chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 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 had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN; LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19.  Additional information: The patient received Paxlovid for the treatment of COVID 19, start date is 19May2022 and stop date is 24May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 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 included: (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "known allergies Gluten" (unspecified if ongoing); "known allergies Latex" (unspecified if ongoing); "known allergies Raw tomato" (unspecified if ongoing); "known allergies Nickel" (unspecified if ongoing); "allergy Beeswax" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19. Vaccine received and Other medication in 2weeks was received. Patient had Paxlovid for Indication of COVID-19 treatment start date on 19May2022 and stop date on 23May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; 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 42-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (Dose 1, single, Vaccine lot unknown reason=Not available/provided to reporter at the time of report completion), administration date: Mar2021, for COVID-19 immunization; Moderna (Dose 2, single, Vaccine lot unknown reason=Not available/provided to reporter at the time of report completion), administration date: Apr2021, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient experienced Rebound COVID on 26May2022 which was not recovered. Other medication in 2weeks was unknown. Anti-viral details were provided as, COVID 19 Treatment with Paxlovid from 15May2022 to 20May2022.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 43 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 included: "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: Confirmed by positive antigen test; (05May2022) Positive, notes: Positive tests continued thereafter for another six days; (unspecified date) Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive other medications in two weeks of vaccination. Rebound covid symptoms started five days after end of Paxlovid course of treatment. Confirmed by positive antigen test. Positive tests continued thereafter for another six days.  Product Quality investigation result: Lot No: FJ1620: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FJ1620 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FJ1620, fill lot FJ1606, and the bulk formulated drug product FJ8507. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 63.0
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 64-year-old male patient received BNT162b2 (Pfizer/BioNTech), on 02Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies and no other medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: Covid-19 Test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19; used Paxlovid for COVID 19 Treatment from 17May2022 to 21May2022. It was also reported that the patient had rebound covid on 27May2022; recovering.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19, 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Jun2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (24May2022) Negative, notes: tested negative on the sixth; (28May2022) Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for COVID-19 treatment from 19May2022 to 23May2022 (for five full days) and tested negative on the sixth day (i.e. 24May2022). Four days after that (i.e. 28May2022) patient started feeling poorly again and tested positive. The event was about rebound covid infection.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history and had no known allergies. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 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: "Migraine" (unspecified if ongoing); "known allergies: Mango" (unspecified if ongoing), notes: known allergies mango. Concomitant medication(s) included: WELLBUTRIN, start date: 01Aug2020; AIMOVIG, start date: 01Dec2019. 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, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 and patient was treated with Paxlovid from 16May2022 to 22May2022.  Clinical course includes Antiviral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 16May2022, Treatment stop date: 21May2022, Indication: Treatment of COVID-19, Adverse event: rebound on day 10. congestion, fatigue. Patient not recovered. No treatment for AE.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dry mouth, Oral pain, Sleep disorder, Tongue discomfort
Clinical narrative: dry mouth; my mouth still hurts; my tongue burns; I get up in middle of night to use my biotine mouth sprays; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: SLEEP DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "I get up in middle of night to use my biotine mouth sprays"; DRY MOUTH (non-serious) with onset 2021, outcome "not recovered"; ORAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "my mouth still hurts"; TONGUE DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "my tongue burns". The events "dry mouth", "my mouth still hurts", "my tongue burns" and "i get up in middle of night to use my biotine mouth sprays" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dry mouth, oral pain, tongue discomfort, sleep disorder.  