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CDC VAERS and Covid-19 ‘Vaccines’: Records of Adverse Events containing the word 'paralyzed' or 'paralysis' as of April 16, 2021.
4/29/2021 | Vanity, based on CDC VAERS data

Posted on 04/29/2021 7:33:19 PM PDT by ransomnote

This thread post is long because it contains over 200 records of reported adverse events in VAERS in which the adverse event description contains the word 'paralysis'. For this reason, if you want to read the comments, you may want to return to the forum and click 'reply' beneath the title of the thread.

The vast majority of events including the words paralyzed or paralysis pertain to facial paralysis (Bell's Palsy or other). However, I may have missed records which used 'Bell's Palsy' and omitted the word 'paralysis'.

Many reports detail temporary loss of hands/arms and some ability to stand.

Approximately 40 detail long term loss of of limb movement, all extremeties paralized, or whole/entire body paralysis. 2 reports detail partial vocal cord analysis. I'll put that excerpted data, which excludes facial paralysis (specifically Bell's Palsy) in Post #1 below.

2 reports detail 'paralysis/death A few report 'ascending paralysis' starting at the extremeties and moving up the body with time. Many report transitory paralysis of arm(s) and hand(s).

There are still 2- 4 records in the group which negate paralysis (e.g., 'no paralysis').

I'll put a summary table and chart illustrating the number of days after vaccination prior to the onset of paralysis here.

 

Note that the CDC has not updated VAERS with most of the reports the CDC received, and only a fraction of a percent of actual adverse reactions are ever reported to VAERS. In the chart below, you can see that the CDC dramatically reduced reporting after January - there are almost no reports for April.

About 2 months ago, VAERS sharply decreased their entry of current reports received and began filling in some old reports from December.

The full record of 228 reports to VAERS (observations only, not the result of forensic analysis or indicating legal liability) below. 

If you find this full table of data useful, please copy and paste it into MS Excel and share it. Yesterday the CDC 'updated' their software and this data will not be available going forward.

I'll put the isolated list of VAERS patient ID's below the table for those who may want to make their own exports for the group of patients in the table, or look up individual records.

