chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Has treated two patients with polymyalgia rheumatica that developed within 2-3 weeks after receiving a COVID vaccine; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as "Has treated two patients with polymyalgia rheumatica that developed within 2-3 weeks after receiving a COVID vaccine". The event "has treated two patients with polymyalgia rheumatica that developed within 2-3 weeks after receiving a covid vaccine" required physician office visit. Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical course: Rheumatologist reported that she had treated two patients with polymyalgia rheumatica that developed within 2-3 weeks after receiving a COVID vaccine. She was not aware of the type of COVID vaccine (Pfizer or other brand) or whether it was initial or booster. It was unknown if patient had covid prior vaccination or was tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event polymyalgia rheumatica 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 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-202300440664 Same vaccine/reporter, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis
Clinical narrative: frozen shoulder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "latex allergies" (unspecified if ongoing); "preservatives allergies" (unspecified if ongoing); "can't tolerate gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flu shot. The following information was reported: PERIARTHRITIS (non-serious), outcome "unknown", described as "frozen shoulder".  Additional information: Patient has problems with gluten, eggs, dairy, can eat yogurt, can't drink milk or cream, or use cream, anything like that. Gluten and eggs really make her sick. Can eat yogurt, doesn't bother her but milk or cream bothers her. Has not been diagnosed with, does not know name, that disease where people can't tolerate gluten. Does not remember if that happened last year. Two years ago, she had flu shot and Covid shot real close together, got frozen shoulder afterwards. That was probably 2 to 3 years ago that happened, did report that.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 72.0
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 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE), administration date: 04Feb2021, when the patient was 70-year-old, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE), administration date: 25Feb2021, when the patient was 70-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 30Sep2021, when the patient was 70-year-old, for COVID-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 22Apr2022, when the patient was 71-year-old, for COVID-19 immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), administration date: 12Oct2022, when the patient was 71-year-old, 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 with paxlovid from 15Nov2023 to 25Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Patient got COVID a few months after first dose of vaccination.; Patient got COVID a few months after first dose of vaccination.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 12-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Aug2022 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Patient got COVID a few months after first dose of vaccination.". It was unknown if therapeutic measures were taken as a result of drug ineffective, suspected covid-19.Clinical course: Patient got COVID a few months after first dose of vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: experienced 3 strokes; had clots form after the vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) 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: "patent foramen ovale" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "significant headaches". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 2023, outcome "unknown", described as "experienced 3 strokes"; THROMBOSIS (medically significant) with onset 2023, outcome "unknown", described as "had clots form after the vaccination". Clinical Course: Within a few hours after the second dose, they experienced 3 strokes. The upshot their healthcare team determined was that they had a patent foramen ovale, and it was believed that they had clots form after the vaccination, which passed through the foramen ovale, and into the brain.   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-PV202300200553 same patient, different events/ dose;
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 at 10:00 as dose 1, single (Lot number: HG4589) at the age of 35 years, 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Nov2023, outcome "recovered" (04Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Nov2023) Positive; (04Dec2023) Negative, notes: tested negative, returned to work. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 27Nov2023 to 01Dec2023. Clinical course: Patient had no known allergies.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 4 (BOOSTER), SINGLE , Vaccine Administration Time 11:00 AM,, Vaccine Lot Unknown True, Reason Misplaced/Discarded, Vaccine location Left Arm), administration date: 08May2023, when the patient was 67-year-old, for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, 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 "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient did not have any known Allergies. The patient received vaccine. The patient received other medication in 2 weeks was Pravastatin, Lisinopril Metformin and Valtrex. Anti-Viral Details: Product Covid 19 Treatment, Brand Pfizer, Treatment Start Date 25Nov2023, Treatment Stop Date 30Nov2023, Indication Treatment of Covid-19.   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: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; LITHIUM; DIAZEPAM. The following information was reported: COVID-19 (medically significant) with onset Nov2023, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Nov2023, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 29Nov2023 to 03Dec2023.   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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Nov2023, outcome "recovered" (06Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Dec2023) negative, notes: Tested negative and felt fine on 06Dec which included Paxlovid from 28Nov2023 to 03Dec2023. Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Original onset of COVID had been night of 27Nov at which point a 5 day course of Paxlovid began.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM, start date: Aug2009, stop date: 09Dec2023; BUPROPION, start date: Aug2009, stop date: 09Dec2023; METOPROLOL SUCCINATE, start date: Aug2017, stop date: 09Dec2023. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: EL9264, Vaccine administration time: 02:00 PM, Anatomical location: Left arm), administration date: 04Feb2021, when the patient was 66-year-old, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Batch/Lot number: EN6200, Vaccine administration time: 02:30 PM, Anatomical location: Right arm), administration date: 25Feb2021, when the patient was 66-year-old, for COVID-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: FF8841, Vaccine administration time: 02:00 PM, Anatomical location: Right arm), administration date: 04Oct2021, when the patient was 67-year-old, for COVID-19 immunisation; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot number: FM9992, Vaccine administration time: 01:00 PM, Anatomical location: Left arm), administration date: 15Apr2022, when the patient was 67-year-old, for COVID-19 immunisation; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Vaccine administration time: 01:00 PM, Anatomical location: Right arm), administration date: 07Nov2022, when the patient was 68-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Nov2023, outcome "recovered" (05Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Nov2023) Positive, notes: AM; (05Dec2023) Negative, notes: had 2 negative tests Tues 05Dec2023 PM; (05Dec2023) Negative, notes: had 2 negative tests Tues 05Dec2023 PM. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient tested Positive for Covid AM 29Nov2023, started PAXLOVID on 29Nov2023 PM and finished AM 04Dec2023. Fever and headaches stopped within 12 hours of taking 1st dose of Paxlovid. Patient had 2 negative tests Tues 05Dec2023 PM. 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.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypersensitivity
