chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired vaccine of Boostrix administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7zd7l, expiry date 09-DEC-2023) for prophylaxis.   On 16-JAN-2024, the patient received the 1st dose of Boostrix. On 16-JAN-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: expired vaccine of Boostrix administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 16-JAN-2024 The intern reported that, an expired dose of Boostrix vaccine given to a patient, which led to an expired vaccine used. The reporter did not provide details for adverse event (AE) and stated that they would ask supervisor for permission and would call back. The reporter did not consent to follow-up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Dec2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sulfur, reaction: "Known allergies: sulfur"; Cipro, reaction: "Known allergies: cipro". Vaccination history included: COVID-19 vaccine (Dose number unknown, Batch/Lot No: Unknown, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 26Jul2023, when the patient was 63-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with nirmatrelvir, ritonavir (PAXLOVID) from 05Jan2024 to 10Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  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) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "type 2 diabetic" (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), outcome "recovered" (Jan2024) 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; (Jan2024) Negative, notes: Tested negative two days after Paxlovid was done. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 01Jan2024 to 05Jan2024. Clinical course: Patient had no known allergy, vaccine administration time was 5:30 PM.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 49-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "heart palpitations" (unspecified if ongoing); "allergies: sulfa" (unspecified if ongoing); "allergies" (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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid from 31Dec2023 to 04Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Nurse.  A 32-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer / biontech (DOSE 1, SINGLE, vaccine administration time: 02:00 PM, vaccine location: Left arm), administration date: 30Dec2020, when the patient was 29-year-old, for Covid-19 immunization; pfizer / biontech (DOSE 2, SINGLE, vaccine administration time: 02:00 PM, vaccine location: Left arm,), administration date: 20Jan2021, when the patient was 29-year-old, for Covid-19 immunization; pfizer / biontech (DOSE 3 (BOOSTER), SINGLE, vaccine administration time: 01:00 PM, vaccine location: Left arm,), administration date: 08Aug2021, when the patient was 29-year-old, for Covid-19 immunization; pfizer / biontech (DOSE 4 (BOOSTER), SINGLE, vaccine administration time: 12:00 PM, vaccine location: Left arm,), administration date: 22Mar2022, when the patient was 30-year-old, for Covid-19 immunization; pfizer / biontech (DOSE 5 (BOOSTER), SINGLE, vaccine administration time: 11:30 AM, vaccine location: Left arm), administration date: 28Oct2022, when the patient was 31-year-old, for covid-19 immunization; pfizer / biontech (DOSE 6 (BOOSTER), SINGLE, vaccine administration time: 03:00 PM, vaccine location: Left arm), administration date: 08Jun2023, when the patient was 31-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 06Jan2024 to 11Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Vaccination Failure and COVID 19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202400015401 Same patient/same product, different dose/event;
Age: 63.0
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 Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Lot number: HG4628) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: having skin reaction of itching/arms are itching every other day; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 22Aug2021 as dose 2, single (Lot number: FC3181) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "A-Fib" (ongoing). Concomitant medication(s) included: ELIQUIS oral taken for atrial fibrillation (ongoing); VERAPAMIL oral taken for atrial fibrillation (ongoing). Vaccination history included: BNT162b2 (DOSE 1, lot number: FA6780), administration date: 01Aug2021, when the patient was 73-year-old, for Covid-19 immunisation. The following information was reported: PRURITUS (non-serious), outcome "not recovered", described as "having skin reaction of itching/arms are itching every other day". Therapeutic measures were taken as a result of pruritus.  Additional information: The reporter was calling about Pfizer original shot, the Covid shot. He mentioned that both him and his wife received the Covid shot. He has had no reaction. However, his wife has been having skin reaction of itching. Her arms were itching every other day. The patient received both the second and first shot in. There were no issues after the first shot, but it was after the second shot. The patient received the second shot on 22Aug2021, and it was after then that the patient started to experience the event. It was usually sometime after a shower, and it happened every other day. Usually, it was a couple times a week. The patient was trying not to scratch. The patient confirmed that she knew it was not the soaps or anything because she has not changed the soap or anything. Treatment included putting cream, anti-itching cream that they can get over the counter and was still miserable. The event did not require a visit to an emergency room or physician office.
