| # | Vaccine Manufacturer | Onset Interval | Age | VAERS ID | Adverse Event Description | | 1 | JANSSEN | 0 days | 65+ years | 1111792-1 | 3-14-21 @ 10PM, slipped to the floor and was unable to get up for 2hr until a family member arrived to help him up. reports he can walk when walking slowly. reports he had a 2ndary fall outside in his driveway on 3-16-21 before going to the doctor. Denies numbness, tingling, paralysis describes What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): PCP visit, had blood work and urine sample. Is expected to go back Tuesday (3-23-21) | 1 | | 2 | JANSSEN | 7 days | 30-39 years | 1089578-1 | Bilateral upper and lower extremity paralysis, jaw clenching, dystonic contracting of bilateral upper and lower extremities. Urinary retention. | 1 | | 3 | JANSSEN | 10-14 days | 50-59 years | 1163209-1 | Numbness in extremities, paralysis full body. Pneumonia left lung. Now diagnosed with Guillain-Barre syndrome, due to reaction to covid-19 vaccine | 1 | | 4 | JANSSEN | 15-30 days | 40-49 years | 1202379-1 | Significant flaccid paralysis in the right arm and right leg with some difficulty swallowing | 1 | | 5 | JANSSEN | 15-30 days | 60-64 years | 1186151-1 | Severe COVID-19 infection with ARDS. Requiring mechanical ventilation, paralysis and flolan nebulization. | 1 | | 6 | MODERNA | 0 days | 30-39 years | 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 | 1 | | 7 | MODERNA | 0 days | 65+ years | 1094159-1 | Motor paralysis of the left foot. Could not move at all.: dorsiflex, plantar flex, invert, or evert | 1 | | 8 | MODERNA | 0 days | 65+ years | 1101161-1 | couldn't move her body at all; lay there unable to move or crawl or even pull herself up for 6-7 hours before she was discovered; no recollection of this episode of what happened to her or what she was doing at the time it occurred; she fell to her garage floor; speech was gargled; brain fog and difficulty; residual confusion; local reaction limited arm movement; local reactions such as pain; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced local reactions such as pain and limited arm movement (vaccination site movement impairment/vaccination site pain), fell to garage floor (fall), couldn't move body at all (paralysis), lay there unable to move or crawl or even pull self up for 6-7 hours before discovered and taken to hospital (paralysis), brain fog and difficulty (feeling abnormal), no recollection of this episode of what happened or what she was doing at the time it occurred (amnesia), speech was gargled (dysarthria), and brain fog is improved now but still has some residual confusion (delirium). The patient's medical history was not provided. Relevant concomitant medications were not reported. On 27 FEB 2021, prior to the onset of events, the patient received their second dose of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 27 FEB 2021, the patient experienced vaccination site movement impairment and vaccination site pain. On 28 FEB 2021, the patient experienced paralysis, amnesia, fall, dysarthria, and feeling abnormal and due to these events hospitalization was required. On 04 MAR 2021, the patient experienced Delirium. Laboratory details was provided as CT Scan on 28 FEB 2021 and the result was normal. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. At the time of this report, the outcome of the event's, local reactions such as pain and limited arm movement,fell to garage floor, couldn't move body at all , lay there unable to move or crawl or even pull self up for 6-7 hours before discovered and taken to hospital, brain fog and difficulty, no recollection of this episode of what happened or what she was doing at the time it occurred, speech was gargled, and brain fog is improved now but still has some residual confusion, 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. | 1 | | 9 | MODERNA | 1 day | 40-49 years | 0987242-1 | Paralysis, weakness, numbness in bilateral lower extremities. Symptoms started 1/26/2021 resulting in hospitalization. Discharged on 1/28/2021 with Out-patient physical therapy | 1 | | 10 | MODERNA | 1 day | 40-49 years | 1050142-1 | Paralysis for 2 days. Unable to use either arm, barely able to bear weight or walk. Had to be fed, given water, and helped to go to the bathroom. | 1 | | 11 | MODERNA | 1 day | 65+ years | 1086931-1 | Shingles in the ear; Passed out; Couldn't mover her arm, head, legs, chest, felt paralyzed; Felt weak; A spontaneous report was received from a consumer concerning a female patient of 75 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced loss of consciousness, paralysis, weakness and shingles in the ear. The patients medical history, as provided by the reporter, included myasthenia gravis. Concomitant medications reported included lidocaine patch and prednisone. On 10 feb 2021,prior to the onset of events, the patient received their first of two planned dose of mRNA-1273(Lot number:010M20A ) intramuscularly on an unknown arm for prophylaxis of COVID-19 infection. On 11 feb 2021, one day after vaccination,patient experienced loss of consciousness,paralysis and weakness. The event loss of consciousness and paralysis was also considered to be medically significant. On 16 feb 2021, patient experienced shingles in the ear. Treatment for the events included acyclovir and ice. