chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound of covid symptoms and positive test 3 days after finishing full course of Paxlovid.; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: en6201), on 12Mar2021 as dose 2, single (Lot number: en6201) and on 22Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "eczema" (unspecified if ongoing); "migraines" (unspecified if ongoing); "known allergies: penicillin (hives)" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: allergies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 31Aug2022, outcome "not recovered", described as "Rebound of covid symptoms and positive test 3 days after finishing full course of Paxlovid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Aug2022) Positive, notes: Rebound of COVID symptoms and positive test 3 days after finishing full course of Paxlovid. Therapeutic measures were taken as a result of covid-19, vaccination failure. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: The patient received Covid-19 treatment from 23Aug2022 to 27Aug2022. Rebound of covid symptoms and positive test 3 days after finishing full course of Paxlovid. Rebound symptoms severity and duration significantly greater than original. The patient had not received Other medication in 2 weeks.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; New symptoms of weakness/lightheadedness/difficulty concentrating with positive rapid Covid test 6 days after completing Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The patient had not received any other vaccine within 2 weeks of vaccination. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 01Sep2022, outcome "unknown", described as "New symptoms of weakness/lightheadedness/difficulty concentrating with positive rapid Covid test 6 days after completing Paxlovid"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2022) Positive, notes: Positive rapid COVID test 6 days after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient orally received Paxlovid as treatment for COVID 19 from 25Aug2022 to 30Aug2022. On 01Sep2022, new symptoms of weakness/lightheadedness/difficulty concentrating with positive rapid Covid test 6 days after completing Paxlovid. It was unknown if patient received treatment for new symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events  DISEASE RECURRENCE and DRUG INEFFECTIVE  and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Atrophy of 1 kidney" (unspecified if ongoing), notes: Slight atrophy of 1 kidney; "UTI" (unspecified if ongoing), notes: male UTI. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound of covid by home test 7 days after completion of Paxlovid. Two days after completio of Paxlovid tested negative.; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL, start date: Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 03Sep2022, outcome "unknown", described as "Rebound of covid by home test 7 days after completion of Paxlovid. Two days after completio of Paxlovid tested negative.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (29Aug2022) Negative, notes: Two days after completion of Paxlovid tested negative; (03Sep2022) Positive, notes: Rebound of covid by home test 7 days after completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical Course:Rebound of covid by home test 7 days after completion of Paxlovid. Two days after completion of Paxlovid tested negative.Known allergies No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: The patient received treatment of COVID-19, brand: paxlovid, treatment start date: 22Aug2022, treatment stop date: 26Aug2022. No Known allergies were reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; disease recurrence; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 01Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 06May2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "artery disease" (unspecified if ongoing), notes: other medical history: artery disease; "hypertension" (unspecified if ongoing); "sulpha based meds" (unspecified if ongoing), notes: known allergies: sulpha based meds. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2015, stop date: 21Aug2022; CLOPIDOGREL, start date: 01Jan2021; GABAPENTIN, start date: 01Jan2018; METOPROLOL TARTRATE, start date: 05Aug2015.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (03Sep2022) Positive, notes: I have tested positive on 03Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence.  Additional information: Patient appear to be had a relapse of covid 19 after taking Paxlovid. Patient had tested positive on 03Sep2022 with symptoms of headache and nasal congestion. Patient started Paxlovid on 22Aug and took all 5 days of the prescribed medication.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive in the middle of Jul; I tested positive in the middle of Jul; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "weak lungs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered", and all described as "I tested positive in the middle of Jul". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had been vaccinated and boosted. He/She had weak lungs and was very nervous about getting covid 19. He/She tested positive in the middle of Jul. He/She contacted his/her doctor, and he prescribed the medicine Pfizer developed to help me beat Covid. He/She was sick for 10 days but recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tympanic membrane perforation
Clinical narrative: had surgery on my ear 09Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 at 16:00 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CRPS" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot No: Unknown. NA, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 16Nov2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: TYMPANIC MEMBRANE PERFORATION (medically significant) with onset 09Jan2022, outcome "recovered", described as "had surgery on my ear 09Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of ear operation.  Clinical Information: The reporter (Patient) stated, Not too long after the shot I had a metallic taste that lasted 7 days. I was told that was rare but would go Away. 08Nov2021 I went to the ENT because my right ear ruptured a week later. I just had surgery on my ear 09Jan2022 so hopefully the surgery is a success. I was in perfectly good health was forced by employer (withheld). The patient received thyroid medication in two weeks. No any other vaccine received in four weeks.Other medications in two weeks Thyroid medication. no other vaccine in four weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Testing positive day after testing negative; Treatment of COVID-19/Testing positive day after testing negative; Treatment of COVID-19/Testing positive day after testing negative; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN; ACETAMINOPHEN. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovering" and all described as "Treatment of COVID-19/Testing positive day after testing negative"; DISEASE RECURRENCE (medically significant) with onset 04Sep2022 at 07:00, outcome "recovering", described as "Testing positive day after testing negative". Patient was Tested positive day after testing negative with runny nose, congestion, headache. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive, notes: Testing positive day after testing negative,(Disease recurrence). Therapeutic measures were taken as a result of drug ineffective, covid-19 with anti-viral Treatment Paxlovid from 26Aug2022 and stopped on 30Aug2022. Therapeutic measures were not taken as a result of disease recurrence.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2022 at 11:00 as dose 4 (booster), single (Lot number: FM7533) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 04Sep2022, outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2022) Negative, notes: 3 days after completing series of paxlovid; (04Sep2022) positive, notes: On 5th day after completing paxlovid I started to feel ill again and tested covid positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence with paxlovid from 26Aug2022 to 31Aug2022.  Clinical course: The patient received other medication in 2weeks. Patient Took paxlovid 5 days. Tested negative 3 days after completing series of paxlovid. On 5th day after completing paxlovid I started to feel ill again and tested covid positive again.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Without your boosters (Pfizer COVID-19 Vaccine) I would have died, I have had two of the Boosters and my first COVID shot was Johnson & Johnson so, I have had three shots; Without your boosters (Pfizer COVID-19 Vaccine) I would have died, I have had two of the Boosters and my first COVID shot was Johnson & Johnson so, I have had three shots; Without your boosters (Pfizer COVID-19 Vaccine) I would have died, I have had two of the Boosters and my first COVID shot was Johnson & Johnson so, I have had three shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Interstitial cystitis" (unspecified if ongoing), notes: I have interstitial cystitis (captured in history). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "Without your boosters (Pfizer COVID-19 Vaccine) I would have died, I have had two of the Boosters and my first COVID shot was Johnson & Johnson so, I have had three shots". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 166, notes: My blood pressure shot up to 166 over a 100; Better, notes: Now it is better and not 166. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Consumer stated side effect for Paxlovid, I have interstitial cystitis (captured in history). I don't know if that caused it or what but after I took the Paxlovid, I took one and I started on the second little card and my blood pressure Shot up to 166 over a 100 and I took it three times to make sure, it was right and then I passed out. They called a doctor he said, immediately stop it and I needed to come in to their urgent care. Well I guess, now it is better and not 166 but it hasn't come all the way back down to normal."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Paxlovid rebound two days after negative test, 11 days post initial symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 08:00 as dose 1, single (Lot number: EN6199), in left arm, on 31Mar2021 at 08:00 as dose 2, single (Lot number: ER8732), in left arm, on 06Oct2021 at 08:00 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 13May2022 at 08:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PROSTATE CANCER" (unspecified if ongoing), notes: Other medical history: Prostate Cancer; "Gleason 6" (unspecified if ongoing), notes: Other medical history: Gleason 6, on active surveillance Protocol. Concomitant medication(s) included: DUTASTERIDE, start date: 01Jun2022, stop date: 25Aug2022. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 24Aug2022, outcome "not recovered", described as "Paxlovid rebound two days after negative test, 11 days post initial symptoms"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication for treatment of COVID-19; Negative, notes: Paxlovid rebound two days after negative test; Positive, notes: Paxlovid rebound two days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical information: COVID 19 treatment, treatment start date 26Aug2022, treatment stop date 01Sep2022, Paxlovid rebound two days after negative test, 11 days post initial symtoms, adverse event start date 24Aug2022, adverse event start time 07:00 PM, Other medical history: Prostate Cancer, Gleason 6, on active surveillance Protocol.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He took all of the Pfizer vaccines and boosters, all four, two boosters and Pfizer shots, and he thinks he caught COVID; He took all of the Pfizer vaccines and boosters, all four, two boosters and Pfizer shots, and he thinks he caught COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "He took all of the Pfizer vaccines and boosters, all four, two boosters and Pfizer shots, and he thinks he caught COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (01Sep2022) Positive, notes: he contracted COVID for a second time, and yesterday tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Echocardiogram, Imaging procedure, Magnetic resonance imaging, Myopericarditis
Clinical narrative: Myopericarditis after Covid-19 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myopericarditis after Covid-19 Vaccination". The patient underwent the following laboratory tests and procedures: Echocardiogram: Unknown results; Imaging procedure: Unknown results; Magnetic resonance imaging: unknown results.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: U
Vaccine: COVID19
Symptoms: Echocardiogram, Imaging procedure, Magnetic resonance imaging, Myopericarditis
Clinical narrative: Myopericarditis after COVID-19 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myopericarditis after COVID-19 Vaccination". The patient underwent the following laboratory tests and procedures: Echocardiogram: unknown results; Imaging procedure: unknown results; Magnetic resonance imaging: unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/ drug/event and different patient.;
Sex: U
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Imaging procedure, Magnetic resonance imaging heart, Myopericarditis
Clinical narrative: Myopericarditis after Covid-19 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacture), for COVID-19 immunization. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myopericarditis after Covid-19 Vaccination". The patient underwent the following laboratory tests and procedures: Echocardiogram: Normal; Electrocardiogram: Unknown result; Imaging procedure: Unknown result; Magnetic resonance imaging heart: unknown results.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/ drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Imaging procedure, Magnetic resonance imaging heart, Myopericarditis
