Pfizer

Flu-like symptom reports

Male, 60 - 75 years

Age Reported Symptoms Notes
60 2021-01-04 headache, chills, malaise Chills- HA's and feeling unwell; Chills- HA's and feeling unwell; Chills- HA's and feeling unwell; T... Read more
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.
60 2021-01-05 chills, sweating DIZZY , VOMITING, SWEATING 15 MIN AFTER VACINATION LASTED 5 MIN THEN 2 -3 HOURS OF CHILLS
60 2021-01-05 fatigue, headache, chills Tiredness; nausea; headache; chills; This is a spontaneous report from a contactable Other HCP, the ... Read more
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.
60 2021-01-05 fever, chills Low grade fever,Chills, muscle and joint pain. No treatment required. Symptoms resolved on 01/06/21
60 2021-01-06 headache, malaise, fever Low grade fever, malaise, headache, mild body aches, sort of out of it at times. Stated feeling bad... Read more
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.
60 2021-01-07 chills Approximately 11:00 am I got crazy chills, put on my coat, and turned a heat lamp on, this lasted ab... Read more
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.
60 2021-01-07 headache Dizziness, Headache, Arm sore and painful. C/O feeling eye pressure
60 2021-01-07 fever Fever; He sweated the whole night; He slept for 24 hours and that is abnormal; This is a spontaneous... Read more
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.
60 2021-01-08 fever Myocardial Infarction: patient began to complain of severe chest pain 3 hours after the vaccine was ... Read more
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.
60 2021-01-08 fever Fever fever Narrative:
60 2021-01-09 influenza like illness, headache body aches, injection site soreness, joint stiffness, nausea, head ache, flu like symptoms
60 2021-01-10 headache, fever, throat pain, chills pt states experienced headache, soar throat, bone pain to (R) hand, chills, and low grade fever onse... Read more
pt states experienced headache, soar throat, bone pain to (R) hand, chills, and low grade fever onset night of vaccination lasting 2-3 days
60 2021-01-10 headache Headache, Myalgia & NauseaVomiting Narrative:
60 2021-01-11 fever, chills Low grade fever; muscle and joint pain; muscle and joint pain; mild chills; This is a spontaneous re... Read more
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.
60 2021-01-12 influenza like illness Joint pain in both shoulders and knees; flu like symptoms; This is a spontaneous report from a conta... Read more
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.
60 2021-01-12 fever, fatigue Fever 103+ the night of. Deep fatigue and low grade fever the following day. Large area of pain an... Read more
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.
60 2021-01-12 fever, headache Headache, Myalgia, Arthralgia & Fever Narrative:
60 2021-01-14 chills, influenza like illness, fever, fatigue The night of the vaccination I became ill with flu-like symptoms. I experienced muscle aches, chills... Read more
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.
60 2021-01-14 chills, fever, headache Fever up to 101.1, 2 days after vaccine administration, chills, headaches, moderate to severe body ... Read more
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.
60 2021-01-14 nasopharyngitis, throat clearing One week of the vaccine, while having some coffee and cookies. About tens of consuming them, I felt ... Read more
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.
60 2021-01-15 fever, headache, chills Fever, chills, headache, myalgia
60 2021-01-18 cough Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient... Read more
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.
60 2021-01-18 headache Slight dizziness, forgetfulness, increased sinus discharge, headache, memory lapse
60 2021-01-18 fever, chills I had fever and severe chills/ shaking
60 2021-01-19 body temperature increased Body aches, temperature 102.7, chest tightness
60 2021-01-19 chills, fever Fever of up to 101.2 Fahrenheit; Chills; muscle soreness; This is a spontaneous report from a contac... Read more
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.
60 2021-01-20 headache Abd pain, diarrhea, HA
60 2021-01-21 fatigue, fever, throat pain 1/19 2300- INJECTION SITE DISCOMFORT 1/20 0100- FEELING OF FEVER, BODY ACHES, SORE THROAT 0830- NAUS... Read more
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
60 2021-01-21 headache, fever, chills Chills (freezing/shaking), headache, fever.
60 2021-01-22 sweating, headache Shakes headache nausea sweats for 7 days weight loss
60 2021-01-23 chills, fever, headache Patient experienced fever 103 degrees, body and muscle aches, chills, ringing in the ears, headache... Read more
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.
60 2021-01-24 fatigue On the third day I woke up with body aches and extreme fatigue.
60 2021-01-24 headache Elevated blood sugar, unable to get it under control. Right side of skull and face extremely painful... Read more
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.
60 2021-01-25 chills, fever Had the shot at 8pm on 1/21. Starting the morning of 1/22 when I woke up, was stiff and achy. As the... Read more
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.
60 2021-01-25 fever, chills, fatigue Fatigue and muscle ache morning after. Chills, Fever developing afternoon after injection. Took Tyle... Read more
Fatigue and muscle ache morning after. Chills, Fever developing afternoon after injection. Took Tylenol
60 2021-01-26 chills, headache Extrem headache and chills
60 2021-01-26 headache Headaches, body aches, nausea, & loss of appetite.
60 2021-01-27 chills, fever fever; chills; This is a spontaneous report from a contactable consumer. A 60-year-old male patient... Read more
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.
60 2021-01-27 fever, chills, headache, fatigue Chills; Fever 101.9; Fatigue; Body aches; Headaches; This is a spontaneous report from a contactable... Read more
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.
60 2021-01-27 fever, chills Metallic taste beginning 20 min after injection. Chills beginning 15 hours after, then fever up to ... Read more
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.
60 2021-01-28 chills, fatigue This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient recei... Read more
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.
60 2021-01-28 headache, fever Muscle aches, fever, diarrhea, really bad chills, headache
60 2021-01-28 fever, chills I had chills, 102.7 fever that lasted the evening of 27th until about noon on 28th, some loose stool... Read more
I had chills, 102.7 fever that lasted the evening of 27th until about noon on 28th, some loose stool but a lot better
60 2021-01-29 fever, chills Chills/fever 14 hours after injection Lasted about 7hours
60 2021-01-31 headache, chills Second shot vaccine was end of Jan 2021 chills that lasted 48 hours, I lost appetite the next day fo... Read more
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.
60 2021-01-31 headache headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male pat... Read more
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.
60 2021-02-04 chills, fever, fatigue CHILLS, FEVER UP TO 105.5, FATIGUE, ANOREXIA,
60 2021-02-04 fever, fatigue Fatigue, muscle aches, low grade fever (99.8). Treatment Advil with mild improvement. Outcome conti... Read more
Fatigue, muscle aches, low grade fever (99.8). Treatment Advil with mild improvement. Outcome continue to work does not interfere with ADLs.
60 2021-02-12 fever The first day, soreness at the sight of the injection. Days 4-5, a fever 3 degrees above normal.
60 2021-02-17 fatigue Double Covid Pneumonia; feeling tired; weak; doctors were concerned that the Covid vaccine had taxed... Read more
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.
60 2021-02-17 fever This is a spontaneous report from a contactable consumer. A 60-year-old male patient received second... Read more
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.
60 2021-02-17 fever I had a really severe left shoulder ache. I couldn't lay on that side, and I had general body aches ... Read more
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.
60 2021-02-18 sweating, headache, fever Fever, body aches, headache, rapid heart rate, short of breath, sweaty, 3 hour priapism
60 2021-02-21 chills Diarrhea; body aches; chills; This is a spontaneous report from a contactable consumer. A 60-year-ol... Read more
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.
60 2021-02-23 chills, headache, fever Upset stomach, headache, severe entire body aches short of breath, diarrhea, chest pressure, chills,... Read more
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.
60 2021-02-23 headache 1 day post second Covid 19 vaccine patient experienced severe headache that progressively intensifie... Read more
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.
60 2021-02-25 chills, throat pain Phizer-BioNtech COVID-19 Vaccine EUA. Mild, sore throat for a 30 minute period; then dizziness; then... Read more
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.
60 2021-03-04 headache headache, "feels like something in throat" nauseous. Evaluated by EMS- Cleared
60 2021-03-04 fever Fever of 99.1 degrees, soreness at injection site.
60 2021-03-04 sleepiness The described waking up around 9pm after going to be early the day after he received the vaccine. ... Read more
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.
60 2021-03-07 sweating, chills, headache 12-14 HOURS AFTER RECEIVING THE VACCINE PATIENT REPORTS HE DEVELOPED HEADACHE, MUSCLE ACHES, CHILLS,... Read more
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.
60 2021-03-08 fever, influenza like illness, headache Fever and headache. Felt flu-like for 24 hours. By Sunday morning I was fine
60 2021-03-11 fatigue, fever Very sore arm. fatigue and fever March 9th ,10th and 11th. Dizziness the morning of the 12th. No is... Read more
Very sore arm. fatigue and fever March 9th ,10th and 11th. Dizziness the morning of the 12th. No issues after lunchtime on the 12th.
60 2021-03-11 sweating During observation felt hot and sweating No LOC vision blurred Responded to lying down
60 2021-03-11 sweating After first dose of vaccine, developed 5/10 persistent chest pain accompanied by diaphoresis. Known ... Read more
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.
60 2021-03-12 fatigue, body temperature increased Escalated temperature in a range of 99.9 to 100.7 over a 19 hour period of time. Extreme fatigue - D... Read more
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
60 2021-03-13 headache Diarrhea began about 4:30 pm on 3/1/2021, continued intermittently for 4-5 hours. Significant loss ... Read more
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.
60 2021-03-14 headache, fatigue fatigue; problems with his gall bladder; 2nd day joint pain; First day sore arm; slight headache/hea... Read more
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.
60 2021-03-15 headache, fever Patient received Pfizer vaccine on 3/5/21. On 3/13/21 patient had fever, headache, diarrhea and test... Read more
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.
60 2021-03-15 sweating Pt began to feel lightheaded and dizzy. He did pass out while sitting in chair. Quickly came back,... Read more
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.
60 2021-03-16 body temperature increased, fever Fever, Lightheadedness, Shortness of breath 15 minutes post vaccination felt very dizzy with SOB. ... Read more
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
60 2021-03-16 headache Body aches, headache vomiting diarrhea, high white blood count, accelerated heartbeat
60 2021-03-16 productive cough, cough I have a lot of chronic coughing all throughout the day and at night when I'm trying to sleep at nig... Read more
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
60 2021-03-17 chills, fever Severe chills with uncontrollable shaking that lasted 4-5 hours. Fever up to 103.7F for 24 hours. Al... Read more
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.
60 2021-03-17 throat pain WEAKNESS - GENERALIZED GENERALIZED BODY ACHES SORE THROAT ALLERGIC REACTION
60 2021-03-18 fatigue, cough, headache, upper-airway cough syndrome Started briefly with a drip that led to a cough at about one hour. That went away but then headache ... Read more
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.
60 2021-03-18 headache, chills, fatigue, fever 10 hours after vaccine administered. Started with cloudy vision and a headache. Went to bed. Awoke t... Read more
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.
60 2021-03-18 sweating Sweating When Veteran returned to receive his 2nd Pfizer COVID-19 vaccine on 3/15/21, he reported th... Read more
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.
60 2021-03-18 sweating Patient felt nausea and started dry heaving. He was sweating profusely and had tremors. BP 140/60,... Read more
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.
60 2021-03-19 headache Headache, serious joint and muscle pain that lasted for about 30 hours
60 2021-03-20 cough her husband could have been exposed or contracted COVID-19 on that Friday before receiving his vacci... Read more
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.
60 2021-03-20 headache, chills Headache, chills, stomach cramps
60 2021-03-20 headache, throat irritation Patient complained of headache and throat itching and difficulty swallowing.
60 2021-03-20 headache Continual headache.... forehead.
60 2021-03-21 fatigue, influenza like illness, headache "flu-like" started 03/20/21 in the afternoon. Has had nausea, tiredness, headache, bodyaches that ... Read more
"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.
60 2021-03-21 fatigue, fever, throat pain, chills The following day after the second shot, I had a fever for 24 hours, lost my sense of taste, injecti... Read more
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.
60 2021-03-21 fatigue, sleepiness, influenza like illness, chills, headache, fever, lethargy Flu like for 24 hours. Starting at 8am I was very lethargic. Absolutely no energy. Progressed to te... Read more
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.
60 2021-03-22 headache, chills, fatigue Arm pain first day. Lightheaded, feeling like fainting, dizziness, above stomach pain nausea, that h... Read more
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.
60 2021-03-22 headache 1) Cup right ear with hand; Arc described from thumb to little finger, 1/2 -1" depth. Needle sharp ... Read more
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.
60 2021-03-22 headache Sore joints in upper body, neck, shoulders, elbows , wrists & hands. Fingers are tingly and numbing... Read more
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
60 2021-03-23 chills, fever, headache Splitting headache in the afternoon followed by 100.8 fever, chills, and body aches starting about ... Read more
Splitting headache in the afternoon followed by 100.8 fever, chills, and body aches starting about 2 AM.