Clinical narrative: had an allergic reaction to the COVID vaccine; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 05Jan2022 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (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"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "had an allergic reaction to the COVID vaccine". Therapeutic measures were taken as a result of drug ineffective, covid-19 Paxlovid from 22Nov2023 to 26Nov2023.  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 events Drug ineffective and COVID-19 cannot be ruled out.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Jun2018, stop date: 29Nov2023. 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 (Paxlovid treatment start date: 29Nov2023, stop date: 04Dec2023) were taken as a result of vaccination failure, covid-19.  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: F
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 53-year-old female 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 53 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 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: She received Paxlovid as COVID 19 Treatment from 29Nov2023 to 04Dec2023. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Magnetic resonance imaging
Clinical narrative: Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Dec2023 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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 02Dec2023, outcome "unknown", described as "Stroke". The event "stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (06Dec2023) stroke.  Clinical course: The patient got the vaccine on the Friday and was very sick the next day. Then the patient went to the doctor/ hospital, emergency room on Wednesday and they did an MRI and said the patient have had a stroke.  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: Dementia, Dementia Alzheimer's type, Memory impairment
Clinical narrative: Alzheimer; dementia; my memory has just gone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 included: "hard of hearing" (unspecified if ongoing), notes: I am hard of hearing. 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. The following information was reported: DEMENTIA ALZHEIMER'S TYPE (medically significant), outcome "unknown", described as "Alzheimer"; DEMENTIA (medically significant), outcome "unknown"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "my memory has just gone".  Clinical course: Consumer stated, "Well, I have had 3 Pfizer shots, I had to get them because they would not let me in without this stupid shots and there is 4th one I believe, I am not going to I take because my memory has just gone, I think, I have got either Alzheimer or something. I forget things from second to second, minute to minute and it is really interrupting my life here and I heard this from different people at and from patients and they all have same complaints (Further details were not available over the call)." Consumer stated, "I am hard of hearing (Intent: History) It is the part, I am loosing it really fast, I don't know if its Alzheimer or dementia what but it all started when I have taken it, I used to be very sharp. I forget words, I use by my wife to get up things." Consumer stated, "Right now, I got only a few minutes but I would like to do something I mean a call back or something. A call back would be great possibly tomorrow or something, right now I am going to baby sit my great grand child."  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: 65.0
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 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Jul2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "high LDL" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "opiates allergy" (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 29Nov2023 to 04Dec2023.  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: U
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 patient (no qualifiers provided) 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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 15:15 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies: peanuts/ Fish" (unspecified if ongoing); "allergies: penicillin" (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. The following information was reported: VACCINATION FAILURE (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 vaccination failure, Covid-19 with Paxlovid from 29Nov2023 to 04Dec2023.  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: Gait inability
Clinical narrative: After receiving the Pfizer Civic booster. I could not walk; 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 received bnt162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: GAIT INABILITY (disability) with onset 11Oct2021, outcome "unknown", described as "After receiving the Pfizer Civic booster. I could not walk". It was unknown if therapeutic measures were taken as a result of gait inability.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Rebound Covid/Drug ineffective; Rebound Covid/COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-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) at the age of 25 years 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; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION. The following information was reported: COVID-19 (medically significant) with onset Nov2023, outcome "unknown", described as "Rebound Covid/COVID-19"; DRUG INEFFECTIVE (medically significant) with onset Nov2023, outcome "unknown", described as "Rebound Covid/Drug ineffective". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 25Nov2023 to 30Nov2023.  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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 63-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 62 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 20Apr2021 as dose 2, single (Lot number: ER8729), in left arm, on 08Nov2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 26May2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheamatoid Arthritis" (unspecified if ongoing); "Atrial Septal Anurism" (unspecified if ongoing); "Iron Anemic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 22Jul2023 to 24Jul2023. Clinical course: The patient also received COMIRNATY (2023-2024 Formula) on 19Oct2023 at 01:00 PM as dose 1, single in left arm for covid-19 immunisation.
