chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: EW0164) at the age of 47 years, in left arm 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; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23May2022 at 15:00 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022 at 09:00, outcome "not recovered" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (04Jul2022) positive, notes: tested positive and continue to test; positive (4 days now); (05Jul2022) positive, notes: tested positive and continue to test; positive (4 days now); (06Jul2022) positive, notes: tested positive and continue to test; positive (4 days now); (07Jul2022) positive, notes: tested positive and continue to test positive (4 days now). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid as COVID 19 Treatment from 26Jun2022 to 30Jun2022. 4 days after completing Paxlovid patient tested positive and continue to test positive (4 days now) without fever. Patient stated that she did feel like might have a sinus infection.  No Follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
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 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm 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: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gluten, reaction(s): "allergies gluten", notes: known allergies gluten. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (29Jun2022) positive, notes: Paxlovid was taken within 5 hours of testing positive. Therapeutic measures were taken as a result of Drug ineffective, covid-19; included Paxlovid from 29Jun2022 to 03Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder
Clinical narrative: I have mobility issues, So the whole left arm and my body wasn't able to perform a function; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 1, single (Lot number: FJ1620) at the age of 32 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: MOVEMENT DISORDER (non-serious), outcome "unknown", described as "I have mobility issues, So the whole left arm and my body wasn't able to perform a function". Therapeutic measures were not taken as a result of movement disorder.  Additional information: It was reported that the patient had no medical conditions. The patient did not undergo any lab tests and had no prior vaccinations. The patient receive regular medications, most are vitamins. The patient did not receive any treatment for the event.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasal congestion, Sneezing
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Sneezing; stuffy nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 at 13:00 as dose number 2, single (Lot number: ENG206) at the age of 69 years, in left arm and on 04Oct2021 at 13:00 as dose number 3, (booster), single (Lot number: FD84218), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), from 25Apr2022 at 13:00 (Lot number: 056M21A) to 25Apr2022 at 13:00 at single (dose number 4, (booster), single) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), (Batch/Lot number: unknown) at single (dose number unknown, single) for covid-19 immunisation. There were no concomitant medications. The following information was reported: SNEEZING (non-serious) with onset 06Jul2022 at 03:00, outcome "recovering"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022 at 03:00, outcome "unknown" and all described as "Treatment of COVID-19"; NASAL CONGESTION (non-serious) with onset 06Jul2022 at 03:00, outcome "recovering", described as "stuffy nose". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of sneezing, nasal congestion. Clinical course: Patient had no known allergies. Patient received Paxlovid for COVID 19 Treatment from 27Jun2022 to 02Jul2022.
Age: 66.0
Sex: M
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 contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 06Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 30Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Still's disease" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 28Jun2022, stop date: 06Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive, notes: Antigen test pos on 28Jun (lHealth brand); (04Jul2022) Negative, notes: Neg antigen test on 04Jul (Abbottt brand); (06Jul2022) Positive, notes: Symptoms returned on 06Jul, Tested pos again (Abbott antigen kit). Therapeutic measures were taken as a result of vaccination failure, covid-19.; included Paxlovid from 28Jun2022 to 03Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Vaccination failure.
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). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 22Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Insulin resistance" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: XYZAL, start date: 01Apr2022; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE], start date: 01Jun2022; FLONASE [FLUTICASONE PROPIONATE], start date: 01Apr2022. Past drug history included: Aspiring, reaction(s): "Known allergies: Aspirin". The following information was reported: VACCINATION FAILURE (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: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: COVID 19 Treatment was Paxlovid (lot number: GA7394) on 27Jun2022 and stop date on 01Jul2022. All other medication used in 2 weeks. The adverse event Rebound infection started on 06Jul2022 at 09:30 am results. No treatment for AE. The event was recovering.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac dysfunction, Pulmonary embolism, Pulmonary thrombosis, SARS-CoV-2 test
