chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
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 non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing). 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19; Negative, notes: for Covid on last day of treatment, but rebounded; Positive, notes: 4 days later with infectious symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, 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). The reporter is the patient. A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Apr2022 as dose 4 (booster), single (Lot number: GH9694), in left arm and on 18Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 67 years, in left arm for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "high cholesterol" (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 2023, outcome "recovered" (2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative. Therapeutic measures were taken as a result of drug ineffective and COVID-19. Clinical information: It was reported that the patient had received PAXLOVID as treatment of COVID-19 (noted in 2023) from 20Mar2023 until 24Mar2023. The patient then had negative test after treatment in 2023.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Investigation, Oxygen saturation, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Apr2022 as dose 4 (booster), single (Lot number: GH9694), in left arm and on 18Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 67 years, in left arm for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "high cholesterol" (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 2023, outcome "recovered" (2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative. Therapeutic measures were taken as a result of drug ineffective and COVID-19. Clinical information: It was reported that the patient had received PAXLOVID as treatment of COVID-19 (noted in 2023) from 20Mar2023 until 24Mar2023. The patient then had negative test after treatment in 2023.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Lot number: GJ6665) 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: "hypothyroidism" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; SARS-CoV-2 test: Positive, notes: positive test days after feeling better; negative, notes: Increase in Covid symptoms and positive test days after feeling better and testing nearly negative. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Apr2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Suicidal ideation
Clinical narrative: 3rd shot made me and my father almost commit suicide; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete, Manufacturer Unknown), for COVID-19 IMMUNISATION. The following information was reported: SUICIDAL IDEATION (medically significant), outcome "unknown", described as "3rd shot made me and my father almost commit suicide". Clinical course: The reporter and his father (patient) went to the hospital because reporter honestly wanted to die to the fact that Pfizer truly made a big disaster. Getting the Pfizer 3d shot made the reporter and his father almost committed suicide.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product to the development of event SUICIDAL IDEATION cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis following mRNA vaccination; This is a literature report for the following literature source(s): "One year follow up for case series of myocarditis following mRNA vaccination against SARS-CoV-2.".  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis following mRNA vaccination".; Sender's Comments: Considering a plausible drug-event temporal association and/or known drug safety profile, a reasonable possibility that the event myocarditis is related to BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN) cannot be excluded.  This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202300140924 Same article/ drug/event and different patient;US-PFIZER INC-202300140925 Same article/ drug/event and different patient;US-PFIZER INC-202300140926 Same article/ drug/event and different patient;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke".  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: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID today; tested positive for COVID today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Apr2023, outcome "unknown" and all described as "tested positive for COVID today". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99, notes: 99; SARS-CoV-2 test: (02Apr2023) Positive, notes: tested positive for COVID today 02Apr2023. The patient was fully vaccinated with Pfizer COVID-19 vaccine according to the schedule (received the vaccine shortly after it was announced for patient age group) and tested positive for COVID on 02Apr2023. The patient had a mild temperature (99), headache, cough, sore throat and feeling generally unwell.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: relative died; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: DEATH (death, medically significant), outcome "fatal", described as "relative died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: The reporter mentioned her 2 relatives died when they took the vaccine and her husband became sickly when he took the vaccine too.  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-202300141645 same reporter/vaccine/event, different patients;; Reported Cause(s) of Death: relative died