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the events loss of consciousness, paralysis, weakness and shingles in the ear were considered as unknown.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. | 1 | | 12 | MODERNA | 1 day | Unknown | 1086874-1 | Paralysis of entire body; A spontaneous report was received from a consumer concerning a 79-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced paralysis of his entire body. The patient's medical history was not provided. Concomitant products included Evolocumab, blood pressure medication and metformin. The patient received the first of two planned doses of mRNA-1273 (Batch number: unknown). The date of administration of first dose of vaccine was not mentioned. On 19 Feb 2021, approximately one day prior to the onset of the event, the patient received the second dose of two planned doses of mRNA-1273 (Batch number:006M20A) intramuscularly for prophylaxis of COVID-19 infection. On 20 Feb 2021, Patient experienced paralysis of his entire body at night and the ambulance had to come to put him back in bed. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The event paralysis of his entire body, was considered resolved on 21 Feb 2021.; 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. | 1 | | 13 | MODERNA | 2 days | 65+ years | 1100271-1 | Lost control of muscles; ended up blacking out; could not move; could not talk; A spontaneous report was received from a Consumer concerning about a 82 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Paralysis, Syncope, Mobility decreased and Aphasia. The patient's medical history was provided as diabetes, dementia as current illness. Relevant concomitant medication was reported as blood thinner for blood clots. On 08 FEB 2021, prior to the onset of event, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 10 FEB 2021, the patient experienced Paralysis, Syncope, Mobility decreased and Aphasia. Due to these events patient's required hospitalization and on oxygen. Laboratory details was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event's Paralysis, Syncope, Mobility decreased, and Aphasia was as unknown.; Reporter's Comments: The events were consistent with increased risk of cerebrovascular complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product. | 1 | | 14 | MODERNA | 4 days | 65+ years | 1078636-1 | Severe onset of autoimmune vasculitis and renal failure. Loss of movement & sensation (paralysis) of left arm and leg. Mild cognitive deficit and confusion. Fell due to loss of use of L leg. Hospitalized x 5 days, now in rehab facility slowly regaining function of L arm and leg, and relearning how to walk. Sudden renal failure (stage 4 renal disease) onset suddenly as well with this reaction. | 1 | | 15 | MODERNA | 5 days | 60-64 years | 0982023-1 | Third cranial nerve palsy; A spontaneous report was received from a 63-year-old male pharmacist who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed third cranial nerve palsy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 31 Dec 2020, approximately 5 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 left arm for prophylaxis of COVID-19 infection. On 05 Jan 2021, the patient began to have blurred vision which progressed into double vision. He then experienced a headache that felt similar to when you have the wrong prescription glasses or cross-eyed. On 06 Jan 2021, he was seen by his ophthalmologist who ordered a CT scan which was negative. His eyelids were drooping and he wore an eye patch on the right eye because his right eye is completely shut. The patient reports that the muscle that keeps the pupil in focus in the middle is paralyzed, so his pupil is turned to the right and down, which is what was causing the double vision.The treatment of the event include eye patch. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, third cranial nerve palsy, was considered unknown.; Reporter's Comments: This case concerns a 63 year old male patient, who experienced a serious unexpected event of IIIrd nerve paralysis. The events of IIIrd nerve paralysis occurred 6 days after first dose of mRNA-1273, lot # 037K20A. Diagnostics included a CT scan, which revealed no abnormality. Treatment for the event include eye patch and no other details were provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded. | 1 | | 16 | MODERNA | 6 days | 18-29 years | 0970949-1 | I had left arm pain and swelling for 3 days following the injection. By the 20th symptoms were more tolerable and mild, the 22nd I had Bell?s palsy and left side paralysis and had to go to the ER. Now I?m on antiviral medication. | 1 | | 17 | MODERNA | 7 days | 30-39 years | 1042447-1 | Intense pain at the injection site and radiating down right arm for 24 hours after the injection. 