Pfizer

Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold

Starting at 0100 am I noticed chills, body aches, vomited, then felt crappy all day. Thursday night 12/31 symptoms worsened with above & headache

12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. 12/20/20 loose bowel movement, rash on back and disappeared face red lips swollen. 12/21/20 symptoms continued medications taken Benadryl. Imodium; rash resolved and loose bowel movements later in the day. Abd discomfort, pain and nausea present since vaccine given.

* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight

nausea/waves of nausea; lower abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2; reported as COVID19 Vaccine; lot number: EJ1685; expiration date: Mar2021), via an unspecified route of administration right arm on 18Dec2020 15:00 at single dose for Covid-19 vaccination. Medical history included IBS (irritable bowel syndrome), hysterectomy at age 42 and she doesn't have periods (amenorrhea). The patient family medical history included her family are all dead and has been for a long time. The patient's concomitant medications were not reported. It was reported that vaccinations within 4 weeks included shingles vaccination 5 weeks before covid-19 vaccine wherein the patient first singles shot was fine. Her second shingles shot made her sick, body aches, and fever for about 24 hours. She received it from a pharmacy inside a store. The reporter mentioned that she took her first covid vaccine shot and was able to experience nausea, headache lower abdominal pain. She inquired if there was information on until when she will be experiencing this or how long the symptoms will last. She mentioned that she had headaches and waves of nausea, and before nausea, she had lower abdominal pain. She doesn't know if abdominal pain was coincidental. She had a hysterectomy, so she doesn't have periods. She lives with IBS, but this abdominal pain was different. Immediately after COVID-19 Vaccine within about 20 minutes after injection (18Dec2020 15:20), she had headaches and she still has been having headaches. She had strange lower abdominal pain that lasted a minute and a half then shortly after that started having waves of nausea. She added that the waves of nausea began 24 hours after the COVID-19 Vaccine (19Dec2020 15:00). The outcome of the event headache was not recovered, as for nausea was unknown while the outcome of the other event was recovered on Dec2020.

Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."

Vomiting, chills, headache. Began 18 hours post injection. Lasted for 12 hours. Continued to have chills and excessives sleepiness for 48 hours.

Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20

Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.

INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.

19th received Covid Vaccine at noon 21st negative Covid surveillance test completed due to ED Cluster 22nd Bedtime approx. 2100 A very strange feeling of overwhelming fatigue "spacey feeling"" 23rd nausea dizzy general malaise 24th nausea dizzy general malaise 25th nausea dizzy general malaise Contacted Health Service 26th still nauseous dizzy general malaise and then chills Health Service Ordered Covid Test 26th negative Covid. 26th video appointment with PCP states no need for labs feels it's Vaccine related 27th minimal nausea no chills episodes of feeling ?spacey? and tired 28th Minimal nausea 29th Morning nausea and fatigue 30th Morning nausea and fatigue 31st increased nausea and fatigue all day easing as day progresses "spacey" with fatigue

12 hours post injection 7:30p, low grade fever 99F, queasy, brain fog and exhaustion. Fever went away over night, the rest of the symptoms stayed through the day.

Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. without any issues. Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite. The body aches, fatigue continued the following day, appetite returned slightly. Thankful these were my scheduled days off from work. Third day after injection body aches dissipating able to go out of the house to do errands.

Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), via an unspecified route of administration on 30Dec2020 at 09:15 (at the age of 60-years-old) as a single dose, in the right arm for COVID-19 vaccination. Medical history included lymphedema, lipedema, depression, osteoporosis, osteoarthritis, hypothyroid, malabsortion with vitamin deficiencies, anemia, and allergy to latex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, however it was reported the patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took thimerisol and influenza vaccine both from unknown dates to unknown dates for unknown indications and experienced allergy. On 30Dec2020 at 10:00, the patient experienced sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site. The patient did not receive any treatment for the events. The clinical outcome of the events sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021. Information about lot and batch number was requested.

Significant nausea that came on about 24 hours after the injection. No vomiting. Symptoms are significantly improved and subsiding at the time of this report.

Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.

four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless. The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor. Each time I fell it too approximately 20 minutes for me to get either in bed or a chair. Still had fever of a 100-101 through out the day, took ibuprofen to help, which it did for a short time but then fever was back. About 7pm I took some Benadryl and was finally able to fall asleep. The next morning, no fever but very weak. Went to health club to help with my legs. This day was ok, weak but improved. No falls

Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and moves. Diarrhea started 1-5-2021. No fever 97.7. Off work for 4 days. Using heating pad and inhalers. Has appointment with provider 1-5-2021 and 1-7-2021. Test for COVID on 1-7-2021 and negative Symptoms resolved 1-9-2021 and returned to work on 1-11-2021

Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and experienced a headache. The next day at 2:15pm the patient reported a temperature of 99.0 degrees Fahrenheit, not being as tired, but starting at 9:30 am that morning experiencing "tongue being tied" and having difficulty communicating described as "know what they want to say but it... doesn't come out" that lasted three hours. The patient denied problems walking or being confused. The patient was immediately referred to the emergency department for evaluation. Upon arrival to the emergency department patient had clear speech speaking in complete sentences and ambulating independently with a steady gait. Physical and neurological exams both normal: no aphasia and no focal neurological deficits, normal strength and sensation throughout. Initial vital signs within normal ranges except blood pressure 149/88 mmHg. Patient remained asymptomatic and stable throughout emergency department stay. Repeat vital signs were within normal ranges and patient was discharged to home with a diagnosis of transient ischemic attack. On follow-up visit with primary care physician four days after vaccination patient reports feeling much better and no new symptoms reported.

Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.

dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nauseous, mild shortness of breath

Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown. Information on the lot/batch number has been requested.

developed nausea and light headedness approximately 6 hours post vaccine. patient unable to report to work the following day, symptoms then resolved.

Headache, NauseaVomiting, severe migraine, arm pain-sore for 2 weeks, red streak up the shoulder and neck Narrative: Experienced a red streak that went up the shoulder and neck from the injection site. Also felt very foggy, difficulty focusing.

Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of appetite, fatigue.

Chills; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration on 08Jan2021 11:45 AM at single dose on the right arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), on 18Dec2020 12:00 PM on right arm. COVID-19 vaccine was administered in the hospital. The patient experienced chills, nausea and headache on 09Jan2021 01:30 AM. No treatment received for the events. The events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.

Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.

limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;

WHEN I GOT TO WORK I DIDN'T FEEL AT MYSELF. I WAS DIZZY AND VERY SHAKEY AND DIDN'T FEEL RIGHT THE MAIN PROBLEM IS IF I CLOSE MY EYES AND GET REALLY DIZZY AND GET SICK AT MY STOMACH

fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt really hot in my face; I just kind of felt little nauseous; Little bit of chills; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing hypertension. Concomitant medication included amlodipine besilate at 5 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg once a day, vitamins and metoprolol succinate at 50 mg twice a day for hypertension. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On Jan2021, the patient reported that: " I was running a fever like above 100.4, I was a little ache like a flu" and " I woke up and I just felt really hot in my face, I just kind of felt little nauseous and a little bit of chills and I took my temperature and it was like a 100, so I went to work and I did take a TYLENOL, 2 extra strength TYLENOL around 9:00 and I felt much better and now I am feeling like a fever is coming back so I took my temperature and I was getting like chills again and I took my temperature and it is 101". The patient outcome of the events was unknown.

Lot number for the first dose was EK5730. After receiving the 2nd dose on the 01/11/2021 went to lunch and in the evening started feeling nausea and was throwing and abdominal pain. Went to work sick Tuesday and Wednesday low grade fever, nausea and abdominal pain, wasn't eating was to sick to eat. Thursday early morning hours the pain was unbearable so she went to the ER and the cat scan. It was determined that she had appendicitis and they removed my appendix same day. Feels so much better now.

Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.

Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart rate increased. Nurses came over and took VS. BP 180/100, P128, Throat scratchy and hard to swallow. Monitored continuously and had epinephrine ready but didn't inject as about 10 minutes later symptoms started to subside. Stayed in hospital for longer period (unsure of exact time) and then went home. Over the next 2 days, felt listless, weak and no appetite.

Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS GSH ED Was given Benadryl, Prednisone and Pepcid orally Was discharged after 4 hours

1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later. Fever ran about 102 degrees most of the time. 2. Chills 3. Loss of appetite and body aches lasting approximately 3 days 4. Hives in armpits, worse on the side of the injection. I noticed it 48 hours after the injection, and I still have them 1 week later. They are much better, but still visible and itchy. 5. Sensitive and painful gums

taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.

12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.

Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days

Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walking to the bathroom. Vertigo caused severe nausea and vomiting, with inability to drink or eat for 36 hours. I became dehydrated. Went to the ED and was admitted overnight for vertigo, orthostatic hypotension, dehydration.

Fever 100.7; dizziness; fatigue; labile hypertension; confusion; forgetfulness; difficulty concentrating; nausea; severe headaches; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ElL0142), via an unspecified route of administration in left deltoid on 03Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included wheat allergy, celiac disease, and hypotension from an unknown date and unknown if ongoing. Concomitant medication included buspirone, cefixime (FLEXERIL), paracetamol (TYLENOL) and esomeprazole. On 05Jan2021 09:00 PM, the patient experienced fever 100.7, dizziness, fatigue, labile hypertension, confusion/forgetfulness, difficulty concentrating, nausea and severe headaches. No treatment was given to the patient for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, PCR and Nasal swab both negative on 06Jan2021.

26th 0130-can't move, all joints bones-Can't get out of bed. No eating. Poor voiced quality. She's been vomiting. When I asked her the Lot# and manufacturer-she said-stop yelling- don't get frustrated-began to cry-I softy asked the question again Lot# and Manufacturer. Told to go see her PCM.

C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccine. No problems with #1 vaccine Tx antiemetic, H2 blocker, anti histamine, Tylenol push fluids

weird taste in mouth; like a burnt oatmeal taste; Nausea; This is a spontaneous report from a contactable nurse. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283, expiry date not reported), intramuscular on 09Jan2021 12:00 at a single dose in the left arm for COVID-19 immunization. Medical history included had known allergies to sulfa and patient had the COVID virus back in Oct2020 to an unknown date. The patient was not pregnant at the time of vaccination. Concomitant medication included celecoxib (CELEBREX). The patient had the first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. Patient wanted to report a side effect and was reading a little about it. She had her second dose of the Pfizer Covid-19 vaccine last Saturday, 09Jan2021 and has like a weird taste in her mouth on 11Jan2021. It's like a burnt oatmeal taste. Patient wanted to know if anyone has ever reported that. Patient reported nausea with weird taste in my mouth, not a loss of taste but taste of burnt oatmeal. Patient had the COVID virus back in Oct2020 and she didn't have taste or smell at all then and now she has a taste so it's not like she has COVID again. No treatments received in related to the events reported. Since the vaccination, the patient has not been tested for COVID19. The outcome of the events "weird taste in mouth; like a burnt oatmeal taste" and nausea was not recovered. Information on the batch/lot has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021025273 Pfizer

Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.

arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, tender lymph node left axillary area; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK4176; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 08:30 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 18Dec2020 10:30 at a single dose for covid-19 immunization. The patient experienced arm pain, light headedness, abdominal pain and swollen, tender lymph node left axillary area on 08Jan2021 04:00 PM. The patient received treatment for the adverse events includes acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The outcome of the events was recovered on in Jan2021.

Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left upper arm on 11Jan2021 around 3:45-4:00pm at a single dose for COVID-19 vaccination. Medical history included hypothyroidism. Concomitant medication included levothyroxine from 2006 for hypothyroidism. The patient was administered the first dose of Pfizer-BioNTech COVID Vaccine on 11Jan2021 at work. On 12Jan2021, the patient experienced muscle pain, chills, nausea. The outcome of the events was not recovered. The patient underwent rapid COVID-19 nasal swab test and the result was negative on 12Jan2021. Second dose scheduled to be administered on 01Feb2021 with no dose change made. Information on the Lot/batch number has been requested.

day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling crummy, migraines by day 6, 7 and 8... worst than normal and lasting longer than normal. usually get relief after 1 dose but it would take at least 2 before feeling somewhat better. some diarrhea, body aches. pain in my left arm and side around lung area. had chest x-ray on 1-11-21 clear. this all lasted until 1-27 or 1-28 felling a lot better today 1-29-21.... these are all the symptoms i had when i had covid in Nov. it was like having it all over again......

Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain Headache

Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown. The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.

nose bleed/kind of "blew like a quarter size of blood clot"; congestion in her throat; headache; tired, very tired and just wanted to sleep; nausea, some nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140 and expiry date unknown) via unspecified route of administration on 14Jan2021 at single dose for Covid-19 immunization on her job (nursing home). Medical history included blood pressure high. Concomitant medications vitamins. The patient took that COVID-19 vaccine shot yesterday (later clarified the date as 14Jan2021) on her job. The patient informed that she was okay the first day, but yesterday (15Jan2021) last night she had some new problems and she wanted to talk about and see it's a clinical sign. The patient informed that it was headache, tired, very tired and just wanted to sleep. The patient had no swelling/no swelling in arm, nausea, some nausea and even she has been just feeling unwell. The patient informed that today (16Jan2021) this morning, she was having nosebleed until the last time she felt like congestion in her throat and she kind of "blew like a quarter size of blood clot". The patient blew her nose and it bled a while, but then a quarter size blood clot come out and since then it wasn't bleeding, her nose was not bleeding. The patient did not receive treatment due to the events. The patient underwent lab tests and procedures which included COVID testing; swab the nose: negative on 13th or maybe 14th (Jan2021). The outcome of the events headache, tired, very tired and just wanted to sleep, nausea, some nausea, feeling unwell, nose bleed/kind of "blew like a quarter size of blood clot", congestion in her throat was unknown.

6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.

Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but sleep; administration date=15Jan2021 (dose number: 2); administration date=23Dec2020 (dose number=1); This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on 15Jan2021 at 13:30 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included allergies when younger, known allergies to wheat, dairy, cats, and mold. There were no concomitant medications. The patient previously took levofloxacin (LEVAQUIN) and nitrous oxide and experienced allergies; also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) on 23Dec2020 at 11:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient experienced fatigue, headache, earache, sore throat, and fever of 101.4 for 24 hours, and diarrhea. The patient could do nothing but sleep. The patient did not receive any treatment for the reported events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.

Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.

Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.

Received vaccine #1 Phizer on Jan 5th 2pm. Started to feel tired by 7pm. 5am woke up achey with general malaise. Took Tylenol 500mg and came to work. I started the attestation form and called employee health to let them know about my aches. They recommended me getting tested for Covid 19 in which I did before I left at 8:30am. My health continued to decline as I became ferverish, with a headache, nauseas, foggy, and exhausted. When I got home, I couldn't get off the couch. I felt horrible for 36hrs. My headache lasted for 5 days. Covid 19 test and flu test negative.

Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to calm down. A slight headache was starting. The next morning I had a massive headache all day Saturday, by 8 PM it was a full-fledged nauseating migraine. The severe migraine lasted from 8 PM the previous night to 10 PM on Sunday night. By Monday I was doing better but a bit confused and having difficulty thinking. Now it is Wednesday and I am a bit exhausted and still having trouble thinking but doing so so much better! I am so happy to be feeling better!

11pm evening of shot woke with body aches. Approx. 2am woke again with extreme chills, headache & nausea. Somewhat lethargic throughout the day but no symtoms other than slight headache. Woke the next morning at 3am with extreme chills again. Seem to feel ok but not 100% today.

Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hours later she began having fever, chills and muscle aches. Fever improved with Motrin.

nausea and dizziness/dizziness and nausea went pretty extreme; nausea and dizziness/dizziness and nausea went pretty extreme; This is a spontaneous report from a contactable consumer (husband of patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 13Jan2021, 2 days after vaccination, patient experienced nausea and dizziness, that went away. Until yesterday, 19Jan2021, her dizziness and nausea went pretty extreme. She was scheduled for a second dose in about 2 weeks, on 09Feb2021. Outcome of events was not recovered. Information on the lot/batch number has been requested.

After less then 48 hours I woke up with diarrhea. Then I started throwing up followed by severe chills & body aches, a fever & a headache

High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.

Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: En5318; Expiration date was not reported) on 22Jan2021 (10:45) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included multiple (MS), blood clots and pulmonary embolism. Concomitant medications included rivaroxaban (XARELTO) and omeprazole. The patient previously took clarithromycin (BIAXIN), and had drug allergies. The patient was not pregnant at the time of vaccination. On 23Jan2021 (16:00), the patient had nausea. The patient did not receive any treatment for the event, nausea. The outcome of the event, nausea, was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.

Started to feel achy, then it got worse; very painful. Some nausea, chills, headache, lethargic. Most symptoms gone in 20 hrs. After that a few days feeling sluggish.

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3249, exp.date May2021 on 15Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm. The patient had get earlier in January a DPT (diphtheria, pertussis, and tetanus) vaccine in the left arm. The patient had have a Pneumonia and Shingles vaccines in the last 2 years and she had no problems in past with vaccines, but stated she did get a little bit of swelling and had to put heat to the area with vaccines, but never had a fever afterwards. The patient had not medical history. Concomitant medications were not reported. No other vaccines given the same day. Since 16Jan2021, he started having symptoms, fever, cough and Diarrhea. On 17Jan2021 the patient was positive to SARS-CoV-2 test. On 19Jan2021 she received monoclonal antibody therapy. The outcome of the event was not recovered.

Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the neck. Then my arm pit was swollen, hot and the swelling went down my arm. I also had diarrhea, Nausea, slight head ache, chills, body ache with a temp of 101.5. Went to the doctor yesterday because of my armpit swelling, hot to touch and it had a red band. She said where they gave it was not in a muscle. It was given sub Q & that it went into my lymph gland and leaked down my arm to swell. Right now I just have on and off nausea , pain in my lymph glands in my arm pit. The swelling and pain has gone down and the other symptoms have faded away.

Soreness at site of injection; loose bowels; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via unspecified route of administration on 26Jan2021 at 02:30 PM in left arm at single dose for COVID-19 immunization in the workplace clinic. There was no other vaccine administered in four weeks. Medical history included gluten intolerant. No Known allergies. Concomitant medication included calcium, ergocalciferol (VIT D), ibuprofen (ADVIL), multivitamin. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient experienced soreness at site of injection and loose bowels on 27Jan2021 at 07:15 AM. No treatment was received for adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was not recovered. No follow-up attempts possible. No further information expected.

2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.

Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , headache, cough, fatigue, upset stomach, diarrhea. Subsided in about 36 hours.

8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; severe body aches; injection site throbbing; upset stomach and a feeling of nausea. Temperature 100.2 at 8:45. Took temp every hour. By midnight temp reached 102.7. Head ache started. Couldn?t sleep on my left side because of the extreme pain around the injection site and down my left arm. Finally fell asleep around 2:30 and woke at 5:30. Fever was gone. Temp read 98.9. Body aches still present but not as severe. Arm pain had eased but head ache remained most of the day. Felt much better but just very tired.

12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue. Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.

Pfizer-BioNTech COVID-19 Vaccine EUA At 2:30 am woke up with nausea and stomach ache. Continued through the night. I could not sleep. In the morning (9:00) I tried to sleep but had very bad chills for over an hour. Went down to couch and covered up with many blankets. Chills continued for 4-5 hours. Also experienced tiredness, and general 'feeling unwell' throughout the day, as well as extreme heartburn. I stayed home from work and sat on the couch all day, feeling unwell. By about 8pm all of the symptoms disappeared.

Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.

lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.

During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.

I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's possible but wanted to report it anyway. body ache, joint discomfort, migraine headache all day, fever, chills & nausea - this started about 10am on 2/23/2021 and lasted until 2am the following morning 2/24/2021. I took 600 mg of motrin every 6 hrs and 600 mg of tylenol every 4 hrs. I feel fine today

Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.

IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever

Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Friday night, started coughing and feeling unwell. I had a fever in the morning and had lost my voice but wasn't coughing anymore. Today no fever but no voice and I just don't feel well. No appetite today either.

slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss of taste and smell, fatigue) since Wednesday 2/24/21. Missed work due to symptoms on Thursday 2/25/21. Returned to work amidst continuing flu-like symptoms on Friday 2/26/21. As of Sunday, 2/28/21, symptoms continue; maybe slightly diminished.

At 48 hours After vaccines I developed a headache nauseous Hot the following day I was sore all over still having a headache still nauseous my ribs hurt my hand hurt four days today still not well tired weak headache! So sick ! I do not wish to have the second dose! I really thought I was gonna die

That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches, headache, sore arm, nausea, 102 fever, joint pain

Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping. Transferred to ED for acute, painless, unilateral facial paralysis with no forehead sparing most likely secondary to Bell?s Palsy. Patient was monitored and discharged with prescriptions for valacyclovir 1000mg tid and prednisone 50mg qday x 7 days

At first I didn't feel anything or any different. I started to get a weird sensation behind my eyes like before with the first vaccine. The muscles of my eyes and eye lids feel weak and difficult to focus. I started having extreme nausea and could not go to work. No appetite either. I now have Oscillopsia and feel sick.

I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge. During the night I woke up because the phlegm was much worse and abundant I wanted to sleep so at first was swallowing it, then it was so much that I got up and went to the bathroom. That is when I noticed that the palms of my hands were scarlet red. on both hands and not on the wrists or any where else. by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach. Yesterday , 3 days later, still had diarrhea and nausea and was tired,,symptoms are not severe, but since these are not typical symptoms for me. I figured they will go away, but also I figured that I should communicate the reaction . I am scheduled for my 2nd shot in 3 weeks,

Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.

5 minutes after receiving the vaccine, patient became flushed. She also stated that she had a sore throat without SOB or difficulty swallowing. She was able to drink water without difficulty. Her airway was patent and oropharynx was normal on exam. She had no stidor on exam. Patient was advised to seek care at the ED, but she did not.

SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSEA, SWOLLEN LYMPH NODES UNDER BOTH ARMS, FEELING UNWELL

Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature was 101 at 0930 this morning. Pt has minimal coughing at this time. Current temperature is 99.9 The pt denies any SOA prior or currently at this time. The pt was informed to eat small amount of crackers as tolerated and fluids as tolerated. Get plenty of rest. Should sx's worsen or SOA occur, then call for an ambulance for assistance.

Pt in 30 min waiting area. At 10:36 am reported tongue feeling funny. Upon assessment tongue was thick , interfering with speech. BP: 186/93, Heart Rate : 66, Oxygen Saturation 99%, Temperature 97.6 F. Epinephrine 0.3 mL administered on left thigh at 10:42 am and 911 called. Pt reported inability to swallow and chest tightening at 10:51 am. Ambulance arrived.

COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD

4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling on Face, Ankles, & Wrists -Very tired = fatigue / sleep

Sore throat, and chest feels heavy. Hurts to swallow. No treatment. I am currently monitoring my issue. If symptoms worsen I will go to ER

I received the shot at 4:30 pm. About an hour after receiving the shot, I felt a little dizzy, and my heart started beating faster. My body felt weird. I had a small headache and was very tired and laid down. I fell asleep pretty quickly. I woke up around 2:30 am the following morning, with a greater headache. I took tylenol for the headache. I took another dose of tylenol 4 hours later. I had loose stools, fatigue and my lungs felt heavy (cough) for approx 12 hours. Most symptoms resolved by the following day. A little fatigue and heaviness remains.

Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she was unable to swallow while driving home. Used rescue inhaler when she reached home for relief. Symptoms now resolved. H/O asthma

This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.

within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my body. Then my heart started racing. This lasted about a minute. I just sat there since I wasn't sure if this was normal. I started to feel like my heart was going back to normal so I just sat there for the specified 15 minutes. After I left and was driving home, I stated to feel a shortness of breath and difficulty getting air. I also felt like a hard to swallow. I was about 1 mile from venue so this happened with 30 minutes of receiving the shot. This only lasted what seemed like a short time and then I started to feel like I could get my breath. By the time I returned home I was breathing ok but my lips were a little tingly. I felt fine by 5:00 pm.

Saturday, March 6 felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with dizziness, nausea and sweats that would last about a minute. Remained sitting still with my eyes closed about 3 hours and then eyes could be open but could not move without the dizziness and subsequent nausea. I did not vomit. My temperature was-low in the morning but climbed just to 99.3 Sunday. By Sunday afternoon, I no longer had the short sweats but remained dizzy and nauseous mostly upon any movement. I went to sleep at 11:00 pm Sunday night with the slight 99 fever. Woke Monday , March 8 much improved from the dizziness and temperature 98.6., but felt extreme tiredness. I did not go tot work Tuesday and rested on the couch most of the day-temperature 98.6.

mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after injection lasting 2 days. Headache, nausea and weakness day after vaccination lasting 24 hours.

Enlarged lymph nodes following 1st shot-- Diagnostic Mammogram and ultrasound; Severe Diarrhea for 48hrs following 2nd shot. Pain in arm for about 4 days following both shots

Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9

Fatigue starting at 20:25 on 1/27/2021. Ended on arising on 1/29/2021 at 0530 Nausea with vomiting starting at 2200 on 1/27/2021. Continued thru the night and early morning hours stopped at approximately 0930 on 1/28/2021 Diarrhea starting after midnight on 1/28/2021 Ended at 0700 on 1/28/2021

Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance 1526: 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.

2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache

swollen lymph nodes; tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 10Feb2021 09:15 at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included AFib, hypertension, known allergies: TB test (allergies to medications, food, or other products: TB test). Concomitant medications included apixaban, digoxin, metoprolol, enalapril; the patient received all the drugs within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), in left arm on 20Jan2021 09:15 AM at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient experienced swollen lymph nodes, tiredness, diarrhea. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was recovering.

Fever, nausea, whole body aches, pain in arm, armpit, back, chest, dizziness, palpitations, headache.

About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hours having bouts of diarrhea every 5 to 10 minutes along with chills and feeling hot and abdominal pain. This morning on the 16 of March I feel okay with some fatigue and sore right shoulder at injection site.

my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow water; my tongue was tingling and was slightly swollen; I felt some tingling in my face; I felt light headed right after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot Number: EM9810), via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 vaccination. Medical history included depression, anxiety and the patient was diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included 6 prescribed meds daily plus vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Upon vaccination on 04Feb2021 at 16:15, patient felt light headed right after the shot. She waited 15 minutes and started driving home. she felt some tingling in her face. By the time she got home, 35 minutes after the shot, her tongue was tingling and was slightly swollen. She had some difficulty swallowing saliva but could swallow water. Her tongue was still slightly swollen the next morning but did not tingle. No seriousness criteria was reported. The patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date of Feb2021.

Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.

15 hours after vaccination sever diarrhea and vomiting, which lasted 8 hours. Chills and shaking. Fever that climbed to 102.7 and lasted 24 hours. Took acetaminophen. Fever back to normal on 3/16/2021, four days after the vaccination.

12 hours post vaccine, began to experience extreme chills, hyperventilation, breathing difficulties, and fever of 103. Couldn't talk due to chills without extreme stuttering. Ended up being transported to a local ER for care where I remained for approximately 7 hours. Was given IV fluids and Toporol to control fever. Fever persisted for 72 hours, loss of appetite and extreme fatigue. Now 7-days post 2nd shot and still experiencing fatigue.

Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick at my stomach, started have Diarrhea, Severe Headache, My arm hurt really bad could not use it for a Day and 1/2. Just felt like I had been run over by a Bulldozer.

The event began with me feeling extremely cold and unable to warm up. It later progressed to needle like sensations where ever touched. I do not remember the next week. Per my husband I had a sustained temp of 102 and was difficult to keep hydrated. My O2 sats remained stable. The following week I became unable to drink anything thicker than water. This has improved but continues to this day. My husband is a physician.

Fifteen minutes after vaccination pt c/o lightheadedness; symptoms progressed w moderately severe headache and nausea. She was hemodynamically stable no signs of any allergic reaction. There are concerns her V-P shunt is not working properly. After lying in a recumbent position for 30+ minutes headache worsened. We elected to transport to ER, via ambulance so she was recumbent during transport.

Beginning on the second day after the patient first vaccine she began experiencing fever up to 102.5, body aches, headache, profound fatigue, chills and nausea. She came to my clinic as this is her 9th (ninth) day of experiencing fevers and fatigue. The other symptoms have resolved.

This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was seen at care now urgent care with the complain of epigastric pain associated with nausea vomiting and intermittent diarrhea. Patient received her initial COVID vaccine 2 days ago. History is obtained from urgent care chart. As per notes patient started nausea vomiting 6 hours post COVID vaccine administration. Patient was seen in urgent care for epigastric pain and nausea vomiting. Patient was found unresponsive at 0902 by tech. No carotid pulses palpated. CPR was started. Patient was brought into the emergency department with Lucas on. Patient was given 5 epinephrine prior to arrival. CPR was in progress. Patient was asystole. Resuscitation was continued in the ED. Patient was intubated in the ED by physician assistant 5 epinephrine 2 bicarb and 1 calcium chloride was given in the ED. Cardiac Ultrasound didn't show any cardiac activity. Asystole on the monitor. No corneal reflex people are fixed and dilated. Patient was pronounced at 1007 am

After about 10 minutes felt head pressure and light headedness. Reclined patient - lightheadedness resolved; slight nausea when leaving - felt much better

I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bloated, it was weird. The next day, couldn?t get out of bed, all I had yesterday was diarrhea and felt like someone kicked me in the ribs. Today I am having a hard time taking a deep breathe or coughing without my ribs hurting so bad. My stomach feels better. Haven?t eaten anything, I am more concerned about under my breast hurt so much when I take a deep breathe or cough. I haven?t gone to doctor because I just wonder if it hurts so much there because if the vomiting

Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired the day after. I was incredibly sore everywhere - back,chest, hips, legs, neck... very hard to move. Around 5 PM the day after the vaccination, I became violently ill. Diarrhea, chills, feverish, sweating. etc. This lasted until about 3 AM on the 18th.

pt. called stating she recieved her first COVID vacc. past weekend, now having swollen lymph nodes and trouble swallowing. Pt. was advised to go to UC or ER. Pt. presenting today for Swollen glands (had 1st dose vaccine on Saturday, Monday started having swollen glands in neck

Body aches; fever (100.5); chills; nausea; headache; This is a spontaneous report from a contactable consumer, the patient (patient). A 60 -years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration in the left arm on 12Feb2021 at 14:15 as a single dose, for COVID-19 immunization. Historical Vaccine includes BNT162B2, Dose 1, Lot number EL8982, Administered on 22Jan2021 at 14:30 in the right arm. Medical history included Allergy: Egg intolerance. Concomitant medication includes Prempro, and multi vitamin. The facility in which the vaccine was administered No other vaccines were given within 4 weeks. On 13Feb2021 at 13:00 the patient experienced Body aches, fever (100.5), chills, nausea, headache. No treatment was given for the events. Lab data includes Body temperature 100.5 on 13Feb2021. The clinical outcome of the events Body aches, fever (100.5), chills, nausea, headache were not recovered.

Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone

Dizzy; Nausea; Vomit; Pain on all body; Frequent fall; Severe fatigue; Strange feeling; Abdominal pain on and off; Arrhythmia; This is a spontaneous report from a contactable physician. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on 11Feb2021 09:00 (batch/lot number was not reported) as single dose for COVID-19 immunisation. Medical history included (G60.9) PN - Peripheral neuropathy (SCT42658009), (M79.2) A Neuralgia (SCT16269008), (R55) Syncope (SCT271594007), (I10) HTN - Hypertension (SCT38341003), (R00.0) Tachycardia (SCT3424008), (E16.2) Hypoglycemia (SCT302866003), (R55) Vasovagal symptom (SCT248229009), (M25.50) Joint pain (SCT57676002), (F41.9) Anxiety (SCT48694002), (K21.9) Acid reflux (SCT235595009), and (M06.4) Polyarthritis (SCT416956002); all were current or ongoing. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 12Jan2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, administration time: 09:00 AM, route: intramuscular, vaccine location: left arm). On 11Feb2021 11:00, the patient experienced dizzy, nausea, vomit, pain on all body, frequent fall, severe fatigue, strange feeling, abdominal pain on and off, and arrhythmia. The AEs resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. There were no treatments given for the events. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID post vaccination. The patient has no known allergies. No other vaccines received within four weeks prior to COVID vaccine. The events were reported as serious and disabling. The patient has not recovered from all the events. Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Pt was admitted 6 weeks post second covid vaccination with c/o sudden onset of generalized abdominal pain, nausea, vomiting and diarrhea resulting in 2 syncopal episodes. CBC showed leukocytosis with neutrophilia which resolved. She was treated with IV fluids and antiemetics and was discharged on 3/19/2021

swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really tired.

Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache

I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. Around 10 am I developed chills and just did not feel great. My husband took my temp and the highest it got was 102.6 which is high for me since my baseline is 97.6 or so. I did not have a great appetite and felt very stiff when I moved around. I pushed fluids and took 3 naps Saturday. I have a low grade fever of 99 today but feel much better. Did take 2 naps and slept well last night. Took Advil with each meal and doing so today.

nausea & lightheadedness (10 minutes), diarrhea (one instance), fatigue (2 days), headache (1,5 days), sore injection site (1 day)

Same symptoms as when I had Covid in November 2020. Extreme fatigue, headache, nausea, sinus congestion, severe flu-like symptoms. These lasted 48 hours.

Fever (fluctuated between 99 and 102 degrees), chills, achy body, nausea, headache for approximately 12-15 hours did not feel well. The next morning (Sunday 3/21) woke up nauseous and had trouble breathing. Went outside for cold air and breathing was OK.

COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance, attempted to located on site MDs. 1526: No MDs on site, 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.

Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started afternoon. 99.4. Took Tylenol but it gradually rose to 102.3. Took 3 hours for fever to go down. By 5:30 fever was gone & I was feeling better. Next day I felt great but by three days later I had a fever blister & very sore, dry and stuffy nose which lasted two weeks. And headache as well. I?m thinking because of stuffy nose. I did have Covid last March/April 2020 so I have heard that I would have side effects.

Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg; Oral ulcer; Chill; Body ache; Joint pain; Joints swelling; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201), via unspecified route of administration in the left arm on 17Feb2021 as single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies. The patient is not pregnant. There were no vaccine in four weeks. Other medications in two weeks included cholesterol med. The previously received the first dose of BNT162B2 on 26Jan2021 12:00 intramuscular at left arm (lot number: EL9262) for COVID-19 immunization. The patient was seen at urgent care on 04Mar2021 due to 4 days progressive worsened skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg from 28Feb2021 (12:00 AM). Patient presented with chill, body ache, joint pain, joints swelling and diarrhea since second dose of vaccine on 17Feb2021. She also has oral ulcer at the same time when rash started on 28Feb2021. Vital sign was stable, no shortness of breath (SOB) and no chest pain. Events resulted in Doctor or other HCP office/clinic visit. The treatment for the events included Hydroxyzine 25 mg prn. It was unknown if patient had COVID prior vaccination or if COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph nodes in neck and under arm, treatment was motrin 600 mgs q6hrs from 2/18/21-02/22/21 returned to work on 02/23 lymph nodes still slightly enlarged as of today, 03/22/21

After about 20 minutes felt head pressure and lightheadedness, Reclined patient, light headedness resolved. Slight nausea when leaving felt much better. VS 168/90; 73; 97%SaO2

Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; Tingling; prickly sensation on tongue when eating; cold items felt opposite of what they should, more like burning sensation; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 12:45 as single dose for COVID-19 immunization. Medical history included known allergies to Sulph. The patient was not pregnant. Concomitant medications included aceclofenac (BIOFLEX [ACECLOFENAC]), calcium (CITRICAL [CALCIUM]) and vitamin D (VITAMIN D [VITAMIN D NOS]). On 01Mar2021 08:00, the patient experienced sialadenitis (salivary gland inflammation), glossitis (tounge inflammation), inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips. Tingling, prickly sensation on tongue when eating, cold items felt opposite of what they should, more like burning sensation were also reported. Onset of symptoms Monday morning, symptoms peaked Wednesday evening through midday Thursday, greatly improved by Friday morning. The patient had a COVID test on Friday to be sure and it was negative. There were no treatment for events. No COVID prior vaccination. The patient had a COVID test type post vaccination-Nasal Swab (Covid 2 PCR) on 05Mar2021 which was negative. The patient had The outcome of the events was recovered on unspecified date in Mar2021.

EUA Phizer-BioNtech vaccine reaction. patient reported vomiting associated with nausea and abdominal discomfort s/p getting the covid

Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning the evening of injection. All symptoms, except sore arm, gone by morning. No treatment given.

At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.

March 21 I had fever 101 , fatigue, nausea, body aches, headache that kept me from my daily functions. Reporting app did not ask about that date and I want to report that was a bad day. I did not seek medical treatment. Treated with ibuprofen and rest

Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next day, I had diarrhea and stomach upset starting by mid day. Since then, I have had daily diarrhea, lethargy, weakness, off and on headache, body aches (especially joints) and overall feeling of unwell.

I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything. On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue. The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy. I developed a large lump on my left clavicle area that seemed to be filled with fluid. My knees I had replaced are still very painful today ( 7 days post vaccine). I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day. I am doing this now for the second day with some relief. I feel this is very unusual to feel this way 7 days after the vaccine. On day 1-2 the only symptoms were a sore arm from the vaccine. Saturday was actually a good day with no symptoms, the other symptoms started on Sunday. I feel like my heartbeat is irregular also but my BP is good. I would like to be able to to report daily on v-safe like I was the first few days.

Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and minor headache and fatigue on the day after injection through the following day (2 days after injection).

20 hours of terrible body aches, headache, chills, nausea. Fever (that got up to 100.2) for 12 hours.

this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.

gradual onset of diarrhea and fever 2 days after injection for a duration of 4 days. fever of 101, chills diarrhea and inflammation under left arm and breast.

seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I felt dizzy and then had diarrhea this continued off and on for several hours...in the ER they gave me steroid, saline solution for dehydration and pepcid. I had a headache and chills while in the ER. Went home and felt fine that night other than mild headache.

things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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.

Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 30 minutes of injection. Then, three hours after administration (at approx. 12.30 p.m.), the following symptoms in order of severity: 1. Severe tiredness/fatigue. Lasted 4 hours. Resolved when I took a half hour nap. 2. Sore throat. Still present at 10.30 pm. 3. Swollen lymph nodes (lymphadenopathy). Significant improvement after 4 hours from onset (3 hours after administration). However, still present at 10.30 p.m. 4. Feeling unwell/malaise. Resolved after I took a nap. 5. Dry eyes. I had to remove my contact lenses and put on eyeglasses when I got home at approx. 2pm. 6. Dry mouth. Unresolved, even with drinking a lot of water and tea. Symptoms were fairly severe. I had to leave work and go home to rest. I was unable to drive myself home.

The first day body discomfort, arm pain, today vomiting and diarrhea chronically, mild stomach pain. Discomfort all day from the morning and vomits and diarrhea from 3 in the afternoon. Body pain.

Day 1..... couldn't sleep that night Day 2.....fever, chills, bad headache, fell asleep at 4pm and slept all night with 800 mg Tylenol. Day 3.....fever, Chills, bad headache, cough, diarreha Day 4..... headache, cough diarreha

100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fatigue, headache.

Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021

Severe cramping, bloody diarrhea, dry heaves. It calmed for a week, now I have cramping and bloody diarrhea again.

Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.

3/25/21 2:00 AM sore throat congestion 3/26/21 3:09 AM. Awoke with chills 101.5 fever, sore throat nausea aches cough Continue with very sore throat, fatigue nausea congestion dry cough nasal congestion

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe

I have taken Pfizer-BioNTech COVID-19 Vaccine EUA Three days later I have muscle pain, ear infection, headache, stomach very up set, feeling not well

Severe headache beginning around 9:00 PM after vaccination. Extreme fatigue for approximately 48 hours. Some fever and chills. Lack of appetite.

Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, and tireness

patient states a few seconds after receiving the vaccine she was light headed, and had a low grade headache. Later on that evening she began to have 1/10 central abdominal pain. C/o coughing spasm in the middle of the night that went away after a few minutes. Also c/o moderate fatigue.

felt nausea and dizziness on day of vaccine. 2-3 days after sore throat, hard to swallow, 5 days after vaccine lost voice and/or voice change. no fever at any time

Moderate indigestion; constipation; This is a spontaneous report from a contactable consumer(patient herself). A 60-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; batch/lot number and expiry date were not reported), via an unspecified route of administration on 24Jan2021, 12:00pm (at the age of 60-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took acetaminophen and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient has not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. At 4:00pm (16:00) of 25Jan2021, the patient experienced moderate indigestion and constipation. Treatment was not received for the events. The outcome of these events was recovering. The events were reported as non-serious by the reporter. Information on the lot/batch number has been requested.

Muscles around hip replacement were affected for 2-3 days. Sore muscles in the buttocks, hip and quad. It only affected this site. It went away but I found it odd. I got the usual bit of nausea, wooziness, fatigue and sore arm, but those were expected

Pt. stated she felt nauseous 10 Minutes after getting vaccinated. She also stated she suffers from migraines and when she is about to get a migraine she feels nauseous. She stated she has her migraine medication at work and she will take it as soon as she gets there. At 9:30am she stated she feels better. At 9:33am pt. stated she was ready to go.

Low grade fever; itchy throat and face/slight hives, cold compress; few hours Tues: fatigue; Wed: okay; Thurs: all day diarrhea; Fri: morning diarrhea; Sat. okay; Sun and Monday; Sneezing and runny nose; Tues: runny nose

Nausea, sweating,sick to my stomach, sick for about 4 hours and started to feel better after laying down

That night felt tired with chills and body aches. The next day I had a fever of 102.2, horrible body aches, joint pain, chills, headache, nausea, zero appetite, fatigue. Felt like a bad flu. By Monday the fever was gone but was very weak, nauseous, with joint pain. Didn?t feel like myself for several days-almost a week.

I had every single side effect listed. Severe headache starting almost immediately, lasting 5 days. Fever of 102, gradually coming down, over 5 days. Severe dry coughing, lasting 6 days and continuing. Severe muscle aches, lasting 6 days so far. Diarrhea lasting 1 day. Nausea, lasting 3 days.

Site soreness immediately following vaccine which dissipated quickly. HOWEVER, 4 days AFTER vaccine experienced extreme vertigo, dizziness, nausea which required an ER visit. Side effects still lingering next day.

Headache chills fever upper respiratory cough, muscle aches, earache, stomach ache, pain at injection site and itching

3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of face, nausea and vomit once. Went to ER around 12:30am on 3/30/21. Admitted to the Hospital from 3/30/21-3/31/21.

EXTREME fatigue and nausea. I'm still feeling tired and it's been a week since I received my first shot.

Shot 3/3/2021 9:05am, headache started around 7:00pm, overnight also had fever and chills. 3/4-Headache and fever continued, also had nausea and vomiting. On 3/5/3021, other symptoms resolved, but woke with double vision due to 6th cranial nerve palsy. This is the fourth acute occurrence of the nerve palsy. As of today, 4/2/2021, the double vision is still acutely present.

Tachycardia, hypertensive episode within 2 minutes. Diarrhea, flushing, and palpitations about an hour later, and later that afternoon. Diarrhea, dizziness, fatigue, and palpitations the afternoon of 4/2/2021.

Sore arm within 8 hours. Headache within 24 hours which became increasing severe. At 32 hours after the vaccine, severe headache, chills, nausea and vomiting. The headache lasted up to 47 hours after the vaccine and then started to become better. By noon 48 hours after the vaccine, I felt better but still a little shaky.

