chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; a dose of PNEUMOVAX 23 was administered after the labeled expiration date.; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 13-FEB-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, at a dose of 0.5 milliliter, product quantity: 1, lot #U021995, expiration date: 13-JAN-2023 (route of administration and anatomical location were not provided), administered for prophylaxis (expired product administered).  No additional adverse event was reported.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Cervix disorder, Smear cervix abnormal
Clinical narrative: abnormal pap smear with 1 "lesion"; abnormal pap smear with 1 "lesion"; This spontaneous report was received from a nurse via company representative concerning a 28-year-old non-pregnant female patient. The patient's medical history, concurrent conditions, and concomitant medication were not provided.   On 13-DEC-2007, she was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) administered via intramuscular, for prevention of Human papillomavirus (HPV) (dose, injection anatomical location, lot # and expiration date were not reported).   On unspecified dates, the patient was vaccinated with the second and third doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) administered via intramuscular, for prevention of HPV (dose, injection anatomical location, lot # and expiration date were not reported).  On approximately 06-FEB-2023 (reported as "a week ago"), the patient had an abnormal Papanicolaou smear (Smear cervix abnormal) with one lesion found (Cervix disorder) and was scheduled for a loop electrosurgical excision procedure (LEEP). It was unknown if treatment was given for the events. The outcome of the events was reported as not recovered.   The causal relationship between the events and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reports PROQUAD that experienced temperature excursion over the weekend was administered to a patient; This spontaneous report has been received from a registered nurse regarding patient of unknown age and gender. Patient's pertinent medical history, drug reactions and allergies and concomitant medication were unknown by reporter.  On 13-FEB-2023, the patient was vaccinated with an improper storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (albumin status rHA), subcutaneous injection, administered as prophylaxis, (strength, dose, route of administration, anatomical location; lot number W024547 had been verified to be valid; expiration date was reported and established as 31-JAN-2024) (product storage error).  The excursion occurred with a temperature of -10 °C up to 8 °C (-9.91 C) for 1 hour and 40 minutes and 0 seconds. There was no previous temperature excursion reported. No additional adverse event provided (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs; patient has received 4 GARDASIL 9 vaccines; 2 of those vaccines were administered subcutaneous. (3rd dose); 3rd dose was administered only 2 months after 2nd dose; 2 of those vaccines were administered subcutaneous. (1st dose); This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies was not reported.  On 10-JUN-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered subcutaneously (dose, lot #, and expiry date were not provided) (incorrect route of product administration) for prophylaxis.   On 12-JUL-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, lot #, and expiry date and route of administration were not provided) administered for prophylaxis.   On 14-SEP-2022, the patient received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered subcutaneously (dose, lot #, and expiry date were not provided) (incorrect route of product administration) for prophylaxis. It was also noted that the 3rd dose was administered only 2 months after 2nd dose (inappropriate schedule of product administration). When the patient was asked about how he/she had known the injections were subcutaneous, the patient stated "One was too low and the other was too high."  Additionally, on 17-JAN-2023, the patient received a fourth dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (dose, lot #, and expiry date and route of administration were not provided) administered for prophylaxis (extra dose administered).   No additional adverse event was reported.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: patient passed out in the elevator after receiving his first dose of GARDASIL 9.; This spontaneous report was received from a pharmacy technician referring to her grandchild, a 12-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient received his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route of administration, and anatomical location were not provided), administered for prophylaxis.   On an unknown date, after receiving the vaccine, the patient passed out in the elevator (Loss of consciousness). It was unknown if he completed the series. At the time of reporting, the patient recovered from the event.  The causal relationship between the event of loss of consciousness and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   Upon internal review, the event of loss of consciousness was determined to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA007319:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired GARDASIL 9 on 02/23/2023; This spontaneous report was received from a healthcare business professional referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 23-FEB-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #T026323, expiration date: 22-FEB-2023, (strength, dose, route, vaccination schedule and anatomical location were not provided) for prophylaxis (Expired product administered). No temperature excursions were reported. No additional adverse event (AE) was reported.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AEs; Expired Sterile Diluent was administered on 1/30/2023; Expired Sterile Diluent was administered on 1/30/2023; This spontaneous report has been received from a pharmacist, concerning a 25-year-old female patient.  The patient's medical history, concurrent conditions, concomitant therapies, and historical drugs were not reported.  On 30-JAN-2023, the patient received an expired sterile diluent (MERCK STERILE DILUENT) (lot number T014588 was verified to be valid for sterile diluent [MERCK STERILE DILUENT], expiration date reported and confirmed as 25-NOV-2022) (Expired product administered), and also received measles, mumps, and rubella virus vaccine live (M-M-R II) (not expired and stored properly) (doses and routes of administration were not provided) (Product preparation error).  No additional adverse events (AEs) were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA008360:
