Pfizer

Immediate warm flushing sensation lasting a couple seconds/coincident with change in taste to a metallic taste. Lasted only a few seconds.

Patient went to Emergency Room @ 5PM day following vaccine with difficulty moving eyes and drooping cheek.

Got home about 11:30 in the morning, eyes were foggy, everything was tilted to the left, seeing double. Around 5:00 pm it got a little better. Left eye feels like a shadow in his eye.

Rapid heart rate (140bpm-160bpm) @ 7:00 PM on day of vaccination. Heart rate was normal (60-66bpm) the morning of Friday, 02/26/21. Double vision was experienced the morning of Saturday, 02/27/21, 2 days after vaccination. Double vision continues at this time (12:15 PM).

on 2/13, noticed red band across eyelid of right eye and eye looked a little off. Didn't think much of it. Week of 2/21 noticed rash on forehead on right side. 2/28 rash had spread to top of head and right forehead and right eye is now swelling.

Bell's Palsy/drooping of his face and mouth; Bloody nose; vertigo (dizzy / lightheaded); vertigo (dizzy / lightheaded); swallowing issues; Chewing issues; weak; tired / does not have stamina; This is a spontaneous report from a contactable consumer (the patient's wife). A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9264), via an unspecified route of administration in the right arm on 09Feb2021 at 12:30 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included vertigo (before the 2nd dose all the time), diabetic type 2 due to exposure to Agent Orange, stent in Dec2019, sulfa allergies, blood pressure abnormal. Concomitant medications included metformin, buspirone, sitagliptin phosphate (JANUVIA), hyoscyamine sulfate (OSCIMIN), doxepin, lisinopril for blood pressure, silodosin, simvastatin (ZOCOR), exenatide (BYDUREON) for diabetes, fish oil, zinc tablet in the morning, ubidecarenone (COQ-10), vitamin D3, cyanocobalamin (VIT B12), allium sativum bulb (GARLIC EXTRACT), ascorbic acid/ betacarotene/ biotin/ calcium/ chloride/ chromium/ copper/ folic acid/ iodine/ lycopene/ magnesium/ manganese/ molybdenum/ nickel/ nicotinic acid/ pantothenic acid/ phosphorus/ potassium/ pyridoxine hydrochloride/ riboflavin/ selenium/ silicon/ thiamine/ vanadium/ vitamin b12 nos/ vitamin d nos/ vitamin e nos/ vitamin k nos/ xantofyl/ zinc (CENTRUM SILVER FOR MEN 50+). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 23Jan2021 at 10:30 (at the age of 76-years-old) in the right arm and experienced pain in arm and fatigue. On 09Feb2021, the patient developed a bloody nose that was unstoppable at home. The reporter took the patient to the emergency room (ER), where his nose was packed, and he was kept overnight. The following day, while his nose was being unpacked, drooping of his face and mouth was observed. Tests for a stroke were negative on Feb2021. The patient was kept in the hospital for three days and was diagnosed with Bell's Palsy on 11Feb2021. The events "Bell's Palsy/drooping of his face and mouth" and bloody nose resulted in hospitalization/prolonged hospitalization in Feb2021 for 3 days. The patient's wife reported that as of 09Feb2021, he had swallowing issues when it came to solid foods and was looking for suggestions on what he can eat. The tongue was not swollen, and he was breathing better since the packing had been removed. As of Feb2021, the patient had chewing issues and cannot take solid food. The patient had vertigo before the second vaccination dose all the time, and experienced it again last night on 16Feb2021, he was dizzy and lightheaded. As of an unspecified date in Feb2021, the patient was weak and tired (did not have stamina). The patient was treated for "Bell's Palsy/drooping of his face and mouth" with prednisone 20 mg 2 tablets once a day and valacyclovir 500 mg 2 tablets twice a day. The patient was not treated for bloody nose and swallowing issues. The clinical outcome of " Bell's Palsy/drooping of his face and mouth", swallowing issues, chewing issues, weak, "tired / does not have stamina" was not resolved; bloody nose was resolved on Feb2021; "vertigo (dizzy / lightheaded)" was resolved on 17Feb2021.

Loss of taste and smell. Sore neck, shoulder, arm on side vaccination was given. Generalized body aches. Congestion, extreme fatigue and chills all lasting for 3-4 days.

Numbness and tingling in right leg about 4 days after 2nd vaccination, moved to right foot. Then moved to left foot but didn't affect left leg.. Feet are cold now, legs are okay now, just the feet. Hands, lips, & tongue, & face feel numb and tingly too. Spoke with Dr on phone. Client stated he took Tylenol for a couple of days after vaccination. Stated injection site is black & blue. Client still dealing with numbness & tingling. Waiting to speak with Dr again. Phone call to office.

Took Covid vaccine February 28, 2021, lack of sleep that night and next 2 nights. On March 3, 2021, about 12:30 am was sleepwalking until 7 am next morning. Kept getting up and going to bed about ever 10 to 15 minutes. Fell on his back once but did not wake up. Next morning (9 am), March 4, 2021, had bad taste in mouth. Rinsed mouth with mouthwash which helped. Was not hungry for breakfast. went back to bed at 10 am. got up at 10:30 am and said he felt bloated. gave him Pepto Bismol and he went back to bed. Slept approximately 3 hours. Ate soup and sandwich with no problem. was alert and at 100%. Said he felt good and didn't remember anything from previous night.

symptoms of bell palsy; Numbness of upper and lower lip on right side.; sore muscles in neck; sore muscles in neck and shoulder; watery eyes; muscle aches; pains; problems in sleeping; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program. This is a spontaneous report from a contactable consumer (the patient). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration, in the left arm on 01Feb2021 at 14:30 (at the age of 76-years) as a single dose for COVID-19 immunization. Medical history included chronic asthma, nasal polyps, vestibular schwannoma, alopecia, gastrooesophageal reflux disease. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 07:00 AM, the patient experienced symptoms of bell palsy, numbness of upper and lower lip on right side, sore muscles in neck and shoulder, watery eyes, muscle aches, pain, problems in sleeping. He felt the symptoms after the first dose. The patient visited the emergency room/ department or urgent care due to the events. The patient did not received treatment for the events. The clinical outcome of the events was not recovered.

He had his Vivid shot and awoke blind in left eye 4 hours later. Went to ER and then on Friday went to eye Dr. at clinic.

Within 1/2 hour of vaccine, patient states he had fever, chills, shortness of breath, aches, throughout the body - "eyeballs hurt" - "hair hurts" loss of appetite, lost his sense of taste, increased hoarseness, decrease O2 saturations.

Blood pressure spike 10 minutes after shot. 6 hours later had intense burning of nerve bundles down arms and legs for 2 hours. After that had 1 hour of uncontolled severe shaking and shivering . Next day felt fine. Afew days started noticing LOW FREQUENCY INTERMITTANT TINNITUS THAT IS A HUM, BUT ONLY IF I AM AROUND HIGH VOLTAGE POWER TRANSMISSION LINES AND POWER TRANSFORMERS . HEAR IT IN MY HOME WHICH IS 1000 FEET FROM HIGH VOLTAGE LINES 24/7 SINCE DAY 2-4 OF DOSE #1. Can hear it in other enclosed areas, but doesn't seem to happen AS MUCH outdoors, although if I am within 1000 feet of high voltage lines I will hear it UNLESS there are many trees to block the EMF's or HUM between me and the source. SOUNDS CRAZY, BUT IS TRUE FOR PAST 3 MONTHS 24/7 AND HAS RUINED MY LIFE BECAUSE I CANNOT SLEEP AND SLEEPING PILLS DON'T WORK. HAS DISRUPTED MY SLEEP CENTER SOMEHOW. ALL OF THIS IS SINCE FIRST COIVD19 SHOT ! HAVE HAD #2 SHOT AND WILL NEVER GET ANOTHER !

Onset of ocular flashes in both eyes, mostly noticeable at night. On 2/22/2022 had an abrupt onset of floaters in both eyes, this occurring at the same time. This prompted an ER visit suggested by my PCP and subsequent visits to an ophthalmologist. Diagnosed as vitreal detachment.

Vasovagal/pre-syncopal event. Accompanied by paresthesia/ weakness/ blurred vision/ lightheadedness.;a seizure-like episode followed' patient was transported to ER via EMS.

4/3 = SATURDAY - 12:30 AM , USED 2 ACETAMINOPHEN PM ( This what i use nightly ) 6:30 AM , CHILLS (FEVER) LASTED COUPLE OF HOURS TIRED NO ENERGY , NO FOOD UNTILL DINNER TIME , WAS TOLD I LOOKED PALE , ** THAT SATURDAY AFTERNOON I WAS SMELLING AN ODOR LIKE GARBAGE, WIFE SAID SHE DIDN'T SMELL ANYTHING, LASTED FOR A FEW HOURS.??? 4/4 = SUNDAY - STILL LOW ENERGY. EVERY MORNING FOR PAST 20 YEARS I RINSE EYES WITH SALINE SOLUTION. I SKIPPED SATURDAY, TRIED SUNDAY & MY EYES STARTED BURNING, TRIED A DIFFERENT BOTTLE STILL BURNING, HAD TO STOP. 4/5 = MONDAY - FEELING BETTER & EYES RINSED WITH NO PROBLEM .???

Patient received 1st Covid-19 Pfiser Vaccine shot on Thursday February 11, 2021. Patient received the 2nd Covid-19 Pfiser Vaccine on Thursday, March 4, 2021. 7 days after second vaccine shot on Thursday, March 11, 2021, patient showed some symptoms of a itchy-horsed throat & a slight dry cough. Called doctors - they said nothing to worry about, drink hot fluids and take couch drops. It went away in 2-3 days. Exactly 4 weeks after second Covid-19 Pfiser vaccine on Thursday, April 1st 2021, patient was sent to the ER for a seizure.

patient reported numbness in right side of face and tooth pain on the day after his covid-19 immunization. His prescriber evaluated him today and said he has a sinus infection with mild bells palsey. Unsure if related to immunization.

Altered sense of taste to foods some worse than others . Taste of some foods so bad causing gagging and unable to swallow the food. This lasted for 4 weeks and slowly improved over time . Sense of smell not affected.. lost weight as not able to eat much

Contracted hissing sound around same time of my wife VAERS #458377 on 4/15 4/16 but went away for now,.

I previously had mild tinnitus. The day after receiving the second shot, I awoke with the tinnitus much louder. This increased level of tinnitus still exists four weeks later.

This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (BNT162B2), dose 1 intramuscular on 25 Feb 2021 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunization administered at clinic. Medical history included hypertension, blood cholesterol increased, myocardial infarction, colon cancer (had surgery for that and also had chemotherapy), coronary artery disease (30% blocked coronary artery), covid-19 from 19May2020 to an unknown date. Concomitant medication(s) included lisinopril for hypertension; amlodipine; rosuvastatin for blood cholesterol increased; evolocumab (REPATHA), subcutaneously at 140 mg (twice a month) for blood cholesterol increased. The patient reported, he was diagnosed positive with COVID-19 on 27May2020 from which he seem to have recovered without any residues of symptoms or side effect. He received first Pfizer COVID vaccination at noon time this past Thursday 25Feb in a vaccination clinic set up, the following day Friday the 26 he woke up the next morning and entire body was so sore from head to toe and could hardly get himself out of bed, but when he got up, he was having difficulty walking, so anyway he stayed in bed all day on 26 and 27. He initially had a slight temperature, some chills, slight cough, runny nose and those symptoms except for the cough seem to have resolved, what hasn't resolved is about every 30 or 40 minutes or so he had been having to urinate ever since 26Feb2021 night, his mouth has been constantly very dry. Still urinating every half hour 45 minutes and ongoing. Mouth has been very dry and had a couple of areas where it seems like maybe he had bit his lip or something, maybe when he was sleeping. It was nothing like that in mouth anymore but the mouth is still constantly so dry like dehydrated and no matter how much of fluid he drank that doesn't seem to help it and what in fact has also caused was on yesterday morning he had been a little constipated on Friday night and then yesterday morning had a severe case of diarrhea. Now he had not had another bowel movement since yesterday morning as no appetite and feeling so lousy, and so tired and fatigued. He had been feeling even much worse since getting the vaccine. He still feels very fatigued, very sore all over, very tired, still have the slight cough and he would say that's about it. Outcome of events for cough, pain and tiredness was not recovered and for the rest of the events it was unknown. No follow-up attempts are possible. No further information is expected.

At 8 PM on May 1, the day of the vaccination. I experienced loss of vision in my right eye. The loss was the top half of the eye and symptoms were similar to retinal TIA. Loss of vision was complete in the top half and lasted for several minutes. It resolved eventually but I went to emergency room at the request of my eye doctor.

I HAVE BEEN EXPERIENCING AN ANNOYING CONTINUOUS SOUND IN BOTH EARS. THE SITUATION IS VERY DIFFICULT TO PUT UP WITH. I NEED HELP TO OVERCOME THIS ANNOYING SITUATION.

Diagnosed with Covid-19 via Rapid Test on 04/30/2021. Received Pfizer vaccines in Feb 2021. Took Covid Rapid Test (NEGATIVE) on 04/18/2021 prior to leaving for vacation home. Arrived in 04/22/2021 and only went out in public twice, both times masked and social distancing. On 04/26/2021 I started having flu like symptoms, cough, fever (99-100 degrees F), headache, body aches, shortness of breath. 04/27/2021 I lost my sense of smell and taste. 04/30/2021 since I was still feeling unwell, I went to Urgent Care in for evaluation. Rapid Covid test POSITIVE for CV-19. Prescribed rest, fluids, Tylenol for fever and monitor breathing. Returned home 05/07/2021. As of today, 05/13/2021 I continue to have cough, lack of taste and mild shortness of breath and feeling generally lousy.

jaw bone like what hooks onto his head gets achy; it gets achy and is weird; terrible muscle pain and joint pain; little shaky when getting out of the chair; terrible muscle pain and joint pain; his hands joint do not work right; This is a spontaneous report received from a contactable consumer or other non hcp (patient himself). A 76-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EP7534, Expiration date: Unknown), via an unspecified route of administration in Arm Left on 18Mar2021 10:30 as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. There were no prior vaccinations within 4 weeks and no adverse events prior vaccination. There was no family history relevant to adverse events. The patient previously received first dose was received in his left shoulder as an injection on 25Feb2021 10:30 and the lot number is EN6200. On 19Mar2021, the patient experienced terrible muscle pain and joint pain, little shaky when getting out of the chair, on unspecified date in Apr2021, experienced jawbone like what hooks onto his head gets achy, it gets achy and is weird and on unspecified date in 2021, experienced his hands joint do not work right.. It was stated that he was calling to report what has happened to him from the second shot. The patient stated he got the shot on 18Mar2021 and when he woke up in the next morning he had terrible muscle pain and joint pain so he decided to call his doctor. The patient stated he could not get a hold of his doctor but the information that was given to the caller was provided from the nursing staff. It was stated that before he got the COVID shot he was working out with weights in the fitness center and doing really good and now he was fighting a battle. The patient stated also his jawbone like what hooks onto his head gets achy. The patient stated that mostly the joint pain was in his shoulders. It was stated he was sitting down on his chair and he used to be able to get up real easy but he now he was a little shaky when getting out of the chair now. The patient stated also his hands joint do not work right but he bought some stuff to rub on them which seems to help a little bit, but he has never had any of this before. It was stated he was working out, handling barbells, and for an old guy people would be surprised what he was lifting and he had no problems and stated for example if he goes to eat a breakfast meal with the egg, sausage, and biscuit he can barely open his mouth enough to eat it. The patient stated this started probably at the end of April. It was stated this is no 24 hours a day but he had it this morning and it gets achy and was weird. It was stated that eventually he will go back to the dentist since the dentist has a machine to take a picture of his jaw since he has not gone yet because of COVID but once he gets all this squared away he will go to dentist so they can take that picture. It was stated he was able to squat down towards the floor and go way down all the way down and pop right up and stated he knows he could not do that in the last couple of weeks anyway but he has not tried it since he has had trouble getting out of chair. It was clarified that this started as an introduction the day after getting the second shot on 19Mar2021 and it was still going on. It was stated he was not sure if it is getting worse or not since he has not followed it like a documentary. It was stated the doctor told him to take Tylenol and he has never had anything like this happen to him. It was stated what the doctor relayed to him was to go get a Tylenol rapid release and he takes two pills which is 1,000mg and he takes this 3 times a day and has a schedule knowing it was not recommended to take more than the 3,000 since the doctor was not wanting him to go over 4,000mg because effect the kidneys or liver. It was stated but he had not talked face to face with his doctor and he needs to get an appointment with his doctor but there is a wait and probably won't be able to see him for about a month. The outcome of the events terrible muscle pain and joint pain, jawbone like what hooks onto his head gets achy were not recovered and rest of the events was unknown. No follow-up attempts are needed. No further information is expected.

hearing loss; my nose started to run non stop; type of vertigo symptom's; This is a spontaneous report from a contactable other HCP (patient herself). This 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number el3249), via an unknown route, on 01Feb2021 (at the age of 76-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided) on unknown date for COVID-19 immunisation. No relevant medical history was provided. Relevant concomitant medications included lisinopril and atorvastatin. The patient received the last shot on 01Feb2021. The next day ''my nose started to run nonstop''. The runny nose lasted for about 6 days. The next thing that happened was a type of vertigo symptom's that lasted for 4 days. On 12Feb2021 ''I woke up and could not hear out of my left ear''. The hearing loss was trying to come back but did not. The events required a physician office visit. She was treated for the events. On 23Mar2021, the patient performed a hearing test, but results were not provided. On 12Apr2021, a nasal swab was done and resulted negative. The patient had recovered from 'my nose started to run non stop' on 08Feb2021 and from 'type of vertigo symptom's' on 06Feb2021. The outcome of 'hearing loss' was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.

Viral sore throat; Complete loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9265) via an unspecified route of administration in the left arm on 16Feb2021 at 13:00 (at the age 76-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1283), via an unspecified route of administration in the left arm on 19Jan2021 at 13:00 (at the age 76-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient experienced viral sore throat and complete loss of taste on 14June2021 at 15:00. The clinical outcome of the events viral sore throat and complete loss of taste was not resolved. No follow-up attempts are needed. No further information is expected.

Patient tested positive for COVID-19 on 07/09/2021. Sx onset 07/04/2021 (SOB, cough, loss of taste/smell, fatigue, body aches, subjective fever; afebrile at time of testing). CXR has been ordered, pending. Lab contacted to request specimen be held, and requested they contact TN DOH to coordinate with CDC to discuss the case further. Attempting to coordinate monoclonal antibody infusion for this patient.

Adverse event #1: approximately 12 hrs after receiving the first dose while at home he became paralyzed and fell to the floor. This soon wore off and he was able to get up so medical assistance was not requested. This never happened before. Adverse event #2: approximately 6 weeks after the 2nd dose he noticed onset of swollen lips and large hives over the body. He was started on steroids/montelukast/cetirizine. 2 weeks after stopping the steroids/monteluklast he again broke out in intermittent hives. Pt has never had hives before. He continues to take ceterizine for this issue. He did not see an immunologist for this problem.

Pulsative Tinnitus with embolization of right dural AV fistula by angiogram performed by neurosurgeon. Still have tinnitus but slight improvement after embolization. Quality of life is greatly affected

Annoying continuous sound in both of the ears and was diagnosed with tinnitus; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the right arm on 22Feb2021 at 10:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient received other unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9810) via an unspecified route of administration in the left arm on 04Feb2021 at 17:30 (at the age of 76-years-old), as a single dose for COVID-19 immunisation. Prior to the 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 four weeks prior to the COVID vaccine. On 08Apr2021 at 17:00, the patient experienced annoying continuous sound in both of the ears and was diagnosed with tinnitus. It was reported that, this situation was very difficult to put up with and the patient needed help to overcome this annoying situation. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event annoying continuous sound in both of the ears and was diagnosed with tinnitus was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Very sore upper right arm at site of innoculation. By 01.25 pain had resolved. 01.25.2021, 12 Noon, Very sore jaw, right side.

Approximately 8 hours after shot I suddenly had dizzy feeling, my eyes became crossed, could not focus my eyes, everything was a blur. I could think correct and carry on a conversation. Took 2 Ibuprofen, drank 8oz of water and laid down for a half hour or so. After about 40 minutes my eyes started coming back in focus. My left eye was not seeing some cobweb stands but eventually stopped and became normal. I then ate some food and everything seemed to be ok. As I write this 5 hours after the above incident nothing more has happened. My arm does not hurt either. No other symptoms of any kind are occurring.

1- Within minutes noticed a very slight effect on perception. Fogginess. Never mentionned to staff 2- Drove home feeling good but very slight headache. Has continued. 3- The PROBLEM started several hours later. Severe ringing...Tinnitus. 4- Never stops even when I wake up in the middle of night, first thing in the morning and at night. 5- Nothing helps, called my PCP the day after injection. 6- PCP assistant called back next day. Suggested I call an ENT. 7- Called my insurance UHC Advantage to speak with nurse. Gave me a list of ENTs 8- PCP instructions were to give it a day or two to see if the ringing would stop. 9- Tinnitus is very significant and is causing me much distress...Max Words!

Patient began complaining of dizziness and changes in vision (but no loss of consciousness) following 1st dose of COVID-19 vaccine. Patient was also diaphoretic and hypotensive with blood pressures of 82/57, 80/36 mmHg. No wheezing or respiratory distress were noted, and the patient did not endorse any changes in sensation/tingling/itching to face, lip or mouth. Patient was taken to the ED for monitoring. Workup in the ED was negative, and the patient was discharged home.