Headache, metallic taste, nausea. BP 156/81 (pulse 59). Final BP 160/76 (pulse 52). Sent to ED, but left upon arrival, as she felt OK.

Day 1 - within 5 minutes I felt extremely sleepy and my eyelids were heavy 15 - 20 minutes of receiving the vaccine, I was experiencing itchiness - like hives or from allergic reaction (I had them previously from allergy test reactions and allergic reactions). It was generally all over, but then I started itching under my arms. At that point, we informed the medical person who was monitoring our waiting section. He asked if I had any Benadryl, and I responded that I did. I took 12 ml (?) of Benadryl liquid and the effects subsided somewhat. I slept and when I woke up, I was itchy again and my stomach was cramping. I took more Benadryl and over the next 5 days got better.

Nausea; Decreased appetite; Fatigue; Severe chills 8 days post 2nd does.; This is a spontaneous report from a contactable consumer. This 60-years-old (at the time of vaccination) female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9264) via an unspecified route of administration from 06Feb2021 to 06Feb2021 at single dose (dose number; 2) on left arm for covid-19 immunisation. Patient's medical history and concomitant medications (if other vaccine in four weeks; no) were not reported. Patient experienced severe chills 8 days post 2nd dose, could not get warm on 15Feb2021, nausea and loss of appetite and severe fatigue for 24 hrs on an unknown date. Treatment for adverse event was reported as no. If covid prior vaccination; no, if covid tested post vaccination; yes, covid test type post vaccination; nasal swab, covid test name; PNR, covid test date; 16Feb2021, covid test result; pending. The outcome of events was recovered for chills while for other events was unknown. Information about batch number has been requested.

chills; body aches; under arm/neck/torso/inner thigh rash; diarrhea; This is a spontaneous report from a contactable consumer (patient reported herself) reported in response to non-HCP letter sent in cross-referenced case. A 60-Year-old female patient received second dose of BNT162B2 (COVID 19, Pfizer/BioNTech, Formulation: Solution for injection, Lot number: EL3247, Expiration Date: May2021) via an unspecified route of administration on 16Feb2021 02:45 PM at single dose to her left arm for Covid-19 immunization. Facility type vaccine: Workplace clinic. The patient's medical history was not reported. Known allergies included gluten intolerant. Historical vaccine details included: product: COVID Pfizer, vaccine date: 26Jan2021, lot number: EL3247, vaccine location: arm left, Expiration Date: May2021, time the vaccination was given: 14:24 (24hour clock), anatomical location of administration of Pfizer vaccine considered as suspect: arm left, events: soreness at site of injection and loose bowels; fine now; did not receive any treatment. Concomitant medications included lisinopril, MULTIVITAMIN, ongoing ergocalciferol (VIT D), ongoing calcium and ibuprofen (ADVIL) from an unspecified date to an unspecified date. Covid was not tested prior or post vaccination. On 17Feb2021 01:45 PM, the patient experienced chills, body aches, under arm/neck/torso/inner thigh rash and diarrhea. Outcome of the events was not recovered.

12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.

Pt reports onset on nausea and palpitations approximately 10 hours after receiving first dose of vaccine. Pt reports Emergency room visit, where she states she was diagnosed with atrial fibrillation. Pt reports she underwent 3 days of hospitalization, converting spontaneously without treatment to normal sinus rhythm.

She got the vaccine, only had the real sore arm. She went to bed and trying to get ready to go to work, had a slight fever, headache, chills, aches, stomach didn't feel right. Felt like she had the virus again. She was in bed all day on Friday, and then that night she still had chills and 101.1 fever. Did not feel well on Saturday and was out of work for 2 days. She is feeling better, tired. The arm is still sore to touch, but not as bad. She just felt sick, and is feeling better today. Her stomach is still not right, but overall feeling better. She did take Tylenol which helped and a couple of other times for the symptoms.

On the 3rd day I was sick to my stomach (cramping and diarrhea) and ran a fever of about 102. I had chills and was a bit achy. This lasted two days.

Woke up at 2 AM with severe chest pain, no dyspnea, but she felt like she was going to die. Chills, back pain (from the front of the chest to the back), slight nausea. Sore arm the next day, chest continued to hurt over the next 24 hours, developing lower right groin pain ~ 32 hours after injection onset. Diaphoretic 36-48 hours afterwards, severe abdominal pain when waking up in the morning . 53 hours s/p injection, pt now feeling queasy.

Massive headache at front of head, dizziness, ringing in ear, nausea, restless, diarrhea, stomachache, shallow breathing, hearing sensitivity, exhaustion, sleep sweat, lack of appetite.

Sharp stabbing stomach pain without nausea or diarrhea. Burning, achy joint pain followed by chills, fever ,headache and general weakness. Lack of appetite due to stomach pain. Continued for 48 hours. Slow improvement on 4/4. Still having moderate, intermittent stomach pain and now diarrhea. Poor appetite, feel flushed, without fever. Still headache,weakness and fatigue

Two hours after receiving vaccination had extreme nausea and diarrhea. Nausea and vomiting lasted until 8 pm. Vomiting at least 30 times. Diarrhea lasted into the next day, all day, until I took two ammonium.

Cold Feet, Nausea, Vomiting, Diarrhea/abdominal cramps. The diarrhea and abdominal cramps/stomachache are still happening as I write this report today April 5, 2021.

Scratchy throat, cough within 10 minutes of vaccine administration; some nausea, abdominal cramps and headache. Also felt burning during vaccine administration. Given oral benadryl with improvement. Observed one hour total after vaccine. Called 2 hours post vaccine with almost complete resolution of all symptoms. instructed to not get second dose and follow up with PCP/allergist.

Morning of April 4th: Nauseous, Fever (100 F), High Blood Sugars -Took 2 Tylenol pills - Felt better early afternoon Late Afternoon April 4th: Dizzy, Nauseous, Light Headed, Collapsed and was unconscious for 2ish minutes - Called 911 -> Medics ran heart and bp tests which were all normal and did not consent to go to hospital Evening April 4th: Chills, Fever spiked to 100F, Nauseous, Light headed -Took 2 Tylenol pills - Did not take Ciprofloxacin evening dose Morning April 5th: Fever hovering around 100F, more color in face and up and moving around -Reported incident to doctor & pharmacist where Ciprofloxacin came from - Pharmacist contact information

Nausea - Not Diaphoretic Reports being "lightheaded" No Emesis No Syncope No rash Reports being cold Reports tightness in throat - EMS activated

Severe headache, vomiting, nausea, body aches. Most severe symptoms lasting 24 hours. Milder symptoms persisting 48 hours beyond.

soreness extreme dizziness 4 days after with vomiting , unable to keep food down. headaches still vomiting second day with no fever but on and off chills

Received shot on Friday afternoon. On Saturday morning had sore arm at injection site. Then developed very achy shoulder, with ache spreading up neck and down back on left side. Some fatigue as well. Aches dissipated after a couple of hours, but fatigue continued and worsened on Sunday and continued into Monday. Also on Monday, woke up nauseated, and it continued, on and off, throughout the day until bedtime. Nausea gone on Tuesday, but still a bit more tired than usual.

Liquid diarrhea, vomiting, chills, fever from Friday morning until this morning Tuesday (4 days so far).

12 hours following injection, nausea leading to vomiting and heat flush. Fine immediately following vomiting.

Fever ranging from 99.5-101.5, fatigue, loss of appetite, rash, began 24 hours after the shot and continued for 48 hours. Used Advil, which could have been the cause of the rash but I am not certain. I often get rashes when I have a virus, and and Advil seems to make them worse. It was a little unusual in that it spread to my legs and back, as well as my face and torso. It was completely gone after 4 days.

My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested.

IMMEDIATELY AFTER VACCINATION I HAD DIZZINESS, VOMITING, MENTAL BLACKOUT, HIGH BLOOD PRESSURE, TOTAL FATIGUE, HEADACHE. THAT WAS SEEN BY PARAMEDICS

March 28: Bright red cheeks, extreme thirst, cold sores, severly chapped lips, clammy sweat (continued through entire series of symptoms) March 31 - April 2: Fever, Chills, Excrutiating muscle and joint pain, nausea, severe headache. Unable to function, think clearly, or eat/drink. No vomiting April 2 - April 5: Severe upper stomach pain and burning/soreness under right side rib cage. Uncontrollable watery diahhrea. Unable to eat the first two days of this. Able to drink some. April 5 to current: Still fighting the diahhrea but pain stopped. Have been on the BRAT diet since April 4th. Began taking a prescription from doctor to help with diahhrea on April 8. Still experiencing dizzyness, lack of clarity.

Severe headache unresponsive to OTC analgesics, body aches, chills, coughing, burning sensation in central chest, severe fatigue, nausea continuing for 5 days starting the second day after the initial dose.

nausea; This is a spontaneous report from a contactable other HCP (patient). A 60-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included (BNT162B2, covid vaccine) via unspecified route and unspecified date for covid-19 immunisation and experienced fatigue. Patient states that she is having occasional fatigue. Patient did have a Covid vaccine and the first injection she took during her on week and just had fatigue. The second dose was during her off week and she states she slept for three days and had nausea on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch no. cannot be obtained.

Flu like symptoms for two days after. Developed red rash on top of both forearms, Hives in various places on body. Sores inside mouth.

~12 hours after vaccination, began experiencing chills, lower back pain, bilateral side/abdominal cramping (gas-like), and rapid heart rate with elevated blood pressure (normal 120s/80 but up to 146/84), was advised to come to EC for evaluation but patient declined

Vomiting, diarrhea, fever, headache that lasted 2 days. This was horrible, I very rarely ever get sick. I do not want to get the second shot, especially since it's been reported that the second shot is worse.

The patient received her second Pfizer vaccine at 1401 pm, was monitored in the observation area for 15 minutes per pre-vaccination screening, and was discharged to home at 1421 pm without incidence with her spouse who was discharged at 1435 pm. At approximately 1445, the spouse states that the patient lost consciousness in the vehicle and that he panicked and brought her back to the clinic site because he couldn't remember where the hospital was. The patient was found to be sitting in the clinic alert and oriented, pale, diaphoretic, and nauseated. Vital signs were checked at 1457 with B/P of 124/71, O2 sat 99%, HR 80, and blood glucose of 149. After being monitored for 15 minutes in her vehicle, the patient stated she was feeling better and was escorted to the restroom via wheelchair. The patient stated that she felt like she could go home but was advised to call 911 immediately if symptoms returned or she started having any other reactions. The patient and spouse both verbalized understanding and agreement.

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium

I woke up Wednesday morning extremely dizzy and nauseous. I was unable to open my eyes because of how dizzy I was. I violently threw up for 2 hours . I was carried back to my bed by my husband. When I tried to roll over onto my side, I threw up again. I was unable to move on Wednesday. I actually thought that dying was easier. This sickness last 24 hrs. The next day I got out of bed around 11am and still suffered mild nausea. I am still a bit light headed today even when I woke up.

Thursday April 8, 8:15pm arm starts to ache; 8:30pm feel a little nauseous; 11:30pm feel dizzy (like the bed is moving under me) while I'm laying down. Friday April 9: 5:20am headache, body aches, nausea and fatigue; stayed in bed. 4:15pm went out to feed the cats and felt dizzy and kept loosing my balance; 5:30pm feel bad again: dizzy, headache and exhausted; That night my head ached and I felt mildly unwell. Saturday April 10: I feel better all around but I'm still getting dizzy and loosing my balance; also I still have a slight head ache. By 11:00 am, I'm feeling much better - just about normal.

tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both knees; numbness in both thighs; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 21Mar2021 14:30 (Batch/Lot number was not reported) at the age of 60 years old, as single dose for covid-19 immunization. Medical history included sleep apnea, history of breast cancer left side lumpectomy, chemotherapy, radiation, asthma, osteoarthritis, vestibular disorder, allergies to unspecified medications and food, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL); hydrochlorothiazide; hydroxyzine; and meloxicam (MELOX); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 03:00, the patient experienced tightness in chest, headache, dizziness, shortness of breath, nausea, itching, severe pain in both knees, and numbness in both thighs. The events resulted in: doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events were treated with Benadryl, solution medrol pf, sodium chloride. The patient has not recovered from the events. The patient has not been tested for COVID post vaccination. The events were reported as non-serious. Information on the lot/batch number has been requested.

Experience exact symptoms of Covid19 virus as when I had it in Dec/2020. nausea, fever, cough, and body aches. It lasted 24 hours.

vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.

1) I hour after 2nd dose was dizzy 2) 2 hours after had vertigo, hands felt like vibrating for 2-3 minutes, nauseous, vomiting, diarrhea, elevated tinnitus 3) taken to ER at Hospital and sat there with no treatment for several hours. Symptoms were resolving on own. Given an IV and Benadryl. 4) started again (similar to after 1st dose) on Meclizine 5) after light exercises this morning got dizzy, vertigo and nauseous- lasted for over 4 hours!!

around 1106am patient complained of "harsh" throat and "just not feeling right" EMS on scene performed EKG 11:10am patient had emesis, 118/72, HR-76, 98% on room air, PA evaluated pt on site and ordered Hydroxyzine 25mg po x1. pt took this and has no complaints.

Dizziness, achy all over, fever, sick to stomach, hot and cold, extremely weak and fatigued, still upset stomach and weakness today but getting better

Chills, nausea, vomiting, diarrhea - Wednesday night 04/07/21 Very severe heartburn, body aches, headaches, pain behind eyes - Thursday all day 04/08/21 Headaches - back of neck, pain behind the eyes, side of face - Friday and Saturday all day 04/09/21 and 04/09/21

Feeling feverish and achey, hot but not registering any high temperature. Headache. Nauseous and itching at injection site. This all started at 12 hours after the shot, almost to the minute. I have been taking Ibuprofen for the aches and headache, drinking water and eating small meals, trying to rest.

approximately 12 hours after vaccination 4/10 woke up with severe muscle aches, arms, shins, ankles and headache. Also felt nauseous. In morning had very slight fever and sore throat. Overnight on 4/10 woke up with extreme tightening feeling in center of chest Today 4/11 have rash on arm where I received vaccination in an area that covers an oval about 5 x 8". Took Ibuprofen in am for pain then tylenol for slight fever and pain. have marked rash to see if it spreads.

Within 12 hours of receiving the vaccine, I became very nauseous and remained so through the next day (4/7). I could not eat anything and by 3pm on 4/7 I threw up. I could not keep food down through 4/9 - my stomach was acidy and I was throwing up bile. I did not have a fever. On 4/9 I went to the Urgent Care and was advised to take an anti nausea medicine and get some Pepcid and try electrolyte drinks until I could keep down solid food. I slept and only had liquids on 4/10 and 4/11. Today - 4/12, I am able to keep down crackers. I have never had a reaction like this (except when I had stomach flu - and then I had a fever). Even today I am very weak. I believe it is related to the COVID vaccine.

Arm pain immediately afterwards. Beginning at 18 hours after vaccination: excruciating headache, nausea, diarrhea, elevated temperature/flushing, chills, fatigue, swelling and redness at injection site. Unable to eat or drink anything for 12 hours. Symptoms started to ameliorate after taking 1,000mg of acetaminophen around 28 hours after injection. 48 hours after vaccination, most symptoms had passed except for some residual headache and fatigue. Short fainting spell at 49 hours but did not pass out.

MSG LEFTTC 4-9-21 STATES HAS NAUSEA/VOMITING. STATES HAD CALLED PCP. 4-12-21 10AM RETURNED TC:NO ANSWER.

u1st Pfizer vaccine on 3/17/21 the next day I only has pain with swollen area in left arm around shot location. My 2nd Pfizer vaccine on 4/7/21 the next day around 4pm I started all the symptoms until chills, aches and pains, fever, and nausea, This was severe Thursday evening and most of Friday. Friday night I had swollen lymph nodes in the armpit and near the collarbone on my shot arm. This was very uncomfortable. Saturday the chills, aches and pains, fever, and nausea started to go away. Sunday mostly swollen lymph nodes and aches and pain in joints. Sunday night swollen lymph nodes stared to go down. Monday am still a bit tired but feeling better

4/6/21 headaches lasting days 4/8/21 sore throat 3 days 4/10/21 severe vomiting for 10 hours , dizzy, severe headache, body aches no fever 96.7°

Bleeding at injection site. Seven minutes after being seated for observation, I fainted and vomited while I was out for 5 minutes. An ambulance was called and took vitals for the 20 minutes after I awoke and vitals were all good, so I declined going to the hospital.

Rash at injection site, severe itching at injection site, continued headaches, stomach issues, metal taste in mouth, fatigue.

Sweats Abdominal Cramps Body Aches Severe Fatigue Swelling and Redness and Induration and Warmth and Tenderness to Palpation at site of injection after the second shot All symptoms started about 8 hours after the second dose and have continued to today. Today is the first day the symptoms seem to be decreasing in severity a little. Symptoms are worse at the end of the day.

very bad migraine, nausea, chills, overall very sick feeling, could not get out of bed Took migraine meds & some Tylenol, did not help to counter symptoms and migraine The entire day, starting at 4am, I was unable to get out of bed For the past 1 1/2 weeks I feel very run down and my brain is foggy Will not take a booster vaccine ever! These entire after effects are not worth the taking the vaccine.

Called 911, hospital dianosed with Vertigo. woke up in bed during night turned to right side and got dissy and nausus, happened twice called 911, hispital dianosed with vertigo , ct scan showed no clots in neck or brain, said could be iner ear, follow up with family doctor. was givenMeclizine 25 mg tablets, Ondansetron ODT 4mg tablets

I got extremely dizzy at 4:00am on Sunday after getting the shot about noon on Friday (so roughly 40 hours later.) The vertigo was so severe that I had to lay on my back and try no to move my head any direction. Getting up even to go to the bathroom resulted in nausea because of the intense dizziness. The dizziness/vertigo lasted until about 9:00am Monday morning (so nearly 30 hours.) I actually still have some residual dizziness when I move my head a certain way, but it goes away quickly and doesn't cause nausea. (I was worried I'd have a similar reaction to the second shot, but I only had some fatigue and a sore arm with the second shot.)

I felt fine following vaccination so kept appointment to donate blood 3 days later. I've donated many, many times in past without any side effects. It was uneventful. The following AM, I felt exhausted, dizzy, had mild headache, thirsty, and had minimal nausea. And when I tried to do my daily walk of 3 miles, I was SOB on hills so I stopped. I had no F/C, cough, CP, palpitations or resp symptoms at rest. I pushed fluids and rested. I held my BP meds thinking I was a bit dehydrated and maybe my BP was low. After 4 days of no improvement, I went to see my internist. Exam, ECG and CBC, Chem 7 were all normal. BP was mildly elevated so I restarted my meds. These symptoms slowly resolved over next several days and now I feel back to normal. So I don't know if these were delayed side effects to COVID vaccine or due to the blood donation. I'm a bit worried about receiving the #2 vaccine.

One week after receiving the first vaccine, I developed severe headaches. I got my booster 21 days later. One week after receiving the booster, I started having severe headaches, severe neck, back and abdominal pain. I went to the ED the morning of 3/5/21, was admitted to the hospital and release on 3/8/21. It is in the H&P from Health facility.

Slight headache, fever (100.4), reduced appetite. It felt like a mild case of the flu. I was allowed to leave work and go home. I slept for a few hours, ate a little bit and went to bed very early (8:45pm). By the next morning, the fever broke and I was fine.

chills, joint pain, muscle aches, low-grade fever, fatigue starting at 4:00 pm 4/12/2021 through 2:00 am 4/14/2021 diarrhea 4/14/2021 6:00 am - 2:00 pm

Felt fine until 11 hours after 2nd shot, then felt like I was hit by a truck so went to bed. Could not sleep all night because bones started to ache terribly...felt like my bones were going to explode, which seemed like a very unusual reaction. Halfway through the night, got nauseous. Later in the night got stuffed nose and headache. Woke with headache, body aches, fuzzy head and had fever up to 101.5 all day. Took a Tylenol in the morning and drank a cup of coffee and lots of water which made headache disappear. Finally took a Motrin at 6pm and started feeling much better by 9pm. Slept well. By 7am next morning, was 100% fine albeit tired.

SOB and wheezing much improved and nausea subsided. Pulse OX remained 96% or above. Team member allowed to leave and return to work. ,Team member had some brief nausea after vaccine given however it passed and she left the vaccine site after 15 minute, Team member rested on stretcher for 15 minutes Hr decreased to 90 SOB and wheezing much improved and nausea subsided. Pt had Shortness of Breath, Wheezing.

Severe digestion problems -- vomiting and diarrhea. Continued for several days so went to hospital where CT showed inflammation of colon. Received IV and antiobiotics; released after three days. No fever or other symptoms. Mostly better now.

Nausea Chill - Bone Chilling/Chattering Teeth/Cold more at extremities/cold to the touch Headache Achy All over Achy joints Exhausted/Extremely Tired Diarrhea

Body chills/aches, followed by an elevated temperature (102), naesua/vomiting, headaches, and lethargy. Fever broke approximately 12 hours after I began to experience body chills with my body temperature returning to normal 28 hours after receiving the 2nd dose.

1st IM Pfizer vaccination on 4-8-21, no issues until awakened at 4am on 4-13-21 with severe dizziness-room spinning, very mild nausea, still mild dizziness until midafternoon - no other issues until 4-18-21 at 5 am, once again awakened by severe dizziness, room spinning out of control- incapacitating dizziness continued well into next 12 hours of the day accompanied by severe nausea and headache, nausea improved with ondansetron and dizziness improved with meclizine after hours of not being able to ambulate.

Extreme muscle soreness, low grade temp. Within 30 hours excessive vomiting started & continued for over 12 hours, resulting in dehydration, leading to trip to ER.

Following my first Covid 19 Pfizer vaccine 03/11/21: **Note, I went through 1 1/2 days dull ache in arm no concerns > days 2--5 went through a HYPER-WELL (no age aches, prior-hurt finger didn't ache, energy, ladies room habits back to what I reported to daughter "age 20!" for these four days, amazing, enjoyable, then > day 6 very early am woke up with swollen neck lymph nodes half-palm sized rocks on neck, breathing difficulties (lungs not neck), bad dull intrusive headache (different pain from Migraine, or low-hydration pain), cough dry and have called this my HYPER-CRASH because I could barely walk, backward C-shape abdomen hurt (dull ache big always + frequent stabbing pains from below bra bottom line to left abdomen down side then curving to my right across bottom abdomen at both leg-attaches-to-abdomen locations. Difficulty breathing, pain, extreme swelling over upper abdomen when I even drank water to swallow morning Hydrochlorothiazide pill and would stay swollen for 4-8 hours with continued surprise to me gulps of air throughout period, weak, nausea but not vomiting, dizzy, unable to walk more than a few steps at a time, fever taken and wavered from 95 to 99 degrees (my usual body registered 97.8 degrees) but never over 99 degrees, and only over 97.8 degrees perhaps three times very little above it and only for a few hours. >>I went to Urgent Care in person no better at all on 3/24/21/roughly day 12 after vaccine shot 3/11/21 (Urgent Care) which took blood and urine tests determining roaring infection and blood in tests and a CT CONTRAST scan should be ordered by my PCP asap at appt PCP already scheduled 3/26/21 but she couldn't order CONTRAST version the PCP would need to and she prescribed three antibiotics to take over next 2 weeks >> I went to PCP 3/26/21/day 14 after vaccine shot and he ordered CT Scan but insurance required pre-auth and they refused it at first so PCP referred me to GI SPECIALIST who again referred me for CT CONTRAST test, which I did have on Friday afternoon 4/16/21 (Clinic), and I await the results today 4/19/21. Today I continue to have pain abdomen, though softer and throbbing, same C-shaped region, HUGE issue even drinking water with Hydrochlorothiazide pill only for many hours as abdomen swells at bottom bra-line center in a palm size mound for hours, and back hurts badly, solid headache which may be only right side of head more than left but I am taking nothing for any symptoms afraid of GI issue. NOTING AGAIN: Yes I was diagnosed roughly 2015 with a single incidence of diverticulitis/osis by GI SPECIALIST in Town and went through series of Colonoscopies and tests, but tests only determined incidental few polyps removed over all tests and no incidents at all since that. Knowing what I know of my body and health, the trigger seemed to be the first shot of Covid 19 Pfizer vaccination which remarkably seemed to react first with a few days of better health than I have had for decades (eating, moving, energy etc. for my age), where after days of extreme great health and energy (where I went nowhere, and still did not push myself much) my body then crashed to unable to move much or even breath normally for many days after and with a multi-level infection in my gut that needed three antibiotics and after those I still hurt in the same locations. I cannot confidently rule out the Vaccine as the cause, and what I know of my body suggests in fact some "overdrive" function in my system was triggered and then caused the crash that resulted in infection and that continues to interfere with my walking, eating, moving, breathing, and even drinking a small glass of water today. Final note: PCP confirmed I should take the second Vaccine Pfizer shot, which I did on 4/1/21 - same site, Lot #EW0150, after which second vaccine shot I had the same two days of dull arm pain, and I continued to finish the antibiotics until finished (but pain though softer continues to today). I did not experience a #-Days HYPER-WELL episode then HYPER-CRASH after this second vaccine shot, only the arm ache, but throughout was still very unwell (breathing, pain, no activity, weak, unable to eat, swelling, headache, cough intermittent, back hurts, etc.) throughout, and same to this day 4/19/21 as I await CT CONTRAST results. I felt compelled to share I feel this was triggered by the first Vaccine shot, and would not have happened had I not had the Vaccine shot. Thank you.

Abdominal cramp/diarrhea on day of injection and 2 days later 4/17/21, 4/18/21, 4/19/21 Headache and feeling of weakness and foggy head day after injection 41/18/21 subsided by third morning 4/19/21.

appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.

4/4/ Patient returned to the ED with SOB, cough and home pulse ox readings in the 80's. She was started on O2 at 2L NC and was admitted on IV Remdesivir and Decadron. By 4/8, she was able to be weaned off O2 and completed 4 days of Remdesivir and Decadron therapy. She refused rx to complete 10 day course of Decadron due to concerns regarding hyperglycemia and her diabetes.

left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday some had subsided but not all. tylenol of no use!

I experienced the known, Headache, body/joint pain, injection site pain....what followed was severe abdominal pain followed by frequent diarrhea & high levels of gas. This started approx 10 hours after my second injection(on Wed 4/14/21)and lasted until midday 4 days (Sunday 4/18/21). I did not run a temperature. After waiting for it to go away (48 hours), I called COVID-19 line and they said to go to BRAT diet. I did that & added Pedialyte to replenish electrolytes & help with the extreme fatigue(over and above my usual MS fatigue). I also treated the extreme gas with gas-x chewable tablets. The diarrhea was like prepping for a colonoscopy, nothing stayed in my system & the stools were very loose & yellow in color.

Dose 1: Redness, swelling at injection site, Headache, dizzy, nauseous, fever over 100 degrees F. Everyday or every other day. Diarrhea, muscle aches, joint aches, neck pain, fatigue all lasting 2-3 weeks. Still had 100 degree fever the night before Dose 2. Told nurses at Super Station about all the side effects from first dose and they had me take a Benadryl before 2nd shot, stay 30 min. for observation, then they told me to take Tylenol when I got home, which I did. Taking 2-3 more over the next day or so. Did not get redness or swelling at shot site, did have headache, fever, fatigue, muscle and joint pain, but much more muted than with the first dose with no medication. I continue to have a fever of 100 degrees about every 2-3 days. Some days I have diarrhea or feel headachy and have to be in bed most of the day. Usually fever is first symptom on those days. It's been 3 weeks since last dose and my fever was 100 yesterday and spent 15 hours in bed.

Sat (4/17): severe chills for two hours starting at 11:55 pm Sun (4/18): woke and could not walk across the room without falling down due to dizziness, was nauseated, strong headache, fever of 102 all day, bedridden Mon (4/19): Fever was reduced but nausea, headache still persisted all day, continued chills. Right middle finger began to swell and turn purple Tues (4/20): Lost feeling/sensation in right middle finger, head feels off, nausea still persists, stomach pains. Called doctor and had televisit with nurse practitioner

APPROXIMATELY 4 DAYS AFTER GETTING THE FIRST SHOT OF THE COVID-19 VACCINE, MS. THREATT EXPERIENCED NAUSEA, BODY ACHES, VOMITING (FOR FOUR DAYS), AND A CHANGE IN TASTE BUDS. SHE SAYS SHE NO LONGER CAN DRINK ANYTHING BUT WATER AND CLEAR LIQUIDS AND THAT FOOD SUCH AS MEAT AND BREAD ARE NO LONGER ABLE TO BE EATEN.

her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.

Onset of severe chills and headache approximately 8 hours after the injection of the second vaccine. Extreme fatigue, nausea and chills lasted 24 hours plus after injection. Still feel weak, nauseated and have headached 48 hours after injection.

The day following the vaccination, I had a fever, intense chills, and a mild headache. I have had an upset stomach since the second vaccination, with intermittent stomach pain. Last night (04/22/2021, starting around 7:30 PM), I had intense lower abdominal pain, loose stool, vomiting, and an intense chill. The symptoms came on suddenly (over the period of a half hour). After vomiting, I was seized by sudden, intense, lower-back pain immediately followed by full-body tremors. The tremors started with my legs, then went to my hands and finally my arms. I have never had a problem with tremors or seizures before. The back pain and tremors fully subsided after 10 minutes. I did not visit a doctor, since it is doubtful that they would definitively blame the Covid vaccine, and I would be stuck with a large hospital bill. However, the symptoms were too peculiar to be attributed to a random illness. I do believe they are a side effect from the second vaccine dose. This morning I feel tired and am a pound lighter, but I am quickly recovering.

Cold sores around mouth and chin. Accompanied by severe nausea. They are still breaking out so unsure how bad yet or if hospital is needed.

Developed fatigue and nausea two days after vaccine. Began to have skin irritation the same day. Developed a rash five days after vaccine and was diagnosed with shingles six days after vaccination. Took Enbrel and methotrexate two days after vaccination.

Injection site pain, extreme tiredness, ?hangover? headache/awful headache, joint pain, 101 degree fever, feeling unwell, no appetite (but not nauseous) X 1-1/2 days Sore arm/difficulty raising arm X several days; tolerable

Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Severe, Error: Incorrect Reconstitution

Have had rapid heartbeat, little shortness of breath, blood pressure has been elevated. More severe than normal heartburn, little burning in chest and gallbladder pain. not sleeping well because of it

At time of injection- immediate warm sensation in stomach, neck and face. Slight flush color in face. Itching in face and forehead however NO signs of hives or labored breathing. Intake if fluids. No Benadryl or Epi-pen required. Symptoms diminished and left facility in 10-15 minutes. 2-3 hours later- body aches, mild nausea and mild headache. NO Tylenol 1 am- woke from sleep- Headache . Took 2 Tylenol. Went to sleep. Woke at 6 am- string body aches, nausea, and very sore arm. NO headache. Took Tylenol. Stated in bed with fluids until 2 pm. Little appetite. Slight headache in evening. Achey feeling subsided . Next day - Mild body aches and nausea. Took one Tylenol. No appetite.

severe headache- took Maxalt, went away vomiting- began 12 hours after injection painful arm, especially when lifting arm up

Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, diarrhea, muscle and joint pain, stiff fingers, feet and leg muscles, rash all over the body, fatigued and shortness of breath, tiredness.

Chills; body aches; fever; nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration in the left arm on 11Feb2021 at 08:45 AM (at the age of 60-year-old) as a single dose for COVID-19 immunization at Workplace clinic. Medical history included allergies to medications, food, or other products was Sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination included citalopram at 20 mg. Patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 immunization. On 12Feb2021 at 12:00 AM, on the second day, the patient experienced chills, body aches, nausea and fever. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the chills, body aches, nausea and fever were recovering. No follow-up attempts are Possible. No further information can be obtained.

Day after shot (Saturday 10 April) - nausea, headache, 101.5 fever, body aches, arm soreness, tiredness 2nd day after shot (Sunday 11 April) - slight headache, tiredness, red rash around injection site and itching. My arm was also swollen and more sensitive to touch than movement. The itching wasn't bad enough that I needed to take any meds. I just wanted to report this adverse reaction to the second shot.

3/19/21: patient is a 60yo female who presented with complains of facial droop. The sister reports the patient complained about headache in the left temporal area around 8-9pm, reports having the same pain throughout the week but today was stronger, and the sister noticed she had facial droop and was unable to open her left eye. The patient also reports abdominal discomfort the the epigastric region and LUQ that started today and was associated with nausea. She denies diarrhea or fever. Of note patient reports having Covid Pfeizer vaccine yesterday and 5 minutes later being were unable to speak with edema in her lips and tongue, associated with SOB. She was taken to a ER, was given epipen, albuterol, benadril, prednisone and was discharged home at night with improvement on her symptoms. Patient discharge note on 3/22/21: Admitted for facial paresthesias in setting of arnold-chiari malformation, HTN, HLD, after covid vaccine, neuro work up neg, discharged home on 3/22/21.

possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like vibrating; nauseous; threw up; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 60 years of age), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included tinnitus and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin (RESTASIS) and vitamin d nos (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number: EL9629) (at 60 years of age), dose 1 in the left arm on 08Mar2021 13:00 for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccine in four weeks prior to covid vaccine. The patient had no covid prior to vaccination. The patient has not been covid tested post vaccination. The patient experienced repeated night time episodes of elevated tinnitus (pre-existing), possible hearing loss, vertigo, dizzy, hands felt like vibrating, nauseous, threw up, diarrhea, and chills, all on 05Apr2021 14:00 PM with outcome of recovered/resolved with Sequel. The events resulted to Emergency room/department or urgent care. No treatment received for the events.

feeling nauseated; warm; This is an initial spontaneous report from a contactable consumer(patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported) first dose via unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. The patient medical history stated she had COVID-19 back in October. The patient concomitant medications were not reported. Patient wanted to know if the reaction happens right away when they ask us to wait for 15 mins. Patient wanted to know if vaccine have the virus in it. Patient wanted to know what if she does not take the second dose. On Apr 2021 patient stated that she received the Pfizer COVID vaccine on 07Apr and feeling nauseated, warm, patient has celiac sprue and wanted to know about the ingredient/ gluten in it. The outcome of the event was unknown. Information on the lot/ batch number has been requested.

Fever, chills, muscle aches, malaise, site pain extending down arm and into shoulder, headache, nausea. Adverse events lasted 2 days. Treated with tylenol.

Headache started after 2nd dose?started Wednesday evening. Diarrhea on Thursday. Headache continued. Night sweats on Thursday to the point of waking up soaked. Friday headache continued, no energy. Saturday felling slightly better and by Sunday appetite returned. Treated with IBP and Tylenol plus rest.

This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.

I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at age of 60 years) at single dose for COVID-19 immunization. Patient relevant medical history included chronic obstructive pulmonary disease (COPD). Patient concomitant medications were not reported. After receiving covid-19 vaccine patient started running really high temperature and pain at the vaccination side, really tired, headache, chill, throat pain, fever, nausea, Patient said swollen lymph nodes, throat has been sore on unspecified date. Patient stated that run temperature but took Tylenol and it took it down it was high, but I still have the soreness. Patient also mentioned having COVID 19 infection months ago. Treatment received for events was unknown. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.

This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:30 (at the age of 60-years-old) (Batch/Lot Number: ER-8730) as SINGLE DOSE for covid-19 immunization. Medical history included Hypothyroid, High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID); losartan potassium (LOSARTIN); amlodipine; hydrochlorothiazide; all taken for unspecified indications, start and stop dates were not reported. On 27Mar2021 13:30, the patient experienced Bleeding at the site, fainting and vomiting while passed out for 5 minutes. The patient believes the injection was too high and she hit a vein. It was further reported that the patient is not a squeamish person and have never had reactions to any shots or blood draws in the past. The event fainting and passed out was assessed as serious (medically significant). Therapeutic measures were taken as a result of bleeding at the site. The patient did not receive treatment for the events fainting, passed out, and vomiting. The outcome of the events was recovered.

Extremely confused and agitated. Vision was reduced significantly. Not able to understand or comprehend simple tasks. This went on for 3 days.

Received Vaccine on 12/19/20 around 5pm. next day Sunday on 5/20/20 in the evening had, nausea, abdominal pain, headache, fatigue symptoms worsened to include chills and fever went to Emergency room 12/21/20 evening, had high Blood pressure and fever. had labs done, bedside ultrasound, and Abdominal CT. was diagnosed with Acute Appendicitis. I just learned that Appendicitis was one of the serious adverse side effects of the Pfizer Vaccine.

After 1st vaccine it was just like I had COVID all over again - severe headache lasting 48 hours, sweaty/cold, diarrhea. After 2nd vaccine severe body aches, extreme fatigue, sweaty/cold and diarrhea.

Cerebral venous sinus thrombosis Patient received vaccine in March (exact date is unknown but around March 8-12 per husband); in mid-April patient started reporting intermittent low intensity headaches. On April 23, patient had severe headache and vomiting, went to urgent care and was thought to have sinusitis and started on antibiotics and discharged home. On April 24th, patient became more drowsy with worsening headache and unresponsive. On April 25, she was taken to outside hospital and was noted to have abnormal brain MRI. She was transferred to our facility on April 26 after clinical worsening. Imaging revealed venous sinus thrombosis in deep cerebral veins and patient was intubated due to worsening mentation. Imaging also revealed a venous stroke with hemorrhage in her left thalamus and diffuse brain edema. Treatment includes extraventricular drain placement, anticoagulation (heparin), hypertonic saline to manage brain edema. We also did extensive workup but no history of hormone therapy, contraceptive pills, underlying cancers. Tumor markers are negative. Hypercoagulable panel and rheumatologic panel are negative. Body imaging did reveal multiple uterine fibroids but no other cancer. Patient remains in the ICU, on the ventilator, heavily sedated for management of refractory intracranial hypertension.

anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.

Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency room; couldn't swallow; right side of the patient's face swelled up and her lips were numb; right side of the patient's face swelled up and her lips were numb; face numb; hands itching; tongue had swelled up; voice was scratchy; This is a spontaneous report from a contactable consumer, Reporter's sister via Pfizer-sponsored. A 60-year-old female patient received the second dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Ex-piry Date: Unknown) via an unspecified route of administration on 01Mar2021 on an unknown ana-tomical location as a single dose for COVID-19 immunization. Caller provided that her sister got the vaccine for COVID Prevention and because the patient has a handicapped, bedridden husband who has MS and is immune compromised, and it was to help prevent him from getting sick. Caller reported that the patient received the product during the daytime, all the women at the patient's job, which was home health payroll, everyone left to get the vaccine during work hours, like in the AM at around lunch time. Patient's medical history and concomitant medications were unknown. Patient has not received any prior vaccinations within 4 weeks. Patient had no other vaccines on the same day as the suspect product. Patient received first dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Expiry Date: Unknown) on 08Feb2021 with no reaction. She worked for a health agency and the whole office went and got it. Caller provided that her sister had a reaction the first time, on 03Apr2021, where her sister woke up with itching started in her hands and ended up migrating to her whole body. By morning patient's tongue had swelled up, couldn't swallow and her voice was scratchy, like the caller couldn't understand her sister's speech well. Caller provided that her sister went to the ER and said there was a whole team giving her urgent care, medication, and such. Caller reported that her sister said the ER didn't find anything in her bloodwork, and the caller did not think the patient was being treated for any other medical conditions, and caller did not think her sister is on any medications, but caller said to not quote her on that. Caller knew her sister had a weight problem, but she did not know if her sister needed blood pressure medication or anything. Caller reported her sister said that the bloodwork from the ER did not find any-thing, and the patient was not admitted to the hospital. Caller reported that at this time, her sister's adverse events were no longer ongoing as her sister was given Steroids, like Prednisone, Benadryl and Famotidine, and she took those products as recommended by the doctor. Caller did not know the end date of her sister's events; all she knew was that the reaction initially started on 03Apr2021. Caller stated that her sister was allergic to nothing, and she has never had incidences of itching like that, where the itching was so bad that she was stripping down and the patient's daughter was patting the patient down with witch hazel. Caller stated that ER released the patient and gave her some medications and such. Caller stated that a day or so later, there was a second round of reaction: the right side of the patient's face swelled up and numb and her lips were numb, like when people have a dental procedure. Lips were numb for a while. Upon completion of the medications she was given, the reactions stopped. Patient regularly saw the family doctor. She would go back to see her Doctor on Thursday. HCP Information was unknown to the caller, but caller stated that her sister had been recommended to go to her PCP and get an Epi Pen. Caller stated that knock on wood, so far, her sister was holding her own, and it had not happened again. Caller stated that she was reporting the data that her sister gave to her after having the Pfizer vaccination. Caller stated the patient had an anaphylactic reaction twice that caused her to go to the emergency room. No relevant tests were done. Caller stated that she had the dates that she had her shots and where she had her shot at. Caller stated somebody called and reported it already. Caller stated she was trying to press three but never could figure out which prompts was. Caller stated they said if she called this number, they would tell her at the medical information department if this occurrence has happened to other people, like statistics. Caller stated they tried to call this number, but it was too long of a wait. Caller stated that she did not have the vaccination card, she never asked for them. Caller does not have card with her at time of call for LOT, NDC, Expiry date. Caller stated that she knew that all the COVID vaccines are just in the Emergency Use Authorization stage and in clinical trials, but caller really thought that all manufacturers should be advertising that they would like feedback from patients. Caller has not heard anything from any of the manufacturers saying that people are welcome to reach out and report side effects. Caller states that she only knew to call because she used to be a Home Health Worker, and she thought this is an important data. Caller has never seen on any of her 19 TV channels about calling to report. Caller stated that the girl who first answered her call, read a clinical data sheet about joint pain being seen in 23% of patient's and not knowing a percentage for anaphylactic reactions, caller was wondering if this was true. Caller verified that she just wanted to ask basically that patient was not alone, if other people might have had that happen too. Caller stated that she tried to call, and it would ask another question and it would say press 1 or 2, then it would ask other questions and it would say press 1 or 2, she never got an option 3. Caller asked: how much percentage, has anyone reported this side effects weeks after the second dose. Caller was wondering if this reaction could have been from the vaccine. Investigation Assessment: No. The outcome of the events were unknown. Information on the lot/batch number has been requested.