Additional information: It was reported that after the patient's first or second dose, the patient started to get dry mouth and did not know if it was a side effect. She consulted her doctor. The doctor took blood work and everything was good. The patient consulted oral specialist for six weeks and found nothing. The patient reported that her mouth still hurt, her tongue burned. She got up in middle of night to use her biotine mouth sprays etc. The patient reported that she was 78 year old and it had lasted almost a year. The patient got Pfizer vaccines one and two also got two booster shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Possible rebound COVID infection. Patient diagnosed with COVID 19May2022. Started Paxlovid on 20May2022. After 3 days of treatment, felt better. Had positive test again 29May2022.; Possible rebound COVID infection. Patient diagnosed with COVID 19May2022. Started Paxlovid on 20May2022. After 3 days of treatment, felt better. Had positive test again 29May2022.; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EN9581), in right arm, on 25Feb2021 as dose 2, single (Lot number: EL9267), in left arm and on 27Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Breast cancer" (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 19May2022, outcome "not recovered" and all described as "Possible rebound COVID infection. Patient diagnosed with COVID 19May2022. Started Paxlovid on 20May2022. After 3 days of treatment, felt better. Had positive test again 29May2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive, notes: Patient diagnosed with COVID 19May2022; (29May2022) Positive, notes: Had positive test again 29May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: It was reported that, the other medication in 2weeks was Unknown. Adverse event: Possible rebound COVID infection. Patient diagnosed with COVID on 19May2022. Started Paxlovid on 20May2022. After 3 days of treatment, felt better. Had positive test again 29May2022. Started with nasal congestion on 30May2022. Never had negative COVID test. no Known allergies.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Weight decreased
Clinical narrative: Arm bled; Have lost 20 Lbs. Since first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old patient received BNT162b2 (BNT162B2), on 11Apr2021 at 09:40 as dose 1, single (Lot number: EW0151) at the age of 60 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious) with onset 11Apr2021, outcome "unknown", described as "Arm bled"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Have lost 20 Lbs. Since first shot". The event "have lost 20 lbs. since first shot" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: There were no prior vaccinations. Specific relevant test for thromboembolic events with thrombocytopenia was not done. It was reported that the patient had been to their PCP and dentist for weight loss.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Psoriasis, Suspected COVID-19, Vaccination site pain
Clinical narrative: COVID-19; COVID-19; Vaccination site pain; Psoriasis flare-up; MARKETING PROGRAM NAME NOT AVAILIBLE  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-163-4409065-00.  A 60-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; VACCINATION SITE PAIN (non-serious), outcome "unknown"; PSORIASIS (non-serious), outcome "unknown", described as "Psoriasis flare-up". The action taken for risankizumab was unknown. Patient stated that she experienced a flare following covid and she had sore arm from covid vaccine.  It was unknown if patient was enrolled in a covid 19 vaccine trial.   Causality for SKYRIZI (RISANKIZUMAB): The reporter causality for the events of covid/Experienced a flare following covid, Sore arm from covid 19 vaccine and plaque psoriasis flare was not provided.   The reporter's assessment of the causal relationship of "covid-19", "vaccination site pain" and "psoriasis flare-up" 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.  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 of the vaccine  BNT162b2, a causal relation between the reported events Suspected Covid-19, Drug ineffective, "vaccination site pain" and "psoriasis flare-up" and the administration of the vaccine cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had 2 Pfizer vaccines plus 2 boosters before getting Covid; I had 2 Pfizer vaccines plus 2 boosters before getting Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 04Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulpha" (unspecified if ongoing), notes: Known allergies: Sulpha. Concomitant medication(s) included: SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I had 2 Pfizer vaccines plus 2 boosters before getting Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment; Negative, notes: testing negative. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient got a bounce back infection after Paxlovid, 5 days after testing negative. His symptoms were a runny nose and a little fatigue. He had 2 Pfizer vaccines plus 2 boosters before getting Covid. His symptoms were a bad cough, mild temperature and fatigue for 3-4 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 68-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick after second covid-19 vaccine/it put patient down; 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-163-4410114-00 (AbbVie).  A 63-year-old female patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose:1), administration date: 27Mar2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "Epilepsy"; BNT162b2 (dose:1), administration date: 27Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "Sickness", "Sleep excessive", "Bronchitis asthmatic", "Tinnitus on both ears". The following information was reported: ILLNESS (medically significant) with onset Apr2021, outcome "recovered" (Apr2021), described as "sick after second covid-19 vaccine/it put patient down".  