chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Second dose: muscle soreness and muscle pain; Second dose: flu-like symptoms, hot and cold, chills and fever; Second dose: flu-like symptoms, hot and cold, chills and fever; Second dose: flu-like symptoms, hot and cold, chills and fever; Second dose: flu-like symptoms, hot and cold, chills and fever; Second dose: arm soreness; This is a spontaneous report from a contactable nurse (patient). A 72-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0187; NDC number and expiry date was reported as unknown) via an unspecified route of administration on 01Jul2021 at 15:00 (at the age of 72-years-old) in right arm as a single dose for covid-19 immunization. Medical history (including any illness at time of vaccination) included multiple sclerosis from 1980 and ongoing. Family medical history relevant to adverse event was reported as heart disease from an unknown date and unknown if ongoing. No investigation assessment was reported. It was unknown if the patient had SARS-CoV2 antibodies at diagnosis. No information was provided on multiorgan failure or any new/ worsened symptoms/signs during the covid-19 illness experienced (including date of onset/worsening). The patient was not a smoker/former smoker. She was not taking any medications routinely prior to the event being reported. Additional vaccines administered on same date of the Pfizer suspect were reported as none. Prior Vaccinations (within 4 weeks) and list of any other vaccinations within four weeks prior to the first administration date of the suspect vaccine included nothing except for the first shot. The patient's concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number: EW0176; NDC number and expiry date was reported as unknown) on 11Jun2021 in right arm for COVID-19 immunization and experienced sore arm. The patient did not have a positive test for SARS-CoV2. The patient experienced flu like symptoms, chills, fever and she was hot and cold on 01Jul2021 at 20:30. She also had muscle soreness and muscle pain on 01Jul2021 at 23:00. She noticed arm soreness before she went to bed, somewhere around 23:00. The events were bothering her. She did not require emergency room and physician office visit. The patient was not hospitalized or admitted to an intensive care unit and she did not require supplemental oxygen. Treatment medication included Tylenol. Relevant tests were reported as none. The outcome of all the events was not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea neonatal, Exposure via breast milk, Infantile vomiting
Clinical narrative: infant (4 weeks old) had vomiting and diarrhea after breastfeeding after vaccine; infant (4 weeks old) had vomiting and diarrhea after breastfeeding after vaccine; infant (4 weeks old) had vomiting and diarrhea after breastfeeding after vaccine; This is a spontaneous report from a non-contactable consumer (patient's mother). This consumer reported information for both mother and baby. This is a baby report. A 4-weeks-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number was not reported), via transmammary on an unspecified date as dose unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient was infant (4 weeks old) had vomiting and diarrhea after breastfeeding after vaccine on an unspecified date. The patient mother (age: 35-year-old) was breastfeeding. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021831986 Maternal case
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient, reported for self). A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Wag 10838, Expiration Date: not reported) via an unspecified route of administration in left arm on 02Jun2021 as dose 1, single for COVID-19 immunization. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's medical history and concomitant medications were not reported. Patient reported that "between vaccine 1 & 2, patient started feeling pain in my right ankle, which turned into severe pain" on 27Jun2021. The adverse event resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The patient received treatment with steroids for the adverse event. The event was reported as non-seriousness. The outcome of the event was reported as recovering. Device Date : 04Jul2021
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died in his sleep 3 days after taking the Pfizer covid vaccine; This is a spontaneous report from a contactable consumer. A 13-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient experienced died in his sleep, 3 days after taking Pfizer COVID vaccine on 16Jun2021. This is coincidental, this is not causative. Cause of death was unknown. No investigation assessment. The patient died on 16Jun2021. The county health department confirmed the investigation and the autopsy was being performed. The information is being sent the CDC to see if there is a correlation. The reporter mentions that we all know a lot of 13-year-old falling over for that.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cause of death was unknown
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hyperhidrosis
Clinical narrative: got hot and was sweating; got hot and was sweating; had a headache; This is a spontaneous report from a contactable other hcp (patient). This is Report 2 of 2. This report was not related to a study or programme. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: unknown; Expiration date was not reported)DOSE 1, via an unspecified route of administration on 14Jun2021 as single dose for covid-19 immunisation. Lot number was not provided as caller unwilling to complete the report. The patient's medical history and concomitant medications were not reported. The patient got hot and was sweating, had a headache on an unspecified date. Investigation assessment was not reported. Caller stated she has not reported on this and declined to make a report as she was more worried about her son at the time of this report. No further details provided. Caller stated she can call back later if needed and report. Clinical outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Electrolyte depletion, Lethargy, Nausea, Skin odour abnormal
