Pfizer

Pt son, reports patient passed away on 2/1/21 in the early hours. Pt wife, told Pt's son that patient started feeling "bad" with common cold like symptoms on 1/31/21, had a temp of 99.0. Pt's wife went to take a shower, when she got out patient was unresponsive. She called EMS, they pronounced patient deceased upon arrival. Pt's son also reports patient and Pt's wife both had their 1st COVID-19 vaccine 13 days prior. He was told by EMT on sight to notify the facility where they received their vaccines. He did contact them and was told to notify PCP.

diaphoresis, flushing, anxiety Narrative: Began feeling symptoms during monitoring period-mildly diaphoretic, dizzy, flushing upon standing. Was anxious about second vaccine. Received monitoring of vital signs for additional 15 min and water provided. Released to home.

Fever to 100 degrees F., shaking teeth rattling chills, headache , myalgia, sore muscles, fatigue, joint pains and insomnia

Pronounced soreness near injection site; Mild flu-like symptoms; vivid dream; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration in left arm on 22Jan2021 21:30 at a single dose for COVID-19 immunization. Medical history included none. Concomitant medication included levothyroxine sodium (THYROXINE), vitamin D, tamsulosin. The patient experienced pronounced soreness near injection site, mild flu-like symptoms, and vivid dream on 23Jan2021 01:00. Pronounced soreness near injection site. Mild flu-like symptoms strong for two hours and then diminishing with time. Very, vivid dream, detail rich, color, flashing light. No treatment received for the events. The outcome of the events was recovered on an unspecified date. The events were assessed as non-serious. Facility where the most recent COVID-19 vaccine was administered was Hospital. No other vaccines received within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been been tested for COVID-19.

Client verbalized feeling anxious after receiving the vaccine. Client was evaluated by Fire Rescue Paramedics onsite and cleared to go home. Patient wanted to be transported to the hospital for further evaluation. Client was transported to Hospital at 10:am.

Patient presented for second COVID vaccine (1st dose given 1/21/21). While in observation, patient started feeling chest & throat tightness. Nurse in observation reports pt looked anxious. EMS was called over. EMS assessed patient and advised transfer to emergency department. Patient was taken to ER. At the ER, patient was diagnosed with chest tightness and shortness of breath. He received 325 mg of aspirin. EKG showed rate 63, no ST-T changes, no ectopy, normal PR & QRS intervals with rhythm atrial fibrillation. No epinephrine was given in the field (at vaccination site) or while in the ER. Patient was in NSR at time of discharge with recommendation for close cardiac follow up.

Following day after vac. resident had increased lethargy, nausea, altered mental stats, temp 100.1 bp 96./52, hr 107. Sent to er 1/29, returned 1/31 diagnosis systemic inflammatory response syndrome. On 2/1 resident had temp and respiratory distress. Sent to er again. Returned 2/3 with diagnosis CHF. On 2/7 resident sent out again after stat labs and xray. xray showed infiltrates. Returned from er on 2/10 diagnosis acute encephalopathy and metabolic encephalopathy.

Patient was vaccinated tihe Pfizer #1 2/12/21. Started feeling weak 2/13 and presented to ED on 2/14. Was admitted to Hospital. Found to be COVID +, required O2 per NC 2-3 L for approx 24 hours. Was found to have NSTEMI. Was transferred for speciality/cardiology care at General Hospital. Was on heparin gtt. Cardiology-no intervention. Was not treated for COVID and was discharged to home on 2/16. Was unable to care for himself at home and was readmitted with in hours. He has failed discharge twice and is being now discharged to SNF

he violently threw up/vomiting; lost control of all of his extremities; acute pancreatitis; had no strength; affected his memory; barely moving; balance was horrible/his whole balance everything was off; lost his appetite right away; not eat; This is a spontaneous report from a contactable consumer reporting for the husband. A 76-year-old male patient received the first dose of bnt162b2 (Batch/lot number: EL3302), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included Allergy from an unknown date, blood pressure abnormal from an unknown date, ongoing kidney patient and was on dialysis three times a week. Concomitant medication included insulin aspart (NOVOLOG), insulin glargine, vitamin b complex (SUPER B COMPLEX), acetylsalicylic acid (BABY ASPIRIN), vitamin d3, ascorbic acid, biotin, folic acid, mecobalamin, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine (DIALYVITE), atorvastatin, cetirizine for Allergy, fish oil, docusate, amlodipine besilate for Blood pressure and other medications as the patient was kidney patient. For Concomitant medication amlodipine besilate, the consumer stated, Right now at this time he was not supposed to take them on his dialysis days. So, he took one tablet on Saturday & Sunday, Tuesday & Thursday. The patient had his first shot of the Pfizer on 21Jan2021, he lost his appetite right away and wasn't eating. And then on 29Jan2021 he took 2 bites of a meal, and had extremely volatile vomiting and lost control of all of his extremities. He violently threw up on the 29Jan2021 and from that's when on he had no appetite, she couldn't get him to eat anything. Her daughter had to help her pick him up of the floor, the Friday night 24 hours it was just horrible. The consumer stated, Saturday morning (30Jan2021) he had gotten use of extremities back but barely moving and still very, his whole balance everything was off. He was able stand up and use the restroom by himself. This had all affected his memory, he couldn't do his medications alone anymore and he couldn't take care of himself. And then on the 12Feb2021 the consumer took him over to the hospital because after when he vomited on the 29Jan2021 he lost all use of his extremities. They diagnosed him with acute pancreatitis, but he still, he was in the hospital from Friday 12Feb2021 and they released him on the 17Feb2021. And he still had no strength. His balance was horrible. It was affecting, whatever it was affecting his memory. The consumer stated they had no idea why he came down with acute pancreatitis and he never had any pain with it. They said they were amazed that he was not in severe pain, never any pain. The outcome of events had no strength and balance was horrible was not recovered. The outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187441 Same reporter/patient/product, Different dose/AE

I felt great after my vaccine until midnight that same day. My legs from the knees down including my feet were painfully cold as if they were on dry ice. I didn't get much sleep that night, but the next morning at 2:00 a.m. the pain was gone. I was just extremely fatigued which was a symptom I expected. I don't know what to think of the first symptom but wanted you to know. Thank you.

Patient presented to the Emergency Department with fever and confusion. After receiving his second dose of Pfizer Covid vaccine, someone stopped in to check on him and he was confused. He had only had a donut since he got the vaccine 24 hrs ago. He was struggling to do his normal activities of daily living. Oxygen readings were in the 80s at home, heart rate was over 100, and temperature was over 100. The patient was complaining of diffuse body aches. He did not have a headache, chest pain, shortness of breath, abdominal pain, vomiting, or diarrhea. Past medical history is remarkable for chronic pulmonary disease due to asbestos exposure, Covid infection the last November. While in the ED, he was treated with a liter of normal saline, a liter of lactated ringers, 1000 mg of acetaminophen, and 600 mg of ibuprofen. His heart rate decreased and fever was gone after receiving fluids, acetaminophen, and ibuprofen. The patient was then discharged home.

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.

Received 2nd vaccine on 3/5/21 & developed symptoms on 3/6/21. Symptoms lasted 2 days. Symptoms included confusion, Fever > 100, Oxygen Saturation upper 80's, & body aches.

Same evening of vaccine injection 3/24 - chills and severe headache and extreme fatigue. Overnight - nausea, vomiting and fever 102.6. Next morning 3/25, woke up and tried to get out of bed. Legs were so weak they gave out and I fell out of bed on the floor. I had no strength to get back up to get on the bed. My wife could not lift me, so she called 911 for a "lift assist". Paramedics were told I received the 2nd dose of the Covid vaccine the day before, so they picked me up off of the floor and put me back in bed. They took my vitals - blood pressure was 116/73 and temperature was still 102.6. Paramedics offered to take me to the hospital but I refused. Paramedics told my wife that if my breathing became labored, she should get me to the ER or call 911 again. I was not able to get out of bed the whole day on Thursday 3/25, because I was so weak I could not stand up, and I also had body aches and had to use a urinal because I could not walk to the bathroom. My wife gave me Tylenol and the fever finally broke late evening of Thursday 3/25 and I started to feel a little bit better. I had not eaten all day, but my wife made sure I stayed hydrated with water. On Friday morning 3/26 I was able to sit up on the side of the bed, and I was able to walk with the assistance of a cane to the bathroom. Extreme fatigue affected me all day Friday, but I did feel better. Fever did not come back after it broke. Saturday 3/27 - still experiencing extreme fatigue, but feel better overall.

12h after COVID vaccination awoke with severe bilateral muscle/buttock/leg pain, nausea, vomiting and ultimately some confusion and disorientation with possible left sided focal neurologic deficits. Sodium initially 127 on admission, but may have been artifact, as simultaneous venous blood gas electrolytes showed 135. On following day had platelet count of 115k, repeated at 90k

2/17 received 1st dose vaccine, Pfizer 2/20-3/9 admitted. Found to have seizures (twitching of upper extremities, aphasia). 2/24 RML pneumonia. Found to have MSSA bacteremia and bacteriuria. Transition from vanco/pip-tazo to cefazolin Mental status improved and he was sent on cefazolin which he was to complete on 3/26/21. Was not sent out on seizure prophylaxis. 3/23 second dose Moderna. Had recurrent seizure on 3/27. Evidence of post central stroke. Expressive and receptive aphasia.

onset of chills around 10 pm, poor sleep due to chills. next day weak, tired. achy. fever of 103. chills and fever continued through next day. feeling better on 04/02/2021. still weak. was hospitalized in October 2021 for five days due to COVID.

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 !

At 30 mins he began shaking and appeared to pass out for a moment. He became confused. This morning he had fever, oxygen was low, not speaking not walking.

Vaccine kicked my Restless Leg Syndrome into high gear, making it impossible to sleep. Did not sleep for 2 nights in a row, until finally the reaction started to subside. Also, the vaccine gave me a minor case of hives rash. This has not subsided yet. But the RLS is NOT a minor problem, it is major, to me.

Could not sleep night the shot; Had chills; No appetite; could not have a bowel movement; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received first dose of BNT162B2 (solution for injection), via an unspecified route of administration, administered in left arm on 23Feb2021 14:00 (Batch/Lot Number: EWG200) at single dose for covid-19 immunisation. Medical history included covid-19. Concomitant medication included clarithromycin (CLARITIN [CLARITHROMYCIN]); atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN) colecalciferol (VITAMIN D). No known allergies. The patient not had other vaccine in four weeks. The patient was not tested for COVID post vaccination. The patient could not sleep night the shot. He had chills, chills stopped after 16 hours, No appetite, could not have a bowel movement on 23Feb2021 at 02:00 PM. Outcome of chills was recovered on 24Feb2021 and outcome of other events was recovered on an unspecified date of 2021.

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.

His arm was sore; Nausea; Headache; Fatigue; This is different feeling than what he normally feels; This is a spontaneous report from a contactable consumer (patient's wife). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264, Expiration Date: 31May2021) via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. Medical history included diabetes mellitus. On 04Feb2021 the patient experienced his arm was sore, nausea, headache, fatigue. On an unspecified date Feb 2021, the patient experienced this is different feeling than what he normally feels. The reporter stated, Yes, he takes a lot, I would rather not because its lot he is diabetic and he takes blood thinner and statin and its very long list, but these are different so those, the reason I called because this is different feeling than what he normally feels when he gets ups in the morning, and that's why I thought maybe it because of Covid. The patient underwent lab tests and procedures which included glycosylated hemoglobin, diabetes, I do I have to look up the result and the date, the date was 30Jan and it was blood draw for his A1C. The outcome of event different feeling than what he normally feels was unknown and other outcome of the events was not recovered.

1st shot, none. 2nd shot, 22Feb21 fatigue joint and wound soreness. Soon diminished.. But, I got shot through my throat and shoulder in RVN ?68 and a deep gash to my inner right forearm 11Sep01 exposing my bones and severed arteries. 2 months later I still feel tightness/constriction, soreness in my lower throat and upper lungs when I breath deeply such as running, exercising or sex to the point I have to slow down. Also my right forearm is no longer sore but still feels a little swollen.

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.

Had average Saturday at home, no illness. Layed in bed talking. Became nauseated, got up to vomit. Went back to bed, talking again. Said something wasn't right. Massive Heart Attack and Immediate Death. Police arrive in 2 minutes to begin CPR. Medic soon after. Efforts to resuscitate unsuccessful.

Chills, Pain all over the body, Palpitations, loss of appetite.insomnia. Today May 10, finally feeling better. Took Tylenol (1000 MG) as of Saturday night.

Acute pancreatitis; No appetite/he was starving himself to death; he lost all use of his extremities; Still not eating and is so weak/No energy/he still has no strength; Whole balance everything was off/His balance is horrible; he took 2 bites of food and vomited; Dizziness; Still not eating and is so weak; Affected his memory; This is a spontaneous report from a contactable consumer (patient wife). A 76-year-old male patient received second dose of BNT162B2 (mRNA PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262; 76-year age at the time of vaccination), via an unspecified route of administration on 09Feb2021 as single dose for COVID-19 immunization. Medical history included allergy, blood pressure, kidney patient (on dialysis three times a week, so he was a kidney patient). Concomitant medication(s) included Insulin aspart (NOVOLOG) (He takes Insulin with each meal he takes 6 units of NovoLog with his Demeter 6 units), Amlodipine besilate (5 mg tablet) taken for Blood pressure as 5 mg (one tablet on Saturday and Sunday, Tuesday and Thursday), Atorvastatin (40 mg tablet), 40 mg daily, Acetylsalicylic acid (BABY ASPIRIN) daily, Cetirizine (5 mg tablets) for Allergy at 5 mg daily, Ascorbic acid, biotin, folic acid, mecobalamin, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine (DIALYVITE) daily (1 pill daily), Docusate (DOCUSATE capsule) by oral 1 DF, 2x/day (One capsule by mouth twice a day), Fish oil (100 mg capsule) 100 mg, 2x/day orally, insulin glargine 1x/day (At bed time he takes 8 units of his Insulin glargine), Vitamin B complex (SUPER B COMPLEX [VITAMIN B COMPLEX]) and vitamin D3 daily; patient was taking other medications for kidney. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3302; 76 Year age at time vaccination) on 21Jan2021 for COVID-19 immunization and experienced lost his appetite right away, extremely volatile vomiting, lost control of all of his extremities, this has all affected his memory, acute pancreatitis, barely moving, balance was horrible/his whole balance everything was off; had no strength. It was reported patient received his 1st Pfizer vaccine shot on 21Jan2021. He "lost his appetite right away and wasn't eating." Then on 29Jan2021 he took 2 bites of a meal, and "had extremely volatile vomiting and lost control of all of his extremities. My daughter had to help me get him up from the floor." the next day "he was able stand up and use the restroom by himself. This has all affected his memory, he cannot do his medications alone anymore and he cannot take care of himself." 09Feb2021 he received the 2nd vaccine dose. "Again that night he took 2 bites of food and vomited. The next day, he still had no appetite, he took shower and then went to bed with dizziness (10Feb2021) and no energy." stated she took him to the (hospital name) on 12Feb2021 and he was admitted to the (hospital name) with "acute pancreatitis (Feb2021) and was released on the 17Feb2021. They should have kept him longer, because he is still not eating and is so weak (Feb2021), I am worried." Further stated, " He had his first shot of the Pfizer on 21Jan2021 and then he violently threw up on the 29Jan2021 and from that's when on he had no appetite, I couldn't get him to eat anything. And then he had his second shot on the 09Feb2021. On Thursday, the 11Feb2021 he violently threw up again after taking two bites of food. And then on the 12Feb2021 I took him over to the (hospital name) because after when he vomited; he lost all use of his extremities (Feb2021). My daughter and I were having to pick him up of the floor, the Friday night 24 hours it was just horrible. Saturday morning he had gotten use of his extremities back but I mean barely moving and still very, his whole balance everything was off (Feb2021). Now when I took him into the hospital they diagnosed him with acute pancreatitis, but he still, he was in the hospital from Friday the 12Feb2021 and they released him on the 17Feb2021. And he still has no strength (Feb2021). His balance is horrible. It was affecting, whatever it is affecting his memory. the medical records when he went in the hospital and everything if they would like. They have no idea why he came down with acute pancreatitis and he never had any pain with it. They said we are amazed that he was not in severe pain, never any pain. I want to find out if they feel that it had anything to do with the vaccine and if it did if there's anything we can do to improve because he is terribly, terribly getting worse." also stated, "He started experiencing the problems right with in that time period of him getting both shots." Also reported, Affected his memory in Feb2021. Reporter stated, "Because I didn't know, he was starving himself to death (in Feb2021) he couldn't hold anything down. He wouldn't eat and when I went (incomplete sentence)" The seriousness was reported as hospitalization for the events Acute pancreatitis; Appetite lost; Muscle disorder; Asthenia. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021191555 Same reporter/patient/product, Different dose/AE

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.

he did not feel well; he then got tested for covid and tested positive for covid; he just did not feel like himself and still thought it was from the shot and he was not 100 percent it seemed; he did not want to eat but could smell and taste food but did not want to eat it/ loss of appetite; he started feeling drowsy/ kept falling asleep/ dozing off; the next day started feeling very tired/ tiredness; lost about 12 pounds; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 18Feb2021 10:30 (Batch/Lot Number: EN5318) at the age of 76-years-old as first dose, single in the left arm for COVID-19 immunisation. Medical history included acute pancreatitis, diagnosed about 10 years ago (2011) and cirrhosis liver, diagnosed maybe 7-8 years ago. The patient's concomitant medications were not reported. The patient previously took Hepatitis A vaccine on 03Feb2021 and has no dosage, lot number, expiry date to provide. The patient stated that he was calling about the Pfizer COVID vaccine and stated that he had the 1st dose on 18Feb2021 10:30 and did not get the 2nd dose; stated that he had the first dose and the next day (19Feb2021) started feeling very tired and thought it was a result of the shot and it lasted until the following Friday, 26Feb2021 and he then got tested for covid and tested positive for covid on Friday 26Feb2021. The patient stated that his healthcare professional (HCP) sent him for an infusion that day and hooked him up to the infusion and said it would help him get better faster and the patient does not know the name, dosage, lot, expiry date of the infusion and has none of that information to provide. The patient stated that he was told he can't get the 2nd shot for 90 days after the infusion and heard that he could get it and the infusion center told him he would have to start all over again with the 1st shot of the Pfizer COVID Vaccine and he does not know but has heard different stories and some say he can get the 2nd dose of the vaccine and others say no he has to wait 90 days after the infusion and he called the facility and the HCP said he would have to wait 90 days after the infusion; states the facility said to wait 90 days and he was told they are going by the agency. The patient stated that his patient card for the Pfizer COVID Vaccine says he was supposed to go back for the 2nd dose on 11Mar2021. The patient also stated that when he went home after the Pfizer COVID Vaccine 1st dose he felt fine and got up and went to work and was fine and then noticed at work he started feeling drowsy (on 19Feb2021) and usually works in the street outside but was in the office that day; patient stated that he started dozing off and then the next day on Saturday (20Feb2021), he just did not feel like himself and still thought it was from the shot and he was not 100 percent it seemed and he went to go to work the following Monday and Tuesday and Wednesday and kept falling asleep in his office and then it was finally Friday. The patient also stated that he did not want to eat but could smell and taste food but did not want to eat it on 19Feb2021 and the following week he took the whole week off of work and lost about 12 pounds; he also stated that the tiredness lasted into the following week and the loss of appetite, dozing off is not ongoing and lasted probably a good three weeks total until he started feeling from the day after the vaccine on 19Feb2021 for three weeks and then he started feeling more like himself. The patient stated that he was fine up until he did not feel well and it was not probably from the vaccine but was just a coincidence the next day when he started feeling tired and he does not know the results from the vaccine but got worse and worse and could not function normally like he is supposed to and just wanted to lay down. The patient stated that he did not have treatment for the reported events. The outcome of the event "the next day started feeling very tired/ tiredness" was recovered on 26Feb2021, for events: decreased appetite and somnolence was recovered on an unspecified date. The outcome of all other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

nausea; Headache; Fatigue; different feeling than what he normally feels; His arm was sore; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 23Feb2021 14:02 (at the age of 76-year-old) (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included diabetes from 1996. The patient's concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN9264) administered in the right arm on 02Feb2021 (at the age of 76-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization where patient also experienced his arm was sore. On 24Feb2021, the patient experienced nausea, headache, fatigue, different feeling than what he normally feels, and his arm was sore. The onset time for the events headache and nausea was at 09:00. The patient was admitted to the hospital due to the events nausea, headache, fatigue, and different feeling than what he normally feels. The events did not require emergency room and physician office visit. There was no treatment received for all events. On an unspecified date, the patient recovered from all events. Follow-up attempts are needed. Further information has been requested.

Lost weight; He had no appetite; Stomach cramps; Dehydrated; Tired; no energy; Confused; Headache; Diarrhea; Not digesting food; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Lot Number: EL9269), in left shoulder on 13Feb2021 06:30 as dose 1, single for covid-19 immunisation (76 years old when vaccinated). Medical history included damaged his thumb a couple of years ago. There were no concomitant medications. The patient reported that he got the shot this morning. After he got the shot on 13Feb2021 he had to wait for 15 minutes before he could leave. While waiting the 15 minute time period he got a slight headache at that time. He later stared to drive home and realized he was feeling confused. He decided to get something to eat and that did make him feel better. However, he felt like he was not digesting his food all day. He felt like he was still bloated. He was not processing the food he had eaten. He added, the food he did eat he thought the eggs were not done. Normally, he would not eat them, but he was in a hurry. After that he did not eat any food. He was unable to eat any food. Later that day he began to have a bad reaction. He felt extremely tired. He then started to lose his body fluids. He would sit down and it would run out of him. He decided to quarantine himself. He stated he could not use the internet because he lives in a place where they do not have internet. He was tired, had no energy. He just kept losing body fluids constantly. He has lost weight. He felt dehydrated. Stated he did not have a fever. He had a thermometer and was checking it every hour. It felt like at the time when events first started he was getting worse and worse and so he just laid there. He stated he does not know his current weight. He was dehydrated so bad. He lost so much weight his shoes does not even fit his feet. Later, he confirmed he no longer has a headache. He last had a headache slightly yesterday. He added that the headache could have also occurred due to lack of eating. He had no appetite. He was unable to provide if recovered completely or recovered with lasting effects when probed for outcome. He stated he just felt ran down. He clarified losing body fluids as he had like water, like diarrhea, it was running right out like it would out of a body bag. He could not stop it from coming. It would happen every few minutes. He confirmed that he no longer has diarrhea. He had started taking Kaopectate. He reported that he last had diarrhea a little yesterday morning. He does not have it anymore. He just has no energy left. He would lay down because he was so tired and then he started having the diarrhea and it kept getting worse and worse. He ate a little this morning, a breakfast roll. The day he got the vaccine he was so tired. He slept a lot. This was early afternoon. He got up because he realized he had made a mess with the diarrhea. He started having stomach cramps the night of 13Feb2021. He had some when he laid down. He still had some last night when he laid down. He does not know if the stomach cramps have resolved yet, stated he is still waiting to see. He will have to see when he lies down. However, he is trying to get out and about to get some things done and get something to eat. He stated he was taking Tylenol, but the Tylenol was mainly for the stomach cramps. By 14Feb2021 he started to feel dehydrated. He felt that by then he had already stopped up the sewage system. He was taking electrodes from (Pharmacy) due to the dehydration. He knew this was going to be a problem. Therefore, someone went out and got this for him. He stated that he feels better overall. He will truly see when he tries to get something to eat. He stated he does not take any medications whatsoever on a regular basis. He added, the guy who gave him the shot caller does not believe he has given too many shots before. He thought he was a rookie. He stated he went too high to begin with. He said that normally, shots don't hurt with him and this time it did slightly. He reported that he gets the flu vaccine every year. He was supposed to get the second shot 06Mar2021, but he was not sure about if he should get it and has questions about that. The outcome of the event headache was recovered while diarrhea, he had no appetite, lost weight and confused was not recovered. The outcome of the event not digesting food, dehydrated and stomach cramps was unknown while the outcome of tired; no energy was recovering. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

pain in right elbow and both knees; pain in right elbow and both knees; fell down; he has had chronic pain in his knees prior to receiving the vaccine, however, it has gotten worse; had a problem in his left back, and then went to his left shoulder; had a problem in his left back, and then went to his left shoulder; bedridden; knees have gotten weaker; more scared; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical in-formation team. Pfizer sponsored program (CEP ID: 159558). A 76-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176) via an unspecified route of administration and administered in right arm on 01Jun2021 10:00 (at 76 years old) as dose 1, single for COVID-19 immunization in pharmacy. The patient medical history included ongoing high blood pressure diagnosed maybe over 10 years ago. The patient concomitant medication include allium sativum (KYOLIC) taken for high blood pressure 2 tablets, formula 100, 600 mg (It was a cardiovascular formula. He substituted this because he did not like what he was taking before); vita-min c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for something i guess for cold (been taking all his life) 500 mg; fish oil (OMEGA 3 [FISH OIL]) taken for something that builds you up (started taking years ago) at 100 mg once daily. The patient did not had any AE(s) following prior vaccinations, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine, no family medical history relevant and no relevant tests. There was no history of all previous immuniza-tion with the Pfizer vaccine considered as suspect. On 02Jun2021 (in the morning when he tried to get out of the bed) patient experienced pain in right elbow and pain in both knees after 1st dose and last-ed days, then weeks, and continues to on and off. Tried getting out of bed and he fell down and went to the hospital. Patient stated that he has had chronic pain in his knees prior to receiving the vaccine, however, it has gotten worse since the vaccine. Reported that on an unknown date in 2021 he had a problem in his left back, and then went to his left shoulder and that he was "practically bedridden for days, and then weeks after the first dose, things have been different since the Pfizer shot and my knees have gotten weaker". Patient provided information that he does take a ginger supplement in the mornings. Next morning patient did not use a full breakfast, he wanted to know if he had done some-thing to make his body feel different. Patient stated that he was more scared now than he was before the shot because he does not know if he was protected. The reporter said that he expects that pain and aches could be symptoms of the Pfizer shot but he did not know if this experience was normal. Patient was supposed to get the second COVID vaccine on 22Jun2021, but he had pain 3 days after the received the first shot. He stated the pain was in his right elbow and both of his knees. He mentioned that he missed his second dose because he went to the hospital to get checked out. Patient wanted to know why he had been experiencing this pain for 3 weeks now and would like to know if it was ok or if he was in danger. Patient confirmed that he went to the hospital because of everything that was hap-pening to him. He stated one night, a Thursday, before he went to the hospital, which was the follow-ing week, all of the sudden woke up and had to go to the bathroom. He tried to get out of bed and he fell. He could not get up off of the floor, because his knees were not strong enough to push himself up. He told the hospital everything that happened to him. Patient stated the problem started after the first shot. They proceeded to give him a scan for his brain and his back. After, they wanted to scan his knees. He told them he came from an (withheld) where he played soccer and rode bikes. He has had problems with his knees bothering him, but not both knees at the same time. He said they wanted to scan his knees. He told them he had problems before and he uses hot water and salt, and his knees were fine. He does not think his knees are the problem, he has a different problem. They said fine, you do not want it, fine. Then they said they would do a chest scan. He has not had any problem for three weeks. No problem with breathing or anything. He wanted to find out what happened after he got the shot. Patient stated he was never in immediate pain. He had pain with movement. For three weeks he was only going to the toilet. He almost fell on the toilet and could not get up because his knees were so weak. He had to take like 10-15 minutes trying to get off of the toilet. Patient stated now he was sitting, his knees have no pain. But when he gets up he knows his knees will hurt. Pain on his right elbow, clarified that the pain in his elbow started on 2Jun2021. Patient was using his elbow to push himself up from lying down, and said very very rarely he has any problem in his elbow. His elbow was okay after a couple of days. If he was in bed he usually uses his elbows to roll over. Stated that he has recovered about 95%. He stated he was 76 years old, he was not young anymore. Patient con-firmed his elbow and knees began to hurt after receiving the first COVID-19 vaccination. He stated it was debilitating when he was trying to get out of bed or sit or stand up. It was immediate, but not the day that he got the vaccine. It was all around him trying to get out of bed and do certain thing that he needed to do and he found that he could not get out of bed; unable to clarify further. Patient unable to provide start date. knee pain: He said it is not causing any irritational pain when he is sitting down. When he tries to get up he can feel the stiffness in his knees. At that point he knows there is a problem in his knees. Patient stated when he went to the hospital they told him they were going to take some blood. He turned away from what they were doing and they gave him some kind of intravenous. He was in the hospital for over an hour. After he questioned them about the first test, and there was no problem. When they said they were going to do his knees and his chest, which was a complete set of tests that they were doing, it has nothing to do with what he was experiencing. He thought he was ex-periencing something from Covid and he was wanting to know if he was going to die. They did not seem to care about what his problem was. He thought COVID had a system where people would be tested for reactions and things like that. Has had problems with his knees off and on maybe once or twice a year but has never gone to the hospital for them. Sometimes his brain does what it wants to do. There was no additional vaccines administered on same date of the Pfizer suspect. Patient visited the emergency room. The patient underwent lab tests and procedures which included chest scan, scan brain on an unknown date with unknown results. The outcome of event pain in right elbow was recovering and pain in both knees and fell down was recovering, outcome of event pain in right elbow and both knees was not recovered, outcome of events had a problem in his left back, and then went to his left shoulder, gotten worse, bedridden, knees have gotten weaker and more scared was unknown. Follow-up attempts are completed. No further information is expected.

kept going back and wanting to go to sleep; Fever; weak; chills were real bad, it made him shake; pulse has been high ever since the shot; has the thing you put on finger to read oxygen, it was 92 one time; arm sore; This is a spontaneous report from a contactable consumer(patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Deltoid Left on 11Feb2021 (at12:00) (Batch/Lot Number: EN9581) as Dose Number Unknown, 0.3ML Single for Covid-19 immunization. Medical history included Gastroesophageal reflux disease, Blood cholesterol; Only takes acid reflux and cholesterol medicine and Covid-19 From an unknown date and unknown if ongoing. The patients' concomitant medications were not reported. The patient experienced Arm sore on 11Feb2021, Fever on 12Feb2021 at 05:48, Chills were real bad, it made him shake, Pulse has been high ever since the shot and Has the thing you put on finger to read oxygen, it was 92 one time, weak on 12Feb2021, Kept going back and wanting to go to sleep on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 101 on 12Feb2021, Body temperature: 101.6 on 12Feb2021, Body temperature: 100.3 on 12Feb2021, Heart rate: high on 12Feb2021, Oxygen saturation: 96-98 on 12Feb2021, Oxygen saturation: was like 92 one time on 12Feb2021. There was no Assessment. A query was raised to confirm Patient's last name and then the response was received After listening to the recording. The outcome of event for Arm, Chills were real bad, it made him shake, Pulse has been high ever since the shot and Has the thing you put on finger to read oxygen, it was 92 one time, and Kept going back and wanting to go to sleep sore was unknown. The outcome for event Fever and weak was resolving. Follow-up attempts are completed. No further information is expected.

