chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD).    No concomitant medications were provided.  Dosage text for suspect product was reported as unknown.  14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15 MAY 2023-10 JUN 2023. No reported symptoms at that time.  No treatment medication was provided.  This case contains information for the 10th out of 14 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD).    Concomitant medication was not provided. Dosage text was reported as unknown. It was reported that 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15MAY-10JUN2023. Treatment information was not reported. This case contains information about patient 14 out of 14.   This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023.) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023.).    Concomitant medication was not provided. Suspect product dosage text was reported as unknown. It was reported that 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023. Treatment information was not reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD).    No concomitant information was reported. Suspect product dosage text was reported as unknown. Doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15MAY-10JUN2023 No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD).    Concomitant medication was not provided. Dosage text was reported as unknown. It was reported that 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15MAY-10JUN2023. Treatment information was not reported. This case contains information about patient 12 out of 14.   This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023).    Concomitant medication was not provided. Suspect product dosage text was reported as unknown. It was reported that 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023. Treatment information was not reported.  This case contains information about patient 13th out of 14 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:Master case
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza like illness, Thrombosis
Clinical narrative: Blood clots; Felt like they had flu/ symptoms for long Covid but never had Covid; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (Blood clots) in a female patient of an unknown age 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. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Felt like they had flu/ symptoms for long Covid but never had Covid). At the time of the report, THROMBOSIS (Blood clots) and INFLUENZA LIKE ILLNESS (Felt like they had flu/ symptoms for long Covid but never had Covid) outcome was unknown.        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.   Concomitant medication was not provided. Patient reported that it's really awful, that none of the medical department will talk to those that had really bad permanent issues because of the booster shots. Patient underwent all kinds of tests and blood work and doctors determined that it's from shots. She had a feeling that many more other people had these issues. Treatment information was not reported. Company comment- This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the serious (medically significant) and unexpected AESI thrombosis. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, given as a booster dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. Patient reported that she is not the only one having issues from these shots. There are people who are experiencing the same she is. They have blood clots and feel like they have flu every day, or symptoms for long COVID but never had COVID. There are people who are having long term problems. The benefit-risk relationship of the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-705410 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2023: Follow-up received and added patient initials, gender, updated event verbatim and updated narrative. On 18-Jul-2023: Follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705410:Other people case
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abnormal behaviour, Alopecia
Clinical narrative: Behavioral differences; Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) and ABNORMAL BEHAVIOUR (Behavioral differences) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Feb-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 01-Feb-2023, the patient experienced ALOPECIA (Hair loss). On an unknown date, the patient experienced ABNORMAL BEHAVIOUR (Behavioral differences). At the time of the report, ALOPECIA (Hair loss) and ABNORMAL BEHAVIOUR (Behavioral differences) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter. It was unknown if the patient experienced any additional symptoms/events.  Treatment Medication use information was not provided by reporter.
Age: 24.0
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; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 17:15 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 24 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), in Apr2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022 at 17:15, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 14 days after testing negative for covid and the end of my paxlovid treatment; Positive, notes: I tested positive for covid. Paxlovid was taken as therapeutic measures 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300253550 Same patient, different drug, different event;
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: On the morning of this event i printed out the list of patient we would be seeing for the day. It tell me which vaccines the patient has or hasn't had yet. At the time of pt's appt, I misread the form and thought he was due for a flu shot. I was not aware until later that day that the flu shot I gave was expired and had been sitting out of the refridgerator for almost 24 hours. When I gave the shot to patient there was no immediate reaction.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Nasopharyngitis, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: My symptoms began with a sore throat. I took a home COVID-19 test and it was negative. I had cold symptoms. I continued to have symptoms and tested positive on June 18, 2023. I had runny nose, cough and mild congestion.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: My symptoms began with a sore throat. I took a home COVID-19 test and it was negative. I had cold symptoms. I continued to have symptoms and tested positive on June 18, 2023. I had runny nose, cough and mild congestion.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EFFECT, REPORTING AS PER PUBLIX PHARMACY PROTOCOL: VACCINATION GIVEN BEYOND USE DATE OF 07/13/2023
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT: JUST REPORTING AS PER PUBLIX PHARMACY QRE PROTOCOL : ADMINISTERED VACCINATION AFTER BEYOND USE DATE OF 07/19/2023