Clinical narrative: Nausea; Lethargy; Her body smells different; she "Developed reaction to sterling silver, electrolytes "bottomed out" and it took 2,5 days to balance; This is a spontaneous report from a contactable consumer (patient) via a Regulatory Authority. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Jun2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced nausea, lethargy and she developed reaction to sterling silver, electrolytes bottomed out and it took 2,5 days to balance and felt her body smells different. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cerebral palsy
Clinical narrative: he told me on of his patient his cerebral palsy came back/he flared up with cerebral palsy; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer or other non-health care professional reported for another patient. A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: Unknown), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunisation. Medical history included cerebral palsy when patient was in 20 from an unknown date and unknown if ongoing. Patient went on mission for 30 years. The patient's concomitant medications were not reported. The patient's cerebral palsy came back on an unspecified date. The patient got the pfizer shot and within the week flared up with cerebral palsy. The outcome of event was unknown.  Follow-Up (06Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Illness, Malaise
Clinical narrative: Was sick for 24 hours; Had to lay down; She was miserable the whole night; She wasn't feeling good by 2000; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller mentioned that her daughter had a reaction to the Covid-19 Vaccine. On an unspecified date her daughter got the vaccine and was sick for 24 hours then it was done. The caller read so much online, and her daughters symptoms were pretty right on. They said that younger people would get a robust reaction. She was not feeling good by 2000 and had to lay down. She was miserable the whole night and it lasted for 24 hours. The caller did not think she needs to do a report on her. It was straightforward. She had a reaction that was one and done like a miracle. She felt better after 24 to 30 hours. The outcome of the events illness, malaise, dizziness, feeling abnormal was recovered on an unspecified date.  Information on lot /batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: muscle in right leg and bottom foot hurt her for and on achy almost like slight Muscle cramp and felt weakness; muscle in right leg and bottom foot hurt her for and on achy almost like slight Muscle cramp and felt weakness; muscle in right leg and bottom foot hurt her for and on achy almost like slight Muscle cramp and felt weakness; right big toe and index felt burning on and off for days/Feel burning but those toes once in a while; Still have right leg pain on calf and under knee and upper leg; This is a spontaneous report from a non-contactable consumer. A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Ew0150), via an unspecified route of administration on 11Apr2021 at 09:45 (at the age of 50-year-old), as dose 2, single in left arm for COVID-19 immunization at hospital. The patient's medical history included migraine and had allergies for penicillin. Concomitant medications within 2 weeks of vaccination included magnesium, ibuprofen (ADVIL 12 HOUR), atorvastatin one pill; all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Ep7534), via unspecified route of administration on 21Mar2021 at 09:45 (at the age of 50-year-old), as single dose in left leg for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021 at 08:00, after the administration of second dose of vaccine, the patient muscle in right leg and bottom foot hurt her for and on achy almost like slight muscle cramp and felt weakness. Third day same with leg and right arm. Fourth day felt muscle pain but not weakness, but right big toe and index felt burning on and off for days. The patient reported that months later now it was July and still had right leg pain on calf and under knee and upper leg. The patient felt burning but those toes once in a while. Adverse event result in Emergency Room visit. Patient had Doppler Ultrasound as treatment for the events. The patient underwent lab tets and procedures which included SARS-CoV-2 test (nasal swab): negative on 11May2021. The patient had COVID prior vaccination and was tested COVID post vaccination. The clinical outcome of all the events was not resolved.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: muscle in right leg and bottom foot hurt her for and on achy almost like slight Muscle cramp and felt weakness; muscle in right leg and bottom foot hurt her for and on achy almost like slight Muscle cramp and felt weakness; muscle in right leg and bottom foot hurt her for and on achy almost like slight Muscle cramp and felt weakness; right big toe and index felt burning on and off for days/Feel burning but those toes once in a while; Still have right leg pain on calf and under knee and upper leg; This is a spontaneous report from a non-contactable consumer. A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Ew0150), via an unspecified route of administration on 11Apr2021 at 09:45 (at the age of 50-year-old), as dose 2, single in left arm for COVID-19 immunization at hospital. The patient's medical