#

Manufacturer

Onset Interval

Age

VAERS ID

Month Vaccinated

Adverse Event Description

1JANSSEN0 days40-49 years1159539-1Mar. 2021immediately felt tingling in left arm (like ben gay), then after about 10 min felt go into neck and and cheek. A little light headed. At 15 minutes asked nurse if normal. Then started sweating. left hand turned purple. Dont really remember anything else. Went unconscious. Remember them yelling Code something and Cardiac arrest. Taken to ER. Think they may have said anaphalatic shock. I think they gave me epinepherine. Had paralysis in left hand when i woke up for a few minutes. Blood work and EKG were normal. Went home within a couple of hours. Light-headed two days later still. Saw doctor two days after. Blood pressure is high.  Little bit of fatigue and brain fog.
2JANSSEN0 days40-49 years1183606-1Apr. 2021Small Cold Sore began to appear on bottom lip midday - 1/2pm  Fatigue hit hard - 4pm  Fever/chills - 7pm  Numbness and mild paralysis on left side of face - 11pm
3JANSSEN0 days65+ years1111792-1Mar. 20213-14-21 @ 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)
4JANSSEN0 days65+ years1131797-1Mar. 2021Right Unilateral Cranial Nerve 7 Paralysis, 6 hours after administration of vaccine, associated symptoms included diarrhea, emesis Treatment included prednisone and valacylovir
5JANSSEN7 days30-39 years1089578-1Mar. 2021Bilateral upper and lower extremity paralysis, jaw clenching, dystonic contracting of bilateral upper and lower extremities. Urinary retention.
6JANSSEN10-14 days50-59 years1163209-1Mar. 2021Numbness in extremities, paralysis full body. Pneumonia left lung. Now diagnosed with Guillain-Barre syndrome, due to reaction to covid-19 vaccine
7JANSSEN10-14 days50-59 years1182506-1Mar. 20214/6/21 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
8JANSSEN15-30 days40-49 years1170056-1Mar. 2021The 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.
9JANSSEN15-30 days40-49 years1202379-1Mar. 2021Significant flaccid paralysis in the right arm and right leg with some difficulty swallowing
10JANSSEN15-30 days50-59 years1151131-1Mar. 2021The morning of 3/29/2021 patient noticed right side facial drooping/paralysis around 8:30am. Her vaccine dose of COVID-19 (Janssen) was given on 3/8/2021. Patient was seen by her general practitioner on 3/29/2021. He ordered a brain CT with contrast. Patient is awaiting results. She was given prednisone 10mg  twice daily. She is going to follow up with physician today (3/31/2021).
11JANSSEN15-30 days50-59 years1173013-1Mar. 2021Left-sided Bell's Palsy, facial droop, headache syndrome, neck and jaw pain, facial paralysis and numbness, left eye dryness (does not close) Treatment:  ketorolac (TORADOL), followed by 10 days predniSONE 20 mg and 5 days valACYclovir 1gram 2 weeks later, still have all symptoms...  some improvement with facial droop. Numbness remains, headache neck and jaw pain remain fairly constant...  Ibuprofen and Naproxen used for treatment.
12JANSSEN15-30 days60-64 years1186151-1Mar. 2021Severe COVID-19 infection with ARDS.  Requiring mechanical ventilation, paralysis and flolan nebulization.
13MODERNA0 days18-29 years0946271-1Jan. 2021Uncontrollable tremors, flopping around like a fish out of water, head pressure, like my head was a balloon and it was being inflated. Temporary paralysis, felt like a magnet was pulling me down. dizziness, light sensitivity, no appetite, blurred vision.   It really sucked......
14MODERNA0 days18-29 years0950870-1Jan. 2021Paralysis of arm injected, erythema and edema surrounding injection site. Mottled skin, headache, extreme fatigue,  abdominal cramping, diarrhea. Onset 3 hours post injection. Over the counter meds, Tylenol extra strength , ibuprofen, Benadryl. 72 hours mostly resolved symptoms
15MODERNA0 days30-39 years0921386-1Dec. 2020Patient was vaccinated in upper left arm with COVID Moderna vaccine on 12/30/20 at around 4:25 p.m. Around 5:00 p.m. patient developed tingling feeling in left side of face which lasted remainder of day. Patient took Benadryl which seemed to help symptoms. On 12/31/20 left side of face had slight swelling which went away over course of day. Tingling has continued on and off since 12/30/20 and at times has manifested as mild jaw or muscle pain on left side of face. No diminished function in eye, mouth, and no paralysis or sagging in facial features.
16MODERNA0 days30-39 years0933771-1Jan. 20211/7- RECEIVED VACCINE AND REPORTED HAVING TINGLING TO LIPS (A FEW HOURS LATER), TOOK BENADRYL AND REPORTED THAT TINGLING WENT AWAY.  1/8- REPORTED TINGLING TO LEFT OUTERLIP AND AND WENT TO ER AND DIAGNOSED WITH BELL PALSY / FACIAL PARALYSIS AFTER EVALUATION
17MODERNA0 days30-39 years1097867-1Mar. 2021Headache, 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
18MODERNA0 days30-39 years1098995-1Jan. 2021Within 3 hours of getting g the vaccine my blood pressure went up, my breathing became difficult & the whole left side of my body went into paralysis. I was taken to the ER, later that day was admitted to the hospital. I spent 5 days there getting tested. I was released with 0 use of my left arm or hand, and my left leg was weak. It?s been 3 months and I still can?t use my left arm. I am seeing multiple different doctors to try & help me.
19MODERNA0 days30-39 years1179191-1Jan. 2021Upper extremity dysfunction; felt like it was paralyzed; Left arm hurt; pain in shoulder down to armpit; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (felt like it was paralyzed) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Migraine and Sinus disorder. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and SALBUTAMOL (ALBUTEROL HFA) for Asthma, IBUPROFEN for Migraine.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 06-Jan-2021, the patient experienced PARALYSIS (felt like it was paralyzed) (seriousness criterion medically significant), PAIN IN EXTREMITY (Left arm hurt) and PAIN (pain in shoulder down to armpit). On an unknown date, the patient experienced MUSCULOSKELETAL DISORDER (Upper extremity dysfunction). At the time of the report, PARALYSIS (felt like it was paralyzed) and PAIN IN EXTREMITY (Left arm hurt) had resolved and PAIN (pain in shoulder down to armpit) and MUSCULOSKELETAL DISORDER (Upper extremity dysfunction) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  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.
20MODERNA0 days30-39 years1198211-1Feb. 2021The patient received his 2nd dose of Moderna (LOT#, site, time unavailable) at an outside clinic the morning of 2/10/21 and presented to the ED with coughing and hypoxia (sp02 occasionally dropping into 70's) at 8 PM that day.  He had quadriplegic spinal paralysis as a result of a remote MVA and has been hospitalized and critically ill in the past due to recurrent UTI's and pneumonia with associated sepsis.   CT negative for pulmonary embolism and showed bilateral infiltrates.  Clinical presentation consistent with bilateral pneumonia and started on Rocephin/azithromycin.  He was initially stable in the hospital on 1-2 LPM 02.  The following evening he became febrile and acutely developed asystole without any pre-existing arrhythmia.  Resuscitation was attempted for 45 minutes but unsuccessful.  Overall, I suspect his death was related to bacterial pneumonia and resulting acute respiratory failure, complicated by his quadriplegia and autonomic dysreflexia but reported this event as it did occur within 2 days of receiving his 2nd Moderna vaccination.
21MODERNA0 days40-49 years0912735-1Dec. 202012/28/2020 flushed neck to face and R side face paralysis (duration for 30 minutes). symptoms resolved and pt feeling better  No further symptoms to report
22MODERNA0 days40-49 years0934729-1Jan. 2021Thursday night shortly after the vaccine I was exhausted and headed home to go lay down. While driving, I developed a severe headache. I went home and went to sleep really early. Friday morning, woke up, went to work. Extreme lethargy and severe headache. Left work early (2 ish) with joint pain, headache, lethargy. In the evening (still Friday) I went to the grocery store and walking in the parking lot to the store my joints hurt with every step. I sent my partner in and I went back to the car. I could not do it. Went to sleep soon thereafter. Saturday morning, we woke up and had planned to go to the cabin. We were trying to run errands (coffee shop, post office, bank...simple errands) and I was exhausted and feeling bad. Still headache, lethargy, achy. Assumed it was flu like which was a side effect, so I continued to press on through the discomfort. Left for the mountains. less than 1 mile from home, started to feel tingling and ""buzzing"" throughout my body, like a vibration sort of. Stayed quiet and thought about this. Another block or two and the feeling was in my tongue. Then I felt it in each tooth root and spoke up. I asked to go home and rest for 30 minutes before going to the cabin. At this point, I could not move my hands. We got to the house and I could not open my car door or take off my seatbelt. I had hand paralysis for about 10 minutes. Made it in the house. Got to the couch and laid down for about 60 seconds. Got up had to use the restroom. Solid, not diarrhea, but took 45 minutes. Apparently, I was pale like a piece of paper. I do not remember being in the bathroom for 45 minutes, I felt like it was 5 minutes, partner said 45 minutes. Made it back to couch, laid down, freezing! Under 2 blankets, one of them was an electric blanket on high. Began throwing up, clear bile. Had not eaten anything yet. Stayed on couch, also lost track of time, was there for 5 ish hours. Tried to eat something so I could take Tylenol for the headache. Barely ate anything, so I never took the Tylenol. It lessened. Cabin trip cancelled. Still lethargy and dizzy yesterday but no joint pain, no nausea. Now, Monday morning, still dizzy/lightheaded. Symptoms are subsiding, but not gone.""
23MODERNA0 days40-49 years0951964-1Dec. 2020Part of face a little paralyzed; Part of face numb; Chills; Tiredness; A spontaneous report was received from a health care professional, who was a 45 year-old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced chills, tiredness, part of face numb, and part of face a little paralyzed.   The patient's medical history included type 1 diabetes. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the evening after vaccine administration, the patient experienced chills and tiredness.  On 31 Dec 2020 the patient woke up with his face numb and a little paralyzed. At the time of reporting, the patient mentioned that the numbness and paralysis on his face had been like that for various days and was still ongoing. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, chills and tiredness, was unknown. The outcome of the events, part of face numb and part of face a little paralyzed, was considered not resolved.; Reporter's Comments: This case concerns a 45 year old male patient with medical history of type I diabetes, who experienced a serious unexpected event of Facial paralysis, a NS unexpected event of Hypoaesthesia, and NS expected events of Chills and Fatigue. The events of Chills and Fatigue occurred on the same day when the patient received the first of two planned doses of mRNA-1273. The events of Facial paralysis and Hypoaesthesia occurred the next day of administration of mRNA-1273. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
24MODERNA0 days40-49 years1076153-1Mar. 2021Received vaccine on 3/3/21 at 2:30pm. Waited for 20 minutes at pharmacy for allergic reaction. Given the all clear, so headed home. Around 5pm, I started noticing how extremely sore my left arm was, almost as if somebody had hit it with a baseball bat (no bruising, redness, etc., just VERY sore). I also started noticing numbness and tingling in my left arm that traveled down the outside of my arm into my left hand and into my left pinky finger.   As the evening progressed, I lost my appetite, developed a headache, felt extremely fatigued, was dizzy, had muscle and joint aches, had left kidney pain, and began to feel flushed and hot. I took my temperature and it showed I was running a low-grade fever of 98.7F (my normal temperature is anywhere between 96.9F and 97.1F). I went to bed around 9pm.  Around 3am (which is now 3/4/21), I woke up with nausea, and my left arm/hand/finger really experiencing numbness and tingling (it's as if that portion of my arm/hand/finger was semi-paralyzed). I went to the bathroom and was on the verge of throwing up. I broke out into a cold, clammy sweat but did not vomit. I got back into bed and went back to sleep.  Around 5am (still 3/4/21), I woke up again with nausea and my left arm/hand/finger still numb and tingling (semi-paralyzed). I went to the bathroom and was again on the verge of throwing up. I, again, broke out into a cold, clammy sweat but did not vomit. I got back into bed. I decided to take a Zofran around 6am for the nausea.  I slept from 8am-12pm on 3/4/21 due to the Zofran. When I woke up, I called the pharmacist at pharmacy to notify them of my symptoms. The pharmacist everything I experienced was normal and should go away in 2-3 days (if they didn't then contact my regular doctor), that I could take Tylenol for any pain, and I still needed to keep my follow-up appointment for the second shot.  The entire day on 3/4/21 from 12pm until I went to bed around 10pm, I still experienced an extremely sore arm, loss of appetite, slight headache, fatigue, dizziness, muscle and joint aches, left kidney pain, low-grade fever (for me), and the numbness/tingling/paralysis in my left hand and left pinky finger.  I was able to sleep through the night, and woke up around 6am on 3/5/21. Currently, I am still experiencing an extremely sore arm, fatigue, and the numbness/tingling/paralysis in my left hand and left pinky finger. I am EXTREMELY concerned about the numbness/tingling/paralysis in my left hand and left pinky finger as it does not seem to be getting better.
25MODERNA0 days40-49 years1203129-1Jan. 2021left arm started to hurt pretty bad; patient felt flushed and hot; skin was red; shivering and shaking on left side of their body; left side numb, kind of Bells Palsy syndrome; feel cold in their shoulder; cold behind left eye then from wrist to behind both eyes; left side of the body was swollen, like swollen pecks, back and chest, like they had been stung; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical event).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PERIPHERAL COLDNESS (feel cold in their shoulder), ABNORMAL SENSATION IN EYE (cold behind left eye then from wrist to behind both eyes) and SWELLING (left side of the body was swollen, like swollen pecks, back and chest, like they had been stung). On 09-Jan-2021, the patient experienced FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome) (seriousness criterion medically significant) and CHILLS (shivering and shaking on left side of their body). On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm started to hurt pretty bad), HOT FLUSH (patient felt flushed and hot) and ERYTHEMA (skin was red). At the time of the report, FACIAL PARALYSIS (left side numb, kind of Bells Palsy syndrome), PERIPHERAL COLDNESS (feel cold in their shoulder), ABNORMAL SENSATION IN EYE (cold behind left eye then from wrist to behind both eyes), PAIN IN EXTREMITY (left arm started to hurt pretty bad), SWELLING (left side of the body was swollen, like swollen pecks, back and chest, like they had been stung), CHILLS (shivering and shaking on left side of their body), HOT FLUSH (patient felt flushed and hot) and ERYTHEMA (skin was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; 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. Further information has been requested.
26MODERNA0 days50-59 years0908479-1Dec. 2020Left Jaw pain at temporomandibular joint, (Trigeminal neuralgia?).   No numbness or paralysis.  Jaw aches.  Best description is after the anesthetic from dental work wears off and jaw aches from injections and dental procedure.   Injection given at 1pm left arm.   Painless injection.  Injection site pain increased to moderate throughout day.    Jaw pain began at 10:45pm.    Next morning jaw pain still present.  Took two naproxen 200mg tablets at 05:30 am.
27MODERNA0 days50-59 years0942586-1Dec. 2020complete paralysis on the left side of her body and felt like it was bell's palsy; complete paralysis of the left side of her body and felt like it was bell's palsy; forearm, thumb, and pointer finger feels tingly; can't get a grip on things; Chills; headache; A spontaneous report was received from a 51-year-old, female consumer, who was also the patient, who received Moderna's COVID-19 vaccine and experienced the events, complete paralysis on the left side of her body and felt like it was bell's palsy, forearm, thumb and pointer finger feels tingly, can't get a grip on things, chills, and headache.   The patient reported a history of anaphylactic shock, but had not experienced an episode in about 10 years. Concomitant product use was not reported.    On 27 Dec 2020, approximately two hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, about two hours after receiving the vaccine, the patient felt chills and had a headache. The patient went to sleep and woke up to complete paralysis on the left side of her body and felt like it was bell's palsy. Since 27 Dec 2020, the patient's forearm, thumb, and pointer finger have felt tingly and she can't get a grip on things. Treatment for the events included ibuprofen.   Action taken with mRNA-1273 in response to the event was unknown.   The events forearm, thumb and pointer finger feels tingly and can't get a grip on things were considered not resolved. The outcome for the events, complete paralysis on the left side of her body and felt like it was bell's palsy, chills, and headache was unknown.; Reporter's Comments: This case concerns a 51-year-old, female subject with medical history of anaphylactic shock, who experienced a serious, unexpected events of hemiplegia and facial paralysis; and non-serious, unexpected events of paresthesia, motor dysfunction; and non-serious, expected events of chills and headache. The events of hemiplegia, facial paralysis, paresthesia, and motor dysfunction occurred same day of mRNA-1273 (lot # unknown) administration. The event of chills and headache occurred 2 hours after the vaccine administration. 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.
28MODERNA0 days50-59 years1026005-1Jan. 2021Facial 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.""
29MODERNA0 days50-59 years1086024-1Feb. 2021bell'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.
30MODERNA0 days50-59 years1094021-1Jan. 2021Around 4pm left arm was swelling (entire) and pain. my left eye closed completely,tears and right eye barely closed. I was very sleepy was driving home.The next day I exp fatigue,diarrhea, chills and headache(right side) for the remainder of the week. I took Tylenol for headache the pain wasn't going away.I went to ER did a test for Paralysis discharged with drops for eyes. I followed up with Ophthalmology clinic they put a light to my eyes due to both being completely closed and did some test. I was told to stop using the drops from the ER because it was toxic for my eyes.Upon my discharge given instructions to due warm compress on my eyes for swelling and blurred vision. As of today I'm still ex blurred vision (both eyes) to see, hard for me to see computer,cell phone, letters.
31MODERNA0 days60-64 years1114267-1Mar. 2021Bell'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.
32MODERNA0 days65+ years0976543-1Jan. 2021Intermittent paralyzed left side; Hives; itching; Redness; Shortness of breath; A spontaneous report was received from a nurse who was also a 70-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed left sided paralysis, shortness of breath, hives, itching, and redness.  The patient's medical history included asthma. Products known to have been used by the patient, within two weeks prior to the event, included albuterol sulfate, epinephrine and diphenhydramine.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 075T202A) intramuscularly for prophylaxis of COVID-19 infection.     On 05 Jan 2021, after receiving the vaccine the patient developed redness, itching and shortness of breath. On 06 Jan 2021, she developed hives and was paralyzed after sleeping. She experienced paralysis on the left side and her right side felt heavy. Treatment for the events included diphenhydramine, epinephrine, and albuterol.  Action taken with the second dose of mRNA-1273 in response to the events was not provided.    The events, paralysis on the left side and hives, was considered resolved on 07 Jan 2021. The events, redness, itching and shortness of breath, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 70 year old, female patient, with a medical history of asthma, who experienced a serious unexpected event of hemiplegia, a non-serious unexpected event of dyspnoea, urticaria, pruritus and a non-serious expected event of erythema. The event of dyspnoea, pruritus, and erythema occurred 1 day after first dose mRNA-1273 (Lot# 075T202A) administration. The event of hemiplegia and urticaria occurred 3 days after first dose mRNA-1273 (Lot# 075T202A) administration. Both concomitant and treatment medications included Benadryl, Primatene mist and albuterol. 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.
33MODERNA0 days65+ years1002073-1Jan. 2021Extreme 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.
34MODERNA0 days65+ years1040803-1Jan. 2021Bell's Palsy; .A spontaneous report was received from a consumer who was also a 79 years-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. Concomitant medication reported included metformin.  On 29 Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: 012L20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 29 Jan 2021, after the administration of vaccine, the patient developed Bell's palsy. The patient went to the emergency room (ER) for treatment but was unable to get the condition resolved. The patient was referred to a neurologist, but the side effects were still present up to this point.  Action taken with second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, Bell's palsy, was not recovered.; 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.
35MODERNA0 days65+ years1050028-1Feb. 2021Bell's Palsey, paralysis left side of face
36MODERNA0 days65+ years1057377-1Feb. 2021On the evening of the first vaccination, my sister experienced chills and fever. The next morning she experienced a kind of paralysis, could not sit up or stand up, was falling out of bed and out of her chair, had to be carried to the bathroom, although she usually can walk by herself. This lasted about a day. I took her to the ER where they excluded other possible causes of her condition and simiply attributed it to the vaccine. No treatment was prescribed.
37MODERNA0 days65+ years1070583-1Feb. 2021He 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.
38MODERNA0 days65+ years1094159-1Mar. 2021Motor paralysis of the left foot. Could not move at all.: dorsiflex, plantar flex, invert, or evert
39MODERNA0 days65+ years1101161-1Feb. 2021couldn'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.
40MODERNA0 days65+ years1111267-1Jan. 2021Limp; Paralyzed (pain was so bad he couldn't move it); Low grade fever; Severe left hip pain; A spontaneous report was received from a consumer who was also a 85-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced left hip became paralyzed (pain was so bad he couldn't move it) (paralysis), low grade fever (pyrexia), limp (gait disturbance), and severe left hip pain (arthralgia).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 09 Jan 2021, approximately 10 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09 Jan 2021, the patient woke up at 10:00 pm with severe left hip pain. His left hip became paralyzed (pain was so bad he couldn't move it), and he took 2 ibuprofens then went to bed.   On 10 Jan 2021, he was still in pain with a low grade fever of 98.8 which is 1 to 2 degrees higher than normal for him. He reported using his wife's walker to ambulate and took 4 ibuprofens which helped his hip.   On 11 Jan 2021, the patient was still in pain, had a limp, and ran a low fever until the afternoon. Treatment for the events included ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, low grade fever, was considered resolved on 11 Jan 2021. The outcome of the events, left hip became paralyzed (pain was so bad he couldn't move it), low grade fever and limp, was unknown.; Reporter's Comments: Based on the information provided, the events of low grade fever, gait disturbance and severe left hip pain are temporally associated with the administration of mRNA-1273 and a causal association cannot be excluded. Fever and arthralgia are consistent with the known safety profile of the product.  The event of paralysis is considered unlikely pending additional information.
41MODERNA0 days65+ years1114898-1Feb. 2021Bells palsy effect; Rapid heartbeat; Numb nose, nasal cavity, cheeks; Numb eyelids; A spontaneous report was received from a consumer, concerning a 65 year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a rapid heartbeat/tachycardia, her nose, nasal cavity, cheeks and eyelids were numb/hypoaesthesia, Bell's palsy effect/facial paralysis.  The patient's medical history included were overweight and pre diabetic. The patient was allergic to latex and was dairy sensitive was not provided. Concomitant product included was vitamins.  On 16 Feb2021, few minutes prior to the onset of symptoms, the patient received her first of two planned doses of mRNA-1273 (batch number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient, while she was staying for 15 minutes in the facility, she felt a rapid heartbeat. It was not alarming, but it was faster than normal. Five minutes after leaving the facility, which was 20 minutes after she received the vaccine, her nose, nasal cavity, cheeks and eyelids were numb. This numbness stayed for two hours and the disappeared. The numb sensation on the nose stayed for 3 whole days after the vaccine was administered. The patient consulted the primary doctor, who stated that it was a Bells Palsy effect. Treatment information was not provided.  The outcome of the events of rapid heartbeat, nose, nasal cavity, cheeks and eyelids were numb were considered recovered and the outcome for Bells palsy effect 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.