Age: 53.0
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 53-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Lot number: Hd9835) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "some liver compromise from past Hep B and Hep A" (unspecified if ongoing); "Genital herpes" (unspecified if ongoing); "some liver compromise from past Hep A" (unspecified if ongoing); "some liver compromise from past Hep B" (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. 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 with Paxlovid from 25Nov2023 to 30Nov2023. Clinical course: Patient had no known allergies.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 86 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Lot number: 025520A), in left arm, on 03Nov2021 as dose 3 (booster), single (Lot number: 939901), in left arm, on 08Apr2022 at 12:00 as dose 4 (booster), single (Lot number: 033k212A), in left arm and on 05Oct2023 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Type 2 Diabetic" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "known allergies: IV Dye Latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Nov2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Nov2023, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 30Nov2023 to 04Dec2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 at 14:30 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Vaccine administration time: 14:00, Anatomical Location: Left arm), administration date: 16Sep2022, for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), MANUFACTURER UNKNOWN), 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 "recovered" (Dec2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: After testing negative twice; Negative, notes: After testing negative twice. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 29Nov2023 to 02Dec2023.  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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid rebound after Paxlovid, 5 days post end of treatment; Covid rebound after Paxlovid, 5 days post end of treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GJ3277), in left arm and on 18Jun2023 at 15:00 as dose 6 (booster), single (Lot number: GJ6743) at the age of 77 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Feb2021 at 15:45 as dose 1, single (Lot number: EL9264), in right arm, on 06Mar2021 at 13:00 as dose 2, single (Lot number: EN6199), in left arm, on 25Sep2021 at 14:00 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 30Mar2022 at 11:00 as dose 4 (booster), single (Lot number: FK9729), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Oct2023 at 13:00 as dose 7 (booster), single (Lot number: 3031283), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lisinopril Allergy" (unspecified if ongoing); "Type 2 DM" (unspecified if ongoing); "HTN/ Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "multiple joint replacements" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 01Dec2017; METOPROLOL, start date: 02Dec2015; VITAMIN D [VITAMIN D NOS], start date: 01Jan2000; PAROXETINE, start date: Jan1990; METFORMIN XR, start date: Jan2020; ROSUVASTATIN, start date: Jan2020, stop date: 05Dec2023; MELATONIN, start date: Jan2021. Past drug history included: Lisinopril, reaction(s): "increased my creatinine", notes: Lisinopril increased my creatinine, o/w no. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Covid rebound after Paxlovid, 5 days post end of treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 Paxlovid from 05Dec2023 to 10Dec2023.; 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 01Feb2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Fat" (unspecified if ongoing). Concomitant medication(s) included: RETIN A, start date: 01Jun2021, stop date: 10Dec2023. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 Paxlovid from 29Nov2023 to 03Dec2023. Clinical course: Patient had no known allergies. Patient was Fat for 5 years due to depression. Currently 47% back to healthy.  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, 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 51-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), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Bariatric surgery" (not ongoing); "known allergies: Penicillin" (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. 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 with Paxlovid from 28Nov2023 to 02Dec2023.  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, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-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: "type 1 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Nov2023, outcome "recovered" (08Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Nov2023) Positive; (08Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 01Dec2023 to 05Dec2023.  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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Haematemesis, Oesophageal rupture, SARS-CoV-2 test, Vertigo
Clinical narrative: esophagus had torn; Lost of hearing in one ear; vertigo spells that also made me so side that I was vomiting blood; vertigo spells that also made me so side that I was vomiting blood; 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), on 24Feb2021 as dose 1, single (Lot number: EN6202) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Allergy to sulfa antibiotics" (unspecified if ongoing); "Allergy to other antibiotics" (unspecified if ongoing); "Allergy to narcotic pain meds" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 03Mar2021, outcome "not recovered", described as "Lost of hearing in one ear"; OESOPHAGEAL RUPTURE (medically significant) with onset 03Mar2021, outcome "not recovered", described as "esophagus had torn"; HAEMATEMESIS (medically significant), VERTIGO (non-serious) all with onset 03Mar2021, outcome "not recovered" and all described as "vertigo spells that also made me so side that I was vomiting blood". The events "esophagus had torn", "lost of hearing in one ear" and "vertigo spells that also made me so side that i was vomiting blood" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of haematemesis. Clinical course: No other vaccine was reported in four weeks. Patient did not have covid prior vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300442968 Same patient, different vaccine doses/AE;
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-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)), on 16Oct2023 at 12:00 as dose 1, single (Lot number: HG2282) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma triggered by respiratory infections" (unspecified if ongoing); "Asthma triggered by respiratory infections" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Administration time: 12:00, Lot number=GJ6665,, Anatomical location=Left arm), administration date: 22Oct2022, when the patient was 52-year-old, for COVID-19 immunization; 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (08Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2023) Negative, notes: tested negative on the 08Dec. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 01Dec2023 to 06Dec2023. Clinical Course: Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.