history included migraine and had allergies for penicillin. Concomitant medications within 2 weeks of vaccination included magnesium, ibuprofen (ADVIL 12 HOUR), atorvastatin one pill; all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Ep7534), via unspecified route of administration on 21Mar2021 at 09:45 (at the age of 50-year-old), as single dose in left leg for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021 at 08:00, after the administration of second dose of vaccine, the patient muscle in right leg and bottom foot hurt her for and on achy almost like slight muscle cramp and felt weakness. Third day same with leg and right arm. Fourth day felt muscle pain but not weakness, but right big toe and index felt burning on and off for days. The patient reported that months later now it was July and still had right leg pain on calf and under knee and upper leg. The patient felt burning but those toes once in a while. Adverse event result in Emergency Room visit. Patient had Doppler Ultrasound as treatment for the events. The patient underwent lab tets and procedures which included SARS-CoV-2 test (nasal swab): negative on 11May2021. The patient had COVID prior vaccination and was tested COVID post vaccination. The clinical outcome of all the events was not resolved.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac failure congestive, Chest X-ray, Dyspnoea, Electrocardiogram
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's sister) or other HCP. This is 1st of 2 reports.A 60-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration at Arm Right on 10Mar2021 at 11:00 (at the age of 60-years-old) as Dose 1, single for COVID-19 immunization. The patient's medical history included atrial fibrillation, cardiac disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other products were used.On an unspecified date the patient experienced congestive heart failure and shortness of breath on an unknown date in Mar2021. The patient underwent lab tests and procedures which included blood test: good on, chest x-ray: good on, electrocardiogram: good on. Outcome of the event was cardiac failure congestive was unknown, shortness of breath was not recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Poor quality sleep, Pruritus, Rash, Skin exfoliation
Clinical narrative: rash around the injection site and some on the chest, on both of my arms on my neck my face and sides on my right leg; rash came on both of my arms on my neck my face and it was peeling on the face; Within a half an hour swelled a little bit and then went down.; rash around the injection site and some on the chest that went away; the swelling on the face also; a lot of itching; Really Disturbed quality of sleep.; rash came on both of my arms on my neck my face and it was peeling on the face; This is a spontaneous report received from a contactable consumer (Patient). A 79-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:00 (at the age of 79-year-old) as dose 2, single for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medication included LOSARTAN, METOPROLOL, DILTIAZEM HCL, MAGNESIUM P. AMINOBENZOATE. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient historic vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in Arm Left on 28Jan2021 10:15 AM as dose 1, single for covid-19 immunisation. On 04Mar2021, within a half an hour swelled a little bit and then went down. After second shot in about two days rash around the injection site and some on the chest that went away but then rash came on both of her arms on her neck her face and it was peeling on the face the swelling on the face also. Then the rash was on her chest on her sides on my right leg. It had continued since the 1st of March. She did have to go to Urgent Care twice and get medication. She was not able to get into her doctors office She was just now going to be able to go on July 7th. The medication helped temporarily. She was going to do a natural bowel cleanse and then a liver cleanse and then a kidney cleanse to try to get this eliminated. She reported a lot of itching. Really Disturbed quality of sleep. Had gone on for so many months she was tired of it. But she reported, it was better than getting covid and being in hospital with heart or lung problems. Events were reported as serious by the reporter. Patient did not receive any treatment due to adverse events. On an unspecified date in 2021 the events swelled a little bit and rash around the injection site and some on the chest was recovered and other events was not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Vaccination site rash
Clinical narrative: rash around the injection site and some on the chest, on both of my arms on my neck my face and sides on my right leg; rash came on both of my arms on my neck my face and it was peeling on the face; Within a half an hour swelled a little bit and then went down.; rash around the injection site and some on the chest that went away; the swelling on the face also; a lot of itching; Really Disturbed quality of sleep.; rash came on both of my arms on my neck my face and it was peeling on the face; This is a spontaneous report received from a contactable consumer (Patient). A 79-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:00 (at the age of 79-year-old) as dose 2, single for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medication included LOSARTAN, METOPROLOL, DILTIAZEM HCL, MAGNESIUM P. AMINOBENZOATE. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient historic vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in Arm Left on 28Jan2021 10:15 AM as dose 1, single for covid-19 immunisation. On 04Mar2021, within a half an hour swelled a little bit and then went down. After second shot in about two days rash around the injection site and some on the chest that went away but then rash came on both of her arms on her neck her face and it was peeling on the face the swelling on the face also. Then the rash was on her chest on her sides on my right leg. It had continued since the 1st of March. She did have to go to Urgent Care twice and get medication. She was not able to get into her doctors office She was just now going to be able to go on July 7th. The medication helped temporarily. She was going to do a natural bowel cleanse and then a liver cleanse and then a kidney cleanse to try to get this eliminated. She reported a lot of itching. Really Disturbed quality of sleep. Had gone on for so many months she was tired of it. But she reported, it was better than getting covid and being in hospital with heart or lung problems. Events were reported as serious by the reporter. Patient did not receive any treatment due to adverse events. On an unspecified date in 2021 the events swelled a little bit and rash around the injection site and some on the chest was recovered and other events was not recovered.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Pyrexia, Swollen tongue
Clinical narrative: Fever; Headache; Feels like my tongue is swollen; Body aches in different places; Started feeling poorly, my condition got worse; This is a spontaneous report received from a contactable consumer (patient). 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration on 01Jul2021 at 10:00 (at the age of 74-year-old) as single dose for covid-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient stated I called because I had the Pfizer vaccine at 10: 00 on 01Jul2021 2 days ago and I started feeling poorly yesterday afternoon and today my condition got worse, I just wanted to know if that is normal, I have fever, a headache, my body aches in different places, and it feels like my tongue is swollen on Jul2021. Therapeutic measures were taken as a result of the events with Tylenol 500mg. The outcome of the events was reported as unknown.   Follow up attempts are possible. Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: Still feverish; Dizzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not provided), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date as 1st dose, single for COVID-19 immunization. The patient had experienced still feverish and dizzy on an unspecified date. It was reported that patient got vaccinated with second dose on tuesday and was still dizzy, still feverish and wondered was that normal. The outcome of the events was reported as unknown.  Information regarding the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse (patient reported for herself). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 11Jun2021 (at the age of 72-year-old) as dose 1, single for COVID-19 immunization. Medical history included multiple sclerosis from 1980 and ongoing, heart disease. The patient concomitant medications were not reported. The patient was not taking any medications routinely prior to the event being reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced first dose: sore arm/sore arm after the first dose on 12Jun2021 at 08:00 AM. Patient stated she did fine with the first injection, nothing except for a sore arm. It just lasted a day. AE does not require to visit emergency room, physician office. The patient does not have a positive test for SARS-CoV2. The patient does not have a SARS-CoV2 antibodies at diagnosis. The patient was not hospitalized and not admitted to an intensive care unit. Reporter seriousness for first dose: sore arm was medically significant. Outcome of the event was unknown. Event relatedness for first dose: sore arm was related.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious event Pain in extremity cannot be totally 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.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Oesophagogastroduodenoscopy, Oropharyngeal discomfort, Thrombocytopenia, Varicose vein
Clinical narrative: The caller and his twin brother both have thrombocytopenia.; stage I varices; Something is getting in the way in his throat; This is a spontaneous report received from a contactable consumer(Consumer or other non health professional Specify Consumer or other non health professional: brother). This consumer reported adverse events with similar suspect for 2 patients. This report is One of two patients. A 54-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date in Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history included thrombocytopenia. The patient Concomitant medications were not reported. On an unspecified date, the patient experienced thrombocytopenia. On an unspecified date in Mar2021, the patient experienced stage I varices/ some type of clot or thrombosis, Something is getting in the way in his throat. This was 2 days ago. It was reported that patient read an article that there is a link between the Pfizer COVID vaccine and thrombocytopenia patients producing clots and reporter declined safety report because they don't know if it is related or not. The lab tests included test: Blood work, result: Excellent (blood work is perfect so far and It can't be cirrhosis because he has excellent blood work); Test : EGD, result : had nothing like this when they did the last one in 2018; Test: EGD, result: Abnormal (They found stage I varices/ some type of clot or thrombosis). The outcome of the events was unknown.  Information on the lot/batch number has been requested