2 days after the shot I woke up and I had a hard time moving my mouth and my bottom lip was completely swollen. Its still puffy and very very red.

Four days after receiving the first Phizer COVID-19 vaccination (2/7/2021) I began experiencing double vision. This double vision was intermittent, lasting for several hours at one time. This double vision persisted and worsened with double vision all day long. At the ER prior to discharge, Dr. diagnosed me with possible "Ocular myasthenia gravis" and prescribed me with Pyridostigmine Bromide. After having been 30mg of this medicine daily for 1 week, the double vision has not subsided. Starting today (2/24), I am beginning to take 60mg daily. This double vision continues today (2/24/2021) even with the newly prescribed medication

Irritation of the outer lips Redness, cracking, scaling minor swelling. Some eight days after the first vaccine. Saw nurse practitioner prescribed Zyrtec and Prednisone. Also recommended a moisturizer. Using Vaseline with Aloe Vera. After two days of Pred. no results and received 2nd vaccine. Moisturizer giving relief of minor cracking and scaling. Swelling has gone down some.

Patient received the first shot on 2/17/21. Nothing seemed unusual during the following days; no complaining of soreness or anything. He hadn't introduce any new medicine or food into his routine. On the morning of 2/21/21, he woke up around 5 AM as usual. He spoke with his wife for a bit. Around 7:00 AM, he started having trouble breathing. He asked for help from family members. 911 was called. EMT's preformed heart compressions for about 45 minutes before pronouncing patient deceased. During EMT's initial encounter, EMT's struggled getting a tube down patient's throat due to his tongue being swallon

3-3-21 unable to open jaw, sweating (sweating resolved). 3-4-21 swelling to chin area with redness. took tylenol reports it helped him. asked if he had any fever, wife reports "no". called PCP spoke with his nurse, pending further instruction from PCP and or nurse. Wife called back states her Husband has abscess tooth, so feels maybe related to that. Wife states he was given Amoxicillin yesterday at MD office. She states he is feeling better today, eating slowly.

Pt reports having double vision and vision being blurry. Pt was seen by Fire rescue which took patient's vital signs and were all stable. Pt reported he had an episode of this three days ago. Pt was asked if he wanted to be sent to the ER and reported he did not. Pt's wife drove him home and reported he has dementia and she would contact his PCP and Opthalmologist. Pt's vision had cleared up by the time pt was assessed by EMS.

hearing loss; This is a spontaneous report from a contactable consumer reporting for self. A 77-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration in right arm on 08Feb2021 (Age at Vaccination was 77 years old) 13:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient stated overall in good health. Concomitant medication included finasteride, gabapentine. From 11Feb2021 12:00, patient almost a total hearing loss right ear. He wore hearing aids and they were checked to be working properly. He was concerned about this hearing loss and went to urgent care today. He was given a prescription for PredniSone and also a prescription for Neomycin- Polymyxin-hc (ear drops). 2- For the first time in 77 years, he had been given a prescription for glasses this week. Outcome of event was not recovered.

Awakening on Saturday, March 13, I saw blood on my pillow and a pee spot on the bed (my first time for either). I could barely get out of bed (an awkward rollover did it). My tongue was numb (still is) and raw from the presumed chewing on it. Walking was slow and painful as all muscles hurt. If I sneezed or coughed, my back would hurt. Those last problems are still true. I periodically cough up phlegm and lacking a good place to spit it out, I just swallow it. I have for the first time in my life been using a walker for stability. Right arm is almost useless due to pain.

After a couple of weeks one or 2, I went to the gym in the morning and my vision seemed blurry, so I closed my eye and now the vision of my left eye was worse and the shark shape or fish shape that I started seeing before (the branch retinal occlusion), was now a big blob and it was in my opinion about 1/3 on the bottom of my left eye. I was seen by Dr. who checked it and said it was bigger than last time and closer to the central retinal artery.

Almost immediately felt swelling at the injection site, which I felt as being normal. Next day when I woke up felt a slight headache , abnormal vision issues that included sparkles, blurred vision and a general tiredness. Did not feel refreshed as I normally do when I wake up in the morning. As the day went on sparkles and vision issues remained and headache got worse. Went to bed earlier than normal and next day when woke up the symptoms got worse, I felt like I had a migraine. Vision issues persisted. Laid down around 11AM and took a nap and when I woke up I noticed a blotch in my left eye reminiscent of the shape of a fish (looked like a shark) and it had different colors. Bright yellow and black almost kind of an iridescent green and orange. The shape was still just the colors were different. I panicked and called the optometrist and explained what happened. They wanted to see me right away. I was able to be seen in the afternoon. They looked at it, did two tests and came with the diagnosis of a branch retinal artery occlusion. I visited my neuro- ophthalmologist on 01/28 and he confirmed the diagnosis had previously given. He then ordered fedrate and a couple of other tests. They also did a visual acuity in the left eye (20/30) and color vision (8/8 normal) and color plates and intraocular pressure (16 OS)

Patient reports that he received vaccine on 03/17/2021. on 03/19/2021 he started to have a headache on the left side of his head. This is the same side he received his vaccine. He also started having an ear ache on left side starting on 03/20/2021. These symptoms are continued however improved.

tinnitus, which I have had for 20 years, was worsened. Today (3 days after shot) seems better. Purchased ear buds day after shot to mask extra tinnitus noise for sleep. Part of the associated ear bud app has a hearing test. (Who knew?) Anyway, this hearing test showed hearing loss for maybe 40% of their test I told primary care doc about it and she said should see ENT doc asap. Have not noticed any hearing loss, just "failed" the test . Appt with ENT is 3 days away. On prednisone in the interim per the rec of pcp.

Received first vaccine 11 FEB 2021: Initially had no issues. On 01 Mar 2021, felt myalgias and fatigue with temperature up to 99.2F and patient insists his basal core temp is 97.5F. Received his second vaccine on 04 Mar 2021 with temp < 100F therefore staff encouraged him that he had no contraindication. Same day, noted aches, pains, N/V, decreased appetite, loss of taste. Subsequently noted increased temperature up to 100.4F (single true fever) on 09 Mar 2021. Developed cough on 13 Mar 2021. His remaining symptoms are fatigue, loss of taste, decreased energy. The patient also noticed acute onset Rt chest wall pain after an episode of coughing ? states that it feels like a similar episode previously with known prior Dx of rib fracture. Not worse with exertion or relieved by rest. Not associated with meals. Worse with contact and position changes. He is taking ASA-325, 2 tabs each morning for pain, then 2 x 200mg Motrin tablets at night.

Patient has been experiencing metallic taste, tongue feeling like sandpaper, and upset stomach. Patient still has upset stomach but the metallic taste has disappeared and the tongue feeling like sandpaper is not as severe as it was initially. Patient has tried Prilosec to relieve upset stomach with no relief and has contacted MD with no new orders. Suggested for patient to take Mylanta, will follow up on 4/4/21. Patient feeling much better, has taken Mylanta as requested, no longer has upset stomach.

Developed a ringing in both ears in early hours of Mar 3rd. Virtual doc on Mar 6th. He prescribed 7 day amox/k clav 875-125 tab and ipratropium bromide nasal solution 0.06%. After the meds the ringing persists especially at night.

in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.

Vomiting for 3 days, terrible splitting head ache, ear ringing, disoriented, confused. bed ridden for 5, heard things not there unable to eat.

Muscle soreness; slight headache on top of head; hearing constant high pitched hissing noise/Wheezing sound in head, not ringing but like wheezing sound like hissing; Sore in my left arm where they give me shot; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6201), via an unspecified route of administration, on 03Mar2021 14:00 PM (at age of 77-year-old), as single in Arm Left, for Covid-19 immunization. The patient's medical history included high blood pressure, high cholesterol, diabetes, gout, sciatica, and penicillin allergy. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EL9262), via an unspecified route of administration, on 10Feb2021 14:00 PM (at age of 77-year-old), as single in Arm Left, for Covid-19 immunization. The patient's concomitant medications included telmisartan (MICARDIS) at dose of 80mg per day, insulin glargine (LANTUS), clonidine (CLONIDINE), simvastatin (SIMVASTATIN), gabapentin (GABAPENT) and insulin (INSULIN) taken for diabetes mellitus. Prior to vaccination, the was not patient diagnosed with COVID-19 and since the vaccination, had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient stated that he had second dose on Pfizer, on 03Mar2021 (on last Wednesday). He was a veteran and had the shot 2 o'clock in the afternoon. Then six hours after his shot, he had the sore in his left arm where they give him shot and then he had sore. He had little bit of headache, but not much so he took some Tylenol as a treatment. The next day, Thursday it disappeared, and he had little bit of sore, but his headache seems like disappeared. But, yesterday around noon time he suddenly heard wheezing sound in his head, he thought it was from his ear, but it was not, it felt like inside his head. It was like a wheezing sound, not ringing but like wheezing sound like hissing, something like that. Sometimes it was little bit higher, sometimes it was low. Right now, it was steady on, the sound was still there but he could hear everything plus the sound that made, therefore he called if it was normal or side effect of what he had. He tried to call his doctor today (on Saturday) but he never answered yet, so he had to call and report. The patient confirmed that it was after the second dose of Pfizer vaccine. On 03Mar2021 16:00, the patient experienced sore in my left arm; slight headache on top of head; hearing constant high pitched hissing noise/wheezing sound in head, not ringing but like wheezing sound like hissing; and sore in my left arm. The patient received treatment for the event headache. The patient was provided with the number of Pfizer Medical Information. The outcome for the reported events was not resolved. No follow-up attempts are needed. No further information is expected.

Headache, eye pain, doctor unsure of whether it was from blood clot removal or vaccine. Lasted 1 week. Went to neurologist and they thought it was related. Only took Tylenol.

Swollen Cheek; Swollen lips; This is a spontaneous report received from a contactable consumer, the patient. A 77-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via an unspecified route of administration in the left arm on 25Jan2021 at 12:15 (at the age of 77-years-old), as a single dose for COVID-19 immunisation. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 at 15:15 (at the age of 77-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 at 09:00 (after receiving the first dose of COVID-19 vaccination), the patient experienced swollen cheek and lip. On an unknown date 2 weeks and 4 weeks, (after second dose of COVID-19 vaccination) the patient experienced swollen cheek and lip. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with prednisone and anti-histamine for the events. The clinical outcome of the events swollen cheek and lip was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.

Night of first injection my dad said he missed his bed and fell on the floor and laid in the floor and couldn?t move for an hour. The day after second injection he almost passed out and we went to the ER. He was sent back home. Now he has been diagnosed with Parkinson?s disease. He has low Vitamin D. He is anemic and his iron is so low he is receiving 2 iron infusions. He has blood that has showed up in his stool and is having a colonoscopy on July 15th. He stays very dizzy and weak. He also has problems now with his eyesight.

Works in a quarry. Kills skunks. Could smell the skunks even when it sprayed several time. Loss all sense of smell. Sense of smell hasn't returned. Slight fever after the shot. Upper nasal passages seem to be constricting, has increased in severity. Now it is concerning . Does feel like he is getting any better.

drooping eye lid in the left eye; a little double vision sometimes; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL92104) via an unspecified route of administration in arm on 05Feb2021 at 11:00 (at the age of 77-year-old) as dose 2, single for COVID-19 immunization. Medical history included myasthenia gravis from 1992 and ongoing, thymectomy from 1996 to an unknown date and drug hypersensitivity (he's allergic to penicillin, he thinks he got hives, he doesn't know, when he was 10 or 12 years old. He states that's when they told him he had an allergy with the penicillin, and he got red lumps on his legs). The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL92104; Dosage text: injection, unknown dosage, arm) on 15Jan2021 at 11:00 (at the age of 77-year-old) for COVID-19 immunization. The patient did not receive vaccinations within four weeks prior to the first administration date of BNT162B2. The patient reported that 2 or 3 weeks after the vaccination, in Feb2021, he experienced a dropping eyelid in the left eye. He states now the thing that's important in this issue was he has myasthenia gravis, which is considered to be an autoimmune disease. The drooping eyelid might be some effect that the vaccination had on the myasthenia gravis, there might be a connection between those two. He sort of has a little double vision sometimes while watching the television. He stated that could be a characteristic of the myasthenia gravis, but it also could be the vaccination has caused a problem with the myasthenia. The drooping eye lid seems to be a little better, but the double vision was not. The double vision was not there all the time. The drooping eyelid he can't always tell was there, he had to look in the mirror and the reason he started paying attention to it was somebody motioned it to him. They asked what was wrong with his eye and he said nothing. He couldn't really tell without a mirror. Over a period of time, he started seeing drooping eyelid if they look through the side. He noticed that the drooping was usually worse later in the day. For a little double vision, he stated that usually when he was looking straight ahead, it did not seem to be there. He looked to the side or his eyes tire out a little, he tends to see it, the vision was a little off. It was a little worse than it was in the very beginning. He further reported that the first symptoms of the myasthenia were drooping eyelid and double vision which was what has getting now. He stated now whether these have anything to do with each other he did not know. The patient visited physician (ophthalmologist) office due to the drooping eyelid. The patient did not undergo relevant tests. The patient reported that the drooping eye lid and double vision may not be related. Therapeutic measures were taken as a result of drooping eye lid in the left eye. The clinical outcome of drooping eye lid in the left eye was resolving; and double vision was not resolving.

24 hours almost exactly after the first dose, my husband's top lip swelled up massively. He was able to get some benadryl around noon and took that then took more when he returned home. The swelling went down as he continued the benadryl for several days every 4 hours during the day and then before bed. It has now been almost a week (Feb. 1, Monday) and the lip is still a little swollen and is tender and sore.

During 30 minute observation period, patient c/o lip swelling which was progressive when evaluated by APP on-site; Administered Epipen and benadryl; EMS transported to ED

Had no symptoms of any kind up to the time of shot. 2 hours later I developed double vision in my right eye

He woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen; He woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen; He woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen; This is a spontaneous report from a contactable consumer reporting on behalf of the husband. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER VACCINE, lot number: EL9262), via an unspecified route of administration on 20Jan2021 at about 9am at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received a first Pfizer vaccine on Wednesday (20Jan2021) morning at about 9am. And he woke up this morning everything was fine until this morning, Saturday morning (23Jan2021) and he woke up with his left side of his mouth and face, the lips, the cheeks of the left side are very swollen. They didn't do any lab work or blood. The patient did not receive any treatment. The only other question was whether he should go to the emergency room. He could breathe, he could swallow. The event outcome was unknown.

left eye became swollen; aching in the eye socket and eye ball; vision was clouded; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: DL9263), via an unspecified route of administration at the site of left arm at 12:15 on 24Jan2021 at single dose for COVID-19 immunization. Medical history included cancer survivor, penicillin allergy and aspirin allergy. Concomitant medication included ibrutinib (IMBRUVICA), testosterone, cyanocobalamin (VITAMIN B-12) and vitamin d3 (VITAMIN D3), all received within 2 weeks of vaccination. The patient's left eye became swollen and aching in the eye socket and eyeball and vision was "clouded" at 19:00 on 25Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse reactions did not result in any serious consequences. Case assessed as non-serious by reporter. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.

3 days after the first Pfizer COVID vaccination, the patient had nausea, vomiting, dizziness, hearing loss and loss of equilibrium. These symptoms slowly resolved, but recurred 3 days after the second dose of the Pfizer COVID vaccine.

Bell's Palsy caused the side of my face to swell up and droop on one side; Eyes have been bothering him and he is blinking; Can't talk very good because his lips are swelled up/hard to talk; This is a spontaneous report from a contactable consumer reporting for himself. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EM9809/expiration date: not provided), via intramuscular route of administration, on 04-FEB-2021 at 14:30 (at the age of 78 years old) 0.3mL as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included patient was diabetic since an unknown date and has psoriatic arthritis. Concomitant medication included infliximab (REMICADE) infusion every 8 weeks for psoriatic arthritis and cetirizine hydrochloride (EQUATE ALLERGY RELIEF). The patient had infliximab infusion the morning of 04Feb2021, prior to receiving the vaccination and was told that infliximab would not be a problem with receiving the vaccination on the same day. On 07Feb2021, the patient went to the emergency room due to Bell's palsy, which was described as swelling of lips, nose, mouth, and side of face and stated that he can't talk very good because his lips are swelled up/hard to talk and his eyes have been bothering him and he is blinking. The patient stated, "I went to the emergency room at a hospital and what they said is totally unrelated to the COVID shot I got. In the meantime, few days after I had the shot, I had somehow got Bell's palsy caused the side of my face to swell up and droop on one side. I just wanted to get back to you so you knew that was not some reaction to the COVID shot, it was something else." Treatment for the event Bell's palsy included took Allergy Relief Equate 25mg ultra tablet and another allergy pill and it did not help swelling of lips, nose, mouth, and side of face. Relevant tests included blood work on an unspecified date in 2021 "two weeks ago" that was all good. The outcome of the events Bell's palsy, eyes have been bothering him and he is blinking and hard to talk was unknown.; 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 totally 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.

2nd SHOT Thur Feb. 18, 2021 2:30pm Fri. Feb 19 6:00 p.m Chills! Sun. Feb 21 lost taste Fri Feb 26 extreme weakness in legs Otho has had side effects THAT OTHERS HAVE NOT REPORTED. Otho received the first Pfizer shot on January 28, 2021 and only suffered a small ache in his arm. Otho received the second shot of Phizer on February 1 8, 2021 adminsted at the same location. Day 1 arm a little uncomftable Day 2 6:00 pm extreme chills Day 3 chills gone, tired, weak Day 4 LOST SENSE OF TASTE Day 9 Legs so weak, could not walk without a walker Day 13 TODAY Still very weak and still connot taste. Otho is a male age 78 yrs. Usually very active. He does suffer from Carcinod Caner of many years. We did visit with our doctor. He prescribed to take two Ibuprifen morning and night to help with inflammation. And if Legs weakness increases to get back to him.

the onset of blurred vision in one eye and flashing colored lights in both eyes.; the onset of blurred vision in one eye and flashing colored lights in both eyes.; This is a spontaneous report from a contactable physician (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), intramuscular at the left arm on 21Jan2021 08:45 at single dose for COVID-19 immunization. Medical history included Parkinson's and neuropathy. The patient has allergies to CIPRO antibiotics. Concomitant medication included unspecified multiple supplements. On 22Jan2021 at 09:00 (24 hours after vaccination), the patient had the onset of blurred vision in one eye and flashing colored lights in both eyes. This was unlike anything he has ever experienced, and it persisted for several hours. Vision gradually returned to normal and lights disappeared. This was not a retinal detachment or vitreous detachment. It was not associated with eye pain. The patient did not receive any treatment for the events. The patient recovered from the events on an unspecified date in 2021.

Severe hypoglycemia with blurred vision and neuropathy in legs roughly couple hours after receiving vaccine

watery eyes; runny nose; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 30Jan2021 for COVID-19 immunisation, administered at hospital. The patient medical and concomitant medications were not reported. The patient previously received the 1st dose of bnt162b2 (BNT162B2) on 04Jan2021 (also reported as 07Jan2021) for COVID-19 immunisation, administered at hospital and the reporter did not indicate that he had any side effects. The patient experienced watery eyes and runny nose in 2021. He did not experience any headache. No treatment was received. No admission to hospital due to the events. The outcome of events was recovered in 2021, he was fine now. Information about lot/batch number has been requested.

Dizziness following vaccination, swelling of eyes, slight facial swelling around cheeks and eyes. without resp distress. BP 138/94, 76, 18, 98%, BS 135

He received his vaccine, and immediately he could taste it in his mouth. About 5-6 days later his normal routine was to work outside and noticed that he had lost his energy issue, and had this issue in the past when his pacemaker was out of wack. As the month went on it got worse and worse. In March he was out cleaning up the yard and as he worked it got worse and worse. He would have to work for 5 and sit down for a minute. He has hyperventilation syndrome and diagnosed back in 1980 and has been under control, this is one thing that always happens, which seems to be an ongoing problem that he's having. His settings on his pacemaker seem to be OK. He was sitting on his couch and watching a race on 3/8/21 and got a shock coming up from the bottom part of his head, through his chest and out through his right eye, this was less than 2 seconds. This was an event, but not a hard "mule" kick event. He wasn't doing anything to get the shock. The defibrillator is connected to the bottom part of his heart. He has a logic system and had an episode of 190-200 BPM which was at the top part of his heart. He had all of his equipment checked out yesterday, but they could not give him an answer why he got a shock. He now has to set up an appointment with his cardiologist to see tomorrow. He has had the pacemaker for 6-7 years now and the device goes into the device clinic and he gets reports regarding this information. They device people said there was no registration that he had any event.

Pt presented to ED on 3/9 with R eye pain and blurred vision, plus R-sided facial dropping which started that morning. Physical exam positive for facial asymmetry. Per ED provider note: "Pt now with clear R-sided 7th nerve palsy compared to arrival when lower portion was more pronounced.... Labs largely unremarkable.... Overall, exam at this point most consistent with Bell's palsy. Will start on prednisone, acyclovir, eye patch, and artificial tears."

I've had chills; I want to sleep all the time/He is lethargic like he wants to sleep all the time; my mouth feels like it has cotton in it; tired; head feels strange/ He doesn't feel good/ He doesn't feel right; The temperature 100.1; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL3248, Expiration Date: unknown), via an unspecified route of administration, anatomical location-Left Arm On 29Jan2021 at single dose for COVID-19 immunization. The patient medical history included high blood pressure, High cholesterol, psoriasis. concomitant medication included Humira 2 days after the first vaccine dose in the belly.The patient experienced chills, lethargic, dry mouth, tired, feeling abnormal, the body temperature 100.1. The clinical course reported as 'He doesn't feel good. He had chills before the shot then he had more chills after the shot. He is lethargic like he wants to sleep all the time. He doesn't if know his immune condition psoriasis, for which he takes Humira has anything to do with it. He doesn't feel right, its the Pfizer BioNtech Covid Vaccine. He wants to know if this is a normal side effect. He has a Temperature of 100.1'. The patient underwent lab tests 03-FEB-2021 Blood test, Body temperature, 100.1, COVID-19 test result was negative. The outcome of event was unknown. Follow up information completed. No further information is expected.