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT REPORTED BY PATIENT: REPORTING AS PER PHARMACY QRE PROTOCOL GUIDELINES  FOR VACCINATION ADMINISTERED AFTER BEYOND USE DATE OF 07/19/2023
Age: 50.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Diarrhoea, Malaise, Pyrexia
Clinical narrative: Fever, diarrhea, malaise
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Breast pain, Pain, Pain in extremity
Clinical narrative: Patient's arm was extremely sore the next day, and the pain radiated to her armpit & left breast the day after.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Axillary pain, Breast pain, Erythema, Pain
Clinical narrative: Patient's arm was extremely sore the next day, and the pain radiated to her armpit & left breast the day after.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Pharmacist (myself) reporting that Patient used a different last name and fancified personal information to get an extra dose of Moderna bivalent vaccine. could not find patient vaccination history on VAIRS so tried to look up with  just the first 2 letters of first name. Record found on VAIR verified patient identity and vaccine history. Patient had stated that she is in need of a second dose of covid vaccine and has no insurance and no id on her, where as this was actually her 6th dose.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No event; Improperly stored vaccines on unspecified dates; Information has been received from a nurse concerning a 2-months-old male patient. Patient's concomitant medications included hepatitis b vaccine, diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13). Patient's concurrent condition's and pertinent medical history were not provided.  On 20-JUN-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1968385 with expiration date 07-MAR-2024, for prophylaxis (strength, frequency, and dose were not reported) that underwent a temperature excursion (incorrect product storage). It was reported that the alarm believed to be due to sensory issues. Monitoring temperatures were in range again with new data logger in use. Vaccines were returned and waste was in progress.  No adverse effects were reported.  This is one of several cases from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects were reported.; HCP reports PROQUAD was expired and administered to patient. No side effects were reported.; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 19-JUN-2023, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection, as prophylaxis (lot number: U039957, which was determined to be valid, with an expiration date on 14-JUN-2023) (strength, dose, scheme, route and anatomical location of administration were not reported) (expired product administered).  No side effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse reported AE related to improperly stored and administered PROQUAD. No additional AE/no PQC.         ?    Names of vaccines involved (including lot/exp)--PROQUAD X002292 6/21/2024        ?    Temperature--6.93 F        ?    Time frame--1 H; This spontaneous report has been received form a health care professional (Licensed Practical Nurse (LPN)), referring to a patient of unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 12-JUL-2023, the patient was vaccinated with 1 dose of improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) injection, (strength, exact dose, frequency, route of administration, and anatomical injection site were not provided; lot # X002292 was verified to be a valid lot number with a reported and validated expiration date on 21-JUL-2024) for prophylaxis (product storage error).  Administered dose of vaccine experienced temperature excursion of 6.93 degrees Fahrenheit for 1 hour 30 minutes and 0 seconds. There were previous temperature excursions of 52.01 degrees Fahrenheit for 2 hours 6 minutes and 0 seconds and 9.74 degrees Fahrenheit for 4 hours 34 minutes and 0 seconds. No additional adverse event was reported.
Age: 0.08
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; Caller reported AE for inadvertent administration of VAXELIS and ROTATEQ after TE`; This spontaneous report has been received from a consumer referring to a 1-month-old patient of unknown gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On unspecified date rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS), experienced 2 temperature excursions, one at 65.2 F for 9 hours and 45 minutes and another one at 32.4 F for 42 hours and 45 minutes. On 01-MAY-2023, the patient was inadvertently vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot number: W020326, expiration date: 17-OCT-2023) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) (lot number: U7217AA, expiration date: 12-NOV-2024) via unspecified route for prophylaxis (strengths, exact doses and dose numbers, were not known) after the aforementioned temperature excursions (TE) (product storage error). No symptoms were reported. At the time, no additional adverse event (AE) or product quality complaint (PQC) was reported.
Age: 0.08
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP reported following excursion 65.2F for 9 Hours 45 Minutes; 32.4F for 42 Hours 45 Minutes; This spontaneous report was received from a health care professional (HCP) and refers to a 7-week-old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 01-MAY-2023, the patient was vaccinated with inappropriate storage rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W020326, (expiration date: 17-OCT-2023), administered orally; and  diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection (anatomical site injection and route of administration were not provided), lot #U7217AA, (expiration date: 12-NOV-2024), both vaccines administered for prophylaxis (strengths, doses were not provided) (product storage error) The HCP reported following temperature excursion 65.2 Fahrenheit for 9 hours 45 minutes; and 32.4F Fahrenheit for 42 hours 45 minutes for both vaccines. No adverse event was reported.  This is one of several reports  from the same reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; SARS-CoV-2 infection; 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 26Sep2022 as dose 5 (booster), single (Lot number: gh9693) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: Ep6955), in left arm, on 04Apr2021 as dose 2, single (Lot number: FH8030), in left arm, on 05Dec2021 as dose 3 (booster), single (Lot number: RA5285), in left arm and on 09May2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2023, outcome "not recovered", described as "COVID-19"; COVID-19 (medically significant) with onset Jul2023, outcome "not recovered", described as "SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (17Jul2023) Positive, notes: Rebound symptoms and positive test after Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Patient received treatment with paxlovid from 10Jul2023 to 14Jul2023.