72 hours after injection paralysis of right wrist possible radial nerve damage. | 1 | | 18 | MODERNA | 8 days | 65+ years | 0967969-1 | cerebral hemorrhage and left sided paralysis of the body | 1 | | 19 | MODERNA | 15-30 days | 65+ years | 1039884-1 | Lost control of bladder; Could not walk; Paralyzed from the waist down for about 24 hours; Received the 2nd dose on 22Jan; Diarrhea; Vomiting; A spontaneous report was received from a consumer, concerning a 67-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced paralyzed from the waist down for about 24 hours/PT: Paralysis, received the 2nd dose on 22 Jan 2021/PT: inappropriate schedule of product administration, lost control of bladder/PT: urinary incontinence, could not walk/PT: gait inability, diarrhea/PT: diarrhoea, and vomiting/PT: vomiting. The patient's medical history was not provided. Concomitant medications included omeprazole, fluoxetine hydrochloride, propranolol, colestipol, acetylsalicylic acid, and calcium. The patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) on 28 Dec 2020. On 22 Jan 2021, the same day as the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, following the second vaccination, the patient experienced vomiting and diarrhea. On 23 Jan 2021, the patient could not walk, was paralyzed from the waist down for about 24 hours, and lost control of her bladder. Treatment information for the events was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events was not applicable. The outcome of the event, paralyzed from the waist down, was considered recovered/resolved on 24 Jan 2021. The outcome of the event, received second dose on 22 Jan 2021, was considered resolved on 22 Jan 2021. The outcome of the events, vomiting, diarrhea, could not walk, and lost control of bladder, was unknown.; Reporter's Comments: This case concerns a 67 year old female subject, who experienced a serious unexpected event of paralysis after second dose of mRNA1273 (Lot# 032L20A). Very limited information regarding this event has been provided at this time. Further information has been requested. | 1 | | 20 | PFIZER\BIONTECH | 0 days | 30-39 years | 0960439-1 | Cardiac event; Paralysis; Fever; Numbness; Chest Pains; Dizziness; Weakness; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient started to receive first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 15Jan2021 14:15 at SINGLE DOSE for covid-19 immunisation. The patient was not pregnant. Medical history included tachycardia, Pre-ventricular contractions, allergies to Latex, covid-19 (reported as covid prior vaccination: Yes). Concomitant medication included metoprolol and multivitamin. No other vaccine received in four weeks. On 15Jan2021 14:30, the patient experienced chest pains, dizziness, weakness. On 15Jan2021 18:20, the patient experienced cardiac event, paralysis, fever, numbness, chest pains. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event)]. Treatment received for the events. No covid tested post vaccination. The outcome of the events was recovering. Information on batch/lot number was requested. | 1 | | 21 | PFIZER\BIONTECH | 0 days | 50-59 years | 1004433-1 | bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose ""on the left side"" for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer. She asked if shellfish is in the vaccine. Information about lot/batch number has been requested."" | 1 | | 22 | PFIZER\BIONTECH | 1 day | 65+ years | 0990523-1 | he is shrinking; chills; tired; cant walk; it hit me like I had the virus; it hit me like I had the virus; My eyes are hurting; no matter which way I turned it was hurting, knees, everything was hurting really bad/aches and pain; dizzy/dizziness; weak; muscle pain; joint pain/back knees elbow joint pain; fever; headaches; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received first dose of bnt162b2 (Pfizer BioNtech Covid 19 vaccine, lot number EL1283) , via an unspecified route of administration on 17Jan2021 01:15 at single dose for covid-19 immunisation. Medical history included open heart surgery 11 years ago, covid-19 from Jul2020 to an unknown date. The patient's concomitant medications were not reported. The patient received bnt162b2 yesterday, with no problems. However today (18Jan2021), in 15 minutes after waking up at 11, he had the chills really bad, that went away, then he went to sleep again and woke up and he had all the symptoms on the paperwork, he had dizziness, headache, he's hardly ever had a headache ever. He had aches and pain. Caller states that he was just asking right now about another company, and their vaccine in started with an M, and her daughter is at a girls home, because she has a epileptic type thing, and this particular shot, that started with M, the nurse called over, and the problems that he is having he explained to the nurse is like when he had the virus previously about in Jul2020, when he had the virus he was in hospital for a week, because he had to get rid of the virus, and they got him out of that. Now he took this shot yesterday and the next day is when he got all these symptoms, he's tired, cant walk, muscle pain, had chills not any more, pain in the knees, everywhere really, he couldn't get any position to go back to sleep, his back knees elbow joint pain. Since he had these things, the nurse at the girls home, told his wife if having these problems he can take 300 mg of