chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Hemorrhaging in the hospital; Suspected to be pregnant has a miscarriage; Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting.; Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting; This is a spontaneous report from a Pfizer Sponsored Program  A contactable consumer reported for a female patient   A female patient of age 3 decade received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Not reported) Via an unspecified route of administration on an unspecified date as a dose number unknown, single for (at the age of 3 decade) COVID-19 immunization. Patient medical history and concomitant medication were not provided. After administration of the vaccine, on an unspecified date she was hemorrhaging in the hospital and suspected to be pregnant, has a miscarriage. Her period has also become "messed up" that became longer and heavier with cramping and nausea and vomiting. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Anger, Anxiety, Depression, Fatigue, Gait disturbance
Clinical narrative: Suicidal thoughts; Numbness; Tingling; Anxiety; Depression; Insomnia; Anger outbursts; leg weakness; Still had some trouble walking at times; would forget what was working or go to the bathroom; So tired when walking; This is a spontaneous report from a Pfizer-sponsored program. Social Media Platforms from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 24Apr2021 at single dose, dose number unknown for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had leg weakness, numbness and tingling; insomnia; suicidal thoughts; anger outbursts; anxiety and depression. And patient would forget what was working or go to the bathroom, then came sit at desk, and then not remember what was doing. On 24Jun2021, things got a lot better. Patient still had some trouble walking at times. Patient just get so tired when walking. Outcome of events "had some trouble walking at times" and "tired when walking" was not recovered, of the other events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Memory impairment, Muscular weakness, Paraesthesia
Clinical narrative: Suicidal thoughts; Numbness; Tingling; Anxiety; Depression; Insomnia; Anger outbursts; leg weakness; Still had some trouble walking at times; would forget what was working or go to the bathroom; So tired when walking; This is a spontaneous report from a Pfizer-sponsored program. Social Media Platforms from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 24Apr2021 at single dose, dose number unknown for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had leg weakness, numbness and tingling; insomnia; suicidal thoughts; anger outbursts; anxiety and depression. And patient would forget what was working or go to the bathroom, then came sit at desk, and then not remember what was doing. On 24Jun2021, things got a lot better. Patient still had some trouble walking at times. Patient just get so tired when walking. Outcome of events "had some trouble walking at times" and "tired when walking" was not recovered, of the other events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Suicidal ideation
Clinical narrative: Suicidal thoughts; Numbness; Tingling; Anxiety; Depression; Insomnia; Anger outbursts; leg weakness; Still had some trouble walking at times; would forget what was working or go to the bathroom; So tired when walking; This is a spontaneous report from a Pfizer-sponsored program. Social Media Platforms from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 24Apr2021 at single dose, dose number unknown for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had leg weakness, numbness and tingling; insomnia; suicidal thoughts; anger outbursts; anxiety and depression. And patient would forget what was working or go to the bathroom, then came sit at desk, and then not remember what was doing. On 24Jun2021, things got a lot better. Patient still had some trouble walking at times. Patient just get so tired when walking. Outcome of events "had some trouble walking at times" and "tired when walking" was not recovered, of the other events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Vaccination site erythema, Vaccination site swelling
Clinical narrative: lymphadenopathy and erythema on the right side, which was the right of the injection; lymphadenopathy and erythema on the right side, which was the right of the injection; erythema around her arm, the injection site/It was swollen; erythema around her arm, the injection site/It was swollen; This is a spontaneous report from a contactable Other Health Professional (Specify as Anesthesiologist, also the patient). This is the second of 2 reports for dose 1 and dose 2. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration in Arm Right on 23Dec2020 (Lot Number unknown) at the age of  61-year-old, and dose 2 via an unspecified route of administration in Arm Right on 13Jan2021 (Lot Number unknown) at the age of  61-year-old, for Covid-19 immunization. Medical history included scoliosis; pain. Concomitant medications included pregabalin (LYRICA) taken for scoliosis; diazepam (VALIUM) taken for scoliosis; ibuprofen taken at night for the pain help to relieve pain; calcium; amlodipine (AMLODIPIN); baclofen; ibuprofen (MOTRIN), multivitamin (unspecified), and "Xytone" (unspecified). Due to scoliosis, the patient was taking LYRICA and VALIUM which sort of kicked up in getting a 3rd vaccine. Also stated it was her Second vaccine on 13Jan2021 so, she was 8 months out. Also stated that she thought aphrodisiac (Not clarified). No prior vaccination ever in her life. It was reported that, she got her 3rd dose because she was on various medicines. On last Thursday and Pfizer so, The 1st two, anyway, what happened was that, she got lymphadenopathy and erythema on the right side, which was the right of the injection. She also had erythema around her arm, the injection site, that hasn't changed that was about like, it was like 3 into 5 inches. It was swollen and she had that 2 times, The 1st two times.  She had not had the swollen Adenopathy so. The outcome of the events was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a Literature report. This reporter reported 3 reports, this is the 3 of 3 reports. This case was split from master case 202101198829 for a patient taking Bnt162b2 and experienced Bell's palsy.This information was from FDA briefing document.    A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, both for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Bell's palsy. It was reported in the Food and Drug Administration briefings suggest risk of Bell's palsy is greatest within 1 month of a second vaccine dose. Of the Pfizer briefing notes "from dose 1 through 1 month after dose 2, there were three reports of Bell's palsy in the vaccine group and none in the placebo group". The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101207187 Same article, different patients with same drug;US-PFIZER INC-202101207186 Same article, different patients with same drug
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive test result for Covid 19; positive test result for Covid 19; This is a spontaneous report from a contactable consumer. A 71-year-old male patient (father) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), dose 2 via intramuscular route in right arm on 05Mar2021 at 09:00 as single dose for COVID-19 immunisation. The patient's medical history included hypertension from an unknown date. There were no concomitant medications reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported) dose 1 via intramuscular route in right arm on 15Feb2021 at 10:00 as single dose for COVID-19 immunisation. On 11Sep2021 at 07:00, approximately 190 days after the second dose, the patient had positive test result for COVID-19, first dose was received on 15Feb2021/ second dose was received on 05Mar2021, flu like symptoms, slight fever, feelings of light headedness, cough and runny nose. The adverse events resulted in physician's office visit. The patient underwent sars-cov-2 test (nasal swab) which was positive on 13Sep2021. The patient was not tested positive for covid-19 prior to vaccination. The outcome of all the events was not recovered.  The lot number for the vaccine was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: My husband got the first shot but he broke out in, Like blisters, All over his body.; : This is a spontaneous report from a contactable consumer or other non hcp (patient's wife) for a male patient (husband). A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The reporter reported her husband got the first shot but he broke out in, like blisters, all over his body on an unspecified date. She asked was that happened to anyone else. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Neuropathy peripheral, Paraesthesia
Clinical narrative: since the second dose the neuropathy is "three times worse"; since the second dose the neuropathy is "three times worse"; missed work because his feet and legs bother him; like standing on pins and needles; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0186 and expiration date was not reported), via an unspecified route of administration, administered in Right Arm on 01Aug2021 at 16:00 hours (Age at vaccination was 55 years) as dose 2, single for covid-19 immunization. Medical history included ongoing neuropathy peripheral. The patient did not have any other adverse event within 4 weeks of vaccination and also prior to vaccination. The patient did not take any additional vaccine. There were no concomitant medications. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EY0584 and expiration date was not reported), via an unspecified route of administration, administered in Right Arm, on 8Jul2021 (Age at vaccination was 55 years) as dose 1, single for COVID-19 immunization. In Aug2021 patient reported that he had a previous diagnosis of peripheral neuropathy in his feet and legs, related to his work in a battery factory, and since the second dose the neuropathy is three times worse like standing on pins and needles. The patient was missed work because his feet and legs bother him, like standing on pins and needles that diabetics usually get, but he was not diabetic. The patient did not perform any relevant tests. Patient was treated with Gabapentin 800mg 3 times a day, which was almost the max dose. Patient states he went to the doctor a week and a half ago and discussed it with him and he said to stick with what he was doing and if it doesn't get better to come back. Patient states it doesn't seem to be letting up, but some days are worse than others. The outcome of all the events was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Paraesthesia oral, Vaccination site pain