After the first vaccine he suffered a massive brain bleed. Then in the nursing home he contracted Covid-19 and was in Hospital Heart Transplant unit for 6 days. After 4 or 5 days back in the nursing home he contacted Covid-2 pneumonia. His balance is off he has memory loss and a lot more.

Momentary loss of memory and lapse of time. Memory loss. Hard to concentrate; Momentary loss of memory and lapse of time. Memory loss. Hard to concentrate; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 15Mar2021 15:00 (Batch/Lot Number: EN6206), age at vaccination of 76-years-old, as single dose, for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, coronary artery bypass from an unknown date and unknown if ongoing (6 years ago or more), mycotic allergy from an unknown date and unknown if ongoing (allergy medicine for mold weekly). The patient previously took erythromycin and experienced drug hypersensitivity. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Right arm on 22Feb2021 16:00 (Batch/Lot Number: EN6198), age at vaccination of 76-years-old, as single dose, for covid-19 immunisation. The patient received unspecified concomitant medications (Other medications in two weeks: Too long to list - as reported). The patient experienced momentary loss of memory and lapse of time, memory loss, hard to concentrate, all on 29Mar2021; the events were serious as medically significant. No treatments were given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.

THE NIGHT OF VACC DAY, C/O SEVERE INJ ARM PAIN. THE FOLLOWING DAY, HE BEGAN DISPLAYING VERBAL AGGRESSION AND OUTBURST TOWARDS STAFF WHICH IS OUT OF NORMAL FOR HIM, INCREASED DIFF REMEMBERING SHORT TERM, C/O DIZZINESS AND SEVERE HEADACHE RATED 10/10 ON PAIN SCALE NOT RELIEVED WITH SEVERAL DOSES OF PAIN MEDS AND RANDOM DIZZINESS

THE NIGHT OF VACCINATION DAY, RESIDENT BEGAN C/O SEVERE PAIN IN THE INJECTION ARM. THE DAY AFTER THE VACCINE, HE BEGAN HAVING MOOD ISSUES, VERBAL AGGRESSION/OUTBURSTS (ABNORMAL FOR THIS RESIDENT), DIZZINESS AND A SEVERE HEADACHE HE RATED AT 10/10 PER PAIN SCALE THAT DID NOT RESOLVE WITH SEVERAL DOSES OF PAIN MEDS.

Increased temp of 99.2F oral, extreme fatigue, lethargy, episode of incontinence, hallucinations beginning in the morning and has continued through the day.

Pt received injection, immediately became dizzy, mildly anxious. Dizziness lasted, 5-6 minutes and resolved without any intervention. Pt monitored for 30 minutes, ambulated out of clinic independently.

Patient received unknown covid vaccine 1/20/21, sometime before or after became Covid PCR+. 3 days later developed encephalopathy, was quite agitated, walking around hospital naked. He had LP which ruled out infection and CT imaging to rule out CVA. Improved after 24 hrs with supportive care, pt returned to mental status baseline

Massive Confusion. Resident usually very alert and aware, and had a huge lapse in time and span. Resident has never exhibited this type of confusion..

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!

The night of vaccination (Sat): Pain at right side hip bone difficulties falling in sleep The next day (Sun): Pain at right side hipbone when I bend to put on socks, sit down, get up, or walk. No pain while sitting in one position. The night the next day (Sun): The pain subsided enough that I could fall asleep. Two days later (Mon): The pain reduced enough that I could put on socks with little difficulties. I could move normally with little or no pain. It is getting better rather quickly.

I had my second Covid-19 vaccine last Friday at noon, January 29, 2021. I felt fine until late Friday evening. I woke up around 3am violently panting and trying to get his breath. After what could have been a minute or many minutes, I started breathing normally. My Friday night sleep was terrible. I woke with a temperature around 101. After taking Acetaminophen, my temperature went back to normal. Towards evening my temperature went up to about 101 and I was achy all day. Saturday evening was a good evening and I woke up feeling fine on Sunday.

fever 102-chills- unable to walk-disorientated-loss of appetite-dizzy- we had to take him to his Dr in a wheelchair on Monday ,February the 1st. Doctor put him on covid meds and he is still to this date (Feb. 6th) still weak . we had a covid test done and it was negative.

WHEN I WAS GETTING OUT OF BED I WAS VERY DIZZY AND UNSTABLE. I SAT ON THE BED FOR ABOUT 10 MINS AND WAS ABLE TO WALK AROUND, BUT FELT LIGHT HEADED. I CHECKED MY BLOOD PRESSURE AND BLOOD SUGAR AND THEY WERE FINE. I HAVE NO PAIN. I GOT UP THIS MORNING FEB. 6 AT 6 AM. I SAT ON BED FOR A FEW MINUTES BEFORE I STOOD UP AND I FELT UNSTABLE FOR A FEW MINUTES, BUT DOG OKAY.

Patient complained of feeling light headed and "weird". Patient alert and oriented. Denies n/v/d or itching. BP 147/92, HR 97, SAO2 96%. Patient reports similar feeling after annual influenza vaccine but did not require medical care. Patient requests transport to ED for further evaluation.

had a feeling like taste liberty; Diarrhea; hemorrhoids; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: unknown) via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetic. Concomitant medications were not reported. The patient stated he took the vaccine shot, Covid 19 and he suddenly got diarrhea, hemorrhoids that was on 22Jan2021 on the Friday. Then he experienced some problem with it, the next day the 23Jan2021 it was Saturday. Again he woke up this morning (on 25Jan2021) which was Monday and had a feeling like taste liberty. Asked if that was probably the side effect or a reaction to be treated. Patient stated blood work but he did not have the records right now. Patient stated he took bismuth subsalicylate (PEPTO BISMOL) and a zinc sulfate (PEPTIN, reported as Kill Peptin). He took bismuth subsalicylate Pepto Bismol. It was for the fluid of the stomach and diarrhea. It was called Pepto Bismol. He did not how to spell it. The events were considered as non-serious. The outcome of events was unknown. Information on the lot/batch number has been requested.

1. Pain at site of injection started about 6 hours post second vaccine injection (7-8 on a 0-10 scale) that lasted for almost 48 hours, most intense during the day following injection. No treatment for that. 2. Significant fatigue on the morning 14 hours following the injection (could have started during the night) . Difficult to maintain balance. Just rested the whole day. Unable to exercise on stationary bike. 3. Low grade fever (just under 99 F; base line for me has been 97.6 F) in the evening following injection, gone next morning. No treatment.

48 hours after the 2nd dose of the COVID-19 vaccine, he had generalized body aches that had worsened, chills, agitation/anxious, dizzy, and hyperventilating/ shortness of breath. He went to the hospital with his wife on 3/1/2021. He stated "I think I'm going to die". Patient had been off Cymbalta for 3 days completely- treating neuropathy (previous daily medication that his primary physician advised him with weaning down the dose). The patient was manic and had tangential thoughts- from crying/angry to laughter. It is believed that the agitation could be due to medication withdraw.

Patient described the event as "severe anaphylaxis" that included redness all over the body and a rash on the face, with a strange feeling in the esophagus but no trouble breathing. The patient self-medicated with prednisone and did not seek medical care. Symptoms resolved later the same day they appeared. The patient indicated he had an appointment unrelated to this event scheduled with his primary care physician on March 3, 2021, and was advised to discuss the reaction with the physician at this appointment.

had severe acid reflux; trouble breathing for about 15 minutes; was wheezing and sounded like an asthma attack.; Felt like something was stuck in his throat; He feels tired now; vomited lying down; Right now his throat is burning; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient woke up and had severe acid reflux, trouble breathing for about 15 minutes, couldn't catch his breath, was wheezing and sounded like an asthma attack. He felt like something was stuck in his throat. It cleared in 10 seconds and he could breathe and swallow fine. He took a Benadryl as treatment and drank water. He also felt tired. The patient further reported that he had the covid vaccine shot. He did not know if he was having a reaction, but he was taking a nap, and he guessed he regurgitated. He had a difficult time catching his breath, it was like it was stuck in the throat. He vomited lying down. He felt the stomach acid come up into mouth after he was able to breath better. But before he was not breathing at all. This never happened before. He was lying flat, he guessed he threw up. He had a large lunch, maybe too large. It was like he was getting something caught in in throat. The patient also reported that his throat was burning and mentioned that he slept on a triangular pillow. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.

Five days after vaccine shot, patient experienced extreme dizziness which lessened each day but lasted 10 days. There were three episodes of confusion.

1st vaccination Friday. I was fine on Friday. Saturday woke with sore throat, neck, mucus, sore muscles and weak. By mid-afternoon had to go to bed and slept for hours. Got up at 9PM and went back to bed at 11PM. Sunday was better, but this AM (Monday) awakened with itchy skin, pins and needles on hands and feet (gone now) and total exhaustion. Had difficulty breathing (better now), can barely lift arms and had to miss work and went back to bed. I am reporting this because I am scheduled for a 2nd shot on the 26th and not certain it's a good idea.

Insomnia; Chills; This is a spontaneous report from a non-contactable healthcare professional, the patient. This 77-year-old male reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En5318) via an unspecified route of administration in the left arm on 05Feb2021 at 02:30 (as reported) (at the age of 77-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications were not specified. The patient experienced insomnia onset at day 8 then thru day 14 and chills day 10. The patient was not treated for insomnia and chills. The clinical outcome of insomnia and chills was recovering. No follow-up attempts are possible. No further information is expected.

mental fog/bit of fog; foggy; Nausea; very sleepy; tired; Injection site pain/pain to the injection site; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 19Feb2021 08:40 at a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (Afib) about 10 years ago (2011). Concomitant medication included unspecified medications including blood thinner and Afib medications. The patient takes 6 medications: some of those medications for 40 years, some for a bit less. There were a couple more added for his heart because 10 years ago he had a case of Afib and the doctor who has now retired took him from 3 meds to 6; and has had no issues for the last 10 years. The patient had his first dose on 19Feb2021 at a clinic and was due/scheduled for his second on 12Mar2021. The patient had severe reactions to the first one so he wanted to know if he should accelerate second shot or stay within three weeks. His reaction was for the first two weeks, he had severe nausea, etcetera, which was getting better that week. He gives 20-minute presentations each morning and the participants in the presentation were nice about it but they say that the patient has fog and thought he should see if he should go in sooner as they were worried about him. His only symptoms remaining after two weeks of severe reactions was that he was very sleepy. All that was left was being tired and mentally in a bit of fog (also reported as mental fog). The patient only had pain to the injection site for a day and was not an issue, then it didn't take long for him to start getting extremely tired and have nausea. He says all he knows was that from the sheet listing severe reactions, he had every one during the first couple weeks (unspecified), though he never had a fever. He says this week he felt better and he was starting to eat, this was not normal for him to be tired all the time, but at least he was not sick. He says he didn't treat the pain or nausea, because he was healthy as a horse, and has no problems with a vaccine, shots don't bother him other than having soreness the first day. The patient was just foggy and tired. The patient was recovering from nausea. The patient recovered from injection site pain on 20Feb2021. The patient has not recovered from mental fog/bit of fog and tired. The outcome of the remaining events was unknown. Information on the lot/batch number has been requested.

Patient received a vaccine at museum sight on 03/23/2021 at 0130 pm according to fiancé. Around 1:30 the next day, his fiance tried to call him and she stated that his voice was garbled, she found him face down with his chin on the table, covered with his own feces and urine. EMS notes that upon their arrival the pt had a right sided facial droop along with some contracture to his left side. Pt was originally awake and confused as he gradually became unresponsive and is only responsive to pain of sternal rub. He has no history of stroke. Pt's BP was noted to be 88/50's en route.

Evening of injection: confusion, weakness, Night developed more weakness and incontinence, Next day: severe weakness, unable to ambulate, follow directions, mumbling, sleepy, incontinent. Taken to ER - CT of head, EKG, Chest Xray, Labs, UA. Radiologist diagnosis start of Right lower lobe pneumonia. Given IV antibiotic and admitted to hospital. Admission MD thinks no pneumonia with profound weakness. Improved next day and discharged. Same evening as discharge had expressive aphasia. Next day speech normal again and weakness gone. Admitting physician said had another dementia patient with same symptoms and cleared in a couple of days.

Extreme pain around hip, lower left front torso first night; subsequently, very sore left leg front of thigh ever since and unable to sleep.

Hospitalized on 30Jan2021 for COVID pneumonia; Cannot support standing and walking and vocal cords not fully closed yet; Cannot support standing and walking and vocal cords not fully closed yet; Cannot support standing and walking and vocal cords not fully closed yet; Weakness; confusion; This is a spontaneous report from a contactable consumer (patient himself). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8982), via an unspecified route of administration in right arm on 18Jan2021 at 14:00 (at the age of 77-year-old) as a single dose for COVID-19 immunization. The patient's medical history included AFib, high blood pressure. Concomitant medications included apixaban (ELIQUIS), hydrazaline hydrochloride (APRESOLINE), losartan potassium (COZAAR) and metoprolol; All received within 2 weeks of vaccination. The patient previously took lisinopril and experienced known allergies: Lisinopril. Allergies to medications, food, or other products: Lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient been tested for COVID-19 was unknown. The patient did not receive other vaccine in four weeks. Hospitalized on 30Jan2021 for COVID pneumonia which occurred on 24Jan2021 at 08:00 AM and put on ventilator on 05Feb2021. 18 days on ventilator, ICU and released to hospital. On 17Mar2021 admitted to hospital for speech, occupational, and physical therapy. Cannot support standing and walking and vocal cords not fully closed yet on 24Jan2021 at 08:00 AM. Weakness and some confusion on 24Jan2021 at 08:00 AM. The adverse events resulted in emergency room/department or urgent care. The patient was hospitalized for 55 days. The events were considered as serious (hospitalization and disability or permanent damage) by the consumer. The patient was treated with medications and ventilator for the adverse events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

weight loss; no appetite; breathing is shallow; low oxygen 89%; muscle aches; imbalanced; can't sleep; blood pressure down/128/68/and 132/76; weird dreams; minimal injection site pain; This is a spontaneous report from a contactable pharmacist. A 77-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection) via an unspecified route of administration, administered in Arm Right on 13Feb2021 17:15 (Batch/Lot Number: EL9209) as single dose for covid-19 immunisation. patient medical history about 20 years ago for a torn ACL and also general surgery. Concomitant medication(s) included levothyroxine taken 100 ug once a day for an unspecified indication from 2018 and ongoing; atorvastatin (LIPITOR) oral 100 mg, once a day taken for blood cholesterol increased from an unspecified start date and ongoing and vitamins Cs and Bs as supplements. The patient experienced minimal injection site pain on 14Feb2021, can't sleep, blood pressure down 128/68/and 132/76, no appetite, breathing is shallow, muscle aches, imbalanced, low oxygen 89% and weird dreams on 26Mar2021. weight loss on 27Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021, body temperature: 98.3 on 26Mar2021, oxygen saturation: 89 % on 26Mar2021, blood pressure measurement: 132/76 on 28Mar2021, body temperature: 98.3 on 28Mar2021 and oxygen saturation: 95-96 % on 28Mar2021, body temperature: 100.8 on an unspecified date and oxygen saturation: 96 % on 29Mar2021. The report considered as a serious. The outcome of the events can't sleep , weight loss, no appetite, breathing is shallow, muscle aches, imbalanced and weird dreams was reported as not recovered, minimal injection site pain was reported as recovered as 15Feb2021 . blood pressure down/128/68/and 132/76 and low oxygen 89% was reported as recovering,; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be completely excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

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.

vertigo is debilitating. Caller wanted to know if there have been reports of vertigo; he could not drive. Caller stated he was ok when laying on the couch but when he got up he could not walk without falling down; vertigo is debilitating. Caller wanted to know if there have been reports of vertigo/Vertigo; staggering and unable to walk on his own without someone helping him; complain of being dizzy/slight dizziness/dizziness; This is a spontaneous report from a contactable consumer (wife) on behalf of a 77 years-old male patient. A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiry Date: unknown), via an unspecified route of administration on arm Left on 3Mar2021 at single dose for COVID-19 immunization. The patient medical history included ongoing Peritoneal dialysis from 2018, ongoing Heart bypass from Jan2019. The patient concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 17mar2021 or 18Mar2021, the patient complained of being dizzy. By 20Mar2021 he was staggering and unable to walk on his own without someone helping him and ongoing vertigo from 20Mar 2021 and reported as vertigo worsened. By 21Mar2021 he could not drive. The patient was ok when laying on the couch but when he got up he could not walk without falling down. The patient had extreme vertigo that started about 2 weeks after the vaccine and is debilitating. The patient is just under 6 feet, he shrunk a little. The events dizziness resulted in hospitalization from an unspecified date. The event vertigo resulted in ER visit and hospitalized from 22Mar2021 to 28Mar2021. The lab test included CT scan and MRI, results: negative; He also had lab tests, but nothing showed a reason why he has the vertigo. No further details provided about lab work. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected

Pfizer Vaccine Dose 1 2/5/2021 Pfizer Vaccine Dose 2 3/6/2021 COVID positive 3/27/21 3/27/21: Patient was admitted and started on Solu-Medrol, Rocephin, and azithromycin. Initially had oxygen requirements upward of 6 L. His COVID-19 antigen as well as PCR returned positive. He had received his 2nd vaccine does 3 weeks prior. His D-dimer and CRP were low throughout his hospital stay. Not felt that he needed treatment for his COVID positive. Had significant purulent sputum production. Was on CPT with vest therapy as well as Mucinex. Patient did have significant issues with sundowning and required Seroquel at night as well as sitter at bedside at times. During the day he was much better. Sputum culture returned with Pseudomonas. He does have history of bronchiectasis as well as Pseudomonas in his sputum. Antibiotics were switched to Levaquin for 10 days. Patient's oxygen requirements improved and on the day of discharge needed 2 L which was his baseline. Patient felt near baseline and wished for discharge home. He does have a 16 hour care although was recommended that he have 24 hour care given his dementia issues at night. Also recommended that he not drive. He complete a prednisone taper as well as 10 days of oral Levaquin. Did discuss with Pulmonary about his COVID positivity and a COVID antibody was ordered prior to discharge and will need follow-up as an outpatient. He will follow-up with his pulmonologist and PCP in 1-2 weeks. 4/2/2021: Patient was admitted and started on Solu-Medrol, Rocephin, and azithromycin. Initially had oxygen requirements upward of 6 L. His COVID-19 antigen as well as PCR returned positive. He had received his 2nd vaccine does 3 weeks prior. His D-dimer and CRP were low throughout his hospital stay. Not felt that he needed treatment for his COVID positive. Had significant purulent sputum production. Was on CPT with vest therapy as well as Mucinex. Patient did have significant issues with sundowning and required Seroquel at night as well as sitter at bedside at times. During the day he was much better. Sputum culture returned with Pseudomonas. He does have history of bronchiectasis as well as Pseudomonas in his sputum. Antibiotics were switched to Levaquin for 10 days. Patient's oxygen requirements improved and on the day of discharge needed 2 L which was his baseline. Patient felt near baseline and wished for discharge home. He does have a 16 hour care although was recommended that he have 24 hour care given his dementia issues at night. Also recommended that he not drive. He complete a prednisone taper as well as 10 days of oral Levaquin. Did discuss with Pulmonary about his COVID positivity and a COVID antibody was ordered prior to discharge and will need follow-up as an outpatient. He will follow-up with his pulmonologist and PCP in 1-2 weeks.

Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 76 and presented to the ER on 2/20/21 with altered mental status, weakness, and persistent diarrhea after just being discharged previous week for bacteremia. Hospital progression included a GI bleed requiring blood transfusions, esophageal varices, and unrecoverable mental status. Care was transitioned to hospice where he passed on 2/28/21. Comorbidities include cirrhosis, CKD, DM, pancytopenia, frequent paracentesis for ascites.

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

From the day following the injection, I felt to be in a mental fog that has very slowly nearly abated. Uncommonly tired, no headache fever, chills, or neurodeficit otherwise. ( I am a retired physician). This lead to change in gait: slow, foot dragging, unstable. Near accident in driving auto. More than 4 time of urinary incontinence ie incontinence when bladder overfilled. Mental clarity lost. speech impaired by word searching. Obvious change in behavior to those around me.

This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 13Feb2021 11:30 at 77 years old as 2nd dose, single for COVID-19 immunization. Medical history included hypertension from an unknown date. No medications received within 2 weeks of vaccination. No other vaccine received within 4 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the first dose BNT162B2 on an unspecified date (lot number: EN6200) for COVID-19 immunization on the left arm. On 14Apr2021, it was reported that patient had lost energy to get out of bed. Patient was transported to the emergency room with fevers and altered mental status. The patient was admitted in the hospital for 6 days from 14Apr2021 to 20Apr2021. The reporter considered the events to have caused disability. The patient received an unspecified treatment. Multiple tests were done to the patient on an unspecified date with unknown result. The patient had a COVID-19 test post vaccination via nasal swab on 15Apr2021 with a negative result. The outcome of the events was recovering.

Immediate memory loss. MRI has been taken with no abnormalities noted. Sugar count went from 116, 120 to 299 and continued through April and May with memory loss that he cannot remember anything within 2 minutes. He has been very confused and repeats the same questions over and over. His blood sugar has been the same for years until the vaccine

Was living happily and independently in a retirement community. After the second dose because losing his memory, focus, depression, followed by 2 strokes, brain bleed, blood clots, seizures, and a Dx of Parkinson's and Parkinson's dementia. He saw doctors monthly and never had any signs of any of these things.

Case developed extreme fatigue and disorientation resulting in a fall. Case was taken by ambulance to Hospital. Case suffered a stroke, admitted to hospital 06/02, then into ICU 06/07/2021.

Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS.

spiking of his blood pressure; sore arm; legs swollen; pain on one leg; on and off nausea; not feeling right; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Feb2021 (Lot number was not reported) at the age of 77 years, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, dose 1 on unspecified date for COVID-19 immunization. On an unspecified date the patient experienced spiking of his blood pressure, sore arm, legs swollen, pain on one leg, on and off nausea, not feeling right. The patient had lab tests and procedures which included blood pressure measurement: 190/80. The clinical outcome of the events was unknown. The clinical course was reported as follows: 77-year-old caller reported receiving his second dose of the Pfizer-BioNTech COVID-19 vaccine 24Feb2021 and experienced a "sore arm" after. He explained that a week after vaccination, on the Monday, he " woke up with his legs swollen and pain on one leg". He stated he also experienced spiking of his blood pressure (BP), however on Monday 03Mar2021 he went to the ER since his BP rose over 190/80. He explained at the ER, he guessed they got him more call, and he received a prescription of "water pills" to take for "a couple weeks". He added then, there were moments when he "didn't feel right". He specified he would be "good" in the morning then he "just didn't feel right" in the afternoon. He reported about a month later, 13Apr2021 he had a "second incident with the spiking" of his BP, which led him to the ER. He explained his cardiologist then changed his amlodipine prescription to "5mg in the morning and 5mg at night". He explained he would take 1 pill of Amlodipine 10mg in the morning before vaccination. He added he would take 5mg of amlodipine for a year before being increased to that 10mg a day. He explained before vaccination, he "never experienced such spiking with his BP and considers himself healthy for his age. DSU agent reported his BP is generally around 120/70 and he routinely use the treadmill. He mentioned he now seems ok, has not have a "violent" BP spike, but has "not felt 100%" yet. He added some days he is "fine" and others he has "on and off nausea" or he "feels his legs are swollen in the evening". The main reason for his call is to see if Pfizer have any experience with people who have covid, the long haulers, with the effects for quite a while, that are 3 months in. He was wondering whether or not any long hauler folks that have had on and off side effects attributed it to the vaccine. Information about Lot Batch number has been requested.

Feeling sick, muscle soreness, chills, trembling and loss of muscular control, fever, headache, nausea, hyperglycemia, uncontrollable diarrhea, polyuria, insomnia. Event lasted 32 hours. Slept 16 hours of that time, interrupted 11 times due to polyuria and diarrhea. Lost 5 lbs. Have not felt this sick in at least 20 years - not for any bout of influenza, But it only lasted a day. Took no medication including ibuprofen or acetaminophen. Completely recovered

That evening about 6:30 PM he got upset about something because he wanted a cup of coffee and his wife said no and he got really upset about what was on TV, then became anxious and confused then got very depressed. The next day he remembered what happened and described it as feeling like a zombie.

The next two days following the vaccination, the patient was lethargic and not getting out of bed. His caregiver had to make him eat and bathe. On the third day his care giver had woken him up and found that he had wet himself (this has never happened before). He had altered mental status and was not able to recognize any of his family members. He was taken to the emergency room on 2/6/2021 where he had a seizure and found to have a subarachnoid hemorrhage. He is still hospitalized.

We feel as if the vaccine completely counteracted with his Parkinson's medication. Patient was hallucinating for 2 days, completely unaware of surroundings, making non sensical words, mumbling, showing Parkinson side affects such as hand wringing, not able to balance, walk, completely different than his normal self. Side affects wore off in about 36 hours.

Injection site developed numbness and tingling of left arm that began 45-60 minutes after reciving the vaccine on 2/8/2021. Resolved within an hour or so, then no strength between thumb and index finger. Symptoms resolved that night. On 2/10/2021 patient had difficulty picking up things and had less strength than usual. Patient stated he felt clumsy.

Patient is positive for COVID-19 and being admitted to the hospital. Patient received dose 1 of the vaccine on 2/11/21 and began feeling ill several days before presentation to the ED. He is unable to pinpoint an exact date but states it has been a few days that he has felt unwell. Presentation to the ED was on 2/23/21 and his oxygen saturation on presentation was in the 80s with mild confusion. Patient is requiring supplementary oxygen. The patient is receiving dexamethasone.

Patient received his first dose of vaccine on 2/10 at 11:30am. (His 2nd is scheduled for 3/3) He started with sx ~13 hrs later - He started drifting out of consciousness, then had labored breathing through night rendering him unable to sleep. After getting up in the morning, his breathing was better but he felt lightheaded/weak through the day. By the next morning (Friday 2/12), he was so bad next morning that wife called 911 - He reports that he was there and then not there and was losing track of train of thought. He was taken to ER via EMS, where his HR was initially 15 - He was admitted to hospital - initially a temporary pacer was placed, then a permanent one on Monday, 2/22. He has had other episodes like this in past 13 mos. PCP referred him to neurologist and EENT. Neurology work-up, including MRI and 72 hr EEG were unremarkable, although he learned retrospectively that there was a time during EEG where HR was only 35. EENT found no auditory or other issues . *MD in ER told him that if issues were not neuro in nature, they were probably cardiac.

stated that he developed confusion; experienced awful dreams; concentration to do normal things/it was too difficult to concentrate on the road and talk to her at the same time.; This is a spontaneous report from a contactable consumer (the patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249, expiry 31May2021), intramuscular in the left arm, on 27Jan2021 at 09:30 AM (at the age of 78 years) as a single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ergocalciferol (VITAMIN D). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jan2021 he developed confusion, in which it took a lot of concentration to do normal things and he experienced awful dreams last night. The slight degree of confusion causing him to have to concentrate more than usual for ordinary tasks. The clinical outcome of the events he developed confusion, in which it took a lot of concentration to do normal things and he experienced awful dreams last night was recovering.

Felt as though truck kept turning over, but it was all in his head; Felt as though truck kept turning over, but it was all in his head; Was hot and everything; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: PK12ER/EL9261; Expiration date was not reported) on 26Jan2021 (11:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization/to not get COVID at the public health department. The patient had no relevant medical history and concomitant medications. The patient had no history of problems with vaccines in the past. On 27Jan2021, the patient had felt as though a truck kept turning over, but it was all in his head; and was "hot and everything". The outcome of the events, 'felt as though a truck kept turning over, but it was all in his head' and '"hot and everything"', was recovering.

shivering/having in and out chills; slight fever; fever, headache, dry heaves, fatigue, and crazy dreams; Adding strange dreams/crazy dreams/ so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up; hands were cold; headache fades in and out; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM5318, via an unspecified route of administration in the right arm on 08Feb2021 at 11:45 (at the age of 78-years-old) as a SINGLE DOSE for Covid-19 Vaccination. Historical vaccine includes BNT162B2 Dose 1, Lot Number 'He thinks its EL3302'. The patient had no known medical history or allergies. Concomitant medication included metoprolol tartrate (METOPROLOL TARTRATE), lisinopril (LISINOPRIL), atorvastatin (LIPITOR [ATORVASTATIN]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Late on Wednesday 10Feb2021 The patient experienced his hands were cold, he went to bed and he was shivering, he had to put on clothes and 3 quilts and in the meantime he was having in and out chills and slight fever, fatigue and crazy dreams/so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up/three types all repeating four or more times and on Feb2021 experienced headache fades in and out and dry heaves. The patient underwent lab tests and procedures which included pyrexia: little high (using the strips on his forehead) on an unspecified date. As a result of the event abnormal dreams patient did visit a professional office/clinic visit. No treatment was given for the event. The clinical outcome of the event shivering/having in and out chills, slight fever, dry heaves, fatigue, headache and hands were cold were unknown while abnormal dreams was recovered Feb2021.

