracture, head CT did not show any signs of new strokes, and labs showed mild BNP elevation. Per ED note, ""Based on the patient history, physical, and initial vital signs - the patient's initial presentation is concerning for heart failure/volume overload->pulmonary edema and bilateral pedal edema."" He received ipratropium neb x1 and returned to facility. Neurology consulted (12/22/20), ""It is difficult to determine whether the patient has a new facial palsy or whether this is recrudescence of his previous stroke deficits. Given the swelling of his left face it is quite possible that there is inflammation causing some partial left facial nerve dysfunction that would not include the forehead. The pattern of weakness is, however, also consistent with what would be expected from his documented right MCA stroke. At this point it is appropriate to consider this a possible complication of his vaccination (Bell's palsy has been reported in some after Covid19 vaccination). However, I would not recommend any specific treatment for the facial weakness as the etiology is still somewhat unclear."" Patient admitted to hospital 1/2/21-1/8/21 for mild hypothermia with possible AMS and found to have adenovirus. Head CT negative for CVA. Sepsis/toxic/metabolic w/u was unrevealing. Given IVF for diarrhea; C diff negative. Discharged to facility. Patient received 2nd COVID-19 pfizer vaccine on 1/13/21 in Right Deltoid w/o complications (lot#: EK9231, exp. 04/30/2021)"" | | 709 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 0977593-1 | Patient is a 71-year-old female with PMH of type 2 diabetes, hypertension, hyperlipidemia, cataracts, glaucoma who was transferred from Medical Center as a stroke code after she presented there for right-sided weakness, facial droop and visual changes. Patient was given TPA in the past she was within window and she was then transferred here for further management. Patient's symptoms continue to resolve. She was admitted in the ICU and managed by neuro critical care and neurology. Further imaging including CTA head and neck, MRI brain did not reveal any stroke. An assessment of small vessel disease was made which likely resolved after TPA was given. Patient was assessed by PMR and PT/OT and deemed safe to go home with family care and no restrictions. Echo, telemetry and EKG showed no signs of cardiac involvement. Patient was started Plavix x21 days and chronic baby aspirin. She was also started on Crestor 20 mg daily. Patient is to follow-up with neurology in 3 months as she got TPA. She will also follow-up with her PCP on discharge. | | 710 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 0992762-1 | Basal Ganglia Stroke | | 711 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 0994676-1 | stroke-like symptom; Left arm droop; no feeling on left side; loss of mobility in left arm; droop on left side of face; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: Ek4176) via an unspecified route of administration on 16Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. Medical history included blood pressure needs controlling and allergies: penicillin. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included nebivolol hydrochloride (BYSTOLIC), terazosin, famotidine, olmesartan (reported as olmsartan), amlodipine, and atorvastatin calcium (ATORVASTIN). Facility where the most recent COVID-19 vaccine was administered at nursing home/senior living facility. The patient was not pregnant at the time of vaccination. On Tuesday 19Jan2021 at 5 am, patient had stroke-like symptom: left arm droop, no feeling on left side, loss of mobility in left arm, droop on left side of face. The event resulted in emergency room/department or urgent care, and hospitalization. The event was reported as serious with seriousness criteria of caused/prolonged hospitalization. It was unknown if treatment received for event. The outcome of event was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. | | 712 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 1000051-1 | bad chills/terrible chills; terrible acid reflux for 3 hours; couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything; threw up; very dizzy/dizziness; vertigo; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, unknown expiration), via injection in right arm on 13Jan2021 at a single dose for COVID-19 prevention. Medical history included ongoing vertigo (in car accident a little over 5 years ago, that affected a big nerve in left temple, and so every once in a while she will get vertigo so bad that she falls over), ongoing GERD (from a hiatal hernia; diagnosed many years ago), ongoing high blood pressure diagnosed about 15 years ago, ongoing bad cholesterol diagnosed 10 to 15 years ago, ongoing heart burn, ongoing hiatus hernia, and car accident a little over 5 years ago. Concomitant medications included ongoing omeprazole sodium (OMEPRAZOLE) for GERD, heart burn, and hiatal hernia (started this product at least 10 years ago; takes the product as needed if she is having heart burn or is going to eat spicy food); ongoing vitamin D3 for vitamin supplementation (started product about 8 months ago, because her doctor told her too, she guesses her vitamin was low); ongoing metoprolol for high blood pressure and to prevent stroke (started product at least 15 years ago; her BP could be regular but it could shoot up when she is upset, so she takes this to prevent stroke); ongoing hydrochlorothiazide for blood pressure (started product at least 5 years ago); pravastatin for bad cholesterol (started the product at least 4 or 5 or more years ago); and ongoing acetylsalicylic acid (BABY ASPIRIN) to prevent stroke (has been taking this product forever, at least for 10 years). The patient reported that she received the first COVID shot on 13Jan2021. She was okay on the 13th, 14th, and 15th. However, on the 16th (16Jan2021), she woke up and threw up once and was very dizzy for three days. She mentioned that she had like vertigo, she couldn't even walk, she had to crawl and her husband had to walk her around, she couldn't do anything. She had vertigo (16Jan2021). She was that way on Saturday and Sunday. On Monday, the patient's son took her to acupuncturist for her dizziness and was able to get up fine and walked away. After the acupuncture, she felt fine, like she was all better. On 19Jan2021 (reported as yesterday), she was fine. She woke up at midnight and had terrible acid reflux for 3 hours even though she had hardly eaten. She does take omeprazole for heart burn, and she had taken omeprazole earlier in the day, but it was just coming up, that acid and burning. She drank milk to coat the stomach and it went away at 03:00 AM. She had very bad chills/terrible chills (20Jan2021) and her teeth were chattering, she couldn't even talk, and couldn't control the chills. She is fine now. She clarified that she got vertigo from a car crash years ago and haven't had it in almost a year. Chills are not ongoing at this time, she has not had any for about 4 hours now, and she is hoping she is recovered completely, but it may be too soon to tell. She did not receive other vaccines on the same day as the COVID vaccine. The patient is wondering if all this could be from the vaccine. The patient wanted to know if it is safe to take the second shot. She was scheduled to receive the second dose on 03Feb2021. The patient recovered from the events threw up on 16Jan2021; unable to walk and vertigo on 18Jan2021; dizziness on 19Jan2021; and terrible acid reflux on 20Jan2021. While unknown outcome for chills. | | 713 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 1017113-1 | Was not able to walk/He could not move his legs, but now he is able to stand; His knees were hurting; This is a spontaneous report from a contactable consumer. A 75-year-old male patient (reporter's brother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via intramuscular on 22Jan2021 at single dose for COVID-19 vaccination. Medical history included 2 heart attacks, stroke, she said that he had had numerous other things. His physician said that he was doing fine with all of the different things that he had. She said that he did not get enough oxygen when he was born and was a little slow because of that. There were no concomitant medications. The caller said that her brother today 25Jan2021 got up after doing a few little things and said that the paperwork talks about joint discomfort. He was not able to walk after a little while. This was something new. She said that his knees were hurting. She had to use a wheelchair to get him to the car. The cardiologist said that there was nothing wrong with his heart when and said that she made an appointment with his primary care doctor as well. She said that she made an appointment with his primary care for tomorrow evening 26Jan2021. Caller said that she was not saying that it was from the vaccine. She said that he could not move his legs, but now he was able to stand. At 15:00 central time 25Jan2021, he was able to stand up and walk to the chair. She said that it was an improvement. The caller said that her brother took the shot on Friday 22Jan2021. He got up did his regular routine and at about 11:50, he was in the den and was standing with a cane and was holding on to the cane and was not moving his legs. They got the wheelchair out of the car and sat him down. He said that his knees were hurting at that time. He was not able to move his feet at all. She said that he does not complain at all. Caller said that when this happened, her bother He was not slurring his words or having any other symptoms. The outcome of the events was recovering. | | 714 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 1026699-1 | Had a stroke 3 days after round one of Covid vaccine and subsequently died the next week due to complications of stroke. Upon admission to hospital, was in afib. | | 715 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 1036647-1 | On Monday, 15 February my mother in law suffered a stroke. She has been hospitalized since the stroke at Hospital. | | 716 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 1044569-1 | THROMBOTIC STROKE IN THE DISTRIBUTION OF THE LEFT MCA DISTRIBUTION | | 717 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 1056641-1 | cranial nerve 3 palsy. Ptosis of the left eye, it was completely shut; cannot hear; This is a spontaneous report from a contactable physician. A 93-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included atrial fibrillation, hypertension, hyperlipidaemia, diabetes, and chronic kidney disease. Concomitant medications were not reported. No additional vaccines administered on the same date of the vaccine and no prior vaccinations within 4 weeks. The reporter is the family's physician, who stated that the patient received the first dose of the Pfizer COVID vaccine on 22Jan2021 and three days later (25Jan2021), his left eye had ptosis - he was unable to open his left eye and it was completely shut. The patient came to him and when he would try to lift the eyelid up, it would just drop down. He then called a neuro ophthalmologist, he thought to himself that the patient could be having a stroke. The patient was sent to the Emergency Room and kept overnight to do CT of brain, MRI of brain, CT of orbits and MRI of neck. All tests came back normal, there was no stroke. The patient was discharged and was told to go see an ophthalmologist; the eye doctor diagnosed him with Cranial Nerve 3 Palsy. The reporter had read the consultation notes; the eye doctor ""wrote 1-2 days after he had COVID and had this happen"". The reporter clarified that the patient never had COVID, maybe this was a misunderstanding or typo with the doctor, but the patient just had the vaccine. The point is that the patient was diagnosed. The reporter further added that the patient can't hear, and so he will provide the patient's son's phone number. The reporter would like to know if this is a possible side effect of the vaccine and if he should receive the second dose of the vaccine as he is due in two days (Friday at 8:30AM on 12Feb2021). It was also reported that the ptosis has not gotten worse and has not resolved. The reporter added that the patient was admitted to the hospital for a full day. The patient underwent lab tests and procedures which included computerized tomography (CT) of the brain, CT of the neck, magnetic resonance imaging (MRI) of the brain and MRI of the orbits-all of which resulted normal in Feb2021. The events cranial nerve 3 palsy and 'Ptosis of the left eye, it was completely shut' had not resolved while the outcome of the rest of the events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: By close temporal relationship, the company cannot completely exclude that the reported cranial nerve 3 palsy' is related to BNT162b2 administration, even though medical history including atrial fibrillation, hypertension, hyperlipidemia, diabetes, and chronic kidney disease, in the setting of elderly age, can be considered confounding factors in the overall clinical evaluation of this event occurred three days after the vaccination. Conversely, even though cannot be excluded as reportable event based on the information provided, the company deems there is not a reasonable possibility that the reported deafness is related to BNT162b2 administration, but, at the present time, evaluated as an intercurrent condition that cannot be also excluded as already present before the vaccination. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."" | | 718 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 1087308-1 | her mother didn't want anything to eat; her mother wasn't making any sense when she talked; Dizzy; Weakness; shaky; stomach became upset; her mother had a pretty severe headache come on; Nose bleeds; Blood pressure increased; her mother's comprehension is not at the same level as prior to being hospitalized; This is a spontaneous report from a contactable consumer. A 92-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 15Feb2021 12:30 at SINGLE DOSE for covid-19 immunisation. Medical history included blood pressure high, high cholesterol. Caller stated her mother has had high blood pressure for around 15 years. She said her mother's blood pressure medicine has changed over the years, providing her current blood pressure medication as: Ramipril 2.5mg capsule, once a day, Bisoprolol 5mg tablet, once a day. Reported her mother has had high cholesterol for at least 30 years. She said her mother's cholesterol is controlled with Simvastatin 40 mg, once a day. She said her mother has been on Simvastatin for at least 10 years and her mother's Simvastatin dose has been bumped up gradually over that time. She said the Simvastatin 40mg is dispensed in a pharmacy bottle with no NDC, Lot, and expiration date. Concomitant medication included omeprazole (OMEPRAZOLE), simvastatin (SIMVASTATIN) for high cholesterol, ramipril (RAMIPRIL) for blood pressure high, bisoprolol (BISOPROLOL) for blood pressure high. The patient experienced nose bleeds on 18Feb2021 with outcome of recovered on 22Feb2021, her mother had a pretty severe headache come on on 18Feb2021 with outcome of not recovered, blood pressure increased on 18Feb2021 with outcome of recovering, dizzy on 20Feb2021 with outcome of unknown, weakness on 20Feb2021 with outcome of not recovered, shaky on 20Feb2021 with outcome of unknown, stomach became upset on 20Feb2020 with outcome unknown, her mother didn't want anything to eat on 21Feb2021 with outcome of unknown, her mother wasn't making any sense when she talked on 21Feb2021 with outcome of not recovered, her mother's comprehension is not at the same level as prior to being hospitalized on an unknown date with outcome unknown. The patient was hospitalized from 21Feb2021 to an unknown date. Reporting on her 92 years old mother who received her first Pfizer COVID-19 Vaccine dose last Monday, 15Feb2021. She said the first couple days her mother was fine after receiving the COVID-19 Vaccine. She said on Thursday, 18Feb2021, her mother had a pretty severe headache come on. She said her mother normally doesn't have headaches. She said her mother began having nose bleeds that started on Thursday (18Feb2021), and continued on Friday (19Feb2021), and Saturday (20Feb2021). She said her mother's blood pressure was up during that time, as well. She said on Saturday night (20Feb2021) at 9:00 PM she took her mother to the Emergency Room because her mother's blood pressure was very high. She said a CT scan of her mother's head was done and was negative for a stroke. She said her mother was kept in the Emergency Room and monitored. She said her mother's blood pressure was gotten under control with given blood pressure lowering medication in the Emergency Room and her mother was discharged home at around midnight. She said she does not know the name, dose, NDC, Lot, and Expiration Date for the blood pressure medication. Reported her mother takes Warfarin for blood clots. She clarified her mother is monitored monthly and her mother's Warfarin is adjusted accordingly. She said her mother takes a Warfarin 1mg tablet daily on Monday through Friday, and a 1/2 Warfarin 1mg tablet (0.5mg) on Saturday and Sunday. She said the Warfarin is dispensed in a pharmacy bottle with no NDC, Lot, and Expiration Date. She said her mother has been on Warfarin for around 20 years, since her mother had a blood clot. Reported her mother takes a stomach medication, clarified as Omeprazole 20mg capsule once a day. She said her mother has been on Omeprazole for years. She said the Omeprazole 20mg capsule was dispensed in a pharmacy bottle with no NDC, Lot and Expiration Date. She said her mother's stomach had been fine. She said her mother didn't get sick to her stomach, until the night she was released from the Emergency Room (20Feb2021). She said when her mother sat up and tried to stand while she was in the Emergency Room on Saturday night (20Feb2021), her mother was dizzy, and felt weak and shaky. She said her mother was given some orange juice and peanut butter crackers at the time. She said her mother's stomach became upset then. She said she thinks her mother's stomach upset had more to do with having the orange juice and peanut butter crackers than anything else. She said her mother has never had nose bleeds or headaches before. She said her mother has blood pressure issues that she takes blood pressure medicine for. She said she thinks the COVID-19 Vaccine may have exasperated her mother's issues. Reported on Sunday (21Feb2021), her mother didn't seem much better to her. She said her mother's blood pressure was up, her mother was dizzy, weak and had a bad headache. She said her mother has a healthy appetite for 92 years old and her mother didn't want anything to eat. She said she ended up calling 911 because her mother wasn't making any sense when she talked. She clarified her mother was picked up by the ambulance at 9:00PM on Sunday (21Feb2021); and admitted to the hospital. She said her mother is still in the hospital as of today, Tuesday, 23Feb2021. She said her mother had a CT scan, a MRI, and an EEG. She said the CT scan, and MRI were negative, and the EEG results were not back yet. She said her mother may be released home today, 23Feb2021, depending on the EEG results. Reported her mother has never had nose bleeds or headaches before. Reported on Sunday, 21Feb2021, she took her mother's blood pressure. She said her mother was very weak and incoherent. She said her mother was unable to comprehend the way she usually does. Reported her mother has had no more nose bleeds since yesterday 22Feb2021. She said her mother is still quite weak, but her blood pressure is now under control. She said her mother has been on a stroke watch while at the hospital, and her mother has not been allowed to get up out of bed as of last night (21Feb2021). She said the hospital staff are supposed to let her mother walk today (23Feb2021) to see if her mother's blood pressure stays stabilized. She said her mother's comprehension is not at the same level as prior to being hospitalized. She clarified her mother still drives a car at 92 years old and takes care of her own check book. She said she doesn't know if her mother will still be able to do that at this time. Reported her mother was checked for a UTI while at the hospital. She said the hospital went ahead and treated her mother for a UTI without knowing if her mother had a UTI. She said because her mother is elderly, a lot of times the elderly have UTIs. She said the hospital didn't want to waste time and went ahead and treated her mother for a UTI because her mother hadn't been on antibiotics recently. The caller stated she did not have any information on the medications her mother has been given while at the hospital. Reported at first she did not think her mother's symptoms had to do with her mother's first COVID-19 Vaccine dose, but then there was a new part to her mother's story that made her think her mother's symptoms had to do with the COVID-19 Vaccine. Caller stated she is apprehensive for her mother to go get her second COVID-19 Vaccine shot. The patient underwent lab tests and procedures which included blood pressure abnormal: up on 18Feb2021, Head CT: negative on Feb2021, Head CT: negative for stroke on 20Feb2021, EEG: unknown results on Feb2021, MRI brain: negative on Feb2021. Therapeutic measures were taken as a result of nose bleeds, blood pressure increased, dizzy, weakness, shaky. | | 719 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 1099173-1 | 1/24/20211 unresponsive, sent to Hospital. Admitted with diagnosis: Acute Ischemic left MCA stroke. 