chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Epistaxis, Gluten sensitivity, Nasal dryness, Nasopharyngitis
Clinical narrative: Plaques; achy joints; could not eat gluten without getting sick; Bloody nose; Dry nose; Sinus congestion; Scratchy throat; Head cold; Pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3950656-00.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown); adalimumab (HUMIRA), on 15Mar2019 as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Jun2021, outcome "not recovered", described as "Head cold"; PNEUMONIA (medically significant) with onset Jun2021, outcome "not recovered"; THROAT IRRITATION (non-serious) with onset Oct2021, outcome "recovering", described as "Scratchy throat"; PSORIASIS (non-serious), outcome "unknown", described as "Plaques"; ARTHRALGIA (non-serious), outcome "recovered", described as "achy joints"; GLUTEN SENSITIVITY (non-serious), outcome "unknown", described as "could not eat gluten without getting sick"; EPISTAXIS (non-serious), outcome "unknown", described as "Bloody nose"; NASAL DRYNESS (non-serious), outcome "unknown", described as "Dry nose"; SINUS CONGESTION (non-serious), outcome "unknown".  The reporter's assessment of the causal relationship of "pneumonia", "plaques", "achy joints", "could not eat gluten without getting sick", "bloody nose", "dry nose", "scratchy throat", "head cold" and "sinus congestion" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Psoriasis, Sinus congestion, Throat irritation
Clinical narrative: Plaques; achy joints; could not eat gluten without getting sick; Bloody nose; Dry nose; Sinus congestion; Scratchy throat; Head cold; Pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3950656-00.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown); adalimumab (HUMIRA), on 15Mar2019 as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for psoriatic arthropathy, psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Jun2021, outcome "not recovered", described as "Head cold"; PNEUMONIA (medically significant) with onset Jun2021, outcome "not recovered"; THROAT IRRITATION (non-serious) with onset Oct2021, outcome "recovering", described as "Scratchy throat"; PSORIASIS (non-serious), outcome "unknown", described as "Plaques"; ARTHRALGIA (non-serious), outcome "recovered", described as "achy joints"; GLUTEN SENSITIVITY (non-serious), outcome "unknown", described as "could not eat gluten without getting sick"; EPISTAXIS (non-serious), outcome "unknown", described as "Bloody nose"; NASAL DRYNESS (non-serious), outcome "unknown", described as "Dry nose"; SINUS CONGESTION (non-serious), outcome "unknown".  The reporter's assessment of the causal relationship of "pneumonia", "plaques", "achy joints", "could not eat gluten without getting sick", "bloody nose", "dry nose", "scratchy throat", "head cold" and "sinus congestion" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, 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). Concomitant medication(s) included: BUPROPION; DULOXETINE; ZYRTEC ALLERGY; PEPCID AC; NALTREXONE. other medication in 2 weeks of product include Naltrexone, Pepcid, Multivitamin, Zyrtec, Duloxetine and Bupropion. 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: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. anti-viral details for COVID-19 Treatment was started on 27Apr2022, treatment stop date was 28Apr2022. Indication was treatment of COVID-19. Extreme vomiting and uncontrollable diarrhea started as a result of this treatment with paxlovid. Start date was 27Apr2022 at 11:30 PM and patient recovered, adverse event stop date was 01May2022. No treatment was taken for this  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 56.0
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). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 at 13:00 as dose 1, single (Lot number: ER8729), on 29Apr2021 at 13:00 as dose 2, single (Lot number: EW0170) and on 06Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; COMBIPATCH; LATANOPROST. 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: (12May2022) Negative; (17May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient received Product COVID 19 treatment, Brand Paxlovid, with start date- 05May2022 and 10May2022 for treatment of COVID-19.
