Pfizer

Chills- HA's and feeling unwell; Chills- HA's and feeling unwell; Chills- HA's and feeling unwell; This is a spontaneous report from a contactable Other Health Professional (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH 9899, intramuscular in the Arm Right, first dose on 16Dec2020 18:45 (or 06:45 PM) at a single dose for Covid-19 immunization. Medical history included blood pressure abnormal (reported as BP). The patient's concomitant medication included unspecified statin for BP. The patient had not received any other vaccine in four weeks. The patient experienced chills, HA (headache), was feeling unwell X four events (pending clarification) on 16Dec2020 (onset time at 0200, pending clarification) with outcome of Recovered/Resolved with sequel. The events were reported as non-serious which requires sleep and rest. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested since the vaccination.

Tiredness; nausea; headache; chills; This is a spontaneous report from a contactable Other HCP, the patient. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Dec2020 at 13:30 (at the age of 60-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole, montelukast, and vitamin D3, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 08:00, the patient experienced tiredness, nausea, headache, and chills. The patient did not receive any treatment for the events. The clinical outcome of the tiredness, nausea, headache, and chills was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Low grade fever, malaise, headache, mild body aches, sort of out of it at times. Stated feeling bad within 2hrs of shot. Tx-rest, lots of sleep, Tamiflu. Felt bad for 2days.

Approximately 11:00 am I got crazy chills, put on my coat, and turned a heat lamp on, this lasted about 30 minutes. After the chills my mind went in to a fog, found it very hard to concentrate, and felt like I was moving in slow motion. Also had some GI upset, but discharge. The fog lasted until 4:00 pm.

Fever; He sweated the whole night; He slept for 24 hours and that is abnormal; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Batch number: 20201221E; Expiration date was not reported) on 21Dec2020 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included previously having COVID-19 from Oct2020 to an unspecified date; abnormal cholesterol; and abnormal blood pressure. Concomitant medications included acyclovir [aciclovir] (ACYCLOVIR); atorvastatin for abnormal cholesterol; hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS) for abnormal blood pressure; and vitamin D NOS. On 22Dec2020, the patient had fever. In Dec2020, the patient had sweated the whole night; and had slept for 24 hours and that was abnormal. The patient had body temperature values of 101.4 to 101.6 degrees Fahrenheit on 22Dec2020; and 98.8 to 99.9 degrees Fahrenheit on 23Dec2020. The patient had received ibuprofen (MOTRIN) and paracetamol (TYLENOL) as treatment for the fever. The patient considered his adverse reaction "mildish". The outcome of the events was recovered on 22Dec2020 (21:00) for 'fever'; and was recovered in Dec2020 for 'sweated the whole night' and 'slept for 24 hours and that was abnormal'. The reporter's assessment on the causal relationship between the vaccine and the event was related.

Myocardial Infarction: patient began to complain of severe chest pain 3 hours after the vaccine was given .. Vaccine NDC # 59267-1000-1. 0.3 ml given by RN. Patient called his PCP: "... I had very bad chest and shoulder pains, neck pains and slight fever from 9 pm until early this morning (Jan 8). My blood pressure was 155/95 mmHg. Should I see you today? Still feel sore all upper body. Above message received at 0720 am (Jan 8) and the patient was called back at 0757 am (Jan 8): patient was told that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the patient go to the emergency room. Patient understood the importance to seek medical attention..... Emergency Room notes: seen by MD on Jan 9. Note at 0749: patient complained of chest pain on/off since received COVID vaccine on Jan 7. Pain was substernal and radiated to the left shoulder, assoc with some SOB. EKG obtained and revealed ST segment elevation and a "cardiac alert" was called.

pt states experienced headache, soar throat, bone pain to (R) hand, chills, and low grade fever onset night of vaccination lasting 2-3 days

Low grade fever; muscle and joint pain; muscle and joint pain; mild chills; This is a spontaneous report from a non-contactable physician (patient). A 60-year-old male patient receive first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in left arm on 04Jan2021 14:00 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history included none. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced low grade fever, muscle and joint pain, mild chills on 05Jan2021 09:00. This case was non-serious. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.

Joint pain in both shoulders and knees; flu like symptoms; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 07Jan2021 and first dose on 19Dec2020 08:00 (lot number: EH9899) in left arm; both via at single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 19Dec2020 10:00, the patient experienced flu like symptoms and joint pain in both shoulders and knees that continued until second shot on 07Jan2021 that eventually subsided. The outcome of the events was recovered with lasting effects on unspecified date. No treatment given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.

Fever 103+ the night of. Deep fatigue and low grade fever the following day. Large area of pain and inflammation near injection site. About 7 inches by 3 inches. Fever resolved by the evening of the day following administration, fatigue was mostly resolved also. Inflammation and pain at site lasted about 5 to 6 days.

The night of the vaccination I became ill with flu-like symptoms. I experienced muscle aches, chills, a fever, fatigue, and stomach cramping that lasted 3 days.

Fever up to 101.1, 2 days after vaccine administration, chills, headaches, moderate to severe body aches and pains, especially to elbow and knee joints. I am now in day 3 and still having low grade fever with continued headache, body aches and pains.

One week of the vaccine, while having some coffee and cookies. About tens of consuming them, I felt like I was getting a cold and had to keep clearing my throat. I told my wife I feel wired and she mentioned my right eye looked different. In about two more minutes my right was swollen closed and speaking became difficult due to the swelling. My wife drove me to Hospital and I received Epinephrine and Benadryl and fluids.

Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient presented to Urgent Care on 15-Jan-21 complaining of left sided chest pain that started the evening before with an associated slight cough. Pt was afebrile with a heart rate of 88 and an O2 sat on room air of 98% in triage. His EKG showed a sinus tachycardia of 114 with a slightly prolonged QTc of 463 ms. Physical exam was significant for bibasilar crackles and X-ray showed bibasilar infiltrates consistent with COVID pneumonia but bacterial pneumonia could not be excluded. The patients BP was documented as 97/64. He was treated with Zofran for nausea and tylenol. He was prescribed a five day course of Azithromycin, an Albuterol inhaler, guaifenessin with codeine cough syrup, and Zofran. Labs were drawn and he was discharged. His lab results were reported after his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes, an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit was reported as negative and a swab performed at his employment on 13-Jan-21 was also reported to be negative. Patient could not be reached by phone after discharge from Urgent Care about these labs. On the evening of 16-Jan-21, Police Department received a 911 call about an adult at the patient's address who was found unresponsive. Upon arrival on scene, the patient was found to be deceased and a decision was made not to attempt to resuscitate. The death was deemed to be non-suspicious and the patient's body was transported to a funeral home. On 19-Jan-21, I contacted the State Medical Examiner's Office. They have decided to perform an autopsy and have recovered the CBC and chemistry specimens obtained for further testing.

Fever of up to 101.2 Fahrenheit; Chills; muscle soreness; This is a spontaneous report from a contactable other hcp (patient). A 60-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 12Jan2021 11:00 at SINGLE DOSE on Left arm for covid-19 immunisation. Medical history was none. The patient had no known allergies. Concomitant medication included ibuprofen (IBUPROFEN). The Historical Vaccine included product=COVID, brand=Pfizer, lot unknown=False, administration date=22Dec2020, administration time=10:30 AM, vaccine location=Left leg, dose number=1. The patient experienced fever of up to 101.2 fahrenheit, chills, muscle soreness on 12Jan2021 23:30. The patient underwent lab tests and procedures which included body temperature: 101.2 fahrenheit on 12Jan2021 23:30. No treatment was received. The event outcome was recovering. The events reported as non-serious. The patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.

1/19 2300- INJECTION SITE DISCOMFORT 1/20 0100- FEELING OF FEVER, BODY ACHES, SORE THROAT 0830- NAUSEA, FATIGUE 1050- TEMP 100.4. TOOK TYLENOL 1000MG @ 0100 AND @1030

Patient experienced fever 103 degrees, body and muscle aches, chills, ringing in the ears, headache, loss of appetite. Dr. suggested Tylenol and fluids for treatment. Spent 24 hours in bed as I had no energy.

Elevated blood sugar, unable to get it under control. Right side of skull and face extremely painful, including tongue lips, teeth eye, skin. Some soreness continued after 2 days.

Had the shot at 8pm on 1/21. Starting the morning of 1/22 when I woke up, was stiff and achy. As the day progressed got more achy and then started to feel chills. Late afternoon/early evening started to have low level fever. Took Tylenol at 10pm and Advil at 3am (1/23). Woke up on 1/23 at 8am and all symptoms had subsided. Felt fine from then on.

Fatigue and muscle ache morning after. Chills, Fever developing afternoon after injection. Took Tylenol

fever; chills; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as the second single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever and chills on an unspecified date. The outcome of fever and chills was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Chills; Fever 101.9; Fatigue; Body aches; Headaches; This is a spontaneous report from a contactable Other HCP (patient). This 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, on 15Jan2021 (at 12:00) at single dose on the left arm for COVID-19 immunisation, administered at hospital. The patient had COVID-19 before vaccination. He had allergy to coconut. No additional medical history was provided. The patient was not receiving concomitant medications. No other vaccine was received in four weeks. On 16Jan2021 (at 08:00), he had chills, Fever 101.9, fatigue, body aches and headaches. The patient was not treated for the events. Post-vaccination COVID test was not performed.The events were resolving. Information on lot/batch number has been requested.

Metallic taste beginning 20 min after injection. Chills beginning 15 hours after, then fever up to 100 F at18 hours after. Treated with 400 mg ibuprofen every 6 hours. Fever resolved at 20 hours after injection. Lymphadenopathy in left axillary nodes with tenderness.

This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: Apr2021), via an unspecified route of administration on 12Jan2021 08:00 at a single dose on left arm for COVID-19 immunization. Medical history included diabetes, stent, and cholesterol. Concomitant medication included metformin for diabetes, atorvastatin from 2009 (also reported as Jan2020) for cholesterol, ticagrelor (BRILINTA, NDC: 01860776-60, LOT: MM0189, EXP: Apr2023), saxagliptin hydrochloride (ONGLYZA, NDC: 0310-6105-90, LOT: MJ0731, EXP: Feb2023) for diabetes, and terbinafine. The patient experienced felt bad the first day, chills, wooziness/ woozy, felt wobbly all on 12Jan2021. Then experienced feeling like has a big weight on him, blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96/ checked his blood sugar again later and it was 153, which is not through the roof on 14Jan2021, and he is real tired on Jan2021. Patient says he got the Pfizer vaccine, clarified to Pfizer BioNTech COVID-19 vaccine, a couple days ago and the first day he felt bad and had chills and felt wobbly and woozy. He says yesterday (13Jan2021) he felt pretty good, and even worked out. He says he also worked out today, but he has had chills and feels like he has a big weight walking on him, he doesn't know the right word. He says he is also a diabetic, and he noticed today that his blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96. He says he is careful with his diet and eats the same thing. He says he hasn't taken his meds today, and he checked his blood sugar again later and it was 153, which is not through the roof, even without his medication so he would like to know does the vaccine affect your blood sugar? He says he got his first dose of the vaccination on Tuesday at 08:00AM, in his left arm. He clarifies that he has had chills today and then feels like there is a big heavy weight on him, he is real tired and his sugar is low, that was odd. The outcome of the events was unknown.

I had chills, 102.7 fever that lasted the evening of 27th until about noon on 28th, some loose stool but a lot better

Second shot vaccine was end of Jan 2021 chills that lasted 48 hours, I lost appetite the next day for 24 hours, I continued working, I started getting headaches and ringing in ears I perceived this as hypertension and it lasted 2-3 weeks, losartan 12mg per day, I checked it and it was high it?s never been that high so I took 24mg instead. I took 50mg total of losartan and it?s taken until now to get down to 25mg daily. I may have been exposed in Jan of 2020.

headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration at the right arm on 16Jan2021 at single dose for Covid-19 immunization in a hospital and not in military facility. The patient's medical history included sinus headache and headaches; both ongoing. The patient informed that he usually gets the sinus headache but wanted to know if this was normal. The patient was getting sinus headaches this time of the year. The patient was taking different medication but was taking sinus medication daily due to the chronic sinus condition. The patient informed that he was seeing an ENT regularly for the headaches and sinus condition. The patient informed that with the flu vaccine he normally has mild flu symptoms for a day. He got the shingles vaccine this fall and he had a more severe reaction with it in terms of flu symptoms. The patient thinks that shingles vaccine was called Shingrix. The patient has no prior vaccinations within 4 weeks. The patient had a headache after the COVID vaccine on Saturday. The patient informed that he got the vaccine on 16Jan2021 at about 10 am or 10:15 am and about 3 pm the headache started, it lasted about 2 hours. The patient had nothing other than the headache and for that he can't say that wasn't his normal sinus headaches he gets normally during this time of the year. The patient explained that the headache occurred later in the day but he can't say it wasn't his normal sinus headaches. The patient informed that the headache wasn't severe, not even a Tylenol was needed, there was no treatment. The patient was scheduled for the second dose on day 20 instead of the 21st day. The patient explained when he got his first shot he was given a window of days to choose from for the second dose. He picked one day which happened to be day 20 after the first dose. The patient informed that he wanted to know if that was ok but was told to check with his physician. The patient didn't want to get it the next day which would be day 21 as he was working that day and didn't want to risk feeling bad, in case there was a side effect. The event did not require a visit to emergency room and physician office. The outcome of the event headache was recovered on 16Jan2021 17:00. Follow-up activities are possible, information on the batch number has been requested.

Fatigue, muscle aches, low grade fever (99.8). Treatment Advil with mild improvement. Outcome continue to work does not interfere with ADLs.

Double Covid Pneumonia; feeling tired; weak; doctors were concerned that the Covid vaccine had taxed his immune system; This is a spontaneous report from a contactable consumer (patient; a direct care staff for a group home). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: 613247, expiration date: May2021), intramuscularly to the left arm on 21Jan2021 at 0.3 mL, single for COVID-19 immunization. He was given the vaccine at work. It's a group home facility. The patient's medical history included high blood pressure, and positive for the covid virus from 09Jan2021 to an unknown date. Concomitant medication included benazepril from 22Jan2021 and ongoing for high blood pressure. He saw a doctor on 22Jan2021 and he prescribed Benazepril; it was started on 22Jan2021. The patient previously received a flu vaccine on Sep2020 for immunization. The patient called about the Covid vaccine. He reported that on 09Jan2021, he was positive for the COVID virus. He was then cleared on 16Jan2021 to go to work. His work then offered the COVID vaccine on 21Jan2021 and he got it. Then on 29Jan2021, he was diagnosed with Double Covid Pneumonia. His doctors were concerned that the Covid vaccine had taxed his immune system. The patient was a direct care staff for a group home. He cares for adults that are developmentally challenged. He has a CPR license. The patient confirmed that he received his first dose of the vaccine on 21Jan2021. He started feeling tired and weak about evening of 22Jan2021. He then started feeling out of breath Wednesday 27Jan2021, 28Jan2021 Thursday, and Friday 29Jan2021. He thought maybe he might be having a normal side effect. He stated that the Double Covid Pneumonia was detected on the X-ray that took place on the 29Jan2021. He is scheduled for second dose on 11Feb2021. The patient stated that the weakness was horrible. They gave him antibiotics; he was starting to recover. He was off of work till Saturday due to the pneumonia. He doesn't know if he will be getting the second dose. The patient was prescribed antibiotic Cefuroxime Axetil 500mg 1 tablet by mouth twice a day for 7 days, antibiotic Doxycycline Monohydrate 100mg 1 tablet by mouth twice a day 7 days, a Steroid Prednisone 20mg 2 tablets by mouth daily at same time in morning for 5 days, and a breather Albuterol HFA 90mcg/att inhale 2 puffs by mouth every 4 hours as needed for shortness of breath, wheezing, or cough. It was reported that they did a Covid Nasal Swab Test on 09Jan2021, then on that Sunday or Monday he got positive result, and by that time he had fatigue. After he got the vaccine, he went back to work. After the vaccine, it was a big surprise about the double Covid pneumonia, and they think it was taxing the immune system. He has had no issues with vaccines in the past. He had a Flu vaccine recently and there was no problem, that was Sep2020. He wants to know should he get the second dose.The outcome of the events double Covid pneumonia and "doctors were concerned that the Covid vaccine had taxed his immune system" was unknown. Regarding his double Covid pneumonia, the doctor said his O2 level will determine how he is doing. They will also do another lung X-ray. The doctor said the antibiotic should take care of it. The doctor did warn him that things could get worse. They said he can possibly go back to work on 06Feb2021, but this is not certain at the moment; it could change.

This is a spontaneous report from a contactable consumer. A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot: unknown, brand: Pfizer), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Pfizer product) at single dose for COVID-19 immunisation. It was unknown whether the patient diagnosed with COVID-19 prior to vaccination or not. It was unknown whether the patient been tested for COVID-19 since the vaccination or not. It was reported that this was the second shot. The patient described muscle aches and a fever the night of the shot (on an unspecified date in Jan2021) and into the next day. It was unknown whether the patient received treatment for the adverse event or not. No seriousness criteria were reported for events. The outcome of the events was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.

I had a really severe left shoulder ache. I couldn't lay on that side, and I had general body aches and a low grade fever. Some nauseous. Really vivid dreams.

Diarrhea; body aches; chills; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown) via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunisation. Medical history included covid-19 (if covid prior vaccination Yes). The patient's concomitant medications were not reported. The patient experienced diarrhea, body aches and chills on 29Jan2021. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021. No follow-up attempts needed. No further information expected.

Upset stomach, headache, severe entire body aches short of breath, diarrhea, chest pressure, chills, fever and body weakness. Talk to Dr. and she recommended to drink plenty of fluids, take Tylenol , and rest.

1 day post second Covid 19 vaccine patient experienced severe headache that progressively intensified and loss of vision out of the right eye. Subsequently, he presented to the ED and was found to have a left occipital lobe intraparenchyma hemorrhage & 1-acute subdural hemorrhage posterior left tentorial. He was air transport to another facility for treatment:/monitoring. He is currently still admitted . He remains without right eye vision.

Phizer-BioNtech COVID-19 Vaccine EUA. Mild, sore throat for a 30 minute period; then dizziness; then nausea /vomiting, chills; T36.2-36.7 celsius. Lasted from 6:00 pm on 2/25/21 to 3:30 am on 2/26/21.

The described waking up around 9pm after going to be early the day after he received the vaccine. He said that his hands burned and itched. He took Benadryl and the symptoms eased after about an hour. He reports he had a similar experience after being exposed to rubella many years ago. At that time the symptoms spread to his whole body.

12-14 HOURS AFTER RECEIVING THE VACCINE PATIENT REPORTS HE DEVELOPED HEADACHE, MUSCLE ACHES, CHILLS, SWEATS, LOSS OF APPETITE. HE ALSO NOTED A RASH ON HIS NECK, FIRST ON THE NECK AND NOW HAS SPREAD TO THE ENTIRE BODY. PATIENT ALSO REPORTS SHORTNESS OF BREATH WHEN LAYING FLAT ON HIS BACK THAT STARTED AT THE SAME TIME.

Very sore arm. fatigue and fever March 9th ,10th and 11th. Dizziness the morning of the 12th. No issues after lunchtime on the 12th.

After first dose of vaccine, developed 5/10 persistent chest pain accompanied by diaphoresis. Known history of CAD. EMS was called for transport to hospital for urgent medical evaluation. Per family, the patient was taken to local ED on 2/27/21. Had EKG, blood enzymes x 2 and "everything checked out" and he was discharged home. Family notes that PCP follow up arranged and patient reported anxiety.

Escalated temperature in a range of 99.9 to 100.7 over a 19 hour period of time. Extreme fatigue - During a 34 hour period beginning 6 hours after receiving vaccination, I slept approximately 30 hours Diarrhea lasting fewer than 4 hours

Diarrhea began about 4:30 pm on 3/1/2021, continued intermittently for 4-5 hours. Significant loss of energy and headache began around 8:00 pm on 3/1/2021, and persisted with gradually decreasing intensity until 3/5/2021.

fatigue; problems with his gall bladder; 2nd day joint pain; First day sore arm; slight headache/headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration at the age of 60-year-old at left arm on 23Feb2021 08:15 at single dose for COVID-19 immunization. Medical history included heart failure, sarcoidosis and psoriatic arthritis. The patient wasn't allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced sore arm and slight headache in first day on 23Feb2021 09:00, joint pain in 2nd day on 24Feb2021, headache and fatigue and problems with his gall bladder in 3rd day on 25Feb2021. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient wasn't received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There wasn't treatment received for the adverse event. The outcome of events was recovered in Feb2021. This report was reported as non-serious report. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect.

Patient received Pfizer vaccine on 3/5/21. On 3/13/21 patient had fever, headache, diarrhea and tested positive for COVID 19 on 3/15/21 in our office.

Pt began to feel lightheaded and dizzy. He did pass out while sitting in chair. Quickly came back, woke back up and was able to answer orientation questions. He did report that this always happens to him when he takes antihistamines. Observed for a period of 5-7 minutes and felt / looked better. Told him we would observe him for a period of 30 minutes. Within 5 minutes, he had the exact same reaction. Patient passed out, was pale and diaphoretic. Blood pressure was 65/39 with HR 45 (3/16 @ 1430). At that time, he was moved to a gurney and placed in Trendelenburg position. Patient observed. repeat blood pressure at 1435 was 104/64 with HR 68. Patient continued in Trendelenburg position. Patient observed until 1455. Repeat blood pressure at 1452 was 105/69 with HR 73. Patient looked and felt better. He refused to go to ED. Wife to stay with patient and observe this evening and afternoon.

Fever, Lightheadedness, Shortness of breath 15 minutes post vaccination felt very dizzy with SOB. Had similar symptoms 2 days ago. Found to have temp 101.5 Sent via butler to ED for further evaluation

I have a lot of chronic coughing all throughout the day and at night when I'm trying to sleep at night, and I also cough up some flem with my cough

Severe chills with uncontrollable shaking that lasted 4-5 hours. Fever up to 103.7F for 24 hours. All over skin tingling and pain that lasted 24 hours. Treated with Tylenol and ibuprofen alternating every 3 hours. Applied cold compress to back of neck.

Started briefly with a drip that led to a cough at about one hour. That went away but then headache kicked in at about 3 hours. With the headache was dizziness and fatigue. That lasted from Saturday around noon until Tuesday morning.

10 hours after vaccine administered. Started with cloudy vision and a headache. Went to bed. Awoke two hours later with a fever of 102 and severe chills. That lasted 6 hours. Body temp went down to normal. Ate a little breakfast. Tired and achy. Went back to bed. Awoke several hours later. Fever was back. Though not as high, 100. Entire body hurt. Joints, head, abdominal pain, pain in left armpit. Stayed for several hours. Went back to bed about 4:00PM woke up an hour later fever down to 99. Ate a little supper. Acid reflux uncontrollable. Went back to bed. Awoke at 8:00PM . Fever still at 99. Stayed awake until 10:30. Went to bed. Tossed and turned with body aches all night. Had to get up every two hours to urinate. Awoke at 7:30AM. No fever. Feeling somewhat better. Still pain in left armpit. Headache almost gone. Joint pain almost gone, abdominal pain still present. Worst is over.

Sweating When Veteran returned to receive his 2nd Pfizer COVID-19 vaccine on 3/15/21, he reported that he had a mild reaction on the day of his first vaccine (2/23/21). Approximately 15 minutes after the vaccine, he experienced sweating, nausea, and one episode of vomiting. After drinking some water, the symptoms self-resolved within 3-5 minutes.

Patient felt nausea and started dry heaving. He was sweating profusely and had tremors. BP 140/60, HR54, O2 sat 98. He stated that he had not had a meal today and it could be his sugar. His glucose was evaluated and was normal. Pt. was taken to NWMC and was accompanied by his wife.

her husband could have been exposed or contracted COVID-19 on that Friday before receiving his vaccine; He has a little stuffiness, and coughs up a little phlegm when clearing his throat; He still has his sense of taste and smell, although he feels his smell is diminished; He still has his sense of taste and smell, although he feels his smell is diminished; received his first dose last Friday and has tested positive for covid; This is a spontaneous report from a contactable Consumer. This Consumer (Patient's wife) reported for a male patient that. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot number was not reported) intramuscular on arm left at single dose for covid-19 immunisation. Medical history included She woke up that Friday, 22Jan2021 feeling very ill with a headache. The patient's concomitant medications were not reported. It was reported that The caller's husband received his first Pfizer COVID-19 vaccine last Friday, 22Jan2021. That Sunday, her daughter tested positive for COVID. Her husband went and got tested and was positive. If he was positive and is due to having second shot, should he be getting it reporter questioned. He technically could have had COVID when he received his first vaccine. She did not know. She explains he did not have any symptoms, she clarifies further he has mild symptoms. Caller clarifies further her daughter does not live with them. She came home on her birthday on 21Jan2021. Her daughter works from home. She has no idea where she contracted COVID-19. She has gone nowhere. It's all a mystery. She woke up that Friday, 22Jan2021 feeling very ill with a headache. Her daughter tested positive on Sunday, 24Jan2021. Therefore, her husband could have been exposed or contracted COVID-19 on that Friday before receiving his vaccine. Obviously, they are not certain. He has mild symptoms. She clarifies her husband has been stuffy for months. He has a little stuffiness and coughs up a little phlegm when clearing his throat. He still has his sense of taste and smell, although he feels his smell is diminished. When attempting to confirm when these symptoms began, she states its unknown. It was just been chronic. He feels fine. He would never say he has COVID based on how he is feeling. He was due to get the second shot and she is just trying to determine if he should get it or if should wait questioned. They both went through a drive-thru clinic on 27Jan2021 and had the nasal swab. They got the results yesterday, 28Jan2021, and her husband tested positive. Outcome of the events was unknown. No further information was provided or obtained.

"flu-like" started 03/20/21 in the afternoon. Has had nausea, tiredness, headache, bodyaches that continue through 03/22/21. Called his own PCP who told him to call the Health Department.

The following day after the second shot, I had a fever for 24 hours, lost my sense of taste, injection site pain, weakness/fatigue, chills, swollen lymph nodes/sore throat. 96 hours later (as of this writing) still have diminished sense of taste, swollen lymph nodes/sore throat, quick fatigue.

Flu like for 24 hours. Starting at 8am I was very lethargic. Absolutely no energy. Progressed to terrible headache, had slight fever and chills. After sleeping from 1pm 3/18 to 6am 3/19 I awoke and felt 100 percent better. Still felt a little tired throughout Sunday 3/20 but not to the point that I couldn't function.

Arm pain first day. Lightheaded, feeling like fainting, dizziness, above stomach pain nausea, that happened parallel to erratic high blood pressure, 199/98. Chills, shakes, joints and muscle pain, headache, palpitations, night sweats, severe fatigue. From day 3 to day 17. Went to healthcare facility twice, and two doctor calls.

1) Cup right ear with hand; Arc described from thumb to little finger, 1/2 -1" depth. Needle sharp jabbing pain, lasts for an instance, yet whole arc "lights up"/pain felt throughout arc. Jabbing every 10-15 secs. Started ~08:00pm 03/03/21 (day after vaccine administered), and continued through the night, till mid-next day 04th. 2) Headache 3/02/21 6pm for the week ( through to 3/9/21) 3) right arm, site vaccine administered, bruised to the touch.

Sore joints in upper body, neck, shoulders, elbows , wrists & hands. Fingers are tingly and numbing , this is the most problematic symptom. Headaches come and go infrequently

Splitting headache in the afternoon followed by 100.8 fever, chills, and body aches starting about 2 AM.

Fever, joint aches, chills, headache lasting from about 11:00 p.m. the night of the vaccination date through around noon the following day.

Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 3/24/2021 Patient: DOB: Date: 3/24/2021 MRN: Subjective Patient is a 60 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection he did fine. However, pt noted to be sitting on side after pushing his sister in wheelchair to take a "break." He was noted to be wheezy and sob along with diaphoresis. Pt states he has hx of asthma and forgot to bring his inhalers. He normally doesn't walk much anyway and today was a long walk. He was offered a wheelchair and brought to the bay for inhaler treatment. . He denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms. Active Problem List Diagnosis ? Essential hypertension [I10] ? Long term (current) use of anticoagulants [Z79.01] ? New onset atrial fibrillation (HCC) [I48.91] ? Neuropathy (HCC) [G62.9] ? Hypotonic bladder [N31.2] ? Diverticulosis [K57.90] Per previous hx report, colonscopy 2004 ? Diabetes mellitus type 2 in obese diagnosed 2014 [E11.69, E66.9] ? Class 3 severe obesity due to excess calories with serious comorbidity and body mass index (BMI) of 45.0 to 49.9 in adult (HCC) [E66.01, Z68.42] ? Unspecified hemorrhoids without mention of complication [K64.9] ? Open wound of other and unspecified parts of trunk, without mention of complication [IMO0002] ? Obstructive sleep apnea (adult) (pediatric) [G47.33] ? Hypertrophy of prostate with urinary obstruction and other lower urinary tract symptoms (LUTS) [N40.1] ? Degeneration of lumbar or lumbosacral intervertebral disc [M51.37] ALLERGY REVIEW OF SYSTEMS: Patient complains of shortness of breath and wheezing Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 03/24/21 0825 Pulse: 89 Resp: (!) 24 SpO2: 100% Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is not ill-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Tachypnea present. Breath sounds: Decreased breath sounds and wheezing present. Comments: Albuterol inhaler used. Improved with use. O2 maintains at 100%. Skin: General: Skin is warm. Coloration: Skin is not pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Pt with reported improved symptoms and breathing after 2 puffs of albuterol. Pt declined blood pressure check. Heart sounds RRR. Improvement of wheezing and air movement. Eupneic. Skin dry. Assessment/Plan Treatment included: albuterol Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Asthma exacerbation due to exercise. Recommend keeping albuterol on him at all times if he is out of the home. Continue maintenance. Follow up with pcp accordingly. APRN Electronically Signed 3/24/2021 8:31 AM

Runny nose, sensation of throat closing up, difficulty swallowing. I could continue breathing nasally and could also drink water. Event cleared up around 6:00 PM the same day (date of vaccination).

Body aches, chills, and head ache for approximately 48 hours. Took ibuprofen to help reduce symptoms.

After vaccine shot developed 102-103 fever for about 36 hours. Everything back to normal on Wednesday pm. My wife gave me 2 Tylenol 500mg maximum strength after 24hours. I had also contracted the vaccine last September 15-22 and have fully recovered from it Thank you

Rapid heartbeat (90-115bpm) for 2-3 days while laying in bed. Low pulse ox (88) Fever (101-102F) and chills Related difficulty urinating and frequent urination due to prostate inflammation Loss of memory (Brain Fog?) in which I had no memory of events occurring from 3/7-3/9 and little memory on 3/10. Memory was close to normal on 3/12. Two Covid tests with negative results (taken on 3/8 and 3/11) Some lung congestion which could be due to bloody sinus mucus and post nasal drip I did retain my sense of smell and taste but had no appetite and did not eat or ate very minimally from 3/7pm until 3/11pm Very fatigued and weak with knee, hip and general joint pain. Increasing levels of fatigue started on 3/2 with little energy from 3/7-3/11. Fatigue is mostly gone as of 3/23.

series of 4 periods where I became quite hot inside and broke out in a heavy dripping sweat over a period of 6 hours or so. It would happen each time, lasting only 15 minutes or so.

Left upper extremity felt numbness and tingling to Right Chest. Pt experienced some diaphoresis to face, denies dyspnea. Pt has hx of a vaccine reaction three years s/p 3 years.

Patient waited 30 minutes after the shot was given then drove home. While driving, he experienced scratchy throat like mild food allergy reaction. Upon arriving home, he took one Benadryl around 4:46 pm, drank water and rest.

At around 2:20 in the morning I started getting really bad chills and shakes, I got 103 temperature and within 30 minutes diarrhea and stomach cramps and bodyaches

Saturday 313 am, chills, 400am extreme sweats ended by 630am - 718am unable to breathe, It felt like right lung collapsed. I was able to pull up breath, however light chest pain persists at this time, 12;12pm.

Started being cold around 11:00 on 3/29 - less energy throughout day - goose bumps from being cold around 9:45PM. Woke up throughout night with lower back/neck pain and headache. Now (7:18AM) experiencing headache, nausea, neck ache, chills and lower back pain. Feels like a hangover.

Severe hives outbreak all over the body 4 days after second dose of Pfizer vaccine. Hives started in groin and armpit then expanded to forearms, knees, neck, eyes, hips, back, tailbone area, head, and was severe in the hands and wrists. Also -- The evening and through the night after the second dose (given at 8:35 AM) side effects included headache, chills, fever, muscle aches.

loss of taste; possible allergic reaction to the drug; Can't pronounce words right; can't close right eye; eyes started to tear a lot; can't smile; right side of his face started drooping like that of a stroke; right side of his face started drooping like that of a stroke; headache at the back of his head; mouth started to feel numb; mouth started to feel numb; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 61 year old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) at the age of 60 years old, via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EL6205) as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, mouth started to feel numb and allergies to tree pollen; and family history of diabetic and heart disease (father); all from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium (TEMISARTAN), gabapentin, escitalopram oxalate (LEXAPRO), furosemide, potassium, valproate semisodium (DIVALPROEX) and tizanidine; all taken for an unspecified indication from an unspecified start date and ongoing. The patient received the first dose of BNT162B2. The next day, he said his mouth started to feel numb, and he had a loss of taste. Then on Saturday, his eyes started to tear a lot, and the right side of his face started drooping like that of a stroke. He also said he had headache on the back of his head, and his eyes do not. The patient wanted to know if he should go to the emergency room or if this is a normal reaction to the vaccine. The patient did have a sensation starting on Thursday of numbness in his mouth. The patient describes it as a feeling like when he was younger and would use chloraseptic spray, it feels like same numbness. He states that on Saturday his eyes started tearing up, and he does have allergies to tree pollen. The right side of his face feels and looks like he had a stroke, it is droopy on right side. The patient can't pronounce words right, can't smile, and can't close his right eye. The patient was checked with heart rate and EKG with his little machine and his temperature, and they all seem fine. The patient was also getting headaches at the back of his head. The patient took Advil for headaches, but it is not improving. The patient ran out of the Advil and doesn't have the bottle anymore. The patient took allergy pills, a knock off Benadryl, because he thought his eye tearing was possibly from allergies to tree pollen allergy or possible allergic reaction to the drug. The patient underwent lab tests and procedures which included body temperature: fine, CAT: not reported, EKG: fine, complete blood work: not reported and heart rate: fine; all on 15Mar2021. The outcome of loss of taste was unknown. The outcome of the rest of the events was not recovered. Information on the lot/batch number has been requested.

Woke up feeling foggy, achey, low grade fever (98.8 F). Just moved slow for most of the day, really had to concentrate as I went through my work day. Not as sharp or quick with mental processing and decisioning making. Work from home, so it's really obvious when I am off my game. Drank 6 x water at 12 oz per. Took two ExStrength Tylenol about 130, no fever, knocked down achey joints, head began to clear, but still not sharp. Not sharp mentally continued into morning of 31 March.

Initially headache, and sore arm at injection site. Only sore on contact and not too bad. Fatigue and loss of muscle strength (I am a hard core cyclist), not detectable during normal activities. A week later it persists. On the fourth evening, I could not stay asleep. As soon as I would drop off I would dream. It would be a violent encounter. I would physically strike out and I would wake up.

Headache, muscle aches, chills, high fever, rash,, swollen joints, fatigue, minor chest congestion lasting 9 days. Administered Tylenol, Ibuprofen, Mucous DM. Tested negative for Covid 19 on rapid and lab test.

The day of vaccination I felt like I was on steroids. I had lots of energy and felt a bit aggressive. The next four days I was exhausted and needed to sleep a lot.

He got his vaccine, and on Saturday 3/27/21 started having a slight fever, head cold/foggy head, slightly runny nose, loss of appetite. Had a COVID test yesterday which was negative, but he still continues to run low grade fevers which was 100. He has taken Ibuprofen for the symptoms. His temperature today 4/1/21 at 8:58 AM is 99.5, his blood oxygen has been between 95-97%, his pulse and BP have been a little high as well, and his pulse is 90, his BP was 141/99 yesterday at the store BP machine. He has not called his doctor to report his reactions.

Day 1-Chills/Shaking, Body Aches, Dizziness, Itchy Throat, wheezing breathing, difficult walking, extreme fatigue, Abdominal cramping. Day 2-Injection site pain, Nausea, fatigue.Day 3-Nausea,fatigue.Day4-Extreme lower and mid back pain, indigestion, gas, bloating, constipation.Day5-Fatigue lower back pain.Day6-Fatigue,lower back pain.Day7-Fatigue,lower back pain.Day8-Fatigue, Rash appears on torso and back, red bumps and itchy, Fever onset.Day9 Fatigue, Fever, rash itchy red bumps.Day10-Joint pain onset, Knees swollen large, reduced range of motion, hamstrings cramped up. Feet swollen and tingling. Rash over entire torso.Day11-rash abated, knees and legs swollen with limited range.Day12-Cramps hamstrings and knees swollen. Day13-Knees and leg cramps, fatigueDay14-Knees and legs cramped, fatigue.Day15-nausea,fatigue, hives on side and feet.Day16 Migraine onset, severe nausea, high fever, no sleep.Day17- extreme migraine, fatigue, nausea, hives.Day18-migraine,nausea,hivesDay19-Nausea,hives,fatigueDay20patchy hives, fatigue. Fatigue through to April 1, Skipped second dose.

Arm pain at injection site started 24hours later lasted 72 hours, Drowsiness started with in hours of injection lasted 48 hours,Sweating,Vomiting ,Dizziness,chills and Rapid heart beat started 48 hours later,sweating and vomiting lasted and hour.Rapid heart beat lasted about 15 min. Took anti nausea medicine for the vomiting and Tylenol & Motrin for arm pain.

Chills,Body Aches, Headache, Feverish/Hot. In bed two days. Mostly bad aches from my arthritis I would guess. Made it much worse.

Awoke around 10:00 next morning, March 31, with a bad sore throat, and feeling of fullness in my throat. Observed that my uvula was swollen, but not so much as to interfere with breathing. Symptoms improved over course of the day. General malaise all day, and into following day. I called my primary care doctor, their office said the symptoms were not serious and didn?t require any professional attention.

Fever, headache , body aches, tried Ibuprofen and acetaminophen lots of rest. Lasted about 36 hours

First injection: Sore arm that received initial injection for about one day. No treatments. Second injection received on other arm (right): Sore arm. The next day arm was sore, perhaps sooner. Also, the next day I was lethargic/sleepy, had a slight chill and was sore in at least some joints, including ankles. No treatments other than staying in bed. The second day I was close to back to full energy. Now a month later I'm occasionally naps these days, which I wonder whether are prompted by the vaccination.

Had shot at 2:30 Pm, Sitting in my truck and about 2:35 i started getting a warm feeling in my legs and feet (waist down) (Felt like same feeling when getting a CT scan when getting the dye put in veins,) Lasted about 25 minutes . then stated to feel it wear off. tired next day but dont know if from vaccine. (did not go to doctor)

Fatigue, Sore Throat, Chills, Headache, Some Nausea, Soreness at the Injection Site, Fast Palpitations

4/3/21 Fever 101.6 F, minor headache, moderate fatigue, slight throat discomfort 4/4/21 adverse reaction gone

4/3/2021, Initial Stinging pain at time of injection 4/3/2021 - 4/5/2021, Pain on the left arm (injection site) extending into my shoulder and down to my wrist. 4/5//2021 - Current, Pain Reduced, but will be setting up an provider appointment. 4/3/2021 - 4/5/2021, Nauseas 4/3/2021 - 4/5/2021, Severe Headache, used Tylenol medication to reduce the pain. 4/5//2021 - Current, Light headache, Using Tylenol for relief

lightheaded; stomach pain; feeling like fainting; that happened parallel to erratic high blood pressure 199/98.; nausea; Arm pain first day.; fatigue; palpitations; shakes; joints and muscle pain; joints and muscle pain; headache; Chills; night sweats; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 10:30 (Batch/Lot Number: EN6199) as SINGLE DOSE (at the age of 60 years) for covid-19 immunisation . Medical history included immune thrombocytopenia from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing , covid-19 from Mar2020 to Sep2020, (COVID 19 Long-Hauler from Mar-Sep2020). Concomitant medications included amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL); simvastatin (SIMVASTATIN). The patient previously took aspirin [acetylsalicylic acid] and experienced anaphylactic reaction, zantac and experienced rash and experienced peripheral swelling. The patient experienced feeling like fainting (medically significant) on 13Mar2021 14:30 with outcome of recovering , that happened parallel to erratic high blood pressure 199/98 on 13Mar2021 14:30 with outcome of recovering , palpitations on Mar2021 with outcome of recovering , lightheaded on 13Mar2021 14:30 with outcome of recovering , stomach pain on 13Mar2021 14:30 with outcome of recovering , shakes on Mar2021 with outcome of recovering , joints and muscle pain, headache on Mar2021 with outcome of recovering , chills on Mar2021 with outcome of recovering , night sweats on Mar2021 with outcome of recovering , nausea on 13Mar2021 14:30 with outcome of recovering , arm pain first day on 09Mar2021 with outcome of recovering , fatigue on Mar2021 with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: 120's-30's/70's, blood pressure measurement: 199/98 on 13Mar2021, platelet count: 99, sars-cov-2 test: Several negative tests on unspecified date. The patient went to Urgent Care twice. The patient took no other vaccine in four weeks and the patient was not COVID tested post vaccination.

Starting Monday at work I began to feel very tired, my muscles started aching across my back at shoulder level, and my hands went numb. I went home and took Tuesday off to rest. Wednesday this has continued and I may leave work again. I have also had some very sharp pains in my joints.

All symptoms began 21 hours after shot. Extreme fatigue continued for 24 hours. Body aches continued to this point over a day later along with a headache.

SOB, nausea, headache. Felt chest heaviness. Vital signs wnl, O2 sat 97%. Given albuterol 2 puffs. Went to ED.

Woke middle of night (04/06/21 at 3:30am) w/extreme chills. Took 1000mg acetaminophen. Woke back up 7am w/sweats & soaked clothing. Felt tired w/flu like achy symptoms rest of the day.

Extreme body aches. Slight Fever (101). Excessive unproductive coughing. Loss of appetite. Vomiting. Diarrhea. All symptoms continuing on 4/9/2021 except fever is gone.

I ran a low grade fever (100.1) for approximately one week. I had body aches (separate from the sore injection site for a single day starting 3/20/2021) and some headaches, but no life-threatening issues, nor enough reason to seek professional medical treatment. After the contiguous week was over, I had similar off and on symptoms for the following week, but these symptoms lessened with time.

4 days following the vaccination I experienced chills; my body temperature went 4 degrees F above normal; steady fever; flu; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot number: EM 9809) via an unspecified route of administration, administered in Arm Left on 08Feb2021 15:00 as single dose for covid-19 immunization. Medical history included mitral valve prolapse, other medical history= MVP, herpes, chronic sinusitis, enlarged prostate , herpes virus infection all from an unknown date and unknown if ongoing. Concomitant medications included Tamsulosin, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), vitamin C [ascorbic acid]. It was reported that, 4 days following the vaccination patient experienced chills, his body temperature went 4 degrees f above normal , steady fever, flu all on 12Feb2021 12:00. Also reported that, he was at day 8 following the vaccine, and he still have the fever. He was vaccinated for the flu, and these are not flu-like symptoms. It's not a cold, because he was not sneezing or coughing. It was a steady fever. The patient underwent lab tests included body temperature: 4 degrees f above normal on 05Feb2021, body temperature: steady fever on 05Feb2021, sars-cov-2 test: negative on 14Feb2021 covid test type post vaccination: Nasal Swab covid test name post vaccination: PCR, and Rapid Test covid test result: Negative. Outcome of the events was not recovered.

Burning upon injection. Numbness at injection site and entire left arm. 100.6 fever. Switch between chills and feverish and sweating. Intense pain under left breast radiating tru to left shoulder blade. 22 hours after injection, vomiting began and lasted the next 14 hours. Appetite is gone. 4th day post shot and all I've consumed is a banana and a yougurt. I has Covid 09/20 and the injection reaction was worse than Covid.

Significant rash over entire body, (torso, arms, legs, back). I am debating whether to go to emergency clinic or see my doctor. Other initial site effects (fever, chills, etc) have dissipated as of this morning.

Constant tiredness for over a week. Lost consciousness in a parking lot and hit head. Bleeding around the brain causing confusion and loss of memory

Patient was with Medical Examiner. She was reviewing his allergies (PCN, bee stings) and discussed with patient need to wait 30 minutes after vaccine for observation. She then gave him pfizer vaccine. Within 1 minute of giving vaccine, patient began to have seizure. He was assisted to ground by MD and RNs at vaccination site. He was assessed and assisted to remain safe throughout seizure, 911 called and arrived on scene. Meanwhile, caregiver with patient stated seizures are "normal" for him and he has 4-5 a day. She reported that in line he was not feeling well and had precursors to seizure. Patient had reported to MD that he felt fine today and did not report seizure history to her previous to giving vaccine. It was also later reported that he had a seizure the night before as well. IVF were started by RN's. When emergency services arrived, patient was recovering and refusing to go to ER - against medical advice. He was assisted back into wheelchair by emergency services personnel. Patient was alert, and oriented and able to make decision not to go to emergency room. Patient left facility with caregiver in private vehicle. Patient was instructed to contact his primary care physician and let them know what happened and ask if 2nd dose of pfizer is appropriate for him. Patient was also instructed if MD wants him to get 2nd dose to go to a more controlled setting then Mass vaccination site.

This was the second shot. I didn't expect to get sick since I had been sick after the first one. Symptoms were for the first night uncontrollable shaking, vomiting & light fever (100). This is the second day and I feel tired although I slept about 20:00 hours yesterday and 12 today. Expect to recover tomorrow!

Body muscle aches. Cold sweats. Weak upset stomach. Raised body temperature 99.7 and dissyness and brain zaps.

Reaction to first dose was nil. Below is reaction to the second dose: Same evening: slight fever and chills Next day: Stomach upset, dizziness, mild headache, nausea. One fainting episode at 8PM followed by vomiting. Heartrate: 55-63. The day after: Another fainting episode at 11:AM, followed by vomiting. Heartrate: 55-60.

Immediately I lost my sense of taste - that lasted for four days. I had a little swollen in my arm- I felt nauseous but I wasn't sick. I had a fever but just slightly elevated. Two days after vaccine, my kidneys were in pain. It took a couple of days for it to go away and then it stopped. Called the doctor but he had said just to wait it out -and I kept taking my regular meds but no additional.

Arm soreness at injection site and tiredness starting about 12 hours after injection. Arm soreness is a little better today (day after injection), but still feeling quite tired.

About 30 minutes after the injection experienced a cough and itching in throat. Denies shortness of breath. BP 178/88, HR 82 97% pulse oximetry. Given a bottle of water, states feels a little better. . Given Benadryl 50.mg. . States feels better about 10 minutes after Benadryl. Meeting with son after visit. Patient refused Epinephrine dose earlier.

After receiving my second Pfizer vaccine I have been having headaches. Several times a week I wake up with bad headaches. I also get them at night and during the days sometimes. Note, I do not have a history of headaches before the vaccine.

sweating; loss of appetite; diarrhea; vomitting lasted for a day; chills; could hardly eat anything for 5 days; This is a follow up spontaneous received from a contactable Consumer (patient). This 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (manufacturer: Unspecified) first dose on 11MAR2021 2 weeks ago (Lot: EN6207, NDC/UPC number: Unknown, Expiry Date: Unknown) at single dose for COVID-19 immunisation. Medical history included COPD, allergies, asthma, all from unspecified date to unspecified date and probably diagnosed from 10-15 years ago. Concomitant medications included Montelukast, Fluconazole, Trazodone for Muscle relaxant, tiotropium bromide (SPIRIVA), oxycodone hydrochloride (OXYCONTIN) for bad back and hip replacement and all of his pain medicine, Nebulizer at 2 times a day, all from unspecified date to unspecified date and other unspecified Concomitant Products. He took a sleeping pill at night so that he could sleep. He took 'Steopus' that was 2 times in the evening for his allergies. The patient previously took multivitamin at one dose every day for couple of months for low on some Vitamins. Received on 2021-03-30 19:21:32 UTC, Originating AE Request: REQ-219680. Submitted by Call Centre 1 Reference: W2021379399; PRIMA: 21-181755. Reporter was warm connected with agent with ID reportum number 542ANWOH. Reporter received the Pfizer covid vaccine, first dose 2 weeks ago and 3 days after that he had diarrhea, vomitting lasted for a day, chills, sweating, he could hardly eat anything for 5 days. The symptoms come and went but from yesterday he stated to feel better now. Probably about 13MAR2021 was when patient first had started with diarrhea and stuff and he vomited just for one day because he had quit eating so then giving up his appetite and from then it was like he would say, it had set off yesterday but he had had chills on and off possibly all day long and all night long, not really heavy heavy sweat but sweat and loss of appetite. Reported event seriousness was unspecified. When probed if the events are improved, worsened or persisting, the patient stated they were about gone now. He was scheduled for his second shot on the first of this month, not this month the coming month. He hoped his second won't be that bad, second shot was 01APR2021. The patient underwent lab tests and procedures, which included did a lab test month and they said he was low on some Vitamins. He was low in some vitamins, he thought. The outcomes of the events was Recovered. No follow-up attempts are needed. No further information is expected.

