chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
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) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunization; 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, single (Batch/Lot number: unknown). The patient had no relevant medical history and no known allergies. Concomitant medication(s) included: ZOLOFT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; also reported as other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 16May2022 and stopped on 20May2022. Clinical course was reported as, Rebound covid 5 days later on 24May2022. No treatment received for symptoms and patient was recovering from symptoms.  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 reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6201), in right arm, on 30Mar2021 as dose 2, single (Lot number: RR8134), in right arm, on 11Sep2021 as dose 3 (booster), single (Lot number: FC3183), in right arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative by the 5th day; Positive, notes: became symptomatic and started testing positive again 8 days. Therapeutic measures were taken as a result of suspected covid-19, drug ineffective. Clinical information: Anti viral details: product-COVID 19 Treatment, brand-Paxlovid, from 04May2022 to 09May2022, Indication: Treatment of COVID-19.  Conclusion: The complaint for lack of effect of the Pfizer- Biontech Covid-19 Vaccine injectable lot FC3183 and EN6201 were 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 FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657 and lot EN6201, fill lot EN5333, and the formulated drug product lot EN5322. 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: 42.0
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 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 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing), notes: other medical history: Type 2 Diabetes, PCOS, androgenic alopecia; "PCOS" (unspecified if ongoing), notes: other medical history: Type 2 Diabetes, PCOS, androgenic alopecia; "androgenic alopecia" (unspecified if ongoing), notes: other medical history: Type 2 Diabetes, PCOS, androgenic alopecia. Concomitant medication(s) included: OZEMPIC, start date: 26Apr2021, stop date: 26May2021; METFORMIN ER, start date: 26May2021, stop date: 26May2022; FAMOTIDINE, start date: 26May2021, stop date: 26May2022; VIT D [COLECALCIFEROL], start date: 01Sep2021, stop date: 26May2022; SPIRONOLACTONE, start date: 01Mar2022, stop date: 26May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26May2022 at 12:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative on rapid test; Negative, notes: then negative again on Day 8; Positive, notes: Tested positive on rapid test in afternoon. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti viral details: product COVID 19 Treatment, treatment start date 16May2022,stop date 21May2022, indication treatment of COVID-19. Other medication in 2weeks: Yes, other medication in 2weeks product Multivitamin, started on 26May2021, stopped on 6May2022. Adverse event type 2 Diabetes, PCOS, androgenic alopecia started on: 26May2022 at 12:00 AM, If patient recovered: Not Recovered, If treatment ae: No, known allergies: No. Other medical history: Type 2 Diabetes, PCOS, androgenic alopecia. Patient was not a pregnant at time of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Testing positive day 12; Testing positive day 12; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 at 01:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Chronic Bronchitis" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07May2022 at 02:00, outcome "not recovered" and all described as "Testing positive day 12". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that Paxlovid was taken as treatment for the events. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 at 11:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Anti viral brand=PAXLOVID was given from 10May2022 to 14May2022, for treatment of COVID-19. Other medication in 2weeks was unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing). 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 "Covid". Addition information: Caller would like to know if there's a second booster shot of the Pfizer-BioNTech Covid 19 Vaccine for group of 50 years old of age and older. Her husband is 66 years old and she was 64 years old and they received the first booster shot on 31Mar of this year and they did not notice that they had Covid when they received this shot. She also mentioned that both of them are immunocompromised and that they only received 2 doses of the primary series. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200765817 Same reporter/vaccine/event, different patient
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 30Apr2022, outcome "recovered" (15May2022), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive, notes: Tuesday 03May upon receipt of positive PCR results; (10May2022) Negative, notes: Negative rapid antigen test on Tues 10May; (14May2022) Positive, notes: On Sat 14May had cold symptoms & fatigue & positive rapid antigen test; (15May2022) Negative, notes: The next day (Sun 15May) felt normal again & rapid was negative. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: The patient took Paxlovid treatment for COVID 19, treatment start date was 03 May 2022 and stop date was 08 May 2022. Paxlovid was rebound. Patient had COVID symptoms flu like fatigue body aches chills etc it started on sat 30 Apr then started 5 day course of Paxlovid. Symptoms had been improved over course of treatment and days following.