Clinical narrative: First dose: Severe flushing; First dose: Tingling in upper lip and tongue; First dose: Pain at the injection site of her right upper arm; This is a spontaneous report from a contactable consumer (patient).  A 36-years-old female patient received bnt162b2 (BNT162B2,Solution for injection,Batch/Lot Number: ER8729,Expiry date was unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 05Apr2021 15:30  as DOSE 1,SINGLE for covid-19 immunisation (At the age of vaccination-36 yrs).  Medical history included immune system disorder (previously had compromised immune system but not for about 2 years now), drug hypersensitivity (penicillin), respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity and lot of drug allergies from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took heptitis A vaccine on an unknown date other than several years ago and experienced got hives. 05Apr2021 at 15:30 She reported at 15:30, immediately after injection she experienced pain at the injection site of her right upper arm. She thought it was just a muscle reaction; it was not swollen or hard. The Nurse examined her about 10 minutes later and asked her to stay longer so patient stayed another 30 minutes. Within that 30 minutes she had onset of severe flushing-clarified time of onset about 20 minutes after injection administered so around 15:50. She was administered 25mg of Benadryl oral. Also around 15:50 the flushing progressed to a little tingling in upper lip and tongue. She was sent to the emergency room and administered another 25mg of Benadryl and 20mg Pepcid oral. She was not admitted to the hospital, she was monitored and kept under observation in the hospital emergency room for a couple of hours and then released. She recovered completely from all of these events within about 24 hours of onset. Therapeutic measures were taken as a result of first dose: pain at the injection site of her right upper arm, severe flushing, tingling in upper lip and tongue. On 14Sep2021 she was pre-medicated with 25mg of Benadryl and 20mg of Pepcid. She was administered second dose of Pfizer Covid-19 Vaccine on 14Sep2021 at 10:23. She started to flush slightly around 10:40. She was administered 25mg of Benadryl and that resolved the event of started to flush slightly. She had no further incidents, was able to tolerate the second dose. She recovered completely from this event within about 24 hours also. They did not send her to the emergency room this time, they felt that the reaction was well controlled with the antihistamines. The patient visited emergency room and physician office. On 06Apr2021 the clinical outcome of the event was recovered.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; Fatigue; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored Program COVAX Support. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0162) via an unspecified route of administration, administered in Arm Left on 23Apr2021 13:00 (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. Medical history included barrett's oesophagus from an unknown date and unknown if ongoing. Concomitant medication(s) included lansoprazole (PREVACID) taken for barrett's oesophagus from an unspecified start date and ongoing. Patient historical vaccine included FLU vaccine via unspecified route of administration on 2019 for immunisation (the Pfizer vaccine is the only thing he has had since he had the flu vaccine in 2019). The patient experienced sore arm, fatigue on Apr2021. Reported as, he had none of the side effects after the vaccinations other than maybe a sore arm; and more like fatigue. Adds he doesn't really want to emphasize the fatigue as he is a truck driver, he was tired all the time, and he just kind of felt a little extra tired. He completely recovered from these effects. Outcome of all the event was resolved on 2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mycobacterium tuberculosis complex test, Pain in extremity, Paraesthesia
Clinical narrative: left leg from the thigh down to her foot was numb and tingling, on and off after first dose/left leg from thigh down to foot was numb or tingling after second dose; left leg from the thigh down to her foot was numb and tingling, on and off after first dose/left leg from thigh down to foot was numb or tingling after second dose; arm where she got the shot was sore after first dose/after her second dose; her left arm is sore; This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: FW0173, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 24Aug2021 at 15:45 hours as dose 1, single (at the age of 37-years-old) and received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: 30135BA, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 15Sep2021 at 09:15 hours as dose 2, single (at the age of 37-years-old) both for COVID-19 immunisation (at  Clinic). Patient had no medical history (including any illness at time of vaccination) and had no relevant family medical history. Patient had no prior vaccinations (within 4 weeks). Patient had no additional vaccines administered on same date of the Pfizer suspect. Patient did not receive any other products/concomitant