chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "chronic angioedema" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "small intestinal bacterial overgrowth" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Dry eye syndrome" (unspecified if ongoing); "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE, Vaccine administration time: 11:00, Lot number=EP7534), administration date: 18Mar2021, when the patient was 55-year-old, for COVID-19 Immunization; comirnaty (DOSE 2, SINGLE, Vaccine administration time: 11:00, Lot number=ER8729), administration date: 08Apr2021, when the patient was 55-year-old, for COVID-19 Immunization; moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Lot number=077c218), administration date: 02Nov2021, when the patient was 56-year-old, for COVID-19 Immunization; comirnaty (DOSE 4 (BOOSTER), SINGLE, Vaccine administration time: 16:00, Lot number=FM9992), administration date: 06May2022, when the patient was 56-year-old, for COVID-19 Immunization; comirnaty original/omicron ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Vaccine administration time: 17:00, Lot number=GJ5342), administration date: 19Oct2022, when the patient was 57-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Nov2023, outcome "recovered" (27Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Nov2023) Positive; (27Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient was taking Paxlovid treatment from 21Nov2023 to 25Nov2023. Initially tested positive for covid 21Nov2023 per home rapid test, started Paxlovid on said date, completed Treatment 25Nov2023. Tested negative per home rapid test 27Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "NSTEMI" (unspecified if ongoing); "renal stone" (unspecified if ongoing); "BPH" (unspecified if ongoing); "HTN" (unspecified if ongoing); "elevated cholesterol" (unspecified if ongoing); "chronic GERD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 1, SINGLE), administration date: 29Dec2020, for Covid-19 immunisation; moderna (DOSE 2, SINGLE, Anatomical location: Left arm), administration date: 26Jan2021, for Covid-19 immunisation; moderna (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: 28Oct2021, for Covid-19 immunisation; moderna (DOSE 5 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: 17Nov2022, for Covid-19 immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Left arm), administration date: May2022, for Covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: Day 1 with mild URI sxs; (Nov2023) Negative, notes: Antigen test negative Day 7. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 18Nov2023 to 23Nov2023. Clinical Course: Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "PCOS/insulin resistance" (unspecified if ongoing); "PCOS/insulin resistance" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "extra heartbeat" (unspecified if ongoing); "chronic water retention" (unspecified if ongoing); "bloating" (unspecified if ongoing); "constipation" (unspecified if ongoing); "Known allergies:  Shellfish and yellow summer squash; possibly quinoa, raspberries and zucchini" (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 Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 19Nov2023 to 26Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 41.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 11Apr2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in left arm 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 Nov2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date 21Nov2023, stop date 25Nov2023).  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 58-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "HTN" (unspecified if ongoing); "mild sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 16Dec2022, for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 20Nov2023 to 25Nov2023. Clinical course: The patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: had to have heart stents put in; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COVID-19 VACCINE OMI XBB.1.5 - MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (medically significant), outcome "unknown", described as "had to have heart stents put in". Therapeutic measures were taken as a result of cardiac disorder. Clinical Course: Reporter's son did not wanted reporter to get the vaccine because he had a friend who got the COVID-19 vaccine (manufacturer unknown) that had to have heart stents put in after getting it.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 71.0
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 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Lot number: HG4665) at the age of 71 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, which included treatment with Paxlovid from 23Nov2023 to 27Nov2023.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report received from contactable reporter(s) (Physician).  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 2023, outcome "unknown", described as "blood clot". Clinical course: Reporter stated one female of around 70 years of age had a blood clot. Reporter did not know when was it occurred but it occurred sometime that year. Reported it as a potential side effect of the vaccine. Patient received vaccine at the pharmacy.  Causality assessment: Relatedness of drug to reaction(s)/event(s): Primary Source Reporter was Unknown.