Age: 39.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: 9266), on 10Mar2021 as dose 2, single (Lot number: EN6199), on 01Oct2021 as dose 3 (booster), single (Lot number: FF8839) and on 03Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin". 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, notes: COVID 19 Treatment.Anti viral details: product:COVID 19 Treatment, brand: Paxlovid, treatment start date:06May2022, treatment stop date:10May2022, indication=Treatment of COVID-19.Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200735225 Same patient, different product and event
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with active Covid 19; diagnosed with active Covid 19; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; Expiry Date of COVID-19 vaccine was Not Provided. COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) and as dose 2 , single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Heart condition" (unspecified if ongoing), notes: 65 year old patient with heart condition (waiting for a hear surgery). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with active Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: He is very sick and has all the symptoms and this Tuesdays he went to urgent care and was diagnosed with active Covid 19.  Clinical course: It was reported that the patient got booster dose ( 3rd dose of vaccine ) about 3- 3.5 or 4 weeks ago. Then he got really sick on Sunday, he was very sick and had all the symptoms and this Tuesdays he went to urgent care and was diagnosed with active Covid 19 and on Sunday the patient started coughing, sneezing, nose started running, sore throat, and complaining about back pain on lung side in patient's right upper quadrant. Patient had an elevated temperature but no fever. Patient mentioned last night that he is loosing smell and taste.. The patient was suffering with heart condition (waiting for a hear surgery). Reporter also reported that the vaccine did not work in the patient's body to build up antibodies and that's why he got full blown covid.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient diagnosed with COVID 09May2022; Patient diagnosed with COVID 09May2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adolescent male patient received BNT162b2 (BNT162B2), on 05May2021 as dose 1, single (Batch/Lot number: unknown) and on 10Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "recovered" (May2022) and all described as "Patient diagnosed with COVID 09May2022". The event "patient diagnosed with covid 09may2022" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course of the events: Facility type vaccine: Unknown. If other vaccine in four weeks: Unknown. Patient diagnosed with COVID 09May2022. Ae resulted in: Doctor or other healthcare professional office/clinic visit. If covid prior vaccination: Unknown. If covid tested post vaccination: Yes  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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient diagnosed with COVID-19 on 13May2022.; Patient diagnosed with COVID-19 on 13May2022.; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adolescent female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 02May2021 as dose 1, single (Batch/Lot number: unknown), on 23May2021 as dose 2, single (Batch/Lot number: unknown) and in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "unknown" and all described as "Patient diagnosed with COVID-19 on 13May2022.". The event "patient diagnosed with covid-19 on 13may2022." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive, notes: (test name). Therapeutic measures were taken as a result of vaccination failure, covid-19. 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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Off label use
Clinical narrative: She also mentioned that she also got Moderna; She also mentioned that she also got Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number Unknown. Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "She also mentioned that she also got Moderna".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease, Exophthalmos, Granuloma
Clinical narrative: Graves' Disease; bulging eyes; polygenetic granuloma in her nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 44-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BASEDOW'S DISEASE (medically significant), outcome "unknown", described as "Graves' Disease"; EXOPHTHALMOS (medically significant), outcome "unknown", described as "bulging eyes"; GRANULOMA (non-serious), outcome "unknown", described as "polygenetic granuloma in her nose".  Clinical course: It was reported that reporter's friend was forced to get the shot as a healthcare worker, and previously has never had a problem in her life. Last week, this friend was diagnosed with Graves' disease, Thyroid eye disease (TED), and polygenetic granuloma in her nose. Reporter states that the internet, the doctors, and the pharmacists all say it was definitely the Covid (vaccine). Million people got graves' disease from the shot; a million people have their thyroids messed up. Caller is seeking information as to these side effects. Reporter said that she was trying get some information on side effects. It seems like her friend has every side effect she can have from the vaccine. The caller reported that her friend got Grave's disease and bulging eyes from it, she got a polygenetic granuloma in their nose, and they were told that it came from the shot. Reporter wants to know is it is related to the shot. Her friend's body doesn't like the shot and she was forced to get it because her friend is in the medical field.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (23May2022): Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Test positive for Covid; Test positive for Covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4397011-00.