chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of PERICARDITIS (Pericarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Pericarditis) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered PERICARDITIS (Pericarditis) to be related.    This case was for patient no.2, who experienced pericarditis after second dose of Moderna vaccine.  No concomitant or treatment medications were reported.   This study is based on a evaluation of all adults administered =1 mRNA COVID-19 vaccine, including boosters, Health Administration between 14 December 2020 and 9 October 2022. From 14 December 2020 to 9 October 2022, 2 184 449 first and 2 036 948 second doses of mRNA-1273 (Moderna) were administered. In addition, 1 156 160 mRNA-1273 booster doses were administered. Among vaccine recipients in our aged 1839 (predominately male, as expected), estimated incidence rates of confirmed myocarditis/pericarditis ranged from 0.46 cases per million (for Moderna dose 1, all ages) to 19.76 (Pfizer dose 2, ages 1839). Of the 178 potential safety events identified, only 33 were ultimately confirmed following an mRNA vaccine. Potential cases were ruled out after chart review for various reasons. In summary, the incidence of myocarditis or pericarditis in patients was low across >10 million doses of mRNA COVID-19 vaccines (primary or booster doses) administered.  Company Comment: This literature-non-study case concerns a patient of unknown age and gender, with no medical history reported, who experienced the expected and serious (due to medically significant) event of Pericarditis, which occurred on an unknown date after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.      This case was linked to US-MODERNATX, INC.-MOD-2023-734758 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2023: Live follow-up received by safety on 27-JUL-2023 has email with full text article, contains significant information: Reporter information, literature information and an updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734758:Same literature (Master case)
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: After he got the Moderna Covid 19 vaccine 2 years ago, he has been experiencing headache every day; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (After he got the Moderna Covid 19 vaccine 2 years ago, he has been experiencing headache every day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (After he got the Moderna Covid 19 vaccine 2 years ago, he has been experiencing headache every day). At the time of the report, HEADACHE (After he got the Moderna Covid 19 vaccine 2 years ago, he has been experiencing headache every day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medication use information was not provided by reporter.  Patient confirmed that it was not a vaccine of clinical trial.   Treatment Medication use information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died after receiving the Spikevax injection; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died after receiving the Spikevax injection) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was not performed.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 1 out of 16.   This case was linked to US-MODERNATX, INC.-MOD-2023-734806, US-MODERNATX, INC.-MOD-2023-734808, US-MODERNATX, INC.-MOD-2023-734811, US-MODERNATX, INC.-MOD-2023-734820, US-MODERNATX, INC.-MOD-2023-734823, US-MODERNATX, INC.-MOD-2023-734833, US-MODERNATX, INC.-MOD-2023-734834 (E2B Linked Report).; Reporter's Comments: This spontaneous case concerns patient of unknown gender and age, with no medical history reported, who died an unknown time after a dose of mRNA-1273 (seriousness assessment reported as fatal). Cause of death was not reported. Information regarding clinical evaluation, diagnostic tests, autopsy report, and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734820:Patient 8 US-MODERNATX, INC.-MOD-2023-734834:Patient 14 US-MODERNATX, INC.-MOD-2023-734833:Patient 13 US-MODERNATX, INC.-MOD-2023-734811:Patient 4 US-MODERNATX, INC.-MOD-2023-734806:Patient 2 US-MODERNATX, INC.-MOD-2023-734808:Patient 3 US-MODERNATX, INC.-MOD-2023-734823:Patient 9; Reported Cause(s) of Death: Unknown cause of death
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Aphasia, Musculoskeletal stiffness, Pyrexia
Clinical narrative: stiffness of my neck and shoulder; Not able to speak; Alopecia; fever; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Alopecia), MUSCULOSKELETAL STIFFNESS (stiffness of my neck and shoulder), APHASIA (Not able to speak) and PYREXIA (fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Jan-2022, the patient experienced PYREXIA (fever). On 27-Jan-2022, the patient experienced ALOPECIA (Alopecia). In July 2022, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness of my neck and shoulder) and APHASIA (Not able to speak). At the time of the report, ALOPECIA (Alopecia) had not resolved and MUSCULOSKELETAL STIFFNESS (stiffness of my neck and shoulder), APHASIA (Not able to speak) and PYREXIA (fever) outcome was unknown.            Concomitant medication was not reported.  Patient had fever next day after booster shot. 2 weeks later, had alopecia on beard and 2.5 month later, had alopecia on hair. It was still continuing as of 28-Jul-2023. In Jul-2022, patient was not able to speak and had sever stiffness of neck and shoulder. Treatment medication was not reported. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; 8 year old child received the vaccine with the dark pink cap for the agent range of 6mo to 5yr by mistake; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old child received the vaccine with the dark pink cap for the agent range of 6mo to 5yr by mistake ) and NO ADVERSE EVENT (No adverse event) in an 8-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    On 28-Jul-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jul-2023, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old child received the vaccine with the dark pink cap for the agent range of 6mo to 5yr by mistake ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old child received the vaccine with the dark pink cap for the agent range of 6mo to 5yr by mistake ) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old child received the vaccine with the dark pink cap for the agent range of 6mo to 5yr by mistake ).    Concomitant medication not reported.   8-year-old child received the vaccine with the dark pink cap for the agent range of 6 months to 5 years by mistake on 28 Jul 2023 child had not shown any signs of distress follow up about an hour after they the office and parent stated no reactions originally received Pfizer monovalent orange cap sk5618 92222.  Treatment medication not reported.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bedridden, Dizziness, Headache, Laboratory test