Pt received Pfizer vaccine at 12:15 pm and at 12:23 pt became nauseated. Pt taken to vaccination clinic observation room to lay on cot 1:1 with MD supervision. Pt was given a bottle of water to sip and rest until nausea passes. PT had no other complaints other than a headache which she had prior to vaccination. PT gets frequent migraines and has a scheduled aimovig injection for tomorrow 5/2/21. Pt in no visible distress, no difficulty breathing and o complaints other than nausea. PT was monitored for 30 minutes and released by physician. Pt stated had no dizziness or other symptoms at time of discharge. PT was educated and instructed to call 911 if symptoms of allergic reaction occur at home and to follow up with PCP if nausea comes back.

has mild tinnitus prior to being vaccinated, but started having really bad tinnitus a week later to the date after receiving first dose Pfizer Covid 19 Vaccine; nausea and vertigo kind of feelings; nausea and vertigo kind of feelings; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Expiry Date: 31Jul2021, Lot Number: ER8733) in right upper arm on 30Mar2021 at single dose at 60-year-old for COVID-19 immunization. Medical history included, on a low dose blood pressure medication. Mild tinnitus prior to being vaccinated. There were no additional vaccines administered on Same Date of the Pfizer Suspect, did not even get the flu shot. There were no prior vaccinations within 4 weeks. Concomitant medications were not reported. Past drugs included steroids make blood pressure go up that was all. States like zithromax (Z-paks) or dexamethasone or whatever, makes blood pressure go up. Patient took the Covid vaccine 2 weeks ago. One week after taking the vaccine she contracted tinnitus. She is calling to inform Pfizer she feels they should put this on the list of side effects so patients can have the option of receiving the Pfizer vaccine or not. She went to a specialist and the doctor stated he has seen several patients that this has happened to. She would like to speak with someone about this. She is in good health and is on a low dose blood pressure medication (she would not give name of medication). Patient was a consumer who received the Pfizer Covid 19 Vaccine dose one on 30Mar2021. Reports wearing KN95 masks and haven't gone anywhere. One week later on 06Apr2021, after receiving the first dose Pfizer Covid 19 Vaccine caller started having really bad tinnitus. Caller reports she has mild tinnitus prior to being vaccinated, but started having really bad tinnitus a week later to the date after receiving first dose Pfizer Covid 19 Vaccine. Caller states she doesn't know how much, like how much of her personal life she wants to give. Just thought her husband is the superintendent and was calling to report the side effects, wanted to be a good citizen. Caller reports trying to be responsible and feel like caller is doing the right thing. Caller is going to sit down now. Was walking around the kitchen while on hold, was on hold for a while. Caller reports having a history of tinnitus, but very mild. All of a sudden, the tinnitus got really like the volume turned up, and has just been like that since. Reports also having nausea and vertigo kind of feelings on 06Apr2021. Tinnitus is very profound. Reports the vertigo and nausea kind of feelings come with the tinnitus. Reports the tinnitus, nausea and vertigo kind of feelings have been the same since last Tuesday. Caller states she has so many KN95, so many masks, because her husband is the superintendent. The KN95 masks are all they have worn for the past year. Inquires if caller should still be wearing KN95 mask even after being vaccinated. Caller states she is just making conversation, she uses KN95 masks all the time, the mask question has nothing to do with what the caller is reporting. Caller's husband is so organized being who he is, caller has the time in the calendar. Caller got to the administration site at 16:55. There was no adverse event required a visit to Emergency room or Physician office. Patient talked to the Doctor on the phone about how to deal with the symptoms. Patient was scheduled for second dose Pfizer Covid 19 Vaccine not this Wednesday, but the next Wednesday. There was no adverse event following prior vaccinations. The only thing that caller has bad reactions to are steroids, caller did not do well with steroids. Caller is unable to provide NDC/lot/expiration for the steroids. States, no just like caller's whole life, steroids make caller's blood pressure go up that's all. States like Z-paks or Dexamethasone or whatever, makes blood pressure go up. Caller is not able to provide NDC/lot/Expiration for the Z-pak or Dexamethasone drugs. States no, just been caller's whole life steroids tend to make blood pressure rise. No family medical history relevant reported, stated her Mom is dead and father just passed away. Caller request an email that she spoke to agent. Caller asks how this information will be used, if it even matter caller reported events. Caller requests specific information on what happens to Safety reports and how many adverse events are reported. Caller states she probably will not call again, was just being a good citizen and reporting events. Outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

Fatigue and malaise. Then on 4/6/21 experienced intense skin sensitivity/pain (especially on back) and chills, followed by a papule type rash on elbows, hands, fingers, back, and at the gluteal fold. Rash on fingers and back were also itchy. The rash had subsequently resolved, but it returned again accompanied by skin sensitivity/pain on my back along with nausea and lightheadedness on 4/29/21. It has not resolved as of this day.

DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable/discomfort; nights were the worst for the pain; pulse ox was low; d-dimer was very high; fainted; Fracture of ankle/two fractures on her ankle; severely nauseous; Vomiting; Diarrhea; deathly sick; This is a spontaneous report from a contactable consumer, reporting for herself. A 60-year-old female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: ER8727), via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 at a single dose for covid-19 immunisation. Medical history included osteoporosis at least 10 years, terrible nausea, mild case of covid from Nov2020 to an unknown date. There were no concomitant medications. The patient previously took alendronate from 2008 to an unknown date and experienced very sick, nausea, diarrhoea and zoledronic acid (RECLAST) from Dec2017 and experienced nausea and vomiting. On 27Mar2021 at 2:00, the patient experienced deathly sick, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, and diarrhea. On an unknown date, the patient experienced dvt blood clot, ankle was still swollen and uncomfortable/discomfort, the nights are the worst for the pain, pulse ox was low, and d-dimer was very high. The event, deathly sick, was life-threatening. The clinical course was as follows: the patient had the first dose of the vaccine on 26Mar2021 at 14:00 in the afternoon in her left arm. Twelve hours after the first dose, later in the night about 02:00 AM she woke up deathly sick; and severely nauseous. She remembered she was going to the bathroom then she must have fainted because they were taking her to the hospital. She went to the ER and they found she had a fractured ankle. She was not admitted to the hospital. She was in the ER from about 03:00 AM to noon the next day. There must have been something in there; she knew there must be something in the vaccine because of her reaction. Adds a few years ago, something like this happened before. She had osteoporosis and had similar reactions with other products she had tried for osteoporosis; she had terrible nausea. The other products she tried included: in 2008 she took alendronate, it made her very sick but not as severe as this time, she never fainted. She had nausea and diarrhea. Then in Dec2017 she had zoledronic acid. She went for an infusion at the hospital then went shopping, and was fine until the early morning, when she woke up with nausea and vomiting. In the ambulance, they gave her ondasetron (ZOFRAN) for the nausea so the vomiting stopped. With regard to her ankle, first they thought it was a DVT blood clot. They did the xray and saw actually two fractures on her ankle but she does not need surgery. She saw the orthopedic doctor the other day and he said her ankle was healing but she still will have no weight bearing for 6 weeks and she was in a boot. Adds her ankle was still swollen and uncomfortable. She hated to take medications and they gave her oxy but she didn't want to take it. She was taking ibuprofen but that messed up her stomach. The nights are the worst for the pain and discomfort. Doctor at the hospital and primary care agreed she should not have the second dose. She did have mild case of COVID in Nov2020 and they are hoping she had antibodies from the infection and the first dose. Her primary care doctor was reviewing the blood work she had done at the hospital and told her they were surprised the hospital didn't admit her for observation because her pulse ox was low and there was another test that she was questioning because the d-dimer was very high. They did a chest x ray with unknown results. The doctor was questioning why they didn't do something else to rule out a blood clot. Therapeutic measures were taken as a result of the events, deathly sick, DVT blood clot, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, diarrhea, ankle was still swollen and uncomfortable/discomfort, nights were the worst for the pain, pulse ox was low, and d-dimer was very high. The clinical outcome of the events, deathly sick, fainted, severely nauseous, vomiting, diarrhea, was recovered on 27Mar2021. The clinical outcome of the events, DVT blood clot and nights were the worst for the pain, pulse ox was low, and d-dimer was very high, was unknown. The clinical outcome of the event, fracture of ankle/two fractures on her ankle, was recovering. The clinical outcome of the event, ankle was still swollen and uncomfortable/discomfort, was not recovered. No follow-up attempts are needed. No further information is expected.

4/9/21 Pt had URI symptoms. She was seen at a Minute Clinic. Tested negative for Sars-Co-V-2 4/12 Had continued symptoms. Test positive for SARS-CoV-2 4/15 Treated with mAB 4/17 Presented to ED w/nausea and decreased appetite. Vitals stable. No hypoxemia. +electrolyte imbalance K+ was 2.9. Given IFV and K repletion and discharged to home 4/19 Started on Zpack and Decadron as outpt 4/21 Returned to ED with increasing SOB and reported home pulse ox 75-82% w/ exertion. In ED, sats in low 90's. Tachypnea with RR24-28. CTA + for PNA and new PE Discharge summary : Pulmonary embolus Likely secondary to COVID-19 infection; HRT possibly contributing Chest CTA showed a small subsegmental pulmonary embolus in the left lower lobe. Flattening of the interventricular septum possibly indicating acute right heart strain Lovenox 1 mg/kg twice daily in the hospital and transitioned to Eliquis at discharge Patient currently on estrogen placement therapy-discontinued Covid-19 Virus Infection Date of onset of symptoms: 4/9/2021 Symptoms present on admission: Productive cough, dyspnea Date of covid positive test: 4/12/2021 Vaccination status: First dose given on 3/31/2021 Special isolation anticipated end date: 4/22/2021 if symptomatically improving Imaging: Chest CTA with interval worsening of diffuse interstitial infiltrates Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: Continue oral Decadron 6 mg daily Consultants following: None Inflammatory markers: LDH 306, ferritin 507, CRP 54.3 and D-dimer 2.07 Disharged on codeine cough syrup and Tessalon for persistent cough

Pfizer-BioNTech COVID-19 Vaccine EUA: patient with seizure disorder reports seizure one day following vaccination. No loss of conscioussness or speech. Seizure reported as arm weakness, incontinenece, and vomiting. Afterwards rested all day and able to eat and drink. Patient also reports fatigue, myalgias, arthralgias, and nausea. Symptoms improving and no additional seizures documented.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: syncope-Mild, Additional Details: Patient reported throat tightness and difficulty breathing. immediately after patient lost consciousness. patient was repositioned and one injection of epinephrine was given. paramedics came within 10 minutes and carted her off to hospital.

Patient received 2nd dose of Pfizer Vaccine. Patient reported to Vaccinator that she had experienced sudden onset of nausea and vomiting and chest tightness post 1st dose and was taken by EMS to Hospital after 1st dose. Per patient she was given clearance by her PCP to receive 2nd dose of Pfizer Vaccine. Within 5 minutes of receiving dose, patient with sudden nausea, sharp headache, and complaining of chest pain. EMS called, and patient transported to ER. Vital Signs Stable: 124/71, HR 80, 100% on Room Air upon transfer.

pt. c/o of nausea and vomitting (vomited x1 the liquid drink that was injested earlier as reported by the patient) Patient reported slight dizziness. Vitals: BP:116/74 Pulse: 84 RR:19 o2 sat 98% RA Advised to rest on gurney in sit up position and take sips of water for the nausea. Monitored Vital signs. pt no signs of SOB and no change of LOC. Pt. alert and verbally responsive 10:07am Vitals: BP:124/79 Pulse: 69 RR:18 o2 97% RA Pt. went home and pt. stable and relief with symptoms noted.

blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back had some excruciating pain; Nauseous; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I got a mark on my arm, my arm started swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0164/expiration date: 30Jun2021), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6208/expiration date: not provided), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced a headache. Relevant ongoing medical history included Diabetes Type II from about 5 years ago in 2016, fibromyalgia diagnosed about 6 years ago in 2015, and high blood pressure. Concomitant medication included gabapentin from an unspecified date at 600mg 3x/day for fibromyalgia, empagliflozin (JARDIANCE) from an unspecified date at 10mg 1x/day for Diabetes Type II, clonidine from an unspecified date at 30 mg, 2x/day for high blood pressure and labetalol from an unspecified date at 200 mg, 2x/day for high blood pressure. On an unspecified date in Mar2021, the patient experienced her blood pressure (BP) went over 269/149, it made my blood pressure go up, which required hospitalization overnight. Also on an unspecified date in Mar2021, the patient experienced a mark on her arm, and her arm started swelling. On 16Mar2021, the patient experienced major body ache, described as it started hurting the minute she put it in her arm, excruciating pain and pain in the neck down the arm, and she was nauseous. She described that she couldn't get out of the bed because of so much body pain. On 21Mar2021, the patient experienced her left side of middle back had some excruciating pain. The clinical course was as follows: I had a major body ache with the second vaccine. I did not have any problem except the headache with the first one but I took second one on this past Friday, I got very nauseous, it started hurting the minute she put it in my arm, which is on the left side. I got a mark on my arm, my arm started swelling. Saturday morning I couldn't get out of the bed because of so much body pain, Sunday my left side my middle back I had some excruciating pain I rushed to the doctor to the ER, my BP went over 269/149 and they had to give me pain medicine and BP medicine to reduce the blood pressure. I made it to the doctor and I'm getting medicine for the pain. I woke up in the morning there's pain in the neck down the arm and it's aching, the side I got the shot, the side is hurting, excruciating pain in my arm. I had to go to the ER straight to my doctor's office, they wouldn't let me drive or anything straight to the ER where they administered 2 doses of pain medicine and 3 doses of blood pressure, the pain was so intensive it made my blood pressure go up, the doctor said all of this was coming from the vaccine." Relevant lab data on an unspecified date in Mar2019 included blood pressure 269/149. The patient received treatment for the events blood pressure high, body pain, neck pain, pain in arm, and back pain. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446955 same reporter/patient/drug, different event in separate dose

sickness to her stomach; fibromyalgia flared up; heaviness in the muscle of her arm; vomiting; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, lot number: EN6206), via an unspecified route of administration in left arm on 08Mar2021 at single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, fibromyalgia, diabetes diagnosed almost 10 years before, obese, knee replacements 10 years before on both knees, and Sjogren's disease. Concomitant medications included loratadine from 13Mar2021, hydrochloorthiazide for Sjogren's disease from little over a year before, fluoxetine, cetirizine hydrochloride (ZYRTEC) for years like 20 years for asthma, and montelukast sodium (SINGULAIR) for years for asthma. Patient previously received varicella zoster vaccine (shingles shot) 2 years before. The patient experienced sickness to her stomach, fibromyalgia flared up, heaviness in the muscle of her arm and vomiting within 24 hours after the vaccination. After the 1st dose she was really sick and it affected her fibromyalgia and rheumatoid arthritis and she was just a mess and ended up vomiting and this took about three days which was normal. Patient was on a lot of medicines that counter act anything the Pfizer COVID Vaccine could do to her regarding side effects and thought the vaccine was too much for her body. Patient took several different asthma medicines and made the reported event not as severe. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.

High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

12 hours after the 2nd injection I developed sudden severe nausea that lasted 24 hours non-stop. I was also very thirsty and had chills. The nausea stopped as suddenly as it started but I had fatigue for a few days afterward. I had slight left arm pain. I had fatigue for several days after I recovered from the nausea.

Positive Covide`19 on 5/7/2021 Symptoms: c/o sinus congestion, productive cough, stomach" feels like I'm getting diarrhea," subjective fever, HA, chills, body aches started with morning. Temp 99.6 now,

Immediate feeling of pain that shot down arm of left arm ("tendonitis-feeling") after receiving vaccine. Developed odd lower back and abdominal cramping 4 days later accompanied with loss of appetite. Provider thinks possible colitis but unsure.

After 15 minutes, lightheaded as ready to leave. Is DM, BS 126 before came; ate lunch; takes 75U. BP 100/60--bit low for her; pulse 80, pulse ox 98. No hives, itching, trouble breathing. Monitoring, gave water, juice, cracker. BP 118/60. Still lightheaded plus nausea. Rapid response; agreed to be monitored in ED; went by cart.

Chest pain and couldn't hardly breathe and hard to get up off the bed; Chest pain and couldn't hardly breathe and hard to get up off the bed; Sweats; Hot and Cold; Chills; Sweats; Hot and Cold; Chills; Sweats; Hot and Cold; Chills; Body Aches where can't walk; Body Aches where can't walk; Fatigue; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Dehydrated and Dry Mouth and Mucous; Dehydrated and Dry Mouth and Mucous; Dehydrated and Dry Mouth and Mucous; Fever 102F; Weak and Can't Hardly Walk; Diarrhea; Blurred Vision in Both Eyes; Right Arm Pain; Headache; Lightheadedness; flu bug, virus in her body; This is a spontaneous report received from a contactable consumer (patient). A 60 years old female patient received the first dose of bnt162b2 (Pfizer COVID 19 vaccine) via unspecified route of administration in right arm on 09Apr2021 09:10 AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as no. No history of all previous immunization with the Pfizer vaccine considered as suspect ad no additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No family medical history. The patient experienced diarrhea on 18Apr2021, blurred vision in both eyes on 18Apr2021, sweats; hot and cold; chills on 19Apr2021, body aches where can't walk on 19Apr2021, really bad fatigue on 19Apr2021, nauseated and can't eat; vomiting dry heaves on 19Apr2021, dehydrated and dry mouth and mucous on 19Apr2021, fever on 19Apr2021, weak and can't hardly walk on 19Apr2021, chest pain and couldn't hardly breathe and hard to get up off the bed from 20Apr2021 to 20Apr2021, right arm pain from 09Apr2021 to 12Apr2021, headache from 09Apr2021, lightheadedness comes and goes from 09Apr2021. Right after the shot her headache started and the soreness in the arm. The patient stated she didn't know how to ride out her headaches, they were so severe like bricks in her brain. For diarrhea, the patient stated it is like water and she is going to the bathroom right now. For Nausea, the patient stated if she eats or drinks anything she is throwing up, further clarifies that nothing comes up but dry heaves. For fever, the patient stated her temperature was 102F 19Apr2021 night, 100F 20Apr2021 morning, and it is 101F at the reporting time. The patient stated she had a cold rag on her forehead. For weakness, she has to use a cane to get up and move around because of the weakness. The patient received none treatment. The events did not require a visit to Emergency Room or Physician Office. The PCP stated he is treating it like flu bug and said she just has to ride it out. The patient stated she was supposed to go back for her second shot 28Apr2021, but she is hesitant because she can't take care of her children because she is sick. The patient stated she didn't know if she was going to take the second vaccine and didn't know what to do for her side effects. The patient asked, with these symptoms, if recommended she get the second shot, because it is like a virus in her body. The outcome of the events sweats; hot and cold; chills was resolving. The outcome of the event chest pain and couldn't hardly breathe and hard to get up off the bed, right arm pain was resolved. The outcome of the other events was not recovered. Diarrhea, blurred vision in both eyes worsened. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Fatigue; Started feeling sick again on 30Mar2021 and she could not move and ended up vomiting; started feeling sick again on 30Mar2021 and she could not move and ended up vomiting; Vomiting/throwing up; Vomiting/throwing up; Rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 60 years old, administered in arm left on 29Mar2021 (Lot Number: ER8734) at single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus which diagnosed almost 10 years ago, obesity, sjogrens disease, knee replacements which done like 10 years ago on both knees and she did not know the exact dates of the knee replacements, asthma. Concomitant medications included loratadine taken for an unspecified indication from 13Mar2021 and ongoing; hydrochlorothiazide taken for sjogrens disease from an unspecified start date and ongoing; fluoxetine taken for an unspecified indication as antidepressant from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC) taken for asthma from an unspecified start date and ongoing; montelukast sodium (SINGULAIR) taken for asthma from an unspecified start date and ongoing. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 60 years old, administered in arm left on 08Mar2021 (Lot Number: EN6206) for covid-19 immunisation, and experienced sickness to her stomach, fibromyalgia flared up, heaviness in the muscle of her arm and vomiting within 24 hours after the vaccination. The patient also previously took shingles shot for immunization. The patient experienced vomiting/throwing up on 30Mar2021, rash on 30Mar2021, fatigue on an unspecified, started feeling sick again on 30mar2021 and she could not move and ended up vomiting on 30Mar2021. After the 2nd dose within 24 hours the patient started feeling sick again on 30Mar2021 and she could not move and ended up throwing up and got a rash that appeared on her left arm; stated she had both doses of the Pfizer COVID Vaccine in her left arm and the rash is a little above where the vaccine doses were administered. She had the 2nd Pfizer COVID vaccine on 29Mar2021 and has been coming in and out of feeling good and bad since then and for the rash she has she used the Triamcinolone Acetone cream and the rash seems to subside and then flares back up and when the rash flares back up she gets sick again. Stated the Triamcinolone Acetone cream is 0.1% with lot 0LT0435, expiry date Sep2022. She just got over this this weekend and was sick on Friday, was ok on Saturday and then on Sunday she could not move and was sick. The rash had gotten larger than when it first appeared and when it does flare it itches and was hot and she also has Sjogrens disease in that rheumatology thing and has had the shingles shot 2 years ago; states she has no name of the shingles shot to provide but had it 2 years ago in September. The patient stated this was not shingles and she had the shingles shot and this does not look like shingles to her. She stated she takes several different asthma medicines (cetirizine hydrochloride and montelukast sodium) and made the reported event not as severe and the rash is not as severe. The outcome of the event rash was not recovered, of the other events was unknown. No follow-up attempts are needed. No further information is expected.

throat closed up and my tongue feels thick; throat closed up and my tongue feels thick; I couldn't swallow; severe itching in the shot area; severe itching in chest area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170) via unspecified route on right shoulder (right arm) unknown single for COVID-19 immunization on 23Apr2021 at 60-year-old. Medical history and concomitant medication were not reported. 15 minutes after the patient took the shot (23Apr2021), patient throat closed up and tongue felt thick, the patient couldn't swallow but the patient was medical services at the bin where the patient had the shot. After about 30 or 40 after minutes (23Apr2021), maybe 30 minutes after the shot, the patient started doing lot of itching, severe itching in the shot area in the shoulder in chest area, severe itching was given some diphenhydramine hydrochloride (BENADRYL) and it did a help so but still had itching in chest area. Outcome of the event severe itching in chest area was not resolved, outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.

Right arm did not hurt immediately after shot. By 12:30 am arm hurt extensively and I started with chills that were so bad my teeth were chattering. By approx 2am I had a fever of 103.2 and every single part of my body felt like I had been beaten with a baseball bat. I hurt so badly that I was unable to sleep at all that night. I took two 500mg Tylenol at approx 2:15 am but it was vomited right back up. Nausea continued through the night. Started vomiting every time I had to get up for something. Was not able to take my morning meds or more tylenol until approx 11:00am. even with tylenol, fever hovered between 101.6 - 102.5. Unable to do anything all day. Now, at 5:54pm on day 2 I still hurt all over, though not as badly. My fever is 100.9.

Severe joint pain, mild nausea, lethargy, and Headache for 5 days. The headache still mildly persists and I have no history of headaches.

24 hours after second shot I had a sever migraine, nausea, pain in joints/bones, and fatigue. My lungs also had a minimal amount of pressure/discomfort

My throat was itchy/my throat felt worse; My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I am allergic to them/ Severe reactions and had to be hospitalized overnight; had problem swallowing a little bit and voice changes after talking; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. Medical history of the patient included anxiety, depression, nerve pain, ongoing blood pressure (hypertension), change in personality and cardiac disorder. Concomitant medication of the patient included levothyroxine, atorvastatin calcium (cholestat [atorvastatin calcium]), pantoprazole, 1300mg fluconazole (Fluxizol), 81mg aspirin, lubiprostone (Amitiza), alpha lipoic acid, baclofen, linezolid (Zenix [linezolid]), centrum silver, 10mg rosuvastatin calcium (Crestor), 100mg docusate sodium (stool softener), amlodipine and magnesium oxide for blood pressure. Patient was on Benazepril HCTZ for heart, Pristiq for anxiety or depression, citalopram for pain (something to do with pain I can't remember), Effexor for Anxiety, Lexapro, Levaquin, and Sulfa for rashes. Patient got it from her bladder infection. Cyclobenzaprine (I can't remember), Gabapentin, change in personality and nerve pain. Metoprolol for heart. Patient was not taking any of these medications now she got several allergies from them. Patient had a lot of allergies. She was on lot of medications. But it was not what she was taking any these medications on the same, so she was like what was going on. Patient not taking the medication (Unspecified Medication), she was allergic to them, but she was taking other medication. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number, PF12ER6200), via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. On 15Mar2021, the patient had severe reactions and had to be hospitalized overnight. Within mild reaction for 15 minutes and within 40 minutes severe. Patient went to have it done at the hospital they walked her down to the ER they get to give her an epi Pen injection into IV." When again probed for the concern, Patient stated, she had it done at the hospital, they after 15 minutes her throat was itchy they may say another half hour in between that half hour her voice started to change and her throat felt worse they walk her down to the ER her throat was hurting then slowly they gave her Epi Pen and they injected in an IV with steroids. Patient had wheezing in her lungs and she spent the night in hospital for observation. Patient stated that she still had problem swallowing a little bit and voice changes after talking. Patient wanted to know it was like how she supposed to find out what she was allergic. Patient further stated, "Because she want to you know she need an update how was it bad so she want to had to go all this what she was allergic. Event outcome for the events swallowing difficult and for voice alteration it was not recovered and for other events it was unknown. Information about lot/batch number has been requested.

This is a spontaneous report from a contactable consumer (patient). This 60-year-old female (no pregnant) patient received 2nd dose of BNT162B2 on 14Apr2021 03:45 PM on Left arm at single dose for covid-19 immunization. Medical history was Myasthenia Gravis. Past drug was allergies to Z pack. Historical Vaccine was 1st dose of BNT162B2 on 24Mar2021 03:45 PM on Left arm for covid-19 immunization. No other vaccine in four weeks. Other Medications in Two week included Olmesartan, Calcium. On the second day of the second dose of Pfizer (15Apr2021), she had the expected side effects, such as chills, muscle pain during the day. But, around 11 p.m. she suddenly started having abdominal pain, then throwing up, cold sweats, shivering, dizziness. She was taken to ER that night. The ER doctor did a CT, lab work but didn't find anything remarkable, so she was sent home. The next day (16Apr2021) she found blood in the toilet when she had bowel movement, so she went to see family doctor. He confirmed it's blood. He then set up an appointment for her to see a specialist the next Monday, since it's Friday afternoon. The bleeding got worse at night (16Apr2021), so she went to that ER again. She was then admitted to the hospital due to the big drop of red blood cell count. Later, the specialist did a colonoscopy on her and the result showed ischemic colitis. She was released from the hospital on 18Apr2021. This is very surprising to her as she had never had GI problems before. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days). Outcome of the event was Recovering. No covid prior vaccination. No covid tested post vaccination. Information on the lot/batch number has been requested.

SARS-CoV-2 test positive; Vomiting; She was still sick; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:00 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization.There patient's medical history included blood clot.The patient's concomitant medications were not reported. The patient experienced sars-cov-2 test positive and Vomiting on 21Apr2021, she was still sick on Apr2021. Caller was calling about the Pfizer Covid-19 Vaccine. She was having a problem. She was due to schedule her second COVID Pfizer Vaccine on 03May2021. Caller states that she was still sick, she is still sick with it. She was going to go on 03May2021 but she was vomiting and she could not make it for her second shot. Now, she was trying to contact the place she went to which was care center in (With held). She did not have a number to call to reschedule. he lost her registration card. She did not know how to go about getting the second vaccine. Caller clarifies that she received her first dose of the vaccine three weeks ago this past Monday on 12Mar2021. Call handler clarifies infor-mation and caller asks what she said and then states she meant she received the first vaccine 12Apr2021. On 12Apr2021, caller received her first vaccine. On 21Apr2021, caller got a test for COVID and was diagnosed with COVID. Caller states they went to use urgent care on 21Apr2021 and her and her husband tested positive. caller does not provide address. Caller states that her husband has an e-mail address because she does not know how to use the computer. Caller states that it was okay to use this e-mail address. caller provides name and facility name, does not provide address or any contact information. Caller states she is not fully sure if that is the spelling of the doctor's name. Caller adds she was afraid to go to get her second vaccine because she was vomiting. Caller adds that she had vomiting a couple of times during - caller interrupts sentence - and states she had it but she does not have it no more. Caller adds she had vomiting on Monday and two other times but that was all. The last ten day, but she can not remember what days it was. Caller clarifies that she received a COVID-19 test and they put a swab in her nose. That was very uncomfortable. caller states she does not know. She misplaced her card and she can not find it. Her husband and her looked all over for it.Caller does not have any additional details. caller adds that she just wanted to get the COVID vaccine. She adds just so that she does not get sick. She was anxious to get it like everyone else was. She ended up getting sick. Caller adds she has never been so sick in her life and would not wish this on her worst enemy.Caller clarifies that she means with the vomiting. caller states she does not have any medical concerns. caller was not sure which COVID-19 test she received. Caller adds that she did not go to the emergency room. She went to an urgent care and does not know the name or contact information. She only knows that, she states she was just vomiting, They performed two culture and She had to wait 20 minutes and then they sent another one out. Caller confirms both were positive.Caller adds she was just concerned about where and when she can get her second shot. She wanted to see where she should go. The paper she was given is how she got Pfizer's number and that is where they wrote 03Mar2021 for her sec-ond dose. They did not give her local numbers or anything like that where she could go. Caller was advised that Pfizer cannot schedule appointments for the vaccinations. Caller states she was just glad she got to talk to a person and that she knows where to call. Caller advised to contact her physician or local health authority and states she will do so.The patient underwent lab tests and procedures which included culture: positive (they did two) on unspecified date, unspecified COVID19 test: positive on 21Apr2021.Therapeutic measures were taken as a result of sars-cov-2 test positive,vomiting she was still sick.the doctor just told her to take Tylenol. he has taken Tylenol. It was 500 mg tablets.The doctor she saw there also told her to take vitamins. She is now taking Vitamin C 1000 mg, zinc 50 mg, and Vitamin D3. Caller adds the Vitamin D3 is 50 mcg, whatever that means. The doctor also put her on a baby aspirin in case she gets a blood clot or something - like a low dose aspirin. Caller adds there is also one more thing, it is a probiotic.The outcome of she was still ill was not recovered and outcome of rest of the events was unknown. No follow-up attempts are needed. information about lot/batch number cannot be obtained.

Patient reported symptoms ~ 2mins after receiving vaccine per administering clinician. Patient noted to have coughing. Patient reported lip numbness and mild shortness of breath. Patient then continued to say that she was having difficulty swallowing. EMS was contacted. Patient awake, alert, oriented. Patient refused EPI administration at vaccine site. Patient taken by EMS to ED. Per medical record patient received IV antihistamines and steroids and was observed.

starting 1st day of injection pain at injection site and radiating up to shoulder with swelling around the site area. Nausea . starting days 2 & 3 pains increased up further on left side of the arm to neck (left side only) , switched from taking Ibuprofen 800mg throughout the day after day 3 - 4 body aches and pains in left leg/thigh muscles , switched to Tylenol 1000mg everyday from day 1 rubbing down multiple time daily with rubbing alcohol , nightly alcohol with Epsom bath soaks. pains for about 2 weeks before relief. May 11 no pain just still tiredness . Yesterday and today believe all resolved .

Twelve days after 1st covid vaccine dose profuse sweating and increased heart rate 148. Two days later no energy or appetite and decreased exercise intolerance

sensitive stomach. She reports that this can happen not only with the Pfizer vaccine; significant hearing loss; ringing in the ears; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 12Apr2021 (Lot number was not reported) as single dose (at age of 60-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in Apr2021 patient experienced significant hearing loss, ringing in the ears, also reported as ear ringing like crazy and lost significant hearing. On unknown date she experienced sensitive stomach (she reported that this can happen not only with the pfizer vaccine). Patient stated that after receiving the first dose of Pfizer COVID-19 Vaccine, 10 hours later she developed a ringing in the ears (also reported as her ears started buzzing like ringing like crazy) to which she has seen her health care professional (HCP) and an ear specialist and has under gone hearing tests and states "has significant hearing loss" to which she is on steroids to help, she would like to know if Pfizer had any documented cases on this and what she needed to do about this. She has been going to an ear specialist and he said that she lost significant hearing in that ear where she heard the noise. For treatment, they are doing an injection into her ear. She is still having to go for injections but it does not sound like anything. She researched the internet and there is a whole group of people who experienced this with the Pfizer and Moderna and the other vaccine. Patient added that a doctor did not want to give an opinion or say anything. They did not know if this was permanent or will go away. Patient stated that a lot of people are out there, there are a lot of people with the same problem. She does not know which vaccines they got. She is halfway vaccinated because she is afraid to take the second one. She read comments of people who took the second, and people say it was worse. They discussed with doctors that it should go away eventually. Some say it went away in 9 weeks, some still had the hearing problem and it is uncomfortable. Patient added that it is all day ringing in the air, in her left ear. She went to the emergency room because it was so unbearable, and they did not know what to do. Patient did not take any medications like she did not have any issues, no blood pressure or nothing. Patient said that she cannot take steroids by mouth because she has a sensitive stomach. She reports that this can happen not only with the Pfizer vaccine, it happened with people taking Moderna, Astra Zeneca and Johnson and Johnson reported that. It is all over the internet. A bunch of people are having this problem. Therapeutic measures were taken as a result of significant hearing loss and ringing in the ears. Outcome of the events was unknown. Patient skipped the second dose because she does not want to make it worse. Information on the lot/batch number has been requested.

Since having COVID in November 2020 still experiencing shortness of breath and ringing in ears. After the shot , Felt fine first day, next morning woke up nauseous and dizzy, achy in muscles , especially in legs, pain in knees. Worsen shortness of breath with even short distances . Ringing in ears louder and high pitched. Brain fog. Each day the symptoms got worse, more intense. By the 8th day, pain in muscles so bad , had to be helped to walk or use a cane. Breathing was gasp for breath within short distances.Stayed in bed for several days and muscle pain got better. Breathing got better.

Pt also had received covid vaccine at~934am. Hx of HTN and DM (nonadherent to BP meds). then around 9:57am, pt c/o be Vomiting, Diaphoresis, HA, Chest pain 3/10. Pt was offered by staff to call ED but pt decline. Pt will go to ED with family member for further evaluation. During ED visit, it was found by provider that patient has been out of her blood pressure medications for over a year. Pt was prescribed amlodipine and recommended for pt to follow-up with PCP at discharge

appendicitis. Nausea for maybe the week prior, feeling tired, unwell. Sunday, May 2, 2021 at noon stomach pain. Moved into lower right side. Went to emergency department at 9 p.m. as pain was intense. CAT scan done. Inflamed appendix. Appendectomy done the next morning.

Chills; fever; shaking; Diarrhea; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no. EN6208) via an unspecified route of administration in the right arm on 12Mar2021(at the age of 60 years old as a single dose for COVID-19 immunisation. The patient's medical history not reported. Concomitant medications for an unknown indication. The patient did not have any allergies to medications, foods or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19. On12Mar2021 The patient was experienced diarrhea and vomiting 15 hours after the vaccination which continued for 12 hours. The patient also experienced chills, shaking and fever that climbed to 102.7 from 24 to 48 hours after the vaccination. The patient also reported that it took another 48 hours for the fever to end. The patient did not undergo any lab tests and procedures. The patient had not received any treatment for the events Diarrhea, vomiting, chills and shaking were recovering and the event fever was recovered at the time of report. No follow-up attempts are needed. No further information is expected

An hour after vaccination, it hurt around my heart and for 3 days there was pain in my collar bone on the left side, a lot of heart burn or air bubbles in my chest also, and now I'm scared to get the 2nd dose and I've not felt right since.

Nausea; High fever 101; Mussel aches; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200], as first dose via an unspecified route of administration, in left arm on 14Mar2021 at 01:00 AM (at the age of 60-years-old) as single dose for COVID-19 immunization. The patient's medical history included diabetic, ulcerative colitis and non alcoholic steatohepatitis (NASH) also the patient was allergic to Morifine. The patient was diagnosed with COVID-19 prior to vaccination. The patient received prescribed medicines (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021, the patient experienced high fever 101, muscle aches (reported as mussel aches) and nausea. The patient did not receive any treatment for the reported events. The clinical outcome of the events high fever 101, muscle aches and nausea were resolved with sequelae. No follow-up attempts are needed. No further information is expected.

Injection site pain; Nausea; Fever (unknown temperature); Chills; Body aches; Bad headache; This is spontaneous report from contactable consumer, the patient. A 60-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 2, via an unspecified route of administration in the right arm on 15Mar2021 at 01:00 PM, (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown, whether the patient was diagnosed with COVID-19, prior to vaccination. Since the vaccination the patient was not tested for COVID-19. The patient had no current illness. Past drug history included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248), dose number 1 via an unspecified route of administration in the right arm on 22Feb2021 at 01:15 PM, as a single dose for COVID-19 immunisation. Medical history included allergy to ibuprofen and breast cancer. Concomitant medications included daily vitamin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), 81 mg aspirin (MANUFACTURER UNKNOWN) all for unknown indication. On 15Mar2021 at 01:00 PM, the patient experienced bad headache, body aches, fever (unknown temperature), chills, nausea and injection site pain. The injection site pain was minimized. No therapeutic measures were taken for the events. The clinical outcome of bad headache, body aches, fever (unknown temperature), chills and nausea were unknown. The clinical outcome of injection site pain was resolving. Action taken with BNT162B2 was not applicable No follow-up attempts are needed. No further information is expected.

Tongue swelling, facial numbness, rash to both arms, tachycardia, headache, eye pain, elevated b/p 210/103, dizziness, and shaky. Epinephrine given with relief of swelling within 20 min. Two hours later reports vomiting and diarrhea.

no energy; Sore arm; spike of asthma; chills; tiredness; fever; body ache; headache; nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Lot /Batch Number: EN6205), Dose 2 via an unspecified route of administration on left arm on 04Mar2021 at 10:15 (at the age of 60 years) as a single dose for COVID-19 immunization. Medical history included heart attack, diabetes, obesity, asthma and Sulfa allergic. The patient's past medical history included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: EN6201) dose 1 on 13Feb2021 at 10:00 as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took Nasal swab test for COVID-19 and was tested negative at 04Feb2021. Concomitant medications include Meloxicam ER (Manufacturer Unknown), Metformin (Manufacturer Unknown), Spironolac (Manufacturer Unknown), Pantoprazole (Manufacturer Unknown), Metoprolol tartrate (MANUFACTURER UNKNOWN), Atorvastatin (Manufacturer Unknown), Clopidogrel (Manufacturer Unknown), Losartan (Manufacturer Unknown), Montelukast (Manufacturer Unknown). The patient experienced no other adverse event except for sore arm until 11Mar2021. On 11Mar2021 around 03:30am it started with chills but moved on and would cycle through between chills, fevers up to 102.4, headaches, body aches, tiredness, spikes in asthma, nausea, and just an overall feeling of feeling bad and 6 days later the patient feels ok, just no energy. Patient not taken any treatment for reported events. Therapeutic outcome of reported events was recovering at the time of report. No follow-up attempts are needed. No further information is expected.

It was swollen up pretty big/My arm swelled up. It almost looked like I had a big muscle; Feeling really sick; Her arm was hurting/Sore arm; I did have COVID, the virus; Slight headache; Weak; I don't even feel that well right now with the first shot; So I think this was an allergic reaction to the medicine because its not real clear; She was pale and dizzy/kind of dizzy; She was pale and dizzy; Nauseated; She's tired/I just feel tired; I just feel like I am dragging; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0176) dose 1 via an unspecified route of administration in the left arm on 04May2021 (at the age 60 years old), as single dose for COVID-19 immunization. The patient's medical history included patient had a pulled tendon for which she was wearing a boot, hypothyroidism for which the patient was taking Synthyroid since 1991, COVID-19 in Dec2020 and was sick from Dec2020 to Jan2021, it took patient a month to get over it. The patient's concomitant medication included Diclofenac Sodium delayed release tablets 75mg, two times a day for 2 pulled tendons in her foot. On 05May2021, patient's arm was hurting/Sore arm. On 06May2021, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle, feeling really sick. On an unspecified date in May2021, patient did have COVID, the virus, patient was pale and dizzy/kind of dizzy, felt nauseated, tired/ just feel tired like patient was dragging, slight headache, weak, patient didn't even feel that well right now with the first shot and patient thought that this was an allergic reaction to the medicine because it was not real clear. Patient was started on Diclofenac Sodium 75mg two tabs daily- started on Tuesday, the same day she got her Pfizer Vaccine. On an unspecified date, patient had ultrasound of the leg to check for clots, but she did not have any. The patient reported that her arm was still really sore, and she was not as nauseous and pale as she was last night but then was tired and slept all night. She just felt tired. The patient did not receive any treatment for the adverse events. Patient wanted to know if this could be a reaction between the medication (Diclofenac Sodium) and the vaccine and also wanted to know if she was allergic to something in the vaccine and how many days side effects might last, patient did not know anyone who got sick after the first dose. Patient was scheduled for the second dose of the vaccine on 26may2021. Outcome of the pale and nauseated was recovering, patient's arm was hurting/sore arm, arm swelled up, it was swollen up pretty big, it almost looked like patient had a big muscle not recovered was not recovered while for the other events was unknown. Patient reported that her 83-years-old mother got Moderna and her arm was a little sore after the first dose and nothing after the second shot. No follow-up attempts are needed. No further information is expected.

allergic reaction; she couldn't get warm; chills; rash all over; swelling in her arms and legs; diarrhea; Extremely tired; headache; Nausea; her blood pressure was taken and it was 165/40.; her blood pressure was taken and it was 165/40.; throwing up; dizzy; Numb on body on right side; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 04May2021 08:30 (Lot Number: EW0172) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as none. There were no concomitant medications. Patient had investigation assessment. No additional administered vaccines. No Prior vaccinations within 4 weeks. The patient had an allergic reaction to the first dose of the Pfizer covid 19 vaccine and wanted to know if she should take the other one. The patient had throwing up, numb on body on right side, dizzy, nausea on 04May2021; headache and extremely tired on 05May2021; diarrhea on 06May2021; rash all over, swelling in arms and legs, chills on 08May2021; her blood pressure was taken and it was 165/40 mmHg on 04May2021, she couldn't get warm on an unspecified date. Events did not require a visit to emergency room or physician office. The outcome of events rash all over, swelling in arms and legs, chills was not recovered; event throwing up was recovered on 04May2021; numb on body on right side was recovered on 06May2021; events diarrhea, headache and extremely tired was recovered on 07May2021; events dizzy and nausea was recovered in May2021; of other events was unknown.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild

This vaccine triggered my meniere?s. It has proceeded to to get worse. I have been dizzy now for 4 weeks along with a headache and nausea. It is very debilitating and cannot continue to cope this way. I need to get back to a normal life.

Server abdominal pain around incision area. Cat scan revealed nothing wrong. Gabapentin prescribed for the pain. Systems disappeared 4 weeks later

body and headache; chills; body and headache; low grade fever; nautiated for 48 hours; Very weak for 2 days after.; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old non pregnant female patient received second dose of BNT162B2 (Formulation: Solution For injection, Batch/Lot Number was not reported) via an unspecified route of administration, administrated in left arm on 17Feb2021 as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. The concomitant medications included in two weeks Lisinopril was taken.No known allergies.The patient previously took first dose of BNT162B2 (Formulation: Solution For injection, Batch/Lot Number was not reported) via an unspecified route of administration, administrated in left arm on 28Jan2021 13:30 as 1ST dose, single for COVID-19 immunization and experienced chills, headache and 101 fever. Took some Ibprofane temp went down and was fine the next day. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks.On 17Feb2021, the patient experienced with 8 hours later, chills, body and headache, low grade fever and nauseated for 48 hours. very weak for 2 days after. No treatment was received for the events. The outcome of the events was recovered in Feb 2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

One week later (overnight Apr 18/19) I woke during the night with fever (highest 101F) and lower right side abdominal pain. I called my primary care dr on Apr 19 at 10.15am. Due to prior history of intestinal surgery and resection July and Aug 2015, Dr advised me to go to Hospital ER for a CT scan. During some 7 hours in the ER, blood work, urinalysis, EKG and CT scan were done. The urinalysis showed possible UTI (though no other symptoms) and appendicitis was suspected from the CT scan. I also got a migraine during the hours in the ER. IV antibiotics and med for migraine were started and I was moved to a room. I saw surgeon and his team over the next two days. Another CT scan - with contrast drink - was done on Apr 20, and from this Dr advised the inflamed appendix was visible. Again due to my prior abdominal surgery and potential scar tissue Dr advised that removing the appendix in this state was at a bit higher risk. He suggested continuing IV antibiotics in the hospital for 48hrs and if the appendix responded well to finish oral antibiotics at home and then schedule appendectomy in approximately 6-8 weeks. This is now the plan. I am going for another CT scan with contrast drink next week in advance of potential appendectomy the week of June 14.