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous. 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 10May2022, outcome "recovering" and all described as "Test positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive. The action taken for risankizumab was dosage permanently withdrawn. The reporter considered "test positive for covid" related to BNT162b2.  Clinical course: Causality for SKYRIZI (RISANKIZUMAB): The reporter's causality for the event(s) of COVID with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. Causality: COVID-19 (COVID-19); Action(s) taken with drug : Drug discontinued; Causality as per reporter (Drug/Vaccine): Not Related; Dechallenge: Yes.  PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) Causality: COVID-19 (COVID-19); Action(s) taken with drug : Unknown; Causality as per reporter (Drug/Vaccine) : Possible; Dechallenge : N/A.  Did event abate after stopping drug was reported as yes.  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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Condition aggravated, Illness
Clinical narrative: sick; worsened eye problem/lost vision; major eye problems that may lead to a possible cornea transplant because she was losing her vision; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient. Other Case identifier(s): 22K-163-4397226-00.  A 66-year-old female patient received BNT162b2 (BNT162B2), 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), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 2019 (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "eye surgery", start date: 1995 (unspecified if ongoing), notes: In 1995, the patient had Radial keratotomy vision surgery, since had vision issues relating to the surgery. The patient's concomitant medications were not reported. The following information was reported: BLINDNESS (medically significant) with onset Apr2022, outcome "not recovered", described as "major eye problems that may lead to a possible cornea transplant because she was losing her vision"; CONDITION AGGRAVATED (non-serious) with onset Apr2022, outcome "not recovered", described as "worsened eye problem/lost vision"; ILLNESS (non-serious), outcome "recovered", described as "sick". The action taken for adalimumab was dosage permanently withdrawn. Therapeutic measures were taken as a result of blindness, condition aggravated.  The reporter considered "major eye problems that may lead to a possible cornea transplant because she was losing her vision", "sick" and "worsened eye problem/lost vision" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracting COVID; Contracting COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4399548-00.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), on 04Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, all intramuscular for COVID-19 immunization; adalimumab (HUMIRA), first regimen (Lot number: 1160362) and second regimen since Apr2022 (Lot number: 1160362), all subcutaneous. 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 "Contracting COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter considered "Contracting COVID" related to BNT162b2 while the reporter's causality for the event(s) Contracting COVID was not provided for Humira (Adalimumab).  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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
Age: 49.0
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 a contactable reporter(s) (Physician).  A 49-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was none. There were no concomitant medications. 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) Positive; (unspecified date) Negative, notes: He took a Binax home test on 19May that was strongly positive (had been negative before); (19May2022) Positive, notes: He took a Binax home test on 19May that was strongly positive (had been negative before). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not had other medication in 2weeks. Patient may have experienced rebound symptoms after completing course of Paxlovid. He finished last dose of Paxlovid on 12May2022. Before finishing, he had complete resolution of symptoms (sore throat, myalgias). He remained well until 18May, when he had rhinorrhea and nasal congestion. He took a Binax home test on 19May that was strongly positive (had been negative before). The patient did not had Known allergies. The other medical history was none. The patient received paxlovid (Treatment Start Date: 07May2022, Treatment Stop Date: 12May2022) as treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: SARS-COV 2 PCR test positive; SARS-COV 2 PCR test positive; This is a literature report.  A 71-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, 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: "intermittent asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovered" and all described as "SARS-COV 2 PCR test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Day 0 BinaxNow, Abbott Laboratories; negative, notes: Day 16; negative, notes: day 35; 23.7, notes: Day 1; 28.9, notes: Day 3; 32.2, notes: day 5; 31, notes: Day 7; 18.6, notes: Day 9; 22.5, notes: Day 11; 27, notes: Day 12; 29.5, notes: Day 14; 34.2, notes: Day 18. Therapeutic measures were taken as a result of sars-cov-2 test positive, drug ineffective. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Upon follow up (23May2022), this is a literature report. A triple-vaccinated 71-year-old patient with known asthma starts the five-day regimen one day after the onset of symptoms and a few hours after a positive antigen test the protease inhibitor combination. The symptoms regress quickly. The tightly controlled viral load decreases. Four days after discontinuing the drug, however, symptoms reappear. At the same time, virus replication increases and the antigen test, which was negative in the meantime, becomes positive again. After originally the omicron subtype BA. He was found, can later other pathogens and other SARS-CoV-2 variants can be excluded by multiple sequencing.; Sender's Comments: Linked Report(s) : DE-PFIZER INC-202200758910 Same article, other patient (2);DE-PFIZER INC-202200758911 Same article, other patient (3);DE-PFIZER INC-202200758912 Same article, other patient (4);DE-PFIZER INC-202200758913 Same article, other patient (5);DE-PFIZER INC-202200758914 Same article, other patient (6);DE-PFIZER INC-202200758915 Same article, other patient (7);DE-PFIZER INC-202200758916 Same article, other patient (8)