Arm pain; Tired; Abdominal swelling; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8730), via an unspecified route of administration, in left arm on 27Mar2021 at 12:00 (at the age of 60-year-old) at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive concomitant medications. The patient didn't 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, patient hasn't been tested for COVID-19. The patient experienced arm pain, tired and abdominal swelling on 29Mar2021. The events were reported as non serious. The patient didn't receive any treatment for the events. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

injection site pain; extreme tiredness; headache; chills; sweating; feeling unwell; dizziness; This is a spontaneous report from a contactable consumer. A 60-year-old male consumer (Patient himself) reported that he received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via unspecified route of administration in arm left on 28MAR2021 11:00 AM (at 60-years-old) as a single dose of administration. Patient medical history included high blood pressure, prostate cancer. No record of allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On29Mar2021 3:00, patient experienced injection site pain, extreme tiredness, headache, chills alternating with profuse sweating, feeling unwell, dizziness. No therapeutic measures were taken for the event caused. Outcome of the events was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Joint pain, muscle aches, flatulence, hands (only) faded or appeared light brown, head ache (nail hammered into the skull pain), back pain, check tightness, and upset stomach.

Day after 2nd injection extremely sore right shoulder. Extreme headache. Very fatiqued for two days.

Patient complained of headache, dizziness, unsteady gait x1 month. Triage was completed on 04/19/21. Pt was seen in the office 04/21/2021 for complaint by Provider orders were placed.

Pfizer-BioNTech COVID-19 Vaccine EUA Pt presented to ED on 4/10/21 @0523 with c/o SOB, F/C and cough. Admitted to ICU with acute hypoxic respiratory failure on BiPAP, non-STEMI, acute decompensated heart failure, acute kidney injury and suspected severe sepsis. Reportedly received 2nd dose of COVID-19 vaccine 2 days prior. Shortly after admit, pt developed worsening respiratory status requiring intubation @1045. Pt with continued hypoxemia despite 100% FiO2 and PEEP of 15. Pt experienced cardiac arrest with PEA @1100 with return of spontaneous circulation. Repeat arrest with PEA@1135 with return of spontaneous circulation. Family decision to change code status to DNR CCA, repeat arrest- time of death 1203.

Temporary: aches, chills, fatigue Ongoing: chest pain/discomfort with activity, short breath, headaches, fatigue

Fever, chills and body ache started on 3rd day after 1st shot then continued for five days in a row (fever 99-102). Fatigue and cough got worse with each day and continued for another 7 days. Cough and fatigue continue, (to a lesser degree). I'm VERY apprehensive about getting the second shot this Saturday, April 24.

On the morning after the 2nd injection, about 09:00, I started experiencing flu-like symptoms: muscle aches, then I was feverish and sweated heavily, then I felt lethargic and craved sleep. I slept heavily. I experienced these symptoms for three days, from 4/20/2021 until 4/22/2021. Today is 4/23/2021 -I have muscular soreness in left arm / injection site. I also ache and have a low- grade head-ache.

Patient c/o feeling dizzy and lilting to the left. Unsteady on his feet. B/P 162/87, HR 92 SPO2 100%, starting feeling nasal passages becoming stuffy, used EpiPen at 1310 and repeated at 1315 when he c/o heaviness in chest. HR increased to 105, TEAM alert CALLED and patient taken to the emergency room.

Flu like feeling very bad for 2-3 days - fever over 100. muscle aches and pains- still occurring now.

To bed about 10:30p. Awoke 11:30p & could not talk, shivering uncontrollably, couldn't move my legs, & no feeling in feet & legs. Very difficult to breathe. Was alert. Wife up to BR, looked over, I was trying to say help. Brought me water. she assisted me up , then back to bed, still shivering uncontrollably. 30 mins to 1 hr later, my son saw me in the hall and said, "Dad, you look like ****". I could not make a sentence. Per my son all I said was, "Gatorade". I drank it then fell asleep. next morning 101 temp, severe fatigue, severe aches and pains, could not make complete sentences I was told. I did have COVID 19 for 4 weeks Oct-Nov 2020.

Chills and body pain started evening of 30th with fever up to 102.5 and headaches. Body pain went away afterctwo days and only chills down to 89 (min.) deg. F and fevers up to 104 (max.) for next 17 days. Average low temp 95 DEG. F, average high 103 deg. F. Minor fevers and chills followed for 5 more days. Fevers always had headache. Dr. prescribed steroids and ZPak on 15th of April. Took Tylenol and ibuprofen alternate with naproxin.

Chills, Dizzinesss and Weakness 5-10 minutes after invection. Cough and sore throat 12 hours after injection.

Minor arm pain. Aches started in jaw followed by headache and fever. Significant fatigue. Lasted about 22 hours.

2 weeks after 1st dose of covid vaccine, some fatigue and sob. The next morning, sudden onset of sob, chest pain. To Emergency department, cath lab, stent. Home within 36 hrs.

he got positive with Covid-19; dizziness; woke up sweating; chills; muscle spasms; can not eat; Coughing; This is a spontaneous case is received from a contactable consumer. A 60-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced he got positive with covid-19 (sars-cov-2 test positive), dizziness on 06Apr2021, chills on 04Apr2021, muscle spasms on 04Apr2021, coughing (cough) on 01Apr2021, woke up sweating (hyperhidrosis) on 06Apr2021, cannot eat (feeding disorder)on 03Apr2021. The patient underwent lab tests and procedures which included sars-cov-1 test: positive. Therapeutic measures were taken as a result of, woke up sweating (hyperhidrosis). The outcome of the events sars-cov-2 test positive was unknown, chills, cough, feeding disorder were recovering, dizziness, hyperhidrosis were recovered on 06Apr2021, muscle spasms were recovered on 04Apr2021. Follow-up activities have been completed and no further information is expected.

Caller reports ER visit day after getting vaccine for chest tightness and ?extreme sedation?. Caller was discharged and has had some chills since then. Also reports fogginess and tension headaches. States he was in the ER last night and was treated and released.

I took the covid 19 vaccine on the 04/05/2021. The following days I started to feel tired and sleepy. Some Rushes started to appear on my buttock and went down to my right leg and also under my foot, making me really difficult to walk. I have been diagnosed with Herpes Zoster (Shingles). I was prescribe with Acyclovir 800MG per 10 days! My covid 19 second dose is due on April 28. I got advised not to take second dose of the vaccine before I get better from the Herpes Zoster.

Injection site soreness, tiredness on 4/27/21. At 2 a.m. on 4/28/21 woke up with chills, sweats, fever of 102, headache, muscle pain, joint pain, nausea, feeling unwell, dizziness, weakness, injection site soreness, somewhat fast heartbeat, shortness of breath. If he talked then short of breath and would cough. About 8 a.m took 1 Tylenol. About 9:30 a.m. had major stomach cramps, barely walk but made to bathroom to throw up. Used cold wash cloth for his fever then after he threw up he ate one piece of toast, took his medications and 1 Tylenol (since he threw up the first one). Heart rate better and breathing better. Went back to bed to go to sleep about 10:30 a.m.

After first and second night had 101 F fever. Rash started on back as mild faliculitis, now has spread to cover a large portion of his back and to his legs and arms. The rash appeared the 3rd day after the vaccine. Rash is very itchy and burns/stings. PCP gave prednisone - may have helped a little but has now quit responding. Will begin tapering.

On 4/28, I was feeling some side affects like tired, body pain and joint stiffness . I work at home and I was finished with work at 7pm. My legs felt like led weights and my right hand had lots of joint pain. I ate supper at 7pm. It was getting towards 8pm and was starting to have signs that Unintentional tremors. shaking in my legs, hands and head. I laid in bed and it was far worse, this was a seizure. was having hard time speaking or breathing at times. I managed to take a clonazepan and with in a hour it starting to calm down.

Review of Systems - Review of Systems Constitutional: Positive for fatigue and fever. HENT: Positive for congestion and rhinorrhea. Respiratory: Positive for cough.

Muscle pain and rash at injection site, both lasting for 3-4 days. Body and joint aches lasting 1 1/2 days. Feeling of being too warm, tiredness and chills lasting 1 1/2 days. Did not seek treatment since I knew these were normal reactions that would subside. Most of the side effects only lasted a day and a half except for the arm soreness and rash at the injection site which lasted 3-4 days.

diverticulitis aggravated by added bile in digestive tract.; diverticulitis aggravated by added bile in digestive tract.; agonizing pain; dehydration; constipation; sweating profusely; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 13:15 (Batch/Lot Number: ew0169) as SINGLE DOSE for covid-19 immunisation, at 60 years old. Medical history included diverticulitis and recurring atypical pneumonia from an unknown date. No other vaccine in four weeks and no other medications in two weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient has no known allergies. There were no concomitant medications. On 16Apr2021 23:45, the patient experienced diverticulitis aggravated by added bile in digestive tract. Spent entire night in agonizing pain and sweating profusely. Perhaps aggravated by dehydration/constipation. Reporter stated he suggests that people with this condition completely avoid nuts or other lipid/fatty acid foods as much as possible. Treatment was not given for the events. The events recovered on an unspecified date in Apr2021.

Fever lasted 2 days, headache lasted 3+ days, chills lasted 2 days, body aches lasted almost 2 days, sore arm lasted 2-3 days. Took 500mg Acetaminophen one time about 23 hours after symptoms began.

Severe muscle aches, severe headaches, sever joint pain, low grade fever and hyper fatigue. All of these symptom's occurred the next morning after the shot on April 18th.

4 days after 1st shot my husband became ,confused,garbled ,speech,,did not know who the president was or what year it was.admitted to Hospital .Released with a diagnosis of TIA.Went back to work .Sent home due to garbled speech and confusion .Second shot given.Sick for 10 days .Fever 101,diarrhea ,slurred speech ,confusion .awaiting to get second MRI.

fatigue; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 05Mar2021 09:30 (Batch/Lot number was not reported) as single dose at the age of 60-year-old for COVID-19 immunisation. The patient medical history included known allergies not specified. No COVID prior vaccination. The patient was taking concomitant medication but they were not specified as "to many to list". No other vaccine in fourweeks. The patient experienced fatigue in Mar2021. It was unknown if the patient received treatment for the event. COVID was not tested post vaccination. The outcome of event was unknown. Information on the Lot/Batch number has been requested. No follow-up attempts are needed. No further information is expected.

flu-like symptoms; Headache; fever / low grade fever after second dose; felt bad all over; face was red; This is a spontaneous report from a contactable consumer. A 60-years-old male consumer (patient) reported for himself that he received second dose of second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW6170) via an unspecified route of administration in right arm on 19Apr2021 at 13:00 at single dose for COVID-19 immunization. The patient had Covid before Christmas. he was active and gets around. He had friends who had Covid (2020) and he had a bad run with it. The patient's concomitant medications were reported as no. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in right arm on 29Mar2021 at 09:30 COVID-19 immunization and felt bad. The patient took second dose of Pfizer covid vaccine yesterday i.e. on 19Apr2021 at 13:00. He felt bad after the first. He felt great yesterday until he started feeling bad in the evening. He went to work today, he was feeling better, but now he was experiencing a low grade fever. Caller was asking if he was a slight risk to his coworkers or if he is a potential carrier of the COVID19 virus. He knows there was no live virus in the vaccine. He was just looking for clarification. He felt like he had the flu, felt like crap. He felt bad all over. Last night his wife told him his face was red. He had an infrared thermometer at his desk, he thinks his temperature is 99.5 to 100 tops. He did not take his temperature last night but thinks the fever started last night. He started feeling flu-like at 10:30 today. He was going home after he gets off the phone. Clarified his temperature was 98.8 degrees, but he felt hotter than it reads. His face was 101.8 degrees on his cheek and 100.4 or 101.2 degrees when checking on another area. He took 3 Excedrin this morning for a headache. The outcome of events was unknown. No follow-up attempts are possible; No further information expected.

Originally went to ER, they diagnosed it as torticollis. They sent me to my PCP who confirmed it. I had violent & severe neck pain and severe headaches. Also an extremely stiff neck where I couldn?t turn it 1/8th oh an inch to either side. It all got so severe that I didn?t eat for days at a time and was literally not with it. Couldn?t respond when spoken to, and became excessively weak where I couldn?t walk w/o help, and speech was slurred. It all lasted 5 days where it was so severe. With medication it slowly began to back off.

felt sweaty, however denied CP or SOB, no lightheadedness or dizziness, no nausea or vomiting vitals take were stable, observed in car for 40 minutes and then sent home

Fever; felt like trash and didn't feel good at all; both of his pinkies down to his wrist were numb; Got really winded; didn't have any oxygen; Got really winded; didn't have any oxygen; Uncontrolled Chills; he was shaking like crazy and he couldn't get warm enough; Sore Right Arm after Second Dose; he was shaking like crazy and he couldn't get warm enough; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (BNT162B2), dose 2, administered in arm right on 14Apr2021 09:50 (Batch/Lot Number: EW0158) as single dose at the age of 60-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were none. The patient received bnt162b2 (BNT162B2), dose 1, administered on 18Mar2021 09:50 (Batch/Lot Number: EN6208) as single dose at the age of 60-year-old for COVID-19 immunisation and experienced on 18Mar2021 17:10 left arm hurt and on 19Mar2021 felt really fatigued, recovered on 25Mar2021 and 20Mar2021 respectively. No additional vaccines administered on same date of the Pfizer suspect. On 14Apr2021 22:00 the patient experienced got really winded; did not have any oxygen, uncontrolled chills, sore right arm after second dose, he was shaking like crazy and he could not get warm enough, he was shaking like crazy and he could not get warm enough. On 15Apr2021 the patient experienced 102 degree fever fever, felt like trash and did not feel good at all, both of his pinkies down to his wrist were numb. The course of events was as follows: On 14Apr2021 after his second shot that evening around 10:00 P.M., he had uncontrollable chills. He could not hold a cup of water without spilling it. He fought that off and it calmed down and he fell asleep. The next morning on 15Apr2021 he felt like trash and did not feel good at all and he had a 102 degree fever. He took Advil as treatment and one hour later he sweated that out and his fever went away then. Both of his pinkies down to his wrist were numb for the rest of the day and the next morning, his left hand was already feeling back to normal, and his right hand took the rest of the day and it got back to normal. No event required a visit to Emergency Room or physician office, but he almost went to the ER with the second dose because he was shaking like crazy and he couldn't get warm enough, but finally it wore off. It got to a point where he did not have any oxygen, he was shaking that bad. When he went up the stairs, he got really winded and sat and down. It lasted at least an hour, during that time he was awake he was trembling bad and couldn't get warm. When he quit shaking, he fell asleep. Patient stated his wife mentioned something about they gave him some tests, like COVID Experimental Drugs, when he was in hospital for 12 days. He could not even tell the names of them. That was 15-27Oct2020. He did not know if that has anything to do with his reaction. The outcome of got really winded; did not have any oxygen, he was shaking like crazy and he could not get warm enough was recovered on 14Apr2021, of uncontrolled chills, fever, was recovered on 15Apr2021, of sore right arm after second dose, both of his pinkies down to his wrist were numb, felt like trash and did not feel good at all was recovered on 16Apr2021.

Fever 12 days out from the vaccination/fever averages 100F during the day; This is a spontaneous report received from a contactable pharmacist (patient himself). A 60-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown and Expiry date: Unknown), via an unspecified route of administration on 07Apr2021 (at the age of 60-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On an unspecified date in Apr2021, the patient reported to have a fever 12 days out from the vaccination, his fever averaged 100 Fahrenheit during the day. There was no other symptoms. The patient's laboratory test and procedure on an unknown date included body temperature: 100F during the day. The clinical outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Fever, chills, sweats, rigors, cough, shortness of breath, right sided chest pain, pneumonia- confirmed on cxr and Ct chest, small pleural effusion, hypoxia, decreased BP.

Chills body swats extreme aches and fatgue loss of appetite brain fog. Sleeplessness Started 05/02 and continues today. It hasnt gotten better

Fever running around 102 it spikes to 104.5; Nausea; Bodyache; Vomiting; soreness in my arm where shot was given; rapid heartbeat; Lethargic; This is a spontaneous report received from a contactable consumer (reporting himself). A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8735), via intramuscular in left arm (left upper arm) on 22Apr2021 at 23:30 as a single dose for COVID-19 immunization. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient's concomitant medication included diltiazem hydrochloride tablet; once a day by mouth for High Blood Pressure, Irbesartan/ Hydrochlorot tablet; 300-12.5 mg; frequency as once in a day and route of administration as orally, daily for High Blood Pressure. Patient stated, I trying to report, I have severe reaction to the Pfizer 2nd Covid shot. On 22Apr2021, the patient experienced fever, running around 102 it spikes to 104.5, nausea, bodyache, vomiting, soreness in my arm where shot was given, rapid heartbeat and lethargic. The patient received Advil 200 mg, took two pills for total 400mg as treatment medication for events. Patient confirmed about taking the shot from the nurse. The outcome was not recovered. No follow-up attempts are needed. No further information was expected.

Fever, body aches, fatigue, dehydration. Started about 30 hours after injection. Acute symptoms lasted about 12-18 hours.

4 days after shot woke with headache and difficulty breathing. Deep breaths would hurt a bit and sometimes cause a cough. Temp was 99.7 to 99.9 for 2 days. Lethargic for about 4 to 5 days after start of symptoms.

Per Client, received second COVID 19 on 4/22/2021, in the left arm. Client C/O that in 2-3 days started having joint and muscle pain throughout body. On the sixth day, joint and muscle pain worsen, and now for eight days pain is still present. Per Client, by the seventh day, started taking Ibuprofen, now having itchiness throughout body, and very fatigue. Client has not followed up with PCP, but has an appointment already scheduled in two weeks to see PCP. PHN suggested that Client try following up with PCP sooner than two weeks, to go into Urgent care, ER, and with medical emergency to call 911 if needed. Client verbalized understanding information provided.

Stomach Bloating; Headache; All over body pain; Muscle Weakness; Fatigue/Tiredness; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient previously administered with first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) administration date on 01Feb2021 at 9:15 AM on left arm for COVID-19 immunization and Shingrix vaccine dose first dose administered on 16Nov2020 and second dose on 23Jan2021 both in in right arm. The patient had no known allergies or other medical history. The patient did not have covid prior to vaccination. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D), ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), colecalciferol (50m D3) and apple cider vinegar (600m Apple Cider Vine). On an unspecified date in 2021 at 08:00 AM, the patient experienced headache (lasted 2 days), all over body pain, muscle weakness, fatigue/tiredness, stomach bloating and diarrhea. The patient did not receive treatment for the events. The patient did not test for covid post vaccination. The outcome of headache was resolved and for other events it was recovering. Information about lot/batch number has been requested.

2 hours after, tiredness, next morning soreness in arm, insomnia, numb face for 3 days, loss sense of taste

5/5/2021 - developed a scratchy/painful throat, markedly enlarged lymph nodes on left side of throat and chills. 5/10/2021 - seen by PCP. negative monospot, strep. Elevated CRP and SED rate. Treated with augmentin 5/12/2021 - seen by ENT. Improvement of tonsil size post augmentin. Prescribed Medrol dose pack and CT ordered 5/13/2021 - seen by PCP. Continued improvement of lymph node size even though Medrol dose pack was not started. Upcoming CT and return appointment by ENT.

This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 27Apr2021 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing tremors and prostate issue. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included clonazepam, tamsulosin, oxybutynin. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 27Apr2021 (the first day), the patient was a little tired. On 28Apr2021 (the second day), the patient experienced joint pain, felt very tired and weak. By 19:00-20:00, the patient realized he was going to have a tremor attack, but quickly turned into what would be called a seizure. The patient lost motor skills, speaking and breathing issues accrued. The symptoms where coming and going. With the help of his wife, the patient managed to take one 0.5 mg clonazepam. The situation lasted for around an hour, after which the patient went to bed. The next morning, 29Apr2021, the patient still had a lot of joint and muscle pain. As soon as he tried to start some minor work around the house, the tremors started again, but this time the patient took clonazepam and rested in bed all day. Today, 30Apr2021, the patient was tired from the situation and will be resting also. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of seizure, " tremor attack / tremors started again", joint pain, tired, weak, lost motor skills, speaking and breathing issues accrued and muscle pain was resolving. Information about lot/batch number requested.

Office Visit 3/12/2021 WellSpan Family Medicine - Crossroads DO Family Medicine COVID-19 virus infection +10 more Dx Fever Reason for Visit Progress Notes , DO (Physician) ? ? Family Medicine ? ? Encounter Date: 3/12/2021 ? ? Signed Expand AllCollapse All Office Visit Assessment/Plan Diagnoses and all orders for this visit: COVID-19 virus infection Suspected COVID-19 virus infection - POCT COVID-19 Antigen Mild intermittent asthma without complication Essential hypertension with goal blood pressure less than 130/80 Coronary artery disease involving native coronary artery of native heart without angina pectoris Paroxysmal atrial fibrillation (CMS/HCC);Gastroesophageal reflux disease without esophagitis;Irritable bowel syndrome with diarrhea;Hyperlipidemia with target LDL less than 70;Chronic anticoagulation;Close exposure to COVID-19 virus;covid Ag is positive;MAB tx Clinical Support 3/12/2021 WellSpan Infusion Center - Ephrata RN COVID-19 virus infection Dx Medication Infusion Reason for Visit Progress Notes RN (Registered Nurse) ? ? Encounter Date: 3/12/2021 ? ? Signed arrived to the ambulatory infusion site with his wife via car. Reports intermittent fatigue, dizziness, diarrhea, nausea, dry nonproductive cough, and shortness of breath, stated he discussed Bamlanivimab infusion and associates risks with his doctor prior to this infusion. Reports all question were answered to his statisfaction. Denies any concerns or needs at this time.

May 13, 2021, at 10:30 pm I suffered from severe sinus drainage and phlegm clogging throat that caused severe nauseau and dry wretching in an attempt to vomit. Since that time I have endured sinus drainage, coughing and phlegm clogging in throat. Symtoms have been moderate to severe and nothing alleviates the symptoms. Symptoms are worse at night or when I am sitting.

severe muscle pain in back and legs; Chills; Fatigue; Headache; severe pains in abdomen; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (COMARNITY; Lot/batch no: UNKNOWN) via an unspecified route of administration on 12Mar2021 at 09:00 AM (at 60-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included many food and environmental allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included fluticasone propionate (FLONASE) and essential amino supplements (MANUFACTURER UNKNOWN), for unknown indications from unknown dates and unknown if ongoing. The patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 09:00 PM, twelve hours after the injection, the patient had severe pains in abdomen with severe muscle pain in back and legs. The patient experienced some chills, headache and fatigue which were mostly over in 24 hours. The patient did not receive any treatment for these adverse events. At the time of this report, the patient was recovering from the events abdominal pain, muscle pain, chills, headache and fatigue. No follow-up attempts are possible; information about lot number cannot be obtained.

Called health system call center to report the following symptoms post vaccination on 4/30/21: fatigue and minor sore throat since 5/2/21, Joint pain and muscle aches since 5/1/21. No fevers or respiratory symptoms. Pt scheduled for urgent care visit on 5/4/21. Pt was advised to go to ED if worsening of symptoms. Pt verbalized understanding.

High fever, Nausea, joint pain, body aches, fatigue, vomiting, red spots all over body. Injury to kidney and liver

Client admitted to Medical Center on 5/19/2021 due to fever, chills, and nausea. Covid plus admitted for further assessment.

Patient had high fever of 101.5 with body aches, headaches, rash all over body for 4days. Injured kidney and liver through lab test

Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: At this point in time, patient was taken by paramedics and they took him to the local hospital. Additional symptoms,issues, or outcome unknown.

Pt was admitted on 5/10/21 c/o of rigor. Patient complains of fatigue, weakness, intermittent fevers up to 100.8 °F. EMS found patient to be hypotensive up to 84/52 and tachycardic up to 120s per minute. He woke up the morning of admission and then began to have shaking rigors at 10 AM and felt profoundly fatigued, dizzy and lightheaded. Patient does have a history of COPD which is non-O2 nonsteroid dependent and has some chronic shortness of breath. He does use inhalers and nebulizers and also continues to smoke. He also has a history of melanoma who follows with provider. In the ER he was found to have hypotension and was given 2 L of IV fluids. He also had a 3 g drop in his hemoglobin over the past 5 days and there was concern for a possible upper GI bleed. Because of the hypotension and drop in hemoglobin he was admitted to the ICU. He was started on Protonix IV. Chest x-ray, CT of the chest CT of the abdomen and pelvis were unremarkable for any acute process. He was admitted for unspecified shock which was initially thought possibly due to sepsis but this was ultimately ruled out. He was treated with 5 days of vancomycin and Zosyn and then antibiotics were discontinued. Patient's troponin was elevated with an elevated delta. He was seen In consultation by cardiology who felt that no further cardiology work-up was needed the cause for the patient's hypotension was unclear but his home lisinopril was discontinued. he did require albumin but not pressor support. As he was more stable he was transferred out of the ICU to the medical floor. He was started on midodrine. His blood pressure has improved he has remained afebrile throughout his hospital course he has remained stable off antibiotics. At this time he is medically stable for discharge to home and will continue on midodrine for new autonomic failure/dysfunction. the cause for his fevers/rigors was not found

Pt developed fever, cough and production of yellow phlegm for 4-5 days prior to clinic visit. When Pt was examined and labs draw he was found to have blood and protein in his urine. labs from 5/21 BUN 16 Cr 1.77, 5/25 BUN 17 Cr 2.01. Labs prior to vaccine from 02/2020 wer BUN 15, Cr 1.07

Post vaccination at approximately 10:30 am client reported feeling numbness and tingling in hands, developing a cough and a subsequently developing a felling of throat "closure" or tightness. Client was evaluated by Emergency response team and relocated to the Emergency response tents. At 10:45 am client was noted to become hoarse and requiring neck extension to swallow water. Client at this point was reported to be unable to speak in full sentences. Epinephrine was administered by Emergency Response physician at 10:50 AM. EMS was on site, oxygen was administered and transport to a nearby hospital emergency room was initiated and completed. Note: In retrospect client stated that he had similar symptoms after his first intramuscular vaccine dose (Pfizer, three weeks prior) for three days and had self medicated with Benadryl but had subsequently felt better.

Headache; Aches/pains,aches/pains, especially of back,; Aches/pains,aches/pains, especially of back,; Nausea; Cramps; Fatigue; Felt worse next day with arm pain; This is a spontaneous report received from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administration in Arm Left on 03Mar2021 10:30 (at age of 60-year-old) as a single dose for covid-19 immunisation. Medical history included high cholesterol, High blood pressure and General anxiety from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, losartan, alprazolam and xanax only as needed. The patient had no allergies to medications, food, or other products. The patient experienced headache, aches/pains, especially of back, nausea, cramps, fatigue; felt worse next day with arm pain on 03Mar2021. The events assessed as non-serious. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In pharmacy or drug store most recent COVID-19 vaccine was administered. The outcome of the events was reported as recovered on unknown date. Follow up: This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: The patient told reporter about the event on 3Mar2021 (day of vaccination) and PRD for initial report updated to 03Mar2021 accordingly. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

headache; muscle aches; sore achy muscles; fatigue; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received BNT162B2(COMIRNATY, solution for injection, Batch/Lot number: EN6203), via an unspecified route of administration, administered in left arm on 04Mar2021 13:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension, ongoing pancreatitis, asthma from an unknown date and unknown if ongoing, overweight from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included hydralazine (HYDRALAZINE) taken for hypertension from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing; insulin human injection, isophane (HUMULIN N) taken for diabetes mellitus from an unspecified start date and ongoing; insulin human (HUMULIN R) taken for diabetes mellitus from an unspecified start date and ongoing. The patient previously took first dose of bnt162b2 for covid-19 immunisation, keflex [cefalexin monohydrate] and experienced drug hypersensitivity. The patient experienced headache, muscle aches, sore achy muscles on 05Mar2021 04:00. Outcome of headache, muscle aches, sore achy muscles was unknown. No follow up attempts are possible. No further information is expected.

EE called hotline stating he received a call from Urgent Care that he has a POSITIVE covid test result from 5/28/21. He was called from Urgent Care providers. EE symptomatic. EE went on his own on 5/28 to Urgent Care and was swabbed. EE was not swabbed through EH hotline. Results not available on Epic. EE called dls and Urgent Care for a copy of his results, but they have not given it to him. Instructed EE to email a copy of positive covid results to Employee Health and covid surveillance. EE to update manager. Spoke with nurse at Urgent Care who verified that EE is Covid Positive. States she will email the results. EE states he is fully vaccinated, last dose on 1/13/21. EE states he is not a part of the SARS study, but he would like to do the antibody blood test. EE to do antibody testing after quarantined. Orders placed and instructions given to EE to obtain blood test at DLS. Instructed EE he will need to isolate & quarantine at least 10 days and/or until symptom free. EE to call hotline when he is released from DOH and to update us on his symptoms. HISTORY 5/28/21: EE stated he woke up with sore throat, feeling lethargic, fever, and cold sweats today 5/28/21. EE stated he went to Urgent Care on his own today, swabbed for strep which was negative and swabbed for covid; awaing covid test results. EE instructed to quarantine while results pending; if negative no longer needs to quarantine. EE instructed to call the hotline with his results. EE informed when he calls hotline, he will be given further guidance for clearance and will be asked to email the results to employee health. EE informed to keep his manager updated.

On Friday, 5/28/2021 I had my second Covid vaccine. My first vaccine in my left arm on 4/30/2021 was accompanied by a sharp soreness under my left arm and 12 hours of iritis in my right eye. Both symptoms were mild. For my second Coivd vaccine in my right arm on Friday, 5/28/2021, my symptoms included a headache and fatigue which lasted for Friday and Saturday. I also had a bad night on Saturday. I had trouble sleeping, was achy and may have been running a slight fever. I have been slightly more sweaty than normal. Today, 5/31/2021, I had some blood in my urine.

Chills; flu-like feeling; This is a spontaneous report from a contactable consumer (reported for himself). A 60-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot unknown: Not available), dose 1 via an unspecified route of administration, administered in Arm Left on 24Feb2021 15:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included eosinophilic granulomatosis with polyangiitis from an unknown date and unknown if ongoing. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) via Resp Inhalation route, montelukast, fexofenadine hydrochloride (ALLEGRA) and mepolizumab (NUCALA) taken for an unspecified indication, start and stop date were not reported. Patient had not received any other vaccine in four weeks. Patient dont have covid prior vaccination. patient had not performed any covid tested post vaccination. Patient had no known allergies.The patient experienced chills and flu-like feeling on 02Mar2021 01:00. Patient had not received any treatment for the events reported. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Pain at injection site, sore muscles, headaches, painful and swollen lymph node on left side of neck under left ear -- still painful and swollen after 3 months since injection

Sore arm, headaches, painful and swollen lymph node on left side under left ear -- still swollen and painful after 3 months since the first injection.

Flu-ish; nauseous; feeling quite wonderful; This is a spontaneous report received from a contactable consumer, the patient . A 60-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 05Mar2021 at 16:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and he was A-1 healthy specimen. Concomitant medications were not reported. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that he was not advised not to drink alcohol, and as this shot happened to be administered on a friday late afternoon, he went home and about an hour later had a glass of Scotch. About an hour after that, he apparently was feeling quite wonderful (loopy)(05Mar2021 at 18:15) but do not remember saying or doing things much at all. The next day the felt nauseous and flu-ish all day long. The patient did not receive any treatment for the event. The clinical outcome of events nauseous ,flu like symptoms and Euphoric mood was recovered with sequelae at the time of the report.. No follow-up attempts are needed. No further information is expected.

TIA; Swollen lymph nodes in chest and abdomen; enlarged spleen; fever; night sweats; exhaustion; This is a spontaneous report from contactable consumer. This 60-years-old male consumer(patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: unknown) at single dose for COVID-19 immunization on 03Apr2021. Relevant history and concomitant drugs were unknown. 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 experienced TIA (Transient ischaemic attack), Swollen lymph nodes in chest and abdomen, enlarged spleen, fever, night sweats, and exhaustion. Emergency room/department or urgent care was need, the patient was hospitalized due to the events. Outcome of events was not resolved. The patient was very sick in the hospital per patient's wife. The patient had SARS-CoV-2 test (Nasal Swab) in Apr2021 (After post vaccination) with negative result. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

HAD PHIZER VACCINE: HEADACHES, CHILLS, HOT FLASHES, NAUSEA, SLIGHT TEMPERATURE. STARTED AT 6:00PM DAY OF VACCINE AND TODAY IS FRIDAY THE 4TH AND I STLL HAVE HEADACHE

Fever; chills; headache; muscle aches; joint pain; fatigue; pain in injection area; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 05Mar2021 12:15, as single dose for COVID-19 immunization. The patient's medical history included hypertension. The patient had COVID-19 prior vaccination. Concomitant medications included chlorthalidone, hydralazine and losartan potassium. On 06Mar2021 08:00 AM, the patient started experiencing fever, chills, headache, muscle aches, joint pain, fatigue and pain in injection area. No treatment was received in response to adverse events. The patient was not COVID tested post vaccination. The outcome of the events was reported as not resolved. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Body aches/ achiness; Lethargy; Fever; This is a spontaneous report from a contactable other HCP. A 60-year-old male patient reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 12Jan2021 08:30 in left arm as a second dose, single for COVID-19 immunization at public health clinic facility. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccine within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient experienced body aches, achiness, lethargy and fever on 12Jan2021 at 11:00. The patient did not receive any treatment. The outcome of all events was recovered in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Got 2nd Pfizer vaccine on Tuesday 3/30. Felt bad afterwards. Went to another city next day Wednesday-Thursday-Friday for work. By Monday 6/7 I was very sick with bronchitis. It got very bad, went to ER. Went ER a second time and they did a CT Scan. Found fluid buildup on heart- Pericarditis. Hospitalized, sent to ICU. Two days in a row BP 85/35 HR47. Finally a Thoracic Surgeon agreed to take me to surgery following morning. Drained 300ml fluid off heart. Heart arrhythmia went into afib. Chemically converted- released on 6/22/2021. Chronic cough has lingered for 10 weeks.

Normal reactions sore arm -fatigue lasted 3 days 3 weeks later he was getting some brain fog and little confusion 2nd shot fatigue- sore arm which lasted a week more brain fog more confusion couldn't get his words out. could not work his phone or computer Went to doctorMay 24th

At approximately 1102 (15 min after vaccine admin) pt c/o generalized itching without rash, headache and fatigue. Denied any difficulty breathing or swallowing. BP 163/99, HR 65, O2 95%, RR 16 (pt notes baseline hypertension). Attending provider, Dr. (Name), notified of pt's symptoms, bedside assessment performed, 50mg Benadryl IM ordered and given at 1110. At approx. 1120 pt c/o intermittent chest pain, describes as stabbing, and mild difficulty swallowing. BP 186/100, O2 96%, HR 74, RR 16. Provider updated, continued to monitor. At approx. 1125 pt notes increased itching, BP 161/103, HR 59, 02 97%, HR 18. Pt assisted to supine position with HOB elevated. Continued to deny difficulty breathing. Approx 30 min admin of Benadryl pt noted initial improvement of itching, BP 173/93, HR 58, O2 96%, RR 18. After approx. 1 hr after vaccine admin pts states symptoms mostly resolved, bedside assessment performed by Dr. (Name), pt cleared for d/c home.

Symptoms started when waking up on Monday 6/14; headache, muscle ache, joint pain, tiredness, sore arm; started taking Ibuprofen throughout the day. Tuesday 6/15 experienced fever, chills, still aches and pains, headache.

AT 1605 PALE, DIAPHORETIC, NAUSEA TREATMENT- AMMONIA, ICE PACK, OUTCOME- WENT HOME WITH WIFE WITHOUT ANY ISSUES

Both doses first 2 days no fever but feeling very cold and mild headache. Following 4 days nausea ,unsteadiness and headache . Gradually reducing after 9 days

Was much sicker when he was little and received small pox vaccine than with the Covid vaccine; Severe fever; Throwing up; This is a spontaneous report from a contactable consumer or other non hcp (patient). Communication: Report 2 of 2. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, FORMULATION: SOLUTION FOR INJECTION, LOT NUMBER: ER2613) via an unspecified route of administration in right arm on 23Mar2021 as single dose (age at vaccination 60-year-old )and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, FORMULATION: SOLUTION FOR INJECTION, LOT NUMBER: RE8736) via an unspecified route of administration in right arm on 29Apr2021 as single dose (age at vaccination 61-year-old ) for covid-19 immunisation. The patient's medical history was none, and concomitant medications were not reported. At age of 8-year-old, patient took smallpox vaccine on an unspecified date in 1968 in left arm for immunization and experienced sickness. When reporting on wife to agent, caller mentioned that he was much sicker when he was little and received the smallpox vaccine than with the Covid vaccine. Patient was sick for only a few days after he had the smallpox vaccine. Patient had severe fever and was throwing up. The outcome of events was unknown.

Talking caused SOB & nauseous/vomiting; Talking caused SOB & nauseous/vomiting; Fatigue after vaccination; fatigue increases.; Passed out at end of trip (confirmed ventricular tachycardia); Passed out at end of trip (confirmed ventricular tachycardia); Unable to walk > 10 ft/During trip, difficultly walking uphill; By midMay tolerates walking but gets SOB on staris/talking caused SOB & nauseous/vomiting/By midMay tolerates walking but gets SOB on stairs; Admitted to hospital (6/4) in 100% A fib & significant ventricular arrhythmias.; Admitted to hospital (6/4) in 100% A fib & significant ventricular arrhythmias; Continued to worsen; Right ventricle pumping inadequately; Cardiogenic shock; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration, on 23May2021 (at the age of 60-years-old), as unknown dose, single dose for COVID-19 immunization and varicella zoster vaccine RGE (CHO) (SHINGRIX) on 27May2021 for immunization. Medical history was not reported. Concomitant medications included Furosemide (LASIX). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 after vaccination, the patient experienced fatigue and it was increased. By mid of the May the patient tolerates walking but got shortness of breath (SOB) on stairs. On 20May2021, the physician doubled Furosemide (LASIX) dose for unspecified trip. During the trip, the patient had difficulty walking uphill. It was reported that patient passed out at end of trip, it was confirmed with ventricular tachycardia. On an unknown date, the patient underwent echocardiogram, and the ejection fraction was 25%. On 04Jun2021, the patient admitted to hospital in 100% atrial fibrillation & significant ventricular arrhythmias. The patient was treated with Intravenous heparin and he was kept for 2 nights in the hospital. It continued to worsen. On 08Jun21, the patient was unable to walk more than 10 feet, while talking caused shortness of breath and nauseous/vomiting. The patient was admitted to another hospital. On an unknown date, in hospital the patient had an esophageal echo to rule out (R/o) any clots in heart or lungs. On 09Jun2021, a cardioversion and on 10Jun2021, an angiogram was performed, it did not show any blockage or valve problems but showed the right ventricle pumping inadequately. The patient was advised new medications which included amiodorone. The patient was currently diagnosed with cardiogenic shock and expected to remain in CCU (cardiac care unit) until end of week. It was also reported the patient was hospitalized for Life threatening illness (immediate risk of death from the event). Seriousness criteria was reported as life threatening and prolonged hospitalization. The outcome of all the events was unknown. Information on Lot/Batch number has been requested.

1st dose of vaccine administered on 03/25/21 at 1:30 pm. Side effects: 03/25/21-03/28/21 ? pain on the site of injection; nausea. 03/26/21-04/04/21 ? increased tone of facial muscles; tiredness. 04/05/21-04/07/21 ? stomach pain; slight increase in body temperature up to 37.2 C; nausea; vomiting; muscle and joint pain in the belt region. 04/08/21-04/12/21 ? increased maximum body temperatures up to 37.8 C; temperature declined overnight to 36.7-37.2 in the morning and then rising again; change of voice; all other side effects are gone. 04/13/21-04/14/21 ? maximum body temperature decreased to 37.4 C; change of voice. 04/15/21-04/20/21 ? maximum body temperature decreased to 37.2 C; change of voice. 04/20/21 blood test results - inflammation: Erythrocyte Sedimentation Rate (ESR) 56 mm/hr SARS-CoV-2 Antibodies, Spike Protein 15.10 U/mL C-Reactive Protein (CRP) 1.06 mg/dL 04/21/21-05/08/21 ? maximum body temperature decreased to 36.7-37.0 C; change of voice persists; chest pain. Multiple rectal bleedings: 04/30/21, 05/01/21, 05/11/21, 05/12/21, 05/15/21, 05/16/21, 05/21/21, 05/22/21, 06/03/21, 06/04/21(small). Temperature is in the normal range since 05/09/21. 06/01/21 blood test results ? inflammation gone: Erythrocyte Sedimentation Rate (ESR) 10 mm/hr SARS-CoV-2 Antibodies, Spike Protein 10.10 U/mL C-Reactive Protein (CRP) 0.44 mg/dL Looking for suggestion to do or not to do second vaccine administration.

Felt hungover; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in left arm on 10Mar2021 at 13:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether 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. Concomitant medications included pravastatin (MANUFUTURER UNKNWON), allopurinol (MANUFUTURER UNKNWON) and famotidine (MANUFUTURER UNKNOWN) all for unknown indication and from an unknown date. On 11Mar2021 at 09:00, patient experienced sore arm. On 12Mar2021, the patient experienced moderate headache which lasted for 15 hours and on 13Mar2021, the patient felt hungover. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was reported that the patient did not receive any treatment for the event. The clinical outcome of sore arm, moderate headache and felt hungover was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

Received 2nd dose of vaccine on 4/15/21. Reported (no feeling well 10-14 days after vaccine) Tired, fatigued, no energy. Symptoms worsened. Started to experience bilateral numbness in both legs, gradually moving up into arms. 4/30-5/3 developed coordination issues,. Stated, "I wouldn't be able to pass a field sobriety test." Tripping, stumbling, dropping items. 5/3 had a CT scan of brain (did not show history of stroke) Early am on 5/4 fell and lost all movement on left side. MCA occlusion removed/stent placed/brain swelling worsened. Informed by neuro team that he was experiencing more brain swelling in 24 hours than a stroke victim had in 4 days.

Numb tingly fingers is the worst; Tingly fingers; Upper body joint ache in neck, shoulder, elbow, wrist, hands; Infrequent headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration in the left arm, on 19Mar2021 at 15:30 (at the age of 60-years-old) for COVID-19 immunisation. Medical history includes Barretts esophagus and crab allergy (seafood allergy). The patient did not receive any other medications within two 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 had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 17:00 patient experienced numb tingly fingers, upper body joints ache, neck, shoulders, elbows, wrists & hands, infrequent headaches. The patient described numb tingly fingers as worst. Therapeutic measures and treatment were not received as a result of reported 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 numbness in fingers and tingling (in fingers), joints ache and headache were not resolved. No follow-up attempts are needed. No further information is expected.

Extreme muscle pain, chills, headache over right eye, fatigue, nausea, arm soreness at injection x 24 hours

On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 26Mar2021 14:15 (at the age of 60-year-old) as dose 2, single for covid-19 immunisation. The patient previously took BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, on 05Mar2021 (at the age of 60-year-old) as dose 1, single for covid-19 immunisation and experienced sore arm. The patient medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported; ezetimibe taken for an unspecified indication, start and stop date were not reported. 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 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 26Mar2021, the patient experienced fever, headache, body aches, dizziness, sore arm. No treatment was taken for the events. The outcome of the events were recovering. No follow-up attempts are needed. No further information is expected.

tachycardia; Sudden onset diaphoresis, 2 dry heaves, sudden elevation of blood pressure to 160 / 110.; Sudden onset diaphoresis, 2 dry heaves, sudden elevation of blood pressure to 160 / 110.; Sudden onset diaphoresis, 2 dry heaves, sudden elevation of blood pressure to 160 / 110.; This is a spontaneous report from a contactable other hcp reporting for himself. A 60-years-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9262; Expiration date was not reported), intramuscular, administered in Deltoid Left on 12Feb2021 15:15 (at the age of 60-years-old) as single dose for COVID-19 immunization. Medical history included spinal stenosis, spinal laminectomy from Jun2003 and ongoing, intervertebral disc operation from Jun2003 and ongoing, intervertebral disc operation from an unknown date and unknown if ongoing Failed L3-4 LAMI Discectomy, seroma from 2003 to an unknown date, intervertebral disc protrusion, HNP L4-L5 Protrusions, back pain (Back spasms), reduced inflammation from an unknown date and unknown if ongoing. It was reported that the patient had laminectomy discectomy approximately from June 2003 and not fully remedied, ongoing; pertinent details: L3-L4 laminectomy/ discectomy in 2003 with infection with difficile large seroma. family history: copd. Concomitant medications included hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN) taken for intervertebral disc operation, spinal laminectomy, intervertebral disc protrusion from 2021 and ongoing; diazepam (DIAZEPAM) taken for back pain; lidocaine (LIDOCAINE) taken for impaired work ability from 2013 and ongoing; curcuma longa (TURMERIC [CURCUMA LONGA]) taken for inflammation from 2020 and ongoing. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3247), via intramuscular route in left deltoid on 22Jan2021 at 15:15 for covid-19 immunization. The patient previously took penicillin and had known allergy. Other vaccine in four weeks, covid prior vaccination, prior vaccinations (within 4weeks) included none. Vaccine was administered at hospital and not administered at military facility. The patient experienced sudden onset diaphoresis, 2 dry heaves, sudden elevation of blood pressure to 160/110 on 19May2021 11:30. Patient received treatment with portable B/P monitor and reduced duty in Radiology. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 22Apr2021 Nasal Swab test. Other Relevant tests included none. It was reported that patient experienced tachycardia on 22May2021 11:30. Reporter considered the event seriousness criteria as important medical event. AE required patient a visit to Physician Office and patient received no treatment for tachycardia. Outcome of tachycardia was not recovered, and other events were recovered with lasting effects on unspecified date in 2021. Reporter considered that the Pfizer product had a causal effect to the adverse events.

pt called on 5/24/21. Pt c/o productive cough with greenish mucus, congestion, feeling sinus pressure from stuffy nose, feels tired, headache, chills on/off, loss of taste since 5/19/2021(wednesday) next day after he got his 2nd dose covid vaccine Pfizer on 5/18/2021. Pt speech clear. AO X3. Also denies emergency sx at this time. Scheduled an appt with urgent care provider telephone f/u 5/24/21 for further treatment and evaluation .Notified pt if any emergency sx arises call 911 or go to nearest ED.

