chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 11:45 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive; (06Jul2022) Positive; (12Jul2022) Negative; (15Jul2022) Positive; (16Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
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) (Physician). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HYN" (unspecified if ongoing), notes: Other medical history: HYN. There were no concomitant medications.No other medication in 2weeks. No known allergies. 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: unknonw results, notes: Rebound of the symptoms 6 days after finishing the treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment included Paxlovid from 05Jul2022 to 10Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EL9267), on 02Mar2021 as dose 2, single (Lot number: EN6205), on 07Oct2021 as dose 3 (booster), single (Lot number: 30130BA) and on 16Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Adhesive" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE (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: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the reported event and suspect drug  cannot be excluded.The case will be reviewed further with information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata, SARS-CoV-2 test
Clinical narrative: alopecia areata; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 13-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2022 as dose 3 (booster), single (Lot number: Fk9894) at the age of 13 years for COVID-19 immunisation. The patient's relevant medical history included: "known allergies: grapefruit" (unspecified if ongoing), notes: known allergies: grapefruit; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0175), administration date: 19Jul2021, when the patient was 12-year-old, for COVID-19 immunization, reaction: "Inappropriate schedule of vaccine administered"; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0186), administration date: 29May2021, when the patient was 12-year-old, for COVID-19 Immunization. The following information was reported: ALOPECIA AREATA (non-serious) with onset May2022, outcome "recovering". The event "alopecia areata" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia areata.  Additional Information: The facility type that the vaccine was administered was a pharmacy or drug store. The patient had not received any other vaccines in four weeks. About 1 month after the reporter's daughter's 3rd COVID vaccine, the reporter noticed about 4 bald spots on the back of the patient's head. It was completely smooth with bald spots. The pediatrician referred them to a dermatologist, who diagnosed the patient with alopecia areata. She received multiple triamcinolone injections in the areas of hair loss at that visit. The patient did not have a COVID prior vaccination and had a COVID test post vaccination.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 at 13:30 as dose 1, single (Lot number: EN6201), in left arm, on 01Mar2021 at 13:00 as dose 2, single (Lot number: EN6205), in left arm, on 28Sep2021 at 08:30 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 19Apr2022 at 08:45 as dose 4 (booster), single (Lot number: FM0698) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2015, stop date: 05Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Negative, notes: had negative at-home test yesterday; (16Jul2022) Positive, notes: Today congested and retested positive after course of Paxlovid. Therapeutic measures were taken as a result of covid-19.  Additional information: COVID 19 treatment was started on 06Jul2022 and stopped on 11Jul2022. Other medication used in 2weeks was Atorvastatin from 01Jan2015 to 05Jul2022. Adverse event reported was relapse and had negative at-home test and retested positive after course of Paxlovid on 16Jul2022 and the patient was not recovered. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
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 The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 05Jan2021 as dose 2, single (Lot number: EL12B4), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 18May2022 at 13:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: other medical history: GERD; "Allergy" (unspecified if ongoing), notes: other medical history: Allergy; "Sinus" (unspecified if ongoing), notes: other medical history: Sinus; "Environmental allergies" (unspecified if ongoing), notes: known allergies: Environmental allergies. The patient took concomitant medications. 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: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid as Covid-19 treatment from 04Jul2022 to 08Jul2022. Patient received other medication in 2weeks.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 28-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 at 09:30 as dose 1, single (Lot number: EW0158), in left arm, on 28Apr2021 at 09:00 as dose 2, single (Lot number: ER8736), in left arm and on 03Dec2021 at 11:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid-19 treatment received of Paxlovid from 14Jul2022 to 17Jul2022 of lot number GC8236.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 71 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: "Pneumonia" (unspecified if ongoing), notes: Recovering from pneumonia (7 weeks post dx). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "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 drug ineffective, covid-19.  Clinical course: The patient had no known allergies. The patient received treatment with Paxlovid from 08Jul2022 to 12Jul2022.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2022 as dose number unknown, single (Lot number: FJ6369) at the age of 50 years, in left arm for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE BESYLATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical Course: The patient has been taken other medication within two weeks. The patient received other medication in 2weeks product- Amlodipine Besylate. The patient has been treated with Paxlovid (batch no:2815225), started from date: 15Jul2022, Lot number-2815225, for treatment of COVID-19. Adverse event: I have a very weird, nasty taste in my mouth.  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 information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Severe nose bleed after both doses; approximately 12-15 hours after injection.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 3-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jul2022 at 11:15 as dose 2, single (Batch/Lot number: unknown) at the age of 3 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Leg Left), administration date: 25Jun2022, when the patient was 3-year-old, for COVID-19 Immunization, reaction(s): "Severe nose bleed after both doses; approximately 12-15 hours after injection". The following information was reported: EPISTAXIS (non-serious) with onset 17Jul2022, outcome "unknown", described as "Severe nose bleed after both doses; approximately 12-15 hours after injection.". Therapeutic measures were taken as a result of epistaxis.  