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 Consumer or other non HCP.  A 78-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single, in left arm for covid-19 immunisation. The patient's relevant medical history included: "peripheral neuropathy" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2024) Positive, notes: initial 04Jan2024 Covid; (12Jan2024) negative, notes: being negative; (13Jan2024) Positive, notes: Rebound Covid Took a test twice; (13Jan2024) Positive, notes: Rebound Covid Took a test twice. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events vaccination failure and Covid-19 are  related to BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)) cannot be excluded.  This case will be reassessed should additional information become available.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: heart arrhythmia; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not 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: ARRHYTHMIA (medically significant), outcome "unknown", described as "heart arrhythmia". The patient reported he got ahold to a doctor who indicated several people have reported heart arrhythmia.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Dec2023 at 10:30 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: "Exercise-induced asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "CKD 3" (unspecified if ongoing); "hx pneumonia" (unspecified if ongoing); "seasonal environmental allergies" (unspecified if ongoing); "seasonal environmental allergies" (unspecified if ongoing); "known allergies: Some nuts and fruits" (unspecified if ongoing); "known allergies: Some nuts and fruits" (unspecified if ongoing); "known allergies: lobster" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 07Jan2024 to 11Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccine failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 80.0
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 Consumer or other non HCP.  An 81-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1 (toppac), single (Lot number: HG4680) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild-mod kidney disease" (unspecified if ongoing), notes: mild-mod; "PAD" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing), notes: known allergies: Gluten; "known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "known allergies: doxycycline"; Tramadol, reaction(s): "known allergies: tramadol". Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Dose 7 (booster), single, Lot No: Pfizer GH-9702, in the right arm), administration date: 11May2023, when the patient was 80-year-old, for COVID-19 immunization; 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; Covid-19 vaccine (Dose 6 (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13Jan2024) Negative, notes: Negative Covid tests until Jan 13. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Age: 63.0
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 Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (batch/lot number: unknown) at the age of 63 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). Concomitant medications included: LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE], stop date: 26Dec2023; PREVACID, stop date: 26Dec2023; CIALIS, stop date: 26Dec2023. Vaccination history included: Covid-19 vaccine (dose 5 (booster), single, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (dose 4 (booster), single, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (dose 3 (booster), single, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (dose 2, single, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (dose 1, single, unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, 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 27Dec2023 to 01Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 52.0
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 Consumer or other non HCP.  A 52-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 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (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 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: the patient was treated with Paxlovid on 31Dec2023 to 04Jan2024 for Covid-19.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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 Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Blood culture, COVID-19, Drug ineffective, Nucleic acid test
Clinical narrative: contracted COVID-19; contracted COVID-19; This is a literature report for the following literature source(s):   A 45-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 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) for covid-19 immunisation. The patient's relevant medical history included: "HLA-B27-negative spondyloarthropathy" (unspecified if ongoing); "former smoker" (unspecified if ongoing); "eczema" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing), notes: replacing the prior diagnosis of ankylosing spondylitis; "gout" (unspecified if ongoing); "chronic abdominal bloating" (unspecified if ongoing); "inflammatory nature of his rash" (unspecified if ongoing); "COVID-19 infection", start date: 2021 (unspecified if ongoing); "GPP after COVID-19 infection" (unspecified if ongoing). The