- Tinnitus increased from 2 to 10 in severity - Intermittent stab in pain on lower.back of head slightly above left ear lobe

Large influx of saliva in mouth; Nauseated; Thrown Up; stomach cramping; This is a spontaneous report from a contactable 78-Years old male consumer reported for himself that he received bnt162b2 second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 09Feb2021 at single dose in left arm for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 18Jan2021 (First dose lot number: EL8982, received both COVID-19 Vaccines in his left arm). On 12Feb2021, the patient experienced stomach cramping and on 15Feb2021, Large influx of saliva in mouth and he felt nauseated and thrown up. The outcome of the events was unknown. Information on the lot batch number has been requested.

eye blurriness; gate affected; auto immune system deterioration; practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); heart/organ issues; heart/organ issues; brain fog; joint and muscle stiffness/joint stiffness; joint and muscle stiffness; blood; limb numbness/toe numbness; neurological deficit; soreness injection site; mild right temporal headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (BNT162B2, formulation: solution for injection)Batch/Lot # EP7534, via an unspecified route of administration in the right arm on 22Mar2021 14:00 (at the age of 78-years-old) as SINGLE DOSE for COVID-19 immunization. Medical history included heart dysfunction, heart surgery, kidney function abnormal and neural dysfunction. Concomitant medication included silodosin (RAPAFLO) at 8 mg daily. The patient previously took bnt162b2 (administration date=03/03/2021, administration time=02:15 PM, vaccine location=Left arm, dose number=1). On 23Mar2021 05:45, the patient experienced auto immune system deterioration, practitioner shook bottle and injected discolored (brown) vaccine right arm (# 2 injection march 22, 2021 - 2pm), heart/organ issues (cardiac disorder), brain fog, joint and muscle stiffness/joint stiffness, joint and muscle stiffness, limb numbness/toe numbness, neurological deficit, soreness injection site, mild right temporal headache. On 24Mar2021, the patient experienced eye blurriness, gate affected. Practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection 22Mar2021 - 2pm). The patient was concerned about current and future adverse effects as it relates to auto immune system deterioration, heart/organ issues, brain fog, joint and muscle stiffness, blood, limb numbness, neurological deficit and whether such existing health issues have been exacerbated by vaccine injection : currently soreness injection site, mild right temporal headache, toe numbness, joint stiffness, 24Mar early morning eye blurriness, gate affected. The patient did not receive any treatment for the events. The outcome of the events was unknown. Follow-up (25Mar2021) and (31Mar2021): This is a follow-up spontaneous report from a contactable consumer. New information included: Lot/Batch number of the second dose, medical history updates.

Received his vaccine, he had soreness in the arm, but nothing else. On 3/3/21 he went to hospital ER with diagnosis of kidney stones, had a morphine injection, Flomax and a prescription for Oxycontin and Flomax. At that time he was experiencing also in his right eye swelling and it was reddish, and there was an itching around the eye, and there was a couple blotches on top of his head and his cheek, but did not mention it as he was there for kidney stones. On 3/9/2021 he saw a Urologist, Dr. and that morning he passed a kidney stone. The urologist took an x-ray and did not see any more. The eye then became an issue on 3/9/21 and he made an appointment to see the eye Dr., Dr. at Eye institute on 3/11/21 @ 9:00 AM. The doctor diagnosed shingles on the face and right eye, and she put him on 2 medications (Durezol ophthalmic drops). He is still on that medication still 4/16/21. The other medication that they prescribed for him was Valacyclovir which he took 3 times a day, they reduced it from 1000 mg to 500 mg twice a day. The swelling of the eye itself has gone down a little bit. He is still seeing the eye doctor, and has a FU on 5/5/21 as it is getting better but still has symptoms. He did get a single dose Shingrix shot a couple of years ago.

Presented to hospital with shortness of breath for one week on 4/13/2021. Additional symptoms reported include productive cough with blood tinged sputum, diarrhea, and food tasting like salt. Supplemental oxygen, tocilizumab and remdesivir treatment initiated

from office visit 4-19-21: Chief Complaint Patient presents with ? Facial Droop started yesterday. ? Neck Pain right side. Yesterday noticed a facial droop without any arm weakness or change in gait. No headaches. Using some artificial tears but eye is getting more red and matting of eyelashes. Having more right rhinorrhea, but that's been a chronic issues. Feels like hearing is off in his right ear. More neck soreness on the right.

Patient came back to Mass vaccination site to report that after he received 2nd dose of Pfizer COVID vaccine, he had angioedema with Left eye swelling completely shut. T99.3 He reports he did not notify his PCP, did not go to urgent care or ER for treatment as he does not believe in doctors. He reported to his cardiologist who instructed him to come back to vaccination site to let us know of his reaction. Patient states he is a doctor himself. At time of patient report, on 4/29/21, symptoms had resolved.

Muscles hurt and was weak; Muscles hurt and was weak; got excited; tongue became swollen; fell down; felt so weak that he could not lift himself to get up; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history included COVID-19 from Jul2020 to an unknown date; he also mentioned that he had COVID-19 back in July but has already recovered. The patient's concomitant medications were not reported. On an unspecified date in Jan 2021, the following day, he woke up and his tongue was swollen. He got excited and called doctor and he went in. He went to get dressed and as he went in, he fell down. Then he is trying to get up and cannot get up. He layed there for 1/2 hour. He could not get up. He was trying and trying. His wife had to call neighbors to help him get up. He did not want to go to the hospital and wait for 2-3 hours. He took some Benadryl and a couple of Aspirin and fell asleep. The following day when he woke up, his mouth was not swollen and he was able to get up and around. His muscles hurt and he felt like a weakling. The clinical outcome of tongue became swollen, fell down, felt so weak that he could not lift himself to get up was resolved and the outcome of other events was unknown. He is scheduled to get second dose on 24Feb2021. He would like to know if he should get it or not. He was an EMT in Fire Department before he retired. That day when it happened, he really felt old. No further details provided. The seriousness of the events was reported as non-serious. Follow-up (16Apr2021): This follow-up is being submitted to notify that 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.

started seeing strange things- saw things that weren't there. The yellow wall in his bedroom came up but had all kinds of art work on it, the ceiling and doors too; couldn't remember things; Weird things happened in my brain; lost his vision while driving; CT scan it did show hardening of the arteries in his brain ,was told had a TIA (Transient Ischemic Attack) or some kind of a stroke; had issues with confusion as well; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 06Apr2021 as 2nd dose, single dose (at the age of 78-year-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 as 1st dose for COVID-19 immunization. On 02May2021 (26 days later), patient lost his vision while driving and it came back good enough to drive within a half hour (medically significant) and when it recovered on 02May2021, patient started seeing strange things, saw things that were not there. The yellow wall in his bedroom came up but had all kinds of artwork on it, the ceiling and doors too (medically significant), patient couldn't remember things, had weird things happened in his brain. Patient stated that it didn't go away entirely until about 10 days later. Patient also had issues with confusion as well. Patient stated that he thinks he was back to normal now. A computed tomography (CT) scan was completed a week or so earlier and it did show hardening of the arteries in his brain. Patient saw his primary care physician and was referred to a neurologist. On unspecified date of May-2021, patient was told he had a transient ischemic attack (TIA) or some kind of a stroke (medically significant). Patient had a Magnetic resonance elastography (MRE) (like a Magnetic resonance imaging (MRI) of the brain) yesterday (27May2021), but it had not been read yet. Patient asked if he was the only one that had done this or had other people had this problem, even two or three people or he was an isolated case and in response it was stated that, unable to find information about his symptoms in resources and the Product Information (PI) for the vaccine does not contain information reporting his symptoms (vision loss, memory loss, confusion, hallucinations) as side effects of the vaccine. The outcome of had a TIA (Transient Ischemic Attack) or some kind of a stroke was unknown, for lost his vision while driving was recovered on 02May2021 while recovered for rest of the events on May2021. Information about lot/batch number is requested.

1st vaccine: Pain in shoulder neck and head same day. Next day whole body was hurting. After 3 days gout flare-up. NP did labs. Found GFR to be 18.Had been in the 40's prior to vac. 2nd vaccine: worse. Body pain, extreme nausea and vomiting. Dizziness, difficulty walking. Down for 14 days. June 17: Chest pain of # 9and jaw pain. No history of heart problems. To ER with wife. Admitted to hospital. Discharged home 6/19/21. Now sleeping a lot. Trying to resume activity.

Very irritating unidentified smell always present,also very vivid dreams every night since about 2 days after 2nd vaccination.

Patient stated after receiving his second covid vaccine on 06/15 he started having visual changes, which was confirmed a stroke on 06/25 by MRI. Patient stated he noticed his stroke symptoms after receiving his second vaccine.

Pfizer-BioNTech COVID-19 Vaccine EUA: Within fifteen minutes of receiving vaccine patient experienced lightheadedness and dizziness. Remained awake alert and oriented and able to stand and ambulate. Initial vital signs were within normal rnage except blood pressure 152/67 mmHg. Patient denied chest pain, palpiatations, shortness of breath, difficulty breathing, nausea, vomiting, and pain. Patient stated they had not eaten yet that day and was immediately given juice, food, and water. One hour after vaccination patient stated symptoms were resolving. One hour and fifteen minutes after vaccination patient stated lightheadedness and dizziness returned and were slightly worse and developed a new symptom of "ear and head pressure". Repeat vital signs were within normal ranges except blood pressure was 139/92 mmHg. After discussion with healthcare provider decision made to transfer patient to urgent care/emergency department.

Sudden onset of tinnitus followed by complete hearing loss in Right ear upon awaking from sleep (7 hours)

Chills, loss of taste and smell, weakness, shallow breathing Narrative: Patient referred to facility ER for COVID- 19 testing and evaluation of symptoms

On February 9, 2021 (exactly 2 weeks after receiving my first vaccine dose) I woke up with double vision.. Saw eye doctor that afternoon and was diagnosed with Left Cranial Nerve 4 Palsy.

"Pfizer-BioNTech COVID-19 Vaccine EUA" Exagerrated numness on the left side of my face from ear to mouth

Flu like symptoms, with no high temp since original vaccination and continued with 2nd vaccination. Muscles, joints shoulder neck, head. Tonge very sensitive to any acidic , spicy or rough food

Itchy lips and mouth "dissipating now" Vital Signs: B/P: 120/70 HR: 62 O2sat: 97% BS: 69 Skin Signs: Warm and dry Circulation: Cap refill <2sec Resp.: Breath sounds clear Bilaterally Treatment: Juice for low blood sugar Repeat Assessment @ 14:10 Vitals: B/P: 120/80 HR: 60 Resp.: 10 O2sat:96 % Blood Sugar: 105 Skin signs: warm and dry Circulation: Cap refill <2sec Resp.: Clear Bilaterally Patient clear to go home

LEFT EAR TINNITUS Narrative: Patient presents to extended monitoring for intermittent tinnitus in left ear a few minutes after receiving first dose of Pfizer covid vaccine. Symptoms resolved few minutes after presenting to extended monitoring. No other symptoms. Patient released and advised to consult PCP of symptoms return.

severe allergic reaction; has a drop foot that felt rubbery; Dizziness; Dry mouth; This is a spontaneous report received from two contactable consumers (once is patient himself). A 79-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection and Lot Number: EN6208), via an unspecified route of administration in the left arm on 15MAR2021 15:15 (at the age of 79-years-old) at a single dose for COVID-19 immunization. Patient medical history included Diabetes ongoing, patient has had three heart attacks. The first was over 20 years ago. He is waiting to have a stress test prior to having an angioplasty and Heart condition ongoing. Concomitant medications were reported as none. Lab data includes patient had all kinds of testing at the emergency room, test results that he had at the emergency room were all negative. They checked his heart and did a CT scan on 15Mar2021. Patient received the first dose of the COVID-19 vaccine on 15Mar2021. He received the vaccine at 3:15 pm. Within a minute after getting the vaccine he was getting dizzy. He was monitored for 15 minutes. He thought the dizziness went along with it. On the way home the dizziness was really hard to explain. He has never gotten this dizzy. It took his whole head over. It wasn't a spinning dizziness. He is 79 years old and has a lot of physical problems. He has a drop foot on his good leg. When he got home his drop foot felt rubbery. It is not usually like this. He also had a dry mouth. The papers said this is under the severe allergic reaction. Patient's daughter called the doctor and was told to go to the emergency room. He had all kinds of testing at the emergency room. 3-4 hours later the dizziness dry mouth went away. His foot was back to normal. He is wondering about the second dose. He is asking if the second dose will be stronger than the first. Patient received first dose of vaccine on 15Mar2021 and experienced dizziness, he believes it was a severe allergic reaction. His symptoms subsided a few hours later. He has a history of diabetes and heart issues. Event has already been reported to Pfizer. Patient has a Nuclear cardiac stress test on 01Apr2021. His second dose is schedule for 06Ap2021. He would like to know is it safe to get second dose considering his side effects. Outcome of event (severe allergic reaction) was unknown and recovered on 15Mar2021. No follow-up attempts are possible and no further information was provided

He reported that he had puffiness around his lips and he was itching like crazy; itchiness; This is a spontaneous report from a contactable consumer or other non hcp. A 79-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EN4809) as SINGLE DOSE for covid-19 immunisation. Medical history included surgery (three or four years ago) and gastrooesophageal reflux disease. Concomitant medication(s) included metformin; metoprolol; acetylsalicylic acid (BABY ASPIRIN); amlodipine; rosuvastatin; ezetimibe; famotidine (PEPCID [FAMOTIDINE]) for gastrooesophageal reflux disease; irbesartan and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient reported, he received his first shot of the Pfizer BioNTech COVID-19 vaccine on 04Feb2021 and is scheduled to receive his second on 22Feb2021. States that after his first dose, he experienced puffiness around his lip and itching like crazy with scratching his forehead, scalp, and shoulder. He hasn't experienced these symptoms for the last 4-5 days and reports it wasn't nasty. It doesn't last long. It has been tolerable. He remembers when he got the Shingles shot he had some itchiness. At the end of this week, he has to get the second shot. The outcome of event Lip swelling was recovered and for itchiness it was unknown on 06Feb2021.

Pt began experiencing metallic taste in mouth after 1 st shot on 3/31/21. Pt worked the rest of his shift that night. Pt spouse called in to work on 4/1/21 stating pt felt crummy, arm swollen, and headache.

Received the vaacine on 2/3/2021 I felt fine that whole day. The following day as I was showering I got lightheaded and fell in the bathroom . I went to the ER and the sent me home because I had no injuries. My blood pressure was high . For a few days I got lightheaded off and on. Then on 2/24/2021 I went for the second dose again i felt fine the whole day. On 2/25/2021 as I was showering I got lightheaded and fainted. My family called the ambulance and I was hospitalized from 2/25/2021 to 2/27/2021. I had facial fractures, fractured septum (nose) and cut upper lip received 10 stitches and teesth and gums were numb and still are a little numb.

Long distance vision slightly blurred for 3 days.; Hands were slightly red for two days; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration in left arm on 08Feb2021 at 15:45) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced long distance vision slightly blurred for 3 days on 09Feb2021. Now fine. Hands were slightly red for two days on 09Feb2021. Now fine. Both me and my wife hands were red for the same time. No treatment received for the reported events. The outcome of the events was resolved on an unspecified 2021.

My tongue developed a raw, cracked and sore area similar to a reaction I had to a sulfonamide when I was a teenager. This is 4/30 and area on tongue is still tender, but crack disappeared 2 days ago snd area is no longer raised. I have a photo of tongue.

Covid positive 4/19/2021, off balance, weak/tired, trouble hearing, cannot taste, cough, runny nose, reports not short of breath but breathing heavy, fever comes and goes,

swelling and it felt numb, the numb feeling starting on left side of cheek and wound up settling in upper lip; swollen gland he noticed on the left side; the swelling in the mouth on the 11Feb2021 on his lip lasted about 2 days,his upper lip irritated on inside for a day or 2,; swelling that occurred in his mouth/1st occurrence of swelling was like golf ball size, it was visible; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 11:00 (at 79-years age) as single dose for covid-19 immunisation. Medical history included diabetes and hypertension (he was diabetic and was on blood pressure medication, but both his hypertension was under control, and his diabetes, sure his A1C is higher than it should be but was under control with oral medication), root canal infection (though this was contributed to the root canal which he had on 29Jan2021, the root canal was on the lower left of the mouth, tooth number 20). Patient provided relevant Family medical History of Hypertension. Concomitant Medications: He was just taking his general medications, like his maintenance medication, nothing out of the normal. He had no other vaccines on the same day as the covid vaccine or in the 4 weeks prior. He had no positive covid or antibody test prior to the first dose (he had never had a test).On 08Feb2021, the patient had the 1st occurrence of swelling was like golf ball size, it was visible, but it went away after 3-4 hours and he didn't have to take anything. Then on the 11Feb2021, the patient woke up at 4:30AM, experienced the swelling and it felt numb, the numb feeling starting on left side of cheek and wound up settling in upper lip, it gave him a distorted appearance, it was severe. The swelling in the mouth, that wound up settling in upper lip which was the 2nd occurrence in a 3-day period. The first occurrence was swelling, not as severe, in the lower inside of the mouth in the lower right inside of the gum, the swelling appearance from the outside, though this was contributed to the root canal (had on 29Jan2021). The swelling in the mouth from 08Feb2021 subsided for him in 3-4 hours. He called endodontist, and told her about the second swelling, she said to come in and look at it, that was on 11Feb2021, she took X-rays and result was normal, she said it was not connected to the root canal and told him to contact his Primary and go from there, he agreed with her because he did not feel any type of sensitivity. On 11Feb2021, patient then called the Primary Care doctor, told how he developed the swelling, and the primary care said that he would rather see an ENT specialist and he got an appointment with the ENT that same day 11Feb2021 at 15:00 in the afternoon. The patient went to see him, the ENT checked his mouth out, checked his nose and throat, he did not know what it was stemming from, and said he will put him on an antibiotic. On 11Feb2021, the ENT said that the patient did had a swollen gland he noticed on the left side. The swelling in the mouth on the 11Feb2021 on his lip lasted about 2 days, his upper lip irritated on inside for a day or 2, but it lasted till about the 13Feb2021. On 11Feb2021 (5 days ago), the patient was put on an antibiotic for swelling that occurred in his mouth which was Clindamycin HCL 300mg, 3 pills a day with his last 2 pills of antibiotics falls same day (18Feb2021) as his second vaccine dose was scheduled on Thursday (18Feb2021; appeared to be scheduled outside of the 21-day recommendation). Patient felt like he was sort of on edge for another occurrence possibly happening. Being on the antibiotic, maybe this was some type of infection. The ENT told honestly that he didn't know why this happened, but if it happened again, he might have a CT scan for the suspect salivary gland, maybe it was clogged or there was an infection in the gland. He asked if he should take the pills or reschedule the vaccine dose and if it was ok to receive the second shot while on this antibiotic (his prescribing doctor couldn't give an answer). On 18Feb2021, the patient was due to have booster. Patient would have 2 pills left on the 18Feb2021, after that he was finished. Therapeutic measures of antibiotic were taken as a result of swelling that occurred in his mouth (mouth swelling). He did not have to go to the emergency room for the mouth swelling but he has visited the physician's office. The outcome for swelling in the mouth and lips was recovered on 13Feb2021 (Duration 5 Day); outcome for swollen gland was unknown. Follow up (16Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported patient information, new event information.

Initially had chills, myalgia, and weakness. Symptoms worsened with fever and ongoing headache that lasted for 2 weeks. Developed visual disturbances. Was admitted twice and ultimately diagnosed with giant cell arteritis

Dizziness; weakness; fever; tinnitus; chills; acid reflux; vomit; difficulty breathing; enhanced smells and taste; enhanced smells and taste; via unspecified route of administration in left leg; This is a spontaneous report received from a non-contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198), via unspecified route of administration in left leg on 25Feb2021 08:15 AM (at the age of 79-year-old) at 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medications, it was reported that patient received any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 the patient experienced dizziness, weakness, fever, tinnitus, chills, acid reflux, enhanced smells and taste, vomit, difficulty breathing. The events were reported as serious with hospitalization and life-threatening criteria. The patient was hospitalized on 14Mar2021 and duration of hospitalization was reported as 5 days (19Mar2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported that since the vaccination, the patient had been tested for COVID-19 with test type nasal swab (negative) and test type other with test name antibodies test to SARS-COVID 19 (negative). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Diagnnosis: Bell's Palsy, right ear ache, right peripheral facial palsy, and corneal injury. March 29 to April first. Treatment by Opthomologist: eye drops every hour and eye lubricant before bed.

ear buzzing like a mini tornado or hurricane wind sound/ right ear sounded like it had a motor running in it. It was a loud humming in his ear; dry mouth; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 25Jan2021 as single dose for covid-19 immunisation. Medical history included excessive cerumen production and cerumen removal. The patient's concomitant medications were not reported. Caller stated he wanted to report side effects for the first dose of the Pfizer vaccine he got on the 25Jan2021, He said when he wakes up his "ear buzzing like a mini tornado or hurricane" wind sound. it usually goes away after few hours, it has been happening in the morning. On 26Jan2021, he also has dry mouth, had never experienced something like this before. Then, yesterday morning on 28Jan2021, at 3 am, his right ear sounded like it had a motor running in it. It was a loud humming in his ear. It eventually went away before he got up.This morning, he had the same thing at about 4-430 am. He turned over and his ear had like a mild roaring. It sounded like a motor running. It was like a rushing sound. It went away by this morning. He didn't have a prescribing doctor. The dry mouth wasn't a solid 12 hours.It comes at odd times. Patient understood mouth breathing could cause dry mouth, but he isn't breathing from his mouth. He is normal breathing. His mouth is dry and has to keep drinking water. Sometimes later on in the day it is randomly dry. He has never noticed anything like this in his entire life. When he rolled over in his sleep, he could hear a rushing in his right ear.He had wax in his ear before, and the nurse would pop a ball of wax out that was blocking his ear, but this noise isn't anything like that. Patient never had this noise before. In his 70 some years he has never had ear problems. The outcome of the event tinnitus was not recovered and dry mouth was recovering. Information about Lot/Batch number is requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that 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.

