chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 at 10:00 as dose 1, single (Lot number: EL0142) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL EXTRA STRENGTH, start date: 03May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure before pregnancy
Clinical narrative: Maternal Exposure Before Pregnancy; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 15Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing). Date of last menstrual period: 29Dec2021. The patient was 20 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05Oct2022. Concomitant medication(s) included: BAYER ASPIRIN, start date: 28Jan2022, stop date: 22May2022. Past drug history included: Sulfasalazine, reaction(s): "allergy", notes: known allergies: Sulfasalazine; Amitryptylline, reaction(s): "Allergy", notes: known allergies: Amitryptylline. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19"; MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious), outcome "unknown". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course information: It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  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 the known safety profile and Limited information in the case report a casual association between reported events and the suspect drug BNT162B2 cannot be excluded.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID symptoms and positive COVID test; COVID symptoms and positive COVID test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 18Nov2021 at 16:00 as dose 1, single (Lot number: 32030BD), in left arm and on 04Jan2022 at 20:00 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE, start date: 01Jan2021, stop date: 20May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (2022) and all described as "COVID symptoms and positive COVID test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient received COVID 19 Treatment with Paxlovid (fy6826) from 03May2022 to 07May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Exposure to SARS-CoV-2, Laryngitis, Pharyngitis, Pyrexia
Clinical narrative: sx ST pharyngitis laryngitis HA high fever 102 + AG; sx ST pharyngitis laryngitis HA high fever 102 + AG; sx ST pharyngitis laryngitis HA high fever 102 + AG; exposed to COVID positive family member 12May2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 31-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247) and on 07Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. She exposed to COVID positive family member 12May2022, sx ST pharyngitis laryngitis HA high fever 102 plus AG 16May. was told by teledoc that she was too thin and too young to get paxlovid she would have rather had the therapy. The following information was reported: EXPOSURE TO SARS-COV-2 (medically significant) with onset 12May2022, outcome "unknown", described as "exposed to COVID positive family member 12May2022"; PHARYNGITIS (non-serious), LARYNGITIS (non-serious), PYREXIA (non-serious) all with onset 14May2022, outcome "unknown" and all described as "sx ST pharyngitis laryngitis HA high fever 102 + AG". The patient underwent the following laboratory tests and procedures: Body temperature: (16May2022) 102; SARS-CoV-2 test: (16May2022) Positive. It was unknown if therapeutic measures were taken as a result of exposure to sars-cov-2, pharyngitis, laryngitis, pyrexia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, the event EXPOSURE TO SARS-COV-2 was considered unrelated to suspect drug BNT162B2. 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: sx ST pharyngitis laryngitis HA high fever 102 + AG; sx ST pharyngitis laryngitis HA high fever 102 + AG; sx ST pharyngitis laryngitis HA high fever 102 + AG; exposed to COVID positive family member 12May2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 31-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247) and on 07Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. She exposed to COVID positive family member 12May2022, sx ST pharyngitis laryngitis HA high fever 102 plus AG 16May. was told by teledoc that she was too thin and too young to get paxlovid she would have rather had the therapy. The following information was reported: EXPOSURE TO SARS-COV-2 (medically significant) with onset 12May2022, outcome "unknown", described as "exposed to COVID positive family member 12May2022"; PHARYNGITIS (non-serious), LARYNGITIS (non-serious), PYREXIA (non-serious) all with onset 14May2022, outcome "unknown" and all described as "sx ST pharyngitis laryngitis HA high fever 102 + AG". The patient underwent the following laboratory tests and procedures: Body temperature: (16May2022) 102; SARS-CoV-2 test: (16May2022) Positive. It was unknown if therapeutic measures were taken as a result of exposure to sars-cov-2, pharyngitis, laryngitis, pyrexia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, the event EXPOSURE TO SARS-COV-2 was considered unrelated to suspect drug BNT162B2. 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: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: exposed over the w/e, then sx 17May2022 PM cold symptoms mild and then tested Ag positive am 18May2022; exposed over the w/e, then sx 17May2022 PM cold symptoms mild and then tested Ag positive am 18May2022; cold symptoms mild; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 24-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 19Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 17May2022, outcome "unknown", described as "cold symptoms mild"; COVID-19 (medically significant) with onset 18May2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "exposed over the w/e, then sx 17May2022 PM cold symptoms mild and then tested Ag positive am 18May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive, notes: Nasal Swab. 