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 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 event Thrombosis and the use of suspect product cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300429231 Same reporter, different patient/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Reporter/consumer tested positive for Covid via a home test within 2 months after receiving the most recent vaccine; Reporter/consumer tested positive for Covid via a home test within 2 months after receiving the most recent vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 45-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA taken for influenza immunisation as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "Reporter/consumer tested positive for Covid via a home test within 2 months after receiving the most recent vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a cerebrovascular accident; This is a spontaneous report received from contactable reporter(s) (Physician).  A 70-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 2023, outcome "unknown", described as "had a cerebrovascular accident". Clinical course: Reporter stated one male around 70 years of age had a cerebrovascular accident. Reporter did not know when this occurred but it occurred sometime this year. Reported this as a potential side effect of the vaccine. Patient received vaccine at the pharmacy.  Causality assessment: Relatedness of drug to reaction(s)/event(s): Primary Source Reporter was Unknown.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 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 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.The impact of this report on the benefit/risk profile of the Pfizer drug 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. ,Linked Report(s) : US-PFIZER INC-202300429220 Same reporter, different patient/event.;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Lot number: HGW436) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Negative, notes: Negative Covid test on day 9. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 17Nov2023 to 22Nov2023.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 66-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 3 (booster), single (Lot number: GJ6669), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Jan2021 as dose 1, single (Lot number: 029k20A), in left arm and on 17Feb2021 as dose 2, single (Lot number: 015M20A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary disease" (unspecified if ongoing); "Benign prostatic hypertrophy" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN oral, start date: Jan2021, stop date: 28Nov2023; RAMIPRIL oral, start date: Jan2020, stop date: 01Dec2023. Past drug history included: Codeine, reaction(s): "Drug allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Nov2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 29Nov2023.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 22Sep2022 at 10:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (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 Nov2023, outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took Paxlovid from 21Nov2023 to 25Nov2023.  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
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Janssen (12Mar2021)/Moderna (21Dec2021)/Pfizer / BioNTech (04Oct2022)/Interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 3 (booster), single (Lot number: Gh9693) at the age of 32 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Dec2021 as dose 2 (booster), single (Lot number: 037F21A), in left arm for covid-19 immunisation; covid-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 12Mar2021 as dose 1, single (Lot number: 1809029), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "overweight" (unspecified if ongoing); "chronic pain" (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 Nov2023, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered", described as "Janssen (12Mar2021)/Moderna (21Dec2021)/Pfizer / BioNTech (04Oct2022)/Interchange of vaccine products". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 22Nov2023 to 26Nov2023.  Conclusion based upon investigation: 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 GH9693. 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. (Site withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains 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.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 12Feb2021 at 10:00 as dose 1, single (Lot number: EN6201), in right arm, on 05Mar2021 at 10:00 as dose 2, single (Lot number: EN6199), in right arm and on 07Sep2021 at 22:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 67 years, in right 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) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Nov2023 to 19Nov2023.  Based on investigation result conclusion for lot/batch number: EN6199 and EN6201: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6199, EN6201 were investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot EN6199, fill lot EN5331, EN6201, fill lot EN5333 and the bulk formulated drug product lot EN5320 and EN5322. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No corrective or preventative actions were identified because it was determined that the controls currently in place are sufficient for preventing and removing any vial damage as observed in the complaint sample. All release testing performed prior to the release of the reported batch was within specifications.  Based on investigation result conclusion for lot/batch number: FC3184: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FC3184 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FC3184, fill lot EY0563, and the bulk formulated drug product lot EP8663. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No corrective or preventative actions were identified because it was determined that the controls currently in place are sufficient for preventing and removing any vial damage as observed in the complaint sample. All release testing performed prior to the release of the reported batch was within specifications.