Fatigue; Headache; Muscle pain; Nausea; Feeling unwell in general; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 24Mar2021 at 15:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was allergic to CEFTIN. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within the 4 weeks prior to the COVID-19 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 25Mar2021 at 11:00, the patient experienced fatigue, headache, muscle pain, nausea and feeling unwell in general. The 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 fatigue, headache, muscle pain, nausea and feeling unwell in general were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Patient was a previously healthy 60 year old male who developed an acute change in mental status on 4/9/21 after first receiving the Pfizer COVID-19 vaccine; he was ultimately diagnosed to have hemophagocytic lymphohistiocytosis, and other underlying etiologies were ruled out (malignancy, infection, autoimmune disorders) and improved only after initiation of HLH-directed treatment with etoposide and dexamethasone. He is currently in remission. Patient was initially admitted in 4/2021 for fevers, night sweats, weight loss, and worsening altered mental status. Patient symptoms reportedly started in ~ 4/2021. Per patient's wife, there is a temporal correlation between the patient receiving the COVID-19 vaccine and his symptoms worsening. He was admitted in 4/2021 for stroke-like symptoms after his 1st dose and was diagnosed with a TIA. He was cleared to receive the 2nd dose of the COVID-19 vaccine (received on 4/25/21), and he reportedly became worse after this dose as well. He underwent an extensive workup over the last 2 months to further evaluate his symptoms. He was found to have mediastinal lymphadenopathy on imaging. He had an excisional biopsy of these LNs which were ultimately reactive in nature (negative for lymphoma). There was no evidence of a lymphoma or a lymphoproliferative disorder. Patient was ultimately readmitted to hospital on 5/17/21 due to worsening symptoms. His labs were notable for anemia/thrombocytopenia. A bone marrow biopsy and aspirate to rule out suspected lymphoma was performed and his labs/bone marrow were consistent with a diagnosis of HLH. He was found to meet 6/8 criteria (splenomegaly, peripheral blood cytopenias, elevated ferritin, hemophagocytosis noted on bone marrow, fevers, and elevated Soluble IL-2). The hope was to do a PET/CT and LP before starting therapy to rule out secondary causes of HLH. However, his clinical status continued to deteriorate before these tests could be performed and so he was ultimately started on Dexamethasone and Etoposide as per HLH protocol. These therapies were started on June 3rd. His mental status significantly improved once the medications were started. A PET/CT and LP on 6/7/21 were finally obtained ; however, both did not show overt evidence of an underlying trigger for HLH. "Prominent mediastinal, hilar, and RP LNs seen on previous imaging were not FDG-avid." It did show a few small, mildly FDG-avid patchy B/L pulmonary opacities which were likely infectious or inflammatory for which a follow-up CT Chest was recommended. The flow from the CSF was grossly unremarkable. CSF PCR and other viral studies were negative. Of note, it is uncertain at this juncture if these tests are negative because they are truly negative, or if they are possibly falsely negative since patient was started on treatment before they were obtained. Currently, patient's mental status has significantly improved with Dexamethasone and Etoposide. Per the HLH protocol (which is a scheduled over 8 weeks), patient was started on Dexamethasone 10mg/m2 (equates to 20mg daily) and Etoposide 150mg/m2 biweekly for the 1st 2 weeks. Pt received his 2 weeks of biweekly Etoposide while inpatient (6/3, 6/9, 6/11, and 6/15). The remaining Etoposide doses are to be given weekly and his next dose would be ideally due on 6/22/21 (today). He also completed his 14-day course of Dexamethasone 10mg/m2 on day of discharge (6/16/21). Pt was advised to reduce his Dexamethasone to 5mg/m2 (or 10mg daily) on 6/17. Of note, ID was contacted on day of discharge who recommends that patient be placed on PCP PPx while on HLH therapy. He was recommended to start Mepron on 6/17/21.

headache/severe headache; sweating among other side effects/breakdown in sweat; arm still hurts/pain to arm where he received the shot; Lethargic; issues with his vision; sensitivity to light; absolutely miserable; light headed; chills; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a 60-year-old male patient (reporter's husband) via medical information team. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0165), via intramuscular route of administration, administered in left arm (left upper arm) on 22Apr2021 at 10:30 (at the age of 60-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included propranolol hydrochloride taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733), via intramuscular rout of administration in the left arm (left upper arm) on 01Apr2021 at 10:30 (at the age of 60-year-old) as dose 1, single for COVID-19 immunisation. No other prior vaccination was administrated. The patient got his 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE on 22Apr2021 and experienced headache, sweating among other side effects until "today", almost 2 months after getting his 2nd dose. The reporter would like to know if it was normal to still experience the above-mentioned side effects for this amount of time. The reporter stated that it was okay, so her husband had the Pfizer vaccine his second dose was two months ago, and he has been having adverse "I" think almost immediately afterwards he got severe headache. He was lightheaded, breakdown in sweat his arm still hurts after two months. He was lethargic, issues with his vision. He was just wiped-out walking across just across the room. He breaks out a sweat and has got a whole bunch of symptoms. "They" are very similar to COVID symptoms, but they gave him a COVID test, and he does not have COVID. "We" had gone to his regular doctor two or three times. They did not know what was wrong with him and how to fix anything. "They" did not know what kind of doctor to send him to they did a blood test, and nothing was out of line. "They" did a COVID test send it for stress test. He was absolutely miserable, severe headache "you" know sensitivity to light; all kinds of things and "we" need to do something. The reporter like to report it and hoping "you" can connect "me" with somebody who has some knowledge about whether anybody else in the world was having similar symptoms after two months and what can be done, what kind of doctor we go to. The reporter stated, "Okay so the first one I have a LOT Number, I don't have an expiration number. The LOT number was ER8733 the second one was EW0165." The reporter stated, "It was his left upper arm and was a shot. I did not know, i think It was in the muscle was not that what they are yes." Reporter stated, "That was also 10:30 in the morning." The reporter stated, Well, yes, the pacemaker, there was only one thing he not taking really. Okay, so he does not want to take medications the only thing he takes was Propranolol Hydrochloride looks like it was 60 mg once a day. He had a blood test couple weeks ago and everything was normal and had a stress test on "Monday" and "I" did not have the results from it yet. He was still experiencing the symptoms that "we" are calling about yes. That's why reporter was called. Events was persistent and has tried taking Aspirin or Tylenol and he was tried some Benadryl, and nothing has relieved his symptoms. The reporter has been complaining of chills, pain to arm where he received the shot, headaches which came on even if he was having a conversation. The patient underwent lab tests and procedures which included blood test: nothing's out of line on an unknown date in 2021, stress test: don't have the results on an unknown date in 21Jun2021, COVID test: he doesn't have covid (negative) on an unknown date in 2021. Therapeutic measures were taken as a result of headache/severe headache. The outcome of headache/severe headache, sweating among other side effects/breakdown in sweat, arm still hurts/pain to arm where he received the shot, lethargic, issues with his vision, sensitivity to light, absolutely miserable, light headed was reported as not resolved; chills was unknown. Information on Lot/Batch number was available. Additional information has been requested.

injection site pain.; fever; entire body joint pain; muscle pain; This is a spontaneous report from a contactable other health care professional, the patient. A 60-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via an unspecified route of administration in the left arm on 25Mar2021 at 19.00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) 20mg on every other day for an unknown indication and from an unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200) via an unspecified route of administration in the left arm on 04Mar2021 at 19.00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. 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 had not received any vaccines within four weeks prior to the COVID-19 vaccine. On 26Mar2021 at 15:00, the patient experienced injection site pain, fever, entire body joint and muscle pain. No therapeutic measures were taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care 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 events vaccination site pain, fever, body joint pain and muscle pain was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

skin irritation.; felt like a pulled muscle under my left rib cage about 1 hour after the shot. Thought I just pulled a muscle some how but the next day I sneezed and the pain was incredible.; I'm in severe pain.; cough; sneeze; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732, Expiration date: Not reported), via an unspecified route of administration, administered in right arm on 26Mar2021 18:30 (at the age of 60-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included diabetes, asthma, glaucoma, tinnitus, Known Allergies: raw apples make my mouth itch. Concomitant medication(s) and received within 2 weeks of vaccination included solifenacin, losartan, tadalafil, atorvastatin. The patient had allergies with raw apples makes mouth itch. The patient had no other vaccine within four weeks. 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 filed this information in the initial report but got the vaccine on 26Mar2021 Friday and maybe 1-2 hours after that he thought he pulled a muscle somehow under his ribcage area and the next day on Saturday he still felt it but it was not a big deal. States then he sneezed while he was driving his car and almost crashed and the pain was incredible and was one of the most painful things he has had happen. States he couldn't believe this and then when he went home and bought Salon Pas which are those heat things that heat up and he is using so many of them but they are causing skin irritation. States he went to the emergency room on Monday but according to him people showed no interest and was not quite alarmed of the situation even though they do not know what is it specifically. His physician, prescribed him with the cough syrup because if he coughs or sneezes was when it really really hurts him and hurts more when he sneezes and oxycodone for the pain which he didn't took. He also mentioned that physician requested for a CAT Scan which didn't show anything on the results Normal. He is also scheduled for his second shot tomorrow. The adverse event resulted in emergency room/department or urgent care visit. The patient did not receive any treatment. Outcome of the event skin irritation was unknown, while that for other events was not recovered, at the time of this report. Information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient briefly lost consciousness and came too once we were able to lie him down and elevate his feet. Ambulance was called and they took him for further evaluation. per patient the next morning they observed for and hour and a half and he was released. was fine the next day

Pt just got his + test for COVID-19 which were positive, pt has had some ? contacts at work, also he went to an Astros game where he may have been exposed; pt reports dry cough, mild malaise, denies any shortness of breath, no diarrhea, no changes in smell / taste.

Headaches the next day and tiredness, short of breath, had to go to the hospital unable to breath when laying down quizzing couldn't catch breath ER dx him with Cardiomyopathy. Had knot holes on his thyroid.

Positive for COVID-19 by PCR test on 7/15/2021. Patient had mild low grade fever and was exposed to household members who were also positive for COVID-19

wheezy; sob along with diaphoresis; shortness of breath; This is a spontaneous report from a non-contactable other healthcare professional. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: ER8727) via unspecified route of administration on 24Mar2021 (at the age of 60-years-old) as a single dose for Covid-19 immunisation. Medical history included asthma. Concomitant medications were not reported. During the 15 minutes waiting period after the injection the patient did fine. However, patient noted to be sitting on side after pushing his sister in wheelchair to take a "break." On 24Mar2021, the patient experienced wheezy, sob along with diaphoresis and shortness of breath. Patient had history of asthma and had forgot to bring inhalers. Patient does not walk much and was a long walk today and was offered a wheelchair and was brought to the bay for inhaler treatment. Patient denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Therapeutic measures were taken as a result of wheeziness, diaphoresis and shortness of breath which include treatment with albuterol. The clinical outcome of wheeziness, diaphoresis and shortness of breath were unknown. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: 1. patient's last name updated. 2. Country added in patient tab. 3. leading sentence updated to a non-contactable other healthcare professional. Reported Event: During his 15 minute waiting period after the injection he did fine. However, pt noted to be sitting on side after pushing his sister in wheelchair to take a "break." He was noted to be wheezy and sob along with diaphoresis. Pt states he has hx of asthma and forgot to bring his inhalers. He normally doesn't walk much anyway and today was a long walk. He was offered a wheelchair and brought to the bay for inhaler treatment. He denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient complains of shortness of breath and wheezing Treatment included: albuterol

Runny nose.; throat closing (thickness); itchy throat; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via unspecified route of administration in the left arm on 10Mar2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no concomitant medication within two weeks of COVID vaccine. The patient was not allergic to any medications, food, or other products. 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 10Mar2021 at 16:45 (25 minutes after vaccination), the patient experienced runny nose followed by sensation of throat closing thickness, followed by itchy throat; which was possible to breathe through his nose. The patient did not receive any treatment for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event runny nose, itchy throat and throat thickness was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information expected.

Initially, the event consisted of a fever on and off for 5 days reaching 103 at one point. Took Tylenol. Covid test on 4/15 resulted positive; Covid test on 4/18 resulted negative. Sporadic fever resumed 1st week of May on and off for a few days; visited doctor. 2nd Covid vaccine administered on 5/13 at same location (Pfizer EW0165). Since then I've experienced sporadic fevers lasting 1-3 days at a time each 2-3 weeks. Fevers are usually between 99 and 102. Most recently (7/14), experienced violent trembling with 102 fever. Visited doctor on 7/16 where bloodwork, urinalysis and chest x-rays were taken for "fever of unknown origin". Results not in yet.

Expected fever, myalgia, malaise for a couple days after the second dose. Approximately April 2021 I started to notice palpitations and vague chest discomfort that was not associated with exertion. It resolved in late June 2021, and I had a normal stress test on July 14. I have no symptoms now.

After vaccine, could not sleep for 2 nights, less than an hour a night, normally take 1 melatonin a night, but took 2 and it did not. Told to take Benadryl by cardiologist, which helped sleep. Extreme stomach cramps, nausea, joint pain, sprained ankle flared up again, fatigue. Went to work, but had to leave early because of symptoms.

Systemic: Headache-Severe, Additional Details: Patient started having headaches 1-2 weeks after administration date. Patient gets them 2-3 times per week and the pain level varies from mild to severe as well.

Got Pfizer vaccine on 3/10/21 and 3/31/21. Symptom onset on 7/15 with cough, runny nose and nasal congestion. Tested positive for Covid-19 on 7/21/21.

Got Pfizer vaccine on 3/10/21 and 3/31/21. Symptom onset on 7/15 with cough, runny nose and nasal congestion. Tested positive for Covid-19 on 7/21/21.

heavy wheezing; coughing; left side of back hurts; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration, in the left arm on 02Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux and seasonal allergies, and the patient was allergic to dyes, and a kind of antibiotic. Concomitant medications included bisoprolol celecoxib (CELEBREX), amphetamine aspartate, amphetamine sulphate, dexamphetamine saccharate, dexamphetamine sulphate (ADDERALL), esomeprazole magnesium (NEXIUM), and multivitamin (MANUFRATURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 03Apr2021 at 03:00, the patient woke up with heavy wheezing and a lot of coughs. He had tried and breathed shallow to not cough. Coughing lasted about an and couldn't controlled it. He took an over-the-counter allergy pill that seemed to help after about 40 minutes. He had to call in sick to work because excessive movement would get coughing again. It was reported that, at 11:00 he was breathing better. His left side of back was hurting from all the coughing. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. As the result of adverse events an unknown over-the-counter allergy pill was taken as therapeutic measure. The clinical outcome of the events wheezing, coughing and back pain were recovering. No follow-up attempts are needed. No further information is expected.

rectal abscess; this time it worsened; I was in pain; high fever; This is a spontaneous report received from a contactable consumer (patient). A 60-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0171) via an unspecified route of administration on 27Apr2021 at 18:15 (at 60-year-old), as dose 2, single for COVID-19 immunization. The medical history of the patient included amoxicilin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was mentioned that patient was not diagnosed with COVID-19 prior to vaccination and patient had not been tested for COVID-19 since the vaccination. On 10Apr2021 at 07:00 the patient had rectal abscess which started 3 days after the first jab. It peaked in 10 days and without the surgery and disappeared in about 17-18 days. The abscess returned 3 days after the second jab on an unspecified date in Apr2021 and this time it worsened and required Surgery as treatment to get rid of. The patient was in pain and high fever for several days on an unspecified date in Apr2021. Therapeutic measures were taken as a result of events. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information had been requested

Severe thrombocytopenia; bone marrow showed hemophagocytosis/Met criteria for hemophagocytic lymphohystiocytosis (HLH); other causes triggers of HLH (infection, cancer, autoimmune disorder ruled out); Delirium; Worse after 2nd COVID-19 vaccine; fevers; Lymphadenopathy; Transaminitis; Splenomegaly; Anemia; This is a spontaneous report from a contactable physician. A 60-year-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER8735, expiration date unspecified), via intramuscular route on 25Apr2021 (at the age of 60-year-old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. The patient reported she was healthy before vaccination. Medical history included depression and gastroesophageal reflux disease from an unknown date. Concomitant medications (received within 2 weeks of vaccination) included sertraline, lansoprazole (PREVACID), both concomitant medications taken for an unspecified indication, from an unknown start date. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EP7533, expiration date unspecified), intramuscularly on 03Apr2021 as DOSE 1, SINGLE for covid-19 immunization (at the age of 60-year-old) and experienced altered mental status. 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 the vaccination. Since the vaccination, the patient had been tested for COVID-19 (on 17May2021, Test: COVID-19 PCR, Nasal swab) which was negative. Clinical course of the events was reported as: Previously healthy 60-year-old male, presented to hospital with altered mental status 6 days after the first COVID-19 vaccine, on 09Apr2021. Had a negative neurological work up but continued to decline, worse after 2nd COVID-19 vaccine (fevers, lymphadenopathy, transaminitis, splenomegaly, anemia, severe thrombocytopenia, delirium). Suspected to have lymphoma ruled out but ruled out; bone marrow showed hemophagocytosis, and labs showed high soluble IL-2 receptor (33,903). Met criteria for hemophagocytic lymphohystiocytosis (HLH); other causes triggers of HLH (infection, cancer, autoimmune disorder ruled out). Positron emission tomogram (PET) scan negative for malignancy. Patient improved only after starting Etoposide and dexamethasone, now (as reported) in remission. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for 68 days for the events. The events assessed as serious (life threatening and caused/prolonged hospitalization). Outcome of the events at the time of report was resolving.; Sender's Comments: Limited information precludes a comprehensive causality assessment ,however causal of BNT162B2 vaccine cannot be excluded for the reported 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

Constant headache since the nite after the vaccine. Some headaches are really bad, almost migrane level occurring on right side of temple. After a month, headaches are not as bad, still persistent. Dizziness to the point that i have gotten nausea 5 out of 5 times being a passenger in a car, 2 of those times vomiting. Driving a car is fine with no dizziness or car sickness. 2 intense bouts of vertigo, starting 1 week after the vaccine Could hardly walk, bumping into things, like i got off a spinning carnival ride drunk. I took zanax and went to bed, and woke up fine. Overheating, hot flashes, and fatigue also come and go.

Headache; Fatigue; Nausea; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old male 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 10:30 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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, the patient experienced headache, fatigue, nausea and chills. 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 headache, fatigue, nausea and chills were not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.

Headache; Diarrhea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 30Mar2021 at 14:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 31Mar2021, the patient experienced headache, diarrhea and fatigue. The 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 events headache, diarrhea and fatigue. The clinical outcome of the events headache, diarrhea and fatigue were recovered on an unknown date. No follow-up attempts are needed. No further information is expected.

A few days after my second Covid vaccination I started experiencing fatigue, dizziness and shortness of breath. I also noticed the calf muscle in my lower right leg began to swell. The swelling continued to get worse and about a week later I noticed a significant amount of petechial hemorrhaging in my lower right leg. I started using an ice-pack in an attempt to reduce the swelling. I also sat/lay with my leg up (horizontal) as much as possible. On 6/28 I visited with my primary care doctor to seek help in addressing the swelling. My doctor sent me for an ultrasound which discovered a deep-vein thrombosis (DVT) and a CT scan which highlighted pulmonary embolisms in my lungs. I was admitted to hospital where I was treated with blood thinners; Note: I had my first shot on 4/13/21 and also experienced fatigue, dizziness and shortness of breath, but did not experience any swelling. As a result of feeling unwell I delayed getting my second shot.

Sore throat 3 days after shot; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes mellitus and hypertension. The patient was allergic to strawberries and penicillin. Concomitant medications included metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), atorvastatin (MANUFACTURER UNKNOWN) and chloramphenicol (CHLO); all for unknown indications from an unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccination. On 04Apr2021 at 05:45, 3 days after the vaccination, the patient experienced sore throat. The patient did not receive any treatment for the reported adverse event. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event sore throat was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Fever began about 6 hrs and lasted for about 48 hours. Temperature reached 102.6.; Followed by a couple days of exhaustion.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 31Mar2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications. The patient previously took penicillin (MANUFACTURER UNKNOWN) and experienced allergy on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER6207) via an unspecified route of administration in the arm left on 10Mar2021 at 14:30 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 31Mar2021 at 21:30, the patient experienced fever began about 6 hrs and lasted for about 48 hours. Temperature reached 102.6, followed by a couple days of exhaustion. The 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 events. The clinical outcome of the events fever and exhaustion was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 4/30/21). Patient presented to ED on 7/25 c/o rash on his back, feeling generalized fatigue and weakness for last few days and had tested positive for SARS-CoV-2. Patient remained stable and was discharged from ED on same day. On 7/29 patient returned c/o headache and SOB, he was placed on 3.5L NC and given albuterol neb, acetaminophen and prednisone.

initial reactions for 5 days: sore arm, tiredness, fuzzy brain, fever, gastric distress. All of these would fluctuate in intensity and sometimes weren't noticeable at all, except the sore arm which started strong and gradually lessened and disappeared after 3 days. The real adverse reaction I've experienced and has actually been getting worse is a racing heart. It may have actually started in May but I simply thought I had gotten out shape. I really noticed it going uphill. But starting in July, especially the last two weeks, the racing from just a brisk walk on flat land. I have to stop and rest when I haven't really exerted myself. There's no rational explanation where this has suddenly come from, until I just googled and found that it's been a reaction for some to the vaccine.

I felt light headed, sore arm, head ache and fever at first and that evening. Then woke up the next morning I felt fine but had swelling to the face more swelling to the left side then the right with a heavy feeling to my left side of my face along with pain to the eye. I feel very lethargic and very tired I could not go to work. I feel to bad to work.

Severe night sweats for 3 nights in a row. Severe fatigue for 2 weeks. No fever. No cough. No sick contacts and no contacts became sick.

tested positive for COVID-19; tested positive for COVID-19; Headache; feeling unwell; muscle pain; This is a spontaneous report from a contactable nurse reporting on himself. A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 28Dec2020 at 08:15 AM (at the age of 61 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Jan2021, the patient experienced mild side effects consisting of headache with feeling unwell and muscle pain. The patient reported this happened on 01Jan2021, and 02Jan2021 and on 03Jan2021 and later, the patient did not experience any side effect. Since the vaccination, the patient was tested for COVID-19 on 02Jan2021 with a Nasal Swab Rapid Test and tested positive for COVID-19. The adverse events resulted in Emergency room/department or urgent care visit. The patient did not receive any treatment for these events. The outcome of the events headache with feeling unwell and muscle pain and tested positive for COVID-19 was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further 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 RAs, Ethics Committees, and Investigators, as appropriate.

Fever to 103.7F, respiratory rate 36. Was transferred from facility to hospital. Since then has been found to have gram-negative rod bacteremia, although urinalysis was negative, urine culture pending. Patient has since defervesced after receiving 1 dose of cefepime. Overall the most likely cause of fever seems to be urosepsis w/ bacteremia, pending confirmation with urine & blood cultures.

Myalgia & Diarrhea Narrative: Per employee, 14 hours after vaccination, felt abdominal cramps followed by watery diarrhea and sore left arm (vaccine site). No hx of changes in food prep nor diet 1/1/2021. Denied fever, some sniffles (chronic) diarrhea improving bowel movement mid morning following day

The day after the vaccine, I felt a bit fatigued. Then for 2 days, I felt fine. Then starting on the 3rd day until present, I feel extremely light-headed and unsteady with a persistent severe headache. Almost feels like there is pressure in my head for lack of a better description. I feel feverish as well but do not have a fever. I have difficulty maintaining balance on my feet so it is difficult to walk. I did seek medical attention yet since I live alone and do not feel comfortable to drive. Although the symptoms are difficult, I also don't consider them an emergency to warrant calling an ambulance.

on 12/24/2020 I started feeling a little tired on 12/25/2020 I was feeling exhausted i had a cough and breathing problems, also had headaches & fatigue. I'm taking antibiotics for pneumonia Visited urgent care twice

Got dizzy after vaccine and was told to sit down for 15 min after 15 I still felt dizzy so I stayed seated for an extra 10 min, still felt not ok but enough to go. Went home and still felt dizzy and then I felt like I need to pee but I was very cold , urinated 3 more times thinking it was because it was due to being cold but doctor explained it was due to me drinking lost of water. Went to bathroom and bassed out and woke up about an hour later, but during the fall I injured the neck by heating your head on the sink, back and broke my nose, when I woke up I was still very dizzy. Also felt a fast heart rate, chest pain, very nauseas and started sweating a lot.

Awakened 0300 the next day, Saturday the 9th with chills, fever 2 degrees above normal, headache and left arm pain from deltoid to elbow. Went to work in ICU at 0638, feeling like i had been ran over by a truck. Fatigue and general malaise throughout day. Sunday, i had no problems. Monday morning awakened with diarrhea, I never have diarrhea! I felt bad most of Monday. Tuesday today, i feel fine!

High fever; Vomiting; Severe fatigue; Weakness; This is a spontaneous report from a contactable physician (patient himself). This 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1442), via intramuscular, on 05Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 61-year-old. Vaccine location was deltoid left. The subject did not have a relevant medical history and concomitant medications. On 06Jan2021, the patient developed high fever, vomiting, severe fatigue and weakness. He did not experience anaphylaxis. The events were considered serious as medically significant. The patient stated that side effects mentioned lasted 3 hours and he felt much better now. However, the final clinical outcome was unknown. The patient is not sure if he should get the shot again in 3 weeks since he was really sick. The reporting physician considered the events 'high fever', 'vomiting', 'severe fatigue' and 'weakness' related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, vomiting, fatigue and asthenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Patient experienced weakness on lower legs post 3 hours of receiving COVID-19 first dose that lasted for a few minutes. The weakness subsided after 15 minutes of resting and only complaint of mild headache. Patient has a medical history of HTN and type II diabetes. The facility called 911 and the paramedics crew took patient with them to monitor the vital signs.

headache, chills, injection site pain, feeling unwell, difficulty breathing, dizziness, weakness and imbalance

COVID-19 virus test positive; COVID-19 virus test positive; Headache; Sinus congestion; This is a spontaneous report from a contactable consumer reported for himself. A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9899 and expiration date unknown), via intramuscular on left arm on 22Dec2020 at single dose for COVID-19 prophylaxis. The patient medical history reported as none. Concomitant medications reported as none. The patient is a radiology technician that reported that he got the Pfizer vaccine on the 22Dec2020. He said that he got a positive Covid test on 04Jan2021. The patient had the Covid symptoms as of last Monday night on 04Jan2021. He stated that he developed a headaches and sinus congestion on the 04Jan2021. Stated that he has not had a fever. He said that there was no adverse reaction from the vaccine itself. He said that he was due for the second dose on the 11Jan2021 and he is currently quarantined so he will not be getting the second dose. The outcome of the events was unknown.

Mildly feverish evening after vaccine; Soreness and tenderness at left arm injection site; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; second dose (lot number: EL1284, expiry date: unknown) via an unspecified route of administration on 07Jan2021 07:00 at single dose (Left arm) for COVID-19 immunization. Patient took bnt162b2 first dose (lot number: EK5730, expiry date: unknown) on 17Dec2020 07:00 am (Left arm) for COVID-19 immunization. Medical history included known allergies: Sulfa, Hypothyroid, Asthma, Hi Cholesterol. Concomitant medication included cetirizine hydrochloride (ZYRTEC), atorvastatin, levothyroxine. The patient previously took tamiflu and experienced allergies. Facility type vaccine was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Mildly feverish evening after vaccine, Soreness and tenderness at left arm injection site on 07Jan2021. The patient took Motrin as treatment. Therapeutic measures were taken as a result of mildly feverish evening after vaccine, soreness and tenderness at left arm injection site. The outcome of the events was recovered on an unspecified date. The events were reported as non-serious.

Chills; Right eye was swollen; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing diabetes and blood pressure high from an unknown date and unknown if ongoing. The patient's concomitant medication included metformin at 500 mg for diabetes. On 06Jan2021, the patient experienced chills and right eye was swollen. The patient outcome of chills was recovered and the outcome of "right eye was swollen" was not recovered.

Sore arm for approximately 24 hours, headache for approximately 12 hours,muscle/ joint aches 12 hours. Took 2 Tylenol. All symptoms gone after 30 hours.

fever of 101; Chills; loose watery stool; stomach problems; threw up a couple of times; headache; Nausea; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), via an unspecified route of administration on 05Jan2021 at a single dose (with a syringe left shoulder once; as reported) for Covid protection. Medical history was reported as none. There were no concomitant medications. It was reported that the patient experienced side effects on first Pfizer Covid injection that he had. He got it on Tuesday, 05Jan2021, and got a headache and nausea which started Tuesday evening. His temperature is 99.6. On Thursday, 07Jan2021, he had a fever of 101, nausea, chills, loose watery stool, stomach problems and threw up a couple times. He was under a blanket for the chills all day. His lasting effects was that he still has watery loose stool and went to the bathroom an hour ago. He took Tylenol for fever. He took Immodium yesterday three tablets and woke up at 3-3:30 am and took a couple (also reported as started taking it at 11am then took some at 4am and then two this morning) then some Tylenol. He was still feverish and has loose stools. The patient underwent lab tests and procedures which included body temperature: 99.6 on an unspecified date and 101 on 07Jan2021. The outcome of the events headache, nausea and loose watery stool was not recovered; the events fever of 101 and chills was recovering; and the event threw up a couple of times was resolved on 07Jan2021; while the outcome of all other events was unknown.

5AM: TEMP 101.7, HEADACHE, CHILLS, LOWER BACK PAIN, LETHARGY. SYMPTOMS PROGRESSED THROUGOUT THE DAY. SYMPTOMS STARTED ABATING 1/8 TIME 2100. 5AM TOOK 2 EXTRA STRENGTH TYLENOL. 8AM- 2 EXCEDRIN. 1300 - 2 ADVIL; 1600- EXTRA STRENGTH TYLENOL. 01/0 0700 - 2 EXTRA STRENGTH TYLENOL FOR HEADACHE.

have a persistent severe headache; feverish; I feel very light headed; unsteady with difficulty maintaining balance when I walk; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old male patient received the first dose of BNT162B2 (Pfizer, lot number: EH9899), via an unspecified route of administration in left arm on 31Dec2020 12:00 at single dose for COVID-19 immunization. Medical history included known allergies: penicillin, and deep vein thrombosis (DVT). Concomitant medications in two weeks included dabigatran etexilate mesilate (PRADAXA) at 150 mg twice a day, and hydrochlorothiazide/losartan potassium (LOSARTAN + HIDROCLOROTIAZIDA) at 100-25 mg. On 04Jan2021, patient felt very light headed, unsteady with difficulty maintaining balance when I walk, had a persistent severe headache and feverish. However, he did not have a fever. Temperature was 97.5. Blood pressure (BP) was normal. Pulse was normal. No soreness at the injection site from day one. Treatment was not received. Patient was not recovered from all these events.

Not feel very good; This is a spontaneous report from a non-contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient described that the vaccine made him "not feel very good" on an unspecified date. He did not sound overly concerned. No treatment received for the event. The outcome of the event was recovered. The event was considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it is unknown if the patient has been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Got the injection around 8:15 AM, by around 2:00 PM started to feel mildly achy and tired. Around 6:00 PM arm was sore, I was tired, not feeling well. Went to bed, started to get chills, nausea, and vomited around 9:30 PM. Did not sleep well. The next day I had a headache, felt tired and wiped out. Started to feel better around 2:00 PM . Lost day of work was able to return to work on 1/21/2021. My arm still ached for several days. It felt like someone had hit me in the shoulder with their fist

Injection site pain, Tiredness, Headache, Muscle cramps & pain, Chills, Joint pain (extreme), Fever, Feeling Unwell.

This is spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included Blood pressure high, Cancer (Two or less years ago; In remission, Taking medication to follow through with remission period), Allergies and sinus issues, covid virus (in July). The patient reported soreness in the arm (15Jan2021), fatigue (15Jan2021) and palpitations (16Jan2021) that he felt below the mouth and above the heart, calling it the esophagus area. He wanted to know if others had reported this same palpitation. The reporter further reported that he has a little bit of concern. He felt fine, had sore arm and fatigue that has gone away. Noticed lately, somewhere in his esophagus between his heart and mouth that he is feeling palpitations. Doesn't know if it's more indigestion. Stated it could be gas. Sometimes comes and goes, feels different than what he's already experienced. Wanted to double check if this has been heard of or anything similar to it. Clarified product as first dose of COVID-19 Vaccine. Received last Thursday. Received COVID-19 Vaccine in left arm on 14Jan2021 between 15:00 and 16:00. Both arms are sore, but only because other arm is injured. Pain level in injection arm was around 5-6 and he wasn't able to sleep on that side. Within the second day, 16Jan2021 in late afternoon soreness and fatigue was gone. Indigestion or Palpitations, feeling was happening again. They wanted to know if that is something he is experiencing from the COVID-19 Vaccine. Stated it doesn't appear to be related. It is around the esophagus. Stated it affects breathing. Stated maybe that has something to do with it. For the dose, they noticed it was a small amount of fluid in the tube that was injected into him. The outcome of the events soreness in the arm/sore arm and fatigue was recovered on 16Jan2021, while for other events was unknown. Information on the batch number/lot number has been requested.

Employee described malaise and body aches the day after receipt of the vaccination (1/13/21). The symptoms were bothersome enough to keep the the employee out of work for one day.

I have been have contact with my primary care doctor because of the reaction with the first dose. He advised me to take Benadryl 15 minutes before receiving the injection. I stayed at the vaccination site for an hour instead of 15 minutes. I left the vaccination site and went home and went to sleep, I worked over night. I did not sleep well that day. I got up around 6pm and I went to work at 10pm and I was extremely anxious and tired all night. I was a little confused while at work. I got off work and went to my chiropractor who noticed and my wife also noticed that I was extremely pale, after the appointment I went home and went back to bed. When I woke up I was still exhausted that I ended up calling out out of work that night. I went back to bed and slept all night till 9am this morning. The next morning my color was back and I was looking better. My energy level is slowing improving but still feel tired even when I got a good nights of sleep. I don't know if it related, but I went and brought some new shoes and then my hip started hurting. It is to the point where I set up a doctor's appointment on Monday to have my hip looked at. See VAERS report 906796 for first dose reaction.

anxious, restless, weak, dizzy, felt "horrible". Continued to C/O symptoms,. At 01:15, patient lost consciousness , then stopped breathing and lost pulse. Narrative: Patient was first vaccinated for COVID 19 on 1/8/21. On 1/24/21: 61 year old presents to E.R. with CC of chest pain/sob, with multiple medical conditions including hypertension, atrial fibrillation on apixaban, cardiomyopathy with poor EF, dyslipidemia, COPD, CVA, lung CA s/p radiotherapy, PTSD, depression, Churg Strauss Syndrome, Sjogren's syndrome presented with chief complaint of chest pain or shortness of breath. He has been having worsening shortness of breath the past few days, also complains of cough productive of yellowish sputum, no hemoptysis. He complains of left upper chest pain with no radiation. There is no diaphoresis, palpitations or lightheadedness. He denies fever or chills. He complains of having fallen a few times recently, thus he passed out. Could not say if there were seizures activity. Admitted to 3D Tele. On 1/27, Pt advises he had episode of substernal CP this am. RN advises pt was in afib w/ RVR at a rate >140 at time of CP. Pt CP improved w/ prn NTG. Pt HR improved after daily medications. Pt sts his CP has resolved. Pt admits to continued dyspnea. Increased trop, transferred. 1/28, struggling with orthopnea and cough. He has no peripheral edema. He does have intermittent chest pain. Patient having periods of A-Fib RVR with non-sustained rates of 140's-150's 1/29 more chest pain at 04:00, relieved with NTG. HR = AF, with RVR 145. At about 08:00, Cardiology sees patient and signs off, "shortness of breath and cough not due to heart failure as evidenced by orthostatic hypotension and no improvement in symptoms with diuresis. Consider underlying lung disease vs acute pulmonary disease." No pulmonary consult noted. 1/29 Patient received 2nd dose COVID19 vaccine at about 3:30-4p. No notes from staff on this event. No notes from MD that this was discussed and still part of the plan. 1/29 nurse's note: At around 2240 Pt was able to rest briefly but is now restless and anxious again. Tachypneic, stating he feels so weak and dizzy and overall just feel horrible. Continuing to get up frequently to have small soft bowel movements with assistance. Pt also stated ever since he got "that shot" he hasn't felt well. When asked what shot pt replied "COVID shot." Pt did receive 2nd dose of COVID vaccine 1/29 at 1530. Around 2250 Spoke w MOD to relay above information and overall concern for pt, asked for MOD to come to bedside to evaluate pt. MOD states he's handing off to oncoming MOD and they will come to bedside to see pt. Around 2300 oncoming MOD called and all above and previous information discussed Around 2310 MOD came to bedside to see pt. Will continue to monitor closely. 01/30/2021 ADDENDUM Around 0115 pt called for help to use bedside commode to urinate and have BM. Assisted x2 to BSC. While sitting on BSC pt's eyes rolled back and pt made postures consistent with a seizure, body became very rigid. Pt was unresponsive still with pulse. Lifted patient back to bed with 3 staff assist. Pt stopped breathing and lost pulse. Chest compressions started immediately and Code Blue called at 0120. 1/30 Hospitalist note: Called for CODE BLUE AGAIN AT 4:53. While on Vent after s/p Code blue for reasons not clear patient went into Asystole and code called second time. Patient had a prolonged CPR and was actually called off at 5:17 but he started having pulse and agonal resp. he was placed on Levophed and D5NS. He got a total of 9 amps of epi, 3 amps od Bicarb and 1amp of D50. Trope bumped from 0.12 to 0.43 prior to this he already was on ASA, Apixiban for afib. Cards are on board for his CHF for his pulmonary edema Lasix ordered. Hid lactic acid is elevated. Blood cultures pending. Started Zosyn and is on Levophed. Continue to monitor. Updated patients Mom and she requested to do everything at this point. Coded again at 5:40, survived, but AOD writes a death note(?) Coded for the 4th time at 08:18. Family at beside, Mother asks for code to be stopped.

acute hepatitis/The transaminase was elevated to four times the upper limit; Fever/temperature yesterday was 103 degrees/ Today it is 98 degrees; Fatigue; Myalgia; Malaise; This is a spontaneous report from a contactable pharmacist and a contactable consumer. A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Not at Military Facility. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed an acute hepatitis after receiving the second dose of the Covid-19 vaccine on 20Jan2021. The transaminase was elevated to four times the upper limit. The aspartate aminotransferase (AST) was 183 and alanine aminotransferase (ALT) was 270. The patient reported fever on 18Jan2021, fatigue on 16Jan2021, malaise on an unknown date in Jan2021 and myalgia on 16Jan2021. Events of acute hepatitis, Fever and Fatigue were assessed as serious due to medically significant and Myalgia was non-serious, the events of Fever, Fatigue and Myalgia were Related to Covid-19 vaccine, and unable to provide causality of acute hepatitis. Pharmacist was unable to confirm if the patient was still experiencing myalgia. The patient reported that he felt better today. His temperature yesterday (21Jan2021) was 103 degrees. Today (22Jan2021) it is 98 degrees. Adverse event required a visit to Physician Office. The patient underwent lab tests and procedures which included ALT: 270 on 20Jan2021, AST: 183 on 20Jan2021, alkaline phosphatase: 241 on 20Jan2021, body temperature: 103 degrees on 21Jan2021, body temperature: 98 degrees on 22Jan2021, serology test: negative on 20Jan2021. The outcome of the event acute hepatitis was not recovered, event Fever was recovered on 22Jan2021, event Fatigue was recovering and the events of Myalgia and Malaise was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events hepatitis acute, fever and fatigue. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

1/31/21 0730 am confused and low grade temp 99.5, 12 noon Temp 100.6 and sitting in recliner non responsive twitching. Sent to Hospital with EMS to rule out stroke. Admitted 1/31/21.

31 Jan 2021-Sunday-Very weak, diarrhea, migraines,-no diagnosis-pt states nights sweats 1Feb 2021-Monday-Same as above 2 Feb-Tuesday-feeling a little better 3 Feb-WED-more fatigued 4th Feb-TH-home from work-later that day 5th Feb-Fri-no work-at home 6th FEB-Sat-feeling up & up-has a migraine-takes aleve 7th Feb-Sun-still diarrhea-stayed in bed 8th Feb-Monday-**diarrhea-taking Immodium AD

Pt began to feel dizzy and light-headed with progressing headache pain within 15 minutes. Pt BP was 170/86 at time of event and HR 74 bpm. Pt given O2 at 5 LPM . Pt lungs clear bilaterally and pt denied SOB. Pt O2 saturation at 99% on 5 LPM via mask. Pt stated vision was blurry but resolved after 15 minutes. Pt advised to go to ER via ambulance but denied transport, pt wife at facility to transport pt to ER.

Within 24hrs fever, malaise, progressive weakness beginning in the lower extremities and advancing proximally to affect arms. Severe neuropathy

headache; Left arm sore; This is a spontaneous report from a contactable consumer (patient) This 61-year-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL3247 at left arm on 26Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation . Facility where the most recent COVID-19 vaccine was administered:Workplace clinic. the patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.Medical history :none. Concomitant medication included atorvastatin calcium (LIPITOR ) bupropion hydrochloride (WELLBUTRIN), acetylsalicylic acid (ASPIRIN) 81 mg.The patient experienced left arm sore and minor headache on 27Jan2021 06:00 .No treatment received.Events reported as non serious.Outcome of the event was recovering.No Prior to vaccination, was the patient diagnosed with COVID-19 .Since the vaccination, The patient hadn't been tested for COVID-19

the swelling and extreme tenderness of the site of injection; the swelling and extreme tenderness of the site of injection; headache; I couldn't sleep last night because I have headache, thrombing headache and back pain; Nausea; I had like metallic taste; Dizziness; The initial case was missing the following minimum criteria: suspect drug. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician. A 61-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685, expiration date Mar2021) on his left arm, intramuscular on 18Dec2020 at 0.3 mL, single for COVID-19 immunization. Medical history included hypertensive, 2 stents in heart in 2016, Hyperlipidemia, hypothyroidism, coronary artery disease in 2016 and Allergic (Allergic rhinitis + Chronic sinusitis). Concomitant medication included acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX). It was reported that the patient had swelling and severe tenderness left his arm. He couldn't sleep last night because he had throbbing headache and back pain on 18Dec2020. Initially, he had nausea. Patient stated further stated that Headache and swelling and extreme tenderness of the site of injection, that is the swelling, no redness but the swelling and tender and painful. Initially, he had till now the mild back pain. He patient said she took Tylenol. She also mentioned that initially she had like metallic taste and then disappear. The patient also had dizziness a little bit. The outcome of the event vaccination site swelling, dysgeusia and tenderness was recovered on unspecified dates, headache and back pain was not recovered, recovering for nausea while unknown for the remaining events.

Pt reports he started shaking all over on 2/6/21 and it gradually improved over the next week. He continues to experience problems with short term memory and recall. Headaches, myalgias/arthralgias. Positive for mild nausea, constipation. Dizziness with turning his head started on 2/6/21 but has now resolved.

pt states when he woke up that he felt like he had fever but when he checked his temp on forehead it was 99 and when he checked his temp around the ear it was 101.

This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 02Feb2021 08:45 at single dose for COVID-19 immunization. Medical history included stage 4 prostate cancer. 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. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications were not reported. The patient previously took celecoxib (CELEBREX) and experienced allergies. On 04Feb2021, the patient experienced extreme soreness on side where injection was given, also had malaise and tiredness. The patient underwent lab tests and procedures which included SARS-COV-2 test: unknown results (COVID test result Pending) on 05Feb2021. No treatment was received for the adverse events. Clinical outcome of the events was recovered/resolved with sequel (reported as recovered with lasting effects). Information on the lot/batch number has been requ

This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 26Jan2021 13:15 at single dose in left arm for COVID-19 immunisation. Age at vaccination was 61 years. The vaccine was administered at Doctor's office/urgent care. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) received on 05Jan2021 at 01:30 PM at single dose in left arm and the patient experienced sore arm. Medical history included Supraventricular tachycardia (SVT), Herpes, Hyperlipidemia, idiopathic mesenteric lymphadenopathy. The patient has no known allergies to medications, food, or other products. Concomitant medications included Valacyclovir, cyclobenzaprine, Metoprolol, lipitor. The patient reported second dose 8 hours post headache, sore arm and entire upper torso pain, chills and fever 101-102F 12 hrs. Patient was lethargic the whole next day with severe headache. Normal 2nd day after. Adverse events start date was reported as 26Jan2021 16:00. No treatment was received for the events. The events were reported as non serious. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The events were resolving (as reported).

Extreme exacerbation of patient's longstanding Crohns Disease. Intractable liquid diarrhea for 5 days beginning approximately 48 hours after first shot; almost constant Fever; Body Aches; Strong lower back and hip pain; Bilateral pedal edema; dehydration; inability to absorb fluids for 5 days; arm, ankle, hip, back, shoulder, and wrist joint pain; difficulty getting out of bed in the morning, or getting up from the stationary position. Symptoms finally resolved day 7 just before I anticipated going to ED in local hospital, and were gone for two days. Symptoms returned on day 9 following vaccination and lasted 5 additional days, with symptoms resolving for good only on the 15th day after the initial injection.

Chills, bad headace, possible light fever from bedtime throughout the night (Friday night). Next day headace and tiredness all day (Sat). Felt fine by Sunday

Flu/fever-like symptoms (but temperature at 96.9), moderate to severe body aches, moderate to severe headache, fatigue. This started 12 hours after injection, and ended 24 hours after symptoms first appeared.

Flu-like symptoms lasting about 36 hours (myalgias, arthralgias, malaise, low grade fever, and intermittent chills)

Approximately 10 minutes post vaccine patient complained of dizziness, shortness of breath and diaphoresis. Patient transported to ER for further evaluation.

1/04/2021, 1/25/2021 Pfizer ej1685, en5318 Reports that he "passed out" on 1/6 at work, taken to ER and was diagnosed with kidney failure & hyperkalemia, also positive for covid. Hospitalized till 1/13, underwent dialysis. Received 2nd vaccination 1/25, once again "passed out" in breakroom while at work. Pt was awoken after approx 1 hour, unable to move arm at that time, went home and did not seek medical care at that time. Pt was re-hospitalized on 2/2/2021 due to difficulty breathing & AMS. Dx with pneumonia & hyperkalemia at that time, discharged home 2/11/2021. Continues on hemodialysis 3x/week.

Per patient, he received his second dose of Pfizer COVID-19 vaccine on 02/20/2021. Approximately 48 hours later, he developed left-sided lip paralysis. He went to his doctor that day, no medications were prescribed and no tests were ordered. Over the next 24 hours, he states that his symptoms progressively worsened and now the left side of his face seems "completely paralyzed." He described left ear pain, increased sensitivity to loud sounds, runny nose, and inability to close his left eye. He saw another doctor the next day, who diagnosed Bell's Palsy and prescribed valacyclovir for 7 days. Patient also noticed a transient "crooked smile" after his first dose of Pfizer vaccine, but did not relate this

Pain in left arm was so strong that I could not roll over to get out of of bed. All other joints and areas in which I have minor aches and pains were very sore. Mind somewhat clouded. Modest temperature, 101. Chills. Like a bad flu, but more pain and less congestion. Strong but not splitting headache. Not like a migraine--not at all as bad. Very minor nose congestion and sore throat. Symptoms all ended by 36 hours after 2nd shot

After the vaccine he came home, felt a little less sore than a flu shot. The next day when he took a shower, and when he went to wash under his armpit was very swollen, and very tender. He put some ice on it which did not help the swelling. It bothers him when his T-shirt touches the area, so he tried to wear a regular shirt. He also had achy pain in his back, weakness in his arms, sore throat and a little cough, no fever. The armpit still hurts and is still swollen. Other than the ice he did not take anything else as he takes a lot of medications as it is. He has not called his doctor because it happened over the weekend, but is going to call her today. He did have a COVID test yesterday drive through facility at the community hospital as he has a surgery coming up, and they were going to call him if it was positive. He is scheduled for surgery on his right knee on Thursday.

he was not comfortable; allergic reaction; dizziness; feeling a lot of pressure in his head like his "brain wanted to pop out of his head"/ his brain wanted to swell up; felt like he was going to lose his mind / go crazy; fever; headache is recurring- worse at bedtime; almost passed out; This is a spontaneous report from a contactable consumer reporting for himself. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9621), intramuscular on the left arm on 22Jan2021 (reported as 07:45 to 08:00) at a SINGLE DOSE for prevent COVID, at 61 years old. Medical history included triple bypass surgery from an unknown date. There were no concomitant medications. The patient previously took morphine and experienced the same thing with his brain, almost identical to what he was experiencing after the COVID vaccine. He reported that the first time he received morphine it was fine and then he got a shot of morphine and he experienced the pressure on his brain after receiving morphine, about 5 or 6 years before reporting time. He stated it was almost the same reaction. He was given a shot of Demerol (he was not sure if it was Demerol) to counteract it. History of all previous immunization reported as none. No additional vaccines administered on the same date. No prior vaccinations within 4 weeks. The patient reported he experienced an "allergic reaction"/ bad reaction to his first dose of BNT162B2 on 22Jan2021. His symptoms included dizziness as soon as he got the vaccine, got dizzy right off the bat, still dizzy, very little; feeling a lot of pressure in his head like his "brain wanted to pop out of his head"/ his brain wanted to swell up; felt like he was going to lose his mind / go crazy; fever; headache is recurring- worse at bedtime. Symptoms (unspecified which) reported as recurring and are notably worse at bedtime. Patient is hesitant to receive the second dose. The patient stated he just went to sleep and prayed and then when he woke the next day, at night it did it again. At night it comes and goes, and he still has it happen but not like the first time. He tried to describe that he was washing his hands and he almost passed out like on an unspecified date in Jan2021, he was going to lose his mind. Last night he went to bed no problem, he felt a little pressure on his brain, stated it is hard to describe, it was not a good feeling. He was running a fever. Last night he had a slight fever, like it was going away. He was not able to drive when this was happening and today was the first day he could drive and he was not comfortable (27Jan2021). The patient declined any treatment. He already talked to his doctor and was told to call Pfizer. He asked if he was to get the second shot, is there something he could to take to make that feeling go away or counteract it. No relevant tests were reported. Events did not require a visit to the emergency room nor physician office. The outcome of the events, allergic reaction, headache is recurring- worse at bedtime, almost passed out and he was not comfortable was unknown. Outcome of the events dizziness, "feeling a lot of pressure in his head like his brain wanted to pop out of his head/ his brain wanted to swell up", felt like he was going to lose his mind / go crazy, and fever was reported as recovering.