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 event Drug ineffective and Covid 19 and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: indication=Treatment of COVID-19; indication=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 67-year-old female patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: en107), 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. The patient's relevant medical history included: "Diffuse Large B Cell Lymphoma" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR HCL, start date: 31Jan2022, stop date: 22May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (10May2022) 100.3, notes: Fever never over 100.3. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow up attempts are needed. No Further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9929) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (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: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: BENZONATATE, start date: 10May2022, stop date: 17May2022; PROMETHAZINE DM, start date: 10May2022, stop date: 13May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID Rebound starting 20May, 11 days after starting Paxlovid. Symptoms much worse than while taking Oaxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: 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) from product quality group. The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Oct2021 as dose 2 (booster), single (Lot number: FH8020) at the age of 36 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 01Apr2021 as dose 1, single (Lot number: 1808609) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: DULOXETINE, start date: 01Jul2019, stop date: 20May2022; BUPROPION, start date: 01Jul2019, stop date: 20May2022; AMPHETAMINE, start date: 01Jan2011, stop date: 20May2022; ACETAMINOPHEN, start date: 12May2022, stop date: 20May2022. 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) Positive; (19May2022) negative; (22May2022) Positive; (23May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment medication included Paxlovid, treatment start date= 14May2022, treatment stop date= 19May2022, lot number= GA3990, indication= treatment of COVID-19. Adverse event: Relapse or rebound of Covid-19. The patient started testing negative after her 6th Paxlovid dose. Started testing positive again after my 9th Paxlovid dose. Still testing positive 24 hours after finishing 10th Paxlovid dose. No fever, other symptoms are still mild. Adverse event start date: 19May2022. Adverse event start time: 01:00pm, event recovering.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, SARS-CoV-2 test, Throat irritation
Clinical narrative: Positive Ag test; Positive Ag test; mild cough; scratchy throat; fatigue; HA congestion; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3247), on 15Mar2021 as dose 2, single (Lot number: EL3247) and on 03Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 20May2022, outcome "unknown", described as "HA congestion"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "unknown" and all described as "Positive Ag test"; FATIGUE (non-serious) with onset 20May2022, outcome "unknown"; COUGH (non-serious) with onset 20May2022, outcome "unknown", described as "mild cough"; THROAT IRRITATION (non-serious) with onset 20May2022, outcome "unknown", described as "scratchy throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, cough, throat irritation, fatigue, upper respiratory tract congestion. If other vaccine in four weeks was unknown. Adverse event: Travel from (place withheld) wedding back 18May, sx on 20May mild cough and scratchy throat and fatigue and HA congestion and Positive Ag test.  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 Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion, Vaccination failure
Clinical narrative: Positive Ag test; Positive Ag test; mild cough; scratchy throat; fatigue; HA congestion; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3247), on 15Mar2021 as dose 2, single (Lot number: EL3247) and on 03Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 20May2022, outcome "unknown", described as "HA congestion"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "unknown" and all described as "Positive Ag test"; FATIGUE (non-serious) with onset 20May2022, outcome "unknown"; COUGH (non-serious) with onset 20May2022, outcome "unknown", described as "mild cough"; THROAT IRRITATION (non-serious) with onset 20May2022, outcome "unknown", described as "scratchy throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, cough, throat irritation, fatigue, upper respiratory tract congestion. If other vaccine in four weeks was unknown. Adverse event: Travel from (place withheld) wedding back 18May, sx on 20May mild cough and scratchy throat and fatigue and HA congestion and Positive Ag test.  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 Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 40.0
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). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), in the left arm, on 23Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 26Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NYQUIL, start date: 03May2022, stop date: 05May2022. Past drug history included: No, reaction(s): "Allergy". 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: (04May2022) Positive, notes: I was tested positive with COVID-19 on 04May2022; (14May2022) Negative, notes: I was better and was tested negative with antigen at home test on 14May2022; (21May2022) Positive, notes: I started having some COVID-19 symptoms today 21May2022 and tested positive for COVID-19 with an at-home antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient stated she was tested positive with COVID-19 on 04May2022 and started taking Paxlovid on 05May2022. She was better and was tested negative with antigen at home test on 14May2022. She started having some COVID-19 symptoms today 21May2022 and tested positive for COVID-19 with an at-home antigen test.