Clinical narrative: Myopericarditis after Covid-19 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacturer), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myopericarditis after Covid-19 Vaccination". The patient underwent the following laboratory tests and procedures: Echocardiogram: Normal; Electrocardiogram: unknown result; Imaging procedure: unknown result; Magnetic resonance imaging heart: unknown result.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Myopericarditis and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/ drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Imaging procedure, Magnetic resonance imaging heart, Myopericarditis
Clinical narrative: Myopericarditis after Covid-19 Vaccination; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacture), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "Myopericarditis after Covid-19 Vaccination". The patient underwent the following laboratory tests and procedures: Echocardiogram: Normal; Electrocardiogram: Unknown result; Imaging procedure: Unknown result; Magnetic resonance imaging heart: unknown results.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/ drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Imaging procedure, Magnetic resonance imaging heart, Myopericarditis
Clinical narrative: Myopericarditis; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation.  The following information was reported: MYOPERICARDITIS (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Echocardiogram: Normal in reported cases; Electrocardiogram: unknown results; Imaging procedure: unknown results; Magnetic resonance imaging heart: unknown results; unknown results.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of myopericarditis 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.,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/ drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Imaging procedure, Magnetic resonance imaging heart, Myopericarditis
Clinical narrative: Myopericarditis; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Echocardiogram: Normal in reported cases; Electrocardiogram: unknown results; Imaging procedure: unknown results; Magnetic resonance imaging heart: unknown results; unknown results.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Myopericarditis and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-PV202200057449 Same article/ drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Myocarditis; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Echocardiogram: Unknown results; Electrocardiogram: Unknown results; Magnetic resonance imaging heart: Unknown results.  Clinical course: Wederived532post-vaccinecasesofCTorMRfindingsofmyocarditis,including462 (86.8 percent) males and70(13.2 percent)females(agerange:1280years).Intotal,113(21.2 percent)cases had positive disease history or comorbidities.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-PV202200057464 Same article/drug/ event; different patient.;
Sex: U
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Myocarditis; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Echocardiogram: Unknown results; Electrocardiogram: Unknown results; Magnetic resonance imaging heart: Unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Myocarditis" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-PV202200057464 Same article/drug/ event; different patient;
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Feb2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 01Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29May2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Anti-viral treatment for COVID-19 with Paxlovid from 24Aug2022 to 29Aug2022. Rebound COVID-19 after completing full 5 day Paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; dose 1, dose 2 and dose 3 are pfizer and dose 4 as Moderna; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Lot number: EH9899), on 07Jan2021 as dose 2, single (Lot number: EL3246) and on 28Aug2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 57 years for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: EH9899) for COVID-19 immunization. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing); "renal stones" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Apr2022 at 04:00, outcome "unknown", described as "dose 1, dose 2 and dose 3 are pfizer and dose 4 as Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient started the treatment with Paxlovid on 27Aug2022 and stopped on 31Aug2022 for the treatment of COVID-19. Other medications in two weeks was reported as unknown. The patient had no known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events INTERCHANGE OF VACCINE PRODUCTS, VACCINATION FAILURE, COVID-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound infection, positive test result 7 days after finishing Paxlovid; COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Patient has no known allergies. Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 treatment"; DISEASE RECURRENCE (medically significant) with onset 05Sep2022, outcome "recovering", described as "Rebound infection, positive test result 7 days after finishing Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2022) Positive, notes: Rebound infection, positive test result 7 days after finishing Paxlovid; (Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (treatment start date: 24Aug2022, treatment stop date: 29Aug2022). Therapeutic measures were not taken as a result of disease recurrence.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 08Feb2021 as dose 2, single (Lot number: EL9265), in left arm and on 22Jan2022 as dose 3 (booster), single (Lot number: EL3208) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "higher BMI" (unspecified if ongoing); "Known allergies: chicken eggs" (unspecified if ongoing); "known allergies: Yeast" (unspecified if ongoing). Concomitant medication(s) included: ZINC COLD THERAPY, start date: 02Sep2022, stop date: 04Sep2022; AMPHETAMINE SALTS, start date: 01Aug2021, stop date: 02Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid (Lot no. GE4259) for treatment of COVID-19 from 04Sep2022 to 04Sep2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngeal swab, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID illness. Positive test result with home test kit. Reported symptoms are similar to a common cold.; Breakthrough COVID illness. Positive test result with home test kit. Reported symptoms are similar to a common cold.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), on 28Mar2021 as dose 2, single (Lot number: EN6205), on 28Dec2021 as dose 3 (booster), single (Lot number: FE35Q4) and on 28Jun2022 as dose 4 (booster), single (Lot number: FM0173) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Sep2022, outcome "recovering" and all described as "Breakthrough COVID illness. Positive test result with home test kit. Reported symptoms are similar to a common cold.". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (04Sep2022) Positive, notes: covid test type post vaccination=Nasal Swab covid test date=04Sep2022 covid test result=Positive; SARS-CoV-2 test: (unspecified date) Positive, notes: home test kit. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: Breakthrough COVID illness. Positive test result with home test kit. Reported symptoms are similar to a common cold. Dose received More than 3.  Follow-up attempts are completed. No further information is expected.