chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chills, Pain in extremity, Thrombosis
Clinical narrative: bad pain in the leg, near the calf/ confirmed the patient had blood clot in the leg; hurting in the arm; chills; This is a spontaneous report from a contactable consumer (patient). A 54-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 15Apr2021 (batch/lot number and expiration date were unknown) as a single dose for COVID-19 immunization. The patient had no medical history. The patient was taking other unspecified medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Mar2021 at the age of 54 years old for COVID-19 immunization. The patient reported having the normal side effect like the hurting in the arm, chills, and stuff on an unspecified date, but after that the patient got a really bad pain in the leg, near the calf and left it go for a week maybe, thinking it would go away, but didn't go away, so the patient went in to the emergency room and the emergency room work on it. That's what they did something to come up wrong with one of the blood test, so then they did an ultrasound and they confirmed the patient had blood clot in the leg, for which the patient was currently on a blood thinner. The patient didn't know if this was going to fix the problem or this was not going to fix the problem. The patient knew that some of the other vaccine caused blood clots, but the patient's doctor won't give any kind of pain medicine, and all they do was to give paracetamol (TYLENOL). They did start the patient on a pill called apixaban (ELIQUIS) taken at 25 mg tablet in the morning and 25 mg in the evening, and this was the thing the patient had never had; anything like this had never happened with the patient before, since the patient had been healthy in all his/her life, so the patient called to ask if there would be any relief as the patient didn't want this. Before the patient went into the emergency room, the patient had taken TYLENOL as treatment for all the events. The patient underwent lab tests and procedures on an unspecified date, which included blood test and chest x-ray with unknown results and an ultrasound, which revealed blood clot in the leg. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: bad pain in the leg, near the calf/ confirmed the patient had blood clot in the leg; hurting in the arm; chills; This is a spontaneous report from a contactable consumer (patient). A 54-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 15Apr2021 (batch/lot number and expiration date were unknown) as a single dose for COVID-19 immunization. The patient had no medical history. The patient was taking other unspecified medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Mar2021 at the age of 54 years old for COVID-19 immunization. The patient reported having the normal side effect like the hurting in the arm, chills, and stuff on an unspecified date, but after that the patient got a really bad pain in the leg, near the calf and left it go for a week maybe, thinking it would go away, but didn't go away, so the patient went in to the emergency room and the emergency room work on it. That's what they did something to come up wrong with one of the blood test, so then they did an ultrasound and they confirmed the patient had blood clot in the leg, for which the patient was currently on a blood thinner. The patient didn't know if this was going to fix the problem or this was not going to fix the problem. The patient knew that some of the other vaccine caused blood clots, but the patient's doctor won't give any kind of pain medicine, and all they do was to give paracetamol (TYLENOL). They did start the patient on a pill called apixaban (ELIQUIS) taken at 25 mg tablet in the morning and 25 mg in the evening, and this was the thing the patient had never had; anything like this had never happened with the patient before, since the patient had been healthy in all his/her life, so the patient called to ask if there would be any relief as the patient didn't want this. Before the patient went into the emergency room, the patient had taken TYLENOL as treatment for all the events. The patient underwent lab tests and procedures on an unspecified date, which included blood test and chest x-ray with unknown results and an ultrasound, which revealed blood clot in the leg. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, SARS-CoV-2 test negative
Clinical narrative: spontaneous abortion; This is spontaneous report from a contactable nurse. A 27 year old female patient who was not pregnant at the time of vaccination received bnt162b2 (BNT162B2 Formulation: Solution for injection, Batch/Lot Number: EL3247) dose 1 intramuscular administered on Arm left on 15Feb2021 as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Seriousness criteria was reported by the patient that it was not serious, no death life-threatening or cause of prolonged hospitalisation. It was not disabling and did not have any congenital birth defect. COVID-19 vaccine was administered at the hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive medications within 2 weeks of vaccination. 12Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test negative. On 29Mar2021, the patient had spontaneous abortion and was taken to emergency room in hospital. On 25Apr2021, the device date given. vaccine facility, race and ethnicity information was available. The outcome of the event was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, spontaneous abortion cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021458221 mother/baby case