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over; This is a spontaneous report from a contactable consumer (Patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date (at the age of 59-years-old) as dose number unknown, single for COVID-19 immunisation. No medical history and concomitant medications were reported. On an unspecified date, the patient experienced rash all over. The outcome of the event was unknown.  Information on the lot/batch number has been requested. Additional information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Post first dose of comirnity: headache and tired for 48 hours; Post first dose of comirnity: headache and tired for 48 hours; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. Post first dose of comirnaty, patient experienced headache and tired for 48 hours on an unspecified date. The outcome of events was recovered on an unspecified date.   Information about batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: blacked out; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on 30Jun2021 at 10:15 as DOSE 2, SINGLE for covid-19 immunisation. Patient historical vaccine included received first doe of bnt162b2 (BNT162B2, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 30Jun2021 at 10:30, The patient experienced blacked out for 15 minutes after the second injection. I blacked out for 15 minutes when I got home which had been about 26 minutes after I got the shot. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I received both doses of the Pfizer vaccine in March 2021. I just tested positive for Covid-19. The vaccine does not work.; I received both doses of the Pfizer vaccine in March 2021. I just tested positive for Covid-19.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on an unknown date in Mar2021 as dose 2 single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on an unknown date in Mar2021 as dose 1 unknown both for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received both doses of the Pfizer vaccine in Mar2021 and tested positive for COVID-19 on 02Jul2021. The vaccine did not work. The patient underwent lab tests and procedures which included COVID-19 test: positive on 02Jul2021. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Rash
Clinical narrative: Broke out severe rash and patches all over my body on buttock, legs, back, breast and neck; itching so bad that I can't stand up; took Benadryl and used Cortisone but it does not seem to be working; I haven't slept since I have this shot; Broke out severe rash and patches all over my body on buttock, legs, back, breast and neck; itching so bad that I can't stand up; took Benadryl and used Cortisone but it does not seem to be working; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 64-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0181), 1 via an unspecified route of administration, administered in Arm Left on 28Jun2021 (at the age of 64-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing Verbatim: High blood Pressure. The patient's concomitant medications were not reported. When probed for event start date, consumer stated, I started itching that day 28Jun2021 but rash did not start until the 29Jun2021 and then it coming out getting worse. The patient experienced broke out severe rash and patches all over my body on buttock, legs, back, breast and neck, itching so bad that I cannot stand up, took Benadryl and used Cortisone but it does not seem to be working was reported as worsened and I have not slept since I have this shot, On 29Jun2021. The events itching, rash all over assessed as serious (medically significant) and while other event was non-serious. When probed for the concern, patient stated, I got my first round shot on 28Jun2021 at (withheld) and I am calling because I broke out severe rash all over my body and I am itching so bad that I cannot stand up. I want to know that what I can do because I took Benadryl and used Cortisone but it does not seem to be working. Patient second dose vaccination due date: 19Jul2021. Treatment was received for the events as Benadryl and Cortisone. Consumer stated, I just went to Emergency Room and they just cannot helped me. I think if they cannot help me, what is the shot if it cannot help. I called CDC and I do not know what to do about it. Consumer stated, nobody can help me today. What should I do. I broke out the rash on my body. I have patches all over my body. Pfizer do not give an information in weekends. I gave information and you gave me nothing. I wish I never got this. This is stupid there should be somebody, hell with the Pfizer. The outcome of the events was reported as not recovered and while for other was unknown.  Follow-Up (06Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache started that night; Fever; Chills; Super tired; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age, gender received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, lot Number and expiry dates were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COMIRNATY) for COVID-19 immunisation, post first dose of comirnity: headache and tired for 48 hours. Post second dose of vaccine, the headache started that night (10 hours later) that night fever chills and was super tired for48 hours. Event took place after use of product. The outcome of the events was unknown.  Information about batch/Lot number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Insomnia, Psychiatric symptom