Zinc, 1000mg of Vitamin C, and 2000IU or Vitamin D, the same thing, that amount, he asks will it over come the symptoms. Another person felt good after getting those, it helped him he does state however that is what the person took when he actually had the Covid 19 Virus. Caller states that he received paperwork after the vaccine from the (State), it has a bunch of blocks asking if he has this or that symptom. His First dose was 17Jan2021 at 1:15, then on 07Feb2021 if this Second Dose. All the side effects started Today 18Jan2021. His doctor said he's in good health. He did have open heart surgery 11 years ago. The patient reported he is 5 feet 8 and a half inches, he is shrinking. He stated, ""I was good until this morning, it hit me like I had the virus. The product they gave me at the (State) was the Pfizer-biontech vaccine. I had all the symptoms except vomiting/throwing up. I got all the other symptoms. no matter which way I turned it was hurting, knees, everything was hurting really bad. I was dizzy and weak so I don't want to walk around too much. I had muscle pain, joint pain, fever, headaches, chills, never went away. I hurt everywhere. I am really weak. My eyes are hurting. My daughter is in a girls home (paralysis problem). They had the vaccine from the another company and they have heard so many negative stuff so they decided they did not want to, when my wife told her I was having these problems. I had the virus 4 months, the nurse told me to take 300mg of zinc, 1000mg vitamin C and 2000mg vitamin D (the person took that when he had the disease). Should I take this stuff? Is there any information on that? what's in this? protein? my wife got the disease. They said she had enough antibodies. How long is the immunity? When does it start?"" The outcome of the event chills was resolved, of other events was unknown."" | 1 | | 23 | PFIZER\BIONTECH | 1 day | 65+ years | 1129059-1 | The vaccine was administered to this patient while in Skilled Nursing Care at this facility for Lumbar Spinal Stenosis. Following the injection the patient has experienced intermittent fever of unknown origin, severe skin pain to extremities, and paralysis to both upper and lower extremities. The symptoms are being investigated and the patient remains hospitalized. | 1 | | 24 | PFIZER\BIONTECH | 2 days | 18-29 years | 1045622-1 | phrenic nerve damage resulting in unilateral diaphragm paralysis; phrenic nerve damage resulting in unilateral diaphragm paralysis; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 03Feb2021 11:45 (lot number EN9581 and expiry date unknown) at single dose for Covid-19 immunization in the physician office (doctor's office/urgent care). Medical history included anxiety, scoliosis, milk thistle allergies, laundry detergent fragrance allergies. The patient has no covid prior vaccination. Concomitant medication included clonazepam (KLONOPIN), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP) and ""multi-vita""; all from unspecified date for unspecified indication. The patient previously took diflucan and experienced allergies. The patient had no other vaccine in four weeks. On 05Feb2021 (two days after receiving vaccination), the patient experienced phrenic nerve damage resulting in unilateral diaphragm paralysis. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment due to the events. The patient was not covid tested post vaccination. The outcome of the events was recovering. Follow-up activities are possible, information on the batch number has been requested."" | 1 | | 25 | PFIZER\BIONTECH | 4 days | 65+ years | 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. | 1 | | 26 | PFIZER\BIONTECH | 8 days | 40-49 years | 0971280-1 | left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left jaw; face swelling including eyes; left ear and teeth pain; left ear and teeth pain; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; numbness/swelling to left side of face/some numbness and tingling intermittent left arm; numbness/swelling to left side of face; some numbness and tingling intermittent left arm; Left neck stiffnes and pain; Left neck stiffnes and pain; Left arm pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Dec2020 15:45 at left arm, at single dose for covid-19 immunization. Medical history included facial paralysis from 2010, ongoing chronic migraine, Known allergies was None. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen; paracetamol (TYLENOL); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient was not pregnant at the time of vaccination. The patient experienced left arm pain day of vaccine lasting through the week from 23Dec2020 06:00. Headache everyday after. On 28Dec2020 the patient noted numbness/swelling to left side of face, some numbness and tingling intermittent left arm. Left neck stiffness and pain. On 31Dec2020 increased left neck pain 10/10 and noted drooping of right side of face at mouth, left ear and teeth pain. On 02Jan2021 face swelling including eyes, increase ear and teeth pain including left jaw. Headache and neck pain continued. On 05Jan2021 Virtual visit with NNP started AbX and steroids (possible bells palsy flair up) and