Hospital course 1/31 ? 2/20/21 1/31 in ED pt was at home when children noticed his lips were blue, ems arrived and found him to be 50% on RA, on Non-rebreather pt got to 78%, covid on 01/26 Shortness of Breath 61-year-old male presents with EMS for evaluation of shortness of breath hypoxia. History is limited due to the patient's current clinical condition and so is primarily obtained from EMS. EMS reports that he tested positive for COVID-19 5 days ago. He began developing shortness of breath yesterday and his family called because his lips and fingers were blue today and he appeared short of breath. On EMS arrival he had a room air saturation of less than 50% so he was placed on nonrebreather with improvement in his saturation to 70% and he was transported to the emergency department. Patient does admit to shortness of breath. He denies any chest pain. He is noted to have a cast on his left ankle and said that he broke his left ankle on 23 December but has not had surgery. He denies any new pain or swelling of the leg. In the ED he was placed on 15L nasal cannula and NRB mask with improvement in SPO2 to low 90s. Additional work up revealed troponin of 1.35, lactic acid 5.8, and d-dimer 14.4. He received dexamethasone and was placed on heparin gtt. 1/31 admitted to ICU Acute hypoxic respiratory failure due to COVID-19 vs heart failure vs PE. CXR with bilateral hazy infiltrates more pronounced in the bases and left periphery and suspected multifocal pneumonia. At risk for PE given LLE immobility in the setting of COVID-19 with significantly elevated d-dimer. RISK of CTA outweighs benefit given AKI and iodine allergy. Continue with empiric treatment with heparin gtt. Admitted to ICU with SO2 in 60s-70s on 15L and NRB. Attempted 50L 95% FIO2 high flow and nasal cannula. Given lasix 40mg IV with good diuresis however SPO2 still remained low 80s with RR 40s and PO2 42 so the decision was made to intubate. Oxygenation improved following intubation, with further improvement following recruitment maneuver and increase in PEEP. FIO2 weaned to 90% with SPO2 remaining in mid 90s. Will continue to wean FIO2 as able. ARDS net protocol as much as possible. Consider prone ventilation and/or epoprostenol if unable to improve . VAP Bundle: HOB >30 degrees; Oral care per nursing standard and on DVT/PPI prophylaxis Sedation: Target Richmond Agitation and Sedation Scale (RASS) of 0 to -2 with propofol and fentanyl. Check baseline TG levels. COVID - 19: Convalescent plasma: Not indicated Steroids: Dexamethasone 6 mg / day for 10 days Remdesivir: Not indicated d/t AKI IL-6 inhibitor: Meets criteria for tocilizumab Systemic AC: Heparin gtt. No signs of bleeding (Platelets and Hb stable). Antibiotics: Start 3 and 7 day course of azithromycin and ceftriaxone, respectively. Elevated troponin Suspect demand ischemia d/t hypoxia; EKG does not show any ischemic changes AKI: Suspect d/t hypoxia in the setting of COVID infection. Urine output and electrolytes acceptable. Closed fracture of left ankle Suffered fracture following a fall on ice in December. Cast was placed on 12/30 by SOS. He was due to be re-evaluated this week for possible cast removal. Inhaled epoprostenol started Considered for ECMO but not initiated due to not a candidate Vasopressors required at times Antihypertensive infusion required at times severe hypoxia with position changes switched from heparin drip to enoxaparin prophylaxis 2/20 discharge summary 61 y/o male admitted to Hospital on 1/31 with hypoxia. He was diagnosed with COVID 19 5 days prior to admission, and had worsening respiratory status. He was intubated after arrival, and was on ventilator for the entire intervening time, until he was extubated on 2/20 at the time of transition to Comfort measures only. Prior to developing COVID 19, he had received his first dose of the Pfizer vaccine, as a member of the school system. He had a fractured L ankle after a fall on 12/31/20, and had a cast in place at the time of admission. He received Tocilizumab on 1/31, and underwent several cycles of prone positioning, beginning on 2/2. He completed a course of Decadron, he received Ceftriaxone and azithromycin beginning on admission, and completed a course of these. Anticoagulation with enoxaparin was utilized due to coagulopathy associated with COVID 19. Vasopressor support was required at times, as well as diuresis for fluid management. He required high levels of sedation to maintain ventilator synchrony, and high levels of ventilator support with high oxygen levels throughout his stay. Tracheostomy was being considered, but family decided that since he was not going to have good recovery, withdrawal of support, and allowing death was the appropriate choice for the patient and for them. He was extubated at 2100 on 2/20/2021. Death was pronounced at 2123 on 2/20/2021. Children were at bedside.

When I woke up this morning I was lethargic, on the way to work, I started getting tired. Mid way through the day I started getting chills

sore arm at injection site; tiredness; feeling unwell; loss of appetite; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247 and expiration date: unknown), via an unspecified route of administration on 02Feb2021 at 11:30 at a single dose for COVID-19 immunization. Medical history included likely COVID in Apr2020 based on a video call with his physician. Concomitant medications included celecoxib (CELEBREX), gabapentin (NEURONTIN), zinc (ZINC), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ascorbic acid (VIT C), colecalciferol (VIT D3), and cyanocobalamin (VIT B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm at injection site, tiredness, feeling unwell and loss of appetite on 02Feb2021 at 18:00. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The events had not resolved.

Headache/Fatigue set in about 1 hour after my second does of the Pfizer vaccine. It only lasted for about an hour. Rest helped alleviate the symptoms.

This came on gradually over a period of about 5 hours: headache, aching in the joints, abdominal cramping, lethargy.

THE SAME DAY OF MY SECOND VACCINE AND ONE DAY LATER I EXPERIENCED A KIND OF JUMPS ON MY LEFT CHEK, MY NOSE FLOW MORE THAN NORMAL AND A LITTLE BLOOD CAME OUT OF MY NOSE

Chilling, shivering, muscle and joint ache, fatigue for about 24 hours, then tapered off. Lymph node under left arm swelled and pain for about a week.

Approximately two hours after getting the shot, I felt clammy and had a fever. Very fatigued, left arm very sore. In bed by 7 p.m.. Slept till 7 a.m. Friday(3-5). Chills and fever subsided that morning. Headache and ringing in my ears. This and extreme fatigue lasted until Sunday(3-7). Unable to work for 2.5 days. Lost income. Went back to work Sunday morning, but not completely recovered. Felt back to normal by Monday morning .

On Saturday he felled very tired, Monday experienced tongue numbness, and Monday experienced loss of taste.

Headache, sore arm at injection, leg cramps - evening of injection >>> Blood pressure spike to 150/100 on second evening after injection, felt funny, bad sleep <<<

Patient reported dizziness, headache, racing heart and mild chest tightness. Was evaluated by NP. HR in 80's. Lung sounds clear. Moved to private area for rest, water, snack. Encouraged to use his personal albuterol inhaler for his asthma. Repeat HR at his baseline 52bpm. Lungs sounds remained stable. Final pulse ox 99%. Observed for another 30 minutes. All symptoms resolved.

Had chills, head ache, body aches threw up for three(3) days could not keep anything down took promethazine did not help. Still felt bad a few days after vomiting stopped.

Within 15 minutes of my 2nd covid shot I developed extreme lightheadedness, shortness of breath, disorientation, dehydration and consequently extreme anxiety from the incident. I was taken to an examination room at the vaccination clinic by their nurse director. Blood pressure was high and there was a question if I was having a stroke or heart incident. the director sent me by ambulance to Hospital as they didn't know if I was having an anaphylactic shock or cardiac incident. All this occurred within an hour if the first symptoms.

Bells Palsy affect 60 hours after injection. Right eye.....same manifestation as I had during Covid-hospitalization in 2020. Seems to be abating finally (approx 18 hrs from detection). Severe headaches, chills and fatigue commenced approx 8 hours after injection. LAsted two days. On third day, headaches and fatigue continued, but mildly.

onset of self-described 'sinusitis' a week after vaccine administration, and then 2 days after that developed severe tinnitus

Fever (up to 101.6), body aches, nausea and headache peaking between 12-18 hours after dose, mostly resolved by 30 hours. Nausea, and headache persisted until about 30 hours (took Tylenol Extra Strength at 24 hours). Pain at injection site, could not sleep on that side. Gradually developed and peaked 12-18 hours after dosing. Still slightly sore at 30 hours.

14 hours after shot, mild headache began. Headache lasted for 12 hours. Also at 16 hours post shot, I had severe chills that lasted for approx 30 min.

Started 03/18 Headaches - stabbing/ache/pressure/burning/tingling Started 03/14 Tired Started 03/14 Dizzy Started 03/14 High Blood pressure Started 03/14 Slight nausea

migraine head ache, back ache, fever, nausea, lack of apatite , brain fog,, i had covid in november, felt about the same, was very sick for 5 days, felling much better 8 days after the vaccine, very afraid to get the second dose, if reaction is more severe as reported in the second dose, i'm afraid i won't servive

Fever within 12 hours reached 102.5. Within 18 hours, fever subsided to near normal levels. Severe chills. Ongoing fatigue and muscle soreness and stiffness. Still mild fever after 30 hours.

Developed fever to 104 degrees on the morning after vaccination and had a grand mal seizure that lasted about 1 minute followed by generalized tremors that lasted about 10-15 minutes and resolved with administration of rectal Diastat 5mg. Tremors resolved within 5 minutes. Temp treated with Ibuprofen 600mg and cool sponge bath. Temp down to 101 within one hour and afebrile after 8 hours. Temp did not recur. Normal postictal mental status. Somewhat lethargic for a day or two then gradual return to baseline cognitive and physical functioning over 10 days. Wilmer has had this type of seizure with high fever in the past.

Fever 99.8, nausea, tiredness, feeling unwell. Slept and rested. Symptoms gone by 3-24-2021 at 11:00 AM

Patient received first dose of Pfizer COVID vaccine on 3/17/21. Around 3/19 or 3/20, patient started to feel fatigued with nausea, vomiting and diarrhea. He also developed fever, cough, and shortness of breath. He presented to the ER on 3/22 and was admitted to the hospital for supportive care and monitoring. Agency service was conuslted, and patient was started on COVID treatment with remdesivir and dexamethasone, and well as enoxaparin for VTE prophylaxis on 3/24.

Low fever 0.5 F above the normal, heart rate increased from 75/min to 110/min. Blood pressure 15 above the normal daily reading. coughs 3 to 4 times. Then, after 30 hours of the shot of vaccine, felt headaches. At that time, heart rate was closed to the normal. But had a couple of coughs. Just felt having a light flu at the beginning and tired. Pain on the shot area in the arm was not a concern. After 60 hours of the shot, feel good. Just report what I had.

On going flu symptoms since the 2nd vaccination. It is going on 8 days and I still have flu symptoms. I feel weak, sometimes low level headache, mostly feel weak and tired. Don't feel like I have a temp. On scale of 1-10, I would say it's around 2-3. It does affect my work ability. Not overly hungry(which can be good).

My left after 5 hours or so got really sore and just got worse during the day. It also got me really tired and had to go to bed early and slept for 10 hours. Got up and felt good. The soreness in my arm was almost gone. By mid day no more soreness. I did take 800 mg of Ibuprofen twice in a 24 hr period. I don't believe it did any good.

I have had 3 cycles of vaccine symptoms since receiving my first shot 9 days ago. First round of normal symptoms (low grade fever/chills) began approx. 24 hours after first shot. Symptoms lasted for approx. 24 hours. No symptoms for next 2 and 1/2 days and then experienced 2nd round of same symptoms which lasted for approx. 24 hours. And then another 2 and 1/2 days with no symptoms and then experienced 3rd round of same symptoms which lasted for approx. 24 hours. 3rd round of symptoms has just ended as of this morning.

Pfizer COVID-19 Vaccine EUA Pt received Dose 1 of Pfizer vaccine series 3/10/21. 3/21/21: A 61-year-old gentleman presented to the emergency room with increasing shortness of breath for 2 days. Patient reports mild nonproductive cough. Reports shortness of breath, worse with activities. He had his first dose of Pfizer COVID-19 vaccine 10 days ago. In the emergency room is noted to be hypoxic at 87% on room air, and now he is comfortable on 2 L of oxygen via nasal cannula, at about 94%. Chest x-ray suggestive of bilateral pneumonia. He is now testing positive for COVID-19. 3/26: The patient was diagnosed with moderate severity COVID-19 pneumonia and received Convalescent plasma and Remdesivir on March 21st and completed 3/25. He was on dexamethasone, doxycycline and pantoprazole. Initially D-dimer significantly elevated then trended down and the inflammatory markers trended down. The patient initially required 2-4 L of oxygen then improved and till he did not require any oxygenation today. His liver enzyme mildly elevated without disturbance in the liver function or kidney function. The patient will be discharged home on taper dexamethasone PO with pantoprazole for GI prophylaxis and follow-up with his PCP.

By 2nd day and for one week, had an extreme headache (unlike any migraine). Extreme flu like symptoms for 1 week after vaccination. Reports severe bruising on left arm from collar bone to elbow. "It was black".

Symptoms appeared roughly 12hrs after the second dose. Chills, slight fever, body aches. Symptoms lasted for less than 24hrs.

Injection site is sore, my body feel achy. 101.2 temp. It is down to 99.6 at 2:00 pm My joints feel like a dull pain.

2//20/2021 - Vaccine administered at 10am, strong pounding headache began about 5 hours later- aspirin. Headaches returned for the next couple of days. 03/13/2021 - Vaccine administered at vaccine center at 10am: at 10 pm (12 hours) strong headache began - 2 aspirin x 250mg - at midnight (14 hours) chills began and lasted until about 7am (3/14/2021), then dizziness, feeling dehydrated (drank a LOT of water) and very tired. This lasted until Monday 3/152021 about midday. So, a draining 1 day flu.

Approximately 40 hours after injection, I began to experience unexplained fatigue and a reoccurring low-grade headache. This condition, as of this writing , has lasted 48 hours. However, I am not severely affected by this condition, and have treated it with rest and occasional ibuprofen.

Pain at shot side so that arm not usuable for 12 hrs, chills for a few hours, extreme fatigue (slept twice normal amount) mild headache

Moderate to severe headache, chills, weakness, and sleeplessness through the night with headache lingering through the next day.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: pt passed out for 10 seconds, blood pressure low, when he regained consciouness he vomited.Recovered in about a half hour.

Low grade fever, headache, joint pain began about 28-24 hours after injection and lasted for about 18 hours and resolved.

Note: I AM reporting this because I strongly believe that patient's death was caused by his second COvid-19 vaccine. The exact date of the vaccine is unknown. His girlfriend told me he got his second Vaccine at the end of February. I also don't know what vaccine (Moderna or Pfizer) he got, so the Pfizer is just a guess. Patient started feeling bad and looking bad after his second vaccine. He complained that he wasn't feeling well and missed appointments saying he wasn't feeling well during the two weeks or so between the time of his second vaccine and his death.

1:00 am on 4/1 chills and slight fever. Remainder of day on 4/1: fever, chills, exhaustion and headache Friday 4/2 Headache and numbness in left hand. Tired most of day Saturday 4/3: slight numbness in left hand.

Severe chills (unable to hold a glass of liquid). Fever of 101.5. Inability to sleep until 5 am. Tiredness all day the second day.

Dizziness. Noticeable / moderate on 4/5/21 lying in bed and for hours after waking, slight on days prior. On morning after injection there was just some fatigue and soreness at injection site.

Tinnitus in left ear. Soft high-frequency crickets when my throat gets stressed, including hiccups, burping, stretching, sometimes yawning, muscle tensing, sometimes swallowing, stretching to wake up in the morning. Last for the duration of the stress, a few seconds. Left eustachian tube slightly sore, slight earache. Has gone on for almost a week now. Best guess is nerve is pressured or damaged? Will try hydroxide in ear next, in hope it kills whatever's going on. Whether this will go away or not is unknown at present.

sweat fever out; slight fever; whole body muscle aches; headache.; felt pain in upper left buttocks like someone sticking me with knife followed by muscle contractions in same area; felt pain in upper left buttocks like someone sticking me with knife followed by muscle contractions in same area; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on Arm Left on 18Mar2021 12:00 (Batch/Lot Number: EN6205) as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. Concomitant medications included losartan (LOSARTAN)m colecalciferol (VITAMIN D), vitamin b complex (VITAMIN B-COMPLEX) and magnesium (MAGNESIUM) all taken for unspecified dates and indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient receive the vaccine on 18Mar2021 and he was okay on Friday. By Saturday morning (20Mar2021 9:30), he felt pain in upper left buttocks like someone sticking with knife followed by muscle contractions in same area that would repeat 2 to three times but was intermittent for 4 hours. He felt ok with no symptoms rest of Saturday. Then on Sunday morning around 4 a.m., the same feeling came back and lasted until Sunday noon (21Mar2021). Then, his whole-body muscle aches that lasted whole Sunday along with headache. On 22Mar2021 (Monday), the patient had still intense whole-body muscle aches all day headache but no buttocks contractions. By night, he slight fever took paracetamol (TYLENOL) and also had sweat fever. By Tuesday morning, the patient still had faint muscle aches slight headache. The patient had no COVID-19 prior vaccination and not tested for COVID-19 post vaccination. The patient did not receive treatment for the events of pain in upper left buttocks like someone sticking with knife followed by muscle contractions, whole-body muscle aches, headache and sweat fever. The patient was recovering from the events and was feeling much better No follow-up attempts are possible. No further information is expected.

Approximately 12 hours after the injection I started to get chills headache dizziness and was not able to sleep, it is the next day now and I?m still feeling pretty bad and body aches all over

tinnitus - started at 2nd shot and is still continuing. It is significant enough to get medical treatment and is very annoying. Over Easter I was with family, the TV was on and people were talking. I had significant trouble understanding people talking to me. I had significant joint pain of the left hand, knee's, and ankles which has decreased. I had headaches which have decreased but still continue

Started with a severe runny nose. Runny nose and sneezing lasted approx 48hrs. When nose stopped running breathing got more laborious and a cough persisted. Slight fever and muscle aches for two more days. Trouble sleeping and cough started to produce mucus. It has been over 1 week since symptoms started and I am still experiencing coughing and mucus, as well as a loss of appetite. This was what I have experienced before when I have had a severe cold.

The day after the shot, I was real tired. My arm was sore. I had the chills. My stomach was quezy . I had a slight headache . The day after that I woke up with a slight headache but by the afternoon all symptoms had disappeared.

Tiredness headache muscle pain chills joint pain fever nausea difficulty breathing swelling in the face a fast heartbeat dizziness and weakness stomach pain

headache; teeth hurt; leg pain; chills; low grade fever; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Right on 03Feb2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. On 04Feb2021 at 09:00, patient experienced headache, teeth hurt, leg pain, chills and low-grade fever. Since the event onset date was presented as 04Feb2021, however, PRD was noted as 08Feb2021, query was raised to provide the awareness date of AEs. The patient responded that the symptoms started on 04Feb2021, the day after receiving the second vaccine shot. Patient reported this to the health clinic on 04Feb2021 and filled out the report when he returned to work on 08Feb2021. The date of start of event in the report is correct and the date of receipt of the most recent information is on 08Feb2021. The outcome of the event was recovered. Information on the lot/batch number has been requested.

Morning of 4/9/2021, mild headache. Also cough that lasted about 10 minutes. That night, headache become more severe, swelling, inflammation in right eye. Also burning in right eye, similar to peeling onions. Damp clothe to eye provided relief. Acetaminophen relieved pain.

61 yo male w/ history of DM, HTN, CKD IV and sleep apnea presents on 4/9/2021 with dsypnea that started while sleeping last night around 10PM. Also c/o cough , fatigue, diffuse wheezing. Had temp 99.9, chills. Does not use home oxygen and never smoked. Does not use a CPAP machine for his sleep apnea. He denies any recent ill contacts or new illness. diagnosed with sepsis and severe b/l pneumonia and significant hypoxia and admitted to the hospital on ivf, abx, oxygen. Currently follows with wound care for a right foot ulcer and is taking ciprofloxacin. For his diabetes he requires U-500 insulin. Today in ED he is on 5L oxy mask due to hypoxia. Noted to have leukocytosis. Normal lactate. CXR suggestive of pneumonia with bilateral diffuse consolidations.

atrial fib; Short of breath; fatigue; Nausea; Dizziness; Unable to function; discolored; This is a spontaneous report from a contactable consumer(patient himself). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration, at Right Arm on 24Mar2021 12:30 (at age of 61 years old) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. 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 experienced Short of breath, atrial fib, fatigue, nausea, discolored, dizziness, unable to function, all on 24Mar2021 14:00. Adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

After about 14 hours receiving my second dose, had severe chills with shaking/shivering for about a half-hour. Then a slight fever for about 6 hours. Then body aches- muscles and joints for 6 hours. Then it went away with mild fatigue for a couple days.

Pfizer-BioNTech COVID-19 Vaccine EUA 2 Days following the vaccine both my Psoriasis (Plaque, Guttate, and Intertriginous) began to flare. It had been in remission for many months prior to this. I also had the usual chills and general malaise.

Chills and mild's fever for 5.5 hours. Then threw up a couple of times. I felt 95% better after throwing up. Now 5 days later my digestion system is still not back to normal with mild abdominal paisa.

4/7/2021 @ noontime: Began to have cold shakes. Approximately 15 minutes later, began to experience slight headache and some fatigue. Within an hour, extreme shaking, fatigue and worse headache ever experienced in my life. Went to bed, covered up and tried to rest, but headache was too severe. About 6:00pm, took ibuprofen and headache began to subside, but too weak to walk without holding onto support items. Nausea left me unable to eat and drinking water was unpleasant. Fell asleep about 10pm and woke at midnight with cold shakes and did not get back to sleep. Went to work next morning and just felt somewhat fatigue and had no appetite.

Arm pain morning after shot, general fatigue and achiness in joints afternoon after shot (i.e. 24 hrs after vaccine administered). Arm pain lasted a day, fatigue about 12-18 hours.

About 30 minutes after getting the vaccine his developed a headache. Shortly after that he developed left leg weakness and inability to use left leg. The next morning his symptoms somewhat improved. Friday morning, 2 days later, his left leg weakness returned. He was directed to the ER where stroke was confirmed.

Fever and tiredness Can take ibuprofen/motrin/tylenol for fever, use cool compress/wet rag on forehead to help 4/9-Spoke with wife. Patient slept all day yesterday and then woke up this morning feeling fine and went to work. Did not really take anything other than 1 expired ibuprofen.

The next day I was very sick. It felt like someone had beaten me up. I spent most of the day lying down and drinking water. I tried to eat something and slept more. When I awoke, it felt like four huge needles piercing my lungs. I had to use my albuterol inhaler it was so bad. My symptoms are normally completely arrested by the use of Advair and Spiriva. The albuterol caused a dry heaving fit during which I expelled quite a bit of phlegm from my lungs. I felt better and the pain went away after that. Since then I've been suffering higher levels of chest congestion than is normal for me.

Morning of 4/8 at 0615, patient was in shower, started feeling pressure on top of head, was struggling to use arms, trouble using legs, unable to stand well. Wife noticed slurred speech, drooping left side of face. Called 911. Was taken ED and transferred to another Hospital. Was found to be having ischemic Stroke.

Bell's palsy/eyes droopy; annoying headache 3-4 days; This is a spontaneous report from a contactable consumer (patient, self-reported). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via unknown route, on 22Mar2021 (last Monday) as a single dose for COVID-19 immunisation. Patient's medical history included Bell's palsy. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Lot number and expiry dates were not reported) for COVID-19 immunisation. Patient stated that patient received COVID-19 Vaccine second dose last Monday, (22Mar2021). He had started with annoying headaches for 3-4 days. On Friday (26Mar2021), had lost control with talking, eyes were droopy etc. Patient mentioned that he had Bells palsy once before, and that now got it again. Patient asked if it would be possible that the vaccine caused the disease?. He mentioned that the hospital gave him Prednisone and Valtrex. Seriousness of the events was considered as hospitalization. Outcome of the events was unknown. Information on about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Lightheadedness, felt like he was going to black out, he did not faint. He was evaluated by a MD and due to the distance of his drive home was advised to go to ER via ambulance. Seen in ER- no chest pain, nausea, or vomiting. He did have some diaphoresis. Has a history of vasovagal syncope associated with needles. Seen and released without further interventions.

After receiving my shot around 4:00 pm on April 13, 2021, I was restless and did not sleep well that night. When I woke up on April 14, I was tired but otherwise felt fine except my arm was a bit sore. However, after working at home for a couple of hours, shortly before 10:00 am I began to feel nauseous. I rushed to the bathroom thinking I was going to throw up, and almost immediately fainted. My wife and sons found me on the floor and woke me up. I threw up shortly after and felt pretty lousy the rest of the day with low grade fever, chills, body aches, fatigue, and a headache. I began to feel better at night and had a good night of sleep. Today (April 15), I feel fine except I'm a little tired.

Severe pain at each sight I had surgeries at and neck and back. Severe pain started about 2 hours after the infection and throughout the day and night the pain increased to about a 8/9. I woke up in the morning about 7 am in so much pain that I had a very difficult time rolling over in bed to get out of be to go to the bathroom. I had to take a Percocet 10 every 4 hours for pain management. the pain lasted till I went to bed about 2am and when I woke up the next morning the pain was mostly gone. about a 1/2 but felt very tired/exhausted. I got up walked the dogs and had a light breakfast and found myself nodding off several times and went to bed and fell asleep till about 1:30pm and just felt wiped out until the following day.

Patient told the vaccinating pharmacist he had a history of fainting after receiving vaccinations. Patient was feeling okay after vaccination and went into waiting area. Pharmacist was called over because patient fainted. By the time we got to the patient he was awake, alert and sitting upright. He knew who he was, where he was, and that he just received a covid vaccine. The patient said he felt light headed. We offered water and an ice pack as the patient was sweating but he did not say he was hot. The patient was able to get up after a few minutes of sitting and sat in a chair. After another few minutes, the patients head went backwards and he was making a snoring sound. I tried to talk to the patient but he didn't respond. We called 911. We placed the patient on the floor and turned him on his side. After about 1 minute he was with it again. He knew where he was and thought he fainted again. Upon speaking with the patient we received details about his history of seizures due to alcohol withdrawal. He also confirmed the last time he drank was that morning and he had "a few shots and was cutting back." Patient told us he was not on any medications but did take 50 mg of benadryl around 12:00pm that day. The paramedics arrived and took him to the hospital.

4/3 to 4/5: Fever over 101. General malaise. Extreme chest congestion and productive cough. 4/5 to 4/9: Difficulty breathing, congestion and sever productive cough continued. Chocking on chest mucus. O2 levels 89-91. 4/7: visited urgent care. EKG was irregular. Chest x-ray indicated needed further CT scan. Rapid Covid-19 test was negative. 4/8: Outpatient CT Scan. Indicated Interstitial Lung Disease. 4/10 to 4/12: Coughing and congestion started to clear. Extreme fatigue with any activity. O2 level starting to rise: 91-93. 4/13 to 4/15: Cough and congestion much better. Still some production. O2 level at 93 to 94 (95 - 96 with breathing exercises)

Upper respiratory: Cough/Phlegm producing General feeling of malaise Swollen (L) Lymph node (Submandibular) All symptoms coming to a head ~ (2) weeks post second shot

Arm pain at injection site, headache, fever, fatigue. Affects began about 15 hrs. after receiving the shot and lasted about 12 hrs. Experienced the same affects, minus the fever, after the first shot, but this time the affects were more severe then the first time. Did not require or seek medical or doctor assistance, simply stayed hydrated and rested.

Fever of 101.5, which persisted for 3 days. Headache for two days (04/09 PM thru 04/11) not elevated by 2X Tylenol dose. Pain and swelling at the vaccine sight. Left upper arm swelling and hot (102.4 with digital thermometer. Marked swelling in underarm (arm pit) grossly visible (photos taken) and arm it temp over 102 to 2 days and over 101 for 4 more days (total of 6 days) with notable swelling and elevated temperature in the area. Appears normal at day 8 DPI. This is the most adverse reaction I have ever had to any vaccine in my memory. As I have been working in Asia, I have had several vaccines in my life and in recent years. Never a reaction like this.

Arm pain at injection site, fever, fatigue. Affects began about 18 hrs. after receiving the shot and latest about 12 hrs.

About 12 hours after the vaccine (2nd dose) I developed fever, chills, teeth chattering (rigors), sweats, muscle aches and dry cough. Other symptoms have resolved after 2 days - but some muscle ache persists - along with a dry, non-productive cough (worsened upon deep inspiration). Although my overall sense of well being has improved over the few days since vaccination, the cough is persists and not improving.

Headache, body aches, joint aches, fatigue . Majority of pain subsided within 24 hours, fatigue and a mild headache with mild sinus congestion persisted for about 48 hours. Fully subsided within 3 days.

Started the day after the second injection. Feeling very tired, most of the day. Fall asleep on my couch. Flu like muscular pain in back and legs. Sometimes my legs feel very weak. I will call my Doctor if I am not feeling better by tomorrow the 20th of April.

POST VACCINE PT BECAME DIZZY, DIAPHORETIC, HOT. TRANSFERRED TO OBS VIA W.C. PT REPORTS FEELING BETTER ONCE PLACED IN TRENDELENBERG ON STRETCHER. VS MONITORED THROUGHOUT OBSERVATION. HX OF HTN, TAKES BP MEDS QHS. ONCE SYMPTOMS RESOLVED, PATIENT AND SPOUSE ESCORTED TO EXIT WITHOUT ISSUES AT 1200, INSTRUCTED TO MONITOR BP AND SEEK FURTHER EVAL/TREATMENT IF UNRESOLVED OR WORSENS. PER ON-SITE MD, PT EXPERIENCED CLASSIC NON SYNCOPAL VASOVAGAL REACTION-RESOLVED. 1120 INITIAL BP 193/100 HR 70 SATS 99% RA 1125 BP 185/94 HR 75 SATS 100% RA 1135 BP 186/105 HR 65 SATS 99% 1155 STANDING BP 175/98 HR 59 SATS 98%

Fever or chills Cough Shortness of breath or difficulty breathing Fatigue Muscle or body aches Nausea or vomiting Diarrhea

PALPITATIONS, SWEATING AND MILD LIGHTHEADEDNESS POST VACCINE ADMIN REPORTED BY PATIENT, BROUGHT TO OBS VIA WC. PLACED IN TRENDELENBERG ON STRETCHER IN OBS, PATIENT STATES S/S RESOLVED SOON AFTER. VSS. ESCORTED TO EXIT WITH NO ISSUES AT 1415.1408 BP 128/80 HR 72 RR 16 SATS 96% RA.

After an unannticipated time elapse after my first shot I experienced a throat irritation, then a need to cough, mucus and a wheezing, similar to that one would experience with pet dander, mold , etc. these lasted about an hour and a half and occurred about 36 hours after injection. Nothing in my life in that interval was different or unusual, neither diet, supplements, alcohol or environment.

Angina-like chest pain and frontal headaches off and on for three weeks from date of 1st injection. I believed it to be vaccine side effects and continued normal daily exercise routine, which is quite rigorous in some instances. Exercise seemed to alleviate problem temporarily. I never considered angina or heart issues as a problem since I've had great exam stats, including low cholesterol, low triglycerids, normal EKG, not overweight, never smoke, exercise regularly, maintain healthy diet. Day of second dose, chest pain and headaches increased significantly. EKG performed by PCP and Emergency Room confirmed abnormal. Diagnosed with acute myocardial infarction, emergency angiosplasty performed on right coronary artery. I felt this all to coincidental given timing and duration of side effect with 1st and 2nd shot. All EKGs in past, including one in August 2020, normal, and then abnormal six months later.

Severe chills (2am 20 Apr thru 5am 20 Apr), fever to 103 (3am 20 Apr thru 3pm 20 Apr), mild fever (intermittent, 9pm 20 Apr to present), severe fatigue, diarrhea, dizziness, periodic nausea (all thru current)

Tongue swelling; could not process his breath; Could not swallow his saliva; headache; Nausea; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer(manufacturer control number: US-AMGEN-USASL2021053617), license party for etanercept (ENBREL). This non-serious solicited report (USASL2021053617) was reported on 07/APR/2021 by a consumer from a commercial program (PSP00046b) and involves a 61 year old male patient who had headache [PT: headache], nausea [PT: nausea], tongue swelling [PT: swollen tongue], could not process his breath [PT: dyspnoea] and could not swallow his saliva [PT: dysphagia] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis. The patient's concomitant medications included methotrexate. The patient's co-suspect medication included covid-19 vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. It was reported that the patient was using Enbrel for about five to six years. On an unknown date in MAR/2021, the patient received a recent injection of Enbrel. On 27/MAR/2021 at 10:00 AM, the patient received covid-19 vaccine. On the same day, the patient had nausea and headache but then it went away. On the same day at 05:30 PM, the patient had tongue swelling. The patient could not swallow his saliva and could not process his breath. Subsequently, the patient went to ER (Emergency room) and was started on Benadryl (diphenhydramine hydrochloride), prednisone and ranitidine. The patient was instructed by the physician not to receive a second dose of covid vaccine. The outcome of the events headache and nausea was reported as recovered/resolved. The outcome of the events swollen tongue, dyspnoea and dysphagia was reported as unknown. The events headache, nausea were resolved on 27/MAR/2021. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events headache, nausea, swollen tongue, dyspnoea and dysphagia. The causal relationship between the events headache, nausea, swollen tongue, dyspnoea, dysphagia and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested for lot number. Causality Assessment: Events Swallowing difficult, Breathing difficult, Swelling of tongue and Nausea were assessed to be not related to etanercept.; Sender's Comments: Based on a temporal association and the known safety profile, the reported events are considered possibly related to BNT162B2. The events were unrelated to etanercept. 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.

First dose Sore arm; This is a spontaneous report received from a contactable consumer (reporting on himself). A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL1284 and Expiry date: Mar2021), via an unspecified route of administration in Arm Left on 05Jan2021 13:30 (at the age of 61-years-old) as single dose for COVID-19 immunization. Medical history included supraventricular tachycardia, herpes virus infection, lymphadenectomy and idiopathic mesenteric lymphadenopathy. Concomitant medication(s) included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]); cyclobenzaprine (CYCLOBENZAPRINE); metoprolol (METOPROLOL) and atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that patient experienced first dose sore arm. Patient took second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL1284 and Expiry date: Apr2021), via an unspecified route of administration in Arm Left on 26Jan2021 13:15 (at the age of 61-years-old) as single dose for COVID-19 immunization. Second dose 8 hours post headache, sore arm and entire upper torso pain, chills and fever 101-102F 12 hrs. I was lethargic the whole next day with severe headache. Normal 2nd day after. Since the vaccination, patient not tested for COVID-19. The outcome of the event was recovering.

Pt presented for 2nd dose of Pfizer Covid vaccine on 4/5. for second Pfizer COVID vaccine, and reported to have Left facial droop, and slurred speech same night after first dose. He reports as soon as he made it home he "felt sleepy and went to bed, and woke up around 8:00 pm with my tongue swollen and Left facial droop, and unable to speak." States he did not follow up with PCP or ER.Uon assessment by LVN and MD facial droop swollen tongue still present 2nd COVID vaccine not give and instructed on EC visit. Pt diagnosed with CVA in EC. Pfizer noted as an allergy.

Severe headache from neck to eyebrows. Chills, running 104.4 temp muscle cramps in legs, extremely tired

Sore throat; stuffy nose; slight headache; sleepy; This is a spontaneous report from a contactable consumer(patient reported). A 61-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Feb2021 as SINGLE DOSE for covid-19 immunization. Patient was 61 years old at the time of vaccination. Patient medical history was not reported. Concomitant medications included hydrochlorothiazide, metoprololon an unspecified date for unknown indication. On 18Feb2021 the patient experienced sore throat, stuffy nose, slight headache and sleepy. The outcome of the events was recovering. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Atrial flutter; Fatigue; Dizziness; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 62 years old male patient received bnt162b2 (BNT162B2, Pfizer BioNTech COVID-19 vaccine), dose 2 intramuscular, administered in Deltoid Right on 09Mar2021 (Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included Bladder issue, Elevated cholesterol, Elevated BP. Received BNT162B2 dose 1 on 16Feb2021 for COVID-19 immunization when he was 61 years old. Concomitant medications included rosuvastatin taken for Elevated cholesterol; losartan potassium taken for Elevated BP; oxybutynin taken for Bladder issue; tamsulosin taken for Bladder issue. The patient experienced fatigue on 12Mar2021, dizziness on 12Mar2021, shortness of breath on 12Mar2021, atrial flutter on an unspecified date. The patient underwent lab tests and procedures which included echocardiogram with atrial flutter on 05Apr2021, electrocardiogram with atrial flutter on 01Apr2021. After he saw the cardiologist, he was prescribed a betablocker and a blood thinner in the interim. He clarifies he was prescribed Metoprolol tartrate 25mg, twice a day. He was also prescribed Eliquis 5mg, twice a day. There were no additional vaccines administered on same date of the Pfizer. Events require a visit to physician office. prior vaccinations within 4 weeks was none. The outcome was unknown. No follow-up attempts are needed. No further information is expected.

Severe Headache; Muscle ache; Abdominal pain; lost his appetite; had a horrible feeling in his stomach, almost like the stomach flu; cold and had trouble maintaining his body heat; significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week; nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick; Sore Arm; Runny Nose with Mucous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2, via an unspecified route of administration, administered in Arm Left on 31Mar2021 (Batch/Lot Number: EN6206) (at age of 61-year-old) as single dose for COVID-19 immunisation. Medical history included Slightly Diabetic from 2009 to an unknown date. The patient stated he doesn't smoke or do drugs, or drink and he tried to eat good healthy food. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 10Mar2021 (at age of 61-year-old) (Lot number: EN6200) and experienced sore arm and runny nose with mucous. The patient experienced sore arm on 01Apr2021, runny nose with mucous on 01Apr2021, nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick on 02Apr2021 , severe headache on 07Apr2021, muscle ache on 05Apr2021, abdominal pain on 02Apr2021, lost his appetite on 02Apr2021, had a horrible feeling in his stomach, almost like the stomach flu on 02Apr2021, cold and had trouble maintaining his body heat on 02Apr2021, significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week on 02Apr2021.Clinical course: The patient had his second shot last Wednesday, 31MAR2021, and he was calling to report his adverse side effects. The patient stated he had a sore arm which was okay and runny nose with mucous, which was similar to his experience with his first shot, but then things went downhill. The patient stated with the first vaccine, he had arm pain that evening and it really wasn't bad. Stated there was an hour where it was really intense like he got shot up with something pretty powerful, he had a yucky feeling like when you catch the flu and get the first kick and then it went away. Stated he had a runny nose that first came on and lasted pretty much until he got the second vaccine, stated it got not so severe and heavy and decreased until the second shot and then went up again. Stated with the second vaccine he lost his appetite and he developed nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick. Clarified he did not have vomiting or diarrhea. Stated he just had a horrible feeling in his stomach, almost like the stomach flu. The patient stated yesterday (07Apr2021) was bad and he spent the last 2 days in bed. Stated while he was sick, her ate half a sandwich, that was all he could stomach and could eat. Stated he had significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week. Stated looking at his waist line he can tell he has lost weight. Clarified most of the pain was in his lower abdominal pelvis region, large intestine area. Stated he had a severe headache yesterday (07Apr2021). Clarified that it has significantly improved. Stated he still felt tension in his head but nothing compared to yesterday (07Apr2021) with the pounding migraine type of headache. Stated he was cold and had trouble maintaining his body heat. The patient clarified the phases of his events mimic the flu but unlike the flu, he wasn't coughing, but he was having the physical pain of the flu but not the normal symptoms you would expect like heavy mucous, coughing, sneezing, like if he had the flu or a cold, but he felt like he was going through the flu. Stated he had muscle aches. States his back is normally okay but he injured it in the past and it started to hurt especially at the points that were injured. The patient stated just before he called, his husband brought him some soup and he just finished that and he didn't feel immediately sick after eating something so it seems to have significantly improved. Caller states yesterday (07Apr2021) was the worst. Stated he has isolated, he didn't have to go out and lives in the mountains, he only goes out for groceries and they bring it out to him. Stated he did go to the hospital where he received the vaccine, he could have picked up something at the hospital. Stated he hasn't exposed himself to anything, no bars, gym, church, he is not hanging out with anyone, he maintained as restrictive environment as one could have and he wears a mask when they are putting the groceries in his vehicle. Restated that yesterday (07Apr2021) and last night were the worst and everything has significantly improved. Treatment: Been in bed for the last 36 hours, today (08Apr2021) he is actually up enjoying a beautiful day. The events did not result in emergency room visit or physician office visit. AE(s) following prior vaccinations: Every time got flu shot, and he didn't get them anymore, he got sick as a dog for a couple of weeks, with yellow phlegm. Stated he thought it was supposed to protect him, why is he so sick and hacking up phlegm? Stated maybe he is one of those people that doesn't do well with vaccines. Stated this is a new type of vaccine MRNA and it could just be him. Stated not all vaccines, it seems like flu vaccine kicks him in the keister but has had other vaccines like the MMR and no issues with that, no pain no nothing. The outcome of events Sore Arm was resolved on 03Apr2021 and Runny Nose with Mucous was resolved on 06Apr2021 and of the rest of events was Resolving. No follow-up attempts are possible; No further information is expected.

he had a stroke; felt pressure on his head; He had slurred speech; he fell as well; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737) in left arm on 06Apr2021 10:30 am at single dose for COVID-19 immunisation. Medical history included ischemic cardiomyopathy, chronic heart failure, pace maker/dif, diabetes, high blood pressure. Concomitant medications in two weeks included aspirin, carvedilol, valproate semisodium (DIVALPROEX), furosemide, and other medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 16Mar2021 10:30 AM at 61-year-old in left arm at single dose for COVID-19 immunisation, received levofloxacin (LOVENOX) and experienced allergies. No other vaccine in four weeks. At approximately 10:00 pm on 07Apr2021, patient started having a fever and flu symptoms that lasted into the first day after taking the second covid shot. By the second day, on 08Apr2021 at 6:15 am, patient took a shower felt pressure on his head and his arms would not work. He had slurred speech, and he fell as well, his lip was curled up on one side and patient sated he thought he was in trouble. He was transferred to ER, and they said he had a stroke. He then went to the Neurological ICU where he stayed until his discharge three days later. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was hospitalization for 3 days. Treatment received for all the events in patient hospitalization. No COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was not recovered.

Blistering, wet rashes on legs; Rash and blisters affecting feet; muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine; Fever; Feeling unwell/Wasn't feeling good; Lost a lot of weight; Had to overuse inhaler; joint problems; Couldn't think; Affecting mental health; Blistering, wet rashes on legs; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old-male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 09Mar2021 (received at 61-year-old) as single dose for COVID-19 immunization. Medical history included arthritis, overactive immune system, unspecified mental health issues, and ongoing muscle pain. Concomitant medications were unspecified; the patient stated that he is on 4 vials of different medicine, or maybe 5. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), on an unspecified date for COVID-19 immunization. The patient reported that he had the Covid-19 vaccine. He reported that he was given a handout sheet that he read after he had the second dose of the Covid-19 vaccine. It was highlighted in yellow that he shouldn't have taken the Covid-19 vaccine with an overactive immune system. He further reported that the second dose of the Covid-19 vaccine is affecting his mental health. His mental health started being affected about 7-8 days after receiving the second dose of the Covid-19 vaccine. He stated that he is getting blistering, wet rashes on his legs again. He would like to see what he can do about this, but he will have to do it by mail. He reported that he has to get pictures taken of himself. He has an appointment tomorrow where he got the Covid-19 vaccine. He stated that he also has to go back to the dermatologist that is taking care of his immune system. He reported that he has lost a lot of weight. He reported that his weight is 147 pounds or maybe 141 pounds. He has lost a lot of weight since receiving the Covid-19 vaccine. He was given an emergency authorization release after he got the second dose of the Covid-19 vaccine. He noticed that he wasn't feeling good right away after getting the Covid-19 vaccine. When his legs started getting a rash and then blisters, his medical provider took pictures. The rash and blisters are affecting his feet too. The rash on his legs appears about 7-8 days after the second dose of the Covid-19 vaccine on 09Mar2021. He reported that what is on his legs started as rash and then turned into blisters. The blisters popped and it's like poison comes out. The fluid from the blisters smells, and that the fluid is ruining his clothes and is going to ruin shoes. The rash got worse the other day, with blisters forming. The blisters have now popped and there's going to be scars. The patient reported that he now has open wounds on his legs that bleed from the popped blisters. He also reported that it felt like all of his arthritis and muscles were affected. He took something for muscle spasms and arthritis, a muscle relaxant, for his back. Everything hit about the same time, 7-8 days after receiving the Covid-19 vaccine on 09Mar2021. The muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine. The patient also experienced joint problems, fever, feeling unwell on an unspecified date, had to overuse inhaler, couldn't think on an unspecified date. Outcome of affecting his mental health was recovering. Outcome of blistering, wet rashes on legs, muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine was not recovered. Outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Aches, profuse sweating, fever, chills, no appetite. No resolution after 4 days. Ambulance called after 3 days w/ recommendation to be taken, but refused.

Patient started not feeling well and told friends and family that he was not feeling well and that his doctor believed he was having a side effect to the 2nd dose of his COVID-19 Vaccine. He died 11 days after receiving his vaccine.

Diarrhea, chills, tiredness, fatigue, anxiety, insomnia, aching joints, aching muscles, headache, dizziness.