Upset stomach; Sore arm; Headache; Tired; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 11:15 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 23Feb2021 at 11.45 as a single dose for COVID-19 immunisation. Concomitant medication included Celebrex for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient was not diagnosed with covid-19 prior to vaccination. Since the vaccination, patient had not tested positive for COVID-19. On 16Mar2021 at 19.00, patient experienced sore arm, headache, tired, upset stomach. Clinical outcome of the events sore arm, headache, tired, upset stomach was recovering. No follow-up attempts are needed. No further information is expected.

shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips; Because of the blisters she had a hard time breathing and couldn't can't eat; had a fever of 102°F; weak; tooth throbbing; body aches; food tasted like crap for anything that she could get into there; Because of the blisters she had a hard time breathing and couldn't can't eat; Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling; injection arm was "swollen so bad" from her neck to her fingertips; vomiting; lightheaded, dizziness; Migraine headache/migraine; her arms swollen down to her fingertips which she could not sleep on her left side; could not get out of bed; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EWO182) as single dose for COVID-19 immunisation. Medical history included allergic reaction to back yard tree and had sniffles and watery eyes prior to shot. There were no concomitant medications. The patient received her first Pfizer Covid vaccine dose on 18May2021. That evening she began to experience side effects. Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling. She had Migraine headache and vomiting. At 5 AM the following day 19May2021, she was vomiting, had diarrhea, a migraine, and then developed blisters in her mouth. Because of the blisters she had a hard time breathing and couldn't can't eat, had a fever of 102 degree F, was feeling weak, had to crawl to bathroom. She reported that 24May2021, was the first day that she felt ok. It was reported that her arms swollen down to her fingertips which she could not sleep on her left side, blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips, stated that she could not go to her dentist appointment the following day because of blisters and her tooth was throbbing on 19May2021. Stated that she had migraine headaches with vomiting, diarrhea, heart palpitations, weak, 102 fever, food tasted like crap for anything that she could get into there. The patient is supposed to go on 08Jun2021 for her second shot and was told that the second is worst than the first. Stated that she refused second shot. Stated that she could not get out of bed. Stated that she has a 7 and 8 year old to take care of by herself. Stated that the shot entry is the size of an apple on 24May2021. Clarified that she had the shot in her left arm. Caller stated that she had the Covid shot 18May2021 and she still does feel well today. Clarified that the blisters all started at the same time. Stated that she has had no heart palpitations since 5am this morning (24May2021). Stated that her fever is 99.9 Caller keeps rambling on; unable to clarify details with each event. Stated that the migraine is now a headache. She wants to know what would happen if she doesn't get the second dose of the vaccine. The patient received no treatment. Outcome of the events could not sleep on her left side, could not get out of bed was unknown; peripheral swelling was recovered with sequelae on 23May2021, vomiting was recovered with sequelae on 24May2021; Heart palpitations was recovered on 24May2021; Fever, migraine, couldn't lift up her arm, hard time breathing was recovering; all other events was not recovered. Follow up attempts needed. Further information is expected

odd sensation in her mouth; difficulty swallowing; mouth full of saliva; Her face, neck and chest were all very red and flushed; Her face, neck and chest were all very red and flushed; This is a spontaneous report from a contactable consumer (patiemt). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration on 04Mar2021 13:00 (at the age of 60-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included shellfish allergy from 2011 and ongoing (patient had an Epi-pen prescription on her patient portal information but she has never filled or used that prescription), pneumonia in 2017 and 2018 (occurred 2 years in a row, probably around 2017 and 2018), bronchitis from 2016 (one year bronchitis without Pneumonia, may have been 2016), prediabetic (Onset date: Probably 2015), obesity (Onset Date: Probably 2000), compromised immune status, blood pressure and thyroid. Concomitant medications included lisinopril taken for blood pressure from 2016 and ongoing; atenolol taken for blood pressure from an unspecified start date and ongoing; amlodipine taken for blood pressure from an unspecified start date and ongoing; hydrochlorothiazide taken for blood pressure from an unspecified start date and ongoing; levothyroxine taken for thyroid from 2016 and ongoing. On 04Mar2021 about at 13:50 the patient experienced odd sensation in her mouth, difficulty swallowing, mouth full of saliva, and her face, neck and chest were all very red and flushed. The patient stated that it was a slight reaction. The patient reported that she received her first dose of Pfizer COVID-19 Vaccine on 04Mar2021. She waited the 30 minutes and then left. As she was driving home felt she felt an odd sensation in her mouth, had difficulty swallowing and her mouth filled with saliva; so she pulled over and she looked in the mirror she was all red, her face, neck and chest were very flushed. She just did some breathing and tried to relax. She called her doctor and waited to hear back from her but didn't yesterday. She tried to drink water and just relax; she did not feel like she had to go to the emergency room. Her doctor got back to her today and had a teleconference. The patient did not have other vaccinations within four weeks prior to the first administration. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Hypersensitivity; I feel like I have a arthritis like rheumatoid arthritis in my hands; little tender on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm/ feet are swollen; mild chills; body aches; weird muscle; fatigue; Diarrhea; had marking on my legs actually in elbow area; had like ulcers in my mouth; I lost in the meantime, currently now I am 108 pounds; Bone Ache; blistering in the mouth; blisters; sandpaper like rash on the hands and the feet's; mild rash and itchiness on the arm; This is a spontaneous report from a contactable consumer reported for self. This 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 17Feb2021 Arm Left at the age of 60-year-old as 2nd dose, single (Lot # EN6201) for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Anatomical location: Left Arm for covid-19 immunisation. The patient had it, 2nd one was then on 17Feb2021, 10 days later had a guess what you call hypersensitivity because that is the thing can relate to and the they had at the urgent care (emergency room visit) and then the hospital (further not clarified) because had therapy in multiforme. Symptoms on 27Feb2021 and then had gone through an urgent care that following Tuesday and Thursday went back. So, thought it was from that. She had the initial little tender on the arm and it is swollen and little itchy and then had mild chills and body aches initially and did not take, that is better than other people are having with headaches and everything else but it was 10 days later that had this multiforme beginning of this blisters (27Feb2021), sandpaper like rash on the hands and the feet's (27Feb2021), blistering in the mouth (27Feb2021) and had that everything multiforme all over body it is in neck and head. After the 2nd shot on 17Feb2021. She have been mild rash and itchiness on the arm and then little bit of mild chills and mild body ache, it was nothing serious or anything took a steroid and then 10 days later have little bit of sensitivity on index finger and middle finger and then from the next day had marking on legs actually in elbow area, thought it was mosquito bit because of the experienced of itchiness and then it progressed and migrated upward had sandpaper and blisters on face, hands and feet. The rash was on under, it progressed from the ankle and up through the shoulder and had the blister and sandpaper, rash feeling on hands and on feet and then had like ulcers in her mouth. She also had weird muscle and bone aches, body aches and fatigue and diarrhea and everything but she still had she felt like she had a arthritis like rheumatoid arthritis in hands and feet are swollen. She lost in the meantime, currently now was pounds. Treatments included a corticosteroid shot (Further not clarified) and took steroid for the 5 days at the hospital (further clarification unknown) they give her the shot, corticosteroid shot and then took the pills for the 5 days. Outcome of the events was unknown.

Right away the vaccine made my arm tingle and it was painful. I woke up that morning and I had chills and I felt very nausea. I had body aches and I was breaking out into sweats. I took some Tylenol , I had a headache. The nausea was very horrible, and I didn't have much dizziness. The brain fog is the worst thing that I have experienced. I have severe brain fog . I have no appetite and certain smells will bother me and make me more nausea. When I am sitting still , I feel a dizziness where I feel like I am seeing stars. After the vaccine I wasn't able to keep up anything not even ginger ale or water.

vomiting; fever; chills; diarrhea; dizzy and shaky; dizzy and shaky; she "felt [her] gut and pieces of tissues from [her] gut were coming out; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Jun2021 (at the age of 60-year-old) as single dose for COVID-19 immunization. Patient medical history included COVID-19 in Nov2020 and long haulers before getting the vaccine. Concomitant medications were not reported. On an unspecified date in Jun2021, after receiving first dose of vaccine, patient experienced violent vomiting, fever at 101.9F, chills, diarrhea, felt dizzy and shaky. Patient explained she was sitting on the bowl, had diarrhea, and had her "head in a bucket" but the force at which she was vomiting was unbelievable. Patient described she felt [her] gut and pieces of tissues from [her] gut were coming out; and the content sprayed on her walls, even 6 feet away reaching the shower. Patient specified she didn't vomit when she was infected with COVID-19. Patient explained that she feels better this morning but would like to know if she was contagious. Patient asked if she should quarantine for 14 days after experiencing side effects from the Pfizer-BIoNTech COVID-19 vaccine. Outcome of the events was unknown. Information about lot/batch no has been requested.

Approximately 10 minutes after receiving vaccine, patient became very hot and sweaty, nauseous, and dizzy. We laid her down flat on the floor with a pillow and got her some water. We checked her blood pressure, and it was approximately 90/58. Patient says her BP usually runs very low. She stated she had just been for a 4 mile run in 90+ degree heat, had not eaten much that morning, and had not drank much water. After about 20 minutes, she began vomiting. After about 40 minutes from time of vaccine, her son picked her up and took her to a nearby ER at her request. I called her the following day, and she had recovered.

Superficial thrombophlebitis of the forearm distal to injection site. Persistent nausea and vomiting following injection

May 1, 2021 ? Received 1st Covid19 shot around 3:00PM at a Pharmacy. No concerning reaction. May 2, 2021 ? Arm a little sore at site of shot. Not a problem. Later afternoon some posterior leg muscle pain. Not severe. May 3, 2021 ? Bowels are hardened and a little difficult to push out. In the afternoon definite pain in various places in the large posterior muscles of both legs. In the evening abdominal cramping. A little tired feeling. May 4, 2021 ? Bowels hardened. Abdominal cramping. Deep specific areas of pain in both my posterior leg muscles including: calves, hamstrings, gluteals ? felt like someone sucker punched me up and down the backs of my legs. Right thigh is going numb while I work. Forearms and hands are going much more numb. Extreme fatigue by afternoon, to the point I had to sleep for a while. Diarrhea by early evening. May 5, 2021 ? Hardened bowels. Pain in legs is less severe but still there plus pains in inner thigh. Slight headache (I very rarely get headaches), extreme fatigue by afternoon, Debilitating, I had to take a nap. Thigh continues to go numb off and on while I work. My forearms and hands are tingling and going numb at times. May 6, 2021 ? I am noticing mild headache comes and goes, am experiencing ringing in head like I had with past concussion. Extreme fatigue by afternoon and have to lie down. My bowels are less hardened but still not regular. Still have deep pains in legs muscles but not as severe. Joints are achy: wrists, elbows, hips, knees. May 7, 2021 ? Same as day before. Also realize my blood pressure is running high. May 8, 2021 ? One Week Since Shot. Have noticed I am not able to focus in on specific things as well as normal. The fatigue is debilitating at times. It is affecting my daily chores. I have definitely gained weight, joints continue to be achy and stiff. Less headaches and leg pains are much less. No more abdominal cramping. Bowels are still a little hard. May 8, 9, 10, 11, 12 ? Still more tired than usual but not as debilitating. Bowels are better. My joints and muscles are still sore but not as bad. I am noticing swelling in my arms and legs and face ? feels like I am retaining fluid. I have occasional periods where I am not mentally focused/ forgetting things/ not as observant. Ringing in head happens from time to time. Blood pressure is higher than normal. May 13, 14, 15, 16, 17, 18 ? No more leg muscle pains but continue to have fluid retention. My joints are more sore than normal. Thigh and forearms are no longer going numb. Still more tired than normal but no longer need naps. Mental clarity is better but still feel ?off.? May 19, 20, 21 ? Exhausted. Completely exhausted. Legs and arms and face swollen. Bowels are hardened again. I feel like I have regressed. No deep muscle pain. Joints are stiff again. Mentally out of it. Not able to intently focus. Blood Pressure is up again. May 22, 23, 24 ? Body edema continues. On Sunday the 23rd my face literally swelled up! I took a benedryl and did lymph drainage massage on myself. It eventually went down after several hours. Never experienced difficulty breathing, my parotid glands did not seem to be swollen. May 25 to June 13 - Some days I feel okay, other days I am having swelling in legs, arms / seems like I am still retaining fluid, still more tired than I was before the Covid shot/ still have times a don't focus in as well as normal / joints are stiff at times from swelling and right thigh goes numb off and on when standing.

Migraine, Seizure, Grand Mal, could not move out of bed, low awareness for 2 weeks. Took 3 months to get to walk. Dizzy and off-balance, nausea

Really bad headache; Nauseous; Diarrhea; Maybe she was hyperventilating; She's feeling a little sick; Having a problem breathing a little bit; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181), via an intramuscular route on 08Jun2021 at 10:45 (at the age of 60-years) as single dose in the right arm for covid-19 immunisation. The patient's medical history included high cholesterol, temporal arteritis. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atorvastatin (LIPITOR) with dose 20 mg, daily for high cholesterol, Fish Oil with dose 2000 mg, daily for unspecified indication, venlafaxine hydrochloride (EFFEXOR) with dose 150 mg, daily for depression. The patient previously took Prednisone for temporal arteritis since 24Dec2020 and she had been holding off on getting the COVID 19 vaccine until she was taking a lower dose of the Prednisone. She's taking 8mg of Prednisone. The Prednisone is in a pharmacy bottle. The Prednisone 5mg tablet is in a yellow pharmacy bottle. She took her Prednisone every day at 2:30PM. Her doctor told her on 07Jun2021, that she was ok to get the COVID 19 vaccine. She was taking 60mg of Prednisone but she's weaning off of the Prednisone. She has gained weight while taking the Prednisone. On unspecified date at 14:30 (4 hours after vaccination), the patient experienced really bad headache, nauseous, having a problem breathing a little bit, maybe she was hyperventilating and She's feeling a little sick. She had diarrhoea when she first got home after getting the COVID 19 vaccine. She's scared. She hadn't reached out to her doctor or gone to the emergency room. She doesn't wanted to got the COVID 19 virus. She was been quarantined for a year. Patient reported that she took Ibuprofen and her headache is going away. She thinks she's feeling better now. She's still a little nauseous. And her breathing, maybe she was hyperventilating because of the nausea. She is starting to feel better. The outcome of the events really bad headache, breathing, maybe she was hyperventilating was recovering and other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Seven hours after the vaccine I began vomiting, followed by diarrhea and indigestion that lasted for two days May 28th and 29th 2021.

feeling like legs were made of jello.; Very hot; flushed face; weak; Merely nauseated; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 05Mar2021 at 12:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included hashimoto's thyroiditis. Patient had allergies to penicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) for an unknown indication. On 05Mar2021 at 13:30, patient experienced very hot, flushed face and weak and feeling like legs were made of jello. This lasted for approximately 3 hours. On 05Mar2021, patient experienced merely nauseated. On 17Mar2021, patient underwent lab tests nasal swab (PCR) and result was negative. No therapeutic measures were taken for the reported events. The clinical outcome of the events very hot, flushed face and weak, feeling like legs were made of jello and merely nauseated was recovered/ resolved on 05Mar2021. No follow-up attempts are needed. No further information is expected.

When she took her Pfizer vaccine on 5/29/2021, she had a feeling of pressure around her heart that made her anxious on Day 2 and Day 3, Lymph node under her left arm was swollen the size of a credit card for Days 3 & 4 post vaccine. Had a fever on Day 4 & 5 after the Covid Vaccine. Would wake up in the night with her bed soaked with sweat and she would have to change her clothes. She had a horrible smell in her nostrils. Had diarrhea.

Stomachache; diarrhea very liquid stools; Feel flu like symptoms; Achy; Chills; Very sleepy; This is a spontaneous report from a contactable Consumer, the patient. A 60-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) (at the age 60 years) via an unspecified route of administration, on the left arm, on 18Mar2021 at 13:30 as a single dose for COVID-19 immunisation. The patient medical history includes diabetes, high blood pressure, thyroid and glaucoma. Concomitant medications include Bystolic [MANUFACTURER UNKNOWN], amlodipine [MANUFACTURER UNKNOWN], synthroid [MANUFACTURER UNKNOWN], allopurinol [MANUFACTURER UNKNOWN], and spiron [MANUFACTURER UNKNOWN], for unknown indications. The patient was allergic to Pineapples, stations and ceclore. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Mar2021 at 10:00 AM, the patient experienced achy, chills, diarrhoea very liquid stools, flu-like symptoms, stomach-ache and very sleepy. No treatment was received to treat adverse events. The clinical outcome of the events stomach-ache, watery diarrhoea, flu-like symptoms, ache, chills, and sleepy was reported as not resolved at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.

Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Pain in the right side of her leg and in her stomach; Caller stated she has been vomiting mainly from the draining that is choking her.; Throat tightened up and glands swell; Barely able to breath, shortness of breath; Pain in right side, below her breast; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; She was so sick; Caller stated she has been vomiting mainly from the draining that is choking her.; Headaches; Pain in the right side of her leg and in her stomach; Burning in her chest and throat/ pain was in the right side of the chest; Burning in her chest and throat/ throat has been like its on fire; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 02Jun2021 (Batch/Lot Number: EW0177) as 1ST DOSE, SINGLE for covid-19 immunisation. Time the Vaccination Was Given: Between 12:00 and 1:00pm. Medical history included when she was a child, she had bronchial asthma. Has not had any problems in years. Prior Vaccinations (within 4 weeks): No, has been years. Has not even had the flu shot in 3 years. The patient's concomitant medications were not reported. Caller stated she had the first dose of the Pfizer covid 19 vaccine and stated she is having a reaction. Caller stated it feels like she has covid. Caller stated she got the vaccine 3 days ago and within 1 hour had tightness in her chest, wheezing and her throat started to tighten up. All she could do was wheeze. Her throat started tightening up and her glands started swelling. Caller stated she then had draining down the back of her throat. Caller reported burning in her chest and throat. Caller reported pain in the right side of her leg on 02Jun2021 and in her stomach. Caller stated she has been vomiting on 02Jun2021 mainly from the draining that is choking her. Caller stated she is still draining but not vomiting. Caller reported she is having headaches. Caller was concerned about what she should do, go to her doctor or go to the ER. Caller wanted to know how long the symptoms should last. Caller stated she is 52 hours out from the vaccine, Throat tightened up and glands swell, Barely able to breath, shortness of breath, pain on 02Jun2021. She was so sick. She was barely able to breathe within an hour and has been in pain. It is now a struggle, with shortness of breath. Her throat has been like its on fire, and lungs filled with a huge amount of drainage in the back of her throat. Is having right leg pain and pain in her stomach. It is not severe pain, but there is some pain there, is having a lot of burning sensation with the drainage. It now feels like she has Covid now. She read in the paperwork that this could not cause Covid. She was perfectly fine when she had the vaccine. She has no allergies. Does not know what to do. It has been 48 hours. She was perfectly fine until an hour later. She contacted the pharmacy and they didn't do anything. She then contacted this number to report this. Her biggest concern was the severe drainage. There were globs of drainage down the back of her throat. Her chest tightened prior to that and she was wheezing. She has not had bronchial asthma since she was a child. Has had no flus, or nothing. Had the pain after the burning in her chest, the pain was in the right side of the chest. Pain in right side of leg: Hasn't stopped completely. Still has pain in the right leg and in the chest. It is barely any better. It is probably because it is in one spot in the calf on her right leg. The pain in the right side, below her breast. The pain seems to be in the right side. Pain in stomach: Seems to be both sides. Has gotten better some, in the stomach. Vomiting: Was vomiting from all the drainage, it was choking her. It started within 2 hours. She is still experiencing the drainage, but not the vomiting. Has also been experiencing headaches. Shortness of breath: Was the same time as the tightness in the chest. It was within an hour after she left. They kept her there 15 minutes and she was fine when she left. Within the hour, she could barely breathe. She didn't know if she should go to the emergency room or if it would get better in a few days. The shortness of breath and wheezing is not worse, but is constant and really hard. Her breathing is really labored. She is not having pain, other than the tightness and wheezing, which she can hear. It is like she had asthma for years, or pneumonia. Outcome of events Wheezing, Chest burning, Throat burning sensation, headache, and Shortness of breath, pain of was not recovered, of Pain in leg, Stomach pain was recovering, of Vomiting was recovered in Jun2021, of others was unknown.

Heartbeat 120 on April 27 and May 18 at night after both shots went away the next day. Dizziness and Nausea right after 1st shot. Sore arm 1st shot.

After the vaccine I started feeling dizzy , and I was extremely tired the next day. I woke up probably about 4 in the morning and I woke up very nausea, had diarrhea, and stomach cramping. I had body aches all over my body, I felt horrible, I also had a massive headache. It felt like I had the flu but it was painful. Following the vaccine I also had to get my left thyroid removed on May 25,2021.

Patient describes nausea and mild dizziness . Patient being sent home with mother who is driver . ER precautions given . Patient advised to follow-up with PCM for persistent symptoms.

about 15 min. after injection pt. began feeling anxious, tearful, difficulty swallowing, pt. able to drink water, speaking in full sent., no rash, no hives, no itching, voice normal, no audible wheezes noted. Team alert called and pt. taken to ED for evaluation

her voice feels a little weak; having problems breathing; lot of Phlegm; coughing a lot; fingers started tingling; waves of nausea; light headedness; She started to itch; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN8203 and expiration date 30Aug2021), via an unspecified route of administration in left arm on 01Mar2021 at 14:30 (age at vaccination 60-year-old) as single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus, hashimoto's disease, high cholesterol and high blood pressure. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. On 01Mar2021, with a few minutes just driving to the waiting spot she was having problems breathing. There was plenty of staff there in the hospital parking lot to help. They were monitoring her oxygen and her heart also on 01Mar20210, patient experienced lot of phlegm, coughing a lot, fingers started tingling, waves of nausea, light headedness and on 03Mar2021, patients voice felt a little weak. She was treated with Benadryl and an inhaler. The outcome of event having problems breathing, fingers started tingling, light headedness, waves of nausea was recovered on 01Mar2021. The outcome of event lot of Phlegm and coughing a lot was recovering at the time of reporting. The outcome of itching and her voice feels a little weak was unknown. No follow-up attempts are possible. No further information is expected.

Patient states loss of apatite, flatulence, burping, feeling hot and sweating since day after Vaccine

Within 4 hours of receiving the vaccine, I developed chills and an fever of 101.5. I had muscle aches, pains, stomach upset, and nausea. At night I had difficulty breathing so I had to take extra medicine for my asthma. My temperature had went down to 100. I had severe body pains, abdominal pains, and vomiting. I was told to take Tylenol and stay hydrated by my doctor. He sent me to ER on March 11th. I went to ER and they ruled out a Covid or flu infection and any other infections. They said it was caused by the vaccine. They administered IV fluids, pain medicines, and vomiting medicines. 9 hours later after waiting, I decided to leave the ER and continued with taking pain and vomiting medicines. The symptoms lasted for 16 days. I met with my PCP and decided to get the 2nd shot three weeks later. I got similar symptoms as 1st shot with 2nd dose. Off and on I have been having adnominal discomfort. I have been having a hard time swallowing and chewing food. June 2nd I seen my PCP, and he said there was a problem with food processing into my stomach. He sent me to a gastroenterologist on June 22nd and they are scheduling a procedure to take a look into my esophagus and stomach to see the issue.

Day of First shot: headache, sore arm, extreme exhaustion, feeling that some virus or illness was coming on, intermittent chills. 36 hours after first shot: sore arm, headache, stomach ache (upper and lower), cramping, swollen gland on front of neck (just one gland). Had all of these symptoms on my second shot too, but not as bad. I did not have a swollen throat/neck gland, BUT had shortness of breath/asthma reaction on my second shot, and chest & sinus congestion. The intermittent asthma/shortness of breath, (haven't had in a long time), was without wheezing. I used my albuterol rescue inhalor and it seems to help me get through these boughts. The asthma came on at about 29-36 hrs and has lasted 6 days so far.

At 6pm the evening of my 2nd dose I started feeling nausea. Within an hour later I had a slight fever of 99.8 degrees and had terrible headaches like I suffered when I had the Covid back in 12/04/2020. My symptoms from the 2nd shot lasted until Sunday. June 27th, 2021 up till 6:30 pm

24 hours post vaccine developed fever (101); Nausea; lack of appetite; muscle aches (entire body); Fatigue; This is a spontaneous report received from a contactable health care professional, the patient. A 60-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FR2613) via an unspecified route of administration in the right arm on 19Mar2021 at 16:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to sulpha. The concomitant medications included losartan (MANUFACTURER UNKNOWN), felodipine (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), CRESTOR and CARVIDEX; all for unknown indications from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was tested for COVID-19, but the result was unknown. On 20Mar2021 at 16:00, the patient experienced fever of 101 (units unspecified), nausea, lack of appetite, muscle aches (entire body) and fatigue. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with TYLENOL for the reported events. The clinical outcome of the events fever, nausea, lack of appetite, muscle aches and fatigue were resolved on an unknown date in Mar2021. No follow-up attempts possible. No further information expected.

4 Days after 2nd injection I woke up having pulsing in my ears, I was very lightheaded and nauseous as if I was having motion sickness at 11 a.m. I checked my blood pressure and it was extremely high, Over the course of 15 minutes, I got a pain in my shoulders, and could barely walk. I check my blood pressure again it was 180/120. My stomach was upset and I had to crawl to the bathroom, too dizzy to walk. I checked my blood pressure again and it was 178/130. My head was pounding and I was losing my ability to walk. I was taken to the Emergency Room, I wasn't sure if this was a stroke or Heart attack, or neuro problem. I was admitted for two nights and released on January 19, 2021. I still had extremely high blood pressure and motion sickness. The hospital did several tests and ruled out a heart attack and stroke. As of today, I am still undergoing treatment for high blood pressure. I had no issue with this before the vacine

Headache; Nausea; Feeling unwell; Fever; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot Number: Er8727) via an unspecified route of administration in the left arm on 19Mar2021 at 13:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto, depression and allergy to shellfish. The patient received unspecified medications within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021, the patient experienced headache, nausea, feeling unwell and fever on that night but no fever at the time of the report. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department, or urgent care. The clinical outcome of the events headache, nausea and feeling unwell was resolving while the outcome of fever was resolved on an unknown day in Mar2021. No follow-up attempts are needed. No further information is expected.

Dizziness; vomiting, unable to move; unable to move; This is a spontaneous report from a contactable consumer, the patient. . A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the right arm on 13Mar2021 at 18:15 (at the age of 60-years-old) as a single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. The Patient did not have any allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient experienced Dizziness, vomiting and unable to move on unknown date (reported date 12Mar2021 at 09:15). It was unknown if patient received treatment for the events. The clinical outcome of the Dizziness, vomiting and unable to walk was not recovered. Information about lot number cannot be obtained. No further information expected

This is a spontaneous report from a contactable consumer or other non health care professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: 9W0187), intramuscular, administered in upper Arm Left on 17Jun2021 14:15 (Age at vaccination: 60 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she don't know if she has high blood pressure or diabetes at that time. Patient did not received any vaccinations prior to COVID vaccine. It was reported that she haven't took any medicine since Thursday morning (further not clarified). On 17June2021 the patient experienced fever went highest as 104 but it's down to 101 today, lot of pain, headache, muscle ache, tiredness, chills, joint pain, Feeling unwell, severe nausea, pain in her ear, severe vomiting, really draining she haven't eaten anything since Thursday at 6 pm, everything keeps 'coming', diarrhea, pain in 'neck area'. Consumer stated that I don't have my, the card with me, I am downstairs on the couch I don't have the card in front of me and I don't have enough energy to go upstairs to get it. Consumer stated, "I got the Pfizer shot (COVID Shot) on Thursday and Thursday evening I have been having the problems and it's still going today 20Jun2021 and I got the call from the pharmacist and he concerns about the side effects, I am not sure what caused all of this 'up again', I was fine before the shot and now that evening different things started happening, not feeling well." Patient did not had swelling. Consumer was suggested to share information and a safety report will be filed by the call handler which is going to be forwarded and if consumer want to speak to someone then call back attempt can be done in order to get a person. The patient underwent lab tests procedures which included body temperature was 104 , body temperature was 101 on 20Jun2021. Patient did not received any treatment for the events. last night something to control diarrhea Ammonia AD, that was the only thing that she took, to stop the diarrhea. But the pain was still there, diarrhea stopped. The patient was recovered from diarrhea in Jun2021,Outcome of Lot of pain was not recovered ,the outcome of the rest of the events was unknown.. Consumer was informed about the role of Pfizer Medical Information and offered the number. Information on the lot/ batch number has been requested.

Fever; Body aches; Shakes; Fatigue; Joint pain; Headache; Weakness; Chills; Sore arm; Nausea; Stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 19Mar2021 at 15:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had only known allergy with z-pak. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR), estradiol (ESTRACE), simvastatin (ZOCOR) and multivitamins, all for unknown indication received within 2 weeks of vaccination and was unknown if ongoing. The patient experienced fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea on 20Mar2021 at 06:00. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, body aches, shakes, fatigue, joint pain, headache, weakness, chills, sore arm, nausea, stomach cramps and diarrhea was resolving at the time of reporting. Information about lot/ batch number cannot be obtained. No further information expected.

Headache; Dizziness; Fatigue; Nausea; Swollen lymph node; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included losartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and labetalol (MANUFACTURER UNKNOWN), all for unknown indication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 20Mar2021, at 19:00, the patient experienced headache, dizziness, fatigue, nausea, swollen lymph nodes, sore arm. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events headache, dizziness, fatigue, nausea, swollen lymph nodes and sore arm was resolved on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.

Possible anaphylactic shock, acute kidney injury, shock liver, hypotension, rash, thrombocytopenia. Full body rash, abdominal pain, vomiting, diarrhea, RLE pain, fever, dizziness, body aches, headache. Sx onset 06/26/2021 after receiving COVID vaccine #2 the same day. Pt went to medical facility on 06/30/2021 and was sent to ED. Pt admitted to ICU 06/30 - 07/02. Transferred to general medical floor on 07/02/2021.

Sick with had fever; flu-like symptoms; She felt like she was having neuro symptoms in her head, like she was having a stroke; Palpitations; Blood pressure high; Tingling in her feet, fingers, face, arms, legs, and head; She reports having extreme anxiety; D-dimer is still high; She says her feet have gone numb; Waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. She couldn't control that; Abdominal pain; Fogginess in the head; fever; Shaking; Chills; This is a spontaneous report from a contactable consumer or other non health care professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EM9809, Expiration date: Unknown), dose 2 via an unspecified route of administration, in Left Arm on 20Feb2021 (at the age of 60 years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included high blood pressure Diagnosed 20 something maybe 30 years ago, underactive thyroid Diagnosed 20 something maybe 30 years ago, autoimmune thyroid disorder. Patient previously received first dose of bnt162b2 (Solution for injection, Lot number EL3248, Expiration date: Unknown) via an unspecified route of administration, in Left Arm on 30Jan2021 (at the age of 60 years-old) as 1 ST DOSE, SINGLE for Covid-19 immunisation. The patient concomitant medications included Atenolol years ago, she doesn't know taken for hypertension, Levothyroxine taken 20 years ago, a long time ago for thyroid disorder. The patient experienced abdominal pain on 01Mar2021. Patient had, palpitations, blood pressure high , tingling in her feet, fingers, face, arms, legs, and head, she reports having extreme anxiety, d-dimer is still high, she says her feet have gone numb, waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. she couldn't control that, She flu-like symptoms, she felt like she was having neuro symptoms in her head, like she was having a stroke in Apr2021. she was sick with had fever on an unspecified date. she had fever, shaking, chills, had fogginess in the head in 2021. She stated she was at the emergency room 3 times since receiving the vaccine. The reason she went to the emergency room was she felt like her blood pressure was very high, and it was extremely high, they had to bring it down with a beta blocker. She was on blood pressure medication prior to this but her blood pressure was under control, it then became un-controlled. She had to start seeing a Cardiologist. she has become an extremely anxious person. She states that due to SOB and pulse ox and all, he did CAT scan to determine if she had pulmonary embolism. She did not. She states her D-dimer is still high so he changed blood pressure meds, increasing and manipulating them. Now she feels her blood pressure is under control. The cardiologist has manipulated her medications, increased them, and that has brought her blood pressure under control. She is seeing a neurologist. She states she was perfectly fine until she took the vaccine. She hopes that will show some things on the status of her nerves. She does not know where all of this came from as she was perfectly fine before the vaccine. Waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. She couldn't control that; that went on for awhile. She tried different antidepressants which didn't work. She tried 2 antidepressants and that didn't help, it made it worse. Since she has gotten off these she feels a little bit better now. she was calling were for the cardiology, neurology, and anxiety issues. still has to work and her feet and legs are not the best. She reported that going to the ER on 17Apr2021, and she also thinks she went on the 25th and 29th. She reports they put her on gabapentin, a nerve drug and it is helping her nerve problem. states she does not have results of the tests other than she does not have a blood clot in her lung. After the first dose she had total and complete brain fog for an entire day, also she had a sore arm. Patient was working with the elderly in nursing home type of environment. The patient underwent lab tests and procedures which included computerised tomogram results unknown, fibrin d dimer was high, magnetic resonance imaging showed mri of brain it was ok. She has a nerve conduction test on 12Jul2021. The Outcome of event abdominal pain was recovered on an unspecified date in 2021. Outcome for the events palpitations, blood pressure high, She reports having extreme anxiety, Waking up in the morning feeling like the petal was to the metal, feeling everything is revved up. She couldn't control that, fever, Shaking, Chills, flu-like symptoms, She felt like she was having neuro symptoms in her head, like she was having a stroke was recovering. Outcome for the other events tingling in her feet, fingers, face, arms, legs, and head, She says her feet have gone numb, fogginess in the head was not recovered. The outcome of D-dimer is still high, Sick with had fever was unknown. Information on Lot/Batch number was available. Additional information has been requested. No Follow-up attempts completed. No further information is expected.

face/hand sensation/Tingling; Elevated tinnitus; Night sweats; Sweats; light-headed; Vertigo; Dizzy; Nausea; vomiting; diarrhea; hands sizzling; chills; Tinnitus/Tinnitus in other ear; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP letter sent in cross referenced case. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EP7533, Expiration Date: not reported) via intramuscular, administered in left arm on 05Apr2021 at 13:00 as dose 2, single for COVID-19 immunization. Prior vaccination within 4 weeks was none. Medical history included vitamin d deficiency, dry eye, and Injury. Concomitant medication included vitamin d [vitamin d nos] taken for vitamin d deficiency and ciclosporin (RESTASIS) taken for dry eye. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) on 08Mar2021 at 13:00, and experienced vertigo, dizzy, hearing loss, tinnitus, nauseous, diarrhea, chills, sweating, Hands felt like vibrating, and vomiting. The patient experienced vertigo, dizzy, nausea, vomiting, diarrhea, hands sizzling, chills and tinnitus/tinnitus in another ear on 05Apr2021 at 14:00. On 10Apr2021, the patient experienced light-headed. On 15Apr2021, the patient experienced sweats and on 19Apr2021, night sweats. Elevated tinnitus on 20Apr2021, face/hand sensation/tingling on 24Apr2021. The patient underwent lab tests and procedures which included blood test: all else normal, eosinophil count: low Eosinophil absolute- low, full blood count: normal, lymphocyte count: low and neutrophil count: high on 05Apr2021. The events recovered but reoccurred again. The patient did not received treatment for the events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Left-arm shot area very sore first 24 hours. Slight headache. Left work nauseous feeling day after. Slept very heavily 2nd night 2nd day woke up with hives on my left arm as the day progressed had a rash on my chest, stomach, back, and arms causing my anxiety to spike. Went to urgent care. Informed that I have hives,/rash, anxiety and that it had been day 2 of vaccine from pharmacy on Thursday

Within 1 hour of receiving the 1st of 2 vaccine doses my mouth became extremely dry; Extremely thirsty; Suffered from a mild headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration on left arm 20Mar2021 at 12:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient medical history included colon issues. The patient had allergies which included codeine, cipro and flu meds. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Mar2021 at 13:30 the patient reported her mouth became extremely dry and extremely thirsty within 1 hour of receiving the first of 2 vaccine doses. Patient did not get enough to drink. Later on the same day patient suffered from a mild headache and nausea. Therapeutic measures were not taken as a result of the events. The outcome of the events mouth became extremely dry, extremely thirsty, mild headache and nausea were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

fever, sore arm at site, flu-like symptoms for 32 hours following the vaccine Today (7/6/21) I have dry mouth, dry eyes, sores on torso, tender thyroid, cracking skin, constant metallic taste in mouth, food tastes awful and irritates my mouth. Water helps to calm but symptoms never go away.

Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Sore arm; Extreme chills; Body and muscle ache; Body and muscle ache; Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EW0182), via an unspecified route of administration in left arm on 10May2021 10:45 as single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included COVID-19. Concomitant medication included (paracetamol) TYLENOL. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via unspecified route in left arm on 19Apr2021 24:00 (Batch/Lot number EW0171) as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 11May2021 23:00 the patient experienced with felt like COVID pneumonia all over again, sore arm, extreme chills, feels like ice in blood, Body and muscle ache and diarrhea. Treatment received was reported as no. The outcome of events was recovering.

AFTER RECEIVING MY FIRST DOSE I WENT TO WAIT IN THE WAITING ROOM AND BEGAN HAVING A RACING HEARTBEAT ABOUT 10 MINUTES AFTER THE SHOT. I BEGAN TO FEEL DIZZY, MY HEART WAS RACING, MY PULSE SHOT UP FROM 64 TO 154 PER MY WATCH AND MY MOUTH GOT DRY. I ASKED FOR A NURSE AND THEY ESCORTED ME BACK TO A ROOM. I WAS FEELING LIKE I WAS GOING TO PASS OUT SO THEY LOWERED ME ON THE THE TABLE. THEY CHECKED MY PULSE AND 02. MY MOUTH WAS DRY AND MY LEGS AND HANDS WERE TINGLING. MY HEART WAS POUNDING AND I FELT SICK TO MY STOMACH. THEY CHECKED MY BP WHICH IS USUALLY LOW AND IT WAS REALLY HIGH. I WAS FEELING WEAK AND UNABLE TO STAND SO THEY TOLD ME THEY WERE TRANSPORTING ME TO THE ER. I WAS SHAKING, FREEZING, MY MUSCLES WERE CRAMPING IN MY ARMS AND LEGS. MY HEART CONTINUED TO RACE, I WAS DIZZY AND REALLY WEAK. I HAVE CONTINUED TO HAVE A RACING HEART BEAT AT RANDOM TIMES DURING THE DAY, STILL FEEL DIZZY AND FATIGUED. MY HEART ALSO POUNDS AT RANDOM TIMES DURING THE DAY. I AM NOT FEELING WELL.

Headache; Fever; chills; Body ache; Nausea; Swollen armpit; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534), via an unspecified route of administration in the left arm on 23Mar2021 at 09:30, (At the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, atrial tachycardia, thyroid disease and Hashimotos disease. Concomitant medications taken within 2 weeks prior to vaccination include Levothyroxine (MANUFRATURER UNKNOWN) and Diltiazem hydrochloride (CARTIA) both for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203), via an unspecified route of administration in the left arm on 02Mar2021 at 10:00 as a single dose for COVID-19 immunisation. The patient was allergic to codeine and demerol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Mar2021, the patient experienced headache, fever, chills, body aches, nausea and swollen left armpit. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. The patient did not take any medication for headache, nausea, chills, fever, swollen arm, general body pain. The clinical outcome of the events headache, nausea, chills, fever, swollen arm, general body pain was recovering at the time of this report. No follow-up attempts possible. No further information expected.

Face bright red & swollen, red rash all over my body, headache, dizziness within the first few hours of vaccination. The first evening my headache got significantly worse. I was extremely thirsty, very tired, nauseous, vomiting, diarrhea, muscle pain, chills, fever, my left arm was very sore & swollen @ the injection site. I slept for longer periods of time than normal, very disoriented & not clear on my thoughts & memory for days after.

rheumatoid arthritis; was really sick and it affected her fibromyalgia; she was just a mess and ended up vomiting and this took about three days; feeling sick; This case has been considered invalid initially upon follow up information case was processed as valid file The initial case was missing the following minimum criteria: Other-Info not qualifying for AE reporting Medical Information. Upon receipt of follow-up information on (20Apr2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 1st of two reports. This 60-year-old female consumer reported for herself that: a 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6206, Expire Date: unknown) via an unspecified route of administration, in the left arm on 08Mar2021 as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8734, Expire Date: unknown) via an unspecified route of administration, in the left arm on 29Mar2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing Diabetes, Sjogren's disease, obese and knee replacements like 10 years ago on both knees and she did not know the exact dates of the knee replacements. Concomitant medications included loratadine taken for rash from 13Mar2021 and ongoing; hydrochlorothiazide taken for sjogren's syndrome, fluoxetine taken for antidepressant therapy; montelukast sodium (SINGULAIR) taken for asthma, cetirizine hydrochloride (ZYRTEC ALLERGY) taken for rash. No additional vaccines administered on same date of the pfizer suspect. The patient did not receive any vaccines within four weeks prior to the vaccination. Caller stated she had a reaction to the Pfizer COVID vaccine and had the 1st dose on 08Mar2021 and after the 1st dose she was really sick and it affected her fibromyalgia and rheumatoid arthritis and she was just a mess and ended up vomiting and this took about three days which was normal. Stated after the 2nd dose within 24 hours she started feeling sick again on 30Mar2021 and she could not move and ended up throwing up and got a rash that appeared on her left arm; stated she had both doses of the Pfizer COVID Vaccine in her left arm and the rash was a little above where the vaccine doses were administered. Stated she had the 2nd Pfizer COVID vaccine on 29Mar2021 and had been coming in and out of feeling good and bad since then and for the rash she had, she used the Triamcinolone Acetone cream and the rash seems to subside and then flares back up and when the rash flares back up she got sick again. Stated the Triamcinolone Acetone cream is 0.1% with lot 0LT0435, expiry date Sep2022 and NDC number. Stated the rash has gotten larger than when it first appeared and when it did flare it itches and was hot and she also has Sjogrens disease in that rheumatology thing and has had the shingles shot 2 years ago; stated she had no name of the shingles shot to provide but had it 2 years ago in September and it was at Walgreens. Stated she just got over this weekend and was sick on Friday, was ok on Saturday and then on Sunday she could not move and was sick. Caller stated the 1st dose of the Pfizer Vaccine was administered on 08Mar2021 with lot EN6206; 2nd dose administered on 29Mar2021 with lot number ER8734; states the patient card has no expiry date or NDC written on it; stated she has had no treatment for the reported events and had not gone into the HCP office but wanted to. Stated her husband got nervous when he looked on the site and saw there were problems with the Pfizer COVID Vaccine in Israel about bringing up shingles in people and he read this in an article; caller stated her husband was concerned about her and thought maybe she had shingles and caller stated this was not shingles and she had the shingles shot and this did not look like shingles to her. Caller stated her husband himself had shingles and he got a little nervous and she herself was going to go to urgent care and did not feel like going that route; stated she had no other treatment. Stated she was having a bad reaction and sees enough doctors and went often enough if this was a real problem she would bring it up and the further away from testing the longer the distance was between her feeling ill; no further details stated by the caller. Stated she took quite a bit of medications and takes Hydrochlorothiazide for her Sjogrens disease and began taking that a little over a year ago and takes 300mg once per day by mouth. Stated she was on an antidepressant and takes Fluoxetine 60mg once per day by mouth and all the names of these medications a was going crazy in her head; stated she began taking Fluoxetine about 10 years ago. Stated she was on a lot of medicines that counter act anything the Pfizer COVID Vaccine could did to her regarding side effects and thinks the vaccine was too much for her body; no further details provided by the caller except she states she took several different asthma medicines and made the reported event not as severe and the rash was not as severe. Caller clarifies to state the medications she took for asthma that made the reported events less severe are Zyrtec 10mg tablets and she took it once per day and had been on it for years like 20 years; she takes Singulair 10mg once per day and had been on that for years and had two new medications just prescribed to her that was Loratidine 10mg once daily that she started taking on 13Mar2021 and then clarified this was the only new one prescribed and she also used nose sprays; no further details provided by the caller. Caller asks that based on what she had told medical, was she doing the right things for this and was she treating this the right way by letting it run its course; caller aware that Pfizer cannot offer medical advice or treatment recommendations and she was referred to her HCP. Adverse events not required in a visit to ER or MD office. Outcome of all events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076803 same reporter/drug/event, different patients

Symptomatic, started on 7/9/21 with cough, runny nose, muscles aches, nausea, loss of smell & taste, sore throat, nasal congestion, fever, headache, fatigue abdominal pain, & ear ache.

hives on my knees; light sensitivity; concentration difficult throughout experience; felt very dizzy; Knees swollen; neck discomfort; headache; area swollen from nose to chin; sore injection site,; fatigue; foggy during day; felt my heart beating hard within 5 minutes of vaccine; my lips were numb; I felt a little trouble swallowing.; Had chills; had swelling around lips/mouth; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no : ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 11:300 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. The patient had no Medical history. Concomitant medications included with supplements. The patient previously received Sulpha Drugs on an unknown date for unspecified indication and experienced a sulfonamide allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 11:00, the experienced heart beating hard within 5 minutes of vaccine and her lips were numb and she felt a little trouble swallowing, and had chills, and had swelling around lips/mouth. On 25Mar2021, the Patient experienced area swollen from nose to chin and Had headache, sore injection site, fatigue, foggy during day. On 26Mar2021, the patient experienced Fatigue and neck discomfort. On 27Mar2021, the patient experienced very dizzy, Knees swollen and Could not sleep on injection site. On 28Mar2021, the experienced hives on her knees, Light sensitivity and concentration difficult throughout experience. The patient underwent lab tests and procedures, which included Blood pressure on unknown date and resulted normal. The patient called clinic for instructions and receive Benadryl for lips numbness, heart beating hard, trouble swallowing and chills. Patient had called doctor and awaited to call back. The clinical outcome of felt heart beating hard, numb lips, trouble swallowing, chills, area swollen from nose to chin, headache, fatigue, foggy during day, neck discomfort, dizzy, swollen knees, hives on knees, light sensitivity and concentration difficult was not recovered and of the vaccination site pain was recovered on 26mar2021. No follow-up attempts are possible. No further information is expected.