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He got COVID after getting the booster; He got COVID after getting the booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (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 "He got COVID after getting the booster". Clinical course: During a call, the patient mentioned that he got COVID after getting the booster, but he did not mention if the booster was from Pfizer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic to Covid-19 shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:   A male patient received BNT162b2 (BNT162B2 NOS), 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic to Covid-19 shots". Additional information: A consumer was calling because she has been dating an older gentleman who is allergic to COVID-19 shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: MEN
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: was accidently given a dose of MedQuadfi with no reported adverse event; Initial information received on 30-Mar-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and gender patient and reporter reported that meningococcal A-C-Y-W135 (T CONJ) vaccine [menquadfi] dose was given to patient accidently with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (lot 49281, expiry date: 23-Sep-2024) via unknown route and strength and in unknown administration site for prophylactic vaccination (immunization).  On an unknown date, patient was accidently given a dose of medquadfi with no reported adverse event (extra dose administered) (latency: same day).  It was also reported that patient had 2 Mentara was accidently given a does of MedQuadfi. 1st 9-9 Any bad advice effect of this Happening ? 9-9-2015 and 2nd was 12-7-2021.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for an 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Sex: U
Vaccine: DTAP
Symptoms: No adverse event
Clinical narrative: DAPTACEL experienced a temperature excursion which was not covered by the extended stability data, and DAPTACEL was administered after the excursion occurred with no reported adverse event; DAPTACEL experienced a temperature excursion which was not covered by the extended stability data, and DAPTACEL was administered after the excursion occurred with no reported adverse event; Initial information received on 31-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] experienced a temperature excursion which was not covered by the extended stability data, and daptacel was administered after the excursion occurred with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection (strength, lot number and expiry date: not reported) via unknown route in unknown administration site for immunization experienced a temperature excursion which was not covered by the extended stability data, and  was administered after the excursion occurred with no reported adverse event (product storage error) (latency: unknown) (poor quality product administered) (latency: same day).  It was reported as Suspected power glitch Max/low temperature reached: Max temperature was 6.8C; low temperature was negative 0.1C Human error? No Does extended stability data cover the excursion? No If negative advice, was the product administered to a patient? Yes.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Pruritus
Clinical narrative: Fatigue and itchy legs
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; improperly stored VARIVAX were administered to patients.; This spontaneous report was received from a registered nurse and refers to patients of unknown age and gender. The patients' medical history, concurrent conditions abd concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W021740 with expiration date: 10-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided). Temperature and time frame were unknown. There was previous temperature excursion (-9.8 degree celsius for 8 hours and 38 minutes) (product storage error).  This is a non-valid case due to no exact patient number and no patients' identifiers.  Follow-up information has been received from a registered Nurse on 30-MAR-2023.  Report refers to a 13 month 21 days old female patient. Patient demographics updated. Concomitant medications included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), pneumococcal vaccine conj 13v (PREVENAR 13) 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).   On 20-MAR-2023, varicella virus vaccine live (oka/merck) (VARIVAX) was administered via subcutaneous on right thigh and on 21-MAR-2023 it was found on the look back data logger monitoring that the defrost on the freezer (the temperature was getting too warm) out of range of manufacturer storage recommendations. No complications, no reactions, no complaints.   The outcome of the event was reported as recovering.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA011232: US-009507513-2303USA011231: US-009507513-2303USA011230: US-009507513-2303USA011233:
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored VARIVAX were administered to patients.; No additional AE reported; This spontaneous report was received from a registered nurse and referring to a 4 year and 5-month-old male patient. The patients' medical history was not reported. Concomitant medications included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX). Current condition included allergic rhinitis.    On 10-MAR-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W021740 with expiration date: 10-JUL-2024, administered subcutaneously on right thigh for prophylaxis (strength, and route of administration were not provided).   On 21-MAR-2023, it was found on the look back data logger monitoring that the defrost on the freezer has been getting too warm, out of range temp noted to be out of manufacturer storage recommendations. No complications, no reactions, no complaints Temperature and time frame were unknown. There was previous temperature excursion (-9.8 degree celsius for 8 hours and 38 minutes) (product storage error).  The outcome of the event was reported as recovering.