42MODERNA0 days65+ years1115603-1Feb. 2021Tongue feels funny; Chewing is hard; His left eye and face are changing shape, smiling is hard; Possible Bell's Palsy; Numbness on left side of face; Swelling arm; Painful arm; Headache; A spontaneous report was received from a consumer concerning a 70-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced possible Bell's Palsy/facial paralysis, numbness on left side of face/hypoaesthesia, tongue felt funny/paraesthesia oral, chewing was hard/mastication disorder, left eye and face were changing shape, smiling was hard/ facial discomfort, sore arm/pain in extremity, arm swelling/peripheral swelling, and headache.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 13 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient initially had pain, swelling, sore arm and headache. Patient stated on 15 Feb 2021, he had some numbness on left side of face, chewing and smiling was hard. Patient stated a couple days later, he had numbness and on 01 Mar 2021, his left eye and face were changing shape, tongue felt funny, and it was hard to brush teeth. Patient spoke with doctor and MRI was scheduled on 12 Mar 2021, according to patient there was a possibility for Bell's Palsy.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, facial paralysis, hypoesthesia, paraesthesia oral, mastication disorder, facial discomfort, pain in extremity, peripheral swelling and headache 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.
43MODERNA0 daysUnknown0980584-1Jan. 2021like a slight paralysis; stiffness in the face; numbness in the face; A spontaneous report was received from a 64-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced like a slight paralysis, stiffness in the face and numbness in the face.   The patient's medical history, as reported, included high blood pressure. Concomitant medications reported included losartan.   On 13 Jan 2021, about 5 minutes 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 13 Jan 2021, about 5 minutes after getting the Moderna COVID-19 vaccine, the patient experienced a stiffness and numbness in the face, like a slight paralysis. It started in the nose and spread out to the eyes and forehead. After about half an hour, he still experienced it a little bit. No medications were taken for the events.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, like a slight paralysis, stiffness in the face and numbness in the face, was recovering/resolving.; Reporter's Comments: This spontaneous report refers to a case of a 64-year-old, male patient with medical history of high blood pressure who experienced a serious event slight paralysis and non-serious events of stiffness in the face and numbness in the face.  The events occurred 5 minutes after the administration of the mRNA-1273 vaccine (lot # unknown, expiration date-unknown). No treatment was administered, and patient is recovering. Based on the information provided which includes a temporal association, a causal association cannot be excluded.
44MODERNA0 daysUnknown1068362-1Feb. 2021Bell's Palsy; Neck pain and rigidity; Neck pain and rigidity; Pain in the ear; Epiphora; Could not blink; Shoulder soreness; Chills; Fever; A spontaneous report was received from a Consumer and a healthcare professional concerning a √ 35 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial paralysis, arthralgia, chills, fever, neck pain, nuchal rigidity, ear pain, lacrimation increased and lagophthalmos.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12-Feb-2021, prior to the onset of the events, the patient received their second planned dose of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the same day, the patient experienced shoulder soreness, pain in the ear, chills, fever, neck pain and rigidity, epiphora, couldn't blink and face paralysis.  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 was unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 vaccine cannot be excluded. The events of arthralgia, chills and fever are consistent with the known safety profile of the vaccine.
45MODERNA0 daysUnknown1073473-1Feb. 2021Bells Palsy; Numbness in left side of face; A spontaneous report was received from a consumer who was also a 43 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced Bell's Palsy / facial paralysis and numbness in left side of face / hypoaesthesia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021 at 3:15 pm, approximately 25 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.   On 17 Feb 2021, about 25 minutes after receiving the vaccination administration, the patient reported numbness on the left side of his face. His doctor informed him that he had Bell's Palsy and to take diphenhydramine. Consent to follow up from safety was provided by the patient.  Action taken with the first dose of mRNA-1273 vaccine was not reported.  The events, Bell's Palsy and numbness in left side of face, were ongoing 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.
46MODERNA0 daysUnknown1074598-1Feb. 2021little bit sore; possible Bell's Palsy; left side of his face was swollen; Couldn't open his mouth; A Spontaneous case report was received from a consumer concerning a 67 year old male patient ,who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced swelling face, facial paralysis, couldn't open his mouth and pain.  The patient medical history, as provided by the reporter, included hypertension and type 2 diabetes.  On 13-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(Lot number:024M20A)  in the left arm for prophylaxis of COVID-19 infection.  On 13-FEB-2021, the patient felt his left side of his face was swollen, and he couldn't open his mouth. On 17-FEB-2021 he went to emergency room and diagnosed with possible Bells palsy. Lab tests was done: x-ray and imaging and couldn't find anything. On 26-FEB-2021 he also felt little bit sore.  No treatment was given for the events.  Action taken with mRNA-1273 in response to the events was unknown.   The events ,swelling face, facial paralysis, couldn't open his mouth were considered resolving on 26-FEB-2021 and pain was considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
47MODERNA0 daysUnknown1081740-1Feb. 2021Paralyzed from the waist down for a few minutes and fell down; Feels disoriented; Sometimes can't even stand up; A spontaneous report () was received from a physician concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was paralyzed from the waist down and fell down/paralysis, feels disoriented/disorientation and sometimes can't even stand up/dysstasia.  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 poly vitamins.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 10 Feb 2021, approximately a few hours post vaccination, the patient experienced paralysis from the waist down for approximately 15 minutes which made her fall down. This event occurred two times. The patient stated she felt disoriented and could not stand up.   Treatment information was not provided.  The outcome of the events, was paralyzed from the waist down and fell down/paralysis, feels disoriented/disorientation and sometimes can't even stand up/dysstasia, 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.
48MODERNA0 daysUnknown1100211-1Jan. 2021face looked droopy on the left side;; itchy; felt like my face had been punched on the left side; A spontaneous report was received from a consumer concerning a 60-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pruritis, facial pain and facial paralysis.   The patient's medical history, as provided by the reporter, included bell's palsy 20 years ago. Concomitant medications were not reported. On 03 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 03 Jan 2021, prior to receiving mRNA-1273, the patient felt itchy and like her face had been punched on the left side. On 06 Jan 2021 she felt her face looked droopy on the left side. Her dimple came back in her face. On 21 Jan 2021 her eyes was droopy and can see a line on one side, and other side doesn't have a line. It's gotten better with acupuncture. She gets acupuncture and electrostimulation; she had a horrible reaction to steroids. Her eye was stuck open for 3 months, she had a patch. Treatment for the events include 3 sessions of acupuncture. Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, pruritis, facial pain and facial paralysis 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.
49MODERNA1 day30-39 years0945249-1Jan. 202101/07/2021- Following injection, site pain radiating to hand/fingers. Resolved 01/08/2021. 01/07/2021 - Headaches, intermittent still. 01/07/2021 - Neck Pain - Left Side, intermittent still. 01/08/2021 - Pain Left Index Finger/Tightness, Resolved 01/08/2021 evening. 01/08/2021 - Left Hip Pain, Intermittent/Ongoing. 01/08/2021 - Left Side Face Numbness/Tingling at 4PM.  No paralysis. Bell's Palsy ruled out.  Continues as of 01/14/2021. 01/08/2021 - Left Side Mouth Numb, cannot feel pain/temperature when eating/drinking. Tongue Numb. Resolved 01/12/2021. 01/08/2021 - Slight Nausea, Resolved 01/09/2021. 01/08/2021 - Feeling of swollen throat, or something in throat, Resolved 01/10/2021.
50MODERNA1 day40-49 years0966653-1Dec. 2020On 12/28 I had paralysis of the left side of my face and was diagnosed with Bell's Palsy.  It took about 2 1/2 weeks for it resolve. The top of my face is at 100 percent  while the bottom half is at 90 percent.
51MODERNA1 day40-49 years0987242-1Jan. 2021Paralysis, weakness, numbness in bilateral lower extremities. Symptoms started 1/26/2021 resulting in hospitalization. Discharged on 1/28/2021 with Out-patient physical therapy
52MODERNA1 day40-49 years1046424-1Feb. 2021Diagnosed Bell's Palsy. Facial paralysis.
53MODERNA1 day40-49 years1050142-1Jan. 2021Paralysis 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.
54MODERNA1 day40-49 years1115503-1Mar. 2021After 24 hours, I started having body aches, that night couldn't sleep I took Ibuprofen it helped, over the weekend I kept taking Ibuprofen. Monday my tongue and half of head was sensitive and weird, it kind of hurt to rub through my hair and tongue felt like pins and needles this lasted through Thursday, and that morning woke up wit a lump behind my ear, I went to clinic, the doctor or PA diagnosed me with shingles, but I don't have any sores, he gave me a prescription but the next morning I woke up and notice i lost facial control on left side, could blink or close mouth on left side. I went to clinic and they diagnosed me with  Bells Palsy and gave me a prescription for steroids and that was last Friday and its been a week that I've been on these meds. The main problem is the Bells Palsy has made my left side not work, dizziness,  pain down my neck, the lump behind my ear finally went away after a week but the paralysis on the left side of my face is still there and the dizziness. I was having headaches but stayed on top of it with Advil and today I go back to clinic for a follow up appointment.
55MODERNA1 day50-59 years0933793-1Jan. 2021Numbness in right side of head and right arm (where he received injection). Starting getting confused. Legs started to give out. Continued working. Symptoms got worse. On and off paralysis of legs. Eyes flickered and darted. When he sat down at 1am, he took two nitroglycerin for chest pain. He asked a nurse to take his blood pressure. It was low. He felt he was losing control. He was struggling for breath. Eyes were tearing up real bad and tremors started. He stated he fought to stay conscious. Was started on oxygen. Was assisted in a wheelchair and taken to ER. Waited there for 4 hours. Was delusional. I left without being seen by a doctor after blood work and EKG. Went to sleep and woke up in river of sweat. Went to urgent care at that time. Was given a COVID test and it was negative. Was prescribed zinc and vitamins. He had the same symptoms like he did when he originally got COVID. Today at 9:36am, have fever off and on. Continues to feel pretty bad. Still dizzy.
56MODERNA1 day50-59 years0937613-1Jan. 2021Pt states she awoke at 0600 01/05/2021 with right side facial paralysis Was seen by PA diagnosis with Bells Palsy was started on Prednisone 01/05/2021
57MODERNA1 day50-59 years0951737-1Jan. 2021Paralysis on my left side of face.  I got my vaccine on Thursday 1/14/21. On Friday 1/15/21 evening started have numbing of left side of my face.
58MODERNA1 day50-59 years1001430-1Jan. 2021Bell's Palsy/ Facial paralysis/ Dropiness on the rightside; Light sensitivity; Tearing; Felt like flu; Sore; A spontaneous report was received from a 50 year-old, male patient who received Moderna's COVID-19 vaccine and experienced sore, felt like had the flu, light sensitivity, tearing of his right eye, Bell's palsy (right eye won't blink on its own, lip and speech issues).  The patient's medical history was not provided. Concomitant medications were not reported.  On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A), intramuscularly in left arm, for prophylaxis of COVID-19 infection.  On 10 Jan 2021, he was sore, felt like had the flu. On 13 Jan 2021, he experienced light sensitivity, and tearing of his right eye. On 19 Jan 2021, he went to the emergency room and found with facial paralysis, droopiness on the right side. He was diagnosed with Bell's palsy (right eye won't blink on its own, lip and speech issues).  Treatment included Valtrex.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, sore, felt like had the flu was considered resolved on 11 Jan 2021. The outcome of the event, Bell's palsy (right eye won't blink on its own, lip and speech issues) was not recovered. The outcome of the events, light sensitivity, and tearing of right eye was unknown.; Reporter's Comments: This case concerns a 50-year-old male patient. The medical history is not provided. The patient experienced a medically significant and unexpected event of Facial paralysis and unexpected non-serious events of Influenza, Pain, Photophobia and Lacrimation increased. The events of Influenza and Pain occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot number: 025J20A). Photophobia and Lacrimation increased occurred approximately four days after the first dose of mRNA-1273 (Lot number: 025J20A). Event of Facial Paralysis was diagnosed approximately ten days after the first dose of mRNA-1273 (Lot number: 025J20A). Treatment included Valtrex. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
59MODERNA1 day50-59 years1053663-1Feb. 2021Bell's Palsy; A spontaneous report was received from a physician concerning a 54 year old female patient.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On 03Feb2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  On 04Feb2021, the patient experienced waking with Bell's Palsy.  No treatment was reported.  Action taken with the mRNA-1273 in response tot he event was not reported.  The outcome of the event, facial paralysis, was unknown.; Reporter's Comments: This report concerns a 54-year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273). (Lot # not reported) and experienced Bell's palsy. Very limited information regarding this event has been provided at this time. Further information has been requested.
60MODERNA1 day60-64 years1086879-1Feb. 2021Bell's Palsy; diarrhoea; fever between 98-99 degree Fahrenheit; several headache; nausea; A spontaneous report was received from a consumer concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bell's palsy, diarrhea, fever between 98-99-degree Fahrenheit, several headache and nausea.  The patient's medical history included: Covid-19 (start date 08-JAN-2021).  No relevant concomitant medications were reported.  On 8-FEB-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch:012M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 09-FEB-2021, the patient's symptoms had started. The patient mentioned a fever between 98ªF - 99ªF,  headache, nausea, and diarrhea. Then on 15-FEB-2021, she had a (facial) paralysis, the left side of the mouth bent to the side and the eye fell. On 20-FEB-2021, the patient had visited the doctor's office and she was diagnosed with Bell's palsy. The patient was treated with, prednisone , valacyclovir, injection (unspecified) like a Cortisone. At the time of this report everything was coming back to normal, but it was not at 100%. The adverse event of ball's palsy was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event of bell's palsy, diarrhea, fever between 98-99-degree Fahrenheit, several headache and nausea was resolving.; 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.
61MODERNA1 day65+ years1022613-1Feb. 2021Bell's Palsy- steroids, Valtrex, speech therapy. ongoing left facial paralysis
62MODERNA1 day65+ years1086018-1Jan. 2021Bell's Palsy; voice was sort of ugly; A spontaneous report was received from a consumer who is a 67-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and his voice was sort of ugly/dysphonia and Bell's palsy/facial paralysis.  The patient's medical history included hypertension, triple bypass, operation in stomach and intestine and depression. No relevant concomitant medications were reported.  On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Jan 2021, the patient stated he woke up at 0800 and noticed his voice sounded ugly. When he looked in the mirror his face looked crooked. The patient went to the hospital and was diagnosed with Bell's palsy. The patient stated he was discharged home the following day. He was given unspecified steroids.  Treatment information included unspecified steroids.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, voice was sort of ugly/dysphonia and Bell's palsy/facial paralysis, were considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
63MODERNA1 day65+ years1086931-1Feb. 2021Shingles 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.
64MODERNA1 day65+ years1115340-1Feb. 2021One of her eyes and mouth were dropping a little bit/Bell's palsy; Broken out with fever blisters; Rash and itching all over the trunk; Itching all over the trunk; A spontaneous report was received from a patient's spouse in the concerning a 77-year-old female patient who experienced one of her eyes and mouth were dropping a little bit/Bell's palsy/database: facial paralysis, rash and itching all over the trunk/database: rash, rash and itching all over the trunk/database: pruritus and broke out with fever blisters/database: oral herpes.   The patient's medical history was not reported. Concomitant medications included metoprolol, lisinopril, acetylsalicylic acid, omeprazole rabeprazole sodium, vitamin D, duloxetine, folic acid, vitamin A, balofloxacin, vitamin B12 and amlodipine.  On 25-Feb-2021, one day before the start of symptoms, this patient received the planned dose of mRNA-1273 solution for injection, dosage not provided, (Lot/Batch number: 012A21A) via unknown route at unknown anatomical location for prophylaxis of COVID-19 infection.   On 26-Feb-2021, the patient developed a rash and itching all over the trunk. The events resolved on 27-Feb-2021. On 28-Feb-2021 the husband noticed one of the patient's eyes and her mouth were drooping a little bit. He took her to the ER (Emergency Room) because he thought she was having a stoke. She had also broken out with fever blisters. They ran tests NOS and everything was normal. The treating Physician said it was Bell's palsy and it was due to the vaccination. The events were treated with prednisone 15 mg and valacyclovir 1 gram.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome for the events, one of her eyes and mouth were dropping a little bit/Bell's palsy/database: facial paralysis and broke out with fever blisters/database: oral herpes is unknown. The outcome for the events, rash and itching all over the trunk/database: rash, rash and itching all over the trunk/database: pruritus is recovered.; 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.
65MODERNA1 day65+ years1124089-1Mar. 2021Early next morning noted to have difficulty with lisp which progressed over several hours to full left sided facial paralysis including eye, cheek, and lip.  Also swelling and pain from top of head all the way to neck on left side.  Still unable to drive or use left eye.
66MODERNA1 dayUnknown1086874-1Feb. 2021Paralysis 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.
67MODERNA2 days50-59 years0991202-1Jan. 2021Patient reported facial paralysis on one side two days after her Moderna covid19 vaccine.  Her school nurse (she works at a local school) confirmed that it looked like Bell's Palsy.  We and the nurse recommended that she go to the emergency but she wanted to wait until the next morning to see her physician.
68MODERNA2 days50-59 years1087234-1Mar. 2021Joint pain in elbow and wrist paralysis in fingers
69MODERNA2 days65+ years0920769-1Dec. 2020( 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
70MODERNA2 days65+ years1020784-1Jan. 2021Paralysis  swelling. Seizure,  lost eye sight,  partial speech  ! And is bed riding and loss of balance
71MODERNA2 days65+ years1049241-1Feb. 20212/15/2021 diarrhea thru 2/20. Starting on 2/19/2021 Left side facial numbness NOT paralysis. HIGH BLOOD PRESSURE> 200/88 without intervention.  Severe headache , nausea and vomiting, generally feeling very bad. No fever.
72MODERNA2 days65+ years1100271-1Feb. 2021Lost 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.
73MODERNA2 days65+ years1116828-1Mar. 2021I 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.
74MODERNA2 daysUnknown0990354-1Jan. 2021Facial paralysis; A spontaneous report was received from a pharmacist concerning a patient between 51 to 55 years of age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed facial paralysis.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, approximately two days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient began having symptoms of facial paralysis and the symptoms got progressively worse.  On 08 Jan 2021, the patient sought medical attention where they received an official diagnosis of facial paralysis. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, facial paralysis, was unknown.; Reporter's Comments: This case concerns a patient between 51 to 55 years of age of unknown gender. The medical history is not provided. The patient experienced a medically significant and unexpected event of Facial paralysis approximately two days after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
75MODERNA2 daysUnknown0990357-1Dec. 2020Bell's palsy stage 4/partial face paralysis; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine and diagnosed with Bell's palsy stage 4.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 25 Dec 2020, after receiving the vaccine the patient was diagnosed with stage 4 Bell's palsy. She has a partial face paralysis. Treatment for the event was not provided.   Action taken with the mRNA-1273 in response to the event was not reported.   The outcome for the event was Not recovered/Not resolved.; Reporter's Comments: This case concerns a female patient of unknown age. The medical history is not provided. The patient experienced a medically significant and unexpected event of Facial paralysis approximately two days after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time. However, based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
76MODERNA3 days30-39 years0941638-1Dec. 2020Bells Palsy. I had left sided facial paralysis starting 77 hours my injection. I called the Hospitalist at my hospital and treatment of Valacyclovir 1000mg tid x7 days  and Prednisone 60mg daily x7days. The next day I had numbness around my lips and chin on the left side and the third day I had minimal paralysis around my mouth. It was resolved by day 4.
77MODERNA3 days50-59 years0977362-1Jan. 2021Moderna 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
78MODERNA3 days65+ years0964540-1Jan. 2021Possible Todd's Paralysis. h/o L craniotomy for meningioma. s/sx stroke ruled out, aphasia and R hemiparesis. Started on Keppra
79MODERNA3 daysUnknown1037722-1Jan. 2021Paralysis 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.
80MODERNA4 days30-39 years0977523-1Jan. 2021Bell's Palsy onset 4 days after vaccination, right sided acute facial paralysis
81MODERNA4 days65+ years1078636-1Feb. 2021Severe 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.
82MODERNA5 days30-39 years0978034-1Jan. 2021Inmate diagnosed with Bells palsy. Right sided facial droop, inability to close right eye completely, paralysis of right cheek.
83MODERNA5 days40-49 years1023583-1Jan. 2021Severe left ear pain and fullness with associated right side complete facial paralysis.  I was diagnosed with Bell's Palsy 1/9/20, 5 days after getting my first moderna vaccine.
84MODERNA5 days60-64 years0971665-1Jan. 2021Left 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).
85MODERNA5 days60-64 years0982023-1Dec. 2020Third 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.
86MODERNA5 days65+ years1017355-1Jan. 2021Right side vocal cord paralysis
87MODERNA5 days65+ years1123796-1Feb. 2021Bells palsy; Numbness in face; Pain in head; A spontaneous report  was received from a consumer (patient), a 70-year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273), and developed Bell's palsy (facial paralysis), pain in head (headache) and numbness in face (hypoaesthesia).  The patient did not report medical history. Concomitant medications were also not reported.  On 03 Feb 2021, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscularly in the arm for prophylaxis of COVID-19 infection.  On 08 Feb 2021, after administering the vaccine, the patient developed headache followed by numbness on face on 09 Feb 2021. On 11 Feb 2021, the patient was diagnosed with Bell's palsy. No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the events, headache, numbness in face and Bell's palsy, 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.
88MODERNA6 days18-29 years0970949-1Jan. 2021I 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.