1/26/2021 Transferred to Hospice care. 01/30/2021 died. I don't believe the hospital was aware of her vaccination date as it is not recorded in her records, therefore I assume that a previous VAERS report has not been submitted. My relationship to the patient is that I am her daughter. | | 720 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 1104607-1 | Stroke on 2/11/2021 caused by a blot clot | | 721 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 1112649-1 | Stroke, Acute Ischemic Left MCA Stroke | | 722 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 1122739-1 | 3 days after 1st shot, I suffered a stroke; This is a spontaneous report from a contactable consumer (patient himself). This 77-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on the left arm on 02Feb2021 at 09:30 AM (at the age of 77-year old) at single dose for COVID-19 immunization. Relevant medical history included type 2 diabetes, kidney disease, heart failure, cutaneous T-cell lymphoma (CTCL) and allergy to lisinopril. Concomitant medications included atorvastatin (LIPITOR), metformin, losartan, potassium and acetylsalicylic acid (ASPIRIN). On 05Feb2021 at 01:30 PM, after 3 days from the first dose of vaccine, the patient experienced a stroke that resulted in hospitalization for 4 days. Treatment included CAT scan, MRI (with unknown results) and intravenous blood thinner. The outcome of the event was recovering. The event was serious due to hospitalization and life threatening illness (immediate risk of death from the event). Information on the lot/batch number has been requested. | | 723 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 3 days | 1129122-1 | pt states about 3 days after taking vax he started having severe lower back pains that lasted about 4 days. On 3/15/2021 he went to ER in because his heart was racing. His heart rate went from 64 to 176. He was treated as if he was having a heart attack or stroke. Labs showed he had not had a heart attack. He was admitted for AFIB and irregular heart beat and stayed for 4 days. Pt was discharged to FU w/PCP and Cardiologist. Appt w/ Cardiologist is on 3/26/2021. On 3/24/21 Pt still has a heart rate of 102. | | 724 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 0986749-1 | 5:30 am I found husband by bed, babbling, Called 911, Had Lt Hemi Stroke. Aphasic, Rt side limp, given TPA. Sent to ICU. Recovered within 2hrs, speech, movement of extremities. lt hemi clot found on ct angiogram & mri. 2nd mri found clot busted with residual. transfered to telemetry next nite. echo unconclusive. 02 sats low, venogram done 3days later show lt dvt, lung ct wnl. ld asa & b/p meds were given. blood work to be drawn for baseline prior to anticoagulent therapy. possible d/c 9/30. | | 725 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 0994613-1 | after shot i didn't have any problems and then i came home. On Monday I slipped getting out of bed and hit my head on the floor , i couldn't move or talk, Wife called 911 and went to ER. had a Stint put in my head. Went into ICU discharged. I was diagnosed with Stroke | | 726 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1000653-1 | Dramatic unexplained drop in INR from 2.9 on January 11, 2021 to 1.3 on January 25, 2021; This is a spontaneous report from a contactable consumer (patient). This 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231) via an unspecified route of administration in the right arm on 21Jan2021 at 09:45 at single dose for COVID-19 immunisation. Vaccination facility type: urgent care center. The patient did not receive other vaccines in four weeks. Relevant medical history included recent stroke, cardiac failure congestive, chronic obstructive pulmonary disease, chronic renal failure, diabetes, high cholesterol, SP aortic valve replacement, atherosclerotic cardiovascular disease and COVID-19 (the patient had COVID-19 prior to vaccination). Concomitant medications included hydralazine, carvedilol, warfarin and isosorbide. On 25Jan2021 at 09:00, the patient experienced dramatic unexplained drop in INR from 2.9 on 11Jan2021 to 1.3 on 25Jan2021. The event resulted in life-threatening illness (immediate risk of death from the event). Corrective treatment taken as a result of the event included subcutaneous enoxaparin sodium (LOVENOX) twice daily. The patient was not tested for COVID-19 after the vaccination. At the time of the report, the outcome of the event was unknown. | | 727 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1006921-1 | Began having leg weakness 4 days after the vaccine on the evening on 1/29/21. The next day the leg weakness was more significant and went to the emergency room where they found greater weakness in the left leg than the right leg. An MRI showed ""Punctate focus of diffusion restriction within the left cerebellar vermis consistent with acute infarct."" He was also found to have a critically low platelet level of 30 and then 27 while in the emergency room. He was then admitted to the hospital, placed on steroids to increase his platelet level and given physical therapy following the stroke. He was admitted to the hospital for a total of 3 nights. He was discharged home on Aspirin, Carvedilol, and Atorvastatin, has follow up with hematology to check platelets and physical therapy."" | | 728 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1009884-1 | Fell, head injury and vertebrae fractured. Probable stroke. Dizziness. | | 729 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1022055-1 | Had a mild a heart attack and mild stroke; had a mild a heart attack and mild stroke; urinary tract infection; Blood infection; A1C was 6.5; there was a little blood in his urine; he fell out of bed and couldn't get up; he was flushed; he had a fever of 101; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL1283) at 0.3 mL single on 20Jan2021 for COVID-19 immunization. Medical history included thyroid; hypertension, was under control with the medication; dementia, taking memantine as a treatment for dementia, no other impairment other than what he normally has from his dementia. Concomitant medications included levothyroxine; memantine for dementia; fish oil tablet; Vitamins. Patient had a mild heart attack and a slight stroke and he did have urinary tract and blood infection on 24Jan2021. They both had the first dose of the Pfizer covid vaccine on 20Jan2021, Saturday night into Sunday. He was a dementia patient, alert to his name. On 24Jan2021, he fell out of bed and couldn't get up, he was flushed, so patient's wife took his temperature, he had a fever of 101. Patient's wife couldn't move him, so called the paramedics and they took him to Hospital. Patient's wife just found out that he had a very mild heart attack and slight stroke, no impairment other than what he normally had from the dementia. Patient's wife was wondering should he get the second shot and what was the timing of the 2nd dose of vaccine. Reporter seriousness for mild heart attack, slight stroke, urinary tract and blood infection was hospitalization. They also have him on some sort of penicillin derivative for a urinary tract infection. Since he had been to the hospital, he had at his doctor's office about 2 weeks ago today, he had a blood test, a urine test. His A1C was 6.5, there was a little blood in his urine. For that since Sunday (24Jan2021) he was having MRI, he had a couple of PET scans, he had an electrocardiogram. The neurologist came in to check on him. He was in hospital now. Hospitalization date was 25Jan2021 early in the morning. The outcome of events was unknown. | | 730 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1041279-1 | 1st day sore arm, 4th day-stroke like reaction, had to go to er | | 731 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1045951-1 | Stroke in third branch of middle cerebral artery and intramural clot of right carotid artery | | 732 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1048679-1 | Double vision; the way she talked she kind of had slurred speech; mouth was dry; she had Bell's Palsy/ Droop in her lip/mouth; her eye was still watering; puffiness around her eye; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (manufacture unknown, Lot Number: 9264), intramuscularly in left arm on 29Jan2021 14:55 at 0.3 ml, single for COVID-19 immunization. Medical history included non-hodgkin's lymphoma from Jul2019 and ongoing (The first time she was diagnosed was Jul2019. She then went into remission and then got the cancer back, she doesn't know when. She knows they started treating it as the cancer had returned in Aug 2020), watering eyes from an unknown date and unknown if ongoing (Her eye was watering before the injection. She knows her eye was watering before she received the vaccine), chemotherapy from an unknown date and unknown if ongoing (she is a cancer patient on chemotherapy), fever blister from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced she had bell's palsy and she does not know if she got this from the covid shot or not but she still has the droopy lip which apparently that can last a while. on 02Feb2021, droop in her lip/mouth on 02Feb2021, her eye was still watering on 02Feb2021, there was a little puffing around the eye/ puffiness around her eye on 02Feb2021, double vision on an unspecified date, the way she talked she kind of had slurred speech on an unspecified date. Caller was calling about the Pfizer COVID 19 vaccine. She said on Friday 29Jan2021 she had the first shot at about 12:30. Her eye started watering in the morning Thursday the day before and she maybe assumed she was getting a cold in her eye but it was really runny and she got the shot. She was a cancer patient on chemo and she went to the doctor because she was supposed to get her chemo. That Tuesday morning she had a droopy lip on the right side and her eye was still watering, there was a little puffing around the eye and the way she talked she kind of had slurred speech so she thought stroke but she was going to get her chemo in an hour or 2 so she when they checked her she told them what happened, she was seeing the PA that day so she left and came back 10 minutes later and said she had talked to the doctor, they were not going to give chemo today and told her she had Bell's Palsy and she does not know if she got this from the COVID shot or not but she still has the droopy lip which apparently that can last a while. This was her first shot so as a cancer patient on chemo should be getting the second shot 21Feb. She was concerned about taking that when she already has Bell's Palsy now, what else would it cause and then if she does not get it would she be 50 % protected. The doctor seemed to say she thought it was from the vaccine, but caller does not know because the eye watering began the day or 2 prior to getting the vaccine. Product details: She does not have the vaccine card right with her and she was using a walker to get up and down and so she was not able to provide NDC lot expiration right now. It would be available if needed at a later time. Indication: doctor said she should have it because she has no immune system. They don't know what to do they are just following what they told her and they were scared to death. The caller states she was a cancer patient on chemotherapy. She received her first Pfizer COVID-19 injection on Friday, 29Jan2021. Prior to the vaccine, her eye had been watering Thursday or Friday morning before she had shot, it was just her right eye. On Tuesday, 02Feb2021, she developed a droop in her mouth and puffiness around her eye and so forth. Caller clarified it was just on the right side and with her right eye. She also has double vision in her right eye. She got up in the morning on 02Feb2021, and her husband was in the other room and told her that she sounded funny. She explained to her husband her mouth was dry and she was kind of slurring her speech. Her husband came into the room she was in and said, ""huh, your lip was drooping"". Since it was in the morning and she had no other symptoms besides the talking funny and the puffiness around her eye, she didn't take it as a stroke. She figured she would just until she went to her chemotherapy appointment she had the same day, 02Feb2021. She went into her appointment and showed the person and gave her information on what happened. The person wanted an MRI of the brain to make sure she didn't have cancer there or cancer anywhere else up in that area and also that she didn't have a stroke. She confirms the MRI was fine, both were negative for any signs of this. She was told she developed bell's palsy. She has a drooping lip. The caller was concerned about her second shot. She wants to know should she getting the second vaccine, because the person at the (institution name) office (where she receives her chemotherapy) believes the bell's palsy came from the COVID-19 vaccine. She was supposed to have chemotherapy that day (02Feb2021), but they wouldn't give it to her then, but she did have it done yesterday. Caller explains she has no NDC, Lot number or expiration date for the chemotherapy she receives. She isn't given any stuff with any numbers and she gets numerous medications. Patient's Medical History (including any illness at time of vaccination): Her eye was watering before the injection. She knows her eye was watering before she received the vaccine because as she was sitting waiting to receive her injection, she remembers wiping her eye and thinking to herself, ""I wish this eye would quit watering"". Caller states she had a fever blister, but she was not quite sure about when this appeared. She doesn't know if she had developed the fever blister before or the next day after receiving the vaccine, she was not quite sure. The any events were not required a visit to Emergency Room. She went to the Oncology Office for her chemotherapy appointment. No Prior Vaccinations (within 4 weeks). Caller had the MRI (magnetic resonance imaging) on 02Feb2021 showed she didn't have a stroke and no cancer of the brain. The patient underwent lab tests and procedures which included magnetic resonance imaging: negative on 02Feb2021 Negative for stroke and/or cancer. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected."" | | 733 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1048680-1 | Acute ischemic stroke on 02Jan2021; This is a spontaneous report from a contactable Healthcare Professional. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at single dose for COVID-19 immunisation at the age of 78-year-old. Medical history and concomitant medications were unknown. The patient was not pregnant at the time of vaccination. Patient had Acute ischemic stroke on 02Jan2021; the patient was hospitalized, and she was treated for the event. On 01Feb2021, nasal swab resulted negative. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was recovering from the event. Patient has not tested positive for COVID-19 since having the vaccine. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information there is no evidence or argument to suggest a causal relationship between the reported event of ischemic stroke and BNT162B2 administration. Event occurred prior to vaccination. | | 734 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1056640-1 | Lt parietal occlusion; DVT; Right paralysis; This is a spontaneous report from a contactable Nurse reporting for her husband. A 71-years-old male patient received the first dose of bnt162b2 (BNT162B2; Lot # EL 1284) vaccine , intramuscular in the left deltoid on 22Jan2021 17:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. Concomitant medication included apixaban (APIXABAN), acetylsalicylic acid (ASPIRIN) atorvastatin (ATORVASTATIN), cyanocobalamin (CYANOCOBALAMIN), metoprolol tartrate (METOPROLOL TARTRATE) , pantoprazole (PANTOPRAZOLE), sumatriptan (IMITREX [SUMATRIPTAN]), triazolam (TRIAZOLAM). The patient experienced DVT (deep vein thrombosis) on 26Jan2021 with outcome of not recovered , left parietal occlusion (ischaemic stroke) on 26Jan2021 05:30 with outcome of unknown , right paralysis on an unspecified date with outcome of unknown. The patient was hospitalized for DVT (deep vein thrombosis) and stroke from 26Jan2021 to 30Jan2021. The patient underwent lab tests and procedures including blood pressure diastolic: 84 mmhg on 30Jan2021 , blood pressure systolic: 141 mmhg on 30Jan2021 , body mass index: 26.4684 kg/m2 on 26Jan2021 , body temperature: 98.2 ªF on 30Jan2021, heart rate: 55 bpm on 30Jan2021 , magnetic resonance imaging: acute left parietal lacunar infarct, Lower extremity ultrasound: left popliteal vein DVT, oxygen saturation: 95 % on 30Jan2021 , respiratory rate: 18 br/min on 30Jan2021. The reporter considered the reported events to be possibly related to BNT162B2 vaccine. Follow up information has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate. | | 735 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1065920-1 | never woke up after arrival; Suffered with vascular dementia; Death cause: Covid/Tested positive to Covid 31Jan, tested due to increased lethargy; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient received the vaccine at nursing home/senior living facility. Medical history included dementia, hypertension, past strokes. The patient was exposed to asymptotic staff member on or prior to 25Jan2021. The patient had no known allergy. No COVID prior vaccination. Concomitant medication included lisinopril. No other vaccine was received in four weeks. The patient was tested positive to COVID on 31Jan2021, tested due to increased lethargy started from 26Jan2021. The patient suffered with vascular dementia. She was ambulatory up to 31Jan2021. The patient was sent to hospice that evening on 31Jan2021 to quarantine, never woke up after arrival. Palliative Care started 02Feb2021, the patient expired 12Feb2021. Cause of death was COVID. The patient did not receive treatment for events. The autopsy was not performed. The outcome of events ""never woke up, vascular dementia"" was unknown. Information on Lot /Batch Number has been requested.; Reported Cause(s) of Death: Death cause: Covid"" | | 736 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1068270-1 | Suffered a stroke 4 days later 06Feb2021; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 02Feb2021 at 14:45 (at the age of 71-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient suffered a stroke 4 days later 06Feb2021 after vaccination. The event resulted in an emergency room/department visit and hospitalization in Feb2021 for 3 days. Treatment for the event stroke included medication and therapy. The outcome of the event stroke was recovering. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. | | 737 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1076911-1 | passed away shortly after her vaccine; started dealing with signs that are common with a stroke; developed swelling in her arms; This is a spontaneous report from a contactable consumer report for grandmother. A 101-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EM9809) via an unspecified route of administration in left arm on 08Feb2021 04:30 AM at single dose for covid-19 immunisation. Medical history included elderly. No covid prior vaccination. No other vaccine in four weeks; No other medications in two weeks. On 12Feb2021 12:00 AM, patient passed away shortly after her vaccine. She started dealing with signs that are common with a stroke. Event considered Life threatening illness (immediate risk of death from the event). She also developed swelling in her arms. No treatment received, patient not recovered from stroke and swelling arm. The patient died on 12Feb2021. No covid tested post vaccination. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: passed away shortly after her vaccine | | 738 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1106591-1 | 4 days after I had the 1st shot I had an optic nerve stroke in my right eye with complete and permanent vision loss | | 739 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1123123-1 | Had stroke; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9269) via an unspecified route of administration, administered in Arm Right on 15Feb2021 (12:00) as SINGLE DOSE for covid-19 immunisation, at 70 years old. Medical history included Cad atrial fibrillation (atrial fibrillation), Cad atrial fibrillation (Coronary Artery Disease), CHF kidney disease (congestive heart failure), CHF kidney disease (kidney disorder) from unspecified dates. No other vaccines in four weeks. No COVID prior vaccination. Concomitant medications included verapamil; alprazolam (XANAX); allopurinol (ZYLOPRIM); furosemide (LASIX); potassium; and mirtazapine (REMERON), all taken for an unspecified indication, start and stop date were not reported. The patient previously took antihistamines and experienced allergies (Known allergies: Antihistamine). The patient experienced had stroke on 19Feb2021. The patient required emergency room visit and was hospitalized for had stroke for 4 days from 2021 to 2021. Treatment reported as unknown. The patient underwent lab tests and procedures which included investigation: SARS-CoV-2 test (Nasal Swab): negative on 19Feb2021. Event outcome was recovering. | | 740 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1125833-1 | seizure like symptoms; she was drooling; Incoherent; was making a bazooka sounding noise; arms and legs shot straight out; This is a spontaneous report from a contactable consumer reporting for their sister (patient). A 69-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 69-years-old, via an unspecified route of administration, administered in arm right on 24Feb2021 (lot number: EL1269, expiry date not reported) as single dose for covid-19 immunisation. Medical history included stroke from Sep2020 to an unknown date, cognitive impairment from having stroke, chorea movement of the mouth (she is on medication), blood pressure, cholesterol, anxiety, blood thinner, bones, mouth movements and tooth cleaning from an unknown date and unknown if ongoing. Concomitant medications included ongoing amlodipine at 2.5 mg, daily taken for blood pressure abnormal; ongoing rosuvastatin at 20 mg, daily (has been taking for years) taken for blood cholesterol abnormal; ongoing aspirin [acetylsalicylic acid] from Sep2020 at 81 mg, daily (was on a higher dose but was decreased); ongoing sertraline from Oct2020 at 25 mg, daily taken for anxiety; olanzapine from 20Jan2021 at 2.5 mg, unspecified date at 5 mg, 7 mg, and from 17Feb2021 and ongoing at 7.5 mg, daily taken for mouth movements; ongoing alendronate sodium at 70 mg, weekly (has been taking for years) taken for bone disorder; ongoing apixaban (ELIQUIS) from Sep2020 at 5 mg, daily taken for anticoagulant therapy. It was reported that the patient received the first dose of the Covid-19 vaccine on 24Feb2021. Four days later on 28Feb2021, she had seizure like symptoms. It was not a seizure but it looked like it. She is not sure if this is related. The doctors ruled it out. They said it would be immediate. This could be a coincidence. She is on medication for Chorea movement of the mouth. She was taken to the emergency room and she was admitted to the hospital. Her arm did not even hurt. She was incoherent for about an hour. Things seemed to calm when they gave her IV fluids. Her arms and legs were straight out until she went to the emergency room. She made a noise that sounded like a bazooka. It lasted for a little while. The gave her fluids and took her vital signs. Her arms and legs were no longer stuck out. She was calm when they laid her on the table in the emergency room. It was also reported that the patient was drooling. It was reported that they ran all kinds of tests, MRI, EKG, brain wave thing, unable to find any sign of seizure. Her arms and legs shot out and she sounded like an automatic gun, ""ah, ah,ah,ah, us"". She told them in the hospital, that she had the covid vaccine, and they said no, it was not that because it was to long after the vaccine. The patient was hospitalized for seizure like symptoms from 28Feb2021 to 03Mar2021. The patient underwent lab tests and procedures which included computerised tomogram: normal, electrocardiogram: normal both on 28Feb2021, magnetic resonance imaging: negative on 02Mar2021, scan brain: normal on 01Mar2021. Therapeutic measures were taken as a result of incoherent and was making a bazooka sounding noise which included IV fluids. The patient recovered from seizure like symptoms, was making a bazooka sounding noise, arms and legs shot straight out on 28Feb2021, from incoherent on 01Mar2021, while the outcome of drooling was unknown."" | | 741 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 4 days | 1127818-1 | Pt suffered an embolic stroke to left MCA on 3/16/2021, 4 days after his vaccine. He was also within 90 days of PCR confirmed COVID-19 infection (tested positive 1/5/2021 and was still positive on 3/16/2021). This is likely unrelated as patient had multiple risk factors for stroke, but felt it worth reporting as no association cannot be found if people don't report events like this. | | 742 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 5 days | 0972784-1 | STROKE SYMPTOMS 5 DAYS LATER. SEVERE HEADACHE, DIZZINESS , SLURRED SPEACH, TROUBLE REMEMBERING SOME WORDS, DIFFICULTY SIGNING NAME, HIGH bp WAS ADMINISTERED EMERGENCY CLOT BUSTING DRUG IV AND THEN TRANSFERRED TO NEUROLOGY HOSPITAL. SYMPTOMS OF SLURRED SPEECH, DISAPPEARED NEXT DAY, WRITING HAND RETURNED TO NORMAL RAPIDLY AFTER IV. SLIGHT HEADACHE REMAINED FOR A COUPLE OF DAYS | | 743 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 5 days | 0993606-1 | hallucinations; having stroke like symptoms; having intense headaches; felt exhausted; has pain in her arm; her vision affected/wavy lines throughout her eyes; numbness in her face, hands, and lips; This is a spontaneous report from contactable Nurse reporting for herself. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Patient age at time of vaccination was 65 years. The patient did not have reactions with other immunizations except a severe reaction with the measles, mumps, and rubella (MMR) vaccine when she was younger. She had seizures after receiving the MMR vaccine. The patient's concomitant medications were not reported. The patient mentioned she had a severe reaction. She described her adverse reaction by having intense headaches, having stroke-like symptoms in which she described as she cannot speak, having headaches, having numbness in her hands, face, and lips. She also felt exhausted. She also had some pain in her arm that she is not concerned about. She mentioned that she also has her vision affected, she couldn't drive, there were wavy lines all though her eyes. She started to have hallucinations such as seeing people that weren't there, seeing snow storms, and seeing things whipping throughout the wind. All the events started on 04Jan2021. She reported she was very sick in the hospital and is now getting well. However it was unknown if she was admitted to hospital (clarification pending). She wanted to know recommendations about the second shot of the COVID-19 vaccine because with her experience, she is not comfortable having the second shot of the COVID-19 vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 744 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 5 days | 1016785-1 | profound dizziness, work up for stroke plaque on arm | | 745 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 5 days | 1037842-1 | may have had a mini stroke; Bell's Palsy/developed facial drooping/her eye was drooping; fell; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (BNT162B2, Pfizer COVID-19 Vaccine; Batch/lot number: EL9262), via an unspecified route of administration injection to right upper arm on 22Jan2021 14:00 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing she was a fainter (She was a fainter, she just faints so she has a hard time getting shots. Pfizer COVID-19 Vaccine administered to her by nurse while she was in her car seat. She just asked the nurse to let her lay down in the car seat when injection was administered so that if she fainted she would not fall far; she was still getting the wash cloth on her head preparing when the Nurse had already finished administering the injection.); ongoing depressed sometimes (she was depressed sometimes, was stressed. She was the primary caregiver for her 96 year old mother. She had seen something about stress and COVID and shots and everything); ongoing Very tired (She was almost 80 years old so she was very tired often. She was the primary caregiver for her 96 year old mother. By the time she comes home at night around 21:30 she was just wiped.); Obesity (She was really overweight but she did not like the term obesity.); thyroid disorder; hypertension; Cataract and glaucoma in left eye; family history of ongoing facial paralysis (Dad had Bell's palsy that might have been 30 years ago. He died at age 87 years.); diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes). Concomitant medication included Levothyroxine at 100mcg taken once daily in the morning early before she eats with Start date unknown, but at least 10-15 years ago for Thyroid. Enalapril at 10mg taken once daily (Caller initially reported product name as Vasotec, but clarified it is not Vasotec, it is drop for eye cataract and glaucoma) for High blood pressure. Brimonidine with Strength unknown, 1 drop in both eyes twice daily, started maybe 1 year ago. Specified cataract and glaucoma in left eye; but drop was administered to both eyes; and left eye was eye affected by Bell's palsy for Cataract and glaucoma in left eye. The patient previously took codeine and experienced allergy with onset maybe about 50 years ago, she was not sure; occurred during dental procedure; had bad headaches but no lasting effects so they assumed allergy to codeine; she did not know if still has allergy but says she does if asked. The patient experienced bell's palsy/developed facial drooping/her eye was drooping on 29Jan2021 with outcome of recovering, may have had a mini stroke on an unspecified date with outcome of unknown , fell on 27Jan2021 with outcome of unknown (reported date of end of reaction was 27Jan2021), she could not blink that eye on 29Jan2021 with outcome of not recovered. Five days later she fell and developed facial drooping. HCP suggested she may have had a mini stroke causing facial drooping and the fall. She went to the ER on 29Jan2021 and the ER believed it was Bell's Palsy. She was still experiencing facial symptoms but they are improving. This consumer was administered her first dose if Pfizer COVID-19 Vaccine 22Jan2021. She reported having fell 27Jan2021. She was diagnosed with Bell's palsy in 29Jan2021 after having been seen in the emergency room. She is supposed to have the second dose/booster of Pfizer COVID-19 Vaccine on 12Feb2021. She called to ask if she should or should not still get the second dose as scheduled; and if Bell's palsy could be a reaction to the Pfizer COVID-19 Vaccine. The emergency room staff did not know how she got Bell's palsy, but knew she had the Pfizer COIVD-19 Vaccine and were kind of assuming the Bell's palsy was a reaction to the vaccine. She dis not have Bell's palsy bad. The emergency room staff thought at first she had a stroke before diagnosing her with Bell's palsy. On Wednesday, 27Jan2021 she had a friend named (Name withheld) who came over for tea. Patient has an oriental rug, and around 15:00 patient fell face first on oriental rug. She was just fine after the fall initially. She wonders if her having fell has anything to do with the Bell's palsy. She thinks it was the night of 27Jan2021 or 28Jan2021 when she asked her son if her face looked funny, did she look ok, because her face felt a little funny. She was looking in the mirror and her smile was looking crooked, and her eye looked like it was drooping. When she got up Friday, 29Jan2021 she could see her eye was drooping, and she could not blink that eye. She called her Ophthalmologist who saw her the afternoon of 29Jan2021 around 13:30-13:55. The Ophthalmologist said yeah something is going on with that eye. Her friend called his friend who is a Pediatric Neurologist that advised her to go to the emergency room. She was seen in the emergency room of (Hospital name withheld) around 17:00 on 29Jan2021. She was not admitted to the hospital at that time; but was evaluated and treated. She Bell's palsy outcome: she is doing so much better. She still has a hard time blinking her left eye, she still cannot blink her bad eye: left eye, without also closing her good eye: right eye. She is not drooling, she can drink without drooling. Her smile is still just a little crooked. She was given 2 prescriptions in the emergency room which were Prednisone and Valtrex. On 29Jan2021 in the emergency room they did tests including testing her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure. There were no notable or abnormal results of any of those tests. They wanted her to go see her doctor last week but she did not have a chance to do so. She has an appointment with her primary doctor on Monday coming up. She has not yet seen her primary doctor about this. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. The event Bell's palsy require a visit to Emergency Room, no to Physician Office. The patient was not hospitalized. No Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient underwent lab tests which included her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure, all with no notable or abnormal results of any of those tests on 29Jan2021. | | 746 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 5 days | 1057071-1 | On the morning of 2/11/2021, I woke up with SUDDEN HEARING LOSS IN MY RIGHT EAR, was dizzy, had balance issues, and was nauseous. I went to the ER. I had a CT in the ER which also was negative for stroke. My hearing loss has NOT returned, and I still have some balance issues as well for which I am receiving PT. | | 747 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 5 days | 1067982-1 | slight fatigue the next day; some left arm soreness; This is a spontaneous report from a contactable consumer (reported for himself). A 79-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL 9261, expiry date not reported), via an unspecified route of administration on 21Jan2021 at a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure, a-fib, small stroke 5 years ago and some weakness from that (stroke). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included atenolol, amlodipine, warfarin, and lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. On 26Jan2021, patient experienced slight fatigue the next day (as reported) and some left arm soreness. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events fatigue and left arm soreness was recovered in Jan2021. | | 748 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 5 days | 1104155-1 | Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and it felt heavy and it just dropped. She then started to raise the arm and she was not able to do it. She then suddenly lost sensation in her left arm. She then could not control it, would raise when it wanted to but was not able to feel it or control it. (had the feeling that it was not connected to her body and it was just floating around). Then started having involuntary muscle spasms in her mid torso region. The same thing then happened again and the muscle spasms were more intense and she waited around and lasted for minutes. She never lost consciousness, but then it happened again and was spreading on her left side. It then encompassed from her hip up to her shoulder. The involuntary muscle spasms were moving from the side toward her chest to where she felt it would impact her breathing. She then went to the ER and they started doing testing, and she had more spasms, and then started having double vision. In talking with the doctor about all of this she had a CVA with complex partial epilepsy with recurrent seizures and that the double vision was related to the infarct in her brain and that the stroke triggered the seizure that she had. She did not lose any memory, loss of consciousness, no weakness or loss of sensation. These episodes only lasted minutes and a refractory time of minutes and when she got to the ER she the other episode when they were trying to test her. They were not able to do the EKG or EEG due to the involuntary movements and these resolved. She is now completely recovered other than the fatigue with no residual. She saw a neurologist on 2/24/21 who felt like that she had a stroke and put her on Keppra and is going to FU in 3 months at IU. It was ruled out that there was no relationship of her transplant to this reaction. She is now on Keppra, Atorvastatin for the swelling in her brain, and also put on aspirin 81 mg. Her blood tests that were done were all drawn and were all within normal limits except for kidney function, but is only a minor #'s for her secondary to the transplant. She then had some titers drawn for CMV and that was also negative. Then she had a COVID test that was negative. Then she had spinal tap that came back normal results. | | 749 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 5 days | 1105963-1 | I was hospitalized for loss of vision to left eye. It was diagnosed as a stroke to the eye. | | 750 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 5 days | 1109309-1 | After vaccine was administered patient was seemingly fine until a loss of consciousness/mini stroke on Jan 16 (5 days after vaccine) causing a fall and massive stroke on Jan 22 (11 days after vaccine) that left patient unresponsive and on life support until family decided to stop services and begin hospice care with no fluids or food until death | | 751 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 5 days | 1113869-1 | Cerebrovascular Hemorrhage (Stroke), left occipital zone; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK4176) at single dose, in the left arm, on 13Jan2021, at 15:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Relevant medical history included Sulfa allergy (Sulfonamide allergy) and drug hypersensitivity due to pethidine hydrochloride (DEMEROL) was reported as past drug event. On 03Feb2021, received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN5318) at single dose, in the left arm, for COVID-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID) and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). On 18Jan2021, at 12:30 PM, the patient experienced cerebrovascular hemorrhage (stroke), left occipital zone. Hospitalization and treatment (stroke Center ICU care) were required (duration of hospitalization 4 days). Clinical outcome of the adverse event was recovering at time of this report. Post the vaccination, the patient has been tested for COVID-19 (Nasal Swab) on 18Jan2021 and resulted negative. | | 752 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 5 days | 1120870-1 | Stroke - small area of acute ischemia along right anterior margin of the pontomedullary junction | | 753 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 5 days | 1125094-1 | Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; Extreme Bloating in stomach, upper chest, neck and face. Enough discomfort to undergo Upper GI; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in the right arm on 15Feb2021 as single dose for covid-19 immunization at age 73 years. Medical history included stroke and heart disease from an unknown date. There were unspecified concomitant medications taken within two weeks. The patient previously took BNT162B2 (Lot number EL9261) on 27Jan2021 as the first dose for covid-19 immunization at 73 years old, xylometazoline hydrochloride (SUDAFED) and experienced allergy. The patient experienced extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI on 20Feb2021, at 12:00; the event was serious as it involved hospitalization for three days. The patient underwent lab tests and procedures on an unspecified date which included computerised tomogram (CT) scan with contrast and endoscopy, both with unknown results. Details were as follows: The patient had extreme bloating in stomach, upper chest, neck and face. The events was described as enough discomfort to undergo upper GI, CT Scan with Contrast. The patient was hospitalized for three days, and had an outpatient endoscopy. No Covid was noted prior to vaccination, and the patient has not been tested post vaccination. It was unknown if treatments were given for the event. The outcome of extreme bloating in stomach, upper chest, neck and face. enough discomfort to undergo upper GI was not recovered. | | 754 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 6 days | 1007315-1 | Excessively tired during the week after the first vaccine. One week after an undiagnosed episodic atrial fibrillation was discovered when treating a stroke. Causation not researched. | | 755 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 6 days | 1056610-1 | Nauseated; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 20Jan2021 01:30 at single dose for covid-19 immunization. Medical history included heart problem, she is a pump diabetic user/diabetes, mini stroke, Heart attack. The Family Medical History included heart problems and diabetes. There were no concomitant medications. Patient took the Pfizer COVID vaccine. She was reading the side effects and was wondering if she would have side effects this long after having the shot. She woke up today (26Jan2021) feeling nauseated and started diarrhea this morning. This is day 6 after the shot. No treatment. The outcome of the events was recovering. Information on the lot/batch number has been requested. | | 756 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 6 days | 1059623-1 | Possible Stroke per Medical examiner but Reported symptoms after covid vaccine 2/11 therefore being considered poss Covid vaccine related also. No hospitalization prior to death. (Symptoms reported to office 2/17) Fatigue, decreased appetite- | | 757 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 6 days | 1099335-1 | Stroke (ischemic - isolated) occurred 6 days after vaccine administration | | 758 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 6 days | 1110563-1 | Sustained a hemorrhagic stroke in the right basal ganglia on 3/10/21 requiring hospitalization | | 759 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 6 days | 1174035-1 | Lightheaded; almost fainted; dizzy; dizziness; Almost passed out; Very light headache; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9263), via an unspecified route of administration in left arm (shoulder), on 26Jan2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history included blood pressure, acid reflux, and multivitamin. The patient's concomitant medications included amlodipine for blood pressure, esomeprazole for acid reflux, and ascorbic acid/ biotin/ boron/ calcium/ calcium pantothenate/ chloride/ chromium/ colecalciferol/ copper/ cyanocobalamin/ folic acid/ iodine/ lycopene/ magnesium/ manganese/ molybdenum/ nickel/ nicotinamide/ phosphorus/ phytomenadione/ potassium/ pyridoxine hydrochloride/ retinol acetate/ riboflavin/ selenium/ silicon dioxide/ sodium metavanadate/ thiamine mononitrate/ tocopheryl acetate/ xantofyl/ zinc (CENTRUM SILVER ADULTS 50+) as multivitamin, all were ongoing; omeprazole for acid reflux; and an unspecified multivitamin. The patient really had no issues going on prior to onset of these events. The patient has been administered both first and second doses of Pfizer-BioNTech COVID-19 vaccines. The patient had been having some strange things that he didn't know if its COVID-19 shot related but they're symptoms he never had before. About 8 to 11 days after first