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Coccidioidomycosis, Cough, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for self.   A 45-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm, on 19Mar2021 13:15 (Batch/Lot Number: EP7534) as a single dose (at the age for 45-years-old) for COVID-19 immunisation.  Medical history included asthma and allergies.  The patient did not receive other vaccines in the 4 weeks prior. She received an unspecified concomitant medication for allergy in the two weeks prior. The patient had not experienced COVID prior to vaccination. On22Mar2021, chills and headache started. On 23Mar2021, chills and headache continued and the patient experienced 102 fever with a little cough. She went to the Urgent Care and they diagnosed it as a side effect of the vaccine. On 01Apr2021, the coughing got worse and it turned into pneumonia. On 10Apr2021, she was admitted to the ER for over 103F fever, chills, cough, and shortness of breath. "Low immune from pneumonia developed or flared up the Valley Fever."  The events were treated with steroid shot, antibiotic IVs, fluid IV, and more. The patient was COVID-tested post vaccination with Rapid COVID test (nasal swab) on 25Mar2021 with Negative result, and with PCR test (nasal swab) on 10Apr2021 with negative result. The outcome of the events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pneumonia, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for self.   A 45-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm, on 19Mar2021 13:15 (Batch/Lot Number: EP7534) as a single dose (at the age for 45-years-old) for COVID-19 immunisation.  Medical history included asthma and allergies.  The patient did not receive other vaccines in the 4 weeks prior. She received an unspecified concomitant medication for allergy in the two weeks prior. The patient had not experienced COVID prior to vaccination. On22Mar2021, chills and headache started. On 23Mar2021, chills and headache continued and the patient experienced 102 fever with a little cough. She went to the Urgent Care and they diagnosed it as a side effect of the vaccine. On 01Apr2021, the coughing got worse and it turned into pneumonia. On 10Apr2021, she was admitted to the ER for over 103F fever, chills, cough, and shortness of breath. "Low immune from pneumonia developed or flared up the Valley Fever."  The events were treated with steroid shot, antibiotic IVs, fluid IV, and more. The patient was COVID-tested post vaccination with Rapid COVID test (nasal swab) on 25Mar2021 with Negative result, and with PCR test (nasal swab) on 10Apr2021 with negative result. The outcome of the events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray abnormal, Chest pain, Chills, Computerised tomogram
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for self.   A 45-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm, on 19Mar2021 13:15 (Batch/Lot Number: EP7534) as a single dose (at the age for 45-years-old) for COVID-19 immunisation.  Medical history included asthma and allergies.  The patient did not receive other vaccines in the 4 weeks prior. She received an unspecified concomitant medication for allergy in the two weeks prior. The patient had not experienced COVID prior to vaccination. On22Mar2021, chills and headache started. On 23Mar2021, chills and headache continued and the patient experienced 102 fever with a little cough. She went to the Urgent Care and they diagnosed it as a side effect of the vaccine. On 01Apr2021, the coughing got worse and it turned into pneumonia. On 10Apr2021, she was admitted to the ER for over 103F fever, chills, cough, and shortness of breath. "Low immune from pneumonia developed or flared up the Valley Fever."  The events were treated with steroid shot, antibiotic IVs, fluid IV, and more. The patient was COVID-tested post vaccination with Rapid COVID test (nasal swab) on 25Mar2021 with Negative result, and with PCR test (nasal swab) on 10Apr2021 with negative result. The outcome of the events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Electrocardiogram, Fatigue, Headache, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for self.   A 45-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm, on 19Mar2021 13:15 (Batch/Lot Number: EP7534) as a single dose (at the age for 45-years-old) for COVID-19 immunisation.  Medical history included asthma and allergies.  The patient did not receive other vaccines in the 4 weeks prior. She received an unspecified concomitant medication for allergy in the two weeks prior. The patient had not experienced COVID prior to vaccination. On22Mar2021, chills and headache started. On 23Mar2021, chills and headache continued and the patient experienced 102 fever with a little cough. She went to the Urgent Care and they diagnosed it as a side effect of the vaccine. On 01Apr2021, the coughing got worse and it turned into pneumonia. On 10Apr2021, she was admitted to the ER for over 103F fever, chills, cough, and shortness of breath. "Low immune from pneumonia developed or flared up the Valley Fever."  The events were treated with steroid shot, antibiotic IVs, fluid IV, and more. The patient was COVID-tested post vaccination with Rapid COVID test (nasal swab) on 25Mar2021 with Negative result, and with PCR test (nasal swab) on 10Apr2021 with negative result. The outcome of the events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Urine analysis