Severe abdominal cramps/abdominal cramping; Drowsiness; I had a sore shoulder and fatigue; I had a sore shoulder and fatigue; pain; anxiety; small bowel blockage/He had an intestinal blockage; His peristalsis shut down.; bowels are very irritated; He feels bruised; his guts just feel bruised; His blood pressure actually was low while in hospital; Glucose levels were very high while in hospital/when in pain and anxiety his sugar goes up; 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, Solution for injection, batch/lot number: EL3248) injection to upper left arm just below shoulder at approximately on 29Jan2021 10:00 at age of 78 years old at single dose for vaccination. There were no additional vaccines administered on same date of the Pfizer suspect. Relevant medical history included: for ongoing asthma and adult onset maybe 25-28 years ago. He did not have when he was a kid. He did not have allergies. Part of problem was lives in an area that had a very high allergy problem; a lot of people in that area have allergies; for sleep apnea, used CPAP machine; for diabetes from 2006 and onset date approximate. A1C is where doctors want it to be. Went through half a dozen pills and stuff for diabetes that worked for short time and stopped: Names/Lots/NDCs/Expiries: Unknown, does not have this information to provide. He was pretty good at judging carbohydrate content in meals to make adjustments to Humalog and Toujeo dosing as needed; for ongoing overweight, weight gain started after oral injectable product for diabetes stopped working, he went on different insulin product and gained 30-35 lbs. Oral injectable product: name/lot/NDC /expiry: Unknown, does not have product or this information to provide. Different insulin product: Name/Lot/NDC/Expiry: Unknown, does not have product or this information to provide; modestly high blood pressure; history of intestinal blockages (occurred quite some time ago, no continuing); had operations in the past. The adverse events (AEs) following prior vaccinations: Adverse Event: He was pretty sure he hit the floor before the needle was even out of his arm when he was administered gamma globulin vaccine which he thinks was around year 1972. The company he worked for at the time had a hepatitis break out, a couple of employees had hepatitis, so they had him receive the gamma globulin vaccine. Vaccine/Brand Name: Gamma globulin vaccine/brand name unknown, whatever it was that was available for hepatitis at the time which he thinks would have been 1972. He is pretty sure in those days they used horse serum in the gamma globulin vaccine; the doctors at the time felt pretty sure that the reaction was to the horse serum aspect of the gamma globulin vaccine. Lot/NDC/Expiry: Unknown, he does not have product or this information to provide. Vaccination Date: Thinks would have been in 1972, further details unknown. Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: All relevant information documented in formal fields of other conditions. Family Medical History Relevant to AE(s) was reported as none. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. He was supposed to have the Shingrix vaccine but decided to hold off on that until after he got the Pfizer COVID-19 Vaccine. He had the Flu vaccine around Sep2020 or Oct2020 when the senior version came out. Ongoing Concomitant medications included: losartan 100mg daily from 2019 for high blood pressure, furosemide (LASIX) 20mg daily from 2019 for high blood pressure causing some fluid buildup, fenofibrate 134mg daily for years for triglycerides, finasteride 5mg daily for years for benign prostatic hyperplasia, multivitamins, boosters of other vitamins (advised by PCP since COVID pandemic started), insulin lispro (HUMALOG) fast acting insulin taken as needed for diabetes, insulin glargine (TOUJEO) slow acting insulin taken as needed for diabetes. It was reported patient stated, he had his first dose of the Pfizer vaccine a week ago Friday 29Jan2021 at 10am. He had a sore shoulder and fatigue. At midnight he suffered abdominal cramping by 7am. He took himself to the ER and called his doctor who met him there. He had an intestinal blockage. His peristalsis shut down. He spent a couple days on an NG tube, had x-rays and imaging study, they found a small bowel blockage. It seemed very coincidental within 18 hours of the vaccine. He had them when he was younger. His physician who was an GI specialist said he had 2-3 other patients with similar reactions. He spoke to the safety team regarding this. He was due for his 2nd vaccine a few weeks. Right now his bowels were very irritated, not consistent to bowel movements. He was still on a low fiber diet. Asked if there was any evidence people are having gastrointestinal reaction. He had had blockages in the past, that was his weakness. Asked what to do about 2nd dose. He had asthma, diabetes type 2, mildly hypertensive. This consumer had his first dose of Pfizer COVID-19 Vaccine 29Jan2021 at approximately 10:00. On 29Jan2021 at about 23:30, he had went through usual drowsiness and took a nap. Around midnight 00:00 30Jan2021 he started having abdominal cramps that became very severe. He was taken to the Emergency Room where he was admitted to the hospital from 30Jan2021 until discharged home evening of 03Feb2021. Severe abdominal cramps: His peristalsis stopped, just shut down. As a result he had an intestinal blockage. He had nasogastric tube placed for 4 days. He was scheduled for surgery with a gastrointestinal surgeon who he happens to know personally. He had called that gastrointestinal surgeon before he was admitted to the hospital. The gastrointestinal surgeon thought he heard some sounds, so he delayed the surgery. That night the intestinal blockage broke up. He was discharged from the hospital before they normally would have released him to get people out as quickly as possible due to risk of contagion in hospitals. Both he and the gastrointestinal surgeon are very concerned about him having the second dose of Pfizer COVID-19 Vaccine as scheduled which is due in like 1.5 weeks. The plan at this time is for him to go on a liquid diet 2 days before the second dose so that there is nothing in him to create intestinal block. Outcomes of events: Bowel movements are irregular because just starting to get back into eating really for a few days. The first few days home he was on a soft diet of basically jell-o pudding and broths. He is on an ultra-low fiber diet right now so it's a different diet than he is accustomed to. Some of what he is eating goes right through, other times there is no bulk to come out; he kind of feels like he is constipated but it is just that there is nothing there. Doctor later this week will determine how much he can normalize his diet. Metamucil which a lot of diabetics do, doctor did not want him to take that until everything settles down. He feels bruised; his guts just feel bruised; he thinks from just the pressure there and getting in and out of the hospital bed was horrible. When he called doctor before he went to the hospital 30Jan2021, doctor told him this is coincidence, that this patient was the third that he has had who in 24 hours has had significant intestinal or bowel reaction; that he is not the first who has dealt with severe gastrointestinal problems following the Pfizer COVID-19 Vaccine. Caller clarified he has no first hand knowledge of those other patients/events/products, this was just mentioned to him by the doctor over the phone. He had no further information to provide for this report; but doctor might be able to provide further information. Relevant Tests: they did a COVID test when he was admitted to hospital 30Jan2021, gave results when he left the hospital-took them 6 days-unknown result. They did X-rays and scan of his abdomen to monitor intestinal blockage-results unknown. Blood work done but nothing remarkable there-results unknown. His blood pressure actually was low while in hospital-specific results unknown. Glucose levels were very high while in hospital which he is sure was because they had him on an IV drip that must have had glucose in it because he was not eating anything and when in pain and anxiety his sugar goes up-further details of results unknown. Patient had no further information to provide regarding testing/investigations/lab work, blood work, imaging, x-rays, etc for this report. Outcome of events were reported as unknown.

pneumonia; strange dreams; While there I went into AFIB; I had a dry cough that I attributed to several bouts of dry heaves; I had a dry cough that I attributed to several bouts of dry heaves; This is spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of bnt162b2 (lot number EN5318), via an unspecified route of administration in right arm on 08Feb2021 11:45 at single dose for covid-19 immunization. The patient had no relevant medical history. Concomitant medication included metoprolol, lisinopril, atorvastatin (LIPITOR). The patient experienced pneumonia on 10Feb2021, while there he went into AFIB (atrial fibrillation) on 19Feb2021, he had a dry cough that he attributed to several bouts of dry heaves on 10Feb2021, strange dreams on an unspecified date. The event pneumonia was reported as serious per hospitalization. The patient was hospitalized for pneumonia from 19Feb2021 to 21Feb2021. Previously reported side effects along with strange dreams and he would also like to mention a couple of more issues. Throughout 10Feb2021 and 14Feb2021 adverse reaction period he had a dry cough that he attributed to several bouts of dry heaves, Since the cough continued and he wasn't feeling better he went to emergency care facility on the 19th and he was diagnosed with pneumonia and went to the hospital and was admitted. While there he went into AFIB. Pneumonia was located in left lower lobe (infectious organism). Discharged from hospital on 21Feb2021. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, Hospitalization for 2 days. The patient underwent lab tests and procedures which included covid test nasal swab: negative on 20Feb2021. Therapeutic measures were taken as a result of pneumonia and cough. Treatment included antibiotics. The outcome of events for pneumonia was resolving, for dry cough was not resolved, for other events was unknown. Facility type vaccine: Nursing Home/Senior Living Facility. No other vaccine in four weeks. No covid prior vaccination. Covid test post vaccination: Covid test type post vaccination Nasal Swab, covid test date 20Feb2021, covid test result negative. Not known allergy.

muscle stiffness and soreness - legs,arms, shoulders, etc.- for the past 14days or so - since injection.; muscle stiffness and soreness - legs,arms, shoulders, etc.- for the past 14days or so - since injection.; Movement, sleeping, bending, etc.,almost impossible; Movement, sleeping, bending, etc.,almost impossible; This is a spontaneous report from a contactable consumer reported for himself. A 78-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=em9801), via an unspecified route of administration at the age of 78 years old on 12Feb2021 at single dose on arm left for covid-19 immunisation. Medical history was none. No Allergies to medications, food, or other products. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received no other medications within 2 weeks of vaccination. The patient's concomitant medications were none. The patient experienced muscle stiffness and soreness - legs, arms, shoulders, etc.- for the past 14 days or so - since injection. Movement, sleeping, bending, etc., almost impossible. 4- 200mg-ibuprofen helps for about 4 hrs. The onset date for the adverse events was reported as 13Feb2021. The events outcome was not recovered. The seriousness of the events was reported as no.

Collapsed in house; Chills; Total Weakness; Memory problems; Racing heart beat; This is a spontaneous report from a contactable consumer. A 78-year-old male consumer reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 23Feb2021 at 01:00 PM at single dose for COVID-19 immunization. The patient had Covid prior vaccination. No other medical history. Concomitant drugs were unknown. On 23Feb2021 at 04:00 PM the patient experienced chills, total weakness, memory problems, collapsed in house and racing heart beat. The patient was hospitalized, he was in hospital 4th day now. Cannot get out of bed or walk. the patient was treated with Physical Therapy. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223394 similar report from same reporter

fell, hit head, confusion, memory loss, balance disorder, tremors and shaking, vomiting, headache, high blood pressure, TIA, CVA, aneurysm

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.

back started hurting/back aching and hurting; Chills; coughed once and stomach rolled; chest tightness; coughed once and stomach rolled; arm started hurting; my neck got stiff; can't sleep; This is a spontaneous report from a contactable consumer via medical information team. A 78-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right on 12Mar2021 11:00 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included HIV positive ongoing (Diagnosed 8 years ago); Psoriasis ongoing (over 5 years that he was diagnosed); Diabetes from 2017 and ongoing; Family History includes operation on face for melanoma. Concomitant medication included abacavir sulfate, dolutegravir sodium, lamivudine (TRIUMEQ) at 600 mg, 1x/day; then 50 mg, 1x/day; then 300 mg, 1x/day ongoing all were via orally for hiv infection; metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR) orally 50 mg, 1x/day for diabetes ongoing; adalimumab (HUMIRA) from an unspecified start date and ongoing at 40 mg every 14 days for psoriasis. It was reported on friday the 12Mar2021 week patient took the shot at a hospital. On the 13Mar2021 his arm started hurting and his neck got stiff. The 14Mar2021 his back started hurting like a knife, chest and back was tight. He states his back hurts and has chest tightness; coughed once and his stomach rolled up on 14Mar2021. On the 15Mar2021 same result, back aching and hurting. The 16Mar2021 he went to the hospital and took the x ray of his back and front and couldn't find nothing. States his lungs were ok and everything was ok so he doesn't know what is going on. Clarified that he went to the Emergency Room at the hospital, he was not hospitalized. He was treated in the ER and released the same day. on the 17Mar2021 his back was killing him. he can't sleep in Mar2021. He states that he still hurts this morning and has chills on 17Mar2021. The outcome of the events Cough; Stomach discomfort; Neck stiff; vaccination site pain was recovered on 14Mar2021; Chest tightness; Chills, Back pain was not recovered; Sleep disorder was unknown.

2 hrs after injection , felt a URGENT need for Bowel movement, while I was having this bowel movement, I had what I think was a severe Panic attack, felt like I was going to die !!! lasted for 5 or 10 min. After which I felt fine , went to work ,after another 2 hrs I had the same episode ,at work. timing was about the same . went home . Had another aproximently 2 hrs from the last ,was less severe . took a nap , BUT was unable to urinate for 6 hrs . Felt OK ,slepted fine. Felt OK the next couple of days Then had mild case of chills, then mild case of feeling poorly. Very slight fever. AS of today I'm more tired then usual but not debilitating .

The day after the injection I started felling disoriented and suffering from what I call a mind-body disconnect. Walking was unsteady and organizing thoughts was difficult. This was my primary symptom with the infection which lasted through 02/16/2021. The last three days were spent in the Covid-19 unit of a local hospital after which the symptoms disappeared. The day after the vaccination, the symptoms came back but only lasted for about 24 hours.

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.

He began showing dementia like behaviors within 24 hours of receiving 2nd Pfizer vaccine. To be clear, not referring to forgetfullness, referring to full on, can't remember names children or grandchildren, up to and including 'word salad' related symptoms. On a 04/07/2021 follow up he was given 'SLUMS' test and scored 24 of 30, yet struggled to recall appropriate words in the appropriate context. Ex. degrees for years of age, check for the word 'injection', coinciding with circular coversations, where the same topic is repeated numerous times in a conversation, without recollection...

Client went to Urgent Care on 4/16 complaining of excessive fatigue, excessive sleeping, unsteadiness and fatigues easily when mobile. He was having trouble getting up and down the stairs. States he had a runny nose and congestion and started taking Mucinex since approximately 4/6. He had some chills on 4/15. When he wakes up in the morning he still feels tired and could go back to sleep. After his initial assessment he was admitted to hospital for treatment and further evaluation.

Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination.

On March 2, he woke up feeling bad and had a fever of 102.7. He took tylenol and liquids all day and the fever came down to around 100. The next morning he woke up complaining of excruciating pain in his left arm (site of the injection). He couldn't stand to have anything touch it, couldn't move it and couldn't sleep because of the pain. The next morning he woke up very weak, wasn't able to speak clearly, wasn't making sense. He had a telemedicine appointment scheduled that morning for another matter. The doctor took one look at him and said we should have him evaluated asap. I took him to the emergency room at Hospital. They did some tests and said he was septic and immediately put him into the ICU. He was started on IV antibiotics while the blood cultures were growing out. It was determined that the bacteria was Strep G but they were unable to identify the source. He was put on a ventilator and an echo cardiogram was done. It was believed that the source of the infection was his pacemaker and I was told the pacemaker would have to be removed. They couldn't do it at that hospital. He was transferred to another hospital. The doctors at that hospital determined the pacemaker was not the source. It was believed by some doctors that the source of infection was the injection site. The infection was cleared from his body and the ventilator was removed after 2 weeks. He lived another 2 weeks but never was able to recover. Until the day he was put on paliative care, he expressed pain in the arm where he had received the vaccination. He died at 5:30 a.m. on April 1, 2021.

Light headedness/ Dizzy; Equilibrium was way off/ he was wobbly; Nauseous; Mild case of vertigo; he ached; felt terrible/ yucky feeling; Stayed down all the day/ he was wobbly; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Jan2021 17:20 (Batch/Lot Number: EL3249) as single dose for COVID-19 immunisation. Medical history included tinnitus, Blood pressure, Gout, Cholesterol, Acid Reflux. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for blood pressure abnormal from an unspecified start date and ongoing; aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal from an unspecified start date and ongoing; allopurinol (ALLOPURINOL) taken for gout from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. No prior vaccinations within 4 weeks. No history of previous immunizations with the Pfizer vaccine considered as suspect, this was the first dose. No additional vaccine administered on same date of the Pfizer suspect. On 13Jan2021, the patient received the vaccine. He clarified the reaction as, on Saturday 23Jan2021 all of a sudden it was quick he got real light headed, dizzy, he felt like his equilibrium was way off. He felt like he had a mild case of vertigo. He was wobbly, he ached, and felt terrible. It was a yucky feeling. He also felt nauseous, and it went away soon as he ate. He had never had a feeling like that before. He stayed down all day. He noticed all these events that occurred on Saturday 23Jan2021 started late morning around 10-11 in the morning. By the afternoon he was on his back for the rest of the day. It knocked him for a loop. Sunday 24Jan2021 he woke up and felt a little better. He still had some of the symptoms, but they were milder and kept getting milder through out the day. By Sunday afternoon they were almost gone and by Monday 25Jan2021 he felt normal and great. Tuesday 26Jan2021 these same feelings hit him again, but not the same way and was not as bad. Then 27Jan2021, they were gone and he felt fine. He went to the doctor's office yesterday (27Jan2021). The doctor thought he was having an inner ear problem. He has a history of tinnitus and the doctor thought this was causing the light vertigo symptoms. He was light headed, wobbly. He was prescribed Meclizine-25mg one tablet by mouth three time a day. Now, today, 28Jan2021, he woke up this morning and he had the same feelings again. He was wobbly. He had the same feelings that he experienced on Saturday 23Jan2021. However, they were milder. He felt like it is a little vertigo. He did not feel stable. He had never had anything like this happen before. The patient stated he is pretty healthy for his age. he is very active. He usually plays golf, but has not recently. The patient believes he is having a reaction from vaccine, he is not sure, but he is having some of the symptoms. The doctor provided him with medication, but he has not started it yet. He does not know if he should. Caller is thinking these events are related to the shot. He is due to get his second shot on 03Feb2021. Outcome of the events was not recovered.

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.

Hallucinations beginning after first dose in February, patient did not report symptoms to doctor until some weeks after second dose when they became more severe and was.noticed by family members. Doctor requested MRI test. No treatment has been given yet.

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.

unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have been experiencing for 4-5 days; unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have been experiencing for 4-5 days; unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have been experiencing for 4-5 days; This is a spontaneous report from a contactable consumer. This 78-year-old male consumer (Patient) reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL 9264 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 10:15 (Batch/Lot Number: EL 9264) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included, chronic kidney disease, coronary artery disease, hypothyroidism, hypertension from an unknown date and unknown if ongoing. No known allergies were reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), dose number; 1 on 18Jan2021 at 09:30 am at left arm for covid-19 immunization. Facility type vaccine was reported as other. The patient did not receive any other vaccines within 4 weeks. Concomitant medications (Other medications in two weeks) included allopurinol taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID), eicosatetraenoic acid ethyl ester (VASCEPA), rivaroxaban (XARELTO), rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported. On 02Mar2021 the patient experienced unsteady on feet, almost "tipsy", as if returning to land after being on boat, have been experiencing for 4-5 days. 2 others, not related, with same approx schedules, experiencing same feelings. No treatment was given for the AE. If covid prior vaccination: No, If covid tested post vaccination: No. The outcome of events was not recovered. No follow up attempts are possible. No further information is expected.

He was living independently in a retirement home. They administered the vaccine. Since the jab he has been diagnosed with Parkinson's, Parkinson's dementia, Suffered two strokes and we were recently told he now suffers from seizures and will require medication for the rest of his life AND 24 hr. Care.

extreme body aches/pain; joint aches; muscle pain; I can hardly function; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: en6206), via an unspecified route of administration on 09Apr2021 (at the age of 78-year-old), as 2nd dose, single dose in right arm for COVID-19 immunization. The patient's medical history included prior heart attack, diabetes, and neuropathy. Concomitant medications included atorvastatin, clopidogrel, metoprolol, finasteride, all taken for unspecified indications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200) on 05Mar2021, as single dose in left arm for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Apr2021, the next day after the second dose of vaccine, the patient experienced extreme body aches, joint aches, and muscle pain all over his body. Patient can hardly function and was in constant pain. Patient received treatment for the events with Predisone, Advil, and Tylenol. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.

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

Pfizer COVID vaccine EUA Pfizer Dose 1 2/13/21 (EN6201) Pfizer Dose 2 3/13/21 (EN6204) COVID Positive 5/24/21 5/24/21: 78-year-old man brought to the emergency department for further evaluation of worsening shortness of breath and cough. He was in his usual state of health until approximately 11 days ago when he started to have upper respiratory symptoms characterized by congestion, rhinorrhea, sneezing episodes. Symptoms gradually worsened until 5 days ago when he started to have for productive cough accompanied by shortness of breath. He denies accompanying fever, chills, nausea or vomiting. His sister who accompanied him has been checking on him daily and has noted worsening bouts of coughing as well as shortness of breath, unable to keep up with ADLs. Upon checking on him today she noted that his lips were blue, brought in to the emergency department by private passenger car and in trial urge his oxygen saturation was noted to be 64% on room air. He was immediately started on supplemental oxygen via OxyMask, nebulizer therapy. COVID-19 rapid antigen test was subsequently positive, CT pulmonary angiogram was done which is negative for PE but also did not demonstrate any evidence of pneumonia. He is fully vaccinated against COVID-19 since March, denies any known contacts being treated for or with symptoms suggestive of COVID-19 infection. While in the ED continued to deteriorate requiring increasing amounts of oxygen via OxyMask, desaturating to 82-85% on 15 L OxyMask. Has been started on NIPV and will be admitted to the ICU for further treatment and evaluation. Of note, he reports that he and 5+ of his family members were all fully vaccinated and all tested positive to COVID around the same time. 6/14/21: The patient presented to the hospital on May 24 with cough and shortness of breath, COVID-19 test positive, initially he was hypoxic requiring 6 L of oxygen then his oxygen demand increased until he require to be on BiPAP and high-flow nasal cannula, then on May 29th require endotracheal intubation the ICU and started on Remdesivir, Decadron, but he was not candidate for Acterna, on June 3rd the patient had a fall with dislodged endotracheal tube require immediate re-intubation and his CT show simple nondisplaced skull fracture and subgaleal small hematoma without intracranial hemorrhage. Patient extubated on June 6 to BiPAP then the oxygen requirement taper down. The patient post extubation kept having shortness of breath and cough, sputum culture grow Klebsiella pneumonia and he was on Zosyn which cover it and will complete the antibiotic on June 15th. The patient is hypercoagulable with elevated D-dimer 2 to COVID-19 infection and will continue Lovenox b.i.d. with his aspirin and Plavix for CAD with pantoprazole. Will continue his chronic steroid. The pulmonologist recommend to keep the patient in isolation due to prolonged virus shedding. On per oral Vanco for C diff prophylaxis due to history of recurrent C diff infection and he is currently on antibiotic. Echocardiogram showed normal EF without significant valvular disease. Patient had episodes of dysphagia and swallow studies show some aspiration and he placed on pureed diet/dysphagia level 1. Sign-out given to SELECT LTAC team, they will follow on management.

Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home.

Patient has Parkinson?s with dementia. There has been some history of hallucination. Upon awakening the day after receiving the vaccination, he was incoherent and having hallucinations much more pronounced than previously observed. This lasted for about 3 hours and he slowly returned to his baseline status.

After duing light work on Saturday morning. I sat down for a few minutes and felt a little light headed. My stomach became quisy and I had to go into the bathroom, became nauseated and had to vomit. I had a quisy stomach most of the balance of the day. I experiecnced a restless night. However, by mid-morning Sunday I began to feel better and have had no additonal inegative effect. The only other unexplained item was that on Sunday I checked my blood presure and it was 154/ 85. This is very unusual, as due to the nifedipine I take for my DES, my average for years is around 125/80. Today, Tuesday, I checked it again and it still at 158/87. I have an appointment with my cardiologist in 2 weeks and will discuss this with him.

aches and pains; nausea; some confusion; the patient woke up in the middle of the night on 20Jan; This is a spontaneous report from a contactable consumer A 79-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 19Jan2021 in the left arm at 18:00 at SINGLE DOSE for covid-19 immunisation . Age at vaccination: 79 Years. Facility where the most recent COVID-19 vaccine was administered:Public Health Clinic.The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included history high blood pressure, covid-19 (covid prior vaccination: Yes) and the patient has a pace maker. Concomitant medication included hydrochlorothiazide, losartan potassium (HYZAAR), carvedilol (COREG), acetylsalicylic acid (ASPIRIN , colecalciferol (D3 VITAMIN). The patient experienced Sleeplessness on 20Jan2021, Ache , nausea and confusion on 21Jan2021 02:00.Clincal course reported as follows: the patient woke up in the middle of the night on 20Jan with aches and pains, nausea and some confusion, confusion resolved in 15 min, tylenol administered for aches and pains, no issues when patient woke up in the morning.All events reported as non serious . The patient was recovered from confusion on 21Jan2021, while the outcome of the other events was recovered on unknown date .Since the vaccination, the patient had not been tested for COVID-19 information on the lot/batch number has been requested

on 1/23, rt became winded and confused, weak and began to require more assistance with ADL's, 1/24/21 acting bizzare, anxious, uncomfortable, increasingly more confused, restless, 1/27 blood noted in urine, SOB and abdominal breathing, was sent to ER - returned with dx of SOB and UTI. 1/29/21 confused and trouble voiding, very restless, 1/30/21 confused and restless, 1/31/21, confused and anxious, 02/02/21, very low heart rate, lethargic, admitted to hospital with cystitis and bradycardia, 2/4/21 returned to facility, 2/11/21 received second dose of Pfazer_ BioNTech vaccine, 2/17/21 very lethargic, bradycardia, 2/21/21 large amount of rectal bleeding, sent to hospital and admitted - remains in the hospital at this time

Initially mild pain and tenderness Left arm shoulder muscle. On third day after second vaccination, should symptoms gone but I started to develop diffuse myalgias. By 4th day, began having problems with my memory. I could not figure out some instructions on a computer program. I had some trouble recognizing a common object in my hand. Then mild ataxia. Excessive sleepiness in 2-3 hour intervals. On 8th day, developed abdominal pain similar to diverticulitis. And became very constipated. I had forgotten to take the Parnate and missed two doses. I had forgotten to take Metamucil and Miralax. these led to the constipation and abdominal pain. On advice of psychopharmacologist, I resumed Parnate and started to feel better. I resumed laxatives and good effect. Abdominal symptoms abated in two additional days. I had gone to ER but seen only informally by my medical friends. After 3 hour, and getting better, I left. Blood tests were normal. No exam. Since 02/27/2021, I have felt perfectly normal. Recovered.

feeling lousy; chills; low grade fever 101.9; everything hurt, muscles, head; everything hurt, muscles, head; everything hurt, muscles, head; real tired; weak; a lot of the same symptoms from the COVID virus, he can relate to COVID because he had had the COVID and for 2 weeks he was like that; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is the first of two reports, reporting for self. This 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 29Jan2021 at 9 AM at single dose for COVID-19 immunisation. The patient's medical history included COVID virus in Aug2020. The patient's concomitant medications were not reported. The patient received the first dose of vaccine on 29Jan2021 at 9 AM and got a reaction around 9 PM. The patient stated a lot of the same symptoms from the COVID virus came back after the vaccine. The first thing was chills, patient took a couple of paracetamol (TYLENOL), and they went away after about a half hour. The patient had a low grade fever 101.9 at 29Jan2021 night to 30Jan2021, and took paracetamol then as well. The patient reported the biggest thing was everything hurt including muscles and head. Patient felt weak, more or less tired with no energy following the vaccination. The symptoms were from 29Jan2021 night until probably 31Jan2021 morning noon, then he started to feel little bit better. The patient hardly miss work, but missed work on 30Jan2021. The patient stated feeling pretty good and pretty much back to normal on 01Feb2021, it did not affect breathing or cough, just fever and feeling lousy. The patient commented that he can relate to COVID because he had had the COVID and for 2 weeks he was like that. He also had the breathing problem with the virus in Aug2020, and he think he had every symptom but did not lose taste or smell. The patient asked if he should take his second dose of vaccine. The outcome of event chills was resolved on 29Jan2021. The outcome of event fever was resolved on 30Jan2021. The outcome of other events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148753 same reporter/drug/events, different patients

Right Hand swollen and fingers tingle. Unable to hold fork for the past 4 days. Plenty of pain. 1st shot 3 weeks ago attacked my upper leg muscles - front and back- and shoulders - both sides. Even though rules say not to get 2nd shot if an allergic reaction is still viable, I didn't know this was an allergy reaction. Thusly, I got the 2nd shot. Sorta wish I hadn't. My original e-report # is 327694

Pain developed in right arm at injection site. Pain very slowly diminished for 10 days. First day temperature of 101.3F. Very debilitating, making it difficult to dress and to sleep. Hand to take anti anxiety drugs to help sleep for 8 days. I had COVID -19 and was hospitalized from Nov.16 to Dec. 4 2020. Then 2 weeks in bed before able to walk downstairs. Not a pleasant experience!

I am in bad shape here, I have had everything it's a bad situation; I have been in bed for two days; Swelling; Chills; Headache; Muscle pain; Joint pain; Slight fever; This is a spontaneous report from a contactable consumer (patient reported himself). A 79-year-old male patient received BNT162B2 (Formulation: Solution for injection, NDC number/UPC number: Unknown (there was nothing over here, there was nothing on the card), Expiry Date: Unknown (it was not there)) via an unspecified route of administration on an unspecified date at single dose to his right arm for Covid-19 immunization. The patient's medical history included ongoing blood pressure. Concomitant medication included hydrochlorothiazide (HCT) from an unspecified date and ongoing at 50 mg once a day for blood pressure. Consumer stated, "it was a pill" (not clarified further). It was reported that, about two days ago on 10Feb2021, he was in bad shape here, he have had everything it was a bad situation. He had been in bed for two days. On 10Feb2021, the patient experienced swelling, chills, headache, muscle pain, joint pain and slight fever. Consumer stated "It looked like lot number L8982 and then the next one was, it was two lot number on here, the second dose is 813248." Consumer stated "he just reported all the symptoms that, he took vaccine and he was in bad shape here, he had been in bed for two days. He got swelling, chills, had everything, it was a bad situation, got headaches, muscle pain, joint pain slight fever, right he got all." Consumer confirmed it was Pfizer vaccine, however name was not clarified. When probed for age, consumer stated, "he started feeling the symptoms about two days ago. He did not understand." Consumer stated, "about two days ago 10Feb2021." (not clarified further). When probed for the name of the Centre where patient was administered the vaccine, consumer stated, "The VA, that's the service, he was in the service the (state name) VA." Regarding lot number, consumer stated, "It looked like lot number L8982 and then the next one was, it was two lot number on here, the second dose is 813248." (Not clarified further). Consumer stated, "he did not see dose." When probed if still experiencing the problems (event not specified), consumer stated, "yeah, it was been improving a little bit, not much". (not clarified further). The patient received paracetamol (TYLENOL) as a treatment for the events. Regarding the treatment, consumer stated, "he did not know, he took it over the counter that's all he knew." Outcome of the events was unknown. Information of lot/batch number has been requested.

COUGH, WEAKNESS, INSOMNIA, ACUTE ON CHRONIC CKD, ACUTE ON CHRONIC CHF, EMESIS, DEATH Narrative: 1/12/21-PT REPORTED FEELING TIRED, UNABLE TO SLEEP AND EXPERIENCING DYSPNEA ON EXERTION THAT HE FEELS MAY BE RELATED TO RECENT COVID VACCINE 1/17/21-patient admitted to hospital due to 'severe abdominal pain;' received 1 unit PRBC due to symptomatic anemia and weakness (Hgb 8.4->7.1); dx: acute on chronic CHF exacerbation and difficulty breathing, acute kidney injury-CKD Stage IV; HPI includes chief complaint "weakness/sob since last night, cough x 2 weeks since covid vaccine;" HPI includes "pt states that for 2 weeks he has had SOB, cough, chills, body aches, and weakness, symptoms not improved over the last few days, more weak as of late" 1/28/21-transferred to facility 2/12/21-transferred back to hospital due to SOB, abnormal labs, pleural effusion 2/16/21-episode of coffee ground emesis 2/19/21-EGD showed ulcerative esophagitis and gastritis 2/24/21-transferred to SNF 3/9/21-admitted to hospital d/t multiple episodes of vomiting 3/10/21-pt passed away at hospital Possibility that acute inflammatory process triggered by vaccine resulted in patient's eventual death, but difficult to ascertain due to patient's various comorbidities. Patient never tested positive for COVID. Did not experience immediate ADR following 1st dose of vaccine. Did not received 2nd dose due to illness. Hospitalized multiple times following 1st vaccine dose.

urticarial type rash on the left side of anterior torso and left arm. mildly itchy. mild irritability.