A hazy, cloudlike coverage of a portion of my visual field. Possible only one eye but not sure. Difficult to see through. Lasted several minutes and then dissipated on its own. Occurred again two weeks later. Same. Unsure if it will occur again.

Sudden and complete loss of vision in left eye for about 1 minute followed immediately by sudden and complete recovery of vision. No other symptoms. Lovastatin increased from 20mg/day to 40mg/day. Aspirin increased from 81mg every other day to 81mg every day. I have not subsequently experienced any symptoms to date.

Tiredness, loss of appetite, coughing, nausea, Arm ache, excessive thirst, some sweating. NO high temperature.

he is shrinking; chills; tired; cant walk; it hit me like I had the virus; it hit me like I had the virus; My eyes are hurting; no matter which way I turned it was hurting, knees, everything was hurting really bad/aches and pain; dizzy/dizziness; weak; muscle pain; joint pain/back knees elbow joint pain; fever; headaches; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received first dose of bnt162b2 (Pfizer BioNtech Covid 19 vaccine, lot number EL1283) , via an unspecified route of administration on 17Jan2021 01:15 at single dose for covid-19 immunisation. Medical history included open heart surgery 11 years ago, covid-19 from Jul2020 to an unknown date. The patient's concomitant medications were not reported. The patient received bnt162b2 yesterday, with no problems. However today (18Jan2021), in 15 minutes after waking up at 11, he had the chills really bad, that went away, then he went to sleep again and woke up and he had all the symptoms on the paperwork, he had dizziness, headache, he's hardly ever had a headache ever. He had aches and pain. Caller states that he was just asking right now about another company, and their vaccine in started with an M, and her daughter is at a girls home, because she has a epileptic type thing, and this particular shot, that started with M, the nurse called over, and the problems that he is having he explained to the nurse is like when he had the virus previously about in Jul2020, when he had the virus he was in hospital for a week, because he had to get rid of the virus, and they got him out of that. Now he took this shot yesterday and the next day is when he got all these symptoms, he's tired, cant walk, muscle pain, had chills not any more, pain in the knees, everywhere really, he couldn't get any position to go back to sleep, his back knees elbow joint pain. Since he had these things, the nurse at the girls home, told his wife if having these problems he can take 300 mg of Zinc, 1000mg of Vitamin C, and 2000IU or Vitamin D, the same thing, that amount, he asks will it over come the symptoms. Another person felt good after getting those, it helped him he does state however that is what the person took when he actually had the Covid 19 Virus. Caller states that he received paperwork after the vaccine from the (State), it has a bunch of blocks asking if he has this or that symptom. His First dose was 17Jan2021 at 1:15, then on 07Feb2021 if this Second Dose. All the side effects started Today 18Jan2021. His doctor said he's in good health. He did have open heart surgery 11 years ago. The patient reported he is 5 feet 8 and a half inches, he is shrinking. He stated, "I was good until this morning, it hit me like I had the virus. The product they gave me at the (State) was the Pfizer-biontech vaccine. I had all the symptoms except vomiting/throwing up. I got all the other symptoms. no matter which way I turned it was hurting, knees, everything was hurting really bad. I was dizzy and weak so I don't want to walk around too much. I had muscle pain, joint pain, fever, headaches, chills, never went away. I hurt everywhere. I am really weak. My eyes are hurting. My daughter is in a girls home (paralysis problem). They had the vaccine from the another company and they have heard so many negative stuff so they decided they did not want to, when my wife told her I was having these problems. I had the virus 4 months, the nurse told me to take 300mg of zinc, 1000mg vitamin C and 2000mg vitamin D (the person took that when he had the disease). Should I take this stuff? Is there any information on that? what's in this? protein? my wife got the disease. They said she had enough antibodies. How long is the immunity? When does it start?" The outcome of the event chills was resolved, of other events was unknown.

loss of hearing; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 12:00 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if patient had COVID prior vaccination. The patient experienced loss of hearing the day after vaccination administered on 19Jan2021. It was unknown if treatment was received and unknown if patient had tested COVID post vaccination. The outcome of event was unknown. Information on the lot/batch number has been requested.

Noticed facial drooping on the left side starting on Friday night and symptoms increasing. Went to urgent care on Monday morning. facial drooping increased over the weekend also lift eye was irritated from lack of moister and did not close or blink without extra effort. wore a patch and lubricated over the weekend. Diagnosed as Bellys Palsy at Lander urgent care medical clinic. Prescribed course of prednisone. Also Erythromycin op mgigm oin akor for the left eye and wear a patch until eye will blink and close normally.

irregular hearbeat; Belching; Gas; Stomach cramps; felt antsy; his blood pressure went up the day he hook the vaccine to 200/93; He was anxious feeling; sharp pains in his right eye; Ears Felt Funny; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiry date not reported), via an unspecified route of administration on 19Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included high cholesterol and blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication included propranolol hcl for blood pressure and an unspecified cholesterol pill. The patient previously received influenza (Flu shot) on an unspecified date (years) ago for immunization and experienced light headed. The patient reported that his blood pressure went up the day he hook the vaccine to 200/93 and he was real concerned about that. He took a blood pressure pill and was having some sharp pains in his right eye (he had 3-4 at different times). He was anxious feeling and could hear it blowing in his ears (which happens when his blood pressure is high). He stated he has never had his blood pressure that high and has never had any heart problems. The patient asked, whether he was in the danger zone, the danger zone of having a stroke and if they should take their second dose. The patient wondered if they could just take the first dose only. It was further reported that he took the vaccine yesterday or the day before (19Jan2021) at 11'o clock. He didn't have any problems, he just got home. Then 11'o clock at night he had fallen asleep during the day and woke up at that time, 11'o clock and he felt Antsy, his blood pressure was up, his ears puffed real high, he's on Blood Pressure medication. He Clarified further that his First Dose was on 19Jan2021 at 11 o clock during the day. Then 12 hours later that same day, he woke up, and that's when he felt antsy and the blood pressure being up. Normally he takes his Blood Pressure 2-3 times a week but that day it was like 190/80 something. When he saw it, he sat down, and thought if he relaxed it would go down. He went back over in 45 minutes or an hour later and it was 200/93, he thought he had sharp pain in the right eye during that time as well. He Never had that before, he had pain in eye before, but not like this. He then told himself maybe he should take a blood pressure pill, because he was concerned he didn't want to stroke out. He took a Blood pressure pill and then relaxed for an hour later he checked it was 189/82. He waited some more, and it kept coming down. He stayed in the recliner all night. Then on 20Jan2021 he checked and it slipped to 140/55 at about 5 o clock. The Blood pressure kept coming down 10 to 15 points every hour. The last one he took later that day was 118/65. He explains that his Blood pressure normally runs 120/65 to 140/70 normally. His blood pressure medication is only 10mg, its a low dose, he is a Healthy Person, he walks every day, his weight is good. The blood pressures provided were from 11AM to 11PM at night of 19Jan2021. It was the same day when he felt the ears feeling funny, and the sharp pain in the right eye, he has never had that before. He also forgot to mention that the next day he had a lot of stomach irregularities , he had cramping, it was uncomfortable, this was on 20Jan2021, he was also belching, and had gas. It went away that evening lasting 4-5 hours, it started in the morning 10 o clock went till 3 or 4PM. The BP value of 140/65 was from today, before lunch. The right eye sharp pain went away during the night, after he took his blood pressure pill, he didnt notice it anymore after. He doesn't know if the vaccine caused this. He couldn't tell any difference even with the pain. The ears feeling funny, he took his blood pressure a couple times a day. The monitor is showing an irregular heart beat, he didn't notice that before. He has had no positive COVID test or Antibody Test prior to the vaccine. The patient recovered from sharp pains in his right eye, ears felt funny on 19Jan2021, stomach cramps, belching, gas on 20Jan2021 while the outcome of the rest of the events was unknown.

Reaction occurred on 2/7/21 (about 48 hours after first dose): Severe dizziness and blurred vision for 10 minutes. Patient has no prior history of dizziness, vertigo, or blurred vision.

Approximately 18 minutes after administration of Pfizer COVID-19 vaccine IM 1st dose patient c/o having tongue swelling, hives to chin and facial redness. Administered Epi 0.3 mg IM to right deltoid approximately 20 minutes after vaccine administered. Right arm noted to have swelling at site of vaccine administration. IV access obtained and diphenhydramine 50 mg IV administered. NS IV started and approximately 100 ml given prior to EMS arrival. Pt did state he felt better after Epi 0.3 mg IM dose and diphenhydramine 50 mg IV dose provided. Pt alert and able to speak in complete sentences throughout event. Tongue swelling improved after epinephrine and diphenhydramine administered. Pt transported by EMS emergently to local emergency department for further observation and treatment.

Fatigue swollen lips mouth and tongue sore lips bleeding chest burning No treatment Lasted one week

Moderate allergic reaction; itchy skin; itchy eyes; Headache; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 9263), via an unspecified route of administration in right arm on 24Jan2021 11:45 at a single dose for COVID-19 immunization. Medical history included Diabetes2, HiBloodPress and HiCholesterol. Concomitant medication included lisinopril, simvastatin, and unspecified diabetes medication. On 26Jan2021, the patient experienced moderate allergic reaction, itchy skin, itchy eyes and headache. The patient was taking antihistamines with some relief for moderate allergic reaction, itchy skin, itchy eyes. There was no treatment for headache. The outcome of the events was recovering. Prior and since the vaccination, the patient was not tested for COVID-19. The events were assessed as non-serious.

'Severe stiff neck from 2/4 to3/10, with shoulder muscle aches, vague headache, and slight "fuzzy" feeling and fatigue. By 3/1, I also had thigh and buttock ache with effort and left TMJ pain. On 3/2, I saw Dr. My sed rate was 24. She made a diagnosis of probable PMR and prescribed prednisone. After I single dose, my symptoms almost magically abated and I was almost normal. On 3/11, the only residual symptom with soreness with with extreme neck rotation. On clinical grounds, this confirms the diagnosis of PMR. I assume treatment will continue for several weeks.

About 72 hours after the 1st dose, I experienced a fullness in the left ear accompanied with a low frequency, low volume buzzing or humming . These symptoms persisted over the next week, but would switch from left to right ear or occasionally in both. At the end of the first week I experienced two episodes of mild vertigo lasting for about 3 or 4 hours on two separate days & then stopped. The fullness & humming persisted until about 14 days after vaccination & then cleared & have not returned. The symptoms seem to stop when I went to bed at night.

Pt presented to the ED with right-sided facial drooping and was diagnosed with Ball's Palsy. Pt was prescribed prednisone in the ED. Evaluated today at our office and was prescribed valtrex. Currently experiencing right eye dryness and irritation.

Shaking Uncontrollably, Sweats, Dry mouth, sore all over, injection site was swollen, memory loss, confusion

Pfizer-BioNTech COVID-10 Vaccine - case of COVID-19 resulting in hospitalization. Pt presented to ED of facility on 4/20/21 with dry cough, malaise, altered sense of taste/smell and worsening dyspnea. Afebrile (T=98.6 F). Symptoms began approximately 4/13/21. Reportedly was hypoxic at PCP's office prior to presentation to ED. S/P 2 doses of the Pfizer-BioNTech COVID-19 vaccine - 1/29/21 and 2/19/21 (dates obtained from database). Admitted to inpatient unit 4/20/21. Treated with dexamethasone 6mg po daily, remdesivir (x2 doses prior to discharge). Transiently required increase in oxygen by nasal cannula but remained on baseline of 3L oxygen majority of admission. Discharged home 4/22/21.

This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reported). A 80-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date 31 Jul 2021), via an unspecified route of administration in right arm on 22Apr2021 at 10:30 as single dose for COVID-19 immunization. Medical history included malignant melanoma from an unknown date in Dec 2019 (ongoing), illness from an unknown date. Concomitant medications included nivolumab (240 mg/m2) taken for malignant melanoma, start and stop date were not reported. The patient previously took penicillin b and experienced hypersensitivity. On 22Apr2021 patient got the 1st dose and on 25Apr2021, The patient experienced he broke out in a rash/he says the red dots are still there on his body with outcome of not recovered, itching with outcome of not recovered , his is a little blurry with outcome of unknown , rashes all over his stomach with outcome of unknown. The patient underwent lab tests and procedures which included positron emission tomograms on 19 Jan 2021. Therapeutic measures were taken as a result of he broke out in a rash/he says the red dots are still there on his body (rash), itching (pruritus). The CDCs Advisory Committee on Immunization Practices (ACIP) has provided interim considerations for the use of COVID-19 mRNA vaccines (like the Pfizer-BioNTech COVID-19 Vaccine) during the Emergency Use Authorization. These interim considerations state that antihistamines (like diphenhydramine) should not be taken prior to vaccination to prevent allergic reactions, including anaphylaxis (anaphylaxis is a serious and potentially life-threatening allergic reaction). Follow-up on (26Apr2021): The patient took COVID 19 vaccine to protect his wife and himself for immunity against COVID 19. He said that is a fusion solution and he started taking this a month after the doctor cut the melanoma out of his head and it was cancerous, clarified as melanoma and he is on the last treatment. On the last PET scan, there was no melanoma on any place on his body. He says the PET scan was probably at least 2 months ago. He says he had a "C scan" last week but he hasn't gotten the results of that. He stated that took a couple Benadryl and it doesn't seem to be quite as bad as it was. He says the red dots are still there on his body. He confirms the rash has improved a little bit. He initially provides the Lot number ER3735. He has trouble reading his vaccination card, stating his is a little blurry. He gets his wife's card to compare as him and his wife received the vaccine at the same time. He explains his wife's card says ER8735, he believes the Lot number is probably the same on his card but the top part of the number 8 isn't connected and it made it look like an 8. He gets his magnifying glass out and confirms the Lot number is ER8735. He says that this is his first dose of the COVID-19, The patient did not receive any other vaccine in four weeks. The outcome of the events rash and itching was recovered and the outcome event little blurry was unknown. No Follow-up attempts are needed. No further information expected.

Skin rash on his whole body; Urticaria; Right mouth swelling/left mouth swelling; Swelling face; Lower lip is swollen; Touches his face, the skin feels thicker; This is a spontaneous report from a contactable physician (patient). An 80-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that about 13 days ago, on 22Apr2021, he had the Pfizer Covid-19 Vaccine. He thinks that about one week or 8 days later he had a skin rash on his whole body. Treatment of skin rash on his whole body was applied. The patient added that he took Benadryl 25 mg only once and and a few hours later the rash faded. One day later, it was completely gone and was no more (as reported). Today, this morning (as reported), the patient woke up and his right mouth right below the chin to the mouth area to the lower lip is swollen. The patient adds that his body had urticaria. He took Benadryl, another one, 25 mg and one or two hours later his body urticaria disappeared. Right mouth swelling: the patient adds that his face was swollen below the cheek to lower the lip line and it is not disappearing but seems a little bit smaller. It used to be a bump and now it feels like skin is still thick but he feels better on the right side. Left mouth swelling: the patient adds that he thought probably he would caller interrupts statement and says he does not know why but it turned to the left side, the left lower lip and it became swollen again (as reported). The right side has come down a little more but still feels like the inside of his mouth on the right side, he does not feel anything now, except when he touches his face, the skin feels thicker (as reported). Now, it has become to the left side left lower lip area, and lower chin. He does not know what to do. The patient confirms that this was his first dose of the Pfizer Covid-19 Vaccine. The outcome of the event "Skin rash on his whole body" and "Urticaria" was resolved, the outcome of the other events was unknown. No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Assuming a plausible drug-events temporal association and considering the nature of the reported events suggestive of a possible allergic reactions (the events urticaria and skin rash are also mentioned in the safety profile reported of the suspect product), the company deems there is a reasonable possibility that all the reported events are related to BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administration. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Pt received 2nd Pfizer vaccine in right arm at 1439. Pt complained of swollen tongue and left side of face at 1515. Pt immediately transported to ED via wheelchair for further evaluation and care. LPN called ED Charge RN to give report

Arm soreness after each dose was given/ Severe pain in legs; was 187 pounds and now down to 170; fell and busted his spleen; fell and busted his spleen; started peeing; developed blisters in his mouth and on his tongue; developed blisters in his mouth and on his tongue; Vaccination facility staff made a mistake resulted that the patient received the third dose of Covid-19 vaccine; mouth was also full of saliva, started slobbering and couldn't stop; Pain in shoulder/ Severe pain in joints; Severe diarrhea; having problems with words; had some problems with his balance; couldn't hardly walk because of his balance; Has no taste of food; Mouth Burning; break out with bumps around mouth; Scrotum blood blisters; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in left arm on 17Apr2021 (Batch/Lot Number: EW0171) as 3rd dose, single for covid-19 immunisation. Ongoing medical history included diagnosed with vertigo 5 years ago but had vertigo long before that, diagnosed with COPD, emphysema, asthma 12 years ago, Congestive heart failure after having a heart attack in Nov2018, stomach problem (had gastric bypass back in the 80's), had Pacemaker in 2020. Patient does take medications, but is unable to provide details. Patient received flu shot in Nov2020. No Prior Vaccinations within 4 weeks. Patient had first dose on 02Feb2021, second dose on 05Mar2021, and Vaccination facility staff made a mistake resulted that the patient received the third dose of Covid-19 vaccine on 17Apr2021. He had gone to Vaccination facility to get a B12 shot and the staff messed up and gave him the Covid-19 vaccine. He states he had arm soreness after each dose was given. On the night of 17Apr2021 after the third dose, pain in his shoulder began, the pain lasted about 3 days and had intensified a little more from the previous dose of the Covid-19 vaccine. When he woke up on 21Apr2021, his mouth was also full of saliva, he started slobbering and couldn't stop. On 22Apr2021 or 23Apr2021, he began experiencing severe diarrhea he began and having problems with words, he knew what he wants to say but it just doesn't come out. About 23Apr2021 or 24Apr2021, he began experiencing problems with his balance. He had vertigo for a long time and has always had some problems with his balance, couldn't hardly walk because of his balance, but the problems with his balance have intensified to where he needs someone to help him stand up now. On 24Apr2021 when he first gets up in the morning, he developed blisters in his mouth and on his tongue. On 27Apr2021 he began having problems with control, and started peeing all over himself, he didn't take his water pill on 27Apr2021 because he was going out and he still peed all over himself, he has been wearing adult diapers so that he doesn't mess himself again. On 04May2021 night, he fell and busted his spleen. And on an unspecified date in Apr2021, has no taste of food, Mouth Burning and break out with bumps around mouth. Scrotum blood blisters. Severe pain in legs and joints. He was 187 pounds and now down to 170. Patient received fourth injection on 21Apr2021 in left arm, but he is unsure if he received a B12 shot or something else. Attempts were made to clarify if the patient received 3 or 4 doses of the Covid-19 vaccine. Patient had blood tests, an EKG, and X-rays with unknown results, his heart looked good. The outcome of events was unknown.

his neck was stiff; it was very, very cold; a lot of pressure on his eyes; pain in arm the injection was given in; I got a lot of headaches and I still have them./unbelievable headaches; More back pain than usual; My blood pressure went up a little bit but not much; This is a spontaneous report from a contactable consumer (patient). Follow-up information received on 17Feb2021 was processed together with initial information. A 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EM9809, Expiration date: UNKNOWN), via an intramuscular route on 08Feb2021 (at the age of 80-years-old) as single dose in the left arm for covid-19 immunization. The patient medical history included and back pain. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021, the patient experienced blood pressure went up, More back pain than usual and on unspecified date experienced Stiff neck, Headache, pain in arm the injection was given in, pressure on his eyes, cold. The clinical course of the event was as follows: blood pressure went up a little bit but not much. It was reported that blood pressure was up which he was told by the nurse was normal. It was just a little bit high. The nurse at the facility said it was not that concerning and that it was fine. The facility let him stay a half an hour and then he was able to driven home. He hadn't wanted to stayed long because it was very, very cold. He had a lot of back pain. He does have back pain all the time, but not that much. It was more back pain than usual. The pain in his back increased/doubled, and the pain is still high. He clarifies he has had problems with his backed and have had backed pain normally, but after the shot it was liked a lot of pain in his backed and his neck was stiff very, very stiff hasn't knew if it's from vaccine or what. Patient stated that before the vaccine, he was okay and was able to worked in his house and outside. He believes the stiff neck began after 2 or 3 days of receiving the vaccine and it have had worsened. Patient stated that pain in his armed where he received the shot went away completely. He clarifies further the pain in his armed went away the second day. He got a lot of headaches and he still had them. The headaches began right away, and the headaches still c continued. He mentions the headache got a little better last night. He was really worried about it and hadn't knew what to did. It was reported that he told his son everything and his son said to not went to hospital because there was a lot of people that had been in contact with covid and it's going to have been worse. He states his son told him to drink a lot of water and saw if he got better. He did that and he did got a little better but not that much. Patient mentions that he had a lot of pressure on his eyes. The patient did not went to emergency room because he was told it was normal to had headaches but they went away and his should went away in 2-3 days. His armed where he received the vaccine was also okay the next day. The patient did not visit to physician office. Patient mentions that he took blood pressure medication, and everything was under controlled and he took 10mg of a cholesterol medication. Patient declined to include these medications for the report, stating he gave all of this information at the facility he received the vaccine at. He had to filled the paperwork out. He confirms he hasn't had any NDC, lot number or expiry date for these medications at this time. It was reported that patient had a blood tests done about 3 weeks before he received the vaccine and the doctor said everything was okay at the time. The outcome of the events headache was recovering, backed pain and neck was stiff was not recovered and other events was unknown.