Additional information: Severe nose bleed after both doses; approximately 12-15 hours after injection. No other vaccine in four weeks. No vaccination prior covid. Not tested for covid post vaccination. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19, 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 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "multiple sclerosis." (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: With two test, I was once again positive; (2022) Negative, notes: having two negative test I felt tired again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received Anti-viral therapy of Paxlovid from 07Jul2022 to 11Jul2022 for the treatment of COVID-19. No other medication received in 2weeks.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 66-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "AVR" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Partial complex seizures" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN; ALFUZOSIN; DYAZIDE; LAMOTRIGINE; ROSUVASTATIN; LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19".  Clinical course: Partial complex seizure on 15Jul, likely related to low lamotrigine dose. This was not adjusted and not listed on meds to change. All other med interactions were accounted for by adjusting as recommended and sprained shoulder with a fall from the seizure, in sling.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ELDERBERRY EXTRACT, start date: 01Mar2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Other medication in 2weeks: Yes. Antiviral details: Product: COVID 19 Treatment, Brand: Pfizer, treatment start date: 12Jul2022, Treatment stop date: 16Jul2022, Lot number: GA8849, Indication=Treatment of COVID-19. Other medication details: Multivitamin (Centrum) start date: 01Jan2021, Nutrafol Women's Balance (Nutrafol) start date: 10Jun2022, Elderberry with Zinc and Vitamin C (Bioschwartz Natural) start date: 01Mar2020, Magnesium, (Nature Made) start date: 01Jun2022. Adverse event: On day 1 of taking paxlovid experienced an odd taste in my mouth within an hour of the first dose. Over the next five days the taste was constant but would ebb and flow in its strength. On day 2 experienced extreme backache and stomachache as well as diarrhea. All of these symptoms persisted for Days 2 through 5. I would take my morning dose at 9am and the pain would start within 90 minutes and then last on and off for the next 14 hours. It never asted more than 2 hours after the evening dose at 9pm and would stay away until about 10:30 the next morning. The pain was equivalent to extreme period cramping that could last hours at a time before subsiding and then coming back on in another wave 30 mins later. I tried taking the meds with food and it made no difference. Adverse event start date: 12Jul2022, Adverse event start time: 10:30 AM, AE resulted in: None of the above, If patient recovered: Recovering, If treatment AE: No, Known allergies: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received COVID 19 Treatment; received 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 62-year-old male patient received BNT162b2 (BNT162B2), on 10Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jul2022 at 14:00, outcome "not recovered" and all described as "received COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive; (16Jul2022) Positive. The testing kept showing Positive since 06Jul2022, and today's testing showed Positive as well (16Jul2022). The patient received COVID 19 Treatment Paxlovid from 06Jul2022 to 10Jul2022. No known allergies or other medical history, no other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Lot number: FP4544) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Covid Rebound. then positive again starting 15Jul2022; (unspecified date) Negative, notes: Tested negative for 5-6 days; (15Jul2022) Positive, notes: then positive again starting 15Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Therapeutic measures included anti-viral treatment with Paxlovid with start date 06Jul2022 and stop date 10Jul2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 at 15:30 as dose 1, single (Lot number: EL9266), in left arm, on 12Mar2021 at 15:30 as dose 2, single (Lot number: EN6208), in left arm and on 23Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FH8020) at the age of 49 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications with in 2weeks. Past drug history included: Asprin, reaction(s): "Known allergies: Aspirin", notes: Known allergies: Asprin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown Result. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2020 at 08:00 as dose 1, single (Lot number: Eh9899), in left arm, on 19Jan2021 at 09:00 as dose 2, single (Lot number: EL3247), in left arm, on 18Jul2021 at 12:00 as dose 3 (booster), single (Lot number: Ew0198), in left arm and on 24Dec2021 at 12:00 as dose 4 (booster), single (Lot number: 331308a) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin likely not certain" (unspecified if ongoing), notes: Penicillin likely not certain. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, 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, notes: pos test happened 5 days after stopping Pax and testing neg; (unspecified date) Negative, notes: pos test happened 5days after stopping Pax and testing neg; (2022) Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks product was Paxlovid, other medication in 2weeks start date was 04Jul2022 and other medication in 2weeks stop date was 08Jul2022. Other medical history was Healthy. The patient was treated with Paxlovid for COVID-19 treatment.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive again on Day 10; positive again on Day 10; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 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: "Known Allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs; "Hypothyroid" (unspecified if ongoing), notes: other medical history: Hypothyroid. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "positive again on Day 10". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Rebound COVID-19 infection on Day 10. Tested negative on Day 5 and 6. Developed symptoms and tested positive again on Day 10; (unspecified date) Negative, notes: Rebound COVID-19 infection on Day 10. Tested negative on Day 5 and 6. Developed symptoms and tested positive again on Day 10; (unspecified date) Positive, notes: Rebound COVID-19 infection on Day 10. Tested negative on Day 5 and 6. Developed symptoms and tested positive again on Day 10; (2022) Positive, notes: COVID 19 Treatment tested positive again on Day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medications within two weeks of vaccination.   