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA007314:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; improperly stored VARIVAX were administered to patients.; This spontaneous report was received from a registered nurse and referring to a 1 year-old female patient. The patients' medical history was not reported. Concomitant medications included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Hepatitis A Vaccine, Inactivated and pneumococcal vaccine conj 13v (PREVENAR 13).   On 27-FEB-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W021740 with expiration date: 10-JUL-2024, administered subcutaneously on left thigh for prophylaxis (strength, and route of administration were not provided).   On 21-MAR-2023, it was found on the look back data logger monitoring that the defrost on the freezer has been getting too warm, out of range temp noted to be out of manufacturer storage recommendations. Temperature and time frame were unknown. There was previous temperature excursion (-9.8 degree celsius for 8 hours and 38 minutes) (product storage error). No complications, no reactions, no complaints. No adverse event.  The outcome of the event was reported as recovering.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2303USA007314:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; improperly stored VARIVAX were administered to patients.; \This spontaneous report was received from a registered nurse and referring to a 12 months 22 days old male patient. The patients' medical history and current conditios were not reported. Concomitant medications included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), Hepatitis A Vaccine, Inactivated (VAQTA) and pneumococcal vaccine conj 13v (PREVENAR 13).   On 13-MAR-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W021740 with expiration date: 10-JUL-2024, administered subcutaneously on right thigh for prophylaxis (strength, and route of administration were not provided).   On 21-MAR-2023, it was found on the look back data logger monitoring that the defrost on the freezer has been getting too warm, out of range temp noted to be out of manufacturer storage recommendations. Temperature and time frame were unknown. There was previous temperature excursion (-9.8 degree celsius for 8 hours and 38 minutes) (product storage error). No complications, no reactions, no complaints. No adverse event.  The outcome of the event was reported as recovering.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2303USA007314:
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; improperly stored VARIVAX were administered to patients.; This spontaneous report was received from a registered nurse and referring to a 13 months 14 days old male patient. The patients' medical history and current conditions were not reported. Concomitant medications included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), Hepatitis A Vaccine, Inactivated (VAQTA) and pneumococcal vaccine conj 13v (PREVENAR 13).   On 02-MAR-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W021740 with expiration date: 10-JUL-2024, administered subcutaneously on right thigh for prophylaxis (strength, and route of administration were not provided).   On 21-MAR-2023, it was found on the look back data logger monitoring that the defrost on the freezer has been getting too warm, out of range temp noted to be out of manufacturer storage recommendations. Temperature and time frame were unknown. There was previous temperature excursion (-9.8 degree celsius for 8 hours and 38 minutes) (product storage error). No complications, no reactions, no complaints. No adverse event.  The outcome of the event was reported as recovering.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2303USA007314:
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (Fever) 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)) for COVID-19 prophylaxis.     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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.            No concomitant medications were reported. It was reported that patient had fever after receiving the Moderna vaccine and had to stay in bed for 3 days to recover; it eventually resolved on its own. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-718094 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718094:Husband case
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Syncope
Clinical narrative: Patient had headache that started right after the vaccination was given; Patient felt dizziness; Within 24 hours of receiving the Moderna Covid-19 booster dose the patient fainted.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SYNCOPE (Within 24 hours of receiving the Moderna Covid-19 booster dose the patient fainted.) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 043L20A and 025J20-2A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, the patient experienced HEADACHE (Patient had headache that started right after the vaccination was given) and DIZZINESS (Patient felt dizziness). In October 2021, the patient experienced SYNCOPE (Within 24 hours of receiving the Moderna Covid-19 booster dose the patient fainted.) (seriousness criterion medically significant). The patient was treated with Physical therapy for Dizziness. In June 2022, HEADACHE (Patient had headache that started right after the vaccination was given) had resolved. At the time of the report, SYNCOPE (Within 24 hours of receiving the Moderna Covid-19 booster dose the patient fainted.) and DIZZINESS (Patient felt dizziness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient did not had adverse reactions after Dose 1 and dose 2. Patient received medication for the headache.; Reporter's Comments: Company comment: This spontaneous case concerns an 82-year-old female patient with no reported medical history who experienced the unexpected serious (medically significant) event of Syncope which occurred within 24 hours of receiving a dose of mRNA-1273 vaccine received as booster dose in COVID 19 vaccination series. Event was ongoing at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling, Nasopharyngitis