Loss of balance, dizziness,ringing ears, slight headache, pressure at back of head. Prescribed Meclazine, flonase and Zyrtec. Symptoms still on going but improved.

sweating; felt cold/intense cold even in his bones; He was told by the professional health care that he had small clots in his blood; death cause: Medication; arm started to sore; Doctor identified he had DVT; her husband during that night was not able to sleep; He started having fever; This is a spontaneous report from a contactable consumer (patient's spouse). A 61-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 21Mar2021 09:00 (Batch/Lot number was not reported) as single dose f(at the age of 61-year-old) or COVID-19 immunisation. Medical history included dialysis, diabetes mellitus, known allergies: A7, Penicillin, Aspirin, Iodine, Povidone, Pepcid, dyes, iodine allergy. The patient's concomitant medications were not reported. The patient previously took Aspirin, povidone and pepcid ac and experienced drug hypersensitivity with all. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced death cause: medication on 18Apr2021, he was told by the professional health care that he had small clots in his blood in Mar2021, felt cold/intense cold even in his bones on 21Mar2021, sweating on 26Mar2021, her husband during that night was not able to sleep on 21Mar2021, he started having fever on 21Mar2021, arm started to sore and DVT on 29Mar2021. The patient was hospitalized for he had small clots in his blood, felt cold/intense cold even in his bones, sweating for 27 days. The event DVT was medically significant. The course of events was as follows: After getting the vaccine in 21Mar2021 her husband during that night was not able to sleep. He started having fever and felt cold. Days later he continued with the symptoms. On 26Mar2021 after vaccination he had dialysis same day in the afternoon. When arriving home the person notifies symptoms of intense cold even in his bones and then he started to sweat excessively on 26Mar2021 (Friday). The reporter decided to take her husband to the emergency room on 28Mar2021 (Sunday) where he had a general checkup. He was told by the professional health care that he had small clots in his blood. After some time he had health complications where they had suggested to amputate some of the limbs because of this, the reporter alleges those complications were due to the vaccine. On Monday 29Mar2021 same symptoms reappeared and he was admitted to Hospital. Had a blood test and notified to health professional that blood presents small clots. His arm started to sore severely after the sample. Doctor identified he had DVT. Doctor decided to proceed with various medications. Patient received treatment and he was injected: Percose, Morphine, Benadryl, Triphetarin for blood clot reduction. The patient underwent lab tests and procedures which included blood test: blood clot in Mar2021, Sars-cov-2 Nasal swab test: negative in Mar2021 post vaccination. The patient died on 18Apr2021. It was not reported if an autopsy was performed. The outcome of death cause: medication was fatal, of the other events was unknown. Information about the lot/batch number has been requested.; Reported Cause(s) of Death: death cause: Medication

Caller states they are experiencing "flu like" symptoms including fever, chills, fatigue one day after second dose of Pfizer vaccine

headaches; bad migraine/Migraine headache and headache which has not improved; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 16Mar2021 14:30 (Lot Number: EN 6208, Expiration date: unknown) as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced the day after he took the shot on 17Mar2021, a migraine, it was awful, the migraine came down to a headache and he haven't had that level of migraine. Since then his headache is not gone away and he does not know if he has migraine right now but it was not improved on 17Mar2021. Patient reported he was not going to take the second shot. But he is scheduled to take the second shot tomorrow, but there is no way he could take that. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of bad migraine. Nabumetone 500 mg twice a day was taken as treatment for migraine. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Brain fog; Cognitive issues; Fevers; Stated that he had a positive test to Covid; This is a spontaneous report from contactable consumer. A 61-Year-old male 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 25Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated that her husband's friend received his first dose of the Pfizer Covid19 vaccine on 25Mar2021 and was exposed to Covid-19 prior to getting the vaccine. Stated that he had a positive test to Covid on 02Apr2021 and he has been having significant Covid related brain fog, like cognitive issues and fevers. He rescheduled his second dose due to the infection and wanted to know if he should wait to take the second dose until he has no symptoms of the disease. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

He is complaining of rhinorrhea, nasal congestion and a dry cough. He denies any fevers or chills. Patient said that he felt off yesterday. Since getting up today patient has felt more short of breath on exertion. He feels like he is breathing heavy. He is denying any chest pain or pressure. Patient did feel some pain behind his left knee over the last week, but has none at this time. He is also felt some mild right ankle discomfort, but that has resolved as well. He denies any recent COVID-19 exposures. Treated with heparin and catheter directed alteplase

Patient received first Pfizer COVID-19 vaccine. About 10 minutes after vaccine was given, patient passed out. He was diaphoretic and unconscious. At one point, he respiration rate stopped, patient had very diminished, weak carotid pulse. Epi was about to be given and patient started spontaneously breathing. Patient did not fall. Patient became conscious a few minutes later. He said he felt lightheaded and dizzy then he was out. Patient's wife said he has no allergies and not diabetic. He ate breakfast this morning. Medical response was called to bedside. Vitals were taken. Medical response transported patient to ER. As patient was getting transported, he started to go in and out of consciousness again. Patient in ER at this time.

The second dose of the vaccine triggered a moderately severe RA flare lasting from 28 April to 29 April. Significant flu-like full-body joint pain, moderate fever (100.5 F against a normal base of 97.3), and light nausea. Joint pain continues as is usual for such flares, since some light damage likely occurred in my joints. I was unable to take NSAID or Prednisone (as I normally would for a flare) due to the vaccine. Acetaminophen taken but ineffective. NOTE: My RA is being treated with Rituximab, two doses every 4 months. Next dose scheduled 11 May 2021. Prior dose completed 12 January 2021.

I felt fine following the 2nd shot, for 48 hours, but unusally tired so I knew it must have been the shot. The next day my sinuses became burning and I assumed it was hayfever because I had experienced some symptoms of that for the previous two weeks. But the next day, Tues., it was worst, like a bad cold (which all of this "reaction" may have been), but then the next 3 days I could barely get out of bed--and that's unusual because I run every day and nothing stops me. I had bad headaches for 5 days or so and that included coughing, from a dry cough at first to a very wet cough and very large thick segments of gelled mucous coming out of my sinuses, something I've never seen before. After almost two weeks I felt much better but was still coughing, and now three weeks later I'm still really tired, can't think as tightly as usual.

Day 1 headache and sore arm. Day 2 intermittent weakness in both legs and cramps in the calves. Day 3 gradual withdrawal of reactions. Early am Day 4 , while sleeping stabbing pain in liver and gallbladder area (under right rib). Pain came on 5-10 minute intervals for 4 hours. Day 4 was at a hotel in another city. Pain was gone by Day 5. Neck was sore throughout the 5 days post vaccine.

sinus infection; couldn't breathe; extreme high anxiety; couldn't sleep; lack of appetite; nervous about everything; dehydrated; kidney levels numbers raised; headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 2 via an unspecified route of administration, administered in the right arm on 12Apr2021 at 11:15 (at the age of 61 years-old) for COVID-19 immunization. Medical history included blood glucose abnormal from an unknown date and unknown if ongoing other medical history: sugar, kidney problems, coronary artery disease (CAD), high blood pressure and renal disorder from an unknown date and unknown if ongoing. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 in the right arm on 22Mar2021 at 11:15 AM. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medication for high blood pressure and "sugar medicine." The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 14Apr2021 at 06:00 AM, the patient experienced sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache. The patient was hospitalized for sinus infection for 1 days. The patient was hospitalized for couldn't breathe for 1 day. The patient was hospitalized for extreme high anxiety, couldn't sleep and lack of appetite for 1 day. The events sinus infection, couldn't breathe which led to extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache required an emergency room and physician's office visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Apr2021. Therapeutic measures were taken as a result of sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache and included antibiotics and medicine to help sleep. The clinical outcome of sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache were recovering. It was also reported that since the vaccination, the patient was tested for COVID-19. Information on the lot/batch number has been requested.

Nausea and dizziness started around 11:00 AM and ran for 4-6 hours. Mild fever and coughing started around 3:00 PM got up to 99.8 and ran till bed at 8:00 PM. Took Acetaminophen PM at bed time and was over majority of symptoms by morning, 5:00. Felt like prelude to when I got Covid in April of 2020. Have heard 2nd shot is usual side affects and worse so not looking forward to second shot. (but will be getting on 5-28-2021)

having heart attack feelings; tightness and pain on the chest; tightness and pain on the chest; nausea; lightheadedness; fatigue; dizziness; shortness of breath; cold sweats; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 09:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Relevant medical history included type 2 diabetes and high blood pressure. The patient had allergy to some nuts. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, 24 hours after his first Pfizer shot, the patient thought that he was having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats. These events were resulted in a visit to the Emergency Room. The Hospital Emergency Room diagnosis was "anti-viral reaction to vaccine" for the adverse event. The patient received with IV treatment. As of 24Apr2021, the clinical outcomes of the events "having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats" were resolved on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Additional Details: patient's husband says pt was admitted to hospital with burning in chest, heart, throat swelling, anxiety and trouble breathing.

body aches to "back, legs, knees and ankles," loss of appetite, fatigue and mild cough. Hypoxia Pneumonia due to COVID-19 virus Nausea & vomiting COVID-19 virus infection

Within 24 hrs started to experience slight fever. Within seven (7) days I went to the ER with high fever symptoms. They prescribed Amoxicillan 875mg for 10 days. While on the antibiotic I still experienced fevers (101.5-103.1) for the first 5-7 days after the ER visit

2 hours after receiving his first vaccine the patient was presenting with light headedness, sweaty, pale, and stomach pain. I took his BP and it was 80/60 with a pulse of 60. I called 911 because he had a history of CHF and I didn't want his pulse to drop and not have other trained personnel on hand if CPR was required. I gave him water to try to raise his BP and rechecked his BP after 5 minutes and it raised to 127/83 with a pulse of 64. He stopped sweating and his color came back in his face at that time. The EMT's rechecked vitals and ended up taking him to the ED to run tests.

Went to bed around 9:00 to 9:30 PM and he woke up around 11:00 PM; Couldn't even move; Whole body is aching; Sweating; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0170), via an unspecified route of administration in left arm, on 29Apr2021 at 03:00 PM (15:00), as first dose, single, for COVID-19 immunization. The patient's medical history included blood pressure, atrial fibrillation, cholesterol, and heart problem. The patient's concomitant medications included metoprolol and acetylsalicylic acid (BABY ASPIRIN); both were ongoing. The patient takes acetylsalicylic acid because he can't take blood thinners because he works with sharp objects all day. The patient had no prior vaccinations within 4 weeks; and he didn't know adverse events following prior vaccinations as he received vaccines as a child. The patient received his first COVID-19 vaccine in his left arm (because he's right-handed) yesterday (29Apr2021) and his whole body is killing him, it's aching, and he's sweating. The patient was asking if his symptoms are normal. Last night (29Apr2021) when the patient was sleeping, he went to bed around 9:00 to 9:30 PM and he woke up around 11:00 PM and he couldn't even move. The patient got up this morning and took 2 paracetamol (TYLENOL) for the events. The patient was sweating like there's no tomorrow, but he thinks that paracetamol is working. The events did not require a visit to the emergency room and physician office. The patient's second COVID-19 vaccine is scheduled for 20May2021. The patient had not recovered from "Whole body is aching" and "Sweating". The outcome of the other events was unknown.

Called patient for a follow up and patient states has been sick for 3 days. Asked patient what sick meant and patient states has been vomiting and had cold chills every since he received the vaccine. Asked the patient if he would like an anti-nausea medication and patient stated that it wouldn't hurt. Sent in prescription for Zofran 4 mg po q8 hours as needed for nausea and vomiting x 5 days to patient's pharmacy. Told patient to watch for s/s of dehydration and to go to ER if these occur. Told patient to increase non-caffeinated fluids. Told patient that a report would be made.

I was working at my desk seeing patients via telehealth and had the sudden onset of extreme sweating, felt odd/dissociated. BP and P were normal sitting and standing. No other associated symptoms. I cancelled the rest of my day. Took about 3-4 hours to feel normal again. No recurrence.

fatigue; myalgias; Mild nasal congestion; Headache; This is a spontaneous report was received from a contactable physician (patient). A 61-years-old male patient received 2nd dose bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3246), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 as single dose for COVID-19 immunization. The patient medical history included BPH. The patient had received unspecified concomitant medications. The patient had no history of allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 in right arm on 18Dec2021 at 8:00 for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications the patient received within 2 weeks of vaccination. On 09Jan2021 at 11:00, 28 hours after injection, the patient developed fatigue, then myalgias, lasted about 44 hours, mild nasal congestion, and headache briefly. The patient did not take treatment for the adverse events. The outcome of the fatigue and myalgia was recovered on 11Jan2021 while for the events headache and mild nasal congestion was recovered on an unspecified date in Jan2021. Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.

ED to Hosp-Admission Discharged 4/3/2021 - 4/10/2021 (7 days) Hospital MD Last attending ? Treatment team Severe sepsis with acute organ dysfunction Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Date: 4/10/2021 Admission Date: 4/3/2021 Length of stay: 6 Days PCP: MD Discharging provider: MD Admission diagnosis: Primary Admission Diagnosis Hospital Problems POA * (Principal) Severe sepsis with acute organ dysfunction Yes Left hip pain Yes Primary osteoarthritis of left hip Yes Intractable vomiting with nausea Yes Acute metabolic encephalopathy Yes COVID-19 virus infection Yes Gastrointestinal hemorrhage with hematemesis No Urinary tract infection associated with indwelling urethral catheter Yes HPI: Admitted with severe left hip pain and altered mental status. patient with history of stroke Was also found to have Covid positive at the time of admission Hospital Course: Following issues were addressed during this hospitalization Acute encephalopathy: At the time of admission Most likely secondary to gabapentin Held medication during this hospitalization and also stopped at the time of the discharge. Patient was started on this medication recently due to his left hip pain. COVID-19 infection D-dimer was elevated at the time of presentation. CT chest ruled out pulmonary embolism. Ultrasound did not reveal any DVT. Patient did not qualify for any convalescent plasma remdesivir during this hospitalization as he is saturating well on room air. Possible catheter associated urinary tract infection Patient with chronic indwelling Foley catheter. Urine culture grew Staphylococcus hemolyticus and Enterococcus faecalis faecalis. Patient was started on ampicillin during this hospitalization he completed the 5-day course. Sepsis ruled out at the time of admission Acute kidney injury present at the time of admission Suspect underlying chronic kidney disease Patient needs to follow-up with the PCP for the follow-up on the creatinine in 1 week. Left hip pain Patient underwent extensive work-up during this hospitalization. MRI of the left hip showed high-grade tear of the iliopsoas tendon. Patient was seen by orthopedics recommending continued therapy and pain management. Acute GI bleed, presented as coffee-ground emesis Acute on chronic anemia Iron deficiency anemia Underwent extensive work-up during this hospitalization. CT angiogram of abdomen pelvis revealed suspected bleeding in the stomach. Patient underwent EGD which showed severe esophagitis most likely cause of the bleed. Gastroenterology recommending continuing pantoprazole twice daily. Patient hemoglobin remained stable during this hospitalization. Biopsy did not reveal any H. pylori infection. Patient was seen by PT OT during this hospitalization who recommended acute inpatient rehab. But patient and family decided to take the patient home patient was discharged home in stable condition with home health.

Flu symtems for 3 days. Body aches, fever, weakness. After that, low grade fever from May 8 to present (May22)

Had itchy eyes, loss of smell, loss of taste, fever for 15 hours started 5/24/21 at 1pm until 5/25/21 4am.

Bad cold; Coughing, from a dry cough at first to a very wet cough; Coughing, from a dry cough at first to a very wet cough; Very large thick solid segments of gelled mucous coming out of my sinuses; could not think as tightly as usual on 19Apr2021; Sinuses became burning; Bad headaches; Unusally tired; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 16Apr2021 17:00 (Lot Number: Lot EW0151) as 2nd dose, single for covid-19 immunisation. Medical history included Mild seizure disorder and Hay fever. No known allergies. Concomitant medications received within 2 weeks of vaccination included carbamazepine; oxcarbazepine; diphenhydramine hydrochloride (BENADRYL). The patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 in arm left on 20Mar2021 05:00 PM (Lot number: ER8727). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. The patient felt fine following the 2nd shot, for 48 hours on 18Apr2021, but unusually tired so he knew it must had been the shot. The next day on 19Apr2021 his sinuses became burning and he assumed it was hay fever because he had experienced some symptoms of that for the previous two weeks. But the next day on 20Apr2021, Tuesday, it was worst, like a bad cold (which all of this "reaction" may had been), but then the next 3 days he could barely get out of bed and that's unusual because he run every day and nothing stops him, including a cold. he had bad headaches on 19Apr2021 for 5 days or so and symptoms included coughing, from a dry cough at first that Wednesday to a very wet cough and very large thick solid segments of gelled mucous coming out of his sinuses, something he had never seen before. After almost two weeks he felt better but was still coughing, and now three weeks later he was still really tired, could not think as tightly as usual on 19Apr2021. His doctor's office told him not to come in, just to take pain reliever and cough syrup, which he was doing anyway. Test was neg. The adverse event result in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. The patient underwent lab tests included covid test (Nasal Swab): negative on 24Apr2021. The outcome of events could not think as tightly as usual on 19Apr2021, sinuses became burning, bad cold, bad headaches and very large thick solid segments of gelled mucous coming out of my sinuses was recovered and other events was not recovered. No follow-up attempts are needed. No further information is expected.

blood pressure had dropped a lot/blood pressure dropped a good deal; his heart rate was 30 beats per minute; Not feeling well; Sore arm; felt strange; his bone spur in his heel quit bothering him immediately/he can walk long distance/he would get that real soreness or pulling after a walk and that kind of stopped; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 09Apr2021 (lot number: EW0158), as 1st dose, single, for COVID-19 immunization, at a clinic. Medical history included high cholesterol (controlled with diet); bone spur in left heel (bone spur in his left heel began coming on gradually, probably for 10 or 12 years) which has gotten little worse and made it hard for him to walk in the evening, in long distances, it was like a knife in his heel and he would get that real soreness and pulling after a walk; and allergy to sulfa drugs, more specifically sulfa antibiotics (he was given them 25 years ago and had a reaction). The patient has not had any vaccines or shots for years. He reported that he is very healthy and has not had the flu or anything in 25 years. The patient does not smoke and is careful with what he eats. There were no concomitant medications. On 09Apr2021, within minutes of receiving the first dose of the COVID-19 vaccine, the patient was not feeling well, he felt strange. He wondered if it was his imagination or if something was going on. Then it got worse and worse within 12-15 minutes after the COVID-19 vaccine. The staff member sent paramedics over to him. The paramedics set him up with a blood pressure cuff and heart monitor. Apparently, his blood pressure dropped a lot/dropped a good deal and his heart rate went to 30 beats per minute. His heart rate is normally around 65 beats per minute. The paramedics informed him that if his blood pressure and heart rate didn't come up, he was going to have to go to the hospital. The paramedics instructed him to stand up and it seemed to bring his blood pressure and heart rate back up to normal. The patient reported that everything returned to normal within a 15-20-minute time frame. He was then able to leave the vaccination facility. His health care provider advised him not to take the second dose of the COVID-19 vaccine. His physician informed him that he could possibly go into cardiac arrest. The patient did not have any problems after that other than a sore arm later in the day on 09Apr2021. His arm was sore for a day or two. The patient stated that this was the only effect after the incident in the vaccination facility. The patient also reported that on the weekend after receiving the COVID-19 vaccine, in Apr2021, he can walk long distance and his bone spur in his heel quit bothering him immediately. He reported that if he walks a mile and back, it quit the hurt. He reported that he would get that real soreness or pulling after a walk and that kind of stopped. The patient thought this was really strange. The patient reported that he cancelled the appointment for the second dose and did not get it. He was a little apprehensive about the second dose of as he didn't know if his reaction would be worse. The patient asked if the vaccine is 80% effective after one dose, if Pfizer has heard of that type of reaction from others, if his reaction was rare, and if he should get the second dose of the COVID-19 vaccine. He mentioned that he would like to have a second dose of the Covid-19 vaccine, but he is afraid to get it because he doesn't want to go into cardiac arrest. The patient recovered from "blood pressure had dropped a lot/blood pressure dropped a good deal", "his heart rate was 30 beats per minute", not feeling well and felt strange on 09Apr2021, and from sore arm in Apr2021. The outcome of "his bone spur in his heel quit bothering him immediately/he can walk long distance/he would get that real soreness or pulling after a walk and that kind of stopped" was not recovered. No follow-up attempts are needed. No further information is expected.

Had a household member who was ill at home for several days preceding this patient's onset of symptoms; Headaches; Developed symptomatic COVID infection; Developed symptomatic COVID infection; This is a spontaneous report from a contactable other hcp. A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK9231; Expiry date Unknown), dose 2 via intramuscular route of administration, administered in Deltoid Left on 14Jan2021 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient had received first dose of PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EH9899; Expiry date Unknown) dose 1 via intramuscular route of administration, administered in Deltoid Left on 22Dec2020 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. From an unknown date, the patient had a household member who was ill at home for several days preceding this patient's onset of symptoms in Apr2021. The household member was tested positive for COVID 19. On 07Apr2021, (at the age of 61-year-old) the patient developed symptomatic covid infection. The patient had headaches throughout the course of illness, for which the patient responded to OTC pain reliever. On 08Apr2021 and 09Apr2021, the patient underwent Test for SARS-CoV-2 by PCR, which was revealed to be positive. Therapeutic measures were taken as a result of headaches. The outcome of the event symptomatic COVID infection was recovered. The outcome of the events vaccination failure, exposure to SARS-Cov-2 and headache was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and the suspect drug BNT162B2.

First day: Arm pain, followed by a severe headache lasting approximately 24 hours, with pain in extremities, joints, ankles, wrists, knees, neck pain, high fevers and intermittent sweating. Something that triggered me and that I had never suffered before was ALLERGIES TO POLLEN. Today a week later I still feel sick from it. A lot of headache, runny nose, and sneezing. I assume they are allergies to pollen because I took some pills for that {CLARITIN} and I calm down and we feel them a bit, however I do not take it off.

sore in arm shot the next day, slight fever the next day, fatigue the next day, frequent urination the night of vaccination

Lump on left side of face near ear, Lump on left cheek, Lump on left side of neck, lump on right side of neck Dizziness and Lightheadedness Fatigue Seen by Dr. Ultrasound of impacted areas

Doctors are suspecting I might have mucous or blood colitis, we are just not sure; Hands, both right-left hand and wrist, right-left foot and ankles and toes, heels, right-left knees are numb; Burning sensation; Doctors are suspecting I might have mucous or blood colitis, we are just not sure; Shooting pain like flu; This is spontaneous report from contactable consumer (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, (patient not sure if it's right arm or left arm) on 13Mar2021 (Batch/Lot Number: EP7534) as 1ST DOSE, SINGLE, for covid-19 immunisation. The patient took the second dose on 04Apr2021 (Batch/Lot Number: ER8732). The patient medical history and concomitant medications were not reported. The patient stated that "I wanted to report about suspected side effects to covid-19 shot. I'm not sure if it's the Covid-19 shot or not or has to do with it but I wanted it to be documented may there's some coincidence, you can tell me about. All extremities hands, both right-left hand and wrist, right-left foot and ankles and toes, heels, right-left knees are numb. Burning sensation, shooting pain kind of like flu but no body temperature change, body temperature is 97.7 down there, it's been occurring now past my 2nd shot." The patient later corrected it as," It's 5-10 days after the 1st shot." When paraphrased, the consumer stated," I've got a number of doctors working on trying to figure out what's wrong with me. So, if we cannot find anymore answers then I'm sure, I'll contact Pfizer. I don't know if it has anything to do with the shot or not, I don't even know if the side-effects are from Pfizer or not. Doctors are suspecting I might have mucous or blood colitis, we are just not sure." When asked for the anatomical Site of administration of Vaccine: The patient stated, "I'm not sure if it's my right arm or left arm." For the event start date: patient stated, "18 or 19 June, somewhere around there. I am not sure. (pending clarification)" The patient also added: "Do you guys also report to VAERS? I don't know my physician asked to say, if you guys report to VAERS, otherwise I should call VAERS and report my symptoms." The outcome of the events was unknown. Information on the Lot/Batch number has been requested.

tiredness; headache; chills; Achy; threw up; nausea; This is a spontaneous report from a contactable consumer (patient wife) reported for her husband (patient). This is the report 2 of 2. A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm right on 05May2021 at 15:45(at the age of 61-years-old) as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history included high cholesterol, ongoing from an unspecified date, high blood pressure, ongoing from an unspecified date and acid reflux, ongoing from an unspecified date. It was reported that, the patient takes medications for these, but the reporter does not feel these medications are relevant. The patient's concomitant medications were not reported. Patient took Covid-19 vaccine to prevent Covid-19 virus. No other vaccinations within four weeks prior to the vaccination. The history of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Adverse events following prior vaccinations were reported as none. The caller stated that, 14 days after receiving the first Covid-19 vaccine, the patient experienced tiredness, chills, headache, achy, nausea and he threw up when he got to work on 19May2021. Stated that, she does not have her husband's Covid-19 vaccine record card with her at the time of the call. It was reported that, no adverse events required a visit to emergency room or physician office. The relevant lab tests and procedures included were none and no investigation assessment was reported. The outcome of the events was recovering. Follow up (25May2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer(patient wife) reported for her husband (patient) included RMH, Patient details, outcome details, suspect product details, event details. Information about batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021599251 same report/drug/AE, different patient

He had extreme fatigue for 2 days after the vaccine. About 2 days after the vaccine, he developed watery diarrhea that has persisted for 2 weeks.

He got his vaccine, he had a very, very bad headache. About 3 weeks later his neck stiffened. He developed a pain in his chest, stabbing in nature, down his neck, left arm, arm pit, down his side and through to his back and down his spine. He also has had numbness in his hands. He went to the ER because he thought he was having a heart attack, and they did a bunch of tests on him including a COVID test which was negative . They did a chest x-ray, EKG, blood work and possibly some others, and everything seemed to be OK, and could be a neuromuscular thing. He then went to see his PCP the next day who reviewed the ER results, and he sent him to a cardiologist and he is in the process of having tests done with him. He also has an APT set up with a neurologist and an Orthopedist as it has been 5 weeks since this started, and the pain is fairly severe. He has an overall feeling of weakness, light headedness and nothing really relieves the pain and has been using Advil. They told him to take Advil. The cardiologist has not given him any results yet. He did ask his PCP and his cardiologist if they felt that it was due to the vaccine, perhaps a delayed reaction and they told him that they would not rule that out.

Reports nausea, myalgias, lightheadedness, headaches, chills, diaphoresis, fatigue, chest pain, cough, dyspnea on exertion and shortness of breath at rest, most symptoms are chronic but reports worsening with second Covid vaccine.

Bad headache continuosly; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 61-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6202 and expiration date was not reported), via an unspecified route of administration in left arm on 09Mar2021 at 16:30 (at the age of 61-year-old) as first dose, single for COVID-19 immunization. Patient had no known allergies and other medical history. The concomitant medication included fenofibrate, daily multivitamin administered on an unspecified date for an unspecified indication. Patient did not have any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not test for COVID post vaccination. On 10Mar2021 at 01:30, nine hours after receiving vaccination, patient experienced bad headache continuously. Patient did not receive any treatment for the adverse event. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

I got a sinus headache; body ached; Terrible feeling; lost all energy; was cold; This is a spontaneous report from a contactable consumer(patient). A 61-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581) via an unspecified route of administration, administered in right arm on 18Feb2021 12:00 as single dose for COVID-19 immunization. Patient medical history included Early Onset Alzheimers, high blood pressure, acid reflux, diverticulitis, and allergies to pollen and ragweed. Past drug event included Lipitor orifarm, amlodipine for allergies (Hypersensitivity). The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via intramuscular, administered in arm Left on 28Jan2021 12:00 as single dose for COVID-19 immunization. Patient stated that on 19Feb2021 01:00 when she was in store, she had terrible feeling came over her. She lost all her energy, she got a sinus headache, she was cold, her body ached all over. She had to leave the store. Barely had enough energy to walk from the car into her house. The patient did not receive any other vaccines prior to the COVID vaccine in four weeks. Patient received other medications in two weeks after vaccination. Patient did not receive any treatment for AE. Patient was not tested covid prior vaccination or post vaccination. The clinical outcome of events was not recovered.

This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number; EN6203) via an unspecified route of administration in left arm on 12Mar2021 at 10.00AM as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number; EL3247) via an unspecified route of administration in left arm on 19FEB2021 10:00 AM as a single dose for COVID-19 immunization. Medical history and concomitant medication was not reported. Patient was allergic to Iodine. Prior to vaccination, patient was not diagnosed with COVID-19, since the vaccination, patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 12Mar2021 at 23:00 hours. the patient experienced body temperature (101 degrees), headache, diarrhea, nausea, chills, fatigue and body aches. The clinical outcome of the reported events was recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

First shot induced week and a half migraine headache. Second shot has caused extreme fatigue and every joint in my body hurts to the point I have experiences a severe reduction in quality of life. So, extreme fatigue and pain. I just can't seem to catch up on sleep and have to think twice about the next move due to the pain it will cause.

Approximately 1 month after second injection, I began having the sensation of menthol in my mouth, nose, tongue, throat, and lungs. The sensation is constant and continuous. It seems to be getting stronger with time.

Migraine headache after the shot. Since the shot on 3/16/2021 I have a headache. This headache is 24/7 all day every day. It has not gone away or improved. I have visited my primary care physician, ENT doctor, ophthalmologist and two neuologists. I have been prescribed numerous presciptions. I have had a CT scan, MRI and MRA. My headache has not improved after 3 months from the initial vaccine. I had no history of headaches prior to receiving the vaccine.

Heart arrhythmia, skipped beats (usually every fourth beat), and palpitations starting about 2 days after vaccination, and lasting about 4 weeks. Eventually resolved on its own before date of doctor's appointment with cardiologist was reached. In addition, fatigue, flu-like symptoms

tested positive; fever; chills; cough; This is a spontaneous report from a contactable physician. A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) on 28Jan2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that after getting first dose the patient subsequently developed fever, chills and cough 1-2 days later (unknown date in 2021). They tested him for COVID-19 and he tested positive on 02Feb2021. Patient had high risk criteria for severe infection so they proceeded with giving him Bamlanivimab infusion on 03Feb2021. They were waiting 90 days now post infusion prior to vaccinating him. It was enquired that since how much time would have lapsed since getting his first vaccine, should patient start the series over or does he just need one more dose. Therapeutic measures were taken as a result of fever, chills, cough and tested. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

30 minutes after vaccination he did not feel good, has droopy eyes , slurred speech, numbness of left arm. high blood pressure, headach, shortness of breath 2 days after vaccination he feels better but still has mild headache , pressure behind eye, Rt eyelid ptosis, numbness of left upper arm and slight shortness of breath

Received the first Pfizer COVID vaccine (ew0161) injected at 4:30PM on 29 April 2021 at the Pharmacy. He became weaker, more tired and sleep afterwards, He developed decreased oral intake. He was unable to recall his name, so family brought him to the ER. In the ER he was noted with significant anemia Hgb 6.5 and thrombocytopenia with platelet of 6. There is question of hemolysis with reticulocyte 8, LDH 1757, total bill 3.8. There is elevated D-dimer and renal function. Hematology consultation was placed for possible TTP versus COVID vaccine induced thrombocytopenia. PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times on 4, 5, 6, 8, 9, 10, 11, 12, 13, 17, 19 May 2021. Received Rituximab 375 mg/m2 = 731 mg IV weekly X 4 on 5, 13, 19, 26 May 2021. Completed high dose steroids 1000 mg x 3 days AMS and seizures 2/2 TTP related metabolic encephalopathy(i mproved), Small R parietal subdural hematoma­ likely related to TTP. No focal deficits. Treated for TTP with plasmaphoresis.initially alert but not oriented. Had an episode of seizure, intubated for airway protection Patient was hospitalized for 15 days 4-19 May 2021. He was in ICU for 1 week and 8 days in general ward. He was unconscious for the first week experienced 2 episodes of seizure. He has been comatos since he developed the first episode of seizure on 5/5/21. He developed another episode of seizure after the brain MRI on 5/5/21. PT discharged on 19/5/21 and continued blood works and Ritoximab therapy as out patient. Assessment: TTP, based on his clinical features including altered mental status, fe1er, hemolytic anemia and thrombocytopenia, renal insufficiency, and peripheral smear with 7-8 schistocytes per HPF (5/4/2021). Adam Ts 13 activity <3 Hemolytic anemia, severe thrombocytopenia 212 TTP with AdamTs13 deficiency In setting of hemolytic anemia, thrombocytopenia, AKI and AMS Hgb 6.5, Bili 3.8, LOH 1757, ARC 3.6 significant for hemolytic anemia on adm Peripheral smear showed anisocytosis, microspherocytosis and possible 1 schistocytes Platelet 6, multiple petechiae, no active bleeding, guaiac negative. Received 1U PRBC. Direct Coombs test -ve , Tbili elevated Plasmic score 6 Acute kidney injury 212 TTP vis Prerenal (Resolved) , Hyponatremia (resolved) FENA 0.5 Hematology followup: TTP (THROMBOTIC THROMBOCYTOPENIC PUPURA) 5/14/21 He developed a new ulcer in the mid of tongue. He coughs and sputum is clear. He feels better. Sip plasmapheresis and rituximab infusion yesterday. 5/13/21 He continues improling. Good appetite. He still coughs with blood streak, slightly pinkish sputum. 5/12121 His mental status is back to baseline. He is able to eat regular food and walk inside his room. Clo cough with blood streak, slightly pinkish sputum. 5/10/21 Fully alert and awake, but reported confusion and forgetful episodes. Eating better. Clo tightness in arms 5/9/21 More alert and awake. Started eating. Feeling tired. Clo mild pain at shoulders. Sip 1 unit PRBCs 5/8/2021 Mild improvement. Wife is at bedside. No acute overnight events. Still has intermittent confusion. Surgery re-placed left IJ Shiley for PEX 5/7/2021 He has intermittent confusion and irritation, mixed with short-term of AAO x 3. He pulled out his PEX line and has urinary incontinence. He is NPO and remains sleeping most of time. 5/6/2021 Sip extubated. He appears tired, but arousable, follows commands and carries normal communication with b/I symmetric strength with no motor deficits. Afebrile since last night. 5/5/2021 He developed 1 episode of seizure. Sip Ativan and 1 dose of propofol for intubation. He has been in comatose since then. Brain MRI was performed this afternoon. He developed another episode of seizure after the brain MRI. Sip 1 unit packed RBC 5/4/2021 and 1 unit packed RBC 5/5/2021. He de1.eloped mild bleeding from the bronchial suction and Foley catheter. He de1.eloped fe1.er temperature 101 during the first plasmapheresis. Temperature was 104 about 2 hours after the first plasmapheresis. He has had persistent high fe1.er since then. 5/4/2021 Lab showed WBC 7.1, Hb 6.5, pit 6, MCB 92.1, neut 68%, re!8%, PT 14, PTT 30. 5, D-dimer 2.19, fibrinogen 490, CMP normal except Ca 8.1, Glu 189, BUN 47, Cr 1.57, T bili 3.9, direc!0.9, and AST 56. LOH 1757, TSH 4.828, serum HIV and hepatitis panel negati1.e, COVID-19 Ag, SARS-CoV2 Rapid and Flu Ag negati1.e. 5/5/2021 WBC 21,500, hemoglobin 6.2, platelets 17,000, neutrophils 69%, PT 14.9, PTT 28.3, D-dimer 5.5, glucose of 296, BUN 63, creatinine 2.18, total bilirubin 2.5, albumin 3.6, LOH 891, AST 57, ALT 32, alkaline phosphatase 51. Laboratory results: WBC H 13.2 (MAY 14) H 11.6 (MAY 13) H 13.4 (MAY 12) H 16.8 (MAY 11) ? Hgb L 9.9 (MAY 14) L 11.3 (MAY 13) L 10.8 (MAY 12) L 10.4 (MAY 11) Hct L 30.2 (MAY 14) L 33.3 (MAY 13) L 31.5 (MAY 12) L 31.2 (MAY 11) Pit L 92 (MAY 14) L 58 (MAY 13) L 63 (MAY 12) L 74 (MAY 11) Risk Assessment: Denies Alcohol Use Substance Abuse Risk As sessment: Denies Substance Abuse Tobacco Risk Assessment: Denies Tobacco Use

Sweats; Body aches; Chill, as if had flu; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269) via an unspecified route of administration on left arm on 03Mar2021 at 13:15 (at the age of 61-year-old) as a single for COVID-19 immunisation. Medical history included liver transplant, lymphoma and spleen removed due to lymphoma. The patient had not received any other vaccination within 4 weeks. Patient had taken other medications within two weeks prior to vaccination which were too many to list. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had SARS-CoV-2 test (nasal swab) on 23Feb2021 and resulted negative. On 04Mar2021 at 18:00, the patient experienced sweats, body aches, chill as if the patient had flu. No treatment was received by the patient for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events sweats, body aches, chill was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.

Chills; Lack of energy; slight fever; This is a spontaneous report received from a non-contactable consumer, the patient. A 61-years-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6205) via an unspecified route of administration in the right arm on 12mar2021 at 1:30 for COVID-19 immunisation. TMedical history included asthma and sinus. Concomitant medications included antibiotics received within two weeks. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. and 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 experienced Chills, lack of energy and slight fever on 20Mar2021 at 9.00.The patient did not receive any treatment for reported events. The clinical outcome of the events Chills, lack of energy, slight fever was not recovered . No follow-up attempts are needed. No further information is expected.

Headache; Internal shaking when lie down.; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ENG206) in the right arm via an unspecified route on 06Mar2021 at 14:45 as a single dose (at the age of 61-year-old) for COVID-19 immunisation. The patients past drug history included allergy to sulfur. The patient did not receive any vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included multi vitamins (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), crestor (MANUFACTURER UNKNOWN), RAPFLO all for unknown indications from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Mar2021, the patient had SARS CoV-2 test via rapid nasal swab and resulted negative. On 11Mar2021 at 07:00 am (5 days after vaccination), the patient had headache started with internal shaking when patient lied down. Therapeutic measures were taken as resulted events and included treatment with muscle relaxer. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events headache and internal shaking was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Headache; Fever; Chills; injection site soreness; Rash on inside of right thigh. Rash on left side of waist on the back side.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in left arm on 19Mar2021 at 10:30 (61-year-old at the time of vaccination) as a single dose for COVID-19 immunisation. Medical history included cardiac artery disease. The patient had allergy to shrimp. Concomitant medications included atenolol (MANUFACTURE UNKNOWN), PLAVIX and CRESTOR for unknown indications from unknown dates. Patient had not tested positive for COVID-19 since having the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 01:00, the patient experienced headache, fever, chills, injection site soreness, rash on inside of right thigh and rash on left side of waist on the back side. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fever, chills, injection site soreness, rash on inside of right thigh and rash on left side of waist on the back side were not recovered. No follow up attempts are needed. No further information is expected.

I ended up having a brain hemorrhage ! Terrible headache in the hospital for seven days in the intensive care unit !

Mild soreness at injection site then tired and achy that night. Fine next morning. Traveled to Dr's appointment and went shopping. Upon returning home, as I carried items up 3 steps to porch, I felt my heart begin to race. Thought I was just winded in cool temp. Parked and walked to house, up flight of stairs, drank water and set down. Still my heart was racing. My Watch beeped that I might be in possible A-Fib. Daughter-in-law, an LPN, stopped to pickup our grandchild. Took my pulse, said it was rapid and irregular. Told me to take 4 baby aspirins and get to ER. EKG showed I was in A-Fib , Blood work, tests etc. Admitted to Hospital for 1 1/2 days. Given Diltiszen and shots for blood thinner, IV's. Sent home, Converted to Normal Rhythm in couple of days. Saw Dr. He switched me to Cardeilol and Xarelto. Scheduled Echo of my Heart. Results were clean and fine. Now in Lymes (PLDS) Flareup.

Extreme exhaustion; serious muscle pain; joint pain; Injection site swelling; Injection site redness; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 22Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. It was unknown if the patient was allergic to any 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 previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on 01Mar2021 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. On 22Mar2021, the patient experienced extreme exhaustion, serious muscle and Joint pain, swelling and redness at the site of injection. It was unknown the patient received treatment for the reported events. The patient was tested for pain scale and the result was 6 on a scale of 1-10. 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 event extreme exhaustion, serious muscle and joint pain, swelling and redness at the site of injection were recovered on an unknown date at the time of this report No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Chest pains, almost passing out. profuse sweating,throwing up, EMT ride to Hospital, full series of heart and arty tests. Cat scan EKG,ultra sound, blood tests, All came back negative no known cause for episode. Only thing different in life style was the vaccine

Dec 7, 2020 felt chest pain on deep inspiration with fatigue, malaise over 7 days. No cough, no fever, no headache, no smell or taste alteration. On Dec 31 developed aching pain right shoulder scapular area, on Jan 5 developed weakness in the right arm and hand with intrinsic hand muscles weak and wrist flexion extension weak. Transient numb feelings in the right little finger. Diagnosed by myself as a Neurologist as an immune mediated motor brachial plexopathy affecting C6,7,8 and T1 myotomes. Prednisone 60 mg/ day for 5 days followed by a tapering dose completed. Complete recovery in 8 weeks.

Peripheral Neuropathy symptoms; tinnitus/Ringing/buzzing/chirping/humming in both ears; difficulty concentrating; Extreme sensitivity to sound; Vertigo; Dizziness; Earache; Anxiety; Chest pains; Chest stress; Spasms in chest and back; Began to get blur in right eye; Bowel movements changed; Numbness on face: lips, checks, forehead; Muscles have shrunk throughout body; Joints popping; Neck ache; Throat tight; Face and smile have changed; Hair is thinner; Hair gotten gotten more grey since these issues; Feet burning; numbness and tingling sensation in both legs to feet and both arms to hands and extremities; Back aching; muscle weakness; Brain fog; Fatigue - constantly feel like laying down; Difficulty Sleeping through night/Unable to nap throughout day; feet aching in joints; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0150) via an unspecified route of administration, administered in left arm on 30Mar2021 at 14:45 as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included finasteride, ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride. The patient previously took augmentin s. On 03Apr2021 at 18:00, the patient experienced tinnitus/ringing/buzzing/chirping/humming in both ears, difficulty concentrating, extreme sensitivity to sound, vertigo, dizziness, earache, anxiety, chest pains, chest stress, spasms in chest and back, began to get blur in right eye, bowel movements changed, numbness on face: lips, checks, forehead, muscles have shrunk throughout body, joints popping, neck ache, fatigue - constantly feel like laying down, throat tight, face and smile have changed and hair is thinner. The outcome of the events was not resolved.

Fever, delirium, stomach pain. Thrombocytopenia, Encephalitis, viral and bacterial meningitis, Rhabdomyolyses, episode of torsades de pointe, pulmonary pneumonia, pneumonitis. Eventual double lung transplant.

his first cup of coffee about killed him, it tasted so bad; dryness in the mouth; his voice has changed to raspy; his urine has a smell; lethargy; metallic taste in the mouth; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration administered in Arm Left on 08Jun2021 (age at vaccination 61-years) (Batch/Lot Number: EN0180) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient states coffee tastes strange/bad and this is ongoing but had improved some. Caller states starting out his taste was completely gone, his first cup of coffee about killed him, it tasted so bad. Caller states he has dryness in the mouth every day and he was drinking more water. Caller state he normally drinks a lot but this is more. Caller states his voice has changed to raspy most of the time and his urine has a smell. Caller states it was not like when he eats asparagus but another smell he hasn't had before. Caller states it started the morning after on 09Jun2021. Caller states his coffee is not back to normal taste yet, it still just tastes weird. Caller states he was also lethargic but that has improved some. Caller states he figured that out because he usually only has 1 cup of coffee and he was having 2-3 cups so he could stay focused and work, it was kind of weird. He also states he had a metallic taste in the mouth and for a while he had to brush his teeth 5 times a day. Outcome of the events was not recovered.

Fever; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male 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 19Mar2021( at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not take any 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 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 26Feb2021 at 07:45 ( at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination the patient had been tested for COVID -19. On 25Mar2021 at 13:00 the patient experienced fever which began 6 days after second injection and now it was over 72 hours with fever. The patient underwent lab tests which included PCR test on 26Mar2021 and tested negative. The clinical outcome of the fever was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Patient admitted to MCH-BG on 7/12/21 with complaint of chest pain starting 2 days prior and worsening. No radiation quality of chest pain. Also complaint of diarrhea x2 days and sweating. Diagnosed with community acquired pneumonia on admission. Possible exposure to COVID at residential facility, so COVID testing was ordered which resulted as positive.

Muscle weakness; tired; Feeling hot; eyeball pain; Headache; Caller is the patient that received one dose of the Moderna Covid vaccine on 20 Jan 2021. Yesterday he received the Pfizer Biontech covid 19 vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program support. A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0198, expiry date: not reported) via an unspecified route of administration, administered in Arm Left, on 30Jun2021 at 15:00 ( at the age of 61 years), as 0.3 ML single for covid-19 immunisation. The patient received covid-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot Number: 027L20A), via an unspecified route of administration, on 20Jan2021 at standard dose, in left arm, for covid-19 immunisation and had a bad reaction to it. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior vaccination (within 4 weeks) was reported as the patient had shingles vaccine about a month ago. Family Medical History Relevant to AE was reported as no. On an unspecified date, the patient had experienced muscle weakness, tired, feeling hot, eyeball pain, headache. Reported feeling a little bit of eyeball pain, not bad and a little bit of a headache. The symptoms started the night before the day of reporting and most of the effects were on that night and on the morning of reporting. Stated his cup of coffee made him really hot. Side effects were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Adverse events did not require visit to emergency room or physician office. The outcome of the event headache was reported as recovered. The outcome of other events was unknown.

Headache persisting and worsening despite meds.; This is a spontaneous report from a contactable healthcare professional, the physician. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an intramuscular route of administration in the left arm on 16Mar2021 at 14:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and thyroid disease. The patient had no known allergies. Concomitant medication included losartan (MANUFACTURER UNKNOWN) and levothyroxine sodium (UNITHROID) for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. On an unknown date in Mar2021, the patient experienced headache, which was persisting and had worsened despite the medications. The event had resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken for the event included nabumetone. The clinical outcome of the event persistent headache was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Dehydration; Symptoms of the flu; Soreness; Unable to sleep; Aches in joints; Nausea; Fever; Tiredness; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: er8732) via an unspecified route of administration in the left arm on 30Mar2021 at 13:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. 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 medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: er8732) via an unspecified route of administration in the left arm on an unspecified date in Mar2021 (at the age of 61-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. On 31Mar2021 the patient experienced dehydration, aches in joints, nausea, fever, soreness, symptoms of the flu, tiredness and unable to sleep. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events dehydration, aches in joints, nausea, fever, soreness, symptoms of the flu, tiredness and unable to sleep were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Swelling and lots of pain in left arm at injection site, radiates up to left side of neck, left inner ear and left side of back of my head. panful headaches, pain in all my bones, vomiting, feverish , extremely tired and in bad mood. Chills and numbness on the left side of my face, including left side of my mouth and left eye making me almost lethargic and extreme bad mood. Light bother me a lot, feel nauseas. I am extremely weak when walking and have to make a great effort to walk since is extremely painful and I don't have much strength. Everything hurts, especially when I walk, I feel very weak.

This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 31Mar2021 at 18:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, aortic valve replacement and allergy to statins. Concomitant medications include metoprolol (MANUFACTURER UNKNOWN), desipramine (MANUFACTURER UNKNOWN), esomeprazole magnesium (NEXIUM), ezetimibe (MANUFACTURER UNKNOWN) and acetyl salicylic acid (ASPRIN). The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. 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 15:00, the patient experienced severe headache, muscle aches, chills, sweats and fatigue. The 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 events. The clinical outcome of events severe headache, muscle aches, chills, sweats and fatigue were resolving at the time of report. No follow-up attempts are needed. No further information is expected.

low grade fever; body aches; fatigue; some nausea; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via an unspecified route of administration in the right arm on 31Mar2021 at 11:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included gout. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN) 300 mg daily from an unknown date and for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6199) via an unspecified route of administration in the right arm on 10Mar2021 at 11:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. 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 was not tested for COVID-19. On 01Apr2021 at 04:00, the patient experienced low grade fever for 2 days, body aches, fatigue and some nausea. The patient did not receive any treatment for the reported 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 low grade fever was resolved on 03Apr2021, while that of body aches, fatigue and nausea was resolved on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.

death E87.1 - Hyponatremia J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified

I was immediately confused about where I was at, when leaving the vaccination site. I immediately felt flush with red splotches on my face. I came home and took a nap just to sleep it off. I woke up with severe tinnitus, a headache, and brain fog. Both the tinnitus and headaches have only gotten worse. The flush feeling, (suspecting higher blood pressure than usual), comes and goes with more frequency as time goes by. The ?brain fog? has been more like brain damage. At first, I just couldn?t think. My ability to think has slowly improved, but it is no where near the same as my abilities prior to the vaccine. My memory has been impaired, both long term and short term. My hand/eye coordination has been impaired. Prior to the vaccine, I didn?t feel my age. After the vaccine I felt like I aged 25 years in a week. I need to figure out what is going on inside my head, and what can be done about it. The degeneration is a serious concern. Both in the severity of the adverse reactions, and in the permanence of the damage. This will be devastating if I?m entering early stages of dementia, decades before the course of natural causes of aging.

Vertigo; Dizziness; Arm pain; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04Apr2021 at 13:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: UNKNOWN) via an unspecified route of administration on unknown date 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 05Apr2021 the patient experienced vertigo, dizziness, arm pain and fatigue. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vertigo, dizziness, arm pain and fatigue were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Fever; Chills; Aches; Injection site pain; Headache; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 05Apr2021 at 12:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and penicillin allergy. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and Amlodipine-Benazepril (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 14:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 01:00, the patient experienced fever, chills, aches, injection site pain, headache and feeling unwell. The 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 event. The clinical outcome of the events fever, chills, aches, injection site pain, headache and feeling unwell was not recovered. No follow-up attempts are needed. No further information is expected.