Muscle ache, loss of smell and taste The PUI started feeling ill on 4/29/21 with minor symptoms. The patient is having body aches and a loss of appetite due to his loss of taste/smell. The patient is currently undergoing chemo therapy and is most likely the reason why he still got sick with COVID-19 even though he is fully vaccinated. Cause of Death: ACUTE HYPOXIC RESPIRATORY FAILURE, COVID 19 PNEUMONIA

ED to Hosp-Admission Discharged 6/18/2021 - 6/19/2021 (17 hours) Hospital MD Last attending ? Treatment team Musculoskeletal chest pain Principal problem Hospitalist Medicine History and Physical Date: 6/18/2021 Admission Date: 6/18/2021 PCP: MD DOB: 3/16/1940 Hospitalist: MD Assessment/Plan Medical Problems Hospital Problems POA * (Principal) Atrial fibrillation with RVR (CMS/HCC) Yes COVID toes Yes Angina of effort (CMS/HCC) Yes Atrial fibrillation (CMS/HCC) Yes Medical Problems Plan: 1. Will be admitted to icu because of angina like smptoms montor 2.repat tropon 3. Check bmp bnp and echo in am 3.check tsh mag 4.covid precautions5. Cardiology and ID consut in am if needed VTE prophylaxis: already on eliquis avoid nsaids because he is on eliquis will try tylenol if needed morphine for severe pain Full Code History of Present Illness Pt. is an 81yr male. Very pleasant male with history of choronic afi on eliquis history of hypertenson hyperchol Had ultrasound of the carotid arteris which showed stenosis Today he was mowing lawn developed left sided cheestpain pressure with no radiation to the neck arm s shoulder he was not diaphoretic. No fever chills or cough his covid is postive denies nausea vomiting or abdominal pain Came to the ER initially he was tachycardic with heart rate of 136 ekg showed right bundle with A-fib His initial troponin is negative less than 0.03 Has wbc cont of 11.8 hb 14.3 hct Normal platelets 188 na 142 k4.0 cl 110 c02 223 bun 17 cr 1.07 ast 15 alt 16 blood sugar of 148 Continue with chestpressure little anxious sats stable Considered his multiple risk factors and rapid a fib on arrival therefore he will be admitted in icu And montor his oxygen sats in case if it get rapid may need iv blocker or amiodarone Family history father died at the age of 63 from cAD /MI Mother died of old age at 93 Assessment Review of Systems Constitutional: Negative for activity change, appetite change, chills, diaphoresis, fatigue, fever and unexpected weight change. HENT: Positive for trouble swallowing. Negative for congestion, ear discharge, mouth sores, sinus pressure, sinus pain, sore throat and voice change. Eyes: Positive for visual disturbance. Negative for photophobia, pain and redness. Respiratory: Positive for chest tightness and shortness of breath. Negative for apnea, cough, choking and wheezing. Cardiovascular: Positive for chest pain and palpitations. Negative for leg swelling. Gastrointestinal: Negative for blood in stool, diarrhea, nausea and vomiting. Endocrine: Negative for cold intolerance, heat intolerance, polydipsia and polyphagia. Genitourinary: Negative for difficulty urinating, flank pain and hematuria. Musculoskeletal: Positive for arthralgias. Negative for back pain, gait problem, joint swelling, myalgias, neck pain and neck stiffness. Skin: Negative for color change, pallor and rash. Neurological: Positive for headaches. Negative for dizziness, tremors, seizures, syncope, facial asymmetry, speech difficulty, weakness and numbness. Psychiatric/Behavioral: Negative for agitation and behavioral problems. Past Medical, Social and Family History Medical History No past medical history on file. Surgical History No past surgical history on file. Social History Socioeconomic History ? Marital status: Married Spouse name: Not on file ? Number of children: Not on file ? Years of education: Not on file ? Highest education level: Not on file Occupational History ? Not on file Tobacco Use ? Smoking status: Not on file Substance and Sexual Activity ? Alcohol use: Not on file ? Drug use: Not on file ? Sexual activity: Not on file Other Topics Concern ? Not on file Social History Narrative ? Not on file Social Determinants of Health Financial Resource Strain: ? Difficulty of Paying Living Expenses: Food Insecurity: ? Worried About Running Out of Food in the Last Year: ? Ran Out of Food in the Last Year: Transportation Needs: ? Lack of Transportation (Medical): ? Lack of Transportation (Non-Medical): Physical Activity: ? Days of Exercise per Week: ? Minutes of Exercise per Session: Stress: ? Feeling of Stress : Social Connections: ? Frequency of Communication with Friends and Family: ? Frequency of Social Gatherings with Friends and Family: ? Attends Religious Services: ? Active Member of Clubs or Organizations: ? Attends Club or Organization Meetings: ? Marital Status: Intimate Partner Violence: ? Fear of Current or Ex-Partner: ? Emotionally Abused: ? Physically Abused: ? Sexually Abused: No family history on file. Allergies and Medications No Known Allergies Prior to Admission medications Medication Sig Start Date End Date Taking? Authorizing Provider apixaban (ELIQUIS) 5 mg tablet Take 5 mg by mouth 2 (two) times a day Yes Provider, Historical, MD atorvastatin (LIPITOR) 10 mg tablet Take 10 mg by mouth at bedtime 5/20/21 Yes Provider, Historical, MD clonazePAM (KlonoPIN) 0.5 mg tablet Take 0.5 mg by mouth at bedtime 6/14/21 Yes Provider, Historical, MD metoprolol succinate XL (TOPROL-XL) 25 mg 24 hr tablet Take 12.5 mg by mouth daily 6/2/21 Yes Provider, Historical, MD NIFEdipine XL (PROCARDIA XL) 30 mg 24 hr tablet Take 30 mg by mouth daily 6/12/21 Yes Provider, Historical, MD omeprazole (PriLOSEC) 40 mg capsule Take 40 mg by mouth daily 5/26/21 Yes Provider, Historical, MD tamsulosin (FLOMAX) 0.4 mg capsule Take 0.4 mg by mouth daily 4/26/21 Yes Provider, Historical, MD Objective Objective Current Min/Max Temperature: 36.1 °C (97 °F) Temp Min: 36.1 °C (97 °F) Max: 36.1 °C (97 °F) Heart Rate: 99 Pulse Min: 80 Max: 116 Resp: 18 Resp Min: 18 Max: 18 BP: (!) 148/89 BP Min: 121/103 Max: 148/89 SpO2: 96 % SpO2 Min: 94 % Max: 98 % No intake/output data recorded. Weight: Wt Readings from Last 1 Encounters: 06/18/21 75.8 kg (167 lb 1.7 oz) Physical Exam Physical Exam Vitals reviewed. Constitutional: Appearance: He is well-developed. He is not ill-appearing or diaphoretic. HENT: Head: Normocephalic and atraumatic. Eyes: Extraocular Movements: Extraocular movements intact. Pupils: Pupils are equal, round, and reactive to light. Neck: Vascular: No hepatojugular reflux or JVD. Trachea: No tracheal deviation. Cardiovascular: Rate and Rhythm: Rhythm irregular. Pulmonary: Effort: Pulmonary effort is normal. No accessory muscle usage. Breath sounds: Normal breath sounds. No stridor. Abdominal: General: Bowel sounds are normal. There is no abdominal bruit. Palpations: Abdomen is soft. There is no splenomegaly. Tenderness: There is no abdominal tenderness. There is no rebound. Musculoskeletal: Cervical back: Normal range of motion and neck supple. Lymphadenopathy: Cervical: No cervical adenopathy. Skin: General: Skin is warm. Capillary Refill: Capillary refill takes less than 2 seconds. Coloration: Skin is not cyanotic or pale. Findings: No rash. Nails: There is no clubbing. Neurological: General: No focal deficit present. Mental Status: He is alert. Cranial Nerves: No cranial nerve deficit. Motor: Weakness present. Psychiatric: Mood and Affect: Mood is anxious. Signed, MD Hospitalist Medicine 6/18/2021 10:08 PM

Severe canker sores all over inside of mouth and lips; This is a spontaneous report received from a contactable consumer, the patient. An 80-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the right arm on 22Feb2021 at 09:30 (at the age of 80 years) as a single dose for COVID-19 immunisation. Medical history included white blood cell count low (recently diagnosed with low white cell under doctor care for that). Concomitant medications included Apixaban (ELIQUIS), amlodipine (MANUFACTURER UNKNOWN), solitol (MANUFACTURER UNKNOWN) Atorvastatin (LIPITOR), multi vitamin (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. 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 four weeks prior to the vaccination. On an unknown date after the first vaccine the patient experienced severe canker sores all over inside of mouth and lips. The patient did not receive any treatment for the events. The patient stated that severe canker sores all over inside of mouth and lips, highly inflamed swollen area around lips after first shot and now second shot on 24Feb2021, happened two days after each shot. The clinical outcome of the event severe canker sores all over inside of mouth and lips was not resolved at the time of the report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Sour tongue; sour taste in my mouth 24 hours a day; Diarrhea like symptoms; Tiredness; Occasional tingling in my fingertips; Mouth irritation; This is a spontaneous report form a contactable consumer. This 80-year-old male patient reported for himself stating that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205) via an unspecified route of administration into the left arm on 11Mar2021 14:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Have a surgery but have seem to get a clean health, thinks that all was good. He has no other health problems really, nothing other the old age, no problems. Concomitant medication included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop dates were not reported, takes one of them every day. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9266) via an unspecified route of administration into the left arm on 18Feb2021 16:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. On 11Mar2021, the patient experienced mouth irritation. On an unspecified date, he experienced sour tongue; sour taste in his mouth 24 hours a day, diarrhoea like symptoms, tiredness and occasional tingling in his fingertips. The patient underwent lab tests which showed magnetic resonance imaging on 10Jun2021 and positron emission tomogram on 15Jun2021, both as negative, they could not find any cancer, correct. He spoke to several doctors since his changes of taste were occurring and had constant mouth irritation, sour tongue since, third week from his first COVID shot. Did not know how to describe it but it was a sour taste in his mouth 24 hours a day and it seems to he does not know what else to say about it expect talked to doctor several times and couples of other specialists that he has been seeing and they think it possible that it could be linked to the COVID shot since it was the sourness that he feels in his mouth was one of the symptoms of COVID. He had a couple of other side effects but few weeks ago they went away, for about a month from that day he was going to call loose bowels, not terrible but diarrhoea like symptoms and they lasted probably 3 weeks. Had tiredness that he experienced and was not experiencing now. Seemed to be quite good about that and occasional tingling in his fingertips but that seems to be helped, it was almost gone but once in a while. Those all sort occurred at same time but the sour taste in his mouth and tongue was constant or just do not go away. No other medical conditions. Treatment for event included that he went to doctor several times and he just suggested nothing to do about it.no prior vaccination. He was thrilled that he was able to get through there that day. Outcome was not resolved for event sour tongue; sour taste in my mouth 24 hours a day and was unknown for rest of the events.

Periorbital swelling, conjunctival inflammation, facial and neck swelling, shortness of breath. Patient was treated on 2/5/21 with Depo-Medrol 80mg IM, Prednisone 40mg daily x 5 days, Augmentin 875mg 1 tab po bid x 10 days.

non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; This is a spontaneous report from a contactable other health professional. An 81-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3249), intramuscular in left arm on 22Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included Parkinson's disease, post polio syndrome, Alzheimer's disease, atrial fibrillation, benign prostatic hyperplasia, right knee replacement, sleep apnoea, restless legs syndrome, covid-19 prior to vaccination. Concomitant medication included carbidopa monohydrate, levodopa (CARB/LEVO), cephalexin (unknown manufacturer), cetirizine (unknown manufacturer), citalopram (unknown manufacturer), donepezil (unknown manufacturer), etodolac (unknown manufacturer), finasteride (unknown manufacturer), furosemide (unknown manufacturer), metoprolol (unknown manufacturer), omeprazole (unknown manufacturer), oxybutynin (unknown manufacturer), senna alexandrina leaf (unknown manufacturer), tamsulosin (unknown manufacturer). The patient experienced had vaccine on friday and on sunday had neurological symptoms, non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused on 24Jan2021 14:00 with outcome of recovered in Jan2021. The patient was sent to ER and CVA/TIA were ruled out. Has no history of seizure disorder. Returned and had 1 more episode later in the day. Vitals were all within his normal limits. ER physician felt was possible reaction to vaccine. The patient was not treated due to the events. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal 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 RAs, Ethics Committees, and Investigators, as appropriate.

I received the vaccine Friday morning, 09:15 AM, (EST) I was woken up at 04:23 AM (EST) by a very loud hissing noise, I thought it was outside, however I soon realized it was in my ears. I was not able to go back to sleep. I realized it was Tendinitis, as I have had systems of Tendinitis, over the years, but it just came and went, and was not loud enough or lasted long enough to be anything but a minor annoyance . In this case while it is not loud, it is loud enough to be annoying, and it still did not go away. (time is now -01:13 PM 2/16, I am hoping it is just the vaccine working its way through my system. I notified my primary care doctor at the VA, as well as audio dept.

Stroke; like he had a film over his eye, it was cloudy, like a cloudy day; This is a spontaneous report from a contactable consumer (patient). A 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283 and expiry date: 30Apr2021) solution for injection, intramuscular in left arm on 18Jan2021 13:10 at a single dose for Covid-19 immunization. Medical history included chicken pox, measles, and mumps (had chicken pox vaccine, measles, and mumps when he was younger, and he got the flu shot for flu). The patient's concomitant medications were not reported. The next day (19Jan2021) after receiving the injection, patient reported it was like he had a film over his eye, it was cloudy, like a cloudy day. This went on for a couple of days before it improved. There was still a little bit in his left eye, but he can read and it has improved. He can see now and his eyes were improving. He found out that he had a stroke on 28Jan2021. He did not go to the hospital. He does not think the stroke affected anything else. He was supposed to have an MRI sometime this week. He went to the eye doctor and the eye doctor was the one that discovered the stroke and his eye doctor sent the report over to his primary office. He had a vision field test which was how the stroke was diagnosed. He was taking a baby aspirin and he will be put on a blood thinner called Plavix. He has not started Plavix yet, he has to go pick it up. Outcome of the event stroke was unknown while the other events was recovering. No follow-up activities are needed. No further information is expected.

Day after vaccine given, large red bump appears over RIGHT eye. Then non stop throbbing headaches (still up til today), teary eyes. Then on 2/25/2021 very large (size of half dollar coin) red bump appears over LEFT eye. VERY swollen shut. Hurts, throbs and itches. Took photos and having tele med call with physician today at 1:50 pm. More bumps appearing higher up on scalp and skin on bump is red and pealing. Very swollen L. eyelid and swollen under eye as well. Hot to the touch. Bumps coming and going behind left ear.

Day after second vaccine woke to complete loss of hearing in left ear. Next day balance was off and still is-and hearing in left ear is still gone.

4 intermittent episodes of blurred vision/unclear speech/unsteady gait/slight confusion lasting 30-45mins in past 9 days.

Tinnitus began 3 d day after receiving 1st dose of vaccine. Continuing through today when I received 2d dose of vaccine, and continues.

Patient received his 2nd dose of the Pfizer vaccine at on Monday, February 15. That evening, he experienced visual disturbances with slightly blurred vision. Not thinking anything of it at the time, the vision cleared, and he continued about their evening/week without telling anyone of his visual disturbances. On Sunday, February 21, he experienced additional visual disturbances including double vision and dizziness, and we had him visit a local ER for evaluation. He was discharged with a diagnosis of dehydration and vertigo. No scans were performed. The visual disturbances cleared up the following week and the only persistent symptom was a slight dizziness. An eye exam was performed on Friday, February 26 with no problems found. An MRI was performed on March 3, and he was diagnosed with the below conditions. Impression (3/3/2021) 1. Small acute to subacute infarcts in the left splenium of the corpus callosum and parasagittal left occipital lobe. 2. Trace subarachnoid hemorrhage in the parasagittal left parietal lobe. 3. Mild chronic microvascular ischemic disease. He was admitted to the hospital and remained there until Saturday, March 6. Follow-up scans and testing were performed with no underlying reason for the stroke being determined. Prior to the stroke, he had been a very active individual with osteoarthritis as is only health complaint. He was not on any prescription medication prior to the stroke. While in the hospital, the tests for high blood pressure, high cholesterol (LDL 92 MG/DL), sugar inadequacies (glucose 93 mg/dl, A1C 5.7%), etc. came back without major concerns. His follow-up CT scans also did not reveal the stroke shown on the MRI. No inquiry was made by any of his doctors or hospital staff as to his COVID vaccination status/dates to even consider the connection. Below are the results of the last CT scans: Impression (3/4/2021) 1. Age-related volume loss and white matter disease similar to prior exams. 2. Small infarct seen on MRI are not well seen on CT. 3. No acute intracranial abnormality demonstrated on the CT scan. Impression (3/5/2021) 1. No evidence of acute infarct or intracranial hemorrhage. No significant change. 2. Periventricular white matter disease is likely secondary to chronic small vessel ischemic changes.

Janssen COVID-19 Vaccine EUA; patient reports intermittent blurry vision and fatigue after vaccination. Presents to infusion center for chemotherapy, experienced blurred vision, found to be hypotensive and bradycardic, and transferred immediately to emergency department (ED). In the ED diagnosed with acute left lower lobe segmental pulmonary embolism and thrombocytopenia. Admitting to hospital for further management.

difficulty breathing; He hasn't been able to walk the last couple of days and has had to use his wheelchair; she has been taking his temperature; no energy; can't walk; very thirsty; extremities he complains are cold even though they are not and he is feeling pain in them; dry heaves; pain and bloating in his stomach; pain and bloating in his stomach; his extremities felt cold; shivering; night sweats; wasn't eating or drinking/Has not been able to eat; This is a follow-up spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer. A 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), Lot number was not reported), via an unspecified route of administration on 02Feb2021 (at the age of 81-year-old) as single dose for COVID-19 immunization.Medical history included Transverse Myelitis which is a virus of the spinal cord (from age of 11 yr), wheelchair user, difficulty walking (from the transverse myelitis). Reporter and her husband both received the first Pfizer Covid vaccine on 02Feb2021.The patient's concomitant medications were not reported. On11Feb2021, patient experienced dry heaves, pain and bloating in his stomach, his extremities felt cold and he was shivering, had night sweats and wasn't eating or drinking. He has been feeling progressively worse since Feb 11th, but she stated she has been taking his temperature and he did not had a fever but had been very thirsty. He had not been able to walk the last couple of days and had to use his wheelchair. Last night on 10Feb2021, he probably drank gallons of water due to his excessive thirst. His doctor told him to take acetaminophen and ibuprofen, which he did, but it didn't help. His symptoms have progressed such that the reporter dropped her husband off at the ER today. Reporter stated that he now did have a fever and is awaiting results of a chest x-ray and lab work (performed on 16Feb2021). He was having difficulty breathing, but his oxygen levels were normal. Reporter read online about two people in (city) developed transverse myelitis after receiving a Covid vaccine, but she was not sure which vaccine they received. She was calling to report this information to Pfizer and to see if these types of reactions have been reported and at 10 days post initial vaccination. The patient Is currently in the emergency Room and has not been able to eat for 5 days. The outcome of events was unknown. Information on the lot/batch number has been requested.

Lost hearing in left ear; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6199), via an unspecified route of administration in left arm on 11Mar2021 11:00 (at the age of 81-years-old) as single dose for covid-19 immunisation. No additional vaccines administered on same date of bnt162b2. No prior vaccinations (within 4 weeks). The patient received first dose of bnt162b2 (Batch/lot number: EL1283) in left arm on 18Feb2021 (at the age of 81-years-old) for Covid-19 immunization. Medical history included ongoing borderline diabetes (had that for years; has always been the same; His last test was 6.7 which was pretty good); 2 stents in leg (at least 5 years ago; takes a blood thinner (ongoing)); partial knee replacement (a couple years ago, that came out fine) and shots (when he was in the military, he got all the shots and had no problem). Concomitant medications included clopidogrel bisulfate (PLAVIX) as blood thinner from an unspecified start date and ongoing and just takes his normal medications that the doctors prescribe. He has been taking them for quite a few years so he didn't think they have anything to do with it. He never knows, it could be a mixture. But no, he didn't think any medications he takes were relevant. The patient previously took only one flu shot last Sep2020. No events following prior vaccinations. The patient experienced lost hearing in left ear on 26Mar2021 at 07:00, he woke up and that was it, he had no hearing, it was complete hearing loss. Then he thought maybe it would come back during the day. He heard something and picked his head off of the pillow. His partner was talking, but his right ear was buried in the pillow. When he raised it he could hear her talk. That's when he noticed. The next day he went to same day care and they put him on an antibiotic. He took 2 of the antibiotic the first day and then 1 each day. He didn't know if he has it. He did not have information for the antibiotic or remember the name of it. The event did not require emergency room visit but a visit to the physician's office. went to the same day clinic on 27Mar2021, the day after his hearing loss. He had thought maybe it might come back. The antibiotic didn't work, so he went to his primary doctor on 01Apr2021 and made an appointment with an ENT on 07Apr2021. On 07Apr2021 the hearing test with result of the bottom was completely dead on his left ear, everything else was dead. His right ear was great for his age. What they did was put a needle in his ear drum and shot it with a steroid. They said a couple of treatments sometimes brings back the hearing and sometimes doesn't. They called it sudden hearing loss. He could hear out of his right ear okay. He had good hearing before and had no problems. The patient wanted to know if there had been any problems with loss of hearing after the Covid vaccine. He wished that he would have some improvement. There was no one in his family that lost their hearing, so he would say probably not. No one in his family has any problems or lost hearing or anything. He didn't know of any other problem that would be significant. The outcome of the event was not recovered.

