chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: received all vaccines and the booster on the first round. We both contracted Covid twice; received all vaccines and the booster on the first round. We both contracted Covid twice; received all vaccines and the booster on the first round. We both contracted Covid twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "received all vaccines and the booster on the first round. We both contracted Covid twice"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "received all vaccines and the booster on the first round. We both contracted Covid twice". Clinical course: Reporter's husband and she received all vaccines and the booster on the first round. They both contracted Covid twice. (age 63 & 70)  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300190645 same reporter, different patient/events;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: received all vaccines and the booster on the first round. We both contracted Covid twice; received all vaccines and the booster on the first round. We both contracted Covid twice; received all vaccines and the booster on the first round. We both contracted Covid twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "received all vaccines and the booster on the first round. We both contracted Covid twice"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "received all vaccines and the booster on the first round. We both contracted Covid twice". Clinical Course: Reporter's husband and she both received all vaccines and the booster on the first round. They both contracted Covid twice (age 63 & 70).; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300190645 Same reporter, different patient/events;
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Vaccine brand Moderna, vaccine dose number: 3/vaccine brand Pfizer / BioNTech, vaccine dose number: 4; COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Aug2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 07May2023 as dose 3 (booster), single (Batch/Lot number: unknown) and on 13Oct2023 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "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 2023, outcome "unknown" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Aug2023, outcome "unknown", described as "Vaccine brand Moderna, vaccine dose number: 3/vaccine brand Pfizer / BioNTech, vaccine dose number: 4". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid as COVID-19 treatment from 04Nov2023 to 08Nov2023. known allergies: no  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.; Sender's Comments: Based on available information a contributory role of bnt162b2, bnt162b2 omi ba.4-5 to the reported events, interchange of vaccine products, drug ineffective, Covid-19 cannot be totally excluded as efficacy of a drug varies from individual to individual.The case will be reassessed once further information is available
Age: 66.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION 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 drug ineffective, covid-19 which included Paxlovid from 11Nov2023 to 16Nov2023. Clinical course: Patient had no known allergies.  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-202300392317 same reporter/patient, different drug/AE;
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose number unknown (booster), single (Lot number: GJ6738) at the age of 61 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 24May2022 as dose number unknown, single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: 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 from 11Nov2023 to 15Nov2023. Clinical course: The patient had no known allergies.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300392303 same reporter/patient, different drug/AE;
Age: 64.0
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 64-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergies" (unspecified if ongoing); "sulpha drugs allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oxycodone, reaction(s): "allergies"; K-flex, reaction(s): "allergies". Vaccination history included: Covid-19 vaccine (DOSE 1; SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); SINGLE, 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". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 10Nov2023 to 15Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Drug ineffective, Neuropathy peripheral, Peripheral swelling, Suspected COVID-19
Clinical narrative: Got COVID; Got COVID/Suspected COVID-19; got neuropathy all throughout his body; his feet swell; has pain all throughout his back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Got COVID"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Got COVID/Suspected COVID-19"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "got neuropathy all throughout his body"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "his feet swell"; BACK PAIN (non-serious), outcome "unknown", described as "has pain all throughout his back". Clinical course: Caller stated when he took his 1st dose of the Pfizer-BioNTech COVID vaccine, he felt alright but when he got the 2nd dose, he, along with his son got COVID. After that, caller said he got neuropathy all throughout his body and " he can not hardly work and do nothing anymore." He added his feet swell and he has pain all throughout his back.  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: Linked Report(s) : US-PFIZER INC-202300396367 same reporter, same product, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Neuropathy peripheral