I had a severe headache like a migraine the night before and then in the morning it was really severe. I couldn't stop throwing up. The night before I took the butalb-acetamin-caff. I went to an urgent care facility, and they sent me directly to the emergency room.

Diarrhea, severe stomach cramps. Started 11 days after the first dose. Had a tele-medicine visit with a nurse at my primary doctor's office. They did blood work and several fecal tests - all lab results were normal. The gastrointestinal problems lasted about 3 weeks, with alternating bouts of diarrhea and constipation. Slowly over the past few months I have returned to normal.

pain in injection side; cherry angioma; fatigue; muscle weakness; chills; fever; diarrhea; skin rash (urticaria); on day five start of abdominal pain; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration in the right arm on 13Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included cholinergic urticaria, lactose and fructose intolerance. The patient's allergic history included rhinitis, animal fur, mites, dust, NSAIDS (Nonsteroidal Anti-Inflammatory Drugs) causes urticaria. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 18Mar2021, the patient experienced abdominal pain. On 20Mar2021 at 10:00, the patient experienced pain in injection side, fatigue and muscle weakness, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma. Since the vaccination, the patient had been tested negative for COVID-19 on 21Mar2021. As a corrective measure the patient received cetirizine for all the events. The clinical outcomes of the events, pain in injection side, fatigue and muscle weakness, abdominal pain, chills, fever, diarrhoea, skin rash (urticaria), cherry angioma were recovering. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Postal Code added, Verbatim was updated for medical history. Relevant Med History Rhinitis was deleted as it is the reaction of animal fur, mites, dust allergy, Lab data "Rapid Diagnostic RNA test" deleted as it can be combined with PCR (Nasal Swab), Vaccine Facility Information added.

Pain/heaviness in left arm; Sweats; Chills; Diahrea; Nausea; Weakness; Fatigue for 3 weeks; This is a spontaneous report received from a contactable health care professional (patient). This is the 1st of 2 reports, for the 1st dose. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231) via an unspecified route of administration on the left arm on 07Jan2021 at 17:00, as single dose for COVID-19 immunisation (age at vaccination 60-years-old). Medical history was reported as asthma, hypothyroidism, neuro damage in spine and wrists, vertigo, migraines (none in past 5-6 years), arthritis, and mood disorder. Concomitant medications included bromide, vilanterol trifenatate (ANORO); levothyroxine sodium (UNITHROID); paliperidone; valproate semisodium (DEPAKOTE). The patient previously took Darvon [dextropropoxyphene hydrochloride] and was allergic to it. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Jan2021 at 14:00, the patient experienced pain/heaviness in left arm, sweats, chills, diarrhea, nausea (nausea for 3 days), weakness, and fatigue (fatigue for 3 weeks). The patient received treatment for the reported events as an injection of a medication with high NSAID (non-steroidal anti-inflammatory drugs) levels. Patient visited the doctor or other healthcare professional office/clinic visit for adverse event. The events outcome were recovered with sequalae. No follow-up attempts are needed. No further information is expected.

Client reported nausea, tingling in her left hand, and slight dizziness at 6:45ish. Vitals obtained at 6:53PM PM were as follows: BP 120/78, HR 71, O2 96%. The client reported a history of nausea when she is nervous. Client was provided an emesis bag. Vitals obtained at 6:58PM were as follows: BP 120/68, HR 65, and O2 98%. The client reported a history of hypotension. The client stated she has to be sure to stay adequately hydrated or she notices a decrease in her blood pressure. Current medications include Avapena. The client denied any s/s of anaphylaxis. At 6:55PM the client reported a headache. The client did eat today. At 7:02PM RN provided the client a cotton ball with peppermint oil on it to smell.. The client stated her headache was very light at 7:05PM. The client left at 07:10PM.

Chills; Fever; Nausea; Headache; General body pain / Body aches; Extreme tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history, however, the patient had allergies to penicillin, sulfonamide, codeine and clindamycin. The concomitant medications include red yeast rice (MANUFACTURER UNKNOWN), zyrtec (MANUFACTURER UNKNOWN), CoQ10 (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vitamin E (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN) all for an unspecified indication from an unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 04:30, the patient experienced chills, fever, nausea, headache, general body pain (body aches) and extreme tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the reported events. The clinical outcome of the events chills, fever, nausea, headache, general body pain (body aches), extreme tiredness was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.

Severe vertigo and nausea with any movement , but most severe when putting head down. Symptoms started 3 days after the first vaccine , lasted 2 weeks . Vertigo and nausea returned much worse the morning after getting the second vaccine and symptoms continued for 3 weeks. Currently still has slight vertigo and imbalance intermittently.

Diarrhea. No appetite. Flu-like symptoms: Headache; Weak; No energy; I am currently having digestive issues.

pain/heaviness in left arm; pain/heaviness in left ram; pain/heaviness in left arm; sweats; chills; diahrea; Weakness; nausea; fatigue; low tolerance to sound and light; low tolerance to sound and light; vertigo; feeling cold; headaches; muscle/joint pain in all extremities; muscle/joint pain in all extremities; diminished sense of taste; blurred vision; confusion; mood changes; increased sleep; physical agitation; difficulty breathing; Aggravation/exacerbation of underlying neurological/ pulmonary conditions; Pain in injection arm persists; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 60-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9261) via an unspecified route of administration in Arm Left on 29Jan2021 07:00 (age at vaccination 60 years old, Pregnant at Time of Vaccination No) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, vertigo from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing None in past 5-6 years, arthritis from an unknown date and unknown if ongoing, affective disorder from an unknown date and unknown if ongoing, nervous system disorder from an unknown date and unknown if ongoing. The patient had unknown allergies Darvon. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included umeclidinium bromide, vilanterol trifenatate (ANORO); levothyroxine sodium (UNITHROID); valproate semisodium (DEPAKOTE); paliperidone (PALIPERIDONE). All taken for an unspecified indication, start and stop date were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EK9231) via an unspecified route of administration in Arm Left on 07Jan2021 17:00 (age at vaccination 60years old, Pregnant at Time of Vaccination No) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced after second dose pain/heaviness in left ram, sweats, chills, diahrea, nausea 3 days. Weakness and fatigue for 3 weeks, low tolerance to sound and light, vertigo, feeling cold, headaches, muscle/joint pain in all extremities, diminished sense of taste, blurred vision, confusion, mood changes, increased sleep, physical agitation, difficulty breathing. These lasted 5 weeks. Mood changes, breathing difficulties, vertigo, muscle and joint pain persist. Aggravation/exacerbation of underlying neurological/ pulmonary conditions. Pain in injection arm persists on unspecified date. Therapeutic measures were taken as a result events which included injection of a medication with high NSAID levels. AE resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the events was recovered with sequelae in 2021. No follow-up attempts are possible. No further information is expected.

Hypertension after second vaccine noted. B4 vaccine avg at home bp 115/70, after vaccine noted as high as 180/90. Avg after vaccine 150/90. Had to go to cardiologist and received medication bystolic 5mg. Gastrointestinal issues: after second dose severe bloating, no bowel movements, could not eat solid food for over 10 days. My primary physician ordered ct scan with contrast. Outcome no blockages or masses. Still bloating but am moving bowels.

Slight sore arm; Severe headache; chills; nausea; vomiting; This is a spontaneous report from a contactable healthcare professional, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150), via an unspecified route of administration in the left arm on 01Apr2021 at 10:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis, alopecia areata (not chronic but recent) and penicillin allergy. Concomitant medications included loratadine (CLARITIN), ascorbic acid; calcium; minerals nos, retinol; tocopheryl acetate; vitamin b nos; vitamins nos; zinc (CENTRUM SILVER) and others (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 08:00, the patient experienced slight sore arm, severe headache, chills, nausea and vomiting. The headache started within 24 hours of the vaccine. It became worst and most severe approximately around 32 hours after the vaccination. The severe headache and chills lasted for approximately 26 hours after they started. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events slight sore arm, severe headache, chills, nausea and vomiting. The clinical outcome of the events slight sore arm, nausea and vomiting was resolved on an unspecified date in Apr2021. The clinical outcome of the events severe headache and chills was resolved on 03Apr2021 at 10:00. No follow-up attempts are needed. No further information is expected.

Splitting headache; Extreme fatigue; Hot flashing; Felt nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: PAA16596S/06/2022), via an unspecified route of administration in the left arm on 15Mar2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Meniere's disease. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), multivitamin (MANUFACTURER UNKNOWN), ubidecarenone (COQ10) and vitamin D not otherwise specified (NOS) (MANUFACTURER UNKNOWN) all since an unknown date for an unknown indication. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 11:05, within 5 minutes of vaccination, the patient felt nausea and had nausea all day for 48 hours. Four hours after the shot, at 15:00, extreme fatigue had kicked in and experienced hot flashing. On 16Mar2021, the morning the patient woke up with a splitting headache that lasted for 24 hours. On 17Mar2021, the patient felt great and free of symptoms. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events felt nausea, extreme fatigue, hot flashing, and splitting headache were recovered on 17Mar2021. No follow-up attempts are needed. No further information is expected.

pneumonia; loss of consciousness; difficulty in breathing; feeling weak; diarrhea; Arm fracture; Fall; This is a solicited report received from a contactable consumer (patient) based on the information received by Pfizer. (MFR Control No. # 21K-163-3955081-00). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 26Apr2021 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation; adalimumab (HUMIRA 40MG/0.4ML, Solution for injection in pre-filled pen), subcutaneous from 03Apr2020 (Batch/Lot number was not reported) to Mar2021, at Citrate Free (40 mg,1 in 2 wk), subcutaneous from Mar2021 (Batch/Lot number was not reported) and ongoing, at 40 mg for Ulcerative Colitis. Medical history included tobacco user: one pack of cigrette per day (Started 1978), abstains from alcohol. Concomitant medications included tizanidine; carvedilol (COREG); pregabalin; atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS). The patient previously took hydrocodone. The patient experienced loss of consciousness on May2021 with outcome of recovered on May2021, pneumonia on 05May2021 with outcome of recovered in 2021, feeling weak on 27Apr2021 with outcome of unknown, difficulty in breathing on 27Apr2021 with outcome of unknown, diarrhea on Mar2021 with outcome of recovered in 2021, arm fracture on 27Feb2021 with outcome of recovering, fall on 27Feb2021 with outcome of recovering. Clinical course: In 2021, the patient experienced chest tube had been drained and removed. On 27Feb2021, the patient experienced broken right arm in two different places and fell. In Mar2021, the patient experienced diarrhea. in May2021, the patient experienced loss of consciousness. on 05May 2021, the patient experienced pneumonia. in May 2021, the loss of consciousness resolved. in 2021, the pneumonia and diarrhea resolved. Covid-19 vaccine was also considered suspect. the patient shared that she fell in 27Feb2021 and broke her right arm so she went to the emergency room. Her x-ray revealed that she broke her arm in two different places. she was then asked to meet with an orthopedic surgeon and was scheduled for an out-patient procedure to repair her broken arm with pins and plates on the second week of Mar2021. she was sent home and was given hydrocodone for pain. she also added that the physician placed her humira on hold two weeks prior and after the procedure. because of humira was placed on hold, she experienced diarrhea for a week until it resolved. she received her first dose of her covid-19 vaccine in 26Apr2021. she noticed that she started feeling weak and had difficulty in breathing the next morning. she was rushed to the hospital in 05May2021 because her weakness and difficulty of breathing worsened. a series of unrecalled tests had been performed including chest x-ray which showed that she had pneumonia. she was then admitted and was hooked up to a machine because she had difficulty in breathing. she added that she could not recall any other treatments or diagnostic tests that was done to her because she was unconscious for three weeks and was monitored in the intensive care unit. she added that her chest tube had been drained and removed the day she got released in the hospital. she was sent home in 25May2021. alternative etiology of pneumonia, weakness, loss of consciousness, difficulty breathing were reported as covid-19 vaccine.it was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was unknown. Causality for humira 40mg/0.4ml(adalimumab)-the reporter's causality for the event(s) of loss of consciousness, broken right arm in two different places, pneumonia, fell and diarrhea with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of chest tube had been drained and removed was not provided. Programs opinion is that there is no reasonable possibility that the events of loss of consciousness, broken right arm in two different places, chest tube had been drained and removed, pneumonia, fell and diarrhea are related to humira 40mg/0.4ml(adalimumab). COVID-19 VACCINE (COVID-19 VACCINE)(Injection) (COVID-19 VACCINE), Causality: Loss of consciousness-Causality as per reporter (Drug/Vaccine): Probable; Arm fracture-Causality as per reporter (Drug/Vaccine): Not Related; Pneumonia-Causality as per reporter (Drug/Vaccine): Probable; Fall-Causality as per reporter (Drug/Vaccine): Not Related; Diarrhea-Causality as per reporter (Drug/Vaccine): Not Related. The reporter's assessment of the causal relationship of the events (feeling weak, difficulty in breathing) with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the plausible temporal relation, the association between the events of loss of consciousness, pneumonia, asthenia and dyspnoea and the suspect product of BNT162B2 cannot be completely ruled out. The confounding factor for the event of pneumonia is the co-suspect drug Humira Due to implausible temporal association, the events of diarrhoea, arm fracture and fall are assessed as unrelated to BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

the aches and pains were severe and affected all of her joints; cramping up in her calves and it hurts; sight issues; She could barely move; arthritis; she has real sensitivity to light; She still has pain in her knees when she walks, it's almost like her knees want to give out. Severe pain in hips; severe pain was also in her back, hips and neck; severe pain was also in her back, hips and neck; aches and pains; Diarrhea; Severe fatigue; a little bit of swelling; pain at the site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0169; Expiration Date: Aug2021, at the age 60-year-old), dose 1 via an unspecified route of administration, administered in arm left on 27Apr2021 13:00 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Prior vaccinations (within 4 weeks), adverse events following prior vaccinations, patient's medical history (including any illness at time of vaccination), family medical history relevant to adverse events and relevant tests: none. Caller stated she had the shot and a reaction with the first shot and haven't had the second. She clarified she was referring to the covid 19 shot. On 27Apr2021, she had the first vaccine. The day of the vaccine, she experienced normal swelling, a little bit of swelling (not much), and pain at the site, which was normal. The pain went away but she doesn't know it went away. No treatment received. Then, after a few days, she started out with aches and pains but then it got to the point, the aches and pains were severe and affected all of her joints. She could barely move. Her husband had to help her on and off the toilet and that lasted a good week. She also mentions she had diarrhea. She doesn't know. It was probably a couple days later after receiving the vaccine. She was still having diarrhea, but it had improved. She has been taking Imodium. Patient reported that 2 days after she got the shot, she was severely fatigued and that's when the aches and pains started. Caller doesn't know the exact date. If she stands for more than 5 minutes, she has cramping up in her calves and it hurts. She confirms she has recovered with lasting affects. She adds she also has arthritis which might be a factor. She clarifies the aches and pains started on third day. She believes the third day, she is not exactly sure. The aches and pains got worse. When she says severe fatigue, she means she was in bed all day. Time of onset: She would say the fatigue started the 2nd or 3rd day. She provides the start date as: 29Apr2021. The severe fatigue is better than it was but hasn't gone away. She makes the comment she doesn't know why she reacted so bad to the first vaccine. She mentioned she was supposed to go on 18May2021 and get second shot, but she cancelled it. She explains this is one of the reasons she is calling. She needs to know should she get the second shot. Patient wanted to be protected against covid the best she could, her husband has major heart issues and she can't have him being exposed to the virus and she needs to get a shot. She's scared. DSU agent stated we suggest caller reach out to her primary care provider if she has questions on whether or not to get the second vaccine we wouldn't be able to provide her with any medical advice over the phone. Caller stated her doctor said not to take the second shot because she had such a severe reaction to the first one. Her main problem is that she is having sight issues. She has her husband read off the product information from her vaccine record card because she can't really see it. She has always been near sighted but this is to the point, she has real sensitivity to light, that's her main concern right now. First, she had severe pain and then had sight issues. She explained the sight issues started about two weeks in after receiving the first dose, it was right after the severe pain. It has persisted. She has an appointment on Thursday to see her ophthalmologist. She mentions its hard to get into her ophthalmologist. The severe pain started on the 4th day after receiving the first dose, around 30Apr2021. The severe pain lasted a good week, week and a half. She still has pain in her knees when she walks, it's almost like her knees want to give out. Other than that, it's better. She mentions the severe pain was also in her back, hips and neck. Her doctor prescribed diclofenac, 50 mg. She mentions she can see this dose because its bolded and its bigger. No emergency visit. The doctor said to call and see what Pfizer had to say about the second shot because she is really nervous. The outcome of event a little bit of swelling was resolved, diarrhea, fatigue was was not recovered and outcome of all other events was unknown. No follow-up attempts are needed. No further information is expected.

excruciating pain in the bones; sharp neck pain; Headache; sore throat; Difficulty swallowing and breathing; Difficulty swallowing and breathing; Swollen and blistered on the right leg; Swollen and blistered on the right leg; itch and hurt; itch and hurt; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration in Arm Right on 04May2021 10:00 (at the age of 60 years old) as single for COVID-19 immunisation at Hospital. Medical history included lupus erythematosus, rheumatoid arthritis, fibromyalgia. Concomitant medication received within two weeks included baclofen (SOLOFEN), clonazepam (KLONOPIN), trazodone hydrochloride (TRAZODON) all taken for an unspecified indication, start and stop date were not reported and Plasma Capilar. The patient previously took tramadol and experienced allergies, ultacit and experienced allergies, ultram and experienced allergies. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Right on 13Apr2021 08:00 (at the age of 60 years old) as single for COVID-19 immunisation. Patient did not have COVID prior to vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced excruciating pain in the bones, sharp neck pain, headache, sore throat, difficulty swallowing and breathing, swollen and blistered on the right leg, itch and hurt on 06May2021 16:00. Event reported as, After three days excruciating pain in the bones. Still sharp neck pain. Headache and sore throat. Difficulty swallowing and breathing. Swollen and blistered on the right leg. They itch and hurt. The pain in the neck is excruciating. Adverse events resulted in emergency room/department or urgent care. Treatment given for adverse events included toradol, sodomedrol, ataraxia, norflex. Patient did not tested for COVID post vaccination. Outcome of all the events were not recovered. Information about/lot batch number is requested.

Nauseous; Night sweats; Chills / more of the chills; Headache; Aching all over; Off balance/ head felt like it was swimming off balance; Throwing up; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), buspirone (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and fluoxetine (MANUFACTURER UNKNOWN) all for unknown indications from an unknown dates. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00, the patient started experiencing chills and headache. By the night, the patient experienced aching all over, throwing up and off balance. On 01Apr2021, the patient experienced more of the chills, nauseous and head felt like it was swimming off balance. On an unknown date in Apr2021, the patient experienced night sweats. The patient experienced headache the whole time. The patient did not receive any treatment for the events. The clinical outcome of the events chills, headache, loss of balance, night sweats and nauseous was resolved on an unknown date in Apr2021.The clinical outcome of the events general body pain and vomiting resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Body aches; Fever; Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 01Apr2021 at 08:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and mild depression. The patient not had known allergies to medications, food or other products. Concomitant medications included levothyroxine sodium (SYNTHROID) and lexoprin(MANUUFACTURER UNKNOWN), both from an unknown date, for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 11Mar2021 at 08:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 02:00, the patient experienced fever, nausea, headache and body aches. No therapeutic measures were taken as a result of reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, nausea, headache and body aches was recovered on an unspecified date in Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Dizzy immediately following injection; Tired; Nauseous; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 29Apr2021 at 11:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included scoliosis. The patient did not receive any medication within two weeks of vaccination. The patient previously received unspecified medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, the patient experienced dizzy immediately following injection, tired, nauseous and sore arm. The clinical outcome of the events dizzy immediately following injection, tired, nauseous and sore arm was recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Severe dizziness; nausea; severe headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at 16:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder and latex allergy since an unknown date. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 17:30, the patient experienced severe dizziness, nausea and severe headache. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Patient did not receive any treatment for the events. The clinical outcome of the events severe dizziness, nausea and severe headache were recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Tiredness; muscle pain; chills; joint pain; Headache; Fever; injection site pain; Nausea; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 03Apr2021 at 17:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. It was reported that the patient had no allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), dextromethorphan hydrobromide and guaifenesin (ROBITUSSIN DM) and azithromycin (MANUFACTURER UNKNOWN) started on an unknown date for an unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 6:00, the patient experienced tiredness, muscle pain, chills, joint pain, headache, fever, vaccination site pain, nausea and malaise. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tiredness, muscle pain, chills, joint pain, headache, fever, vaccination site pain, nausea and malaise were recovered on an unknown date in 2021. No follow-up attempts are needed; information about the lot number cannot be obtained.

Body aches; Diarrhea; Severe headache; Vomiting; This is a spontaneous report from a contactable healthcare professional, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient did not had any allergies to medications, food, or other products. The patient received unspecified other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0202) via an unspecified route of administration in the left arm on 03Mar2021(at the age of 59-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced severe headache, vomiting, diarrhoea and body aches for four days. The patient received treatment for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events of headache, general body pain, vomiting and diarrhoea was recovered on 04Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

2nd dose was EW0162, 4/15/2021;~3 wk after first dose had episode of epigastric pain, malaise, light headedness for ~3 hrs. Got 2nd dose ~4 days later. Then 5/14, had ER visit for above epigastric pain, malaise, lightheadedness then 5/22-5/25; had ER visit after similar episode but also developed whole body hives, low blood pressure event, suspected to be mastocytosis, however bone marrow biopsy later suggested against this. 5/31 similar episode started, required epi at home and led to another 3 day hospitalization.

Vertigo; Diarrhea; Brain fog; Muscle pain; Headache; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0164) via an unspecified route of administration in the left arm on 22Apr2021 at 15:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included polycystic kidney disease, dry eye, iritis and uveitis. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) of dose 180 milligram (mg), irbesartan (MANUFACTURER UNKNOWN) of dose 75 mg and valaciclovir (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications. The patient past drugs included paracetamol (TYLENOL), topiramate (TOPAMAX), penicillin (MANUFACTURER UNKNOWN), latex and cefalexin (KEFLEX). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 29Mar2021 at 16:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Apr2021, next day of vaccination, the patient experienced muscle pain and headache and on an unknown date in Apr2021, the patient experienced tiredness for three days then felt fine until brain fog started on 8th day after vaccination on 30Apr2021 at 12:00. On 02May2021, 10th day after vaccination, the patient experienced diarrhoea and on 03May2021, 11th day after vaccination, the patient experienced vertigo. The clinical outcome of the event tiredness was resolved on an unknown date in Apr2021 where as the outcomes of the events muscle pain, headache, brain fog, diarrhoea and vertigo were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Headache; Diarrhea; Bronchospasm; Chills; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 01Apr2021 at 08:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, migraine, diverticulitis, sepsis. The patient had previously experienced milk allergy, fish allergy and allergy to nuts (walnuts allergy). The patient previously took Cipro and Flagyl and experienced drug allergy to Cipro and Flagyl. Concomitant medications taken within two weeks included aciclovir (ACYCLOVIR), propranolol (MANUFACTURER UNKNOWN) and testosterone cipionate (DEPOTESTOSTERONE) all from unknown date for unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 10:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 14:00, the patient experienced headache, diarrhea, bronchospasm chills and fatigue. Therapeutic measures were taken as a result of the adverse events and included treatment with Ibuprofen from an unknown date. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, diarrhea, bronchospasm chills and fatigue was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

I was so sick on 03Jun2021; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; sweating; migraine; Headache; nausea; hair still falling; shaking; I was aching worse on 2nd shot; This is a spontaneous report from a contactable Nurse (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0172), via intramuscular route of administration on 03Jun2021 at 09:10 AM (at the age of 60-year-old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from 18Feb2021 to an unknown date (my hairs still falling out after had covid by hands full as of 18Feb2021. I had Covid & so sick. I could not get out of bed). The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP753), via intramuscular route of administration on 12May2021 at 09:00 AM (at the age of 60-year-old) as dose 1, single for COVID-19 immunization and experienced shaking, I was aching all over. The patient experienced shaking, I was aching worse on 2nd shot, hair still falling on an unspecified date in 2021, sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed on an unspecified date in Jun2021, I was so sick on 03Jun2021. Pertinent Details: shaking, I was aching worse on 2nd shot & had to go to bed when got up at 10 AM and sweating, migraine, headache & nausea. Could not eat, had to stay in bed & whole Day & Night. My hairs still falling out after had covid by hands full as of 18Feb2021. Family medical History: Patient husband (withheld) took Moderna & no symptoms at all. But patient was so sick on 03Jun2021. Patient never want to take that shot again because patient felt like I did when I had Covid & so sick. Patient could not get out of bed. The patient underwent lab tests and procedures which included COVID test: had covid (my hairs still falling out after had covid by hands full as of 18Feb2021) on 18Feb2021, blood test was kidney, liver, heart all good and thyroid good (everything good & doctor still don't know why my hair is falling out in hands full) on 01Jun2020. The patient received Tylenol, Chicken soup as a treatment for the event shaking. Outcome of the events I was aching worse on 2nd shot, hair still falling was not recovered; sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed was unknown; shaking was recovered on an unspecified date in 2021, I was so sick was recovered on 03Jun2021. Follow-Up: Follow-up attempts are completed. No further information is expected.

Injection site pain; Tiredness; Headache; Muscle pain; Chills; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 27Apr2021 at 13:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient received unspecified medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 09:00, the patient experienced injections site pain, tiredness, headache, muscle pain, chills, nausea and feeling unwell. The clinical outcomes of the events injections site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell were recovering. No follow-up attempts are needed; No further information is expected.

Approximately 48 hours after receiving vaccine, I developed nausea and extreme diarrhea. This lasted 2.5 days

Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.

VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADACHE,PAIN IN LEFT ARM AT INJECTION SITE. TEMP SEEMED TO BREAK THAT EVENING 98.0 . MONDAY INJECTION SITE VERY RED AND RAISED, ITCHY, ABOUT 1 TO 1 1/2 INCHES IN SIZE. TODAY TUESDAY SAME SIZE ITCHY NOT RAISED .

Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.

Woke up this morning (the day after receiving the vaccine) with chills, fever of 101.9 & diarrhea. Called my manager at work. Went back to bed. Around 8am took 2 Tylenol extra strength 225 caplets, 500mg each. 3 hours later temp down to 99.2. My normal is 97.6

Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one hour, headaches, fatigue, abdominal pain that cleared 1/7 in the afternoon. The nausea was so bad I could not eat. Vomited only one time. I missed one day of work, slept the whole day, and night, too.

Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; temperature 102; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer-BioNTech ;lot number: EK9231) intramuscularly at right arm on 02Jan2021 at 07:45 A.M. at a single dose (dose number: 1) for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19 on 07Dec2020. No known allergies (no allergies to medications, food, or other products) and no other medical history. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination were none. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included chills, temperature 102, general aches, fatigue, pain at injection site, dry cough, general malaise, no appetite. Temperature elevated till 03Jan2021, 6pm. Symptoms similar to what she experienced when diagnosed with covid-19 on 07Dec2020. All events with start date on 02Jan2021 at 06:00 P.M. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Since the vaccination, the patient had not been tested for COVID-19.

1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM

Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.

Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Nausea; Diarrhea; shivering; Sweating; Body ache; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: PFL72TRA9899), intramuscular in left arm, on 31Dec2020 at 07:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (diagnosed prior to vaccination). There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 31Dec2020 at 8 PM (also reported as after exactly 12 hours; possibly discrepant), the patient experienced swollen stiff arm at the site of the injection, severe episode of nausea, diarrhea, shivering, sweating, and severe body ache. Treatment received for the adverse events included paracetamol (TYLENOL). The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.

Headache; Nausea; Vomiting; Diarrhea; I just ache all over; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Solution for injection; lot number: EJ1685; expiration date: not known), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension. The patient's concomitant medications were not reported. The patient had been feeling fine after her last vaccination when she took it at a hospital on 29Dec2020 until today (01Jan2021), in which she experienced headache, nausea, vomiting, diarrhea, and she just ache all over. The patient stated it was not serious and just wanted to make sure she was not supposed to be doing something. The patient did not receive treatment for these reported events. The outcome of the events was unknown.

patient reports fasting high blood sugar >200 12+ hours after vaccination - she is diabetic on oral metformin and has never had elevated blood sugar >140 with fasting; controlled HgA1C at 6.1%; felt dizzy, nauseated, HA and sweaty as if she may pass out - never passed out

01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to this being so bad, 01/08/21 08:54am hip pain/throbbing, took motrin. reported difficulty to bear weight, stayed in bed all day. 01/09/20 01:00pm reports much improved continues with slight pain today, but able to ambulate and function without problems.

1-24 hours AFTER vaccination: headache, fatigue, body aches, chills, fever (102) 24-48 hours AFTER vaccination: headache, fatigue, cough, GI distress, fever (100) 48-72 hours AFTER vaccination: headache, elevated temperature (99.7)

injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13 hours after injection lasted 72 hours. headache started 12 hours after injection lasted 60 hours tiredness started 4 hours after injection lasted 48 hours I only took tylenol

I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a few days after.

fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen after the injection; This is a spontaneous report from a contactable other HCP (patient, Respiratory Therapist) reported that a 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , Batch/lot number: EJ1685) via an unspecified route of administration on 21Dec2020 around 6:00 PM in left upper arm at 0.3mL single dose for COVID Prevention. The patient's medical history was covid at the end of Apr/May2020 with shortness of breath, seasonal allergies and allergies to "some anitbiotics." The concomitant medications was reported as none, received no other vaccines on the same day as the COVID vaccine. The patient experienced soreness at site, redness and swelling, fever, nausea, general feeling of unwell 3 days. Patient stated, "I had covid at the end of April/May with shortness of breath. I thought I would have less reaction from the vaccine. I know someone who was out of work for a while week after the vaccine." States that she read that the 2nd dose is supposed to have worse side effects than the first. If she had bad side effects from the 1st dose, will the 2nd be worse? Also asking if the side effects are the immune system reacting or just an allergic reaction. Patient was anxious about getting her second COVID shot on 11Jan2021. Patient stated that she had all the side effects listed, for three days. Patient stated that she didn't mind the side effects at the time, she had fever, soreness at the injection site, nausea, and a general feeling of unwell, but Patient stated that she could not work like that. Patient stated that her question was, statistically she has read that the side effects from the second shot are supposed to be worse than the first shot, but she was wondering, if she had bad side effects from the first shot, will her side effects be worse after the second, or will they maybe be lessened because she already had bad side effects. Patient reported that she did fill out the VSafe significant because she had to work on the third day after her shot, which was Christmas Eve, and work, was so busy and she did not feel well. Patient stated that she does have two days scheduled off work after her next injection, but it is the third day that she was worried about because she does not want to work feeling like that. Patient stated that the arm soreness started that same day (21Dec2020). At first, Patient reported that the arm soreness resolved, but then she states that it is still a little sore to the touch. So Patient confirmed that it is ongoing but improved. Patient reportsed that the fever started the day after the injection, 22Dec2020 and it has resolved. Patient reported that the last day she recorded a fever was on 24Dec2020. Patient stated that she woke up on 24Dec2020 and her temperature was normal, so she went to work and she did not feel so well at work, but they were so busy that she barely noticed, and then when the Patient went home that night, she took her temperature and it was 100 degrees Fahrenheit. Patient reported that the nausea started on 22Dec2020, which was mild at times, but then she got to where she did not want to eat. Patient reported that the nausea has resolved but she was not entirely sure when it resolved because she had been so busy at work on 24Dec2020, and it was hard to tell what she was feeling because she was non-stop busy that day. Patient stated that she was nauseous for a full three days, and she remembered that she did not eat much on the 24th either. So Patient stated that her nausea may have resolved on the third day after her injection, but it is unknown to her what day exactly that it resolved. Patient was also experiencing the general feeling of unwell from 22Dec2020 for a few days, but stated that by 25Dec2020 she felt okay. Patient also included that her left arm was also swollen, like her whole upper arm was swollen after the injection in Dec2020. Patient stated that she also experienced redness, there was a like a red mark that was further down her arm than the injection site in Dec2020. The outcome of soreness at site was recovering. Patient confirmed that both the swelling and redness had resolved in Dec2020.The outcome of fever was recovered on 24Dec2020. The outcome of general feeling of unwell and nausea was recovered on 25Dec2020.

Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!

Nausea, chest pain, difficulty breathing following first dose of Pfizer COVID-19 vaccine 0.3 mL IM in right deltoid. Went to outside ED and placed on BiPAP. Given diphenhydramine, epinephrine, and steroid (unknown doses). Prescribed outpatient epinephrine in case of flare of reaction once stabilized.

Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills and extreme fatigue lasted 4 hours. Low grade fever lasted 12 hours.

Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at injection site. Swelling at injection site. Diarrhea for 2 Days

Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at midnight the same day. The following day shew had a fever a high as 103. She continued to feel fatigued, achy, headache, slightly nauseated and weak. Her symptoms improved over the course of the last 2 days. She is fever free today

At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested for about 45 mins before I felt well enough to drive. All better after about 2 hours.Next day, tired, sweaty, nauseous, lightheaded when standing.

Fever to 102 F. Chills. Total body aches. Severe headache. Nausea. All began around midnight, 16 hours post-shot. Worsened throughout the night and began to diminish about 8 hours later. After about 12 hours had only slight fever, more manageable headache, was achy all over and fatigued. Back to baseline 36 hours after onset of symptoms.

but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; Got the vaccine early Friday afternoon and had a sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine early Friday (08Jan2021) afternoon and had a sore arm but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever. The patient asked if that normal for side effects to occur 2 days later. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating; Abdominal cramps; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 07Jan2021 07:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient experienced abdominal cramps on 07Jan2021 13:30, diarrhea and chills for 20 or 30 minutes and then it all went away on 08Jan2021. Again today 24 hours later, she had abdominal cramping that was almost debilitating. Had Covid 19 Test up the nose test, thinks it was PCR that was negative on 06Nov2020. The outcome of events was recovered on 08Jan2021.

"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle pain, fever, loss of appetite, HR in lower 90's, pulse OX in low 90's.

Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.

Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a circular redden skin rash on her arms, legs, and torso. Temperature: 99 degrees. Employee took Tylenol and Claritin for rash, complained of diarrhea, vomiting, and weakness of both knees within 24 hours all symptoms were gone.

fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the left arm, on 08Jan2021 at 17:00, at a single dose, for COVID-19 immunization. Relevant medical history included diabetes type 2, high blood pressure, hyperlipidemia, and glaucoma. Concomitant medications included orphenadrine (K-FLEX), empagliflozin (JARDIANCE), losartan, atorvastatin calcium (LIPITOR), and insulin. The previously took metformin and experienced allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 18:00, the patient experienced fatigue, headache, body aches, chills, cough, gastrointestinal (GI) distress, and high fever (102). The patient did not receive treatment for the events. Outcome of the events was recovering. Information on the lot/batch number has been requested.

itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swelling back of neck; inj site very sore; fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK923) , via an unspecified route of administration on 29Dec2020 09:45 at the first single dose at arm left for covid-19 immunisation. Medical history included known allergies: Sulfa. The concomitant drug was unspecified. The patient previously took cipro and experienced drug hypersensitivity. On 29Dec2020, the patient expected side effect of inj site very sore and fatigue for 24 hours. On 06Jan2021 14:00, the patient started with itching of scalp, arms, legs ,rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck, took 50 mg Benadryl w some relief. 630 PM symptoms reoccurred, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of the back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER. The patient received Prednisone 50 mg orally and for the 4 days. The outcome of event inj site very sore and fatigue was recovered on 30Dec2020; the outcome of events was recovered.

Doesn't feel like eating; Fever; Chills/ Chilled; Nausea; Severe Headache/Dull headache/Frontal headache; Fatigue; Body aches; This is a spontaneous report from a contactable Nurse (patient). This 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686), via intramuscular, on 06Jan2021 (at 14:30) at single dose at left deltoid for COVID-19 immunisation, administered at hospital. Age at vaccination is 61-year-old. Historical vaccine included Diphtheria and Tetanus vaccine (intramuscular, at single dose) on 15Dec2020 for immunization; and Shingles vaccine (intramuscular, at single dose) on 15Dec2020 for varicella immunization. Relevant medical history included usual tenderness. No relevant concomitant medications were provided. On 07Jan2021, she woke up at 2:00 in the morning, she had a high temperature, she was chilled, she had a severe headache, nausea, fatigue, and body aches. She got up and took ibuprofen (ADVIL). She was basically in bed, she had to cancel all her appointments in the morning, she just laid in bed and the following afternoon her fever broke at about 4:30 in the afternoon then she just had a low grade temperature and a dull headache, nausea through the next day, Friday the 08Jan2021. She still has a very dull headache and just not right, kind of like a flu bug. She had no fever; she had not had any fever after Friday afternoon or Saturday. Fever started at 2 in the morning 07Jan2021 and she experienced the chills until after fever broke. Fever went above 102 degrees. She still had a little of the nausea, she just didn't feel like eating. She still had the dull headache. The nausea and headache have improved when compared to how it was on the 07Jan2021. She was back to work now she just has a dull frontal headache. The reporting nurse assessed all the events, except of 'Doesn't feel like eating', serious for disability. She stated she may have had usual tenderness but nothing like this. The patient had recovered from the event fever on 08Jan2021 and from the event 'chills/chilled' on 07Jan2021; the patient was recovering from 'nausea' and 'severe Headache/Dull headache/Frontal headache', while the outcome of the remaining events was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded due to temporal relationship. It is worth noting that patient had other vaccines not far ago, including Diphtheria and Tetanus vaccine and Shingles vaccine on 15Dec2020 for immunization. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 THRU 01/19 SORE ARM 01/09 THRU 01/19

Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date 30Apr2021), via an unspecified route of administration on 07Jan2021 second dose at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included lisinopril for blood pressure. The patient stated that she took her second dose on 07Jan2021 afternoon and today 08Jan2021 the patient feel really cough "ing" (not clarified), light headache, dizzy. I am having fever "99.4" (not clarified). The patient asked are not they not safe to take Tylenol, is it okay to take Motrin or just have to be Tylenol (treatment)." It was clarified that patient experienced Dizziness, headache, fever, a low grade fever and little Nauseous. Just my whole body aches completely aches my whole body like I have the flu." The patient was treated with Tylenol for the events. The outcome of the events was unknown.

Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.

After waiting 15 mins I developed a dry throat and walked to my car (8-10 mins later). Began to develop difficulty swallowing by the time I reached my car. Waited a few minutes and it did not abate and continued worsen,. Went to hospital's ER and was seen by Dr. At that time, my voice had become coarse and gravely. Was given oral steroid and a Benadryl. Symptoms lessened a bit and were gone after about 2 hours. While at first I thought my breathing wasn't affected, after symptoms cleared, I realized that my breathing was easier. Symptoms did not reoccur.

Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and needles in arms, hands, and feet b/l, with "slight tingle" in lips. Unusual taste in mouth (that happened after 1st dose as well). Small wave of nausea. Sensation of heat in chest. At 1301 on 1/20/2021, 50 mg of IM Benadryl administered to RD (Lot # 080010, Exp 8/20/2022) by NP. At 1320, arms were less flushed, however b/l pins and needles persistent in both arms and feet, with "tingling" still in lips. Pt will wait until symptoms improve further to d/c to home. NP checking in continuously.

Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic sensation of tilting while sitting on a couch. Had I been driving, this would likely have caused an accident. This is the first time I have ever experienced this feeling. There were 2 or 3 other episodes of feeling like I was falling. 2 of this happened while lying down. They were sudden sensations that made me gasp. Spent most of 1 week in bed with fatigue, vertigo, and 2 times vomiting. Vomiting occurred day 2 post vaccine. Fatigue was continuous for about a week. At day 16 now, certain movements still illicit vertigo. All vertigo symptoms have lasted under 1 minute. However, some have been back to back, such as after repositioning multiple times in bed. Ears have felt very full for almost 2 weeks. Certain head positions or movements, still illicit sensations of the room moving. There was no specific headache, but my head did not feel good for about 2 weeks. There was no fever, but there was chilling one night, a couple of days after the vaccine. I don't know if getting 2nd vaccine is wise.

Diarrhea about 6hrs after injection chills fever body aches and dull headache continued for about another 24 hrs

The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint hurting and headache. It was not like I could not work or anything, it was just there. On the 9th day I woke up with fever and chills and a super bad headache and I felt so bad I could not even go seek medical care, I finally went after 3 or 4 days feeling like that. At the walk in clinic they tested me for flu, covid and strep and on the rapid the result was negative but when done the PCR it came back positive (around 12/29/20). I did not have any respiratory issues on this one. I do remember having diarrhea.

felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."

STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine. Went home early from work. As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)

Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, muscle ache, light headness, dizzy. January 22, 2021 temp 100.1 tympanic

Headache 8:00pm to current 4:00pm 1-22-21 Nausea 6:00 am 1-22-21 to 3:00 pm Vomiting 8:00 am to 1:30 pm. Took zofran

No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache after 5 days on the right side. Throwing up 6 days after for 3 days. Went to the hospital 10 days later for four days was taken by ambulance because she was to ill to drive.

Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.

Intense indigestion followed but intense vomiting; Intense indigestion followed but intense vomiting; This is a spontaneous report from a contactable Nurse reporting for herself. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685), via an unspecified route of administration at right arm on 23Dec2020 15:00 at single dose, then received the second dose of BNT162B2 (lot number: E10140), via an unspecified route of administration at left arm on 11Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypertension, and depression, and allergy to latex. Concomitant medication included desvenlafaxine succinate (PRISTIQ), hydrochlorothiazide, olmesartan medoxomil (BENICAR HCT). Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced intense indigestion followed but intense vomiting on 25Dec2020 11:00. Occurred 48hours after 1st injection and 56 hours after 2nd. Was much more intense after 2nd injection. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Jan2021.

Chills, low grade fever right away. Next 9 days--severe stomach burning, nausea, unable to hold fluids down, "metal taste"--by day 9 went from 103 kg to 92 kg. Slowly got better after this with time and Pepto Bismol.

A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headache, no appetite, and tired/achy. I slept for 3 hours and woke up a little after 8 p.m. Temperature was 100.5. After calling work and notifying my doctor, I drank a Powerade and went to bed. This morning, I feel almost normal. Slight headache (maybe from lack of food) and my stomach is still a little upset.

Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been resolved on the date of her death which occurred 01/27/21, She was found unresponsive by staff, 911 contacted, and paramedics pronounced her deceased at 7:48 AM. After consultation with PCP manner of death was noted as cardiac arrest. PCP was to sign off on death certificate.

10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; trouble swallowing : elevated blood pressure Told nurse 25 minutes later.given benedryl injection Things improved and an hour later tongue began to swell again and blood press increased Paramedics called and they transported me to the ER where I was given an Epi injection and steroids. Monitored for three hours and sent home with prescription for steroids: epi pen; and zyrtec Still experiencing fatigue , headache and lots of drainage off and on

tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe nausea/nauseous light headed when standing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Lot number: 3302), via an unspecified route of administration in right arm on 13Jan2021 13:00 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included escitalopram, vitamin d. At the time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested about 45 mins before feeling well enough to drive. All better after about 2 hours. Next day (14Jan2021), tired, sweaty, nauseous light headed when standing. No treatment received. No pregnant at the time of vaccination. The outcome of the events was unknown.

headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3249) via an unspecified route of administration in the left arm on 12Jan2021 09:15 AM at a single dose for COVID vaccine. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide, paroxetine, and ergocalciferol (VITAMIN D) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA) and mefloquine. It was reported that the patient had 4 days of headaches and achy feeling on 12Jan2021. During her 30-minute wait after the injection, she experienced some nausea and felt hot on 12Jan2021. Treatment was not received for the events. The patient had no COVID prior vaccination. She did not have COVID tested post vaccination. The outcome of the events was recovering.

FEVER, CHILLS, NAUSEA, FATIGUE, FLU-LIKE SYMPTOMS, TREATED WITH TYLENOL 650MG BID, EFFECTIVE - SYMTPOMS RESOLVED

Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contactable nurse (patient herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 13:00 at single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 14Jan2021 01:00, the patient experienced fever 101, pain in both thighs, chills, nausea and headache. No treatment was received for the adverse events. Clinical outcome of the events was recovered with sequelae on Jan2021.

alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.

12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)

Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting

Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to do anything, very tired.

Patient's reaction(s) noted during COVID vaccine observation period: At 1700, patient had left observation area, gotten to car, drove away but returned because she was experiencing nausea and headache. Patient was seated, used wet cloth to forehead and back of neck. VS: B/P 127/86, HR 98, O2 sat 98%, Temp 98.0. At 1715 VS: B/P 124/76, HR 88, O2 sat 98%, temp 98.1. At 1730 VS: B/P 121/91, Hr 86, O2 sat 98%,. Still c/o headache, refused tylenol. Nausea still present but slightly improved. Reassured by staff and husband and taking sips of Sprite 1745 B/P 118/64, HR 85, )2 sat 98%, nausea improving still has H/A, states these symptoms have occurred in past with other events. 1800 B/P 117/69, HR 89, O2 sat 98%. Was walked out to car, denies lightheadedness or shortness of breath. States other symptoms are improving. Disposition: Declined going to ED. Left to go home with no further concerns.

Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHING-Medium

very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; headache; felt nauseous; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 18Jan2021 10:00 at first single dose for COVID-19 immunization. Medical history included high blood pressure (BP) on medication, known allergies: Penicillin (PCN), levaquin, covid-19 on 18Nov2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient had a very sore painful arm at injection site, no redness, started chilling and ran a fever between 102- 103 degrees during the night and into the next day. Had headache felt nauseous. Events start date/time: 19Jan2021 02:00 AM. By 6 pm the next day the patient started to feel a little better. The patient tested positive for covid 19 in 18Nov2020. Covid was not tested post vaccination. No treatment was received for the events. Outcome of the events was recovering.

lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back of her head; Diarrhea; Throwing up/threw up 4 times; low grade temp of 100; This is Spontaneous report from a contactable consumer reporting for self. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration in Right arm on 14Jan2021 10:00 at single dose for covid-19 immunisation. Patient received 1st dose of bnt162b2 on 24Dec2020, Lot number: EL0140; She only had a little aches with the first dose. States that she has had Covid before. There were no concomitant medications. She got the 2nd covid vaccine and felt like she got Covid all over again, diarrhea, throwing up, cold chills, and headaches started on 15Jan2021 at around 2:00AM, low grade temp of 100 on 15Jan2021, then she got sores in her mouth and now her teeth hurt. States that maybe it's from the fever. States that she can't eat because it hurts. She lost 22lbs because she couldn't eat. She has been gargling with half warm water and half peroxide. States that she threw up 4 times, but she doesn't even remember how many times she had diarrhea. After she was done throwing up she finally sat down and took her temperature, so it was probably around 4:00-5:00 AM. States that she still has a headache; it's mainly in the back of her head. Outcome of event diarrhea, throwing up, low grade temp of 100, chills was recovered, of headache was recovering, of can't eat and lost 22lbs was unknown, of others was not recovered.

Patient reported stomach cramping and had 5 bowel movements after vaccine. Stated was nervous for the shot. Took blood pressure 137/80. No diarrhea bowel movements were normal. Monitored pt and she felt better and reported still a little cramping but much better.

a few days after the 1st I had intestinal discomfort, two days later I was passing only mucus, two days later blood was mixed with the mucus. two days later it was mostly blood. After the 2nd dose, the bleeding increased and went to 100% blood. The bleeding lasted a total of 18 days. My GI appointment was a few days later.

Diarrhea; Chills; Slight headache; Very body tired; This is a spontaneous report from a contactable other HCP reported for herself that a 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: p9231), via an unspecified route of administration at the age of 61-years, on 22Jan2021 17:00 (05:00 PM) at single dose in left arm for COVID-19 immunization, in hospital. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had slight headache on 23Jan2021 and was very body tired. On 24Jan2021 10:00 AM, she had diarrhea and chills. No treatment received for the adverse events. The events were considered as non-serious. Outcome of the events was recovering/resolving. Since the vaccination, the patient has not been tested for COVID-19.

Headaches, dizziness, loose stool, upper body pain, 8/10 for 15 minutes (Felt like a heart attack and then gone completely after 10 minutes)

Difficulty swallowing, tongue swelling, headache, Epi pen 0.3mg, 25 mg Benadryl Improvement in tongue swelling

Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.

I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day

On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal cramping and pain , Temp 99.3 On 2/8 stomach uncomfortable, fatigue and muscle aches. 2/9 feel tired

splitting headaches; chronic nausea; Vomiting is explosive and unpredictable; metallic taste in mouth for 3 days.; This is a spontaneous report from a contactable other hcp, the patient. This 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), dose number 1, via an unspecified route of administration in the right arm on 29Dec2020 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus from 1974 to an unknown date (T1DM dx 1974) and aortic valve replacement from 1990 and unknown if ongoing (AVR 1990 and 1992). Concomitant medication included insulin (INSULIN), simvastatin (SIMVASTATIN) and lisinopril (LISINOPRIL). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 31Dec2020, the patient experienced metallic taste in mouth for 3 days. On 07Jan2021 at 13:00, the patient experienced splitting headaches, chronic nausea began and vomiting which was explosive and unpredictable. No therapeutic measures were taken as a result of the events. The clinical outcomes of the metallic taste in mouth for 3 days, splitting headaches, vomiting and chronic nausea were not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

I had flu like symptoms headache and dizziness with both doses. The symptoms of the first dose stopped at day 3. After the second dose, 3 weeks later, the symptoms appeared later but held on to day 5 or 6, except the more extreme dizziness which I still have. It is worse on some days and there is some nausea in the mornings with headache. I have never had vertigo but this is what I imagine it to be.

Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, feeling unwell, cough

Patient reports feeling unwell after injection. She felt like "throat was swollen." Also reports having nausea/vomiting, fatigue and headache that persisted until 2/9/2021 (approximately 2-3 days after injection). She did not eat Saturday and Sunday (day of the injection and day after injection). She was finally feeling able to eat on 2/9/2021. She also reported sensation of heart going "fast" up to 93 on Sunday (2/7/2021). She denies any fevers or diarrhea. She also developed soreness in left arm at area of injection site, but did not have any redness at injection site.

Wokke up around 3:00 a.m. 3 nights after vaccine. Violent vomiting 3-4 times, then diahhrea for about half hour. Thought I had food poisoning. Sever headache shortly after. Sunday, slight fever, listless, some muscle aches, joint pain. Sunday night, headaches returned. Monday, slight fever, muscle aches, swollen lymph nodes under right armpit. Some mild muscle aches and joint pain. Monday night, headache again. Tuesday, same symptoms. Wednesday, some joint pain, swollen lymph node, otherwise fine.

Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and continuing nausea.

61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.

Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have

almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia and tinnitus/ headaches/migraines; exacerbation of migraine with paresthesia and tinnitus; exacerbation of migraine with paresthesia and tinnitus/ increased tinnitus; some abdominal tightness; This is a spontaneous report from a contactable pharmacist (patient herself) via Medical Information team. A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302, NDC number/expiration date was unknown), via an unspecified route of administration on the left arm (also reported as upper left arm) on 13Jan2021 at 09:00 at a single dose for COVID-19 immunization; the patient was a healthcare worker and was trying to protect herself. The vaccination facility type was reported as a drive thru site. Relevant medical history included previous neurological problems, which included history of underlying migraine with paresthesia/chronic paresthesia (ongoing) and tinnitus. The patient had no family medical history relevant to the adverse events (AEs). There were no concomitant medications. The patient had no other vaccine received on the same day of the Pfizer suspect or 4 weeks prior. She never had any problems with vaccines in the past. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Initially, the patient was asking if there were any reports of paresthesia, serious neurologic adverse events, tinnitus, hearing loss, or abdominal tightness in the studies for the Pfizer-Biontech Covid-19 vaccine. After the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021, she experienced an exacerbation of migraine with paresthesia and tinnitus. She also reported experiencing some abdominal tightness on an unspecified date in Jan2021. The patient reported she was scheduled for her second dose of the Pfizer COVID-19 vaccine, but had concerns because she was still experiencing tinnitus and it was "almost like she also had some mild hearing loss" on an unspecified date. The patient further reported that she was due for the next dose the following day at the time of the report (03Feb2021). She had previous neurological problems and did not know if this did exacerbate things or not. She had migraines, tinnitus, and paresthesia and was wondering how many other patients with neurological problems reported this and was this a common side effect or adverse event reported. One doctor told her not to get the second dose and another one told her to get it and she wanted to know what she should do. The patient had headaches/migraines on the evening of vaccination on 13Jan2021 that were fairly mild and 3 days after that on 16Jan2021, they got bad and was accompanied with nausea with increased tinnitus. The migraines and nausea had gone, and the chronic paresthesia was the same as she always had, but the tinnitus was a lot louder and worse. The patient also mentioned that her migraines usually go away, but this one had lingered. The AEs did not require any visit to an emergency room or a physician office. There were no investigation assessment. The patient recovered from the event "nausea" on an unspecified date, she was recovering from the event "exacerbation of migraine/ headaches/migraines," she was not recovered from the events "exacerbation of paresthesia and tinnitus/increased tinnitus, while the outcome of the events "almost like she also had some mild hearing loss and some abdominal tightness" was unknown. The reporter assessed the events "migraine, tinnitus, paresthesia, and nausea" as serious, other medically important conditions. The relatedness of drug to the reactions/events "migraine, tinnitus, paresthesia, and nausea" was unknown as per the reporting pharmacist (Method of assessment: Global Introspection).; Sender's Comments: The 61-year-old female had relevant medical history included previous neurological problems. The reported neurological events and partial hearing loss were more likely due to pre-existing conditions, and less likely related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Event nausea was likely due to the first dose of bnt162b2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint, foggy head, very fatigue, shaky weak legs & body aches. The chills, body aches, fevers & dizziness were under 48hrs. The other symptoms lasted till 2 days before I got my second dose. Tight Chest going on but I think it might of been anxiety. Phone consult with doctor and prescribe some steroids.

Over a 3 day period, I had chills, fever, entire body aches (I could barely move), nausea, EXTREME labored breathing. Symptoms were more severe than the actual covid virus I had.

Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs felt weak & shaky legs and fuzzy head. I feel with no energy. This symptoms are still going on.

Patient presented for COVID vaccination today, first dose. Prior to receiving dose, she mentioned to RN that she has a history of vasovagal syncope following her shingles vaccine. She routinely has flu vaccines without any adverse reaction. RN requested I standby and observe while patient receives vaccine. Within minutes of receiving vaccine, patient endorses prodromal symptoms lightheadedness, hot flashes, then lost consciousness while seated in the chair. After approximately 1 minute, the patient did regain consciousness. She was given orange juice and crackers and felt well enough to ambulate to a chair in the observation area. Vital signs were WNL and she was monitored closely in the observing area. She continued to complain of "queasiness" often stating that she just feels that she would like to go lay down and nap in her car. Rechecked her blood pressure which dropped to 94/64, patient states she usually runs low but systolic within the low 100's. She was taken to a private hallway where she laid down on a stretcher. Blood sugar checked reading 121. She was given more water but she was uninterested in any more food, as she questions if the orange juice and the crackers were the cause of the queasiness. Blood pressure was rechecked and she was again WNL. Given her persistent fatigue and "queasiness", team lead contacted ED charge nurse to discuss case. The recommendation was to have the patient further evaluated. Discussed with team lead, and it was agreed upon that this was best course of action given her persistent symptoms. EMS was called. Per EMS report, patient's blood pressure did rise which patient attributed to excitement/anxiety surrounding the situation. Patient ultimately declined EMS transfer to ED. Her husband arrived to drive her home. Discussed the importance of monitoring symptoms for the next 48 hours. If she has any worsening "queasiness", weakness, fatigue, nausea/vominting, throat swelling, wheezing, dyspnea then she is to call 911 immediately. Patient verbalizes understanding and is agreeable to emergency services should any of these problems occur.

Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location/vaccination location: arm left) on 29Jan2021 13:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included bad back, penicillin allergy, and covid prior vaccination all from unknown dates and unknown if ongoing. The patient has not had other vaccine in four weeks. Patient was not pregnant. Concomitant medication included oxycodone hydrochloride (OXYCONTIN). The patient experienced extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues (all events assessed as serious - disability) all on 05Feb2021 17:00. Patient's clinical course is as follows: One week after the shot, patient had extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues then continued for 2 more days. No treatment was provided for the events. It was reported that patient was COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with result of negative on 20Jan2021. Facility type vaccine was reported as nursing home. Outcome of the events was recovering. Information on the lot/batch number has been requested.

chest x-ray shows numerous bilateral patchy opacities; catastrophic brain bleed; Brainstem reflexes were lost; Patient died; shortness of breath; nausea; diarrhea; worsening shortness of breath/numerous bilateral patchy opacities; immunosuppressed status; This is a spontaneous report from a contactable pharmacist and a contactable other health professional. A 61-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm right on 28Jan2021 (at the age of 61 years) at single dose for COVID-19 immunization. The patient medical history included bilateral lung transplant on 23Jun2017, lymphangioleiomyomatosis, hepatocellular carcinoma, antibody mediated rejection of lung transplant , bronchiolitis obliterans syndrome, grade 0P, major depressive disorder, RLS (restless legs syndrome), chronic insomnia, long term current use of systemic steroids OSA (obstructive sleep apnea), iron deficiency anemia, bilateral sciatica, hoarseness of voice, memory change, laryngeal stridor, pure hypercholesterolemia senile nuclear cataract, bilateral myopia of both eyes, osteoporosis without current pathological fracture, alopecia, immunosuppressed status, all from an unknown date and unknown if ongoing. Concomitant medication included acyclovir (formulation: capsule, strength: 200 mg) oral at 200 mg twice daily, salbutamol (ALBUTEROL HFA) as needed (MCG/ACT inhaler take 2 puffs by inhalation every 4 hours as needed) for wheezing (shortness of breath), atorvastatin (LIPITOR, formulation: tablet) oral at 80 mg once a day, azithromycin (ZITHROMAX, formulation: tablet)oral at 250 mg (every Monday, Wednesday, Friday), bupropion hydrochloride (WELLBUTRIN XL, formulation: tablet, strength: 150 mg) oral at 150 mg once a day, calcium citrate/cholecalciferol (CALCIUM + VITAMIN D, formulation: tablet) oral at 2 dose form once a day (every morning), everolimus (ZORTRESS, formulation: tablet, strength: 1 mg) oral at 2 mg twice a day, fluticasone propionate/salmeterol xinafoate (ADVAIR, strength: 500 ug/ 20 ug) twice daily (1 puff by inhalation), gabapentin (NEURONTIN, formulation: capsule, strength:100 mg) oral at 300 mg daily (by mouth nightly), loratadine (CLARITIN, formulation: tablet, strength: 10 mg) oral at 10 mg as needed, metoprolol tartrate (LOPRESSOR, formulation: tablet, strength: 25 mg)oral at 50 mg twice daily, minoxidil (ROGAN, strength: 5%) topical apply 1 cap full every other day to affected area on scalp for alopecia, ondansetron (ZOFRAN, formulation: tablet, strength: 4 mg) oral at 4 mg as needed for nausea, pantoprazole sodium sesquihydrate (PROTONIX, formulation: tablet, strength: 40 mg) oral at 40 mg once a day, prednisone (DELTASONE, formulation: tablet, strength: 5 mg) oral at 5 mg daily (every morning), sertraline hydrochloride (ZOLOFT, formulation: tablet, strength: 100 mg) oral at 100 mg twice a day (every morning), sulfamethoxazole/trimethoprim (BACTRIM) 400-80 mg per tablet (1 tablet by mouth every Monday, Wednesday, Friday), tacrolimus (formulation: capsule) at 3 mg daily (2 mg every morning and 1 mg at night), salbutamol sulfate (PROVENTIL HFA) as needed for wheezing (shortness of breath), salbutamol sulfate (VENTOLIN HFA) as needed for wheezing (shortness of breath) , salbutamol sulfate (PROAIR HFA) as needed for wheezing (shortness of breath), ascorbic acid/ferrous fumarate/folic acid/ retinol (PRENATAL, formulation: tablet) oral daily. The patient previously took NSAIDs and voriconazole and experienced drug allergies. It was reported that the patient presented to emergency department (ED) on 04Feb2021 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine. Full viral panel including COVID-19 was not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 08Feb2021 and then VV ECMO cannulation on 13Feb2021. Acute pupil exam changes in the early am hours of 15Feb2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. The events were all serious. The patient outcome of the events was fatal. The patient died on 15Feb2021. It was not reported if an autopsy was performed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported event may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Chest x-ray shows numerous bilateral patchy opacities; Catastrophic brain bleed; Brainstem reflexes were lost; shortness of breath; nausea; Diarrhea; Worsening shortness of breath/numerous bilateral patchy opacities

Pain on right-side of back all the way to front of chest and under breast and part of right shoulder. Week prior felt sensation of "pins and needles" on back. Patient reports 1 blister spot on chest. Patient went to urgent care and was diagnosed with shingles. Doctor prescribed Valtrex and Ibuprofen.

chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.

Had chills, nausea and ringing in the head/ears about 4 hours after the first shot. The chills and nausea stopped by the next morning. But the ringing in my head/ears is still going on. It?s driving me crazy. It?s a high pitch buzzing sound that never stops. At times I feel dizzy and nauseous because of it.

Nothing too horrible... Nasseau periods, and diarrhea for 2 days, slight headache. I took some pepto bismol today. Hope it helps. I am still not sure if these are due to the vaccine or not?

Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if she pressed where the injection was it is still a little sore; She called in sick last week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiration date not provided), via an unspecified route of administration in the right arm on 19Jan2021 13:30 at a single dose for COVID-19 vaccination. Medical history included Blood pressure high diagnosed a couple years ago. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) for COVID-19 immunization on 29Dec2020 and unspecified flu shot last fall, she thinks in Sep or Oct2020, but she has never had problems with those. Concomitant medications included unspecified medications. The patient called and said she had reaction to the Pfizer COVID-19 vaccine 12 hours after her second dose and wanted to report it. She said also this past weekend, on Sunday, on 24Jan2021, she started to develop a localized rash that has like a border to it. She added that she got her second dose of the COVID-19 vaccine on 19Jan2021 at about 01:30 PM in her right arm. She said that she woke up the next morning, 20Jan2021 at 03:00 AM with a high fever, nausea, vomiting, dizziness, and rapid heart rate. She said that the high fever that started the temperature she took was 103 initially, she says she took paracetamol (TYLENOL) and it came down to 101, and the next day it was probably 100 most of the day, then it broke that evening. She said the Tylenol, the dose was the extra strength, unknown if it was 500 mg, they were capsules. She says she normally doesn't keep it around, the in-house nurse suggested it so she went and got a sample thing and took a couple doses, she doesn't have it with her as she is at work and is not at home. She said that the nausea and vomiting subsided after the first day or second day, she had the on and off fever and slept most of the day both days. She said that she doesn't have a fever now. She said that she doesn't have her exact heart rate from when she was having the rapid heart rate, she just felt it in her chest. She added that the only reason she said anything was because she called in sick last week on an unspecified date in Jan2021. She said that the rash started developing after that and it is now probably the size of a 16 oz or 60 oz cup, unable to clarify number with caller, she said that it is definitely big but it doesn't bother her, though she is concerned it is there. She clarified that it is a couple inches in diameter and kind of looks like the state of (State Name), on her injection arm which was her right arm. She said her arm is not sore now, it was after the shot on an unspecified date in Jan2021, if she pressed where the injection was it is still a little sore. She said that the hospital said to report it. She said she also has a concern if she should she get another shot if they decide this is needed for more than two vaccinations. She said that she knows they are still gathering information at this point, so she thought she should better turn in, hopefully there will be solution later on. The outcome of the events localized rash, dizziness, heart rate increased and sickness was unknown. The outcome of the events fever, nausea and vomiting was recovered on an unspecified date in Jan2021 while the outcome of the event vaccination site pain is recovering.

arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips and lower back lasted 3 days. lymph nodes in armpits very sore. headache lasted 2 days. vomiting lasted 8 hrs. fever(99-101) lasted 2 days. had 3 minor breathing incidents which was alleviated by using rescue inhaler(albuterol) Called in to Health Service and messaged primary care, was advised to take advil, tylenol, lots fluids and get tested for COVID19.

Chills and headache beginning 10 pm of the day of injection, followed by fever, nausea, body aches, sinus congestion soon thereafter and extreme fatigue. Aleve (2 tablets) at 7 am the next morning with little, if any, relief but perhaps prevented it from becoming worse and another at 2:30 am on Monday morning (the second day). Slept, although not always well, for the better part of 32 hours, with less than 3 hours of being awake and up, trying to eat little. Was able to make it through a nine hour shift on Monday, still with no appetite and a bit off (attributed to not being truly rested despite 32 hours in bed).

Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - resolved 2/22/21 increased blood pressure - resolved 2/19/2021 swollen eye lids and upper checks - resolved 2/22/2021

Fever, chills, body aches, nausea, pain at injection site, extreme fatigue, headache. Also on 2/8 had a Shingles rash for which I consulted a dr and was treated

mild persistent headache all symptoms are mild flushed face tired lack of appetite/ food tastes different rash

First headache, vertigo, dizziness, nausea, neck tension, left arm weakness. Progressed in the course of several weeks to both legs weakness, and then the right arm, tension in the jaw and the face (altered facial sensation). Poor balance. Symptoms continue getting worse. Unable to work.

Pt s/sx started at 1200. Pt c/o stomach pain 4/10 on pain scale, throbbing pain in the L arm and needing to vomit. Pt denied chest pain, difficulty breathing, and difficulty swallowing. Pt denied any similar reaction to vaccines. Pt stated that she had not eaten anything that day. Pt was offered EMS. Pt refused EMS. Pt was offered an adult dose of diphenhydramine. Pt agreed to take medication. First dose administered at 1222 by RN, second dose administered by RN at 1223. Pt stated at 1250 "I feel like I need to puke." Pt was offered EMS for a second time. Pt refused EMS. Pt left vaccination site with son at 1305 with a steady gait.

still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

I have neuropathy symptoms, sore joints and muscles believed due to Tacrolimus. I see a neurologist later this month. Following the first Covid vaccine, these symptoms increased. I was unsure whether this increase was due to the vaccine. However, following the second vaccine, my symptoms increased again and are substantially more severe than they were prior to the vaccine. I am also having increased pain in the area of my liver following both doses.

Exhausted; Chills; Aches; Fever 100.8; Nausea; This is a spontaneous report from a contactable nurse (patient). This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318) via an unspecified route of administration in the left arm on 26Jan2021 at 14:00 (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included hypertension and Hashimoto's disease; the patient was allergic to sulfa and penicillin. Concomitant medications included enalapril, sertraline, lansoprazole (PREVACID) and rosuvastatin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140) on 05Jan2021 at 12:15 in the left arm. On 26Jan2021 at 15:00, the patient experienced exhausted, chills, aches, fever 100.8 and nausea. All the events were considered as non-serious. Corrective treatments taken as a result of the events included paracetamol (TYLENOL) and she went to bed-slept for 14 hours straight. The patient recovered from the events on an unspecified date. The patient had not COVID-19 prior to vaccination and she was not tested for COVID-19 post vaccination.

I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had a slight rash on chest area. When checked to be released, upon mentioning the rash, they checked my blood pressure, which is normally in the 90-100/68-70 range (low!) and it was 138/80. Sounds normal, but I?ve never had a blood pressure reading that high! I felt ok enough to leave with my husband, but later got dizzy, nauseous and throughout the day my joints (neck, shoulders, arms and legs) got increasingly painful, to the point where I could barely climb the stairs that night without assistance. Note: I run 5K every other day and bike or walk on off days, so I?m pretty active. I took Tylenol and went to bed early and was stiff, but better the next morning. Made myself get outside for a light run and was basically fine (albeit very tired) the next day. First day was a little scary though.

Tiredness, fatigue, headache, nausea, chills, fever. Starting about 9:PM on 02/27/21 continuing all the next day 02/28/21. Still had a slight headache on 03/01/21.

I had to run for the bathroom with sudden-onset diarrhea. No cramps, not much pain to speak of--just a little. My intestines have cleaned themselves OUT beginning last night and continuing to today (noon). I will be feeling nothing and then suddenly--have to RUN for the bathroom, and don't be late.

I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.

Begin 4 days after first vaccine on 3/9/2021- First significant increase in thirst; Extreme chills and fever rapidly spiking to 101.5; decrease to about 100 after a few hours and held steady through early morning; decreasing to my normal (97''s) next day; Significant headache from below forward head to left and right side of neck (eustachian tubes and mandibles and lymph nodes) eye pain; vomiting (limited); leg muscle pain/. No injection site reaction 3/11 feel great

Monday 3/08/21 after work, I was very tired and achy. I went to bed and slept 10 hours. When I eat I had diarrhea. On Tuesday, no appetite. Ate very little - crackers, and some chicken noodle soup. I had headache and chills on Tuesday evening, Wednesday and Thursday. I didn't feel well at all. Lightheaded Thursday morning, another diarrhea after a small breakfast. Called my doctor, suggested a covid test. Had a rapid covid test. It was negative. Teleconference call with my doctor on Thursday at 3pm. Nose bleed Friday morning 11:00am.

February 25, 2021 approximately 9:30 am: Approximately 5 minutes after receiving vaccine had a strong medicine taste in throat. Lasted 45 minutes - 1 hour. Approximately 9:55 am slight feeling of throat closing, which lasted about 45 minutes. Approximately 10:00 am headache, which lasted until approximately 4:00 pm, February 26, 2021. Arm soreness evening of February 25, 2021 lasted approximately 2 weeks. February 26, 2021 approximately 6:00 am diarrhea, headache, chills, legs aching, and fatigue, which lasted until until approximately 4:00 pm.

I got my shot on March 5 and on March 9 I woke-up with super bad headache and vomited many times the morning of the 9th. My headache pain was an 8 out of 10 from March 9 to March 11 and remained super nauseous. I got some anti nauseous medicine from the doctor. On March 12, I woke-up perfectly well. This headache and nauseousness felt like my usual reaction to soybean ingestion. I normally have a delayed reaction when I ingest soy bean. Normally, if I ingest soybean, i react 7-12 hours later. I am positive that I did not have any soybean before or after my vaccination.

Chills, severe body aches - 11pm thru the next day, nausea - 230 am, and vomiting - 6am until 9pm, fever - 530pm-939pm , headache and extreme fatigue - all day and into the next day (3/7)

Already described people - excruciating pain in my right shoulder arm & elbow causing nausea. Shot given in left arm. I?m at home so far nothing dead or hospitalized thank you

Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. One hour later my ears and scalp began to itch. I had chills and severe nausea. Severe stomach cramping. Rash covering arms, legs, scalp, back and shoulders, Hives across chest and down both arms. Swelling and hives on palms of hands. Difficulty breathing. Symptoms began one hour after vaccine and continued to worsen. Was treated at Center for allergic reaction. Was given Benedryl and Famotadine, then released.

Pt c/o tingling in throat progressing to difficulty swallowing and mid sternal CP. Pt given 180 mg allegra and with in 5 minutes was feeling better. VS stable. Released to home with instructions. BP: 125/71, P=100z, Pox=97% 1215 BP=129/73, P=103, Pox=97% 1225 BP=121/66, P=82, Pox= 99%

Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and hot at injection site. All this started the day after injection .so severe that it felt like I had covid AGAIN! Couldnt eat or hardly get out of bed the day after shot and the second day after the shot I still felt the same but was able to eat . The third day after shot, my fever went away and most of the body aches except I still have the headache and my arm is still hot, and swollen. Just have been taking tylenol this whole time and cold wash cloth for fever and swelling.

Tacycardia and shortness of breath, followed by chills. Duration of 10 minutes until resolved. Subsequent abdominal pain with mild diarrhea and then extreme fatigue for 5 hours. Similar to a food allergy reaction

Sore left upper arm by 5pm, 3-13-21. Very tired, muscular aches whole body, chills/feverish, headache overnight to present, nausea. abdominal cramping and diarrhea x 2 days. Feels like 'the flu'.

8 days after vaccine, developed burning sensation of skin which has changed locations in upper and lower extremities. Lasts hours at a time and changes location. Also developed diarrhea, vomiting, body aches, chills 8 days after the vaccine.

Started to become nauseated with dry heaving, observed for 30 minutes. Vitals remained. Stable, nausea resolved, liquid challenge.

Pfizer-BioNTech COVID-19 Vaccine EUA. injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell

Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and neck and in my shoulders. I was not hungry and I had a fever(101.2). I slept until 1pm and I started getting nauseous. I never got up off the couch saturday. Pain in left arm/shoulder blade went away around 5pm Saturday. I still had a slight fever and headache saturday evening. Sunday I felt better but I still had a slight fever and headache but felt generally much better. Monday I had no fever no headache, and a little aching in my right arm at the injection site.

nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.

Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 min, got in my car, and felt the need to defecate. Went back in the store, completed, got in my car to drive home. Started to feel even dizzier but kept driving. Felt like maybe I was having a little bit of a strain swallowing but was breathing fine. I took 2 puffs of my Albuterol. Still felt unnatural and anxious. Got home and started to feel a little better within 15 minutes. The arm is sore, not too much of a bother, body aches. Chills for a few hours. Got up and went about my day. Tired and anxious.

woke up with nausea 36 hours after getting the shot. After vomiting I was able to go back to sleep. The entire next day I didn't feel well. Weak, slightly nauseous. All the symptoms lasted approximately 24 hours then I was back to normal. In case it matters. I believe I had Covid last February but it was prior to public knowledge and test availability.

C/O of difficulty to swallow saliva and throat dryness after covid -9 vaccine. Vitals taken: B/P 140/80, P79, R18, Ox 98% RA Doctor checked pt's mouth, no swelling. 10 minutes after pt states "I can fee my tongue now, feel better." Pt was observe for 30 more minutes. Pt was rechecked and vitals taken: B/P 138/85, P77. Pt discharged home in stable condition.

I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured. I was very weak and at times was unable to get out of bed or stand. I had significant joint and overall body pain, at times unable to stand up straight. As this subsided about 36 hours I remained quite weak. On the night of 16 March I was woken up at 1 am with a very severe headache. I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours. I additionally had stomach cramping but no vomiting or diarrhea, and had no bowel movements until the episode cleared up. During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine. I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered. I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).

My face became numb within 10 minutes of the injection. My throat started to close making it somewhat difficult to swallow, but not to the point of having trouble breathing. It has been 12 hours since the injection and my face still feels numb, but swallowing is just starting to get a little easier. The numbness is mostly around my nose, cheeks and forehead.

Patient felt gassy with chest pain. History of GERD. Burping a lot during the sensation. Some reproducible L sided chest pain likely radiating from the vaccine site.

At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV and a sudden severe pain shot through my chest and followed by tightness and difficulty breathing. It was immediately accompanied by a pain between the shoulder blades, cold sweat, nausea, then neck pain and faintness along with the uncontrollable need to move my bowels which was in diarrhea form and continued 3 times within 20 minutes with the other symptoms. After about 5 minutes of receiving the onset of the initial shocking pain, the intensity of the chest pain left but the tightness remained and faded but would return and then subside again every 10 minutes. I went to the emergency room at 11:20pm discharged at 2:50am on 3/19/21.

Extreme dizziness, nausea, mild pain all over body. Tome Meclizine, 25, 2 pil,, 3 p.m. Advil 7p.m. 200 mg Some relief by 12p.m.march 19, 2021 Still dizziness, mild pain, cloudy thinking, not able to function

Hot flashes, Injection site pain, body aches Narrative: Patient received first dose on 2/24/21. Patient reports experiencing headache (9/10 pain scale), nausea, hotflashes, injection site pain, and body aches approximately I hour after vaccine. Patient had to use " sick leave" for work.

patient experienced burning sensation, nauseous, weakness few minutes (around 5-10mins.) after receiving shot while seated and in waiting observation area.

I have been sick for 9 days and today I have a terrible headache to accompany the flu like symptoms. Everything hurts I am nauseous and exhausted my body feels really heavy

Around 7 hours after the shot the left side of my neck hurt a little along with a little sore throat. That evening, I was really tired with body aches. That night I had deep body aches and vomited. I also had a slight headache and coughing. The worst part was the extreme body aches. I felt like I had been hit by a truck. On Saturday (shot was on Thursday), I?m better but my body is sore and I don?t have much energy.

Patient stated that approx. 5mins after getting the vaccine, she felt very nauseous and had full body itchiness. 50mg of PO Benadryl was given prior to coming to the hospital. Patient arrived at hospital & still complained of itchiness. Pt received solumedrol & Pepcid IV.

1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.

Fever of 100.5 Severe headache Severe body aches Some nausea All lasting about 18 hours Fatigue continuing past that

16.5 hrs after injection stomach cramping and diarrhea every 2 hrs x 3. 24 hrs after injection chills, fever (99.1), joint pain, fatigue.

Face Swelling, lips swelling, felt like inside of mouth was thickening. Called doctors office and spoke to oncall doctor. He recommended to take antihistamine. On way home -stopped at gas station and got Benadryl. Took Benadryl twice Saturday and Sunday. Had cold chills and sweating Sunday night. Stomach pain and diarrhea Monday.

COULD NOT LIFT ARM, DIZZINESS WHEN LYING DOWN, SEVERE VOMITING, DIARRHEA, HEADACHE, SWEATS, CHILLS,

Patient received vaccine then sat in the observation area. I was called over when she looked pale and felt dizzy a few minutes after receiving the vaccine. We took her vitals and her O2 was 98%, HR 61, and BP 92/67. Her normal BP is in the 110s. No history of syncopal episodes or diabetes. Patient then became unresponsive to questions and stared off into the distance for about 10 seconds. She never lost consciousness. She proceeded to gurgle up vomit and I called 911. She became responsive again and able to converse normally, but still felt dizzy. We wheeled her to the front, and EMS arrived. She agreed to go to the hospital due to the concern for her unresponsive episode, inability to walk on her own, and living by herself.

I woke up about 3am with a fever and freezing to death. I was very lethargic. As the days progressed, I became very weak and wanted to sleep all of the time. I lost my appetite, taste and smell. I was tested for COVID on 1/12 and found out I was positive the next day. I was out of work for 2 weeks and returned to work on 1/25/21. I got an infusion on 1/20 so I can't get my 2nd dose until 90 days after that date.

Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb. My insides felt swollen. I had a doctors appointment and went there after picking my son up at home. I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.

Low fever (100 F), pain at injection site, nausea and dizziness. It lasted about 12 hours. I took a Tylenol when nausea subsided (in the afternoon).

Fainting, fever, chills, nausea. Had repeated fainting spells the morning after the day I was vaccinated. Felt better the next day, still had slight fever. By Wednesday (third day after vaccine day), felt fine. The reason I am reporting this is the fainting episodes. I do not see that online as a listed common side effect of the vaccine.

started with slight headache early in the morning. I attributed this to pollen and allergies. It last most of day. Then at 4:30 my head began to pound. I felt dizzy and extremely nauseous. This lasted about 4 hours and then I felt much better.

Got hot, felt nauseated, fast heart rate and a little light headed and dizzy I also did not eat before i got the shot they seem to think my sugar dropped as soon as i had something to eat and drink i was fine

Abdominal pain extreme bloating some upper abdominal pain off and on for six days. Went to dr recommended gasx pepto bismol loose stools six days

minimal chronic portal inflammation ( lymphs, rare eos, some neutrophils, no plasma cells seen); extensive cholestasis; symptoms of mild decrease appetite; some fatigue; This is a spontaneous report from a contactable Physician. A 61-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 19Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included hemiparesis, hypertension, hyperlipidemia, recurrent UTI. Concomitant medications included AMLODIPINE BESILATE, calcium carbonate, colecalciferol (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) for UTI, cefalexin KEFLEX [CEFALEXIN] and nitrofurantoin for UTI. The patient received first dose of BNT162B2 on 29Dec2020. On 02Feb2021 the patient experienced minimal chronic portal inflammation, symptoms of mild decrease appetite, some fatigue and extensive cholestasis. Serologic workup was notable only for ASMA 1:160, including extensive viral and immune workup Liver performed on 24Feb2021: extensive cholestasis, normal reticulin and trichrome stains, minimal chronic portal inflammation; no lobular or interface activity. The patient underwent Sars Cov2 test on 22Feb2021 which resulted negative. At the time of the reporting the patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Hepatitis, cholestasis and other events due to temporal relationship . Additional information is needed to better assess the case, including complete medical history, diagnostics including liver function tests/hepatic enzymes prior to subject drug therapy and during subject drug therapy, abdominal ultrasound, CT/MRI of abdomen, viral hepatitis serology, serum bilirubin, serum alkaline phosphatase, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.

Throat tightness with difficulty swallowing, tingling to face and head. Lasted approx 10-15 seconds. Went to the emergency room and was stable at the time. Toward the latter part of the ER visit, I was given prednisone, Pepcid, and Benadryl. Have had no issues since then.

Within 15 minutes following her COVID vaccine with concerns for a lump in her throat. She states she is able to swallow without difficulty. She denies any shortness of breath, chest pain, nausea, rash, or any other symptoms. Benadryl 25 mg given. Continued to monitor and improved

Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.

Directly after getting the shot I was sleeping harder than I ever have for about 14 days then on March 4 woke up after a very deep sleep tired the next day the same thing March 5 woke up extremely fatigued March 6 same thing woke up extremely fatigued and after going for a short bike ride started getting an intense headache, set up got very dizzy, then proceeded to throw up harder than I ever have and so debilitatingly that I had to call the paramedics and they took me to the emergency room. The ER doc at first said that this could not be an adverse effect 14 days later of the first Covid shot, but then he said he didn?t know, for the next nine days I did not leave my house I was so exhausted. I am an athlete and exercise every day have tons of energy all day long and have never felt this way before. I then met with my regular Doctor Who ordered tests of different varieties everything came back normal and to this day which is now March 25 I have extreme fatigue and I can barely work. Like I said above I am an athlete I run five days a week ride my bike two days a week and swim generally two or three days a week and work as a teacher and I can barely do any of that.

Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen head, dizzy, multiple bowel movements, week leg muscles, tired. Lasted about 1 hour for initial wave, then was tired and out of commission for about 3 hours afterwards.

Began with waves of prickly hot sweats, light headed dizziness, cold chills, nausea. Got progressively worse-was at dentist, sent home, could not walk unaided (dizzy). Threw up in car on way home. Spent evening with these sympyoms gradually decreasing in strength, very fatigued, took effort yo breathe. Also soreness of arm. Next day: very fatigued, sore arm, but test of symptoms passed (little nausea, but not bad)

weak, cold, throwing up, hot flashes, dizziness, head hurt, sweating in sleep, diarrhea , body pain, nausea

Traffic personnel brought patient back to observation room after c/o nausea that started at 1030 am. Patient reported no adverse after her 15 minute observation period Vital signs at 10140 am 163/86 56 28 99% O2 sat on room air She reported a history of anxiety. Given cold compresses and water. Symptoms resovlved and she left. Given instructions to call 911 or her PCP as needed. Ambulated out without difficulty. She left with her husband at 1055 am.

at 3am I woke up with a racing heart rate and mild burning in my belly. I couldnt go back to sleep. The next day the burning in the belly got worse. My stomach became bloated and I was having shortness of breath walking short distances. The racing heart and chest pain ebbed and flowed. I made a video appointment with my PCP group on Thursday and they prescribed omeprazole and asked me to come in for physical exam the next day. When I went in the symptoms persisted, they did blood work, did a chest x-ray and sent me over to the emergency room. At the ER they did an EKG, more blood tests and recommended I have a abdominal CT on an outpatient basis. They couldnt say my symptoms were a result of the Pfizer shot but they could not rule it out that it was related to the shot.