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had Covid symptoms and took a home test and tested positive; had Covid symptoms and took a home test and tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (172086).  A male patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 14Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Vitiligo" (unspecified if ongoing), notes: States his husband has vitiligo.; "his husband are immunocompromised" (unspecified if ongoing), notes: Caller states he was trying to be safe since the beginning of the pandemic as he and his husband are immunocompromised. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had Covid symptoms and took a home test and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: took a home test and tested positive. Therapeutic measures were taken as a result of covid-19 included Paxlovid.  Clinical course: Caller reported on himself and mentioned his husband the next day had Covid symptoms and took a home test and tested positive. Caller stated his husband was vaccinated and boostered just like him and he did Paxlovid also. Caller stated his husband had the Pfizer Covid 19 vaccines and went to the same site on the same days as he did for the 1st two doses on the same days. States for his boosters he does not have the dates. States he got his first booster before the caller did and was not going to do the 2nd booster so they have different dates because he got his 2nd booster after the caller did. Caller stated he doesn't have any details to provide. Caller declined to report for him stating the only side effect for him was printed on the instructions from the pharmacy. States he had a terrible terrible taste in his mouth. Caller stated that was the only side effect he had and it was printed on the instructions. Caller stated he was trying to be safe since the beginning of the pandemic as he and his husband were immunocompromised.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, 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 59-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm and on 24Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (17May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Report was about covid treatment. No Other medications in two weeks. Anti-viral details reported as, Product = Covid-19 treatment, Brand=Paxlovid. Treatment started on 06May2022 and Treatment stop date was 10May2022, Indication was reported as Treatment of Covid-19. Covid vaccine details reported as, Vaccine brand was other= Moderna, Vaccine lot was unknown, Vaccine lot unknown reason reported as, Misplaced/discarded, Vaccine dose Number was 3, Vaccine location was Left arm. Vaccine lot was unknown for Pfizer vaccine, Vaccine lot unknown reason was mentioned as, Misplaced/ discarded, Vaccine dose Number was 2. Vaccine lot was unknown for dose 1, Vaccine lot unknown reason was reported as, Misplaced/ discarded. Adverse event was reported as One week after stopping Paxlovid, I got running nose & watery eyes & lost sense of taste & smell. I started testing positive again after testing negative on day 7. Adverse event start date was 17May2022. adverse event start time was 05:00 PM. Patient was Recovering. No treatment ae. No Known allergies. No Other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Insomnia, Pain, Pyrexia, Vaccination site pain
Clinical narrative: My body began bad aches around this same time; I could not sleep; injection site in my arm started to hurt very badly; I had a fever of 102.5F; fever chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 20May2022 at 11:30 as dose 3 (booster), single (Lot number: FM7553) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number: 2, Lot number: EW6189, Administration date, time and location: 05May2022, 01:30 PM at Left arm), administration date: 05May2022, when the patient was 44-year-old, for COVID-19 immunization; BNT162b2 (Dose number: 1, Lot number: EP7533, Administration date, time and location: 07Apr2021, 02:00 PM at Left arm), administration date: 07Apr2021, when the patient was 43-year-old, for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 21May2022, outcome "recovering", described as "I could not sleep"; PYREXIA (non-serious) with onset 21May2022, outcome "recovering", described as "I had a fever of 102.5F"; PAIN (non-serious) with onset 21May2022, outcome "recovering", described as "My body began bad aches around this same time"; PYREXIA (non-serious) with onset 21May2022, outcome "recovering", described as "fever chills"; VACCINATION SITE PAIN (non-serious) with onset 21May2022, outcome "recovering", described as "injection site in my arm started to hurt very badly". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, insomnia, vaccination site pain, pyrexia, pyrexia.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks to the vaccination or other medications in two weeks. The patient had no known allergies. The adverse events started on 21May2022 at 12:00 AM.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site cellulitis, Vaccination site swelling