89MODERNA6 daysUnknown1038080-1Jan. 2021Bells Palsy symptoms; A spontaneous report was received from a consumer who was also a 65-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's palsy symptoms/ facial paralysis.  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 duloxetine hydrochloride.  On 29 Jan 2021, approximately seven days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot# 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 04 Feb 2021, the patient went to the dentist and started to develop Bell's palsy symptoms afterwards. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, Bell's palsy symptoms, 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 events, a causal relationship cannot be excluded. However, patient's unspecified dental procedure may have been contributory.
90MODERNA6 daysUnknown1045538-1Jan. 2021bell's pausy; strange feeling in my lip; stiff neck; A spontaneous report was received from a consumer concerning a 73-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  developed Bell's Palsy (facial paralysis), stiff neck (musculoskeletal stiffness), and a strange feeling in her lip (oral discomfort).    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 vitamins, atorvastatin calcium and calcium   On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Feb 2021, the patient developed a very stiff neck and had a restless sleep. On 06 Feb 2021, the patient reported awaking with a strange feeling in her lip. She was advised by her primary care physician. On 07 Feb 2021, the symptoms had worsened, and her facial muscle had twisted. Treatment for the event included prednisone and valacyclovir.   Action taken with mRNA-1273 in response to the events was not provided/unknown.  The events, Bell's Palsy, stiff neck and strange feeling in lip, was considered not recovered/not resolved.; Reporter's Comments: Although a temporal relationship exists, there is not enough information to assess the causal relationship of the reported events with the administration of mRNA-1273 (Batch number: 038K20A).  Critical details such as patient's medical history and relevant diagnostic test are lacking. Additional information have been requested.
91MODERNA7 days30-39 years1042447-1Feb. 2021Intense 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.
92MODERNA7 days50-59 years1123802-1Jan. 2021Bell's palsy; A spontaneous report was received from a consumer who was a 59-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's palsy (facial paralysis).   The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 12 Jan 2021, approximately seven days prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 19 Jan 2021, the patient developed Bell's palsy. As per patient, there was loss of taste, his eyeball was not moving, he had facial pain and he could not raise right side of his lips. The patient stated that his symptoms were still on going at the time of report. Both his PCP and neurologist can not confirm this is not related to vaccine.  Treatment for the event included a seven-day course of Valtrex and Prednisone.   Action taken with mRNA-1273 in response to the event was not provided.  The event, Bell's palsy, was considered not recovered/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.
93MODERNA7 days50-59 years1128050-1Feb. 2021Bell's palsy; A spontaneous report was received from a consumer concerning a 58-years-old, female 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 27 Feb 2021, approximately eight days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 6 Mar 2021, the patient started showing symptoms of numbness in face. She went to emergency response on 08 Mar 2021 and was diagnosed with Bell's palsy. She said she didn't have drooping or paralysis, but still have numbness. She went to other provider for second opinion and was given high dose of Vitamin B-12 and Acyclovir. No additional treatment information was given.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, Bell's palsy was considered not recovered.; Reporter's Comments: Based on the information provided which includes a temporal association between the reported events, administration of mRNA-1273 vaccine and excluded all other etiologies, a causal association cannot be excluded
94MODERNA8 days60-64 years1030024-1Jan. 2021Facial paralysis; Shaking all over her body/shaking for 8 days; Can not sleep; Whole body hurts and it does not go away; Terrible chills and shivers; A spontaneous report was received from a consumer who is a 61-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced facial paralysis, terrible chills, shaking for 8 days (tremors), shivers, cannot sleep (insomnia) and whole-body hurts(pain).  The patient's medical history was not provided. Concomitant medications were not reported.  On 13 Jan 2021, the patient received their first two planned doses of mRNA-1273 intramuscularly in her left arm for the prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced terrible chills, shaking for 8 days, shivers and cold all the time, cannot sleep and whole-body hurts. On 28 Jan 2021, the patient experienced facial paralysis which was getting worse more on right side then moved to the middle of her face. The patient was given steroids.  Treatment for the events included steroids.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, facial paralysis, terrible chills, shaking for 8 days (tremors), shivers, cannot sleep (insomnia) and whole-body hurts(pain), were considered unknown.; Reporter's Comments: This case concerns a 61-year-old female who experienced a serious unexpected event of facial paralysis, the non-serious unexpected events of tremors, insomnia and pain, and a non-serious expected event of chills. Events began on 21-Jan-21 after the first dose of mRNA-1273 on 13-Jan-21. Treatment with steroids. Outcomes unknown. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
95MODERNA8 days65+ years0967969-1Jan. 2021cerebral hemorrhage and left sided paralysis of the body
96MODERNA8 days65+ years0971742-1Jan. 2021Pateint developed right sided facial paralysis on saturday, with weakness of the right cheek and drooling.  Seen at the Doctor's office today and diagnosed with Bell's palsy; started treatment with Prednisone and Valacyclovir.  Patient will follow up in 1 week or earlier if needed.
97MODERNA10-14 days30-39 years1046768-1Feb. 2021I received my vaccine on 2/10/21. I had expected side effects of fevers, chills, body aches, headache on 2/11 - 2/13. I continued with a persistent headache throughout the week. A presure in my head, worse with standing up, and it made me dizzy when I stood up. On the night of 2/18/21 I developed left sided ear pain. On 2/19/21 I developed a left sided otitis media. On 2/21/21 I developed sudden onset left sided facial droop. I had a negative head CT, and was diagnosed with bells palsy related to the swelling in my ear from the otitis media.   I continue to have significant ear pain, and left sided facial paralysis today.
98MODERNA10-14 days40-49 years1083852-1Feb. 2021Fever, chills, extreme muscle pain beginning 12 hours after second dose and lasting 24 hours.  Extreme nerve pain in face and head and metallic taste beginning on 3/6 overnight and continuing to worsen over the next 72 hours. Within 48 hours of onset of symptoms, facial paralysis and loss of taste (suspected Bell?s palsy, awaiting confirmation) began in addition to worsening pain and extreme discomfort. Still ongoing.
99MODERNA10-14 days65+ years1051544-1Jan. 2021Bell's palsy. Watery left eye, facial paralysis on left side of face. Numbness   Treatment - one week of steroids and antivirals. Eye cream
100MODERNA15-30 days18-29 years1183808-1Mar. 2021Bell's palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's palsy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was unknown by the reporter Treatment medication include steroids  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
101MODERNA15-30 days30-39 years1129963-1Feb. 2021pt stated that on 3/20/21 he developed facial paralysis on the right side of this face and loss of taste.  Pt went to Urgent Care.  They gave him a glucose test, Covid 19 Rapid test, took BP and Temp. which was 98.5.  Pt diagnosed w/ Bells Palsy and was prescribed prednisone and valacyclovir.  Pt is slightly recovering at this time but feels like he is improving.    Pt was instructed to contact Dr. upon finishing medication to see if he needed to be referred to a Neurologist.
102MODERNA15-30 days30-39 years1173615-1Mar. 2021Developed bells palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Developed bells palsy) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced FACIAL PARALYSIS (Developed bells palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Developed bells palsy) outcome was unknown.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to events was not applicable. No treatment information was 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.; Sender'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.
103MODERNA15-30 days40-49 years0990767-1Jan. 2021Patient developed Bells Palsy, facial paralysis, severe headache, blurry vision, mouth twitch and severe abdominal pain.
104MODERNA15-30 days40-49 years1039885-1Dec. 2020Face was paralyzed; A spontaneous report was received from a consumer concerning a 42-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial paralysis.  The patient's medical history was not reported.  Concomitant medication history was not provided.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number:  029L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient woke up to find that his face was paralyzed.  The patient went to the urgent care center and they referred him to the emergency department at the hospital.  After numerous tests they diagnosed him with Bell's Palsy.    Treatment for this event included prednisone and doxycycline.  Action taken with mRNA-1273 in response to this event was not reported.  The outcome for the event, facial paralysis, 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
105MODERNA15-30 days40-49 years1115342-1Feb. 2021Dizzy; 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.
106MODERNA15-30 days50-59 years0977262-1Dec. 20201st dose December 23, 2020.  Arm pain, swelling, raised red 3 inch bump developed within 12 hours.  Subsided, and reoccurred about 10 days post vaccine.  10-14 days post vaccine I developed New onset forefoot weakness (foot drop) Right, new onset trigger finger Right middle finger, new onset bladder spasms with immediacy and incontinence - not bladder volume dependent, resurgence of body aches, new bilateral knee pain requiring two arm support for sit to stand,  Mental status changes including anxiety, paranoia, mania and depression (personality change!), motion induced nausea and dizziness, visual changes (blurry vision), New intensification of nocturnal muscles spasms - bilateral and progressive and intermittent headache up the Right neck to crown, New onset (01/14/21 - present) burning rubber scent when some food being cooked.  The muscle and joint pain were present with February illness, subsided by April, and came back with a vengeance within two weeks of the 1st injection.  I also lost three teeth (fracture vertically while flossing), thinned hair, and had intermittent dizziness during the initial illness in February.   February Initial loss of taste/smell included metallic taste with artificial flavors, rotten garbage - random, and ?iron taste with meats.  I can now taste some fruits but only get bitterness with other fruits and vegetables.  I had one sided facial paralysis after tooth extractions in September - resolved in 1 week.  I required dental implants to replace the fractured teeth.  I am a vaccinator, and have been administering our vaccines and swabbing for Covid testing since we reopened elective procedures.  I strongly encourage our staff to get the vaccines - and I am the one who gets the reaction.  The constellation of symptoms, temporal proximity to the vaccine with no intervening illness or injury, and commonality of some symptoms with my February illness have prompted further testing and evaluation for central nervous system insult.
107MODERNA15-30 days65+ years0970398-1Jan. 2021Left side of face paralysis. Unable to close left eye or move any muscles on left side of face , and pain behind left ear .   Diagnosed by family practitioner as Bells Palsy
108MODERNA15-30 days65+ years1039884-1Dec. 2020Lost 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.
109MODERNA15-30 days65+ years1045553-1Jan. 2021Facial drooping; blurred vision; A spontaneous report was received from a healthcare professional  concerning a 73 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed facial drooping/facial paralysis and blurred vision/vision blurred.     The patient's medical history included hypertension.  Products known to have been used by the patient, within two weeks prior to the event, included diltiazem, metoprolol, HCTZ, calcium, and multivitamin.   On 25 Jan 2021, approximately two weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The patient began experienced facial drooping with blurred vision on 09 Feb 2021.  The patient presented to the hospital and was treated with prednisone and acyclovir.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events facial drooping with blurred vision were not recovered.  Reporter causality for the events 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 events, a causal relationship cannot be excluded.
110MODERNA15-30 days65+ years1047475-1Jan. 2021Started having unilateral facial paralysis on 2/15/21,  Presented in clinic on 2/17/21 with: R sided facial paralysis with smiling, frowning, raising eyebrows. No other systemic symptoms: no rash, no right sided body weakness - diagnosed with Bells Palsy and sent home with steroids and valacyclovir.
111MODERNA15-30 days65+ years1079498-1Feb. 2021Partial right facial nerve paralysis ( Bell's Palsy ) At 2 PM, Sunday, looked in mirror, noticed drooping of right angle of mouth and flattening of naso labial fold. Seen MD , had MRI of brain which was normal. Was referred to and evaluated by physical therapist, prescribed daily exercises, massages .
112MODERNA15-30 daysUnknown1040546-1Jan. 2021bell's palsy; A spontaneous report was received from a healthcare professional (HCP) concerning a 56-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.  Concomitant products known to have been used by the patient, within two weeks prior to the event, included valsartan, insulin, insulin degludec, rosuvastatin, and acetylsalicylic acid.  On 12 Jan 2021, prior to the onset of the events, the patient received their dose of mRNA-1273 (lot number: 06L20A) intramuscularly in his left arm for prophylaxis of COVID-19 infection.  The patient experienced Bell's Palsy on 25 Jan 2021.    Treatments of these events were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, Bell's Palsy/facial paralysis 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.    .
113MODERNA15-30 daysUnknown1056507-1Jan. 2021Bells 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.""
114MODERNA15-30 daysUnknown1061914-1Dec. 2020Bell's Palsy; A spontaneous report  was received from a health care professional (HCP) concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's Palsy/facial paralysis.  The patient's medical history was not provided. Concomitant medication history was not provided.  On 30 DEC 2020, the patients received their first of two doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   The HCP stated that on 25 JAN 2021 the patient developed Bell's Palsy.    Treatment for this event was not provided.  The outcome of the event, facial paralysis was unknown.; 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. Further information has been requested.
115MODERNA15-30 daysUnknown1119809-1Feb. 2021Bells palsy; A spontaneous report was received from a consumer, concerning a 70-year-old, male who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's Palsy/ facial paralysis.  The patient's medical history was not provided. Concomitant product was not provided.   On 01 Feb 2021, approximately 31 days prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (batch number: 012M20A) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.  On 03 Mar 2021, post vaccination, the patient experienced Bell's Palsy.    Treatment included prednisone 20 mg once daily and valacyclovir 1g TID 7 days.  The outcome of the event, 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.
116MODERNA15-30 daysUnknown1173616-1Mar. 2021Diagnosed yesterday with Bell's Palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Diagnosed yesterday with Bell's Palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced FACIAL PARALYSIS (Diagnosed yesterday with Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Diagnosed yesterday with Bell's Palsy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included prednisone.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
117MODERNA31-60 daysUnknown1080146-1Jan. 2021drooping of the left side of her face/Bell's Palsy; very high BP; A spontaneous report was received from a consumer concerning an approximately 44-years-old female patient who received Moderna's  Covid 19 vaccine (mRNA1273) and who developed Bell's Palsy (facial paralysis) and high blood pressure (BP) (hypertension).  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    The patient received first of two planned dose of mRNA-1273 intramuscularly on 19-JAN-2021 for prophylaxis of Covid 19 infection.  On 22-FEB-2021 patients had a high BP of 130/80 mmHg. Patient noticed drooping of the left side of face. The patient went to the emergency room, was found to have very high BP, and was diagnosed with Bell's Palsy and was getting a CT scan. Treatment for the event included Prednisone.  Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the event were considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
118MODERNAUnknown50-59 years1128049-1Mar. 2021Drooping in face; Numbness traveled from right arm to wrist; Tingling in right arm; Motor and strength issues; A spontaneous report was received from a consumer concerning a 57-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed numbness going from right arm to wrist/ Hypoaesthesia, tingling in right arm/ Paraesthesia, motor and strength issues/ Sensorimotor disorder and drooping in face/facial paralysis.  Medical history or concomitant medications were not reported.  On 09 Mar 2021, the patient received her first planned dose of mRNA-1273 (batch number: not provided) intramuscularly for prophylaxis of COVID-19 infection. Later, she developed numbness in right arm which went up to wrist. She also had tingling in right arm. Moreover, she also reported motor and strength issues along with drooping in face. Treatment information was not provided.  The event drooping in face was considered to be medically significant.  The action taken with mRNA-1273 in response to the events, numbness going from right arm to wrist, tingling in right arm, motor and strength issues and drooping in face, was unknown.  The outcome of the events, numbness going from right arm to wrist, tingling in right arm, motor and strength issues and drooping in face, 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.
119MODERNAUnknown65+ years1090195-1Jan. 2021Right six cranial nerve palsy; A spontaneous report was received from a consumer  concerning a 73-year-old, female patient, who developed right six cranial nerve palsy/facial paralysis.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  In January 2021 (date not specified), approximately 2 weeks prior to the onset of symptoms, the patient received the first dose of two planned doses mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient developed right six cranial nerve palsy. She consulted a physician and a CTR (not further specified) and magnetic resonance imaging were scheduled. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of event, right six cranial nerve palsy, was 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 event, a causal relationship cannot be excluded.
120MODERNAUnknownUnknown0963816-1Dec. 2020Facial weakness - palsy; A spontaneous report report was received from a physician concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273)""  and developed facial weakness - palsy.  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 on 24 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient received the vaccine and a week later on an unknown date had developed chronical complication, facial weakness √ palsy. Treatment information included prednisone.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, facial weakness - palsy, was resolved.; Reporter's Comments: This case concerns a female patient with medical history not provided, who developed a serious unexpected event of facial paralysis. The event occurred approximately 2 weeks after first dose of the mRNA-1273 (Lot# unknown). The patient was treated with prednisone and the event was resolved. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.""
121MODERNAUnknownUnknown1045546-1Feb. 2021diarrhea; chills; headache; she had no use of the right arm; extreme pain down my arm (right), pain was like a stabbing with knife on my arm; extreme pain up my jaw (right side); extreme pain in back (right side); didn't sleep much at all; her arm was sore by 2pm and felt really weak by the )time evening came; felt really weak; arm was sore; Neck pain; A spontaneous report was received from a 72-year-old female patient, who experienced sore arm, felt weak, extreme pain in right arm, right jaw and back, and neck, did not sleep much at all, pain was like stabbing with knife on arm, no use of right arm, diarrhea, and chills.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) on 05 Feb 2021 at 10:45 AM in right arm for the prophylaxis of COVID-19 infection.  On 05 Feb 2021 at 2:00 PM, her arm was sore, felt really week by the evening, extreme pain down her arm, up my jaw, neck and back, did not sleep much. She took acetaminophen which dulled the pain.  On 06 Feb 2021, pain was like a ""stabbing with knife on arm."" She stated that the pain was worse at night and she had no se of the right arm.  On 07 Feb 2021, she had diarrhea, chills, and headache.  On 08 Feb 2021, she had no pain in neck and jaw, and her arm was still mildly sore, had dull headache.  Treatment included acetaminophen.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, sore arm, felt weak, extreme pain in right arm, and back was not resolved; outcome of the events, extreme pain in jaw, back, neck was resolved on 08 Feb 2021; outcome of the events, did not sleep much, pain was like a ""stabbing with knife on my arm"", no use of right arm, diarrhea, chills, and headache was not resolved.; Reporter's Comments: This case concerns a 72-year-old female with a serious unexpected event of LLT Paralysis arm with NS unexpected arm pain, jaw pain, neck pain, back pain, asthenia, diarrhea, difficulty sleeping and NS expected vaccination site pain, headache, chills.  The events occurred 2 days after the first dose of mRNA-1273. 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.""
122MODERNAUnknownUnknown1083720-1Feb. 2021bell's palsy; A spontaneous report was received from a consumer concerning her husband, a 59- years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed bell's palsy (Facial Paralysis).   The patient's medical history included diabetes. Concomitant product use was not provided by the reporter.     On 10 FEB 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A)Intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient developed the event bell's palsy and was considered to be medically significant. No treatment information was not provided.    Action taken with mRNA-1273 in response to the event bell's palsy was not reported  The outcome of the event bell's palsy was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
123MODERNAUnknownUnknown1106173-1Feb. 2021He was paralyzed,couldn't use his legs, hand, got collapsed; Lack of strength; Injection site was annoying, rubbing, scratchy; down deep in his muscle a slight feel pain at injection site; extreme dizziness lasted for a day and a half.; shortness of breath; A spontaneous report was received from a consumer concerning himself, 70 years old, male patient who experienced he was paralyzed, couldn't use his legs, hand, got collapsed/paralysis, injection site was annoying, rubbing, scratchy/injection site pruritus, down deep in his muscle a slight feel pain at injection site/injection site pain, shortness of breath/dyspnoea, lack of strength/weakness, extreme dizziness lasted for a day and a half/dizziness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) on 24 Feb 2021 intramuscularly for prophylaxis of COVID-19 infection.    The patient was paralyzed, he couldn't use his legs, hand, got collapsed. Injection site was annoying, rubbing, scratchy, down deep in his muscle a slight feel pain. He also had shortness of breath, lack of strength and extreme dizziness lasted for a day and a half. Treatment of the events was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event he was paralyzed, couldn't use his legs, hand, got collapsed, injection site was annoying, rubbing, scratchy and down deep in his muscle a slight feel pain at injection site was unknown and of events shortness of breath, lack of strength, extreme dizziness lasted for a day and a half was recovered.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Injection site pain and injection site pruritus are consistent with the known safety profile of the vaccine
124MODERNAUnknownUnknown1170765-1Mar. 2021Bell Palsy; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell Palsy) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Bell Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell Palsy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment drugs included, valacyclovir and Prednisone. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