medications. Patient stated that she was healthy with no health issues and takes no medication. On 24Aug2021, patient stated that the arm where she got the shot was sore. On 25Aug2021, after the first dose, the second day, patient experienced that her left leg from the thigh down to her foot was numb and tingling, on and off. Patient stated that first time arm was sore for two days. On 15Sep2021, patient got her second dose and her left arm was sore; and her left leg from thigh down to foot was numb or tingling and it was doing the same thing, it was back the same way, it feels funny. Patient stated that she did not feel that feeling until when she goes to bed at night, she laid down it starts to feel numb and tingling, last night (15Sep2021) up to today (16Sep2021) and now she was at work in the day, and it had the same feeling and stated that arm was still sore from the second dose. Patient stated that her left leg from the thigh down to her foot was numb and tingling, never totally stopped since then it was persisting, and patient still experience this until now. No relevant tests were performed. Patient just called the doctor this morning (16Sep2021) and they gave her the number to call Pfizer, but if her symptoms do not go away, she was going to call back to be seen. Patient had no emergency room and physician office visit for the events. On an unspecified date 2021, patient had tuberculosis (TB) test done for work and results were unknown. The outcome of all the events was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling is still there under her arm; Arm was sore; Extra dose administered; Off-label; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, Batch/Lot Number: 30130BA), Solution for injection, via an unspecified route of administration, administered in Arm Right on 14Sep2021 between 10:30 and 11 am (age at vaccination 64-year-old) as single dose for covid-19 immunisation. Medical history included Blood pressure high and may be little obesity. Concomitant medication included lisinopril taken for hypertension 30 mg once a day, carvedilol taken for hypertension 25 mg once a day and amlodipine taken for hypertension 5 mg a day. Patient did not receive any other vaccine within four weeks of receiving Pfizer vaccine. No additional vaccines were administered on same date of the Pfizer suspect. Patient received her first dose of the Pfizer COVID vaccine was on 07Mar2021 (batch lot number: EN6206) administered in her right arm and received her second dose of the Pfizer COVID vaccine was administered on 30Mar2021, (batch lot number EP7533) administered into her right arm for covid-19 immunisation. On 14Sep2021, patient received extra dose which was off label. On 15Sep2021, her arm was sore and had swelling and was puffy under her armpit. As per the report, patient received her booster dose of the Pfizer BioNTech Covid 19 vaccine on 14Sep2021. Yesterday her arm was sore and had swelling and was puffy under her armpit. It was staying about the same but the swelling was still there under her arm today. No relevant test was performed. Patient did not visit to emergency room or physician office due to adverse events. At the time of this report, the outcome of swelling was still there under her arm was not recovered and other events was unknown.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Endocarditis, SARS-CoV-2 test
Clinical narrative: endocarditis; This is a spontaneous report from a Contactable Other HCP. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 23Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient received the first dose of bnt162b2 on unknown date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced endocarditis on 23Aug2021 with outcome of unknown. Patient was hospitalized for 20 days. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Patient had Nasal Swab on 03Sep2021 with negative result.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of endocarditis cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported that:  A male patient of an unspecified age received second 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 09Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included 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 12Mar2021 as single dose for COVID-19 immunisation and experienced sore arm. On an unspecified date in 2021, the patient experienced flu symptoms for 36 hours after receiving the Pfizer-BioNTech COVID-19 vaccine. The clinical outcome of the event was reported as recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This is a spontaneous report from a contactable consumer (patient's husband). A 65-years-old female patient (reporter's wife) received first dose of BNT162B2 (COMIRNATY VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 04Feb2021 (Batch/Lot Number: EN5318) as dose 1, single and received second dose of BNT162B2 (COMIRNATY VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 26Feb2021 (Batch/Lot Number: EN6203) as dose 2, single for covid-19 immunization (at the age of 65-years-old). Medical history included ongoing rheumatoid arthritis (diagnosed about 26 years ago). Concomitant medication(s) included adalimumab (HUMIRA) taken for rheumatoid arthritis from 2004 and ongoing. Reporter called on behalf of his wife and stated that after receiving the first dose of vaccine on 04Feb2021 the patient experienced sore arm and stated that she experienced the same after receiving second dose of vaccine as well which received on 26Feb2021. The patient had no reactions to the vaccine except soreness in the arm that started the same day and was gone by the next day. The patient did not receive any treatment for the event. The outcome of the events was recovered initially on 05Feb2021 and later on 27Feb2021.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pulmonary infarction