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for self.   A 45-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm, on 19Mar2021 13:15 (Batch/Lot Number: EP7534) as a single dose (at the age for 45-years-old) for COVID-19 immunisation.  Medical history included asthma and allergies.  The patient did not receive other vaccines in the 4 weeks prior. She received an unspecified concomitant medication for allergy in the two weeks prior. The patient had not experienced COVID prior to vaccination. On22Mar2021, chills and headache started. On 23Mar2021, chills and headache continued and the patient experienced 102 fever with a little cough. She went to the Urgent Care and they diagnosed it as a side effect of the vaccine. On 01Apr2021, the coughing got worse and it turned into pneumonia. On 10Apr2021, she was admitted to the ER for over 103F fever, chills, cough, and shortness of breath. "Low immune from pneumonia developed or flared up the Valley Fever."  The events were treated with steroid shot, antibiotic IVs, fluid IV, and more. The patient was COVID-tested post vaccination with Rapid COVID test (nasal swab) on 25Mar2021 with Negative result, and with PCR test (nasal swab) on 10Apr2021 with negative result. The outcome of the events was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcal urinary tract infection
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the right arm on 12Apr2021 at 15:00 (batch/lot number: EW0153) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient was not pregnant. The patient has no known allergies. There were no concomitant medications. Historical vaccine included BNT162B2 first dose on 22Mar2021 at 01:30 PM (batch/lot number: EP7534) administered in the right arm for COVID-19 immunisation. No other vaccine in four weeks. No Covid prior to vaccination and was not Covid tested post vaccination. The patient experienced urinary tract infection: group B strep on 16Apr2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of urinary tract infection: group B strep which included antibiotic, Macrobid. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Hyperpyrexia
Clinical narrative: My temperature went up to 109.9 to 102 F; I felt drained, and tired; Coughing; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 24Apr2021 at single dose for COVID-19 immunization. Medical history included ongoing smoker. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization and experienced coughing. In Apr2021, the patient temperature went up to 109.9 Fahrenheit to 102 Fahrenheit and the patient felt drained and tired. The patient asked whether she could catch COVID-19 in between the doses since she had been coughing even though she was a smoker. The patient took Tylenol throughout the last day (as of 26Apr2021) and the body temperature dropped to 98.6 Fahrenheit, but the patient's normal temperature usually runs in the 96 Fahrenheit. The patient asked whether these events were side effects of the vaccine. The outcome of the event temperature went up to 109.9 to 102 Fahrenheit was recovering and outcome of other events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; pneumonia; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient had her 1st dose of Covid 19 Vaccine on 03Apr21 and was tested positive for Covid 19 on 07Apr21. She had been hospitalized and just got release from the hospital (19Apr21), she had pneumonia now and wanted to know if she will still get her 2nd dose and if it was still possible to get it on (24Apr21). The patient was hospitalized for tested positive for covid 19 (covid-19) from 07Apr2021 to 19Apr2021. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Hyperhidrosis, Loss of consciousness, Malaise
Clinical narrative: I got super nauseous.; I really wasn't feeling well; Then I got super hot and sweaty; Then I got super hot and sweaty; I passed out.; I had a fever of up to 103.5; This is a spontaneous report from a contactable consumer (patient).  A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 21Apr2021 08:45 (Batch/Lot number was not reported) (at the age of 23 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included ibuprofen. The patient previously took septra and experienced allergies (known allergies); and first dose of BNT162B2 on 31Mar2021 08:45 at right arm for COVID-19 immunization. No other vaccine in four weeks. On 22Apr2021, the patient had a fever of up to 103.5 and was down to around 102 by the time of the incident (around 4:00). The patient woke up and was standing for about 3 minutes to refill water when she got super nauseous. She was making her way to the bathroom to throw up, and the next thing she knew she was on the floor. The patient was not sure how long she was passed out for though she had no reason to believe it was long. She tried to sit up, but she really wasn't feeling well, so she laid back down and closed her eyes for a bit. Then she got super hot and sweaty. Once that passed (maybe a few more minutes), she was able to check her temperature and she was down to around 101 and was able to get back to bed. No treatment for the events. No COVID prior vaccination. The patient had not been COVID tested post vaccination. The outcome of the events was recovered in Apr2021.   