60 2021-03-23 headache, fever, chills Fever, joint aches, chills, headache lasting from about 11:00 p.m. the night of the vaccination date... Read more
Fever, joint aches, chills, headache lasting from about 11:00 p.m. the night of the vaccination date through around noon the following day.
60 2021-03-23 sweating Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All ... Read more
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
60 2021-03-23 runny nose Runny nose, sensation of throat closing up, difficulty swallowing. I could continue breathing nasal... Read more
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).
60 2021-03-24 fatigue, fever, headache headache, low grade fever, muscle/joint soreness, fatigue for about a day and a half.l
60 2021-03-24 headache, chills Body aches, chills, and head ache for approximately 48 hours. Took ibuprofen to help reduce symptoms... Read more
Body aches, chills, and head ache for approximately 48 hours. Took ibuprofen to help reduce symptoms.
60 2021-03-24 fever After vaccine shot developed 102-103 fever for about 36 hours. Everything back to normal on Wednes... Read more
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
60 2021-03-24 upper-airway cough syndrome, fever, fatigue, chills Rapid heartbeat (90-115bpm) for 2-3 days while laying in bed. Low pulse ox (88) Fever (101-102F) and... Read more
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.
60 2021-03-25 sweating series of 4 periods where I became quite hot inside and broke out in a heavy dripping sweat over a p... Read more
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.
60 2021-03-25 sweating Left upper extremity felt numbness and tingling to Right Chest. Pt experienced some diaphoresis to ... Read more
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.
60 2021-03-25 fever, fatigue, chills rashes, fever, chills, pain in joints and legs, extreme tiredness
60 2021-03-25 sleepiness Excessive sleepiness, Bad taste in my mouth
60 2021-03-25 throat irritation Patient waited 30 minutes after the shot was given then drove home. While driving, he experienced sc... Read more
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.
60 2021-03-26 influenza like illness, headache, chills, fatigue, fever Flu-like symptoms: fever (100.6), chills, headache, fatigue, nausea
60 2021-03-27 chills, body temperature increased At around 2:20 in the morning I started getting really bad chills and shakes, I got 103 temperature ... Read more
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
60 2021-03-27 chills, sweating Saturday 313 am, chills, 400am extreme sweats ended by 630am - 718am unable to breathe, It felt like... Read more
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.
60 2021-03-28 fatigue, fever, headache Fatigued, Nausea, Headache, Slight Fever, Occasional Irony taste in throat
60 2021-03-29 chills, headache, nasopharyngitis Started being cold around 11:00 on 3/29 - less energy throughout day - goose bumps from being cold a... Read more
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.
60 2021-03-29 headache, chills, fever Severe hives outbreak all over the body 4 days after second dose of Pfizer vaccine. Hives started in... Read more
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.
60 2021-03-29 fever, chills, headache Muscle aches, joint aches, chills, fever, head ache, muscle spasms
60 2021-03-29 fever Pain in arm where vaccinated, body aches, fever
60 2021-03-30 headache loss of taste; possible allergic reaction to the drug; Can't pronounce words right; can't close righ... Read more
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.
60 2021-03-30 fever Woke up feeling foggy, achey, low grade fever (98.8 F). Just moved slow for most of the day, really ... Read more
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.
60 2021-03-31 chills, fever, fatigue Fever of 102°, ,chills, body aches and fatigue.
60 2021-03-31 fatigue, headache Initially headache, and sore arm at injection site. Only sore on contact and not too bad. Fatigue an... Read more
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.
60 2021-03-31 fatigue, fever, chills, headache Headache, muscle aches, chills, high fever, rash,, swollen joints, fatigue, minor chest congestion l... Read more
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.
60 2021-03-31 fatigue The day of vaccination I felt like I was on steroids. I had lots of energy and felt a bit aggressiv... Read more
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.
60 2021-03-31 headache Neck pain Radiating head pain Headache
60 2021-03-31 fever, runny nose, nasopharyngitis He got his vaccine, and on Saturday 3/27/21 started having a slight fever, head cold/foggy head, sli... Read more
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.
60 2021-03-31 fever, throat irritation, chills, fatigue Day 1-Chills/Shaking, Body Aches, Dizziness, Itchy Throat, wheezing breathing, difficult walking, ex... Read more
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.
60 2021-03-31 sleepiness, chills, sweating Arm pain at injection site started 24hours later lasted 72 hours, Drowsiness started with in hours o... Read more
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.
60 2021-04-01 headache, chills, fever Chills,Body Aches, Headache, Feverish/Hot. In bed two days. Mostly bad aches from my arthritis I wo... Read more
Chills,Body Aches, Headache, Feverish/Hot. In bed two days. Mostly bad aches from my arthritis I would guess. Made it much worse.
60 2021-04-01 throat pain, throat irritation, malaise Awoke around 10:00 next morning, March 31, with a bad sore throat, and feeling of fullness in my t... Read more
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.
60 2021-04-02 headache, fatigue, influenza like illness Feels like flu, exhaustion, lousy feeling, headache
60 2021-04-02 fever, headache Fever, headache , body aches, tried Ibuprofen and acetaminophen lots of rest. Lasted about 36 ho... Read more
Fever, headache , body aches, tried Ibuprofen and acetaminophen lots of rest. Lasted about 36 hours
60 2021-04-03 chills, lethargy, sleepiness First injection: Sore arm that received initial injection for about one day. No treatments. Second... Read more
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.
60 2021-04-03 chills, fever Chills, fever, soreness in injected arm.
60 2021-04-03 fatigue Had shot at 2:30 Pm, Sitting in my truck and about 2:35 i started getting a warm feeling in my legs... Read more
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)
60 2021-04-03 throat pain, headache, fatigue, chills Fatigue, Sore Throat, Chills, Headache, Some Nausea, Soreness at the Injection Site, Fast Palpitatio... Read more
Fatigue, Sore Throat, Chills, Headache, Some Nausea, Soreness at the Injection Site, Fast Palpitations
60 2021-04-03 fever, chills, headache Fever, Chills, Headache. No treatment. Symptoms abated after about 24 hours.
60 2021-04-04 fatigue, headache, fever 4/3/21 Fever 101.6 F, minor headache, moderate fatigue, slight throat discomfort 4/4/21 adverse rea... Read more
4/3/21 Fever 101.6 F, minor headache, moderate fatigue, slight throat discomfort 4/4/21 adverse reaction gone
60 2021-04-05 headache 4/3/2021, Initial Stinging pain at time of injection 4/3/2021 - 4/5/2021, Pain on the left arm (in... Read more
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
60 2021-04-05 headache On 4/2/2021 my dad feel headache and nausea. no power right side arm and leg
60 2021-04-06 fatigue, chills, headache lightheaded; stomach pain; feeling like fainting; that happened parallel to erratic high blood press... Read more
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.
60 2021-04-06 fatigue Starting Monday at work I began to feel very tired, my muscles started aching across my back at shou... Read more
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.
60 2021-04-06 headache, fatigue All symptoms began 21 hours after shot. Extreme fatigue continued for 24 hours. Body aches continued... Read more
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.
60 2021-04-06 headache earache, headache and Bell's Palsy on left side of fac
60 2021-04-06 headache SOB, nausea, headache. Felt chest heaviness. Vital signs wnl, O2 sat 97%. Given albuterol 2 puffs. W... Read more
SOB, nausea, headache. Felt chest heaviness. Vital signs wnl, O2 sat 97%. Given albuterol 2 puffs. Went to ED.
60 2021-04-06 influenza like illness, chills, sweating, fatigue Woke middle of night (04/06/21 at 3:30am) w/extreme chills. Took 1000mg acetaminophen. Woke back u... Read more
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.
60 2021-04-07 headache Adverse event: Severe headache Treatment: Tylenol Outcome: Relief
60 2021-04-07 fever, chills chills 4am 4/8 fever noon - 4/8 achiness noon 4/8
60 2021-04-08 cough, fever Extreme body aches. Slight Fever (101). Excessive unproductive coughing. Loss of appetite. Vomiting.... Read more
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.
60 2021-04-08 fever, chills, headache Fever, Headache, Chills,
60 2021-04-08 fever, headache I ran a low grade fever (100.1) for approximately one week. I had body aches (separate from the sor... Read more
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.
60 2021-04-09 chills, fever, body temperature increased 4 days following the vaccination I experienced chills; my body temperature went 4 degrees F above no... Read more
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.
60 2021-04-09 chills, fever, headache Chills, low grade fever, headache,
60 2021-04-11 chills, sweating, fever Burning upon injection. Numbness at injection site and entire left arm. 100.6 fever. Switch between ... Read more
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.
60 2021-04-11 chills, fever Significant rash over entire body, (torso, arms, legs, back). I am debating whether to go to emergen... Read more
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.
60 2021-04-11 fatigue Constant tiredness for over a week. Lost consciousness in a parking lot and hit head. Bleeding aroun... Read more
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
60 2021-04-12 fatigue shingles diagnosis (pain, blisters, fatigue) Valtrex 7 day course advil
60 2021-04-12 headache, chills Headache, chills for 2 days. Treated with Tylenol which helped to alleviate symptoms.
60 2021-04-12 malaise Patient was with Medical Examiner. She was reviewing his allergies (PCN, bee stings) and discussed ... Read more
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.
60 2021-04-13 body temperature increased, fatigue This was the second shot. I didn't expect to get sick since I had been sick after the first one. S... Read more
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!
60 2021-04-13 body temperature increased Body muscle aches. Cold sweats. Weak upset stomach. Raised body temperature 99.7 and dissyness and ... Read more
Body muscle aches. Cold sweats. Weak upset stomach. Raised body temperature 99.7 and dissyness and brain zaps.
60 2021-04-13 chills, headache, fever Reaction to first dose was nil. Below is reaction to the second dose: Same evening: slight fever an... Read more
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.
60 2021-04-14 headache Bad headache swollen left lifnode golf ball size
60 2021-04-14 fever Immediately I lost my sense of taste - that lasted for four days. I had a little swollen in my arm- ... Read more
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.
60 2021-04-15 fatigue Arm soreness at injection site and tiredness starting about 12 hours after injection. Arm soreness i... Read more
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.
60 2021-04-15 throat irritation, cough About 30 minutes after the injection experienced a cough and itching in throat. Denies shortness of... Read more
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.
60 2021-04-16 headache After receiving my second Pfizer vaccine I have been having headaches. Several times a week I wake u... Read more
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.
60 2021-04-17 chills, sweating sweating; loss of appetite; diarrhea; vomitting lasted for a day; chills; could hardly eat anything ... Read more
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.
60 2021-04-17 fatigue, fever, chills 12 hours of low grade fever - 24-48 hours of body aches, chills & fatigue
60 2021-04-17 fatigue Arm pain; Tired; Abdominal swelling; This is a spontaneous report from a contactable consumer (patie... Read more
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.
60 2021-04-17 malaise, sweating, headache, fatigue, chills injection site pain; extreme tiredness; headache; chills; sweating; feeling unwell; dizziness; This ... Read more
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.
60 2021-04-18 headache Joint pain, muscle aches, flatulence, hands (only) faded or appeared light brown, head ache (nail ha... Read more
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.
60 2021-04-20 body temperature increased, chills, fatigue High temperature 105+, soreness, Fatigue, Diariah, chills.
60 2021-04-20 fatigue, headache Day after 2nd injection extremely sore right shoulder. Extreme headache. Very fatiqued for two day... Read more
Day after 2nd injection extremely sore right shoulder. Extreme headache. Very fatiqued for two days.
60 2021-04-20 headache Patient complained of headache, dizziness, unsteady gait x1 month. Triage was completed on 04/19/21... Read more
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.
60 2021-04-21 cough Pfizer-BioNTech COVID-19 Vaccine EUA Pt presented to ED on 4/10/21 @0523 with c/o SOB, F/C and cough... Read more
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.
60 2021-04-21 influenza like illness Like severe flu lasting over 5 days,COVID test done turned out negative,
60 2021-04-21 lethargy Patient has been feeling lethargic and has diarrhea for the past 3 weeks
60 2021-04-22 fatigue, chills, headache Temporary: aches, chills, fatigue Ongoing: chest pain/discomfort with activity, short breath, headac... Read more
Temporary: aches, chills, fatigue Ongoing: chest pain/discomfort with activity, short breath, headaches, fatigue
60 2021-04-22 fatigue, fever, chills, body temperature increased, cough Fever, chills and body ache started on 3rd day after 1st shot then continued for five days in a row ... Read more
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.
60 2021-04-22 sweating, headache, fever, lethargy, influenza like illness On the morning after the 2nd injection, about 09:00, I started experiencing flu-like symptoms: muscl... Read more
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.
60 2021-04-22 nasal congestion Patient c/o feeling dizzy and lilting to the left. Unsteady on his feet. B/P 162/87, HR 92 SPO2 10... Read more
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.