dose of the vaccine (Feb2021; maybe 09Feb2021 or 10Feb2021), the patient had a very, very lightheaded episode where he almost passed out or almost fainted. The patient clarified he thinks one event was like 8 days and the other was like 10 days after the vaccine doses were administered, but is not sure, so left it as about 8 to 11 days. Also, in Feb2021, the patient had almost a very light headache where he almost fainted. The patient went to the emergency room in Feb2021 and was admitted to hospital from about 13:00 that day, overnight and discharged about 17:00 to 18:00 the following day. The patient spent the night in hospital, they sent him the next day. While in hospital (Feb2021), the patient had electrocardiograms (EKGs) of his head (as reported), magnetic resonance imaging (MRIs) of his head, computed tomography (CTs; CT scan with contrast) of his head, and echocardiograms of his heart (microcardiogram). All of those tests came back normal (okay), nothing abnormal on results. They were relating this to a stroke-like symptom; however, the results were normal, also his blood test results were fine. The patient had blood work done the first time he was in the emergency room when he was admitted to the hospital in Feb2021; they took his blood 3 to 4 times while he was there overnight and blood work results all came back normal. The patient was not sure what they were testing for, but thinks they were looking for stroke type things because the event almost made him pass out. They did not draw more blood the second emergency room visit. Because of the first episode, the patient then went to his family doctor and the doctor ordered some other testing done. The patient was scheduled to get a nuclear stress test and an exercise stress test (stress test of heart), his results on 10Mar2021 came back normal (not performed until after the second reported event following second dose of Pfizer-BioNTech COVID-19 Vaccine). The patient believed that the results of those tests both came back good, family doctor emailed him the results which were normal. The patient was continuing to have some lightheaded episodes or symptoms just about daily but nothing really; continued to have symptoms which was not normal for him. Sometimes, they last for 30 minutes or more, multiple times a day. Sometimes, the patient had a good day, but he had those lightheaded episodes and he never had it before he got the shot. As therapeutic measures in the hospital, the emergency room gave the patient something for dizziness when he was there, but he was no longer taking it. Currently, the patient was really taking nothing. The patient had also gone to the ear, nose, and throat (ENT) doctor where he had a balance test or a videonystagmography (VNG) test done on 17Mar2021. The patient will get results of balance test on Wednesday (24Mar2021). Every year (unspecified), the patient goes and get his yearly test in which they had his blood work done and this and his glucose levels were always good, cholesterol level was always good. All the patient's other tests come back as normal on an unspecified date. The patient had never had these symptoms before, he hasn't changed his medications or habits and it's odd that this happened 9 to 10 days after both doses of the vaccine. The patient would like to know if this has been reported before as a side effect related to the vaccine. The patient was not sure if the events are Pfizer-BioNTech COVID-19 Vaccine related, but they never happened to him before those doses were administered. He does not know if this is vaccine related or just coincidence that they popped up at the same time as the vaccine doses. Also, he does not know if events could be age related, the medical community can't figure it out so he is trying to get information on if events could be related to the vaccines. So the patient doesn't know if anybody else is reporting this but he had 2 sorts of severe episodes both of them around days after each shot and he was continuing to have lightheaded episodes but not severe as those 2 but he had lightheaded (dizzy) episodes daily, since the COVID-19 vaccine. But they didn't know what brought these episodes on, other than timing wise it was during the COVID-19 shot. And he never had anything like that, and he was not blaming it on the COVID-10 shot. That was the only thing changed in his lifestyle. There might be a possibility, because that's the only thing changed, his medication has not changed, and diet doesn't change. Nothing has changed other than the patient got COVID-19 shots. The patient wanted to report it, so the company had a report file and other people reporting it. The patient wanted to know if the company was having any other report or something like this so that he would know if it might be related to the shot. The patient had not recovered from ""Lightheaded; almost fainted; dizzy; dizziness"". The outcome of the other events was unknown."" | | 760 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 6 days | 1211001-1 | Patient is deceased. Had a blood clot travel to her brain and causes an un recoverable stroke | | 761 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 7 days | 0945247-1 | Has underlying dementia and often with difficulty eating. 1 week after immunization she developed a stroke with left sided weakness and difficulty swallowing. Comfort measures instituted. Not sure if this is related to the vaccine, but thought I should report | | 762 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 7 days | 0994107-1 | On 1/26/2021, resident had an elevated blood pressure of 183/102 and he was cold and clammy. Resident sent to ER via 911. He was sent home that same day. On 1/27/2021, resident found sitting in his apartment with a facial droop, slightly slurred speech and left sided weakness. Resident had also fallen the previous night and on the morning of 1/27/2021. Resident transported to the ER for evaluation and treatment and was admitted with diagnosis of TIA; rule out stroke. | | 763 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 7 days | 1038670-1 | The patient received the vaccine on 1/27/21. He had a therapeutic INR on 1/25/21 and also on 2/15/21. On 2/3/21 he developed expressive aphasia with naming difficulties and generalized weakness. CT brain on 2/15/21 showed a left hemisphere subcortical infarction. He has been on warfarin for atrial fibrillation for 9 years without any strokes prior to this. | | 764 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 7 days | 1068268-1 | stroke; This is a spontaneous report from a contactable Pharmacist, the patient's daughter-in-law. An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 (at the age of 84-years-old) as a single dose for COVID-19 vaccination. Medical history included stroke and atrial fibrillation from unknown dates. Concomitant medications were not reported. On 12Feb2021, the patient experienced a stroke. The clinical outcome of the event stoke was unknown. No additional information was reported. Information about lot/ batch number has been requested. | | 765 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 7 days | 1073327-1 | TIA stroke like sysmptom went to ER hospitalized Goa a day in hospital | | 766 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 7 days | 1093887-1 | On 3/8/2021 the patient presented to the ED with stroke-like symptoms. Reason for admission: suspected TIA. Acute CVA-has been ruled out. Incidental finding CT head 9 x 5 mm lesion possibly meningioma, but scans of CTA head and neck no lesion, MRI of the brain shows no lesions. | | 767 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 8 days | 1049091-1 | Raised red bumps (size of quarter) on back of forearms. Only one or two bumps, very itchy. Started on left arm, moved to right arm. Small round raised bumps on lower, inside of left forearm (about 3-4.) Then gastoinstestinal symptoms with diarrhea (second bout more severe.) Subtle red coloration on trunk that when stroked with finders turned white. Trunk itching, genitals itching. Hot burning hands, feeling of unease. The symptoms have lasted for days. Injected on 2/5 still having symptoms on 2/23. Taking Benadryl. | | 768 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 8 days | 1111791-1 | My father developed a severe headache on the evening of 3/15, followed by left sided facial paralysis, facial droop approximately 7 days after receiving the first dose of the COVID-19 vaccine at a CVS pharmacy. He was admitted to hospital on 3/16 for acute stroke workup given his VERY CLEAR Facial droop, slurred speech. His CT Head was negative for acute bleed and his MRI Brain was negative for any acute stroke. He was seen by Neurologist while inpatient and was determined to have Bell Palsy and NOT an acute or subacute stroke. Prior to taking the vaccine, he had NO facial droop. After taking the vaccine, he received no new medications nor did he travel to any other places. Additionally, he lives in a city and has not been hiking in the woods. | | 769 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 9 days | 0986115-1 | Suffered a massive MCA stroke; This is a spontaneous report from a Contactable Nurse. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), intramuscularly in left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history included covid prior vaccination. Known allergies: None. The patient's concomitant medications were not reported. The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly in right arm on 21Dec2020 03:00 PM at single dose for COVID-19 immunization. The patient was not pregnant while receiving vaccine. Facility type vaccine: Hospital. If other vaccine in four weeks: No. Other medications in two weeks: No. The patient suffered a massive MCA (Middle cerebral artery) stroke on 21Jan2021 08:00 after getting second covid vaccine with outcome of not recovered. No history of hypertension, elevated cholesterol or medical issues. No medication being taken. Daily BP (Blood pressure) reading normal. Covid test post vaccination: Nasal Swab-PCR on 22Jan2021 with result negative. If treatment for AE: Unknown. The event was resulted in: Emergency room/department or urgent care, Hospitalization (Number of days hospitalization: 4), Life threatening illness (immediate risk of death from the event), Disability or permanent damage.; Sender's Comments: The event middle cerebral artery stroke appeared 8 days after administration BNT162B2. The Company considers that the event is less likely related to suspect BNT162B2 injection given the weak time association. The status (bleeding or infarction) and cause of the stroke would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 770 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 9 days | 1031786-1 | presented to ED with stroke like symptoms, slurred speech, weakness, hypotension and tachycardia. Stroke team activated and no hemorrhage noted on CT. Treated with alteplase after consult with neurology and then transferred to hospital for further evaluation and treatment. | | 771 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 9 days | 1093348-1 | Platelet count low; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El3247) at single dose, in the right arm, on 08Feb2021 at 15:45, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included HIV disease; cancer (6 years before this report) and small stroke on an unspecified date, in 2019. No known allergies were reported. The patient previously, on 18Jan2021, at 02:00 PM, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El8982) at single dose, in the left arm, for COVID-19 immunisation. Concomitant medications included metoprolol tartrate, rosuvastatin, gabapentin and cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide fumarate (SYMTUZA). On 17Feb2021, the patient had platelet count low and hospitalization was required (duration of hospitalization: 9 days). Normal range of 157000 platelets from blood work completed in Oct2020 that went to a dangerous level of 3800 confirmed on 17Feb2021. Treatment was received (platelets, IVIG infusions and prednisone). Post the vaccination, the patient has been tested for COVID-19 (Nasal Swab) on 23Feb2021 and resulted negative. The adverse event was assessed as serious (hospitalization and life-threatening illness, immediate risk of death from the event). The patient did not recover from the adverse event at time of this report. | | 772 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 9 days | 1142047-1 | Patient received the injection on May 2nd. Following the injection, we noticed an increased weakness and general achiness. On the 8th she was so weak that we purchased a gait belt to assist her. We were not super concerned as we were expecting the second shot to cause body aches or flu like symptoms based on what we had heard from others who had received both vaccine shots. She continued to be unsteady and we found that she has a mild UTI which we had begun treating with prescribed antibiotics. Late afternoon on the 11th, mother suffered a major stroke. we did not take her to the hospital because we had already been told that they would not be able to do anything at her age should she suffer a stroke. On the 12th I called the doctors office and asked for them to send Hospice to the house as we could tell that she was dying. Mother died on the 13th. Just a week prior to her death I had spoken with Dr. and we had discussed how that she was declining in health but that she was not even close to needing Hospice, yet she is dead a week later. Less than 2 weeks after getting her second Covid Shot. | | 773 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 0922673-1 | I woke up with tingling in my right hand and arm, my right side, and down my right leg. I went to the ER at Hospital, and was confirmed to have had a stroke in my left thalmus. | | 774 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 0929175-1 | occipital neuralgia; left-side Bells Palsy; bilateral headache; This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration at right deltoid on 21Dec2020 19:00 at single dose for covid-19 immunization. The patient's medical history included low high density lipoprotein (HDL). There were no concomitant medications. The patient previously took influenza vaccine (longer than 4 weeks ago, and he did not have any reaction), pravastatin for low HDL. Reported 2 days ago (02Jan2021) he developed a bilateral headache. He stated he was asymptomatic until then. He said he now has Bells Palsy on 02Jan2021, clarified he has left-side Bells Palsy. He said it is unknown to him if the bilateral headache and Bells Palsy are related to taking the COVID-19 Vaccine. He stated he started wearing a N95 mask for the past 2 weeks. He said the N95 mask is very tight on the back of his head. He said he believes he is experiencing occipital neuralgia caused by wearing the N95 mask. He said studies show that the N95 mask can cause Bells Palsy, and the N95 mask maybe a confounding factor. He stated he doesn't have any further information on the N95 mask he was using. Initially he had a severe headache and administered to himself a sphenopalatine block of Lidocaine 1% in his nose. He stated being an ER doctor, he knows how to administer the sphenopalatine block to a patient. He went to the ER on 03Jan2021 to make sure he did not have a tumor or a stroke. He said the hospital performed a CT of his head, a MRA, labs, and a COVID-19 test (clarified as a PCR COVID-19 test) with a full viral count. He said all the tests were negative. His wife noticed his Bells Palsy yesterday, 03Jan2021. He said he thinks the Bells Palsy started the night before on 02Jan2021. He said he noticed on the night of 02Jan2021 when he was brushing his teeth, he hit a tooth on that side (clarified as left side) of his mouth with his tooth brush. He hasn't started taking steroids yet, but will be starting steroids real soon. He clarified his doctor prescribed a Medrol dose pack and Valtrex for the Bells Palsy. He stated he has not started the Medrol dose pack and Valtrex. He is ordering Lidocaine 1% viscous for himself, so he can do an internasal sphenopalatine block on himself. He does not know if the bilateral headache and Bells Palsy were caused by taking the COVID-19 Vaccine. The events required Emergency Room visit. The outcome of the event Bell's palsy was not recovered, Headache was recovering, Occipital neuralgia was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162b2 and the onset of Bell's palsy/Headache might not be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 775 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 0960922-1 | On 01/19/2021 patient was observed to have a slight right facial droop and slight slurred speech, hand grips were equal, pupils equal and reactive, she had difficulty moving her right leg. 911 activated due to possible CVA, admitted to the hospital , a MRI was done to rule out a stroke. Readmitted 1/20/21 with the diagnosis of probable Bell's Palsey. The patient is stable medically at this time. Facial droop remains at this time, she is able to swallow without difficulty. | | 776 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1000709-1 | Patient with past medical history of CAD, CKD, sCHF, LGL Leukemia admitted to Hospital on 1/19 with pleural effusion. Pt expired on 2/1/2021. Hs of essential HTN, complete heart block, T2Diabetes,thyroid issues, stroke, papillary CA of thyroid, dyslipidemia, anemia, hypercalcemia, pulmonary nodule, hypoparathyroidism, pacemaker, bilat carotid stenosis, afib, pleural effusion, pancytopenia, cardiomyopathy, severe aortic stenosis, sick sinus syndrome, Dressler syndrome, empyema, ESRD | | 777 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1011317-1 | 12 days after first vaccination: Dizziness; high blood pressure; nearly passed out; right arm numbness; inability to grip or pick up items with fingers; feeling of ""lopsidedness""; unsteady on feet, requiring assistance to walk. Primary care physician recommended ER visit where possible stroke was diagnosed. Hospital MRI confirmed: "" Left acute arterial ischemic stroke, MCA (Middle cerebral artery)"" . Spent 2 days in hospital with high blood pressure, dizziness. Residual right finger numbness upon release."" | | 778 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1014658-1 | Left MCA stroke, is currently in the CCU | | 779 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1016111-1 | her arm was sore but no other adverse reactions until Saturday, Feburary 6th 2021 she had stroke between 4 and 6pm. She died within 6 to 7 hours later. | | 780 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1031821-1 | Presented to ED with altered mental status. He became fatigued and lethargic with a brief period of unresponsiveness. Could not speak and had a gaze to his left. Could not carry on conversation or answer questions appropriately. Stroke team activated and CT completed. CT negative for bleed. Neurology ordered Alteplase to be administered. Patient then transferred for further evaluation and treatment. Patient had left MCA occlusion with TICI IIb achieved. Admitted to neurology stroke service in ICU following procedure. Started on aspirin with plavix. Rehab referral. | | 781 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1040770-1 | 1st vaccine 2/6/21; developed altered speech, drooling, nausea, vomiting 2/17/21; seen at ED 2/18/21 and admitted to hospital for stroke symptoms | | 782 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1044760-1 | 2 weeks after vaccination (2/20/2021) I lost movement of right side of mouth and right eye. Went to ER to check for possible stroke. | | 783 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1056657-1 | 10 days after 1st dose patient suffers ischemic stroke 4 days later the patient suffered a seizure; 10 days after 1st dose patient suffers ischemic stroke 4 days later the patient suffered a seizure; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 23Jan2021 at 08:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included Parkinson's disease, dementia, Post-traumatic stress disorder, high blood pressure and high cholesterol. Concomitant medication were not reported. It was mentioned other vaccine on 28Jan2021, but no further information provided. On 02Feb2021 at 12:00 am, 10 days after 1st dose of BNT162B2 patient experienced ischemic stroke and 4 days later the patient suffered a seizure. The events resulted in 6 days of hospitalization. At the time of the reporting the patient was recovering from events. Information about lot/ batch number has been requested | | 784 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1057266-1 | Bell's Palsy diagnosis. Following 2nd administration of Pfizer COVID vaccine, 97 year old male found on the floor by housekeeping. Sent to ER due to cuts and bruises. MRI ruled out Stroke. Patient presented with a droopy eye & mouth on one side of face. Complained of ear pain on the same side. Patient also tested positive for COVID without any presenting symptoms via PCR test. Patient's will to live has decreased. | | 785 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1063461-1 | Episodes (seizure-like appearance), left arm and leg muscle tension/contraction (clutching of hand, raising of leg), leftward face contortion, extreme pain along entire left side. Periodicity: many events some days (at least 11 events on one day), some days (even a few in a row) no events. Examination for stroke and heart attack were negative. Initial diagnosis of faciobrachial dystonia, followed by negative laboratory blood-test confirmation of diagnosis. No current diagnosis. Several rounds of treatment by IV steroid and oral steroid. | | 786 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1067420-1 | Second dose of Covid vaccine given on 2/7/21. Administered