Information about Batch/Lot number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: I got super nauseous.; I really wasn't feeling well; Then I got super hot and sweaty; Then I got super hot and sweaty; I passed out.; I had a fever of up to 103.5; This is a spontaneous report from a contactable consumer (patient).  A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 21Apr2021 08:45 (Batch/Lot number was not reported) (at the age of 23 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included ibuprofen. The patient previously took septra and experienced allergies (known allergies); and first dose of BNT162B2 on 31Mar2021 08:45 at right arm for COVID-19 immunization. No other vaccine in four weeks. On 22Apr2021, the patient had a fever of up to 103.5 and was down to around 102 by the time of the incident (around 4:00). The patient woke up and was standing for about 3 minutes to refill water when she got super nauseous. She was making her way to the bathroom to throw up, and the next thing she knew she was on the floor. The patient was not sure how long she was passed out for though she had no reason to believe it was long. She tried to sit up, but she really wasn't feeling well, so she laid back down and closed her eyes for a bit. Then she got super hot and sweaty. Once that passed (maybe a few more minutes), she was able to check her temperature and she was down to around 101 and was able to get back to bed. No treatment for the events. No COVID prior vaccination. The patient had not been COVID tested post vaccination. The outcome of the events was recovered in Apr2021.   Information about Batch/Lot number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Loss of consciousness, Vision blurred
Clinical narrative: passed out; no energy; Tired/exhausted; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 09:00 (Lot Number: RW0150) as SINGLE DOSE for COVID-19 immunization. The patient previously took BNT162B2 (lot number: EN6207) dose 1 in the right arm on 24Mar2021 for COVID-19 immunization. Medical history included ongoing hormones are low. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hormone from an unspecified start date and ongoing; hydrocortisone taken for hormone from an unspecified start date and ongoing. The patient took the second dose of the COVID-19 vaccine, the next day he was tired on  15Apr2021.  The patient had never been tired in his life like that. The patient was completely passed out.  His wife wanted to call an ambulance and the caller told her no ambulance please. He knew the tiredness would eventually go away. The patient had no energy, zero, for 4 days or so. He has blurred vision for some reason on 15Apr2021. He thinks that the vaccine was no good. The patient has never had blurred vision before that that he is still experiencing some blurred vision.  The blurred vision is what concerns him. His vision is not right and his side effects were severe. The tired disappeared, but the blurred vision is still there at time of call on 23Apr2021. The patient was wearing his reading glasses but that something has happened with his vision.  He had 20/20 vision and now something is not right. The patient was exhausted, passing out, and not polite. The patient has to go to the doctor for the doctor to check his eyes. The outcome of tired was recovering. The outcome of the event blurred vision was not recovered and the outcome of the rest of the events was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Syncope
Clinical narrative: Woke up with extreme nausea in middle of the night (2:30 AM) and passed out/fainted in the restroom. Unsure of how long episode lasted.; Woke up with extreme nausea in middle of the night (2:30 AM) and passed out/fainted in the restroom. Unsure of how long episode lasted.; Woke up with extreme nausea in middle of the night (2:30 AM) and passed out/fainted in the restroom. Unsure of how long episode lasted.; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 24Apr2021 at 09:00 (Batch/Lot Number: EW0164) at 27-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. Medical history included Ehler-Danlos Syndrome, migraine, gastroparesis, and fibromyalgia; all from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol (VITAMIN D); gabapentin (MANUFACTURER UNKNOWN); promethazine (MANUFACTURER UNKNOWN); ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS); all taken for an unspecified indication, start and stop date were not reported; received within two weeks of the suspect vaccine.. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization (Lot number: RE8732; Anatomical Location: Arm Left; Dose Number: 1) on 03Apr2021 at 27-years-old. On 25Apr2021 at 02:30, the patient experienced: woke up with extreme nausea in middle of the night (2:30 am) and passed out/fainted in the restroom. Unsure of how long episode lasted. (medically significant); with no treatment taken. The clinical outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: received 1st dose of vaccine on 25Mar2021 and then contracted COVID-19; received 1st dose of vaccine on 25Mar2021 and then contracted COVID-19; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 25Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the vaccine on 25Mar2021 and then contracted COVID-19 on an unspecified date in 2021. She was taken out of ICU the day before her second dose was due to be given on 15Apr2021 and she was released from the hospital shortly after. She was hospitalized from an unspecified date in 2021 to Apr2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Pain in extremity, Pneumonia