Age: 58.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 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), 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: having tested negative the previous day; Positive, notes: tested positive 3.5 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Adverse event: I started having symptoms and tested positive 3.5 days after finishing Paxlovid. I tested positive (after having tested negative the previous day).  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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: She had covid once in Jan2023; She had covid once in Jan2023; Dose 1/Dose 2/ Dose 3: Moderna Covid-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: 6H9703) at the age of 68 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Jun2022 as dose 4 (booster), single (Lot number: FM7553) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Dec2020 as dose 1, single (Batch/Lot number: unknown), on 21Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Jun2022, outcome "unknown", described as "Dose 1/Dose 2/ Dose 3: Moderna Covid-19 Vaccine"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "She had covid once in Jan2023". Clinical course: She had COVID once in Jan2023. Had no symptoms and was able to continue working. Felt a little tired maybe, but had no symptoms. Vaccination Facility Type: Pharmacy, Prior Vaccinations (within 4 weeks): None. Family Medical History Relevant to Adverse Events (AEs): None and relevant Tests: None.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300254758 Same patient, different event/dose;
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Afib that occurred 3 days after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: MAGNESIUM GLYCINATE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 15Dec2022, outcome "recovered", described as "Afib that occurred 3 days after vaccination". The event "afib that occurred 3 days after vaccination" required physician office visit. Therapeutic measures were not taken as a result of atrial fibrillation. Clinical course: It was unknown if Other vaccine received in four weeks, COVID tested post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: 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 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Mar2023 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (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 Jul2023, outcome "recovered" (Jul2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Jul2023) Negative, notes: tested negative after the 5-day Paxlovid treatment. Therapeutic measures: Paxlovid was administered to the patient as a treatment from 08Jul2023 to 13Jul2023 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300255011 same patient, different drug/event;
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Pfizer / BioNTech May2022/ Moderna Bivalent Sep2022; Pfizer / BioNTech May2022/ Moderna Bivalent Sep2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), OFF LABEL USE (medically significant) all with onset May2022, outcome "unknown" and all described as "Pfizer / BioNTech May2022/ Moderna Bivalent Sep2022"; 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.  Clinical course: Extreme sore throat and eventual sores/ulcers in back/top of throat. (May be Paxlovid, may be covid) Night sweats. (May be Paxlovid, may be covid) No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chronic kidney disease
Clinical narrative: CKD symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 30-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 immunisation. The following information was reported: CHRONIC KIDNEY DISEASE (medically significant), outcome "unknown", described as "CKD symptoms". Clinical course: the patient suspected that CKD symptoms started after vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
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 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (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 08Jul2023, outcome "not recovered" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2023) Positive; (09Jul2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was treated with Paxlovid from 08Jul2023 to 13Jul2023. 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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm
Clinical narrative: aortic aneurysm; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2021 as dose 3 (booster), single (Lot number: EL0182) at the age of 63 years intramuscular, in left arm for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1st, Anatomical Site of injection: Right Arm, Route of administration: Intramuscular, Batch/Lot number: Lot# EL8982), administration date: 12Jan2021, when the patient was 63-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2nd, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: Lot# EL9269), administration date: 03Feb2021, when the patient was 63-year-old, for COVID-19 Immunization. The following information was reported: AORTIC ANEURYSM (medically significant) with onset 21Jun2022, outcome "recovered" (22Aug2022). Therapeutic measures were taken as a result of aortic aneurysm. Additional information: the patient underwent surgical repair for the event of aortic aneurysm. The patient provided information to the reporter regarding the reported adverse event(s) with the use of the product. The reporter considered the Pfizer product had a causal effect to the adverse event.; Sender's Comments: Based on the known the information available the Causal relation between the event AORTIC ANEURYSM and suspect drug cannot be excluded completely The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis
Clinical narrative: Pfizer COVID vaccine caused her husband to get ALS; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 55-year-old male 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 and concomitant medications were not reported. The following information was reported: AMYOTROPHIC LATERAL SCLEROSIS (medically significant, life threatening), outcome "unknown", described as "Pfizer COVID vaccine caused her husband to get ALS". Clinical course: A lady stopped reporter in the parking lot and told reporter the Pfizer COVID vaccine caused her husband to get ALS. He was 55 and near death.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: his wife tested positive for Covid-19 last night and she was vaccinated.; his wife tested positive for Covid-19 last night and she was vaccinated.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jul2023, outcome "unknown" and all described as "his wife tested positive for Covid-19 last night and she was vaccinated.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2023) Positive, notes: wife tested positive for Covid-19 last night. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Reporter was asking about the extended expiration date of their Paxlovid that shows May2023 expiration date. Caller also asked if the medication was still good since it's still July. Reporter mentioned that his wife tested positive for Covid-19 last night and she was vaccinated.   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: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired quadracel on 07/06/2023 was administered to a patient with no reported adverse event; Initial information received on 18-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 years old male patient who was administered expired diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] on 07/06/2023 was administered to a patient with no reported adverse event.  The patient's past vaccination(s) included Pentacel and Vaxelis. The patient's past medical history, medical treatment(s) and family history were not provided.  On 14-Jul-2023, the patient received 0.5 mL dose 1 of suspect diphtheria-15/ tetanus/ 5 hybrid AC pertussis/ IPV (MRC5) vaccine, Suspension for injection (batch number: C5916AA; Expiry date: 06-Jul-2023) via intramuscular route in unknown administration site no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired quadracel on 07/06/2023 was administered to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA220975:01695556