dentist visit no issues with teeth. On 08Jan2021 neurology visit diagnosed with bells palsy reoccurrence related to vaccine. Throughout the week increased numbness, tingling, and pain to left arm. With intermittent sciatic type pain to left leg. her whole left side had felt different since the vaccine. Constant left arm numbness, tingling, and pain since 09Jan2021. Minimal relief from headaches pain from 8 to 5. On 13Jan2021 10/10 left arm pain, sharp, stabbing, weak, painful to move. Treatment Steroids, pain meds, and MRI scheduled were received. All events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event headache was recovering, the outcome of the other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association, the facial paralysis recurrence is possibly related to suspect BNT162b2 administration. 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. | 1 | | 27 | PFIZER\BIONTECH | 8 days | 65+ years | 1075693-1 | Patient is a 66 y.o. male who presents as a transfer to Hospital from an outside hospital for ICH. Patient states around 1130 he was running on the treadmill and noticed sudden left-sided weakness and decrease in station. He arrived outside hospital and was found to have left-sided hemibody weakness, left-sided decrease in station and a right gaze preference. CT at outside hospital showed large ICH with 3 mm of midline shift and vasogenic edema. repeat scan was performed and showed 7 x 2 x 4 cm frontal parietal region hemorrhage. Patient is now in rehab and states he has left sided paralysis | 1 | | 28 | PFIZER\BIONTECH | 9 days | 65+ years | 1079864-1 | 9 days after receiving vaccine, pt developed rapid onset of ascending paralysis. No use of legs, minimal use of right arm. Limited use of left arm. Repiratory difficulty/failure. | 1 | | 29 | PFIZER\BIONTECH | 10-14 days | 65+ years | 1052747-1 | Patient presented to hospital with increasing SOB, dyspnea on 2/22/21 (vaccine dose on 2/9/21). Patient is still currently admitted to monitor respiratory status and has been diagnosed with unilateral diaphragmatic paralysis. | 1 | | 30 | PFIZER\BIONTECH | 10-14 days | 65+ years | 1201247-1 | Paralysis (CMS/HCC) death | 1 | | 31 | PFIZER\BIONTECH | 10-14 days | 65+ years | 1207253-1 | Death Paralysis | 1 | | 32 | PFIZER\BIONTECH | 15-30 days | 40-49 years | 1017109-1 | Visual problems, diplopia, concerns for left 4th cranial nerve paralysis | 1 | | 33 | PFIZER\BIONTECH | 15-30 days | 60-64 years | 1055759-1 | Loss of use right leg. Paralysis, numbness, tingling, severe pain, and muscle spasms. Acute onset without other trauma | 1 | | 34 | PFIZER\BIONTECH | 15-30 days | 60-64 years | 1098511-1 | 2 weeks after receiving the 2nd dose, do you feel loved left neck had an apathy and sore throat, had pharyngitis laryngitis was seen by knee urgent care hand emergency room hand tested negative for Covid and strep. Developed left vocal cord paralysis and constant flu like symptoms that have lasted for six weeks. My vocal cords will mean to me injected need to paralysis | 1 | | 35 | PFIZER\BIONTECH | 15-30 days | 65+ years | 1081039-1 | Patient presented with acute onset of rapidly progressing ascending weakness and paralysis and associated decrease in sensation | 1 | | 36 | PFIZER\BIONTECH | 15-30 days | 65+ years | 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. | 1 | | 37 | PFIZER\BIONTECH | 31-60 days | 65+ years | 1084326-1 | Patient developed ascending paralysis and was diagnosed with transverse myelitis. All work up has been negative for other etiologies. Lumbar puncture performed showing elevated cell count, elevated protein and low glucose. | 1 | | 38 | PFIZER\BIONTECH | 61-120 days | 50-59 years | 1098619-1 | Pain and paralysis in all 4 extremities. Burning and stabbing sensation, bulging veins in hand. Was hospitalized from 2/28 until 3/5. Left hospital with no diagnosis and no real relief | 1 | | 39 | PFIZER\BIONTECH | Unknown | Unknown | 1035537-1 | developed paralysis in the opposite part of the body; Her hand, fingers and knee all became swollen; Her hand, fingers and knee all became swollen; This is a spontaneous report from a contactable consumer via Pfizer Sponsored program Pfizer First Connect. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient took the first dose of the vaccine on an unknown date for COVID-19 immunization. In Feb2021, about 12 hours after getting the vaccine, the patient developed paralysis in the opposite part of the body where she didn't get the vaccine. Her hand, fingers and knee all became swollen. She had the symptoms on her right and was given the vaccine in her left. The final outcome of the events was unknown.Information on lot/batch number has been requested. | 1 | | 40 | UNKNOWN MANUFACTURER | 8 days | 60-64 years | 1005284-1 | Per patient report, he states he received the first dose of the COVID19 vaccine on 1/23/21. He began noticing sporadic arm twitching , jerking, and paralysis on 1/31/21. He went to urgent care who told him the vaccine may have hit a nerve and to come to ED if not improving. He states the symptoms worsened so he came to the ED for a full workup. | 1 |
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