60 2021-04-22 fever, influenza like illness Flu like feeling very bad for 2-3 days - fever over 100. muscle aches and pains- still occurring no... Read more
Flu like feeling very bad for 2-3 days - fever over 100. muscle aches and pains- still occurring now.
60 2021-04-23 fatigue, chills To bed about 10:30p. Awoke 11:30p & could not talk, shivering uncontrollably, couldn't move my legs... Read more
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.
60 2021-04-23 headache, fever, chills Chills and body pain started evening of 30th with fever up to 102.5 and headaches. Body pain went aw... Read more
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.
60 2021-04-24 cough, throat pain, chills Chills, Dizzinesss and Weakness 5-10 minutes after invection. Cough and sore throat 12 hours after ... Read more
Chills, Dizzinesss and Weakness 5-10 minutes after invection. Cough and sore throat 12 hours after injection.
60 2021-04-24 fatigue, headache, fever Minor arm pain. Aches started in jaw followed by headache and fever. Significant fatigue. Lasted ... Read more
Minor arm pain. Aches started in jaw followed by headache and fever. Significant fatigue. Lasted about 22 hours.
60 2021-04-24 fatigue 2 weeks after 1st dose of covid vaccine, some fatigue and sob. The next morning, sudden onset of so... Read more
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.
60 2021-04-24 sweating, chills, cough he got positive with Covid-19; dizziness; woke up sweating; chills; muscle spasms; can not eat; Coug... Read more
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.
60 2021-04-25 chills Caller reports ER visit day after getting vaccine for chest tightness and ?extreme sedation?. Calle... Read more
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.
60 2021-04-25 fatigue, sleepiness I took the covid 19 vaccine on the 04/05/2021. The following days I started to feel tired and sleep... Read more
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.
60 2021-04-27 chills, fever, headache, sweating, malaise, cough, fatigue Injection site soreness, tiredness on 4/27/21. At 2 a.m. on 4/28/21 woke up with chills, sweats, fe... Read more
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.
60 2021-04-27 fever After first and second night had 101 F fever. Rash started on back as mild faliculitis, now has spre... Read more
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.
60 2021-04-29 fatigue On 4/28, I was feeling some side affects like tired, body pain and joint stiffness . I work at home... Read more
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.
60 2021-04-29 nasal congestion, cough, runny nose, fever, fatigue Review of Systems - Review of Systems Constitutional: Positive for fatigue and fever. HENT: Posit... Read more
Review of Systems - Review of Systems Constitutional: Positive for fatigue and fever. HENT: Positive for congestion and rhinorrhea. Respiratory: Positive for cough.
60 2021-04-30 chills, fatigue Muscle pain and rash at injection site, both lasting for 3-4 days. Body and joint aches lasting 1 1... Read more
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.
60 2021-04-30 dehydration, sweating diverticulitis aggravated by added bile in digestive tract.; diverticulitis aggravated by added bile... Read more
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.
60 2021-05-02 chills, body temperature increased, headache Fever lasted 2 days, headache lasted 3+ days, chills lasted 2 days, body aches lasted almost 2 days... Read more
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.
60 2021-05-02 fatigue, headache, fever Severe muscle aches, severe headaches, sever joint pain, low grade fever and hyper fatigue. All of ... Read more
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.
60 2021-05-02 fever, malaise 4 days after 1st shot my husband became ,confused,garbled ,speech,,did not know who the president wa... Read more
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.
60 2021-05-03 fatigue Vertigo (dizziness), Fatigue.
60 2021-05-03 fatigue Dyspnea on exertion, R sided chest pain, fatigue (all chest imaging normal)
60 2021-05-03 fatigue fatigue; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male pa... Read more
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.
60 2021-05-04 headache, fever, influenza like illness flu-like symptoms; Headache; fever / low grade fever after second dose; felt bad all over; face was ... Read more
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.
60 2021-05-04 headache Originally went to ER, they diagnosed it as torticollis. They sent me to my PCP who confirmed it. ... Read more
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.
60 2021-05-04 sweating felt sweaty, however denied CP or SOB, no lightheadedness or dizziness, no nausea or vomiting vitals... Read more
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
60 2021-05-04 malaise, fever, body temperature increased, chills Fever; felt like trash and didn't feel good at all; both of his pinkies down to his wrist were numb;... Read more
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.
60 2021-05-04 fever Fever 12 days out from the vaccination/fever averages 100F during the day; This is a spontaneous rep... Read more
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.
60 2021-05-05 cough Chest pain on deep inhale and while coughing, onset within 24-48 hours of vaccine.
60 2021-05-05 sweating, fever, pneumonia, cough, chills Fever, chills, sweats, rigors, cough, shortness of breath, right sided chest pain, pneumonia- confir... Read more
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.
60 2021-05-06 headache, fever fever, nausea, and a headache
60 2021-05-06 sweating, fatigue, chills Chills body swats extreme aches and fatgue loss of appetite brain fog. Sleeplessness Started 05/02 a... Read more
Chills body swats extreme aches and fatgue loss of appetite brain fog. Sleeplessness Started 05/02 and continues today. It hasnt gotten better
60 2021-05-06 throat pain, cough, fever Fever Cough Sore throat
60 2021-05-07 fever, lethargy Fever running around 102 it spikes to 104.5; Nausea; Bodyache; Vomiting; soreness in my arm where sh... Read more
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.
60 2021-05-09 dehydration, fatigue, fever Fever, body aches, fatigue, dehydration. Started about 30 hours after injection. Acute symptoms las... Read more
Fever, body aches, fatigue, dehydration. Started about 30 hours after injection. Acute symptoms lasted about 12-18 hours.
60 2021-05-10 body temperature increased, lethargy, cough, headache 4 days after shot woke with headache and difficulty breathing. Deep breaths would hurt a bit and so... Read more
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.
60 2021-05-10 fatigue, headache SERVIER HEADACHE, blurred vision, servier nausea, servier fatigue.
60 2021-05-10 fatigue Per Client, received second COVID 19 on 4/22/2021, in the left arm. Client C/O that in 2-3 days star... Read more
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.
60 2021-05-10 headache, fatigue Stomach Bloating; Headache; All over body pain; Muscle Weakness; Fatigue/Tiredness; Diarrhea; This i... Read more
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.
60 2021-05-11 fatigue 2 hours after, tiredness, next morning soreness in arm, insomnia, numb face for 3 days, loss sense o... Read more
2 hours after, tiredness, next morning soreness in arm, insomnia, numb face for 3 days, loss sense of taste
60 2021-05-11 headache Ringing in ears followed by headache. Still have ringing in ears as of today, 5/12/2021.
60 2021-05-12 chills, malaise Onset of chills followed by feeling not well. Not able to eat and get out of bed. Lasted 36 hours
60 2021-05-12 throat irritation, throat pain 5/5/2021 - developed a scratchy/painful throat, markedly enlarged lymph nodes on left side of throat... Read more
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.
60 2021-05-14 fatigue This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient re... Read more
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.
60 2021-05-16 fever, headache fever (T100.4), headache that brought him to ED. Headache persists over a month from vaccine.
60 2021-05-17 runny nose, nasal congestion loss of taste / smell, runny nose, nasal congestion
60 2021-05-18 cough, fatigue Office Visit 3/12/2021 WellSpan Family Medicine - Crossroads DO Family Medicine COVID-19 virus infe... Read more
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.
60 2021-05-18 malaise First vaccination was overnight expired. I received another the next morning. Got sick
60 2021-05-18 throat irritation May 13, 2021, at 10:30 pm I suffered from severe sinus drainage and phlegm clogging throat that caus... Read more
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.
60 2021-05-19 fatigue, headache, chills severe muscle pain in back and legs; Chills; Fatigue; Headache; severe pains in abdomen; This is a s... Read more
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.
60 2021-05-19 fatigue, throat pain Called health system call center to report the following symptoms post vaccination on 4/30/21: fati... Read more
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.
60 2021-05-19 fatigue, fever High fever, Nausea, joint pain, body aches, fatigue, vomiting, red spots all over body. Injury to ki... Read more
High fever, Nausea, joint pain, body aches, fatigue, vomiting, red spots all over body. Injury to kidney and liver
60 2021-05-19 fever, chills Client admitted to Medical Center on 5/19/2021 due to fever, chills, and nausea. Covid plus admitted... Read more
Client admitted to Medical Center on 5/19/2021 due to fever, chills, and nausea. Covid plus admitted for further assessment.
60 2021-05-19 fever, headache Patient had high fever of 101.5 with body aches, headaches, rash all over body for 4days. Injured ki... Read more
Patient had high fever of 101.5 with body aches, headaches, rash all over body for 4days. Injured kidney and liver through lab test
60 2021-05-20 sweating, chills Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Systemic: Sh... Read more
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.
60 2021-05-22 chills, fever, fatigue Pt was admitted on 5/10/21 c/o of rigor. Patient complains of fatigue, weakness, intermittent fever... Read more
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
60 2021-05-26 fever, cough Pt developed fever, cough and production of yellow phlegm for 4-5 days prior to clinic visit. When ... Read more
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
60 2021-05-27 cough Post vaccination at approximately 10:30 am client reported feeling numbness and tingling in hands, d... Read more
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.
60 2021-05-28 headache, fatigue Headache; Aches/pains,aches/pains, especially of back,; Aches/pains,aches/pains, especially of back,... Read more
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.
60 2021-05-28 headache, fatigue headache; muscle aches; sore achy muscles; fatigue; This is a spontaneous report from a contactable ... Read more
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.
60 2021-05-29 fever, throat pain, lethargy EE called hotline stating he received a call from Urgent Care that he has a POSITIVE covid test resu... Read more
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.
60 2021-05-30 headache, sweating, fatigue On Friday, 5/28/2021 I had my second Covid vaccine. My first vaccine in my left arm on 4/30/2021 was... Read more
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.
60 2021-06-01 chills, influenza like illness Chills; flu-like feeling; This is a spontaneous report from a contactable consumer (reported for him... Read more
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.
60 2021-06-01 headache Pain at injection site, sore muscles, headaches, painful and swollen lymph node on left side of neck... Read more
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
60 2021-06-01 headache Sore arm, headaches, painful and swollen lymph node on left side under left ear -- still swollen and... Read more
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.
60 2021-06-03 influenza like illness Flu-ish; nauseous; feeling quite wonderful; This is a spontaneous report received from a contactable... Read more
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.
60 2021-06-03 fever, fatigue TIA; Swollen lymph nodes in chest and abdomen; enlarged spleen; fever; night sweats; exhaustion; Thi... Read more
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.
60 2021-06-03 fever, headache, chills HAD PHIZER VACCINE: HEADACHES, CHILLS, HOT FLASHES, NAUSEA, SLIGHT TEMPERATURE. STARTED AT 6:00... Read more
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
60 2021-06-03 fever, headache, fatigue, chills Fever; chills; headache; muscle aches; joint pain; fatigue; pain in injection area; This is a sponta... Read more
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.
60 2021-06-03 fever, lethargy Body aches/ achiness; Lethargy; Fever; This is a spontaneous report from a contactable other HCP. A ... Read more
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.
60 2021-06-06 bronchitis, cough Got 2nd Pfizer vaccine on Tuesday 3/30. Felt bad afterwards. Went to another city next day Wednesday... Read more
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.
60 2021-06-06 fatigue Normal reactions sore arm -fatigue lasted 3 days 3 weeks later he was getting some brain fog ... Read more
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
60 2021-06-10 pneumonia J18.9 - Pneumonia, unspecified organism
60 2021-06-13 fever Body aches, sore arm & slight fever 99/100 for one day
60 2021-06-14 headache, fatigue At approximately 1102 (15 min after vaccine admin) pt c/o generalized itching without rash, headache... Read more
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.
60 2021-06-15 headache, chills, fatigue, fever Symptoms started when waking up on Monday 6/14; headache, muscle ache, joint pain, tiredness, sore a... Read more
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.
60 2021-06-16 sweating AT 1605 PALE, DIAPHORETIC, NAUSEA TREATMENT- AMMONIA, ICE PACK, OUTCOME- WENT HOME WITH WIFE WITH... Read more
AT 1605 PALE, DIAPHORETIC, NAUSEA TREATMENT- AMMONIA, ICE PACK, OUTCOME- WENT HOME WITH WIFE WITHOUT ANY ISSUES
60 2021-06-16 fever, headache Both doses first 2 days no fever but feeling very cold and mild headache. Following 4 days nausea ,u... Read more
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
60 2021-06-16 fever Was much sicker when he was little and received small pox vaccine than with the Covid vaccine; Sever... Read more
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.
60 2021-06-17 fatigue Talking caused SOB & nauseous/vomiting; Talking caused SOB & nauseous/vomiting; Fatigue after vaccin... Read more
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.