125MODERNAUnknownUnknown1197618-1Feb. 2021It swells my face; I have numbness; Tingling of the whole thing in my lip; pins and needles in the left side of my mouth/sometimes it goes across my lip and into my right side; she did not get the second dose because her face is bad/more than 36 days after the first dose without receiving the second dose; hair loss; a hole in her hair; bells palsy; This spontaneous case was reported by a nurse and describes the occurrence of FACIAL PARALYSIS (bells palsy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020. Previously administered products included for an unreported indication: ZOSTAVAX (Shingles vaccine).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FACIAL PARALYSIS (bells palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING FACE (It swells my face), HYPOAESTHESIA (I have numbness), PARAESTHESIA ORAL (Tingling of the whole thing in my lip), ORAL PAIN (pins and needles in the left side of my mouth/sometimes it goes across my lip and into my right side), PRODUCT DOSE OMISSION ISSUE (she did not get the second dose because her face is bad/more than 36 days after the first dose without receiving the second dose), ALOPECIA (hair loss) and HAIR INJURY (a hole in her hair). At the time of the report, FACIAL PARALYSIS (bells palsy), SWELLING FACE (It swells my face), HYPOAESTHESIA (I have numbness), PARAESTHESIA ORAL (Tingling of the whole thing in my lip) and ORAL PAIN (pins and needles in the left side of my mouth/sometimes it goes across my lip and into my right side) had not resolved and PRODUCT DOSE OMISSION ISSUE (she did not get the second dose because her face is bad/more than 36 days after the first dose without receiving the second dose), ALOPECIA (hair loss) and HAIR INJURY (a hole in her hair) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She stated that on the third week after the vaccine, she experienced bells palsy.; Sender's Comments: This case concerns a 71-year-old female with a serious unexpected event of facial paralysis, along with nonserious unexpected swelling face, oral paraesthesia, hypoesthesia, oral pain, alopecia, hair injury and product dose omission issue. Based on 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.
126PFIZER\BIONTECH0 days18-29 years0905797-1Dec. 2020Sudden consent of right sided facial numbness paralysis
127PFIZER\BIONTECH0 days18-29 years1000419-1Jan. 2021Left half of face (same side as injection) from chin/neck to scalp was numb for approximately 8 hours. Felt very similar to the numbness of after dental work. Did NOT have face paralysis like that of Bell's Palsy just face numbness. After approximately 8 hours feeling was restored. As of 2+ weeks later no lasting effects.
128PFIZER\BIONTECH0 days30-39 years0909570-1Dec. 2020I am a healthcare provider, received first dose of Vaccine, had slight tachycardia about 5 minutes after receiving. Tachycardia resolved after about 5 minutes, chills lasted about 5 minutes. Most concerning when driving home about 20 minutes after vaccination right side of my face began tingling and numbness. This numbness and tingling lasted throughout the night until sleeping. There was no facial paralysis. When I woke up  symptoms had resolved. Throughout the next 48 hours would have intermittent tingling on right side of face only for a period of a couple minutes. After 48 hours no symptoms.
129PFIZER\BIONTECH0 days30-39 years0960439-1Jan. 2021Cardiac 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.
130PFIZER\BIONTECH0 days30-39 years0970656-1Jan. 2021extreme back pain, paralysis down arms
131PFIZER\BIONTECH0 days30-39 years0971540-1Jan. 2021Unable to move the left side of my face/I could quite noticeably see asymmetry in my face/I was provided with the diagnosis of Bells Palsy; I felt moderate tingling sensations associated with the distribution of the paralysis; Generalized muscle aches; I felt fatigue; Dizziness; This is a spontaneous report from a contactable Physician.   A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246) on 07Jan2021 at 09:00 a.m. intramuscular on left deltoid, at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 on 18Dec2020 at 09:00 on left arm (lot number: EK5730) and experienced headaches that started on the third day and ended on the tenth day. Following the second dose on 07Jan2021, patient experienced fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On 10Jan2021, he noticed that was unable to move the left side of his face. He felt moderate tingling sensations associated with the distribution of the paralysis. When looked in the mirror, he could quite noticeably see asymmetry in his face. Patient immediately visited emergency department at the hospital where his primary care doctor was located. Patient was kept in the hospital into the next day for observation (as reported). After evaluation by a neurology team and an MRI, patient was diagnosed with Bells Palsy. He had never previously been diagnosed with Bells Palsy, and never previously had a hospital stay before. It was also informed that patient underwent Nasal Swab for SARS-CoV-2 test on an unspecified date in Dec2020 and on 10Jan2021, both resulted negative. At the time of the reporting, the symptoms continued.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diagnosed Bells Palsy presented as unable to move the left side of his face/felt moderate tingling sensations associated with the distribution of the paralysis/asymmetry in his face cannot 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.
132PFIZER\BIONTECH0 days30-39 years0994675-1Jan. 2021numbness has moved up her neck; she touches her neck, it hurts a little; maintains numbness and ""no control of her arm""/can barely move her right arm; paralyzed at the shoulder from the elbow up;it's numb; can barely move her right arm; paralyzed at the shoulder from the elbow up; flu like symptoms; Threw up a couple times; mild pain at the injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 31-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL3247, Expiry date 31May2021, via an unspecified route of administration in right arm on 16Jan2021 at 07:30 at single dose for COVID-19 immunization as frontline worker. The patient had no relevant medical history. There were no concomitant medications. The patient received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine in Hospital. The patient reported that she was fine all day Saturday (16Jan2021), she just had some very mild pain at the injection site started a couple hours after getting injection. She developed flu like symptoms on the following day (17Jan2021) at 18:00PM and threw up a couple times. On 18Jan2021 at noon she noticed that she could barely move her arm: anything above her elbow on her right arm was not moving; it was paralyzed at the shoulder from the elbow up. If someone were to pick it up and let go, she couldn't control it at all. She also stated that she had no pain at all in that arm; she couldn't feel anything at all; it was numb. When she woke up on 19Jan2021 the numbness had moved up her neck, instead of being localized to her arm. She stated that when she touched her neck, it hurt a little, but it was not super significant. She stated that it was debilitating at that point as she was maintaining numbness and ""no control of her arm"". The nurse reported that this event had not required yet a visit to physician, but she has a feeling it will. She will probably have to go somewhere due to her paralyzed arm, but she had not yet. At the time of the report the event ""No control of her arm""/can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb"" had not resolved yet; the event ""mild pain at the injection site"" resolved on 17Jan2021, the events ""Flu like symptoms"" and ""Threw up a couple times"" were recovering and outcome of the events ""Numbness has moved up her neck"" and ""She touches her neck, it hurts a little"" was unknown.  The reporter assessed the events ""Pain injection site"" and ""Flu like symptoms"" as non-serious and assessed the event ""Can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb"" as disabling. She assessed all the reported events as related to BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (method of assessment: Global Introspection).; Sender's Comments: Based on the temporal relationship, the association between the events numbness of upper extremity and arm paralysis with BNT162b2 use 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.""
133PFIZER\BIONTECH0 days30-39 years0996918-1Jan. 2021Bell's Palsy; This is a spontaneous report from a non-contactable nurse (patient's wife). A 4-decade-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. Medical history included Herpes Zoster (chicken pox and shingles), and hypogammaglobulinemia from an unknown date. The patient's concomitant medications were not reported. The reporter asked if her husband should receive his 2nd dose of vaccine after experiencing Bell's Palsy 12 hours after 1st dose. The patient had history of herpes zoster (chicken pox, shingles) on the same side of his face as the paralysis now (Bells Palsy). The patient was in a lot of pain and asked how serious Bell's Palsy is. Outcome of the event was unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.; 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 event Bell's palsy 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.
134PFIZER\BIONTECH0 days30-39 years1043783-1Jan. 2021Facial numbness/paralysis started 10 minutes after injection. Paralysis of tongue and jaw muscles followed an hour later. Paralysis of eyelids followed. Medical staff on-site were not informed on how to proceed and recommend to take a benadryl and sleep it off. Muscle function returned 12 hours later.
135PFIZER\BIONTECH0 days30-39 years1179304-1Mar. 2021facial 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.""
136PFIZER\BIONTECH0 days40-49 years0919097-1Dec. 2020He stated he was fine for 20 minutes after the administration, but noticed driving home that the left side of his face felt funny/tingly. He says it progressed that evening to numbness and states his spouse noticed slight swelling to his face. He also complained of pain to his teeth and gums. He voiced concerns about bell's palsy, but stated he didn't notice any asymmetry or paralysis in his face and his symptoms have resolved entirely as of today 1/4. He was never seen or evaluated while he was having symptoms, unfortunately, and was able to continue working. Denied chest pain or difficulty breathing, no rash. He reports self-medicating with prednisone on sat/sun with improvement and as mentioned, is now asymptomatic.
137PFIZER\BIONTECH0 days40-49 years0936355-1Jan. 2021mild brain fog-feeling ""stupid"" and struggling with connections, like not picking up on humor immediately, trying to put things away in the wrong place/ ""stupid"" with brain fog that I called in; mild fatigue; mild intermittent headache; mild intermittent headache/ only mild joint ache in knees; This is a spontaneous report from a contactable other health care professional. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 04Jan2021 11:30 at single dose at right arm for COVID-19 immunization.  Medical history included non-Hodgkins lymphoma from 1995, invasive ductal carcinoma 2009 with breast reconstruction; phrenic nerve paralysis left side; cardiomyopathy. Concomitant medications included beclometasone dipropionate (QVAR), and metoprolol. On 04Jan2021 15:30, noted starting around 4 hours after vaccine, the patient experienced mild fatigue, mild intermittent headache, mild intermittent ache in knee joints. The patient was unsure if they were vaccine related but became a little more intense as the evening went on (next 5 hours) but still overall were mild, but enough for the patient to determine they seemed related to the vaccine. Also noted about 6 hours after vaccine, on 04Jan2021 17:30, mild brain fog-feeling ""stupid"" and struggling with connections, like not picking up on humor immediately, trying to put things away in the wrong place. The patient went to bed about 8-9 hours after vaccine (8pm). The patient usually gets up at 4:45-5am. She was so tired the next morning and ""stupid"" with brain fog that she called in. She wasn't uncomfortable per se, no headache the next day, only mild joint ache in knees, fatigue and brain fog. No serious reactions. The outcome of the events was recovered on an unspecified date in Jan2021. The patient did not receive treatment for the events.   Information about lot/ batch number is requested.""
138PFIZER\BIONTECH0 days40-49 years0996796-1Jan. 2021bell palsy; Headache; rash; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 44-years-old male patient received the first dose of BNT162B2 via an unspecified route of administration on 15Jan2021 15:30 at single dose in deltoid left for COVID-19 immunisation. Medical history included ongoing hypertension, Lactose intolerance, and lipids were a bit elevated on 14Jan2021. Family history included mother has diabetes and hypertension. The patient was allergic to Olives. There was no other vaccine in four weeks. Concomitant medication included ongoing lisinopril daily for blood pressure, ongoing colecalciferol (VITAMIN D) weekly, ongoing duloxetine to help with the blood pressure control, and ongoing Multivitamins daily. On Friday 15Jan2021 night around 11:00 PM he started experiencing headaches and rash. On Sunday night (17Jan2021) he experienced the bell palsy/Facial Paralysis and went to the ER. For bell palsy, the patient first had a shot of steroid, then was given oral Methylprednisonole and oral Famcyclovir. Treatment also received for headache and rash. He is still taking Still taking Methyl-prednisolone and the Famcyclovir and he will end these medications tomorrow. The patient had blood work on 14Jan2021 with normal result, lipids were a bit elevated. Events outcome was not recovered.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
139PFIZER\BIONTECH0 days40-49 years1000209-1Dec. 2020was supposed to get the second dose yesterday 19Jan2021 but location is closed/  could get it up to the 26Jan2021; paralysis of the chin and half of the face; and around the mouth; This is a spontaneous report from a contactable consumer report for self. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 29Dec2021 20:00 PM for COVID-19 immunization. Medical history included ongoing severe migraines. None family history. There were no concomitant medications. No Prior Vaccinations within 4 weeks. After an hour she had paralysis of the chin and half of the face; and around the mouth. It only lasted a few minutes, like 10 minutes and then it went away, she was fully recovered. She did not got to a doctor or the ER. Adds she was supposed to get the second dose yesterday 19Jan2021 but she has to go to another location as that location is closed. They told her she could get it up to the 26Jan2021 and then it would be more problematic to get. The event outcome was recovered on 29Dec2020.  Information on the lot/batch number has been requested.
140PFIZER\BIONTECH0 days50-59 years0921913-1Jan. 2021At 1602 client began c/o numbness on L side of face and pain/tension in L side of neck, radiating down L arm.  Vitals remained stable, no swelling or paralysis noted. No change in mentation, hives or difficulty breathing. Monitored until 16:39. At that time there was no change in her condition. Agreed to return home-monitor for worsening condition, seek medical care if worsens or continues. Treat symptoms with OTC and heat. Followed up with client 1/5. Reports took ibuprofen in pm and again this am to assist with pain and swelling. Still some swelling in face but resolving. No further symptoms appeared.
141PFIZER\BIONTECH0 days50-59 years0925590-1Dec. 2020The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pfizer EK5730) receipt 16 DEC 2020. She reports no immediate reaction except experienced a dry throat which she noted after her 30 minute wait, but no urticaria, SOB, wheezing, oral/face/throat/tongue edema, flushing, pruritic, CP n/v/d. She states about 3 hours later she developed a dermatitis initially to her legs. The lesions were raised, pink, initially nonpruritic, fixed but no vesicles, pustules or bruising. She took a shower which exacerbated the symptoms with erythematous patches and severe burning sensation.  She reports she was seen in ER and her spouse noted lesions to her neck and ears. Her eyes felt swollen. She left ER due to the wait and obtained Benadryl OTC. She saw her PCP in the morning. She received IM dexamethasone and oral prednisone dose pack. She continued to not feel well. She experienced heart palpitations, feeling hot and flushed, fatigue and headache which she treated with Tylenol. She treated the dermatitis with Zyrtec 10-20 mgs q1-2 x daily, but sometimes took Benadryl. Last dose was Benadryl at midnight, Zyrtec 10 at 0600 and has one day of prednisone left. She also experienced bilat tingling in her feet starting day 5. which the left resolved but her right foot continued. She has no paresis, paralysis, altered gait, tripping or fall, difficulty emptying her bladder. She saw PCP on 05 January. ESR was normal . Overall symptoms improved but continued r foot numbness, pain to her legs. She reports PCP ordered CXR and abdominal series which were normal.
142PFIZER\BIONTECH0 days50-59 years0938060-1Jan. 2021immune deficiencies; She said the joint pain felt like ""flu"" joint pain; She said she was really sweaty, so much so, that she had sweat under her eyes; thyroid problems; feels shaky inside; Numbness facial; Exhaustion; Foggy feeling in head/feeling rundown; felt exasperated; sweating like crazy and then gets chills; felt yucky/she didn't feel good at all; Joint pain; Nausea; Chills; after receiving the COVID-19 Vaccine on (Dated), she had left upper shoulder pain.; She clarified she had some injection site pain; and the injection site was a little itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration on 02Jan2021 14:30 at single dose in the left upper arm for COVID-19 immunization. Medical history included Pernicious anaemia from 2006 and ongoing, Hashimoto's disease ongoing, stated she was diagnosed with Hashimoto's disease in either 1994 or 1995. Psoriatic arthritis from Nov2020 and ongoing. Potassium low ongoing, reported she has had low potassium off and on for years. She said she can't remember when she didn't have low potassium. She said she normally finds out her potassium is low when she has blood work done. She stated she has had low potassium most of her adult life. IgA deficiency from Feb2019 and ongoing, Psoriasis ongoing, paralysis in her left trapezius muscle. Concomitant medication included B-12 for pernicious anemia. She said she had the typical reactions that one might get with a vaccine. She clarified she had some injection site pain and the injection site was a little itchy on 02Jan2021. She stated on the second day (03Jan2021) she had joint pain, felt yucky, had nausea, and chills. She said the next day (04Jan2021) she felt a little better, but still had chills. She said yesterday (05Jan2021) she thought she was feeling better, but by yesterday, clarified as late afternoon and evening, she crashed. She said she has a lot of autoimmune issues and immune deficiencies, saying she has pernicious anemia and Hashimoto's disease.  She said yesterday evening she experienced extreme body temperature issues. She said she was really sweaty, so much so, that she had sweat under her eyes. She said she would get really hot and had chills. She said she was feeling really bad and was feeling shaky inside. She said she thought it was important that she report what she was experiencing to Pfizer. She stated she has psoriatic arthritis, too. Reported after receiving the COVID-19 Vaccine on 02Jan2021, she had left upper shoulder pain. She clarified that she had a previous history of paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder. She said she had a weird feeling that went around where her scar was from the surgery on the back of her left shoulder. She said maybe the left shoulder pain had to do with how she held her left shoulder. She said on Monday, 04Jan2021, she had a little bit of pain in her left shoulder and by yesterday night, 05Jan2021, there was not much pain at all. Clarified her joint pain was in her ankles, wrists, hips, neck,  back, and knees. She said the joint pain felt like ""flu"" joint pain. She stated she normally has joint pain with the other issues she has, but this joint pain felt different. She said the joint pain she experienced after taking the COVID-19 Vaccine was all over her body. She said yesterday (05Jan2021) her joint pain felt so much better, but later in the afternoon she didn't feel right. She said she has pernicious anemia, and thought maybe she needs her B-12 shot. She said yesterday (05Jan2021) she experienced a lot more symptoms. She said she had numbness in her face, felt extremely exhausted, had a foggy feeling, and felt exasperated. She said the symptoms didn't start until late in the afternoon into the evening of 05Jan2021. She said she did not feel well and went to bed at 8:45PM, which is early for her. She said she did give herself a B-12 1mcg/ml shot intramuscularly yesterday. She provided the B-12 1mcg/ml NDC Number: 7006900510, Lot Number: C0495, and Expiration Date: Aug2022. She said the name (company name) was listed on the B-12 1mcg/ml packaging. She said she gives herself a B-12 shot every 10 days.  She said she still has some joint pain, but the joint pain is not like it was on 03Jan2021. She said she still has a tiny bit of heaviness in her joints with a constant throbbing pain, which is a different joint pain from her normal. Reported last night (05Jan2021) she didn't feel good at all. She said she felt horrible, and had to go to bed. She said she felt shaky inside all night, and still feels that way now. She said she was sweating like crazy, and then would get chills. She clarified she is used to being hot and cold in her normal life because of her thyroid problems, but stated what she experienced last night was beyond that. She said her hot and cold issue was bumped up several levels last night. She said she was chilled or sweating all the time last night, but did not have a temperature. She clarified her normal body temperature is 96.7, and when she checked her temperature at one point, her temperature was 98 degrees. Reported the hot and cold with sweating and chills, and nausea come and go. She said if she has nausea, it is a mild feeling of nausea. Clarified if Sunday, 03Jan2021. was a work day, she would have called out sick. She said Monday (04Jan2021) and Tuesday (05Jan2021) she did go to work. Reported she has low potassium and made herself an electrolyte cocktail. Reported if her system feels off, she said her electrolytes maybe off. She said her heart felt like it may be shaky, so she ate a banana to get potassium in her system. She said she does her little routine before she would call her doctor to get blood work done. She said she had her blood work done not too long ago. She said she wasn't feeling this way before she had the COVID-19 Vaccine, and is feeling rundown now. She said she was feeling good before she had the COVID-19 Vaccine. She said she feels like something is going on with her body now. Reported her last blood work was done on 04Dec2020 and everything was kind of normal. She clarified her thyroid was a little off, and her doctor adjusted her medication. She said her potassium was a little down. Reported she was told when she got the COVID-19 Vaccine shot she has to be a little more careful, and she might not be as protected as some people. She said she was told there have not been enough studies on the COVID-19 Vaccine. She clarified she was told that information by a person at the site where she received the COVID-19 Vaccination, saying the person was helping her with the COVID-19 Vaccination authorization form. Reported she thought she was doing OK after she received the COVID-19 Vaccine, until after last night and yesterday afternoon. She said if she continues feeling the way she is, she will see her doctor. She said her system seems off. She said she normally tries everything she knows first, like drinking a lot of water, and drinking electrolytes, and will take potassium to see if that is the issue. She said those are her own things that she does before she calls her doctor. Clarified sometimes she has numbness in her face due to not having her B-12. She said she still has a little numbness in face. She said on 05Jan2021, the numbness went across her face from the bridge of her nose down through to her mouth. She said the numbness was nothing like paralysis in her face, but her face was really hot at the same time she had the numbness. Reported she took Tylenol (clarified as (company) brand Tylenol, stating she doesn't have the UPC, Lot and Expiration Date). She said the Tylenol wasn't kicking in, so she took Ibuprofen (clarified as (company)brand Ibuprofen, and she doesn't have the Ibuprofen NDC, Lot and Expiration date). She said she took her normal medications. Outcome of events ""She clarified she had some injection site pain"" ""and the injection site was a little itchy"" and Shoulder pain were recovered on an unspecified date, ""Chills"" and ""feels shaky inside"" were not recovered, ""Joint pain"" ""Nausea"" ""Numbness facial"" were recovering, while outcome of other events was unknown.""
143PFIZER\BIONTECH0 days50-59 years0956345-1Jan. 20219 to 36 hours. Lymphnode swelling , pain left axilla. Fever,  chills ,muscle aches, brain fog.  1 week post Facial paralysis, fatigue,  vocal cord weakness, feeling of unwell.
144PFIZER\BIONTECH0 days50-59 years0965215-1Jan. 2021Systemic: Patient experienced temporary paralysis from the shoulders down lasting approximately 20 minutes-Severe
145PFIZER\BIONTECH0 days50-59 years1004433-1Jan. 2021bilateral 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.""
146PFIZER\BIONTECH0 days60-64 years0903412-1Dec. 2020About two hours after receiving vaccine pt experienced numbness, heaviness in face and progressing to entire head.  Tingling in face, head, neck later.  Feeling like paralysis ""like if I went in and looked in mirror I would see facial dropping. Couldn't smile or raise eyebrows.  There was a heaviness in my muscles. My cheeks felt full. ""  Symptoms subsided by 8pm (four hours after began). ""Felt like being drugged, under the influence.  Felt foggy, cognitvely in a way.""""