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 limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Lot number: Ew0185), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Apr2022 as dose 4 (booster), single (Lot number: 001m21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (Dose 1, Lot number: 012a21a, vaccine location: left arm), administration date: 25Feb2021, for COVID-19 immunization; moderna (Dose 2, Lot number: 008b21-2a, vaccine location: left arm), administration date: 25Mar2021, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood cholesterol: High; SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no Known allergies. She received antiviral treatment with Paxlovid with Lot number GC9437 from 14Jul2022 indicated for COVID-19 treatment.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received treatment with Paxlovid from 30Jun2022 to 04Jul2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19; covid-19; covid-19 Recurrence; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown), on 04Oct2021 as dose 3 (booster), single (Lot number: EW0173) and on 20May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "congestive heart failure" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; CARVEDILOL; FUROSEMIDE; GLIMEPIRIDE; JANUVIA; JARDIANCE; LOSARTAN; METFORMIN; RIVAROXABAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "covid-19"; DISEASE RECURRENCE (medically significant) with onset 2022, outcome "not recovered", described as "covid-19 Recurrence". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (11Jul2022) Negative; (17Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. The patient received Paxlovid for COVID 19 Treatment from 05Jul2022 to 10Jul2022. Patient took the Paxlovid for 5 days. On 11Jul2022, patient tested negative for Covid. Patient felt very tired starting yesterday, took Covid test and it was positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200966972 same reporter/pt, different drug/event;
Sex: F
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (16Jul2022) Unknown results, notes: Covid rebound diagnosed on 16Jul,days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment.; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL3247), on 26Feb2021 as dose 2, single (Lot number: EM9810) and on 30Oct2021 as dose 3 (booster), single (Lot number: 32030BD) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESCITALOPRAM; TRAZODONE. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", described as "COVID 19 Treatment."; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID using at-home antigen tests on Day 5; Positive, notes: Tested positive for COVID using at-home antigen tests on Day10. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had taken anti-viral treatment of drug Paxlovid from 05Jul2022 to 10July2022 for the treatment of covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 17Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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, covid-19.  Clinical Information: The patient received vaccine. No other medication in 2 weeks. The patient received antiviral product Paxlovid for COVID 19 Treatment started from 07Jul2022 to 10Jul2022. No known allergies and other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 05Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 30Oct2021 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jul2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Negative; (15Jul2022) Negative; (16Jul2022) Negative; (17Jul2022) Positive; (07Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has no known allergies and other medical history. The patient had not received any other medication in 2 weeks. The patient reported Paxlovid rebound. Patient's symptoms started on 07Jul2022. She tested positive and started Paxlovid on 08Jul2022. It was taken exactly as prescribed with course completed on 13Jul2022. Symptoms abated by 13Jul2022 and tested negative with Binax on 14Jul2022, 15Jul2022 and 16Jul2022. Symptoms then returned on evening of 16Jul2022. On 17Jul2022, the patient tested positive for COVID-19 using Binax. The patient also had Paxlovid mouth (metallic taste) every time after she took each dose and lasted approximately 3 hours after each dose.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash
Clinical narrative: body rash; felt like it played with my mind a little bit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "An adverse reaction"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "An adverse reaction". The following information was reported: RASH (non-serious), outcome "unknown", described as "body rash"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt like it played with my mind a little bit". Additional information: It was reported that the patient was administered by Pfizer three times and all three times had an adverse reaction. Last time the patient was vaccinated, had a body rash and also felt like it played with the mind a little bit  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). No known allergy. 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 "indication: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Negative, notes: tested negative on 13Jul, 14Jul; (14Jul2022) Negative, notes: tested negative on 13Jul, 14Jul; (16Jul2022) Positive, notes: Scratchy throat on 16Jul, tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 08Jul2022 to 12Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 03Aug2021 as dose number unknown, single (Lot number: EW2164) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension, start date: 01Jan2013. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". 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 drug ineffective, covid-19.  Clinical Information:Anti viral details: Product: COVID 19 Treatment,Brand: Paxlovid,Treatment start date=06Jul2022,Treatment stop date=10Jul2022,Indication-Treatment of COVID-19.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 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 was not reported. Concomitant medication(s) included: LEVOTHYROXINE, start date: 11Jul2022, stop date: 17Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Jul2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) positive, notes: Positive Covid-19 test on 17Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received treatment with Paxlovid in Jul2022. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pericarditis" (unspecified if ongoing). There were no concomitant medications. Other medication in 2weeks was reported as No. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with anti viral COVID 19 treatment Paxlovid started on 28Jun2022 and stopped on 03Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.