Clinical narrative: pulmonary embolism; pulmonary infarction; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Jun2021 12:00 (Lot Number: ER8724) at the age of 38-year-old as DOSE 2, SINGLE, for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Arm Left on 29May2021 11:00 (Lot Number: ER8729) at the age of 37-year-old as DOSE 1, SINGLE for covid-19 immunisation. The patient developed a pulmonary embolism, pulmonary infarction both on 21Jun2021 with outcome of recovering. Therapeutic measures were taken as a result of both events with anticoagulation and blood thinner medication. Events reported as serious with life threatening. Events caused doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient is not pregnant.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: lack of efficacy- fully vaccinated with CV19 + via PCR on 15Sep2021.; lack of efficacy- fully vaccinated with CV19 + via PCR on 15Sep2021.; This is a spontaneous report from a contactable other healthcare professional. A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via intramuscular route, administered in arm left on 08Apr2021 (Lot Number ER8729 and expiry date was not reported, at the age of 31-year-old) as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via intramuscular route, administered in arm left on 29Apr2021 (Lot Number ER8736 and expiry date was not reported, at the age of 32-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. On 13Sep2021, the patient underwent COVID test post vaccination, PCR (Nasal Swab) which was positive. It was unknown if patient received treatment for AE. It was reported lack of efficacy- fully vaccinated with CV19 + via PCR event reported on 15Sep2021. Device Date was 16Sep2021. Outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relationship the causal role between the events Vaccination failure and SARS-CoV-2 test positive cannot be fully excluded. However the possibility of Covid being an intercurrent condition cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable consumer via Pfizer-sponsored program. A 20-year-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and was fine. On an unspecified date, after their second dose, patient felt as sick as they did when they had Covid (prior to vaccination).  The outcome of the event was recovered on an unspecified date. Patient asked if there had been any data collected on how long the antibodies hang around in a person body and asked if they can mix the Moderna and the Pfizer doses, patient stated that she had heard of people that mix the series if one or the other was not available. Patient also asked that if Pfizer can explain why they were that sick, and if they get the booster dose, will they get as sick again. The outcome of the event was recovered on an unspecified date.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101229081 same reporter/drug/AE, different patients
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: Tongue getting a tiny bit swollen; Her voice became a little raspy; A little difficulty breathing and had to take a deep breath; A little while later her teeth began to chatter which she had not experienced since she was a child; Very lightheaded/Dizziness; Some mild anxiety; It felt like an allergic reaction and it could have been more severe, but it was very mild; This is a spontaneous report from two contactable physician (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch no: not reported/ lot number: FC3183, Expiry Date of BioNTech Covid 19 vaccine was unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 27Aug2021 19:00 (at the age of 65 years) as dose 1, single for covid-19 immunization. Medical history included Bladder infections, that was a long time ago about 20 years ago and she had the wheals all over her body she looked like a lizard, her teeth was began to chatter which she had not experienced since she was a child. The patient previously took Nitrofurantoin, an antibiotic for bladder infections and skin wheals. The patient concomitant medications was not reported. On 27Aug2021 the patient experienced tongue getting a tiny bit swollen, her voice became a little raspy, a little difficulty breathing and had to take a deep breath, a little while later her teeth began to chatter which she had not experienced since she was a child, very lightheaded/dizziness, some mild anxiety, it felt like an allergic reaction and it could have been more severe, but it was very mild. Foe AE there was no need to visit emergency room. Therapeutic measures were taken as a result of the events. Outcome of the events was recovering.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between all the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Swollen tongue