147PFIZER\BIONTECH0 days65+ years0938078-1Dec. 2020Facial paralysis; This is a spontaneous report from a contactable Pharmacist.   A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899, Expiration Date 30Mar2021), via intramuscular, on 17Dec2020 (at 15:35), at single dose of 0.3 mL for COVID-19 immunisation. The patient was vaccinated at hospital, age at vaccination was 70-year-old. Vaccine location was deltoid but unsure which deltoid. The patient did not have a relevant medical history and concomitant medications. Pharmacist said that after vaccination, she waited to be monitored the standard 15 minutes at hospital and then when she got in the car and was on the way home like 20 minutes later she had brief episode of what the patient described as facial paralysis. It was like the side of her face in one area felt funny, it felt numb and it was not anywhere else on her face. It lasted the 20 minutes and then went away. The patient had recovered from the events on 17Dec2020. The pharmacist queried if the patient can proceed with the 2nd dose of the vaccine.  The reporting pharmacist considered the event 'facial paralysis' as non-serious.; Sender's Comments: A possible causal relationship between acute onset of facial paralysis and BNT162B2 cannot be completely ruled out considering the temporal relationship and the known adverse event profile of the suspect vaccine.  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.
148PFIZER\BIONTECH0 daysUnknown0945934-1Jan. 2021It felt like a viral meningitis; arm soreness; feel some tension; migraine headache; body started shaking; chills/Rigors; temperature 104; I had sensitivity that I never had; headache; photophobia; Sinophobia; paresthesia/tingling sensation along my upper extremity; I felt like I was freezing; I didn't feel comfortable; vertigo; nausea; hard time to focus; This is a spontaneous report from a contactable other health professional (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  He didn't have any allergies. He was in good health, no underlying issue. He never had a surgery. In Jan2021, patient got the vaccine last night around. It started with arm soreness. Around 10:00 am he started to feel some tension, migraine headache. Around 11:00 he felt his body started shaking. He had chills, rigors and temperature 104. For 5-6 hours he had sensitivity that he never had. Patient had a headache, photophobia, sinophobia, paresthesia and tingling sensation along his upper extremity. he felt like he was freezing. He didn't feel comfortable. It resolved afterwards, he felt no weakness, no facial paralysis. It felt like a viral meningitis. He also had vertigo, nausea and hard time to focus. Outcome of events were unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event viral meningitis 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.
149PFIZER\BIONTECH1 day18-29 years0933755-1Jan. 2021Numbness and tingling bil upper extremities, seizure, temporary paralysis R arm. Started day after vaccine given, was observed overnight in hospital.
150PFIZER\BIONTECH1 day30-39 years0913644-1Dec. 2020Pfizer-BioNTech COVID-19 Vaccine I experienced a seizure like nightmare.  There was a flash of bright light and then I started shaking  and moaning/gurgling.  I could only move my right leg to try to get my husbands attention but my arms and upper body were in paralysis.  I have never experienced anything close to this, but since I was sleeping,  I am not sure exactly what it was.  I believe it only lasted for about 30 seconds, and afterwards, I feel okay.
151PFIZER\BIONTECH1 day30-39 years0926808-1Jan. 2021The morning after I received the shot in my right arm, I woke up and jumped out of bed to turn off my alarm. My right leg buckled and completely gave out. It felt like there was not a muscle or bone in the leg. I  melted down on top of my leg, twisting my ankle and my knee. I ended up with my knee twisted behind me as I hit the floor and my nightstand. I don't know if you would call it muscle fatigue or weakness, it felt like muscle paralysis, but it only lasted less than a minute before it was gone, however, the damage was already done. I hurt my knee very badly because I had no control over my leg muscles. I've never had anything like that happen before.
152PFIZER\BIONTECH1 day30-39 years0953592-1Jan. 2021Facial paralysis; This is a spontaneous report from a contactable consumer (patient herself).  A 36-year-old female patient received bnt162b2 (COVID-19 Vaccine by Pfizer, lot EK9231, expiry date was not reported), via an unspecified route of administration on 08Jan2021 at SINGLE DOSE for Covid-19 immunisation (to prevent the COVID). Medical history was none. There were no concomitant medications. The patient experienced facial paralysis on the left side of her face upon waking up on 09Jan2021. The outcome of event was not recovered.
153PFIZER\BIONTECH1 day30-39 years1044078-1Jan. 2021Syncope I was treated for a split lip, severe neck pain, pinched nerve resulting in L arm paralysis  Muscle relaxers and pain killers were prescribed  Arm movement returned after about  3 weeks
154PFIZER\BIONTECH1 day30-39 years1076916-1Feb. 2021I was suffering from paralysis and numbness on the left side of my face.  I went to the ER and was diagnosed with Bell's Palsy; This is a spontaneous report from a non-contactable consumer (the patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) via an unspecified route of administration in left arm on 21Feb2021 11:30 a.m. at age of 31-year-old, at single dose for COVID-19 immunisation. The patient had history of frequent ear infections. Concomitant medication included fluticasone which was taken within 2 weeks of vaccination for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient reported when he woke up the next day after receiving the vaccine (22Feb2021), he found that he was suffering from paralysis and numbness on the left side of his face. He went to the emergency room (ER) and was diagnosed with Bell's Palsy. He had been experiencing some minor pain in his left ear beginning two days before he received the vaccine (i.e., three days before onset of facial paralysis), and this ear pain had continued as he continue to experience the palsy. Since visiting the ER, he had also seen a neurologist. The doctors he had seen do not necessarily think that the palsy resulted from receiving the vaccine. The onset date of the event ""I was suffering from paralysis and numbness on the left side of my face. I went to the ER and was diagnosed with bell's palsy"" was reported as 22Feb2021 09:00 a.m. The event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The event was non-serious (the event did not result in death, not life threatening, not caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect). Oral steroid and antiviral drugs, eye ointment was received to treat the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.""
155PFIZER\BIONTECH1 day40-49 years0918899-1Dec. 2020I had right sided headache for the first two days, then resolved.  The right sided headaches recurred along with right tongue numbness initially on 12/29/2020.  The symptoms worsen on 12/31/2020 and severe on 1/1/2021.  I was initially started on Valtrex thinking it maybe due to shingles but soon with the right sided facial paralysis, it was obvious it was Bell's Palsy and was started on steriods on 1/1/21 and also received acupuncture treatment on 1/2/21 which significant help improve the symptoms.  I still have some residual weakness of the right eye with some tearing and mouth weakness.
156PFIZER\BIONTECH1 day40-49 years0932371-1Jan. 2021The patient received the vaccine in the left deltoid at 07:45 on 1/7/21.  The patient reports that on 1/8/21 at around 0200, she was awoken with a sharp pain in her left arm followed by complete paralysis of her left hand for about 15 seconds.  Did not re-occur.  Did not seek treatment.   Reported to Dr. and no further issues seen.
157PFIZER\BIONTECH1 day40-49 years1047429-1Jan. 2021After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection.  Currently still symptomatic.
158PFIZER\BIONTECH1 day50-59 years0924550-1Dec. 2020Patient reported a fever and tingling to his face in the morning on 12/17/20. EHS followed up with him at 11:30 am on 12/17. He reported that the fever had resolved, and he was no longer having tingling to his face. He denied paralysis to his face, shortness of breath, and chest pain.
159PFIZER\BIONTECH1 day50-59 years0939419-1Jan. 2021aches/pains shooting down my right leg; severe lower back pain; This is a spontaneous report from a contactable nurse. This 54- year-old female patient (reported for herself) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EK5730), via an Intramuscular route of administration, on 06Jan2021 at 09:00 AM (at the age of 54-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the right arm. The patient reported allergies to food. The patient does not have any medical history. Concomitant medication included omeprazole ((MANUFACTURER UNKNOWN) 20 mg QD, diclofenac (MANUFACTURER UNKNOWN) 75 mg EC tablet QD. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 3:00AM, 18 hours after 1st dose, she experienced severe lower back pain with aches/pains shooting down my right leg. Nine hours, after the injection I took 1 gm of Tylenol. At 3 am, I took another 1 gm of Tylenol with some relief. At 8 am took 400 mg of Motrin with some relief-aches/pain still there. No paralysis or weakness. The patient received Tylenol and Motrin as treatment for the events. The clinical outcome of the events aches/pains shooting down my right leg and severe lower back pain was not recovered. Patient was not tested for COVID-19 since having the vaccine.  No follow-up attempts are possible. No further information is expected.
160PFIZER\BIONTECH1 day50-59 years1037826-1Jan. 2021Bell's Palsy; This is a spontaneous report from a contactable other health care professional (patient). A 51-year-old female patient (Pregnant: No) received second dose of bnt162b2 (Lot number: EL9264), via an unspecified route of administration in left arm on 29Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ammonium succinate, calcium succinate, glutamate sodium, glycine, magnesium succinate, tocopheryl acetate, zinc difumarate hydrate (AMBEREN), collagen, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS) and multi-vitamin. The patient previous received first dose of bnt162b2 (Lot number: EL0143), via an unspecified route of administration in left arm on 07Jan2021 14:00 for COVID-19 immunization. The patient experienced bell's palsy (hospitalization) on 30Jan2021 09:00. The patient was hospitalized for bell's palsy for 2 days. The patient was admitted on 30Jan2021 to hospital and diagnosed with Bell's Palsy. Treatment included: Prednisone and Valacyclovir. Facility type vaccine was hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. The outcome of event was not resolved.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. The information 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
161PFIZER\BIONTECH1 day65+ years0918277-1Jan. 2021Weakness, almost paralysis both lower extremities worse than baseline paresis from ms.
162PFIZER\BIONTECH1 day65+ years0990523-1Jan. 2021he 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.""
163PFIZER\BIONTECH1 day65+ years1041694-1Feb. 2021bilateral facial paralysis, Treatment: Immune Globulin - 5 infusions, steroid, anti-viral; recovering; 6 days
164PFIZER\BIONTECH1 day65+ years1129059-1Mar. 2021The 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.
165PFIZER\BIONTECH2 days18-29 years0935924-1Jan. 2021R side facial paralysis starting 48 hours after second dose of vaccine, diagnosed through ED visit as Bells Palsy
166PFIZER\BIONTECH2 days18-29 years1045622-1Feb. 2021phrenic 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.""
167PFIZER\BIONTECH2 days30-39 years1022053-1Jan. 2021right sided facial paralysis; headache/migraine from base of R skull radiating to R Ear and top of head; This is a spontaneous report from a contactable nurse. This 34-Year-Old female nurse (patient) received 2nd dose of BNT162B2 (lot number=EL3247) Intramuscular on 21Jan2021 00: 00 AM (reported as 20Jan2021 12:00 PM) on Right arm for covid-19 immunization. Medical history and concomitant drug were not reported. Past drug was Known allergies to doxycycline. Historical Vaccine was 1st dose of BNT162B2 (lot number=EL1284, on 31Dec2020, 12:15 PM, administrator route=Intramuscular, vaccine location=Right arm). No other vaccine in four weeks. Patient received vaccine on Wednesday 20Jan2021, went to ER on Sunday 24Jan2021 with right sided facial paralysis and headache/migraine from base of R skull radiating to R Ear and top of head from 23Jan2021 10:00 AM with outcome was Recovering. Treatment was medications prednisone and antiviral. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts possible. No further information expected.; 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 facial paralysis due to temporal relationship and current drug safety profile.  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 RAs, Ethics Committees, and Investigators, as appropriate.
168PFIZER\BIONTECH2 days60-64 years1070764-1Feb. 2021had total paralysis of the left side of his face; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old male patient received 2nd dose of BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at arm left on 20Feb2021 11:00 AM at the age of 61-year-old at single dose for COVID-19 immunisation. Patient previously received first dose of BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at left arm on 30Jan2021 11:00 AM at the age of 61-year-old for COVID-19 immunisation. Patient had no COVID-19 prior vaccination. COVID-19 was not tested post vaccination. There was no known allergies. Other relevant medical history was reported as none. Concomitant medications were not reported. There was no other vaccine in four weeks. Patient had total paralysis of the left side of his face on 22Feb2021 at 07:00 AM. It was reported that the event resulted in disability or permanent damage. Outcome of the event was not recovered. No treatment for the event was received.  Information on the lot/batch number has been requested.
169PFIZER\BIONTECH2 days65+ years1184002-1Mar. 2021paralysis of right side of face (Bell's Palsy); This is a spontaneous report received from a contactable consumer (patient himself). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EMe205) via an unspecified route of administration in left arm on 09Mar2021 at 17:15 (at the age of 76-year-old) as a single dose for COVID-19 immunization. The patient's medical history included ADM II. The patient did not have allergies to medications, food, or other products. Concomitant medications included insulin, carvedilol, furosemide, clopidogrel, simvastatin (SIMVAS); All received within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 experienced paralysis of right side of face (Bell's Palsy) on 11Mar2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The event was considered as serious (disability or permanent damage) by the consumer. The patient was treated with physical therapy - heat, vibration for the adverse event. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
170PFIZER\BIONTECH3 days18-29 years0910639-1Dec. 2020Bell's palsy/facial paralysis; This is a spontaneous report from a contactable other Health Professional (patient). A 28-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/ batch number: 33121, brand: EJ1685), via an unspecified route of administration at left arm on 18Dec2020 09:30 at single dose for covid-19 immunization at hospital. Medical history included anxiety, depression, diagnosed COVID-19 prior vaccination. No known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC) in two weeks. No other vaccine in four weeks. The patient experienced bell's palsy/facial paralysis on 21Dec2020 19:00 with outcome of not recovered. The seriousness was reported as no. The adverse event result in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The treatment received for the adverse event was reported as unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for the reported event of Bell's palsy due to temporal relationship. However, the reported event may possibly represent intercurrent 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, 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.
171PFIZER\BIONTECH3 days30-39 years0938126-1Jan. 2021Following the first COVID vaccine dose on Dec/18/2020, I had headaches that started on the third day and ended on the tenth day.  The headaches were usually light, unilateral, and alternating from one side to the other. I was usually functional except on the fourth and seventh days where the headaches were moderate to severe, and I took naps to help with the headaches for those two days. I have never had an issue with headaches before, and these symptoms were a new experience for me. I did not take any medications as treatment for the headaches. Following the second COVID vaccine dose on January/7/2021, I felt fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On January/10/2021, when I woke up that morning I again felt light, unilateral, and alternating headaches. In addition, I noticed that I was unable to move the left side of my face. I felt moderate tingling sensations associated with the distribution of the paralysis. When I looked in the mirror, I could quite noticeably see asymmetry in my face. I immediately went to the emergency department at the hospital where my primary care doctor is located. I was kept in the hospital into the next day for observation. After evaluation by a neurology team and an MRI, I was provided with the diagnosis of Bells Palsy. I have never previously been diagnosed with Bells Palsy, and I have never previously had a hospital stay before. The doctors prescribed medications which I am currently taking. As of today January/12/2021, the symptoms have had some improvement, but the symptoms still continue.
172PFIZER\BIONTECH3 days40-49 years0918637-1Dec. 2020Right sided jaw pain  started 12/22/20 in the am progressed through the evening. When I woke up I had numbness and weakness in the right of my tongue which I quickly realized included the right portion of my face. Included tongue was numb and I couldn't move it. An Er trip and CT scan confirmed it was Bells Palsy. Today,  My symptoms continue. Top of my head all the way to the  way to bottom of neck is experiencing paralysis.  Can move tongue now and it's partly numb but it's cooperating a bit more now. Nerve pain has worsened all over all the right side of face. Feels like someone  has kicked  face and I have a deep bruise.  It's a deep ache. Nothing will take away the ache away. My eye doesn't lubricate like it should. So I have to either manually close it and wet it manually or tape it closed.
173PFIZER\BIONTECH3 days65+ years0965977-1Dec. 202012/27 vaccination 12/30  felt good all day. Ate supper. Sat down to watch news, read. At about 8 o'clock, i had almost collapsed out of the chair. I was extremely flushed, never felt so hot in my life, thought i was going to pass out. I got to the floor, I was extremely weak. I had a hard time getting up. I made the call to my dr answering service. I did get up and get some water. I took my BP evening meds, it was in the 200's/90-100. When dr called me, i relayed info. Words not slurred, no paralysis. Extreme sensation of being flushed. O2 stats were good; 96-100%. I went to local emergency in  my neighborhood.  'uncontrolled pain' BP 192-100
174PFIZER\BIONTECH3 daysUnknown0944269-1Jan. 2021Bell's palsy; Loss of taste; Can not close one eye, no muscle movement on one side of the face.; This is a spontaneous report from a contactable nurse.  An adult female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 05Jan2021 15:30 at single dose for COVID-19 immunization.  There were no medical history or concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient experienced Half face paralysis, Bell's palsy. Loss of taste. Can not close one eye, no muscle movement on one side of the face. All on 08Jan2021 14:30 with outcome of unknown. No treatment was received.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of Half face paralysis/Bell's palsy cannot be fully excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. 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
175PFIZER\BIONTECH4 days30-39 years0908785-1Dec. 2020Woke up with onset of left sided facial weakness, paralysis, and numbness around 0600. Was evaluated in the ER and diagnosed with Bell?s Palsy.
176PFIZER\BIONTECH4 days30-39 years0996921-1Jan. 2021Bell's palsy / pain in the left side of her face / pain irradiated to ear and jaw / tingling sensation in left side of the forehead / facial weakness; This is a spontaneous report from a contactable Physician reported for self. This 35-Year-old-female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 15Jan2021 08:20 on Arm left at single dose for covid-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No known allergies. None concomitant medication included. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Dec2020 08:20 AM at the age of 35 year old via IM Injection Upper Left Arm for covid-19 immunisation, no reactions with first dose and flu vaccine, Expiry Date: Oct2020 for immunization and no reactions. The patient experienced Bell's palsy on 19Jan2021 and received prednisone 60 mg for 7 days. The same day of the vaccination (15Jan2021), she started to experience pain in the left side of her face, aggravated by 18Jan2021, her pain irradiated to ear and jaw. On Saturday 16 post vaccinated, she experienced also tingling sensation in left side of the forehead on 16Jan2021. She experienced facial weakness on 19Jan2021. And in 19Jan Monday evening Bells Palsy was confirmed. Lab data included Physical exams: weakness in the left side of forehead. No Covid tested post vaccination. Outcome of the event Bell's palsy was recovering. Outcome of other events was unknown. There was a reasonable possibility that the event Bell's palsy was related to BNT162B2.  Information on Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
177PFIZER\BIONTECH4 days30-39 years1062208-1Feb. 2021brain fog; Bell's palsy on left side of face; vision has been off/ Vision is blurry; Numbness and tingly/burning sensation in right leg; Numbness and tingly/burning sensation in right leg; Numbness and tingly/burning sensation in right leg; This is a spontaneous report from a contactable consumer (patient).  A 33-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9264 and Expiration Date: May2021), via an unspecified route of administration in the left arm on 02Feb2021 at 17:45 at 33-years-old at a single dose for COVID-19 immunization; with no other vaccines administered within four weeks of the bnt162b2 administration.  Medical history included anxiety from an unknown date and unknown if ongoing.  Concomitant medications included alprazolam (XANAX) taken for an unspecified indication from an unspecified date to an unspecified date, prednisone (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified date to 16Feb2021.  The patient experienced the following events and outcomes: Bell's palsy on left side of face (medically significant) on 06Feb2021 12:00 with outcome of recovering, vision has been off/ vision is blurry (medically significant) on 06Feb2021 12:00 with outcome of recovering, numbness and tingly/burning sensation in right leg (medically significant) on 06Feb2021 12:00 with outcome of recovering, brain fog (medically significant) on an unspecified date with outcome of unknown; all of which required a physician office visit. The clinical course was reported as follows: The patient received the first dose of the Pfizer COVID 19 vaccine, she began having symptoms on the following Saturday and was seen by her doctor and diagnosed with Bell's Palsy. The patient stated she has reported this via VSafe and the Pfizer website. The patient also reported other symptoms that have not been reported as follows: had tingling in both legs, brain fog, and vision has been off. The patient was not sure if it was related to the vaccine or steroids. The patient wanted to know if she should get the second dose. The patient had been on a steroid, so she did not know if she should wait to get the second dose. The patient just stopped the steroid on 16Feb2021, and the second dose was scheduled for 23Feb2021.  The patient also said she had other symptoms that she had not reported and she said she had tingling that started in one leg now in both legs, brain fog and her vision was off and she was not sure if that was related to the vaccine or the steroid (later clarified as prednisone). The patient was not taking the steroids at the time of diagnosis. ""Correct I mean it started after the vaccine, but I was also on medication (Clarified as Prednisone) so I am not really sure what the difference is at this time."" Treatment in response to event: the patient stated, ""No I mean for the tingling in my leg I have been just putting heat and Ice on it but I have not done anything actual big treatment and then for my eyes no, my doctor is not sure what is related to the Bell's Palsy and what is to medication."" The patient underwent lab tests and procedures which included lab work: unknown result on an unspecified date (patient stated, ""Yes, I have many"").  Therapeutic measures were taken as a result of facial paralysis, hypoaesthesia, burning sensation, and paraesthesia; which included steroids and anti-viral and anti-nausea medicine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.""
178PFIZER\BIONTECH4 days40-49 years0907907-1Dec. 2020Right sided jaw pain started 12/22/20 in the AM progressed through the evening. When I woke I had numbness and weakness on the right side of my tongue which I quickly realized included the lower portion of my right face.  An ER trip and a CT scan confirmed it was Bells Palsy. The upper portion of my face has is now included in the weakness and paralysis.
179PFIZER\BIONTECH4 days65+ years1056640-1Jan. 2021Lt 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.
180PFIZER\BIONTECH5 days40-49 years0940640-1Dec. 2020Within 5 days of vaccination, he developed severe right-sided facial pain, and about two days later developed complete right-sided facial paralysis. In the following days he also developed balance problems and nausea/vomiting. His facial pain has begun to improve with high-dose prednisone.
181PFIZER\BIONTECH5 days65+ years1037842-1Jan. 2021may 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.
182PFIZER\BIONTECH5 days65+ years1067385-1Feb. 2021Paralysis of face