Clinical narrative: Pneumonia; Cold; Fatigue; Pain in arm/Sore arm; This is a solicited report from the  based on the information received by Pfizer from (Mfr. Control No. : 21K-163-3861208-00).  A contactable consumer (patient) reported that a 39-year-old female patient received bnt162b2 (Pfizer Covid-19 Vaccine), intramuscular in Apr2021 (lot number unknown, expiration date unknown because the packaging was discarded) as single dose for Covid-19 Vaccination; adalimumab (HUMIRA), subcutaneous from 01Jan2020 (Batch/Lot number was not reported) to Apr2021, at unspecified dose for Moderate To Severe Rheumatoid Arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of recovered, fatigue and pain in arm/sore arm in Apr2021 with outcome of recovered in Apr2021, and cold on an unspecified date (reported as 2020/2021) with outcome of recovered. The last action taken in response to the events for adalimumab was permanently withdrawn in Apr2021. COVID-19 Vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Humira (Adalimumab): The reporter's causality for the events with Humira (Adalimumab) was no reasonable possibility.  Causality for bnt162b2 (Pfizer Covid-19 Vaccine): Not Reported  The reporter's assessment of the causal relationship of the events with the Pfizer suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on a compatible temporal association and known product safety profile, there was a reasonable possibility that the reported events of fatigue and pain in arm were related to BNT162B2 vaccine. The events pneumonia and cold are attributed to intercurrent medical conditions that were not related to BNT162B2 vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: bloodclots in my leg and lungs; bloodclots in my leg and lungs; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 2 via an unspecified route of administration on 05Apr2021 for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient experienced blood clots in the leg and lungs in Apr2021 within days of receiving the second dose. The clinical outcome of blood clots in the leg and lungs were unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Food poisoning, Loss of consciousness, Nausea
Clinical narrative: blacked out; fatigue; dizziness; nausea/vomiting; nausea/vomiting; symptoms like food poisoning; Hit a pole while driving; This is spontaneous report based on the information received by Pfizer.  A contactable consumer reported for herself.  A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient was  blacked out  on an unspecified date with outcome of unknown , had fatigue on an unspecified date with outcome of unknown , dizziness  on an unspecified date with outcome of unknown , nausea/vomiting  on an unspecified date with outcome of unknown , symptoms like food poisoning  on an unspecified date with outcome of unknown , hit a pole while driving  on an unspecified date with outcome of unknown.  The event blacked out was considered an Important Medical Event. Course of the event: Patient stated she got her Covid (Pfizer) vaccine on 09Apr2021 she experienced fatigue, dizziness, nausea/vomiting, symptoms like food poisoning was able to move around few days later but she got very dizzy, blacked out and hit a pole while driving.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Road traffic accident, Vomiting
Clinical narrative: blacked out; fatigue; dizziness; nausea/vomiting; nausea/vomiting; symptoms like food poisoning; Hit a pole while driving; This is spontaneous report based on the information received by Pfizer.  A contactable consumer reported for herself.  A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient was  blacked out  on an unspecified date with outcome of unknown , had fatigue on an unspecified date with outcome of unknown , dizziness  on an unspecified date with outcome of unknown , nausea/vomiting  on an unspecified date with outcome of unknown , symptoms like food poisoning  on an unspecified date with outcome of unknown , hit a pole while driving  on an unspecified date with outcome of unknown.  The event blacked out was considered an Important Medical Event. Course of the event: Patient stated she got her Covid (Pfizer) vaccine on 09Apr2021 she experienced fatigue, dizziness, nausea/vomiting, symptoms like food poisoning was able to move around few days later but she got very dizzy, blacked out and hit a pole while driving.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: got Bell's palsy, On the right side of his face; This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0150, first dose) solution for injection intramuscular on 05Apr2021 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient got Bell's palsy, on the right side of his face on 19Apr2021 with seriousness criteria of hospitalization. Treatment for the event Bell's palsy included prednisone at 20 mg tablet, 3 tablets by mouth daily; and acyclovir 800 mg tablet, orally one tablet by mouth 5 times daily for 10 days from 19Apr2021. The outcome of the event Bell's palsy was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Muscular weakness, Peroneal nerve palsy