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jan-2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 08-Feb-2021, patient received first dose Moderna COVID-19 Vaccine (lot number 066F21A). On 08-Mar-2021, patient received second dose of Moderna COVID-19 Vaccine (lot number unknown).Patient reports no adverse events to Moderna vaccines. The patient reports that patient had a positive experience to all her Moderna vaccines.  No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of Thyroid cancer" (unspecified if ongoing), notes: Other medical history: History of Thyroid cancer. Concomitant medication(s) included: LEVOTHYROXINE, start date: 27Feb2015; ESCITALOPRAM, start date: 15Jun2017. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline", notes: Known allergies: Doxycycline & Erythromycin; Erythromycin, reaction(s): "Known allergies: Doxycycline & Erythromycin", notes: Known allergies: Doxycycline & Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 06Feb2023 to 11Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70-year-old male patient received BNT162b2 (BNT162B2 NOS), on 02Jan2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment; positive, notes: began testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Feb2023 to 17Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: M
Vaccine: COVID19-2
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) from product quality group. The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Nov2022 at 15:30 as dose 4 (booster), single (Lot number: GJ6738) at the age of 35 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2021 at 13:30 as dose 1, single (Lot number: ER8737), in left arm, on 29Apr2021 at 13:30 as dose 2, single (Lot number: ER8736), in left arm and on 17Dec2021 at 13:30 as dose 3 (booster), single (Lot number: FE3594), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLPIDEM TARTRATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pneumonia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus anticoagulant (w/o lupus)" (unspecified if ongoing); "Lupus anticoagulant (w/o lupus)" (unspecified if ongoing). There were no concomitant medications within 2 weeks. Past drug history included: Benadryl, reaction(s): "Known allergies: Benadryl". The following information was reported: DRUG INEFFECTIVE (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: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 14Feb2023 to 18Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300080882 Same patient, different product and event;
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. From 13Feb2023 to 16Feb2023, the patient received Paxlovid as treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Dyspnoea, Pulmonary mass, Rash, SARS-CoV-2 test
Clinical narrative: lung nodule formed; Immediately after the second shot, I started experiencing shortness of breath; very bad rash; asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jul2021 as dose 2, single (Lot number: ew0185) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "known allergies penicillin" (unspecified if ongoing), notes: known allergies penicillin; "cholesterol" (unspecified if ongoing); "if covid prior vaccination Yes" (unspecified if ongoing), notes: if covid prior vaccination Yes. Concomitant medication(s) included: ARMOUR THYROID taken for thyroid disorder; ATORVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0169, Location of injection: Arm Left), administration date: May2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "Immediately after the second shot, I started experiencing shortness of breath"; ASTHMA (non-serious) with onset Aug2021, outcome "not recovered"; PULMONARY MASS (medically significant) with onset Aug2021, outcome "not recovered", described as "lung nodule formed"; RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "very bad rash". The events "lung nodule formed", "immediately after the second shot, i started experiencing shortness of breath", "very bad rash" and "asthma" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of pulmonary mass, dyspnoea, rash, asthma.  Clinical course: Immediately after the second shot, she started experiencing shortness of breath, asthma, lung nodule formed and very bad rash. Patient scheduled for surgery to have the nodule removed. For AE treatment she have been seeing a lung specialist. No other vaccine in four weeks. Other medications in two weeks thyroid (armour), cholesterol (atorvastatin). Covid prior vaccination and covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300082818 Same reporter, patient/ different event;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: lung nodule formed; Immediately after the second shot, I started experiencing shortness of breath; very bad rash; asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jul2021 as dose 2, single (Lot number: ew0185) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "known allergies penicillin" (unspecified if ongoing), notes: known allergies penicillin; "cholesterol" (unspecified if ongoing); "if covid prior vaccination Yes" (unspecified if ongoing), notes: if covid prior vaccination Yes. Concomitant medication(s) included: ARMOUR THYROID taken for thyroid disorder; ATORVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0169, Location of injection: Arm Left), administration date: May2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "Immediately after the second shot, I started experiencing shortness of breath"; ASTHMA (non-serious) with onset Aug2021, outcome "not recovered"; PULMONARY MASS (medically significant) with onset Aug2021, outcome "not recovered", described as "lung nodule formed"; RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "very bad rash". The events "lung nodule formed", "immediately after the second shot, i started experiencing shortness of breath", "very bad rash" and "asthma" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of pulmonary mass, dyspnoea, rash, asthma.  