The reporter's assessment of the causal relationship of "sick after second covid-19 vaccine/it put patient down" 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.  Clinical course: Causality for event Sickness (Illness): Action(s) taken with drug: Unknown; Causality as per reporter (Drug/Vaccine): Possible; Dechallenge: N/A. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 limited information in the case provided, the causal association between the event illness and the use of suspect product BNT162B2 cannot be fully 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: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: retested and received a faint positive result; (24May2022) Negative, notes: I tested negative on 24May. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Other medication in 2weeks: Yes. Other medication in 2weeks product=Losartan 100mg. Adverse event: Rebound of covid. I tested negative on 24May and really had no symptoms since then for the most part other than tiredness. Symptoms of shortness of breath, sore throat and headache returned today so retested and received a faint positive result. Adverse event start date: 31May2022. Adverse event start time: 08:00 AM. If patient recovered: Unknown. If treatment ae: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 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 23Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 18Mar2021 as dose 2, single (Lot number: EN6207), in right arm and on 02Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 25 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG, start date: Dec1999; LEXAPRO, start date: Jun2017; LISINOPRIL, start date: Feb2017; LIPITOR, start date: Feb2017, stop date: 16May2022. 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: (unspecified date) Positive; (29May2022) Positive; (17May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Other medication in 2weeks. Anti viral details: product-COVID 19 Treatment, brand-Paxlovid, Treatment start date-17May2022, Treatment stop date-22May2022, Indication: Treatment of COVID-19. The patient Tested positive for COVID 5 days after completing the 5 day course of Paxlovid. The patient had no Known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; 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-163-4411272-00.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, (cf), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was unknown.  Additional information: It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter considered "covid-19" related to BNT162b2. The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was no reasonable possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of suspect drug cannot be excluded for the reported events.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: Possible rebound Covid; Possible rebound Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 at 17:00 as dose 3 (booster), single (Lot number: FF8839) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing); "Hay fever" (unspecified if ongoing); "asthma" (unspecified if ongoing); "triple negative breast cancer", start date: Dec2019 (unspecified if ongoing), notes: triple negative breast cancer (treatment completed Dec2019.; "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: almonds" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Betadine, reaction(s): "Known allergies: betadine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Possible rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: rebound.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Fatigue, Pain
Clinical narrative: ulcerative Colitis flare up; Fatigue; body aches; 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-163-4412684-00 (Abbvie).  A 19-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 22Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) and second regimen (Batch/Lot number: unknown) at increased dose (1 in 1 week), all subcutaneous for colitis ulcerative. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered"; PAIN (non-serious) with onset 2021, outcome "recovered", described as "body aches"; COLITIS ULCERATIVE (medically significant), outcome "not recovered", described as "ulcerative Colitis flare up". The action taken for adalimumab was dosage permanently withdrawn.  The reporter's assessment of the causal relationship of "ulcerative colitis flare up" 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. The reporter considered "fatigue" and "body aches" related to BNT162b2 (probable).  The reporter causality for the event(s) of Fatigue, Ulcerative colitis flare up and body ache was not provided for Humira (Adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of fatigue and body aches. Based on the information provided by the reporter, it appears unlikely that suspect drug contributed to the reported event of colitis ulcerative.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 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 had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received no other medication in 2 weeks. Patient received covd-19 treatment with antiviral drug paxlovid from 22May2022 and 26May2022. No known allergies. Rebound COVID positive 4 days after completing Paxlovid 5 days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
