chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Product lot number issue; Patient does not report signs/symptoms of adverse effects.; HCP called to report TE regarding GARDASIL 9. GARDASIL 9 was administered after the TE (TE case 02448226); This spontaneous report was received from a pharmacy technician and refers to a 12-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-JUL-2023, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection administered intramuscularly for prophylaxis (strength not provided) (Product storage error). Reporter reported quadrivalent human GARDASIL with lot #W009829 which was not valid for GARDASIL. However, lot #W009829 was valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Product lot number issue), expiration date: 19-OCT-2024. Patient did not report signs/symptoms of adverse effects (No adverse event).
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, PNC15
Symptoms: Febrile convulsion
Clinical narrative: FBE calling to report an AE on behalf of a HCP, who is also a relative of the patient. Per FBE, HCP's granddaughter received Hepatitis A (the clinic that she goes to only has VAQTA), MMR-II and VAXNEUVANCE and experienced febrile seizure an; Information has been received via Company Representative from a Nurse who is also the patient's grandmother referred to her granddaughter, a 14-months-old female patient. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA), (strength, dose, dose number, route, anatomical location, lot number, and expiration date were not reported), for prophylaxis. On an unknown date, the patient was also vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), (strength, dose, dose number, route, anatomical location, lot number, and expiration date were not reported), for prophylaxis. On an unknown date, the patient was also vaccinated with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE), (strength, dose, dose number, route, anatomical location, lot number, and expiration date were not reported), for prophylaxis.  On 29-AUG-2023, the patient experienced febrile seizure (febrile convulsion), and the patient look for medical attention and was observed in the hospital for one day (hospitalization). On an unknown date in August 2023, the patient recovered from the febrile convulsion.  The reporter did not assess the causal relationship between the suspect vaccines and febrile convulsion.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the second dose given early on 29Aug2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 56-year-old female patient who received HAV (Havrix) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 29-AUG-2023, the patient received the 2nd dose of Havrix. On 29-AUG-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: the second dose given early on 29Aug2023).  The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-AUG-2023 The reporter was a practice manager. The patient was given her second dose yesterday (day before reporting). The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received the 2nd dose of Havrix before recommended schedule, which led to shortening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never came back for the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never came back for the second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 31-AUG-2023 The pharmacist called to inquire that should the patient start the Shingrix series over? or get the second dose? The Registered Pharmacist (RPH) reported that a patient never came back for the second dose and asked how to proceed? The health care professional (HCP) declined follow-up from safety.     Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myeloid leukaemia, Investigation
Clinical narrative: Diagnosed with Acute Myloid Leukemia on 06May2022. Blood work in Nov2021 was normal. AML symptoms started in Mar2022.; 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), on 02Dec2021 as dose 3 (booster), 0.3 ml single (Lot number: FH8927) at the age of 60 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML SINGLE; Lot Number: EW0153, Vaccine location: Right arm), administration date: 16Apr2021, when the patient was 59-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, 0.3 ML SINGLE; Lot Number: EW0173, Vaccine location: Right arm), administration date: 07May2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: ACUTE MYELOID LEUKAEMIA (hospitalization, medically significant, life threatening) with onset 01Mar2022, outcome "recovered with sequelae", described as "Diagnosed with Acute Myloid Leukemia on 06May2022. Blood work in Nov2021 was normal. AML symptoms started in Mar2022.". The patient was hospitalized for acute myeloid leukaemia (hospitalization duration: 30 day(s)). The patient underwent the following laboratory tests and procedures: Blood work: (Nov2021) Normal, notes: Blood work in Nov2021 was normal. Therapeutic measures were taken as a result of acute myeloid leukaemia.  Clinical course: Patient had no other vaccine in four weeks. No covid prior vaccination and covid not tested post vaccination. Patient had no known allergies. Facility type vaccine administered was Other. Diagnosed with Acute Myloid Leukemia on 06May2022. AML symptoms started in Mar2022, Treatment with Chemotherapy.