Clinical narrative: Lungs filled with blood clots; Lungs filled with blood clots; heart was strained trying to pump blood through the clots; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number: unknown at this time in the left arm), for COVID-19 Immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, disability, medically significant, life threatening), PULMONARY THROMBOSIS (hospitalization, disability, medically significant, life threatening) all with onset 28Jul2021, outcome "not recovered" and all described as "Lungs filled with blood clots"; MYOCARDIAL INJURY (hospitalization, disability, medically significant, life threatening) with onset 28Jul2021, outcome "not recovered", described as "heart was strained trying to pump blood through the clots". The patient was hospitalized for pulmonary embolism, myocardial injury, pulmonary thrombosis (hospitalization duration: 6 day(s)). The events "lungs filled with blood clots" and "heart was strained trying to pump blood through the clots" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (03Aug2021) Negative; SARS-CoV-2 test: (03Aug2021) Negative. Therapeutic measures were taken as a result of pulmonary embolism, myocardial injury, pulmonary thrombosis. Additional information: It was reported that the patient lungs filled with blood clots and heart was strained trying to pump blood through the clots. Still having problems. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not received any other medications the patient received within 2 weeks of vaccination. The patient was admitted to intensive care and was given blood thinners. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient been tested for COVID 19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
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) (Physician).  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), on 26Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes II" (unspecified if ongoing), notes: Diabetes II; "OSA" (unspecified if ongoing), notes: OSA; "morbid obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: erythromycin, reaction(s): "allergies erythromycin", notes: known allergies erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) positive, notes: Tested positive for COVID 25Jun; (04Jul2022) Negative, notes: tested negative for COVID on 04Jul; (07Jul2022) positive, notes: patient tested positive for COVID 07Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The reporter provided that the patient received treatment for COVID-19 with Paxlovid. And the route of administration by Oral. Treatment start date was 25Jun2022 and stop date was 29Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on possible temporal association the causal role of  reported events cannot be excluded for  suspect  .Case will be reviewed further on receipt of FU information.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: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Migraine, Nausea, Pain
Clinical narrative: I got just a really bad migraine; really bad pain; really bad nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2, single (Lot number: EW0171) at the age of 64 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "had the migraine symptom before" (unspecified if ongoing), notes: I may be had the migraine symptom before but 7-10 years before the vaccine. Concomitant medication(s) included: WARFARIN taken for atrial fibrillation. Vaccination history included: BNT162b2 (LOT# (first shot): ER8737, Date of first shot: 01Apr 2021), administration date: 01Apr2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "recovering", described as "I got just a really bad migraine"; NAUSEA (non-serious) with onset 2021, outcome "recovering", described as "really bad nausea"; PAIN (non-serious) with onset 2021, outcome "recovering", described as "really bad pain ". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, pain, nausea. Additional information: The patient wanted to report her reaction to Pfizer COVID-19 vaccine. She had her first dose on 01Apr2021 then the second dose on 22Apr2021. She got just a really bad migraine with full on really bad pain and really bad nausea. And then she was on that for a year and would say it was still there, gradually getting better but it was something that she did not suffer before. She did not have before the vaccine. She maybe had the migraine symptom before but 7-10 years before the vaccine. Treatment included gabapentin for a little while, which kind of made her mind foggy, it's a brain fog so she didn't like it and went off of it.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Renal function test
Clinical narrative: I got just a really bad migraine; really bad pain; really bad nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2, single (Lot number: EW0171) at the age of 64 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "had the migraine symptom before" (unspecified if ongoing), notes: I may be had the migraine symptom before but 7-10 years before the vaccine. Concomitant medication(s) included: WARFARIN taken for atrial fibrillation. Vaccination history included: BNT162b2 (LOT# (first shot): ER8737, Date of first shot: 01Apr 2021), administration date: 01Apr2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "recovering", described as "I got just a really bad migraine"; NAUSEA (non-serious) with onset 2021, outcome "recovering", described as "really bad nausea"; PAIN (non-serious) with onset 2021, outcome "recovering", described as "really bad pain ". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, pain, nausea. Additional information: The patient wanted to report her reaction to Pfizer COVID-19 vaccine. She had her first dose on 01Apr2021 then the second dose on 22Apr2021. She got just a really bad migraine with full on really bad pain and really bad nausea. And then she was on that for a year and would say it was still there, gradually getting better but it was something that she did not suffer before. She did not have before the vaccine. She maybe had the migraine symptom before but 7-10 years before the vaccine. Treatment included gabapentin for a little while, which kind of made her mind foggy, it's a brain fog so she didn't like it and went off of it.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I got just a really bad migraine; really bad pain; really bad nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2, single (Lot number: EW0171) at the age of 64 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "had the migraine symptom before" (unspecified if ongoing), notes: I may be had the migraine symptom before but 7-10 years before the vaccine. Concomitant medication(s) included: WARFARIN taken for atrial fibrillation. Vaccination history included: BNT162b2 (LOT# (first shot): ER8737, Date of first shot: 01Apr 2021), administration date: 01Apr2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "recovering", described as "I got just a really bad migraine"; NAUSEA (non-serious) with onset 2021, outcome "recovering", described as "really bad nausea"; PAIN (non-serious) with onset 2021, outcome "recovering", described as "really bad pain ". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, pain, nausea. Additional information: The patient wanted to report her reaction to Pfizer COVID-19 vaccine. She had her first dose on 01Apr2021 then the second dose on 22Apr2021. She got just a really bad migraine with full on really bad pain and really bad nausea. And then she was on that for a year and would say it was still there, gradually getting better but it was something that she did not suffer before. She did not have before the vaccine. She maybe had the migraine symptom before but 7-10 years before the vaccine. Treatment included gabapentin for a little while, which kind of made her mind foggy, it's a brain fog so she didn't like it and went off of it.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Migraine, Nausea, Pain