60 2021-06-23 fatigue Dizzyness, Vertigo, Tiredness, Vomiting
60 2021-06-25 fatigue, body temperature increased 1st dose of vaccine administered on 03/25/21 at 1:30 pm. Side effects: 03/25/21-03/28/21 ? pain on... Read more
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.
60 2021-06-29 headache Felt hungover; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the pat... Read more
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.
60 2021-06-29 malaise, fatigue Received 2nd dose of vaccine on 4/15/21. Reported (no feeling well 10-14 days after vaccine) Tire... Read more
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.
60 2021-06-30 headache Numb tingly fingers is the worst; Tingly fingers; Upper body joint ache in neck, shoulder, elbow, wr... Read more
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.
60 2021-07-02 fatigue, headache, chills Extreme muscle pain, chills, headache over right eye, fatigue, nausea, arm soreness at injection x 2... Read more
Extreme muscle pain, chills, headache over right eye, fatigue, nausea, arm soreness at injection x 24 hours
60 2021-07-02 fever, headache On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 d... Read more
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.
60 2021-07-05 fatigue I had experienced extreme fatigue. minor diarrhea, and stomach cramps.
60 2021-07-06 sweating tachycardia; Sudden onset diaphoresis, 2 dry heaves, sudden elevation of blood pressure to 160 / 110... Read more
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.
60 2021-07-07 chills, nasal congestion, fatigue, headache, paranasal sinus discomfort, productive cough, respiratory tract congestion pt called on 5/24/21. Pt c/o productive cough with greenish mucus, congestion, feeling sinus pressu... Read more
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.
60 2021-07-08 headache, malaise, fatigue Fatigue; Headache; Muscle pain; Nausea; Feeling unwell in general; This is a spontaneous report from... Read more
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.
60 2021-07-10 fever Patient was a previously healthy 60 year old male who developed an acute change in mental status on ... Read more
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.
60 2021-07-11 headache, fever, fatigue Headache, body aches, fever, fatigue, joint pain. Resolved in 24/36 hours
60 2021-07-12 chills, lethargy, headache, sweating headache/severe headache; sweating among other side effects/breakdown in sweat; arm still hurts/pain... Read more
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.
60 2021-07-12 fever injection site pain.; fever; entire body joint pain; muscle pain; This is a spontaneous report from ... Read more
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.
60 2021-07-12 sneezing, cough skin irritation.; felt like a pulled muscle under my left rib cage about 1 hour after the shot. Tho... Read more
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.
60 2021-07-13 lethargy, headache Chronic lethargic, headaches, stiff muscles, lightheadiness
60 2021-07-14 sweating Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
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
60 2021-07-15 cough, malaise Pt just got his + test for COVID-19 which were positive, pt has had some ? contacts at work, also he... Read more
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.
60 2021-07-15 headache, fatigue Headaches the next day and tiredness, short of breath, had to go to the hospital unable to breath wh... Read more
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.
60 2021-07-15 fever Positive for COVID-19 by PCR test on 7/15/2021. Patient had mild low grade fever and was exposed to... Read more
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
60 2021-07-17 sweating wheezy; sob along with diaphoresis; shortness of breath; This is a spontaneous report from a non-con... Read more
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
60 2021-07-17 throat irritation, runny nose Runny nose.; throat closing (thickness); itchy throat; This is a spontaneous report from a contactab... Read more
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.
60 2021-07-18 fever Initially, the event consisted of a fever on and off for 5 days reaching 103 at one point. Took Ty... Read more
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.
60 2021-07-20 malaise, fever Expected fever, myalgia, malaise for a couple days after the second dose. Approximately April 2021 I... Read more
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.
60 2021-07-21 fatigue, respiratory tract congestion After vaccine, could not sleep for 2 nights, less than an hour a night, normally take 1 melatonin a ... Read more
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.
60 2021-07-21 headache Systemic: Headache-Severe, Additional Details: Patient started having headaches 1-2 weeks after admi... Read more
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.
60 2021-07-21 nasal congestion, cough, runny nose Got Pfizer vaccine on 3/10/21 and 3/31/21. Symptom onset on 7/15 with cough, runny nose and nasal co... Read more
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.
60 2021-07-21 runny nose, cough, nasal congestion Got Pfizer vaccine on 3/10/21 and 3/31/21. Symptom onset on 7/15 with cough, runny nose and nasal c... Read more
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.
60 2021-07-22 cough heavy wheezing; coughing; left side of back hurts; This is a spontaneous report from a contactable c... Read more
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.
60 2021-07-23 fever rectal abscess; this time it worsened; I was in pain; high fever; This is a spontaneous report recei... Read more
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
60 2021-07-23 fever Severe thrombocytopenia; bone marrow showed hemophagocytosis/Met criteria for hemophagocytic lymphoh... Read more
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
60 2021-07-25 fatigue, headache Constant headache since the nite after the vaccine. Some headaches are really bad, almost migrane ... Read more
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.
60 2021-07-25 malaise, fatigue Aches nausea fatigue feeling unwell
60 2021-07-27 fatigue, headache, chills Headache; Fatigue; Nausea; Chills; This is a spontaneous report from a non-contactable consumer, the... Read more
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.
60 2021-07-27 fatigue, headache Headache; Diarrhea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. ... Read more
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.
60 2021-07-27 fatigue A few days after my second Covid vaccination I started experiencing fatigue, dizziness and shortness... Read more
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.
60 2021-07-27 throat pain Sore throat 3 days after shot; This is a spontaneous report from a contactable consumer, the patient... Read more
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.
60 2021-07-27 fever, fatigue Fever began about 6 hrs and lasted for about 48 hours. Temperature reached 102.6.; Followed by a cou... Read more
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.
60 2021-07-28 fatigue, headache Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 4... Read more
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.
60 2021-07-28 fatigue, fever initial reactions for 5 days: sore arm, tiredness, fuzzy brain, fever, gastric distress. All of th... Read more
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.
61 2021-01-03 lethargy, fever, headache, fatigue I felt light headed, sore arm, head ache and fever at first and that evening. Then woke up the next ... Read more
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.
61 2021-01-05 fatigue, headache, chills Headaches, severe vertigo, vomiting, tired, chills
61 2021-01-05 fatigue Severe night sweats for 3 nights in a row. Severe fatigue for 2 weeks. No fever. No cough. No si... Read more
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.
61 2021-01-05 fever, malaise LOW GRADE FEVER, 99.9, MILD BODY ACHES, MILD MALAISE LASTED ABOUT 24 HOURS
61 2021-01-06 headache, fever Headache, Myalgia, low grade temp, fascial redness
61 2021-01-06 headache Sore shoulder progressing to bilateral neck and headache over the course of the day 1/6/21
61 2021-01-07 headache, malaise tested positive for COVID-19; tested positive for COVID-19; Headache; feeling unwell; muscle pain; T... Read more
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.
61 2021-01-07 fever Fever to 103.7F, respiratory rate 36. Was transferred from facility to hospital. Since then has been... Read more
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.
61 2021-01-07 runny nose Myalgia & Diarrhea Narrative: Per employee, 14 hours after vaccination, felt abdominal cramps follo... Read more
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
61 2021-01-08 head discomfort, fatigue, fever, headache The day after the vaccine, I felt a bit fatigued. Then for 2 days, I felt fine. Then starting on the... Read more
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.
61 2021-01-08 headache, sweating, fever Headache, Fever, sweats Narrative:
61 2021-01-08 headache, fever, fatigue Headache, Myalgia, Arthralgia, Fever, very fatigued Narrative: Temp was 98.7F
61 2021-01-08 sweating, headache Headache, SkinRash, Sweating, thigh rash and headache Narrative:
61 2021-01-10 fatigue, headache, pneumonia, cough on 12/24/2020 I started feeling a little tired on 12/25/2020 I was feeling exhausted i had a cough a... Read more
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
61 2021-01-10 headache, fatigue Red lump at injection site, fatigue, headache
61 2021-01-10 sweating Got dizzy after vaccine and was told to sit down for 15 min after 15 I still felt dizzy so I stayed ... Read more
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.
61 2021-01-11 fatigue Onset of Body aches, fatigue, tired onset 2 hours after vaccine
61 2021-01-11 headache, fever, chills, fatigue, malaise Awakened 0300 the next day, Saturday the 9th with chills, fever 2 degrees above normal, headache an... Read more
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!
61 2021-01-11 malaise, fatigue, fever High fever; Vomiting; Severe fatigue; Weakness; This is a spontaneous report from a contactable phys... Read more
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.
61 2021-01-12 headache Patient experienced weakness on lower legs post 3 hours of receiving COVID-19 first dose that lasted... Read more
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.
61 2021-01-13 chills, malaise, headache headache, chills, injection site pain, feeling unwell, difficulty breathing, dizziness, weakness and... Read more
headache, chills, injection site pain, feeling unwell, difficulty breathing, dizziness, weakness and imbalance
61 2021-01-13 headache, sinus congestion COVID-19 virus test positive; COVID-19 virus test positive; Headache; Sinus congestion; This is a sp... Read more
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.
61 2021-01-13 fever Mildly feverish evening after vaccine; Soreness and tenderness at left arm injection site; This is a... Read more
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.
61 2021-01-14 chills Chills; Right eye was swollen; This is a spontaneous report from a contactable consumer (patient). ... Read more
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.
61 2021-01-14 fatigue, headache headache, left sided weakness, nausea and fatigue
61 2021-01-16 headache Sore arm for approximately 24 hours, headache for approximately 12 hours,muscle/ joint aches 12 hour... Read more
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.
61 2021-01-18 chills, headache, fever fever of 101; Chills; loose watery stool; stomach problems; threw up a couple of times; headache; Na... Read more
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.
61 2021-01-19 fatigue, headache Headache, Myalgia, Arthralgia, Fatigue Narrative:
61 2021-01-19 headache, body temperature increased, chills, lethargy 5AM: TEMP 101.7, HEADACHE, CHILLS, LOWER BACK PAIN, LETHARGY. SYMPTOMS PROGRESSED THROUGOUT THE DAY.... Read more
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.
61 2021-01-20 fever, headache have a persistent severe headache; feverish; I feel very light headed; unsteady with difficulty main... Read more
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.
61 2021-01-20 fever 4 days of fever, with each passing day worse. Lab tests showing liver damage. Advil
61 2021-01-21 chills, headache, fever headache muscle pain chills low grade fever
61 2021-01-25 malaise Not feel very good; This is a spontaneous report from a non-contactable consumer (patient). A 61-yea... Read more
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.
61 2021-01-27 chills, fever, malaise Fever, chills, aches, nausea, diarrhea, general malaise.
61 2021-01-27 chills, fever Fever of 101, Chills, Body Aches. Used Ibuprofen and Tylenol
61 2021-01-28 fatigue, headache, chills, malaise Got the injection around 8:15 AM, by around 2:00 PM started to feel mildly achy and tired. Around 6:... Read more
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
61 2021-01-28 fever, malaise, chills, headache, fatigue Injection site pain, Tiredness, Headache, Muscle cramps & pain, Chills, Joint pain (extreme), Fever,... Read more
Injection site pain, Tiredness, Headache, Muscle cramps & pain, Chills, Joint pain (extreme), Fever, Feeling Unwell.
61 2021-02-01 fatigue This is spontaneous report from a contactable consumer (patient). A 61-year-old male patient receive... Read more
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.
61 2021-02-03 malaise Employee described malaise and body aches the day after receipt of the vaccination (1/13/21). The s... Read more
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.
61 2021-02-04 fatigue I have been have contact with my primary care doctor because of the reaction with the first dose. He... Read more
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.
61 2021-02-06 malaise, productive cough anxious, restless, weak, dizzy, felt "horrible". Continued to C/O symptoms,. At 01:15, patient lost ... Read more
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.
61 2021-02-07 body temperature increased, fever, malaise, fatigue acute hepatitis/The transaminase was elevated to four times the upper limit; Fever/temperature yeste... Read more
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.
61 2021-02-07 fever 1/31/21 0730 am confused and low grade temp 99.5, 12 noon Temp 100.6 and sitting in recliner non res... Read more
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.
61 2021-02-08 fatigue 31 Jan 2021-Sunday-Very weak, diarrhea, migraines,-no diagnosis-pt states nights sweats 1Feb 2021-Mo... Read more
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
61 2021-02-08 headache Pt began to feel dizzy and light-headed with progressing headache pain within 15 minutes. Pt BP was ... Read more
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.
61 2021-02-08 fever, chills Fever chills and a little vomiting
61 2021-02-09 headache Dizziness, muscular aches, severe headache, overall weakness
61 2021-02-09 influenza like illness Muscle pain at the site, very minor flu-like symptoms lasting about 48 hours.