Fluid in right ear, wax build up in left ear; Fluid in right ear, wax build up in left ear; Ear infection; Dizzy; This is a spontaneous report from a contactable consumer (patient). An 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration Date: Jun2021), via an unspecified route of administration, in left arm (shoulder) on 25Mar2021 at 15:30 as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication(s) included dimenhydrinate (DRAMAMINE) (Lot number: P118702 and Expiration date: 01Feb2023) 50 mg pills/100 count taken for motion sickness, patient mentioned that it did not help. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient mentioned that he and his wife had the COVID virus and they had to wait 90 days for their first shot. On 27Mar2021 in morning, the patient experienced dizzy and went to the doctor. The doctor checked his ears. On 05Apr2021 in morning, the patient experienced fluid in right ear, wax build up in left ear and ear infection. The patient was given drops for a week. On 12Apr2021, he went back to the doctor and reports that everything looked good. The doctor flushed the wax out of his left ear, but noted that he has an ear infection. The patient visited physician office due to events. The patient is taking is Amoxicillin 875 mg tablet, take one tablet by mouth every 12 hours. The patient would like to know if he should still take the, second vaccine, as he has 7 more days left for his antibiotic. The patient asked the doctor if he should take his second vaccine, and the doctor didn't know. The patient thinks the dizziness was the fluid and wax buildup in his ears. He believed it will get better and does not think the vaccine caused the dizziness. He is still dizzy at times but not as dizzy as he was. The wax is gone and the ear infection is not as bad as it was. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Patient felt significant whole body muscle weakness and has not improved after a month. Also have double-vision.

Patient received his first dose of Pfizer and states he immediately began to experience tingling in his throat. Patient did not notify medical personnel at vaccine site and left facility after 15 minutes of observation. Patient states his symptoms resumed for 2 days. Patient sought medical attention on 4/17/21 for tingling symptom. Patient was prescribed Ceftriaxone and Dexamethasone IM and immediately was relieved of symptoms.

Symptoms of Myasthenia Gravis starting 5 days after vaccine including : -Double Vision treated by corrective lenses -Chronic muscular weakness in legs, back, arms and neck treatment on going with prednisone and pyridostigmine. Throat and jaw weakness affecting swallowing and chewing

Blood pressure went to 180/82/ another hour BP was 164/75/ remained up at 154/75 at bed time/ did drop to 135/70 the next morning; 1 hour after the vaccination lower left lip swelled for 15 minutes and slowly went down.; This is a spontaneous report received from a contactable consumer (patient). A 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in arm left on 12Feb2021 14:30 (at the age of 81-year-old) as dose 1, single for covid-19 immunisation. Medical history included stroke-heart stents. Concomitant medications included amlodipine besilate (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication and levothyroxine sodium (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took hydrochlorothiazide and experienced allergies. The patient did not have other vaccine in four weeks. The patient had amlodipine besilate and levothyroxine sodium medications in two weeks. The patient did not have covid prior vaccination and no covid tested post vaccination. On 12Feb2021 15:30, one hour after the vaccination lower left lip swelled for 15 minutes and slowly went down and blood pressure (BP) went to 180/82. After another hour BP was 164/75. Blood pressure remained up at 154/75 at bed time and did drop to 135/70 the next morning. The patient did not received treatment for events. The clinical outcome of the events was recovered on an unspecified date in Feb2021.

20 mts after vaccination when I was driving I suddenly starting feel an intense VIBRATION at the site of the injection(left up arm),then quickly extended to the whole limp and gained the right up limp after my lower extremities THEN my BRAIN and I was loosing vision.i told to my wife take the wheel and at that time EVERYTHING mean the intense vibrations including my sight came to normal.

Pt had his Pfizer COVID vaccinations at Medical Center on 2/23/21 and 3/16/21. on 6/8/21 he presented to the office for an apt for Pulsatile tinnitus in right ear x 2 weeks. Pt was examined and Doctor ordered a CBC and MRI with constrast, ENT referral to be scheduled. Pt to start Fluticasone nasal spray. :Pt referred to Neuroradiology

Sever abdominal pain extending up center of chest to ears and down center of back. Sever pain if trying to lay flat. Initial occurrence March 31,2021 approximately two weeks after 2nd Pfizer vaccination, Released from hospital same day but unable to lay flat for four days. Same symptoms reoccurred on May 26, 2021 and was admitted to the hospital for three days and it was determined my condition was pericarditis.

Swollen lip; Hives near the groin area; This is a spontaneous report from a contactable consumer (patient's daughter). An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via an unknown route of administration, at single dose on 12Jan2021 for COVID-19 immunisation. Relevant medical history included gout and sinuses. The patient did not have relevant concomitant medications.On 12Jan2021, after vaccination, the patient had swollen lips and he thinks like hives on his thought near his groin, on the upper inside of his thighs on both sides, like hives, with swelling but not a rash. She said her father put hydrocortisone cream on his thighs and they were getting better. She said the lip swelling had not gone down, he took an allergy pill for that, he did not apply cream to his lips. She clarified that the hydrocortisone cream was brand Equate 1% Hyrdocortisone Maximum Strength Cream (UPC 319162ET4, Batch: 8JT0419, and EXP Aug2021). She reported that the allergy pill was generic Equate Allergy Relief (UPC: Unknown, LOT P121359, EXP Aug2022). The patient was recovering from the events.

hearing is off/his ears feel like they're full of water so he can't really hear; lost his voice; dizziness/Really dizzy; bottom of the feet is tingling; Slightly blurry vision; This is a spontaneous report from a contactable consumer (caregiver). An 82-years-old male patient (Father) received first dose of BNT162B2 (BNT162B2, lot number: EL1283), via an unspecified route of administration in left arm on 24Jan2021 13:30 at SINGLE DOSE as Scared to death to get COVID. Medical history included ongoing High blood pressure. Family history included Father died of melanoma. Concomitant medication included ongoing lisinopril (strength: 10mg) for High blood pressure. Caller stated her father received the pfizer covid vaccine first dose on this Monday and have weird side effects, he lost his voice, dizziness/ Really dizzy, hearing is off/ Ears feel like they're full of water so he can't really hear, bottom of the feet is tingling/ tingling in his feet and slightly blurry vision. Caller wanted to know if it is normal. Caller also said safety department told her to speak to quality department about the shot her farther received is it a bad batch or not. No visit to Emergency Room and Physician Office. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.

Bleeding gums; This is an spontaneous report from a contactable consumer based on information received by Pfizer from license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: 2021089295) on 28-Jan-2021 and was forwarded to Company on 29-Jan-2021. This spontaneous case was reported by a patient family member or friend and describes the occurrence of gingival bleeding (Bleeding gums) in 82-year-old male patient who received Apixaban (ELIQUIS) for Cerebrovascular accident prophylaxis. Co-Suspect Products included clopidogrel bisulfate (Plavix) for an unknown indication and Covid-19 Vaccine for COVID-19 prophylaxis. Concurrent medical conditions included Diabetes (Diagnosed 40 years ago, type 2), Blood pressure high and Cardiac disorder NOS. In July 2020, the patient started ELIQUIS (unknown route), 5 milligram twice a day. On an unknown date, the patient started Plavix (unknown route) 75 milligram at an unspecified frequency. On 28-Jan-2021, the patient started Covid-19 Vaccine (unknown route). On the same day, the patient experienced gingival bleeding (Bleeding gums). The dose of ELIQUIS(Unknown) and Plavix (Unknown) was not changed. At the time of the report, gingival bleeding was resolving. For ELIQUIS(Unknown), the reporter did not provide any causality assessments. For Plavix(Unknown), the reporter did not provide any causality assessments.

2/25 - loss of taste 2/26 - dizziness/woozy, severe flu like symptoms all day (no energy, ache) 2/27 - continuing dizziness, minimal energy 2/28 - continuing dizziness, wheezing/trouble catching breath (needed oxygen to calm)

Right arm achy/a little achy/only his arm was achy/arm only hurt when he was lying on it; Right ear ache and bumps around ear lobe/ear started hurting/earache/behind his ear started hurting. Going online and believes irritation could be from the masks worn for COVID-19.; Back of his ear was red and swollen/around left ear lobe it is bump and red; Back of his ear was red and swollen/around left ear lobe it is bump and red; Back of his ear was red and swollen/around left ear lobe it is bump and red; Tingling to his ear; lesions are at the top of his ear near his hairline; This is a spontaneous report received from a contactable consumer (patient). An 82-year-old male patient received the first shot of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 11:10, at single dose, for COVID-19 immunization/Want to live, at the hospital. Medical history included being allergic to cats; had triple bypass and valve, had allergies his whole life and had shrunk. Concomitant medications included unspecified allergy pills which the patient takes all year round. The patient previously took amoxicillin and reported that he was immune to it and it did not work; reported that he has taken azithromycin before when he goes to the dentist he has to take azithromycin. On 25Jan2021, the patient took his first COVID-19 vaccine shot. On the same day, the patient was a little achy. He took Tylenol every 5 hours afterwards and iced it and then had had no problem. He woke up the next morning (26Jan2021) perfectly fine. The patient clarified that only his arm was achy, his right arm was achy, and it only hurt when he was lying on it. But then on Wednesday night or Thursday morning (Jan2021), the patient had tingling to his ear and the back of his ear was red and swollen. He reported that "behind his ear started hurting". He also had right earache and bumps around ear lobe. He reported he had little bumps or lesions which were at the top of his ear near his hairline. The patient went to his pharmacist to get their opinion and was given Aquaphor ointment for pain relief, but he reported that it made the area behind his ear worse, so he went back to using the antibiotic ointment and stated that "the cold pack helped the most". The patient reported had doctor's appointment on 01Feb2021 at 12 and the doctor gave him azithromycin tablets, 6 tablets. He also reported that he has an unopened box of Azithromycin tablets USP which he has not taken and will not without doctor's permission. He went online and believes this irritation behind the ear could be from the masks worn for COVID-19 and stated that the KN-95 masks were kind of tight. He stated he now has the thing on the back of his neck to help with the mask. The patient also reported that he doesn't have fever or temperature and he has no cold. The patient was scheduled to receive his second shot two weeks from the time of the report and wanted to know if he can take antibiotics and then get the second shot. The patient recovered from pain in arm on 26Jan2021; and has not recovered from the remaining events.; Sender's Comments: Event ear pain represents an intercurrent medical condition and unrelated to BNT162B2 .

- covid shot Thursday at 1445 - upper lip swelling at 1730 Thursday - Friday fine til evening and was complaining of itching - Saturday morning red raised areas that were itchy on back, buttocks, and back of thighs. Denies discharge. - today better, areas still there, but lighter in color and has not complained of itching so far.

On Saturday patient woke up saying he was in extreme pain with his left arm. At 5 o'clock that night he lost his equilibran and I had to call 911. They came and after an initial examination took him to Hospital's emergency room. They did c-scans, MRI. and they said that a blood clog was showing in his brain and that he had atrium filibration of his heart. His vision has been affected, though the hospital thinks it will improve. The left side of his body is not function right and he needs a walker to walk. He has been in ICU since Sunday. This is late Tuesday.

Vaccine at 2;00.Problem started at 4:30 with a sudden tickle sensation in left nostril. Caused sneezing 8-10 times. Runny nose, eyes red with tears, phlegm required constant blowing of nose. Stuffed cotton up left nostril and breathing through mouth gave some relief. It is now 8;15 and doing much better.

Patient received his first dose of Pfizer COVID-19 vaccine on 02/03/2021. He has significant medical history, but presented to the hospital on afternoon of 02/08/2021 with report of three days of nausea and vomiting. He thought this attributed to a new cholesterol medication. He also reported some shortness of breath, mild cough, no fever. reported some epigastrium pain the day prior but since resolved. Significant other reported some significant swelling and that pt complained of feeling like he had a "blockage in his throat". Workup showed concerns of pneumonia so pt was started on antibiotics and Vitamin K. Shortly after meds started pt started complaining of itching arm and trouble breathing. He became bradycardic and lost consciousness. Resuscitative efforts initiated but unsuccessful. Time of death called on 02/08/2021 at 1737. Hospital notes report "cause of death is anaphylaxis", and pt would be an OME case.

high fever/High temperature; tested positive for COVID-19; tested positive for COVID-19; No taste or smell; No taste or smell; This is a spontaneous report from a contactable consumer via team and Pfizer-sponsored program. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 07Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were reported as none. On 05Mar2021, the patient tested positive for COVID-19 and has been hospitalized twice with a high fever, high temperature: 103.5. The patient has been in and out of the hospital. The reporter was asking, "Does he have to start over from scratch with the second vaccine dose since it has ben over 6 weeks from the first?" The patient also had no taste or smell on 05Mar2021. The patient was hospitalized from 05Mar2021 to 07Apr2021. The patient recovered from the events fever in Mar2021 and also recovered from the event COVID-19 on unspecified date. The outcome of no taste and smell was not recovered. Information about lot/batch has been requested.

Office Visit 5/22/2021 Urgent Care - town Med Asst Encounter for screening laboratory testing for COVID-19 virus Dx Progress Notes Med Asst (Medical Assistant) ? ? Encounter Date: 5/22/2021 ? ? Signed Patient being seen for loss of taste and smell. States that he has received both of his COVID vaccines, but recently started having symptoms. Requesting COVID test but does not wish to see provider today. Patient was swabbed for COVID and order placed in chart. Patient aware that results will be back in 24-48 hours and that he can view these on the portal. No questions or concerns at this time.

twenty six hours after vaccine, hands started itching. Progressed to hive type rash from waist up. Also arms from elbows to hands. Face and eyes turned red. Fifty mg of Benadryl taken every six hours times three. This morning went to a walk in clinic . Was put on a Prednisone taper over 5 days.

on 1/14/2021 out for appointment with family. Returned cold, clammy,m lethargic, thick tongue. POx = 84% on room air. pulse = 44, BP = 110/46. Blood sugar = 120. No fever. No signs/symptoms prior to this

01/22/20When transferring resident from bed to W/C Resident became unresponsive to voice with eyes fix open and point up to the right. Placed resident back in bed found 82% o2 sats B/P 110/106 pulse 110 resp below 16 placed o2 via non rebreather with 20 l/min 02 up to 90% then stabilized at 89% Resident following all commands encouraged to take do breathing exercises, with some compliance, continues ABT/pneumonia , no s/s adverse 1/23/2021 16:48 Discharge Summary Note Text: Resident found unresponsive with no pulse or respirations in bed with emesis on gown. Time of death verified at 1645 with LPN. Funeral Home called at 1900 and body released at 2000.

feeling bad; Had no energy; everything spins inside the room/ went black; everything spins inside the room/ went black; This is a spontaneous report from a contactable consumer reporting for himself. An 83-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer- BioNTech, lot# lot# EL1284), via an unspecified route of administration, on 28Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing wheelchair user, blood pressure abnormal and prostate infection. Patient's body weight was 218-220 pounds. Concomitant medications included acetylsalicylic acid (ASPIRIN) for many years at 1 DF daily, an unspecified prostate medication and an unspecified drug for blood pressure at 20 mg, another unspecified drug that is mixed and eye drops. The patient experienced feeling bad, had no energy, everything spins inside the room/ went black all in Feb2021 with outcome of unknown.

Day 1 after receiving vaccine he started to notice redness on face and fatigue. Day 2 woke up face was swollen and eyes almost swollen shut and hot, started taking benadryl and sleep most of the days. Denies SOB. Day 3 continue benadryl, zyrtec and pepcid. Day 4 came to PCP as it's gotten worst. Swelling of bilateral ears, face, and forehead.

Patient's wife reported via telephone conversation with current nursing staff that patient had presented outpatient this morning around roughly 10:30AM, where he received his Covid-19 vaccination. He then went grocery shopping with his wife, and presented to home, where he began having notable difficulty swallowing and increased confusion, family had then sat him down in living room chair, where his daughter noted acute onset of tongue, upper/lower lip swelling, and right eye drooping. Patient's wife reports that he typically manages all of his home medications by himself, and manages his own ADL's without assistance at home. She reports that he did miss his noon dose of Sinemet, otherwise he has not missed any doses of current prescribed medications, and denies any recent start/change to current medication regimen, or OTC medications. Patient had difficulty swallowing scrambled eggs

vision loss; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: 183599) solution for injection, via an unspecified route of administration in left arm on 20Jan2021 at a single dose for Covid-19 immunization. Medical history included pacemaker, vitiligo, psoriasis, blood pressure, and autoimmune disorder. Concomitant medications included blood thinners and blood pressure medications. The patient experienced vision loss on an unspecified date. It was reported that patient went for an office/clinic visit to a doctor or other healthcare professional. Also went emergency room/department or urgent care. Patient did not receive any treatment. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 since vaccination. Covid-19 virus test: negative. The event was reported as non-serious however it caused disability. Outcome of the event was not recovered. No follow-up activities are needed. No further information is expected.

The pains across his body keeps getting worse, the pains got a little better Saturday but then Saturday night it got pretty bad.; Loss of taste; difficulty talking; Friday night the same thing happened except the pains were a little higher and above his belly button; pain across body; little bit of soreness in left arm; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EL9261, exp. unknown) , intramuscular on left arm on 21Jan2021 08:30 at single dose covid-19 immunization at a clinic. Medical history included thyroid disorder from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine 100mcg once a day for thyroid. The patient experienced little bit of soreness in left arm (non-serious) on 21Jan2021 with outcome of recovered, pain across body (non-serious) on 28Jan2021 20:00 with outcome of recovering , the pains across his body keeps getting worse/the pains got a little better Saturday but then Saturday night it got pretty bad (condition aggravated) (non-serious) on an unspecified date with outcome of unknown, loss of taste (non-serious) on 01Feb2021 with outcome of unknown, difficulty talking (non-serious) on 31Jan2021 with outcome of not recovered , pains were a little higher and above his belly button (non-serious) on 29Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included thyroid function test was low on Sep2020 (levothyroxine was changed to 125mcg from 112mcg), thyroid function test was back towards normal but had not quite reached it on Nov2020 (new dose of 100mcg tablet once a day), thyroid function test was unknown on 25Jan2021 but was on 100mcg of levothyroxine once a day. Therapeutic measures were taken as a result of little bit of soreness in left arm and pain across body included Tylelol (acetaminophen).

Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild

You got the vaccine, and had no reactions to the vaccine, and it was close to 3 weeks later that he walked out of the house, went in the garage and all of a sudden his right ear was not working at all, that was 3/7/21. He still has no hearing from the ear. He has bad balance and afraid of falling down, dizziness when he tries to get up. He called his doctor and he prescribed Methyl Prednisolone, and for him to call back today which he is waiting on him to call him back.

Dizzy, throwing up, sore arm, chills, sweats, headaches, loss of appetite, could not stand due to dizzy or open eyes, temperature variance from 97 to 100.

Awoke with extreme dizziness. Over next few days, blacked out 3 times. Vomited 3 times. Remained in bed much of the time for a week. Constant tinnitus (still present). Current working diagnosis: Vestibular Neuritis and Labyrinthitis. Still have significant problem with balance (current date - 05/10/2021)

TW0 EVENTS; #1 retinal oclusion, #2 disability and pain at left side Details #1 L I VITREO RETINAL, DIAGNOSE RETINAL OCCLUSION, SMALL BLOOD CLOT BACK OF RT EYE. CAUSED LOSS OF VISION ON TUE 5/4/21 AT 2AM, VISION CONSISTED OF BLACK CLOUDS AND PATTERNS WITH HOLES. NO TREATMENT OBSERVATION AND REPORT TO DR. PRESENT CONDITION IS OF CONSTANT THIN PATTERNS WITH HOLES DISTURBING ANY CLOSE READING OR COMPUTER WORK. DISTANCE WITH BOTH EYES HAVE THE PATTERNS BUT MUCH LESS NOTICABLE. #2 ORTHOPEDIC DR. 5/8/2021 6AM SAT 5/8/2021 SEVERE PAIN L SIDE

She had a pfizer vaccine and had a reaction where her BP went up high she had rapid heart beat and palpitations. Tachycardia and blurry vision. Had a headache overnight. Initial troponin elevated, follow up was less. No chest pain now.No dyspnea.

83 yo c/o dizziness and blurred vision 15 minutes after receiving his 2nd dose of the Pfizer vaccine. Patient stated to staff member that after he stood up he felt like passing out. Patient was escorted to the triage area where he was evaluated by on-site EMS and NP. Vital signs and EKG initiated . BP elevated. Patient states he has not taken morning BP meds which may be causing the elevation. Patient has a PMH of HTN. Allergic to Pollens and Perfumes. After about 15 minutes, BP decreases and patient states he's feeling better. Patient agreed to leave and have daughter drive him home.