Clinical narrative: got neuropathy all through my body; I can't walk hardly; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "got neuropathy all through my body"; GAIT DISTURBANCE (medically significant), outcome "unknown", described as "I can't walk hardly". Clinical course: Patient stated that since the patient took shot patient could not walk hardly. Patient got neuropathy all through body cause of it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he recently had Covid; he recently had Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "he recently had Covid". Clinical course: Caller stated he has had the first 2 shots then the first 3 boosters but did not get the most recent booster. Caller stated he recently had Covid the last couple of days of September and into the first 4 or 5 days of October. Caller liked to know how long he had to wait to get the new Pfizer Covid-19 booster for adults.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: 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 60-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown), 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid start date 09Nov2023, stop date 14Nov2023.  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-202300392907 same patient, different drug/event;
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Oct2023 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "cardiomyopathy" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "apnea" (unspecified if ongoing). Concomitant medication(s) included: KLONOPIN, start date: 14May2018, stop date: 09Nov2023; LIPITOR, start date: 14May2018, stop date: 09Nov2023; TRAZODONE, start date: 23Mar2020, stop date: 09Nov2023. 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. 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 drug ineffective, covid-19 which included Paxlovid from 10Nov2023 to 15Nov2023. 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: Linked Report(s) : US-PFIZER INC-202300392960 same patient, different drug/event;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Dose 1: Pfizer/Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 26Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12May2022 as dose 4 (booster), single (Batch/Lot number: unknown), 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12May2022, outcome "recovered", described as "Dose 1: Pfizer/Dose 2: Pfizer/ Dose 3: Pfizer/ Dose 4: Moderna"; DRUG INEFFECTIVE (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: (18Nov2023) negative, notes: I tested negative on 18Nov-20Nov. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 13Nov2023 to 17Nov2023 Clinical course: 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: Linked Report(s) : US-PFIZER INC-202300393012 same patient, different drug/event;
Age: 35.0
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) (Consumer). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's 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 "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Negative; (Nov2023) Negative. Paxlovid was taken as therapeutic measures as a result of vaccination failure, covid-19 from 09Nov2023 to 14Nov2023. 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: Linked Report(s) : US-PFIZER INC-202300393013 Same patient, different drug/events;
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Treated high blood pressure" (unspecified if ongoing); "blood sugar" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (Lot Number: Gj3275, 04:00 PM in left arm as dose 6 (booster), single), administration date: 20Apr2023, when the patient was 78-year-old, for COVID-19 Immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (lot number: Gg1439) on 11Nov2023 until 15Nov2023  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: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got Covid; got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team. The reporter is the parent.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid". Clinical course: Reporter stated that with second dose, he and son both got Covid.  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: Linked Report(s) : US-PFIZER INC-202300393060 Same reporter/vaccine, different patient/events;
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 74-year-old male patient received bnt162b2 (BNT162B2), on 05Jul2022 at 15:30 as dose number unknown, single (Lot number: FM7553) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Mercurochrome, reaction(s): "Known allergies: Mercurochrome". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 18Nov2023 to 20Nov2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300385781 same patient, different drug and event;
Age: 65.0
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 65-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "elevated CHL" (unspecified if ongoing). The patient's 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; 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 "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course:  Patient had no known allergies. Patient received Paxlovid treatment from 07Nov2023 to 11Nov2023.   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: Linked Report(s) : US-PFIZER INC-202300393092 same patient, different drug/event;
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 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, SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER: UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks: No. Anti-viral details: Paxlovid, treatment start date=10Nov2023, treatment stop date=15Nov2023. Covid rebound. Four days following last dose, mild respiratory symptoms returned and rapid antigen test positive.  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: 71.0