61 2021-02-09 malaise, fever Within 24hrs fever, malaise, progressive weakness beginning in the lower extremities and advancing p... Read more
Within 24hrs fever, malaise, progressive weakness beginning in the lower extremities and advancing proximally to affect arms. Severe neuropathy
61 2021-02-10 headache headache; Left arm sore; This is a spontaneous report from a contactable consumer (patient) This 61... Read more
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
61 2021-02-14 headache the swelling and extreme tenderness of the site of injection; the swelling and extreme tenderness of... Read more
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.
61 2021-02-15 headache Pt reports he started shaking all over on 2/6/21 and it gradually improved over the next week. He c... Read more
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.
61 2021-02-16 body temperature increased pt states when he woke up that he felt like he had fever but when he checked his temp on forehead it... Read more
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.
61 2021-02-16 fever nausea and fever
61 2021-02-17 fatigue, malaise This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient recei... Read more
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
61 2021-02-17 fever, chills, headache, lethargy This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient recei... Read more
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).
61 2021-02-19 fever, dehydration Extreme exacerbation of patient's longstanding Crohns Disease. Intractable liquid diarrhea for 5 day... Read more
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.
61 2021-02-20 fatigue, headache, chills Chills, bad headace, possible light fever from bedtime throughout the night (Friday night). Next day... Read more
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
61 2021-02-20 headache, fever, fatigue, influenza like illness Flu/fever-like symptoms (but temperature at 96.9), moderate to severe body aches, moderate to severe... Read more
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.
61 2021-02-21 chills, malaise, influenza like illness, fever Flu-like symptoms lasting about 36 hours (myalgias, arthralgias, malaise, low grade fever, and inter... Read more
Flu-like symptoms lasting about 36 hours (myalgias, arthralgias, malaise, low grade fever, and intermittent chills)
61 2021-02-23 sweating Approximately 10 minutes post vaccine patient complained of dizziness, shortness of breath and diaph... Read more
Approximately 10 minutes post vaccine patient complained of dizziness, shortness of breath and diaphoresis. Patient transported to ER for further evaluation.
61 2021-02-23 pneumonia 1/04/2021, 1/25/2021 Pfizer ej1685, en5318 Reports that he "passed out" on 1/6 at work, taken to ER ... Read more
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.
61 2021-02-25 runny nose Per patient, he received his second dose of Pfizer COVID-19 vaccine on 02/20/2021. Approximately 48... Read more
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
61 2021-02-27 chills, throat pain, nasal congestion, influenza like illness, headache, body temperature increased Pain in left arm was so strong that I could not roll over to get out of of bed. All other joints and... Read more
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
61 2021-02-28 cough, throat pain After the vaccine he came home, felt a little less sore than a flu shot. The next day when he took ... Read more
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.
61 2021-02-28 headache, head discomfort, fever he was not comfortable; allergic reaction; dizziness; feeling a lot of pressure in his head like his... Read more
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.
61 2021-03-02 pneumonia Hospital course 1/31 ? 2/20/21 1/31 in ED pt was at home when children noticed his lips were blue, e... Read more
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.
61 2021-03-03 chills, lethargy, fatigue When I woke up this morning I was lethargic, on the way to work, I started getting tired. Mid way t... Read more
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
61 2021-03-03 malaise, fatigue sore arm at injection site; tiredness; feeling unwell; loss of appetite; This is a spontaneous repor... Read more
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.
61 2021-03-04 fatigue, headache Headache/Fatigue set in about 1 hour after my second does of the Pfizer vaccine. It only lasted for... Read more
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.
61 2021-03-06 headache, lethargy This came on gradually over a period of about 5 hours: headache, aching in the joints, abdominal cr... Read more
This came on gradually over a period of about 5 hours: headache, aching in the joints, abdominal cramping, lethargy.
61 2021-03-06 runny nose THE SAME DAY OF MY SECOND VACCINE AND ONE DAY LATER I EXPERIENCED A KIND OF JUMPS ON MY LEFT CHEK, M... Read more
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
61 2021-03-07 fatigue, chills Chilling, shivering, muscle and joint ache, fatigue for about 24 hours, then tapered off. Lymph node... Read more
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.
61 2021-03-08 chills, fatigue, headache, fever Approximately two hours after getting the shot, I felt clammy and had a fever. Very fatigued, left ... Read more
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 .
61 2021-03-09 headache, fever, fatigue Body aches, headache, fever, tiredness, nausea.
61 2021-03-10 fatigue On Saturday he felled very tired, Monday experienced tongue numbness, and Monday experienced loss of... Read more
On Saturday he felled very tired, Monday experienced tongue numbness, and Monday experienced loss of taste.
61 2021-03-11 headache Headache, sore arm at injection, leg cramps - evening of injection >>> Blood pressure spike to 150/... Read more
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 <<<
61 2021-03-11 headache Patient reported dizziness, headache, racing heart and mild chest tightness. Was evaluated by NP. ... Read more
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.
61 2021-03-11 fever FEVER/BODY ACHES
61 2021-03-13 fatigue Tiredness, Nausea, Headache
61 2021-03-15 headache, chills Had chills, head ache, body aches threw up for three(3) days could not keep anything down took prom... Read more
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.
61 2021-03-16 headache, chills, fatigue, fever Headache, fever (TMAX 100.8), fatigue and chills 5 days after vaccination administered
61 2021-03-16 headache Pain in head/neck, flushing, sweating, tingling of lips and feet
61 2021-03-17 dehydration, fatigue Within 15 minutes of my 2nd covid shot I developed extreme lightheadedness, shortness of breath, dis... Read more
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.
61 2021-03-17 headache, chills, fatigue Bells Palsy affect 60 hours after injection. Right eye.....same manifestation as I had during Covid-... Read more
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.
61 2021-03-17 fever, fatigue, headache, chills fever of 103, fatigue, headache, chills. Symptoms lasted for approximately 24 hours
61 2021-03-17 fever Mild fever of 100.5. Treated with Tylenol. Fever gone by 3/17.
61 2021-03-17 sinusitis onset of self-described 'sinusitis' a week after vaccine administration, and then 2 days after that ... Read more
onset of self-described 'sinusitis' a week after vaccine administration, and then 2 days after that developed severe tinnitus
61 2021-03-18 body temperature increased, headache Terrible Headaches since day one of the Vaccine , also accompanied whit a little temperature.
61 2021-03-19 fever, fatigue, chills Arm soreness at injection site Neck pain Chills Low-grade fever Shivers Fatigue
61 2021-03-20 headache, fever Fever (up to 101.6), body aches, nausea and headache peaking between 12-18 hours after dose, mostly ... Read more
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.
61 2021-03-21 chills, headache 14 hours after shot, mild headache began. Headache lasted for 12 hours. Also at 16 hours post shot, ... Read more
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.
61 2021-03-21 head discomfort, fatigue, headache Started 03/18 Headaches - stabbing/ache/pressure/burning/tingling Started 03/14 Tired Started 03/14 ... Read more
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
61 2021-03-21 malaise, fever migraine head ache, back ache, fever, nausea, lack of apatite , brain fog,, i had covid in november,... Read more
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
61 2021-03-21 fever, chills, fatigue Fever within 12 hours reached 102.5. Within 18 hours, fever subsided to near normal levels. Severe... Read more
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.
61 2021-03-22 fever, fatigue Low grade fever 100.3, tired
61 2021-03-22 fever, lethargy Developed fever to 104 degrees on the morning after vaccination and had a grand mal seizure that las... Read more
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.
61 2021-03-22 fever BODY RASH; 101F FEVER; CONTSTIPATION; ABDOMINAL PAIN (RIGHT SIDE)
61 2021-03-23 chills, nasopharyngitis Cold chills aches
61 2021-03-23 cough, sweating cough, dizziness, and diaphoretic; transported to ED
61 2021-03-23 fatigue, malaise, fever Fever 99.8, nausea, tiredness, feeling unwell. Slept and rested. Symptoms gone by 3-24-2021 at 11:00... Read more
Fever 99.8, nausea, tiredness, feeling unwell. Slept and rested. Symptoms gone by 3-24-2021 at 11:00 AM
61 2021-03-23 headache Headache back of skull muscle pain. Painful Rash near vaccination site and painful Rash on chest
61 2021-03-24 cough, fever, fatigue Patient received first dose of Pfizer COVID vaccine on 3/17/21. Around 3/19 or 3/20, patient starte... Read more
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.
61 2021-03-24 fever, chills Sore arm, chills, fever, dizziness, nausea, aching muscles, diarrhea
61 2021-03-25 influenza like illness, lethargy Body aches Flulike symptoms without fever Brain fog Lethargy
61 2021-03-26 fever, influenza like illness, headache, fatigue, cough Low fever 0.5 F above the normal, heart rate increased from 75/min to 110/min. Blood pressure 15 a... Read more
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.
61 2021-03-26 fever Low fever, achy, very sore injection site
61 2021-03-27 headache, fever, fatigue Headache, fever (101 orally), general fatigue, body aches, neck stiffness, diarrhea. Took Tylenol
61 2021-03-28 headache, fatigue On going flu symptoms since the 2nd vaccination. It is going on 8 days and I still have flu symptoms... Read more
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).
61 2021-03-28 headache Severe joint and muscle pain and headache within first 24 hours of shot.
61 2021-03-28 fever, cough, chills Fever 103,cough,chills,body aches
61 2021-03-29 fatigue My left after 5 hours or so got really sore and just got worse during the day. It also got me really... Read more
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.
61 2021-03-30 chills, fever I have had 3 cycles of vaccine symptoms since receiving my first shot 9 days ago. First round of no... Read more
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.
61 2021-03-30 cough, pneumonia Pfizer COVID-19 Vaccine EUA Pt received Dose 1 of Pfizer vaccine series 3/10/21. 3/21/21: A 61-yea... Read more
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.
61 2021-03-30 headache, influenza like illness By 2nd day and for one week, had an extreme headache (unlike any migraine). Extreme flu like symptom... Read more
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".
61 2021-03-30 fever, chills Symptoms appeared roughly 12hrs after the second dose. Chills, slight fever, body aches. Symptoms la... Read more
Symptoms appeared roughly 12hrs after the second dose. Chills, slight fever, body aches. Symptoms lasted for less than 24hrs.
61 2021-03-31 body temperature increased Injection site is sore, my body feel achy. 101.2 temp. It is down to 99.6 at 2:00 pm My joints feel... Read more
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.
61 2021-03-31 chills Severe chills for ~2-3 hours
61 2021-03-31 dehydration, chills, fatigue, headache 2//20/2021 - Vaccine administered at 10am, strong pounding headache began about 5 hours later- aspir... Read more
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.
61 2021-03-31 fatigue, headache Approximately 40 hours after injection, I began to experience unexplained fatigue and a reoccurring ... Read more
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.
61 2021-04-01 chills, fatigue, headache Pain at shot side so that arm not usuable for 12 hrs, chills for a few hours, extreme fatigue (slept... Read more
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
61 2021-04-01 chills, headache Moderate to severe headache, chills, weakness, and sleeplessness through the night with headache lin... Read more
Moderate to severe headache, chills, weakness, and sleeplessness through the night with headache lingering through the next day.
61 2021-04-01 fatigue Arm soreness, mild body aches and fatigue
61 2021-04-01 sweating Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
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.
61 2021-04-01 fever, headache Low grade fever, headache, joint pain began about 28-24 hours after injection and lasted for about 1... Read more
Low grade fever, headache, joint pain began about 28-24 hours after injection and lasted for about 18 hours and resolved.
61 2021-04-02 chills, fever Chills, fever and moderate body ache for 6 hours
61 2021-04-03 sweating, chills, fever Fever, sweating, chills and diarrhea
61 2021-04-03 malaise Note: I AM reporting this because I strongly believe that patient's death was caused by his second C... Read more
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.
61 2021-04-03 fever, fatigue, chills, headache 1:00 am on 4/1 chills and slight fever. Remainder of day on 4/1: fever, chills, exhaustion and hea... Read more
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.
61 2021-04-04 fatigue, chills, fever Severe chills (unable to hold a glass of liquid). Fever of 101.5. Inability to sleep until 5 am. Tir... Read more
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.
61 2021-04-04 fatigue Dizziness. Noticeable / moderate on 4/5/21 lying in bed and for hours after waking, slight on days p... Read more
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.
61 2021-04-05 fever, headache, cough, chills Cough 2 days Fever 1 day Chills 1 day Dizzyness 2 days Headache 3 days Ey e Pain 3 days
61 2021-04-05 throat irritation Tinnitus in left ear. Soft high-frequency crickets when my throat gets stressed, including hiccups,... Read more
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.
61 2021-04-06 fever, headache sweat fever out; slight fever; whole body muscle aches; headache.; felt pain in upper left buttocks ... Read more
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.
61 2021-04-07 headache, chills Approximately 12 hours after the injection I started to get chills headache dizziness and was not ab... Read more
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
61 2021-04-07 headache tinnitus - started at 2nd shot and is still continuing. It is significant enough to get medical trea... Read more
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
61 2021-04-08 cough, fever, runny nose, sneezing Started with a severe runny nose. Runny nose and sneezing lasted approx 48hrs. When nose stopped run... Read more
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.