Age: 62.0
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 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose number unknown (booster), single (Lot number: GJ6738) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "high bp" (unspecified if ongoing); "Known allergies: Sulfa" (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 Aug2023, 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 drug ineffective, covid-19 including Paxlovid from 22Aug2023 to 26Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291372 Same reporter/ drug/ event for different patients.;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN6210), in right arm, on 03Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: FE3592), in right arm and on 03May2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "prostate cancer" (unspecified if ongoing); "prostate cancer radiation", start date: 2020 (unspecified if ongoing). Concomitant medications included: TADALAFIL, start date: 03Jan2022; ROSUVASTATIN, start date: 01Jul2020, stop date: 20Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 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: "Hashimotos" (unspecified if ongoing); "Known allergies: YES" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: 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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2 (bivalent), 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) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 23Aug2023 to 27Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Physician). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2023) Negative; (29Aug2023) Positive. Therapeutic measures were taken as a result of Treatment of COVID-19 included Paxlovid from 22Aug2023 to 26Aug2023. The patient experienced negative COVID test on day 4 of Paxlovid and then had rebound COVID positive test.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1/Dose 2/Dose 3: Moderna; Dose 4: Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 59 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Feb2021 as dose 1, single (Lot number: 0421L20A), in left arm, on 08Mar2021 as dose 2, single (Lot number: 0291A211A), on 22Oct2021 as dose 3 (booster), single (Lot number: 039021A), in left arm and on 04Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer 7 years ago" (unspecified if ongoing); "Surgery" (unspecified if ongoing), notes: Surgery, radiation, but no chemo; "radiation" (unspecified if ongoing), notes: Surgery, radiation, but no chemo. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Apr2022, outcome "unknown", described as "Dose 1/Dose 2/Dose 3: Moderna; Dose 4: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" 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. The patient received treatment included Paxlovid from 22Aug2023 to 23Aug2023.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 54 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: EW0150), on 01May2021 as dose 2, single (Lot number: EW0171), on 14Nov2021 as dose 3 (booster), single (Lot number: FH9027) and on 03Mar2022 as dose 4 (booster), single (Lot number: FK9896) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. 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: Positive, notes: Treatment of COVID-19; Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing), notes: using a cpap for sleep apnea. The patient's concomitant medications were not reported. Past drug history included: Macrodantin, reaction(s): "Known allergies: macrodantin". 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 28Aug2023 to 31Aug2023.  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: 31.0
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 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 31 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: "Lupus" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Age: 27.0
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; also received Moderna booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 27 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Apr2021 as dose 1, single (Batch/Lot number: unknown), on 05May2021 as dose 2, single (Batch/Lot number: unknown) and on 05Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Oct2022, outcome "recovering", described as "also received Moderna booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The experienced rebound COVID, 5th day of Paxlovid was 28Aug2023, tested negative and had no symptoms on 01Sep2023, symptoms started again on 02Sep2023, tested positive on 03Sep2023.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28May2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: ER8729), in left arm, on 01May2021 as dose 2, single (Lot number: EW0167), in left arm and on 27Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "past history of breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 11Aug2023 to 16Aug2023.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 4 (booster), single (Lot number: GH9694), 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 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 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid, oral, from 31Aug2023 to 04Sep2023  for treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Sex: U
Vaccine: 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "tested positive for Covid". Clinical course: The patient had had 2 vaccines and 2 boosters. The last in Apr2023 and currently tested positive for Covid.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Developed reddened skin over deltoid about 2 inches down arm from vaccination site, starting the day after vaccination and remaining for about 3 days. Patch was painful and warm to the touch, and itchy as it resolved. Patch approximately oval w/ uneven boundarym and about 2 inches wide, 3 inches long.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 77.0
Sex: M
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Muscle spasms, Myalgia