Body ache; upset stomach; Headache; Chills; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the left arm on 05Mar2021 at 13:00(at the age of 61-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 05Apr2021 at 00:30, the patient experienced body ache, upset stomach, headache, chills and tiredness. The patient did not receive any treatment for the event. The clinical outcome of the event body ache, upset stomach, headache, chills, tiredness was not resolved. No follow-up attempts are needed. No further information is expected.

tired; has no energy; can't think straight; dizziness; he has developed two spots on his right leg where the skin has fell off; two spots on his right leg that the skin fell off and swelling really bad; two spots on his right leg that the skin fell off and swelling really bad; throbbing; bad headache; feels hot and cold; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (at age of 61 years old), (Batch/Lot Number: unknown) as dose 2, single for COVID-19 immunisation. Medical history included two heart attacks, three stent implants, and his lung had separated, also he had tube in his chest. He had to have six bypass open heart surgeries. His first heart attack was at age 55. Patient was taking unspecified concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on 15Jun2021, (at the age of 61 years old), in left arm as single dose for COVID-19 immunization. The patient experienced dizziness and he has developed two spots on his right leg where the skin has fell off and are throbbing and swelling really bad for no reason, had bad headaches and feels hot and cold on 16Jul2021 (Friday). The patient stated he can't think straight right now and also stated he is tired, has headaches, and has no energy. If he gets up and walks around he gets dizzy. The headaches are constant. The patient stated he was calling because his son wants to take him to the ER. The outcome of the events was not recovered.

Kind of tired after first shot; Stomach was kind of irritated; Back hurts a little bit more; This is a spontaneous report from a contactable consumer (patient himself). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 12May2021 (age at vaccination: 61 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included pain pump which was removed on an unknown date in 2015 at hospital. It was 16.5mg per day plus outside medicine. They were supposed to remove pain pump, but they let it run dry, he was regurgitating for 5 days, every 30 minutes. They got the pump out because he started getting tremors, and that's what gave him the memory loss. It was helping the pain quite a bit that's the only thing it was doing in the back. When they took the pump out, they left a piece of the catheter in one of the discs, he could feel that more than ever. They had him in like an outpatient for people that abuse drugs, he was just there to get the pump out. The patient had dementia, but he was surprised that he can remember his address and driver's license; that his memory is coming back quite a bit. Surgery on shoulder, fell right on that shoulder a week after surgery on shoulder, allergic to about 15 different medicines mostly the heavier ones like the muscle relaxants, 100 percent disabled, had 8 ulcers, stomach sometimes flares and back pain. Some of the shots he had from pain management were like epidural. The patient's concomitant medications were not reported. On an unknown date in May2021, the patient experienced kind of tired after first shot, stomach was kind of irritated and back hurts a little bit more. He didn't have blood work. He said he would have to terminate pain management if he was not comfortable with this. The patient said that he was unsure if this was related to the shot. It might not have been the shot. The kind of tiredness was more the issue because he already has back problems before, has a compression, broke. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Stuffy nose tingling lips tingling face i took 50 mg of over the counter benedryl..symptoms resolved

felt a little sick; I got my temperature about 100.2/Fever that I have is 7 days after the vaccine; Had mild body ache; Chills; Usual soreness at the site of injection; Cough; mild sore throat; This is a spontaneous report from a contactable Physician (patient). A 62-year-old male patient received NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL01-40), via an unspecified route of administration on 20Dec2020 09:30 at single dose for COVID-19 immunization. Anatomical Location provided as Left deltoid. Medical history provided as none. Concomitant medication included hydrochlorothiazide, levothyroxine sodium (SYNTHROID). Physician stated, he got his Pfizer vaccine on last Sunday on 20Dec2020 around 9:30 there was usual soreness at the site of injection on 20Dec2020, which was there but no problem. But Monday (21Dec2020) after his vaccine that was Sunday he had and Monday night on 21Dec2020 he had chills he thought these were all just the reaction to the vaccine. Next day on 22Dec2020 he went into work he had mild body ache at work, at about 3:30 he felt a little sick and he got his temperature about 100.2, get home rested, next day on 23Dec2020 he worked from home, did not go so for next four days (from 24Dec2020 to 27Dec2020) he rested at home but his chills and body ache are not going away. They were there, they come and go, he took Tylenol, it went he have mild sore throat, cough on Dec2020. Today on 27Dec2020, the patient just took the temperature 100.7. For Causality assessment: Physician stated, "he didn't know, he was just trying to find out to get to bottom of it. Is it really COVID infection or is it due to side effects as from what he read the reaction shouldn't really last long. It may last probably 3-4 days but this has gone beyond that so he was little concerned and the fever that he had was 7 days after the vaccine." The patient still had chills and body ache which he means they were not going away and now mild fever. When probed for the outcome of, Physician stated, "They are persistent you know some day he had one day which was good but after that in the afternoon in the evening he felt the same thing. Fortunately, he was off for four days it didn't really have much problem, physically it was persistent has not gone away." Therapeutic measures were taken as a result of chills, had mild body ache, felt a little sick, cough, fever, mild sore throat. The outcome of events chills, mild body ache was not recovered. The outcome of the other events was unknown.

tingling in mouth and lips, some numbness followed, swelling/puffy feeling on throat under jaw, shivering. Throat and back of tongue started to feel swollen. Started on a benedryl drip and in about 20 minutes I started feeling better, chills stopped, throat improved. After 45min to an hour I went home. Received shot around 10am, symptoms started about 20min later. Received treatment 15 min after reporting symptoms. Took benydryl at 5pm, 9pm, 2am. Took tylenol at 5pm. Jan 6 woke up felling like a fever and minor tingling in mouth and lips. took benedryl at 7am. Slept through the night without symptoms. Taking a 25mg bendryl every 5 hours and ibprofen/tylenol alternating every 6 hours.

PATIENT REPORTED A SORE ARM THE DAY FOLLOWING THE VACCINATION. THE PAIN SUBSIDED BY THE END OF THE SECOND DAY. ON DAY 4, THE PATIENT AWAKENED WITH FEVER, HEADACHE, BODY ACHES, CHILLS, SEVERE FATIGUE, SOB AND COUGH. ON MONDAY, JANUARY 4, THE WAS GOT FEELING ANY BETTER AND WITH TO SEE A PROVIDER AT MEDICAL CENTER. HE WAS GIVEN A CHEST X RAY AND LABS. HE WAS GIVEN A RAPID FLU AND COVID ANTIBODY PCR TEST BOTH NEGATIVE. HE DID NOT REPORT TO THE HEALTH DEPARTMENT AND THE HOSPTIAL DID NOT THINK FEEL THE SYMPTOMS WERE RELATED TO COVID VACCINATION. HEALTH DEPARTMENT ONLY FOUND OUT TODAY DURING F/U PHONE CALL WITH PATIENT. PATIENT IS RECOVERING AT HOME. AS OF TODAY, HE FEELS HE IS GETTING BETTER.

Chills, followed by shaking chills, myalgias, vomiting (x1), headache, lethargy. Chills, myalgias, headache and lethargy lasted all night then took Naproxen in the AM and was able to go to work. Stayed on Naproxen all day and all the next night with no additional symptoms (other than extreme tiredness) throughout the day until night two had drenching night sweats throughout the entire night (changed drenched t-shirt 5 times, soaked sheets and pillow case, until up to go to work at 6:00 AM. Since morning no additional symptoms including no tiredness/lethargy. I currently feel completely normal. Last dose of naproxen was at 6:00 AM and no symptoms since. Currently 1:45 PM.

Fever 102.1, bone, joint, muscle pain, chills, headache, malaise, sore arms lasted 24 hours, took Tylenol, which cut fever and made me feel a little better, and the next day I felt normal again. I had no reaction to 1st dose.

low grade fever/low grade fever of 103; chills; dry cough; lethargy; This is a spontaneous report from a contactable nurse. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 with expiry date Mar2021), via an unspecified route of administration in left deltoid on 30Dec2020 14:30 at a single dose for COVID-19 immunization. The administration was one in a local pharmacy. There were no relevant medical history and concomitant medications. On Saturday night, 02Jan2021, the patient started getting a low grade fever of 103, had chills, lethargy and an intermittent dry cough. The outcome of the events was not recovered. The events were considered medically significant events.; 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.

Patient c/o Itchy rash over his abdomen, shortness of breath, itching inside his throat and feeling as if his throat was mildly closing. Patient received Benadryl 25mg IM, Solu-Medrol 125mg IV and Pepcid 20mg PO. Patient was sent out to ER for further evaluation. Patient returned from ER at 2349 with no new orders. ,No any acute distress reported.

Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine; Postnasal drip in throat; Feeling warm then really hot; Feeling weak; Clammy; sweaty; As if he was going to pass out; almost like a vagal reaction if you got a needle or were scared; vagal reaction but delayed; Heart might have been beating fast; Experience is like the dizziness related in the signs of a severe allergic reaction; Experience is like the dizziness related in the signs of a severe allergic reaction; Anxiety; anxious; This is a spontaneous report from a contactable physician (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left deltoid, on 30Dec2020 10:30, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing mild intraocular pressure. The patient's concomitant medication included unspecified eye drops for a mild intraocular pressure. The patient previously took tetanus vaccine and experienced vagal reaction and passed out (in his childhood). The patient's past COVID tests were always negative. On 30Dec2020, the patient received it at a facility where he is a physician on staff, and they started giving it that day. It was administered by a pharmacist who was very clean and professional, and everything was fine. The patient received the COVID-19 vaccine in the left deltoid and felt pinched when the vaccine was administered, and he felt fine. He did not have any immediate reaction. He sat down, then got up and was standing talking to some colleagues, and about 10 to 15 minutes later, they were talking and felt a little postnasal drip in throat. His colleagues said that is what they felt as well. About 10 minutes later, the patient was feeling warm then really hot to the point where he felt the need for cool air. He added feeling weak and clammy as if he was going to pass out. He started to feel weak and warm and almost like a vagal reaction if you got a needle or were scared. It was almost like he felt hot, sweaty, and weak and feeling like he needed to get to a cool place and sit down. The patient's heart might have been beating fast, but he did not check his pulse. The patient went outside where the temperature was in the thirties and cold. The patient broke out in sweat and felt weak. The patient sat down, and it was cold outside, and he felt better. It passed and he felt fine after that. The symptoms lasted 10-15 minutes top, and it was resolved after the peak. The patient had soreness at the muscle site which got better overnight; little muscle soreness from the vaccine. The patient then got better and felt no other symptoms. He looked up the side effects and talked to the pharmacist. He spoke with a pharmacist, who provided the information on the reported adverse reaction of the COVID-19 vaccines and the signs of a severe allergic reaction included in the PI. He is not an allergic type person. He is familiar with those reactions and never had any trouble. He wasn't quite sure if it was related but then said it is probably somewhat related. The patient explained that he doesn't have any of the reported adverse reactions in the PI; but his experience is like the dizziness related in the signs of a severe allergic reaction in the PI, and he did feel that his heartbeat was fast. He is fine now though. The patient asked if his event is related to the vaccine and what is the impact on getting the second dose when reacting to the first. The patient was thinking that this event is a vagal reaction but delayed. He also explained that he was speaking with his colleagues, right after receiving the COVID-19 vaccine, regarding postnasal drip reaction. The patient also wondered if anxiety related to this discussion could have triggered his symptoms. Originally, he thought it was just him. But after talking to colleagues, maybe he was just a little anxious. He did not feel anxious going in. He did not need any intervention. He did not take any diphenhydramine hydrochloride (BENADRYL) or anything. He sat and rested, and it passed. He has been fine since. He needs a second dose in 3 weeks. There is not a lot of information about the side effects. It was not like he got a rash. He did not have any swelling of the tongue or throat. He just wanted to find out about if he should get the second dose. He really wanted to get the second dose. He just wanted to know if this was common or a concern and should he take the second dose. There were a lot of people getting the vaccine and this was not anything that stopped anyone from getting it. He is just trying to make sure and see how likely it was that it was related to the vaccine and how does it affect him getting the second dose. The patient was recovering from "Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine". The outcome of "Postnasal drip in throat" and "Anxiety; anxious" was unknown. The patient recovered from the other events on 30Dec2020. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Dizziness & Headache Narrative: Employee informed this RN that he "I feel like I'm going to faint and I have a headache". 0910-BP 121/73, HR 52 O2 sat 97% 0915-Employee states "I still feel faint". 0930-Eployee still states he feels faint and like he is going to pass out. Code assist called. 0935-120/76 HR-51. 0940-Employee still feeling faint, assisted to ER by ER staff via W/C for full evaluation.

Severe neck and throat pain, throat hurt when breathing. No chest pain, no shortness of breath. Lasted until about 2am. Anxious because concern about being cardiac. Next day very tired and headache.

Chills, Rigors, extreme sensation of being very cold with intense lethargy, Low grade fever 100.3degrees po. The reactivity was intense enough to be described as incapacitating for a period of approximately 10 hrs

PT received COVID #2 vaccine at 0830 to the left deltoid. Several hours after the vaccine he had arm soreness at injection site, body aches, fatigue, malaise, dizziness and lightheadedness. The symptoms persist the following day at which time pt was evaluated in th employee health clinic. Vitals normal. Neurological exam normal.

Developed fever 102.7 F; Chills; Extreme weakness; This is a spontaneous report from a contactable healthcare professional who reported for himself, a 62-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0140) at the hospital, via an unspecified route of administration in the left arm on 07Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included CVA no residual, patent foramen ovale and known allergies to iodine. Concomitant medications included apixaban (ELIQUIS) and atorvastatin (ATORVASTATIN). Patient did not receive other vaccines in four weeks. On 08Jan2021 at 06:00 AM, the patient developed fever 102.7 F, chills and extreme weakness. Treatment for the events included Tylenol, tepid bath and "cleep". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. The outcome of the events was not recovered.

Chills; body aches; Massive right axillary adenopathy (10cm); headache; This is a spontaneous report from a contactable physician reporting for himself. A 62-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in the right arm, on 07Jan2021 at 04:00 PM, at single dose, for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. Previously, on 21Dec2020 at 05:00 PM, the patient received the 1st dose of bnt162b2, intramuscular in right arm. The patient experienced chills, body aches, massive right axillary adenopathy (10cm), headache all on 08Jan2021 at 04:00 AM with outcome of recovering. The events required physician office visit. The patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.

Shaking chills onset 12 hours after the vaccine, followed by fever to 101.6, sore throat, dry cough, headache, nasal congestion, muscle aches, and fatigue at 24 hours post-injection. The fever and other symptoms subsided within 48-72 hours, however, I was unable to return to work for 4 days and continue to experience a mild headache.

Right arm numbness that radiated to right side of the neck. Weakness headache and shortness of breath, difficulty swallowing.

20-25 min post vaccine pt complains of dizziness, sweating. Patient laid down for approx 10 - 15 min and drank cola. BP taken was 160/120, which elevated but not abnormal. Pulse Rate - 67. After 10-15 min of sitting and cola dizziness improved as well as sweating. Pt. f/u @ 2pm. Feels "off". Not dizzy, but feels ok to work and drive.

Got COVID shot about 10am Friday and started to feel sick about 6pm. Tiredness, headache, muscle pain, fever, nausea. Rough night and still had symptoms all day Sat 1/23/21. By Sunday morning only headache remained, mild compared to day before. Now Monday, and still have light headache and tired.

fever 103.8, shaking chills, extreme fatigue, muscle aches, disorientation, skin extremely sensitive to touch

19th vaccinated; my wife was exposed to COVID on 26th and she developed symptoms on 29th; I developed on 31st and tested Positive on January 2 for COVID; January3, I was admitted to ER for shortness of breath, my oxygen saturation - between 88 and 94; I was in the hospital and discharged on January 8. Remdesivir and Decadron treated with and also Eliquis. I was on oxygen until Wednesday (three days) and then I went home on 8th and continued on Prednisone for last week (Friday). Haven't gone back to work - shortness of breath, fatigue and headaches continue.

Generalized muscle aches; lethargy; This is a spontaneous report from a contactable physician. A 62-year-old male patient received first (1st) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, via an unspecified route of administration in the left arm, on 18Dec2020 12:45 at a SINGLE DOSE for covid-19 immunization. Medical history included hypertension (HTN). 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 hasn't been tested for COVID-19. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HCT), amlodipine and aripiprazole (ABILIFY). On 19Dec2020, the patient experienced generalized muscle aches and lethargy. The outcome of events was not recovered. Therapeutic measures were taken as a result of events included OTC motrin and Tylenol. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

The fist day I started feeling dizzy and stomach didn't feel good. On the second day I started having problems with my vision in my left eye, I went blind for 20minutes. When I did get my Vision back I got and slight headache. About 3am in the morning, I woke up like someone hit me in the head with a hammer. After that every second or third day the pain would come back and it would be worse, it brought tears to my eyes. I started taking Tylenol but then it stopped working. it kept kept getting worse and I went to see my Dr. and she put me on some medication, but they did work and she sent me to a Neurologist and he put two medications. They seem to be working, I'm not having them as much. I'm calling tomorrow to see when my appointment is scheduled.

I got the pfizer covid vaccine on 1/18/21 my initial reactions were slight soreness at injection site and a mild headache for 2 days. I took some ibuprofen for the headache. Prior to the vaccination I have not been ill. When I woke up on Sunday morning , 6 days after my initial injection I have a swollen gland on the left side of my neck about 2 " directly below my ear lobe. The swollen gland is mildly sore. Initially i think the size was about 1.75" by 3/4 ". Now on day 4 after it first presented itself the swelling is slowly going down to about 1"x 1/2 ".

headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of fatigue and Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient receive first dose of bnt162b2 (lot number: EL3249, Pfizer), via an unspecified route of administration in right arm (shoulder) on 16Jan2021 06:30 at single dose for covid-19 immunization. Medical history included hypertension, gout, BP (blood pressure) abnormal, blood cholesterol abnormal all from an unknown date and unknown if ongoing. Concomitant medication included daily losartan for blood pressure, rosuvastatin calcium (CRESTOR) for cholesterol. The patient experienced headache, 10 hours later symptoms of fatigue and bell's palsy on 16Jan2021 16:00 about 10 hours after vaccination. Therapeutic measures were taken as a result of events. He was prescribed Prednisone 6 tabs PO (per oral) for 5 days, tapering down 1 tab daily. B12 Shot in 19Jan2021. He had an MRI (magnetic resonance imaging) appointment on 20Jan2021. His BP and cholesterol are both under control. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies. No additional vaccines administered on same date of the Pfizer suspect. The adverse event was not required a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Family Medical History included: Mother died of cancer in the early 90s. Dad died of heart failure in the early 80s. The outcome of events was not resolved.

Patient reports having his flu vaccination in November 2020 and his Pfizer COVID-19 vaccination on 12/22/2020. 10 days later he noticed bilateral leg cramps subsequently leading to numbness in his feet, weakness in his feet, numbness on side of his legs, both hands and upper back. 2 to 3 days prior to admission on 1/2/21 he has noticed right-sided facial weakness andhas noticed increasing shortness of breath on exertion. He was initially seen by PCP who suspected Guillain-Barré syndrome and had a PFT done which showed reduced tidal volume and FEV1 He was seen by neurologistand had EMG nerve conduction studies which confirmed demyelination & patient has been sent to the hospital for IVIG treatment. Per PT note from 1/30: "UE ROM: WFL UE Strength: WFL, reports grip weaker from baseline LE ROM: WFL LE Strength: proximal WFL, ankle DF/ PF 2+/3-/5             Coordination: reports no deficits with finger to nose B Sensation: numbness B hands; B feet numbness and reports weight bearing feels like standing on something squishy Balance: WFL over level surfaces, able to compensate with strength Posture: midline Other: R side facial droop, able to close R eyelid Bed Mobility: mod independent Transfers: modified independent, no device; able to perform controlled eccentric lowering stand > sit Gait Level of Assistance: Modified independent, requires aide device or extra time Assistive Device: None Distance Ambulated (ft): 10 ft Gait: pt ambulating in room without device, appears mildly unsteady with decreased heel strike with increased foot flat contact, mild increased lateral postural sway (increased with retrowalk). No frank LOB. Stairs: verbally reports has been performing stairs sineonset of symptoms, stairs are hard but able to perform, improved with UE support when available, requires increased time and fatigues quickly Endurance: neuromuscular fatigue, requires increased rest breaks" He was admitted to hospital from 1/28-2/2 for 5 treatmens of IVIG. He had improvement of his SOB and numbness but has not had full resolution of symptoms.

Patient developed a rash starting at ankles and spreading up over legs and torso, also slight cough reportedly got worse, but no wheezing or shortness of breath. Patient was given prednisone course 60mg x 2 days, 50 mg x 2 days, 40 mg x 2 days, 30 mg x 2 days, 20 mg x 2 days, 10 mg x 2 days and will follow up

Blood pressure was high; tired from the night before; Itchy; slight headache; little lightheaded; Heart racing; panic attack; Hot flashes; Sweating; Chills; achy/body aches; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer reported for himself, a 62-year-old male patient who received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration (reported as by injection) to left arm on 14Jan2021 at 3pm at single dose to prevent COVID/COVID-19 immunization. Medical history included anxiety. Concomitant medications included antidepressants. The patient received his first dose of Pfizer COVID vaccine last 14Jan2021 at 3pm, and everything went well. When he left the place, he had a slight headache. He had to stay there for 15-20 minutes to make sure he had no reaction. He just got a little lightheaded, he didn't think much, and it didn't get worse. The patient took 2 paracetamol (TYLENOL) and forgot about it. It went away for a while. He took the shot at 3 pm and he took paracetamol at 4 pm. Later that night, about 10 pm, everything kicked in. He was sick again at 10:30 pm, or so, the headache was gone for several hours. He was ok between 4 pm and 10 pm. Then about 10 to 10:30 pm, when he went to go to sleep, his heart started racing, like he was having a panic attack, then he started getting hot flashes, sweating, chills, and aching, and this went all night from like 10 pm to 11 to the next morning. He had a doctor's appointment to get his knee examined for an upcoming knee surgery. The patient clarified that he didn't go to the doctor because of the symptoms, he went for his knee. He asked the doctor, before getting examined, and the doctor said he got off easy, as the doctor himself was sick for 3 days. The patient asked the doctor if he could take something to calm down, as his blood pressure was high on 15Jan2021 at 8 am. They had taken his blood pressure to examine his knee, and the doctor said it was alright. He was prescribed with alprazolam (XANAX), and the doctor said it would be fine. The next day, he was tired from the night before. He had no symptoms the next day. After he took alprazolam, he slept fine, he felt better. The hot flashes, heart racing, body aches, and chills were gone, and he read everything as far as symptoms. The heart racing went away about 11 the next morning because he took alprazolam. The patient stated that he forgot to add one more, he had all the symptoms described as side effects, but he also had itching. He had very mild itching and was given cetirizine hydrochloride (ZYRTEC, lot number: OHE2723, expiry date: Feb2022, UPC: 4122053077), it was like 80% gone. Every now and again he has a little itch, but it was bothering him all night that first night. Currently, the patient felt pretty good. He has no symptoms other than the slight itch. He further stated that his second dose is on 04Feb2021. Out of all symptoms, the thing that freaked him out the most was the heart racing, he asked if he could take diphenhydramine hydrochloride (BENADRYL) before the shot. He has been on antidepressants for a while, he has a lot of anxiety, but the day he went in, he felt good, and didn't take alprazolam. He also asked if this have triggered all that heart racing stuff. He was seeking for information if there was anything to do to prepare him better, he knew you have to sit there for 15-20 minutes to see if there was a reaction. The outcome of the event headache and lightheadedness was recovered on 14Jan2021, unknown for blood pressure high and tiredness, recovering for itchy, and recovered on 15Jan2021 at 11 am for all other events.

woke next morning w/ temp. 100.8 fever; full body aches; left armpit swollen / sore (inj. arm); left armpit swollen / sore (inj. arm); extreme shaking last 2-3 hours; severe headache; eye ache; administration date of dose 1: 11Jan2021/ administration date of dose 2: 28Jan2021; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249 and expiration date not provided), via an unspecified route of administration left arm second dose on 28Jan2021 at single dose for Covid-19 immunization. The vaccine was administered in the hospital. The Patient's medical history included Esophageal Cancer. The patient's concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686 and expiration date not provided) via an unspecified route of administration left arm first dose on 11Jan2021 for Covid-19 immunization. On 28Jan2021 17:30, the patient experienced extreme shaking last 2-3 hours, severe headache, eye ache, full body aches, left armpit swollen/sore (injection arm). Woke next morning 29Jan2021 with temperature 100.8 fever, later evening, temperature of 99.6. Symptoms lasted almost 72 hours. The patient stayed in bed the entire time. The patient did not received treatment for the events. The outcome of the events was recovered. The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.

1. Mild lightheadedness that lasted about an hour. 2. Periodic very mild headache through the time of this report. Neither of the above have impacted my activities.

Patient had sore arm on the day of vaccination. Per patient's nephew , the next morning patient experienced body pains, aches, headache . Onn Tuesday patient had fever. Patient's condition progressively got worse. He had difficulty breathing by Wednesday night. He had low oxygen levels at 80 per pulse ox reading. Patient was coughing up blood. Family took him to hospital on Thursday morning due to breathing difficulty and patient died 2.18.21 at 10 am

severe chills. shivering at night for 2 hours. no fever, some aching and malaise. this was 4 days after shot. all previous days was fatigued alittle chilled and arm sore. taking alot of tylenol drinking alot of water. things did not get worse.

Pt felt arm soreness 4 hours later than felt fatigued, leg heaviness, arm heaviness, and then felt faint with black spots in eyes and numbness down left extremity. Symptoms are still persisting 5 days later today 2/25/21. PT did not knowingly have COVID prior.

After my vaccine, experienced Covid-19 symptoms for ten days. I was exhausted, had a small fever, had muscle aches, headaches and extreme fatigue. I was in bed for seven days. I had a Covid test performed which was negative.

Allergies; Sinus problems; Dizziness when he is up and moving around; Equilibrium is off; Fatigued; This is a spontaneous report from a contactable consumer (patient who is a transit operator). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318), via an unspecified route of administration in right arm, on 25Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing urinary incontinence (use of medication that does not make him run to the bathroom and helps him hold his urine), ongoing acne, drowsy, and ongoing flow of urine or weak bladder. The patient's concomitant medications included fesoterodine fumarate (TOVIAZ; Expiration Date: 04Dec2021) (about 2 weeks prior to getting the COVID-19 vaccine) for urinary incontinence, doxycycline (Expiration Date: 26Nov2021; makes him drowsy) for acne, and tamsulosin (Expiration Date: 12Nov2021) for flow of urine or weak bladder; all from Jan2021 and ongoing. The patient does not take any of these medications while driving. The patient took his first Pfizer COVID-19 shot on 25Jan2021 (Monday). The patient had been experiencing dizziness which started a few days after getting the vaccine (Jan2021). The patient was supposed to work from Tuesday to Friday, but he did not go into work on Wednesday. The patient was unsure of the specific day the dizziness started. The patient did have allergies (unspecified date), but when he called in his doctor, he sent him a medication for allergies, meclizine (Expiration Date: 28Jan2022). Normally, the medication takes a couple days to make him feel better. After he took meclizine for dizziness, he feels better. The patient notices the dizziness when he is up and moving around. The patient can tell something is off, like his equilibrium is off in Jan2021. It may not be due to the shot, but looking at the paper it says tiredness, which he has been feeling fatigued (also started a few days after the vaccine, but he is unsure specifically what day) and dizziness, which he has in Jan2021. The medication he is taking (meclizine), can also do the same thing, but never for this long. When he takes it, it normally makes him feel better after a few days. The patient has sinus problems as well on an unspecified date, but never lasting this long. The patient had not started feeling better since taking the medication, meclizine (as reported). The patient also said that meclizine could be causing the fatigue because it does make his drowsy and he just sleeps when he takes it - he cannot take it when he drives. The patient would go back for the second dose on 15Feb2021. The patient was recovering from "Dizziness when he is up and moving around". The outcome of "Allergies" was unknown. The patient had not recovered from the remaining events.

fever at 100.4; Headache; Nausea; Sniffles; Chills; he was beated down with sweat; body aches; does not have an appetite; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, intramuscular in the left arm, on 08Jan2021 16:30 at 0.3 mL, single for COVID-19 immunization. Medical history included ongoing high blood pressure and spinal surgery in Jan2019. Patient's eyesight was not the greatest. Patient previously received flu vaccine on an unspecified date (the last couple of years). Concomitant medication included amlodipine besilate for blood pressure. He was scheduled to get second dose on 29Jan2021. The Saturday before he was scheduled to get the second dose (23Jan2021), he started feeling sniffles and stuff. He went to urgent care and he was tested for covid and the test came back negative. He then kept feeling bad. He clarified that on 24Jan2021, he had headache and nausea. He had chills and he was beated down with sweat; body aches which are constant and he would try to blame it on the position he was laying in while on the couch and it was not that; and does not have an appetite on an unspecified day in Jan2021. He has been in really bad shape for the last 9 or 10 days. When he went to go get his second shot, they would not give it to him due to his symptoms that he was experiencing since she had a fever at 100.4 the night before (28Jan2021). They scheduled him to get his second dose the following which was this Friday. He was asking if his side effects are totally normal. He cannot even sleep, reported that he will sleep an hour and then up for two or three hours. It really has him, and he feels miserable. The outcome of events Chills, nausea and fever at 100.4 was not recovered. Outcome of sniffles was recovered in Jan 2021 while the outcome of the remaining events was unknown. Therapeutic measures were taken as a result of sniffles; he went to urgent care and they gave him something like zyrtec, states it was an allergy medication and it wiped out the sniffles for fever, he will take Tylenol and it will break the fever for a few hours and then his fever comes right back. Follow-up attempts are completed. The information on the batch/lot number has been obtained.

Broken bones; Fever 102.2; General weakness; Injection site pain; This is a spontaneous report from a contactable other health professional reported for himself. A 62-year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021 08:15 on Arm left at single dose (Lot # EL9267) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. He experienced Fever 102.2, broken bones, general weakness and injection site pain on 17Feb2021, which were non serious. Tylenol were received for the events. The patient had not been tested for COVID-19. Outcome of the events was recovered.; Sender's Comments: The event broken bones was considered as an intercurrent condition and unrelated to the use of 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.

30 minutes post vaccine pt verbalized 5/10 on pain scale headache. Rested an additional 15 minutes and claimed pain subsided.

3:57PM 'FEELS LIKE PASSING OUT'. PALE, DIAPHORETIC. STATES HE HAD RT HIP SURGERY 3 DAYS AGO. PLACED IN W/C, MOVED TO TENT (UNABLE TO LIE ON COT). COOL CLOTH APPLIED TO NECK. 4:06PM 'FEELING BETTER NOW'. COLOR IMPROVED. NO SOB, DYSPNEA OR DECREASED LOC. PINK, W/D. 4:15PM WIFE TO DRIVE PT HOME. NO ACUT/OBVIOUS DISTRESS. 3-5-214:10PM TC - STATES 'ALL S/S RESOLVED LAST NIGHT - FEELS GOOD TODAY'.

Severe flu-like syptoms: Whole body aches, fatigue, low grade fever, chills. Symtoms came on suddenly over approx 10 minute period 11 1/2 hours after injection. Took hot shower, (2) 500ml Aspirin, went to bed. Upon waking at approx 7:30am all symptoms had subsided. No further reactions occured.

Soreness at injection site now on third day. Headache within two hours of injection along with mild fatigue for several hours.

Onset of side effects approx. 10 hours after injection. Headache, Slight fever, Sweating, Tiredness. Took Tylenol for headache and fever. Tiredness persisted until the next evening ( 24 Hours).

Within 1 minute of vaccine being injected. I started to feel dizzy. I was wheeled in wheelchair to observation area. I kept feeling more dizzy and started to feel tingly in my fingers and legs (both sides equally) After 15 minute observation time was over, I tried to stand up and immediately sat down again as a wave of dizziness hit me. Doctor in observation area saw me and came over. I told him how I felt. He put his fingers to my wrist and felt my pulse. It was initially between 40 and 90, then steadied off around 90-100. He called for EMTs on duty to come over with a stretcher because he thought I should be laid flat. The EMT took my blood pressure and it was 155/94. The doctor said at one point my pulse was thready. By this point the dizziness was stronger and I felt tingly in my teeth as well as other areas. I was asked about my breathing and I said that it was okay. An ambulance was called for and arrived. I don't remember the exact time. The moved me from the wheelchair to a stretcher. I could not stand up on my own and lurched toward the stretcher. I am grateful strong people were there to get me on stretcher and strapped in. All throughout this my normally barely noticeable Atrial Fibrillation was quite apparent and more erratic. This was a major reason for ambulance call. Some of the stroke protocol was done including gripping EMT's fingers equally and following his finger with my eyes. I was very cold throughout. I was brought to the waiting ambulance outside and driven to Medical Center. The EMT took an EKG which showed atrial fibrillation and a line was put into my arm. When we got to the hospital, I was brought into the triage area and had all my vitals taken. Blood pressure was high, so was pulse then for a half hour, I was very hot and sweated a lot after being cold.

12 hours after the second Covid 19 injection I got a severe debilitating migraine with chills. The migraine was the worst I have ever had in my life. It lasted for 10 hours. I have had migraine throughout my life but nothing this severe. I took Tylenol and used cold compress on my forehead.

Patient was seen at Facility 10 minutes after his Pfizer immunization. He had wooziness, and hyperventilation with a breathing rate of 40. He was transferred by wheelchair to a stretcher. Initial Vitals: BP 128/68, O2 sat 96% on 2 liters O2, pulse 68; veteran was diaphoretic, with clear lungs. He did not recall he had an immunization, and was uncertain of his own age. He did report he was on metformin for DMII. 911 was called. He was transported to Hospital ER by EMTs.

Day 1 (evening): soreness in arm radiating to back and neck, accompanied by waves of light nausea, resolved itself after about two hours. Low-grade headache continued to bedtime w/no appetite. Day 2: Low grade headache and lightheadedness. Light nausea only after eating. Resolved by dinner. Day 3: Some lingering fatigue, but symptoms mostly resolved.

he was excited and/or anxious about getting vax after having Covid in November. vax dose approx 305 pm, by 310 he reported feeling weak with rapid pulse and heart fluttering. Gave water to drink, he declined food. 315 he felt hot sweaty and took off his overcoat. 325 said he felt better after drinking the water and declined to have his bp or pulse checked. Follow up phone call 3/14 to check on condition, said he felt ok after leaving pharmacy and has no allergies, no current illnesses and no vaccines within past month.

Fevers, 101.9, body aches, cough, difficulty breathing. Still using Tylenol, vicks formula 44, albuterol, fluticasone propionate nasal spray.

Several minutes after vaccine administration, patient was flushed and diaphoretic. No shortness of breath, No chest pain. No dizziness. Has history or DM and HTN. Denied nausea. PCP had changed his DM medication and he took the new prescription this morning. Felt better after 22 minutes and discharged home.

03/07/21: Onset of dyspnea upon exertion 03/09/21: Worsening dyspnea and non-productive cough 03/11/21: Primary care visit for diagnosis/tests 03/12/21: Elevated BNP levels noted; chest X-ray 03/13/21: Further worsening of dyspnea 03/15/21: D Dimer test elevated (positive) 03/15/21: ED visit; CTA scan indicates pulmonary emboli (lots of clots); admitted to hospital; Heparin IV drip 03/16/21: (evening) Discharge on Eliquis 03/17/21: Moderately severe dyspnea upon exertion and non-productive cough continues Event: Pulmonary emboli

Had body aches, cold chills, thought processing was slow and some what scattered, eyes were dilated slightly, loud noises were painful

I've been running a fever for almost 4 weeks now. I have to continually take Advil. My liver enzymes are high. Tiredness and fatigue. At times I have an upset stomach. I have been checked for Covid 3 times and each time is negative. I went to the emergency room on March 15. I was given fluids and an antibiotic through the IV. I have been to the Dr. multiple times. They have checked me from head to toe and are puzzled. This all started the day after I got the first shot.

Difficulty breathing, throat swelling (feels like it is) dizziness and weakness, nausea, feeling unwell, fever headache, tiredness and injection site pain

Second COVID vaccine received 01/06/21. Within 24 hours developed fever, chills, malaise, myalgia, nausea, vomiting, diarrhea. Duration 8 hours, clinical dehydration, missed one night ED shift(HCP). 5 days post vaccine, 01/11/21 developed neck and chest pain, progressed requiring ED visit 01/12/21. Cardiology consult, negative cardiac evaluation. Persistent intermittent chest pains, usually exertional and post-exertional. 02/05/21 developed atrial fibrillation with rapid ventricular response with unsuccessful cardioversions, small pericardial effusion by echo. 03/11/21 readmission for enlarged pericardial effusion and pericardiocentesis. Continue high dose aspirin, colchicine, metoprolol, flecanide. Have not returned to work.

DECEDENT WAS NOTED TO BE COUGHING FOLLOWING THE ADMINISTERING OF THE VACCINE. FAMILY INTERVIEWED COULD NOT RECALL WHETHER THE DECEDENT WAS COUGHING PRIOR TO RECEIVING THE VACCINE.

Extreme headache beginning 2 days after vaccine was administered. Accompanied by chills and tiredness, and blurred vision. Today is the 6th day after the vaccine was administered and still have extreme fatigue and moderate headache.

1055: Patient in 15 minute observation called for medical with c/o dizziness and diaphoretic. Patient taken to first aid station for further assessment by Physician and EMS on Duty.

Ringing in the ears, headaches, throat hurts when I breath in (swollen glands), shortness of breath, fevers, sweats, chills, jaw pain, sore body

itching nose and had some swelling/welts nose that he could not see but he could feel. Itchy inflamed and swollen left arm distally 3 days after vaccine had some swelling and itching more proximally on left arm 4 days after had itching and welt right side of jaw. No shortness of breath No tingling of lips or tongue No fevers.

Headache; Muscle and body aches; Muscle and body aches; This is a spontaneous report received from contactable consumer, the patient. A 62-year-old adult male received the second dose of BNT162b2 (solution for injection; Lot EL3247expiry not provided) as a single dose via unspecified route in the left arm on 19Feb2021 at 12:00 (at 62-years-old) for COVID-19 immunisation. The patient reported no medical history and denied any allergies to medications, foods or other products. There were no concomitant medications reported. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (lot EL3247) in the left arm on 29Jan2021 at 12:30 (at 62-years-old). The patient denied receiving any other vaccination within four weeks prior to the COVID vaccine. The patient also denied being diagnosed with COVID prior to the vaccination. On 21Feb2021 at 08:00 the patient began to experience headache and muscle and body aches. The patient denied being tested for COVID since being vaccinated. There was no treatment received. The outcome of the events, headache and muscle and body aches was recovered on an unspecified date in Feb2021.

Severe headache, fatigue, very sleepy about two hours after injection. Woke about 1:00 a.m. with severe headache. Gave two Tylenol and cold wash cloth for forehead. Started tossing and turning about five minutes later. Sat up in bed, fell over and struck bedside table. EMT said he suffered stroke around 1:30 am. He passed away on the 5th.

Per report from patient's daughter: Patient received 1st dose of Pfizer around 4:30 pm on 2/7/21. Around 4 am the next morning, 2/8/21, he woke up and didn't feel good. Around 12 pm on 2/8/21 he reported feeling "weak" especially on one side of his body. His daughter said she took him to the hospital around 9:30 pm that night, after he continued to feel unwell throughout the day. At Hospital he was diagnosed as having had a stroke. He was admitted to the hospital and kept for observation for 2 days. When his daughter reached out to the patient's PCP to ask if he should get the 2nd Pfizer dose, she was told he should wait at least 3 months and advised to report his stroke to the public health department.

Fever to 102. Chills. Full body aches, headache. Unable to sleep. Resting heart rate was about 20 beats higher than normal. Mild tinnitus got louder. At 24 hours from shot fever has reduced to 100.

Mild dull headache began about 18 hours post-vax. Unresponsive to OTC pain relief. About 5 hours later, there was an episode of chills, accompanied by severe shaking. Face and neck became very warm and flushed. After about an hour, the episode ended, and even the long-lasting headache felt better. Have not had any adverse effects that were not known to be occurring in some after the 2nd Pfizer vax.

15 hours after vaccination had chills, fever 0f 100 F. 16 hours post vac. had nausea and vomiting (dry heaving) for 6 hours.

Pt developed high fever and rigors 45 minutes after receiving 1st dose of Pfizer COVID vaccine. Presented to ED where he was found to have fever to 101.3, tachycardia, tachypnea, leukocytosis to 25, and lactate 6, meeting SIRS criteria. Pt was admitted and started on Zosyn, but infectious w/u completely unremarkable (neg BCx, unremarkable CXR, normal UA, normal abdominal imaging, no elevated LFTs given h/o cholangitis). He was observed for 24h off of Zosyn and did not develop any further hemodynamic instability or recurrent fevers and rigors. His WBC improved daily 25 -- > 11.5 -- > 7.1 and lactate cleared on night of admission with fluid resuscitation.

A few minutes after receiving the vaccine felt tongue "thickness" but only lasted about a minute. Then about 4 hrs later felt headache, dry throat and sore arm. At about 7 hrs after injection noticed pain in the left wrist, same side as vaccine. Went to bed and all symtoms were resolved this morning except sore arm.

5pm Saturday 3/27 to 8pm Sunday 3/28. Debilitating chills, sweats, aches pains, urinary issues/bladder or prostate

low grade fever (100); general malaise; This is a spontaneous report from a non-contactable consumer (patient). This 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3248) via an unspecified route of administration in the left arm on 19Feb2021 at 13:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Feb2021 the patient experienced a low-grade fever (100) and general malaise. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. Lab tests included body temperature of 100. The clinical outcomes of low-grade fever (100) and general malaise were unknown. It was also reported the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are possible. No further information is expected.

Temperature of 105.7; This is a spontaneous report from a contactable consumer. This 62-year-old male consumer (patient) reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL9267) via an unspecified route of administration from 12Feb2021 at 02:00 pm to 12Feb2021 at 02:00 pm at single dose (dose number; 1) on left arm for covid-19 immunisation (Facility type vaccine: other). Patient was 62 years old at the time of vaccination. Patient's medical history included diabetes, coronary artery disease, kidney disease and covid-19 (If covid prior vaccination: Yes), known allergies: no true allergies, only unwanted side effects of certain medications (unspecified dates). Patient's concomitant medications were not reported (If other vaccine in four weeks; No, other medications in two weeks; Yes). Patient experienced temperature of 105.7 on 13Feb2021 at 06:00 pm. Treatment received was reported as yes (medication unspecified) for the adverse event. Adverse event did not result in emergency room or physician's office visit. Covid was not tested post vaccination. The outcome of event was recovered on an unknown date in Feb2021.

1. First shot, no adverse effect. 2. After the second shot I developed chills, aches and a very slight fever within four to five hours of the shot. Later that night I noticed a decided lack of energy and some arm soreness at the shot site when I touched it. The chills and fever subsided after about two to three hours, but the rest of the symptoms continued until I fell asleep around midnight, which was about 12 hours after getting the shot. The aches, arm soreness and weakness all lasted for about a week afterwards, with the weakness being the last thing to go.

Chills and fever started approximately 12 hours after injection, at 3:00 a.m. on morning of 3/30, followed by a very bad headache and body aches. At around 1:00 a.m. on 3/31, nausea and vomiting began, and continued throughout the day into the evening, anytime food or liquids were injested. Headache and body aches continued.

I began shaking violently and severe cold chills. I began hallucinating and felt like I was turning inside out. I blacked out and woke 2 hours later with severe flu like pain in my entire body and a severe headache. I do not do drugs and I had no alcohol in the 3 days before I wa vaccinated. It is now 47 hours after the vaccination and I have moderate flu like symptoms.

PT (DOB 12/14/1958) received the COVID vaccine (Pfizer dose 1, Lot# EW0150, exp 7/31/2021) at 1525. The client reported feeling dizzy and lightheaded, and his caregiver reported that he was "red and sweaty". EMT alerted the RNs and responded to the client. Upon observation, the EMT observed that the client appeared flushed and diaphoretic. The client was accompanied by his caregiver who reported that the client has a medical history of hypertension, orthostatic hypotension, intellectual disability, schizophrenia, diabetes mellitus 2, and bell's palsy. The client has no allergies and takes the following medications: metformin, lipitor. clozapam, metoprolol, cogentin, iron, prostigmine, and farxiga. At 1530, the EMT obtained a blood pressure of 180/118, with a heart rate of 116, respiratory rate of 22, temperature of 99.1 F and pulse oximeter reading of 94%. At 1536, the client's blood pressure was 172/118, with a heart rate of 116, respiratory rate of 20, and pulse oximeter reading of 95%. At this time, the client stated that he was dizzy and feeling anxious. The client reported that he was feeling dizzy before he was vaccinated but that he "forgot" to tell his caregiver. His caregiver reported that the client had not yet eaten or had anything to drink that day. The client was offered and accepted water. The client and his caregiver deferred Benadryl. Repeat vital signs were obtained at 1542: blood pressure of 166/112, heart rate of 116, respiratory rate of 24, temperature of 99.1 F, and a pulse oximeter reading of 95%. The client practiced deep breathing, denied any difficulty breathing, itching or swelling. At 1550, the client reported no longer feeling anxious or dizzy. At this time, the client's color was improved, he no longer was diaphoretic, and he stated "I'm pretty hungry now." Repeat vital signs were as follows: 156/115, heart rate 108, respiratory rate 20, and pulse oximeter reading of 95%. Client left the facility at 1600 after waiting the recommended 30 minutes from initial symptoms, with symptoms resolved at that time. The client ambulated to his car with a steady gait, escorted by the EMT and his caregiver, and his caregiver drove him home.

Bell's Palsy; stroke; Minor injection site soreness; Extreme sleepiness (2 days); This is a spontaneous report received from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206), first dose via an unspecified route of administration, administered in right arm on 05Mar2021 07:30 as single dose for covid-19 immunisation. Medical history included high blood pressure (HBP) hypertension, Transient ischaemic attack (TIA) twice, pre-diabetic. Known allergies was none. Concomitant medications received within 2 weeks of vaccination included metformin, atorvastatin, losartan, amlodipine, Aspirin (acetylsalicylic acid). The most recent COVID-19 vaccine was administered at work location. 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 experienced bell's palsy (17 days after vaccination - confirmed via ER visit vice stroke) and stroke (seriousness crietria was medically significant), minor injection site soreness (2days) and extreme sleepiness (2 days); all events on 22Mar2021 17:30. The adverse event result in emergency room/department or urgent care. Treatment was received for all adverse events including Steroid/anti-viral medication 7 days by neurologist. The event outcome for all events was not recovered. Follow-up attempts are needed. Information on batch/lot number was available.

Stiff arm, shoulder and neck. Sore arm, shoulder and neck. Severe chills. Couldn?t turn my head to the left and couldn?t raise my arm. Had both shots in the left arm. Still have slight pain in those areas.

Headache first day, headache & fatigue second day, headache, severe fatigue, muscle aches, nausea and diarrhea third day, fatigue and slight headaches Fourth day, mild fatigue fifth day.

This is a spontaneous report from a contactable consumer. A 62-year-old male consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3302, Expiration date: unknown) via an unspecified route of administration in left arm on 26Jan2021 at 14:30 at single dose for COVID-19 Immunization. The patient medical history and family history were none. No prior vaccinations within 4 Weeks. Current condition included, hypochondriac. History Of All Previous Immunizations was Not provided. Additional Vaccines Administered On Same Date Of Pfizer Suspect was reported as no. Concomitant conditions were not reported. On 27Jan2021 patient experienced sore arm, "more pronounced than normal flu shot" On 28Jan2021 patient experienced the events, "nose starting dripping/running", "eyes dry", "dry hacking cough". "sinuses swollen a little bit" the patient said that symptoms were similar to "cold symptoms" and still experiencing nasal drainage and "tickle in throat", "eyes dried out", Paranasal sinus discomfort. Nose dripping stopped after about a week and turned more into sinus pressure. Patient underwent lab test Swab COVID test on 01feb2021, results negative on 02Feb2021. No other testing since the COVID-19 Vaccine. His eyes are dried out and it feels like a cold that progresses into different stages. Arm soreness: lasted two day. More pronounced than flu shots he's received. Lasted through 28Jan2021. Tickle in throat with cough: Has a little tiny bit of irritation still. Not a constant cough. Is talking now and feels like he wants to cough, but doesn't. Nose is not dripping as much. Never been totally stopped up. Feels pressure underneath eyes. Adverse Events did not require Require A Visit To: no, it is just mild, but weird. Relevant Tests included Swab COVID test on 01Feb2021. Negative results came back on 02Feb2021. No other testing since the COVID-19 Vaccine. The patient did not received any treatment for these symptoms. Product Complaint was Yes. Not provided, if a sample of the product available to be returned. No information provided whether product Packaging sealed and intact. Outcome for all events were reported as unknown. No follow-up attempts are possible. No further information is expected.