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound positive Ag test on day 13/Treatment of COVID-19; Rebound positive Ag test on day 13/Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 53 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 was not pregnant at the time of vaccination. The patient's relevant medical history included: "Type 2 DM" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE, start date: 14May2022, stop date: 20May2022 (other medication in 2 weeks product). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "recovering" and all described as "Rebound positive Ag test on day 13/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: on day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Paxlovid.  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 Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive on 20May; tested positive on 20May; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 05Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 41 years 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 19May2022, outcome "unknown" and all described as "tested positive on 20May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Facility type vaccine reported as Workplace clinic. It was unknown if other vaccine in four weeks. It was unknown if Covid prior vaccination. Covid was tested post vaccination. Adverse event reported as wife was sick with COVID 17May then he had sx 19May and tested positive on 20May mild sx ST nasal congestion. Covid test post vaccination was reported along with result.  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 Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 70.0
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 71-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 at 14:30 as dose 4 (booster), single (Lot number: FK9895) at the age of 70 years, in right 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 was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Tested (slightly) positive several days after treatment ended; Negative, notes: Tested negative on day 8; positive, notes: Tested positive on day 10 with symptoms (cough, nasal discharge). Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient received other medication (vitamins and supplements) in 2 weeks. Patient received treatment with Paxlovid from 11May2022 to 15May2022 for the treatment of COVID-19.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: symptoms 18May2022 pm and then positive Ag 20May2022; symptoms 18May2022 pm and then positive Ag 20May2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 49-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3247), on 24Feb2021 as dose 2, single (Lot number: EL3247) and on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 49 years 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 18May2022, outcome "unknown" and all described as "symptoms 18May2022 pm and then positive Ag 20May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; 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 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Apr2021 as dose 1, single (Lot number: ER836), in right arm, on 22May2021 as dose 2, single (Lot number: EW0177), in right arm and on 07Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 28 years, in right arm for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive; (17May2022) Negative; (20May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive other medication in 2weeks. The started taking Paxlovid on 11May (1 day after testing positive). Patient finished the dose on 15May and tested negative on 17May. On 20May, patient started feeling sick again and tested positive for Covid again. Patient wanted to report since these rebounds are rare and in case it is helpful. The patient received Treatment, Brand: Paxlovid, (Treatment start date: 11May2022, Treatment stop date: 15May2022). The patient known allergies was none. The patient other medical history was asthma.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 05May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years, 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: "No" (unspecified if ongoing), notes: known allergies No, other medical history No. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive; (13May2022) Negative; (20May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event start date: 20May2022. If patient recovered: recovering. If treatment ae: No. Known allergies: No. Other medical history: No.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200745233 same patient different drug/events
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease", start date: 2011 (ongoing), notes: Other medical history:Crohn's disease since 2011. Concomitant medication(s) included: VALTREX, start date: 01Oct2020; AZATHIOPRINE, start date: 04Jun2012; ALBUTEROL [SALBUTAMOL SULFATE], start date: 04May2022, stop date: 21May2022. The following information was reported: VACCINATION FAILURE (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: (15May2022) Positive; (16May2022) Positive; (18May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took other medication in 2 weeks. Patient finished the full round of Paxlovid from 10May2022 to 14May2022 and despite feeling improvement in symptoms, they had not all go away despite treatment. Fatigue, cough and nasal congestion remained. However, by Wednesday, 18May2022 at-home test was negative. (It had been faintly positive on 15May2022 and 16May2022.) Because nasal congestion worsened and chills returned today, patient took another at home test on 21May2022 3:00pm, which was strongly positive. The line appearing almost immediately. Patient took a second test to confirm and got an identical results. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