Clinical narrative: Tongue getting a tiny bit swollen; Her voice became a little raspy; A little difficulty breathing and had to take a deep breath; A little while later her teeth began to chatter which she had not experienced since she was a child; Very lightheaded/Dizziness; Some mild anxiety; It felt like an allergic reaction and it could have been more severe, but it was very mild; This is a spontaneous report from two contactable physician (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch no: not reported/ lot number: FC3183, Expiry Date of BioNTech Covid 19 vaccine was unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 27Aug2021 19:00 (at the age of 65 years) as dose 1, single for covid-19 immunization. Medical history included Bladder infections, that was a long time ago about 20 years ago and she had the wheals all over her body she looked like a lizard, her teeth was began to chatter which she had not experienced since she was a child. The patient previously took Nitrofurantoin, an antibiotic for bladder infections and skin wheals. The patient concomitant medications was not reported. On 27Aug2021 the patient experienced tongue getting a tiny bit swollen, her voice became a little raspy, a little difficulty breathing and had to take a deep breath, a little while later her teeth began to chatter which she had not experienced since she was a child, very lightheaded/dizziness, some mild anxiety, it felt like an allergic reaction and it could have been more severe, but it was very mild. Foe AE there was no need to visit emergency room. Therapeutic measures were taken as a result of the events. Outcome of the events was recovering.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between all the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Palpitations
Clinical narrative: heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient (no pregnant) received the first dose of bnt162b2 on 24Mar2021 at 08:45AM (lot number: ER 2613) (at the age of 58-years-old) via unknown route of administration in Right arm at single dose for COVID-19 immunization; the second dose of bnt162b2 on 14Apr2021 at 08:45AM (Lot Number: ER 8735) via unknown route of administration in Right arm at single dose for COVID-19 immunization. Medical history included COPD, Emphysema, Asthma, allergy to egg. The patient received some medications within 2 weeks of vaccination. Patient previously took Eurithimycin and experienced stomache. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. Patient experienced heart palpitations on 24Mar2021 at 10:30 AM. This event resulted in Life threatening illness (immediate risk of death from the event). Patient did not receive any treatment. This event did not result in death, hospitalization, disability or Congenital anomaly. Starting with the 1st Covid shot patient experienced heart palpitations. The second shot after one hour of vaccine patient also experienced heart palpitations but much more serious. Her heart rate was jumping from 40 bpm to 150 on 25Mar2021 and higher back and fourth for over 45 minutes. She was on the interstate on her way home. She thought she was going to die. Since then she now experienced heart palpitations which she had never had before and now some other side effects she had never had either. She still occasionally had heart palpitations. She was going to report this to her physician. The outcome of the event was Recovered with Sequel in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Laboratory test, Neuropathy peripheral
Clinical narrative: she had the condition that she have was kind of neuropathy, it was not kind of severe neuropathy, and she noticed that it has got more intense since she got the shot; she had the condition that she have was kind of neuropathy, it was not kind of severe neuropathy, and she noticed that it has got more intense since she got the shot; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FC3183, Expiry Date: Unknown), via an unspecified route of administration, administered on 30Aug2021 (at the age of 70-years-old) as dose 1, single for covid-19 immunization. Medical history included hypertension, probably pre diabetes, she was supposed to meet her doctor in a little bit because she had mild stroke in 2021, about 2-3 months back and she had ongoing neuropathy but she don't think it's diabetic neuropathy, it was different, started from my neck down to my toes on one side and knee down to my toes on the other side (not clarified further). Concomitant medications included metoprolol, clopidogrel bisulfate (PLAVIX), irbesartan, ascorbic acid (VITAMIN C). The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Consumer stated that she got the first COVID shot on 30Aug2021 and she was due for the second shot on Monday on the 20Sep2021. Since she got first shot, she had the condition that she have was kind of neuropathy, it was not kind of severe neuropathy, and she noticed that it has got more intense since she got the shot in 2021 and she was wondering if she should go and get the shot done on day. The patient just wanted to know if should she take the second shot. She probably got one lab test in Aug2021 with results unknown. The outcome of the events was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood test, Pain in extremity