Clinical narrative: Guillain Barre Like syndrome; bilateral lower extremity weakness with foot drop; bilateral lower extremity weakness with foot drop; This is a spontaneous report received from a contactable physician. A 70-year-old male patient received first dose of BNT162B2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no past drugs, and no concomitant medications were reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 05-Apr-2021, patient was hospitalized due to Guillian Barre Like syndrome, stroke work up negative, bilateral lower extremity weakness with foot drop and LP was noncontributory. Patient was being treated with Corticosteroids for the events and was improving. Outcome of all the reported events were resolving. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Gullain Barre syndrome, muscular weakness and peroneal nerve palsy and the suspect drug.  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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Subarachnoid haemorrhage
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7534 and expiration date was not reported), via an unspecified route of administration in right arm on 18Mar2021 at 17:00 (at the age of 56 years) at single dose for COVID-19 immunization at pharmacy or drug store facility. Medical history included arthritis. Concomitant medications included ibuprofen, vitamin D, magnesium and DoTerra Bone Heal from an unknown date for an unknown indication. The patient was not a pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient experienced subarachnoid hemorrhage-aneurysm on 20Mar2021 at 08:00. The patient was hospitalized for this event on an unspecified date in 2021 and discharged within 16 days. It was unknown whether the patient received the treatment or not for this event. The outcome was recovering at the reporting time.
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Headache, Illness, Myocardial infarction, Neoplasm malignant
Clinical narrative: Pneumonia; Heart attack; Cancer; COPD; Got sick; Headache; This is a spontaneous report from a contactable consumer received via Pfizer sponsored program  support. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 16Mar2021 and she got sick, heart attack, cancer, chronic obstructive pulmonary disease (COPD),  and pneumonia. At the time of report the patient has a headache. The 2nd dose schedule will be on 27Apr2021 and wanted to know if she should go and take the 2nd shot because the doctor's office she went to was unsure if they are open. The outcome of the events was unknown.  Information on the lot/ batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; Heart attack; Cancer; COPD; Got sick; Headache; This is a spontaneous report from a contactable consumer received via Pfizer sponsored program  support. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 16Mar2021 and she got sick, heart attack, cancer, chronic obstructive pulmonary disease (COPD),  and pneumonia. At the time of report the patient has a headache. The 2nd dose schedule will be on 27Apr2021 and wanted to know if she should go and take the 2nd shot because the doctor's office she went to was unsure if they are open. The outcome of the events was unknown.  Information on the lot/ batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Eye disorder
Clinical narrative: His eyes didn't look good and could not see after his first dose.; His eyes didn't look good and could not see after his first dose.; This is a spontaneous report from a Pfizer- sponsored program received from a contactable consumer (patient's wife) reported for a male patient (reporter's husband). A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced his eyes didn't look good and could not see after his first dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: worst seizure; This is a spontaneous report from a non-contactable consumer (patient parent).  A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206 and expiration date not provided), via an unspecified route of administration, administered in Arm Left first dose on 17Mar2021 10:30 at single dose for covid-19 immunisation. The patient's medical history included catamenial epilepsy has been taking 1000 mg Keppra twice daily to help control seizures. The shortest duration between seizures was approximately 1 month, and that was before her epilepsy diagnosis and starting on the Keppra. Additionally, patient's medical history included ADHD. The patient was not pregnant at time of vaccination. The patient's concomitant medications included levetiracetam (KEPPRA) for catamenial epilepsy at 1000 mg, 2x/day,  amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and unspecified medication. On 27Mar2021 08:30, the patient experienced her worst seizure ever.  Also reported as suffered a cluster of seizures which is atypical for her. Last night the reporter read an article about some women starting their periods after years of not having it soon after receiving the Covid vaccine, so I looked back at my daughter's seizure record and noticed a potential link. Treatment included increased her Keppra dosage to 1250 mg. The event caused the patient for physician office visit. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes, Oral herpes, SARS-CoV-2 test