Clinical narrative: Pt states he woke up around 9pm and arm was swollen on the injection area. Pt states he started to experience some cold like symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Malaise, Nasal congestion, No adverse event
Clinical narrative: I did not have an adverse reaction to the vaccine. I began not feeling well on 02/19/2023 with nasal congestion. I tested positive for COVID-19 on 02/20/2023. I did not go to the doctor, and I isolated.  I used all natural products to help with my symptoms and Tylenol for the headache and fever. I did see my ENT after recovering from COVID-19 to check my vocal cords. As of today, I have a lot of congestion due to the pollen.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the vaccine. I began not feeling well on 02/19/2023 with nasal congestion. I tested positive for COVID-19 on 02/20/2023. I did not go to the doctor, and I isolated.  I used all natural products to help with my symptoms and Tylenol for the headache and fever. I did see my ENT after recovering from COVID-19 to check my vocal cords. As of today, I have a lot of congestion due to the pollen.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID ON 3/17/2023 AFTER DEVELOPING SEVERE HEADACHE ON 3/16/2023.  CONTACTED PCP WHO PRESCRIBED PAXLOVID.  RETURNED TO WORK FULLY MASKED ON DAY 6.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Dysphagia, Neck pain, Oropharyngeal pain, Platelet count decreased
Clinical narrative: 3/29/23 I noticed difficulty swallowing and a pain in my neck and throat. I was seen yesterday in the Emergency Room because I am having more trouble swallowing. I have pain in neck and tightness in my throat.  I had an ultra sound  on 4/4/23 and nodules on my thyroid were found. I have a follow up, uncertain of date.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat tightness, Thyroid mass, Ultrasound thyroid abnormal
Clinical narrative: 3/29/23 I noticed difficulty swallowing and a pain in my neck and throat. I was seen yesterday in the Emergency Room because I am having more trouble swallowing. I have pain in neck and tightness in my throat.  I had an ultra sound  on 4/4/23 and nodules on my thyroid were found. I have a follow up, uncertain of date.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Decreased appetite, Dizziness, Fatigue
Clinical narrative: I felt "wonky", like a little out of body, I just knew something was wrong. On the 24th I definitely felt there was something wrong.Then I developed a fever, and ached all over. By Friday night I passed out, I was so exhausted. My husband had to try to get me in to bed, then I slept for 14 hours which was very unusual. The next morning I was really sick. 102 fever, extreme body ache, congestion, dry cough, thirsty. Sunlight bothered me, light headed, no appetite, and just extremely thirsty. I took an at-home COVID19 test and called Doctor's office, they prescribed Paxlovid. I ran a fever for almost five days and it was always highest in the morning, which I found very strange. Wednesday the fever started to drop into the low 100s, and by Friday I didn't have a fever but my doctor recommended that I stay home for the full 10 days. I did take the Paxlovid, everything tasted like metal. It made me dizzy and I had absolutely no appetite. I lost 15 lbs. Two weeks later im still congested and have a sore throat.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Hypersomnia, Loss of consciousness, Malaise, Oropharyngeal pain
Clinical narrative: I felt "wonky", like a little out of body, I just knew something was wrong. On the 24th I definitely felt there was something wrong.Then I developed a fever, and ached all over. By Friday night I passed out, I was so exhausted. My husband had to try to get me in to bed, then I slept for 14 hours which was very unusual. The next morning I was really sick. 102 fever, extreme body ache, congestion, dry cough, thirsty. Sunlight bothered me, light headed, no appetite, and just extremely thirsty. I took an at-home COVID19 test and called Doctor's office, they prescribed Paxlovid. I ran a fever for almost five days and it was always highest in the morning, which I found very strange. Wednesday the fever started to drop into the low 100s, and by Friday I didn't have a fever but my doctor recommended that I stay home for the full 10 days. I did take the Paxlovid, everything tasted like metal. It made me dizzy and I had absolutely no appetite. I lost 15 lbs. Two weeks later im still congested and have a sore throat.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Photophobia, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I felt "wonky", like a little out of body, I just knew something was wrong. On the 24th I definitely felt there was something wrong.Then I developed a fever, and ached all over. By Friday night I passed out, I was so exhausted. My husband had to try to get me in to bed, then I slept for 14 hours which was very unusual. The next morning I was really sick. 102 fever, extreme body ache, congestion, dry cough, thirsty. Sunlight bothered me, light headed, no appetite, and just extremely thirsty. I took an at-home COVID19 test and called Doctor's office, they prescribed Paxlovid. I ran a fever for almost five days and it was always highest in the morning, which I found very strange. Wednesday the fever started to drop into the low 100s, and by Friday I didn't have a fever but my doctor recommended that I stay home for the full 10 days. I did take the Paxlovid, everything tasted like metal. It made me dizzy and I had absolutely no appetite. I lost 15 lbs. Two weeks later im still congested and have a sore throat.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Thirst, Weight decreased