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 a contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EL9262), on 25Jan2021 as dose 2, single (Lot number: EL1284) and on 02Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; AMLODIPINE; MESALAMINE. Past drug history included: Ace inhibitor, reaction(s): "Known allergies: Cough"; Ace inhibitor, reaction(s): "Known allergies: Cough". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive, notes: Initial positive; (25May2022) Negative; (31May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, covid-19 and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: cheeks being numb; lips numb; Headache; both times when she received Covid vaccine She had the same mild allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), 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: "polyethylene glycol allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "cheeks being numb"; HYPOAESTHESIA ORAL (non-serious), outcome "unknown", described as "lips numb"; HEADACHE (non-serious), outcome "unknown"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "both times when she received Covid vaccine She had the same mild allergic reaction". Therapeutic measures were taken as a result of allergy to vaccine.  Additional information: she took Paxlovid pills and completed the 5 days, she mentioned that she experienced numbness in the face, she need to wear a mask after, she wants to confirm that no excess virus is replicated. She also wants to confirms that she cannot infect anyone after 10 days. She is still having some sneezing and coughing but does not know if it is because she is allergic, Caller states that she has had enough Benadryl.she has 2 allergies, specifically ethylene glycol that is from polyethylene glycol, which caller referred to as PEG during the call. Initially because of her allergy, it was not clear if she should get vaccinated. The Pfizer covid vaccine was great, she initially did not believe she could be vaccinated because she was focused on PEG, there has to be an alternative. They will always fail to reach herd immunity with this PEG issue, unless people take Johnson and Johnson but that's terrible, out there in medical community Johnson and Johnson burned down their lab because they can't get rid of the contamination. At the moment it is un clear if she having an allergic response, she had covid now, she is unsure if she will have the booster. Description of Product Complaint: Description of complaint:  PC1: Paxlovid, She completed the 5 days, she mentioned that it was difficult for her to understand the information in fact sheet. Caller states that she has looked at the Paxlovid data sheet, caller complains that maybe she would be able to better read it, if the data sheet was in blank ink instead of grey ink, caller states that she has new prescription glasses, and she also had to use a magnifying glass  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Rebound symptoms worse than before or while taking the antiviral; congestion and more coughing; Rebound symptoms worse than before or while taking the antiviral; congestion and more coughing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8733), in left arm, on 24Apr2021 as dose 2, single (Lot number: WW0170), in left arm and on 11Jan2022 as dose 3 (booster), single (Lot number: FL3197) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 01Jan2017. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 28May2022, outcome "not recovered" and all described as "Rebound symptoms worse than before or while taking the antiviral; congestion and more coughing". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19, treated with Paxlovid, Treatment start date: 21May2022, Treatment stop date: 25May2022, Lot number: GA1189.  Follow-up attempts have been completed and no further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Aug2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Ranitidine, reaction(s): "Known allergies: Ranitidine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result, notes: indication: Treatment of COVID-19; (unspecified date) Negative, notes: Testing + COVID after testing negative; (unspecified date) Positive, notes: Testing + COVID after testing negative; (29May2022) Negative, notes: Tested + again today 11s/p initial +, tested negative 2 days ago and today had stuffy nose again and tested + again; (31May2022) Positive, notes: Tested + again today 11s/p initial +, tested negative 2 days ago and today had stuffy nose again and tested + again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported as patient had Paxlovid on 21May2022 to 25May2022 for Treatment of 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: As there is limited information in the case provided, the causal association between the events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 37-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 12Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for COVID-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "BMI 45" (unspecified if ongoing), notes: Other medical history: BMI 45; "GERD" (unspecified if ongoing), notes: Other medical history: GERD; "OSA" (unspecified if ongoing), notes: Other medical history: OSA; "HSV" (unspecified if ongoing), notes: Other medical history: HSV. Concomitant medication(s) included: SEMAGLUTIDE; VALACYCLOVIR [VALACICLOVIR]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (24May2022) Negative; (28May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: Paxlovid Rebound, after taking paxlovid he had negative test on 24May2022 and felt he had recovered fully without any more symptoms. Then 4 days later on 28May2022, then had redevelopment of symptoms and positive test again. Now had mild symptoms and recovering. He had no known allergies. Other medical history: Obesity BMI 45, GERD, OSA, HSV and VV.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.