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: recurrent positive Ag test; recurrent positive Ag test; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EK5730), on 07Jan2021 as dose 2, single (Lot number: EL1284) and on 05Oct2021 as dose 3 (booster), single (Lot number: EW0198) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Nov2021 as dose 4, (booster) single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing). There were no concomitant medications. There was no other medication in 2weeks.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 19May2022, outcome "unknown", COVID-19 (medically significant) with onset 19May2022, outcome "recovering" and all described as "recurrent positive Ag test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: positive Ag test was negative day 9; Positive, notes: positive Ag test positive day 15). Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details was started on 10May2022 and stopped 15May2022.   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 reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 39.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 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 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: There were no known allergies. Patient received anti-viral product Paxlovid for the COVID 19 treatment (start date 14May2022 and stop date- 18May2022). On 23 May2022, patient gain experienced Rebound Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer or other non HCP) from product quality group. The reporter is the patient. A 39-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 09Oct2021 at 12:00 as dose 3, single (batch/lot number: FF2590) for Covid-19 immunization; COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (batch/lot number: unknown) and as dose 2, single (batch/lot number: unknown) for Covid-19 immunization. The patient's relevant medical history included: "ulcerative colitis" (unspecified if ongoing), notes: on biologics for treatment. Concomitant medications included: STELARA, start date: 09Oct2021 at 12:00. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19 which included Paxlovid from 16May2022 to 20May2022.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 at 10:00 as dose 3 (booster), single (Lot number: EL3249) at the age of 72 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); "Acid Reflux" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Hyper-Cholesterol" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Steroid allergy" (unspecified if ongoing). Concomitant medication(s) included: FORTEO, start date: 31Mar2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "SUSPECTED COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Product investigation Summary Conclusion included the complaint for lack of effect of the Pfizer Biontech Covid-19 Vaccine lot EL3249 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3249, fill lot EL3232, and the formulated drug product lot EL3225. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Clinical course: The patient received Paxlovid as a treatment medication for adverse event Covid-19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Erythema multiforme, SARS-CoV-2 test
Clinical narrative: Recurrent erythema multiforme x 3 since February 2022 with cutaneous and oral presentation; Recurrent erythema multiforme x 3 since February 2022 with cutaneous and oral presentation; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FH8027) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "Pneumonia" (unspecified if ongoing); "bilateral TKR" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; NAPROXEN; EXCEDRIN MIGRAINE. Past drug history included: Plaquenil for Allergy; Pitted fruits for Allergy; Raw almonds for Allergy. Vaccination history included: BNT162b2 (Prev dose Product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Prev dose lot number=EK573P,, Prev dose lot unknown=False,, Prev dose administration date=23Dec2020,, Prev dose administration time=08:30 am, Prev dose dose number=1,, Prev dose vaccine location=Right arm), administration date: 23Dec2020, when the patient was 42-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Prev dose Product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Prev dose lot number=EL3264,, Prev dose lot unknown=False,, Prev dose administration date=13Jan2021,, Prev dose administration time=09:00 am, Prev dose dose number=2,, Prev dose vaccine location=Right arm,), administration date: 13Jan2021, when the patient was 43-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: ERYTHEMA MULTIFORME (medically significant), DISEASE RECURRENCE (non-serious) all with onset 02Feb2022 at 14:00, outcome "not recovered" and all described as "Recurrent erythema multiforme x 3 since February 2022 with cutaneous and oral presentation". The events "recurrent erythema multiforme x 3 since february 2022 with cutaneous and oral presentation" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of erythema multiforme, disease recurrence. Clinical Course: Patient received Other medication in 2weeks.No covid prior vaccination. After post vaccination covid tested positive.Covid test type post vaccination Nasal Swab, covid test name post vaccination PCR and binaxNow numerous times, covid test result Negative.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Erythema Multiforme and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: P24991) at the age of 55 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: CANNABIDIOL; FINASTERIDE; GLUCOSAMINE; TURMERIC CURCUMIN. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 14May2022, outcome "unknown", COVID-19 (medically significant) with onset 14May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: negative; positive; Unknown result. Therapeutic measures were taken as a result of covid-19.  Clinical course: Approx. 4-5 days after completing the course of Paxlovid my symptoms returned: low grade fever, chills, fatigue, and congestion. I tested positive on rapid antigen tests for another 7 days before testing negative.