Injection site pain and redness, tiredness, splitting headache, muscle ache, chills, joint pain, intermittent fever, loss of appetite

From the afternoon of Tuesday, March 23 through early afternoon of Saturday, March 27 gastric cramping, explosive diaherra, stomach pains, vomiting, and belching. The stomach pains were the worst in the first 36 hours, the gastric cramping gradually lessened over four days. Vomiting was confined to the mornings of March 24 and March 25. The explosive diaherra happened every two hours for the entire period. Small sips of water, diluted apple juice, peppermint tea all resulted in increased gastric cramping. The first food (two scrambled eggs) I was able to eat was on Friday morning, March 26.

Chills, fever 101.6F, headache, fatigue, nausea, diarrhea. Today she states she is feeling a little better but is still a little nauseated and fatigued. She states she's been taking Tylenol off and on.

Speeding-like an extreme caffeine high. Couldn?t sleep for two nights. Blinding headache. Diarrhea. Chewed up inside of mouth until bleeding. On day three and symptoms slowly leaving. Now slight headache and extreme fatigue.

3/11-3/12/21 - heart palpitations, start of flu symptoms 3/13-3/18/21 - heart palpitations and high heart rate, blood pressure high and low, chills, weak, diarrhea, nausea, headache 3/19-3/23/21 - heart issues better, still had flu symptoms Propanolol and Alprazolam for heart palpitations. ER visit 3/16 - recv IV's, all labs normal. PCP visit 3/23.

total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning had 4 hours of hallucinations, nausea and extreme vomiting, dizzyness ,loss of appetite slept for 12 hours on saturday and sunday after the 4 hrs of events listed above. still weak after feeling better on sunday afternoon

Injection site pain, tiredness, headache, bodyaches, nausea, feeling unwell, loose bowels ( not diarrhea ), minor congestion

Nauseous within 3 minutes or receiving shot. Lethargic general feeling of being unwell and severe headache.

(03/04/2021) date of first COVID Vaccine, 17 days after the first COVID Vaccine I am experiencing vertigo, fatigue, abdominal discomfort, (all day) if I am active and have food in my stomach I will vomit. Received the second COVID Vaccine (03/05/2021) after returning home from the vaccine I vomited multiple times that day. Symptoms have not improved. Went to the doctor on 03/29/2021 for an evaluation. She recommended a COVID test. The test was negative. The Dr said my condition is an adverse reaction to the COVID Vaccine

Dizzy about an hour later. Worked through it. Itching/swelling as in first dose in arm but handled with anti-itch sprays and cremes. In afternoon, nauseated and dry heaves. After 9:00PM, high fever, aches, constant chills throughout the night. Extreme thirst. Fever through the next day and used a COVID sick day. Symptoms gone by morning of 03/27/2021.

Following day: major headache; body ache; dizzy; coughing; short of breath; chills; nausea; extreme tiredness (stayed home from work) 2nd day: big headache; very light headed; some coughing; short of breath; nausea (stayed home from work). Not restful sleep. 3rd day: pressure headache; very light headed (went to work). Very tired at night. Hard time sleeping. 4th day: light headed; pressure in head; short of breath when going for a walk; hard time sleeping. Since 4th day, haven't slept well; light headed; on-and-off headache; at work but moving slow. Feels like when I returned from being out with Covid + double pneumonia 6/30/2020-7/23/2020.

Within hours became disoriented, thirsty and achy. Next morning, arm was numb and fingers tingly, Achy, fever, nausea, headache, extreme thirst, disoriented. Extremely sore arm that I couldn't lift to my waistline without extreme pain.. Hard to dress/undress. Never felt so sick in my life!

3/26-Caller states her 61 yo F mother had her vaccine 2nd dose yesterday and today at 3 AM developed tooth and ear pain but denies inability to open and close her mouth. Her mom also had multiple episodes of vomiting which have subsided. The caller doesn't have all available information with regards to the patients current medication list for review and or entire PMH.. Caller states that her mom was administered an initial pfizer dose and her second dose was also from pfizer. First dose 3/3/21 EN6199 Second dose 3/25/21 EN6199 Both doses were received on the above dates.

violent heavying, sweating for 2 hours; pain in chest; diarrhea; chills; sore; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 06Mar2021 14:00 as a single dose (at the age of 61-years-old) for covid-19 immunisation. The patient had known allergies to flu shot, contrast dye, aspirin and codeine. She had a major reaction to flu shot so was scared to have this. She took Pepcid and Zyrtec 3 days prior and 1 week following. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. There were no other vaccine in four weeks. There were other medications in two weeks. The patient received the first shot, day 1 and 2 was fine. On day 3 (09Mar2021 11:00), diarrhea started, day 4 (10Mar2021) - violent heavying, sweating for 2 hours then pain in chest. The patient thought she was having a heart attack. After many test it was not her heart, then more test that would not cause these issues. The physician determined it was the vaccine. On Mar2021, she still feel chills and very sore. The patient was scared to get her second dose. It was unknown if the patient received treatment for the reported events. The reported events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not tested post vaccination. The outcome of the events was unknown. Information on the lot/ batch number has been requested.

Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available

Shortly after receiving vaccine experienced phantosmia - smell of perfume or soap. Worked 6 - 11 pm on 3/29/21. Arm very sore at bedtime. Woke up feeling very tired and weak with arm feeling even more sore. No redness or swelling at injection site. Feeling nausea, body aches and cough, called off work on 3/30/21 for 12 - 10 pm shift. Woke up 3/31/21 feeling lethargic with body aches, cough, still smelling perfume and feeling need to suppress cough. Showered around 9 am and noticed rash developing on inside of right thigh and itchiness/rash under right side of jaw. Scheduled to work 5:30 - 10:30 pm this evening. Will attempt to attend work.

For 2 days after my 2nd shot, I had low fever, chills, headache, aches, tired, and a little nauseated

I had my Pfizer vaccine on March 16, 2021. On March 17th I had a headache, body aches and fatigue which I expected since I had Covid in November 2020. Most of these symptoms only lasted 3 days. After the 3 days I had a continuing headache and started having jaw pain. On March 22nd I started having dizziness and a severe headache with jaw pain, fatigue and nausea. On March 23rd I got up abruptly and felt extremely dizzy and almost passed out. I am having continued sporadic headaches, nausea, dizziness behind my eyes with fatigue and a metal taste in my mouth especially when my mouth is dry. As of March 30th, only side effects lingering are dizziness behind my eyes and nausea

Body aches; Sore injection site; Nausea; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Arm Right on 09Feb2021 15:30 as Single Dose for covid-19 immunisation. Medical history included drug hypersensitivity (Sulfa allergy), thyroid disorder and hypertension from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, liothyronine (NP THYROID) from unspecified date to unspecified date for unknown indication. On 09Feb2021 23:00, The patient experienced body aches, sore injection site and nausea. The action taken in response to the events for BNT162B2 was not applicable. Outcome of events was not recovered.

chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nodes are impacted a little bit; nausea/feeling nauseous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206) via an unspecified route of administration, administered in Arm Left (left shoulder), at the age of 61-year-old, on 03Mar2021 19:00, as SINGLE DOSE for covid-19 immunisation. The patient medical history was overweight, diagnosed COVID last Apr2020 she had it for 17 days and had every symptoms. The patient tried to give antibodies for many months and she was told she had two different kinds of antibodies which prevented her from doing that. The patient has long hauler symptoms which are nerve pain in her thighs and mouth. The patient's concomitant included an unspecified medication (she takes something but not relevant). The patient did not receive any vaccine within 4 weeks prior. The patient previously received shingles vaccine on 14Feb2020 and tetanus shot on an unspecified date (years ago) both given for immunization and her arm hurt/ pain at the injection site (if she touches it, it hurts). On 03Mar2021 at 7PM, after receiving first dose, she felt blah described as she developed injection site pain which is dissipating but still there, headache, muscle pain, tiny fever, impacted lymph nodes, nausea/ feeling nauseous which she didn't have before. The patient can get up and walk around. On 04Mar2021, the patient had chills in the afternoon. It was just a little fever. The patient took Tylenol and Advil in the afternoon and it helped it go away. The patient took one of each. It was reported that the COVID headache is like none other and she had the headache again. For the COVID headache if you take things it doesn't make it go away. When the patient said she had the headache again she meant she had the same headache that she had in April. The events did not require ER or physician office visit. Outcome of injection site pain was not recovered while it was unknown for the other events. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.

VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:1/12/2021.pfizer Lot#EL3248 2nd dose:02/02/21.pfizerLot#EN5318 Diagnosed covid positive: 03/10/21 Exposure:Family Symptoms:congestion, cough, fatigue, body ache,Runny Nose, Abdominal Pain, Sweats

Woke up very dizzy, light headed, felt like diarrhea, hot, sweaty, passed out approximately 4 times, had a harder time breathing, than normal being on oxygen. Stayed in bed for approximately 27 hours, just couldnt function well. Didnt contact Dr. About it, had family stay with me for couple days. I know it was from the vaccine.

Feeling of heat in mouth, numbness in mouth, swelling in throat (not severe), difficulty swallowing (not severe), tongue swelling, Day 3 post injection: hives on upper left arm just above elbow, Day 4: headache (severe), numbness/tingling in jaw, neck and face, swelling of lower legs.

patient had a tingly tongue which eventually became swollen and resulted in her not being able to swallow.

Immediate strong metallic taste that has not gone away. High fevers 103, chills and shaking, fatigue, muscle aches and nausea.

Patient was stable and alert, proactively given emesis bag at 1515 Treatment/intervention B/P and O2sat monitored, in reclining chair.VS as follows: 1537 B/P 155/73, P80, R16, Sp02 99% 1545 B/P 144/74, P80, R12, SP02 98% 1535 reclined in chair, Icepack to neck 1550 B/P 133/77, P77, R12, SP02 99% 1600 states feeling "normal" but also states continued nausea and tingling in hands and fingers 1600 ER charge nurse phone and Patient to ER for check in via wheelchair

Day 2, arm soreness, fatigue, chills half day, metallic taste in mouth, exhaustion, lethargy. Day 3, slight nausea half day, metallic taste in mouth, tiredness.

Severe pain in center chest. Felt as if my chest/breastbone was being hit repeatedly with a ball hammer. 10 days after vaccine I had 4 episodes of extreme tightness/pain in chest & right side of lower abdomen. Walking dog when I experienced episode #2. Did not think I would able able to walk home 1 block away. Got on knees and vomited (in neighbors yard!). Got home tried to vomit again (nothing came up) So sever I almost went to ER but episodes dissipated. Experiences 2 more episodes on 3/24. Experienced 1 more episode during night of 3/24. Went to DR. on 3/25 early AM. Have not had any additional episodes!!

received second dose of vaccine on 3/30. On 3/31 presents via EMS due to altered mental status and vomiting. EMS reports that she was found sitting in her van lethargic and actively vomiting. When EMS arrived they noticed that the patient had her fingers in her throat trying to induce vomiting. EMS reports EKG in sinus rhythm with HR 84, BP 178/106, and O2 sat 99% on RA. EMS did not notice focal weakness. Pt c/o HA and is noted on arrival to not be moving her LUE. I spoke with her daughter, who said she spoke to the pt on the phone at 10:45 am today and that she seemed normal at that time. She reports the pt does not have h/o cancer or heart disease and is unaware of any pt medication allergies. She reportedly received her COVID vaccine yesterday.

Severe abdominal pain, leading to ER visit and diagnosed with Pancreatitis. Severe pain started 30 minutes after the vaccination.

Face swelled almost double in size. Severe headache very fast heart rate nausea diarrhea about 3-4 minutes after leaving the vaccine site. Symptoms begin to decrease then stop within 5 minutes. Face remained somewhat swollen for about an hour. Headache remained for about 6 hours then arm hurt for about 6 hours. Diarrhea remained for 24 hours

pt states her arm felt like it was on fire as the vaccine was being administered. She became very dizzy and had a headache. On 3/16/21 her arm was sore at the injection site. Her throat hurt and when she swallowed she would have a sharp pain right between her eyes. Her left arm became very painful and every time she tried to move it would cause pain in her chest. She had diarrhea, sweating and had 101 fever. On 3/17/21 she had to have someone help her our of bed on this day. She felt like she was going to pass out. She had this feeling on at least 3 occasions. Pt had pain when opening her eyes, trouble breathing and having heart palpitations. She called her cardiologist with her symptoms and was told it was related to taking the vax. She had a televisit w/ PCP and she was sent to have a Covid test which was negative. She was told to drink plenty of fluids and rest. By 3/20/221 pt started feeling better at this time.

Woozy, felt like body was swelling, then numb, then tingling, then like a rag doll. Headache, nauseous. Red rash all over face. Very fatigued. Most of it lasted all day.. Next day, Friday, still very fatigued and a slight headache that comes and goes. Everything else was gone. Had no problems with breathing. No fever. Had no treatment.

Fever, chills, aches, nausea Started 12hours after vaccine, not abated 17 hours later Have taken ibuprofen, acetaminophen and tums, with soda water, four times

Dizziness, nausea, sleepiness, fog brain, temperature of 96-96,4 (taken with more than one thermometer), throbbing pain in left arm traveling to neck.

11 hours after?intense shivering shuddering 22 hours after, awoke to?shivering, sweating, dizziness, lightheadedness, inability to get out of bed, dry heaves 23 hours after?attempted to get out of bed, fell/collapsed/fainted sustained many bruises

Pain and swelling ("knot" at vaccination site in left arm muscle); extreme fatigue; headache; nausea; gastrointestinal issues (upset stomach; diarrhea; loose bowels); and lack of appetite.

Complaining of headache, nausea. BPs 124/76 (pulse 109), 153/97 (pulse 101). O2 sat 99%. Taken to the ED.

She got sick with COVID symptoms; body aches; Headache; Stomachache; Chills; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), intramuscular in left arm on 03Feb2021 19:45 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Shingles vaccine and experienced muscle aches. The patient neither received additional vaccines on same date of the Pfizer suspect nor within 4 weeks. She got sick with COVID symptoms. On 05Feb2021 at 20:00, the patient experienced chills. On 06Feb2021 at 09:00, the patient experienced body aches, headache and stomachache. At first, the patient did not associate chills with vaccine. She had been working at the vaccine clinic and can't find her vaccine card. She had the piece of paper that says the type of vaccine and it says Pfizer BioNTech COVID19 Vaccine EUA. She was in a bad place that day. She had just finished a 6 hour shift and didn't drink the entire time. She had a particular bad day, and her immune system was low. She was so sick on 06Feb2021 that she underwent both a COVID test and a Flu test. Both were negative. She was nervous about the second dose. Everyone told the second dose was worse when they had a bad first reaction. The patient did not require to visit emergency room, but she went to an urgent care for chills, body aches, headache and stomachache. On 08Feb2021, the outcome of the events was recovered. Information on the lot batch number has been requested.

ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).

VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:1/12/2021.pfizer Lot#EL3248 2nd dose:02/02/21.pfizerLot#EN5318 Diagnosed covid positive: 03/10/21 Exposure:Community Exposure Symptoms:congestion, cough, fatigue, body ache,Runny Nose, Abdominal Pain, Sweats

Chills, Fever, Diahrrea and headache for 3 days. Took Tylenol which made the fever and chills better.

Day after vaccine Nausea, Headache, Body Aches, Stuffy nose, sore throat, cough on Day 2, 3, 4, 5, 6, 7, Day 8 went to urgent care for cough sinus infection and coughing phlegm. Was given Zpack, cough syrup and steroid inhaler. Recovered by day 13.

Chest flushing and gagging 25 minutes after initial dose. Symptoms were reported by patient and husband to be consistent with previous episodes of "chemical sensitivity" that have not required epinephrine. Pt was given benadryl PO and transported to ED for EMS.

Severe stomach pain ; hospitalized in emergency; patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via subcutaneous; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via subcutaneous at age of 61 years, at single dose in left arm on 01Apr2021 at 11:15 (Lot number: ER8734) for COVID-19 immunisation. Medical history was not provided. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced severe stomach pain on 01Apr2021 at 11:15 and hospitalized in emergency for it. And it was reported that the adverse event result in "Emergency room/department or urgent care" and it was unknown if treatment received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and she was not diagnosed with COVID-19 prior to vaccination or since the vaccination. Event outcome for severe stomach pain was not recovered.

A few hours following vaccination, developed cough, congestion, sore throat and diarrhea. Symptoms have persisted for two days

Complained of swollen glands, difficulty swallowing and had pursed lip breathing. Vitals= 140/83, Pulse= 69, no O2 obtained. 2nd set of vitals= 136/71, P 67. Gave 50 mg of Benadryl, IM, right deltoid by S. Lisman, RN. Pt took one dose of albuterol inhaler (RX'd to her by PMD). EMS was called and arrived on scene to assess patient. Patient refused transport. Observed patient in observation area of an additional 30 minutes. 1:30-1:45 pm. S. Lisman educated patient on signs and symptoms of worsening condition and when to call 911. Pt advised to accept transport if, signs and symptoms return post Benadryl is no longer in her system.

shortly after: dizziness, nauseated, rise in blood pressure, tingly lips/ mouth they sent me to Emergency Room but I did not get seen thinking it would pass nest couple days blood pressure mildly high and then extremely low, dizziness, nausea with vomiting (vomiting started 3 days) and then i stoped eating 6 days later started Zofran to combat the nausea; blood pressure less variable

Injection site swelling, redness, pain, itching, headache, tiredness, chills, fever, nausea, feeling unwell, difficulty breathing, weakness

High fever for 2 night in a row (in excess of 103), nausea, headache, sore muscles and joints, sore teeth, red inflamed area of vaccination about the size of an orange lasting 5 days., dizziness, unproductive cough, extreme tiredness for 3 days and lingering for 5 days.

45 minutes after shot lips tingled and puffed up, roof of mouth became sore , a bit swollen and irritated ,periodic heart palpitations. I took liquid benedryl and after 15-20 minutes symptoms subsided, so I did not use my EPI Pen.

Slept well the night of my vaccination, and woke up feeling okay. About an hour and a half later, I experienced severe chills, to the point of shaking. Half way through breakfast, I stopped eating as I no longer was hungry. I had to go back to bed. The chills subsided, but I ached all over, similar to having the flu. It is now day two, and I am still tiring easy. I did not report this to my physician, as I am doing much better.

Debilitating Vertigo when she rolled over in her sleep. Bad pounding headache, nausea and vomiting for 24 hours, then able to take some excedrin and meclizine and stopped vomiting. Could only drink some liquids for first 2 days, this morning finally able to eat some toast and tea.

Client c/o nausea and dizziness. Client evaluated by Fire Rescue, Symptoms resolved. Vitals WNL. Per Fire Rescue, no further evaluation needed. Client transported home by husband at 4:30pm.

Developed fever up to 102 degrees F as of 9 PM on the day of vaccination, plus muscle and joint aches, chills, and headache. These symptoms continued the next day along with sore arm, and fever went up to 103.6 degrees F. By bedtime on the second day, March 16, fever, aches and pains, and headache were gone. However, I felt very fatigued and I was sweating profusely all night. I had to get up and change soaked clothing three times during the night. Within 3 days, my arm was still very sore and the lymph nodes in the armpit of the vaccinated arm became very sore. I also began having diarrhea several times per day on approximately the third day after vaccination and this has continued to the present.

fever 100.6, nausea, injection site pain, joint pain, tired, chills, headache,muscle pain, sweating alot, sick dizzy & weak

Headache, chills, nausea, fever that went higher as day went on, went up to 101 with taking ibuprofen, severe fatigue, could not stay awake more than half hour, fuzzy headed feeling, constant ringing in the ears , day 4 of effects couldn't catch my breath when walking more than 10 feet. Day 6 still have ringing in ears, some fatigue, breathing better but not 100%.

* After Shot Lots Of Energy * Got Shot At 11:30 am At 9:00pm Arm Started Hurting Real bad * Layed Down Got Real Bad Chills * My Whole Body Is Aching * Had Slight Headache * Temperture 101.3 * Finally Went To Sleep * Woke Back Up Chills Are Back Body Still Sore *Sweating Really Bad *Got Up Finally And Stayed Up 08:30am * Stomach Was Feeling Nausea Went Away Fter few Hours *Back To Normal 100% 04:00pm

fever, aches, joint pain, headache, nausea, chills, injection site pain up to shoulder, weakness, tired, diarrhea Took Tylenol to sleep, most symptoms lasted from lunch time to bed time. About 12 hours. Today, lingering tiredness, and aches.

evening fever, chills, body aches all over , dizzy,sick,tried,headaches diarrrha and still having head ache and dizzy and diarrhea

Approximately 12 hours after vaccines, chills, fatigue, nausea, weakness. These lasted 48 hours after start of symptoms 2nd vaccine symptoms were worse then previous vaccine and include having diarrhea. Still have activity intolerance

not sure if she has Covid; not sure if she has Covid; she got sick; queasy stomach; hurting of her arm that she got the vaccine in; This is a spontaneous report received from a contactable consumer (Patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 13:00 (Batch/Lot Number: EN6206) at the age of 61-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered in parking lot. Not at Military Facility. The patient's medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historic vaccine included 23 years ago with her 1st flu shot she got sick but has not had any issues since. Patient stated she was scheduled for the 2nd Pfizer shot today and she got sick and was not sure if she has Covid on 23Mar2021. Stated she didn't want to get the 2nd shot and exacerbate her symptoms, states she got symptoms with her first shot. Patient was wondering if she can reschedule her shot in general as it was scheduled for today. Patient stated the symptoms after the 1st shot were not detrimental, she had a queasy stomach later that night and natural hurting of her arm that she got the vaccine in. Stated it started that night after 12 at night. Clarified she got the shot 03Mar2021 and the symptoms started after midnight making it 04Mar2021. Stated the symptoms didn't even last 24 hours and were gone by 05Mar2021. No Emergency Room and No Physician Office visit required. The outcome of the events 'hurting of her arm' and 'queasy stomach' was recovered on 05Mar2021 and the outcome of the events was unknown.

New sensitivity to spicy foods with stomach acidity, moderate stomach pain, increased gas. No response to self medicating with Pepcid Complete chewable tablet.

Threw up about an hour later 2pm. Threw up 2 more times in about a 3hr. total time frame. Achy and sore went to bed and slept till 4:30am. Felt better but still achy with a headache. Sun. feeling better.

Received vaccine on 04/07/2021 at 07:47 AM; Presented at ED on 4/08/2021 at 8:29 am and received prednisone 60 mg and diphenhydramine HCl 50 mg: chest tightness and throat swelling that began yesterday afternoon. She explains that she has h/o anaphylaxis to flu vaccine. She got the first dose of Covid19 vaccine yesterday, she did premedicate with benadryl. She was monitored on site for an hour and felt some left neck pain and jolt of pain down left arm, but it resolved and she went home. Shortly after, she began feeling like she was having asthma attack, wheezing, chest pressure and throat swelling. She used inhaler and took benadryl. Last dose of benadryl at midnight, took Zyrtec D at 7am this morning, last nebulizer and symbicort at 6:30am. She states she still feels chest tightness and throat swelling. She feels like her tongue was very swollen but improved after benadryl. States her voice is different. Feels a little harder to swallow but she is able to drink fluids. She took pantoprazole this morning. States this does not feel like her usual asthma. Rates chest tightness a 4/10 on pain scale, states it feels like something is sitting on chest or squeezing chest. States it does feel a little better in anterior chest now, but she feels it on lateral lower chest still. Denies h/o cardiac issues. Denies h/o MI. No jaw or arm pain at this time. Discharged from ED at 9:27 am and reported to ED at 10:03am on 4/08/2021. Received famotidine 20 mg and discharged home at 1206pm on 4/08/2021 with prednisone, Pepcid, EpiPen

Approximately 10 min after receiving vaccine, patient obtained a headache proceeding with tingling in both hands, difficulty swallowing, and feeling funny. She states as soon as she got it she developed an immediate headache, on her drive home she became lightheaded and had pins and needles sensation in her face and got a strange aura that lasted all her way home. She said for a while she felt like she couldn't swallow. She feels that she might have had a panic attack versus an adverse reaction to the vaccine and is declining any further evaluation.

Anxiety thanks to crowds and fleeting initial dis-organization at the vaccine facility. Sore arm the evening of the injection and the next day. Joint/muscle aches and pains nights the 10th and 11th that interrupted sleep; took acetaminophen. Aches during the day and tired the 11th, 12th and 13th (so far). Strange taste in mouth, upset stomach 12th and 13th (so far). Not looking forward to second dose though happy to have started process.

Patient received vaccine this morning and while in observation room at 0924 brought attention to RN that feeling lightheaded and tired. Patient brought to side room, sat on stretcher and placed on monitor. VSS at 0924 O2 sat 97%, HR 64 and BP 146/73. Patient stating she is feeling better and did take BP meds this morning. Patient had difficult drive in and stated some anxiety from that situation. She did lay down and was given water after c/o of stomach upset.. 0930 VSS O2 97%,HR 60, BP 131/79. VSS at 0940 O2 sat 99%, HR 56, BP 138/89. Patient stating feeling much better , last set VSS O2 sat 97%,HR 56 and BP 131/79. She sat up and stood without issue. Felt comfortable to go home.

4/9/2021: mild headache, arm soreness, muscle aches, tiredness and chills beginning about 6pm. 4/10/2021: headache moderate, muscle aches and joint pain moderate; chills, tiredness, diarrhea beginning in the morning and ending early afternoon; 4/11/2021: woke at 5am because left arm (injection site) hurt; arm mildly swollen along with armpit lymph nodes in left arm, tiredness. 4/12 & 4/13: armpit lymph nodes still a little swollen and tender, arm tender, slight tiredness, other symptoms have resolved but lymph node swelling continues

Headache and Body Aches following shots, nonproductive cough starting the next day, diarrhea, temperature of 99 with sweating chills.

Two days after receiving the vaccine, the front of my neck developed a very itchy, warm rash, my lymph glands on the right side of my neck swelled so much that it was difficult to swallow even liquids without pain, and I had a fever of about 100. The itchy area on my neck continued to worsen, and despite the application of OTC anti-itch medications and me taking Benedryl, it got larger and warmer, and the itching became even more severe. At one point my throat was so swollen, I started to think it was closing up and that I'd need to go to the hospital. The discomfort continued into the next day when I contacted Teledoc, and was prescribed an antibiotic, and prednisone, which helped. The itching is still present, but managed by regular spraying of an aerosol cortisone. And the swelling has gone, but there are slight scars like one would get from a scrape. My throat is much better, and my fever is gone.

The morning after the second injection, Woke up nauseated, some vomiting, intermittent chills, no fever. All symptoms were gone within 6 hours. Within a few weeks (timeline not exact) a lump was noticed under the left armpit, which remains

Feeling nauseous. Did not eat breakfast this a.m. V/S B/P 124/50, HR 60, O2Sat 100%; 11:38am Pt. left at 11:38am verbalized that she is feeling better.

Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.

April 12th - 4:30 pm and on - I was very tired and groggy April 13th - 7:30 am until 10:00 pm - I had a headache, nausea, no appetite, chills, fever up to 101.6, constipated and overall felt crappy - slept most of the day. I took Tylenol as advised by the medical center to help reduce the fever and aid injection site tenderness. April 14th - 7:15 am - 11:00 pm - I had a headache (not as bad as previous day, nausea, no appetite, chills, fever up to 99.4, constipated and overall felt crappy - slept a bit less than previous day. Between 2:00 am and 6:00 am, I believe the fever broke - sweats were consistent. I took Tylenol as advised by the medical center to help reduce the fever and aid injection site tenderness. April 15th - 7-20 am - current - All above listed symptoms have gone away. I also had a bowel movement twice today. I feel a bit tired but almost back to normal.

At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin to close. I also began having problems breathing, began coughing and choking, chest pain, and dizziness. The nursing staff at Hospital immediately got a wheelchair and rushed me next door to the ER. The nurses had called ahead so that the ER doctors were ready to assist me. I was given Epinephrine, steroids, nubilizer treatments, Bendryl, IV fluids and oxygen. After some time I began feeling a little better but then the reaction restarted and treatments had to be re-administered several times. It was quite frightening. I also had a severe headache and tightness of the chest . The ER doctor believed that I should be admitted which was done on 4/2/21 and was kept thru 4/4/21.

Patient reported numbness and tingling in both arms, nausea and dizziness starting 4 hours after vaccination. Patient reported that she went to the ER and adverse events resolved on their own after about 4-5 hours (by 6pm).

! day after the second dose patient developed sore throat, mouth sores, body aches and swollen joints. She initially had a fever that resolved.

I had some site soreness for several days...nothing too bad. Took some Tylenol for it. Two days after injection I got pretty bad diarrhea that lasted several days. I also got the chills/shakes the second night. Then I got a pretty bad Eczema flare...on my breasts. It continues at week two. My left armpit HURT terribly for almost a week. Tylenol did not relieve it at all. I also had quite sore Lymph nodes across my chest/side of neck.

Day after injection: painful injection site/ upper arm, body aches. Three days later: diarrhea lasting about 6 hours, until anti-diarrheal pills took effect.

Chills, nausea, headache, body ache, mildly labored breathing, loss of appetite, slight fever (no more than 100 degrees). All happened in a 24 hour period, with nausea, fever and loss of appetite lasting on and off for several days.

Received shot around 1:10pm, a few hours later around 4pm felt tired. Pain at injection site lasted a few days felt like a bruise. Around 8:30pm lips became bright red, felt like there were sores on the roof of the mouth that were painful and interfered with eating for 3 days after shot ate soft foods, eyes really dry, extremely thirsty for about 2 days after shot. On 4/3/21 around 9pm took a 25mg tablet of Benadryl and that helped a little bit with the symptoms. On 4/13/21, 10 days after the shot, felt extremely fatigued, body and joint aches intense, nauseated, headache lasted a couple of days. By 4/16/21 felt better and was able to go to work in retail.

At about 1 A.M., nine hours after my vaccine, I woke up vomiting. I continued to vomit violently for about 10 hour. The vomiting continued intermittently for 2-3 more hours. I also had a severe headache and a mild fever. I continued to feel fatigued for three days.

Strong pains in lower abdomen the following evening, roughly 24 hrs after injection, and considerable blood in urine the following day roughly 8 hrs later. Urine dark pink to red. Bleeding lasted for 3 days after first dose. Bleeding still ongoing currently.

My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.

dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 61 years old, administered in arm left on 23Mar2021 19:15 (Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, arthrosis, osteoporosis, due to arthritis the patient couldn't eat pork because her joints get swollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included etanercept (ENBREL); methotrexate sodium (METHOTREXAAT). The patient experienced fainting, stomachache, stomach cramps, migraine, no appetite, dry cough on 24Mar2021 15:30, dizziness, headache, fever on 25Mar2021. The patient stopped using Enbrel and taking Methotrexate a few days prior Pfizer's vaccine. Next day on 24Mar2021, the patient had stomachache, 3rd day (25Mar2021) started with dizziness, headache and fever. Symptoms kept going after 10 days. 5 days later the patient went to the hospital and was prescribed something for stomach cramps and migraine. But the fever continued. 3 days later doctor prescribed an antibiotic since she didn't know the reason of the fever. During the course of the fever the patient had been taking Tylenol on daily basis. Fever came and went and the patient had no appetite and keep with fainting. Doctor ordered lung rx but the patient couldn't do it. 10 days later the patient had dry cough (event onset date was also reported as 24Mar2021, 15:30). The same symptoms remained. The patient did not receive treatment for all events (except fever). Events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The outcome of the all events was reported as not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

Developed chest pain, fever, chills, dyspnea, and diarrhea beginning a most immediately after the vaccination

headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; fever of 102; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; very tired and exhausted; This is a spontaneous report received from contactable consumer. A 61-years-old female patient had taken BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955), via an unspecified route of administration at the right arm on 23Mar2021 18:00 at single dose for COVID-19 immunization. The patient's medical history included thyroid disorder, severe asthma, osteoporosis, heart disease (previous heart attack). The patient had allergies to penicillin, zpac, sulfa drugs, symbicort, hydrocodone, kiwi, shellfish. Concomitant medications included amlodipine besilate, simvastatin, levothyroxine sodium, fluticasone furoate. The patient had headache 1st 24 hours and very tired into the next 48 (on 23Mar2021), then 4 days later (on 27Mar2021) violent vomiting, diarrhoea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible migraine (not prone to migraines), was sick for about 36 hours and have been exhausted every since. It was reported that patient was homebound for the most part and no one in my house was sick but me. The patient was not diagnosed with covid prior vaccination not tested since vaccination. Outcome of events was reported as recovered with sequel. No follow-up attempts are needed. No further information is expected.

tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.

having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.

Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my face started to burn like acid was rubbed on it. It got really hot and turned very bright red. Then my lips began to feel like they had been sunburned badly. Then my forearms both started burning and also turned bright red. I was very anxious. Had two bouts of diarrhea. All this occurred within about a 20 minute time-frame. I chewed up 4 children's Benadryl (50mg) and the redness, burning and anxiousness subsided mostly. My heart rat was still over 100 bpm even after 6 hours. (Usually my HR is 68-70 bpm). I slept for 12 hours and the next day seemed fine. This has occurred two more times since that first time. The 2nd reaction being 5 days after that first one and the 3rd reaction being 5 days after that. Same reaction, same treatment and same outcome.

DAY ONE April 15, 2021. On Thursday April 15th at 10:00 a.m. I received the first dose of the Covid 19 vaccine. They gave me the shot in my left arm. Within about 5 seconds, I started feeling nauseated and light headed like I was going to pass out. I asked to just sit there for awhile because I did not feel stable to stand up and go to the waiting area. I stayed seated for about 1-2 more minutes then the paramedics took me to the Medical area in a wheelchair. The paramedics checked my vitals. My blood pressure was 135 over ?? I don't remember. I told the medic my BP is normally 98/58. She said my BP was elevated. My pulse was in the high 80's. My temperature was 98.6 and my oxygen was 100. I started getting pain and pressure going up the back of my neck, into my head, eyes and ears. It was very painful and throbbing pressure. I felt dizzy and really high. It felt like I was floating on the top of the ceiling and the people were off in a distance. I was really woozy. I then got diarrhea. The nausea continued but I did not throw up. At times my thinking was spacey, so I talked to the paramedic to help me stay grounded. I narrated what was happening in my body. They did a glucose finger prick test because of my spaceyness, but it was normal. It was like my whole system was freaking out. I was there and then not there, feeling like I was floating. These symptoms continued for about 90 minutes and getting worse. The paramedics offered me to go to the hospital, but I thought eventually I would be fine. I did not want to go to the hospital and have a huge medical bill. At around 90 minutes, I started having pain in my heart left side, under my left breast on my left shoulder. The paramedics did an EKG and did not find anything but some irregular heartbeats. The heart beats felt like BA BOOM, then my heart would do a cartwheel. BA BOOM and another cartwheel. At this time, my husband arrived and took me to the hospital emergency room because the pain in my heart was getting worse. I stayed in the hospital emergency room until around 5:00pm on April 15th. They did another EKG and some lab work and did not find anything but low thyroid. I continued to feel drunk, nauseated, pain pressure and throbbing in my head neck, ears and eyes, diarrhea, and like I was High and going to pass out. The chest pain in my heart was off and on. It felt like muscle cramping in my heart, under my left breast and the left shoulder. I also got a pain in my left groin area, then behind my left knee. It was a sharp and throbbing pain for about an hour in each location, but eventually went away. While in the Emergency room, they tried to give me Ativan. I asked what it was for and they said Anxiety. I said I wasn't anxious; I was just having a reaction to my first Covid 19 vaccine. I said I did not want it because my body was already struggling to handle the Covid 19 vaccine. They said the doctor prescribed it. I said I had not seen a doctor, and they said it is protocol. The nurse then came in and wanted to give me a shot for nausea and I said no, I don't want any more chemicals in my body, it is really having a hard time already with the Covid vaccine. I went home, was wiped out, still feeling drunk/woozy/high, also nauseated, diarrhea, very dizzy, had a hard time walking. The pain, throbbing in my head, neck, ears and eyes was still there. By this time, I could not find clear thoughts, and could not make sense of things. I was very agitated and at the same time exhausted and only wanted to sleep. DAY TWO April 16, 2021 I woke up with a smashing head ache, neck ache, back ache and general feeling like Crap. The nausea and diarrhea were still there and had woken me in the middle of the night. I felt like a truck had hit me. I stayed in bed all day and tried to eat and drink as much as I could. I drank a lot of water that day. I felt horrible, but was able to stand without feeling like I was going to fall over. Had trouble finding clear thoughts at times. Still felt out of it and had chest pain off and on. Also had the BA BOOM heart beats and cartwheels in my heart. DAY THREE April 17, 2021 Very similar to day two. I felt weak, nauseated, diarrhea, pain all over, jittery, not able to have clear thoughts at times. It felt like my body was still on RED ALERT!!! I also had very shallow breathing on day 2, 3, 4 and 5. It tired me and I panted just getting up to go to the restroom. I am able to eat fine and keep food down. BA BOOM hear beats and cartwheels in my heart have lessened. DAY FOUR April 18, 2021 I felt a little better and made the mistake of thinking I was getting over the reactions and did too much. Shortness of breath. DAY FIVE April 19, 2021 I feel horrible again, Nausea is really strong as well as the diarrhea. I am feverish, sweaty and shaky. Shortness of Breath. Tight in my chest. I just took my temperature and it is normal, although I am hot, sweaty, feel feverish and shaky. I am exhausted. The headache is still here as well as the pains in my neck, ears and eyes. The aches in my body are still here. I have no energy. A wave of emotions is also here and I am weepy and crying. This is no fun. I am able to eat food OK and drink lots of water to counteract the diarrhea. DAY SIX April 20, 2021 Shortness of breath, very tight in my chest, having to take Benadryl and use my rescue inhaler to keep my breathing open. Feverish, chills, shakey, hot. Temperature 97.0 Blood pressure 90/66 Pulse 70. I feel like crap, just wiped out.

strong headache focused behind eyes, moderate body aches and chills and fatigue, minor dizziness and nausea, slight cough. All beginning at around 6 pm (9 hours after shot) and ending around 5 pm the next day. Fatigue continues.

Yellow mucus / vomiting/ diarrhea 15+ / headache/ body ache/ stomach ache / can?t smell / can?t eat / lower back is hurting

Was walking my dog the next morning, started out fine, halfway through I was dizzy and nauseous and had to sit down. I put my head between my knees and was sweating though it was 30 degrees out. I threw up 3 times (empty stomach so mostly spit and stomach acid). Took about 10 minutes to feel a bit better to make my way home. Tired and nauseous the rest of the day. Had a wonky stomach up until Sunday (shot was on a Wednesday).

9:45 am: Patient presents with nausea and warmth in the face area. Vital signs: BP 174/73, HR 63, O2sat 98% 10:00 am: Vital signs: BP 151/98, HR 58, O2sat 97% 10:15 am: Vital signs: BP 140/59, HR 59, O2sat 97%

I woke with a migraine headache on the 2nd day after my vaccine and the migraine lasted 28 days in a row, 24 hrs each day. I lost my appetite which led to a 30 lb weight loss, I was dizzy, and fatigued. Furthermore, I was given tramadol, but it did not help and contributed to the dizziness so discontinued that after 1 week.

On 4/18 had fever and aches, but was better and able to work on 4/19. Rash broke out on 4/20 on R anterior shin (somewhat linear set or erythematous papules - look like broken vessels from when an area is scratched, but she denies scratching; lesions don't blanch), back of neck (wide area of erythematous maculopapules with a hint of some mild swelling/raised appearance), over L hip. Patient reports that it doesn't itch or hurt. She did think they were swollen at a point. Patient is also feeling a bit dizzy, with some nausea and a little diarrhea.

On the 15th day after vaccination with Pfizer vaccine, I got dizzy for a few seconds while laying on my couch. Within a few hour after that I started with loud ringing in my right ear; this happens to be the same side I was vaccinated on. That same night I got a headache and was throwing up. The louder ringing in my ear lasted few about two and a half weeks. Since then is has gradually been subsiding.

Severe fatigue onset 5 hours following injection. 24 hours after, developed migraine, fever, chills, vomiting and diarrhea last app. 24 hours. Day 3 and 4 severe fatigue, body and joint aches, migraine, mild nausea.

4/22/21, 7pm ET: Chills, fatigue 4/23/21,1pm ET through 4/24/21 10am ET: Chills, fatigue, slight fever (99.8º), nausea, muscle aches, headache,

headache and pressure; dizziness; nausea followed by vomiting; intestinal discomfort; extreme tiredness followed by sleeping for about 11 hours straight. These symptoms were almost completely gone by the following Monday (3/15/21) when I received the second vaccine.

I got my 2nd vaccine on April 12. My arm was sore. It wasn't with the first shot. I was fine until Thursday. By April 15 I almost vomited, which I never do, but instead had a violent burst of painful, cramping, burning bowel movement. I looked in the mirror and my face was white. My lips were white. I had no problem breathing or with my heart pounding. It was all gastrointestinal. Each day since I've gotten less sick to my stomach each day. For the first few days I could only drink. Then I had popsicles and finally ice cream. Nothing else appealed to me. I never had another violent episode, but my stomach has been upset since April 15, 2021. Even though I continue to get better, I'm calling the doctor tomorrow.

Having injection site pain; Nausea; Can hardly hold her head up; She slept all day yesterday, and slept all night; She just gets hot; Feeling unwell; blood pressure was out of control; lymph nodes are not as bad, they are hurting; She is having hot flashes; Tiredness/ she is still tired; Muscle and joint pain; swollen lymph nodes under arm; muscle and joint pain; Chills; Headaches; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: CR8732 or LR8732) first dose on 03Apr2021 08:30 on right arm at single dose for COVID-19 immunization. Medical history included ongoing High blood pressure (Has had a long time), Breast cancer (Has had 6 years) and covid in Feb2021. History of all previously immunizations was No. Prior vaccincations wtihin 4 weeks was No. AE's following prior vaccinations was No. Concomitant medications included anastrozole (ARIMIDEX, strength 20 mg) for breast cancer (Has not taken the last 3 days, Did not want to take with the shot), bisoprolol fumarate, hydrochlorothiazide (BISOPROLOL HCT) for Blood pressure (States that she was taking 5-6.25mg and increased dose to taking 10 in the morning and 5 at night) and ongoing Vitamins. States that in Feb2021 had Covid and had gotten over that and was discharged. States that she might have had mild Covid and with all of the variances coming out, she wanted to get the vaccine. States that she got her first dose on Saturday (03Apr2021) and didn't know if she hadn't waited long enough. Caller states that she has been having terrible reactions. Has been having injection site pain but even had that with the flu shot. States that she has been experiencing tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. Has also been experiencing nausea and can hardly hold her head up. States that she slept all day yesterday, and slept all night. Woke up this morning feeling a little bit better, then the side effects took a hold of her again. Caller states that cancer meds made her gain weight and hasn't been able to get rid of it. Noticed Tiredness yesterday (04Apr2021) when she woke up. States that she had the vaccine on Saturday the 03Apr2021 at 8:30am, started to have headache that night. States when she woke up yesterday (04Apr2021), she started experiencing all of the other symptoms, tiredness, headaches, muscle pain, chills, joint pain, and lymph nodes under her arm were swollen where she got the shot. States that when she woke this morning, had thought everything was a little better but, then it hit her again. Clarifies she is still tired, and the headache still has not gone away. This morning (05Apr2021) she is having hot flashes, not so much the chills. The chills are still there but not nearly as bad, she just gets hot. She has been experiencing nausea and feeling unwell. States that the lymph nodes are not as bad, they are hurting but, not as bad. States that it is hopefully doing what it is supposed to do. States that she has been taking only Tylenol but has not taking it yet today. States that she is super scared to get the second shot. If this happened with the first shot, is terrified for the second shot. States that she has been taking Tylenol every four hours and is such a lightweight that she has only been taking one Tylenol every four hours. Caller states that she is supposed to be back 24Apr2021 for second shot but does not know if she can go through with it. States that this was recently increased when her blood pressure was out of control when she had gotten Covid. States that she was taking 5-6.25mg and her dose was increased dose to taking 10 in the morning and 5 at night. States that she is not taking as prescribed but she was too chicken to take the 10mg. States she will be back to see her doctor on 16Apr2021. States that she hates taking any medicine. Tests: States that she had bloodwork done Friday (02Apr2021) but has no idea of the results. States she will be seeing her doctor 16Apr2021 to go over the results. Vaccination facility type was Hospital drive up. Vaccine administered at military facility was No. No events required to ER. Caller states she has contacted her doctor to find out about her future vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.

migraine; headache; tiredness; vomitting; chills; feeling hot; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 10Apr2021 as Single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via unspecified route and date as Single dose for COVID-19 immunization and experienced sore arm. The patient experienced headache, migraine, tiredness, vomiting, chills, and feeling hot on an unspecified date in Apr2021. The outcome of these events at the reporting time was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Slight numbness in tongue that lasted several hours beginning within 10 minutes of vaccine along with dizziness; experienced fatigue, nausea, tinnitus, blurry vision in right eye, elevated heart rate, buzzing sensation in back of head, stabbing pains in stomach followed by profuse watery diarrhea. Dizziness and nausea still unabated seven days following vaccination.

on 04/25/21 patient complained of cold like symptoms, mild fever, upset stomach, headache, and shortness of breath 04/26/21 tested positive for Covid

Presented to emergency department with complaints of fatigue, cough, diarrhea, epigastric pain, confusion, and malaise. Patient was admitted for hyperglycemia, suspected UTI and COVID-19 infection. Patient reported symptoms started around the same time of vaccination. Patient is still admitted at time of writing.

thrombocytopenia; Heavy blood in the stool; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (Lot Number: EN6148), via an unspecified route of administration in arm left on 21Mar2021 as single dose for COVID-19 immunisation. Medical history was none. No known allergies. The pateint was not pregnant. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 28Feb2021 for COVID-19 immunisation. No other vaccine in four weeks. No ther medications in two weeks. The patient experienced Heavy blood in the stool, thrombocytopenia on 07Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. No treatment received. No covid prior vaccination. No covid tested post vaccination. No covid tested post vaccination. The outcome of events was not recovered.

Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseous; Headache; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 07Apr2021 02:35PM for COVID-19 immunization. The patient had no relevant medical history and family history. Patient received historical vaccine of first dose BNT162B2 (COMIRNATY) via unspecified route of administration in left arm on 17Mar2021 02:35 PM for COVID-19 immunization. Medical history and concomitant medication was not reported. No family history. Patient reported as does not think her medications had anything to do with the events. she takes all the same medications and didn't have any events with the first vaccine. On 07Apr2021 at 14:35 after second vaccine she got headache right after that and still ongoing. On 08Apr2021 lymph node under arm swollen hurts and she can't touch it and still ongoing, she was nauseous around 5 or 6 in evening. On 08Apr2021 2:00 AM she had chills, tiredness, doesn't feel good weak and fever was 100.5 then it went higher and lower. Second shot on Wednesday and she really sick was 25 percent better today. No Prior Vaccinations (within 4 weeks). The outcome of event recovered for Chills, Fever on 09Apr2021, Nauseous on 08Apr0221 and not recovered for Tiredness, Headache, Doesn't feel good, weak, Lymph node swollen, hurts, can't touch it. No follow-up attempts are needed. No further information is expected.

Patient left facility after vaccine and had only waited 12 minutes in lobby. Patient states she walked to her car to go home and developed metallic taste in her mouth with nausea and diaphoresis. Patient came back into the clinic. She was placed in the cardiac care chair. Denies any shortness of breath, chest pain, difficulty swallowing or hives. Skin warm but she is diaphoretic. BP 144/70, pulse 71, pulse oximeter 100%. Patient states she still has nausea and feels like vomiting. After 10 minutes, patient transferred to ER at hospital.

At 11:15 p.m. (10 hrs. after shot), I woke up nauseous, sat up in bed and felt weird, got up and made it to the foot of bed and passed out. When I came to, had my husband get me a cold rag, but then I felt diarrhea hit, I crawled to the hall to the bathroom, stood up and had the uncontrollable shakes so bad the whole toliet shook with me. After I finished in bathroom I went back to bed and literally shook for 1 1/2 hours and was up most of the night. This was my 2nd shot. On the 1st shot it made me feel like I was in a fog, like when you pass out and come to and your not all there. Took 3 hours to shake that one. I don't know what is in the freakin thing, but my body cant take this kind of stuff and I WILL NOT be doing any more of this quickly made, quickly approved vaccines. Count me out for any further ones. I'M DONE !!! I have never taken the flu shot ever so I WON'T be doing any more of these no matter how much the CDC pleads with me

After my vaccine, I passed out. I went to the hospital for three days and they told me I had an ocular migraine. I also had a post concussion syndrome and was out of work till 04-12-2021 with nausea and severe migraine headaches. I still have headaches today and I am on migraine medication.

Hasn't eaten much; Really bad headache; Migraine; nausea; vomiting; This is a spontaneous report from a contactable consumer reported for herself. This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 09:35 Arm Left at single dose (Lot: EW0151) for COVID-19 immunisation. Family medical history included Migraines. No other products. No additional vaccines administered on same date of the Pfizer Suspect. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Mar2021 at age of 61-year-old Left Upper Arm at single dose (Lot: ER8727) for COVID-19 immunisation. She had only a sore arm after the first dose of the vaccine. Says it started the day of the vaccine and lasted for a couple of days then it was gone. She got her second dose of the vaccine on Saturday 10Apr2021. States right after that she started having a really bad headache on 10Ap2021, not long after the vaccine, that turned into a migraine, Continues but has gotten better. She was nauseous and vomiting on 10Apr2021. States she stayed in bed most of the weekend. Nausea and Vomiting began on 10Apr2021. States she had eaten that day. Hasn't eaten much since then besides crackers. States the nausea and vomiting started before the headache got really bad. States the nausea and vomiting have improved and then again mentions she hasn't eaten anything besides some crackers. States she has also taken some nausea medication. Lab data included a CT Scan of her sinuses and throat; about a week or so ago; has not received any results. Outcome of the event headache, Migraine, nausea, vomiting was recovering. Outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.

severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakness; brain fog; a little tired; a little off; Fatigue; sore arm; couldn't eat; couldn't open her eyes; nystagmus; couldn't walk at all without help; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: EN6208; Expiration Date: Jun2021), via an unspecified route of administration in the right arm on 19Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included ongoing celiac disease diagnosed in 2012 and has been gluten free ever since, allergies, and anxiety. Concomitant medications included zolpidem tartrate (AMBIEN) taken for sleep; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergies; alprazolam (MANUFACTURER UNKNOWN) taken for anxiety; vitamin d nos (MANUFACTURER UNKNOWN) taken for immune system health; and magnesium (MANUFACTURER UNKNOWN) taken for health. The patient previously received the first dose of the bnt162b2 (Lot number: EN6203) at 61 years of age on 26Feb2021 between 5:15PM and 5:30PM in the left arm at a single dose for covid-19 immunization and the flu vaccine (INFLUENZA) for immunization 15 years ago and experienced arm was sore. There were no other prior vaccinations within 4 weeks. On 19Mar2021, the patient experienced sore arm. On 21Mar2021, the patient experienced a little off, fatigue, brain fog, a little tired. On 31Mar2021, the patient experienced severe vertigo, fall down on the floor, nausea, vomited, horrible spinning, generalized weakness. In 2021, the patient experienced couldn't open her eyes, couldn't eat, nystagmus, could not walk at all without help. On an unknown date, the patient experienced dizzy. The events, severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning, required emergency room and physician office (video) visits. The patient was hospitalized for severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning from 31Mar2021 to 02Apr2021. The clinical course was as follows: the patient received the second dose on 19Mar2021 and she didn't really have any bad side effects, a sore arm, and a little tired on the second day, maybe a little off but was fine. 12 days later she was vacuuming and had severe vertigo, she was down on the floor, just horrible spinning, horrible nausea and laid on floor and vomited all day. Her doctor told her to go to the ER. They did all kinds of tests with unknown results on an unknown date and she could not open her eyes for 2 days, she was so violently spinning with vertigo, they gave her fluids. She went in on Wednesday and by Friday she was a little better, she could open her eyes, still had spinning and vertigo. It was like nystagmus, her eyes were, she just really couldn't open her eyes for the doctor, had generalized weakness and couldn't walk at all without help in the hospital. The only time she moved from one position was to go to the bathroom with assistance. In the ER, she could not get up out of bed the first night they were trying all ways of catharizing her. She could not even get out of the bed with the help, they had to carry her to the CAT scan with negative result on 31Mar2021. She had slightly improved but still had vertigo and she was not vomiting anymore, that was only the first couple days. She was sent home with medications for dizziness and nausea but they didn't do anything. Two weeks later she was still dizzy, had vertigo, it was way better than it was, she can open the windows a little bit but she was basically in a dark room for like the first week and a half. Not violent like it was the first couple of days. The events were further described as: she was a little sore on 19Mar2021, 20Mar2021, 21Mar2021, and maybe the 22Mar2021 her arm was still sore. She clarified the sore arm pretty much ended on the 22Mar2021. She was surprised she felt fine on 19Mar2021 and 20Mar2021 and on the evening of 21Mar2021, in the middle of the night between 20Mar2021 and 21Mar2021 she felt a little off and a little more tired. On 21Mar2021, she didn't feel great, fatigued and brain fog but was fine after that. She began feeling a little off and a little tired early morning on the 21Mar2021. That was pretty much gone by the 22Mar2021. The feeling tired and a little off and the brain fog and fatigue went away 22Mar2021. She vomited constantly, started suddenly and violently and was incapable of moving, all she did was vomit and lay on the floor. It was a complete 360, she was fine vacuuming a minute before and then suddenly got dizzy and went down and could never get up. She had to be taken from upstairs in her house and transported to the hospital. She was not really experiencing the nausea now, she was not completely herself but she can eat, she couldn't eat for the first couple of days and was on IV fluids and once she got out of the hospital was able to eat a little and now eating almost normally. It took a week to eat normally and she couldn't eat holiday dinner on 04Apr2021. From 31Mar2021 to 10Apr2021, every day the nausea has slightly been improving. She was not quite herself and still has vertigo and was making herself eat her meals. She vomited 30 times and in the hospital they gave her an IV to stop that and never vomited in hospital, maybe once in the ER. She confirmed the 31Mar2021 was the last time she vomited. She had not recovered completely from nausea. She used be running around all the time, she would walk 10 miles per week to exercise, yesterday she had a mammogram scheduled and she was just so wiped out for doing something for the first time and had to lie down for the whole rest of the day. She was hospitalized from 31Mar2021 until the evening of 02Apr2021 when they let her out. She was given medication for nausea and dizziness didn't do anything. She was given ondasetron (ZOFRAN), 4 mg and meclizine. Because of her weakness, the patient was checked to see if there was any brain bleed or brain stem problems that would explain the vertigo and did not find anything. The tests were negative for any brain problems on an unknown date. Lab data included: blood levels: low on vitamin d (probably because she was not absorbing nutrients as well) on an unknown date, endoscopy: unknown results on an unknown date, and MRI: negative on 01Apr2021. Therapeutic measures were taken as a result of severe vertigo, fall down on the floor, nausea, horrible spinning, vomited, and dizzy. The clinical outcome of the events, severe vertigo, nausea, generalized weakness, could not open her eyes, nystagmus, could not walk at all without help, was recovering. The clinical outcome of the events, fall down on the floor, horrible spinning, dizzy, was unknown. The clinical outcome of the events, a little off, fatigue, sore arm, brain fog, and a little tired, was recovered on 22Mar2021. The clinical outcome of the event, vomited, was recovered on 31Mar2021. The clinical outcome of the event, could not eat, was recovered in 2021. No follow-up attempts are needed. No further information is expected.

She will be deceased, most likely, if she does.; arms really heavy, can hardly lift them; arms really heavy, can hardly lift them; She feels sick and unwell; face little swollen; chest pain; pressure in chest; ears ringing; Difficulty breathing; Migraine headache; heart palpitations; Chills; nausea; really red face, cheeks; back pain a lot worse; very high fever; This is a spontaneous report from a contactable consumer (patient) A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation . Age at vaccination :61 years. Medical history included ongoing epilepsy (started at 16 years old. Has not had a seizure in years, maybe 20 years) ,herniated disc and chronic back pain from 2003 and ongoing , Heart septal defect (repaired) and seizure disorder.Concomitant medication(s) included carbamazepine (CARBAMAZEPINE)at 200 mg, 1x/day taken for seizure from an unspecified start date and ongoing. The patient experienced "she will be dead, most likely, if she does" on an unspecified date , difficulty breathing on 10Apr2021 with outcome of unknown , very high fever (on 08Apr2021 with outcome of recovering , migraine headache on 10Apr2021 with outcome of recovering , heart palpitations on 10Apr2021 with outcome of not recovered , back pain a lot worse on 08Apr2021 with outcome of not recovered , ears ringing on 10Apr2021 with outcome of recovering , chills on 09Apr2021 with outcome of recovering , nausea on 09Apr2021 with outcome of not recovered , pressure in chest on 10Apr2021 with outcome of not recovered , chest pain on 14Apr2021 with outcome of not recovered , arms really heavy, can hardly lift them (non-serious) on 15Apr2021 with outcome of recovering , really red face, cheeks on 09Apr2021 with outcome of not recovered, face swelling on 14Apr2021 with outcome of not recovered and She feels sick and unwell on 14Apr2021 with outcome of not recovered. Clincal course was reported as follows:On 08Apr2021 she had her vaccine. She is running a fever and has every side effect on the template from the pharmacy. She is not doing good and should probably be in the hospital. She can not drive her self, or have anyone else drive her. She feels really bad and is afraid of a clot. This is from the first shot and she is not getting another. She will be dead, most likely, if she does.She can hardly lift her arms up. She did not see this in list of side effects and doesn't know what that is.She tried to make a claim with Covid compensation number, but was unable to connect with them. Her symptoms started 3 days ago. She did this in case she had to. She read she has to keep her fever down. She just took some Tylenol.She didn't look for few days at the paperwork provided to her after the vaccine. She was seeing side effects and she got nervous, this is why she didn't call earlier.She is having trouble breathing now and has never been so sick. Caller asking how long the side effects last and needs to talk with Medical Information.Her Mother recommended she receive the vaccine and told her of all these people coming across the boarder and that they may bring Covid with them.She had a septal defect repaired in her heart. She doesn't know if there could be something wrong with that, but her doctor and heart doctor said she is fine. They haven't found anything from the testing she had had.Her difficulty breathing is on and off. It started 2-3 days after, and she doesn't know with her heart palpitations and if there could be damage. That's why she called the Covid compensation.The first day, she had a very high fever and headache. She didn't take her temperature, but she knew it was a fever. Today it is not as high as it was, it's not bad.She had a migraine and took something for it and it went away for hours. She took aspirin, Bayer Back and Body, and her fever and headache went away for hours.She experiences heart palpitations. Every time she eats they get worse. She has reported this to her physician. Her Physician said to take Tylenol and gets exercise. She recommended she doesn't lay up and caller thinks she wanted her to go to the hospital. Caller's mother can't drive and her sister is dying of cancer. Caller lives near her mother but she can't drive. She's older and caller can't ask her to do that.Her palpitations are sometimes there.She has a back injury from someone hitting her from behind. It is extreme back pain. It worsens after she gets a vaccine. She gets on the heat pad. She doesn't have anything for it, just some patches.Her ears are not ringing now and might be getting better. She had chills, but they're better today.She had nausea. It's better today. Yesterday, when talking to her doctor caller was advised to exercise. That makes her feel worse. It's not a big thing. She feels sick and unwell.Her face is really red and maybe a little swollen. Her Physician was thorough and she even asked about it, and commented it sure is red.Caller lays in bed and keeps her feet up. She knows she's got to move around, her Physician told her to.Caller is concerned about a blood clot. She is having pressure and pain in her chest. It has been the same. What's new is chest pain yesterday and did not feel bad, but it is noticeable. She hopes it doesn't get worse. What is new is her arms feel really heavy and she can't hardly lift them.Her facial redness worsened with her fever. The Tylenol is working, her fever is going down, but her arms are still heavy, but better.Treatment received for arms really heavy, can hardly lift them and very high fever.Additional information:Vaccination Facility Type: Pharmacy/Drug Store . No COVID Prior Vaccinations

heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot number: EN9581, Expiry Date: 31May2021) on 17Feb2021 and 13 days later patient started feeling sick and wholly got sick. Patient went for the second vaccine and passed out as she got the vaccine right there in the hospital (10Mar2021), so they gave her the vaccine and then patient sick for the next three weeks 3 and half weeks. The first-time patient passed out they took her to the emergency room for whole afternoon on 10Mar2021 because patient was so dizzy and queasy and she guessed they did like 'A1C' on her. They made sure that took blood for her they made sure patient was diabetic. They wanted to make sure there was nothing wrong with patient and then they sent patient home at same afternoon and patient went home and another whole week she was so dizzy and nauseous and now she was tingling feeling. All kind of weird things happened to patient and her heart was racing. Patient took herself back to the hospital after a week. Patient had to stay in the hospital for two days. And then they did MRI on her and a CAT scan and then they sent patient to neurologist and then patient to do another MRI. Patient been for past six weeks was being turmoil. Outcome of the events was unknown.

Several things happened to me - within the first 24 hours my digestive track started to make unusual sounds then within 48 hours I had severe diarrhea that lasted for days. However, the reason that I'm submitting this report is that I noticed on day 13 that I had a cluster of about 6 or 7 burst blood vessels on the outside of my left leg. The next day I noticed another one on the inside of my left leg near my knee. An then I noticed another one on the back of my right hand. I was very concerned at this point. Luckily I did not get any additional burst blood vessels and they have since healed. This all happened with my first innoculation.

Pt presented to ED w/N/V, coughing, headache, fevers, fatigue x 1 week and inability to keep PO intake down. Started developing symptoms on 4/16, tested negative for COVID on 4/19. Was found to be COVID positive despite getting Pfizer vaccines (3/11/21 & 4/1/2021). Was admitted for additional management of acute hypoxic respiratory failure due to COVID-19 pneumonia and N/V/D with electrolyte imbalances. Treated w/remdesivir and dexamethasone. Her N/V and electrolyte imbalances improved w/IVFs and zofran. Was discharged on 4/28 w/follow-up in 5-7 days.

around 2nd day have burning feeling in all my joints, migraine, upset tummy, and extremely tired. This went on for a few days. I called my health care provider since I was feeling so bad. I called on Friday and heard back on Monday. Things had gotten a lot better. Now since then my right shoulder hurts, and it never did before, When I move it it hurts, putting pressure on makes it hurt, I think it was caused by the shot. I have a apponitment with my doc on Tuesday to let them check it out. It has not gotten better and seems to be slowly getting worse, pain will go to my elbow and up my collar bone. I have never had this type of pain or issue before the shot.

Almost fainted from struggling to breathe; abdomen swell quite a bit; nerve burning/nerve pain; Diarrhea; Losing some weight; Almost fainted from struggling to breathe; This is a spontaneous report from a contactable consumer (patient). A 61 Years female (no Pregnant) patient received 1st dose of BNT162B2 (Lot number: EN6208) Intramuscular on 25Mar2021 at single dose on Left arm for covid-19 immunization. Medical history was not reported. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications that the patient received within 2 weeks of vaccination was Vitamin C and D and a multi vitamin. Past drug included Allergies to Codeine, Cipro (Cipro gave me central nervous system toxicity). Patient stated that I could immediately taste the shot. Two hours into receiving the shot I could feel it attack my right side. Almost fainted from struggling to breathe. It made the right side of my abdomen swell quite a bit to the point where I felt I almost needed to ice it. It also gave me nerve burning. It has been 3 weeks and I still have some nerve pain from it. Diarrhea. Losing some weight. Unsure if I dare get the second dose. No treatment. Outcome of the event was unknown. Prior to vaccination, patient was not diagnosed with COVID19. Since the vaccination, patient had not been tested for COVID 19. No follow-up attempts are needed. No further information is expected.

Hot and cold chills diarrhea started March 9, 2021 for 3 weeks now my loose stools is loose and I am having diarrhea never had a bowel problem before until i took The Pfizer vaccine on March 9 it is now May 5 and I still have the problem and weight loss Doctor is sending me for more testing because I never had a problem before to find out why this is happening to me it Hass to come from the vaccination shot that?s when everything started happening to me

Day 2 & 3 after my vaccine, I had fatigue & shortness of breath. On Day 3 , it began with a little nausea that became worse, along with shortness of breath. Ado I also pain followed, & no medication or rest with a heating pad helped. After 7 hrs. I sought treatment at Emergency Room. After several tests, and an abdominal cat-scan, it revealed that I had appendicitis, and would need an appendectomy soon. At 5:30 am I received an appendectomy from . I stayed overnight in the hospital.

Cough; Shortness of Breath; Fatigue, Chills, Muscle or Body Aches, Headaches, New loss of taste or smell, Congestion or Runny Nose, Diarrhea; Vomiting. Prednisone (DELTASONE) 10 mg tablet; Take 2 tablets (20 mg total) by mouth 2 (two) times a day for 4 days-Azithromycin (ZITHROMAX) 250 mg tablet; z pack. 500 mg day one 250 mg day 2-5. -Albuterol HFA (PROVENTIL;VENTOLIN) 90 mcg/actuation inhaler; Inhale 2 puffs every 6 (six) hours as needed for wheezing for up to 7 days.

Immediate excruciating headache and earache, tingling disown my left arm to fingers and nauseated I have continued to be sick since my vaccine Visited my doctor yesterday and was put on methyl prednisone

I had the following reactions 12 hours after shot. Which lasted until about noon Saturday. Diarrhea four times Vomiting three times Headache Chills Nausea that lasted about most of the day

Pt suffered appendicitis about 10 days after 1st dose and had to have appendix removed. Doctors did not attribute it to vaccine but pt wanted to report anyways.

Very late diagnosing as shingles; Headache at work after vaccine; then got more severe along with leg very sensitive and burning feeling; then got more severe along with leg very sensitive and burning feeling; severe stomach pain; This is a spontaneous report from a contactable other HCP (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 28Jan2021 09:00 (at 61 years old), single dose for covid-19 immunisation. Medical history included concussion, endometriosis, all from an unknown date. Concomitant medications included estradiol; progesterone. No other vaccine in four weeks. On 28Jan2021 09:00, patient experienced Headache at work after vaccine , then got more severe along with leg very sensitive and burning feeling, better then 5 nights very severe stomach pain-Dr appt and ER to get sonogram, CT-Very late diagnosing as shingles. The outcome of the events was not recovered. Treatment of adverse events was CT, Sonogram. No covid prior vaccination. Not covid tested post vaccination. No Known allergies. Information about lot/ batch number has been requested; Sender's Comments: Based on known disease pathophysiology, the event herpes zoster is assessed as not related to suspect vaccine BNT162B2.

Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.

After injection, while waiting in lobby, patient felt lightheaded and nauseated and looked pale. Vomited once. Appeared to be a vasovagal response and patient was assisted by staff to lie down across 3 chairs. After several minutes laying flat she began to feel better. Sat up in chair and staff provided water and cool damp cloth. She remained for 10 more minutes after which she said she felt much better and color had returned to face. Staff ambulated with her to the lobby and she denied any more symptoms

Day after injection- diarrhea for two days and sore arm. Five days after injection left arm so sore I couldn't use it. Prescribed Motrin 600. Pain gone in two days.

After about 5 minutes, lips started to tingle - they then felt swollen and hurt. I had difficulty breathing (mild), and difficulty swallowing. Symptoms increased until about 15 minutes. Then leveled out. They were mild to moderate. I spoke to the EMT (not helpful). I waited 30 minutes and left. Took a Benadryl 25mg tablet (generic) after getting to my car. The symptoms lessened. By the time I got home (30 minutes) the only thing that bothered me was painful lips. That lasted a few hours. My allergist has advised against the 2nd dose.

Respiratory symptoms - Burning pain when inhaling in lower trachea and upper chest. Feeling of weight on upper chest. Breathing was not obstructed. Chills but not fever, hypothermia (97.1 F), body aches, dizziness, spots and floaters in vision, tiredness, slight nausea. Note this related find from internet research: A team of researchers have found that exposure to the SARS-CoV-2 spike protein alone was enough to induce COVID-19-like symptoms, including severe inflammation of the lungs. https://medicalxpress.com/news/2021-04-sars-cov-spike-protein-lung.html Messenger RNA vaccines work by instructing cells to create "spike proteins." These proteins simulate part of the SARS-CoV-2 cell structure and trick the body into believing it's infected with the virus.

Lower back discomfort/mild joint pain Mild injection site pain Large swelling/redness at site for a week Mild/moderate loss of bladder control Vertigo/nausea Lethargy Chills/fever 102.9 Congestion/cough Headache Unwell for about 24 hours

Mild/moderate loss of bladder control Off balance Injection site pain Headache/ stabbing pain in left temple area,a little in the right temple/"spacey" feeling Lower back pain/General muscle weakness Chills/ low grade fever Nausea Congestion/cough Lasted 24-48 hours

Headache at work after vaccine; leg very sensitive and burning feeling; leg very sensitive and burning feeling; very severe stomach pain-Dr appt and ER; shingles; This is a spontaneous report from a contactable other health professional (patient). A 61-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 61-years-old), administered in Arm Left on 28Jan2021 09:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included concussion (years ago) and endometriosis (decades ago). The patient was not pregnant. Not diagnosed with COVID prior vaccination. No known allergies. Concomitant medications included estradiol (ESTROGEN) patch and progesterone cream: taken for unspecified indications, start and stop dates were not reported. The patient experienced headache at work after vaccine, then got more severe along with leg very sensitive and burning feeling (all on on 28Jan2021 09:00), better then 5 nights very severe stomach pain (unspecified date in 2021)-Dr appt and ER to get sonogram, CT. Very late diagnosing as shingles on an unspecified date in 2021. The events resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included computerised tomogram: shingles on 2021 and ultrasound scan: shingles on 2021. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered. The vaccine facility type was hospital. No other vaccine in four weeks. Not tested for COVID post vaccination. Information on the lot/batch number has been requested.

intestinal upset; blood in nose mucous; Headache/low grade headache; dizziness; sinus stinging; runny nose; diarrhea; numbness in fingers; tiredness; weakness; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 10Apr2021 13:15 (at the age of 61-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included azithromycin. The patient previously took and had known allergies to Sulphur. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced the following events: headache for 2 days, dizziness, then low grade headache for 1 week, sinus stinging and runny nose, blood in nose mucous, diarrhea for 1 week, intestinal upset, numbness in fingers, and overall tiredness and weakness for over one week. No treatment was received for the events. The outcome of the events was recovered in Apr2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information about the Lot/batch number has been requested.

bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue; over all unwell/uneasy feeling; Nausea started about the 5th hour; feeling feverish, but never had a real fever; odd little pains in the left side of her neck; tension type headache; foggy; blood vein and possibly a nerve was hit; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9265) at 10:00 at single dose for COVID-19 immunisation. The relevant medical history included arthritis, breathing issues - asthma/copd still being tested, hypertension, liver issues and known allergies: Ct contrast, Dilaudid, Flagyl combined with doxycyline or cephlexinc. Concomitant medications were reported as none. At injection, a blood vein and possibly a nerve was hit. She felt the nurse followed all proper protocol for finishing the injection and notifying RN in charge. On 03Feb2021 at 2:00 PM, the patient had immediate pain in left finger joints and sudden heaviness in arm within a couple of minutes. It bled a bit. She was still having some issues with the hand, but the injection site was fine. She was concerned about the number of symptoms, the severeness and the length of time they had lasted. This was very worrisome and unexpected from all other accounts by others and everything she had read on the first vaccine. She was feeling 'off' within 2 hours, by the 4th hour She had developed chills, severe fatigue and over all unwell/uneasy feeling. Nausea started about the 5th hour and she started feeling feverish, but never had a real fever, odd little pains in the left side of her neck, but that subsided. Developed tension type headache, joint aches, foggy. This continued for about 4 1/2 days. Unable to function without Tylenol every 5hr. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Medical history included Mitral valve prolapse, Hypothyroidism and white blood cell count never came back to normal after cancer treatment. Concomitant medication included levothyroxine. The patient previously received first dose of BNT162B2, Lot number EP7534, expiration date 31Jul2021, on 27Mar2021 in left arm and experienced sore after the first dose. The patient received her second Pfizer covid 19 shot on Saturday 17Apr2021. After the second dose of the vaccine, the patient woke up in the middle of the night at 3:00am on Sunday 18Apr2021 and she had a sore arm from the shot and the next day it was in and out. Yesterday, 20Apr2021 the patient started getting dizzy, having nausea, vomiting, no fever, the patient threw up 4 times that day. Today she felt like throwing up but was eating things that were safe. She still had this queasy tummy and a headache on 21Apr2021. Her stomach was still like an ocean and she still isn't feeling well. She slept like 12 hours on Sunday. Her arm burned as soon as the pharmacist put the vaccine in, it was sore just at the site. The outcome of Nausea, Vomiting/ threw up 4 times, Dizzy, Headache, still isn't feeling well was not resolved. The outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.

slight cough, lips tingling right after shot, then back pain and discomfort, headache 4 hours later, then next morning - extreme fatigue, nausea, then through the day - brain shut down, slept all day, extreme pains throughout body like being stabbed and twisting the knife, convulsion like movements from pain, couldn't eat or drink. Didn't feel better until next morning. That was the worse experience I've ever been through. This was my second vaccine. I reacted to the first vaccine also, but not with such pain.

Not feeling myself since the vaccination, Body aches, terrible episodes of chills/shakes, No energy, very tired, no appetite, headaches Began getting worse @ April 1, 2021

slept for 2-3 days; Body was Sore; First Dose: Diarrhea; worn out; Arm was sore; This is a spontaneous report received from a contactable consumer (patient's husband). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Jan2021 13:45 at 61 years old (Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included ongoing seizure, seizures began when she was 5 years old, minor seizures. Seizures were under control in 1984, possibility configuration it is the right cocktail; Nerve injury; swelling on the wound leg; Blood pressure abnormal. Family history was none, states her Dad died last year, he was old, died of old age and natural causes. As people get older their body falls apart, nothing that is cancerous. States her Mother died of her heart, something to do with the heart and that was before they got married in 1984, he never met her mom. Concomitant medications included ongoing gabapentin taken for Nerves, she has been taking that for the last 7 years, states she has a wound on her left leg and that was being treated by a wound doctor for the last 7 years, states he got tired of what the wound doctor was doing so he drove her to (withheld) to be treated. Caller states the wound doctor at (withheld) made a suggestion on how to bandage it up and medicate it and it went from 8Jan2021 length was 7.5mm by 10mm and with (withheld) suggestion yesterday it was 1mm by 0.7 mm, so half the size of a penny, states he anticipated within the next week or two weeks that it will be healed; ongoing valproate semisodium (DIVALPROEX) taken for seizure, states she has been taking for at least 20 years; ongoing furosemide taken for Water Pill, states she takes it to reduce swelling on the wound leg; states he gives it to her on the odd day of the month; ongoing metoprolol taken for Blood pressure abnormal, start and stop date were not reported; ongoing zinc taken for an unspecified indication, start and stop date were not reported; ongoing acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported; ongoing pramipexole taken for seizure, start and stop date were not reported, states she takes it at 6pm, because it makes her drowsy and so the best time is at night time when she goes to bed; ongoing Vitamin C taken for an unspecified indication. No other vaccines were administered on same Date of the Pfizer Suspect, every year they get the flu shot and everything is normal. Caller states his wife got her first shot on 09Jan2021. States the effects started immediately, her arm was sore and then the next day (10Jan2021) her body was sore and she had diarrhea for 2-3 days and she also slept for 2-3 days, she was worn out. On the 3rd or 5th day she said she feels good, lets go. Caller states, then they were okay. The outcome of the events was recovered on 12Jan2021.

Second blood clot that traveled to her brain which caused her to have a stroke; Blood clot in her right leg; Weight Loss from 258 pounds, down to 208 pounds, back up to 214 pounds.; She has to learn how to walk again, she is in a wheelchair now; Having Problems Swallowing from the Stoke; Speech went down to 25% and now she is at 50%, because of the Stroke; high blood pressure; slept five days; Arm was Sore; Body was Sore; Diarrhea; Slept and was Totally Exhausted; This is a spontaneous report received from a contactable consumer (husband of the patient) and a contactable other healthcare professional. This consumer reported similar events with different doses of the same product; this case refers to dose 2; only this case is serious. A 61-year-old adult female received the second dose of BNT162B2 (solution for injection, Lot EL3246 expiry information not provided) as a single dose via an unspecified route on 30Jan2021 at 13:45 (at 61-years-old) for COVID-19 immunization. Relevant medical history included ongoing seizures (1964; began at 5 years old, minor seizures; under control in 1984, possibility configuration it is the right cocktail), and wound on her left leg (that was being treated by a wound doctor for the last 7 years). Concomitant medications included gabapentin; 300mg three times a day by mouth (6am, 2pm and bedtime) ongoing from 2014 for nerves; valproate semisodium (DIVALPROEX; 500mg two tablets in the morning and one tablet at 6pm ongoing from 2010 for seizures furosemide 20mg every 48 hours (odd days); States she takes it to reduce swelling (diuresis)on the leg wound leg; states he gives it to her on the odd day of the month from an unspecified date; metoprolol (50mg) one tablet twice a day (6am and 6pm), for Blood pressure management; ascorbic acid, zinc (VITAMIN C WITH ZINC; 500mg/50mg) once daily from an unspecified date for an unspecified indication; acetylsalicylic acid (ASPIRIN) 81mg once daily from an unspecified date for an unspecified indication; and pramipexole 0.5mg once daily at 6pm ongoing from an unspecified date for seizures. The patient previously received COVID-19 immunization with the first dose of BNT162B2 (solution for injection; Lot EL1284) on 09Jan2021 (at 61-years-old) and experienced arm was sore, slept for two to three-days, body was sore, and diarrhea. The consumer reported that on 30Jan2021, the patient experienced her arm was sore, her whole body was sore for about five days, she had diarrhea for five days, and she for slept five days and was totally exhausted. The consumer then reported that on 22Feb2021, she developed a blood clot in her right leg. The reporter explained that her leg swelled up and turned dark blue, almost black. The consumer reported that the patient was immediately rushed to the hospital. Caller states they did all sorts of tests and confirmed she had a blood clot in her right leg. States she was hospitalized from 22Feb2021 through 26Feb2021, so for five days. Caller states the leg went back to normal color, the swelling went down and she felt good. Caller states they came home on 26Feb2021, and she was up moving around, and everything was wonderful. On an unspecified date in Feb2021, around the time of the first blood clot, the patient was diagnosed with high blood pressure. Caller states on 12Mar2021 she had a second blood clot that traveled to her brain which caused her to have a stroke. Caller states when they got to the hospital they said she had a stroke from a blood clot that was somewhere in her system and it traveled to her brain. Caller states she was hospitalized from 12Mar2021 through 16Mar2021 when she was released from the hospital. Caller states she was too sick to go home so she was transferred to Rehab Center. She was there from 16Mar2021-27Apr2021. Caller states on 27Apr2021, she was transferred for rehab. Caller states at the center they only give rehab once a day for 30 minutes and he only works five days a week. Now she gets three hours of physical therapy a day and it is seven days a week. States they are working to get her to walk again and she is receiving speech therapy. States she has to learn how to walk again. Caller states her lowest weight was 208lbs, and they weighed her in yesterday and she was at 214lbs. Caller states with the stroke when she was at the hospital, they put her on baby food because she was having problems swallowing. While at rehab center she went from baby food to mechanical food. On 27Apr2021 she went to regular food. Speech because of the stroke went down to 25% and now she is at 50% and she is also getting one hour of speech therapy at hospital. Caller states they recognized it is important to get as much therapy as possible in the first 90 days, they call it a boot camp and patients are limited to 90 days to repair the damage. After 90 days, that is it. States that is why it was important to transfer her to hospital to heal and get back to normal. Caller states she is in a wheelchair and they are trying to get her to stand up. Caller states at the hospital they were able to get her to take 2 steps. At Hospital they were able to get her to do special training and he was able to get her to take 4 steps. Caller states he has no idea where she is with the walking right now. States she did not do anything on the 27Apr2021, because that was arrival date. Therapy started yesterday on 28Apr2021 at Hospital. The consumer also reported that the patient's current weight is 214 pounds, from 258 when she took the shot and down to 208 pounds on an unspecified date in 2021. Treatment for the events included occupational, physical and speech therapies, as well as apixaban (ELIQUIS), rivaroxaban (XARELTO), and spironolactone 25mg once a day; takes in the evening at 6:00p.m. ongoing from 12Mar2021 for hypertension. The outcome of the events arm was sore, body was sore, diarrhea, and slept and was totally exhausted and slept five days was recovered on 04Feb2021. The outcome of the event blood clot in right leg was recovered on 26Feb2021. The outcome of the event second blood clot that traveled to her brain which caused her to have a stroke was recovered with sequelae on an unspecified date in 2021. The outcome of the event Having Problems Swallowing from the Stoke was recovered on 27Apr2021. The outcome of the events speech went down to 25%, back up to 50%, and weight loss from 258 pounds, down to 208 pounds, back up to 214 pounds was recovering. The outcome of the event high blood pressure was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021484454 PFIZER (Same reporter/patient/different doses/events)

Extreme nausea, dry heaves, sweating, chills, unable to keep food (saltine crackers, Ensure) in stomach. NO FEVER, unable to lift head off pillow, unable to take Tylenol without heaving.

Pt reports after receiving her vaccines and for the past 3 weeks she is still in a lot of physical pain, difficult to walk, and lots of muscle and joint pain in the side she received the vaccine. She has not been able to sleep and her brain feels foggy, states the her memory has been affected severely. Pt also reports still having diarrhea, vomiting and coughs sometimes. At time of call pt also reports she is feeling shaky. Pt states all these symptoms she is experiencing is all because of the vaccine. Pt reports she took Tylenol, and did not help. Pt reports that she called her MD today and was told she should still get her second vaccine.

hives on her mucous membranes/got a few hives on shoulder; bumps; then itching inside nostril and other mucous membranes/whole mucous membrane area down there still feels sensitive or irritated or something/burning feeling in mucous membranes, itching and stinging; then itching inside nostril; hives/red flushy skin/itching; touches something like the remote, patient felt very cold; itching on forehead and on back and on shoulder and in other places/itching; flushing; At first had a funny taste in mouth right away; did have diarrhea a lot when first got home; By evening face was flush red; face was probably a little bit puffy; even today every so often where hair touches face is sensitive/All openings to body are sensitive; mucous membrane area down there still feels sensitive or irritated; got goosebumps right away; burning feeling in mucous membranes; stinging; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER8736), via an unspecified route of administration in right arm on 28Apr2021 08:15 (at the age of 61-years-old) as 1 st dose, single for covid-19 immunisation. No prior vaccinations (within 4 weeks). No family medical history relevant to the events. No additional vaccines administered on same date of bnt162b2. Medical history included strong reaction to bee stings, allergies/some nuts, allergies/shellfish, allergies to a sulfa drug, allergies, hives, red flushy skin and itching (noted from all allergies that never had anaphylaxis before but gets hives or red flushy skin and itching from some or all of these). There were no concomitant medications. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies. The patient received the first dose of bnt162b2 yesterday (on 28Apr2021 at 08:15) and had a reaction to it. The site of the injection for first dose was fine, nothing around the site. On 28Apr2021, the patient experienced at first had a funny taste in mouth right away (vaccination facility said they had never heard that before; gone momentarily after first dose/went away completely); then itching inside nostril and other mucous membranes (within five minutes of receiving the first dose); by evening face was flush red (coloring part was completely gone away); face was probably a little bit puffy; even today every so often where hair touches face is sensitive and will get itchy again; did have diarrhea a lot when first got home (lasted 15-20 minutes and then it was over); right away had itching on forehead and on back and on shoulder and in other places; whole mucous membrane area down there still feels sensitive or irritated or something. All openings to body are sensitive; continued to have burning feeling in mucous membranes, itching and stinging. Skin was really sensitive, when patient felt warm if pushed up sleeves, arm got a little cool and got goosebumps right away. If the patient touches something like the remote, patient felt very cold, skin seemed very sensitive all over. The patient took temperature to see if had a fever, temperature was 98.6, exactly normal, usually runs lower than that but definitely wasn't a fever. The patient left the vaccination facility after half an hour, nothing seemed life threatening. On 29Apr2021, the patient experienced that even today overnight got a few hives on shoulder, back up by shoulder area on one side and noticed the bumps, felt where the bumps were but they are not as big and they were itchy occasionally but not very itchy. (were better now). The events did not require emergency room or physician office visit. The patient stated that it wasn't anaphylactic reaction. The patient have read online that if have a reaction in less than four hours, it was considered severe. The patient was a little concerned when got the shot and was reassured at the vaccination facility that they had not seen anaphylaxis. The patient was wondering if it was okay to get the second dose or should the caller hold off. The patient asked if her symptoms were categorized as a severe allergic reaction (in 2021) and thereby contraindicate her from getting her second dose. The outcome was recovered from taste disorder and diarrhoea on 28Apr2021, from flushing and swelling face on 29Apr2021, from erythema in 2021; recovering from pruritus, piloerection, skin disorder and sensitive skin; not recovered from mucosal pain, burning sensation mucosal, pain, mucosal disorder and nasal pruritus while unknown for the remaining events.

Fast heart beat with palpitations; Tightness in chest felt like burning; Tightness in chest felt like burning; Shortness of breath; Extreme nausea; This is a spontaneous report from a contactable other HCP (patient). A 61-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN5318), via an unspecified route of administration on 31Jan2021 at 10:45 in right arm as 2ND DOSE SINGLE for covid-19 immunization. Medical history included asthma, coronary artery vasospasm. The patient took lidocaine and experienced allergies. The patient had received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previous vaccine included first dose of BNT162B2 (COVID Pfizer vaccine, solution for injection; Batch/Lot Number: EN1204) on 10Jan2021 at 10:45 in right arm for COVID-19 immunization. The patient experienced fast heartbeat with palpitations, tightness in chest felt like burning (coded to chest discomfort and chest pain), shortness of breath and extreme nausea on 31Jan2021. Five days later also she had shortness of breath felt like asthma. She also experienced fast heartbeat with palpitations. The events were reported as non-serious. The patient did not receive any treatment for the adverse event. The outcome of all events was not recovered/not resolved. Follow-up attempts are completed. No further information is expected.

Pt is a 61 yo female with recurrent granulosa cell tumor (s/p secondary debulking/whipple in 2019), stage II colon cancer, and stage IA cancer s/p radiation on tamoxifen/megage, with history of short gut on chronic TPN. On admission (5/4) she presented with weakness, diarrhea, and fever. Pt was tachypnic to 40s, 1L NC with O2 sat > 90% on admission. RR improved and she was eventually weaned to room air. The COVID PCR on admission resulted positive. She is s/p full Pfizer vaccination: first dose on 2/25 and second dose on 3/18. Pt remained stable on room air for the rest of her stay and received remdesivir for 5 total days.