Clinical course: Immediately after the second shot, she started experiencing shortness of breath, asthma, lung nodule formed and very bad rash. Patient scheduled for surgery to have the nodule removed. For AE treatment she have been seeing a lung specialist. No other vaccine in four weeks. Other medications in two weeks thyroid (armour), cholesterol (atorvastatin). Covid prior vaccination and covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300082818 Same reporter, patient/ different event;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Dyspnoea, Pulmonary mass, Rash, SARS-CoV-2 test
Clinical narrative: lack of drug effect; lack of drug effect; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Lot number: ew0169), in left arm and in Jul2021 as dose 2, single (Lot number: ew0185) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "Name of Drug as Reported: penicillin/Reaction: Allergy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, patient was diagnosed with COVID-19.; "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for thyroid disorder; ATORVASTATIN taken for blood cholesterol abnormal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "lack of drug effect". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (Dec2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300082806 Same reporter, patient/ different dose;US-PFIZER INC-202300082806 Same reporter, patient/ different dose;US-PFIZER INC-202300081016 Same reporter, patient/ different event;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: lack of drug effect; lack of drug effect; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Lot number: ew0169), in left arm and in Jul2021 as dose 2, single (Lot number: ew0185) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "Name of Drug as Reported: penicillin/Reaction: Allergy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, patient was diagnosed with COVID-19.; "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for thyroid disorder; ATORVASTATIN taken for blood cholesterol abnormal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "lack of drug effect". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (Dec2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300082806 Same reporter, patient/ different dose;US-PFIZER INC-202300082806 Same reporter, patient/ different dose;US-PFIZER INC-202300081016 Same reporter, patient/ different event;
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (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 Feb2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Feb2023) Negative, notes: Tested negative for two days; (Feb2023) Negative, notes: Tested negative for two days; (Feb2023) Positive, notes: Re-infected 4 days after completion of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with paxlovid, started on 14Feb2023 and stopped on 19Feb2023. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Lot number: Fj1611) at the age of 26 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Feb2023, outcome "not recovered", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Feb2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Feb2023) negative, notes: 7 days later tested negative for covid; (Feb2023) positive, notes: Then tested positive for covid again one day later. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Feb2023 to 16Feb2023.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19; Covid 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 43 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (22Feb2023) positive, notes: Tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 14Feb2023 to 18Feb2023.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jul2021 at 12:00 as dose 1, single (Lot number: EW0191), in left arm, on 14Dec2021 at 12:00 as dose 2, single (Lot number: 33130BA), in left arm and on 16Jul2022 at 12:00 as dose 3 (booster), single (Lot number: FJ4991) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "occasional high blood pressure" (unspecified if ongoing), notes: Takes Olmesartan Medoximil 10 mg PRN. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (Lot number: GG0133) from 20Feb2023 to an unknown date in Feb2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300081211 Same patient, different product and event;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose Number: 1, 2, 3 ; Pfizer/BioNTech, Dose Number: 4, 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27May2022 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Mar2021 as dose 1, single (Lot number: 047A21A), in left arm, on 16Apr2021 as dose 2, single (Lot number: 036B21A), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: 045C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27May2022, described as "Moderna, Dose Number: 1, 2, 3 ; Pfizer/BioNTech, Dose Number: 4, 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Postive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid. Outcome of the events was unknown.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 59.0
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) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 as dose 5 (booster), single (Lot number: 6J6742) at the age of 59 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 13Mar2021 as dose 2, single (Lot number: EN6208), in right arm, on 15Dec2021 as dose 3 (booster), single (Lot number: FJ8762), in right arm and on 27Jun2022 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation. The patient had no relevant medical history and had no known allergies. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (treatment start date: 14Feb2023, treatment stop date: 18Feb2023, lot number: 69-0345-30).