Clinical narrative: full of anxiety; sleep deprived; unsure of herself; This is a spontaneous report from a contactable consumer or other non hcp and from a Pfizer sponsored program Pfizer . A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as dose number unknown, single (age at vaccination 16-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced full of anxiety, sleep deprived, unsure of herself on an unspecified date. It was reported that, reporters 16-year-old daughter got the Pfizer vaccine in Apr2021 and ended up in the psyche ward for two weeks. Before the vaccine, she was a normal healthy teen. Now she is full of anxiety, sleep deprived and unsure of herself. Please look into the effects of the vaccine on teenagers and help us deal with this crisis. The clinical outcome for all events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: achy; arm hurts; Headache; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient's mother). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller states she had a quick question. She forgot what the pharmacist said but her son got the shot and on unspecified date he was achy, his arm hurted and he had a headache. The caller clarified she was referring to the Pfizer BioNTech COVID-19 vaccine. She asked what her son can take, Tylenol or Aspirin. She believes the pharmacist said Tylenol, but he may have said Aspirin, she doesn't know. She doesn't want to give him Aspirin if the pharmacist said Tylenol or Tylenol if he said Aspirin. She doesn't want to give him the wrong thing. Caller declined to complete a report on behalf of her son, stated she just wanted to know if she can give him Tylenol or Aspirin. Caller made the comment she had one too, but her shot wasn't Pfizer. Her son was having the same symptoms as she did: achy, arm feels like there is a knot in it, a headache- she just felt achy. Caller declined to complete a report on behalf of herself or her son because the symptoms seem like normal, it was not anything unusual. The outcome of events was unknown.  Information about batch/ lot number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle twitching, Myalgia, Nausea, Pyrexia
Clinical narrative: She is experiencing now is a muscle twitching in her upper right arm that would not stop in the opposite arm the one she received the injection; Fever; Joint and muscle pain; Joint and muscle pain; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0196/Batch number, NDC and UPC number unknown) intramuscular administered in left arm on 30Jun2021 (at the age of 65-years-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included hypothyroidism. Concomitant medication included hypothyroid medication for hypothyroidism. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot: unknown) on an unspecified date administered as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, the patient experienced muscle twitching in the upper right arm that would not stop in the opposite arm the one in which patient received the injection. Patient also experienced fever, joint and muscle pain and nausea. Patient had taken treatment with Tylenol. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Soft tissue mass
Clinical narrative: Bump on his left shoulder under his collarbone; It has not gone away; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 2 via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient experienced as, bump on his left shoulder under his collarbone; it has not gone away on an unspecified date. Reported as, "I am just concerned about my son, he had the second shot on Friday and he has a bump on his left shoulder under his collarbone that just appeared basically like yesterday evening and today, it has not gone away". Outcome of the event not recovered. Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Headache, Influenza, Palpitations
Clinical narrative: weak short of breath; terrible headache; heart palpitations; flu symptoms; I still feel terrible. I now need to see a immunologist.; This is a spontaneous report from a contactable consumer (patient herself). A 52-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW1077; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: penicillin. Prior to vaccination the patient was diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW1077; Expiration date: unknown) via an unspecified route of administration, administered in Arm left on 24May2021 14:00 as single dose for COVID-19 immunization with reaction fever, flu symptoms, congestion, severe headache, pcn(Drug hypersensitivity). On an unspecified date in 2021 after the second dose the patient experienced weak short of breath, terrible headache, heart palpitations, flu symptoms, i still feel terrible. i now need to see a immunologist. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.  The patient underwent lab tests and procedures which included Covid-19 which was positive on unspecified date prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of all events was not recovered.  Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: weak short of breath; terrible headache; heart palpitations; flu symptoms; I still feel terrible. I now need to see a immunologist.; This is a spontaneous report from a contactable consumer (patient herself). A 52-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW1077; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: penicillin. Prior to vaccination the patient was diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW1077; Expiration date: unknown) via an unspecified route of administration, administered in Arm left on 24May2021 14:00 as single dose for COVID-19 immunization with reaction fever, flu symptoms, congestion, severe headache, pcn(Drug hypersensitivity). On an unspecified date in 2021 after the second dose the patient experienced weak short of breath, terrible headache, heart palpitations, flu symptoms, i still feel terrible. i now need to see a immunologist. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.  The patient underwent lab tests and procedures which included Covid-19 which was positive on unspecified date prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of all events was not recovered.  Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.