I need to talk with someone re: effects getting shots Before getting the shots I was walking 3-5 miles a day, going to the gym 5-7 times a week, playing tennis 5 nights a week and getting up before 7 am Now, I don't want together out of bed. every joint in my body aches, I have no energy, my hands are swollen and i have no stamina when I tr to go to the gym or play tennis I hurt so bas the I do not want to play I have gone from being active and strong to being totally depressed because of the constant pain that I am in

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.

* 4/9/2021: Father in law went to get blood drawn for his INR (before 10am) * 4/9/2021: He started seeing some spots develop on his back. he did not tell anyone * 4/12/2021: Spots spread on his back. He told my mother in law. My sister in law took him to an urgent care. They ran blood and said results would take 3-4 days *4/16/2021: Urgent care said results could take two weeks. My sister in law took him to the medical center. They diagnosed shingles but also said his heart rate was low. My father in law was talking in circles/not making sense/acting confused so they ran the EKG to check pacemaker * 4/16/2021: Heart rate stabilised and they discharged with topical treatment for his shingles

wheezing in the morning; shortness of breathe in-between all the other symptoms; bronchitis; hot flashes/warm flush; lack of appetite; trouble walking; uneasiness in the stomach; feeling of warmth; achiness; feeling so bad; nausea; Fatigue; he got extremely cold; not feeling well/feel lousy/sick; My fever is 97.7 degrees fahrenheit but about 2, 3 or 4 o'clock my fever ticks up a little; chills/Shivering; shaking uncontrollably; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, dose 2, administered in Arm Right on 11Mar2021 (Batch/Lot Number: EN6204) as SINGLE DOSE for COVID-19 immunization. Medical history included prostate cancer from an unknown date and unknown if ongoing and major radial prostatectomy from 04Feb2021 to an unknown date. The patient previously received first dose of BNT162B2 (lot number: EN9581) on 17Feb2021 for COVID-19 immunisation and experienced chills, low grade fever and fatigue. There were no concomitant medications. The patient got the second dose of BNT162B2. The patient was fine, had no problems until 15Mar20201 (4 days afterwards), the patient stated, "I started getting chills, shaking uncontrollably , nausea, fatigue, a little bit of everything. I wouldn't be calling you but this has not subsided. It's been 3 weeks now and I'm not feeling well. It ebbs and tides. I've been taking a diary. I went to the ER last Monday because I was wheezing in the morning and had shortness of breathe in between all the other symptoms. They did all kind of blood tests, covid test which was negative, chest x-ray showed bronchitis. Blood work and ultrasound of my bladder with unknown results. They sent me home with a inhaler, steroid and an antibiotic and every day since then it seems like at night 9, or 10 o'clock I start feeling better and sleep through the night. My fever is 97.7 degrees fahrenheit but about 2, 3 or 4 o'clock my fever ticks up a little and I start to feel lousy, my stomach feels. I feel like I have hot flashes; a feeling of warmth with achiness and lack of appetite. So I take my Tylenol 7 or 8 o'clock at night my temperature is 97.7F. I haven't had 1 good day since. I've been to my doctor, ER, I've talked with the CDC. What information do you have for people who have had long term symptoms/side effects? What am I supposed to do? Someone from Pfizer needs to give me advice. If not I'll go to the news network. I don't feel well. It's directly related. No one has given me relief or help. It's impacting my life. I've been sick every day. Is there someone above you who can tell me what to do? I took their (Pfizer's) vaccine that was recommended. It was your vaccine. Not mine. Someone has to have an answer for me. Unless you want to go and have lawsuit and the news. Just think about it, if you had to go through the symptoms of having the flu everyday. Please relay this to someone. If I don't heard back within a week, then I'm going ballistic. It's not going to be pretty. Someone has to get back to me to help. I want someone to tell me that I'm not crazy, I'm not the only experiencing this. There has to be an answer. I took your vaccine. You are responsible. I want to know. I can't be the only one in the whole world who is feeling like this. I've been to the ER and the doctors. I've had every side effects but theirs go away in a few days, but mine hasn't. I need advice, that I'm not nuts, something that will help me get better. I want to feel better. It's effecting my family my life. Doesn't it seem odd? I can't be the only one? Someone has to know something. They (drug companies) like to hide the facts. I am sick because I took BNT162B2 vaccine. I need someone to get back to me." After the second dose of BNT162B2, the patient has been experiencing an achy feeling, heat throughout the body, shivering, shaking, trouble walking, and some fever. He reports taking Tylenol, and that helps, but he is still having symptoms that come and go and it has been 3 weeks since the second injection of the Pfizer covid-19 vaccine. He reports going to the ER for treatment after the second injection, and a COVID-19 test was negative and they did not find anything else other than the Pfizer COVID-19 vaccine that would be causing his symptoms. The events hasn't gone away, it's now about 3.5 weeks and he hasn't had a good day since then he has been experiencing chills and fever. It goes away for a couple hours, it goes away till around 9 or 10PM at night, then he is good at night, then in the afternoons around 2PM or so the fever kind of comes back and instead of chills he is getting warm flush, when taking his temperature he notices it ticks up. He is taking Tylenol every 6 hours. He would like to know if this is normal and have others reports this? The First time he experienced the chills and fatigue it was on 18Feb2021. Then the second time the chills, fever, fatigue, and nausea started on 15Mar2021. The events were described, "Fever: It is not as steady, when it ticks up, it is never going past 100F, it's been like 98 and 99, that's when he starts to feeling so bad. He provides todays temperatures, this morning 97.5F he usually runs low, then about 10AM 97.7, then at 11AM 98F, then an hour ago it was 98.8F and he can feel the difference. Nausea: It occurs when the temperature ticks up, it's not really nausea but its uneasiness in the stomach, not necessarily nausea but he feels no appetite. It has the Same pattern as the fever. Fatigue: Yesterday morning he got a blood test and he did not have a fever he was normal 97F, but he could barely take 10 steps, the fatigue varies, it does not coincide with the fever. Looking back over the 3 weeks, the fatigue is better now. On 21Mar2021 he went to the ER because he was feeling so bad, there was a little bit of wheezing and shortness of breath, they did lab work and a chest X-ray, they sent him home with an antibiotic and a steroid inhaler. The chest X-ray showed Bronchitis. Blood work results are Unknown. He clarifies that the ER sent him home the same day after 9 hours, he was not admitted to the hospital. When queried if he had a physician office visits he states that he had 2 "Tele-med" appointments with the Primary Care doctor. He has no Allergies. The outcome of the event fever and nausea was not recovered while the outcome of the event fatigue was recovering; and the outcome of the rest of the events was unknown.

Woke up in the middle of the night dizzy on the evening of 3/11/21,started vomiting blood, syncope, when woke up had altered mental state, when reoriented he was able to call EMS, taken to hospital where he was diagnosed with an abdominal clot size of a grapefruit

right wrist was "quite sore and painful"/left wrist then "started swelling and being painful"; carpal tunnel; feeling anxious; feels "warm" outside of his left wrist/ felt like a fire underneath his kneecap/ was hotter than a firecracker; arm was so sore he couldn't pick it up straight in the air; trouble walking; right shoulder was swollen; left knee is swollen real bad; right shoulder was pretty sore and is getting worst all the time; left knee was "sore"; right wrist twice as thick as [his] left one/left wrist then "started swelling and being painful"; This is a spontaneous report from a contactable consumer, the patient. This 80-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in Apr2021 (at the age of 79-years-old) as a single dose for the corona virus, to get rid of it/ it's supposed to be sure he didn't get it. Patient had no medical history. There was no relevant family medical history. There were no additional vaccines administered on same date of the COVID-vaccine. Patient had no adverse events following prior vaccinations. He remembers his first polio shot he got that back in the early 50's and his second shot was a cube of sugar, called the salt vaccine. Stated he's been getting vaccines for a long time and he never had any trouble with any of them. The patient previously received the initial dose of the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) in 2021 (March or April) in the left arm which was deemed invalid by the vaccination provider due to temperature related issues (i.e wasn't cold enough). He explained he received a letter informing him of this incident and recommending a replacement dose (which he thinks was on 06Apr2021). About 2 to 3 weeks before he got his first COVID shot, he got a flu shot in his left arm, about 4 or 5 inches above where he got his COVID shot. The patient's concomitant medications were not specified. He reported that the second vaccine (BNT162b2) caused him problems. On 06May2021, he woke up with his right wrist twice as thick as his left one, it was swollen real bad. The right wrist was quite sore and painful. He didn't know if he was getting carpal tunnel or what it was, so he went to the ER about it and they gave him three different kinds of pills, two of which included tramadol 50mg one every day and ibuprofen 400 mg. The ER couldn't determine the cause for his reaction. About 3-4 days after taking the prescribed medication, his reaction subsided quite a bit and was not nearly as hurtful, but his left wrist then started swelling and being painful/sore. Therefore, he continued to take his medication and it improved. It was like that for a couple/ three days, and it calmed down. He thought he was okay 2-3 days ago, but this morning (14May2021), his right shoulder was swollen and pretty sore and was getting worse; he was in so much pain, so sore he could hardly even move his arm, he couldn't pick it up straight in the air, couldn't get his elbow up past his ear. The patient also reported that when he got off his bed, his left knee was sore and it felt like a fire underneath his kneecap and he was having trouble walking. The left knee was swollen real bad and was hotter than a firecracker. Thus, he went back to taking his pill again. The knee pain started the morning of 14May2021 about the same time it seemed and has worsened, and he took a 400mg ibuprofen and the other pill he's taking, "100 mg doxycycline or something". Patient hadn't been doing much since, he was feeling kind of laid up, he had thought it was all done with yesterday (13May2021). He stated he's been hearing things about allergic reactions to this COVID shot, was sure that a lot of people are having complaints of allergic reactions, and was sure he's not the only one who has had a problem like this. He asked if there was anything he can take to block it because he is sure when this calms down after a week or whatever, it will be his in his right knee or left shoulder or wrists or ankles and he's 100% it's about that COVID shot. He stated he's never had arthritis before. He stated that he has never had any problems like this before. He is supposed to go see his doctor in a week or two. He tried to call the doctor to make an appointment, but he figured he would wait a couple days, but he is hurting bad today (14May2021), and he hasn't been to anybody yet except for the ER. The patient stated it looks like the vaccine is methodically causing this spread into his body. He also reported that it feels warm outside of his left wrist, towards the edge of it and all the way to the joint of the little finger and he thinks the swelling will start again. He expressed feeling anxious about his reactions. He asked if there were any kinds of pills he could take to block the effects of the vaccine from working in his body. He stated it seems like it's going from one area to the next and it seems like it's going through his joints and he doesn't like that. His left wrist still got a little bit of soreness in the back near the joint, but doesn't appear to be swollen. Regarding the right wrist, he has recovered completely, it feels better; doesn't feel any soreness in any place and doesn't look swollen. The clinical outcome of right wrist twice as thick/left wrist started swelling recovered on unspecified date; left wrist painful/sore not recovered; right shoulder is so sore not recovered; left knee was sore not recovered; anxious was unknown; feels "warm" outside of his left wrist/ felt like a fire underneath his kneecap was unknown; left knee is swollen not recovered; arm was so sore unknown; carpal tunnel unknown; trouble walking unknown; right shoulder was swollen was not recovered. The lot number for the vaccine, BNT162b2 , was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021551521 same patient/reporter/drug with different AE/time gap.

Temperatures 105; chills; confusion; unsteady walking needing, great assist; Severe pain in back and neck; Severe pain in back and neck; Not eating, taking water OK; Incontinent of urine and stool; Incontinent of urine and stool; This is a spontaneous report from a contactable (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 04Mar2021 at 10:00 (at the age of 79-years-old), as single dose for COVID-19 immunisation. Medical history included aortic heart valve replaced, mild COPD, edema in legs, irregular heartbeat. Patient had no known allergy. Patient not diagnosed with COVID-19 prior to vaccination. Patient was not received any other vaccine prior four weeks of vaccination. Concomitant medication(s) included MELOXICAM, LASIX and HCTZ. On 04Mar2021 at 14:00 (same day after vaccination), patient experienced temperatures 105, chills, confusion, unsteady walking needing, great assist, severe pain in back and neck, not eating, taking water OK, Incontinent of urine and stool. Patient did not receive any treatment for the events. Since vaccination patient not tested for COVID-19. The patient underwent lab tests and procedures which included Body Temperature: 105 on 04Mar2021. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Wasn't felling heathy/Wasn't feeling well/not feeling good/Felling ill/Feeling sick; Using a bathroom number 2 four times a day, regular stool not soft; Back hurt; Slightly dizzy; I worry about how I am feeling until I know it is from the shot or not I am not going for another shot; Maybe nauseous; Feeling down; This is a spontaneous report received from a contactable consumer (patient) reported that: A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0123; Expiration date: unknown), via unspecified route of administration on 02May2021 (at the age of 79-year-old) as first dose, single dose COVID-19 immunisation. The patient medical history included atrial fibrillation and the concomitant medications included blood thinner for atrial fibrillation. The patient took pfizer shot 3 weeks ago. The patient experienced was not felling heathy, I wasn't felling a 100 percent; Was not feeling well/not feeling good, using a bathroom number 2 four times a day, regular stool not soft, back hurt, Feeling ill, Feeling sick, Slightly dizzy, worry about how he is feeling until he know it is from the shot or not, patient not going for another shot, May be nauseous, Feeling down on unspecified date in May2021. The patient stated that he got the shot 3 weeks ago and patient was due for second shot tomorrow but he have a concern, he do not think he is going for it, 2 days after he was not well about 8 days and then he felt better and then about 4 days ago he felt the same thing again, The patient stated that "he did not really care to report it but what he was calling to see his second shot is tomorrow and he is not going for it, but he would like get it may be when he feeling mentally after it, Could he take it couple of weeks later, if that ok?" the patient had a reaction to the flu shot (Unspecified Flu Shot) and he was feeling ill for about another 9 days it went away, but then it came back 4 days ago; didn't feel well/ not feeling good. The patient was scheduled for my second shot this morning I did not go because he is not feeling that great. The patient said he got the flu shot 3 weeks ago and 2 days after this shot, he did not feel well for about 7, 8, 9 days and then it went away, he felt okay and then about 4 days ago he got back the same feeling, not feeling good, slightly dizzy, maybe nauseous. Using the bathroom, number 2 frequently 4 times a day and he was scheduled for my 2nd shot this morning I did not go because he was not feeling that great. The patient stated that he took the vaccine three weeks ago and he was scheduled for his second shot this morning, he did not go because he is experiencing some side effects(Further not clarified hence captured as verbatim) and he was concerned to see this is related to the vaccine (confirmed as Pfizer COVID vaccine) or not?" He got this vaccine shot 3 weeks ago two days after he was not feeling well, he was feeling down for about 8 or 9 days and then it passed, the patient felt better then 4-5 days ago the same thing come back, this is 3 weeks now. The patient did not receive any treatment for the events, the outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

a shooting pain started up into his knee and it just aches all the time; It is irritated where he cannot wear a shoe now/He cannot get up and out of chair/ He cannot do anything; Everything was normal except for that same mass in his foot; he has a soft tumor on both feet/ the tumor is sticking out; his foot started hurting/his right foot is having pain/ the pain is starting to get worse; now I can't walk; This is a spontaneous report from a contactable consumer (patient reported himself). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 16Feb2021 09:00 (at the age of 79-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history included foot tumor. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior vaccinations. The patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EL9265) via an unspecified route of administration, administered in arm left on 29Jan2021 09:00 as single dose for COVID-19 immunization. The patient reported he has a soft tumor on both feet/ the tumor is sticking out, his foot started hurting/his right foot is having pain/ the pain is starting to get worse, now I can't walk, it is irritated where he cannot wear a shoe now/he cannot get up and out of chair/ he cannot do anything, everything was normal except for that same mass in his foot on an unspecified date in 2021, a shooting pain started up into his knee and it just aches all the time on 26Apr2021. AE resulted to visit physician office. Patient is a consumer, asking what do I do or what can I take to make this pain go away. Patient reported that he received both doses of the Pfizer covid vaccine, his first dose in January and his second dose February 1. Patient reported that around the same time that he got his shots his foot started hurting and now I can't walk. Patient reported that he has a soft tumor on both feet but his right foot is having pain, the tumor is sticking out and the pain is starting to get worse. Patient reported that nothing works to take the pain away. Patient reported that he saw his doctor a while back but reports that back then the pain wasn't as bad, they did x-rays and nothing was wrong. Patient reported that now the pain is terrible. Soon after having the COVID vaccine shot in Jan 2021, patient started having foot problems on his right foot. Patient did have a preexisting soft tumor in that foot. It is irritated where he cannot wear a shoe now. Patient can't stand or walk on it. It is constantly aching. A couple of days ago, a shooting pain started up into his knee and it just aches all the time. Patient was wondering if this is one of the side effects. Patient wants to find out if it is caused by the vaccine. Patient had a x-ray three weeks ago, and there was nothing wrong with his foot. Patient had no break, no spurs, or anything. Everything was normal except for that same mass in his foot. Patient thinks the vaccine affected the mass. Patient can't walk on his foot it just aches. Patient foot became irritated in Jan 2021. It was irritating. It has worsened. The shooting pain up to his knee started 26 Apr 2021. Patient just drove to the hospital today to get information and the pain shot up a little bit today. Even when patient is sitting in a chair he has aching and shooting pains in his foot. Patient went to the store in pain. Patient cannot do anything, cannot get up and out of chair, can't turn around with his foot on the floor. The patient underwent lab tests and procedures which included x-ray was normal -he had a x-ray three weeks ago, and there was nothing wrong with his foot. He had no break, no spurs, or anything. Everything was normal except for that same mass in his foot. Outcome of the event a shooting pain started up into his knee and it just aches all the time was not recovered, and rest of the events was unknown. No follow-up attempts are needed. No further information is expected.

Loss of breath, unable to stand, loss of memory, oxygen level became low, dizzy, weakness, blood pressure declined, diarrhea, vomiting, injection sight swollen, disoriented, shakes, was freezing, uncontrollable bowls, unknown substance coming from mouth, loss of strength in arm

depressed; he was freezing and was shivering; he was freezing and was shivering; blood pressure was a little high; pulse was high; Nauseated; slept a lot; feeling tired; chills; high fever; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (Patient wife). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Lot Number: EN5318), intramuscularly, administered in Arm Left on 03Feb2021 08:00 as 1st dose, single for covid-19 vaccination (79 years old when vaccinated). Medical history included ongoing High blood pressure, additional Information for Other Conditions: Diagnosed years ago, ongoing CAC score high from 2018, ongoing urinary tract disorder from 2007- She said that he takes urinary medication, nephrolithiasis and also felt like it was like when he had a kidney stone. She said that he does not have a kidney stone. She said that he was really sick and hospitalized with the kidney stone. The patient's concomitant medications were not reported. Patient did not receive any other prior Vaccinations within 4 weeks Shingles vaccine, 2nd dose, No manufacturer or lot number at the time of the call, Intramuscular injection, Left arm 1 previous dose, given 2.5 weeks prior to the Covid vaccine at the beginning of Jan2021.It was reported that, Consumer called on behalf of her husband, who had his 1st dose of the Pfizer Covid vaccine last Wednesday morning (03Feb2021). He then started experiencing symptoms yesterday (on 04Feb2021) and last night he started feeling tired, had chills, high fever and muscle aches which was worried. She said that everything was ok until yesterday other than being tired, he had no reaction and no real soreness in his arm. Yesterday he was really tired and slept a lot and at about 20:30 he yelled out he was freezing and was shivering felt like it was like when he had a kidney stone, that he does not have a kidney stone. She said that his fever spiked really high, and he was treated with Tylenol and it came down. His highest temperature was 102. When he first got up this morning(05Feb2021), his temperature was normal, but within the next hour it went to 101.9 at 10:00, then to over 101, and then it came back down to 100. It maintained during the night, he had some muscle aches now, he was a little bit nauseated, but that has gone away also, and the Nausea did not last very long. The blood pressure was a little high and his pulse little high, but the blood pressure is better. His next appointment for his 2nd dose of the Covid-19 Vaccine is 24Feb2021. She said that he takes high blood pressure medication. urinary medication, and cholesterol medication. He had been a little depressed because of Covid and he is taking antidepressant medication, but it should be temporary. Therapeutic measures were taken Tylenol as a result of high fever, blood pressure was a little high, depressed. The outcome of the events Fatigue, chills and Nausea, feeling cold were resolved; for Fever, Muscle ache, pulse was high, Myalgia, Hypertension, Depression mood were not recovered, blood pressure was a little high was recovering was unknown. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

I was doing light yard work and felt discomfort in my chest. Went in the house to get hydrated and test my blood pressure and pulse. Rapid heart rate of 143. Monitored for 3 hours and was consistently 140-142. Called cardiologist who referred me to the Emergency Room at the hospital ER Administered Cardizen IV and returned to normal heart rate within 45 minutes. I have been experiencing foggy brain since the incident. I consider myself to be in perfect health and am very active.

shaking, altered consciousness Narrative: One day after pt received his first covid vaccine, pt experienced upper extremity shaking leading to ED visit and subsequent hospitalization with concern for seizure. Examination and labs were not consistent with seizure. He had features of lewy body disease and parkinsonism. Labs were significant for leukocytosis, but pt had no other signs/symptoms of infection or findings to indicate a source of infection. Pt referred to Neurology.

Patient's wife called this morning stating that her husband has passed away last night. After receiving first dose of Pfizer COVID-19 vaccine at around 0830, patient remained in the Immunizations Department for the 15-minute monitoring period. Per wife, patient's only complaint was pain at the injection site. At 1300, wife states that patient complaint of dizziness which "dissipated after a few minutes" followed by a headache which "dissipated after a few minutes" as well. Then patient complained of nausea, no vomiting and "couldn't relax." Per wife, from around 1400/1500, patient stayed on his recliner while still having a conversation with her--"he didn't get up to eat." Last conversation they had was around 2000/2100. Per wife, at around 2100/2200, patient was quiet and when she checked on him, "he wasn't responding anymore." Wife then called 911, "but they couldn't revive him."

heart attack; chest pressure; hardly slept; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient (reported also as 81-years-old, to be clarified) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL3246), via an unspecified route of administration, on 13Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 80-years-old. Medical history included ongoing emphysema and ongoing diabetes (caller has been diagnosed for 35 years for both conditions), heart was damaged because of the diabetes, and a history of bypass 4 years ago however he hasn't had any issues with chest pressure since before the bypass. Concomitant medications were none. On 15Jan2021 at 1:am he developed pressure in the chest which ultimately resolved. This trouble last night, lasted over 1 hour. He couldn't get back to bed. He had to sleep sitting up on the sofa. That was the only way he was comfortable. Her husband has hardly slept. She was seeing how he was doing. He said he was okay sitting. The pressure on his chest would go away while he was sitting, but laying down it would come back. This morning (15Jan2021) she made him check when he woke up at 8 o'clock. She made him lay down, and he said it was gone after sitting the whole night. He is well now. He is feeling fine. He didn't even ask for help getting on his clothes. He got the vaccine because of his age and because of underlying conditions. Her husband has done very well this year. He even has underlying conditions. He has had Emphysema for 35 years, but it hasn't been bothering him. He has also had diabetes for 35 years. The reporter spoke to her husband's hcp (nurse) who said it could have a heart attack and for him to go to hospital if it reoccurs. She did speak with a nurse with his primary doctor, and she said the pressure in his chest for 1 hour could have been a heart attack. That if it occurs again to give him the nitroglycerin. She told the nurse it wasn't pain. The reporter stated chest pressure could have been a heart attack. He is scheduled to get the 2nd dose on 21Jan2021. The reporter was wondering if her husband can have the second dose given it has potassium in it (given he has bypass history). The reporter is afraid the vaccine is not safe, and they may not go for the second vaccine. She wants more information if it is safe. The events recovered on 15Jan2021.

Patient had his first vaccine on 1/12/21. On 1/13/21 and 1/14/21, he was more confused then normal, very emotional, and has decreased appetite. Patient recieved the second vaccine on 2/2/21. On 2/3/21, he was once again more confused, emotional, and had little appetite. He is now back to normal.

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.

On the 3rd day after vaccination, the patient developed mild malaise. As the day progressed, there was increasing difficulty moving and talking. That night the patient began hallucinating,. Later at night the patient awoke and couldn't move at all. By the morning, things were better and patient could get out of bed and eat. Ity sounds like a dopamine reaction which the aptient has previosuly expeicned, however, there was no irregularity in L-dopa dosing.

Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient found unresponsive sitting in recliner and breathing. Vitals normal. After 5min sternum rub patient became conscious and stated he could hear being spoken to but could not respond. Felt weak rest of the day. Although this occurred several days later there were 3 patients at same facility experiencing similar issues on same day

Hallucinations; He seems impaired mental and emotionally; He became unruly, hostile, angry, indignant; Unreasonable dreams; Belligerent, lost all sense of decorum, couldn't figure out where he was; Cried; This is a spontaneous report from a contactable consumer reporting for himself. A 80-years-old male patient received bnt162b2 (BNT162B2; Lot #ENS318) vaccine , via an unspecified route of administration in the left arm on 30Jan2021 11:15 at single dose for covid-19 immunisation . Medical history included Parkinson's disease, mobility decreased . Concomitant medication included thyroid (THYROID), carbidopa, levodopa (RYTARY). The patient previously took codeine and experienced drug hypersensitivity. One hour after receiving the vaccine, the patient experienced hallucinations on 30Jan2021 12:15 with outcome of recovering , he seems impaired mental and emotionally on 30Jan2021 12:15 with outcome of recovering , he became unruly, hostile, angry, indignant on 30Jan2021 12:15 with outcome of recovering , unreasonable dreams on 30Jan2021 12:15 with outcome of recovering , belligerent, lost all sense of decorum, couldn't figure out where he was on 30Jan2021 12:15 with outcome of recovering , cried on 30Jan2021 12:15 with outcome of recovering. All the reported events were considered Important Medical Events.

Pt experienced chest pain while waiting in line for vaccine. 5 out of 10 chest pain persisted post vaccination. Reported feeling nervous, anxious, cold sweats. Pt with hx of HTN, on cardizem. Denied hx of afib. Denied other past medical hx. Pt with elevated BP 160s with labile pulse, ranging from 30-80s. O2sat 99%. Pt escorted to ED.

Fever (up to 102 F); headache; mental confusion; lack of responsive speech or delay in responding to questions. Symptoms began around 11:30 a.m. on Feb. 21. Administered one Tylenol at 2:30 p.m. on Feb. 21. By 6 p.m. on Feb. 21, the fever and headache abated. But confusion and lack of speech continues to Feb. 22 (10:30 a.m.) as I prepare this report.

Immediately he had a headache associated with dizziness and the headache persisted. He was known to be unstable on his feet with muscle weakness. Other complaints include shortness of breath, confusion, decreased appetite. O2 saturation dropped from 90% to 80% on room air. He complained of low back pain and weakness and heart rate of 115.

Pt received first dose of Pfizer COVID-19 vaccine on 2/9/2021. Pt developed COVID symptoms and presented to hospital, tested positive 2/25/2021 via SARS-CoV-2 PCR NP. Symptoms: generalized fatigue and malaise, max temp 103, confusion with hallucinations, needed supplemental O2. Admitted on 2/25/2021.

Patient was found on bathroom floor by spouse @ approximately 02:30 am (2.5 days after receiving 2nd dose of Covid-19 vaccine). He had fallen and had an obvious head injury & demonstrated altered mentation from usual baseline. Family utilized 911 to transport him to local ED. He was febrile upon arrival to ED and admitted for severe sepsis with unknown etiology. He was found to have positive SIRS criteria and elevated LA. He was admitted to hospital and received IV antibiotics for 11 days (spent 7 days as an inpatient and completed remaining infusions in home environment)

Per Patients Wife - Same day - Flu like symptoms, Nausea, Headache. Restless that night. Next day - Weak, shortness of breath. Wife called squad to get him out of his wheelchair but patient refused hospital as it gets him agitated. Patient passed away around 11 AM the day after vaccination.

Patient is an 80 year old male who has a history of multiple medical problems, including body mass index of 30, hypertension, dyslipidemia, giant-cell arteritis on a slow prednisone taper (currently 2 mg daily), past pulmonary embolism on warfarin, sleep apnea, history of diverticulitis (treated in August 2020), past abdominal surgeries (including umbilical hernia repair ×2 and open recurrent incarcerated epigastric hernia repair with mesh in October 2020), chronic anemia, and type-2 diabetes. The patient had received the first dose of the COVID-19 (SARS-CoV-2) vaccine on January 31, 2021 and the second dose on February 21. He presented to his primary care provider?s office on February 22, 2021 with complaints of 10 days of progressive weakness and muscle soreness. The weakness had reportedly involved the bilateral thighs and arms and was associated with muscle aches. Blood pressure measured 90/40 mmHg and examination was notable for symmetrical proximal weakness in the upper and lower extremities. The peripheral blood leukocyte count measured 3.5 x10e3/µL, hemoglobin 8.3 grams per deciliter and platelets 147 x10e3/µL. A peripheral blood smear was consistent with neutropenia and normocytic anemia with 9% circulating blasts. Total CK measured 1424 U/L. The patient was referred to hematology/oncology and rheumatology and had appointment scheduled for both on February 26. With the above background, he presented to emergency room on February 24 with altered mental status and continued weakness. He was taken to the hospital by emergency medical services. A temperature of 103 degrees Fahrenheit was recorded when emergency medical personnel had arrived. The peripheral blood leukocyte count was 1.4 x10e3/µL for an ANC of 0.8 x10e3/µL. Hemoglobin was 8.1 g/dL and platelets 111 x10e3/µL. A few schistocytes and teardrop cells were noted. The serum creatinine was 1.47 mg/dL. AST was 174, ALT 91 and alkaline phosphatase 93 U/L. The lactic acid level of the venous blood was 2.1 mmol per liter. A repeat total CK was 4631 U/L. Sedimentation rate measured 34 mm/h and CRP 52.3 mg/L. Urinalysis showed 0-2 wbc?s/hpf, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, negative leukocyte esterase. A haptoglobin level of the blood was within normal limits. The lactic acid level of the venous blood was 2.0 mmol/L. LDH measured 838 U/L. A ferritin level was 3464 nanograms/mL. A test for COVID-19 (SARS-CoV-2) was negative. A chest radiograph showed minimal streaky right basilar atelectasis, trace left effusion and a mildly enlarged cardiac silhouette. A head CT showed no acute abnormality. An abdominopelvic CT without contrast was limited by motion artifact. No acute intra-abdominal or pelvic finding was noted. Nonspecific soft tissue stranding was seen in the right inguinal region. There was no soft tissue gas or drainable fluid collection. Cultures of specimens of the blood were obtained. The patient was started on empiric cefepime, vancomycin and doxycycline and admitted for further care. A peripheral blood smear for intracellular parasites was negative. The admission blood cultures came back positive for E. coli. With the blood culture results, the vancomycin and doxycycline were discontinued. The E. coli isolate has since been determined to be pansusceptible. A MRSA PCR of the nares was negative. He was found on exam to have swelling, cellulitis and exquisite pain of the right groin area on February 25. Surgical consultation was pursued. They did not feel that he had necrotizing fasciitis. The CT scan of the abdomen and pelvis was repeated with contrast, revealing increased extensive subcutaneous edema of the right groin region with extension into the thigh musculature and mild extension into the right inferior pelvis. There was no associated soft tissue gas or drainable abscess. A bone marrow biopsy was performed February 25. Results showed acute undifferentiated leukemia with 60-70% infiltration of the bone marrow with blasts. The blasts were negative for lineage markers. He was faintly CD33 positive. He is felt to likely have acute myeloid leukemia. Cytogenetics are pending.