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Vestibular migraine" (unspecified if ongoing). Concomitant medication(s) included: TOPIRAMATE; BUDESONIDE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3(BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 22Dec2022, outcome "unknown", described as "loud banging tinnitus". Therapeutic measures were not taken as a result of tinnitus. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination; Since the vaccination, patient not been tested for COVID-19. List medications the patient received within 2 weeks of vaccination was topiramate, budesonide nasal Spray not aware of any known allergies. No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ASD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medications in 2 weeks.Patient received Covid-19 treatment from 15Feb2023 to 20Feb2023.Patient did not had known allergies.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (unspecified if ongoing); "asthma" (unspecified if ongoing); "retinal (CRVO)" (unspecified if ongoing); "known allergies: mussels" (unspecified if ongoing), notes: known allergies: mussels. The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "known allergies: high doses of Ibuprofen", notes: known allergies: high doses of Ibuprofen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Postive, notes: Treatment of COVID-19; (Feb2023) Postive, notes: positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 treated with paxlovid started on 07Feb2023 and stopped on 12Feb2023.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 as dose number unknown, single (Lot number: GJ6665) at the age of 77 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 05May2022 as dose number unknown, single (Lot number: FK9895) for covid-19 immunisation. The patient's relevant medical history included: "Supraventricular tachycardia" (unspecified if ongoing), notes: Other medical history: Supraventricular tachycardia; "Knwn allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, including Paxlovid.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Biaxin, reaction(s): "Known allergies: Biaxin", notes: Known allergies: Biaxin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received treatment of Paxlovid started on 16Feb2023 and stopped on 20Feb2023.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, covid-19 and the use of suspect product cannot be fully excluded.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codine, reaction(s): "Known allergies: Codine". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Feb2023 to 21Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the causality of the events drug ineffective and covid-19 with the suspect can not be ruled out completely.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 06Apr2021 as dose 2, single (Lot number: EP7534), in left arm and on 09Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Known allergies: Nickel (metal)" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: Apr2021, stop date: Feb2023; OMEPRAZOLE, start date: Apr2021, stop date: Feb2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 14Feb2023 to 18Feb2023.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: FM9992) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Feb2023) Negative, notes: After completing 5 days of paxlovid I tested positive for Covid 19 after 4 days of being negative; (18Feb2023) Negative, notes: After completing 5 days of paxlovid I tested positive for Covid 19 after 4 days of being negative; (19Feb2023) Negative, notes: After completing 5 days of paxlovid I tested positive for Covid 19 after 4 days of being negative; (20Feb2023) Negative, notes: After completing 5 days of paxlovid I tested positive for Covid 19 after 4 days of being negative; (21Feb2023) Positive, notes: After completing 5 days of paxlovid I tested positive for Covid 19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Feb2023 to 17Feb2023.  Clinical course: It was reported that the patient had no known allergies.