61 2021-04-08 headache, fatigue The day after the shot, I was real tired. My arm was sore. I had the chills. My stomach was quezy . ... Read more
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.
61 2021-04-08 fever, chills, fatigue, headache Tiredness headache muscle pain chills joint pain fever nausea difficulty breathing swelling in the f... Read more
Tiredness headache muscle pain chills joint pain fever nausea difficulty breathing swelling in the face a fast heartbeat dizziness and weakness stomach pain
61 2021-04-08 fever, fatigue, headache Headache, feverish, fatigued, sore muscles,no desire to eat or drink
61 2021-04-08 fever, headache, malaise fever, body aches, headaches, felt very much like havign the virsu again only stronger
61 2021-04-09 chills, headache, fever headache; teeth hurt; leg pain; chills; low grade fever; This is a spontaneous report from a contact... Read more
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.
61 2021-04-09 cough, headache Morning of 4/9/2021, mild headache. Also cough that lasted about 10 minutes. That night, headache be... Read more
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 2021-04-09 fatigue, body temperature increased, pneumonia, cough 61 yo male w/ history of DM, HTN, CKD IV and sleep apnea presents on 4/9/2021 with dsypnea that star... Read more
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.
61 2021-04-09 fatigue atrial fib; Short of breath; fatigue; Nausea; Dizziness; Unable to function; discolored; This is a s... Read more
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.
61 2021-04-09 fever, fatigue, chills After about 14 hours receiving my second dose, had severe chills with shaking/shivering for about a ... Read more
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.
61 2021-04-10 chills, malaise Pfizer-BioNTech COVID-19 Vaccine EUA 2 Days following the vaccine both my Psoriasis (Plaque, Guttat... Read more
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.
61 2021-04-10 chills, fever Chills and mild's fever for 5.5 hours. Then threw up a couple of times. I felt 95% better after t... Read more
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.
61 2021-04-10 fatigue, headache 4/7/2021 @ noontime: Began to have cold shakes. Approximately 15 minutes later, began to experience ... Read more
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.
61 2021-04-10 fatigue Arm pain morning after shot, general fatigue and achiness in joints afternoon after shot (i.e. 24 h... Read more
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.
61 2021-04-10 headache About 30 minutes after getting the vaccine his developed a headache. Shortly after that he develope... Read more
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.
61 2021-04-11 fatigue, fever Fever and tiredness Can take ibuprofen/motrin/tylenol for fever, use cool compress/wet rag on forehe... Read more
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.
61 2021-04-11 influenza like illness, headache Mild, flu-like symptoms: headache, joint aches, fatigue, some diarrhea. Lasted just about 16 hours.
61 2021-04-11 respiratory tract congestion, malaise, productive cough The next day I was very sick. It felt like someone had beaten me up. I spent most of the day lying d... Read more
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.
61 2021-04-12 head discomfort Morning of 4/8 at 0615, patient was in shower, started feeling pressure on top of head, was struggli... Read more
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.
61 2021-04-12 headache Bell's palsy/eyes droopy; annoying headache 3-4 days; This is a spontaneous report from a contactabl... Read more
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.
61 2021-04-13 sweating Lightheadedness, felt like he was going to black out, he did not faint. He was evaluated by a MD and... Read more
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.
61 2021-04-14 headache, fatigue, chills, malaise, fever After receiving my shot around 4:00 pm on April 13, 2021, I was restless and did not sleep well that... Read more
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.
61 2021-04-15 fatigue Severe pain at each sight I had surgeries at and neck and back. Severe pain started about 2 hours a... Read more
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.
61 2021-04-15 sweating Patient told the vaccinating pharmacist he had a history of fainting after receiving vaccinations. P... Read more
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.
61 2021-04-15 productive cough, fatigue, fever, respiratory tract congestion, malaise 4/3 to 4/5: Fever over 101. General malaise. Extreme chest congestion and productive cough. 4/5 to... Read more
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)
61 2021-04-16 cough, productive cough, malaise Upper respiratory: Cough/Phlegm producing General feeling of malaise Swollen (L) Lymph node (Submand... Read more
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
61 2021-04-16 headache, fever, fatigue Arm pain at injection site, headache, fever, fatigue. Affects began about 15 hrs. after receivi... Read more
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.
61 2021-04-16 headache, fever Fever of 101.5, which persisted for 3 days. Headache for two days (04/09 PM thru 04/11) not elevat... Read more
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.
61 2021-04-16 fever, fatigue Arm pain at injection site, fever, fatigue. Affects began about 18 hrs. after receiving the shot ... Read more
Arm pain at injection site, fever, fatigue. Affects began about 18 hrs. after receiving the shot and latest about 12 hrs.
61 2021-04-16 fever Joints and muscles sore, Fever-101F
61 2021-04-17 chills, cough, fever, sweating About 12 hours after the vaccine (2nd dose) I developed fever, chills, teeth chattering (rigors), sw... Read more
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.
61 2021-04-17 fatigue, malaise, headache Headache, fatigue, overall feeling unwell.
61 2021-04-17 fatigue, sinus congestion, headache Headache, body aches, joint aches, fatigue . Majority of pain subsided within 24 hours, fatigue an... Read more
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.
61 2021-04-17 headache, fever Substantial Fever, body aches, headache, weakness all over
61 2021-04-18 fatigue, influenza like illness Started the day after the second injection. Feeling very tired, most of the day. Fall asleep on my... Read more
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.
61 2021-04-18 sweating POST VACCINE PT BECAME DIZZY, DIAPHORETIC, HOT. TRANSFERRED TO OBS VIA W.C. PT REPORTS FEELING BETTE... Read more
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%
61 2021-04-19 cough, chills, fever, fatigue Fever or chills Cough Shortness of breath or difficulty breathing Fatigue Muscle or body aches Nause... Read more
Fever or chills Cough Shortness of breath or difficulty breathing Fatigue Muscle or body aches Nausea or vomiting Diarrhea
61 2021-04-19 sweating PALPITATIONS, SWEATING AND MILD LIGHTHEADEDNESS POST VACCINE ADMIN REPORTED BY PATIENT, BROUGHT TO ... Read more
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.
61 2021-04-19 throat irritation After an unannticipated time elapse after my first shot I experienced a throat irritation, then a ne... Read more
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.
61 2021-04-20 fatigue, headache, fever Ringing ears, splitting headache, fever, dizzy, body aches, extreme fatigue.
61 2021-04-20 fatigue Fatigue for approx 36 hours Cognitive impairment ?brain fog? lasted about 5 days
61 2021-04-20 headache Angina-like chest pain and frontal headaches off and on for three weeks from date of 1st injection. ... Read more
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.
61 2021-04-20 fever, fatigue Severe chills (2am 20 Apr thru 5am 20 Apr), fever to 103 (3am 20 Apr thru 3pm 20 Apr), mild fever (i... Read more
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)
61 2021-04-20 fever, headache 102 degree fever 8 hours, head ache 24 hours, nausea, weakness for 24 hours
61 2021-04-21 chills C/O N/V, SOB, Chills, funny taste in month.
61 2021-04-21 headache Tongue swelling; could not process his breath; Could not swallow his saliva; headache; Nausea; This ... Read more
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.
61 2021-04-22 fever First dose Sore arm; This is a spontaneous report received from a contactable consumer (reporting on... Read more
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.
61 2021-04-22 sleepiness Pt presented for 2nd dose of Pfizer Covid vaccine on 4/5. for second Pfizer COVID vaccine, and repo... Read more
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.
61 2021-04-23 headache, fatigue, chills, body temperature increased Severe headache from neck to eyebrows. Chills, running 104.4 temp muscle cramps in legs, extremely t... Read more
Severe headache from neck to eyebrows. Chills, running 104.4 temp muscle cramps in legs, extremely tired
61 2021-04-23 nasal congestion, sleepiness, throat pain, headache Sore throat; stuffy nose; slight headache; sleepy; This is a spontaneous report from a contactable c... Read more
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.
61 2021-04-24 fatigue Atrial flutter; Fatigue; Dizziness; Shortness of breath; This is a spontaneous report from a contact... Read more
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.
61 2021-04-24 nasopharyngitis, headache, runny nose Severe Headache; Muscle ache; Abdominal pain; lost his appetite; had a horrible feeling in his stoma... Read more
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.
61 2021-04-24 fever, head discomfort he had a stroke; felt pressure on his head; He had slurred speech; he fell as well; At approximately... Read more
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.
61 2021-04-24 fever, malaise Blistering, wet rashes on legs; Rash and blisters affecting feet; muscle pain has been going on for ... Read more
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.
61 2021-04-25 chills, sweating, fever Aches, profuse sweating, fever, chills, no appetite. No resolution after 4 days. Ambulance called af... Read more
Aches, profuse sweating, fever, chills, no appetite. No resolution after 4 days. Ambulance called after 3 days w/ recommendation to be taken, but refused.
61 2021-04-25 chills, fever Chills, Body aches, fever, Soreness at injection site
61 2021-04-25 cough, fatigue , I've suffered a minor cough and major fatigue on some days
61 2021-04-25 sweating, fever Fever, pain from left arm to left ear, sweating
61 2021-04-25 malaise Patient started not feeling well and told friends and family that he was not feeling well and that ... Read more
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.
61 2021-04-26 chills, fatigue, headache Diarrhea, chills, tiredness, fatigue, anxiety, insomnia, aching joints, aching muscles, headache, di... Read more
Diarrhea, chills, tiredness, fatigue, anxiety, insomnia, aching joints, aching muscles, headache, dizziness.
61 2021-04-26 head discomfort, headache Loss of balance, dizziness,ringing ears, slight headache, pressure at back of head. Prescribed Mecla... Read more
Loss of balance, dizziness,ringing ears, slight headache, pressure at back of head. Prescribed Meclazine, flonase and Zyrtec. Symptoms still on going but improved.
61 2021-04-26 headache, chills Headache, body aches, soreness, chills
61 2021-04-27 sweating, fever sweating; felt cold/intense cold even in his bones; He was told by the professional health care that... Read more
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
61 2021-04-27 fever, chills Fever, chills body aches no energy or appetite . Slept all day
61 2021-04-28 headache HEADACHE
61 2021-04-29 fever, fatigue, chills, influenza like illness Caller states they are experiencing "flu like" symptoms including fever, chills, fatigue one day aft... Read more
Caller states they are experiencing "flu like" symptoms including fever, chills, fatigue one day after second dose of Pfizer vaccine
61 2021-04-30 headache headaches; bad migraine/Migraine headache and headache which has not improved; This is a spontaneous... Read more
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.
61 2021-04-30 fever Brain fog; Cognitive issues; Fevers; Stated that he had a positive test to Covid; This is a spontane... Read more
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.
61 2021-05-01 headache Site soreness, slight headache onset the following morning.
61 2021-05-02 runny nose, nasal congestion, cough He is complaining of rhinorrhea, nasal congestion and a dry cough. He denies any fevers or chills. ... Read more
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
61 2021-05-03 respiratory tract congestion, fever, runny nose, headache, fatigue Fatigue, Muscle or body aches, Headaches and Congestion or runny nose AND FEVER
61 2021-05-05 sweating Patient received first Pfizer COVID-19 vaccine. About 10 minutes after vaccine was given, patient p... Read more
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.
61 2021-05-05 influenza like illness, fever The second dose of the vaccine triggered a moderately severe RA flare lasting from 28 April to 29 Ap... Read more
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.
61 2021-05-06 headache, cough, nasopharyngitis I felt fine following the 2nd shot, for 48 hours, but unusally tired so I knew it must have been the... Read more
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.
61 2021-05-06 headache Day 1 headache and sore arm. Day 2 intermittent weakness in both legs and cramps in the calves. Day ... Read more
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.
61 2021-05-07 dehydration, sinusitis, headache sinus infection; couldn't breathe; extreme high anxiety; couldn't sleep; lack of appetite; nervous a... Read more
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.
61 2021-05-10 cough, fever Nausea and dizziness started around 11:00 AM and ran for 4-6 hours. Mild fever and coughing started... Read more
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)
61 2021-05-11 fatigue having heart attack feelings; tightness and pain on the chest; tightness and pain on the chest; naus... Read more
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.
61 2021-05-11 sweating Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection... Read more
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.
61 2021-05-12 headache, runny nose, respiratory tract congestion, fever, chills Fever or Chills Muscle or body aches Headache Congestion or running nose
61 2021-05-13 fatigue, cough body aches to "back, legs, knees and ankles," loss of appetite, fatigue and mild cough. Hypoxia Pne... Read more
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
61 2021-05-13 fever Within 24 hrs started to experience slight fever. Within seven (7) days I went to the ER with high f... Read more
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
61 2021-05-14 sweating 2 hours after receiving his first vaccine the patient was presenting with light headedness, sweaty, ... Read more
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.