Age: 48.0
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) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2021 at 10:00 as dose 2, single (Lot number: EW0180) at the age of 48 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), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient took paxlovid from 2nd day of symptoms shown and home tested positive The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot EW0180 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 EW0180, fill lot EP8731, and the bulk formulated drug product lot EP8612. 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 23Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Skelaxin, reaction(s): "Allergy". 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 patient received paxlovid as covid -19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive; Negative, notes: negative antigen test on days 10 & 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid on day 2, symptom free on day 6, negative antigen test on days 10 & 11, and was symptom free through day 13. On day 14, I felt fatigued with nasal congestion and had a positive antigen test. My symptoms which continued for about another week were worse than my symptoms during days 1-6. Anti-viral details include, Product- COVID 19 Treatment, Treatment start date- 03May2022, Treatment start date- 08May2022. Indication- Treatment of COVID-19.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose1, 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: "Diabetes" (unspecified if ongoing); "High Blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical Information: Product used for COVID 19 Treatment, brand:Paxlovid,  treatment start date:25May2022, treatment Stop date:29May2022, lot number:GA3567  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19, 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).  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years 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: "Mild asthma" (unspecified if ongoing), notes: Other medical history: Mild asthma. Concomitant medication(s) included: CETIRIZINE. Past drug history included: Benadryl, reaction(s): "Known allergies: Benadryl". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.COVID 19 treatment included Paxlovid from 13May2022 to 17May2022 via Oral route.10 days after treatment with Paxlovid the patient developed mild COVID symptoms and had a positive result on a repeat antigen test  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 available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 2, single (Lot number: EW0153) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Borderline high blood pressure" (unspecified if ongoing), notes: Other medical history: Borderline high blood pressure, vasomotor rhinitis; "vasomotor rhinitis" (unspecified if ongoing), notes: Other medical history: Borderline high blood pressure, vasomotor rhinitis. Concomitant medication(s) included: CIPROFLOXACIN, start date: 24May2022, stop date: 26May2022. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline", notes: Known allergies: Doxycycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started from 24May2022 to 26May2022 with Lot no. GA1190. Clinical course: Upon Follow up 02Jun2022, Additional information: This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes: Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the business process. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EW0153 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0153, fill lot EP8692 and the bulk formulated drug product EW8071. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: and PR Link (Previously Investigated CR). Received vaccines and other medication in two weeks.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) 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: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Other medication in 2weeks and details provided as patient administered Paxlovid orally from 16May2022 to 20May2022 for COVID 19 treatment. Adverse event reported as on 24May2022-COVID symptoms returned mild nasal drainage, sinus headache, sore throat and Fatigue. Patient was Recovering.Treatment for AE: No. Had no known allergies.  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 role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: P23197) at the age of 37 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: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 27May2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Antiviral details: Product: COVID 19 Treatment Brand: Paxlovid , Start date: 27May2022, Indication: Treatment of COVID-19  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for COVID on 16May; I tested positive for COVID on 16May; This is a spontaneous report received from a non-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 3, 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: "Migraine" (unspecified if ongoing); "IBS" (unspecified if ongoing); "TMJ" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Raynaud's syndrome" (unspecified if ongoing); "sciatica" (unspecified if ongoing); "Known allergies: Red dye" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "not recovered" and all described as "I tested positive for COVID on 16May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: I tested positive for COVID on 16May; (27May2022) Positive, notes: It is now 27May / I have tested positive on a rapid home test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in two weeks of vaccination. Symptoms began on 15May2022, the patient was tested positive for COVID on 16May2022, and began Paxlovid on 17May2022. She took the full course of medication as instructed. It was now 27May2022 and she had tested positive on a rapid home test and feel the same symptoms she did at onset.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment/Covid rebound after taking PAXLOVID and testing negative; COVID 19 Treatment/Covid rebound after taking PAXLOVID and testing negative; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose number unknown, single (Lot number: FM0698) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XARELTO; ATORVASTATIN; VALSARTAN. 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/Covid rebound after taking PAXLOVID and testing negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19; Negative, notes: testing negative; Positive, notes: Covid rebound after taking PAXLOVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 18May2022 to 23May2022.  On 01Jun2022, according to product quality, a complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concluded that the reported defect was not representative of the quality of the batch and the batch remained acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM0698. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Agency concluded that the reported defect was not representative of the quality of the batch and the batch remained acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  Additional information: The patient had no known allergies.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 at 18:00 as dose 3 (booster), single (lot number: FF8841) at the age of 50 years, administered in the left arm for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (lot number: unknown) and as dose 2, single (lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing); "Known allergies: Adhesive tape" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing), notes: blood level was 17; "Blood pressure" (unspecified if ongoing). Concomitant medications included: LISINOPRIL taken for blood pressure management; ESTRADIOL; VITAMIN D3. Other medication in two weeks also included "Rugby 1,000 unit." The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22May2022 at 19:00, outcome "recovering" and all described as "Tested positive for COVID-19." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: Rebound infection after negative Covid test; (21May2022) positive, notes: Tested positive 5 days after treatment end with return of less severe symptoms. Therapeutic measures were not taken as a result of Drug ineffective, Covid-19. No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 65-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported and no other medications the patient received within 2 weeks of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) positive; (19May2022) Negative; (27May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 12May2022 and stopped on 17May2022.   Clinical course was reported as, Symptom onset and positive test 11May2022, Paxlovid initiated 12May2022 and completed 17May2022. Negative test 19May2022 Symptom re-emergence 26May2022, positive test 27May2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the Drug ineffective and Covid 19 cannot be completely excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19 after vaccination; tested positive for Covid 19 after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79-year-old female 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), as dose 4 (booster), single (Batch/Lot number: unknown) and on 07Apr2022 as dose 5 (booster), single (Lot number: FK9894) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: Diagnosed before receiving COVID-19 vaccines. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid 19 after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: wife tested positive for COVID-19 after vaccination. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient's husband reported that it was his wife, who tested positive after vaccination.  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-202200720139 same patient/product; different dose/events