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 72-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jan2023 as dose 4 (booster), single (Lot number: GH9697) at the age of 71 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8732), on 21Apr2021 as dose 2, single (Lot number: EW0153) and on 22Nov2021 as dose 3 (booster), single (Lot number: FG3527) for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (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 which included Paxlovid from 07Nov2023 to 12Nov2023. Clinical course: Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300396391 same patient/reporter, different drug/ events;
Age: 57.0
Sex: M
Vaccine: 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 59-year-old male patient received bnt162b2 (BNT162B2), on 23Apr2021 at 02:30 as dose 2, single (Batch/Lot number: unknown), in right arm and on 18Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), on 02Apr2021 at 16:15 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetic" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing); "Flagyl Allergy" (unspecified if ongoing); "Tetracycline Allergy" (unspecified if ongoing); "Metformin Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 18Nov2023 to 20Nov2023.  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-202300396237 Same patient and product, Different dose and events;
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild 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 "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures (Paxlovid therapy start date: 12Nov2023. stop date: 16Nov2023) were taken as a result of drug ineffective, covid-19. Clinical course: No Known Allergies.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300396281 same patient different drug/ event;
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: El9264), on 09Feb2021 as dose 2, single (Lot number: En6203), on 12Nov2021 as dose 3 (booster), single (Lot number: Ff2593) and on 14Jul2022 as dose 4 (booster), single (Lot number: Fj4989) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "non-alcoholic fatty liver" (unspecified if ongoing); "allergies" (unspecified if ongoing); "altitude induced asthma" (unspecified if ongoing); "Known allergies: Penicillin" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (2023) negative, notes: symptoms came back after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 14Nov2023 to 18Nov2023.  No follow-up attempts are possible. 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.,Linked Report(s) : US-PFIZER INC-202300396602 same patient, different product/events;US-PFIZER INC-202300396695 same patient/product, different dose/events;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: before I was given the latest one I got COVID; before I was given the latest one I got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "before I was given the latest one I got COVID". Clinical course: The Patient had all Pfizer boosters. Yet , before patient was given the latest one patient got COVID. Patient inquired how was that possible. Should patient not be vaccinated, if patient got the virus anyhow.  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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive Covid infection 18Nov2023; Positive Covid infection 18Nov2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown), in left 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 18Nov2023, outcome "recovering" and all described as "Positive Covid infection 18Nov2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2023) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Vaccine administration time was 05:00 PM. There was no other vaccine in four weeks. There was no COVID prior vaccination.  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: M
Vaccine: COVID19
Symptoms: Antibody test, Biopsy, Biopsy kidney, Blood albumin, Blood creatinine
Clinical narrative: Membranous nephropathy developed after Pfizer-BioNTech COVID-19 vaccine; This is a literature report.  A 56-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Pulmonary embolism" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for pulmonary embolism. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunisation, reaction(s): "Swelling in his lower extremities". The following information was reported: GLOMERULONEPHRITIS MEMBRANOUS (medically significant), outcome "recovered", described as "Membranous nephropathy developed after Pfizer-BioNTech COVID-19 vaccine". Clinical course: Patient reported that he first noted swelling in his lower extremities after the first dose of covid vaccine which worsened after he received the second dose. Labs showed a Serum Creatinine of 1.3 mg/dl, urine protein>300, Serum albumin 1.7 mg/dl, HbA1c of 5.8, Spot UPCR was 6.8 g/g and anti- PLA2R titers were 539. Renal biopsy was done which showed positive granular capillary wall staining for PLA2R1 (2+) and mild interstitial fibrosis with tubular atrophy. Immunofluorescence was positive for IgG, C3, Kappa and Lambda light chains. Electron Microscopy showed glomerular subepithelial dense deposits, with slight mesangial expansion and epithelial foot process effacement diagnostic for stage 1 MN and ATN. Patient was treated with supportive measures initially and later switched to Rituximab infusion for two doses after biopsy confirmed MN. He had poor response and his UPCR remained >10g/d. Tacrolimus was subsequently added for persistent proteinuria but without sufficient response. He was then started on a cyclical corticosteroids and Cyclophosphamide with successful achievement of remission.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect vaccine Bnt162b2 to the event Membranous nephropathy cannot be excluded. Case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Coagulation test, Complement factor C3, Glomerulonephritis membranous, Glycosylated haemoglobin