61 2021-05-14 sweating 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... Read more
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.
61 2021-05-15 chills, dehydration, nasopharyngitis Called patient for a follow up and patient states has been sick for 3 days. Asked patient what sick... Read more
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.
61 2021-05-15 fatigue Severe fatigue
61 2021-05-16 sweating I was working at my desk seeing patients via telehealth and had the sudden onset of extreme sweating... Read more
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.
61 2021-05-17 fatigue, nasal congestion, headache fatigue; myalgias; Mild nasal congestion; Headache; This is a spontaneous report was received from a... Read more
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.
61 2021-05-18 bronchitis ED to Hosp-Admission Discharged 4/3/2021 - 4/10/2021 (7 days) Hospital MD Last attending ? Treatme... Read more
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.
61 2021-05-18 fever Severe body aches, shakiness, and fever up to 102
61 2021-05-21 fever, influenza like illness Flu symtems for 3 days. Body aches, fever, weakness. After that, low grade fever from May 8 to pres... Read more
Flu symtems for 3 days. Body aches, fever, weakness. After that, low grade fever from May 8 to present (May22)
61 2021-05-24 fever Had itchy eyes, loss of smell, loss of taste, fever for 15 hours started 5/24/21 at 1pm until 5/25/2... Read more
Had itchy eyes, loss of smell, loss of taste, fever for 15 hours started 5/24/21 at 1pm until 5/25/21 4am.
61 2021-05-25 fatigue Dizziness and fatigue, lasting less than 5 min.
61 2021-05-25 headache, nasopharyngitis, productive cough, cough, fatigue, nasal discomfort Bad cold; Coughing, from a dry cough at first to a very wet cough; Coughing, from a dry cough at fir... Read more
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.
61 2021-05-26 malaise blood pressure had dropped a lot/blood pressure dropped a good deal; his heart rate was 30 beats per... Read more
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.
61 2021-05-27 headache Had a household member who was ill at home for several days preceding this patient's onset of sympto... Read more
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.
61 2021-05-28 chills, sweating, fever Severe joint pain, fever, sweating, shortness of breath, chills, weight loss, depression
61 2021-05-28 fever, headache Severe headache, fever of 100.8 deg F, severe muscle and joint pain all over body
61 2021-05-29 sneezing, headache, sweating, malaise, fever, runny nose First day: Arm pain, followed by a severe headache lasting approximately 24 hours, with pain in extr... Read more
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.
61 2021-05-30 fever, fatigue sore in arm shot the next day, slight fever the next day, fatigue the next day, frequent urination t... Read more
sore in arm shot the next day, slight fever the next day, fatigue the next day, frequent urination the night of vaccination
61 2021-05-31 fatigue Lump on left side of face near ear, Lump on left cheek, Lump on left side of neck, lump on right sid... Read more
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
61 2021-05-31 influenza like illness Doctors are suspecting I might have mucous or blood colitis, we are just not sure; Hands, both right... Read more
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.
61 2021-06-01 fatigue, chills, headache tiredness; headache; chills; Achy; threw up; nausea; This is a spontaneous report from a contactable... Read more
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
61 2021-06-01 fatigue He had extreme fatigue for 2 days after the vaccine. About 2 days after the vaccine, he developed wa... Read more
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.
61 2021-06-01 headache He got his vaccine, he had a very, very bad headache. About 3 weeks later his neck stiffened. He d... Read more
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.
61 2021-06-03 headache, fatigue, cough, sweating, chills Reports nausea, myalgias, lightheadedness, headaches, chills, diaphoresis, fatigue, chest pain, coug... Read more
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.
61 2021-06-08 headache Bad headache continuosly; This is a spontaneous report from a contactable consumer (patient, self-re... Read more
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.
61 2021-06-08 sinus headache I got a sinus headache; body ached; Terrible feeling; lost all energy; was cold; This is a spontaneo... Read more
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.
61 2021-06-09 headache Chronic headache, neck pain/ stiffness, elevated blood pressure that have not resolved.
61 2021-06-10 chills, headache, fatigue, fever This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patien... Read more
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.
61 2021-06-10 fatigue First shot induced week and a half migraine headache. Second shot has caused extreme fatigue and eve... Read more
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.
61 2021-06-10 pneumonia J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified
61 2021-06-10 throat irritation Approximately 1 month after second injection, I began having the sensation of menthol in my mouth, n... Read more
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.
61 2021-06-11 headache Migraine headache after the shot. Since the shot on 3/16/2021 I have a headache. This headache is ... Read more
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.
61 2021-06-14 fatigue, influenza like illness Heart arrhythmia, skipped beats (usually every fourth beat), and palpitations starting about 2 days ... Read more
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
61 2021-06-15 fever, chills, cough tested positive; fever; chills; cough; This is a spontaneous report from a contactable physician. A ... Read more
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.
61 2021-06-23 fatigue, fever Couldn't walk, tiredness, muscle pain, fever, vomiting, elevated heart rate.
61 2021-06-23 headache, malaise 30 minutes after vaccination he did not feel good, has droopy eyes , slurred speech, numbness of lef... Read more
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
61 2021-06-23 fever High fever, nausea, ache pains, dizziness
61 2021-06-25 fatigue, fever, sleepiness Received the first Pfizer COVID vaccine (ew0161) injected at 4:30PM on 29 April 2021 at the Pharmacy... Read more
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
61 2021-06-29 chills, sweating Sweats; Body aches; Chill, as if had flu; This is a spontaneous report from a contactable consumer, ... Read more
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.
61 2021-06-29 chills, fever Chills; Lack of energy; slight fever; This is a spontaneous report received from a non-contactable c... Read more
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.
61 2021-06-29 headache Headache; Internal shaking when lie down.; This is a spontaneous report received from a contactable ... Read more
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.
61 2021-06-29 fever, headache, chills Headache; Fever; Chills; injection site soreness; Rash on inside of right thigh. Rash on left side o... Read more
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.
61 2021-06-30 headache I ended up having a brain hemorrhage ! Terrible headache in the hospital for seven days in the inte... Read more
I ended up having a brain hemorrhage ! Terrible headache in the hospital for seven days in the intensive care unit !
61 2021-07-01 fatigue Mild soreness at injection site then tired and achy that night. Fine next morning. Traveled to Dr's ... Read more
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.
61 2021-07-01 pneumonia PNEUMONIA TREATED WITH DOXYCYCLINE 100MG ON 6/11/21 AND 7/1/21
61 2021-07-02 fatigue Extreme exhaustion; serious muscle pain; joint pain; Injection site swelling; Injection site redness... Read more
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.
61 2021-07-05 headache Severe headache with no remedy. Headache subsided some over time but persists after months.
61 2021-07-06 sweating Chest pains, almost passing out. profuse sweating,throwing up, EMT ride to Hospital, full series of ... Read more
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
61 2021-07-06 malaise, fatigue Dec 7, 2020 felt chest pain on deep inspiration with fatigue, malaise over 7 days. No cough, no feve... Read more
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.
61 2021-07-07 fatigue Peripheral Neuropathy symptoms; tinnitus/Ringing/buzzing/chirping/humming in both ears; difficulty c... Read more
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.
61 2021-07-07 pneumonia, fever Fever, delirium, stomach pain. Thrombocytopenia, Encephalitis, viral and bacterial meningitis, Rhabd... Read more
Fever, delirium, stomach pain. Thrombocytopenia, Encephalitis, viral and bacterial meningitis, Rhabdomyolyses, episode of torsades de pointe, pulmonary pneumonia, pneumonitis. Eventual double lung transplant.
61 2021-07-08 fatigue Patient experienced nausea, vomiting, and tired after his 2nd COVID vaccine.
61 2021-07-10 lethargy his first cup of coffee about killed him, it tasted so bad; dryness in the mouth; his voice has chan... Read more
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.
61 2021-07-10 fever Fever; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male pat... Read more
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
61 2021-07-13 sweating, pneumonia Patient admitted to MCH-BG on 7/12/21 with complaint of chest pain starting 2 days prior and worseni... Read more
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.
61 2021-07-14 fever Fever, Afib, weakness, chest pain, tachycardia
61 2021-07-17 fatigue, headache Muscle weakness; tired; Feeling hot; eyeball pain; Headache; Caller is the patient that received one... Read more
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.
61 2021-07-17 headache Headache persisting and worsening despite meds.; This is a spontaneous report from a contactable hea... Read more
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.
61 2021-07-19 fever, fatigue, dehydration Dehydration; Symptoms of the flu; Soreness; Unable to sleep; Aches in joints; Nausea; Fever; Tiredne... Read more
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.
61 2021-07-20 fever, chills, fatigue, headache, lethargy Swelling and lots of pain in left arm at injection site, radiates up to left side of neck, left inne... Read more
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.
61 2021-07-22 headache, fatigue, sweating, chills This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient re... Read more
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.
61 2021-07-22 fever, fatigue low grade fever; body aches; fatigue; some nausea; This is a spontaneous report from a contactable c... Read more
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.
61 2021-07-25 pneumonia death E87.1 - Hyponatremia J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hypon... Read more
death E87.1 - Hyponatremia J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified
61 2021-07-26 headache I was immediately confused about where I was at, when leaving the vaccination site. I immediately f... Read more
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.
61 2021-07-27 fatigue Vertigo; Dizziness; Arm pain; Fatigue; This is a spontaneous report from a non-contactable consumer,... Read more
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.
61 2021-07-28 chills, headache, fever, malaise Fever; Chills; Aches; Injection site pain; Headache; Feeling unwell; This is a spontaneous report fr... Read more
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.
61 2021-07-28 fatigue, headache, chills Body ache; upset stomach; Headache; Chills; tiredness; This is a spontaneous report from a contactab... Read more
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.
61 2021-07-28 headache, fatigue tired; has no energy; can't think straight; dizziness; he has developed two spots on his right leg w... Read more
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.
61 2021-07-29 fatigue Kind of tired after first shot; Stomach was kind of irritated; Back hurts a little bit more; This is... Read more
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.
62 2020-12-31 headache, chills, malaise Patient experienced one day post immunization malaise, moderate headache, and chills.
62 2021-01-03 nasal congestion Stuffy nose tingling lips tingling face i took 50 mg of over the counter benedryl..symptoms resolve... Read more
Stuffy nose tingling lips tingling face i took 50 mg of over the counter benedryl..symptoms resolved
62 2021-01-04 sweating, headache Rapid response called at 16:47, Care escalated to ED. Dizziness, Headache, Rash & diaphoresis
62 2021-01-04 throat pain, chills, fever, cough felt a little sick; I got my temperature about 100.2/Fever that I have is 7 days after the vaccine; ... Read more
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.
62 2021-01-04 fever, chills, fatigue Right arm soreness Dec 24 , Fatique on Dec 25 , Severe Chills DEC 26 and fever of 101.5
62 2021-01-05 chills, fever tingling in mouth and lips, some numbness followed, swelling/puffy feeling on throat under jaw, shiv... Read more
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.
62 2021-01-05 cough, fever, headache, fatigue, chills PATIENT REPORTED A SORE ARM THE DAY FOLLOWING THE VACCINATION. THE PAIN SUBSIDED BY THE END OF THE S... Read more
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.
62 2021-01-05 lethargy, sweating, headache, fatigue, chills Chills, followed by shaking chills, myalgias, vomiting (x1), headache, lethargy. Chills, myalgias, ... Read more
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.
62 2021-01-06 malaise, fever, chills, headache Fever 102.1, bone, joint, muscle pain, chills, headache, malaise, sore arms lasted 24 hours, took T... Read more
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.
62 2021-01-07 chills, lethargy, cough, fever low grade fever/low grade fever of 103; chills; dry cough; lethargy; This is a spontaneous report fr... Read more
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.
62 2021-01-07 throat irritation Patient c/o Itchy rash over his abdomen, shortness of breath, itching inside his throat and feeling... Read more
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.
62 2021-01-07 upper-airway cough syndrome Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness ... Read more
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.
62 2021-01-08 headache Dizziness & Headache Narrative: Employee informed this RN that he "I feel like I'm going to faint an... Read more
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.
62 2021-01-10 fever, chills Chills, fever
62 2021-01-11 fatigue First day, heart skipping every 5-6 beats. Nausea.. Not able to stand up. Excessive tiredness.
62 2021-01-11 throat pain, headache, fatigue Severe neck and throat pain, throat hurt when breathing. No chest pain, no shortness of breath. La... Read more
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.
62 2021-01-11 fever, lethargy, chills Chills, Rigors, extreme sensation of being very cold with intense lethargy, Low grade fever 100.3d... Read more
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
62 2021-01-12 fatigue, malaise PT received COVID #2 vaccine at 0830 to the left deltoid. Several hours after the vaccine he had arm... Read more
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.