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) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EW0150), on 21Apr2021 as dose 2, single (Lot number: EW0162) and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 42 years 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) with onset 11May2022, outcome "unknown", COVID-19 (medically significant) with onset 11May2022, outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Postitive; (16May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. From 11May2022 to 15May2022, the patient had Paxlovid (Lot number: FY0461) as treatment of COVID-19. Clinical Course: Relapse of Covid symptoms tested positive 11May, started Paxlovid treatment same day, symptoms ended on 13May, ended treatment on 15May. Tested negative on 16May. Symptoms returned on 19May. The patient had no known allergies and no other medication in 2 weeks.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient had symptoms of headache, fever, cough and rhinorrhea on 20May2022 and positive antigen test that afternoon; Patient had symptoms of headache, fever, cough and rhinorrhea on 20May2022 and positive antigen test that afternoon; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 18Feb2021 as dose 2, single (Lot number: EL3247), in left arm and on 09Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 61 years, in left arm 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 20May2022, outcome "unknown" and all described as "Patient had symptoms of headache, fever, cough and rhinorrhea on 20May2022 and positive antigen test that afternoon". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 10Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 17Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 25 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Polycystic ovary syndrome" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; BUSPAR; PANTOPRAZOLE; SPIRONOLACTONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "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 information: During treatment, the Paxlovid interacted with something else she was taking and spiked her blood pressure,causing akathisia-like symptoms which resolved with Propranolol. Three days after finishing the course of Paxlovid she started having nasal drainage and fatigue which she believe was a rebound of symptoms (she did not have seasonal allergies which would cause these symptoms). Yes vaccine received. No other medication in 2 weeks. Anti viral COVID 19 treatment was started from 14May2022 till 18May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: M
Vaccine: 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 45-year-old male patient received BNT162b2 (BNT162B2, Solution for injection), on 06Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROZAC, start date: 01Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". 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, covid-19.  Clinical course: The patient had received anti viral COVID 19 treatment on 20May2022, for treatment of COVID-19. Reporter stated, I am taking generic prozac. The patient had received other medication in 2 weeks with prozac generic start on 01Feb2022. On 21May2022 06:00 PM, the patient experienced adverse event red itchy rash behind each of my knees', outcome "unknown". Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; 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 male patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose 1, single (Batch/Lot number: unknown), in left arm and on 27Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, in right arm for COVID-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunization. The patient's relevant medical history included: "History of allergic rhinitis" (unspecified if ongoing); "eosinophilic esophagitis" (unspecified if ongoing); "chronic gastritis" (unspecified if ongoing). Concomitant medication(s) included: FEXOFENADINE; VYVANSE; NASACORT; PANTOPRAZOLE; AZITHROMYCIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive, notes: I completed a rapid antigen test and was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: On 21May22, patient felt that COVID-19 symptoms was returning. Fever and fatigue specifically. Patient completed a rapid antigen test and was positive. Anti-Viral Details: (Product: COVID 19 Treatment). Treatment Start Date=13May2022, treatment Stop Date=18May2022.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Common Variable Immune Deficiency" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive, notes: Rebound of Covid exactly 5 days after finishing Paxlovid; (2022) Positive, notes: Symptoms same as before. Fever, cough, headache, and positive Covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 12Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (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: (2022) Positive, notes: COVID 19 Treatment; (2022) Positive, notes: still testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication in 2weeks. No known allergies. Pretty healthy. Patient took the Paxlovid for 5 days from 08May2022 to 14May2022 and then on the 7the day felt fine. Initial symptoms were chills, sore throat, body aches and nasal drip. All cleared up by the 7th day and then on the 8th day began to get. Still had a sore throat and the post-nasal drip. Patient had just feeling sluggish. Patient did start taking Amoxicillin on the 10th day and three days into to it and still testing positive with nasal drip and sore throat. Patient believe that he had the recurring case of Covid or that the Paxlovid only masked the symptoms.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test false positive
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 73-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years 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 "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test false positive: (11May2022) 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.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 46 years, in left arm and on 17Mar2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Dec2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown), 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), outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Neagtive; (20May2022) 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.