Rash/hives all over his body and large swollen lump on the back. Itchy and irritable. Doctor prescribed Benadryl and Prednisone 10 mg.

10/5 :Fri 2:00 PM Nausea,9:30 PM Fell down and could not get up without assistance, unable to walk or setup, Dizzy and confused, bad itchy rash on body including large red spots(stomach, back, legs, arms, head , neck) Sat 10/6 admitted at Hospital tests results dehydration. Continued problem with walking. Tues 10/9 visit with primary doctor. Pictures were taken of his body and entered in computer at Clinic. Walking issues getting better.

'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.

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

PATIENT STATED THAT APPROXIMATELY 26 HOURS AFTER HIS INJECTION HE WAS INCOHERENT, FELL, AND COULD NOT MOVE. ADVERSE EVENT LASTED 24 HOURS.

passing out; really bad reaction; This is a spontaneous report received from contactable female consumer (wife) on behalf of her husband 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 29Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 29Mar2021, the reporter stated that patient had a really bad reaction last night and had to go to the emergency room, she stated that overnight her husband kept passing out and states that when he would come to, he would say it's the medicine, the medicine. The reporter thought he was talking about his blood pressure medication because she states she checked and he hadn't taken it yet, but when she asked if what medicine he was talking about, her husband would say the one in my arm. The outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

At some time after the vaccines were given I started having muscle aches and pains throughout my body. Thighs, calves, butt, hips, biceps, forearms, and inside area between bicep and lower arm (opposite side of elbow) which would keep me awake at night due to the pain. That pain was only at night, the other pains were during the day and most times would last the whole day, but other times would lessen as the day went on. I still cannot sleep on my left side, due to hip and arm pain, but the very painful left arm pain persists as described above even when sleeping on my right side. I still have these pains as of the date of this writing, April 17, 2021.

Could not sleep for two days; Sweaty; Chills; Face and palms got really red; Indigestion; Constipation; deathly sick over the weekend; This is a Spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM6207), second dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 15:00 (Batch/), single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing Diagnosed with COPD 3-4 years ago and is not taking any medication for it, (blood pressure) hypertension from an unknown date and unknown if ongoing had been taking Atenolol for blood pressure. Concomitant medication included atenolol. The patient had the first dose of bnt162b2 vaccine (Lot EN6023) on 27Feb2021 for covid-19 immunization and experienced hypertension aggravated. He went back to doctor and had been taking Atenolol for blood pressure. It has always been dose 50/25. His blood pressure was up just a bit and he cannot verify who this girl was that changed it to 100/25. He did not like the way he felt and eliminated it and went back to the previous dose. He had two over a period of 2-3 days. It is in a pharmacy vial. He does not have a lot or expiration for the Atenolol 100/25. The date his blood pressure was up was for the past couple of times.Usually, it is 120/60-70 and then it jumped up to 150/60-70 and that is why it needed to be changed. It was filled on 18Mar2021, which was after first vaccine but before second dose. Patient got deathly sick over the weekend on 02Apr2021. He had the shot on 20 Mar 2021, and it has been more than the two days you could have a reaction. He was deathly sick. On 02Apr2021, he had just about all of the symptoms; sweaty, chills, face red, and hands red, indigestion, constipation and could not go to the bathroom. He was about as sick as he had ever been. He know it is not supposed to be that long. He could not sleep for two days. His face and palms got really red. He did not have a fever. He walked the floor and only slept 2 hours in two days. On 31Mar2021, he goes to a pain center and got shots in his neck. He asked the doctor if his shot had anything different than he had been getting and he confirmed that it was no different. He never had a reaction before the one he got on 31Mar2021, and thought it may have been the virus shot. He said one other thing happened and is not sure if it had anything to do with it or not. He just started to feel worse and worse. Today is the first day he felt better. He is 80 and has not been this sick. It got really bad but today it is much better. He did not sleep for two days and last night he slept and feels better. For the indigestion, it got worse before it got better. For constipation, he got relief last night and that is why he feels better today. NO ER or physician's office required- He had a previously scheduled office visit for pain center. The outcome of the events was recovering. The event insomnia was assessed by the reporter as medically significant. Information on Lot/Batch number was available. Additional information has been requested.

S/P pfizer vaccination for COVID-19 about 6 weeks ago with progressive confusion, new fevers and encephalitis with parkinsonism Appears to be consistent with inflammatory encephalitis

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild

Patient was in his usual state of health and independent with his ADLs until 2-3 days after his 2nd COVID vaccination on Feb 26th when he began to have bilateral knee and LE pain. He then was having difficulty walking for a couple of weeks. The leg pain was not constant, but he did fatigue easily with walking. On 3/11 he had his lower dentures placed and that evening/early morning of 3/12 he apparently fell. Patient does not remember anything about the fall - he cannot recall when he fell, how he fell, or any of his symptoms leading up to the fall. Patient remembers being on the floor and attempting to get up but was too weak. He has rug burns on his forearms from attempting to get up. He was hospitalized on 3/13 for dehydration, traumatic rhabdomyolysis, and w/u following fall. Despite very stable labs prior to 1st dose of vaccination on 2/5/21, following vaccination he has had significant and substained leukocytosis as well as transfusion dependent anemia that has not resolved at the time of the reporting (5/13/21). He remains at a skilled nursing facility due to debility.

Altered mental status, confusion, subdural hematoma. Was lifeflighted to Clinic and remained there about 5 weeks, developed a stage IV pressure ulcer on buttock. Diagnosed with multi organ failure. Went to a SNF for rehab after being discharged. Wife said then patient received 2nd dose of vaccine about 2 weeks ago and is currently at Hosptial in town for a GI bleed, passing frank blood and clots. He was admitted 5/9/21. Patient is still confused and lethargic. Before the vaccine, he was taking care of his farm and home. Now he doesn?t even know his wife or what is going on.

Office Visit 3/23/2021 Urgent Care PA-C Family Medicine 2019 novel coronavirus disease (COVID-19) Dx Covid-19 Screening Reason for Visit Progress Notes PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 3/23/2021 ? ? Signed Cosigned by: MD at 3/24/2021 4:39 PM Expand AllCollapse All MDM Number of Diagnoses or Management Options 2019 novel coronavirus disease (COVID-19): Diagnosis management comments: Patient is an 80-year-old male with history of atrial fibrillation and positive POCT COVID-19. 6 days of symptoms. Excellent candidate for antibody therapy. The health system treatment navigator was notified of this and will schedule him for antibody infusion treatment. Patient is stable at present with no severe or concerning symptoms at this time. Tylenol/continued Eliquis recommended. Clinical Support 3/24/2021 Health system RN COVID-19 virus infection Dx Progress Notes RN (Registered Nurse) ? ? Encounter Date: 3/24/2021 ? ? Signed Patient is here for MAB Infusion Consent for infusion prior to this visit reviewed and verified. O2 sats > or = 90% Signs of potential reaction reviewed with patient. Tolerated IV start and MAB infusion without complication. Pt has access to pulse oximeter and thermometer for home monitoring Provided fact sheet for patients, parents and caregivers- Emergency Use Authorization of BAM for Coronovirus Disease 2019 for pt to review. Discharge instructions reviewed. Patient denies any questions ED to Hosp-Admission Discharged 3/25/2021 - 3/26/2021 (39 hours) Hospital MD Last attending ? Treatment team COVID-19 Principal problem Chronic anticoagulation Persistent atrial fibrillation (CMS/HCC) COVID-19 Confusion Hypoxemia Hospital Course: In his hospital stay we managed his medical issues as follows; Confusion/Syncope in the setting of COVID-19 infection Chronic atrial fibrillation/sinus node dysfunction Hypertension Prediabetes Patient received first dose of vaccination on 3/16 and afterwards started having muscle aches and body pains, later on found out to be having Covid 19+ test, he might be having Covid infection before vaccination as well and symptoms showed with vaccination. On 3/24 he was found out to be having confusion, family called EMS. They tried to debride patient on his feet and he collapsed for about 10 seconds. He did mention that he usually get dizziness/lightheadedness upon standing from bed. Although patient has a history of A. fib but remained rate controlled during hospital stay, we held his antihypertensives including HCTZ and ARBwhile continued his Eliquis. I believe his syncope was likely due to dehydration with decreased oral intake in the setting of acute illness with COVID-19 symptoms. Before discharge is blood pressure was rising so his ARB were restarted while decision regarding HCTZ will be made by primary care physician. In regard to his COVID-19 infection, initially was started on 2 L of supplemental oxygen but his oxygen demand decreased rapidly and most of the time he remained room air, he was not showing any dyspnea, cough, fever or any other generalized symptoms of Covid 19 infection. He did get plasma and remdesivir while inpatient, decision was made to discharge him on 3/26 as patient was symptom-free. He also had received first dose of vaccination. I believe that he would need further remdesivir. We will continue him on steroids for now after completion of dexamethasone for next 8 days he can recent resume his home medication of prednisone.

Patient received second COVID 19 vaccine 5/15/21. Patient presented to the ED on 5/17/21 with cheif complaint of increased shortness of breath and weakness. On 5/16/21, he did not sleep well and felt sweaty with chills. He took ibuprofen and Tylenol. He states he feels like he has no power when he walks. No chest pain. No fevers. He also notes slight diarrhea. Patient denies any Covid contacts. There are no other modifying factors or associated symptoms

Within one week of vaccine dad lost interest in everything, developed incontinence, became extraordinarily sleepy, stopped gregarious talking and only responded to questions asked, became extremely confused, eventually losing his ability to walk, talk, and swallow. All occurring in short order. ER twice, hospitalized twice, rehabilitation twice. As yet, no formal diagnosis despite three hospitals seeing my father and testing him extensively.

crying; feeling nausea; depression; feeling dizziness; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17May2021 09:00 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunization. Medical history included heart valve replacement from 12Mar2021, kidney infection, had a heart bypass and is diabetic. The patient has no concomitant medications. The patient got the Pfizer Covid Vaccine on 17May2021, and the next day (18May2021) he woke up with dizziness. The reporter asked how long the symptoms last after the Covid vaccine. He is sort of getting nausea when he tries to get up. He was also real depressed. It kind of started the next day after the vaccine (18May2021), but Wednesday she was concerned because the patient was crying a lot which is unusual for him. The nausea started today (25May2021). He hasn't been up and about. The dizziness is about the same. They called his primary caregiver who started him on some antidepressants. She picked up the information sheet that was given to them with the Covid vaccine and read there that dizziness was a side effect and a feeling of impending doom which is sort of how he was feeling. Now that's why she was wondering when the symptoms would be over. She doesn't really think he needs anything. He has never been depressed. She thinks now it is a side effect from the vaccine. She thinks the depression has improved. He is not crying anymore, but somebody is with him all the time. This was his first dose of the vaccine. He is supposed to go back on 07Jun2021 for his second. The outcome the event depression was recovering, event crying was recovered on an unspecified date and the other events was not recovered.

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

is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse; he has lost some weight; He is having trouble with his memory; is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse/He has pain down his right side into his crotch and down his leg; This is a spontaneous report from a contactable consumer (wife). An 80-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: 2L3247) intramuscularly into the right arm on 20Jan2021 15:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. The patient's medical history included diabetic, COPD, prostrate cancer. He has a hard time breathing and was on oxygen. Concomitant medications were not reported. The patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EN5318) intramuscularly into the right arm on 17Feb2021 10:30 AM as single dose for COVID-19 immunisation. On an unspecified date, the reporter stated that her husband had the first dose of the Pfizer covid 19 vaccine on 20Jan2021 and was in a lot pain going down the right side into his crotch and legs and screams out in pain. Pain was getting worse and wanted to know if this was a side effect of the vaccine. He was not getting the second dose of the Pfizer covid 19 vaccine because of the adverse event he experienced with the first dose. He was on oxygen and had to carry an oxygen tank. He was due to get the second shot on Wednesday. She wanted to check and make sure. It may be a muscle thing. It seems to be getting worse and worse. He can hardly get up. He cannot hardly sleep in the bed. He does not want to get the next shot and his left side be in pain. Then he would not be able to do anything. He had lost some weight around 230 pounds. He has the first stages of Alzheimer's and clarified that has not been diagnosed yet with Alzheimer's. He had a test a couple years ago and it was normal. He was having trouble with his memory. He got the flu shot on 01Sep2020. He takes two cases full of medication. He was diabetic. He took shots in his stomach. It was changed over. No further details provided. Pain on right side started two days later. She does not know, but was assuming it was the muscle, going to be a little sore. It had progressively worsened. He could hardly move to go to the bathroom. He had prostate cancer a few years ago and has to wear underpants. He cannot bend over to put on his underpants or socks. He screams in pain. He does not do well with pain. No prior vaccinations within 4 weeks. Relevant tests included X-Ray on 26Feb2021 with unknown results. Outcome was unknown for all the events. Follow-up attempts are completed. No further information was expected.

Within a few minutes of his 2nd dose, he said his throat felt tight like it was closing. I alerted staff. They checked his blood pressure. 155/50. Made us wait another 20 minutes and my dad said he felt better after drinking water. Once we got home he said he felt brain fog and a bit dizzy. He passed away on May 4th, 2021. 3 days after his 2nd dose of Pfizer. It was ruled a heart attack.

No adverse event after the vaccination in March. Case went for his Dialysis (at a separated private setting for their covid patients) on 6/29/2021. Was supposed to have dialysis tx on 6/26 but that one got cancelled due to his sxs and subsequent test. After dialysis session on 6/29, case was disoriented (more than usual after tx), hard to direct/assist in transfer, decreased coordination at home, diarrhea. Family tried to care for him but by next day 6/30 (Wed) realized it was more serious, and via ambulance went to the hospital and admitted on 6/30/2021 through 7/7/2021. Was in ICU but not ventilated. DIscharged to an extended care facility on 7/8/2021.

the patient was so excited after the first shot of the Covid-19 vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in left arm on 12Jan2021 (age at vaccination 80-year-old) as 1st dose, single for Covid-19 immunisation. Patients medical history included stent placement from 2005, put in 5 stents, caller reported that the patient had a stent placed in his neck in nov2019, heart attack from 2017, sensitivity to bug bites if the patient went outside and got a mosquito bites, he looked like he had been beat with the knots on him, hypertension, contrast media allergy from 2005, high blood pressure and reaction to contrast dye on 2005. Concomitant medication included cetirizine taken for allergy problem, amlodipine besilate taken for hypertension, aspirin [acetylsalicylic acid] taken for antiplatelet therapy. The patient previously took codeine and experienced drug intolerance. Patient have sensitivity to codeine, goes way back, 40-50 years. The patient previously took tetanus vaccine, 20 years ago at least. The patient was so excited after the first shot of the covid-19 vaccine. The patient underwent lab tests and procedures which included x-ray: normal on 04Apr2021. The outcome of event was unknown. Information on the lot/batch number has been requested.

dizziness; he couldn't stand up; he laid down the bed would float; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry: Apr2021), via an unspecified route of administration on 09Jan2021 11:45 at a single dose for COVID-19 immunization. Medical history included retired, he became allergic to penicillin when he was 17 year old and hasn't taken it since, lost his taste and smell, potassium is high sometimes - the doctor recommend he cut down on banana and potatoes, extra heart beat, stomach acid, and thyroid disorder. Ongoing concomitant medications included levothyroxine sodium - has been taking it for a year and a half to two years for thyroid, metoprolol succinate - has been on it about a year and half because an EKG showed he had an extra heart beat, and omeprazole capsule - been on it two or three years for stomach acid. The patient previously took trimethoprim/sulfamethoxazole (BACTRIM) and experienced allergy. After having a Pfizer shot on Saturday, he had a reaction - dizziness. His wife also received the COVID vaccine but did not have any reaction. He sat in the office for 15 minutes like he was supposed to. He drove home and was fine. Two hours later he was so dizzy he couldn't stand up. He was holding onto things to walk through the house. That was two hours after he took the vaccine. After that he thought it would go away in a day. All day yesterday, which was the second day, he was still dizzy. If he laid down the bed would float. It was an awful experience. He received the vaccine at 11:45am on 09Jan2021. Two hours later is when it started. He had to hold onto the rail to get up there. If he gets up quick it is still there. He just had blood work and was due back in Apr for check up. He hasn't had taste and smell for four years or better. He lost his taste and smell and never got it back. He doesn't know what caused that. He hasn't been sick. Outcome of the event dizziness was recovering, for the other events was unknown.

fatigue Narrative: Did not feel good, appeared to have symptoms prior to getting vaccine, but had declined ER evaluation prior to vaccine. Pt was light headed, VS stable. Pt reported to have fatigue with exertion. Was sent to MER at 1:30p, routine labs revealed elevation in SCR and admitted for AKI. Pt was determined during admission to be volume depleted exacerbated by diuretics and administered IV fluids. follow-up appointment scheduled for 01/31/2021.

I have had tinnitus for a very long time, but it became extremely loud the second day after vaccination. I believe it has to do with the vaccine since I have never experienced tinnitus this severe before. In addition, I started experiencing anxiety all during the day and had a severe panic attack before bedtime. If it doesn't subside, I will need to find a doctor for this condition. It is no better today, Jan. 31, 2021.

Brain fog; anxiety; (minor) sudden brief sharp headache; soreness at injection site; This is a spontaneous report from a contactable consumer reporting for self. A 81-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EL9261,via an unspecified route of administration on 19Jan2021 15:30 (at the age of 81-years old), Dose 1, as a single dose, left arm for COVID-19 immunization. Medical history included high cholesterol and hypothyroidism. The patient had not been diagnosed with COVID-19 prior to vaccination. Concomitant medication included levothyroxine, guaifenesin (ROBITUSSIN), and rosuvastatin calcium (CRESTOR). The patient did not receive any other vaccinations in the 4 weeks prior to the COVID-19 vaccination. On 19Jan2021 at 15:45, the patient experienced brain fog and anxiety, which lasted approximately 20 minutes. Also (minor) sudden brief sharp headache and soreness at injection site. There was no hospitalization for the events. The patient received treatment for the events, reported as "Calming talk, deep breathing, rest." The events were reported as non-serious. The patient recovered from the events brain fog, anxiety on 19Jan2021 at 16:05 and recovered from sudden brief sharp headache and soreness at injection site on unspecified date(s). The patient had not been tested for COVID-19 since the immunization.

Presented to ED with altered mental status. He became fatigued and lethargic with a brief period of unresponsiveness. Could not speak and had a gaze to his left. Could not carry on conversation or answer questions appropriately. Stroke team activated and CT completed. CT negative for bleed. Neurology ordered Alteplase to be administered. Patient then transferred for further evaluation and treatment. Patient had left MCA occlusion with TICI IIb achieved. Admitted to neurology stroke service in ICU following procedure. Started on aspirin with plavix. Rehab referral.

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.

I have a scheduled appointment with my doctor the day of the vaccine at 3PM for my annual physical. When I got my doctor's my blood pressure was high, the top number was 210 I do not remember the bottom now. He said I needed to get over to the ER clinic as soon as possible which is joined to my doctor's hospital. When I made it to the ER the blood pressure was 240 now. They to put on blood pressure monitoring, EKG. They gave my a chest x-ray. Cat-scan , blood work and gave me something in my IV. I went home that about 9:30 PM that night. My blood pressure was 213/99 and started my new medicine Nifedipine 30 MG . The ER Doctor told me to schedule an appointment with my doctor ASAP. The appointment was scheduled for today but was canceled as my doctor's office still has no power and was rescheduled for Monday the 22nd. Prior to receiving the vaccine I have no had high blood pressure. I was feeling anxious once I was informed that my blood pressure was dangerous high.

nauseous; He's having some episodes of going on in his head almost like a headache, hard to explain what's going on; He's having some episodes of going on in his head almost like a headache, hard to explain what's going on; This is a spontaneous report from a contactable consumers (patient's wife and patient). An 81 year old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included bleeding ulcer and stent put in my heart valve. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) and acetylsalicylic acid, clopidogrel bisulfate (CLOPID-AS [ACETYLSALICYLIC ACID;CLOPIDOGREL BISULFATE]). On an unspecifed date, the patient's wife reported that her husband: He's having some episodes of going on in his head almost like a headache, hard to explain what's going on. Also nauseous, with the heart specialist told him to take probiotics with his medicine. He was hospitalized on January 7-11. He is on 81mg low dose aspirin, Clopidogrel 75mg daily medication. Prior to that week before Nov2007 he had a reaction to the aspirin and was hospitalized because it gave him a bleeding ulcer. The patient was hospitalized for the events on an unspecified date. Outcome of the events was unknown.

achy / aches and pain; didn't feel like himself; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The reporter stated that her husband (patient) received the first dose of the vaccine about two and one-half to three weeks ago and he had some aches and pain but it was not that bad. She was unsure of the exact day or time and does not know which arm. She reported that a day or two after the first dose he was achy and didn't feel like himself. He didn't say much about it. Then yesterday 26Jan2021 he got a major headache after the second dose; he would sleep and wake up and sleep again trying to get rid of the headache. She gave him Tylenol 650mg one by mouth and it didn't help. Outcome of the events was unknown. Information about batch/Lot number has been requested.

Patient reports he received his 1st Pfizer COVID vaccine on 3/1/21 at about 1:30 pm, and reports within two hours he had extreme fatigue and memory issues "like in a fog". Patient reports on 3/2/21 and 3/3/21 he continued to feel like he was in a fog, and "today 3/4/21 he almost feels like he ought to be in a senior citizen home, forgot how to get his voicemail(s), and feeling like someone drugged the patient and patient reports he does not drink or take drugs". Patient reports "he is an intelligent man and normally exercises 7 days a week". Patient denies fever, pain/redness/swelling at the injection site, and any reaction to vaccines in the past.

81 y.o. male with a past medical history of anemia, DVT, gout, hyperlipidemia, hypertension, presents to the ER with change in mental status. Patient was otherwise in his usually state of health. He got his 2nd COVID-19 vaccine on 3/5. His wife noticed on Sunday, he started acting strangely, more confused. He was given his remote, and forgotten how to use it. He came to the hospital; has progressively gotten weaker, unable to walk, swallow, severe dysphagia, pupil unreactive, patient staring at ceiling. CT head; normal; CXR is normal. Platelets: 91,000.

4 days after receiving the second injection on Feb20, 2021, I experienced significant weakness in my legs which caused me to be unable to stand upright for any extended period of time and prevented me from taking care of my self. This condition has persisted since then and has not improved significantly.

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

Day 1-Confusion and weakness Day2-Increase in weakness, inability to swallow, confusion, fatigue Day 3-Weakness, confusion, incontinence, hospitalized for hypoxia, pneumonia Day 20- Deceased

Patient developed a syncopal episode one day following the vaccine. Without warning, he fell to the ground, losing control of bowel and bladder, although no seizure activity noted at the time. He transiently lost consciousness and then woke up confused and combative. Brought to emergency room and admitted with multiple rib fractures. Initial brain imaging was negative but 24 hours later, noted to have small hemorrhagic brain contusion in left frontal/temporal region and a small subdural hematoma. One day later, there was not noted to be any extension of the hemorrhage/hematoma.

Approximately one hour after the shot, I felt a little weird. About 3 hours after shot, having just walked up stairs, I felt dizzy. I had to hold a table to prevent falling. I felt so dizzy I couldn?t see. Since then I have walked up stairs, slowly, and have not felt dizzy. Also my left arm is sore.

pain in chest; pain in neck and back; pain in neck and back; sneezes; Feels when muscles are contracting; felt a little nagging; Was like a very dull irritation in the right side of the neck. Was probably the lymph node; Was like a very dull irritation in the right side of the neck. Was probably the lymph node.; coughs; very mild sore arm; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm at the age of 81-year-old on 27Mar2021 (Lot Number: EP6955) as single dose for COVID-19 immunisation. Medical history included cancer from 2018 (started out with BCG treatments, where they insert bacteria into the bladder); Had another form of immunotherapy that didn't work too well for him and the cancer kept growing chemotherapy; Had a couple of operations and surgeries where the doctor removed it all but it came back. Best reaction was chemotherapy (It stopped the bleeding and was working on the cancer). Last one was 15Feb2021. Was getting blood work for every treatment. Had to miss one of the treatments due to low platelets. Has a chest port for treatments and blood work. Was very conscious before having chemo. It is kind of a rough thing to kill cancer but also kills good cells too. Definitely worked on killing the cancer for a while; the last treatment was 15Feb2021. Stage 4 was taking chemo. Had bladder cancer (which got out of the bladder and started spreading in to the lymph system), Height: used to be 5'7", is now maybe 5"4". The caller remarks that when he started with chemotherapy. he also lost a lot of weight. Weight: When he went in for last appointment it was 129 or 130 pounds. The patient's concomitant medications were not reported. The patient previously took chemotherapy nos from unknown date to 15Feb2021 for cancer. The patient experienced pain in neck and back on 28Mar2021, pain in chest on 29Mar2021. Caller stating that he and his wife had shot number one 27Mar2021 and are scheduled for second shot 20Apr2021. Wife had no symptoms, maybe a bit of a sore arm and he had the same reaction. Was a very mild sore arm in 2021. On day 2 or 3 on the right side of the neck, had felt a little nagging in Mar2021 and slight pain, especially when he moved and felt it around his back. It is just starting to go away now at 3 weeks. Around the back, around the perimeter and when he coughs in Mar2021, he can feel it in his chest. He is scheduled for the second shot. Is wondering if the second shot will have those symptoms. It's not like it is anything severe, it is just nagging. What worries is him, is that it lasted this long. Is a cancer patient and had last chemotherapy 15Feb2021. His oncologist said to go ahead and take the shot because he really needs the protection. It was asked what if he has the same reaction again. Will go on website but wanted to find out what other people are experiencing and whether or not to take the second shot. Wants to take it for protection. Really wants to take the shot on Tuesday. Pain in neck and back: Only when he coughs, is more of an ache. Started day 2 after vaccine on 28Mar2021. Was like a very dull irritation in the right side of the neck in Mar2021. Was probably the lymph node in Mar2021. Pain in chest: When he sneezes in Mar2021, there is a sharp pain, all around the perimeter of his chest. Is gone as soon as he stops coughing. Feels when muscles are contracting in Mar2021. Started day 3 after getting the vaccine on 29Mar2021. Stage 4 was taking chemo. Had bladder cancer, which got out of the bladder and started spreading in to the lymph system. Wants to be put on immunotherapy but can't until he is finished with his shots. If he gets the immunotherapy and if he has a reaction, would have to use steroids and they do not want to do that with the vaccine. The doctor wanted to start him earlier on the immunotherapy but thought it was important to get the vaccine first, that taken care of. The pain is only sharp if he lifts something. Otherwise, it is just dull. He knows it is there. It is not completely gone. This morning was the best that he had. Really got good sleep last night. The best since it has happened. When he sneezes, he can kind of feel it around his chest, just around the perimeter of the muscles. Treatment: The first couple of days, just put up with it. Took Tylenol one day and then on another day. Takes at bedtime. Does not like taking Tylenol because it effects his liver. If he doesn't need it, he doesn't take it. In the last week, every night he has been less and less bothered by how he slept. Last night he didn't even know he had it, the pain, and slept really well. Have not taken any meds, just Tylenol on day 4 and 5 to help sleep. Therapeutic measures were taken as a result of events. The outcome of events very mild sore arm, sneezes and feels when muscles are contracting was unknown. The outcome of other events was recovering. No follow-up attempts are needed. No further information is expected.

Increased confusion/dizziness today. Increased weakness. Withdrawn affect. Incontinent of urine/stool.

Approximately 24 hours after the first dose of vaccine he began to complain of stiff neck and back pain. Reported he was unable to lift his head or get out of bed.

Patient got second dose of the vaccine on 2/4/2021. He was diagnosed with COVID 19 on 5/15/2021 (he was negative on 3/19/2021). He was hypoxic, developed changed in mental status. Died on 5/16/2021

continuing hissing noise that is quite bothersome, and does somewhat disturb my sleep; woke up with severe hissing in head and realized it was Tendinitis; woke up with severe hissing in head and realized it was Tendinitis; This is a spontaneous report from a contactable consumer (patient himself). An 81-years-old male patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL3247), via an unspecified route of administration administered in arm left on 12Feb2021 09:15 am as single dose for covid-19 immunization. Patient did not take other vaccine in four weeks. Medical history included high blood pressure which is under control and had put two stents in 2003 and concomitant medications (other medications in two weeks) included omeprazole, losartan, atorvastatin, metoprolol and acetylsalicylic acid (ASPRIN). Caller stated that on 14Feb2021 on Sunday morning at 4:23 he woke up with severe hissing in head and he realized it was Tendinitis. He further stated that he has a touch of this over the years, never for long period or continuous. At 08:30 am the heavy hissing noise died down, however he has since then hear a continuing hissing noise that is quite bothersome and did somewhat disturb his sleep. The patient did not receive any treatment. Patient did not received treatment for AE and not COVID prior vaccination. He was not COVID tested post vaccination. He had no known allergies. The outcome of the events was unknown.

Son reports that the case was not reacting the same after taking his usual blood pressure medications-disoriented, fatigue, complaints of not feeling well and blood pressure was not responding as normal to the medications. THus son took this case to the hospital for his hypertension around 700pm on 05/21/21. He was never in the mechanically ventilated nor in the intensive care unit.