62 2021-01-12 head discomfort, fatigue Fatigue, and head congestion. Lasted one day.
62 2021-01-13 fever, chills Developed fever 102.7 F; Chills; Extreme weakness; This is a spontaneous report from a contactable h... Read more
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.
62 2021-01-14 fever Fever 100.7 resolved with Tylenol.
62 2021-01-15 headache HA, myalgia
62 2021-01-16 chills minor chills for about 24 hours
62 2021-01-19 chills, headache, fever Chills, muscle/ bone ache, headache, low grade fever
62 2021-01-20 chills, headache Chills; body aches; Massive right axillary adenopathy (10cm); headache; This is a spontaneous report... Read more
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.
62 2021-01-20 nasal congestion, throat pain, headache, cough, fever, fatigue, chills Shaking chills onset 12 hours after the vaccine, followed by fever to 101.6, sore throat, dry cough,... Read more
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.
62 2021-01-21 headache Right arm numbness that radiated to right side of the neck. Weakness headache and shortness of brea... Read more
Right arm numbness that radiated to right side of the neck. Weakness headache and shortness of breath, difficulty swallowing.
62 2021-01-21 sweating 20-25 min post vaccine pt complains of dizziness, sweating. Patient laid down for approx 10 - 15 min... Read more
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.
62 2021-01-21 fever, fatigue, chills, headache DAVELOPED HEADACHE, BODY ACHES, FEVER, BACK ACHE, EXTREME CHILLS, NIGHT SWEATS, EXTREME FATIGUE
62 2021-01-24 fever, malaise, headache, fatigue Got COVID shot about 10am Friday and started to feel sick about 6pm. Tiredness, headache, muscle pai... Read more
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.
62 2021-01-25 chills, fever Chills and low grade fever for 19 days after 2nd dose of Pfizer covid vaccine
62 2021-01-25 fatigue, chills, fever fever 103.8, shaking chills, extreme fatigue, muscle aches, disorientation, skin extremely sensitive... Read more
fever 103.8, shaking chills, extreme fatigue, muscle aches, disorientation, skin extremely sensitive to touch
62 2021-01-26 fatigue, headache 19th vaccinated; my wife was exposed to COVID on 26th and she developed symptoms on 29th; I develope... Read more
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.
62 2021-01-26 lethargy Generalized muscle aches; lethargy; This is a spontaneous report from a contactable physician. A 62-... Read more
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.
62 2021-01-27 headache The fist day I started feeling dizzy and stomach didn't feel good. On the second day I started havin... Read more
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.
62 2021-01-27 headache I got the pfizer covid vaccine on 1/18/21 my initial reactions were slight soreness at injection sit... Read more
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 ".
62 2021-01-31 fatigue, headache headache, 10 hours later symptoms of fatigue and Bell's Palsy; headache, 10 hours later symptoms of ... Read more
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.
62 2021-01-31 fatigue Patient reports having his flu vaccination in November 2020 and his Pfizer COVID-19 vaccination on 1... Read more
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.
62 2021-02-04 cough Patient developed a rash starting at ankles and spreading up over legs and torso, also slight cough... Read more
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
62 2021-02-04 sweating, chills, fatigue, headache Blood pressure was high; tired from the night before; Itchy; slight headache; little lightheaded; He... Read more
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.
62 2021-02-07 fever fever, skin peeling off my hands ever since second dose, rash on stomach, lips are chapped,
62 2021-02-08 throat pain Muscle cramps through body, hot flashes, sore throat, and upset stomach.
62 2021-02-09 fatigue muscle pain, weakness, fatigue-Possible GBS/AIDP Narrative:
62 2021-02-10 cough, headache, fever, malaise After about 24 hours, headache, cough, low grade fever of 100.0, palpitations, general malaise.
62 2021-02-17 headache, fatigue Headache, Myalgia, Arthralgia, EXTREEM FATIGUE. Narrative:
62 2021-02-17 fever, headache woke next morning w/ temp. 100.8 fever; full body aches; left armpit swollen / sore (inj. arm); left... Read more
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.
62 2021-02-19 fatigue, fever, headache, chills Fever, headache, chills, rapid heart rate, fatigue, slightly lowered oxygen
62 2021-02-20 headache 1. Mild lightheadedness that lasted about an hour. 2. Periodic very mild headache through the time ... Read more
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.
62 2021-02-21 headache, fever Patient had sore arm on the day of vaccination. Per patient's nephew , the next morning patient expe... Read more
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
62 2021-02-22 chills, malaise severe chills. shivering at night for 2 hours. no fever, some aching and malaise. this was 4 days a... Read more
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.
62 2021-02-24 chills, fever feaver,body akes,chills.
62 2021-02-24 fatigue Pt felt arm soreness 4 hours later than felt fatigued, leg heaviness, arm heaviness, and then felt f... Read more
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.
62 2021-02-28 headache Headache, muscle ache, bone ache, upset stomach, lack of energy
62 2021-03-01 fatigue, fever, headache After my vaccine, experienced Covid-19 symptoms for ten days. I was exhausted, had a small fever, ha... Read more
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.
62 2021-03-01 sinus disorder, fatigue Allergies; Sinus problems; Dizziness when he is up and moving around; Equilibrium is off; Fatigued; ... Read more
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.
62 2021-03-03 runny nose, chills, headache, sweating, fever fever at 100.4; Headache; Nausea; Sniffles; Chills; he was beated down with sweat; body aches; does ... Read more
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.
62 2021-03-04 fever Broken bones; Fever 102.2; General weakness; Injection site pain; This is a spontaneous report from ... Read more
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.
62 2021-03-06 fatigue acute fatigue for 4 days & arthralgia. acute Clouding of consciousness for 15+ days
62 2021-03-06 fever, chills Chills, shakes, 101 degree fever
62 2021-03-07 headache 30 minutes post vaccine pt verbalized 5/10 on pain scale headache. Rested an additional 15 minutes a... Read more
30 minutes post vaccine pt verbalized 5/10 on pain scale headache. Rested an additional 15 minutes and claimed pain subsided.
62 2021-03-07 sweating 3:57PM 'FEELS LIKE PASSING OUT'. PALE, DIAPHORETIC. STATES HE HAD RT HIP SURGERY 3 DAYS AGO. PLACED... Read more
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'.
62 2021-03-07 fever, headache, chills 102.0 fever, headache, chills, body and joint aches
62 2021-03-08 fatigue, influenza like illness, fever, chills Severe flu-like syptoms: Whole body aches, fatigue, low grade fever, chills. Symtoms came on suddenl... Read more
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.
62 2021-03-08 fever, chills 100.9 fever, chills, body aches, more than 6 days
62 2021-03-09 fatigue, headache Soreness at injection site now on third day. Headache within two hours of injection along with mil... Read more
Soreness at injection site now on third day. Headache within two hours of injection along with mild fatigue for several hours.
62 2021-03-09 headache, sweating, fever, fatigue Onset of side effects approx. 10 hours after injection. Headache, Slight fever, Sweating, Tiredness.... Read more
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).
62 2021-03-10 headache Developed Head Ache behind left eye almost immediately after vaccine
62 2021-03-10 sweating Within 1 minute of vaccine being injected. I started to feel dizzy. I was wheeled in wheelchair to o... Read more
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.
62 2021-03-11 chills 12 hours after the second Covid 19 injection I got a severe debilitating migraine with chills. The m... Read more
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.
62 2021-03-11 fatigue Brain fog, fatigue
62 2021-03-11 sweating Patient was seen at Facility 10 minutes after his Pfizer immunization. He had wooziness, and hyper... Read more
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.
62 2021-03-12 headache SEVERE HEADACHE BEGINNING APPROXIMATELY 18 HOURS AFTER INJECTION AND LASTING APPROXIMATELY 10 HOURS.
62 2021-03-13 fatigue, headache Day 1 (evening): soreness in arm radiating to back and neck, accompanied by waves of light nausea, r... Read more
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.
62 2021-03-13 sweating he was excited and/or anxious about getting vax after having Covid in November. vax dose approx 305 ... Read more
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.
62 2021-03-14 chills, headache Chills, headaches, body aches starting the day after the second shot.
62 2021-03-14 chills Chills, blood clot R DVT, Dizzy, balance difficulty, itchy upper torso, sleeplessness
62 2021-03-14 cough, fever Fevers, 101.9, body aches, cough, difficulty breathing. Still using Tylenol, vicks formula 44, alb... Read more
Fevers, 101.9, body aches, cough, difficulty breathing. Still using Tylenol, vicks formula 44, albuterol, fluticasone propionate nasal spray.
62 2021-03-14 headache, chills Bad chills and shaking followed by extreme headache. Lasted 24 hours and then gone..
62 2021-03-14 sweating Several minutes after vaccine administration, patient was flushed and diaphoretic. No shortness of ... Read more
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.
62 2021-03-16 cough 03/07/21: Onset of dyspnea upon exertion 03/09/21: Worsening dyspnea and non-productive cough 03/11/... Read more
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
62 2021-03-16 fatigue, chills, fever fever, chills, fatigue, achiness
62 2021-03-17 chills Had body aches, cold chills, thought processing was slow and some what scattered, eyes were dilated ... Read more
Had body aches, cold chills, thought processing was slow and some what scattered, eyes were dilated slightly, loud noises were painful
62 2021-03-17 fever, fatigue I've been running a fever for almost 4 weeks now. I have to continually take Advil. My liver enz... Read more
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.
62 2021-03-19 fatigue, malaise, fever, headache Difficulty breathing, throat swelling (feels like it is) dizziness and weakness, nausea, feeling unw... Read more
Difficulty breathing, throat swelling (feels like it is) dizziness and weakness, nausea, feeling unwell, fever headache, tiredness and injection site pain
62 2021-03-20 chills Pain at injection site, muscle aches everywhere, chills all day
62 2021-03-21 chills, malaise, fever, dehydration Second COVID vaccine received 01/06/21. Within 24 hours developed fever, chills, malaise, myalgia, ... Read more
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.
62 2021-03-21 cough DECEDENT WAS NOTED TO BE COUGHING FOLLOWING THE ADMINISTERING OF THE VACCINE. FAMILY INTERVIEWED COU... Read more
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.
62 2021-03-21 headache, chills, fatigue Extreme headache beginning 2 days after vaccine was administered. Accompanied by chills and tirednes... Read more
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.
62 2021-03-21 sweating 1055: Patient in 15 minute observation called for medical with c/o dizziness and diaphoretic. Patien... Read more
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.
62 2021-03-21 fever, throat pain, chills, sweating, headache Ringing in the ears, headaches, throat hurts when I breath in (swollen glands), shortness of breath,... Read more
Ringing in the ears, headaches, throat hurts when I breath in (swollen glands), shortness of breath, fevers, sweats, chills, jaw pain, sore body
62 2021-03-22 nasal discomfort itching nose and had some swelling/welts nose that he could not see but he could feel. Itchy infla... Read more
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.
62 2021-03-22 fever, headache fever, body aches and headache
62 2021-03-24 headache, chills, influenza like illness, fever FLU symptoms including fever , chills, headache
62 2021-03-24 headache Headache, Myalgia & NauseaVomiting Narrative:
62 2021-03-24 headache Headache; Muscle and body aches; Muscle and body aches; This is a spontaneous report received from c... Read more
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.
62 2021-03-24 fever, chills fever that peaked at 101.9, chills and very sore shoulder at the injection site
62 2021-03-25 fatigue, headache, fever Headache, body aches, fatigue, Fever 101.5
62 2021-03-25 fatigue, headache, sleepiness Severe headache, fatigue, very sleepy about two hours after injection. Woke about 1:00 a.m. with se... Read more
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.
62 2021-03-25 malaise Per report from patient's daughter: Patient received 1st dose of Pfizer around 4:30 pm on 2/7/21. Ar... Read more
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.
62 2021-03-25 fever, headache Fever to 102. Chills. Full body aches, headache. Unable to sleep. Resting heart rate was about 20... Read more
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.
62 2021-03-25 fever, headache Low grade fever (100.5), body aches, headache
62 2021-03-26 chills, headache Mild dull headache began about 18 hours post-vax. Unresponsive to OTC pain relief. About 5 hour... Read more
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.
62 2021-03-26 fever, chills 15 hours after vaccination had chills, fever 0f 100 F. 16 hours post vac. had nausea and vomiting (d... Read more
15 hours after vaccination had chills, fever 0f 100 F. 16 hours post vac. had nausea and vomiting (dry heaving) for 6 hours.
62 2021-03-27 fever Fever + 99.2 degrees (21 hours later continues. Nausea (occasional after 22 hours).
62 2021-03-28 fatigue general ache in body particularly in knees and feet, tired, felt like I was getting the flu
62 2021-03-28 fever, chills Pt developed high fever and rigors 45 minutes after receiving 1st dose of Pfizer COVID vaccine. Pres... Read more