Clinical narrative: I felt "wonky", like a little out of body, I just knew something was wrong. On the 24th I definitely felt there was something wrong.Then I developed a fever, and ached all over. By Friday night I passed out, I was so exhausted. My husband had to try to get me in to bed, then I slept for 14 hours which was very unusual. The next morning I was really sick. 102 fever, extreme body ache, congestion, dry cough, thirsty. Sunlight bothered me, light headed, no appetite, and just extremely thirsty. I took an at-home COVID19 test and called Doctor's office, they prescribed Paxlovid. I ran a fever for almost five days and it was always highest in the morning, which I found very strange. Wednesday the fever started to drop into the low 100s, and by Friday I didn't have a fever but my doctor recommended that I stay home for the full 10 days. I did take the Paxlovid, everything tasted like metal. It made me dizzy and I had absolutely no appetite. I lost 15 lbs. Two weeks later im still congested and have a sore throat.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site mass, Injection site pain, Limb mass, Pain in extremity
Clinical narrative: Husband noticed 2 inch in diameter lump right of injection site on R upper arm. Visible, possible knot in muscle. Does not hurt unless pushed on, then aches with sensation down to R hand, 4th and 5th fingers sometimes into elbow. Lump still on R arm as of today.  Went to different location for 2nd injection given by the Health Dept. A retired family physician and ED doctor were administering. They both looked at it and we all agreed we would have the 2nd injection administered in the opposite arm, L deltoid.  Seen PCP on 5/28/21, referred to dermatologist. Seen by dermatologist on 6/18/21. Ultrasound completed on 6/25/21. Have been taking Ibuprofen PRN. I realized I had never submitted this when I completed it and felt I should, as the lump is still there as of 4/5/23. If touched, it still creates a numbness to the 4th and 5th digits. I feel this is important to share and would appreciate knowing if this has occurred with others and what their outcomes were. I had spoke with our epidemiologist and neurologist regarding it.  The ultrasound showed a thick mass.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Husband noticed 2 inch in diameter lump right of injection site on R upper arm. Visible, possible knot in muscle. Does not hurt unless pushed on, then aches with sensation down to R hand, 4th and 5th fingers sometimes into elbow. Lump still on R arm as of today.  Went to different location for 2nd injection given by the Health Dept. A retired family physician and ED doctor were administering. They both looked at it and we all agreed we would have the 2nd injection administered in the opposite arm, L deltoid.  Seen PCP on 5/28/21, referred to dermatologist. Seen by dermatologist on 6/18/21. Ultrasound completed on 6/25/21. Have been taking Ibuprofen PRN. I realized I had never submitted this when I completed it and felt I should, as the lump is still there as of 4/5/23. If touched, it still creates a numbness to the 4th and 5th digits. I feel this is important to share and would appreciate knowing if this has occurred with others and what their outcomes were. I had spoke with our epidemiologist and neurologist regarding it.  The ultrasound showed a thick mass.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLUX, COVID19, COVID19
Symptoms: COVID-19, Cough, Fatigue, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: No adverse reaction in September after the vaccine, until I got COVID, with no fever, only cough, congestion, fatigue, runny nose. I have the home test for COVID-19, and it was Positive. I called the doctor on Monday March 27th, and he prescribed Paxlovid, I took it for 5 days, 2 doses per day. Last Sunday I tested Negative, following the CDC giddiness, I waited 48 hours, when I tested it was Positive on April 4th. I don't feel good now with congestion and running nose
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLUX, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: No adverse reaction in September after the vaccine, until I got COVID, with no fever, only cough, congestion, fatigue, runny nose. I have the home test for COVID-19, and it was Positive. I called the doctor on Monday March 27th, and he prescribed Paxlovid, I took it for 5 days, 2 doses per day. Last Sunday I tested Negative, following the CDC giddiness, I waited 48 hours, when I tested it was Positive on April 4th. I don't feel good now with congestion and running nose
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLUX, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: No adverse reaction in September after the vaccine, until I got COVID, with no fever, only cough, congestion, fatigue, runny nose. I have the home test for COVID-19, and it was Positive. I called the doctor on Monday March 27th, and he prescribed Paxlovid, I took it for 5 days, 2 doses per day. Last Sunday I tested Negative, following the CDC giddiness, I waited 48 hours, when I tested it was Positive on April 4th. I don't feel good now with congestion and running nose
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cataract, Condition aggravated, Eye disorder, Post-acute COVID-19 syndrome
Clinical narrative: I issues with my eyes, then I found I had to get cataracts.  I also got a rash on my neck and used medication till now.  I underwent a vision test. I also have long haul of COVID symptoms. I also have depression, anxiety, keratosis and have problems with pain in my wrist.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I issues with my eyes, then I found I had to get cataracts.  I also got a rash on my neck and used medication till now.  I underwent a vision test. I also have long haul of COVID symptoms. I also have depression, anxiety, keratosis and have problems with pain in my wrist.