at central location. Taken to hospital for possible stroke like symptoms with drooping to right eye and mouth, difficulty swallowing, and feeling odd. Admitted and treated from 2/18/21 thru 2/22/21. | | 787 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1072223-1 | Site: Pain at Injection Site-Mild, Systemic: Stroke-Severe | | 788 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1103510-1 | Patient had a stroke about two weeks after the last dose was given. | | 789 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1105307-1 | Patient reported have a slight left sided mouth droop on 3/8/2021- went to ER states EKG, CXR, and CT of head all negative. Kept overnight and had MRI 3/9/2021 in AM revealed ""mini stroke"" TIA per neurology. She was discharged with Plavix and Lipitor. Has follow up appointment with neurologist 4/8/2021 and cardiologist 4/1/2021. Patient states she was on Amiodarone and Bystolic prior to having this TIA. Patient is scheduled for second dose of vaccine 3/19/2021 and wants to receive it. She is cleared to receive from our stand point. Please reach out via email or phone if you guys disagree."" | | 790 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1111554-1 | Multiple strokes resulting from blood clots starting 10 days past 2nd shot. Fuzzy headed with headache prior to strokes. | | 791 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 10-14 days | 1179804-1 | Stroke, pulmonary embolism | | 792 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1024013-1 | Had a stroke, blood clot removed from brain | | 793 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1035546-1 | Stroke; This is a spontaneous report from a contactable consumer. A 94-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 16Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing hypertension (took medication). Patient did not have COVID-19 prior to vaccination. Concomitant included unspecified medication for hypertension. The patient experienced stroke on 31Jan2021. The patient was brought to the emergency room and hospitalized due to the event on 31Jan2021. No therapeutic measures were taken as a result of the event. The patient underwent lab tests and procedures which included COVID-19 virus test: negative in Feb2021 (a week before report); investigation: brain bleed and discovered she had a stroke (on unknown date in 2021). The patient died on 03Feb2021 due to stroke and old age. An autopsy was not performed. Patient's family did not attribute her death to the vaccine at all. The information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: stroke; Old age | | 794 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1049684-1 | DX: CVA History The patient is a 92 y.o. female with a past medical history notable for History of CVA, history of arthritis, history of COPD, history of DVT, history of reflux, history of hypertension, history of hyperthyroidism, recent GI bleed. The patient presents for evaluation of worsening weakness at skilled care facility. Patient had history of stroke. Patient was assessed there was found of have another stroke. Patient's other care and therapies were reviewed. Patient's blood thinners recently stopped within the last 3 months due to GI bleed requiring multiple transfusions. Patient has been slow to recover. Patient has struggled with intake and weight loss. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. | | 795 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1051000-1 | fall; bruised rib; bruised hip; This is a spontaneous report from a contactable consumer (reporting for his father). An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date: 30Apr2021), via an unspecified route of administration into the left arm on 12Jan2021 at a single dose for COVID-19 immunisation (COVID prevention). The patient's medical history included Alzheimer's disease and stroke. There were no concomitant medications. The reporter was calling regarding his father who was an 87-year-old combat veteran. The reporter stated that the patient received the first dose of the Pfizer COVID Vaccine on 12Jan2021. The patient was scheduled for his second dose on 02Feb2021, but they had to cancel that appointment because the patient was in the hospital from a fall he had on 29Jan2021 where he bruised his hip and bruised his rib. The patient was hospitalized from 30Jan2021 and was released from the hospital on 05Feb2021. The reporter stated that the clinic said they are not able to make any more appointments right now. The reporter was wondering if there were consequences of, or a danger in, getting the second dose outside of the recommended timeframe. The patient is now on a waiting list to get the second dose and he would like to know how far past the recommended 21 days can he go and still have the vaccine be effective. The patient received no other vaccines on the same day as the COVID vaccine. The patient has had an MRI before where it was indicated that there were some spots from a past stroke. The reporter stated that no paralysis has been identified. The outcome of the events was unknown. | | 796 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1055341-1 | Sudden death two weeks after first dose of vaccine was administered. No previous symptoms or signs. Family opted not to do an autopsy so cause of death (stroke or heart attack) not known. | | 797 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1065107-1 | Blood pressure feels really high; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 16Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 virus in the past year (2020) from which her husband died last year (2020), receiving occupation therapy (OT) at home, and stroke (in the past). The patient's concomitant medications were not reported. The patient received her first Pfizer COVID-19 vaccine dose on 16Jan2021 and is scheduled to receive her next COVID-19 vaccine booster on 06Feb2021. The last time the patient had her COVID-19 virus antibody blood work was on 11Jan2021, and her COVID-19 virus antibodies were down to 1.9 from 8 (on an unspecified date). The patient's COVID-19 virus antibodies have been progressively going down since she was first being tested for them. The patient received a call today that her occupational therapist tested positive for the COVID-19 virus. Both her occupational therapist and she were wearing masks when working together. The patient received the call today because she was exposed to the occupational therapist. The patient asked if she can still take the COVID-19 vaccine booster that she is scheduled for on Saturday (06Feb2021). The patient really wanted to get the COVID-19 vaccine booster on 06Feb2021. The patient was going to be speaking with a trained healthcare professional when she is transferred to Pfizer medical information. Anyone the patient has spoken to about getting her second COVID-19 vaccine has not been willing to answer her questions. The patient's blood pressure feels really high now (02Feb2021), and she has had a stroke in the past. The outcome of the event was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts. | | 798 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1066209-1 | [COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed. | | 799 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1070759-1 | Something like a mini stroke occur; some kind of injury to his neck; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored program Covax US Support. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9263), via an unknown route of administration on 27Jan2021 (at the age of 68-years-old) as a single dose for Covid-19 immunization. Medical history included a heart patient prior to the vaccine for which he takes heart medications from an unknown date. The patient's concomitant medications were reported as a lot of medications and heart medications for which he has been taking for years (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Feb2021 at 16:00, the patient experienced something like a mini stroke; and he had some kind of injury to his neck from an unknown date. The patient was hospitalized due to heart problems describes as mini stroke on 15Feb2021. The patient underwent lots of test (unspecified) on an unknown date with unknown results. The clinical outcome of the event mini stroke and neck injury was unknown. The patient was still hospitalized. | | 800 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1093337-1 | was in so much pain she was crying; Right ankle and foot was swollen and shiny/wrist was swollen and shiny/knee was swollen and shiny; knee was shiny with a lump she did not have before; arm, hand was swollen and shiny/foot was swollen; right elbow is messed up/its swollen and stiff; right elbow is messed up/its swollen and stiff; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), first dose on 28Jan2021 at 12:30 then second dose at 18Feb2021 at 11:25, both via an unspecified route of administration at a single dose on left arm for COVID-19 immunisation. Medical history included diabetes mellitus (diagnosed 40 years ago) and a heart condition (had 5 stents, angioplasty, open heart surgery, clarified as triple bypass, in 98, 7 heart caths- 2 of them in one day, a stroke and a heart attack) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the vaccine, the second one on 18Feb2021, last Thursday. She was in the hospital yesterday. On 21Feb2021, the patient experienced her right ankle and foot was swollen and shiny, her knee was swollen and shiny and knee was shiny with a lump she did not have before, arm, hand and wrist were swollen and shiny and her shoulder, and her right elbow was messed up. The doctor is the current county health advisor, he said to report all these things. On 21Feb2021, the patient was in so much pain she was crying. She went to the emergency room because it hurt so bad and then was admitted and kept overnight. The patient was put on prednisone to help with swelling. The patient's right elbow being messed up is improved and persisting, its swollen and stiff. The outcome of the events knee was shiny with a lump she did not have before and pain was recovering, right elbow messed up was not recovered, while of the rest was unknown. Information on the lot/ batch number has been requested. | | 801 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1104238-1 | Client was scheduled to get second dose of Pfizer Covid-19 on 02/19/21. Received call from family stating that client suffered a stroke on 02/18/21 and was admitted to hospital. | | 802 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1106603-1 | 100 year old patient in reasonable health (reading, socializing, doing Zoom calls, etc.) took second Pfizer vaccine on February 5, 2021. On the morning of February 22, 2021 the patient suffered a major hemorrhagic stroke. He suffered severe paralysis, could not speak, and suffered from severe pain. Within 24 hours he was moved to Hospice Care. A day later on February 24, 2021 he died. | | 803 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1108439-1 | Acute Embolic Stroke (Diagnostic Code I63.9) | | 804 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1115933-1 | Pt BIBA with sx of stroke, including right sided weakness and numbness. imaging suggestive of transverse myelitis vs. spinal cord infarct | | 805 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1118996-1 | After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shaking body, had to call 911 , in hospital was diagnose with Atrial Fibrillation, did not have this problem before!! Have to take 4 new medications for the rest of my life!!! I may experience stroke in the future. For a early few days had pain in my left arm. For the next few weeks overall tiredness. strange feelings in my head!!!! | | 806 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1124679-1 | Stroke - globus pallidus area Lost ability to speak and recognize objects. Immediately taken to ER and evaluated and TPA given. Results good following drug administration sent home after two days. Some mental affects still. | | 807 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1145005-1 | Patient presented to the ED on 3/4/2021 with left facial droop, left-sided weakness, and dysarthria that started upon awakening that morning. Patient found to have an ischemic stroke and ultimately admitted to hospice. Patient expired on 3/10/2021. | | 808 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 15-30 days | 1183945-1 | called back to schedule her second appointment but is was past 42 days so they said she could not schedule; tested positive for Covid/Got COVID; tested positive for Covid/Got COVID; Tiredness; achiness; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 13:00 (at the age of 68 years) (Batch/Lot Number: EN6200) as a single dose to prevent getting COVID (COVID-19 immunization). Ongoing medical history included high blood pressure (started about 10 years ago) and varicose vein (At least probably about 20 years). Family history includes both of her parents had heart problems, Mother had a stroke (she doesn't know when, she took medications for heart problems) and Father died of a heart attack. Concomitant medications included hydrochlorothiazide taken for hypertension. It was reported that the patient had the first dose on 19Feb2021 and was due to have second dose on 13Mar2021 and two days before that (11Mar2021) she ended up being sick having symptoms (cold) so she had to cancel the appointment and was tested for COVID. On 17Mar2021 the patient found out she got COVID. She called back to schedule her second appointment but is was past 42 days so they said she could not schedule. It was reported that she was not sure when she had COVID-19, it would have been in the evening when she started feeling like she had a cold. She's still having a little bit of tiredness since 11Mar2021 but no cough. Her tiredness is not as bad now. The patient also experienced achiness on an unspecified date in 2021. The patient received the following treatment for the events: Vitamin C, not sure if helped, Vitamin D, not sure if helped, and Advil, helped with achiness. The outcome of the event tiredness was not recovered, while unknown for the rest of the events. | | 809 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 31-60 days | 1075018-1 | 3/3/21 er to hospital admission: 81 y.o. female with a history of Parkinson's in previous stroke. The patient basically is maintained in the nursing home in this state of being bed-bound and nonverbal. She was recently transferred to Rehab after she developed a stage IV sacral ulcer at a previous nursing home. The patient had been seeing wound care and doing very well. Her stage IV sacral ulcer had been healed to a stage II. She had been gaining weight. Unfortunately, at her wound care appointment yesterday the wound had decompensated a little bit and had started to drain some purulent material. It also enlarged in size a little bit. I was called yesterday afternoon and the nursing home reported the patient was not wanting to eat or drink. Lab work showed a sodium of 170 and creatinine consistent with acute kidney injury. She also appeared to have a urinary tract infection. Because of her critical labs she was sent to the nursing home. The patient was evaluated in the nursing home and then admitted to the floor. She was given Zosyn and vancomycin and started on IV fluids. The emergency room physician did counsel the family that the prognosis was very grim. The patient has done reasonably well overnight. She has been grimacing quite a bit and the family has decided they just want her kept comfortable comfort care during admission | | 810 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 31-60 days | 1125541-1 | Stroke | | 811 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 31-60 days | 1128227-1 | Fell twice due to weakness, next day didn't feel good, admitted to hospital, after MRI it was determined a stroke had occurred | | 812 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | 31-60 days | 1210673-1 | patient experienced a massive brain stem stroke on the morning of Friday, April 2, 2021. He was found minimally responsive on the floor at home and rushed to Medical Center which has a comprehensive stroke center. Imaging and testing determined there was no chance of recovery that would restore meaningful quality of life. The family removed life support on Saturday, April 3, 2021. Of note ,Patients sister, also, similarly suffered mild stroke shortly after receiving her 2nd Pfizer COVID-19 vaccine. Her recovery is ongoing and her family has been encourage to also report to VAERS. | | 813 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Over 120 days | 0975214-1 | He had a stroke later that night after receiving vaccine. | | 814 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 0912270-1 | arm stiff and sore two hours after getting vaccine/muscle is stiff in her right arm; arm stiff and sore two hours after getting vaccine, at right arm; she didn't get to sleep last night since it felt heavy and stiff with discomfort; she didn't get to sleep last night since it felt heavy and stiff with discomfort; Couldn't raise her right arm/couldn't lift her right arm/ farthest she can lift her right arm from her side is 2 inches; she didn't have strength to open the bottle it was new and she cannot open it; This is a spontaneous report from a contactable consumer. A 69-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 15:00 at single dose, at right arm for COVID-19 immunization. Medical history included ongoing hypertension (controlled), ongoing prediabetes (controlled), blood thinner, stroke (it was a very mild trace of a very mild stroke) and MRI on 2015. Historical vaccine included flu vaccine on an unspecified date. Concomitant medication included clopidogrel bisulfate (PLAVIX) from 2015 as blood thinner. After the patient got the vaccine on 21Dec2020, she was instructed to sit for 15 minutes and was given flyers and the card that stated the next scheduled dose is on 11Jan2020. She mentioned that the card she was given is the COVID-19 appointment card with a return flyer attached regarding Pfizer vaccine recipients and care givers. She reported that all that she can see on there is that, there was no lot, batch or serial number, just the name of the vaccine. She stated that the vaccine was shipped in the morning and they started giving it around noon and she got hers at three o'clock in the afternoon. She stated this is their facility's second batch, and the first was consumed last week. She stated she made a mistake, and that she should have requested they inject her left arm because she is right handed. The patient reported that she experienced arm stiff and sore two hours after getting vaccine (17:00). It was tolerable at first, but when she got home, she couldn't raise her right arm. She thought it would just be like the Flu vaccine and tolerable but she couldn't lift her right arm. The farthest she can lift her right arm from her side is 2 inches. She tried putting a cold compress on it but it was not working. She doesn't know if she can take TYLENOL. She would like to know if she can take TYLENOL for the pain since it was the only medication she has. Her supervisor advised her to take Advil, but she only has TYLENOL. She says she does feel better and that she was fine, there was nothing else, just her arm is so sore. She has nothing negative, no other side effect, no redness, just her muscle is stiff in her right arm and it feels sore. She stated maybe if she had taken TYLENOL the night before, but last night or today she didn't have strength to open the bottle it was new and she cannot open it. She stated at least the pain is lesser than last night, she didn't get to sleep last night since it felt heavy and stiff with discomfort. She was supposed to get a mammogram on reporting time, but since she couldn't raise her arm she was trying to reschedule. She is supposed to have a blood test the following day. Therapeutic measures were taken which includes cold compress. Outcome of the event ""arm stiff and sore two hours after getting vaccine, at right arm"" was recovering while outcome of all other events was unknown. Information on the lot/batch number has been requested."" | | 815 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 0984494-1 | arm is hurting so bad; could not move her arm, her left arm; it feels like lead; she got the injection in is like equalizing the pain she has; hurts all over; sleeps every 2 hours; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date), via an unspecified route of administration on the left arm on 13Jan2021 10:35 at a single dose for COVID-19 immunization. Ongoing medical history heart failure, kidney failure, scoliosis and strained hernia (causing pain down her right leg). Other medical history includes patient gave up her car and as a result she went from 5ft 4 inches to 5ft 1 inch and went from 150 pounds to 106 pounds (stated she loves this new weight. She looks fabulous and wonderful in clothes). The patient's concomitant medications were not reported. It was reported that the patient was a retired school teacher, called about the shot, the vaccine, clarified as the COVID Vaccine. She mentioned she has a history of heart failure, kidney failure, scoliosis, and hernias. She was concerned about getting the vaccine and did not think she should get it, but her doctor informed her she should get it so she did. Since getting it she is having a hard time. Stated it feels like lead. She contacted her doctor and was informed to wait it out 24 hours and it would be a lot better. It was reported that the patient got the COVID Vaccine shot yesterday (13Jan2021 10:35). She mentioned her arm is hurting so bad. She contacted her doctor's office and was informed to give it another 24 hours for the pain to go away. It was reported that the patient hurts so bad, she hurts all over. She added she guesses the arm where she got the injection in is like equalizing the pain she has. She stated as soon as she got the injection everything was wonderful. It was afterwards she felt like she could not move her arm, her left arm. She felt like at first she was having a stroke. She did some self testing and was happy she realized she was not having a stroke. It was reported that the patient provided conflicting details of when arm hurting started. She initially stated it started 13Jan2021. She then stated she did not feel it until 8am in the morning of 14Jan2021 (pending clarification) when she could not move her arm and thought she was having a stroke. She commented she sleeps every 2 hours. She would later mention in report she felt the arm pain starting yesterday (as reported). Attempts made to clarify start of arm hurting, but unable to clarify further. She is scheduled to get the second does on 03Feb2021. She commented even with her age she is still very useful. She was told to continue taking acetaminophen. She has the 1000 mg, take two pills every six hours. She was told if she continued to have pain to take Aleve. Treatment was given for the events. The outcome of the event was unknown. Information on the lot/ batch number has been requested. | | 816 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1016621-1 | All my stroke symptoms returned immediately; numbness on left side of face, left hand, left foot, left chin; Weakness; pain; all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin. Weakness and pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PF EL3249), via an unspecified route of administration in arm left, on 16Jan2021 12:00 PM at single dose for COVID-19 immunisation. Medical history included massive stroke in Jul2018, left side effected; numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago; asthma. Patient was allergic to shrimp, lobster. Patient is not pregnant. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Concomitant medications included Losartan, Amlodipine, acetylsalicylic acid (ASPIRIN), Atorvastatin, Montelukast. Patient was previously allergic to codine, tetracycline. On an unspecified in Jan2021 (reported as 15Jan2021, pending clarification), all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago returned immediately and had not subsided 2 weeks later. Patient received treatment, physical therapy continued for stroke symptoms. AE resulted in doctor or other healthcare professional office/clinic visit, the reported seriousness criterion is disability. Outcome of the events was not recovered. | | 817 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1022056-1 | his face was feeling funny/his face was paralyzed on the left side/ Bell's Palsy; Pain at the injection site; This is a spontaneous report from a contactable consumer (patient's wife). A 71-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3248), via an unspecified route of administration on 24Jan2021 12:30 at single dose in right arm for COVID-19 immunization. Medical history included Diabetes, Blood pressure high, High cholesterol, Enlarged prostate. Concomitant medications taken within two weeks before the event onset included irbesartan, verapamil, metformin, topiramate, omeprazole, tamsulosin, clonazepam, simvastatin, acetylsalicylic acid (BABY ASPIRIN), all were ongoing. Vaccination facility type was Hospital. The patient received the Pfizer covid vaccine first dose on Sunday 24Jan2021, On Monday (25Jan2021) afternoon, his face was feeling funny, by the time he got home, his face was paralyzed on the left side. The injection site was on his right arm. The reporter called paramedics and he went to the Emergency Room, and was diagnosed with Bell's Palsy. No history prior to vaccination. All his tests were negative in the hospital, EKG, CT, all tests negative in Jan2021. wasn't a stroke or anything like that. One doctor said it could be related to the vaccine and the other said he didn't know. The reporter wanted to know if he could go back for the second dose, if one dose could provide any protection. Consumer calling about the Pfizer COVID-19 vaccine (later referred to as just shot or COVID shot by caller) for her husband, and says the reason why she called was her husband got Bell's Palsy from it, and she didn't know if he should still go for a second shot. She said his face was all paralyzed right now, he got the COVID-19 shot on Sunday, then Monday night he went to the ER and was diagnosed with Bell's Palsy, all tests were clear that it was not a stroke and had to be from the shot. The patient's face was feeling funny, and when he got home his face was paralyzed and she called 911. She said he was admitted from the ER overnight on Monday night (25Jan2021), then she picked him up on Tuesday night. She said he was diagnosed with Bell's Palsy, and they gave him medication, which was Prednisone and patches to keep his eye closed, and another med called Valacyclovir, which was an antiviral medication, and some eyedrops. She said his vaccine card just says first dose, patient number, (City and State name), and has a date on the back for his second shot which was scheduled for 14Feb2021. Treatment Valacyclovir: Caller says that this was in a (Pharmacy name) bottle and that label told instructions to take it and said no refills, discard after 26Jan2022, it was a week's worth of pills. Prednisone 10mg. Caller said this was also in a pharmacy bottle that said take 5, then 4, then 3, then 2, then 1. The label said discard after 26Jan2022. She said that the eyedrops were over the counter lubricant eye drops for his left eye. Caller said the patient took a medication for electrical activity in the brain, so they did a MRI and a CAT scan and they all came back negative on the tests, and his heart tests came back negative (Jan2021). No further details provided about electrical brain activity medication or test results. Caller said that the doctors sent her husband home and said it was Bell's Palsy, likely a result of the vaccine, that there was nothing wrong with him, they can't say for sure, they said it could be coincidental. She said they probably can't say it was the vaccine that gave it to him, some doctors said yes during the stay at the hospital and some said they couldn't say. She said that there were quite a few doctors there, it is a big hospital, that worked in the stroke unit. Caller said that she would like to know if there were any product recommendations about whether her husband should get the second dose. It further reported that on 25Jan2021 at Lunch time his face felt funny and by 17:00 left side of face was paralyzed. He was treated in the ER of (Hospital name and Address). as if he had signs of stroke. Reporter seriousness for Bell's palsy was Hospitalization. The dates when patient was in hospital for Bell's palsy was from 25Jan2021 to Unspecified date. Reporter stated patient also experienced pain at the injection site in Jan2021. MRI, EEG, EKG and Sonogram, all clear and All negative in Jan2021. The outcome of the event ""his face was feeling funny/his face was paralyzed on the left side/ Bell's Palsy"" was not recovered, of the other event was unknown."" | | 818 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1056630-1 | Lightheaded; Weakness; Nauseated; Vomiting; did not have an appetite; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. Medical history included stroke 14 years ago. Concomitant medication included warfarin. The patient was lightheaded, did not have an appetite and experienced weakness on Jan2021. She was even nauseated and threw up earlier on Jan2021. She wanted to know what can she do. She had nauseousness and vomiting. She vomited one time but she was not currently vomiting and just took some Ginger ale to settle her stomach. Patient was asking what to drink or does she take any Tylenol or let it. Outcome of the events was unknown. The date of second dose was 16Feb2021 Information about batch/lot number has been requested. | | 819 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1062237-1 | she had symptoms of a stroke; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) first dose, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Initially, it was reported that the patient experienced symptoms of Bell's palsy before getting the second dose. It was further reported that the patient stated it was not true that she experienced Bell's palsy. She mentioned she had symptoms of a stroke on an unspecified date. She wanted to confirm that her appointment for next 20Feb2021 has not been cancelled. Consumer refused to continue with the survey. The outcome of the event was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected. | | 820 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1068408-1 | Bell's Palsy/drooping of his face and mouth; Bloody nose; vertigo (dizzy / lightheaded); vertigo (dizzy / lightheaded); swallowing issues; Chewing issues; weak; tired / does not have stamina; This is a spontaneous report from a contactable consumer (the patient's wife). A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9264), via an unspecified route of administration in the right arm on 09Feb2021 at 12:30 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included vertigo (before the 2nd dose all the time), diabetic type 2 due to exposure to Agent Orange, stent in Dec2019, sulfa allergies, blood pressure abnormal. Concomitant medications included metformin, buspirone, sitagliptin phosphate (JANUVIA), hyoscyamine sulfate (OSCIMIN), doxepin, lisinopril for blood pressure, silodosin, simvastatin (ZOCOR), exenatide (BYDUREON) for diabetes, fish oil, zinc tablet in the morning, ubidecarenone (COQ-10), vitamin D3, cyanocobalamin (VIT B12), allium sativum bulb (GARLIC EXTRACT), ascorbic acid/ betacarotene/ biotin/ calcium/ chloride/ chromium/ copper/ folic acid/ iodine/ lycopene/ magnesium/ manganese/ molybdenum/ nickel/ nicotinic acid/ pantothenic acid/ phosphorus/ potassium/ pyridoxine hydrochloride/ riboflavin/ selenium/ silicon/ thiamine/ vanadium/ vitamin b12 nos/ vitamin d nos/ vitamin e nos/ vitamin k nos/ xantofyl/ zinc (CENTRUM SILVER FOR MEN 50+). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 23Jan2021 at 10:30 (at the age of 76-years-old) in the right arm and experienced pain in arm and fatigue. On 09Feb2021, the patient developed a bloody nose that was unstoppable at home. The reporter took the patient to the emergency room (ER), where his nose was packed, and he was kept overnight. The following day, while his nose was being unpacked, drooping of his face and mouth was observed. Tests for a stroke were negative on Feb2021. The patient was kept in the hospital for three days and was diagnosed with Bell's Palsy on 11Feb2021. The events ""Bell's Palsy/drooping of his face and mouth"" and bloody nose resulted in hospitalization/prolonged hospitalization in Feb2021 for 3 days. The patient's wife reported that as of 09Feb2021, he had swallowing issues when it came to solid foods and was looking for suggestions on what he can eat. The tongue was not swollen, and he was breathing better since the packing had been removed. As of Feb2021, the patient had chewing issues and cannot take solid food. The patient had vertigo before the second vaccination dose all the time, and experienced it again last night on 16Feb2021, he was dizzy and lightheaded. As of an unspecified date in Feb2021, the patient was weak and tired (did not have stamina). The patient was treated for ""Bell's Palsy/drooping of his face and mouth"" with prednisone 20 mg 2 tablets once a day and valacyclovir 500 mg 2 tablets twice a day. The patient was not treated for bloody nose and swallowing issues. The clinical outcome of "" Bell's Palsy/drooping of his face and mouth"", swallowing issues, chewing issues, weak, ""tired / does not have stamina"" was not resolved; bloody nose was resolved on Feb2021; ""vertigo (dizzy / lightheaded)"" was resolved on 17Feb2021."" | | 821 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1070515-1 | his INR measured 2.1 which has been lower than it has been in 5 years; his arm hurt a little bit; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiry date: 31May2021), via an unspecified route of administration (at the age of 74-years-old) on 30Jan2021 09:30 at a single dose in right upper arm for COVID-19 immunization. Medical history included Mechanical heart valve from Feb2000 and ongoing, Parkinson's disease, heart rate abnormal, blood pressure abnormal, penicillin and sulfonamide allergy, cholesterol, and rashes. Concomitant medication included warfarin from 2000 and ongoing for Mechanical heart valve and blood thinner for mechanical heart valve, carbidopa, levodopa (CARBIDOPA/LEVODOPA) for Parkinson's disease, carvedilol for Heart rate, hydrochlorothiazide for blood pressure (unknown, thinks it is blood pressure), simvastatin for Blood pressure or cholesterol, not sure which, lisinopril for Blood pressure, pramipexole for Parkinson's disease, macrogol 3350 (MIRALAX) as Laxative, docusate sodium (COLACE) as Stool softener. The patient previously took BACTRIM and experienced allergies. The patient experienced his arm hurt a little bit on Jan2021 with outcome of unknown and his INR measured 2.1 which has been lower than it has been in 5 years on 01Feb2021 with outcome of unknown. The patient and his wife received the 1st dose of the vaccine this past Saturday, 30Jan2021 and is scheduled to take the 2nd dose on 20Feb2021. He mentioned that his arm hurt a little bit, but other than that he was fine. He has been taking warfarin for 20 years and has been Home Monitoring his INR for 5 years. This morning his INR measured 2.1 which has been lower than it has been in 5 years. His usual range is 2.5 - 3.0 and he is worried that the lower INR might risk him for clotting diseases and a stroke. He is asking if there is an interaction with warfarin and the vaccine and will it be safe for him to take the 2nd dose. He has a mechanical heart valve placed year 2000 that he takes Warfarin sodium daily for as a blood thinner. He reported that today: 01Feb2021 at 09:05 his INR level is lower than he has ever recorded in last 5 years: 2.1. He asked if the Pfizer COVID-19 Vaccine can affect the Warfarin sodium or affect blood thinning. Adverse events did not require a visit to Emergency Room or Physician Office. No hospitalization. No prior Vaccinations (within 4 weeks). No adverse event following prior vaccinations. Years ago, he recovered completely from all medication reactions. Further described as he thinks all the reactions were rashes. Medications he had reactions to include Penicillin, Bactrim and Sulfa drugs. | | 822 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1070760-1 | Lost part of my vision and it only lasted for three to four minutes; mini stroke/ TIA; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2(Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9284, Expiration date: 31May2021), via an unspecified route of administration at the left arm on 11Feb2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Feb2021 7pm, patient went to get something to open the can of soup but when she went into the pantry, she lost part of her vision and it only lasted for three to four minutes. The patient's daughter who is a neurologist thought it was the mini stroke or TIA (Feb2021). The doctor was setting up the sonogram for her arteries and her neck and also for her heart and said she might have to rely on a pacemaker. The outcome of the events was unknown. | | 823 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1075318-1 | Patient admitted to hospital pontine stroke following day. | | 824 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1076742-1 | Sore arm; This is a spontaneous report from a contactable consumer (patient)╝. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 11Jan2021 at 12:00 (at the age of 65-years-old) at a single dose for COVID-19 immunisation. Medical history included osteoporosis, stroke history (35-years-old), significant lactose intolerance, gastrointestinal (GI) issues, and allergy to Caine family of drugs. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included evolocumab (REPATHA SURECLICK) and lorazepam (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore arm in 2021. The event was reported as non-serious. The patient did not receive any treatment for the event. The clinical outcome of sore arm was recovered in 2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. | | 825 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1092722-1 | STROKE SYMPTOMS, DIFFICULTY AMBULATING, IMPAIRED SPEECH | | 826 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1100298-1 | lower jaw numbness/felt a little numbing in her jaw on right side; Fatigue; Headache; pain in her face/incredible face pain, throbbing; slept most of the two days following the vaccine; face became bright red with swelling and intense in her cheeks and forehead; face became bright red with swelling and intense in her cheeks and forehead; disoriented; dizzy/wooziness; This is a spontaneous report from a contactable consumer herself. A 74-years-old female patient started to receive bnt162b2 (Pfizer-Biontech covid-19 vaccine, Solution for injection lot number: EN5318 and expiration date: unknown) intramuscularly from 29Jan2021 18:10 at single dose for prevent covid. Medical history included stroke from Apr2018 to an unknown date since she had a stroke 3 years ago. Concomitant medication included rivaroxaban (XARELTO) for stroke 30 mg, once a day. The patient previously took diphtheria vaccine. Caller states she spoke to safety agent and gave them all of her information. Caller states she received the first dose of the Pfizer COVID vaccine Friday at 6:15 pm. Caller states after waiting the recommended 15 minutes at the vaccination facility after receiving the first dose caller states four minutes later she began to experience lower jaw numbness that lasted a few seconds 29Jan2021. Caller states her face became bright red with swelling and intense in her cheeks and forehead In Jan2021. Caller states these symptoms were only in her face and no where else. Caller states she was taken back to the vaccination facility and the nurse monitored her every ten minutes for about 30 minutes until she cooled down and then she was sent home. Caller states during this time she was disoriented and dizzy In Jan2021. Caller states the next day she experienced pain in her face and to this day she still gets some pain but no more redness in her face. Caller states she is scheduled for the second dose on 19Feb2021. Caller states she read somewhere online that if you had a severe allergic reaction to the first dose you should not receive the second dose. She stated that within roughly five minutes of receiving the vaccine that she began to experience a numbing in the chin and the surrounding area. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She stated that within a few minutes of the onset of numbness that her face began to swell, and turn extremely red as if sunburned. She also experienced wooziness and a dizziness. She said the experience subsided in approximately 40 minutes of its onset. She is scheduled to receive the second dose on the 19th of Feb, but has some concerns about receiving it due to her experience. The patient had Fatigue, Headache in 29Jan2021. She clarifies her slight headache pain came back with the fatigue, reports it comes and goes. Her headache is off and on. After about 5 minutes of waiting she felt a little numbing in her jaw on the right side. Then 2 minutes later her face got bright, bright red, like there was real heat coming from it. She also had swelling in her face. It was very strange. She is asking if it is safe to get the second dose which is scheduled for 19Feb2021. This reaction lasted about 40 minutes. Her face was all flushed and burning hot red. It took a couple of hours for her face to come back to her normal color. After this faded, she reports she was left with incredible face pain, it was throbbing. She was extremely fatigued and is still fatigued, she can do very little. She is managing to cook. She slept most of the two days following the vaccine. The outcome of the events Numbness recovered on 29Jan2021,red face recovered in 2021, event pain in her face/incredible face pain, throbbing recovered in 31Jan2021, event Fatigue was recovering and other events unknown. | | 827 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1106291-1 | small ischemic stroke; elevated white blood count; fever; body aches; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269, expiration date May2021), via an unknown route of administration on 15Feb2021 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 Prevention/ immunization. The patient's medical history included a dental procedure on 18Feb2021 for a cracked tooth from an unknown date. The patient received procaine hydrochloride (NOVOCAIN) on 18Feb2021 for the dental procedure. On 18Feb2021 the patient experienced fever, body aches, chills, and a headache; and on an unknown date in Feb2021 the patient experienced a small ischemic stroke. The patient was hospitalized for the ischemic stroke on 19Feb2021. The patient underwent lab tests and procedures which included a Magnetic resonance imaging (MRI) of the brain on 20Feb2021 which showed a small ischemic stroke and white blood cell count which was elevated (in the low 20s) on 19Feb2021 and on 20Feb2021, white blood cell count was normal. Therapeutic measures were taken as a result of the ischemic stroke which included Plavix. The clinical outcome of the ischemic stroke was unknown; fever, body aches and chills were recovered on 19Feb2021; white blood cell count increased recovered on 20Feb2021; headache was not recovered. The patient was hospitalized for three days. The patient mentioned that he was not associating the stroke with the vaccine but rather associates it with the added stress on his body. | | 828 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1113929-1 | diarrhea; color of the diarrhea looked red and looked like it had blood on it; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; shaking/trembling out of control; hurting from her neck down to her toes; joints were achy, hurt, and stiff; joints were achy, hurt, and stiff; her teeth were chattering and cant stop, and when she tried to stop that it made it worse; she had hard time walking/Her gait was off and she was kind of jerking; fell in the bathroom; she was too weak; hard time rolling and trying to get out of bed; Her gait was off and she was kind of jerking; little nausea; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea; she was kind of wiped out for a couple of days (in 2021) and it was all over now; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6203), via an unspecified route of administration in left arm on 27Feb2021 (at the age of 76years) as single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia diagnosed in 1999; Covid-19 from 23Nov2020 to Dec2020 (went to the hospital because of pain in her side at night. Was told she had pneumonia and pleurisy, she got it 2 days after her husband did, but hers was a mild case); her husband had Covid in Nov2020 and died in Dec2020 and hemorrhoids (from having babies years ago). Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN). The patient had no investigation assessment. The patient scheduled her first dose for 27Dec2021. The patient had questions about it, but the person administering it did not speak English and she said that initially she did not have any reactions while she was there. The patient received the first dose of the vaccine on 27Feb2021 and has a lot of adverse events. After the getting the shot, she woke up at 0400 and experienced shaking (whole body was shaking), trembling out of control, hurting from her neck down to her toes, her joints were achy, hurt, and stiff, her teeth were chattering and couldn't stop, and when she tried to stop that it made it worse, when she got up she had hard time walking, so much that when she had diarrhea, she had diarrhea on the floor, she also noticed that the color of the diarrhea looked red and looked like it had blood on it but she was not sure. After that, she sat down in a chair and noticed that it had blood when she got up and suspected that she had hemorrhoids and bleeding because of the diarrhea. She thought it was a result of the reaction to the shot. She noted that that she had COVID on 23Nov2020 and that she heard that people who had COVID might not need to get the second shot but it was only speculation so she was asking if this was true. She mentioned that she waited 90 days before getting the vaccine as per CDC guidelines and knew that the 2nd dose can be given for 42 days after the first dose. The patient's daughter in law who was an occupational therapist volunteered to fly in and take care of her after the second shot on 27Mar2021 but her 2nd shot was due on 20Mar2021 so she wouldn't be there until then. The patient was having a hard time rescheduling her appointment so asked if there was anything can be done. The patient would prefer not to take the second dose due to the side effects. The patient also reported that it looked like someone who had a stroke trying to walk again, her gait was off and she was kind of jerking. As she would take a step her foot would go down on a slant like it was skidding. She said that this happened one other time to her. It was like she was leaning forward and could not stop herself. When she was able to get up, she went into the living room and sat in her husband's chair and fell asleep until 15:00. When she got up, she noticed a lot of blood in the chair. The patient asked if this was allowed. She went home and took a couple of acetylsalicylic acid, caffeine, paracetamol because she did not have paracetamol (Tylenol), and she went to sleep. She had a hard time rolling and trying to get out of bed. She turned on her electric blankety and her heat. She said that by 0600 most of the shaking had gone away. She felt a little nausea, but got some dry toast. She said that she wanted to take a shower, but she started getting diarrhea from the injection. She fell in the bathroom and could not get herself up for over an hour because she was too weak. When she fell on the floor, she tried to get on a rug because she was still having the diarrhea on the floor. She said that it was everywhere. The next day she called her son and his wife they said that she could be alone for her second shot. She was scheduled for 20Mar2021 for her second dose. The patient had a hard time changing the appointment and her son could not come to stay with her until 27Mar2021. A friend told the patient that on the news it said that a second shot may not be necessary for people who have had Covid-19 already and she wanted to know if Pfizer has heard of this. The patient said that she was kind of wiped out for a couple of days (in 2021) and it was all over now. The doctor's office was aware of what happened and she was told to take extra strength Tylenol before and after the second injection to address these symptoms. The consumer considered the case as non-serious. The outcome of the event fatigue was recovered in 2021 while for the remaining events was unknown. | | 829 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1114945-1 | Bell's palsy; because it could be a stroke; This is a spontaneous report from a contactable consumer. A 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EM9810), via an unspecified route of administration on the right arm on 19Feb2021 14:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 on 29Jan2021 for COVID-19 immunisation and experienced a sore shoulder. A few years ago he got 2 at the same time, he got a flu shot and a pneumonia shot on the same day. He felt really bad for part of a day. He felt unwell that was years ago. he does not have any brand name, manufacturer name or lot number expiration information to provide for these vaccines from years ago. The patient experienced bell's palsy on 25Feb2021. There is a drooping eye, his eye didn't fully close but his lip wasn't right and the doctor said no because it could be a stroke ( unspecified date in Feb2021), go to the ER and that is where he was diagnosed was in the hospital ER. He was discharged home from the emergency room. The outcome of the event was not recovered. | | 830 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1116558-1 | I had the second vaccine on February 13 in afternoon. I had a stroke causing expressive aphasia on the evening of February 14. I had no side effects from the first vaccine and just soreness in arm of injection after the second vaccine. I realize that the stroke could coincidental but thought I should report it just in case for information in the event others had similar event. | | 831 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1121623-1 | Stroke; Nasal swab COVID test post vaccination/positive; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6205, expiry date unknown), via an unspecified route of administration on 11Mar2021 at a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination on an unknown date. The patient's concomitant medications were not reported. The patient experienced stroke on 14Mar2021, two days (as reported) after having the vaccine. The event required an emergency room/department or urgent care visit and hospitalization for 2 days on unspecified dates in Mar2021. The patient received treatment for the event stroke and unspecified tests and monitoring was done. The event was also considered as a life threatening illness (immediate risk of death from the event) and has caused disability or permanent damage. The patient had a nasal swab COVID test post vaccination on an unspecified date in Mar2021 with a result of positive. The patient recovered from the event stroke with lasting effects while the outcome of the event nasal swab covid test post vaccination/positive was unknown. No follow-up attempts are possible. No further information is expected. | | 832 | COVID19 (COVID19 (PFIZER-BIONTECH)) | 65+ years | Unknown | 1123133-1 | mild peripheral neuropathy/sensory peripheral neuropathy around her gums and lips on her left side, as well as tingling on 4 of the 5 fingers of her left hand; paralysis in her lips and gums all the way down to her finger tips on the side of the injection which was the left side; portion of the trigeminal nerve on the left side seemed to have been impacted; blood pressure had sky rocketed; This is a spontaneous report from a contactable physician and a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), lot no. EL9269, via an unspecified route of administration on 13Feb2021 at a single dose for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The physician asked if there were any reports of paresthesia around the gums and/or tingling in the hands and fingers. The patient received the first dose of the Pfizer COVID-19 vaccine. About 1 week after receiving the vaccine (20Feb2021), she experienced symptom complex, consistent with a mild peripheral neuropathy/sensory peripheral neuropathy around her gums and lips on her left side, as well as tingling on 4 of the 5 fingers of her left hand, She was admitted and a full workup for central disorders and vascular disorders was negative (Feb2021). But her symptoms were continuing intermittently. She had numbness of the gums. A portion of the trigeminal nerve on the left side seemed to have been impacted. Also, peri-orally on the left side. The physician asked if this symptom complex has been reported and if there were reports of these mild sensory peripheral neuropathies coming from the vaccine. The physician stated that any info on dental paresthesia or any reports of other incidents of sensory paresthesia would be very helpful. The patient also called about the COVID 19 vaccine. On 13Feb, she got the vaccine in and then one week later on the following Saturday, the date would have been 20Feb, she started having a sensation of tingling and paralysis in her lips and gums all the way down to her finger tips on the side of the injection which was the left side and that has continued. She went to see the doctor the following Monday 22Feb and not knowing what it was, she sent her to the ER she was kept overnight, she was discharged 23Feb but her symptoms persisted even through today. These sensations were happening on average 3 times per day, sometimes many more anywhere from 3 minutes to 1 hour 45 minutes then it goes away. She did not go to her primary care. She confirmed her first dose was given 13Feb and the tingling and paralysis started the 20Feb it was still ongoing at this time. It has persisted but she can't tell whether it was getting better or not because sometimes it will last 3 minutes sometimes it will last 1 hour and 45 minutes. It started to effect other parts of her so she thinks it might be getting a little bit worse. It was starting to effect other parts of her body the progression goes, it started at the tip of her tongue and gums and then shortly within 30 seconds or less than a minute it spread to her upper and lower lip only on the left side and that was how it was on her gums as well it was only on the left side then she had the tingling in her finger tips on the left hand. She specified that she experienced these sensations on the tip of her tongue, left gums, lower left lip, and into the fingers on the left hand. She would like to know if these symptoms have been reported in association with the vaccine and if so, how long she can expect them to last. She stated that yesterday, a physician called in on her behalf for more information and said he received literature from 29Jan regarding reports that included information about dental paresthesia after the vaccine. She was planning not to get the second vaccine. She was not taking medications, she was in good health she did go and was admitted in the ER, they did a work up. Her blood pressure had sky rocketed on Feb2021 and since she mentioned sensation they ruled out a stroke. On Feb2021, they did blood work, MRI and CT scan and everything was they did not find anything linking to a stroke. She spent the night in observation. She was in the ER, they did put her in the main hospital but it was for observation from the emergency room. She went in on the 22Feb and was discharged home on 23Feb. She asked where this goes from here, these symptoms were concerning to her. She did not find any incidences at least in general of reporting this, asked if there were these kinds of things being reported, she didn't know how long it was going to last or if it will get worse. The outcome of blood pressure had sky rocketed was unknown while outcome of other events was not recovered. | | 833 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | 0 days | 0990524-1 | Stroke like symptoms; This is a spontaneous report from a non-contactable consumer reporting for father in law. An elderly male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced stroke like symptoms in Jan2021 and was admitted to the hospital due to it. Outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. | | 834 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | 0 days | 1114947-1 | stroke; feeling funny from that point on & everything went down hill; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Feb2021 at 11:00 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient felt good all week leading up to the vaccination, until the vaccination was given. From that point on (26Feb2021 at 11:00), the patient started to feel funny and everything went downhill. On 27Feb2021, the patient had a stroke. The clinical outcome of stroke and ""feeling funny from that point on & everything went downhill"" was unknown. Information on batch/lot number was requested."" | | 835 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | 1 day | 0978875-1 | Fell twice and looks like he may have had a stroke; Fell twice and looks like he may have had a stroke; This is a spontaneous report from a Pfizer-sponsored program ""Pfizer First Connect"" from a contactable consumer (patient's wife). A 77-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient fell twice and looks like he may have had a stroke on 16Jan2021 with outcome of unknown. The information on the lot/batch number has been requested."" | | 836 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | 1 day | 1047571-1 | Death after stroke . | | 837 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | 1 day | 1153527-1 | Suffered massive stroke 24 hours after Pfizer vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a (age- 86; unit- unknown) female elderly patient with no pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 13:45 PM at single dose for covid-19 immunisation. No pregnant at time of vaccination. No illnesses or chronic health conditions, no family history of strokes, heart disease or high blood pressure, very healthy prior to vaccine. No other vaccine in four weeks. She suffered massive stroke 24 hours after Pfizer vaccine on 30Jan2021 13:00 PM. Event resulted in Emergency room/department or urgent care, Hospitalization for 27 days, Life threatening illness (immediate risk of death from the event), Disability or permanent damage, Patient died on 18Mar2021. Treatments were received for the event. Outcome of the event was fatal. No autopsy was done. lot/batch number has been requested.; Reported Cause(s) of Death: Suffered massive stroke 24 hours after Pfizer vaccine | | 838 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | 3 days | 0929070-1 | becoming incoherent and talking nonsense; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Physician calling about whether or not she should receive the second dose of vaccine. She received dose on 23Dec2020. On 26Dec2020 she started experiencing several side effects including becoming incoherent and talking nonsense. Her daughter who is an EMT suggested that she go to the ER. While in the ER she received TPA but it was later decided she did not have a stroke. Her EKG, bloodwork and other testing came back negative. She otherwise healthy and has no comorbidities. She already spoke with agency. She has also already spoken with an infectious disease doctor and her neurologist. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the event incoherent is conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agencys, Ethics Committees, and Investigators, as appropriate. | | 839 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | 3 days | 0947596-1 | numbness in her mouth and shoulder; numbness in her mouth and shoulder; blurry vision; elevated pressure; her arm became painful; sharp pain in the middle of the chest; This is a spontaneous report from a contactable consumer reported for self. This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 15:30 pm at single dose for covid-19 immunisation. Medical history included rib surgery last Sep2020. She had an episode on Friday morning 08Jan2021 with a sharp pain in the middle of the chest that was so bad she had to take Ibuprofen and lie down with a heating pad to her chest. After that, she had numbness in her mouth and shoulder, and had blurry vision to which she had her son call 911. As the EMTs arrived they recorded her with elevated pressure and took a cardiogram which reported everything was 'perfect', no stroke, no heart attack. She mentioned that she had a rib surgery last Sep2020 and was still healing and took pressure medication for it, She mentioned that the EMTs told her to take the medication in the morning and not in the afternoon and that the episode was not related to the vaccine. She also reported that her arm became painful for a day after the injection but it did not cause her anything else. She knows that other ladies who received the vaccine in her building had flu-like symptoms and was asking if her symptoms were reported for the vaccine. Patient mentioned that she was calling to report her side effects and that she will receive the 2nd dose on 26Jan2021. Outcome of the events was unknown. Information about lot/batch number has been requested. | | 840 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | 3 days | 1065160-1 | Stroke; This is a spontaneous report from a contactable consumer reporting on behalf of the mother. An approximately 81-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on 23Jan2021 (Batch/lot number: EL3302). Medical history was not reported. Concomitant medications included two unspecified prescriptions. On 13Feb2021 the patient experienced stroke which required hospitalization on the same day. The reporter was not sure of the name but they did a 'CAT' where they went up and pull the clot out of the brain. Event outcome was unknown. The patient was still in the hospital at the time of report. No investigation was performed before the event. | | 841 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | 4 days | 1035529-1 | ischemic stroke; This is a spontaneous report from a contactable consumer. A 9-decade-old (reported as: ""in her 80's"") female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, first dose on 28Jan2021 at single dose for COVID-19 vaccination. Recent medical history included GI complications. The patient's concomitant medications were not reported. On 01Feb2021, the patient experienced ischemic stroke requiring hospitalization. Event took place after use of product. The outcome of the event was recovering. Information about lot/batch number has been requested."" | | 842 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | 4 days | 1058152-1 | stroke; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, first dose) intramuscular on 01Feb2021 (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 05Feb2021, four days after vaccination, the patient had a stroke. The outcome of the event stroke was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. | | 843 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | 5 days | 1001438-1 | Stroke; This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. Facility type vaccine was Nursing Home/Senior Living Facility. The patient medical history was not reported. No Covid prior vaccination. Concomitant medications included unspecified other medications received in two weeks. The patient experienced stroke on 13Jan2021. AE resulted in ''Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization''. The patient was hospitalized from Jan2021 to Jan2021 for 2 days for stroke. Patient not received other vaccine in four weeks. Patient was not pregnant. Therapeutic measures were taken as a result of stroke. The outcome of event was recovering. Information on the lot/batch number has been requested. | | 844 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | 10-14 days | 1005995-1 | Guillain Barre syndrome; he had severe right foot drop and was taken to the ER; This is a spontaneous report from a contactable consumer and nurse. A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 08Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Jan2021, he had severe right foot drop and was taken to the ER, was seen by an internist and evaluated with an MRI and Xray of the spine and was scheduled for EMG and MRI of the brain at a later date. A stroke was ruled out and now wants to know if he has Guillain Barre syndrome (18Jan2021). Outcome of the events was unknown. Information about Lot/Batch number has been requested. | | 845 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 0921284-1 | lost my sense of smell and tested positive for Covid; lost my sense of smell and tested positive for Covid; This is a spontaneous report from a non-contactable consumer (patient) received via a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The content of a post was noted that on Dec2020, ""Got mine! And in a stroke of weird ironic awfulness, lost my sense of smell and tested positive for Covid later that day....If only a month sooner! Thank you for creating this vaccine. I know it had nothing to do with my diagnosis!"". The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. Sender's Comments: The events drug ineffective and COVID 19 are likely intercurrent and are unrelated to suspect drug BNT162B2 based on the short temporal relation between vaccination and onset of events."" | | 846 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 0947573-1 | really extreme high blood pressure (202/104); feeling very sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 04Jan2021 at a single dose for COVID-19 immunization. Medical history included strokes and bleeding disorder (gene that makes blood clot). The patient's concomitant medications were not reported. The patient experienced really extreme high blood pressure (202/104) and feeling very sick on an unspecified date. The clinical course was reported as: The patient received the vaccine on 04Jan2021 and experienced a lot of side effects, the most concerning of which was really extreme high blood pressure. The patient went to the emergency room (ER) on an unspecified date and her blood pressure was 202/104 on an unspecified date. The patient stated that she had been very sick and in bed for days. The patient had a follow-up appointment with her doctor on the day of the report. The clinical outcome of really extreme high blood pressure (202/104) and feeling very sick was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up. | | 847 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 0993529-1 | stroke; This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The physician reported an employee of (institute name) suffered a stroke within a week of taking the Pfizer Covid Vaccine on an unknown date. Dr. (Name) told the physician that he didn't think it was related. The event outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Very limited information is currently available. As the reported stroke occurred within a week of taking the Covid Vaccine, BNT162B2, the Company cannot completely exclude the possible causality between the reported event and the administration of the suspect. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate. | | 848 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 0996744-1 | Huge swelling around my eyes and redness and tenderness; My left eye was swollen shut; Huge swelling around my eyes and redness and tenderness; My left eye was swollen shut; Huge swelling around my eyes and redness and tenderness; My left eye was swollen shut; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EL0140) via an unspecified route of administration on left arm on an unspecified date at a single dose for covid-19 immunization. The patient had a heart condition and a stroke. The patient concomitant medications were not reported. The patient stated that she had a when I had the shot on the 13th (not clarified) and end up going to urgent care on Friday. She had a huge swelling around her eyes and redness and tenderness and her left eye was swollen shut. She went to urgent care and got some antibiotics and some cream to put on it. The patient had not any lab test. However, she did have microblading done to her eyebrows, three days before she had the shot. The patient wanted to know if it was because she had the microblading done and then she got the shot. The outcome of the events was unknown. | | 849 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1000185-1 | Had a stroke; This is a spontaneous report from a contactable consumer via Pfizer-sponsored programs. A male patient (reporter's husband) of an unspecified age received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of Covid vaccine on an unspecified date (Friday) at 12:35 PM, and had a stroke on Saturday morning at 10:30AM and was confined at the hospital (date/s unspecified) at the time of reporting. Reporter asked if there was any correlation or any fact sheets available with the vaccine and the stroke that happened to the patient. The outcome of the event was unknown. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts. | | 850 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1035528-1 | stroke; couldn't speak; feeling tired; diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a stroke (medically significant) after the first shot and couldn't speak, was feeling tired as well and diarrhea. She wanted to know if she could still take the second shot. Patient does not want to give any information. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number could not be requested. | | 851 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1035531-1 | mild stroke; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine. Medical history and concomitant medications were not reported. On an unspecified date, the patient had a mild stroke after the 1st vaccine and she's asking if she could go early to facility for the second dose. The outcome of the event was unknown. Information about lot/batch number has been requested. | | 852 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1045624-1 | Patient passed hit her head; Stroke; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. A 68-year-old female patient received single dose of BNT162B2(Solution for injection, lot number and exp date not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. The patient did not have COVID prior vaccination. On an unspecified date, the patient passed hit her head and had emergency surgery; and stroke. The adverse events resulted in: Hospitalization (date/s unspecified). The patient was not covid tested post vaccination. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. | | 853 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1065136-1 | strokes; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is 1st of 2 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization in a hospital. The patient's medical history reported as none. Concomitant medications were not reported. The physician reported that there were two patients who came in with strokes with no underlying condition/health risks, but they had been recently vaccinated with the COVID vaccine on unspecified date. The event resulted in physician office visit. Outcome of the event was unknown. The event was assessed as serious (hospitalization). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the implied time association, the possible contribution of suspect vaccine BNT162B2 to the event stroke cannot be excluded. The patient's age and detailed clinical course would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021163468 same reporter, product, event; different patient | | 854 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1065137-1 | strokes; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is 2nd of 2 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization in a hospital. The patient's medical history was reported as none. Concomitant medications were not reported. The physician reported that there were two patients who came in with strokes with no underlying condition/health risks, but they had been recently vaccinated with the COVID vaccine on unspecified date. The outcome of the event was unknown. The event resulted in physician office visit. The event was assessed as serious (hospitalization). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of stroke, cannot be fully excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021163467 same reporter, product, event; different patient | | 855 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1065433-1 | stroke; blood clot in the heart; Hospitalization with racing and irregular heart beat; Hospitalization with racing and irregular heart beat; loss of motor function; This is a spontaneous report from a non-contactable consumer. A 46-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer) on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. If other vaccine in four weeks was unknown. Other medications in two weeks was unknown. If covid prior vaccination was unknown. If covid tested post vaccination was unknown. Known allergies was unknown. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer) on an unspecified date for COVID-19 immunization. Patient experienced hospitalization with racing and irregular heartbeat, blood clot in the heart, stroke, loss of motor function on an unspecified date. Treatment included intubation. The outcome of the events was unknown. Events resulted in hospitalization, life threatening illness (immediate risk of death from the event). No follow-up attempts are possible; information about lot/batch number cannot be obtained. | | 856 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1068282-1 | she could have had a mild stroke; Headache; stroke type symptoms of confusion, difficulty talking and right side of face felt funny; stroke type symptoms of confusion, difficulty talking and right side of face felt funny; stroke type symptoms of confusion, difficulty talking and right side of face felt funny; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got a headache after covax last week Wednesday. On Thursday (unknown date), she had stroke type symptoms of confusion, difficulty talking and right side of face felt funny. The patient was taken to the emergency room on Friday and they said she could have had a mild stroke even though her tests were all negative. The outcome of the events was unknown. Information on the lot/batch number has been requested. | | 857 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1070761-1 | A very ""mild"" stroke/heart attack; A very ""mild"" stroke/heart attack; This is a spontaneous report from a contactable consumer. A male elderly patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported at the time of the report), via an unspecified route of administration from an unspecified date at SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that: ""I'm working on a story involving an elderly man whose family says he suffered a very ""mild"" stroke/heart attack about 4 days after getting the first dose of the Pfizer vaccine. The family says it took doctors a couple of days to confirm. They also said none of the doctors could say definitively that the vaccine had anything to do with what happened. The family says they still called the company to report it and have since received follow-up contact. While they were worried about him getting the second dose, they decided to proceed with that. He got the dose last week and the family says he's been fine. I wanted to reach out and see if you had a statement you'd like to provide. Also -Are strokes/heart attacks side effects of the Pfizer vaccine? If someone suffered a stroke or heart attack after getting the first shot and they believe it's related to the vaccine, should they get the second dose? "" The outcome of the events was unknown. Information on the lot/batch number has been requested."" | | 858 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1083742-1 | left side of his face is paralyzed and his left eye will not blink/ he thought he had a stroke/diagnosed with Bell's Palsy/had Bell's Palsy in the past several years ago; left side of his face is paralyzed and his left eye will not blink/ he thought he had a stroke/diagnosed with Bell's Palsy/had Bell's Palsy in the past several years ago; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included that he had Bell's Palsy in the past several years ago. The patient's concomitant medications were not reported. The patient experienced Bell's Palsy after receiving the first dose of the Pfizer Covid 19 vaccine. He stated that the left side of his face is paralyzed and his left eye will not blink. He received the first dose of the vaccine on a Thursday and the following Wednesday he went to the ER because he thought he had a stroke. He was diagnosed with Bell's Palsy, was given medication, and its been a week and his eye still is not blinking. His doctor is uncertain if he should receive the second dose of the vaccine or not. He was asking if he should he get the second dose and how many people were in the study. He also asked if he gets the second dose, if it will make the Bell's palsy worse. Therapeutic measures were taken as a result of event. The outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, and on a positive drug-event temporal association, the Company assessed that a reasonable possibility could not be excluded that the suspect product BNT162B2 contributed to the occurrence of the reported events Bell's palsy and Disease recurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | | 859 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1090196-1 | immediately after getting the vaccine he started with like a post nasal drip cough, now he was not sick before or anything like that; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 08Feb2021, this case now contains all required information to be considered valid. A contactable consumer (patient's wife) reported that a 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included drug hypersensitivity (reported as allergic to penicillin and all Cephalosporins), anaphylactic shock (reported as anaphylactic shock reaction to these medications), cerebrovascular accident (reported as strokes since age 35), paralysis (paralyzed on his right side), cardiac operation (open heart surgery), endarterectomy (had 3 Endarterectomy on his neck which none of them taken), and drug hypersensitivity (allergic to penicillin and all sulphur form drugs). Concomitant medications were not reported. The patient immediately after getting the vaccine started with like a post nasal drip cough on an unspecified date, now he was not sick before or anything like that. Clinical outcome of the event was unknown. Information on the lot/batch number has been requested. | | 860 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1100431-1 | stroke; eye also felt funny found she blew a blood vessel; After the 2nd shot on the 29th she had the taste of rubber bands in her mouth; her face started to go numb.; Her Blood pressure was 150; she felt like she was hit by a truck; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received second of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included migraines and they cause numbness in her face sometimes. The patient's concomitant medications were not reported. After the 1st shot of BNT162B2 she had a metal taste in her mouth. After the 2nd shot on the 29nd she had the taste of rubber bands in her mouth. After waiting 10 mins her face started to go numb. Her Blood pressure was 150. HCP thought it was a stroke but she just went home. She had a history of migraines and they cause numbness in her face sometimes. She took migraine medications and it didn't help. Next day face numbness went away but she felt like she was hit by a truck. Her eye also felt funny found she blew a blood vessel. The outcome of events was unknown. Information on the lot/batch number has been requested. | | 861 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1114318-1 | I was in the hospital on Thursday and Friday for a mini stroke; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3246), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was scheduled to get her second shot tomorrow (16Feb2021). She had the first one 3 weeks ago and was looking at the paper work just to make sure that she did not miss anything and it said tell the vaccination provider about medical conditions including if you were on a blood thinner. The patient stated that she was hospitalized last 4 days ago, she had a blood disorder, blood thinner. The patient was in the hospital on Thursday (11Feb2021) and Friday (12Feb2021) for a mini stroke and was prescribed a blood thinner (Treatment) that she took one Saturday morning one Sunday morning and one this morning (15Feb2021). The outcome of event was unknown. | | 862 | COVID19 (COVID19 (PFIZER-BIONTECH)) | Unknown | Unknown | 1123139-1 | then had a stroke; This is a spontaneous report from a contactable consumer. A female patient (mother) of an unspecified age (Age: 87; Unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 23Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the pfizer covid 19 vaccine and then had a stroke on an unspecified date. Reporter wanted to know the maximum amount of time between the first and second dose. The outcome of the event was unknown. Information on the lot/batch number has been requested. | | 863 | COVID19 (COVID19 (UNKNOWN)) | 60-64 years | 0 days | 1111915-1 | Stroke bland left hemispheric ... resolvesd | | 864 | COVID19 (COVID19 (UNKNOWN)) | 65+ years | 1 day | 0994003-1 | Stroke like symptoms consisting of facial asymmetry & slurred speech. Patient sent to stroke facility w/ Neurology services. | | 865 | COVID19 (COVID19 (UNKNOWN)) | 65+ years | 1 day | 1122561-1 | Patient had a stroke the day following immunization. | | 866 | COVID19 (COVID19 (UNKNOWN)) | 65+ years | 2 days | 1058033-1 | Patient had a stroke two days after vaccine. Recevied TPA for treatment of stroke due to acute onset of altered mental status. Had a history of afib, not on anticoagulation, which is likely cause of stroke. Family opted for comfort measures given poor neurologic status. Passed awaiting hospice placement | | 867 | COVID19 (COVID19 (UNKNOWN)) | Unknown | 5 days | 0999881-1 | after having the COVID-19 vaccine, she mentioned that she was very sick in the hospital and is now getting well; She had seizures after receiving the MMR vaccine; She described her adverse reaction by having stroke like symptoms which she described as she cannot speak; She described her adverse reaction by having stroke like symptoms which she described as having numbness in her hands, face and lips; She described her adverse reaction by having stroke like symptoms which she described as having numbness in her hands, face and lips; She also felt exhausted; she also has pain in her arm; She mentioned that she also has her vision affected/She couldn't drive/There were wavy lines all trough her eyes; She described her adverse raction by having intense headaches/She described her adverse reaction by having stroke like symptoms which she described as having headaches; She described her adverse reaction by having stroke like symptoms; She started to have hallucinations such as seeing people that weren't there, seeing snowstorms, and seeing things shipping throughout the wind.; This spontaneous report has been received from Pfizer Inc, and a nurse, referring to a 65-year-old female patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided. On unspecified date (reported as when the patient was younger), the patient was vaccinated with measles, mumps, and rubella virus vaccine (manufacturer unknown) (dose, vaccine scheme, route of administration, anatomical location, lot number and expiration date were not provided), as prophylaxis. On an unknown date, after received the measles, mumps, and rubella virus vaccine (manufacturer unknown), the patient had seizures. She mentioned that she did not have adverse event (AEs) with other immunizations but the measles, mumps, and rubella virus vaccine (manufacturer unknown). On 30-DEC-2020, the patient was vaccinated with the first dose of included SARS-CoV-2 spike protein mRNA vaccine (PFIZER BIONTECH COVID-19 VACCINE) (dose, route of administration and anatomical location were not provided), as prophylaxis. On an unknown date, after SARS-CoV-2 spike protein mRNA vaccine (PFIZER BIONTECH COVID-19 VACCINE) vaccination, she was very sick in the hospital. On 04-JAN-2021, she stated to experience an adverse reaction described as having intense headaches, having stroke-Iike symptoms (cerebrovascular accident), as she could not speak (speech disorder), having headaches, having numbness in her hands, face, and lips (hypoaesthesia and hypoaesthesia oral). The patient also felt exhausted (fatigue), had pain in her arm (but for that event she reported that she was not very concerned). Additionally, she mentioned that her vision was affected, she could not drive, and there were wavy lines all through her eyes (visual impairment). She also started to have hallucinations, such seeing people that weren't there, snowstorms, and things shipping throughout the wind. It was reported that the patient wanted to know recommendations about the second shot of the SARS-CoV-2 spike protein mRNA vaccine (PFIZER BIONTECH COVID-19 VACCINE) because with her experience, she was not comfortable having the second shot of that vaccine. At the reporting time, the patient was getting well from the event illness. The outcome of the cerebrovascular accident, headache, visual impairment, pain in extremity, fatigue, hypoaesthesia oral, hypoaesthesia, speech disorder, seizure and hallucination was not reported. The causality assessment between the event seizure and measles, mumps, and rubella virus vaccine (manufacturer unknown) was not provided. The causality assessment between the events illness, cerebrovascular accident, headache, visual impairment, pain in extremity, fatigue, hypoaesthesia oral, hypoaesthesia, speech disorder, seizure and hallucination and the suspect vaccine was not provided. Upon internal review, the events cerebrovascular accident, hallucination and seizure were determined to be medically significant. |
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