Clinical narrative: I had my first Pfizer vaccine on 01Apri2021. And then I had my second Pfizer vaccine, the second dose of the covid 19 vaccine on 22Apri2021/So I am in quarantine for covid right now; I had my first Pfizer vaccine on 01Apri2021. And then I had my second Pfizer vaccine, the second dose of the covid 19 vaccine on 22Apri2021/So I am in quarantine for covid right now; 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 65-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8737) and on 22Apr2021 as dose 2, single (Lot number: EW0171) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for atrial fibrillation.The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I had my first Pfizer vaccine on 01Apri2021. And then I had my second Pfizer vaccine, the second dose of the covid 19 vaccine on 22Apri2021/So I am in quarantine for covid right now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Renal function test
Clinical narrative: I had my first Pfizer vaccine on 01Apri2021. And then I had my second Pfizer vaccine, the second dose of the covid 19 vaccine on 22Apri2021/So I am in quarantine for covid right now; I had my first Pfizer vaccine on 01Apri2021. And then I had my second Pfizer vaccine, the second dose of the covid 19 vaccine on 22Apri2021/So I am in quarantine for covid right now; 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 65-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8737) and on 22Apr2021 as dose 2, single (Lot number: EW0171) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for atrial fibrillation.The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I had my first Pfizer vaccine on 01Apri2021. And then I had my second Pfizer vaccine, the second dose of the covid 19 vaccine on 22Apri2021/So I am in quarantine for covid right now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I had my first Pfizer vaccine on 01Apri2021. And then I had my second Pfizer vaccine, the second dose of the covid 19 vaccine on 22Apri2021/So I am in quarantine for covid right now; I had my first Pfizer vaccine on 01Apri2021. And then I had my second Pfizer vaccine, the second dose of the covid 19 vaccine on 22Apri2021/So I am in quarantine for covid right now; 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 65-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8737) and on 22Apr2021 as dose 2, single (Lot number: EW0171) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for atrial fibrillation.The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I had my first Pfizer vaccine on 01Apri2021. And then I had my second Pfizer vaccine, the second dose of the covid 19 vaccine on 22Apri2021/So I am in quarantine for covid right now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, on 13May2022 as dose 4 (booster), single (Lot number: fm9992) at the age of 72 years 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: "recent radiation treatments for prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Patient received paxlovid from 22Jun2022 to 26Jun2022 for treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Additional information: There was no other medication in 2 weeks.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm 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 included: "Known allergies: antibiotics" (unspecified if ongoing); "Known allergies: Sulfa" (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 "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) negative; (2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 28Jun2022 to 02Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
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) (Physician) from Regulatory Authority.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2021 as dose 1, single (Lot number: EW0167) and on 14May2021 as dose 2, single (Lot number: EW0161) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). There were no concomitant medications. The patient had no known allergies. There was no other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received oral paxlovid for COVID 19 Treatment from 25Jun2022 to 30Jun2022. COVID symptoms rebound/recurred on 07Jul2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Lupus" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE; LEVOTHYROXINE; ATORVASTATIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Septra, reaction(s): "known allergies: Septra"; Norco, reaction(s): "known allergies: Norco". The following information was reported: 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: (unspecified date) Unknown results; (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 28Jun2022 to 02Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment/returned/ rebound COVID; COVID 19 Treatment/returned/ rebound COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 68 years 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: "CAD" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Jan2022, stop date: 22Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment/returned/ rebound COVID". The patient received COVID 19 Treatment Paxlovid from 22Jun2022 to 27Jun2022, and on 06Jul2022, symptoms returned/ rebound COVID. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Pharmacist).  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), on 22Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 27Jun2022 to 01Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment/Covid Test: positive; COVID 19 Treatment/Covid Test: positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 30Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 10Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jul2022 at 08:30, outcome "unknown" and all described as "COVID 19 Treatment/Covid Test: positive". Other medication in 2 weeks. AE resulted in: [None of the above]. Known allergies: No Known Allergies. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: eczema; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 88-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), 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; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: ECZEMA (non-serious), outcome "unknown".  Additional information: The reporter stated that she had 3 Pfizer covid vaccine. The reporter also stated that her doctor was not helpful in telling if this was a good medication for her. The patient found out, when you took you cholesterol pill you couldn't take grapefruit which her provider did not know. The Patient had not taken CIBINQO yet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 03:00 PM as dose 1, single (Batch/Lot number: unknown), in right arm, in Apr2021 03:00 AM as dose 2, single (Batch/Lot number: unknown), in right arm, in Nov2021 12:00 PM as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and in May2022 02:00 PM as dose 4 (booster), single (Batch/Lot number: unknown), in left leg for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthiritus" (unspecified if ongoing) and none known allergies. Concomitant medication(s) included: HUMIRA, start date: Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: indication=Treatment of COVID-19; (Jul2022) Negative, notes: tested negative for 4 days; (Jul2022) Positive, notes: then positive again. 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: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had Covid/once after having the Pfizer Biontech COVID-19 vaccine, in mid January and she was symptomatic; had Covid/once after having the Pfizer Biontech COVID-19 vaccine, in mid January and she was symptomatic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: Nov2021, stop date: Nov2021, notes: The first time she had COVID 19 was in Nov2021. She had asymptomatic COVID before receiving the COVID 19 vaccine. The patient's concomitant medications were not reported. There was no other conditions, investigations, nor other products. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "recovered with sequelae" and all described as "had Covid/once after having the Pfizer Biontech COVID-19 vaccine, in mid January and she was symptomatic". The report was not related to a study or programme. The transfer agent has a caller reporting an adverse event for the Pfizer BioNTech COVID 19 vaccine. The caller has had COVID twice.  She thought it was Omicron. She had asymptomatic COVID before receiving the COVID 19 vaccine and has had COVID after receiving the COVID 19 Vaccine and this time was symptomatic. The first time she had COVID 19 vas in Nov2021.  She clarified that the time she had COVID after receiving the COVID 19 Vaccine was in Jan2022. Event End Date: If she had to guess, she took a test 10 days after she got COVID.  It took her 10 days to come back to work.  She tested 5 days after and was positive and went back to work 10 days after.  They are very strict in her office. Event Outcome:  Recovered with lasting effects.  Her eyes seem very dry all the time.  Her vision seems a little blurry.  She had dry eyes before she got COVID.  She has had trouble focusing with her eyes.  She had her eyes checked by her doctor and her eyes are just dry.  It could be an age thing but she does know she got COVID before she had the dry eye problem.  She clarified that her dry eye problem occurred before she received the COVID 19 vaccine. She first received the COVID 19 Vaccine in Apr2021. She hasn't had additional doses.  She did ask about if she should get the booster now or should get the November one.  She tried to ask the Pfizer Medical. Formulation: It was a prefilled syringe maybe. She clarified that it was in little bottle. She declined to complete the supplemental form. The caller had a question about the booster dose to get it now or wait until November but the transfer agent wasn't able to make recommendations but did give the caller some information.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 29Jan2021 as dose 2, single (Lot number: EL9263), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes Mellitus Type II" (unspecified if ongoing); "Migraines" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: METFORMIN, start date: Mar2021, stop date: 28Jun2022; TOPIRAMATE, start date: Sep2021; ESCITALOPRAM, start date: Mar2021. The following information was reported: 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. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 29Jun2022 to 03Jul2022.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug Ineffective and COVID 19  and the suspect drug BNT162b2.   The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 43.0
Sex: M
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 44-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0151), in right arm, on 06May2021 as dose 2, single (Lot number: EW0182), in right arm and on 17Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Negative; (05Jul2022) Positive; (07Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 Treatment included Paxlovid from 25Jun2022 to 29Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in right arm 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: "High-blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: STRATTERA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: being 5 day paxlovid treatment; (25Jun2022) Negative; (03Jul2022) Positive, notes: +ve RAT: Cough and runny nose, some fatigue; (04Jul2022) Positive, notes: +ve RATL w/ faint line, cough; (05Jul2022) Positive, notes: +ve RAT: w/very ver faint line cough dwindling; (06Jul2022) Positive, notes: +ve RAT: w/very dark line minor if no symptoms; (07Jul2022) Positive, notes: +ve RAT: w/very dark line minor if no symptoms; (08Jul2022) Positive, notes: +ve RAT: w/very dark line minor if no symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 63-year-old male patient received BNT162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Lot number: F54989) at the age of 62 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: "GERD" (unspecified if ongoing); "allergies" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19  included Paxlovid from 24Jun2022 to 28Jun2022.