1) I had L elbow injury a few days before 2nd injoction (ind 02/26/2021. 2) Some hast history of vague R shoulder pain- intermittent 3) Severe L elbow pain, swelling, tenderness a few days post 2nd shot. Probable olecranon bursitis and bone bruise. 4) Severe bilateral shoulder, neck, arm pain 8/10 most severe at night interfering with sleep and morning. Inability to raise arms. Significant malaise. Some improvement w acetaminophen. Saw dr. Elevated CRP and ESR . Began Prednisone 20mg/day with dramatic improvement within hours.

PT ADMITTED TO HOSPITAL FOR COVID PNEUMONIA ON 6/17/21. RECIEVED PFIZER VACCINES ON 1/29/21 AND 2/24/21 (UNSURE WHERE THESE WERE RECEIVED). 1.5 WEEK HISTORY OF DECLINE IN FUNCTION INCREASED CONFUSION, CHRONIC PAINS, DECREASED ENERGY, SUBJECTIVE CHILLS, CONGESTION AND DECREASED APPETITE. SAT 89% ON RA UPON ARRIVAL. PUT ON 8L/NASAL CANNULA. REMOTE HX OF LYMPHOMA S/P RADIATION AND CHEMO 3 YEARS AGO. WILL GET REMDESIVIR AND DEXAMETHASONE HERE

First dose 08JAN2021 and second 29JAN2021. Husband tested positive 02JUL2021; Patient received both doses of the covid vaccine. Patient tested positive for covid.; not feeling too good; body aches; weak; chills; listless; restless; This is a spontaneous report from contactable consumer (Patient's wife). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 08:00 (Batch/Lot Number: EJ168) as dose 1, single, second dose on 29Jan2021 (Batch/Lot Number: EL9263) (at the age of 81-year-old) as dose 2, single, both administered in arm for covid-19 immunisation. Medical history included heart problems, leaky mitral valve, patient is waiting to do heart surgery, they are waiting for a new micro valve catheter. Concomitant medication(s) included amlodipine (AMLODIPINE) taken for Blood pressure; lisinopril (LISINOPRIL) taken for Blood pressure; simvastatin (SIMVASTATIN); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); ascorbic acid (VIT C); cyanocobalamin (VIT B12); finasteride (FINASTERIDE). None prior vaccinations within 4 weeks. Patient had Rapid covid test positive on 02Jul2021. Patient was not feeling too good, had body aches and was weak, and chills, listless, and felt weak. After a week of still not feeling great, and being restless. The events not required emergency room visit or physician office visit. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

I still have uncomfortable feeling in my arm/I was finally able to raise it above my head, my left arm, after two days but it was not comfortable to do it, it was painful; I have severe pain in my arm/it started hurting and then it continued to get worse and worse and it was severe; It was the worst pain I have ever had and I could not move my arm; It continued to get worse and that night I went to bed and I cannot sleep, it hurts so bad/I could not sleep on the right side or on a left side; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date was not provided), via an unspecified route of administration (left arm) first dose on 30Dec2020 10:30 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that I had the vaccine back a week and half ago on 30Dec2020 and was due to get the booster this month and wanted to report severe pain arm for two days. The patient stated that he had many vaccine (Unspecified Vaccine) over the years and have never had anything that hurts so bad after about six hours. The patient just wanted to know that was that normal. Consumer further stated, "I took the vaccine about 10:30 in the morning and about four hours later, it started getting sore but that thing was normal you know some vaccines (Unspecified Vaccine) do that but along with that it started hurting about four hours after the vaccine and it continued to get worse and that night I went to bed and I cannot sleep, it hurts so bad. The patient even have thoughts about getting up and go in to the emergency room. It was the worst pain I have ever had and I could not move my arm. I could not sleep on the right side or on a left side and all I did was take Tylenol as prescribed and that helped a little bit but not much but I did not go to the emergency room, I am not going to do that but I felt like it because it hurts so bad but I made it through the night and next day it continued to hurt really bad. I just keep taking Tylenol every four hours and that continued for two days and then finally I was able to raise my arm up above my head without little pain, it was discomfort, but it was not hurting so bad." The patient stated that the event started about two hours later it started, it started hurting and then it continued to get worse and worse and it was severe, that is the reason why I am calling that it was severe. I wanted a shot or morphine to relieve myself that how bad it was." (no clarified further). The patient stated that the vaccine was given in my left arm only about one inch below the top of my shoulder which I think that might have been the problem, I don't know if you can answer that or not but I have never received the vaccine or shot anywhere near that area, it is always three or four inches down in my muscle, on my arm either on left or right, this was given in my left arm but this was given almost in my joint I am wondering if that would cause pain." The patient stated it was given only one inch below the tip above shoulder may be that is causing so much pain." The patient just wanted to report the severe pain, that was for two whole days and then it was subsided and it lasted for four days and I still have uncomfortable feeling in my arm. I was finally able to raise it above my head, my left arm, after two days but it was not comfortable to do it, it was painful." The outcome of the events was unknown. Information on the lot/batch number has been requested.

Complete body ache, nauseous, sweating, fever.......I felt like someone beat me up with a baseball bat....couldn't even get out of bed it started about 12:30 AM and lasted about the rest of the following day...

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.

mental only, no physical effect. Disjointed thoughts, incomplete but w/ accurate data, Felt as if no control over mind and losing my mind.

1-21-21. Got first COIVID-19 vaccination at 7:15 AM (Phizer). No reaction whatsoever. Pfizer Lot:EL3249 2-11-21. Got second vaccination at 7:05 AM. Felt normal all day. Pfizer Lot:EL9264 2-12-21. Felt good early. Played tennis and worked out. About 2 PM, started feeling very poorly. Took 90 minute nap. Woke up nauseous and dizzy. Threw up several times. Could not drink or eat dinner. 2-13-21, Continued to feel badly. Threw up after arising. Couild not drink or eat breakfast. About 1:30 PM, was able to keep yogurt and cottage cheese down. Nibbled off and on. Ate light supper. 2-14-21. Woke up dizzy. Was able to eat normally. Still felt badly. Had bad headache (very unusual for me) before supper. Ate normal supper. Canceled tennis for following week. 2-15-21. Started feeling much better than day before. 2-16-21. Felt much better than the day before. 2-17-21. Best day since 2-11 ? the last 5 days. 2-18-21. Began to feel rocky. Slightly dizzy. Low energy 2-19-21. Felt worse than the day before. Low energy, short dizzy spells, little appetite. 2-20-21. Felt really bad. Very dizzy all day. Drippy nose for 5 hours, but nose okay by bedtime. Very tired all day. 2-21-21. Felt a little better. Still dizzy when I got up. Recovered enough to go to church at 10 AM. Note that it had been 10 days (at 7:05 AM) since I had my second shot. 2-22-21. Got up to the bathroom at 2 AM. Was dizzy. Got back to sleep until 6:30 AM. Was and am better than the last 4-5 days. Still feel a little shaky if I move quickly or get up out of my chair quickly. Very tired all day. 2-23-21, Doing better. Still wobbly on my feet. Only mildly dizzy. 2-24-21. Best day since 2-17. Still a little weak. Worked out in the late AM. 2-25-21. Felt a little dizzy in the AM. Better after lunch. Did light workout. Good day overall. Felt fine. 2-26-21. Felt good in the AM. Worked out. Feeling stronger than yesterday even. 2-27-21. Felt good 2-28-21. Felt tired all day 3-1-21. Did not sleep well. Worked out in the AM and then was very tired. Felt a little dizzy after returning home from the gym. Took short nap before lunch and am doing better in the PM.

wasn't able to sleep; felt like he was in a refrigerator; shaking; lower back pain; The patient reported receiving the Pfizer vaccine in his right arm; right arm/shoulder pain; right arm/shoulder pain; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 06Feb2021 at a single dose on the right arm for COVID-19 immunization. The patient also started to receive mirtazapine (MIRTAZAPINE, 50 mg, Capsule, soft), via an unspecified route of administration, from an unspecified date at 50 mg, once a day for sleep. Medical history included sleep (disorder). Concomitant medications included aspirin [acetylsalicylic acid], calcium, escitalopram, finasteride, lamotrigine, simvastatin, tamsulosin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), on an unspecified date for COVID-19 immunization. The patient reported receiving the Pfizer vaccine in his right arm on 06Feb2021. That evening he took his nightly medication and went to bed at 11:30 pm. He stated he wasn't able to sleep because he felt like he was in a refrigerator and he was shaking. He had lower back pain, right arm/shoulder pain, and went to the bathroom 5 times (all on an unspecified date in Feb2021), which was not normal for him. The patient added that it was the second dosage of the Pfizer (Covid-19 Vaccine) her received on 06Feb2021. And he had some negative response: a little pain in his shoulder but the worst thing that happened, he went to bed 11:30 did not sleep at all. At 11:30 night, he took his medication (Mirtazapine) and went to bed. He was shaking and he had to put another blanket on himself. Eventually, it was okay, but the problem is he was not able to sleep all night, from 11:30 to 9' O clock this morning (07Feb2021). Consumer stated, "Yesterday my wife and I had the second dose of the Pfizer and I had really strange reaction and I will tell you what it was. Last night at about 11:30 I took my night medicine (later clarified as Mirtazapine), I went to bedroom, I started shaking all over. And the worst part is from 11:30 to 10 o' clock this morning, I was not able to sleep. There is slight pain in my shoulder". When confirmed if the consumer wanted to report the same or have any questions, consumer stated, "No, we have no problem with temperature is fine, the oxygen is fine. Just I don't understand why in fact the medication (mirtazapine) is to induce sleeping, use to for sleep within half hour but it didn't help. I wanted to know what happened. So, this will eventually go away?" The action taken in response to the events for mirtazapine was unknown. Outcome of the events was unknown. Information on batch number has been requested.

D= decedent D received the second dose of the COVID vaccine on 3/10/21 @ 10:45AM. His daughter, ************, transported him to the Pharmacy appointment. She notes that D did not have any complaints before or after the appointment?specifically she denies observing any weakness, dizziness, cough, and fever. D went on to have an uneventful day with normal appetite and bedtime. ************ also mentions that there were no adverse reactions following the first dose either. The next morning (3/11/21) at 6am the decedent?s wife found him in bed ?looking around the room? with gurgling agonal breathing. No seizure activity reported.

Pfizer COVID-19 Vaccine EUA Patient received vaccine dose #1 on 1/14/2021 and Dose #2 on 1/31/2021. Patient presented to ED on 2/1/2021 with complaints of acute mental status change. He was recently diagnosed with enterocoal/pseudomonas UTI four days prior to presenting to ED and was being treated with Augmentin and Levaquin. Patient screened positive for COVID-19, with the sample analyzed using PCR or equivalent. Patient suffered a cardiac arrest on 2/7/2021 x3, developed three pressor shock, and required maximum ventilator settings. Patient subsequently expired.

felt very tired/feeling exhausted/tiredness; Headache; muscle and joint pains; muscle and joint pains; Hot Flashes; Chills/cold chills; nauseous; he felt so hot; thought he had a fever; cramping all through the night to the point he wanted to cry; Couldn't Sleep; He specified the pain was in his hands, legs, feet/sore arm; weakness to the point he couldn't get up to go to the bathroom.; Feeling unwell; Dizzy; but everything else was sore too; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was reported as "EUO150"/"LU0150"), via an unspecified route of administration, administered in arm left on 13Apr2021 11:15 (at the age of 82-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included blood pressure, allergy, glucose-6-phosphate dehydrogenase deficiency (G6PD), liver genetic deficiency, and had allergy mice, cat, dust and trees. The patient previously took sulphur and aspirin and makes him bleed because his blood was already thin. Concomitant medications included amlodipine taken for blood pressure; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergy; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for an unspecified indication; all were start and stop date were not reported. An 82-year-old caller received the first dose of the Pfizer-BioNTech COVID-19 vaccine yesterday (13Apr2021), around 11:15 am. He added he was monitored for 15 minutes post injection and then used the public transportation to run some errands and return home. He said he received the injection on his left arm had soreness in this arm after vaccination. He explained around 3-3:30 pm he was walking to get the bus and then felt very tired to the point he wanted to sit on the pavement. He also described it as feeling exhausted. He explained he was so tired on the bus that he was falling asleep and almost missed his stop. He said he also began having joint and muscle pain on the bus. He specified he got home around 4 pm and he then experienced tiredness, headaches, muscle and joint pains, hot flashes, chills, and felt nauseous but didn't vomit. He specified he felt so hot, he had to turn off the heat and remove his clothes, but then he had chills/cold chills and had to turn the heat back on and thought he had a fever. He said around 11 o'clock he had appetite. He added he had cramping all through the night to the point he wanted to cry. He couldn't sleep. He specified the pain was in his hands, legs, feet, and joints. He also said he felt tired like he had worked for 12,000 hours and was not able to move. He said he had weakness to the point he couldn't get up to go to the bathroom. He said he had the headaches all through the night. He was feeling unwell, dizzy. He explained he felt like he was going to die; he was worried about his body. He said he still feels tired. They told him he would only have a sore arm, which he did, but everything else was sore too until about 08:00 today (14Apr2021). He explained that he didn't have all these issues before vaccination. He explained how disappointed he was with his reaction to the vaccine given that he was reluctant to the unapproved vaccine at beginning because he wasn't the person that take a lot of injection and medications, and so finally after his primary physician to influence him to get the vaccine. He mentioned he lives alone, healthy, vegetarian, never smoked, never took recreational drugs, does acupuncture, and takes little medications. He explained most people and his acupuncture doctor said he shouldn't get much reaction from the first dose and the reactions to the second dose are more prevalent. He added he was told that people have mainly experienced soreness in their arm after this vaccination with the first dose. He asked if his symptoms were reported after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine. Everyone told him the first vaccine is a whiz. That it was easy. The second vaccine is the one that have side effects on. He also stated that he almost called to get an ambulance to take him to the hospital. Said that if he had these reactions with the first one, he does not want to take the second vaccine. Sometimes he regret that he have taken it now because he did not expect all of this to happen to him and they just told him that he will have a sore arm on left arm. He was in kind of shock to experience all of this and he was G6PD (Intent: History). He cannot take Sulfur and Aspirin because that makes him bleed because his blood was already thin but that would be no problem also have a liver genetic deficiency (Intent: History). He was allergic to mice, cat, dust and trees (Intent: History). So, he told all what he had that they knew in the beginning they said none of those things will affect. He take B12 (Intent: History) too once a month, he get injection for allergies for his cats and trees and grass once a month but they told him none of the things will affect him. The outcome of the events was unknown. Information about the lot/batch number has been requested.

On April 24, patient started not feeling well while away from home in the early afternoon. Later noticed some balance issues and some memory problems. The next day, balance issues continued and had noticeable mouth drooping on left side first noticed by daughter who was visiting and son-in-law. Was taken to the hospital and diagnosed with a stroke.

Too nervous about second dose of Covid-19 vaccine to drive to vaccination facility; A little shaky; This is a spontaneous report received from a contactable consumer (patient's wife). A 82-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, in left arm on 19Jan2021 10:20 (at 82-years age) as single dose for covid-19 immunisation. Medical history included high cholesterol a long time ago, at least 10 or 15 years, high blood pressure a long time ago, at least 10 or 15 years, high triglycerides a long time ago, at least 10 or 15 years. Concomitant medication(s) included hydrochlorothiazide(HYDROCHLOROTHIAZIDE) taken for high blood pressure from an unspecified start date to Apr2021; eicosapentaenoic acid ethyl ester (VASCEPA) taken for high triglycerides from an unspecified start date to Apr2021; atorvastatin (ATORVASTATIN) taken for high cholesterol from an unspecified start date to Apr2021 and Multi vitamin. Patient underwent laboratory test including a CT scan and MRI, a spinal tap on the patient, and all the tests the medical staff could possibly run to try to find out what the problem was with the patient and the doctors didn't find anything on 2021. On 19Jan2021 patient experienced a little shaky following his first dose of the Covid-19 vaccine and patient was too nervous about second dose of Covid-19 vaccine to drive to vaccination facility on Feb2021. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Covid-19 vaccine might have jump started Alzheimer's; Altered mental status; Patient meant he saw things, he talked to people and he was terrible; Depression; Shaking; Went berserk / He is just crazy. Saying and seeing things that was not there; This is a spontaneous report a contactable consumer (wife). An 82 years old male patient (Height: 170 cm and Weight: 66.68 kg) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6201) intramuscularly, in the right arm, at single dose, on 13Feb2021 at 10:20, for COVID-19 immunization. Relevant medical history included high cholesterol, high triglycerides and high blood pressure, all from an unspecified date, all diagnosed at least 10 or 15 years and acid reflux (esophageal), from an unspecified date. The patient previously, on 19Jan2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EL3249) at single dose, in the left arm, for COVID-19 immunization. After the first dose, the patient experienced shaking ("the patient was a little shaky following the first dose of the Covid-19 vaccine on 19Jan2021, but it was nothing major") and was nervous ("the wife reported that when it was time to get the second dose on 13Feb2021, the patient was so nervous to get the shot that he was too nervous to drive"). Concomitant medications included hydrochlorothiazide 12.5 mg, once daily, in the morning, from an unspecified date to Apr2021, for high blood pressure; eicosapentaenoic acid ethyl ester (VASCEPA) 1 mg, twice daily, from an unspecified date to Apr2021, for blood triglycerides; atorvastatin 40 mg, once daily, from an unspecified date to Apr2021, for blood cholesterol; omeprazole from an unspecified date, for an unknown indication; colecalciferol (VITAMIN D (colecalciferol)) from an unspecified date, for an unknown indication and an unspecified multi vitamins. On 13Feb2021, the patient experienced altered mental status, illusion ("patient meant he saw things, he talked to people and he was terrible. He was saying people called to him. He wanted to go outside; vision illusions like people were calling him to come outside"), depression, shaking and he was feeling abnormal ("he went berserk. He was just crazy. Said and saw things that was not there. Patient was hearing people calling him to go outside"). The patient might have Alzheimer's. Patient's wife reported that the physician stated that the Covid-19 vaccine might have jump started Alzheimer's. Treatment was received. Patient was prescribed donepezil, ondansetron, quetiapine, escitalopram, trazodone, and sertraline after he went berserk to help with altered mental status. None of the medications worked. Patient also received risperidone. Patient's wife reported that even with the risperidone, the patient was not his complete self like he was before he received the Covid-19 vaccine. Risperidone helped some. Relevant laboratory tests, performed on an unspecified date, in 2021, included: computerised tomogram head (CT brain scan) normal, lumbar puncture (Spinal tap) normal, and magnetic resonance imaging head (MRI brain) normal. Clinical outcome of the events was unknown at time of this report.

pt received pfizer #2 on 2/20. on ~3/7 family noticed that he was waking up at night more than his usual. They noticed that the patient was more lethargic and was starting to have visual hallucinations. Reportedly, the patient never endorsed any fevers or chills, neither did he complain of headaches. He also reported that the patient had been having a nonproductive cough since 3/3, constipation around this time. he was admitted 3/10 with altered mental status, respiratory failure s/p intubation. difficult LP, no cell count, had elevated protein. hospital course complicated by delirium, gout flare. he was empirically treated with broad spectrum abx bacterial and viral meningitis, completed 5/6, without significant improvement in mental status. repeat LP concerning for possible autoimmune encephalitis, started on steroids.

issues with his memory and being more confused/Confusion; tiredness/Fatigue; He feels like he is not getting enough oxygen, has had a cough, runny nose, issues with his memory and being more confused; cough; runny nose; Having problems with memory; Not Feeling Right; Muscle pain; Pain areas have been more painful/pain; Sore arm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EJ1685 then says someone changed the 5 to a 6), via an unspecified route of administration in left arm (left shoulder) on 05Jan2021 (at the age of 82 years old) as single for covid-19 immunisation. Medical history included he had two ablations, close together 4 years ago, blood pressure issues from Dec2020 and ongoing, ongoing thyroid condition from several years, ongoing acid reflux, has been on medication on and off for this condition for 5-10 years. Concomitant medications included levothyroxine sodium, 75 mcg once a day for thyroid disorder taking this medication for several years; losartan, 0.5 mg once a day per for blood pressure abnormal from Dec2020 and ongoing, he used to take half a tablet; started taking a full tablet 08Mar2021; omeprazole, 40 mg twice a day for acid reflux, he has been on and off this medication for 5-10 years. Started taking it regularly in the past year. Also increased it to twice a day in the past year. He was on Eliquis for blood thinning. He was started it 01Mar2021. He had been on hit previously for quite a while and had an ablation and was able to stop taking it. Blood pressure went up so he was put back on it in Mar2021, before then he had taken it about 2-3 years ago. He currently takes 5 mg twice a day. Caller also mentions unspecified vitamins and herbs; no further information provided by the caller. The patient previously received flu and tetanus vaccines in Oct2020 and shingles vaccine in Aug2019. The patient did not receive additional vaccines on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The month ago (or more) he has been experienced tiredness, fatigue, pain, although he stated that he always has some kind of pain because he was 82 year old but it has been worse in the past 2 weeks. He felt like he was not getting enough oxygen, had a cough, runny nose, issues with his memory and being more confused. He stated that the tiredness and fatigue started out as intermittent about a month ago and said that it would "come and go" but now in the past couple of weeks it has been much more frequent. He also stated that he has been experienced a runny nose, cough and congestion for the past couple of weeks. He stated that since he got it; and for about a month or two, he has not been feeling right. He has tiredness, fatigue, all of his pain areas have been more painful, muscle pain. He doesn't seem to be getting enough oxygen; he really has to suck in air. His overall biggest problem was the fatigue. He stated that right after the shot he had no issues other than soreness in his arm on Jan2021; he has been going down hill since then. Tiredness and fatigue it has gotten worse gradually. It started a month or more ago. It has gotten worse over the last 2-3 weeks. He has pain all the time, he was 82 year old and something that always bothering him. Increased in pains started along with the tiredness and has also gotten worse over the last 2-3 weeks. He stated that his tiredness and fatigue was intermittent, but now it was more frequent. Before he had more good days than bad days. Now he has more bad days than good days. His feeling of not getting enough oxygen also went along with the tiredness. It has also gotten worse over the last 2-3 weeks. Cough and runny nose seem like it started in the last few weeks and has gotten worse. He has difficulty in answering the questions because his memory has been giving him problems and he's been confused more for about a month or so. It was gotten worse. The patient received second dose of the Covid vaccine (Lot Number: EL3249) on 26Jan2021, He was pretty sure that it was given in his left shoulder. He would like to know if he should go back to the VA where he received the Pfizer COVID-19 vaccine to be evaluated for these symptoms. The patient did not visit to emergency room or physician office. No family medical history relevant to adverse events was provided and no relevant tests were performed. The outcome of sore arm was recovered on an unspecified date in Jan2021, while with other event was not recovered. Information about Lot/Batch Number has been Requested. Follow-up (05Jul2021): 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 completed. No further information is expected.

I could not breathe; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Profound dizziness; Confusion among other things; I still have lot of coughing; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809, expiry date not reported, age at the time of vaccination: 82-year-old), via an unspecified route of administration, administered in Arm (don't know right or left arm) on 19Feb2021 as dose 2, single for covid-19 immunisation administered in vaccination center. The patient had no medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EL9261), in Arm (don't know right or left arm) on 28Jan2021 for covid-19 immunization. The patient did not receive any other vaccination prior to the first shot of suspect vaccine. On an unknown date in 2021 (right after the second dose), the patient could not breath and went into hospital for a surgery in emergency and it turned out to be the blood clots everywhere in his system and he never had before. It has been a couple of week ago. He spent two bouts in a hospital, had surgery and was continuing with multiple MRIs and CAT scans to see if he had brain issues and what not. The problem that developed was he have had all kinds of lupus test and CAT scans and everything and he had no sign of this problem before the vaccine. After the vaccine, he have severe amounts of blood clot in both lungs and severe amount of blood clots in his left leg and he was being treated for those and being operated for those and they removed some of the blood clots in the lungs but not in the leg at this moment. Now he is in home and he had to go back into the hospital again in a different hospital for the side effects from the surgery (further not clarified). But he was still scheduled for lot more tests because they don't know because he still have lot of coughing and a lot of things going on yet. He just said he don't have the exact date of the hospitalization. The patient also experienced profound dizziness, confusion among other things. The patient received corrective treatment for the side effects from vaccine, he is taking Eliquis and many other medications which he don't have the list of them and they are in hospital records. The patient underwent lab tests and procedures which included Lupus test, CAT scan (computerised tomogram) and MRI (magnetic resonance imaging) on an unknown date and results were unknown. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Feeling tired with flu like symptoms; Chills; Experienced clots when blowing his nose; Feel bad; sore; Very tired; Sore; Leg pains; neck pain; shoulder pain; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team. A 82-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8737, Expiration date: unknown) via an unspecified route of administration on 20May2021 (at the age of 82-years-old) as dose 1 single for covid-19 immunization. The patient Medical history included Heart attack from an unknown date and unknown if ongoing Verbatim: Heart attack, diabetes mellitus from an unknown date and unknown if ongoing Verbatim: Diabetes. Concomitant medication(s) included carvedilol (CARVEDILOL AL) taken for an unspecified indication, Metformin taken for an unspecified indication, furosemide sodium (FUROSEMIDE AL) taken for an unspecified indication, tamsulosin taken for an unspecified indication, glipizide (GLIPIZIDE) taken for diabetes mellitus and finasteride (FINASTERIDE) taken for an unspecified indication start and stop date were not reported. On an unspecified date patient experienced Feeling tired with flu like symptoms, Chills, clots when blowing his nose, feel bad, Leg pains, the neck, shoulder, Sore. it was reported that after administration of vaccine patient started to feel bad, this was a first shot, leg pains, the neck, shoulder and chills on an unspecified date yesterday he started to feel a little better, today even had some breakfast and a little lunch and hour and half ago he stared to get chill again real cold and real achy again in his legs and So he kind of bunded up and he took two Tylenol, Confirmed Tylenol as treatment for the side effects He had the blow his nose constantly and he has been getting the 3 good size clots coming out of his wrong side of his nose on an unspecified date kind of blackish and blood and blood on the other side of his nose also. His only problem is his legs, he thinks he got neuropathy (Further clarification unknown), people make this know that some old guy hardly walk believe he just concerned that it might be a side effect and real sick and dying. The outcome of events was Unknown. Follow-up attempts have been completed and no further information is expected

not feeling too good; not able to sleep at night; loose stools; chills; nausea; low grade temperature; sinus issues, like drippage causing him to swallow the mucus all through the night; sinus issues, like drippage causing him to swallow the mucus all through the night; like a tickle in throat and he was coughing; like a tickle in throat and he was coughing; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; Slight headache; A little fever; Bowel movement soft; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), intramuscular at the left arm on 20Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was vaccinated at a clinic. Concomitant medications included clopidogrel bisulfate (PLAVIX), losartan, hydrochlorothiazide, amlodipine, metoprolol; all were ongoing. The patient previously took a flu shot (INFLUENZA VACCINE) on 18Dec2020. On an unspecified date, the patient was not feeling too good, was not able to sleep at night, loose stools, chills, nausea and low grade temperature. On 20Jan2021, the patient experienced sinus issues, like drippage causing him to swallow the mucus all through the night and had like a tickle in throat and he was coughing, had joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area, slight headache, a little fever, and bowel movement soft. Clinical outcome of cough, slight headache and little fever was recovering, while for the other events was unknown.

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.

Patient notified RN after his 15 minute observation time and said he was feeling woozy. Blood pressure and heart rate obtained. 181/108; 80. Patient then notified RN lead of clinic who spoke with patient. Patient stated he felt "fuzzy all over". Encouraged patient to go to ER. Nurse lead got wheelchair and notified wife. Patient was escorted via wheelchair to ED by RN.

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

2 days after 1st Covid vaccination my right arm at the site of the injection, the muscle became very sore and any exertion such as shoveling snow or lifting is very hard.. The muscle is always sore, even laying on my right side when sleeping is uncomfortable and will wake me up from sleeping

At 8:30am, 2/26/21, He was asleep on chair in dining room. Very hard to wake him up! I got him to a recliner, but then he had to throw up. He said he was "foggy" and went to sleep when he got back to the recliner. At 11:45am, his blood pressure was 66/47, then 71/48 in his left arm. In his right arm, 74/51. He did have some top ramen soup and was feeling better. I took his temperature earlier and it was 96.1.

Has there ever been reported of a question about memory loss. While I am 83 I have experience three occurrences of forgetting something that i found that I had done. In the last two weeks. This is new to me. Just checking

Didn't realize what was going on; Whole body felt like itching, whole body was just feeling funny; Feet are numb and cold; Feet are numb and cold; Ended up in the emergency room because I was having some problems with chest pain; heart problems; Sick all day Saturday, all day Sunday, and most of Monday; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male (also age at vaccination) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right (reported as Right upper arm) on 27Feb2021 (Batch/Lot Number: EN6205) as SINGLE DOSE for covid-19 immunization. Medical history reported that "I have had one stent and one angioplasty done. Stent was done last year in 2020 and angioplasty was done in '1990' (not confirmed)." The patient also added "I gained a bunch of weight when I had my thyroid removed." The patient previously took the first dose of bnt162b2 on unspecified date for Covid-19 immunization. For the concomitant medication the patient stated, "Yes, I am taking medications." (specified medications not reported/ provided). It was reported by the patient that, "I got this, my second COVID-19 Vaccine shot Saturday morning. All day Saturday (27Feb2021), all day Sunday and most of Monday, I was so sick, I didn't realize what was going on. Yesterday (02Mar2021), I ended up in the emergency room because I was having some problems with chest pain. So, I presume this is all connected to the second shot I got." It was added by the patient, "I am asking question. About an hour or less than an hour ago I woke up, and my whole body felt like it was itching. I mean my whole body was just feeling funny. I was itching all over, that went away, I took a pill a while ago for that. 'Lorazepam' (not confirmed over the call), it's a nerve, anxiety pill and it kind of helped. But right now, my feet are numb and cold." For the laboratory test the patient stated that, "Yes they did a lab test on me yesterday (02Mar2021) as I went to the emergency room with some heart problems. They did blood work, that's all they did." The patient reported for the results, "They said everything was fine." The outcome of the events was unknown. The patient explained that "No, I didn't take any medication for that." However treatment was received for Whole body felt like itching, whole body was just feeling funny.

PRIOR to receiving the 2nd covid-19 Pfizer vaccine had a bowel movement each day after each meal- 3x/day everyday. 03/17/21- The day after the vaccine, bowel movements stopped completely. Became bloated with severe abdominal pain, shortness of breath and difficulty walking due to pain. Tried OTC stool softeners, miralax, prune juice and no relief. Seen in ER on 03/20/21 for abdominal pain, bloating and constipation. CT scans did not provide answers. Seen by GI specialist and had colonoscopy and EGD on 03/29/21 which did not provide answers on sudden stop of bowel movement. Almost a month later still not having bowel movements regularly despite taking Linzess as prescribed, still have abdominal pain and bloating daily, difficulty eating due to bloating and pain, have lost 7 pounds in the past 3 weeks and now remaining in bed more throughout the day due to pain/bloating. Becoming depressed and irritable which was NEVER a problem prior to the 2nd Pfizer covid-19 vaccine.