Clinical narrative: soft tissue swelling at site of injection, moderate, without cold abscess; superficial cellulitis at site; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 8-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 20May2022, outcome "unknown", described as "soft tissue swelling at site of injection, moderate, without cold abscess"; VACCINATION SITE CELLULITIS (non-serious) with onset 20May2022, outcome "unknown", described as "superficial cellulitis at site". The events "soft tissue swelling at site of injection, moderate, without cold abscess" and "superficial cellulitis at site" required physician office visit. Therapeutic measures were taken as a result of vaccination site swelling, vaccination site cellulitis.  Additional information: It was unknown if the patient received other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient was tested for COVID-19 post vaccination. Treatment for vaccination site swelling and vaccination site cellulitis included antibiotic and NSAID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autonomic nervous system imbalance, Bradycardia, Chest pain, Condition aggravated, Dizziness
Clinical narrative: COVID-19 Nasal Swab  Positive; COVID-19 Nasal Swab  Positive; 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 20Jan2021 as dose 1, single (Lot number: EL9262), in right arm, on 10Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; AFLURIA QUAD, start date: 27Oct2021, stop date: 27Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Nov2021) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included steroids.  Clinical course: At Pharmacy or Drug Store patient received the BNT162b2 vaccine. Patient was not diagnosed with Covid prior vaccination. Patient tested Covid post vaccination on 22Nov2021. On 01Mar2021, patient began developing autonomic dysfunction that progressively worsened over the course of 6 months. Symptoms and signs included flushing, heart palpitations, bradycardia, tachycardia, chest pain, dizziness, vertigo. Patient was diagnosed with small fibre neuropathy in Jan2022. Patient was hospitalised for 7 days and was recovered with lasting effects.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Flushing, Palpitations, SARS-CoV-2 test, Small fibre neuropathy, Tachycardia
Clinical narrative: COVID-19 Nasal Swab  Positive; COVID-19 Nasal Swab  Positive; 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 20Jan2021 as dose 1, single (Lot number: EL9262), in right arm, on 10Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; AFLURIA QUAD, start date: 27Oct2021, stop date: 27Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Nov2021) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included steroids.  Clinical course: At Pharmacy or Drug Store patient received the BNT162b2 vaccine. Patient was not diagnosed with Covid prior vaccination. Patient tested Covid post vaccination on 22Nov2021. On 01Mar2021, patient began developing autonomic dysfunction that progressively worsened over the course of 6 months. Symptoms and signs included flushing, heart palpitations, bradycardia, tachycardia, chest pain, dizziness, vertigo. Patient was diagnosed with small fibre neuropathy in Jan2022. Patient was hospitalised for 7 days and was recovered with lasting effects.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: COVID-19 Nasal Swab  Positive; COVID-19 Nasal Swab  Positive; 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 20Jan2021 as dose 1, single (Lot number: EL9262), in right arm, on 10Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; AFLURIA QUAD, start date: 27Oct2021, stop date: 27Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Nov2021) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included steroids.  Clinical course: At Pharmacy or Drug Store patient received the BNT162b2 vaccine. Patient was not diagnosed with Covid prior vaccination. Patient tested Covid post vaccination on 22Nov2021. On 01Mar2021, patient began developing autonomic dysfunction that progressively worsened over the course of 6 months. Symptoms and signs included flushing, heart palpitations, bradycardia, tachycardia, chest pain, dizziness, vertigo. Patient was diagnosed with small fibre neuropathy in Jan2022. Patient was hospitalised for 7 days and was recovered with lasting effects.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Nasal Swab  Positive; COVID-19 Nasal Swab  Positive; 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 20Jan2021 as dose 1, single (Lot number: EL9262), in right arm, on 10Feb2021 as dose 2, single (Lot number: EN6201), in right arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; AFLURIA QUAD, start date: 27Oct2021, stop date: 27Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Nov2021) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included steroids.  Clinical course: At Pharmacy or Drug Store patient received the BNT162b2 vaccine. Patient was not diagnosed with Covid prior vaccination. Patient tested Covid post vaccination on 22Nov2021. On 01Mar2021, patient began developing autonomic dysfunction that progressively worsened over the course of 6 months. Symptoms and signs included flushing, heart palpitations, bradycardia, tachycardia, chest pain, dizziness, vertigo. Patient was diagnosed with small fibre neuropathy in Jan2022. Patient was hospitalised for 7 days and was recovered with lasting effects.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient had a breakthrough case of Covid-19; Patient had a breakthrough case of Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 16May2022, outcome "unknown", COVID-19 (medically significant) with onset 16May2022, outcome "not recovered" and all described as "Patient had a breakthrough case of Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Patient had a breakthrough case of COVID-19. It was unknown if therapeutic measures were taken as a result of covid-19.Clinical Course: If other vaccine in four weeks Unknown. If covid prior vaccination was Unknown. If covid tested post vaccination was Yes. Covid test type post vaccination was Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.