Clinical narrative: I was diagnosed with oral and genital herpes; I was diagnosed with oral and genital herpes; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 (Batch/Lot Number: EL9269) (at the age of 42-years-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant. The patient's concomitant medications were not reported. There were no other vaccines received in four weeks. The patient previously took droperidol and experienced allergy; nortriptyline and experienced allergy. The patient was not diagnosed with COVID prior to vaccination. The patient was diagnosed with oral and genital herpes on 08Mar2021, which was a complete shock to the patient. The patient stated that it's some kind of side effect to the vaccine. The events required a visit to the doctor's clinic. The event was treated with an unspecified medication. The reporter considered the event as serious (disability). The patient underwent lab tests and procedures which included nasal swab COVID test: negative on 20Mar2021. The outcome of the events was recovered with sequelae.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Diarrhoea haemorrhagic
Clinical narrative: Non Stop diarrhea for four days, the fourth it became bloody; Non Stop diarrhea for four days, the fourth it became bloody; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EW0161) via an unspecified route of administration, administered in Arm Right, at the age of 51-year-old, on 14Apr2021 13:00, as SINGLE DOSE for covid-19 immunisation.  Medical history was reported as none. The patient had no known allergies. The patient was not diagnosed with COVID prior vaccination and was not tested post vaccination. There were no concomitant medications.  The patient did not receive other vaccine in four weeks and had no other medications in two weeks. On 14Apr2021 13:00, the patient started to have non-stop diarrhea which lasted for four days. On 18Apr2021, on the fourth, it became bloody. The patient did not receive treatment in response to the events. Outcome of diarrhea was not recovered while it was unknown for diarrhea bloody.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper
Clinical narrative: Stomach cramps; FACILITATED COLLECT  This is a solicited report received from a contactable consumer reported for himself based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-3866546-00).   A 54-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly in 2021 for COVID-19 immunization and adalimumab (HUMIRA) for moderate to severe adult Crohn's Disease via subcutaneous route. In 2016, the patient experienced motorcycle accident and dull ache in foot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021, the patient received first dose of COVID-19 Vaccine manufactured by Pfizer. On unknown date in 2021 the patient experienced stomach cramping with outcome of recovering.   AbbVie's opinion is that there is no reasonable possibility that the event of stomach cramping was related to Humira(Adalimumab).  The reporter's assessment of the causal relationship of the event with BNT162b2  was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Based on the current available information, the event Stomach cramps is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Crohn's Disease may provide a plausible explanation for the event.
Sex: U
Vaccine: COVID19
Symptoms: Angiogram pulmonary, Electrocardiogram, Magnetic resonance imaging, Myocarditis, Pericardial effusion
Clinical narrative: This is a spontaneous report from a contactable other HCP who reported for a patient. A patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported) on 17Apr2021 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection,) dose 1 on 18Feb2021 04:00 PM, for covid-19 immunization. No prior cardiac past medical history. Medical history was not reported. Concomitant medications were not reported. On Patient received 2nd dose of Pfizer COVID-19 vaccine on 17Apr. That evening noticed SOB and chest tightness. Over the next 3 days went to ED with worsening CP. Found to have elevated troponins and EKG changes. CTPE negative. Symptoms improved with pain management, steroids, and colchicine. Cardiac MRI done on 23Apr that showed EF 52% and findings consistent with myocarditis and small pericardial effusion. Patient managed with ACE and colchicine. The clinical outcome of the events was unknown.   Information on lot/ batch number has been requested.; Sender's Comments: Based on the information provided, the contributory role of the suspect product second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported) to reported events myocarditis and small pericardial effusion is possible. Case will be reassessed upon receipt of follow-up information.