Approximately 1 hour after completion of an IVIG infusion (his 17th dose in the past 22 months) the patient experienced severe chills, altered mental status, temperature of 103.0 and was unable to stand or ambulate. His wife called 911 and the patient was admitted to the hospital.

Swelling face; Chills; Face is deep red; following day my face started getting red; Swelling is going down a little bit now, but it itches; Swelling is going down a little bit now, but it itches; I have been sleeping for 2 days; This is a spontaneous report received from a contactable consumer (patient). An 84-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EL3247) via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunization. The patient medical history included Blood pressure. Concomitant medication included VITAMINS NOS. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1686; Expiration Date: unknown) on 21Jan2021 for COVID-19 immunization. The patient experienced swelling face, chills, face is deep red; following day my face started getting red swelling is going down a little bit now, but it itches, I have been sleeping for 2 days. The patient underwent lab tests and procedures which included blood test and results was unknown on 21Jan2021. The outcome of events swelling face, chills, face is deep red; following day my face started getting red, swelling is going down a little bit now, but itches was unknown. The swelling is going down a little bit now was recovering. The outcome of event I have been sleeping for 2 days was recovered on an unspecified date.

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)

Presented to ED ~ 12 hours after receiving 2nd Covid vaccine. Chief Complaint: FEVER. (Pt had second COVID vaccine around noon. He presents via ambulance " feeling terrible" with fever, malaise. He is somewhat confused and uncomfortable here. Daughter in law here). No muscle aches, chest pain or cough. He has had loss of appetite. He has had dyspnea (chronic). He has had altered mental status (mild confusion). He has had skin rash (chronic LE). Pt was kept for observation x3. He was given IV fluids and a started 4.5 gm of Zosyn (Piperacillin Sod-Tazobactam So). Diagnosed with pneumonia - switched to oral augmentin at discharge. On home oxygen.

Chills; Fever; Weakness; I had couple of days when I had cough at night and little bit of this and that; I am worrying about the reaction because I didn't realize that I probably had Covid antibodies from the mild case that I had and then the shot hit me, was really bit apprehensive; Muscle ache; Tired; I had like laryngitis type like my vocal cords were little bit swelled; Aches; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 12Apr2021 (at the age of 83-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included blood pressure and mild case of COVID-19 both from an unknown date. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date was not reported. On an unspecified date, the patient experienced chills, fever, weakness, i had couple of days when i had cough at night and little bit of this and that, I am worrying about the reaction because I didn't realize that I probably had covid antibodies from the mild case that I had and then the shot hit me, was really bit apprehensive, muscle ache, tired, I had like laryngitis type like my vocal cords were little bit swelled and aches. It was reported that the patient had his first Pfizer shot last week and Monday, he had quite a reaction about four to five hours later and had chills, fever and weakness and so forth. He called one of the pharmacists about it and was asked if he had COVID before. The patient said that he was checked in for that but last month or so and was not checked down but he had couple of days when he had cough at night and little bit of this and that and he suspected that he might have something. The patient had COVID before he got the first shot within 5 or 30 days and that is why he got that reaction when that shot hit him. Now, the patient was concerned about the second shot, like if he will have a problem with that too, he was worrying to go to from about 2 or 3 days for that shot which was scheduled for next Monday, believed it is 3rd of May. The patient was really bit apprehensive about getting the shot simply because they usually recommend 90 days, in other words, after someone had COVID, to not get vaccination until at least 90 days afterwards. So, he was not sure what to do. The patient took as recommended for the fever, he took Tylenol and it was helpful as far as the aches, muscle ache and all that. Also, he was still very tired and the fever that he got after the shot was only for one day or he got it that night and lasted maybe till the next day and he was sure that it's going to come down and he will feel better. The weakness that linked, had a cough anyway, was going through this cough a little bit and had muscle ache. He also had like laryngitis type like his vocal cords were little bit swelled but was now getting better and it took like a good week like week and a half and that's why he was concerned about the second shot. The patient thought what he was hoping to do, was to stop a week or two and give it a little bit of time because he may be close to the 90 day window, it appeared the best way to do that but he thought that it was what the experts should be able to tell him. The patient underwent lab tests and procedures which included COVID-19 virus test: No- Negative on 23Feb2021. Therapeutic measures were taken as a result of events fever, muscle ache and aches included TYLENOL. The outcome of the event I had like laryngitis type like his vocal cords were little bit swelled was recovering and the outcome of all the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient received what he believes was the Pfizer covid-19 vaccine x 2 in March 2021. He generally felt poorly since receiving the vaccine and was eventually tested for covid-19 in mid-May 2021 as an outpatient, which was positive. He was admitted to hospital on 5/23/21 with pneumonia. Transferred to Bigger hospital on 5/26/21 for ICU care.

~5 months following vaccination, COVID-19 infection: Abnormal CXR, fatigue, cough, shortness of breath, confusion, COVID RNA positive; Patient died as result of illness 4 days after admittance to hospital from nursing home.

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.

Our triage nurse retrieved a voicemail from patients daughter on 2/10/2021 stating that her 84 year old father was having delirious reactions from his COVID vaccine. She said that she has taken him to the ER 6 times. The nurse called the daughter back and she said that she spoke with someone at Clinic COVID-19 Vaccine Information hotline and was told that they would consult with a doctor and call her back. The daughter also states that patients primary care physician is involved as well. The daughter is concerned because her father is very restless and cannot sleep. The triage nurse encouraged the daughter to call us back if she did not hear from Health Clinic.

Chills/fever, temp @100, extreme tiredness. Fever broke at noon on day 2, 2/8/2021. Slept most of 24 hours. Day 3, 2/9/2021, slept 3/4 of the day, up for an hour or so and down for 2 hours. Day 5, 2/11/2021, returned to usual activities but residual tiredness.

extreme weakness beginning 3 days after shot; difficulty standing and walking; brain fog - often did not know where I was; could not understand what people were saying. This gradiually improved, but as of 4/7/21 much weakness remains. Hard to stay awake, but that is improving. Felt sicker than I ever have.

Breakthrough COVID-19 infection in fully vaccinated individual admitted to hospital on 04/08/2021 with increased symptoms of combativeness and confustion

4/16/21 Patient presented to ED w/complaint of "fogginess in the head." No dizziness or lightheadedness. Stroke alert was called and pt was placed in observation. Pt screened positive for SARS-CoV-2 in the ED Altered mental status Dizziness Stroke like symptoms CT head-no intracranial hemorrhage or acute findings. Atrophy with chronic microvascular disease CTA H& N-normal CT of the brain. No carotid or vertebral artery stenosis in the neck. EKG-normal sinus rhythm. No significant ST-T wave changes Check A1c, lipid panel Continue aspirin, Lipitor Hold antihypertensives until stroke ruled out with MRI Noted MRI of the brain Consult neurology,PT/OT/ST. Pt discharged to home after assessments COVID-19 positive Chest x-ray-no acute cardiopulmonary process Patient is not hypoxic No indication for remdesivir or dexamethasone at this time Start patient on zinc, vitamin D, vitamin C

Tired the day after shot, then a week or so later, began c/o mild nausea and mild headache .. comes and goes ... Off and on until this past week when he really hasnt felt like doing anything, legs feel week, short of breath more than usual and BP is sometimes LOW for him ...104 / 60 with lower pulse at 45 or 50 instead of his consistent 66. Also , has had intermittent dizzy, foggy head or wobbly legs.

It occurred to him that maybe he had COVID when he got the vaccine and it was just developing; It occurred to him that maybe he had COVID when he got the vaccine and it was just developing; dizzy; irate; yelling; This is a spontaneous report from a contactable consumer, the patient. An 84-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) (at the age of 84-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started feeling bad and it may have nothing to do with a side effect of the vaccination. On an unspecified date, the patient felt pretty bad. He was coughing up phlegm. He was supposed to go back on 28Apr2021 but he was sick. It occurred to him that maybe he had COVID when he got the vaccine and it was just developing. He was pretty sick. He was coughing up a lot of grey mucous from his lungs. He felt terrible like he had a bad flu on an unspecified date. He might go to the hospital. He probably should have done that anyways. He was dizzy and terribly sick on an unspecified date. The patient was irate and yelling on an unspecified date. The outcome of events 'it occurred to him that maybe he had COVID when he got the vaccine and it was just developing', 'dizzy', 'irate' and 'yelling' was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

84 y/o M PMHx of non-hodgkin's lymphoma, adenocarcinoma of the colon (1996) and type 2 DM, presented ED 4/17 with complaints of weakness x 1 week. He reported some Memory loss but denied fever/chills, coughing, dyspnea or fever. Admitted for UTI. On 4/19 patient developed fever, tested positive COVID, started on decadron and remdesivir, pulmonology consulted. 5/1 increasing O2 requirements, prompting transfer to ICU. Mental status improved. 5/3: Fluctuant FiO2 requirements. Transferred to the floor and back to the ICU for hypoxemia. Intubated 5/7. Pt with worsening AKI, metabolic acidosis and shock in the evening of 5/8. Daughter on 5/9 and pt made a DNR. Worsening shock, metabolic acidosis and MODS. Decision to dc to hospice

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.

1/14/2021-0545, blood noted left and right ear. 0715, vomited x 1. Covid Antigen positive. Acute MD visit-basilar crackles right and coughing. Increased confusion.

to not being able to get from his bed to the bathroom without help/to not being able to manage a phone call; From walking from one end of that enormous facility several times, to not being able to get from his bed to the bathroom without help; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Left arm on 05Jan2021 at 03:00 PM as a single dose, for COVID-19 immunization, lot number: unknown. Medical history was not provided. Patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications in two weeks prior to the vaccination included amlodipine besylate, finasteride, hydrochlorothiazide. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 08Jan2021 at 08:00 AM (3 days after the vaccine) patient experienced a drastic decline. From walking from one end of that enormous facility several times, to not being able to get from his bed to the bathroom without help. From still driving his own car, to not being able to manage a phone call. Events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if patient was treated for the events. Since the vaccination patient had not been tested for COVID-19. Outcome of the events was unknown. Information on the lot/batch number has been requested.

No adverse effects for the first two weeks. The morning of 2/7/21 he claimed he was not able to sleep the night before. He was cold, but only wanted something cold to drink. He was not able to get through his normal morning routine. By 8 am we was beginning to get confused and weaker. By 9 am he vomited and was not able to stand up or walk. The confusion was increasing. We called 911. When they arrived he had chills and was agitated. He did not have a fever at that time. He was transported to the emergency room. We were not able to accompany him there, but were told he was confused, agitated and combatant. His fever was up to 101 degrees. The started him on antibiotics and began tests. He tested negative for COVID and the flu. By that evening they diagnosed him with viral meningitis and admitted him to the hospital. The next day we were told that they had ruled out viral meningitis as well as other infections. The infectious disease doctor said that all tests had come back negative, but they were continuing to give him antibiotics. A neurologist and cardiologist were called in and they were not able to find anything either. He did complain of chest pains, but it was determined that it might be heart burn. They did see a sign of Afib, but test were not conclusive. On Friday, Feb. 12th he was sent home with antibiotics and heart medicines. The confusion has improved, but he is very weak and not mobile without assistance.

ound patient in sitting position in elevator s/p 2nd dose of vaccine. Patient awake, opening eyes, mumbling, incoherent speech, noted to be pale. As per patient's wife, "He felt dizzy and used walker to assist himself into a sitting position on elevator floor. He did not hit his head, I do not think he lost consciousness. He waited in the waiting room for more than 15 minutes and drank 2 cups of juice before we left." No obvious injuries noted. Palpated weak, thready pulse. Patient tachypneic w/ shallow respirations. Called for assistance. Vital signs: B/P 98/34, HR 121, RR 23, unappreciated O2 sat. Fingers cool to touch. FS = 139. Attempted to re-orient patient, given small sip of apple juice. 911 activated. Patient transported to ER with wife. Noted patient to be more alert, responsive with clearer speech upon arrival to ER. After monitored in the ER, the patient was cleared for discharge.

brain has slowed down; starting to lose his memory/memory loss; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot nubmer: EL1283), via an unspecified route of administration on 29Jan2021 at a single dose on the right arm for COVID-19 immunization. Medical history included heart valve replacement on an unknown date. The patient stated that he was taking concomitant medications (unspecified) but nothing out of the ordinary. It was reported that on 31Jan2021, Sunday afternoon, he noticed that he was starting to lose his memory. He said he suddenly forgot his age and had to ask his wife about it. He said he has consulted his doctor about this already, but still wants to give Pfizer a call to ask for advice on what to do. He also said he wants to go on record that he's having this kind of experience after receiving the vaccine. He said he has serious memory loss. It was bad Sunday afternoon and Monday morning but Monday afternoon it got better. The day before the report it was better but on the day of the report it is bad again. He went to see doctor regarding this; he hopes he doesn't lose his memory. He stated that on 01Feb2021 his brain has slowed down; his memory is gone. He went to see his primary care doctor, on 02Feb2021 he went to see another doctor, a brain doctor. He did a sleep test on 04Feb2021 with unknown results. The patient stated that he is still struggling with it. He has seen his doctor and is working on it but wanted to let Pfizer know about this and would like us to know the conditions and if Pfizer would have any information on this happening. The patient had blood tests and an MRI done on an unspecified date in 2021 with unknown results. The patient did not receive treatment for the events. The outcome of the events is not recovered.

DIRECTLY FOLLOWING ADMINISTRATION Involuntary shaking in both arms for 2-3 hrs (severe). Not just trembles Fatigue to near incapacitation (severe) Muscular movement unresponsive Unable to stand, sit up right, raise arms Incontinence Confusion, non-responsive, fog 101.3 F temperature Strained breathing

The patient had possible syncopal episode and an increased white blood count with lactic acidosis on admission. He is currently still in hospital and had delirium and acute hypercapnic respiratory failure requiring BiPAP ventilatory support.

I experience muscle pain in my upper back muscles, both sides. When I moved my head, I felp sharp stabbing pains which made me shout. I could not sleep much on March 8 evening. The pain persisted all day Tuesday March 9, 2021. I called my ortho doctor and made a morning appointment for March 10, 2021 at 8:15am. I did not sleep much on evening of March 9. On Wednesday March 10 I went to the doctor. On this morning, the upper back muscles were OK, and the pain and spasms wer now in the neck. I could hardly move my head up or down and left and right. Dr. perscribed Methylprednazolone (4mg, 6-5-4-3-2-1 doses) and cyclobenzaprine 5mg (3x daily). after 1 day and 1 dose, I feel I can movemy head a little farther without the stabbing pain.

Extreme exhaustion and weakness. Loss of appetite. Incontinence. Inability to participate in activities of daily living. Possible stroke. Amnesia. Delerium. Visited Dr on March 1st. Bloodwork taken. Bloodwork showed high white blood cell count. On 3/2/21, Doctor advised patient to go to ER but patient refused. Urine sample dropped off on 3/3/21. Urinalysis showed bacteria in urine. Doctor prescribed cephalexin for possible UTI and ordered brain MRI without contrast. Patient is still exhausted and sleeping a great deal. Appetite is improving. Additional information for Item 18: Patient cannot remember any events between February 24-March 9, 2021. MRI done on 3/12/21. Waiting on results of MRI. Switched primary care on 3/12/21.

Hallucinations (first time ever experienced), confusion, paranoia, loss of appetite loss of balance, dizziness, decline in ambulation ability. Dragging feet on ground, unable to use steps.

about 15 hours after dose of vaccine his daughter could hear him carrying on, and was standing but not responding to verbal cues. He was confused, wet himself, and still doesnt remember anything about the event or the ambulance ride. He would not and could not walk, and was sweating, breathing labored, they called 911. went to hospital and was admitted friday morning and was released monday. patient states his body was in pain from head to toe. His daughter stated he received antibiotics and fluids and is not sure what else. Patient is home now and is doing better.

My father received his first Pfizer vaccine on 02/03/21. On 2/12/21 I rushed him to the ER. He was vomiting uncontrollably and had shortness of breath. Once arrived at ER, they immediately put him on oxygen. Vomiting lasted several hours. They tested him for Covid and did a chest x-ray. Tested positive for Covid. Chest x-ray showed Covid pneumonia. Was admitted. Stayed in hospital for 5 days and was then released to nursing home for physical and occupational therapy. He was very weak and on days experienced what they called Covid fog. After 2 weeks of therapy, he was released on 03/06/21 to go back home to his apartment, with extended visiting nurse therapy. On 3/10/21, was the first visiting nurse appointment. At 12:00 an RN came to his apartment from Home Health Care. She checked his vitals. She said his blood pressure was good, lungs sounded good and oxygen level was 98. She said he was doing good and that she would not need to continue to come out and check on him weekly. She left. At 2:30 the same day, a Physical Therapist from Home Health Care came. She asked him lots of questions and adjusted my fathers' walker for him. He showed her how he was doing using the walker. Walked approximately 15-20 feet in his apartment. She checked his vitals before she left. His oxygen level was now at 91. She had him take a few deep breathes until his oxygen level was up to 93. She left and said she would be back on Friday the 12th to begin the actual physical therapy then. Within 10 minutes after she left my father started shaking uncontrollably and was having difficulties breathing. I called 911. Paramedics arrived. My fathers' oxygen level was all the way down to 74. They took him to the ER. When getting him out of ambulance he began vomiting. Vomiting lasted for hours just like when he went to the hospital back in February. They tried 3 different drugs to control the nausea. They did EKG, chest and abdomen scans. Was found that he had multiple blood clots and inflammation in his lungs and a bacterial infection in his blood. After testing, bacteria was found to be E Coli. Treated him with heparin for clots and antibiotics for infection and had him on oxygen in nose. Every day thereafter, he felt worse. They switched him to a high flow oxygen mask to keep his oxygen levels up. By Saturday night (early morning Sunday) on 03/14, they had taken the high flow oxygen mask off and hooked him up to a BiPap oxygen machine because his oxygen levels were dropping too low. We were then told by the lung doctor, that the damage to his lungs was extreme and that the next step would be to put him on a ventilator and feeding tube. My father did not want this per his will and his discussion with Dr earlier in the week. Dr indicated that he would not get better just being on the BiPap machine and we then chose to have them take him off of the machine because he did not want to go on life support. My father passed away on Sunday, March 14th around 6:30pm.

Patient had chills the night after the vaccine and throughout the night pulse ox dropped to 88, given 3L O2. Pt had little sleep and the next day had no appetite pulse ox between 88-90. After dinner had severe chills, no fever ,extreme SOB , pulse ox down to 79, coughing up blood tinged sputum, fluid in lungs, anxious. EMT called sent to hospital confirmed to have had an MI and new onset CHF, enzymes elevated, creat 1.8. Transferred to hospital and was stable. The next day still SOB, enzymes lessening, trying to wean from O2. The nurse attempted to get the pt to the bathroom he became extremely SOB and became unresponsive. They attempted CPR and the pt expired shortly thereafter due to another MI.

This 85 year old white male hospice patient received the Covid shot on 2/16/21 and went to the ED on 2/21/21 and was admitted on 2/22/21 with altered mental status, pneumonia, severe sepsis, bladder cancer, UTI, dementia and died on 4/19/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Woke with fever at 1AM after receiving the shot at 11AM the previous day (14 hours later). Was moaning from discomfort. Don?t know his exact temperature until the next morning when daughter was called. Fever was 101.1 at 9AM. He was hardly communicative and close to unconscious until 7PM the day after the 2nd dose was administered. Consistently improved after 7PM.

Admit 5/23. Vaccine 1/16, 2/10. H/O CAD, CHF, previous strokes. Presented to ED from NH with AMS, fever. COVID+. CXR shows no infiltrates. No supplemental O2. Also found to have acuta CVA. Palliative care consulted, family agreed to hospice. DC'd to Hospice.

Fever, discomfort, restlessness. Administered Tylenol at Dr's instruction; He collapsed and died. He first reported nausea occurring around 4 am on 2/25/21 and was uncomfortable all day. He felt worse that evening and was showing a fever. He was given Tylenol around 10 pm on 2/25/21. He fell asleep around 2:00 am on 2/26/21 and woke up around 3:00 or 3:15. He had a drink of water then collapsed. I performed chest compressions until the EMTs arrived but he was likely dead by the time they arrived.

Severe cough, shortness of breath, exhaustion leading to emergency room visit followed by hospitalization wherein it was discovered Pt was diagnosed with acute congestive heart failure. Prior to this vaccine he was living alone, preparing meals, driving to errands, etc. Over the following few weeks after release he became unable to live at home so he was moved to an assisted living facility where he rapidly declined and was put on hospice less than 2 weeks after his second Covid shot on 3/2/21 (Lot EN9581) (which he only took because his doctor pressured him). He died on 6/2/21 of heart failure.

severe neurological effects twitching loss of use of left side mental state declined he completely changed 8 days after his second dose he went from being independent and working to now needing 24 hour care

MORNING OF 2/17/21, DEVELOPED WEAKNESS, AND INABILITY TO STAND. GENERALIZED BODY ACHES AND PAIN, AND CONFUSION. WAS TRANSPORTED TO THE ER AND ADMITTED TO THE HOSPITAL.

2/27/21 hpi86 y.o. male with a past medical history notable for Dementia, hypertension, hyperlipidemia, recent skin breakdown. The patient presents for evaluation of worsening issues of cellulitis and acute renal failure skilled care facility. Due to patient's dementia other history could not be taking. Patient has had decreased intake. Patient has had some worsening issues with skin breakdown. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient does show signs of discomfort with his bottom. Patient otherwise appears to be at baseline. Hospital Course: patient was admitted to the hospital for worsening dehydration and finding UTI and pneumonia. The patient is also found have skin breakdown. The patient was placed and patient is started on IV fluids and IV antibiotics and wound care was started on patient. Patient did have some issues with behaviors but this was improved with treatment. 3/20/21 readmission acute renal failure

The background is he was hospitalized for 5 days in November 2020 for coronavirus, admitted with fever, chill, weakness, and inability to walk. Discharged with 3 weeks physical therapy to regain his strength. First vaccine on 2/4/2021 and within 24 hours experienced similar symptoms, profound weakness and fever. Second vaccine on 2/25/2021 and within 12 hours he was unable to walk, with weakness, fever, and confusion. He was taken by ambulance to the hospital on 2/26/2021. I did question his internist and the person at HealthCare facility on whether or not to proceed given prior reactions. During this admission determined to have heart attack with cardiac cath and stent placement. Brain MRI showed new 1cm occipital left infarct and developing pneumonia. Started on anticoagulation with Plavix and ASA 81mg. Readmitted to the hospital on 3/8/2021 with suspected GI bleed. Had colonoscopy and endoscopy with gastric erosion cauterized.

I thought I was having a heart attack; I had severe left arm pain; I didn't get much sleep that night; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration at left upper arm on 08Mar2021 at single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib) and high blood pressure. Concomitant medications included unspecified medications. The patient was taking loads of medications. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 86-years-old, via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization and reported that he had no problems with the first dose. The patient experienced severe left arm pain at the arm where the shot was given on 08Mar2021, the night after he received his second COVID vaccine dose. He almost called a number because he thought he was having a heart attack. What he did was he got up to walk around and the pain went away and when he sat down on his recliner, the pain came back so he didn't get much sleep that night. He was fine the next day. The patient took an ASPIRIN 325 mg coated pill because he thought he might be having a heart attack. If he had known, he would have taken the vaccine on his right arm. His arm hurt the night of 08Mar2021 until 6:00 AM the following day. The patient then stated that his recommendation was to tell the people who are administering the shot that a left arm pain may possibly occur because anybody who has the left arm hurting is afraid and can think they have a heart attack. The outcome of the event pain in arm was recovered on 09Mar2021 at 06:00 AM, and recovered on 09Mar2021 for all other events.

Suffered a stroke 1 to 1.5 hours after vaccination. He was driving when according to my grandmother he couldn't deccelerate and was having trouble communicating. Grandmother had to take control of the wheel and somehow stop the car by driving it off the road. Patient was combative with healthcare and had to be restrained and was confused about why he was there. he no longer remembers the events that lead to his hospitalization.

This 86 year old male received the Covid shot on 2/17/21 and went to the ED on 4/20 with abnormal lab of hypercalcemia and again on 4/25 with altered mental status and was admitted on 4/25 and died on 4/25/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

This 86 year old male received the Covid shot on 1/20/21 and went to the ED on 1/23/21 and was admitted on 1/23/21 and again went to the ED and admitted on 4/4/21 and again to the ED on 4/26/21 with the diagnoses listed below and died on 5/4/21. D50.0 - Blood loss anemia I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC) S09.90XA - Closed head injury, initial encounter W19.XXXA - Fall, initial encounter S01.01XA - Laceration of scalp, initial encounter S06.5X9A - Subdural hematoma (CMS/HCC) S06.5X9A - Traumatic subdural hematoma (CMS/HCC) Z74.09, Z78.9 - Impaired mobility and ADLs

My nervous system is a wreck; Have not slept in two days; My digestive system is unfix, I have gone to bathroom like 3 times yesterday; I feel like I wanted to throw up; discomfort; This is the spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (Pfizer vaccine; Lot number: unknown; Expiry date: Unknown), via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history included unspecified Diabetes. Concomitant medications included Losartan (unspecified dose) and Xarelto 20 mg. On 26Jan2021, patient experienced my nervous system is a wreck (nervous system disorder), I have not slept in two days (insomnia), my digestive system is unfix , I have gone to bathroom like 3 times yesterday(gastrointestinal disorder), I feel like I wanted to throw up (nausea), discomfort (discomfort) and I can't you know (incomplete sentence) and the patient was just trying to find out, how long this side effect would last approximately or what to do, to ease my discomfort. Therapeutic measures taken as a result of the events; Tylenol and patient regular medications were taken. The outcome of the events were not recovered. No follow up attempts are possible. No further information is expected. 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.

Vaccine 3/9, 3/30. Admit 5/3. Admit for COVID PNA, DKA. Treated w/ abx, steroids, remdesivir, zinc. CXR shows bilat opacities. Elevated WBC and procalcitonin. He was found to be COVID-19 positive and pulmonology was consulted. Required increasing amounts O2, tfer to PCU. Some clinical improvement but none for worsening confusion. Family opted for DNR and hospice. DC to IP hospice.

Developed symptoms of SARS-CoV-2 infection including shortness of breath, cough and was tested due to persistence of symptoms despite antibiotic treatment. Antigen testing was positive. Approximately 1 week after symptom onset patient was noted to be lethargic and confused by family who contacted EMS. Patient was hypoxic in ER and required 8 L of O2. Was admitted with COVID-19. Subsequently did decompensate on the floor and required intubation. Currently intubated receiving remdesivir, dexamethasone, and antibiotics.

Developed temp 101.2 on 12/30/2020. Treated with Tylenol. The following day, the patient complained of chest pain and was sent to ED for evaluation. He was transferred to Hospital and admitted with altered mental status. He returned to the Nursing Home on 01/01/2021 with no acute findings and has been stable since that time - Dx was lethargy and altered mental status.

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.

Patient called our clinic to report swelling and redness of the left hand. He said this symptom started several days after receiving the vaccine at an outside location. Symptoms gradually worsened over the last few days until his hand became so swollen that it became difficult to make a fist and is impairing his activities of daily living. Reaction seems to be localized to the hand and patient reports no other symptoms.

Delirious; He woke up sick on stomach and throwing up; He woke up sick on stomach and throwing up; This is a spontaneous report from a contactable consumer (son). An 87-year-old male patient received BNT162B2 (lot number: EK9231, expiration date: 30Apr2021) first dose on 15Jan2021 around lunch time at single dose for COVID-19 immunization. Medical history included high sugar and COPD (Chronic obstructive pulmonary disease). Concomitant medications included gabapentin, metformin, ferrous sulfate, acetylsalicylic acid (ASPIRIN 81). Patient took the vaccine 15Jan2021 around lunch time and this morning (16Jan2021) he woke up sick on stomach and throwing up and kind of 'deluce' or delirious. Consumer just started giving patient fluids and Pepto Bismol as treatment. The outcome of the events was unknown.

Left arm turned red from my shoulder to my elbow. Like a big bruise , Pain in the shoulder and where the shot was given. Still have pain and redness 02/10/21. Pain keeps me from sleeping at night.

death Narrative: 86 year old MALE with PMH of Afib s/p AICD/PPM, HFrEF (EF< 20% 10/2019), DM2, HTN, HLD, BPH, Depression. Was stable and feeling well when he was administered Covid-19 vaccine on 02/17/2021- Pfizer COVID-19 Vaccine 0.3 ml IM. MVX (Manuf); PFR; Lot#; EL9267; Exp Date:05/31/2021 Administration Anatomic site: Right Deltoid; Pt was monitored for 30 minutes after administration and had no adverse effects. He was called later in the day and reports he feels well and has had no adverse reactions, he endorsed his arm is a little sore at injection site. ON 02/19/2021- his dghter found him on the floor, next to his bed, dead. She reported on 2/19/2021- that she was out with him to dinner on 2/18/2021, and he stated he did not feel well, that his insides did not feel right. He proceeded to have dinner and 2 drinks. HE was doing ok, when she took him home.

Patient was admitted for AMS, possible UTI. Patient also tested positive for COVID-19 at this time. He stayed overnight, was felt to be stable and was discharged. He was readmitted 1 day later under observation for weakness, treated, and discharged to a nursing home

I was disoriented, didn't know where I was, I had no hand/eye coordination, difficulty with numbers and letters and showed slight cognitative impairment. I called the hospital and was told it would get better in 24 hrs but it didn't so I went to the ED and was admitted from 01/14/2021 through 01/17/2021 with a diagnosis of having a stroke. I am currently going for cognitative therapy.

he's imagining people are here and he is talking to them/wakes up screaming talking to people who aren't present; Tries to leave the house/ wakes up sometimes and acts as if he is eating and does all of the motions as if he is using a spoon and chewing but he hasn't ate anything; He doesn't recognize where he is; This is a spontaneous report from a contactable consumer. An 87-year-old male patient (also the age at vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EM9809), first dose via an unspecified route of administration, administered in Arm Right on 04Feb2021 02:45 PM as SINGLE DOSE for covid-19 immunization. Medical history included remission from cancer, he has Hypertension (reported also as High Blood Pressure/Hypertension), thyroid disorder (reported as Thyroid), blood cholesterol abnormal (reported as Cholesterol), light symptoms about once or twice a month of disorientation, vision impaired, a PaceMaker and soft stool (reported as Stool: stool softener). The patient is not aware of any allergies to medications, food, or other products. The patient was vaccinated the most recent COVID-19 vaccine in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and not been tested for COVID-19 since the vaccination. The patient had other medications the patient received within 2 weeks of vaccination for High Blood Pressure, Thyroid, Cholesterol, and Stool Softener. It was reported that the patient has had light symptoms about once or twice a month of disorientation. However since he's received the vaccine he has not had any fever with either dose but has throughout the day and night doesn't know where he is, he's imagining people are here and he is talking to them. He doesn't recognize where he is at, at times. He wakes up screaming talking to people who aren't present. Tries to leave the house even though he is vision impaired and has never tried to leave the house on his own. He wakes up sometimes and acts as if he is eating and and does all of the motions as if he is using a spoon and chewing but he hasn't ate anything and there isn't any food near him because he is in his bed. It was reported that the events occurred on 06Feb2021. The events were not considered as serious by the reporter (for any criteria). The outcome of the events was not recovered. No treatment was received for the adverse events.