8 hours after vaccine terrible chills, and cold, stomach ache 12 hours after vaccine had 104.7 temp. 24 hours still was dealing with 104.7 temp - showers and cold compress with tylenol would bring it down, but would spike back up 36 hours temp of 101

Fever and chills 36-48 hours after the second vaccination. Sore arm, sore muscles and fatigue 6 days later.

Headache, metallic taste, tingling of tongue. BPs 148/88 (pulse 62), O2 sat 100%. BP 139/84 (pulse 64), O2 sat 100%. Benadryl 25 mg PO. Final BP 134/83 (pulse 55).

After 17 hours: Uncontrollable chills, though temperature was only slightly elevated at 99 degrees. Malaise lasted 10 hours. Pain at arm lasted 40 hours. Slight pain with pressure continues now. (about 60 hours)

bulging eyes; Mild allergic reaction; metallic taste in mouth; pounding headache; red ears; face/neck rash; fatigue; dizzy.; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on 23Mar2021 12:00 (Batch/Lot number was not reported), at the age of 62-years at vaccination, as SINGLE DOSE for COVID-19 immunization. Medical history included enlarged aorta, high blood pressure, asthma, eggs and corn allergy. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported; budesonide (PULMICORT) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin, ferrous sulfate, folic acid, serine (RESCUE) taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 12:00, the patient experienced mild allergic reaction, started with metallic taste in mouth and pounding headache before leaving (pharmacy name withheld) after 15 min wait period, red ears, face/neck rash, "bulging eyes". No respiratory issues. Subsided after <1 hour but still feeling fatigue and dizzy. The patient also had sore arm. Still thrilled to get it. The outcome of the events was recovering. No treatment was received for the events. Information on the lot/batch number has been requested.

'blood pressure had been up to 180/increase in blood pressure'; he was freezing; he was cold; ''he is usually up at work every day and he hasn't been able to work the last few days''; feels like he can't think'', ''tired; ''he may be getting in for breathing treatments today''; so sick; feels like he can't think'', ''tired; Feeling lousy; Lethargic; Running temperature; Chills; Hives; Anaphylaxis; fell asleep for 16 hours. Caller reported that he doesn't normally sleep for 16 hours; Throat scratching; Eye itching; Bags under eyes; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number: EN6207), via unspecified route of administration on right arm on 19Mar2021 13:09 as a single dose, for COVID-19 immunization. The patient medical history included Ongoing COPD (about 5 years ago), high blood pressure (about 10 years ago and still ongoing) extensive allergies to food and insect bites. The patient was diagnosed with the allergies when he was a little kid, allergic to penicillin ongoing. Concomitant medications included lisinopril at 20 mg once daily in the morning for high blood pressure and albuterol at 2 pumps in AM and 2 in PM before going to bed for COPD (Chronic obstructive pulmonary disease). The patient previously took historical vaccine ampicillin for infection. On 19Mar2021, the patient experienced, ended up feeling really sick right after the shot. He has a lot of allergies and he was advised to take his Epi-Pen kit and stay an additional 30 minutes past the recommended waiting time after receiving his vaccine. His throat began scratching after getting the shot and lasted for about 3 to 4 hours for which the patient received Benadryl and resolved completely. His eyes were itching and lasted for 24 hours, and bags started to form under his eyes like anaphylactic shock. It was reported that the bags under his eyes would normally stay after anaphylaxis for a day or two. His eyes were still a little puffy at the bottom. He did not saw a rash but started to get hives, the paramedics were called and monitored him for another 30 minutes. The paramedics administered a shot of Benadryl. After the Benadryl was administered, his body and blood pressure started to come down. The paramedics reported that his blood pressure had been up to 180. It was reported that on 19Mar2021, afternoon, when the patient got home, he was sick, laid down and fell asleep for 16 hours. He does not normally sleep for 16 hours. He was unsure if his eyes were itchy in his sleep. Later in the call it was clarified that this might have only lasted 3-4 hours, he was so tired he just went to sleep. It was reported that he was not a sleeper, that he was usually up at work every day and he had not been able to work the last few days. It was reported that he started feeling the side effects of the Covid-19 vaccine at 13:20 on 19Mar2021. On 20Mar2021, he felt lousy ever since he received the COVID-19 vaccine. On the same day, his wife took his temperature, and his temperature was hovering around 100-100.9. He felt lethargic, running a temperature between 100.5 and 100.9 pretty consistent every day. On an unspecified date, his wife took his temperature, and it was 99.9. He felt like his mind was in a fog, intoxicated and he had not felt good since receiving the first dose of the Covid-19 vaccine. It was reported that the mental fog made him felt like he cannot think. The paramedics gave him a test and asked him to add 5+7. The patient answered 14, even though he knew that the answer is 12because he could not think, and he felt punch drunk. He reported that he can concentrate a little more, but he still felt drunk, this was hanging around the same now. It was reported that the paramedics were asking him questions and gave him things to do, addition and subtraction formulas, to keep his mind. He could not finish those formulas and that he told the paramedics that he felt foggy or punch drunk. He spoke with his health care provider at the VA and the provider advised him not to get the second dose of the Covid-19 vaccine. It was reported that the patient was inquired if he had any immunity to Covid-19 without taking the second shot and if he was protected with just the one dose of the Covid-19 vaccine. It was also reported that, the reporter also looked through the list of side effects for Covid-19 vaccine and it was like patient had all of them. The patient experienced chills, he was freezing, and he was cold. The patient had the whole list of them. It reported that he had doctor appointment on Monday, 29Mar2021, and that he may be getting in for breathing treatments today. He was waiting for his insurance to finalize the approval for the breathing treatments in the evening. The outcome of the events throat scratching and eye itching was recovered on 19Mar2021, Outcome of the events bags under eyes and blood pressure had been up to 180/increase in blood pressure were recovering. The outcome of the events feeling lousy, lethargic, running temperature and chills were not recovered. Outcome of the other events was unknown. Information on the lot/batch number has been requested. Information on the lot/batch number has been requested.

mental fog for all the following day; Chills; first dose on 16Feb2021/second dose on 21Feb2021; first dose on 16Feb2021/second dose on 21Feb2021; This is a spontaneous report from a contactable Other HCP reported for self. A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose in Left arm on 21Feb2021 12:30 PM (lot number: EN6198) for COVID-19 immunisation. There was no other vaccine in four weeks, no other medications in two weeks. The patient's medical history included known allergies: penicillium and sulfa. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (lot number: En5318) in Left arm on 16Feb2021 10:00 AM for COVID-19 immunisation. The patient experienced chills and mental fog on 22Feb2021 and for all the following day, no treatment received for the events. No COVID tested post vaccination. Outcome of the events chills and mental fog was not recovered.

approximately 10 days post vaccine shot, onset of headaches and tiredness for two days. On the 12th day, I ended up with facial droop and being rushed to the emergency room. Ct. scan and subsequent mri ruled out a stroke and diagnosis after spending two days at hospital was Bells Palsey.

Patient seen at the Vaccination Center on 4/9/2021. He had just received his first dose of COVID-19 vaccine. He was feeling dizzy and felt like he was going to pass out. He was transported by EMT to the Adverse Reaction Area and then moved. Representative served as sign language interpreter via tablet. His wife was also present and is deaf. Patient stated that his heart rate was very slow, and he felt dizzy, hot, and sweating. He also fel very weak and it appeared that was going to pass out. He was also shaking. Ambulance was called due to the above symptoms. Patient also stated that he thought he may need to go to the ER. Vital signs: 9:53 am: Blood pressure was 143/71, heart rate was 71. Patient was given an ice pack. He also took sips of water. He then noted that he felt better, after laying down. Ambulance crew arrived and he declined to go the ER. He got up and walked around stated the he felt better. He notes that his head feels like it's slightly buzzing, so he lay down again. Vitals signs: 10:25 am: Blood pressure 138/63, heart rate is 64, temperature is 98.1 Patient felt better and noted no more buzzing in his head. He also walked around and felt normal. Patient notes that he blacked out as a child whenever he got shots/injections. He was not surprised that this happened to him today. He wanted to know whether he should get the second vaccine injection. It is recommended that he get his second vaccine injection and we also discussed that he may have the same reaction as today. He should allow for extra time and be well-hydrated. He felt safe to go home and his wife would be driving him home. Should he feel worse, then he should go to the ER. The patient and his wife understand this. All questions were answered.

20-30 min post vaccine developed extreme mucous production and uncontrollable cough; 02 sat 98%; MD administered benadryl and decadron; EMS called to transport patient to ED; patient discharged home after ED visit; no issues reported from patient after follow-up call from MD

Swollen uvula, sore throat, fatigue and chills. I have experienced a swollen uvula about 20 years ago as an allergic reaction after eating a nut.

can't hear out of the left side; coughing fit then pukes his guts up; coughing fit then pukes his guts up; chest feels like there are 10 people sitting on it; can't hear out of the left side and the left side is still ringing; head clogged up/ head is still plugged; almost like he had the flu; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 24Mar2021 08:51 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications includes unspecified medications. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EIV6200) first dose via an unspecified route of administration, administered in Left arm on 03Mar2021 for COVID-19 immunization. On 24Mar2021, about an hour after he had the shot, the patient had some wicked side effects. It was like his head clogged up, his chest got heavy, almost like he had the flu, and now the left side of his head, he can't hear nothing out of it, it's just ringing. The patient has a hard time hearing anyway and now he has this other ear thing. He said that one side is plugged and the other side can't hear that great. Head clogged up: Caller states an hour after he had the shot, then he goes into a coughing fit, cough, cough, cough, then he pukes his guts up, then he's fine for half an hour and then he goes back into a coughing fit until he pukes his guts up again. Caller said that this is killing him. He said that his head is still plugged, his chest feels like there are 10 people sitting on it, and he can't hear out of the left side and the left side is still ringing and is like he had his bell rung playing football or something. The patient can't hear nothing out of it, it's just ringing. The patient rolled over on his right ear, power must have gone off because he couldn't hear the fan anymore, then rolled over on other ear and power must have come back on because he could hear it. The ringing didn't start until last night when he was sleeping. Stated he woke up and his ear was ringing. The patient knows it'll go away sooner or later, it's just the ringing The outcome of the event Head discomfort was not recovered. The outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.

Delirious fever; temperature was high enough to where he got delirious; Headache; Muscle aches; he was just tired a little early; Swollen joints, possibly hands, knuckles, arms, shoulders; This is a spontaneous report from a contactable consumer. A 62 years old male consumer reported that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8733), via an unspecified route of administration, on 26Mar2021 at 12:00 in Arm Left (at the age of 62-years-old) as single dose for covid-19 immunisation. The first dose of bnt162b2 was received on 05Mar2021 (Lot: EN6205). Medical history included diabetes mellitus, hypertension from, gastrooesophageal reflux disease from 1977, sleep apnoea syndrome from 2000, pain from 2017, blood cholesterol increased from 2013, vitamin D deficiency from 2013, depression from 2000. Concomitant medications included glipizide for diabetes mellitus; lisinopril started about 1982 or 1983 for high blood pressure; metformin hcl for diabetes mellitus; terazosin hydrochloride from 1987 prescribed for Benign hyperplasia of prostate (BPH) but it turned out to be something else, but he still takes this medication because it helps with his urination; famotidine for acid reflux; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for narcolepsy; oxycodone for pain from 2017; VITAMIN B12 for vitamin deficiency from 2016; calcium citrate from 2019 for blood in his urine; fish oil for blood cholesterol from 2013; colecalciferol (VITAMIN D3) from 2013; ketamine hcl for depression, and CANNABIS he used it recreationally and probably medicinally too because it helps him sleep. He is not a daytime stoner, he just uses it at night to relax and go to sleep. He started about 2009, when he got a medical card. Caller reported had his vaccine shot at noon on 26Mar2021. He stated he felt fine, he was just tired a little early and went to bed at 10. He woke up at midnight with a headache and a delirious fever. He didn't test his temperature or anything but it was high enough to where he got delirious, but he doesn't know how high that was. He took Tylenol 2500mg capsules which helped with the headache and not the fever, so 4 hours later, he took Ibuprofen 800 mg which seemed to helped with the fever. He stated the headache is gone. Caller stated delirious feverish was gone but then clarifies he doesn't know if he has recovered completely actually, it feels like he has, but these things are funny sometimes. Caller reported muscle aches started around midnight on 26Mar2021, and were gone by 27Mar2021. Further Caller reported he had swollen joints- his hands, knuckles. He adds his arms and shoulders, but he doesn't know if that was from laying on them all night for as long as he did because he slept all the next day, too. The swollen joints seems to be resolved at this point. He clarifies all the symptoms started around midnight on 26Mar2021, about 12 hours after the shot. He confirms that he did not have swollen lymph nodes. No follow-up attempts are needed. No further information is expected.

A day after covid vacine shot 7:00 am 4/9/21 ,I developed shortness of breath and fatigue. Then I developed a fever of 99.1 at 3:00pm that afternoon and O2 saturation was at 92 percent on 4/9/21. Saturday evening at 5:30pm I developed a fever of 99.4 and sereve fatigue and 89 O2 saturation level. Later that night at 9:00 pm on 4/9/21 my fever rose to 100.7 and O2 dropped to 85 when I tried to fall asleep. I took two puffs of an inhaler, two extra strength Tylenol and one Allegra D 12 hour tablet at 10pm. My fever broke at 1am on 4/10/21 and at 2am 4/10/21 my O2 stabilized at 92 percent saturation.

Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. He developed lower abdominal pain, diarrhea, nausea, chills and vomiting on ~ 4/9/21 . Patient presented to the ER on 4/11/21 and tested positive for COVID. Patient was admitted to the hospital for observation due to severe nausea and inability to take PO. COVID treatment was not started upon admission due to lack of respiratory symptoms.

Pt presented with substernal chest pain and diaphoresis which started last night. Past medical history of previous MI with stents in place. Allergies - Penicillin. He was placed on stretcher and taken to EMS room for further evaluation. PT states the pressure is a 4/10 non-radiating and made worse when he moves around. PT also stated he started a new blood pressure medication three days ago. First set of vitals were at 13:15hours - HR 84 SPO2 95% BP 192/109 12-lead obtained - normal sinus rhythm Vitals reassessed at 13:20 hours - HR 89 SPO2 94% BP 154/124 Pt states he is still having the substernal chest pain. Upon evaluation pt is hypertensive and given past medical cardiac history 911 was activated for chest pain transport 20G IV was established in left AC Rescue arrived and pt care was transferred over to Rescue Personnel Pt received second dose of Pfizer today.

Patient started having decreased urine output, painful urination, and dark brown urine 5 days after receiving his first Pfizer COVID vaccine. These symptoms were accompanied by migraine and nausea. UA on 4/13 consistent with a UTI and started on Bactrim. On 4/14 he started having chills and weakness with kidney pain on the left side. CT abdomen and pelvis on 4/14 showed a left kidney calyceal diverticula with calcification in the superior pole that could have been a nidus for infection with symptoms showing 5 days after COVID vaccine. Increased suspicion for pyelonephritis and antibiotic changed to Macrobid. After a few days of increased hydration and antibiotics, urinary symptoms improved. Will continue monitoring kidney infection. Still had flu-like symptoms as of 4/15. Heart rate was first recorded on 4/13 at 113 and again on 4/16 at 111. Patient stated it had been elevated all week. Left lower lobe had decreased breath sounds. Working up for possible PE.

On 04/09/2021, day after 2nd Pfizer vaccine, woke up with stuffy head/chills. As day progressed towards work, changed to loss of hearing in right ear with phase shifting and ringing. Very disorienting and dangerous to work in busy kitchen. Made through weekend now little to no hearing in right ear with whirring, roaring, chirping. Saw Dr on 04/13 and started treatment for ear infection. Steroids and nasal spray for 3 days to no relief. Started antibiotics on 04/15. As of now at 10:36am on 04/16 no let up in all symptoms!

My Dad was healthy no symptoms on first shot . On Second shoot just slight pain in arm , he felt sick on Sunday the 4 of April at around 7pm he had a upset stomach. He got worse at night. in the morning Monday the 5 April we decided it was time to take him to the hospital. Due to the covid 19 restriction we were not able to go in with him He was stable until 1 pm when he suffered 4 heart attacks . He Died . He was healthy he exercise and was active every day . We were told to report this because it was close to dates of vaccination.

Woke up next morning, 04/09, after receiving 2nd dose of Pfizer vaccine. Started as feeling like a head cold. Some chills etc. by the time I went to work right side hearing was severely affected with what sounded like phase shifter in my head. No relief through weekend, too dangerous to work due to my job in a busy kitchen. Saw my Dr. on Tuesday 04/13. Treated as an ear infection. 3 day steroid with nasal spray. No relief. By now the ringing, whooshing, roaring and chirping in my right side are extremely disorienting! Started antibiotics on 04/15 with wait and see effectiveness. Today is 04/16 at 10:15am. To date no relief of symptoms.

Started afternoon of Apr 16. 100.2 F fever, chills, aches in joints, tiredness, really sore left arm at injection site. Most symptoms gone by afternoon Apr 17.

Sore arm later in day of injection; Slight fever; Slight fatigue; This is a spontaneous report from a contactable consumer(patient).This 62-year old male consumer(patient) reported for himself that: A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6199), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 09:45 as SINGLE DOSE, via an unspecified route of administration, administered in Arm Left on an unspecified date as an unspecified dose for covid-19 immunisation. Medical history included hypertension hypertension controlled with lisinopril, Allergic to penicillin. Concomitant medications included lisinopril taken for hypertension, the patient experienced sore arm later in day of injection, slight fever, slight fatigue on 30Mar2021 and The events were assessed as serious (medically significant) by health authority.outcome of the events was recovered. No follow-up attempts are needed. No further information is expected.

Herpes simplex outbreak on lower lip and filtrum, plus low grade fever continuing even after 6 days. Wife also got herpes simplex outbreak on her knee after taking second Pfizer shot.

My husband developed severe COVID symptoms, despite testing negative for COVID via pcr tests on Sunday 3/21 /21 and Tuesday 3/23. He was hospitalized on 3/28 due to low blood oxygen levels. Was diagnosed with COVID and pneumonia. Treated with remdesivir and a steroid, then monoclonal antibodies. Despite making progress to the extent doctors were cautiously optimistic on 4/9/21 he would be discharged on 4/16/21, he instead was transferred to ICU on 4/10/21, placed on a ventilator on 4/11/21 and died on 4/15/21.

Ringing in ears started about 30 hrs after 2nd dose Pfizer Covid-19 vaccine. Also had slight fever, chills, nausea but they stopped by next day. Ringing in ears subsided for a few days but has now gotten pronounced all the time.

Received Pfizer COVID-19 vaccines on 12/21/2020 and 1/13/2021. On 4/17/2021 developed cough and congestion. Tested positive for COVID.

Lymph node swelling in Right Shoulder and axillary regions including edema and increased skin temperature/redness extending from axilla into Right pectoral region with pain/discomfort also. Performed gentle lymph drainage massage to Right trunk/shoulder regions and added Lymph Tone II homeopathic drops 3 times daily, with resulting dissipation of fluid in the pec region and decreased soreness.

Approximately, 1 minute after receiving his first dose of the Pfizer Vaccine the patient was noted to be slipping out of his chair. One of the staff members tried to help the patient to the floor but did not make in enough time to break the fall. The patient lost all consciousness and hit the back of his head on the floor. He awoke after about 5-10 seconds and was A&O x 4. EMS arrived at about that time. The patient continued to c/o dizziness and was notably pale. After a few minutes he was able to sit up. But then began to feel like he would pass out again. Patient was laid back and feet propped up on floor and then placed on heart monitor. VS were WNL. Rate and rhythm were also WNL. Patient was still pale, diaphoretic, and dizzy. He was then placed on gurney and brought to EMS station for further eval. When he was transferred the patient then began to vomit. EMS Continued care and then transffered to local hospital. Please see their notes.

Pfizer- BioNTech Covid-19 Vaccine EUA 4/21/2021 - 9:15 am received vaccine and drove home - felt great 11:45 - walked around Mall 36 minutes - felt great 5:00 pm - walked outside for 41 minutes - felt great 7:00 pm - ran 3/4 mile and walked 2 miles 8:00 pm - finished running and nose started running like crazy and kept running until now, 4/22, (17 hours). I believe that the vaccine has affected my sensitivity to pollen and I am having the first allergic reaction that I have ever had in 62 years. I have been walking outside each day of the last week. It has been sunny and dry here with high pollen alerts each day. I have had no reactions to pollen for 62 years, until 11 hours after I had my coronavirus vaccine, yesterday.

Pain in lower abdomen closest to penis. Extreme urgency and frequency (every 15 minutes) in urination. No actual pain during the act of urination. It's almost like there was a blockage. Flow was very weak with lots of dripping. Only lasted for 24 hours (thankfully). Not that this is germane probably but I am Type O+. I did have Covid with 11 days of symptoms March 17-28 2020. Lastly, in this episode I did also experience fever, chills, fatigue, and body aches, and I know those are known AE's

Chills began at 11:00 pm, followed by fever, headache and body aches. this continued for over 48 hours. I could not eat and it was difficult to drink anything.

Received Pfizer COVID vaccine dose #2 on 1/13/2021. on 4/17/2021 developed cough and nasal congestion. Tested positive for COVID.

March 15th COVID shot. March 16th started to get severe dizziness and fatigue. Went to bed early. March 17th speech was impaired and difficulty with gait and balance. Admitted to MAMC ER, which confirmed a stroke and released. March 18th early AM admitted again to ER due to unable to move/walk. Due to lacking proper equipment and space was transferred via ambulance to hospital in March 18th until March 24 Obeservations Inpatient at Hospital. March 24 to April 16th Inpatient rehab.

Initially, the first day as with the first dose, my left arm ached but this time it lingered for about 4 days. I was working a job that requires heavy lifting and at first thought it was the work, but after not working at all for about 3 days, my body would start aching all over. This is approximately 10 days after my second dose of Phizer. My bones ached, sort of like getting the flu. Late in the afternoons is when this pain would begin and by 7-8 at night, all I wanted to do was sleep. Each day, when waking most all the aching would be gone only to start up again about the same time in the afternoon/early evening. Last night, I went to bed about 7 pm and slept up until 6 am. As I am writing this, the aching is beginning in my arms again and I have tons of tiredness. It is 4:25 pm. and day 12 after the 2nd dose of Phizer.

Intense muscle twitching in my lower extremities, especially in the feet and calf muscles of both legs. Abodominal muscle spasms were present but not as prevalent or obnoxious as my legs. Also twitching in my right deltoids, triceps and thumb muscle. Could not sleep for two days . I began to get a headache due to no sleep so I took two 200 mg Advil tablets. I was able to sleep that night because the twitches had greatly subsided. I still have frequent but light twitches .

The first Pfizer shot was on 4-1-21, and I had no reactions to that. The second Pfizer shot was on 4-22-21, and a few hours after, I started feeling soreness in my arms, shoulder, neck, armpits and had chills (although no fever). Throughout the next couple of days, the chills and body aches went diminished and/or went away--except for my left armpit. My left armpit is still sore and it is swollen (now at 52 hours).

Fatigue. Onset a few hours after the second shot and lasted about 36 hours. The fatigue was similar to that experienced when I had covid19 in March of 2020, but not as intense. Other information After the first shot I only experienced arm soreness in the arm that was injected. I was donating antibodies to the through about September/October 2020. I stopped donating for personal reasons, .

Fever, chills and nausea 12 hours; fever and chills for an additional 20 hours. Immediately following the subsiding of fever and chills, I had extreme pain in my left hand (same arm as the shot was given). No swelling in my hand but my hand aches all over. I have very little strength in and use of my hand. I feel like my hand is broken. I have been experiencing the left-hand pain from the wrist down for approximately 12 hours now with no relief as of yet.

Severe fatigue; Vaccination site pain; This is a spontaneous report received a contactable consumer, the patient. A 62-year-old adult male received the second dose of intramuscular BNT162b2 (solution for injection; Lot EL3248 expiry information not reported) as a single dose in the right arm on 05Janr2021 (at 62-years-old), for COVID-19 immunisation. Relevant medical history included ongoing Hypertension (HTN; 2013), and ongoing Coronary Artery Disease (CAD; Aug2020) with coronary stent. Concomitant medications included sans indications and posology included ticagrelor (BRILINTA) ongoing rom 30Aug2020; lisinopril; acetylsalicylic acid (ASA) ongoing rom 30Aug2020; ergocalciferol (VIT D); and magnesium ongoing from 01Apr2020. The patient previously received COVID-19 immunisation with the first dose of intramuscular BNT162b2 (Lot EK5730) in the left arm on 16Dec2020. The patient reported that on 05Jan2021 he experienced injection site pain and that same day at 13:00 he developed severe fatigue. Treatment for the events included oral paracetamol (ACETAMINOPHEN) 1000mg from 05Jan2021 through 06Jan2021. The outcome of the events injection site pain, and severe fatigue was recovered on an unspecified date in 2021. No follow-up attempts are possible; No further information expected.

while I was driving I blacked out and was in a accident in my car; while I was driving I blacked out and was in a accident in my car; dizzy; very sick; soreness in my joints; headache; bodyaches; First dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00; First dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00; This is a spontaneous report from a contactable other health professional (patient). A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly administered into the right arm on 31Mar2021 13:00 (at the age of 62-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took morphine and experienced drug allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly administered into the right arm on 16Feb2021 12:00 PM (at the age of 62-years-old) for COVID-19 immunization. It was reported that the first dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00. On 01Apr2021, patient experienced soreness in his joints, headache and body aches. On 06Apr2021 07:00, while driving patient blacked out and was in an accident in his car, he was also dizzy and very sick. The patient received treatment for the events "while i was driving i blacked out and was in a accident in my car" and did not receive treatment for all other events reported. Outcome of events recovered on an unspecified date. Information on the lot/batch number has been requested.; 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.

anemia; elevated liver enzymes; low protien; Elevated Blood Sugars; Fatigue; Headache; Chills; Fever; Feels awful/ I feel really bad; Feel terrible; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205 and expiration date not reported) via an unspecified route of administration, administered in right arm on 08Mar2021 05:00 as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pravastatin; tamsulosin and insulin aspart (NOVOLOG). The patient reported that he regulates his blood sugar by insulin pump giving him insulin when he needed it. The patient stated that he felt awful. He felt terrible. He could not function. Without drugs, he feels really bad. He got the vaccine on 08Mar2021 and for a couple of days, he felt okay but after that, he just feels really terrible. He does not know what to do. He stated that the events probably started on 10Mar2021. He does not remember but it has been a couple of days since he got the vaccine, quite "hard feeling for him". He stated that he drove up to the stadium in his car, answered a bunch of questions, sat down at his reservation number, got his shot on his arm and drove away. As treatment for these events, he stated, Tylenol, he had taken about 1000 units at least once a day or sometimes twice a day but it varies. If he does not take it, he feels really bad. He does not like to take drugs so, he was trying not to take it. He asked what he was supposed to do. It was also reported that on 11Mar2021 16:00, the patient experienced Fatigue, Headache, Chills, Fever. He had elevated blood sugars on 19Mar2021. On an unspecified date, he had a CBC done which showed anemia, elevated liver enzymes and low protein. He had not been able to function at a normal level. No treatment was given in response to these events. The outcome of the events was not recovered. The patient underwent COVID test post vaccination via nasal swab (PCR) on 02Mar2021 and was negative and on 19Mar2021 and was negative. The reporter assessed the events Feels awful and Feel terrible was related.

Low grade fever (~100), chills, headache, nausea, muscle aches, feeling of fatigue and sore arm. Symptoms lasted about 24 hours.

Shingles on left side of face, on upper lip, interior lip, nose, below left eye. Also left eye is aches, like a pulsating headache. Went to Urgent Care 4/28/2021. Prescription issued, Valacyclovir.

Profusely sweating, rapid heartbeat, dizziness, fatigue, seeing spots, passing dark red/black stool for three days

Presented to emergency department on 4/7/21 with complaints of lightheadedness and feeling like he was going to pass out. He was found to be COVID-19 positive at that time and was deemed stable to return to home. Patient presented to emergency again on 4/24/21 with worsening symptoms of shortness of breath and coughing for past week. He was admitted for further management. He is still admitted at time of writing.

Severe Leg pain (especially calves. Both legs equally) Major Leg swelling Elevated D-Dimer Low platelets Elevated Liver enzymes General Body Aches. Shortness of breath Fever Rash Fatigue / Malaise

headache started about 45 min after shot, laid down on couch (at home) and fell asleep (30 min +/-) when awoke tongue felt a little thick, drank water then tongue felt sore on top and "hairy", but a lot less thick. headache subsiding. tongue top still sore 4 hours later

This is spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program. A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. Patient was experiencing a headache on 11Apr2021. Patient would like to know if he can take aspirin for his headache. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

At 0947, patient reported headache rated 5/10 on the pain scale and chest pain radiating to left shoulder (patient received vaccine on left arm). EMT assessed patient vitals: blood pressure 158/90 mmHg, heart rate regular 69 beats/minute, and SpO2 96%. Patient denied difficulty breathing, difficulty swallowing, itchiness, hives and rashes. Patient reported history of atrial fibrillation, pulmonary embolism, and surgeries on elbows, ankles and esophagus. Patient denied taking current medications. Patient offered 911. Patient declined 911. Patient given water and advised to wait for further observation. Patient reassessed at 1005. Patient vitals were blood pressure 149/90 mmHg, heart rate 67 beats/minute, and SpO2 97%. Patient reported headache decreased to 2/10 on the pain scale. Patient reassessed at 1015. Patient vitals were blood pressure 144/88 mmHg, heart rate 65 beats/minute, and SpO2 97%. Patient stated his headache was gone and he felt fine. Lead nurse educated patient on communicating with primary care provider about his reactions to the vaccine and seeking emergency care if symptoms worsen or has difficulty swallowing/breathing. At 1018, patient left facility to self with steady gait and unlabored breathing.

Fever, chills, muscle ache, headache, weakness. No special treatment; just rest, aspirin, drinking fluids. Lasted about 24 hours; felt fine the next day. Note: no reaction to first COVID vaccine injection 3 weeks earlier.

Atrial fibrillation, dizziness, difficulty breathing, profuse sweating, pulse 110, very high blood pressure starting approximately 10 minutes after injection. Transferred to emergency room.

Fever (101.2), chills, malaise, muscle ache, headache lasting over 24 hours no appetite swollen lymph glands in armpits lasting 48 hours +

I63.9 - CVA (cerebral vascular accident) (CMS/HCC) R47.81 - Slurred speech R29.810 - Facial droop Z86.69 - History of Bell's palsy R51.9 - Headache"

fever, dizziness, lethargy, diplopia, and shakiness in arms. acute encephalitis. Intravenous immunoglobulins started 5/2-5/6. slow cognitive improvement. slow improvement in gait. Transferred to inpatient rehab.

The first dose I had headaches 4 or 5 times a day. From the day of the shot The second dose I had headaches. Then one week later in the morning when I used the bathroom I fell into the wall when I tried to get up. This is now been happening to me for 2 weeks. I then called my Dr and was diagnosed with Vertigo.

Very sore arm, fatigue, headache, then about 30 hours afterwards, extreme pain on right side under ribs, hard to breathe, went to ER, after several test performed, finding is PE in right lung and DVT behind right knee. I had signs of these weeks to months prior, have no underlying conditions before this happen, now I on Eliquis for blood clots! Also due to the blood clots have pneumonia!

Hives left hand, left cheek bone and then profound fatigue, bad insomnia and restlessness, severe bone pain in right foot and right arm; heart palpitations and fast heart rate with dizziness and nausea; headache; Day 8 started having muscle twitches and cranial/ear buzzing; Day 8 experienced severe malaise and nausea and lightheadness; Day 18 difficulty walking in straight line; muscle twitches with heart palpitations very bad in evening; localized headache at left temple area, stiff neck and shoulders; eye vision blurry with heavy floaters and eye socket pain; extremely vivid dreams

Began noticing rapid heart rate and dizziness approximately one hour after getting first dose of COVID vaccine. Symptoms continued and worsened over next two weeks. Went to ER on April 11th, 2021, due to immense head pressure, BP over 200, and ringing in ears. My blood pressure and heart rate were checked at ER and were high, but came down after laying down for a while. I was given blood pressure medication, Amlodipine, 10 mg tablets. Medication had minor positive effects but symptoms continued to get worse. Returned to ER on April 14th, 2021. Same diagnostic testing was performed. I was given more BP medication and recommendations were made for how to lower blood pressure with diet and exercise.

Took covid vaccine on 1/26/2021 first dose with reaction of fever on post vaccine day 1 and 2 and cough starting 3 days ago Fever free for last 24 hours . Last fever was 1/27/2021. Dizziness today for 4-5 mins ,non since . No rapid or slow heartbeat, chest pain or other sx Tingling of both upper extremities. Feels like the world is spinning around him. Also gets some tingling in hands and arms which is mainly on the left. Feels some spasms and body aches. Legs hurt at times. Feels like he is out of his skin..

I recieved the 1st shot at about 5:30 pm and by 10:00 am the following morning is when the symptoms started: head aches, nauseous (that lasted for 4 days), body aches. Hot and cold flashes followed by upset stomach and throwing up. Dizziness chills and trembling of the hands and then diarrhea (that lasted for about 8hrs or so); Sleep was internment for about 3 days and then the symptoms slowly started to fade. Taste for food and nauseousness (after I ate) last for about 5 days after the shot.

Fever; Real bad sweat; throwing up and it lasted for 9 hours; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199, Expiry date: unknown) intramuscular, administered in left arm on 22Apr2021 at 11:00 am (age at vaccination was 62 years) at a single dose for COVID-19 immunisation. The patient's medical history included blood pressure high, heart disease, kidney disease and COPD for which the patient had taken lot of medication (Further clarification unknown). Concomitant medication was not reported. The consumer stated that he had his first Pfizer shot on the 22 which was last Thursday at 11 clock in the morning and at 6 'o' clock that night he started running the fever, having real bad sweats and throwing up and it lasted for 9 hours and but the next morning he was okay and his concern was, whether he should take the next shot or not. The consumer stated that he didn't have any computer, so he didn't have smartphone so he didn't have any email, they could text message him at the phone number he had given them. Reporter seriousness for events was unspecified. The consumer stated that the scheduled date of second shot was 13May2021. The patient did not receive any treatment for the events. The outcome of all the events was unknown. No follow-up attempts are needed. No further information is expected.

Hospitalization, on ECMO, deteriorating lung function - now on lung transplant list, hx. sarcoidosis. Question of whether vaccination caused worsening of lung function / sarcoidosis. Still currently hospitalized. Transferred to our organization for ECMO. Hospital Course: Patient is 62y.o. male with PMH of Sarcoidosis who presented to the hospital with worsening shortness of breath. Over the past 2 weeks, patient has had worsening shortness of breath on exertion and also while talking. On 4/23, patient noted intermittent fever, TMax 102F. Patient was seen by his PCP on 4/25 and started on a zpack, and was also seen in our ED on 4/25. He was discharged home with OP pulm follow up. Since then, patient has been feeling progressively worse, He noted 4/27, that his pulse ox was in the 70s with ambulation and that the cough and shortness of breath were worsening. In ER, patient has been placed on 6 L of oxygen via nasal cannula. He was also febrile with TMax of 101.5 F. POC COVID-19 testing was negative. WBC was slightly elevated at 10.7, Na level was noted to be 129. PCT was negative. CTA PE protocol was negative for PE, there was significant interval progression of nodular and consolidative opacities throughout both lungs when compared to 2017, compatible with interval progression of sarcoidosis. Patient was admitted for further workup and management. Patient's oxygen requirements gradually increased. He was initially treated with IV antibiotics and antifungals. He underwent extensive testing, including urine histoplasma, cryptococcal, respiratory viral panel which will negative. TB QuantiFERON was indeterminate, along with elevated IgM mycoplasma for which he received azithromycin. Patient was also placed on IV Solu-Medrol initially, transitioned to IV Decadron. Inflammatory markers were elevated. D-dimer was noted to be greater than 10,000, he was placed on therapeutic Lovenox dosing. Patient did have Covid testing which was negative, he was also vaccinated. His oxygen requirements continue to increase, he was eventually placed on BiPAP, although due to lethargy and increased work of breathing patient was eventually intubated and sedated. He was also started on paralytics. Patient was transferred to another hospital for possible need of ECMO or lung transplantation.

After 2nd COVID-19 vaccine began having Malaise, chills, fever, polyarthralgias, myalgias Joint pain, stiffness, inflammation and tenderness in multiple Joint, tendon ruputure, DVT.

body aches; chest pain; pressure on chest; low fever; cold; tested positive for covid 19; This is a spontaneous report from a contactable consumer report for self from a Pfizer sponsored program Covax US Support. A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Apr2021 16:30 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations within 4 weeks. Medical history included ongoing high blood pressure started 8-9 years ago. Concomitant medications included lisinopril (LISINOPRIL) taken for high blood pressure about few years; acetylsalicylic acid (BAYER ASPIRIN) taken to keep the blood thin and blood pressure; Carvedilol taken for heart valve, something to do with his heart since couple years ago. Patient received his first vaccine dose on 10Apr2021 and on 11Apr2021 tested positive for covid 19. He was at Emergency Department on an unspecified date. He went because he had body aches, chest pain, pressure on chest, once in a while had low fever, cold, and achy body. He was given a treatment, but doesn't know the name of what was given. It was through the Intravenous site. Patient no longer has symptoms and has completed his required isolation. He is due to get his second vaccine dose on 01May and asked do he get second dose or should wait. The outcome of events was unknown.

Upper respiratory tract something going on; possible bronchitis; Left lower lobe atelectasis; D Dimer that was positive, reading 1.95; Pulmonary embolism; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 21Jan2021 07:30 (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included psoriatic arthritis from 10 years (he started Cosentyx three or four weeks before reporting) and COVID virus from Nov2020. Concomitant medications included secukinumab (COSENTYX) from three or four weeks before reporting for psoriatic arthritis. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration at left arm on 31Dec2020 07:30 (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. Prior vaccinations within 4 weeks was none. Patient states he just wanted to report; and he didn't know if this is significant. Patient reports now he has bilateral pulmonary embolism (from 04May2021) along with an upper respiratory tract something going on. Adds he never had this before. The doctor for his possible bronchitis has him on Omnicef and started Xarelto. Adds they were lucky to find the pulmonary embolism. Mentions the doctor tried a different antibiotic first, Keflex (NDC 68180 0122 02), and it was not helping. The doctor noticed his pulse oximeter (on 04May2021) reading was 92% and did a chest x ray. The chest x ray (on 04May2021) showed left lower lobe atelectasis. The doctor said that would not account for the low pulse oximeter of 92%. She sent him for a D Dimer (on 04May2021) that was positive, reading 1.95; and then had a chest CT at 1:00PM on Tuesday (04May2021), that showed the bilateral pulmonary embolism. Adverse events required a visit to physician office (received outpatient tests). Therapeutic measures were taken as a result of the event possible bronchitis and included Omnicef and Xarelto. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Patient was not feeling well with diarrhea and fatigue past 24 hours. After vaccination, patient went to observation area where they felt fatigue, sweating, and clammy. Patient alerted nurse they were not feeling well, and nurse noted patient was breathing fine. No rapid response was called, however patient was sent over to ED with wheelchair. Patient appears stable, but is being worked up in ED now.

past history of diabetes, hypertension, hyperlipidemia and recent diagnosis of COVID-19. Apparently the patient received his initial dose of COVID vaccine on 03/31/2021 and subsequently developed loss of taste and smell. He was tested for COVID-19 at local Pharmacy and received notification that his result was positive. He subsequently had improvement in his symptoms and was retested 2 weeks subsequent with negative results. On for 01/20/2021 he received his 2nd COVID 19 vaccination and subsequently developed recurrence of feeling ill 2 days afterwards. He progressively had feeling of shortness of breath along with nonproductive cough. The patient then developed complaints of chest pain and rib discomfort. He presented to the emergency department where he was found to be hypoxic along with abnormal labs including a creatinine of 1.84 BNP of 12,699, elevated transaminase levels, hemoglobin of 8.9. Chest x-ray showed patchy airspace disease to the right lung consistent with COVID-19 pneumonia. At time of admission he was given IV Lasix and started on Rocephin and Azithromycin. The use of steroids as well as any antiviral treatment was withheld because of presumptive symptoms related to bacterial pneumonia (secondary to COVID 19.) He also did not require oxygen supplementation during his stay.

The day after 2nd shot I was tired and was feeling chest pressure. Pressure lasted about 10 days and continues on and off. BP went up to 180/101 and remained high. went to urgent care, then primary physician. he heard heart murmur (never had before) and sent me to cardiologist. Prescribed BP meds.

Fatigue, unspecified type Dizziness Fever, unspecified fever cause Weakness COVID-19 virus infection Office Visit 5/12/20Family Practice PA Family Medicine COVID-19 virus infection +4 more Dx Cough Reason for Visit Progress Notes (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 5/12/2021 Cosign Needed Expand AllCollapse All Assessment/Plan TENT. 1. covid positive - symptoms and diagnosis occurred x15 days ago. He was improving but starting yesterday he has developed R sided chest pain and has been slightly SOB. Cough has worsened as well. He has not been taking ASA, will rule out PE at this time. STAT chest CTA ordered, CBC, and CMP. Possibility of secondary pneumonia but will hold off on abx for now, review after chest CTA results. Continue Acetominaphen and hydrating. If any symptoms worsen or the following occurs go directly to ED; fever/chills, chest pain, SOB. Patient understands and agrees. If chest CTA rules out PE and shows pneumonia would cover w/ azithromycin/ceftin/prednisone. Diagnoses and all orders for this visit: COVID-19 virus infection - CBC; Future - Comprehensive metabolic panel; Future - CT angiogram chest pulmonary embolism with and without contrast; Future Fatigue, unspecified type - CT angiogram chest pulmonary embolism with and without contrast; Future Other chest pain - CT angiogram chest pulmonary embolism with and without contrast; Future Tachycardia - CT angiogram chest pulmonary embolism with and without contrast; Future

Day after 2nd dose, discomfort stayed in bed. 2nd day after dose shoulder pain radiating to chest, during night intense chest pain with extremely shallow breathing. By morning chest pain so bad I went to E.R. I was admitted with normal EKG and oxygen levels. Elevated test that indicates blood clot in lung. CT scan done. Diagnosis Pulmonary Embolism. Was admitted to hospital for 2 days while undergoing heparin and warfarin therapy and pain relief. Prescribed blood thinners for 6 mos. After release severe fatigue and low HGB levels limited walking of more than 50' without losing consciousness. It has been 1 month and still can only walk 100' without lightheadedness.

The day after the second dose of the Pfizer vaccine, my father started to experience lethargy, headaches, nausea and vomiting. These are all advertised as common symptoms of the second dose so he did not seek medical treatment until 5/11/21, five days after. He went to the emergency room, his systolic blood pressure was over 200. A CT scan showed bleeding going from his basal ganglia to the right ventricle of his brain. His blood pressure had gotten so high that he had a hemorrhagic stroke. He has since been in the ICU. He had to undergo a ventriculostomy, was put onto a ventilator, and has now had a tracheostomy. He still has not regained full motor function and will have a long road to recovery after the stroke.

This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9262) dose 1 via an unspecified route of administration on left arm on 26Jan2021 at single dose for covid-19 immunization. Time the vaccination was around noon. No prior vaccinations within 4 weeks. Medical history included ongoing blood pressure high. Concomitant medications included metoprolol 50mg once a day taken blood pressure from an unspecified start date ongoing. On 27Jan2021, Wednesday he started to feel pain in his arm which he knew was normal. But now he started to feel his temperature rise and usually takes his temperature every day as he works with the fire department. On 28Jan2021, Thursday he started to notice the rise in temperature. Then it was kind of within normal, but it was 98.4. However, this morning when he took his temperature it was 100 degrees. His usual temperature was between 97-98 degrees. He also had a cough last night and did not had the cough this morning. More, or less the main thing bothering him is the temperature. He has taken some Tylenol 500mg. He stated he does not know if he should be taking Tylenol. He was drinking more tea, coffee, and juice. The pain in his left arm was not immediate and was delayed. He does not know what time it started, but it was early in the day. He was coughing last night but he was not doing it on a consistent basis. Later he was doing it all day but did not know what time it started. He said as pretty much has subsided, no additional details provided. The patient underwent lab test which included body temperature resulted as 98.4 on 28Jan2021 and on 29Jan2021, body temperature resulted as 100. The clinical outcome of the event pain in arm and cough was recovering and the clinical outcome of the event rise in temperature was unknown. Follow-up attempts are completed. No further information is expected.

Headache; low-grade fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and expiration date was unknown), via an unspecified route of administration, administered in left arm on 05Mar2021 15:30 as a single dose for covid-19 immunization. Medical history included prostate cancer (underwent radiation treatment). Allergies to medications, food, or other products included penicillin. Concomitant medications included gabapentin, diazepam, naproxen, diclofenac and cyclobarbital, all taken for an unspecified indication from an unknown date. 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 and since the vaccination, the patient has not been tested for COVID-19. On 06Mar2021 10:00, 18hr 30 min, after vaccination, the patient experienced headache & low-grade fever day. The patient took 2 extra strength Acetaminophen as a treatment & headache began to feel lighter. The patient enquired did the treatment adversely affect the effectiveness of the vaccine by taking them. The outcome of the events was resolving.

within 6 days my brother was sick, everyone said it's the side effects from the Covid vaccine because it was the exact same side effects, chills-headaches, lethargic, just wanted to sleep he said that's all he needed. However that wasn't the case here 4 days later he has brain damage from Encephalitis and meningitis which is so Rare to have together, This all happen to his having the second shot, He was a very health person, body builder/MMA etc now he lays in bed or wonders the room not knowing whats going on this is just Wrong .We're told with his brain damage he won't heal from it. No Short Term Memory.

pt says the next day after taking the vax his arm was a little sore but when he stood up he had a hard time moving around, he was hyperventilating and he felt very exhausted. He got a severe pain in his left hip. He said the pain was so intense he could barely move so he took a low dose pain killer. He was in so much pain he curled up in a fetal position and rock back and forth. He says he was crying and in a hallucination state for about an hour. After that the he said the symptoms seemed to be getting better but was completely exhausted. His eyes were red and had trouble with his vision. On 6/4/2021 he still has some pain and has an ache inside the bone, gets winded w/ moving around but says his symptoms seemed to be improving.

Chills; tired; a dream of going over a glacier trying to slide over the other side; This is a spontaneous report from a contactable consumer(patient). A 62-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, in Arm Left on 06Mar2021 08:30 as 1 DOSE, SINGLE DOSE for covid-19 immunization. The medical history was reported as none. The concomitant medications were not reported. 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 06Mar2021 16:00 the patient experienced chills, tired (fatigue), a dream of going over a glacier trying to slide over the other side (abnormal dreams). The patient did not receive any treatment. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.

shortness of breath; Fever 100 +; left arm pain; malaise/feel sick; headache; feel sick and tired; This is a spontaneous report from a contactable other Health Professional (patient). A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 14:45 (Batch/Lot Number: Unknown) at the age of 62-year-old, as 1st dose, single for covid-19 immunisation. Medical history included covid-19. Prior to vaccination, the patient was diagnosed with COVID-19. There were no concomitant medications. The patient previously received other Pfizer vaccine (unspecified name) on 27Apr2021 administered in left arm for immunisation. The patient experienced shortness of breath, fever 100 +, left arm pain, malaise, headache, feel sick and tired on 19May2021. No treatment was taken for adverse event (AE). Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering. Information about lot/batch number has been requested.; 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 shortness of breath 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.

I've had Covid (01/2021) and Monoclonal Antibodies (01/2021). Was told to wait 90 days before vaccination (04/29/2021 and 05/20/2021). After Covid I began experiencing severe tiredness, headache, brain fog and muscle pain. No issues after 1st vaccination. About 10 days after 2nd vaccination, the muscle pain started becoming severe. Getting up in the morning, muscle pain in legs (mostly things) started mildly, then became so severe it was impossible to put my full weight on my legs. Am able to "walk it off" after an hour or so. NSAIDS are somewhat effective. Other symptoms include tiredness, headache, muscle pain, generally feeling unwell, joint pain, diarrhea.