patient's family history included: "ankylosing spondylitis" (unspecified if ongoing), notes: in his brother and father. Concomitant medication(s) included: ADALIMUMAB taken for spondyloarthropathy; VITAMIN C [ASCORBIC ACID] taken for abdominal distension; VITAMIN D3 taken for abdominal distension; OMEPRAZOLE taken for abdominal distension; RIFAXIMIN taken for abdominal distension; CLOBETASOL topical taken for rash; PREDNISONE taken for gout, psoriatic arthropathy, pustular psoriasis; METHOTREXATE. Past drug history included: Doxycycline for pruritus, reaction(s): "no improvement", notes: 7-day course of 100 mg doxycycline twice daily for suspected infection with no improvement; Calcipotriene, reaction(s): "lack of response", notes: ointment, quickly discontinued due to lack of response; Clindamycin, reaction(s): "lack of response", notes: 1% lotion, quickly discontinued due to lack of response. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "contracted COVID-19". The patient underwent the following laboratory tests and procedures: Biopsy skin: revealed florid subcorneal aggregates of, notes: neutrophils; Blood culture: negative; Nucleic acid test: negative, notes: for gonorrhoea and chlamydia; exam: there were multiple areas of pustular, notes: lesions focally coalescing into larger plaques with involvement of the bilateral hands (left greater than right sided) and fingers. Pustular lesions were also scattered on the groin, bilateral shins, back, arms and left dorsal foot.  No follow-up attempts are possible.; 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, based on the limited information currently available.,Linked Report(s) : US-PFIZER INC-PV202400003785 Same article/drug/patient and different event.;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Physical examination
Clinical narrative: contracted COVID-19; contracted COVID-19; This is a literature report for the following literature source(s):   A 45-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 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) for covid-19 immunisation. The patient's relevant medical history included: "HLA-B27-negative spondyloarthropathy" (unspecified if ongoing); "former smoker" (unspecified if ongoing); "eczema" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing), notes: replacing the prior diagnosis of ankylosing spondylitis; "gout" (unspecified if ongoing); "chronic abdominal bloating" (unspecified if ongoing); "inflammatory nature of his rash" (unspecified if ongoing); "COVID-19 infection", start date: 2021 (unspecified if ongoing); "GPP after COVID-19 infection" (unspecified if ongoing). The patient's family history included: "ankylosing spondylitis" (unspecified if ongoing), notes: in his brother and father. Concomitant medication(s) included: ADALIMUMAB taken for spondyloarthropathy; VITAMIN C [ASCORBIC ACID] taken for abdominal distension; VITAMIN D3 taken for abdominal distension; OMEPRAZOLE taken for abdominal distension; RIFAXIMIN taken for abdominal distension; CLOBETASOL topical taken for rash; PREDNISONE taken for gout, psoriatic arthropathy, pustular psoriasis; METHOTREXATE. Past drug history included: Doxycycline for pruritus, reaction(s): "no improvement", notes: 7-day course of 100 mg doxycycline twice daily for suspected infection with no improvement; Calcipotriene, reaction(s): "lack of response", notes: ointment, quickly discontinued due to lack of response; Clindamycin, reaction(s): "lack of response", notes: 1% lotion, quickly discontinued due to lack of response. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "contracted COVID-19". The patient underwent the following laboratory tests and procedures: Biopsy skin: revealed florid subcorneal aggregates of, notes: neutrophils; Blood culture: negative; Nucleic acid test: negative, notes: for gonorrhoea and chlamydia; exam: there were multiple areas of pustular, notes: lesions focally coalescing into larger plaques with involvement of the bilateral hands (left greater than right sided) and fingers. Pustular lesions were also scattered on the groin, bilateral shins, back, arms and left dorsal foot.  No follow-up attempts are possible.; 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, based on the limited information currently available.,Linked Report(s) : US-PFIZER INC-PV202400003785 Same article/drug/patient and different event.;
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Paxlovid for COVID 19 Treatment; Paxlovid for COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing); "Allergies: Boxen" (unspecified if ongoing); "Mental illness" (unspecified if ongoing); "reactive hypoglycemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergies: aspirin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid for COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid". Clinical course: Caller stated she took the Moderna vaccine on Sunday and got sick with it. She had aching bones, congestion and coughing and she couldn't sleep. She tested positive for covid. The 4 previous covid vaccines she had were Pfizer vaccines and she had no problem with them but she knows people did get really sick after taking them. She was prescribed Paxlovid and wanted to know if taking Paxlovid would prevent the Moderna vaccine from working. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Pruritus, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 5 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid". Clinical course: Caller stated she took the Moderna vaccine on Sunday and got sick with it. She had aching bones, congestion and coughing and she couldn't sleep. She tested positive for covid. The 4 previous covid vaccines she had were Pfizer vaccines and she had no problem with them but she knows people did get really sick after taking them. She was prescribed Paxlovid and wanted to know if taking Paxlovid would prevent the Moderna vaccine from working. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Itching; Patient got sick, sore arm, terrible body aches, congestion, could not sleep, no appetite; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got sick, sore arm, terrible body aches, congestion, could not sleep, no appetite) and PRURITUS (Itching) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057413) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE in October 2023 and Pfizer vaccine (4 Pfizer COVID-19 vaccine); for Drug use for unknown indication: Glyburide. Past adverse reactions to the above products included No adverse event with Glyburide, INFLUENZA VACCINE and Pfizer vaccine. Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN for Diabetes, INSULIN for Itching and Diabetes.    On 14-Jan-2024, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 15-Jan-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (Patient got sick, sore arm, terrible body aches, congestion, could not sleep, no appetite). On 16-Jan-2024, the patient experienced PRURITUS (Itching). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in January 2024 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient got sick, sore arm, terrible body aches, congestion, could not sleep, no appetite) had not resolved and PRURITUS (Itching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2024, SARS-CoV-2 test: Positive.         This case was linked to US-MODERNATX, INC.-MOD-2024-757191 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757191:Same Reporter other patient
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Pruritus, SARS-CoV-2 test
Clinical narrative: Itching; Patient got sick, sore arm, terrible body aches, congestion, could not sleep, no appetite; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got sick, sore arm, terrible body aches, congestion, could not sleep, no appetite) and PRURITUS (Itching) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057413) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE in October 2023 and Pfizer vaccine (4 Pfizer COVID-19 vaccine); for Drug use for unknown indication: Glyburide. Past adverse reactions to the above products included No adverse event with Glyburide, INFLUENZA VACCINE and Pfizer vaccine. Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN for Diabetes, INSULIN for Itching and Diabetes.    On 14-Jan-2024, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 15-Jan-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (Patient got sick, sore arm, terrible body aches, congestion, could not sleep, no appetite). On 16-Jan-2024, the patient experienced PRURITUS (Itching). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in January 2024 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient got sick, sore arm, terrible body aches, congestion, could not sleep, no appetite) had not resolved and PRURITUS (Itching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2024, SARS-CoV-2 test: Positive.         This case was linked to US-MODERNATX, INC.-MOD-2024-757191 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-757191:Same Reporter other patient
Age: 32.0
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 Consumer or other non HCP.  A 32-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 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, 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 12Jan2024 to an unknown date. Clinical course: Reporter reported that he/she could not confirm the manufacturer name of vaccine but to his/her knowledge she had a mix of both Pfizer and moderna.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid rebound and she is vaccinated/ she was administered the vaccine Covid with a lot number.; covid rebound and she is vaccinated/ she was administered the vaccine Covid with a lot number.; This is a spontaneous report received from a Consumer or other non HCP from medical information team and product quality group, Program ID.  A female 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid rebound and she is vaccinated/ she was administered the vaccine Covid with a lot number.". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid as treatment.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: she got sick and she was tested positive; she got sick and she was tested positive; she got sick and she was tested positive; This is a spontaneous report received from a Nurse, Program ID.  A female 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), ILLNESS (non-serious), outcome "unknown" and all described as "she got sick and she was tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Sex: U