183PFIZER\BIONTECH5 days65+ years1109364-1Mar. 2021I was diagnosed with bells palsy in 2005.  Full recovery with small amount of paralysis remaining on left side of face (left corner upper lip).  About 5 days after vaccine noted chewing differently.  Eight day after vaccine new paralysis on left side of face now extending to entire jaw area and upper and lower lip.  New paralysis on right side of face.  Eye won't blink, eye brows won't raise, unable to puff jaw and area next to noise won't move.  Twelve days after vaccine minimal improvementlater
184PFIZER\BIONTECH7 days40-49 years0934877-1Dec. 2020Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) intramuscular, on 17Dec2020 04:15, single dose arm left  for COVID-19 immunization. Relevant medical history included hypothyroidism, hypertension, hyperlipidemia, obesity, and penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), butalbital, caffeine, paracetamol (FIORICET 50-40- 325mg), dexamethasone 4mg Inj., diclofenac (VOLTAREN 1% Gel), Magnesium, valsartan (VASOFLEX) (pending confirmation), cyanocobalamin (VITAMIN B12), losartan potassium. The patient was not pregnant and did not received any vaccine in four weeks. The patient previously took cephalosporin and experienced allergy. On 24Dec2020, the patient experienced pain left side of the face and migraine, and came to emergency room where apparently they diagnosed facial paralysis. The events resulted in emergency room visit/ urgent care where the patient was administered dexamethasone 4mg Inj, Medrol dose pack, Vit B12 500mcg, and Fioricet 50-325-40. Facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. It was unknown if the patient was diagnosed with COVID-19 prior or since the vaccination. The events were assessed by the nurse as non-serious. Outcome of the events was recovering at the time of the report.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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.
185PFIZER\BIONTECH7 days40-49 years0993468-1Dec. 2020facial paralysis; stress; facial pain; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on an 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history includes ongoing facial paralysis (it was reported that the patient experienced facial paralysis caused by stress a couple of year ago and then again after the vaccination). Concomitant medications were not reported. The reporter felt worried about the patient (partner) that had facial paralysis and asked if they could administer the second dose of the vaccine of COVID-19 from Pfizer. The paralysis it was previous from the fist dose of the vaccine, a consequences of the stress, the partner had 42 years. The reporter considered that the event was non-serious. As of 15Jan2021, it was reported that the patient experienced facial paralysis caused by stress a couple of years ago and then again after the vaccination (24Dec2020). The patient also experienced pain in face on 24Dec2020. The patient underwent MRI on an unspecified date. Treatment was given for the events facial paralysis and pain in face (Anti-inflamatories). The outcome of the stress was unknown while not recovered for the other events.  Information on the lot/batch number has been requested.  Amendment: This follow-up report is being submitted to amend previously reported information: country of incidence was updated.  Additional information received on 15Jan2021 from a contactable nurse includes: patient details (medical history and lab data), product details (therapy dates), reaction data (additional event: pain in face) and clinical course details.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of facial paralysis cannot 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
186PFIZER\BIONTECH8 days40-49 years0971280-1Dec. 2020left 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.
187PFIZER\BIONTECH8 days40-49 years0994219-1Jan. 2021Diagnosis 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.
188PFIZER\BIONTECH8 days40-49 years1010624-1Jan. 2021Peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination; This is a spontaneous report from a contactable 49-year-old male other healthcare professional (HCP) (patient) reported for himself received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via unspecified route on left arm single dose for COVID-19 immunization on 09Jan2021, 02:30 PM, at 49-year-old. Medical history included: Borderline Type 2 diabetes; Hepatitis B carrier. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: metformin, entecavir. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2. The patient had peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination (17Jan2021) and was reported as non-serious. Treatment was received as steroids and antiviral. Emergency room/department or urgent care visited. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was not resolved.; Sender's Comments: Based on currently known drug safety profile, a causal association between the reported event peripheral facial paralysis and BNT162B2  cannot be fully excluded. The event facial paralysis can also be caused by other virus infection. Case will be reassessed when additional information is available including viral testing. 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.
189PFIZER\BIONTECH8 days65+ years1075693-1Feb. 2021Patient 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
190PFIZER\BIONTECH8 days65+ years1107771-1Mar. 2021Got COVID shot March 3, then had some alteration of taste around March 8 or so, then L facial paralysis consistent w Bell Palsy on March 11.
191PFIZER\BIONTECH8 days65+ years1111791-1Mar. 2021My 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.
192PFIZER\BIONTECH9 days50-59 years0925034-1Dec. 2020Patient developed Bell's Palsy on 1/1/2021 and was seen in the Emergency department and started on oral steroids. I saw him 1/6/2021 and he continued to have left sided facial nerve palsy/paralysis.
193PFIZER\BIONTECH9 days65+ years1051003-1Jan. 2021Bell's Palsy; This is a spontaneous report from a contactable consumer, reporting for herself. A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 27Jan2021 15:15 at a single dose for COVID-19 immunization. Vaccination was done in a Public Health Department. Medical history included hypertension (HTN), gastrooesophageal reflux disease (GERD), total hysterectomy and osteoarthritis, all from an unknown date and unknown if ongoing. The patient was not pregnant. There were no known drug allergies. Concomitant medication included celecoxib (CELEBREX), omeprazole magnesium (PRILOSEC), estradiol (ESTRACE), metoprolol succinate (TOPROL XL) and ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION). It was reported that the patient experienced right sided neck pain which began a couple of days after vaccination on 06Feb2021 07:00. On 05Feb2021, her right eye was twitchy. On 06Feb2021, the right side of her face felt swollen. It felt like when you go to the dentist and get numbed. She tried drinking a liquid and it ran out of the right side of her mouth. She went to urgent care and they sent her to the emergency department. She had a CAT-scan, MRI and blood work done which all came back normal. Her right eye was not closing all of the way and they diagnosed her with Bell's Palsy on 07Feb2021. She was prescribed a course of prednisone and Valtrex. She has continued to have right-sided facial paralysis and her right eye will not close. She had had severe pain in her right eye and had to tape it shut to sleep and often during the day because it dries out. She was using Systaine eye drops every couple of hours and an eye gel at night. She was concerned about getting the second dose because she does not want this to get worse. There were no other vaccines in four weeks. There was no COVID prior to vaccination and was not COVID tested post vaccination. The outcome of the event was not recovered.
194PFIZER\BIONTECH9 days65+ years1079864-1Feb. 20219 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.
195PFIZER\BIONTECH10-14 days30-39 years0933069-1Dec. 2020Facial weakness (left side), lip paralysis (left side), decreased sense of taste, eye leakage (left side), facial tingling (left side). Onset 1/4/2021 with symptoms worsening through the week. Noticeable lip paralysis starting on the afternoon of 1/10/2021. 2nd vaccine received at 8:00AM on 1/10/2021.
196PFIZER\BIONTECH10-14 days30-39 years1086893-1Feb. 2021Bell's Palsy (left side of face paralysis); This is a spontaneous report from a contactable healthcare professional (patient).  A 35-year-old female patient received the 2nd dose (at the age of 35-year-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot# EL8982), via an unspecified route of administration on the left arm on 05Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient had no known allergies and medical history reported as none. There were no concomitant medications. The patient was not pregnant (including the time of vaccination). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot# EL1283), via an unspecified route of administration on the left arm on 15Jan2021 09:30 (at the age of 35-year-old) for COVID-19 immunization.  The patient developed Bell's Palsy (left side of face paralysis) on Friday afternoon 19Feb2021 (2 weeks after second dose of the vaccine). The patient went to the doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care due to the event (which was considered as serious disability or permanent damage). The emergency room (ER) doctor prescribed valacyclovir and prednisone. Outcome of the event was not recovered.; Sender's Comments: Based on temporal relationship and known drug safety profiles, a possible contributory role of suspect drug cannot be excluded for the reported event Bell's Palsy.  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.
197PFIZER\BIONTECH10-14 days40-49 years1086895-1Feb. 2021Bell's palsy; This is a spontaneous report from a contactable consumer (patient's wife). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 02Feb2021 at 11:00 at a single dose on left arm for COVID-19 immunisation. Medical history included ongoing systemic lupus erythematosus (Lupus), ongoing hypertension (High Blood Pressure), ongoing gout and hip arthroplasty from Dec2020 to an unknown date; all diagnosed about 20 years ago. Concomitant medications included allopurinol, atorvastatin, benzonatate, chlorthalidone, apixaban (ELIQUIS), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN), hydroxychloroquine, iron, loratadine, losartan potassium, mycophenolate mofetil, omeprazole, paricalcitol, prednisone, spironolactone and valacyclovir [valaciclovir] and vitamin D NOS. The reporter's husband had a reaction to the vaccine. She was wondering if it is ok to have the second dose. He got paralysis, Bell's Palsy on 14Feb2021. She clarified vaccine as COVID19 Vaccine. She would like any information available about second dose after having Bell's Palsy with the first dose. The outcome of the event was not recovered.
198PFIZER\BIONTECH10-14 days50-59 years1038438-1Feb. 2021episode 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.
199PFIZER\BIONTECH10-14 days50-59 years1075844-1Feb. 2021PRESENT OF FACIAL PARALYSIS ON  THE RIGHT SIDE OF THE FACE AFTER THE SECOND DOSE OF THE VACCINE.  LOSS OF STRENGTH RIGHT SIDE OF THE FACE FROM EYE TO THE MOUTH. I CAN NOT MOVE THE LIPS AND CLOSED THE RIGHT EYE.
200PFIZER\BIONTECH10-14 days60-64 years0922640-1Dec. 202064-year-old male who presented to the clinic with complaints of left-sided weakness on his face. He stated when he woke up this morning he noticed that the left side of his mouth drooped and that he could not close his left eye all the way. Yesterday he felt fine. Today he went to work. Patient stated that on 12/18 he got the COVID vaccine. It was on a Friday. The following day he had a headache and he felt flu-like. He stated that those symptoms resolved quickly. He then had the facial weakness today (11 days after the vacciantion). He has not had any fever, sweats, or chills. Patient stated that he had called ask a nurse, and he was advised to hang up and call 911 and go to the emergency room. However, he stated he was an EMT and did not feel that was necessary. He denies headache. He has not had any vision change. He has been eating and drinking well without any difficulty.    PHYSICAL EXAMINATION: General appearance - patient was not in any distress. He was conversant, pleasant and appropriate. HEENT - normal conjunctivae and lids. Sclerae anicteric. Pupils equal and reactive to light. Patient was not able to close his left eyelid. Normal ear canals. TMs are pearly gray with bright light reflex. Neck - supple. No lymphadenopathy. Skin - pink, warm and dry. Neuro - alert and oriented. Deep tendon reflexes 2+ upper and lower extremities with no focal weakness. Normal range of motion. Patient can raise his right eyebrow. Could not raise his left eyebrow. There was impaired eyelid closure on the left; tight closure on the right. Smiling of the face revealed lateralization to the right side. When frowning, he had upper and lower facial paralysis on the left with flattening of the forehead. The patient could not tighten the left side of his mouth. ß ASSESSMENT: Bell's palsy. ß PLAN: Discussed pathophysiology of Bell's palsy. Advised patient I recommended him to call the number that he got with the information when he received his COVID vaccine. Advised patient that I could not definitively correlate the Bell's palsy with the COVID immunization, but that he can call the number he has to let them know of his symptoms. Discussed treatment options. Since patient woke up with his symptoms this morning, I advised patient that he would have hopefully the best outcome because he would be able to get on the steroid and antiviral soon after developing the symptoms. He is to wear an eye patch to prevent corneal drying or abrasion of the left eye at night. Using Lacri-Lube at night before placing the eye patch and then following up by using artificial tears during the day. ß Patient was placed on prednisone 60 mg once a day for 1 week to be taken with food. Valtrex 1,000 mg 3 times a day for 1 week. ß Side effects of medication discussed. Handouts were provided. He will follow up with PCP if any changes or concerns. Advised patient that it may take up to 3 weeks before all his symptoms have resolved
201PFIZER\BIONTECH10-14 days65+ years1022066-1Jan. 2021Contrast head CT scan showed a lacunar infarct in the M1 region from MCA; Bell's Palsy; This is a spontaneous report from a contactable physician reporting for himself. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL2437), intramuscularly on 13Jan2021 11:00 on right arm at single dose for COVID-19 immunization. Vaccination facility type was at Clinic. Medical history included Myocardial infarction from 2019, Prostate cancer from 2016 which biochemical reoccurrence caused his PSA to bump up, Subclinical hypothyroidism, prevention of coronary artery disease, prevent platelet aggregation, urgency incontenece, asthma symptoms, High Blood Pressure from 2009 and ongoing, Aortic insufficiency from 2008 and ongoing. Ongoing concomitant medications included Carvedilol from 2011 for high blood pressure, rosuvastatin from 2015 for prevention of coronary artery disease, acetylsalicylic acid (ASPIRIN) from 2019 for prevent platelet aggregation, tamsulosin from Dec2020 for urgency incontenece, levothyroxine from 2011 for Subclinical hypothyroidism, montelukast from 2011 for asthma symptoms. The caller stated that he was a physician and emeritus professor. He received the Pfizer-BioNTech COVID-19 vaccine 2 weeks ago and developed Bell's Palsy on 24Jan2021 after receiving this first dose. He had already reported this reaction but he would like to know if there was any safety information on receiving the second dose after this type of adverse reaction. Patient had ""mentioned"" the reaction to his HCP but he had not spoken with her about specific guidance on whether or not to receive the second dose. Patient wished there was a way he could see more information regarding patients who have reported Bell's Palsy as a reaction to the mRNA COVID-19 vaccine to see if it could be a trend related to mRNA in the vaccines or if it was statistically insignificant. Patient visited the Emergency Room on 25Jan2021. Patient had a Contrast head CT scan on 25Jan2021. The results were read by the radiologist. The neuro radiologist also read the results and made a revision. He had two different reports, it showed a lacunar infarct in the M1 region from MCA. Not causing facial paralysis. There was no defined cause of the paralysis. Patient was asking if we have a resource on the significance of Bell's Palsy following a vaccine. He was scheduled to have the booster on 04Feb2021 and needed to know what to do. Treatment was received for the events included Prednisone and Acyclovir. The outcome of the events were not resolved.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported Bell's Palsy and lacunar infarct, and the administration of COVID-19 vaccine, BNT162B2, 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.""
202PFIZER\BIONTECH10-14 days65+ years1052747-1Feb. 2021Patient 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.
203PFIZER\BIONTECH10-14 days65+ years1201247-1Feb. 2021Paralysis (CMS/HCC) death
204PFIZER\BIONTECH10-14 days65+ years1207253-1Feb. 2021Death Paralysis
205PFIZER\BIONTECH10-14 daysUnknown1070716-1Feb. 2021face paralysis; This is a spontaneous report from a contactable consumer reporting on behalf of her husband.  A 43 year old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 06Feb2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported. The reporter stated her husband received the first dose of the COVID 19 vaccine on 06Feb2021 and was scheduled for the second dose on 19Feb2021 He woke up today (18Feb) with face paralysis. He went to the doctor, got a CT scan and other studies, and everything is normal. The reported stated that the doctor said it was probably the vaccine. Doctor prescribed medication and told him not to get the second dose. Lab data included CT scan and ""other studies"" on 18Feb2021 which were normal. The clinical outcomes of facial paralysis was unknown.""
206PFIZER\BIONTECH15-30 days30-39 years0972019-1Dec. 2020On 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
207PFIZER\BIONTECH15-30 days30-39 years1069019-1Feb. 2021BELL'S PALSY, FACIAL PARALYSIS
208PFIZER\BIONTECH15-30 days30-39 years1083745-1Jan. 2021Patient developed right Bells Palsy on 18Feb2021; This is a spontaneous report from a contactable physician. A 39-year-old not pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 20Jan2021, first dose on 30Dec2020, both at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history was none. Known allergies was no. If COVID prior vaccination was no. If COVID tested post vaccination was no. If other vaccine in four weeks was no. Other medications in two weeks was no. Concomitant medications were not reported. Patient developed right Bells Palsy on 18Feb2021. AE resulted in emergency room/department or urgent care. AE treatment included prednisone, magnetic resonance imaging (MRI) in Feb2021. The outcome of the event was not recovered.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, drug causality cannot be completely excluded. Serious Facial paralysis may be considered as late sequel to BNT162B2 injection, due to appropriate chronological relation. 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.
209PFIZER\BIONTECH15-30 days40-49 years0928549-1Dec. 2020patient states started with symptoms of facial paralysis on 12/24/2020 Patient states pain on left side of face and cephalic region on 12/25/2020 and went to ER, where was diagnosed with Facial Paralisis
210PFIZER\BIONTECH15-30 days40-49 years1017109-1Jan. 2021Visual problems, diplopia, concerns for left 4th cranial nerve paralysis
211PFIZER\BIONTECH15-30 days50-59 years0935743-1Dec. 2020Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye and nose on the right. Fatigue, cough
212PFIZER\BIONTECH15-30 days50-59 years0994739-1Jan. 2021Went to ER with left facial paralysis. Diagnosed with Bell's palsy day 19 after initial dose of Pfizer vaccine (1/5/21 vaccine given). Not sure what the recommendation is as to whether I should still have the second dose. Doctors at the ER were not sure either.
213PFIZER\BIONTECH15-30 days60-64 years1055759-1Jan. 2021Loss of use right leg.  Paralysis, numbness, tingling, severe pain, and muscle spasms. Acute onset without other trauma
214PFIZER\BIONTECH15-30 days60-64 years1098511-1Jan. 20212 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
215PFIZER\BIONTECH15-30 days65+ years1011068-1Jan. 2021Pfizer-BioNTech COVID-19 Vaccine EUA Bell's Palsy  Face paralysis
216PFIZER\BIONTECH15-30 days65+ years1042345-1Jan. 2021Facial paralysis Bells' Palsy; This is a spontaneous report from two contactable consumers (including patient himself). A 73-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in the left arm on 18Jan2021 11:30 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. He was not diagnosed with COVID prior to vaccination. The patient received other medications in two weeks but had not received other vaccine in four weeks. The patient experienced facial paralysis Bells' Palsy on 03Feb2021 08:00. No treatment was received for the event but the event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered. The patient had not been COVID tested post vaccination.
217PFIZER\BIONTECH15-30 days65+ years1051000-1Jan. 2021fall; 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.
218PFIZER\BIONTECH15-30 days65+ years1081039-1Feb. 2021Patient presented with acute onset of rapidly progressing ascending weakness and paralysis and associated decrease in sensation
219PFIZER\BIONTECH15-30 days65+ years1106603-1Feb. 2021100 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.
220PFIZER\BIONTECH31-60 days60-64 years1111052-1Jan. 2021Twenty seven days after my second vaccination I developed Right side of face paralysis and went to ER. After steroids and valcyclovir I was 100 percent recovered.
221PFIZER\BIONTECH31-60 days65+ years1084326-1Jan. 2021Patient 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.
222PFIZER\BIONTECH61-120 days50-59 years1098619-1Dec. 2020Pain 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
223PFIZER\BIONTECHUnknown30-39 years0923419-1Dec. 2020Bell's Palsy; This is a spontaneous report from a contactable physician. A 37-year-old female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on 29Dec2020 17:50 (5:50 pm) at a single dose as Covid vaccine. Medical history included hypertension and depression. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); olmesartan medoxomil (BENICAR); and unspecified medications for depression and blood pressure medication (hypertension). It was reported that the reporter's nurse got her vaccine last night, about 6'o clock at night, and woke up with Bell's Palsy on Dec2020. She woke up in midnight to go to the bathroom and when she looked in the mirror, she noticed that there was discrepancy. The physician examined her this morning, so it was in several hours getting the vaccine that she noticed it. She got the vaccination last night at 5:50 pm. When she went to bed it wasn't a problem. She woke up at midnight and noticed it. The patient was started on Medrol dose pack but she hasn't taken it yet because she's at work so she would start it today (unknown if the treatment was already received); it's steroid, Methylprednisolone, at 24 mg on day one and then decreases 4 mg a day over the next five days until it's done. The doctor inquired what should the patient do about her second dose and also asked if she should not get her second dose. The outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
224PFIZER\BIONTECHUnknown50-59 years1022029-1Jan. 2021Bell's palsy on left side; soreness at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EV1685, expiry date unknown) via an unspecified route of administration on the left deltoid, left arm, on 05Jan2021 08:15 AM at a single dose for COVID-19 immunization. The patient's medical history included allergies to Penicillin and Sulfa from an unknown date and unknown if ongoing. The patient had no current Illness and no family medical history. The patient is not pregnant. Concomitant medications included metoprolol tartrate, Vitamin C [ascorbic acid], Vitamin D3, and Multivitamins; patient received these medications within two weeks prior to the COVID vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Patient had a routine Physical Examination on Nov2020 and underwent lab tests and procedures on 24Jan2021 which included unknown BW and negative Lyme Disease Test. On 23Jan2021 18:30, the patient developed bell's palsy on left side which was reported as getting a little worse every day. The event required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care; the event resulted in Disability or permanent damage. Since 24Jan2021, patient received Prednisone 60 mg, daily for 7days and Valtrex 1g, 3x/day (TID) for 7days as treatment for the event. The patient did not recover from the event Bell's palsy on left side.' It was further reported that patient experienced soreness at the injection site on an unspecified date with outcome of unknown.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event Facial paralysis cannot totally 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.
225PFIZER\BIONTECHUnknown65+ years1123133-1Feb. 2021mild 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.
226PFIZER\BIONTECHUnknownUnknown0971276-1Jan. 2021Bell's Palsy; This is a spontaneous report from a contactable other health professional. A female patient of an unspecified age (age: 34; unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy in Jan2021 with outcome of unknown. The patient who received first dose of vaccine on Saturday and woke up this morning with Bell's Palsy as confirmed by urgent care. She is wondering about the clinical trial participants and if she can receive the second dose.    Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. The information 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
227PFIZER\BIONTECHUnknownUnknown1035537-1Feb. 2021developed 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.
228UNKNOWN MANUFACTURER8 days60-64 years1005284-1Jan. 2021Per 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.