Age: 44.0
Sex: F
Vaccine: COVID19, 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 45-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 at 09:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 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 included: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Plastic" (unspecified if ongoing); "metal" (unspecified if ongoing); "allergic to amoxicillin and doxycycline" (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 Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient recived Paxlovid from 22Nov2023 to 27Nov2023 as COVID 19 Treatment.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Nov2023, outcome "recovered" (30Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2023) Positive; (30Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 24Nov2023 to 28Nov2023. Patient tested positive for COVID 23Nov2023 and began treatment with Paxlovid 24Nov2023. She felt better after completing the full dosage of Paxlovid and tested negative for COVID 30Nov. Patient had no Known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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 61-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid from 23Nov2023 to 27Nov2023.  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, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 57-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; SIMVASTATIN. Past drug history included: Corticosteroids, reaction(s): "hiccups"; Corticosteroids, reaction(s): "Corticosteroids allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID". 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 with Paxlovid from 21Nov2023 to 25Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Wheat/ Egg allergy" (unspecified if ongoing); "High bp" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "vit b12 deficiency" (unspecified if ongoing), notes: Take injection monthly for deficiency. The patient's concomitant medications were not reported. Past drug history included: Sulfa, reaction(s): "Allergy"; Rocephin, reaction(s): "Allergy"; Flu vaccine, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Nov2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 24Nov2023 to 29Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Apr2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 23Nov2023 to 28Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: He cannot walk, he has to wear pampers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49-year-old male patient received bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: GAIT INABILITY (disability, medically significant), outcome "unknown", described as "He cannot walk, he has to wear pampers". The event "he cannot walk, he has to wear pampers" required physician office visit. Clinical course: It was reported that patient didn't feed himself, he can do nothing. Patient had been like this now from 3 years. He got 1 shot, the Pfizer shot (clarified as Pfizer Covid Vaccine). After he got the Pfizer shot that day, about  maybe a day or soon later he got 'it'."   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: 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 37-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; 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 51-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 3 (booster), single (Lot number: GJ6742) at the age of 50 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EL3247), in left arm and on 01Apr2021 as dose 2, single (Lot number: EP6955), 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) all with onset Nov2023, outcome "unknown" and all described as "covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took Paxlovid from 22Nov2023 to 27Nov2023.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3247, lot EP6955, 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 EL3247, fill lot EL3230, and lot EP6955, fill lot EP6954 and the formulated drug product lot EL3223, lot EP6953. 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.  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot GJ6742 was investigated. The investigation included a review of manufacturing and packaging records, deviations, and the complaint history for in scope lots. The final scope was determined to be the finished goods lot GJ6742, bulk and fill lots GJ6729, and GJ6736. 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.
Age: 45.0
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) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 20Jun2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN, start date: 17Nov2023, stop date: 23Nov2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Nov2023 to 24Nov2023. Clinical course: Patient also took Theraflu from 19Nov2023 to 21Nov2023 also 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.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Drug ineffective and COVID 19 cannot be ruled out.
Age: 44.0
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 44-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "RA/ Rheumatoid arthritis" (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 Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 22Nov2023 to 26Nov2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; 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 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Nov2023 at 11:45 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: EN6202), administration date: 24Feb2021, when the patient was 66-year-old, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Batch/lot number: ER8730), administration date: 29Mar2021, when the patient was 67-year-old, for COVID-19 immunisation; comirnaty (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: FH8020), administration date: 14Oct2021, when the patient was 67-year-old, for COVID-19 immunisation; moderna (DOSE 4 (BOOSTER), SINGLE, Batch/lot number: 001M21A), administration date: 29Apr2022, when the patient was 68-year-old, for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID-19 treatment from 21Nov2023 to 25Nov2023.   Product Quality Group provided investigational results for lots FH8020, ER8730, EN6202 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 FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. The final scope included the reported finished goods lot ER8730, fill lot EP8682, and the formulated drug product lot EP8569. The final scope included the reported finished goods lot EN6202, fill lot EN5334, and the formulated drug product lot EN5323. 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.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 53-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "acid reflux disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 21Nov2023 to 26Nov2023. clinical course: Patient denied for any known allergies  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.