Vaccine: RSV
Symptoms: Drug ineffective, Respiratory syncytial virus infection
Clinical narrative: Il 36 hours later I started to get all the symptoms of RSV; Il 36 hours later I started to get all the symptoms of RSV; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 08Jan2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (medically significant) all with onset 09Jan2024, outcome "unknown" and all described as "Il 36 hours later I started to get all the symptoms of RSV".  Clinical course: On 08Jan2024 (reported as Monday early afternoon), the patient received RSV vaccine. On 09Jan2024 (reported as "36 hours later"), the patient started to get all the symptoms of RSV but mild. The patient stated, "Coincidence? I don't think so".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient is reported to have taken all the Pfizer Vaccines. Currently has COVID.; Patient is reported to have taken all the Pfizer Vaccines. Currently has COVID.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 62-year-old female 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 NUMBER UNKNOWN, SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient is reported to have taken all the Pfizer Vaccines. Currently has COVID.". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Since he received Covid vaccince he has no sense of smell; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A male patient received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Batch/Lot number: unknown), on 20Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 03Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious), outcome "unknown", described as "Since he received Covid vaccince he has no sense of smell". Additional information: the caller mentioned that he got two Covid vaccines on 29Dec2020, another one on 20Jan2021 and 03Sep2021. Since he received Covid vaccine, he has no sense of smell.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400006224 Same reporter/drug/event; different patient;US-PFIZER INC-PV202400006346 Same reporter/drug/event; different patient;
Sex: F
Vaccine: COVID19
Symptoms: Glaucoma
Clinical narrative: she had eye surgery for glaucoma; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 85-year-old female patient received BNT162b2 (BNT162B2), 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: GLAUCOMA (medically significant), outcome "unknown", described as "she had eye surgery for glaucoma". Clinical course: During the pandemic and agent is not sure if it was before or after (agent thinks it may have been after) the first dose of the COVID vaccine but she mentioned she had eye surgery (trabeculectomy) for glaucoma.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300328820 same reporter/patient,different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Malaise
Clinical narrative: Severe nausea/vomiting preventing daily activity or required intravenous hydration outside of hospital; Severe nausea/vomiting preventing daily activity or required intravenous hydration outside of hospital; Moderate injection site pain interfering with activity/Significant injection site tenderness (tenderness during rest); Severe fatigue with significant interference with activity; Severe muscle pain significantly interfering with activity; Moderate injection site redness; Moderate injection site swelling; Moderate fever (101.3 to 102 degree F); Moderate malaise/feeling sick present with some interference with activity; Joint pain with some interference with activity; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not 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: HEADACHE (non-serious) with onset 03Jan2024, outcome "unknown", described as "Headache that interfered with activity OR required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset 03Jan2024, outcome "unknown", described as "Joint pain with some interference with activity"; PYREXIA (non-serious) with onset 03Jan2024, outcome "unknown", described as "Moderate fever (101.3 to 102 degree F)"; VACCINATION SITE PAIN (medically significant) with onset 03Jan2024, outcome "unknown", described as "Moderate injection site pain interfering with activity/Significant injection site tenderness (tenderness during rest)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 03Jan2024, outcome "unknown", described as "Moderate injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 03Jan2024, outcome "unknown", described as "Moderate injection site swelling"; MALAISE (non-serious) with onset 03Jan2024, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity"; FATIGUE (medically significant) with onset 03Jan2024, outcome "unknown", described as "Severe fatigue with significant interference with activity"; MYALGIA (medically significant) with onset 03Jan2024, outcome "unknown", described as "Severe muscle pain significantly interfering with activity"; NAUSEA (medically significant), VOMITING (medically significant) all with onset 03Jan2024, outcome "unknown" and all described as "Severe nausea/vomiting preventing daily activity or required intravenous hydration outside of hospital". The patient underwent the following laboratory tests and procedures: Body temperature: Moderate fever (101.3 to 102 °F).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.