About 4-5 hours after he received his 1st COVID-19 Vaccine dose, he had sharp pains in his head. The pain was mostly behind his eye.; About 4-5 hours after he received his 1st COVID-19 Vaccine dose, he had sharp pains in his head. The pain was mostly behind his eye.; This is a spontaneous report from a contactable consumer or other non hcp. An 83-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date: was not reported), via an unspecified route of administration, administered in right arm on 01Mar2021 08:00 as single dose for COVID-19 immunization. The medical history included cardiac disorder from an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccinations prior within 4 weeks. On 01Mar2021, about 4-5 hours after vaccination the patient experienced sharp pains in his head, the pain was mostly behind his eye; on 03Mar2021, the patient experienced mild headache. The clinical outcome of the events sharp pains in his head was resolving and mild headache was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

he lost sense of taste and smell; he lost sense of taste and smell; legs feeling heavy and hard to move; restless sleep; This is a spontaneous report from a contactable consumer (patient). An 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included Patient has recently had a pacemaker implanted. Concomitant medication included potassium Once a day, hydrochlorothiazide (DIURETIC), 20 mg Twice a day, dutasteride (AVODART), Once a day, acetylsalicylic acid (ASPIRIN (E.C.) 81 mg Once a day and a multivitamin QD (Once a day). The patient had the COVID-19 vaccine administered on 14Jan2021. That evening he began waking up several times after a restless sleep approximately six times on 14Jan2021. This lasted approximately two more evenings. On 19Jan2021 he lost sense of taste and smell for approximately three days. As of 20Jan2021 he has regained some sense of taste. The patient's temperature has been normal with no fever and pulse oximetry has been approximately 96%. Lastly on 17Jan2021 patient reported his legs feeling heavy and hard to move which lasted approximately three days. The outcome was recovering. Information on the lot/batch number has been requested.

Per patient, the evening after dose 1 he developed throat discomfort, difficulty swallowing, and shortness of breath. The pain was moderate but main issue was difficulty swallowing. He did not seek medical attention but took tylenol. Symptoms self-resolved.

Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Headache; Eyes are sore; Soreness in arm; This is a spontaneous report from a contactable consumer (patient himself). An 84-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3246), via an unspecified route of administration on the upper right arm, first dose at age 84 years on 15Jan2021, at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Patient had the COVID Vaccination on the 15Jan2021 and he had minor soreness in his arm for 2 days and it went away, it was gone by the 18Jan2021. On 23Jan2021, he started with the symptoms similar to the thrush of the mouth and he went to the doctor 27Jan2021 and they told him it was not thrush because he did not have the white coating in his mouth, and thought it was reaction to the Covid-19 Vaccination (Covid-19 Vaccine by Pfizer) and he has a sore throat and all inside his mouth is sore, his tongue is sore he has headache and his eyes are sore. Patient's doctor told him to take Vitamin C and Vitamin D and Zinc, and he took his first dose this morning 27Jan2021, after breakfast which are Vitamin C and Vitamin D, but he haven't taken the Zinc yet. The outcome of the event soreness in arm was recovered on 18Jan2021, while for the rest of the events, it was unknown.

Injection SUNDAY. within 2 hrs of the 2nd injection, he was amazed to no longer feeling the chronic pain throughout his shoulder. MONDAY: The following evening (after supper) he experienced severe light-headedness, followed by violent, prolonged projectile vomiting, during which, his eyes rolled back and he passed out while continuing to vomit. Low BP. transported to hospital; CT scan showed perforated esophagus, air in chest lining. 2nd CT: air and fluid spread to neck area, bowel obstruction/infection. TUESDAY: 5am: Transferred to hospice ward, unresponsive. Tuesday, 2:20pm: died.

After second dose of the vaccine the middle of the tongue turned black and and yellow film around the black.

Vision changes in right eye/vision complications/getting a dark spot in the bottom part of the vision of his right eye; loss of his peripheral vision; the peripheral vision in his right eye was getting cloudy/eyes go in and out of focus while reading; his vision was getting a little worse; This is a spontaneous report from a contactable 84-year-old retired pharmacist (patient). An 84-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0164) via an unspecified route of administration on an 15Apr2021 at 12:00 (at the age of 84-years-old) as a single dose in the right arm for COVID-19 immunisation. Medical history included ongoing prostate problems from an unspecified date (for probably 15 years), ongoing high blood pressure from an unspecified date (diagnosed with high blood pressure 12-15 years ago), ongoing high cholesterol from an unspecified date (he cannot remember when he was diagnosed with high cholesterol. His cholesterol has been great, since he had been taking cholesterol medications, he has had normal cholesterol. He thought his total cholesterol last time was 170 and that his triglycerides were low), blood pressure from an unspecified date and unspecified if ongoing, heartburn from an unspecified date and unspecified if ongoing and eye problems from an unspecified date and ongoing. The patient did not have a history of adverse events following prior vaccinations. Family medical history relevant to the adverse event was reported as the patient's sister had eye problems. She had to get an injection in her eye every couple of weeks or once a month or something. He did not know if his sister had macular degeneration or what. Other than wearing eye glasses, that was the only family history that he could think of that might be relevant. Concomitant mediations included morniflumate (FLOMAX; capsule) taken for prostate from an unspecified date and ongoing at 1 DF 2x/day (8-10 years ago, started with 1 capsule daily but now took 1 capsule twice daily; the patient reported that at his last report, his PSA was up to 9 and it was now down to 3.1); finasteride (PROSCAR) taken for prostate from an unspecified date and ongoing; hydrochlorothiazide/lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) taken for an unspecified indication from an unspecified date and ongoing (for quite a long time); omeprazole (PRILOSEC) taken for heartburn from an unspecified date and ongoing, as needed (if the patient knew that he was going to have something spicy or tomato based for dinner, he knew he would get heartburn, so he would take a Prilosec in the morning. He had used Prilosec for years off and on, since he was working as a pharmacist and he retired in 2013) and atorvastatin calcium taken for cholesterol from an unspecified date and ongoing (for about a year; he was changed from Zocor because the medication did not get along with his blood pressure sometimes). The patient previously received zocor on an unspecified date for an unspecified indication and experienced did not get along with his blood pressure sometimes. The patient did not receive additional vaccines on the same date or within 4 weeks prior to the COVID-19 vaccine. The patient received the flu (INFLUENZA VACCINE), pneumonia (PNEUMOCOCCAL VACCINE) and shingles (VARICELLA ZOSTER VACCINE) vaccines all at the end of 2020 (at the age of 84-years-old) for immunization. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EB8730) via an unspecified route of administration on an 25Mar2021 (at the age of 84-years-old) as a single dose in the left arm for COVID-19 immunisation. In Apr2021 the patient experienced vision changes in right eye/vision complications/getting a dark spot in the bottom part of the vision of his right eye, loss of his peripheral vision, the peripheral vision in his right eye was getting cloudy/eyes go in and out of focus while reading and his vision was getting a little worse. The clinical course was reported as follows: The patient was a retired pharmacist who called to find out whether there had been any reports of vision complications after the COVID-19 vaccine. He received the second dose of the COVID-19 vaccine on 15Apr2021 and as of about 2 weeks ago, the peripheral vision in his right eye was getting cloudy and the patient was getting a dark spot in the bottom part of the vision of his right eye. He did not know if Pfizer had any types of reports on that type of side effect. He made an appointment with his eye doctor for tomorrow, 04May2021. He wanted to have any information that Pfizer might have. He knew that his eye doctor was going to ask him questions to try to determine what was causing the vision changes. He wanted to check with Pfizer before he went to the eye doctor so that he had an answer to the doctor's questions. The patient reported that his vision was getting a little worse. He was now having a little trouble with the computer. He had to refocus every time he moved his eyes. Yesterday, 02May2021, he had what could have been a problem driving. He was driving on the highway and there was a lighted sign. He could not read the sign because it was on the right side of the road. By the time he could focus on the sign, he could not read it because he was right by the sign. Something like that could be a big problem. He reported that his eyes go in and out of focus while reading. He had to re-focus when he was going to the next line of text that he was reading. He just got an eye exam and new glasses in Feb2021. His problem in Feb2021 was with focus. He was having problems more or less with reading. In the bright light, everything was fine, but that in regular kitchen or incandescent light, he would only be able to read a paragraph or so. He would then have to refocus in order to read more. It became a real problem and the new glasses that he got were not solving it. The patient stated that the last Pfizer representative he spoke with said that Pfizer did not have any vision changes listed as a side effect of the COVID-19 vaccine that the representative knew of. The Pfizer representative informed the caller that there may have been calls that have come in reporting vision changes, but vision changes were not listed as a side effect yet. The patient stated that he saw about 5 doctors. His primary care physician did not know about the vision changes as the changes had just occurred in the last 2 weeks. The patient had absolutely no reaction to either dose of the COVID-19 vaccine. He did not even have a sore arm following the COVID-19 vaccine injections. The vision changes started about 2 weeks ago and he wanted to wait to see if it was going to clear up before he made appointments with his physicians. He reported that his vision did not clear up and that he was now getting concerned, especially with driving. The adverse events required a visit to the physician office. The clinical outcomes of the events vision changes in right eye/vision complications/getting a dark spot in the bottom part of the vision of his right eye, loss of his peripheral vision, the peripheral vision in his right eye was getting cloudy/eyes go in and out of focus while reading and his vision was getting a little worse were not recovered/not resolved. The patient reported that he did not believe (doubted that) that the COVID-19 vaccine caused his vision changes.; Sender's Comments: Based on the information available the changes in vision in this 84-year old patient is attributed to patient's advanced age and assessed unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE).

25 minutes later developed metallic/ink taste; 6th February 2021 for the first one and 23rd February 2021 for the second one; This is a spontaneous report from a contactable physician (patient). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 (Batch/Lot Number: EN6201; Expiration Date: 21Jun2021) (at the age of 84 years old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included ongoing asthma (Very occasionally), sleep apnoea from Apr2020 (use Cpap, use a breathing machine), arthritis, hypertension, benign prostatic hyperplasia, hypothyroidism. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Feb2021 01:15 pm (Batch/Lot Number: EL9262) (at the age of 84 years old) for covid-19 immunisation. Concomitant medications included ramipril taken for hypertension, start and stop date were not reported; metoprolol taken for hypertension, start and stop date were not reported; tamsulosin hydrochloride (FLOMAX RELIEF) taken for benign prostatic hyperplasia, start and stop date were not reported; pregabalin taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for hypothyroidism, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; ezetimibe (ZETIA) taken for an unspecified indication, start and stop date were not reported; vitamin d nos taken for an unspecified indication, start and stop date were not reported; salbutamol (ALBUTEROL HFA) taken for asthma, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed a taste in mouth that was a cross between ink and metallic, mostly ink, that has persisted till the present time on 23Feb2021 01:45 AM (as reported). Physician stated, he received 2 Pfizer inoculations, one on February 6th and second on February 23rd. Within about 20-25 minutes of the time, in the second shot, he developed a taste in mouth that was a cross between ink and metallic, mostly ink, if you have ever touched your lips when you had, the regular ink that you drew up into a fountain pen and that has persisted till the present time. Physician stated, it tasted and thus tasted as ink. If he drinks plain drinking water, it taste like drinking ink. Physician stated, it came on within 20 minutes-25 minutes of the time that he received the vaccine. At first he thought it was the hand sanitizer in mouth but it never went away, so it may be a coincidence, it came on 20-25 minutes after and it never went away. His lab work was normal, all of it. He had a CBC, a complete chemistry, had a Fabre and a CRT, had a lipid exam and they were all absolutely normal, all on 26Feb2021 (as reported). No treatment was received for the event. The outcome of event metallic/ink taste was not recovered while for other event was unknown. No follow-up attempts are needed. No further information is expected.

i was tested in November and December of 2020 and my eyes were good, no macular degenertion, in May i was checked for a follow up and the fact that i was having vision problems. i had bad macular degeneration in my left eye and the start of it in my right eye, plus PED, whatever that is., the Macular degeneration is in the center vision area of the retina so vision is really bad.

He started feeling woozy; Feels things in his workouts in his legs and feet, sometimes his back; He got a scratchy thing in his throat about 2 months ago; Exposed to Covid-19 after having vaccine; Caller states the second shot was really rough; This is a spontaneous report from a non-contactable consumer received from a Pfizer- sponsored program Pfizer RxPathways CEP 5570. A 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 17Feb2021 (at the age of 84-year-old) as a dose 2, single for COVID-19 immunisation. Medical history included cancer and had surgery, prostate surgery in Tombstone and caller stated he always has headaches. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 27Jan2021 (at the age of 84-year-old) as a dose 1, single for COVID-19 immunisation. It was reported that, He gave transfer agent some dates of the 2nd, the 17th and the 21st and then stated it was the wrong one. Those were the dates the transfer agent was given. Transfer agent stated that, the caller never told her which vaccine it was. The caller was transferred to the call handler at that time he was asked to confirm information. The caller was asked whether he was calling about the Pfizer Covid-19 Vaccine when he referred to vaccine and he stated that, he has had both vaccines, he had them both way back. The caller stated that, the first was 27 21. Caller stated, it is the first month, call handler should not ask him that. The truth was, he cannot remember, was had been a while passed. Call handler asked for clarification of first month and caller does not provide. Call handler asked whether first month January and caller were stated that, it had to have been January or he does not know. The second was the 2nd, 17 27. The caller stated that was the second month, January and February. The call handler attempted clarification, but caller could not provide. He stated that, 27Jan2021 and 17Feb2021 he guesses means the second month and a first month, that was what was written on his card. No further clarification was provided. Dates remain unclear. The caller stated that, the second shot was really rough. It was a hard time before. The caller was asked for clarification and additional details were not provided. Caller stated that, he got the shot, he was skeptical about taking it but it was something he was taking. He was talking to a lot of different people and they were getting him to do what was important. The shots - the cold - nothing. He has never had to do that. He was really pretty to snuff other than at one point he got cancer and had surgery, prostate surgery, in Tombstone when he went through all that stuff. The caller did not provide additional details. Caller stated that, his problem was he saw his neighbor two weeks ago. He has not been talking to her a long time because she was over aggressive and pushy. He has tried to treat her kind but she was a drug addict and he was not interested in her or her lifestyle. He does her favors an cuts her grass. He was not interested in more than the process of doing this. Stated that, he had not talked to her in a long time and she stabbed him coming into the back of the house. She was stressed out and he thought she had a problem. He listened to this between him and her and at one point she got four or five feet from him and it was hot, like 90 something degrees. He was talking to her and he came back to her gate and then he started feeling woozy but maybe it was his head and heat. He could hardly get into the house. Since then, he was concerned about her because she said she had the virus and she worked at the hospital and she had the virus for 3 months and that was scary. The caller stated that, he always has headaches, he has always had them and that has nothing to do with this. The second shot gave him different types of things. Like, he had already had headaches so he could not say that was on the shot. Exposed to Covid-19 after having vaccine. Sometimes, he felt things in his workouts, in his legs and feet, sometimes his back. The caller did not clarified and stated that, he could not make a distinction between the workout and this particular thing. He workouts with 115 to 120 pounds every day and for a period of time it has happened over night. He has always done it, he started when 20 to 21 when it started. Stated that, he was not to the point he could not do what he had to do. He could walk and do all those things that has gotten better. He got a scratchy thing in his throat about 2 months ago. This occurred a long time after the vaccine. it was not so bad it was bothering him but he could still eat and do what he had to do. Still do normal things like his weights and stuff everyday. Something told him to get checked out and they told him to go back home because they could not believe he was so strong and he could hold 50 pounds. The caller was asked to clarify his question and events. Stated that, there was concern because he thought about what his neighbor said, that was 2 weeks ago he talked to her and he wanted to know what call handler thinks. The last two times he went to the hospital they said he did not have no Covid and sent him back home. Another day, they put him to another doctor. The caller stated that, he talked to call handler's office once before and she did not know the neighbor. He talked to and did checkups with Pfizer because he does not have knowledge and this was all new to him. The caller did not provide additional information. The caller stated that, not to stop and he was covered when he was talking to her. Caller clarified, he means that, he was wearing a mask and ever since he got the shot he was covered and the only time he was around people was the gas station or grocery store. He has no temperature and never did either. The caller was asked to clarify whether his question was regarding that, he had his Pfizer Covid-19 Vaccine and then was exposed to his neighbor who had Covid-19 for three months. The caller stated as yes, he wanted to know what call handler thinks because call handler works there and deals with people like him all day. The caller then stated that, he will tell call handler what - maybe he should call his doctor and if that was better he would call, where he has been there a long time and they can check him because of his athletic things and age. Stated that, he started calling them before Pfizer but it was lunch time. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

itching; bottom lip was swollen; This is a spontaneous report from a contactable consumer via the Medical Information Team. An 85-year-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date at a single dose for an unspecified indication. Medical history included hard of hearing. The patient's concomitant medications were not reported. It was reported that the patient started itching and bottom lip was swollen. Bottom lip swelling has gone down today but she has still itching all over the body. She tried Benadryl but not helping. The outcome of the event itching was not recovered while recovering for the other event. Information about Lot/Batch has been requested.

Pfizer-BioNTech COVID19 dose #1 given IM LD at 10:30AM 1/27/21. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting. While seated, vital signs were taken- BP 148/76, HR 73, O2 98%. No falls or medication administered. EMS arrived around 11:10am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on EMS assessment, recommenedation was to go to the ER. Patient brought to Sharp Memorial Hospital by EMS staff at 11:20am, spouse was present and in agreement.

like a blood clot; All around eye is real swollen and puffy and in corner/don't know if it looks like a bruise or it's like a blood clot or something; like a bruise; a red, dark red spot/not on the eye but up on the eyelid it looks like; all around his eye was real swollen and puffy and in the corner, not on the eye but up on the eyelid it looks like; This is a spontaneous report from a contactable consumer. An 85-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number like EL1283), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. Medical history included slightly elevated blood pressure from an unknown date. Concomitant medication included clopidogrel besylate (CLOPIDOGREL) for blood pressure; hydrochlorothiazide, losartan potassium (LOSARTAN + HIDROCLOROTIAZIDA) as blood thinner and several of drugs. The patient had the Covid vaccine on the 12Jan2021 and yesterday (14Jan2021) as they noticed his eye, all around his eye was real swollen and puffy and in the corner, not on the eye but up on the eyelid it looks like, the reporter didn't know if it looks like a bruise or it's like a blood clot or something and it's still there, it hasn't gone away and they didn't know if this was from the vaccine, the reporter didn't know if it's bruise or if it's a clot the reporter didn't know, it's a red, dark red spot. after we had the vaccine they gave us a paper that had some information on it and it said on there they should advise them if on blood thinners, they did not told beforehand and the patient was on blood thinners. No treatment was received. The outcome of the events was not recovered. Information about lot/batch number has been requested.

The evening of the vaccine, Pt developed headache and puffiness of his eyes, as well as a decrease in vision. The following morning, his eyes were still very puffy. He was seen by his ophthalmologist 1-2 days later, who diagnosed him with corneal inflammation and keratitis. Steroid eye drops were prescribed to be instilled in both eyes qid. He went back for a follow-up on 1/28/2021 at 9:00 am. His eyes were worse, and he was prescribed a stronger steroid drop. HIs ophthalmologist advised him NOT to get the 2nd dose of the COVID vaccine, which was scheduled for that same day.

unresponsiveness for 2 minutes in seated position; bilateral arm tremor; pallor; eyes rolled back; drooling; nausea; vomiting; This is a spontaneous report from a non-contactable pharmacist. An 85-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on 27Jan2021 10:30 AM at single dose on Left arm for covid-19. Medical history included anaphylaxis history of unknown cause. The patient's concomitant medications were not reported. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position on 27Jan2021 11:00 AM. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting on 27Jan2021 11:00 AM. While seated, vital signs were taken- BP 148/76, HR 73, O2 98% on 27Jan2021. No falls or medication administered. (name withheld) arrived around 11:10 am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on (name withheld) assessment, recommendation was to go to the ER. No treatment received. Outcome of events was recovered on 27Jan2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness is possible. 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.

Facial swelling; I have got Vitallium Partial, there was a pinching, it was very uncomfortable; Gum swelling; This is a spontaneous report from a contactable consumer (patient). This 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number E79262) via an unspecified route on an unspecified date (at the age of 85-years-old) as a single dose in the right upper arm for COVID-19 immunization. Medical history included unspecified health issues. Concomitant medications included unspecified regular medications he took several in the morning and at night. The patient also took vitamins "and different things like that" from unspecified dates for unspecified indications. The patient experienced facial swelling and gum swelling on an unspecified date. The patient had a Vitallium partial. The metal and the partial denture were pinching him; it was very uncomfortable. The patient stated it was not a life or death situation but he was ready to go to the dentist for an adjustment in the partials so it didn't hurt. The patient did not undergo any lab tests. The patient did not receive treatment for the events. The outcome of facial swelling and gum swelling was unknown. No follow-up attempts are needed. No further information is expected.

Client verbalized swollen lower right lid with redness. According to patient no pain present. Client was evaluated by Fire Rescue. Client was given cold compress by paramedics to apply to swollen lid.

Patient is experiencing numbness of the left side of his lower lip/chin since COVID19 vaccine. On exam, he has no cranial nerve deficits but has a patch of subjective numbness involving the above area. Tongue is not involved. Entire dermatome of the Mandibular branch of the L Trigeminal nerve does NOT appear to be involved. There is no swelling. There is no pain currently. Need to assume that this is a vaccine reaction.