Age: 40.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Biopsy breast abnormal, Breast hyperplasia, Breast mass, Imaging procedure, Lobular breast carcinoma in situ
Clinical narrative: I had an appointment coming up for my first ever mammogram, never had any symptoms just a routine screening. There was a mass that was biopsied in January 2022. They globular carcinoma in site two. They found atypical lobular hyperplasia. I got a referral to a breast surgeon and we have been following with frequent imaging.
Age: 40.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Mammogram abnormal
Clinical narrative: I had an appointment coming up for my first ever mammogram, never had any symptoms just a routine screening. There was a mass that was biopsied in January 2022. They globular carcinoma in site two. They found atypical lobular hyperplasia. I got a referral to a breast surgeon and we have been following with frequent imaging.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Blood test, Echocardiogram, Electrocardiogram, Tachycardia
Clinical narrative: I had taka cardia and atrial flutter Had a TEECG,  I had the 2nd dose of the monkey pox vaccine a couple weeks prior. I am scheduled for an appointment in June to potentially have an atrial ablations
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea
Clinical narrative: I take a beta blocker and I noticed in early February I could not take a deep breath. I went in to see my physician, prior to seeing him I had stopped taking my Lipitor as he had increased the dose. We discussed if this could be causing the problem and agreed to that a change may help. I am now taking Crestor. Occasionally, I notice I cannot get a deep breath so I feel the adverse event may have resolved.
Age: 73.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Arthralgia, Rotator cuff syndrome, Scapholunate dissociation, X-ray limb abnormal
Clinical narrative: I seemed to develop fairly quickly a SLAC wrist I did not initially believe it had anything to do with the vaccine, however it came on rather quickly and unexpectedly my PCP referred me to a physical therapist for exercises to do at home but when that wasn't helping she referred me to an Orthopedist. He took x-rays and diagnosed SLAC wrist and shoulder tendinitis and sent me to an OT to have a long splint put on and a Physical therapist for two sessions per week plus exercises at home. After three weeks of PT I started to notice similar pain in my other wrists and ankle and knees not as severe but still there, I was diagnosed in my mid twenties with RA that just disappeared in a couple years.
Age: 41.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Eye laser surgery, Retinal tear, Visual impairment
Clinical narrative: Around the end of January 2023, I started getting a black spot in my vision on my right eye and it would dance around. I spoke to my primary doctor, and she referred to the eye clinic. Teh eye clinic diagnosed me with a retinol tear. They had to a laser treatment around the area to ensure it didn't tear further. I'm still in the recovery process. I will have to see them a couple times this year and then yearly visits after that. Still have the dark spot but it is stable for now.
Age: 0.17
Sex: F
Vaccine: PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PCV 20 given to 2mo old, PCV15 indicated. No adverse effects currently
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Burning sensation, Lymphadenopathy
Clinical narrative: Patient given two vaccination shots, one shot each arm (Hep B and P20). The left arm (P20) seemed to irritate the front left lymph node located just inside the shoulder area and directly below the collar bone.  I first noticed a burning feeling on Friday midday.  No other issues observed. Still has the same feeling  but it seems to be diminishing in intensity. After my second covid-19 shot in the left arm, the same node developed a hard lump about the size of pea that lasted for 5-7 days.