Clinical narrative: Membranous nephropathy developed after Pfizer-BioNTech COVID-19 vaccine; This is a literature report.  A 56-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Pulmonary embolism" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for pulmonary embolism. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunisation, reaction(s): "Swelling in his lower extremities". The following information was reported: GLOMERULONEPHRITIS MEMBRANOUS (medically significant), outcome "recovered", described as "Membranous nephropathy developed after Pfizer-BioNTech COVID-19 vaccine". Clinical course: Patient reported that he first noted swelling in his lower extremities after the first dose of covid vaccine which worsened after he received the second dose. Labs showed a Serum Creatinine of 1.3 mg/dl, urine protein>300, Serum albumin 1.7 mg/dl, HbA1c of 5.8, Spot UPCR was 6.8 g/g and anti- PLA2R titers were 539. Renal biopsy was done which showed positive granular capillary wall staining for PLA2R1 (2+) and mild interstitial fibrosis with tubular atrophy. Immunofluorescence was positive for IgG, C3, Kappa and Lambda light chains. Electron Microscopy showed glomerular subepithelial dense deposits, with slight mesangial expansion and epithelial foot process effacement diagnostic for stage 1 MN and ATN. Patient was treated with supportive measures initially and later switched to Rituximab infusion for two doses after biopsy confirmed MN. He had poor response and his UPCR remained >10g/d. Tacrolimus was subsequently added for persistent proteinuria but without sufficient response. He was then started on a cyclical corticosteroids and Cyclophosphamide with successful achievement of remission.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect vaccine Bnt162b2 to the event Membranous nephropathy cannot be excluded. Case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Immunology test, Light chain analysis, Microscopy, Protein urine, Urine protein/creatinine ratio
Clinical narrative: Membranous nephropathy developed after Pfizer-BioNTech COVID-19 vaccine; This is a literature report.  A 56-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Pulmonary embolism" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for pulmonary embolism. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunisation, reaction(s): "Swelling in his lower extremities". The following information was reported: GLOMERULONEPHRITIS MEMBRANOUS (medically significant), outcome "recovered", described as "Membranous nephropathy developed after Pfizer-BioNTech COVID-19 vaccine". Clinical course: Patient reported that he first noted swelling in his lower extremities after the first dose of covid vaccine which worsened after he received the second dose. Labs showed a Serum Creatinine of 1.3 mg/dl, urine protein>300, Serum albumin 1.7 mg/dl, HbA1c of 5.8, Spot UPCR was 6.8 g/g and anti- PLA2R titers were 539. Renal biopsy was done which showed positive granular capillary wall staining for PLA2R1 (2+) and mild interstitial fibrosis with tubular atrophy. Immunofluorescence was positive for IgG, C3, Kappa and Lambda light chains. Electron Microscopy showed glomerular subepithelial dense deposits, with slight mesangial expansion and epithelial foot process effacement diagnostic for stage 1 MN and ATN. Patient was treated with supportive measures initially and later switched to Rituximab infusion for two doses after biopsy confirmed MN. He had poor response and his UPCR remained >10g/d. Tacrolimus was subsequently added for persistent proteinuria but without sufficient response. He was then started on a cyclical corticosteroids and Cyclophosphamide with successful achievement of remission.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect vaccine Bnt162b2 to the event Membranous nephropathy cannot be excluded. Case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm
Clinical narrative: ascending aortic aneurysm; 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 male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: AORTIC ANEURYSM (life threatening), outcome "unknown", described as "ascending aortic aneurysm". It was unknown if therapeutic measures were taken as a result of aortic aneurysm.  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: M
Vaccine: COVID19
Symptoms: Body height, COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: came down with covid and tested positive; came down with covid and tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetic" (unspecified if ongoing), notes: Type 2 diabetic Does not take medication for that. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, ), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, ), for Covid-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, ), for Covid-19 Immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE, ), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Nov2023, outcome "unknown" and all described as "came down with covid and tested positive". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) About 5, 10, notes: Height: About 5, 10; SARS-CoV-2 test: (13Nov2023) Positive; (14Nov2023) Positive; (17Nov2023) Negative; Weight: (unspecified date) About 250, notes: Weight: About 250. Additional information: patient had all 6 Pfizer shots over the last 3 years and the last shot he had was 6 weeks ago in the beginning of the month. Patient came down with covid tested positive, and has been put on Paxlovid for 5 days and it worked great 3 days after that tested negative.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.