Clinical narrative: She did not get a reaction other than a sore arm with the first one; This is a spontaneous report from a Pfizer Sponsored Program  Support. A contactable 70-year-old female consumer (patient) reported for herself that: A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 19Jan2021 (at the age of 70-year-old), as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date in 2021, the patient experienced did not get a reaction other than a sore arm with the first dose. Patient has antibodies found in body and asked if patient can take third dose even though still has the antibodies. Patient reported that will see doctor on 01Oct2021 and wanted to see second blood test to see if patient still high in antibodies. Patient's antibodies went from 1287 to now 1171 and known people with Covid who have less antibodies and warn that still if patient can catch the virus. patient has seen other people who have had reactions after the 3rd dose and did not have any information to provide on any of those people. Patient did not want to get sick, and patient reported that did not get a reaction other than a sore arm with the first dose of vaccination. Patient already spoken with someone earlier and received a questionnaire in the mail and never returned it. Patient did not want to provide a complete report at this time and did not have a reference number for previous report and said it was a few months ago and forgot it. Patient received Pfizer COVID Vaccine was 19Jan2021 and did not have the lot or expiration for the first dose and it not written on the card. The second dose was given 09Feb2021 with Lot EM9810 expiration is unknown. Patient reported that on 09Oct2021, it will be 8 months in, and it was just approved to have booster 6 months in and received the vaccines. On unspecified date in 2021 the patient underwent lab tests and procedures which included antibody test: unknown results and antibodies went from 1287 to now 1171, on 2021 blood test: unknown results. The clinical outcome of event was unknown.    Information about lot/batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: flu-like symptoms; fatigue; This is a spontaneous report from a contactable consumer reported for a male patient that: A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced flu-like symptoms and fatigue on an unspecified date with outcome of unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Influenza like illness, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: COVID-19 antibody test negative; complained he felt like he had the flu; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a 50-year-old male patient (reporter's husband).   A 50 year old male patient had received second dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 13Apr202 as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient previously took BNT162B2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 23Mar2021as single dose for COVID-19 immunization. On 13Apr2021, the patient had experienced felt like he had the flu, but then in a couple of hours it was gone.  On 03Sept2021, the  patient underwent lab test and procedures which included blood test with unknown result and SARS-CoV-2 antibody test with negative result. The reporter also reported that Comirnaty and the Pfizer-BioNTech COVID-19 Vaccine may not protect everyone. According to the U.S. Centres for Disease Control and Prevention (CDC), if your body develops an immune response to vaccination, which was the goal, you may test positive on some antibody tests. Some antibody tests would only detect antibodies from infection, not from vaccination with the virus that causes COVID-19. The CDC states that antibody testing was not recommended to determine if a person is immune to SARS-CoV-2 (the virus that causes COVID-19) following COVID-19 vaccination because the usefulness of these tests in vaccinated people has not been established. In addition, antibody tests currently authorized under an EUA are not authorized to determine immune responses in vaccinated people. The outcome of the events were recovered.  Investigations: Caller says that for the dates of the antibody tests, her husband and her did not go the same days. The reporter said her husband went and got tested after hers was negative and his were the same tests that she had: SARS CoV 2, IgG NUCLEOCAP, IgM SPIKE, QL as the top one, then indented on the next line it says SARS CoV 2 AB (IgG), NUCLEOCAPSID, QL then SARS CoV 2 AB IGG for specific test with negative next to that, then another title that says negative as well. Caller says that their tests both said negative as well for each result, and her doctor said this morning if one of the two results for the test said positive it would be good, they just did not want both results on the test to say negative. Date for her husband's negative COVID-19 antibody test either not provided or not captured by call handler.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19; Tested positive for Covid 19; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number: UNKNOWN), 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. It was reported that on Thursday (05Aug2021), the reporter learned that the person who had sat closest to him and had the Pfizer Covid Vaccine had tested positive for Covid 19 on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.