VAERS ID BELOW

 

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TOPICS: Miscellaneous
KEYWORDS: 2acdctroll; 2aprotectsthevax; aliens; antivaxxer; bigfoot; learnaboutvaers; lizardpeople; nutcase; qlown; qtard; thenewqanon
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I know that instances of Bell's Palsy and other facial paralysis may or may not resolve, and can sometimes constitute significant debility (loss of eyelid movement, drooling etc.) and I don't wish to diminish their impact, but the list below is an excerpt for paralysis other than facial symptoms.

I'll put the list of the VAERS ID for this table below it for those who want to research those records in the database either singly, or as a group, to make their own exports or research individual records.

 #Vaccine ManufacturerOnset IntervalAgeVAERS IDAdverse Event Description
1JANSSEN0 days65+ years1111792-13-14-21 @ 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
2JANSSEN7 days30-39 years1089578-1Bilateral upper and lower extremity paralysis, jaw clenching, dystonic contracting of bilateral upper and lower extremities. Urinary retention.1
3JANSSEN10-14 days50-59 years1163209-1Numbness in extremities, paralysis full body. Pneumonia left lung. Now diagnosed with Guillain-Barre syndrome, due to reaction to covid-19 vaccine1
4JANSSEN15-30 days40-49 years1202379-1Significant flaccid paralysis in the right arm and right leg with some difficulty swallowing1
5JANSSEN15-30 days60-64 years1186151-1Severe COVID-19 infection with ARDS.  Requiring mechanical ventilation, paralysis and flolan nebulization.1
6MODERNA0 days30-39 years1097867-1Headache, 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 3/13/211
7MODERNA0 days65+ years1094159-1Motor paralysis of the left foot. Could not move at all.: dorsiflex, plantar flex, invert, or evert1
8MODERNA0 days65+ years1101161-1couldn'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
9MODERNA1 day40-49 years0987242-1Paralysis, weakness, numbness in bilateral lower extremities. Symptoms started 1/26/2021 resulting in hospitalization. Discharged on 1/28/2021 with Out-patient physical therapy1
10MODERNA1 day40-49 years1050142-1Paralysis 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
11MODERNA1 day65+ years1086931-1Shingles 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
12MODERNA1 dayUnknown1086874-1Paralysis 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
13MODERNA2 days65+ years1100271-1Lost 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
14MODERNA4 days65+ years1078636-1Severe 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
15MODERNA5 days60-64 years0982023-1Third 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
16MODERNA6 days18-29 years0970949-1I 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
17MODERNA7 days30-39 years1042447-1Intense 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
18MODERNA8 days65+ years0967969-1cerebral hemorrhage and left sided paralysis of the body1
19MODERNA15-30 days65+ years1039884-1Lost 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
20PFIZER\BIONTECH0 days30-39 years0960439-1Cardiac 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
21PFIZER\BIONTECH0 days50-59 years1004433-1bilateral 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
22PFIZER\BIONTECH1 day65+ years0990523-1he 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
23PFIZER\BIONTECH1 day65+ years1129059-1The 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
24PFIZER\BIONTECH2 days18-29 years1045622-1phrenic 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
25PFIZER\BIONTECH4 days65+ years1056640-1Lt 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
26PFIZER\BIONTECH8 days40-49 years0971280-1left 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
27PFIZER\BIONTECH8 days65+ years1075693-1Patient 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 paralysis1
28PFIZER\BIONTECH9 days65+ years1079864-19 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
29PFIZER\BIONTECH10-14 days65+ years1052747-1Patient 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
30PFIZER\BIONTECH10-14 days65+ years1201247-1Paralysis (CMS/HCC) death1
31PFIZER\BIONTECH10-14 days65+ years1207253-1Death Paralysis1
32PFIZER\BIONTECH15-30 days40-49 years1017109-1Visual problems, diplopia, concerns for left 4th cranial nerve paralysis1
33PFIZER\BIONTECH15-30 days60-64 years1055759-1Loss of use right leg.  Paralysis, numbness, tingling, severe pain, and muscle spasms. Acute onset without other trauma1
34PFIZER\BIONTECH15-30 days60-64 years1098511-12 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 paralysis1
35PFIZER\BIONTECH15-30 days65+ years1081039-1Patient presented with acute onset of rapidly progressing ascending weakness and paralysis and associated decrease in sensation1
36PFIZER\BIONTECH15-30 days65+ years1106603-1100 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
37PFIZER\BIONTECH31-60 days65+ years1084326-1Patient 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
38PFIZER\BIONTECH61-120 days50-59 years1098619-1Pain 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 relief1
39PFIZER\BIONTECHUnknownUnknown1035537-1developed 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
40UNKNOWN MANUFACTURER8 days60-64 years1005284-1Per 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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1 posted on 04/29/2021 7:33:19 PM PDT by ransomnote
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To: ransomnote

Woah!


2 posted on 04/29/2021 7:34:34 PM PDT by dynoman (Objectivity is the essence of intelligence. - Marilyn vos Savant)
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To: dynoman

Example 1 of paralyzed.

https://www.brighteon.com/2e88c1b5-4d51-4050-bac4-b0dd809a1aa4


3 posted on 04/29/2021 7:41:14 PM PDT by hotdogjones (Study shows possible link between blood pressure meds and severe cases of COVID-19)
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To: dynoman

Loss of hands/arms, I had no idea how gruesome the Fauci-Stab is in reality. Moving to FLA, fast.

Refugees from Michigania?


4 posted on 04/29/2021 7:41:15 PM PDT by epluribus_2 (He, had the best mom - ever.)
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To: dynoman

Example 2 a Vaccident.

https://pasoroblesdailynews.com/driver-crashes-on-highway-101-reportedly-had-seizure-following-covid-19-vaccine-shot/125402/


5 posted on 04/29/2021 7:42:21 PM PDT by hotdogjones (Study shows possible link between blood pressure meds and severe cases of COVID-19)
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To: dynoman

Example 3

https://www.youtube.com/watch?v=QusYH-wk-f0


6 posted on 04/29/2021 7:43:15 PM PDT by hotdogjones (Study shows possible link between blood pressure meds and severe cases of COVID-19)
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To: dynoman

Example 4

https://www.wpxi.com/news/top-stories/bethel-park-woman-paralyzed-12-hours-after-getting-first-dose-pfizer-vaccine-doctors-searching-answers/ZSYTEX4H4FHKDFVSPGS3ILJZUI/


7 posted on 04/29/2021 7:43:51 PM PDT by hotdogjones (Study shows possible link between blood pressure meds and severe cases of COVID-19)
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To: dynoman

Example 5
https://www.wsmv.com/video/woman-lies-paralyzed-in-nashville-hospital-says-it-happened-after-she-received-pfizer-covid-19/video_98597902-b3fb-5b40-9295-6490b34f3188.html


8 posted on 04/29/2021 7:44:30 PM PDT by hotdogjones (Study shows possible link between blood pressure meds and severe cases of COVID-19)
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To: epluribus_2

Loss of hands/arms, I had no idea how gruesome the Fauci-Stab is in reality. Moving to FLA, fast.

Refugees from Michigania?

~~~~~~~~~~~~~~~~
Ah, the words ‘movement’ in hands and arms are sadly missing. Hands and arms often reported to regain use after several hours or over night.


9 posted on 04/29/2021 7:50:13 PM PDT by ransomnote (IN GOD WE TRUST)
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To: ransomnote

Fascinating. But of course VaERS itself says it is an unverified source and that one cannot presume causality.

So there is always that


10 posted on 04/29/2021 8:17:19 PM PDT by gas_dr (Trial lawyers AND POLITICIANS are Endangering Every Patient in America: INCLUDING THEIR LIBERTIES)
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To: gas_dr

party pooper


11 posted on 04/29/2021 8:24:29 PM PDT by corkoman
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To: hotdogjones

Vaccident! Great word...but is the vaccident intentional or unintentional?


12 posted on 04/29/2021 8:24:54 PM PDT by Jan_Sobieski (Sanctification)
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To: ransomnote

The report of an adverse event to VAERS is NOT documentation that a vaccine caused the event.

- Guide to Interpreting VAERS Data (https://vaers.hhs.gov/data/dataguide.html)
13 posted on 04/29/2021 8:25:36 PM PDT by 2aProtectsTheRest (The media is banging the fear drum enough. Don't help them do it.)
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To: Jan_Sobieski

unintentional side effect of being vaccinated. Mini stroke. Apparently it is happening all over the US. Trucking accidents also.


14 posted on 04/29/2021 8:36:48 PM PDT by hotdogjones (Study shows possible link between blood pressure meds and severe cases of COVID-19)
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To: ransomnote

Wow, 200 people with a side effect that was well-known from the clinical trials! That’s a lot! Or maybe, considering that it’s 200 out of about 90 million vaccinated, it’s exactly how it was reported during the trials - a rare, and in most cases, temporary side effect

200 out of 90 million is about 0.0002%. We are supposed to believe that the vaccine isn’t necessary because the COVID fatality rate is really only 0.1%. We should reject the vaccine because of a 0.0002% risk of a non lethal side effect, and instead accept a risk of death that’s 450 times greater? If you’re willing to accept a 0.1% risk of death, why should a 0.0002% risk of getting Bells Palsy scare you?


15 posted on 04/29/2021 10:17:43 PM PDT by stremba
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To: stremba

>> 200 out of 90 million is about 0.0002%. We are supposed to believe that the vaccine isn’t necessary

Fatality is less than 0.005% for those under 25 YO, and comorbidity is likely the cause. So is the vax necessary?


16 posted on 04/29/2021 10:27:44 PM PDT by Gene Eric (Don't be a statist!)
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To: stremba

200 out of 90 million is about 0.0002%. We are supposed to believe that the vaccine isn’t necessary because the COVID fatality rate is really only 0.1%. We should reject the vaccine because of a 0.0002% risk of a non lethal side effect, and instead accept a risk of death that’s 450 times greater? If you’re willing to accept a 0.1% risk of death, why should a 0.0002% risk of getting Bells Palsy scare you?
~~~~~~~~~~~~~

You’re new to VAERS. Study it and you’ll realize that far less than 1% of actual events are ever entered into VAERS, and now the CDC is intentionally withholding uploading records it receives or Covid-19.

Really, by studying the number of records entered by the CDC after the start of vaccine in administration -what ended up accessible in VAERS is a tiny drop in the bucket.

If you want to pretend that VAERS is up to date, then you’re part of the problem. I think the latter, based on your baiting comment.


17 posted on 04/29/2021 10:37:59 PM PDT by ransomnote (IN GOD WE TRUST)
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To: Gene Eric
200 out of 90 million is about 0.0002%.
~~~~~~~~~~~~

200 is not the total number of paralysis events out of all vaccinated. It's a tiny fraction of 1% of actual events occuring.

If a VERY conservative estimate of 40,000 cases of paralysis are made, that does not count the estimated million or more strokes, anaphylaxis etc. Many cases of 'cerebrovascular events', cardiac events - overwhelming numbers of 'problems' with the vaccine compared with safe effective treatments available for decades.

Our medical establishment is drawing back on the reins of coup and has no plans to let us go.

For example of the math involved extrapolating how much data is NOT in VAERS, I refer people to an overview of stroke data here:

COVID-19 Vaccinations in the United States (27 Apr, as of 06:00 AM ET) (freerepublic.com)

thread, followed by further calculations in response to an apologists' sucggestion that it must be alright anyway.

https://freerepublic.com/focus/chat/3954293/posts?page=135#135

Better to ask what really happened to 38 million cases of flu that disappeared last year. Better of just having the flu.


18 posted on 04/29/2021 11:30:19 PM PDT by ransomnote (IN GOD WE TRUST)
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To: ransomnote

Thanks. Interesting data.

BTW, “the 200 out of 90 mil” was not my assertion.


19 posted on 04/29/2021 11:54:46 PM PDT by Gene Eric (Don't be a statist!)
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To: ransomnote

Each day 8,000 people die is the US. 2.9 million per year. 50% of he US has taken the vaccine. The vaccine prevents death from Covid NOT DEATH FROM CANCER STROKE GUNSHOTS ACCIDENTS. So every day 4,000 people who took the vaccine will die. Do you have a brain? What is your agenda? Who sent you here? Who is your leader?
I’m glad we have a free press so we can all see such compelling evidence of stupidity.


20 posted on 04/30/2021 5:12:58 AM PDT by brookwood (Obama said you could keep your plan - Sanders says higher taxes will improve the weatheryour)
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