Clinical narrative: Patient reported normal muscle pain in left arm after injection that felt like a "charlie horse". 2 days after injection (7/19/2023) muscle pain "moved to the shoulder". This is still ongoing today 9/6/2023. It is limiting patients range of motion still months later.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered vaccine for 18 year and above to a 16 year old male. Patient has not report any adverse reaction as of today.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine had been stored within EUA requirements which provides a 70 day stability; however, vaccine was administered on day 71.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given beyond use date, expiration date was incorrectly listed on the vaccine. BUD: 2/27/2023.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: pt has a large red warm swollen rash travelling down arm below injection site- pt also has felt feverish but not running a fever
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 74.0
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given an injectable Typhoid vaccine which was not needed as the patient had an oral Typhoid vaccine 5-1-2019 and this vaccine was still valid.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given beyond use date, incorrect BUD was listed on the vaccine. BUD: 2/27/2023. Patient did not present with any adverse reactions.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Inflammation, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Pain in legs starting 1 week after vaccination, multiple red rashes throughout body starting after 2 weeks. Rashes are red and inflamed and still ongoing. Patient reported 2 new rashes on forearm just over this past week. Patient saw primary care physician who told patient that reaction was related to MMR shot and that they should have pharmacy report the adverse affect
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given beyond use date, incorrect BUD listed on vaccine. BUD: 2/27/2023. No adverse events were reports by the patient.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Approximately 24 hours later patient started having rash on arms and chin line. Patient complained of generalized itching all over. Patient seen by provider and given medrol dose pak.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given beyond use date, incorrect BUD listed on the vaccine. BUD: 2/27/2023. No adverse events reported by the patient.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Arthralgia, Headache, Inflammation, Musculoskeletal stiffness
Clinical narrative: pt called in to report the adverse reaction to the vaccine. symptoms like fever headache, inflammation in hands, night sweats, joint pain, neck stiffness, rash on head and neck and stomach upset.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Night sweats, Pyrexia, Rash
Clinical narrative: pt called in to report the adverse reaction to the vaccine. symptoms like fever headache, inflammation in hands, night sweats, joint pain, neck stiffness, rash on head and neck and stomach upset.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling cold, Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Patient experienced tingling sensation in the fingers and hand immediately after receiving shot. Patient reported numbness in the arm and cold sensation in the hand.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: Dangerously elevated blood pressure p
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: Atrial Fibrillation
Age: 11.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Child mistakenly received both a MMR-V and a separate Varicella vaccine as vaccinator thought she was administering a MMR. Child monitored for 30 minutes post vaccination and remained asymptomatic.  Parents infrormed of error.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient explained that a few hours after the shot she started experiencing severe pain in her arm that made her go to the emergency room.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site mass, Injection site oedema, Injection site swelling, Loss of personal independence in daily activities, Pain
Clinical narrative: -Swelling, mass/lump -mild edema at injection site per ultrasound (05/25/23) -pain interfering with activities, referred to orthopedics and physical therapy.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Ultrasound scan abnormal
Clinical narrative: -Swelling, mass/lump -mild edema at injection site per ultrasound (05/25/23) -pain interfering with activities, referred to orthopedics and physical therapy.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Asthenia, Fatigue, Gait disturbance, Headache
Clinical narrative: Vaccine on Fri. By Sat. afternoon I was so tired I slept 14.5 hours. Sun. morning my muscles and joints were so stiff and sore I could not walk. Headache. No energy. Gradually improved over the next 8-10 days. Left ankle still very sore. Let elbow so tender I cannot even rest it on a pillow. I've had Covid, boosters, flu & other vaccines, but never had anything hit me the way this RSV vaccine did. Wow!  Q#17 asked for RSV (Abrysvo) or RSV (Arexvy). I don't know which this was, I just picked one.  Q#20 asks for "Yes/No" answer. It's not just yes/no--just very gradual.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Hypersomnia, Joint stiffness, Musculoskeletal stiffness, Myalgia, Tenderness
Clinical narrative: Vaccine on Fri. By Sat. afternoon I was so tired I slept 14.5 hours. Sun. morning my muscles and joints were so stiff and sore I could not walk. Headache. No energy. Gradually improved over the next 8-10 days. Left ankle still very sore. Let elbow so tender I cannot even rest it on a pillow. I've had Covid, boosters, flu & other vaccines, but never had anything hit me the way this RSV vaccine did. Wow!  Q#17 asked for RSV (Abrysvo) or RSV (Arexvy). I don't know which this was, I just picked one.  Q#20 asks for "Yes/No" answer. It's not just yes/no--just very gradual.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Teeth brittle, Tooth discolouration, Tooth extraction, Tooth fracture
Clinical narrative: Teeth were becoming brittle, yellow/brownish no matter how much I brushed. Was given a mouthwash by dentist, while stating I didn't brush my teeth enough (2007) left side had all molders removed. W/having others breaking while eating food
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Skin warm
Clinical narrative: L Deltoid with 2 x 2 cm red warm area - only very sl warm
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Injury associated with device, Laboratory test
Clinical narrative: After employee was finished giving the vaccine, she stuck herself with the needle in her lift index finger.