PMH of CAD, HTN, DM2, atrial fibrillation on Eliquis who was last seen normal at 2330. Family heard a thud in pt's bedroom and found him on the ground with left gaze. EMS called, placed pt on a C-collar and brought to ED as a stroke code activation. On presentation, pt with left gaze and right hemiparesis and LLE weakness. He was non-verbal and not following commands. Head CT showed no acute hemorrhage. CTA with perfusion did not show a large vessel occlusion or significant hypoperfusion. Clinical picture suspicious for ictal event so he admitted to the NSICU for further workup.

Experienced sudden hearing loss 4 days after first vaccine dose, hearing loss did not worsen after second vaccine dose. An MRI brain was done, no evidence of ischemic or hemorrhagic event.

Patient is an 85-year-old male sent from ophthalmology clinic due to concern of blackening of vision. Homonymous right superior quadrantopia likely 2/2 prior ischemic insult.

Wears glasses. Notice blurry vision in right eye. Left eye is already blurry . Couldn't see even with glasses. Put warm compression on eye. Put drops in eye. Call eye doctor. Vision is still blurry. Can't read vaccine card. Eye doctor should get back to him today.

I could not hear anything; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: el8982), via an unspecified route of administration at the left arm on 18Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included hearing problem, CAD and glaucoma. The patient has no allergies to medications, food, or other products. Concomitant medication included tamsulosin, levothyroxine sodium (LEVOXYL), omeprazole, acetylsalicylic acid (BABY ASPIRIN) and astorta. On 19Jan2021, 1 day after injection around 5pm the patient reported to have taken a nap, and when he woke up, he could not hear anything. The patient has a hearing problem only have 10% hearing. He was going to see ENT. The event resulted to doctor or other healthcare professional office/clinic visit. The reporter assessed the event as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 post vaccination. The outcome of the event was not recovered

The day after the 2nd shot, patient developed blisters on his lips and mouth. The care facility said that he had a nut allergy -- but he had never been allergic to nuts. He stopped eating and drinking and his BP had dropped to 60/40. By Jan 16th they called to say he was dying and he passed away on 1/18/21. Patient had COVID19 from Oct 29th - early November. By Nov 21st he had lost 40 lbs. He was 6'3" and had gone from 189lbs to 149 lbs with COVID. By Nov 21st when we could visit, he had recovered from COVID, but was very thin and weak. He could not bathroom alone and kept falling. He didn't seem to have a bad reaction to the 1st COVID shot, But he immediately reacted to the 2nd shot and passed away within 6 days.

hard on hearing/lost his hearing; pain in his right ear; Chills; headache; Fever; Weakness; lacking appetite; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810, expiration date was not reported) (at 86 years of age), via an unspecified route of administration in the left arm on 03Feb2021 15:00 at a single dose for COVID-19 immunization. Medical history included ongoing chronic lymphocytic leukaemia, ongoing blood pressure abnormal and ongoing thyroid disorder. Concomitant medication included hydrochlorothiazide which he was taking for years, ibrutinib which he was taking for 7 years, levothyroxine which he was taking for 10 years and losartan which he was taking for 8 years. The patient had no any other vaccine prior to covid vaccine. It was reported that the patient received the Pfizer covid vaccine on 03Feb2021. 24 hours later (04Feb2021), he experienced pain in the ears, headache, chills, and fever up to 101.5 for almost a week now, and currently is hard on hearing and had been feeling weak and lacking appetite. It was added that a week ago he received the first dose of the Pfizer COVID 19 vaccine on 03Feb2021 at 1500PM in the left arm. Within 24 hours the side effects started. He had a pain in his right ear and a headache. Since then he has gradually lost his hearing in that ear and they are following up with an ear nose and throat doctor. On 04Feb2021, he got a fever of 101.5, chills, weakness and no appetite. Since then in the evening he had been having kind of a fever of 100 to 100.5 and she has treated with TYLENOL. The fever comes and goes. In the morning he was normal. Adds his appetite was better but he still has to force himself to eat. She queried if should the patient get the second dose of the vaccine. Patient is scheduled to receive the second dose on 04Mar2021. The patient did not visit the ER. The patient underwent lab tests and procedures which included body temperature: up to 101.5, fever of 100 to 100.5, and 101.5 on 04Feb2021. The outcome of the event loss of hearing, fever, weakness, and pain in his right ear was not recovered; headache and chills are recovered on 05Feb2021; while recovering for lacking appetite. The loss of hearing was reported as worsened. Therapeutic measures were taken as a result of fever (pyrexia).

He can barely see/he cannot see/his vision is getting worse and worse/visions problems; This is spontaneous report from a contactable consumer who reported for her father. An 86-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 (at the age of 86-year-old) as a single dose for COVID-19 immunization. Medical history included two ongoing autoimmune diseases from unspecified dates and an ongoing pacemaker from an unspecified date. Concomitant medications included ongoing blood thinners from an unspecified date. The patient experienced he can barely see/he cannot see/his vision is getting worse and worse and vision problems, both on unspecified dates. The patient's child called and stated that "my father is on blood thinner. He has two autoimmune diseases and has a pacemaker. He developed visons problems within a few days after receiving the first dose of Pfizer COVID-19. Now he cannot take care of his dog. He will not be able to take care of himself. His vision has gotten progressively worse, he can barely see. I spoke to the specialist and other doctors, but they have no information. He will be seeing the doctor in 2 weeks only. I reported the side effects online. It was hard to get medical help because not many people are informed about what might go on with the vaccine. To get him diagnosed has been difficult. They can't do an MRI on him because he has a pacemaker. He is also 2 weeks out to see a specialist. In the meantime, he cannot see. His vision is getting worse and worse. His next vaccine is coming up too." The reporter had called and spoke with the director of immunization at the health department. She had also called and talked to VAERS as well. No one could point her to any help. The reporter believed this was probably related to the autoimmune diseases. The patient had no consultation not take the vaccine. The reporter had answered some information on the website while she had been waiting. The rest of the family also had autoimmune issues, and now they were all wondering if it was safe for them to take (the vaccine). The reporter wanted to know if we could provide any recommendations and if her father could get the second dose of the COVID-19 vaccine. The clinical outcome of the event was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Pt admitted to Hospital on 2/8/21 with 2-3 days of SOA and cough. His wife was diagnosed with COVID-19 at approximately the same time when the patient received 1st COVID-19 vaccine. Pt had not felt well since receiving the vaccine and had some changes in taste or smell. He became acutely worse 2-3 days p/t admission with DOE, productive cough, H/A, N/V, profound weakness and bilateral infiltrates on CXR. He was hypoxic on room air. During hospitalization, has gone back and forth from BiPAP to HFNC. Unable to prone. Pt and wife discussed goals of care and decided on comfort measure approach. Pt expired on 2/19/21.

Patient had been feeling dyspneic for 1.5 weeks to 1 month prior to his death on 2/28/21. He received vaccine on 2/25/21. On his family found him leaning on the couch with eyes rolled back and foaming at the mouth. He was making noises (like grunting sounds?). EMS was called. He had cardiac arrest while in ambulance enroute to EMS. Resuscitation efforts continued in ED. Family was informed about his status and resuscitation efforts were stopped.

Patient without prior otologic history noted right sudden SNHL ~5-6 weeks after vaccination. No associated vertigo, aural fullness or tinnitus.

he felt very dizzy; his lips felt very swollen; My lips and mouth felt numb and swollen; My lips and mouth felt numb and swollen; headache; his blood sugar was down to 50; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 86-year-old male patient started to receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot# EN9581) via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation. The patient's medical history includes diabetes. The patient's concomitant medications include carvedilol (COREG), rosuvastatin calcium (CRESTOR), repaglinide (PRANDIN), adenosine (TRICOR), metformin and amlodipine besilate (NORVASC). On an unknown date, the patient reported that blood sugar was 130 on that morning. He had his normal breakfast and went to get his shot within about an hour after getting a shot he was home and he was having my lunch. He was halfway through lunch he answered his doorbell and he got extremely dizzy. His lips and mouth felt numb and swollen. On 04Feb2021, his blood sugar was down to 50. There was no reason and no explanation for precipitated drop in blood sugar other than the fact that he had the Covid shot. Subsequently he spoke to cousin of his who is physician to heard of someone who had an adverse reaction like low blood sugar and was hospitalized. Nowhere in the side effects warning doesn't say anything about diabetic with low sugar and with low population over 65 it seems to me that would great number of people who have diabetes and low blood sugar problem. In case indeed of indication of adverse effect of covid. The patient advised that a warning should be on leaf. At least people have sugar tablets or some form of counteracting low blood sugar especially since these are 5-7 have driven to and he was just very thankful but he had to get the shot in (city). He was driving from (city) on 95 for 70 miles an hour. He would have got dizzy and headache and low blood sugar reaction while he was in transit. He was thankful that he got home in time for this not be a tragedy. It was reported that no other treatment was taken by the patient other than consuming large amount of orange peels. The outcome of the events was unknown.

He has double vision; Weakness; Tiredness; Headache; He had problem with lymph nodes; doesn't feel good; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6207), via an unspecified route of administration administered in left shoulder on an unspecified date (at the age of 86-year-old) at SINGLE DOSE for COVID-19 immunisation. Medical history included blood pressure abnormal and blood cholesterol abnormal. Concomitant medication included lisinopril taken for blood pressure. On an unspecified date, the patient experienced he has double vision, weakness, tiredness, headache, and he had problem with lymph nodes. The reporter further stated, "Now I realize that was Wednesday, now this Wednesday afternoon it will be a week do these symptoms last these long normally I am calling because I mean he is not ready for the hospital or anything like that but he just doesn't feel good." The reporter also mentioned that the patient has no fever. The patient was afraid to get the second shot. They are scheduled for the second dose of vaccine on 06Apr2021. There was no treatment received for all events. The patient was recovering from all events.

shortness of breath, generalized weakness, loss of taste and smell, nauseated, diarrhea or abdominal pain supplemental oxygen per hypoxia along with IV remdesivir and IV dexamethasone, Tessalon for the cough

he smelled some kind of chemical; he began to feel real bad; This is a spontaneous report from a contactable consumer (patient's wife). An 87-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 in left upper arm shoulder area at single dose for vaccination; glimepiride (manufacturer unknown), via an unspecified route of administration from 2020 and ongoing at 2 mg, 1x/day (once per day in the morning) for diabetes; vitamin d (manufacturer unknown, lot# 300015, expiration date: Jan2022), via an unspecified route of administration from 2019 and ongoing at 3000 iU, daily (2000 IUs in the morning and 1000 IUs nightly) for bone and immune health; acetylsalicylic acid (ASPIRIN, lot# P139558, expiration date: Aug2022), via an unspecified route of administration from an unspecified date and ongoing at 81 mg, 1x/day for helping thin his blood; apixaban (ELIQUIS, 2.5 mg), via an unspecified route of administration from 2018 and ongoing at 2.5 mg, 2x/day (morning and night) for blood thinner; simvastatin (ZOCOR, 20 mg), orally from an unspecified date and ongoing at 20 mg, 1x/day for cholesterol; metoprolol (manufacturer unknown, 50 mg), via an unspecified route of administration from an unspecified date and ongoing at 25 mg, daily (1/2 tablet once daily (25mg total daily dose)) for an unspecified indication; celecoxib (CELEXA), via an unspecified route of administration from an unspecified date and ongoing at unknown dose with daily (1-20 mg tablet once daily) for clinical depression; vitamin c (manufacturer unknown, lot# 205348, expiration date: Jun2023), via an unspecified route of administration from 2020 and ongoing at 1 DF, daily for supplement to boost immunity; famotidine (manufacturer unknown), via an unspecified route of administration from 2020 and ongoing at unknown dose with 2x/day (1-40mg tablet twice daily) for nauseated; cyanocobalamin (VITAMIN B12, 2500 mg, lot# 511333-01, expiration date: Jun2023), via an unspecified route of administration from 2020 and ongoing at 2500 mg, 1x/day for supplement; magnesium (manufacturer unknown, lot# 205340, expiration date: Jun2022), via an unspecified route of administration from an unspecified date and ongoing at unknown dose with daily (400 mg mostly every day but not strictly every day) to keep himself going; immuneti (manufacturer unknown, Capsule, NDC: 2817636726), via an unspecified route of administration from an unspecified date and ongoing at 1 capsule taken daily for an unspecified indication. Medical history included bad hearing problem. This consumer called on behalf of her husband to ask about possible side effects he was having. She reported that these possible side effects could be from Pfizer COVID-19 Vaccine or his other medications: glimepiride; Vitamin D; acetylsalicylic acid; apixaban; simvastatin; metoprolol; celecoxib; Vitamin C; famotidine; Vitamin B12; magnesium; and Immuneti. She was concerned about the possible side effects and wanted to ask Pfizer if these possible side effects could be from the Pfizer COVID-19 Vaccine or his other medications. Caller's husband was administered the Pfizer COVID-19 Vaccine on 15Jan2021. Caller also got her Pfizer COVID-19 Vaccine on 15Jan2021. Neither patient or caller had any problems with the product initially. Then her husband had onset of possible side effects last night. Starting 17Jan2021 after patient took his usual night medications, which caller was unable to clearly define which of the other suspect products that included, patient began to feel real bad. He said he smelled some kind of chemical and caller said she did not smell anything. Patient got to feeling worse and worse and they stayed up fairly late to see if he got to feeling better. When he got up this morning: 18Jan2021, he was feeling some better. He came in the room and when he put his medications in his mouth, before he even got them swallowed, he began to feel bad again-caller was unable to clearly define which of the other suspect products that included. Patient had been on simvastatin a long time and one time they took him off of this and started it back; he had been back on this for about 1 year. Metoprolol was discarded after 10th and 9th of 2021, documented as provided by reporter. Patient started it maybe 2-3 years ago. Vitamin C was Over the counter product, start date was probably 6-8 months ago. Vitamin B12 was probably started about 6-8 months ago. Magnesium was Over the counter product and probably started about 6-8 months ago. Caller verified that there are no other relevant products/medical conditions to provide for this report. She mentioned separately that patient had a bad hearing problem so caller handled his calls for him. The action taken in response to the events for all drugs (except for bnt162b2) was dose not changed. Outcome of events were unknown. Information about Lot/Batch has been requested.

Second morning after shot woke up with extremely blurry in right eye that improved slowly as the day went by, but not to previous vision. Same problem the morning after sleep and over the next day. Went to opthamalogist on Monday, Feb 1 who immediately referred to retina specialist, seen Feb 2. Have ongoing treatment for glaucoma, has been stable for years. I am not claiming this started because of the shot, but it was so close after that I thought I should report out of an excess of caution.

Patient had 2nd covid vaccine his wife noticed in Observation room his eye was red she did not notice this prior to the vaccine. Patient was taken to urgent care for evaluation. Seen in UC, and discharged home with f/u ophthalmology in 2 weeks or sooner if worsening symptoms.

Complaints of left sided tongue swelling, scratchy/sore throat, dizziness with onset appx 30mins post vaccine administration.

I suddenly experienced sudden hearing loss in my left ear. Thinking it may be ear wax or fluid contributing to this issue, I went to an urgent care and they cleaned both ears. They found no fluid or infection, but I still could not hear in my left ear. I made an appointment with an ENT. He also did not see any physical issues and ordered an MRI.

My father was given his second dose of the Pfizer vaccine on Feb. 13, 2021. He went downhill the following week. He fell 9 times and was very confused. He was taken to the hospital on Feb. 20 and admitted that day. He spent a week there. His condition continued to deteriorate. He was totally bedridden for a week. His mental status deteriorated. By Feb. 22, he was unable to talk, he drooled, and had to be fed. He made slow improvement later in the week. We were never given any reason for his condition. There was no infection, no stroke, etc. He was discharged and sent to rehab on Feb. 27. He remained there until April 8. He is currently doing fairly well. He uses a walker and gait belt in the house and is receiving home therapy. He is not as independent as he was before. His short term memory seems to be more impaired than it was previously.

Drooping of face, double vision and loss of balance representing stroke like symptoms. Symptoms began 4 days after receiving the Pfizer vaccine on the same side as vaccine was administered.

ED to Hosp-Admission Discharged 4/28/2021 - 5/1/2021 (3 days) Last attending ? Treatment team Acute respiratory failure with hypoxia Principal problem Hospital Course Admission HPI: (patient) is an 88 y.o. male come to emergency room for evaluation of cough with thick yellow sputum which is going on since past 2 days. Which is progressively getting worse. Associated with some shortness of breath. On arrival of EMS patient found to have significant hypoxia with 70% at room air. He was placed on nasal cannula. Did bring him to the emergency room. Patient had a dose of Covid vaccine and is due for second dose soon. In emergency room, he was thoroughly evaluated. He found to be septic. He was given dose of IV Levaquin and Covid swab come back positive. Hospitalist service requested to admit the patient. Asking patient, is feeling little better after coming to emergency room. He is having shortness of breath with significant cough with sputum production. He felt wheezy. Denies any fever but had chills. He feels nauseated. Hospital Course: Pt was admitted to the hospital for management of acute hypoxic respiratory failure secondary to COVID-19 virus pneumonia. His breathing improved precipitously. He had resistant hypertension this admission and was started on amlodipine. He did have mild hyponatremia this admission but did not appear to have any volume overload. TSH elevated at 13.8. Will need repeat study. He did also have rising procalcitonin and received few doses of antibiotics. Lipid panel was benign. ED Discharged 5/9/2021 (58 minutes) Hospital ER Treatment team Thrush, oral Clinical impression Sore Throat Chief complaint ED Provider Notes (Physician Assistant) Emergency Medicine Cosigned by: (Doctor) at 5/9/2021 6:45 PM Attestation signed by (Doctor) at 5/9/2021 6:45 PM The patient was seen and treated primarily by the PA-C. I did not independently evaluate the patient. Chief Complaint Patient presents with ? Sore Throat HPI Patient is a very pleasant 88-year-old male with recent COVID-19 infection diagnosed on 4/28/2021 on oxygen 4L NC, who presents to the emergency department complaining of sore throat x 1 day. He states that he started yesterday with a sore throat, painful to swallow, then noticed this morning that he had twice patches on his tongue and mouth. He states he is able to tolerate food and liquid, but that it hurts to do so. He denies any fevers or chills. From a Covid perspective, he states that he would not be here if it were not for the pains and sores in his mouth/throat. He feels that his breathing is stable and he is doing well on 4 L of oxygen nasal cannula as prescribed. He has finished a course of Decadron and states he is currently on no further treatment for COVID-19. ED to Hosp-Admission Discharged 5/10/2021 - 5/13/2021 (3 days) Hospital (Doctor) Last attending ? Treatment team Aspiration pneumonia Principal problem Hospital Course Patient come to the hospital with complaining of abdominal pain and hypoxia and cough. Patient found to have a right middle lobe pneumonia. We are believing that it is aspiration pneumonia which is improving at this time. He had a recent COVID-19 infection which is resolving at this time. During course, GI, pulmonology, urology and oncology consultation obtained. Patient continued to improve clinically. Patient had a urinary retention because of the constipation. He is able to void now. Today morning, I am seeing him. He is feeling better. Is agreed to go home. I discussed with the patient's wife regarding plan. Once he fully recovered from pneumonia he need to have colonoscopy and possible biopsy of colon mass.

woke up two days after with 100% hearing loss in right ear and 70% impairment in left ear. Prior to vaccine, hearing was superb.

has a fever of 102; Caregiver tried to have him eat something but he took one bite said it did not taste quite right; slept most of the day/sleeping more than usual; This is a spontaneous report from a Pfizer Program. A contactable consumer reported that an 89-year-old male patient received first dose of bnt162b2 (Solution for injection) via unspecified route of administration on right arm at single dose on 23Jan2021, 14:00 (Saturday). The patient medical history included ongoing dementia (He has a little bit of dementia which has been ongoing since unknown date but at least 10 years) and Maybe some thyroid issues. The patient concomitant medication was not reported. On 27Jan2021, the patient slept most of the day/sleeping more than usual, caregiver tried to have him eat something, but he took one bite said it did not taste quite right and had a running fever of 102 degrees Fahrenheit. It was reported that patient usually wakes up around 9:00 to 9:30 and read his book but on 27Jan2021 he has been in his chair and slept most of the day, about 3-4 hours until around 14:00 to 14:30. The caregiver gave him some Tylenol and he was reading again with events ongoing and persistent. The reporter enquired whether these events were normal after vaccination because he would have had the symptoms onset closer to the date of vaccination. Therapeutic measures were taken for fever. The outcome of the events was not recovered. Information about lot/batch number has been requested.

03/16/2021: Presented to the emergency department with intractable headache (last 3 days) and vision changes (last 6 months). The patient was admitted for uncontrolled hypertension and rule out meningitis. The patient is still currently admitted.

Incredibly weak; unsteady on feet; 6cm mass on neck; rash on legs; now food all tastes metallic; This is a spontaneous report received from a contactable consumer, the patient. An 89-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown), via an unspecified route in the right arm on 11Feb2021 at 09:00 as a single dose (at the age of 89-years-old) for COVID-19 immunisation. Medical history included benign prostate hypertrophy. The patient had no known allergies. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 after vaccination. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) and prostate pill (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date. On 19Feb2021 at 14:00, the patient experienced incredibly weak, was unsteady on feet, had a 6cm mass on neck, rash on legs and food tasted metallic. It was reported that the patient was perfectly healthy prior to vaccine and had a great appetite prior. The events resulted in emergency room visit twice and the patient was treated for these events. On an unknown date, the patient underwent lab tests as treatment for events which included blood work, EKG, chest X-ray, urinalysis, CT scan all with normal results. All the testing done in emergency room had been normal except for mass on neck, it was scheduled to have biopsy of neck on 23Mar2021. The doctors suggested that it was all from the vaccine. The clinical outcome of the events incredibly weak, was unsteady on feet, had a 6cm mass on neck, rash on legs and food tasted metallic was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.