On 3/5/2021 patients left elbow showed extreme swelling, while the injection was done on the right arm. On 3/14 patients 2 knees down to the ankles showed extreme swelling. By 3/18, patients neck was stiff, and sore created an inability to move and nighttime sleeplessness due to pain/discomfort. By 3/22 patient experienced swelling in the buttocks. Patient visited ER on 3/16/21, Internist on 3/17/21 and internist again on 3/23/21. On 3/23/21 internist referred patient to rheumatologist.

Cerebral infarction due to unspecified occlusion or stenosis of other cerebral artery Altered mental status Anemia Renal insufficiency

Patient received his first dose of Pfizer COVID vaccine on 3/29/21. On 4/9/21, patient developed confusion, dysarthria, shakiness, and falls at home. Patient was brought to the ER by his family on 4/11/21 and was admitted to the hospital. Patient was found to be COVID positive in the ER and had low O2 saturation (83% on room air). Supplemental oxygen and COVID treatment were started and patient was admitted to the ICU on 4/11. Patient was later transferred to a medical floor on the evening of 4/12.

Contact w and exposure to oth viral communicable diseases (Primary Dx); Infection due to 2019-nCoV ED to Hosp-Admission Discharged 3/23/2021 - 3/29/2021 (6 days) INPATIENT DISCHARGE SUMMARY Admission diagnosis: Primary Admission Diagnosis Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Yes Hospital Course Patient is a 87 y.o. male with a past medical history of coronary artery disease, chronic systolic heart failure, hypertension, hyperlipidemia, type 2 diabetes mellitus who was admitted to Hospital with COVID-19 pneumonia. Hospital Course: COVID-19 pneumonia. The patient was treated with convalescent plasma and IV remdesivir and completed the course. He was treated initially with IV Decadron which has been transitioned to oral tablets for discharge to complete a 10-day course. Chronic systolic heart failure. Coronary artery disease. Orthostatic hypotension in the setting of chronic hypertension. The patient does have chronic systolic heart failure with an EF around 20% and is followed closely at the heart failure clinic. He is chronically prescribed Lasix at 80 mg twice daily, however he did have some episodes of orthostatic hypotension during his hospitalization and has been unable to tolerate other guideline directed medical therapy due to his hypotension. He is euvolemic at this time. I have decreased his Lasix dosing to 40 mg twice daily to restart tomorrow morning. His last dose of the 80 mg of Lasix was yesterday morning. I do feel that in the setting of COVID-19 pneumonia and decreased oral intake that he is more at risk for continued hypotension and dehydration aggressive diuresis. He will remain on aspirin, Plavix, and simvastatin. Type 2 diabetes mellitus. His last hemoglobin A1c showed good control at 6.3 on 3/3/2021. His glipizide was held while inpatient. He was on long-acting Lantus insulin 10 units with stable blood sugars in the hospital. He was also on correctional lispro insulin. His glipizide will be resumed upon discharge.

Clouded mental state, very "foggy". Trouble communicating verbally. Muscle weakness, trouble moving and standing. Very tired. Got better after a long night's sleep, mobility retuned as did mental capabilities.

Patient admitted to the hospital with shortness of breath and cough after being diagnosed with pneumonia in the clinic. He was found to have Covid pneumonia and was treated with maximal support but unfortunately became profoundly delirious and developed worsening hypoxia associated with Covid pneumonia. Family was called to the bedside due to progression in his illness and concerns for cardiac dysrhythmias occurring in the setting of worsening hypoxia on maximal support. Decision was made to transition to comfort care and aggressive life-prolonging interventions were discontinued for primary focus on comfort. Patient subsequently expired at 1810 on 04/18/2021. Patient was vaccinated against COVID 19. Death Certificate Information: Part 1: Cause of Death: A. COVID B. SARS COVID 19 Part 2: Other Significant Conditions: Diabetes Mellitus Type 2, Coronary Artery Disease, Hypertension, Hyperlipidemia

Upon leaving the site my husband had great difficulty walking. Upon arrival home he seemed unusually confused and over the course of the next 15 hrs had bouts of incontinence. He was up 6 times during the night (usually only 1-2x) and unable to get himself out of bed without assistance. Walking continued to be very unsteady. I thought perhaps he had a mini-stroke. I relayed this to his PCP but he didn't think it was vaccine related

Extreme confusion High blood pressure was suddenly very high He wandered out of his apartment in the middle of the night. Ambulance picked him up. He was fine before the vaccine.

chills; stomach problems/ stomach pains; back problems; weakness/low energy; sore arm for a couple of days; aching; upset stomach; lost weights; nasal drip; feeling "miserable"; he was really not well; diarrhea; sick/artificial sickness; This is a spontaneous report from a Pfizer-sponsored program. An 88-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER9231), via an unspecified route of administration on left arm on 08Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure high, diabetic and chronic obstructive pulmonary disease (COPD), he had started no new medications and not had any other recent vaccinations. He took a lot of medications for a lot of things. He was diabetic, had high blood pressure, COPD, a variety of things get over the years, he took medication for these things. He was affected by medications more than most people. No further details provided about his medications. He reacted to medications in general and that because of that he usually took lower dosages. The patient's concomitant medications were not reported. After 2 weeks from the vaccine. Have weakness and stomach pains and diarrhea. The patient had been artificially sick like 4-5 days since 21Jan2021, and had a test done and it didn't show up. He said he hadn't been anywhere to get the virus. He said he didn't have any fever, his oxygen level hadn't changed, he had a testing kit with thermometers, so he knew he never had a fever, but he got chills. He got all the symptoms, the stomach problems, diarrhea, back problems, overall weakness and low energy. He was fine two weeks before this, this started almost two weeks to the day and minute from when he went and got the shot. When he got the shot he had nothing, he waited 15-20 minutes with no problems, his arm was hurting for a couple days, but there was nothing else. Two weeks later he got basically an artificial case and the corona virus test said no, clarified to being negative, but he said it didn't go away, it had been from Thursday to Monday, so 5 days. The big problem was he was supposed to get his second shot Friday, and he had an appointment Wednesday, he would like to ask them too, but he would like to know was it dangerous for him to get the second shot. He didn't think he can get any sicker. He did not do a report online, he tried to get onto the website but nothing told him how to do it or whatever, so he stayed on the line waiting to talk to someone. Height: he was five feet and nine and three quarters inches tall, he had shrunk with age, everyone got smaller. His arm was not sore for very much, he didn't remember how long, he got sick two weeks later, and now he was really not well, though he was better than he was on Thursday or Friday, though he was not 100% yet. He would like to know if he should get the second shot, because he was too old to die from a corona virus shot. Investigations: He didn't know which COVID test they used, they did an instant test with results in an hour. The patient inquiry if he should get the second shot since he had had this artificial sickness for 5-7 days, two weeks after getting the vaccine. He had "sore arm for a couple of days" after the 1st injection, but "nothing more". However, in the last 4-5 days, he's been feeling "miserable". He didn't have fever. But he's been experiencing aching, diarrhea, upset stomach, lost weights and nasal drip. He tested negative to the COVID virus. He has a doctor's appointment scheduled this Wednesday. The outcome of events was unknown.

Throwing up foamy stuff; Oxygen saturation was in the 80%s; confused; This is a spontaneous report from a contactable nurse. An 88-year-old male patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3302), intramuscular at the right arm on 25Jan2021 02:30 at a single dose for COVID-19 immunization. The vaccine was administered in a Nursing Home. No other vaccine was given to the patient in four weeks. Medical history included Parkinsons, dementia, diastolic heart failure and known allergies: Iodine, Propranolol. Concomitant medication included paracetamol (TYLENOL), melatonin, quetiapine fumarate (SEROQUEL), ropinirole and sertraline hydrochloride (ZOLOFT). On 26Jan2021 11:30 AM, the patient was throwing up foamy stuff and his oxygen saturation was in the 80%s and was confused. The events led to Emergency room/department or urgent care visit. Treatment was given for the events. The patient has no COVID-19 prior to vaccination. He was tested for COVID-19 on 26Jan2021 with Nasal Swab, Rapid Test and the result was negative. The outcome of the events was unknown.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Bleeding out of ileostomy; Did not sleep; no appetite; Feeling unwell; achy; tired; weaker; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), intramuscular on 30Jan2021 09:45 at SINGLE DOSE in left arm for Prevention. Medical history included Type 2 diabetes diagnosed 10 years ago, Quadruple Bypass surgery in 2003, High blood pressure. He was Diabetic, was a heart patient. Before he had his ostomy, he had colitis that causes the patient to bleed when pooping and his guts were ravaged. His stomach might be weakened from having it for years and years in his 30's, 40's to early 50's. Family medical history included Grandfather died at 42 of bleeding ulcer in his stomach. There were no concomitant medications. Prior Vaccinations within 4 weeks was none. He has allergies to pills but was not taking any. He does not have a fever. She has the names of the pills he is allergic to as follows: Simvastatin, Lisinopril, Losartan, Aggrenox cap. They are listed on his report from (institution name withheld) that he has allergies to. He received his first dose of the Pfizer COVID-19 vaccine on 30Jan2021. There was no prescriber on 30Jan2021 through 01Feb2021, everything was good. On 02Feb2021, that is when his ostomy shot out blood like a faucet when he was taking a shower. He was changing the bandage that day, he was changing his right sided ileostomy bag and he told her that blood shot out of it "like a faucet." On 3Feb2021 was nerve wracking, but there was no blood. He was changing his ostomy pad again on 04Feb2021 and it started bleeding so much that he went to the hospital. He was discharged within a few hours because "they couldn't find anything wrong." He has had colitis for years and has an ileostomy, where they take out a bunch of his colon. This week he has had some funny bleeding in his ileostomy. It was spurting out blood. He had to go to the ER on 4Feb2021 night because it was bleeding and then it stops. People in ER did not know what the bleeding was from. He was bleeding in the ileostomy on 04Feb2021 and 05Feb2021. On 05Feb2021 his ostomy bled a little bit more but it has not bled again since 06Feb2021. She also reports that he feels, " icky, tired, no appetite and achy." The feeling unwell began on 7Feb2021. That worsened since loss of blood made him weaker and worried. When he got back from the hospital/ER, he said they were rude. There was a blizzard. He checked in around 8pm and they discharged him around 11pm that same night. ER visit at the institution on 04Feb2021, 8pm to 11pm and released. They performed CT scan abdomen and Pelvis and IV. Results are unknown. Now he was good. The achiness and tiredness was between persistent and worsened. He was worrying now. She took his forehead temperature and it was good on 7Feb2021. She took everybody's and they were all good. He just feels icky and the blood thing is nerve wracking. He is convinced it is coming back. He was not on a blood thinner or anything listed on the vaccine fact sheet. The patient experienced Feeling unwell on 6Feb2021 with outcome of Not Recovered (Feeling unwell was reported as worsened), achy and tired on 5Feb2021 with outcome of unknown, No appetite on 7Feb202108:30 with outcome of Not Recovered, Bleeding out of ileostomy on 2Feb2021 09:45 with outcome of Recovering, Did not sleep on 7Feb2021 21:30 with outcome of Not Recovered. He has a lot of the risk factors; He is Diabetic, is a heart patient, and has high blood pressure, but he really wanted to get the shot. The patient's primary care provider's nurse do not believe the bleeding had anything to do with the Pfizer COVID-19 vaccine.

Patient became profoundly weak, lethargic, depressed and anorexic. He lives in a retirement community in an apartment alone He became unable to care for himself and was transferred to Skilled Nursing Facility which was onsight. He had a positive PCR test at time of admission on 2/9/2021. He had no respiratory symptoms or hypoxemia. He had 12 lb weight loss. He remained in skilled nursing until 2/25/2021. He looked moribund initially. He was severely depressed, dehydrated and was refusing to eat. He gradually came back to his normal, vibrant self after 13 days.

Severe fatigue, lethargy observed by family members on date of discharge from sub-acute nursing care to home 02/03/2021 and subsequently on 02/04/21 with complaint of shortness of breath. Continued lethargy and shortness of breath on 02/05/21, 02/06/21. Lethargy, shortness of breath and loss of appetite, chills, on 02/07/21. Less lethargic on 02/08/2021 but worsened shortness of breath and loss of appetite. Patient requested 911 call on afternoon of 02/09/2021 for shortness of breath. Rapid Covid screen at ER was positive and staff reported beginning treatment with dexamethasone and remdesivir. Hospital staff reported to family that patient had pneumonia, congestive heart failure, confusion on 02/10/2021. Nursing staff reported patient was getting antivirals and antibiotics. Patient was transported for care by pulmonary specialist at Hospital on 02/13/2021.

Sleepy and diificulty concentrating -- need afternoon sleep and early bed (a bout 7pm). Usually wake up at 7.00 am feeling very good

Mass confusion , lack of appetite, unsteadiness, extreme fatigue and malaise. This started exactly 1 week after his shot and has improved some but still lingers up to this date. We don't know if there was permanent damage.

Then by tuesday nerves in his left heal was jumping all over the place and it was really uncomfortable/Bottom of left foot bothering him; Since the second shot, his arm is still a little sore/Arm soreness; his foot hurt and he didn't feel right so he took Advil /Took Advil for left foot nerve pain in heel; This is a spontaneous report from a contactable consumer (patient). A 88-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unspecified route of administration on left arm on 31Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing Arthritis. The patient's concomitant medications were not reported. His first dose was 10Jan2021. Lot number for the first dose was EJ1686. The first one was 3 weeks before on a Sunday at 9:30 am.On 02Feb2021, patient stated that his nerves in his left heal was jumping all over the place and it was really uncomfortable (Bottom of left foot bothering him he doesn't know what it was).His foot hurt and he didn't feel right so he took Advil (Took Advil for left foot nerve pain in heel).The first shot didn't bother him at all. Since the second shot, his arm is still a little sore (his left arm bothered him a little/ Arm soreness). So Monday and Tuesday, he took two Advil for two days. The foot pain was like a nerve was jumping in his foot. The bottom of his foot was hurting. He is a father and a grandfather, and he wanted to get the vaccine to be safe. He doesn't get to go anywhere right now, and he doesn't want to live the rest of his life this way.It was reported that when he was in the job, he fell down in a hatch, and jammed his left foot. Then, 10 years ago, he got diagnosed with spinal stenosis. Ever since then, his left leg isn't the same diameter as his right leg. Since then, he has lost 15 lbs. He used to be 170lbs.He is now 150lbs, and not as strong. He lost circumference in his left leg up and down.He had a flu shot a couple months ago. The patient received treatment for the events.The events were considered as non-serious. The outcome of the event his nerves in his left heal was jumping all over the place and it was really uncomfortable (Bottom of left foot bothering him) was recovered and the event his arm is still a little sore (his left arm bothered him a little/ Arm soreness) was recovering and outcome of other event was unknown.

pt vaccinated with 2nd covid vaccine on feb 18, 2021 and 2 weeks later developed sudden chorea like movements which progressed to where his wife thought he might be having a seizure and he was brought in and hospitalized on 3/13/2021. Pt admitted with acute choreaform movement pattern, possible encephalopathy(having acute mental status changes) and acute functional decline. Pt prior was independent with ADL's, had smooth speech pattern and walked independently with a walker. there have been no recent medication changes or illnesses.

Extreme confusion, words were unintelligible Dry heaves Could barely walk Doing odd things...trying to drink out of tissue box Sucking on blanket table & walker Could not understand directions Slept then awake every 20 min No fever

2 weeks after vaccine, noted increased essential tremor; "cotton head" trouble wit balance. This lasted about 2 weeks. However, essential tremor continues

"brain fog"- unable to speak clearly, or speak at all, complete numbness of hands, then return of feeling- spontaneously comes and goes. This is in a 88 year old who previously was walking 1/4 mile unassisted, making dinner himself, doing all ADLs- has completely declined since 2nd dose.

The weeks following vaccination, the patient felt lethargic, dizzy, unstable on his feet. Mental cognitive ability was unchanged, and he seemed to still be sharp. Up until the day of death, the patient was still active, able to drive, speak, make jokes, eat, and do everything normally. The morning of death, he had a bad fall, but couldn't recall what happened. It's assumed that a low blood pressure event, syncope, partial aneurysm, something of that nature causing temporary loss of consciousness occurred. We attended a funeral that afternoon, ate lunch, and dropped him off at his home. Sometime during that evening, he fell and died. The cause is unknown and still "undetermined" on the death certificate. (Heart attack or brain aneurysm is what I'm guessing)

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.

My Father had been in his usual state of health when he received his first Pfizer Covid-19 shot on 1/12/2021 and his second dose on 2/2/2021. He complained of being tired and chills on 1/13/2021 and again on 1/20/2021. He was diagnosed with a UTI and placed on antibiotics on 1/27/2021. After the second covid-19 shot on 2/2/2021 my father had a change in his condition on 2/4/2021. He became very lethargic, more confused and unable to speak and was send to the Hospital. He spent from 2/4/2021 to 2/12/2021 in the hospital being treated for a UTI and also was said to have had a Transient Ischemic Attack. He went to a rehab facility for Physical Therapy from 2/12/2021 to 2/19/2021 after which he returned to the Assisted Living Facility. He had another episode of lethargy/unresponsiveness on 2/26/2021 and was once again sent to the hospital where they did not show any new findings. He spent a few days in the hospital before returning to his facility where he continued to have periodic episodes of increased lethargy/confusion and decreased eating. He was placed on Hospice and passed away on March 29th.

Per discharge summary, patient presented to BHL with his wife with increased shortness of breath, diarrhea and hematuria. Found to be COVID +. Patient tested positive for COVID 5/21. He has received both Pfizer vaccinations. Patient was admitted and started on treatment for Covid with remdesivir and steroids. He was continued on his home dialysis schedule. He continued to have intermittent confusion and then for the last 3 to 5 days was very confused and more unresponsive. Reviewed goals of care with wife at length and palliative care was consulted. Decision was made not to pursue feeding tube due to patient having clearly outlined his wishes and his advanced directive. Upon further discussion with family hospice was consulted and patient was transitioned to inpatient hospice

Several hours after vaccine patient had nausea, vomiting (green mucous), chills, diarrhea and confusion. Patient is in generally good health so confusion was concerning. Patient was taken to the hospital via ambulance. Do not know outcome.

losing night time sleep; welts on his body; rashes on delicate parts of belly, buttocks, scalp which were itchy/The rash gradually developed an itch; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899 and expiry date: 31Mar2021), via intramuscular route of administration on 30Dec2020 at 11:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021, a week after the injection, the patient experienced rashes on delicate parts of belly, buttocks, scalp which were itchy. The rash gradually developed an itch and he is now losing night time sleep. Patient stated that there were welts on his body on an unspecified date. He tried everything to stop the itch. He later stated there were objects across the counter that he tried, not prescription. One was alcohol and the other one was peroxide and a third one is Jergen's hand lotion and none worked. The outcome of the event itchy rash was not recovered, while unknown for the other events.

1-12-21 Resident is complaining of heart pain. Resident blood pressure is 228/105. 1-22-21 Dx UTI 1-13-21 His nurse called MD at approximately 0645, reported to him that it was reported to this nurse that resident has not slept in 2 days and night, has an increased blood pressure, reports severe pain in lower back, and appears to be uncomfortable Resident is able to verbalize his pain and where it is at, but is unable to explain the quality of the pain or give a number on the 0/10 pain scale.

Resident was hospitalized for confusion, and hypotension and increased weakness; resident proceeded to have a NSTEMI and died on 5th day in hospital on 1/31/2021.

Resident developed increased confusion on 01/30/2021 that may have been related to vaccine or to residents other medical conditions including dementia, anxiety, shortness of breath, history of lung cancer, and COPD. Sustained a fall with fracture and was transferred to Hospital. Surgical intervention performed to repair hip. Resident returned to Skilled Nursing facility. Did not recover after surgery and family chose palliative measures. Resident died/ expired on 02/09/2021.

patient reported waking up in the night consistently around 1-3 am with tingling/numbness in the left hand. this was the arm the shot was given in. He said it improved over time.

Chief Complaint Arrived via EMS- per wife pt has been more confused than BL, febrile, incont of bowel and bladder. Denied pain. +cough, SOA. Got first dose of COVID shot wed.. A&Ox1. Has left sided weakness from prior CVA History of Present Illness 89-year-old male who presents to the ER via EMS with confusion. He has also reportedly had a cough and some fever. There has been some report of incontinence of both bowel and bladder. He received his first dose of the Pfizer Covid vaccine on Wednesday, 3/17. He and his wife have returned to the home after wintering in another state. According to his wife, with whom I have spoken this evening, last night he suddenly became confused. The confusion continued throughout the day today, thus prompting the EMS called to the house and the subsequent journey to the ED for further evaluation. In the ER this evening, a battery of testing was completed. A Covid swab is indeed positive. His wife is uncertain of any positive contacts. He had some vascular congestion on chest x-ray. He has a prior history of pleural effusion which is thought to be resolved. He does have a history of lower extremity edema. He had some urinary incontinence and his wife held his Lasix Saturday morning. He was noted to be slightly hypoxic around 88% on room air. He was around 85% or so on room air at home with their home pulse oximeter device. He has been placed on 2 L of nasal cannula.

Patient daughter called to report a sudden onset of confusion. She reports that she left to walk the dogs and the patient's behavior was normal she returned to find him confused for example using the wrong utensils to eat his food and saying things that did not make sense. His speech was clear but once again his responses were not appropriate to the conversation. Patient's daughter reports he received his 1st COVID vaccine on 3.24.21 at a vaccine facility. Sent to ED for eval and treatment Reason for Disposition ? Very strange or paranoid behavior Protocols used: CONFUSION - DELIRIUM-A-OH

The way he is acting is more like he had a stroke; eyes glazed over; disoriented; felt funny; very weak; can barely stand and barely walk without human assistance and his walker; can barely stand and barely walk without human assistance and his walker; This is a spontaneous report from a contactable consumer. An 89-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID 19), dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 12:15 (Batch/Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included vascular dementia; hypertension; hypothyroidism; malignant melanoma of back (resected/in remission); bladder cancer (surgery in Nov2018/in remission); prediabetic; chronic kidney disease stage 3 due to hypertension; and sleep related hypoxia. No known allergies. Concomitant medications included donepezil taken for an unspecified indication, start and stop date were not reported; memantine taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; lovastatin taken for an unspecified indication, start and stop date were not reported; fluoxetine taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VITAMIN B-12) taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] taken for an unspecified indication, start and stop date were not reported; and unspecified multivitamin tablet. The patient previously received 1st dose of bnt162b2 (Pfizer-BioNTech COVID 19) on 26Feb2021 07:45 PM in the left arm for Covid-19 immunization. The patient has not received other vaccine in four weeks. The first day after the shot, there were not any adverse reactions. The next morning at approximately 11:00 am, the reporter found patient laying on the floor next to his bed, eyes glazed over, disoriented, and he said "he felt funny". The reporter got him sitting up leaning on the side of the bed and called. The EMT's came and checked his vitals. Within half an hour from finding the patient laying on the floor, he seemed almost back to normal. However, since he is 89 years old, the patient was transported by ambulance. Blood was drawn, a urine sample was taken, a chest Xray, and a CT scan of his head and his spine were the labs that were run. All the labs came back normal. However, once patient got home after being in the ER for 5 hours, he is very weak, can barely stand and barely walk without human assistance and his walker. The way he is acting is more like he had a stroke. Onset of the events reported as 20Mar2021 11:15 AM. The events resulted in emergency room/department or urgent care. Outcome of the events was not recovered. The patient used walker due to can barely stand and barely walk; for other events, there was no treatment given. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination.

slightly dizzy; pain in arm slightly; His head was still just a little foggy; Unrestful night; This is a spontaneous report from a contactable consumer (patient). A 89-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), dose 1 intramuscular, administered in arm right (Injected into right shoulder in the muscle) on 10Feb2021 09:50 to 10Feb2021 09:50 (at the age of 89-years-old) as single dose for prevention (COVID-19 immunisation). Medical history included ongoing AFib (Diagnosed 7-10 years ago), sulfa allergy, ongoing to keep bowels soft and pliable, down from 210 lbs (he found out his wife had breast cancer, he lost the weight, prior receiving vaccine), bad ankles (uses a cane and walker and noticed he was having). Concomitant medications included warfarin at 5 mg daily (Started taking 7-10 years) for AFib; diltiazem hydrochloride at 180 mg daily (Started taking 2 years ago) for AFib and omeprazole at 20 mg daily (Taking for 7-10 years) to keep bowels soft and pliable and unspecified medication. They reported that he called Pfizer yesterday about the same question; however, today he would like to know if he can get a letter stating that it was permissible to get the vaccine 4 days short of the 21 days. Caller reports that he received first dose yesterday, and felt slightly dizzy afterwards and today he had pain in arm slightly Feb2021. Caller reports he had a sulfa allergy. Caller was scheduled for second dose on 27Feb2021. He received the first shot this morning. It went along nicely. He had two questions. He went back in to reschedule next appointment and the only thing they had available at (College name) was this month on 26Feb2021 or 27Feb2021, so he picked out the 25Feb2021, which he later stated was 26Feb2021. He had the shot this morning and it was only 15 days and he understands it was not supposed to be given until 21 days and wanted to know if that was true. His second question was after he had injection and he told them he was only allergic to Sulfa, they told him not to worry about it that there were so little problems with that. Before he got it, he had a sleepless night. He said he was old and he was worried about all kinds of things. He started talking to the guy the drove him over. He noticed he was a little dizzy and he probably could drive but should not. They dropped him off at his place and he was only one block away. When he got home, he drank some water and ate lunch and still feels a little bit out of it. He had a feeling if he got a good nights sleep, he would be fine. But, he wondered if it was related to the Sulfa allergy. He was down from 210 lbs. It just happened when he found out his wife had breast cancer that he lost the weight, which was prior to receiving the vaccine. She just passed away 6 weeks ago and had bone and breast cancer. He was bending and his back was starting to arch. He used to be 5' 11.5". That was before the vaccine. This has been happening for years. He has bad ankles and uses a cane and walker and noticed he was having more trouble right after he got the vaccine. Now, he was not having any more problems than usual. His head was still just a little foggy on 2021. When getting up, he stated he did not fall. He had a very unrestful night on 2021 and it could be related to that. He heard second dose should be 21 days and not 15 days. He provided on his vaccine card. They were having an influx of cases in his area and his wife and he had planned to get the vaccine as soon as they offered it. He said the reason he takes Omeprazole was his insides, all through his hose system, every once in a while he had some problems, and it started to bleed, so this was something to keep it soft and pliable. He was allergic to Sulfa. He does not have the name of medication, manufacturer, lot or expiration. The outcome of event slightly dizzy was recovering and other events was unknown.

States that his symptoms are like he had a stroke; his health declined after the shot; not eating; he is not able to walk by himself; Can't stand up on his own; Mind is not working correctly/The patient was not himself/his mind goes in and out; Speech is Difficult/he was not responding to her and his speech was bad; not feeling very well/not feeling good; Tired and Sleepy; Tired and Sleepy; Noticed patient was warm but didn't take temperature; The patient didn't receive the second shot because he has been in the hospital.; This is a spontaneous report from a contactable consumer (patient's wife). An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 04Mar2021 14:15 (Lot Number: EN6198) at the age of 89 years, as single dose for covid-19 immunisation. Medical history included pituitary gland tumour from 2018 and ongoing (it is not growing according to tests), ongoing asthma which he had for years, and ongoing low blood pressure. His blood pressure goes up and down. He has had it for a long time but started this medication 2 years ago because it was too low. Clarified that it was not taken within 2 weeks of receiving the vaccine because his blood pressure had been too high. There were no concomitant medications. The patient previously took fludrocortisone 0.1 mg once a day. The consumer (patient's wife) stated that she called on behalf of her husband. The patient was still in the hospital. The patient received the vaccine on 04Mar2021 and by 11Mar2021, the patient was in the hospital. They have not been able to find out what was wrong with him. The patient's symptoms were like he had a stroke. The patient was 89 years old, so she took him to get the shot and his health declined after the shot and he is still under the care of the (Hospital name) in (City) (State). The reporter clarified that his symptoms were that he was feeling tired and sleepy on 08Mar2021. The patient said he was not feeling good on 08Mar2021. On 11Mar2021, he was not responding to her and his speech was bad, and now he is not able to walk by himself and can't stand up on his own. This started after he received the shot. The patient didn't receive the second shot because he has been in the hospital. He was doing fine before and now he has these issues. The patient's wife (reporter) noticed the patient was a little warm but didn't take his temperature on 08Mar2021. The reporter stated that last Thursday (11Mar2021) they called the doctor and the doctor suggested taking him to the ER at the hospital. On 11Mar2021, the patient was not himself and not eating and she doesn't know what is going on with him, but he is under care at the hospital. Reporter stated the patient is doing therapy in the hospital and they are helping him to walk but he is having difficulty. She stated they keep asking if she knows what is going on, but she has no results or medical records. Reporter stated the patient's mind is not working correctly and speech was difficult for him. She clarified that he wasn't making sense sometimes and she was not able to understand him. States the patient speaks two languages but he started speaking a third language to her. She stated that his mind goes in and out. Treatment: rest and at the hospital they are doing therapy for his legs. States she will get on update on his progress on Friday. States she can't see him because of Covid restrictions. The patient did not receive any vaccines 4 weeks prior to COVID vaccine. Outcome of the events was unknown.

Patient came in to get Shingles vaccine(Shingrix ) but was given a 3rd dose of COVID-19 vaccine. He was initially given his 2 dose series in February 2021. It was the Pfizer vaccine initially also. After the third dose he experienced: extreme tiredness, shaking, fogginess, and anxiety.

04/12/2021 11:15am received 2nd shot, started feeling goofy, terribly sick, Collapsed in the floor passed out for 14hrs found by management, admitted to the hospital. 04/16/2021 went into Cardiac Arrest. Hospitalized 11 days/discharged 04/27/2021