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered to patient on 09/05/2023. MMR vaccine was expired on 7/30/2023. Patient received vaccine on the right arm SQ. Patient and parents were made aware of expired vaccine was administered. Patient has a follow up appointment.
Age: 79.0
Sex: M
Vaccine: FLUA4
Symptoms: Cough, Dyspnoea, Flushing, Hyperhidrosis, Hypersensitivity
Clinical narrative: After the vaccine the patient 3 minutes after started coughing, became flushed, diaphoretic and had trouble breathing called 911 the paramedics were there immediately and took her to the ER in ambulance. The patient called later to say that they treated her for allergic reaction and she was ok.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Muscular weakness, Urinary incontinence, Vomiting
Clinical narrative: Patient reports they were treated in the Emergency Room for muscle weakness, loss of bladder control, chills and vomiting.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no adverse event; Improperly stored vaccines administered; This spontaneous report was received from other and refers to some patients. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 28-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, three dose series, lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   On 28-JUL-2023, 5 patients in total and additional patients were administered the affected hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from the lot involved in a temperature excursion at the same location (Product storage error). No adverse events reported (No adverse event).   This is a non-valid case due to no patient's identifiers.   Follow up information has been received from an other health professional on 09-AUG-2023 and refers to a 11-year-old male patient. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (lot # 213723, expiration date: 17-OCT-2025 via Right Deltoid) and meningococcal vaccine conj (lot # AMVA767A, expiration date: ??-JUN-2024 via Left Deltoid). The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via Left Deltoid.    This is one of several reports from same reporter. ; Sender's Comments:  US-009507513-2309USA000746: US-009507513-2309USA000745: US-009507513-2308USA001806: US-009507513-2309USA000744: US-009507513-2309USA000747: US-009507513-2309USA000748:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored vaccines administered; This spontaneous report was received from other and refers to some patients. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 28-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, three dose series, lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   On 28-JUL-2023, 5 patients in total and additional patients were administered the affected hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from the lot involved in a temperature excursion at the same location (Product storage error). No adverse events reported (No adverse event).   This is a non-valid case due to no patient's identifiers.   Follow up information has been received from an other health professional on 09-AUG-2023 and refers to a 11-year-old female patient. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (lot # 213723, expiration date: 17-OCT-2025 via Right Deltoid) and meningococcal vaccine conj (lot # AMVA767A, expiration date: ??-DEC-2023 via Left Deltoid). The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via Left Deltoid.    This is one of several reports from same reporter. ; Sender's Comments:  US-009507513-2309USA000746: US-009507513-2309USA000745: US-009507513-2308USA001806: US-009507513-2309USA000747: US-009507513-2309USA000743: US-009507513-2309USA000748:
Age: 11.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored vaccines administered; This spontaneous report was received from other and refers to some patients. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 28-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, three dose series, lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   On 28-JUL-2023, 5 patients in total and additional patients were administered the affected hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from the lot involved in a temperature excursion at the same location (Product storage error). No adverse events reported (No adverse event).   This is a non-valid case due to no patient's identifiers.   Follow up information has been received from an other health professional on 09-AUG-2023 and refers to a 11-year-old female patient. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (lot # 213723, expiration date: 17-OCT-2025 via Right Deltoid) and meningococcal vaccine conj (lot # AMVA767A, expiration date: ??-DEC-2023 via Left Deltoid). The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via Left Deltoid.    This is one of several reports from same reporter. ; Sender's Comments:  US-009507513-2309USA000747: US-009507513-2309USA000746: US-009507513-2308USA001806: US-009507513-2309USA000744: US-009507513-2309USA000743: US-009507513-2309USA000748:
Age: 17.0
Sex: F
Vaccine: HPV9, MEN, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored vaccines administered; This spontaneous report was received from other and refers to some patients. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 28-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, three dose series, lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   On 28-JUL-2023, 5 patients in total and additional patients were administered the affected hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from the lot involved in a temperature excursion at the same location (Product storage error). No adverse events reported (No adverse event).   This is a non-valid case due to no patient's identifiers.   Follow up information has been received from an other health professional on 09-AUG-2023 and refers to a 17-year-old female patient. Concomitant medications included meningococcal vaccine (lot # EN934, expiration date: 31-OCT-2024 via Left Deltoid) and meningococcal vaccine conj (lot # AMVA767A, expiration date: ??-DEC-2023 via Right Deltoid). The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via Left Deltoid.    This is one of several reports from same reporter. ; Sender's Comments:  US-009507513-2308USA001806: US-009507513-2309USA000747: US-009507513-2309USA000748: US-009507513-2309USA000743: US-009507513-2309USA000744: US-009507513-2309USA000745:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored vaccines administered; This spontaneous report was received from other and refers to some patients. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 28-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, three dose series, lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   On 28-JUL-2023, 5 patients in total and additional patients were administered the affected hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from the lot involved in a temperature excursion at the same location (Product storage error). No adverse events reported (No adverse event).   This is a non-valid case due to no patient's identifiers.   Follow up information has been received from an other health professional on 09-AUG-2023 and refers to a 11-year-old female patient. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (lot # 213723, expiration date: 17-OCT-2025 via Right Deltoid) and meningococcal vaccine conj (lot # AMVA767A, expiration date: ??-DEC-2023 via Left Deltoid). The date of the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was 02-AUG-2023 via Left Deltoid.     This is one of several reports from same reporter. ; Sender's Comments:  US-009507513-2308USA001806: US-009507513-2309USA000748: US-009507513-2309USA000743: US-009507513-2309USA000744: US-009507513-2309USA000745: US-009507513-2309USA000746:
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly stored vaccines administered; This spontaneous report was received from other and refers to some patients. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 28-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, three dose series, lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   On 28-JUL-2023, 5 patients in total and additional patients were administered the affected hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from the lot involved in a temperature excursion at the same location (Product storage error). No adverse events reported (No adverse event).   This is a non-valid case due to no patient's identifiers.   Follow up information has been received from an other health professional on 09-AUG-2023 and refers to a 14-year-old female patient. The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was 02-AUG-2023 via Left Deltoid.     This is one of several reports from same reporter. ; Sender's Comments:  US-009507513-2309USA000746: US-009507513-2309USA000747: US-009507513-2309USA000744: US-009507513-2309USA000743: US-009507513-2309USA000745: US-009507513-2308USA001806:
Age: 28.0
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) from product quality group. The reporter is the patient.  A 29-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 28 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8737), in left arm, on 18Apr2021 as dose 2, single (Lot number: ER8731), in left arm and on 14Dec2021 as dose 3 (booster), single (Lot number: FJ1620), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Smoking" (unspecified if ongoing); "known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: known allergies: Sulfa antibiotics. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Negative; (Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid for Covid-19 anti viral treatment from 20Aug2023 to 24Aug2023.