Headache; Sore muscle at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old adult male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration on the left arm on 17Mar2021 at 11:30 (at the age of 62years) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and blockage, major depression, posttraumatic stress disorder (PTSD), sleep apnea, tinnitus. The patient did not have any allergies to medications, or other products. 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 had not been tested positive for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. Concomitant medication was not reported. On 17Mar2021, the patient experienced "sore muscle at injection site. Started developing a headache around 3pm, continued worsening. Around 8am it began to subside. Around 9 it was gone". The clinical outcome of the events sore muscle at injection site and headache was recovered. No follow-up attempts are needed. No further information is expected.

Felt tired; Back hurts; Pop in neck and back; Pop in neck and back; Headache; Cramps, sometimes in his legs and hands; Feels weak sometimes; Has a little bit of pain in his chest; Body hurt, reclarified, joints hurt; This is a spontaneous report from a contactable male consumer reported for himself. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 03May2021 (at the age of 62-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient previously received the first dose of BNT162B2 vaccine on an unspecified date (lot/batch and expiry date unknown). The patient medical history and concomitant medications were not reported. On 03May2021, after the vaccination, the first day patient felt tiredness, later (unspecified date in May2021) the patient explained his body hurt- reclarified as joints hurt, back hurts, pop in his neck and back, headache, cramps sometimes his legs and hands, feels weak sometimes, little bit of pain in his chest. Caller stated he has waited for his effects to go away, but it has been a month. Caller stated his body hurt, reclarified as joints hurt, and it was not going away (not recovered). The outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Severe vomiting during overnight period into next day (approximately 12 episodes in 12 hours), severe cranial pain/headache, open sore in esophagus/lower throat that prevented eating solid foods for 10 days and liquids for at least the first week, even water. Painful area surrounding sternum (uncertain if it was from the vomiting action or possibly heart damage), which also prevented food or liquid to pass down the throat due to spasms, localized pain and possibility of inducing vomit reflex. High blood glucose (ketoacidosis). General overall weakness/lack of energy. Loss of mucous in nose, throat and stomach. Loss of saliva in mouth for first week. Insomnia. High blood pressure.

31March2021 rec'd the 2nd Pfizer shot. Next morning 1April, multiple stripes of severe muscle pain from both ears, extending down the rear corners of neck across top of both shoulders to the shoulder joints. The 2nd set of severe pain was thin stripes of pain on the left & right sides of the spinal column from the neck to waist. The pain strips along spine disappeared in 3 days. The neck pain has continued to this day with varying intensity, sometimes random increases in pain. 7th of April 2021: Sudden onset of Covid like symptoms: extreme fatigue, extreme nausea, wild swings in perception of body temp from freezing cold which nothing warms me, to internal heat like a very high temp but not exhibiting any outward signs of fever. Felt like internal organs were heating up and nothing else like forehead or limbs etc. The symptoms of 7April2021 kept up for at least 2 weeks. No symptoms occurred together, each symptom came for varying lengths of time before subsiding and the next symptom surfaced. Towards the end of April the intensity of the symptoms was easing and eruptions were getting fewer with more time between. By end of May only the neck pain remained. BUT.... then the other symptoms reappeared in stronger form and still ongoing.

AT about 11 pm I got up to go to bed, and all of the sudden I felt like I was freezing and shaking violently. I couldn't even hold my phone to call 911. I passed out. I woke up about 3AM on the floor. I was shivering. I got to bed, called my girlfriend, then fell asleep. The next morning it felt like I had COVID again, I had COVID back in December. I called the doctor, and they if I experienced it as bad as the night before then I should go to the ER, otherwise stay in bed, rest, and drink fluids.

He got the second dose of the Pfizer COVID vaccine on 5/26/21. States he has been extremely fatigued since then. He has been getting headaches daily. He has to drink lots of coffee and take vitamins to get himself going. He's not able to sleep at night due to all the coffee he has to drink to function. He never had any of these symptoms until the vaccine.

Hemorrhagic stroke/bleeding in his brain; He was feeling nauseous and had a very bad headache; He was feeling nauseous and had a very bad headache; Vomitting; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 (Batch/Lot Number: EW0171) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included hypertension. Concomitant medication included unspecified blood pressure medications. The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 15Apr2021 (Batch/lot number: EW0161) as COVID-19 immunization. Then, the 2nd dose on 06May2021. On that same day of 06May2021, he was feeling nauseous and had a very bad headache. He brushed it off as a side effect of the vaccine because that was listed as a common side effect of the vaccine on the CDC website. So, he did not seek medical attention for 5 days. It was later reported that the he suffered a hemorrhagic stroke that day after the COVID-19 vaccine administration. The patient was in the ICU after waiting 5 days to seek medical attention because the supposed to cause headaches, nausea and vomiting. But the nausea and vomiting was from his stroke, not from the normal side effect of the vaccine. They were suspecting that the bleeding in his brain started on the 07May2021. The patient had bunch of blood work (unknown results) done since the past two weeks. Outcome of the events were unknown

Acute bronchitis cough Nasal Congestion - predniSONE (DELTASONE) 20 mg tablet; Take 2 tablets (40 mg total) by mouth daily for 5 days - azithromycin (ZITHROMAX) 250 mg tablet; Take 2 tabs (500 mg) by mouth today, than 1 daily for 4 days. - amoxicillin-pot clavulanate (AUGMENTIN) 875-125 mg per tablet; Take 1 tablet by mouth 2 (two) times a day for 10 days

It felt like his intestines were twisting in knots; diarrhea; joint pain; chills; muscle pain; tiredness/exhausted; dizziness; weakness/lost strength; Arm pain; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0179), dose 1 via an unspecified route of administration, administered in left arm on 20May2021 10:00 (at 62-year-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included ongoing HIV positive from an unspecified date (reported as 5-6 years ago), ongoing immunocompromised due to being HIV positive. History: Patient has been taking BIKTARVY daily ever since he became HIV positive which was years ago. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV positive. He did have vaccinations but he had them way longer than the 4 weeks prior to receiving his first dose of the COVID vaccine. No events following prior vaccinations. The patient stated he received his first dose of the Pfizer COVID-19 vaccine on 20May2021 and this weekend 29May2021 into 30May2021 he developed diarrhea, joint pain, chills, muscle pain, tiredness, dizziness and weakness. He's not sure if he had food poisoning over the weekend or what, but he has been suffering. He received his first dose on 20May2021, and the next dose wasn't due until 10Jun2021. He was reading through the literature and he sees that there are issues with immunocompromised people and all the medications that make a person immunocompromised which he is on. He has been reading the side effects and he has experienced diarrhea from hell, joint pain, he had chills, muscle pain and tiredness. He mentioned he did have some arm pain. He mentioned he didn't have anything soon, it was a little over a week. He also experienced dizziness and weakness, he felt like he lost strength or something like that. It may be coincidental and he could have gotten food poisoning or something over the weekend. Patient clarified his symptoms began on Saturday night, 29May2021 into Sunday, 30May2021. On 31May2021, his symptoms were a little milder, but then towards afternoon, his symptoms started back up. It felt like his intestines were twisting in knots and his diarrhea was back. He mentioned he had been taking Pepto Bismol and Alka-Seltzer. He confirmed the arm pain and diarrhea were still ongoing, however, the rest of his symptoms had pretty much improved. He clarified if he does too much too quick, his tiredness comes back. He felt like he was just zapped, he felt exhausted. The events did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included weight: 157-158 lbs on an unspecified date. The outcome of events arm pain and diarrhea was not recovered, outcome of the other events was recovering.

Injection site pain; Severe chills; Joint pain; Muscle pain; Low grade fever; This is a spontaneous report received from a non-contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 15Mar2021 at 10:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. 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 previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021, as a single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021, as a single dose for COVID-19 immunisation. On 15Mar2021, the patient experienced injection site pain, low grade fever, severe chills, joint pain and muscle pain. The patient reported injection site pain for 3 days, low grade fever for 2 days, severe chills for 3 hours occurring approximately 14 hours after injection, joint and muscle pain for 2 days. The patient did not receive any treatment for the reported events. The clinical outcome of the events injection site pain, severe chills, fever, joint pain and muscle pain was recovered. No follow-up attempts are needed. No further information is expected.

painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was administered; Hard to lift up arm, nothing noticeable on arm; bloodshot eyes; muscle aches; unable to take full breathes/shortness of breath; minor cough; migraine headache; chills; exhausted; aches; nausea; covid like symptoms; body aches; low energy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 15:30 (Batch/Lot Number: EW0173) as single dose for covid-19 immunisation. The patient medical history was reported as none. Patient had not any known allergies. Patient had not received any other vaccine in four weeks nor received any other medications in two weeks. The patient did not received concomitant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 07:30 PM, as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 2nd shot administered on 03May2021 and on 08May2021 09:00 PM six days later developed migraine headache, chills, exhausted, aches, nausea. Chills, migraine, lasted 1 day, night of 08May2021- 09May2021. It was reported that due to lifting weights, vaccine was trapped in the arm/shoulder muscle, released slowly where he developed covid like symptoms 6 days after shot followed by week of covid like symptoms, shortness of breath, body aches, exhausted, low energy. Week of 10May2021 exhausted, bloodshot eyes, muscle aches, unable to take full breathes, developed a minor cough. On 15May2021- 16May2021, painful left arm/shoulder where shot was administered. Hard to lift up arm, nothing noticeable on arm. No treatment was received for the events. The seriousness of events was reported as non serious by the reporter. The outcome of the events chills, migraine were recovered on 09May2021; events painful left arm/shoulder where shot was administered and hard to lift up arm were recovered on 16May2021 and recovering for other events.

hands and feet swelling; headache; back starting hurting; This is a spontaneous report from a contactable consumer (patient's spouse) A 62-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included prostate cancer, surgery for prostate cancer about 4 months ago, tooth extraction on 09Mar2021. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, diphenhydramine hydrochloride (BENADRYL), amoxicillin. On 12Mar2021 the patient experienced hands and feet swelling, he started getting body aches and a really severe headache. All events were assessed as non -serious. It was also informed that on 09Mar2021 he was at the dentist for a dental procedure and they give him amoxicillin. By Friday evening his hand was completely swollen, his legs were swollen a little bit and then his back starting hurting, had a headache so is that may be a combination of amoxicillin and the Pfizer shot (as reported). At the time of the reporting the patient was recovering from the events. No follow-up attempts are possible. No further information is expected.

Was due for his second dose today but woke up with a cold; He is sick; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX US support. A 62-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0175) via an unspecified route of administration in left arm on 20May2021 at 11:00 as 1st dose, single dose for COVID-19 immunization. Patient had no medical history. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 10Jun2021, Patient was sick and was due for his second dose today but woke up with a cold. Patient was taking COVID Vaccine because of COVID Prevention and his wife was bugging him to get it. Patient was not asking about timing but asking for assistance with rescheduling his appointment for his second vaccine dose. Patient had no other vaccines on the same day as the suspect product. Patient did not visit emergency room or physician office. The outcome of the events was unknown.

The AFIB occurred around May 5th and it was continuous almost the whole month of May. Shortness of breath, tiredness and interference with my daily interactions. I would get tired about 30 minutes of anything. Whatever the medical term is for when you get tired easily, shortness of breath etc. Just basic AFIB symptoms. The Dr gave me Solital 2x per day and as soon as he did that, within two days the AFIB went away. He took away my blood pressure medication and gave me the Solital. But I still get tired easier than I did before.

Pt states month after 2nd dose chest tightness, sweating, fatigued. Since then no breath, low energy. Feels like his heart is pounding out of his chest. Doctors ordered stress test, Ekg 04/28/2021. Extreme mental state stress.

Aches; Headache; Chills; Joint pain; Tiredness; This is a spontaneous report received from a contactable consumer, the patient. A male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982) via unspecified route to left arm on 15Mar2021 at 12:45 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included Ambien and multivitamins for unspecified indications received on unknown dates and unknown if ongoing. On 15Mar2021 at 21:00, patient experienced headache, chills, aches, joint pain and tiredness. The patient did not receive any treatment for the events. The clinical outcome of headache, chills, aches, joint pain and tiredness were recovered on unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.

My second dose of Pfizer was on 5/7/21 and I started getting a headache from 5/14/21. It is still going on as of 6/26/21.

Severe vertigo or dizziness and nausea that lasted around 4 hours. After the 1st two hours, I took a couple of aspirins which had me sweating initially and seemed to help a little. I was finally able to leave work around 10 am, at which time I went to bed for several hours. When I got up, the severeness was gone but mildly lingering. As of today, there is a small hint of dizziness in the background, but I feel much better.

Rash on torso (trunk); Chills; Very cold; Nauseated; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 08:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergic history.The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 09:00 as a single dose for COVID-19 immunisation Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, Concomitant medications included Trazodone 50mg (MANUFACTURER UNKNOWN) 2 tablets per day, Baby asprin (MANUFACTURER UNKNOWN), within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced chills, cold and nauseated. On 17Mar2021, the patient experienced rash on torso (trunk). Patient stated that after getting the 2nd dose, that evening patient started getting the chills and was very cold and felt like he had the flu. Patient also felt nauseated but did not throw up and took some Tylenol which helped but he did not check his temperature. Patient stated this lasted nearly 48 hours. On day 2 after getting the 2nd vaccine patient began getting a rash on his torso (trunk). It was mainly on the front side of his body but also some on back. The rash was fairly solid and looked like a sun burn. This lasted nearly a week with itching starting at about day 4 lasting about a full week from getting the 2nd dose. Patient was not feeling very well until about day 4 when he started getting energy to do things. At a week after patient pretty much back to normal. The clinical outcome of the events chills, cold, nauseated and rash on torso (trunk) was resolved on an unknown date in Mar2021.Patient has not tested positive for COVID-19 since having the vaccination. Information about lot/batch number cannot be obtained. No further information is expected.

Exacerbation of MS Symptoms. Including nerve pain and Cognitive difficulties along with heavy fatigue.

Fatigue and swelling with joint inflammation in left extremities. Follow-up for polyarthralgia Brief history: Probable reactive arthritis: One week after getting second COVID vaccine (Pfizer, 5/3/2021) he developed chills, sweats, SOB, cough and red/watery eyes. Initially given topical antibiotics for eyes in walk in clinic. Went back and on 5/17/2021 given Medrol dose pack which cleared up symptoms. From 5/10/2021 onward he developed left shoulder soreness and limited ROM. He has had persistent polyarthralgia with morning stiffness. Seen initially in June 2021 with noted joint effusions in left elbow and left knee. Evaluation around that time significant for positive ANA (1:160, speckled), RF (22, normal < 14), SSB, Scl-70 (weakly positive). Other ENA panel and CCP negative. X-ray of left shoulder (6/3/2021) showed only mild degenerative changes suggestive that the limited ROM in shoulder is related to frozen shoulder. Rheum Medications: Celebrex 200mg daily Doxycycline 100mg daily (started about 2 weeks) Interval history: Patient was last seen 6/3/2021. He reports that the swelling in the left calf has decreased. The left knee has been bothering him. The mornings are the worse time of day. He continues to have swelling in the left knee. He has been doing ROM exercises with the left shoulder. At night he is not sleeping because of pain. He has morning stiffness which lasts from 20-30 minutes. He has noticed some pain in the left thumb. No eye pain/redness. No rashes. As in HPI, otherwise 12 point ROS was reviewed and negative

faint; Soreness at injection site; chills; lethargy; body aches; weakness; Hypotension; This is a spontaneous report from a contactable consumer (patient reported himself). A 62-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 31May2021 at 10:15 AM (at the age of 62-year-old), as a single for covid-19 immunisation. The patient medical history included Coronary artery disease, CABG (Coronary artery bypass) surgery and hypertension. The patient had no known allergies. The patient received an unspecified concomitant medication within two weeks of vaccination. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 10May2021at 10:00 AM, as a single for covid-19 immunisation. 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 did not have covid prior vaccination. The patient was not tested for covid-19 Since the vaccination. On 01Jun2021 at 09:00 AM, the patient experienced faint, soreness at injection site, chills, lethargy, body aches, weakness, and hypotension. Hypotension was continued to till the date. The patient visited physician office for the events. The treatment received for the adverse events was none. The patient was not resolved from all the events at the time of this report. Information on Lot/Batch number was available. Additional information has been requested.

63 year old male patient presents to ED 6/25/21 reporting 5 weeks of progressive cough, dyspnea and intolerance to exertion that has become steadily worse despite supportive therapies. He reportedly completed outpatient ABX from PCP within the past 2 weeks and suffers ongoing deterioration of his breathing accompanied by night-sweats, chills and fever. 1st Vaccine on 5/27/21, 2nd 6/17/21. hypoxemia secondary to large left sided pneumonia.large left sided effusion with compressive atelectasis and question of infectious vs malignant origin.acute hypoxemic respiratory failure requiring HFNC. Patient admitted to the ICU on our service for ongoing care.Hospital Course:Mildly elevated BNP and non-diagnostic EKG.Findings consistent with bilateral pneumonia, large left complex parapneumonic effusion versus empyema with compression of left lung and evidence of external impingement on LV. Systolic blood pressures ranging in the 80s to 90s with MAPs ranging from mid 60s to mid 80s with heart rates in the 90s, which may be attributed to diminished LV filling. Transferred 6/26/21.

A month after I was tried all the time, struggling to get through the day. I feel down a couple of times. I had dizzy spells. Fatigue.

INJECTION SITE PAIN & REDNESS, ARM PAIN. TIREDNESS, HEADACHES, MUSCLE + JOINT PAIN. CHILLS, FEVOR, NAUSEA, VOMITING, FEELING OFF/UNWELL.

I had rusty joints in both shoulders with muscle pain and fatigued. I was modern pain. Seen doctor, after the second shot. They did blood test. There was 5 out 13 abnormal results in the blood test. They believe it was due to inflammation that was from the vaccination. They started me steroid (Methprodnazoe) for the inflammation and joint pains. I was a one-week treatment. That was very affective. After the treatment stopped, the symptom came back, it was about 80% more that traveled down my body. It was more mild pain. I am still having these symptoms. I am going to contact my doctor to get back on a low-level steroid treatment pain. The more I exercise the worst it gets.

2nd vaccine- 01-04-2021; initially started to feel loss of appetite, a lot of weakness and just feeling sick. I got to the point where I could not sit in my wheelchair, literally had no core strength in me. I went to the ER and they gave me a rapid swab for covid. They decided to do blood cultures, were getting ready to plasma when an infectious disease doctor came in and said to that I did not have covid but rather a UTI and my UTI went into sepsis. I was hospitalized, 2 ½ months. I believe that this started with the Pfizer vaccine. I also went to a rehab place to regain my strength. I continue to have today with weakness to my body and struggle with core strength. I do not have lot# to provide.

Shortness of breath; Body aches; Pain; Headache; Nausea; Muscle pain; injection site pain; fever; feeling unwell; swelling of throat; weakness.; This is a spontaneous report from a contactable consumer. A male patient of 62 years age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE LOT number UNKNOWN) On 21Mar2021 16:30 via an unspecified route of administration, on the left arm as a single first dose (at the age of 62 years) for Covid-19 immunization. Patients medical history reports bronchitis, COPD, asthma and oral cancer from 8/01 and operation/recovery/radiation till 11/01. The patient reports allergy to penicillin, nuts. Prior to vaccination patient has was not diagnosed with COVID-19. Since vaccination patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received doxycycline(UNKNOWN MANUFACTURER), metronidazole(UNKNOWN MANUFACTURER), guaifenesin(UNKNOWN MANUFACTURER), aspirin(UNKNOWN MANUFACTURER) within 2 weeks of vaccination. On 22Mar2021 patient reports to have shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. The patient also reports to have a compromised immune system due to oral cancer. No treatment was taken as a result of the events shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. 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 shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness was recovering. No follow-up attempts are possible; information about lot number cannot be obtained.

Dizzy; diarrhea; nausea; fever; tired; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN620), via an unspecified route of administration in the left arm on 23Mar2021 at 09:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for an unspecified indication from unknown date. 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 had not been tested for COVID-19. On 24Mar2021, the patient experienced dizzy, diarrhea, nausea, fever and tired. The 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 reported events. The clinical outcome of the dizzy, diarrhea, nausea, fever and tired was recovering at the time of report. No follow-up attempts are needed. No further information expected.

Headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported for himself that a 62-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EW0173, NDC number/ expiry date: unknown), (at the age of 62-years-old) via an unspecified route of administration in right arm on 07May2021 as single dose for COVID-19 immunisation. The patient's medication history was not reported. Concomitant medications included Nexium (Esomeprazole Magnesium) for an unknown indication from an unknown date. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Batch/Lot Number: EW0162, NDC number: unknown), (at the age of 62-years-old) via an unspecified route of administration in right arm on 09Apr2021 as historical vaccine as single dose for COVID-19 immunisation and no reaction on previous exposure to drug. The patient taking Covid vaccine because he did not want to get Covid 19. Vaccination facilitated in stadium. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. Starting around 14May2021, the patient got a headache. Stated that headache was still there today. It would go away. Sometimes it hurts less or more or was on the left or the right side; but it was always there. The headache was always there but fluctuates and it was not serious. On a pain scale of one to ten he would give it a three or sometimes a two. He has never had a problem with headaches before. The patient visited physician office for headache. He had a computerized tomography (CT) scan recently (in 2021) that was normal, they did not find anything on it. The patient did not receive any treatment for adverse event. The outcome of the adverse event was not recovered.

Came with a moderateheadache; Repeated nausea; vomiting from 7 am to 4 pm, could not hold anything down; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ep7534) and expiry date included 31Jun2021, via an unspecified route of administration to left arm on 17Mar2021 at 16:00 (at the age of 62-year-old), as single dose for COVID-19 immunisation. Medical history includes paroxysmal atrial fibrillation (episodic) and unknown if ongoing. Concomitant medications include pravastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) and flecainide (MANUFACTURER UNKNOWN) for an unspecified indication since an unknown date. The patient had no known allergies to foods, medications or other products. 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. On 20Mar2021 at 07:00 (as reported 08: 00), the patient experienced repeated nausea and vomiting from 7 am to 4 pm, could not hold anything down and came with a moderate headache at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test on 20Mar2021 (since the vaccination) which included nasal swab test (SARS-COV-2) and the test result was negative. Therapeutic measures were not taken as a result of the events nausea, vomiting and headache. The clinical outcomes of events nausea, vomiting and headache were recovered in 20Mar2021 at 16:00 and on an unknown date in Mar2021 respectively. No follow-up attempts are possible. No further information is expected.

Hearing loss; tinnitus; I feel off balance; headache; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 62-years-old as DOSE 2, SINGLE for covid-19 immunisation. The patient previously took the first dose bnt162b2 on 03Feb2021 at age of 62-years-old for covid-19 immunization and experienced Hearing loss and tinnitus. The patient medical history was not reported. Concomitant medication included fluconazole. The patient experienced hearing loss, tinnitus, feel off balance on an unspecified date with outcome of recovering , headache on an unspecified date with outcome of recovered. Ear nose and throat doctor prescribed prednisone. Seriousness criteria reported as disabling and incapacitating. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination. Information on the lot/batch number has been requested.

Also had headaches for approximately two months but those have gone away for the most part; experience times where I feel off balance; Hearing loss in both ears and tinnitus in both ears beginning approximately 10 days after first vaccine on 03Feb2021.; Hearing loss in both ears and tinnitus in both ears beginning approximately 10 days after first vaccine on 03Feb2021.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in arm left on 03Feb2021 at 15:00 (at the age of 62-years-old) and dose 2 via an unspecified route of administration, administered in arm left on 25Feb2021 (Lot Number: EL9266), both as single for COVID-19 immunisation. The patient did not had any medical history and known allergies. Concomitant medications included fluconazole. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021 at 14:00, the patient experienced hearing loss in both ears and tinnitus in both ears beginning approximately 10 days after first vaccine. The onset was sudden and very abrupt. On 25Feb2021, the patient received the second vaccine and the condition continued. On an unspecified date, the patient "also had headaches for approximately two months but those have gone away for the most part" and "experience times where I feel off balance". The patient's hearing was so badly impacted that he had to get hearing aids for both ears. The adverse events resulted in doctor or healthcare professional office/clinic visit and disability or permanent damage. The ear, nose and throat doctor prescribed prednisone. The outcome of event dizziness was unknown and was resolving for the rest of the events.

achy; didn't feel great; This is a spontaneous report from a contactable nurse (patient's wife). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number EW0165 and expiry date Aug2021), via an unspecified route of administration, on left arm, on 05May2021 08:15 AM (at the age of 62-year-old), as dose 2, single for covid-19 immunisation. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously took Ibuprofen before getting Covid 19 vaccines. Historical vaccine included first dose of BNT162B2 (solution for injection; lot number EW0161 and expiry date Jul2021) via an unspecified route of administration, on right arm, on 16Apr2021 at 1:00-1:30PM (at the age of 62-year-old) as dose 1, single for COVID-19 immunisation; shingles vaccine and flu vaccine both given on unspecified dates, for immunization with no reactions. The patient did not receive any other vaccinations within four weeks prior to the first administration. On an unspecified date in 2021, after the second Covid 19 vaccine, the patient was achy and he did not feel great. It was reported that the patient never gets sick and healthy. The patient took the covid-19 vaccine to see his mother who was 94 years old. It was reported that the patient did go to the dentist on 05May2021 and received a Lidocaine injection at that appointment however it was also reported that the patient received a recall letter for lidocaine on 04May2021 (to be confirmed). The outcome for the events were unknown.

Extremely high sugar levels; Shortness of Breath (am COPD to begin with); flu-like symptoms; Malaise; Chills with no fever; This is a spontaneous report from a contactable consumer (Patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot Number: EN6198, expiration date not provided) via an unspecified route of administration (age at vaccination 62-year) in Left Arm on 02Mar2021 at 08:00 AM as DOSE 2, SINGLE for COVID-19 immunization. The medical history included chronic obstructive pulmonary disease, diabetes mellitus, coronary artery disease, and reaction to preservatives (known allergy: Food sulfites (MSG)) all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EL9269) administered in Right arm on 12Feb2021 at 08:00 AM for COVID-19 immunization. There was no COVID prior vaccination reported. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. On 03Mar2021 at 03:30 AM the patient experienced extremely high sugar levels, shortness of breath, flu-like symptoms, chills with no fever and malaise. It was reported that extreme onset of flu-like symptoms almost 20 hours after shoot. Chills with no fever. Shortness of Breath (am COPD to begin with). That relaxed after about 12 hours, but SOB continued. General malaise continued for a few days. Extremely high sugar levels persisted for a few days, readings over 500 and once even over 600 which is rare for me (diabetic). The patient underwent lab tests and procedures which included blood glucose increased: 500 (over 500) and blood glucose increased: 600 (over 600) on 03Mar2021. No treatment was received for the adverse events. The clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Violently Sick; Throwing up/ Violent vomiting to Biel for 6 hours straight; cannot drink fluids or foods for 12 hours plus.; Chills; Joint pain; barely able to move or walk; Fever/Fevor 101; barely able to move or walk; Muscle pain; Nausea; Feeling unwell; Injection site pain; Tiredness; arm pain; Headache; injection site redness; injection site redness & swelling; He has minor discomfort; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in arm left on 02Jul2021 at 10:30 AM (at the age of 62-year-old) as dose 2, single for COVID-19 immunization. Medical history included valtrex for infection in right eye, known allergies: mold, mildew, blue grass, dust, mites, cockroaches (start - 10 to 15 years). The patient concomitant medication included valaciclovir hydrochloride (VALTREX), allergy shots taken for allergy (patient stated it changes based on vials). Patient did not receive any other vaccine within 4 weeks prior vaccinations. Patient was not diagnosed with COVID prior vaccination. Patient was not tested COVID post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in arm right on 02Jul2021 at 05:45 PM (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. The patient experienced he has minor discomfort, diarrhea on an unspecified date in 2021; injection site pain (the date patient received the vaccine), tiredness, arm pain, feeling unwell (subsided from feeling violently sick yesterday), headache, injection site redness, injection site redness & swelling on 02Jul2021; nausea on 04Jul2021; violently sick (It started at 5am (67 to 68 hours after vaccination). It has mostly subsided, gone away. Patient stated he has recovered with lasting effects because he was so beat up from throwing up) on 05Jul2021 at 05:00 AM, throwing up/ violent vomiting to biel for 6 hours straight (at 5 or 6 am yesterday. It lasted around 6 hours until noon), cannot drink fluids or foods for 12 hours plus, chills (around 5 or 6 am), joint pain (5 to 6 am), barely able to move or walk, fever/fever 101 (5 to 6 am, patient temperatures are normal now), muscle pain (around 5 or 6 am) on 05Jul2021. Adverse events did not result in emergency room, physician office visit. Adverse event: 12 of the 17 listed side effects on fact sheet revised 10May2021. injection site redness and swelling, arm pain. Feeling unwell, off. Joint and muscle pain, barely able to move or walk. Chills & Fevor 101. Violent vomiting to bile for 6 hours straight. cannot drink fluids or foods for 12 hours plus. Patient is calling about the vaccine, stated covid 19. He got the vaccine, his second shot and had a reaction that is on the paperwork. The patient underwent lab tests and procedures which included fever was 101 on 05Jul2021. The patient received tylenol, advil and pepto-bismol as treatment medication for the events joint pain, nausea, headache, fever/fever 101, muscle pain. Outcome of the events violently sick, feeling unwell, he has minor discomfort, diarrhea was unknown; tiredness, arm pain, cannot drink fluids or foods for 12 hours plus, joint pain, headache, injection site redness, muscle pain was recovering; injection site pain, throwing up/ violent vomiting to bile for 6 hours straight was recovered on 05Jul2021; chills, barely able to move or walk, nausea, injection site redness & swelling, fever/fever 101 was recovered on 06Jul2021. Follow-up (PRD/SRD 08Jul2021): Follow-up attempts are completed. No further information is expected.

Based on report attached on patient file, exposed to wife who is COVID-19 positive. Outpatient visit on 7/22/21 presenting with runny nose and sore throat that started 7/17/21. SARS-CoV-2 (COVID-19) RNA [Presence] in Nasopharynx with non-probe detection~SARS-CoV-2 (COVID-19) RNA [Presence] in Nasopharynx with non-probe detection performed on 7/22/21. Came back positive. Case investigation interview with patient has not been conducted as of the time of this note.

Patient calls with report of irregular heart rate, shortness of breath, chest congestion, sinus congestion, loss of smell. There have been three positive COVID cases at his work. He is full vaccinated. Reports hx of afib.

Rash on left side of body; Extreme tiredness; Head aches; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 27Apr2021 at 09:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetes. The patient did not receive any concomitant medications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 09:45 (at the age of 62-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 28Apr2021 at 10:00, the patient experienced rash on left side of body, extreme tiredness and headaches. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events rash on left side of body, extreme tiredness and headaches was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Approximately 5 hours after the first jab I became very weak and exhausted. I laid down and got chills to the point I covered up with multiple blankets and started to tremble. Next at the time (unknown afterwards), I experienced the sensation like I was burning up and I began to sweat profusely. I literally felt like I was burning up. I suffer from osteoarthritis and the following day I experienced excruciating pain down my legs and in both hands. While this was occurring my hands became inflamed and I couldn't make a fist. The chills and pain continued over the next four days with the addition of a dull yet present headache in the centre of the forehead. Approximately two days later I experienced the continued swelling in both hands but now the pain lessened and was replaced with needles and pins type tingling in both hands and feet. this lasted about 4 more days. What remained permanent is a trigger finger in the left index finger that is very painful especially in the morning. Also I am have difficulty sleeping

Since the vaccine: nerve issues including tingling and pain, heart palpitation/racing heart beat, burning in arms and shoulders, anxiety, depression, weakness, dizziness, itchy skin, sun sensitivity, heat sensitivity, brain fog, exhaustion/fatigue, tremors, tight chest

Severe headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 at 11:30 (at the age of 62-year-old), as a single dose for COVID-19 immunisation. Patient had no medical history. The patient had no known allergies to medications, food or other products. Concomitant medications included levothyroxine 150 mcg (MANUFACTURER UNKNOWN), colchicine 0.6mg (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date. The patient did not receive any other vaccination within four weeks prior to the COVID-19 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 26Mar2021 at 10:00, the patient experienced severe headache four days after first vaccine. The event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of severe headache and included treatment with ibuprofen 600mg (MANUFACTURER UNKNOWN). The clinical outcome of the event severe headache was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

62 year old male presented for 1st dose COVID vaccine with pfizer. 15-minutes post-vaccination the patient complained of having a minor headache. At this time he expressed no other concerns or symptoms. The patient was moved to a shaded area and provided water. Upon further questioning in Spanish the patient reported that his HA was progressively worsening since onset and he had an associated "tightness" and sensation of a growing lump in his throat. Patient denied SOB, chest tightness, difficulty breathing, itching, hives, lightheadedness, N/V. At this time the decision was made to contact EMS. EMS arrived at 1804 and evaluated the patient. During evaluation the patient reported improvement of his HA and throat discomfort. EMS instructed patient to be evaluated at the local ER. However, the patient refused and signed to leave AMA. Patient left the site at 1825 and stated he would take the bus home. Education was provided and patient instructed to follow-up in ER if symptoms re-emerge.

Chills; Tiredness; Headache; Muscle pain; Fever; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0172) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date. Concomitant medications included salbutamol (ALBUTEROL) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), both for unknown indications from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent nasal swab test and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021 at 15:45, the patient experienced chills, tiredness, headache, fever and muscle pain. The clinical outcome of the events of chills, tiredness, headache, fever and muscle pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Dizziness cough (allergies, per Pt.) noted; appeared anxious Narrative: c/o dizziness. given juice. HX. HTN. @0945 BP 170/81, P. 93, R 18, O2 96%; @ 0955 BP 143/76, P. 89, R 18, O2 97%; @ 1005, BP 175/82, P. 87, R. 18, O2sat 97%. Sent to ED for further evaluation. Given IV fluids for dehydration. resolved.

Joint pain; I started feelings like I am having flu like symptoms like chills; Body fatigue; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported ), via an unspecified route of administration on the upper arm on 23Dec2020 at a single dose for COvid-19 immunization. Medical history included triglycerides (abnormal). Concomitant medication included eicosapentaenoic acid ethyl ester (VASCEPA) for triglycerides. The patient is a dialysis technician in a dialysis Unit. The vaccine was given in a facility. The patient got the Covid Vaccine on 23Dec2020 and its like more than a week now, on an unspecified date, he felt joint pain, body fatigue and two nights ago, he started feelings like he was having flu like symptoms like chills he took his temperature and its normal so he doesnt know if there is a reported reactions like this that he was feeling and he would like to know what does he needs to do, to know anything and an advice. He was scheduled for the blood work done at this month. The patient was taking only paracetamol (TYLENOL) for his joint pain, and chills and that's the only thing that he is experiencing right now. The consumer did not undergo emergency room or physician office. Outcome of the event chills was not recovered, while for the other events was recovered on an unspecified date. Information on the lot/batch number has been requested.

Fever to 102 degrees F; This is a spontaneous report from a contactable physician (patient himself). A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at site of left arm at 12:45 on 29Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient had fever to 102 degrees F at 15:00 on 01Jan2021. The patient had Nasal Swabars for COVID test with negative result on 04Jan2021. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The case was identified as non-serious by reporter. The outcome of event was recovered in Jan2021. Information on the lot/batch number has been requested.

Only slight soreness at injection site first day. I was physically working hard out of town with limited sleep for next three days. I began experiencing significant body aches and pains, sneezing and minor congestion. However, activity involved substantial dust as I was sanding a floor. Saturday, January 2, I began having more extensive cold symptoms, coughing and runny nose with continued body aches and pains. I scheduled a covid test on Monday, January 4, scheduled for Wed. January 6th. I received positive results on Friday. January 8. On Saturday, January 8, I began developing increased light headedness and self monitored my blood pressure. It was at 191/107 when I went to Hospital to have it checked. I was released that afternoon.

COVID-19 PCR test/he was positive per the PCR test; COVID-19 PCR test/he was positive per the PCR test; Sweating; Fever; running to bathroom with urination every 15 minutes with a large amount of urine; running to bathroom with urination every 15 minutes with a large amount of urine; Heart pounding; tired and fatigue; Weight loss; Chills; pain all over the body; Sluggishness; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date was unknown), via an unspecified route of administration on the left arm on 21Dec2020 14:40, at a single dose for Covid 19. The patient's medical history and concomitant medications were not reported. The patient has no prior vaccinations -within 4 weeks. The patient is an EEG technician. On 22Dec2020, the patient reported the next day he started to feel sluggish, chills, tired/fatigue, pain all over his body, patient mentioned he has lost weight everyday since he got the shot from 153 pounds to 142 pounds; then on Wednesday evening 23Dec2020, it was a nightmare, he got sweating; fever with a high of 101.4 Fahrenheit; he was running to bathroom with urination every 15 minutes with a large amount of urine; and he was so tired and fatigued. Added when he was getting up all that night he was having night sweats up to five times a night and chills; and his heart was pounding. The urination, heart pounding resolved the next day. All of these events have improved at the time of report (now) or gone away but he is still sweating once at night for the last two days and he is tired and fatigued. He stated that he is scheduled for the second dose on 11Jan2021 and he is concerned if he should take the vaccine. He mentioned that he was tested for COVID 19 on 18Dec2020 and the result was inconclusive. He went again 23Dec2020 they called him on 25Dec2020 and informed he was positive per the PCR test. He treated himself with 500mg acetaminophen (UPC 0904672059; lot OBE2896 and expiration Oct2021) and azithromycin Z-Pack (NDC 65862-641-69; Lot ZYSA20012-A; and expiration date Mar2022). The sample of the product is not available to be returned. Predisposing factor was that the patient's wife was at home and was sick too at the same time. She was tested Sunday with no results yet. The outcome of the events of fever recovered on 28Dec2020, sluggishness recovered on 29Dec2020, pain all over the body was recovered on 02Jan2021; running to the bathroom with urination every 15 minutes with a large amount of urine and heart pounding were recovered on 24Dec2020, weight loss was not recovered, and for other events was recovering.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (4 days in this case). However, a causal relationship between event "COVID-19 PCR test/he was positive per the PCR test" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded

About an hour later, slight headache. Around 2am on 1/12, woke up with hip joint pain. On 1/13 slight injection site pain and continued hip pain, and around 11am had slight nausea that went away. 1/14 still have hip pain.

sore throat, runny nose, headache, shortness of breath. Stated started on January 5, 2021. Reported to staff 01/15/2021.

Progressive symptoms of mild itchyness of skin all over body on first day to painful pin and needles sensation with continued itching over entire body only occuring at night by day 7 . Symptoms are temporarily relieved with zyrtec and famotidine. Symptoms are ongoing and getting progressively worse each night. No rashes are observed so far. Headache and severe dizziness with nausea were experienced on day 4 but only lasting 4 hrs.

MUSCULAR MILD ACHES GRADUALLY DEVELOPED TO STRONG ACHES TO PAIN AND MUSCLE TIGHTNESS BY 3 HRS OF SYMPTOMS ONSET.(ARMS AND THIGHS). TENDERNESS AT LYMPH NODE AREAS OF AXILLA AND GROIN. LIGHT SWEATING W/O FEVER BY 8 HRS OF SYMP ONSET. GENERALIZED MALAISE AND TIREDNESS FOR 15 HRS FROM SYMPS ONSET. TOOK TYLENOL 650 MG PO., Q 4HRS WITH IBUPROFEN 800 MG

Severe join Pain/ all over/ groin pain/ muscle pain/ night cramps/headaches/ injection pain/ feel unwell/ like sinus infection/ fatigue/ fall asleep midday. 3 weeks later. Still have some body pain/ still fatigued/ unwell and headache. Dizzy sometimes. Not my normal/ alert athletic self. Haven?t felt like exercising since took shot.

LOW GRADE FEVER, JOINT AND MUSCLE ACHES, PAIN AT INJECTION SITE, SLEEPINESS FROM LATE EVENING ON 01/07 TO EVENING OF 01/08. ABOUT 22 HRS TOTAL. TOOK EXTRA TYLENOL. ONE PILL TAKEN TWICE DURING REACTION TIME.

Pt awoke multiple times in the early morning sleeping period profusely sweating and needing to change of clothes, sheets/blankets and undergarments at times 1:00AM, 3:00AM, 5:00AM, fever, headache. Symptoms have improved with Panadol medicine dose. Pt states since 1st dose feeling of drunkenness' and imbalanced has persisted.

rash; developed symptoms of covid on 27Dec / on 30Dec2020 he tested positive for the virus / cough; developed symptoms of covid on 27Dec / on 30Dec2020 he tested positive for the virus / cough; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the 1st does of bnt162b2 (BNT162B2) at single dose left upper arm on 23Dec2020 for Covid-19 immunisation, administered at hospital. Medical history included ongoing hypertension that began maybe 10 years before and still ongoing, controlled with medication. No family medical history relevant to the events. The concomitant medications included paracetamol (TYLENOL). History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the suspect. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. He has not had reactions to any other vaccines. On 30Dec2020 he tested positive for Covid. His symptoms of covid started 27Dec2020 in the evening sometime probably around 7pm. He experienced cough in Dec2020. No visit to physician office was required. On the 06Jan2021 he went to the emergency room but that was because he was concerned about rash he developed. He thought it was due to the Tylenol he was taking. Relevant tests performed in Ja2021 included: blood work and chest X-ray did when he went in for the rash and they were was fine. He was treated with steroid injection for the rash. The rash cleared up in the next couple days. As of 12Jan2021 the only thing he has cough but he coughs anyway. He still had a cough but it was not atypical for him to have a cough. He was scheduled to receive his second dose on 13Jan2021. He no longer had any Covid symptoms and wanted to know if he could still get the second dose as scheduled. The outcome of event tested positive for the virus and not recovered was unknown, of coughs was not recovered. A Product Complaint was filed. Information on lot/batch number has been requested.

At home, approx. 45 minutes after shot, lips started tingling, then itching. Around 10 minutes later, throat began feeling irritated/scratchy. Approx. 10 minutes later lower lip became swollen. I took half a Benadryl. Never had any difficulty breathing or swallowing. Presentation never got any worse. Tingling of lips lasted most of day, but milder than initial reaction - other symptoms gone in approximately an hour after taking the Benadryl.

pt developed a partial small bowel obstruction which required surgical intervention. He was found to have an adhesive band compressing the small intestine. There was no other signs of pathology in the abdomen. The pts only other surgical procedure was a right inguinal hernia repair which was distant from the site of the band. The pt began with persistent nausea, crampy pain and vomiting 5 days after his first dose of the Pfizer vaccine.

After approx 22 hours, a bit chilled, tired; After approx 22 hours, a bit chilled, tired; Went home, dosed a bit, have 99.4 f temp; This is a spontaneous report from a contactable Other-HCP. This 63-year-old male Other-HCP (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular at left arm on 12Jan2021 02:00 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medications included diltiazem, tamsulosin. Historical vaccine included the first dose of BNT162B2 via intramuscular at left arm on 21Dec2020 08:00 AM for COVID-19 immunization. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. On 13Jan2021 00:00 AM (after approx 22 hours), patient had a bit chilled, tired; he went home, dosed a bit, had 99.4 f temp. No treatment was received. Outcome of events was not recovered. Information on the lot/batch number has been requested.

The second dose of Covid Vaccine knocked me out completely : headache, fever ,chills and pain at the injection site . Duration of effects: 48 hours

After receiving first dose of covid vaccine and sitting the observation area, patient complained of a tingling sensation around his lips. The observation nurses continued to observe him, and a few minutes later he developed numbness on his nose, followed by a dry cough. Within a few minutes his lower lip started to swell. Patient showed no signs of respiratory distress, and was alert and oriented. He was then escorted by RN in a wheelchair to the ED for evaluation

soreness in left arm; feeling kind of achy; was wanting to run a fever/Very high fever in excess of 102 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EJ1686) via an unspecified route of administration on 04Jan2021 at a single dose on the left arm for vaccination. Medical history included ongoing hypothyroidism. Concomitant medication include levothyroxine (manufacturer unknown) from an unspecified date probably 2-3 years ago and ongoing for hypothyroidism. The patient reported that the first dose was administered of the Pfizer COVID-19 Vaccine on 04Jan2021. He had onset of soreness in left arm that day, 14Jan2021 which he recovered completely from by 05Jan2021. He stated that starting maybe 05Jan2021 or 06Jan2021, he had onset of feeling kind of achy and like he was wanting to run a fever. Starting 08Jan2021, he started running a very high fever in excess of 102 degrees Fahrenheit which has been ongoing and persistent since then. He has been taking Tylenol every 6 hours to try to control the high fever but the high fever is just not going away. He was wondering if there is anything he can do because his primary care physician (PCP) can't really help him at the clinic; He was wondering if Pfizer is familiar with this reaction and if there are any recommendations regarding them. He has taken Tylenol to help, but it is not making it go away. He wanted to know if steroids could be used to counteract this side effect. He added that he is supposed to get the second dose 25Jan2021 but he does not plan to get the second dose, at this point he does not want to do that. He was administered the vaccine because his mother lives in an assisted living facility where the vaccine was offered to residents; and because he acts as a sitter at the facility it was offered to him. On 11Jan2021 he went to Urgent Care for these events, and was given a Rapid COVID-19 Test which had negative result. The outcome of the event soreness in left arm was recovered on 05Jan2021, the outcome of the event was wanting to run a fever/very high fever in excess of 102 degrees fahrenheit was not recovered and the outcome of the event feeling kind of achy was unknown.

strong shaking; teeth chattering; temperature went up to 101; consumed very little food in 48 hours; This is a spontaneous report from a contactable other-HCP, the patient. A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3249), via an unspecified route of administration on 16Jan2021 at 08:45 (at the age of 63-years-old) as a single dose, in the left arm for COVID-19 immunization. The patient has no relevant medical history, no known allergies and no prior vaccine reactions. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen at an unknown dose, for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Jan2021 at 10:45, the patient experienced strong shaking, teeth chattering. On 16Jan2021 the patient experienced fever up to 101 and on an unknown date in Jan2021 the patient experienced consuming very little food. The patient did not receive therapeutic interventions for the events. The patient described the clinical course as follows: two hours after vaccine administration the patient experienced strong shaking and teeth chattering as would be normal for influenza or Noro Virus per patient. The patient's temperature went up to 101 and the patient was in bed with fever for 40 hours, the patient consumed very little food in 48 hours, and maintained fluid intake. The patient reported he had no nausea, no diarrhea. The patient stated it was unpleasant to the point of not being to do anything but lay in bed. Then, at about 40-48 hours temp was gone, and the patient felt very close to normal and the patient resumed eating. The clinical outcomes of the strong shaking, teeth chattering, temp went up to 101 and consumed little food were recovered on an unknown date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

severe headache; dizziness; nausea; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration (left arm) on 16Jan2021 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) on 26Dec2020 for Covid-19 immunization. The patient's medical history included sleep apnea and increased blood pressure (managed); no known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, dizziness, nausea on 16Jan2021. There was no treatment received for the adverse event. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination

Mild headache. malaise, extra "aching" is areas of known osteoarthritis. Started about 12 hours after vaccine. Resolved about 36 hours after vaccine.

Fever, soreness at site of vaccine and headache were only present early on and resolved in 48 hours of the vaccine. Then after a few days, these symptoms started (below): PAIN in every joint, large and small, including vertebral spine, shoulders, hips, knees, elbows, hands and feet, fingers and toes, as well as costochondral joints in the ribs; SWELLING and REDNESS in many joints including most of right foot, some of left foot, knees, hips and sacroiliac joints. On and off headache. Slight reduction, but still present after 3 weeks.

fatigued and tired; weak; This is a spontaneous report from a contactable consumer (patient's wife). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration (arm) on 19Jan2021 at single dose for Covid-19 immunization (also reported as Covid protection). The patient has no medical history. The patient's concomitant medications were not reported. The reporter confirmed that the patient does take other medications, but they never make him tired or weak. The reporter also confirmed that the patient did not receive any other vaccines on the same day as the COVID vaccine. It was reported that the patient took the Covid 19 vaccine on Tuesday (19Jan2021). The patient was fatigued and tired on 21Jan2021. It was further reported that the patient was tired and weak on 21Jan2021. The reporter added that that she knows tiredness and weakness are known side effects of the product, but she wanted to know how long after they get the vaccine those side effects last, and to what degree do they occur. The outcome of events was unknown.