Clinical narrative: kept him in bed all day long; dizziness; headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BEDRIDDEN (kept him in bed all day long), DIZZINESS (dizziness) and HEADACHE (headache) in an 80-year-old male patient 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.    In February 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 April 2023, the patient experienced BEDRIDDEN (kept him in bed all day long), DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, BEDRIDDEN (kept him in bed all day long), DIZZINESS (dizziness) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: Normal, patient had seen many doctors and they had carried out a large number of tests and they come out normal.         Concomitant product use was not provided by the reporter.  It was reported that on the exact day of reporter's birth day patient had symptoms of headache and dizziness, and went to emergency room and the doctor could not find any problems, the headache and dizziness happens 24 hours a day that keeps him in bed all day long, he was a healthy man, until a few months ago he worked, he could not anymore, patient had seen many doctors and they had carried out a large number of tests and they come out normal. Patient suspected event occurred due to the booster because after that he had felt very bad.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder
Clinical narrative: having a bunch of issues/stomach issues; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: (RA). The reporter is the parent.  A female 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: GASTRIC DISORDER (non-serious), outcome "unknown", described as "having a bunch of issues/stomach issues". Additional information: Nurse stated that her daughter is having a bunch of issues/stomach issues herself. Said it was Pfizer shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Mesenteric panniculitis, Pyrexia
Clinical narrative: fevers; headaches; stomach pain; schlerosing mesenteritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE; FAMOTIDINE. Past drug history included: Neosporin, reaction(s): "Known allergies: neosporin". Vaccination history included: Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 04Nov2022 at 17:00, outcome "not recovered", described as "fevers"; HEADACHE (non-serious) with onset 04Nov2022 at 17:00, outcome "not recovered", described as "headaches"; MESENTERIC PANNICULITIS (non-serious) with onset 04Nov2022 at 17:00, outcome "not recovered", described as "schlerosing mesenteritis"; ABDOMINAL PAIN UPPER (non-serious) with onset 04Nov2022 at 17:00, outcome "not recovered", described as "stomach pain". The events "fevers", "headaches", "stomach pain" and "schlerosing mesenteritis" required physician office visit. Therapeutic measures were not taken as a result of pyrexia, headache, abdominal pain upper, mesenteric panniculitis.  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: Illness
Clinical narrative: I remembered howsick I got from Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An adult 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: ILLNESS (non-serious), outcome "unknown", described as "I remembered howsick I got from Pfizer".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: DTAP, UNK
Symptoms: No adverse event, Vaccine coadministration
Clinical narrative: Daptacel and pentacel being given at the same time, with no reported adverse event; Initial information received  on 26-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of an unknown age and gender and Nurse had administered diphtheria/tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] And diphtheria-15/tetanus/5 AC Pertussis Vaccine [Daptacel] being given at the same time, 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 a unknown dose of suspect diphtheria/tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine via unknown route in the upper thigh of their left leg And diphtheria-15/tetanus/5 AC Pertussis Vaccine (suspension for injection) (strength, expiry date and lot number: not reported) via unknown route in upper thigh of their right leg for immunization and given at the same time, with no reported adverse event (vaccine coadministration) (latency: same day). There will be no information available on the batch number for this case.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient has already received all their scheduled doses, received 3 doses of menquadfi as of today, supposed to have vaxero today instead of menquadfi with no reported adverse event; received 3rd doses of menquadf today, supposed to have vaxero today instead of menquadfi with no reported adverse event; Initial information received on 27-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 17 years old female patient who had already received all the scheduled doses, received 3rd doses of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] today, was supposed to have vaxero today instead with no reported adverse event.  The patient's past vaccination(s) included Menquadfi on 04-Jun-2018 (Dose 1) and on 25-Apr-2023 (Dose 2). The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine and varicella zoster vaccine live (OKA/MERCK) (Varivax) for Prophylactic vaccination.  On 27-Jul-2023, the patient received 0.5 mL dose 3 of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (batch number: U7633AB; expiry date: 25-Apr-2025) via intramuscular route in unknown administration site for Immunization instead of vaxero with no reported adverse event (extra dose administered) (wrong product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  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.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Menactra vaccine was given on 6/16 and it expired on 6/9 (7 days expired) with no reported adverse event; Initial information received on 27-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient for whom Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] vaccine was given on 6/16 and it expired on 6/9 (7 days expired) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Jun-2022, the patient received a 7 day expired dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine solution for injection (dose, strength unknown) (lot: U6952AA, Expiry: 09-Jun-2023)  via unknown route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic adverse events reported. No additional AE/PQC reported; HCP calling to report temperature excursion for VARIVAX in which it was administered.; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 15-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml), once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number X000100 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as 09-OCT-2025) as prophylaxis, that experienced a temperature excursion (product storage error). No symptomatic adverse events reported.  The vaccine experienced a temperature excursion at minus 11.5 degrees Celsius (C) for 72 hours. Call was not because of a data logger. There was no previous temperature excursion.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/No PQC.; HBP called to report a TE with PROQUAD from 8/19/2022.; This spontaneous report has been received from other reporter and refers to a 5-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 29-AUG-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, recombinant human albumin (rha) (PROQUAD) subcutaneous injection, 0.5 milliliter (ml) (valid lot number U039261 [expiration date 09-JUN-2023]) (dose number, frequency, route of administration vaccination scheme, and anatomical location were not provided), administered for prophylaxis, after a temperature excursion (product storage error).   No adverse effects reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Vaccination site pain
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Temporary soreness at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 as dose number unknown, single (Lot number: GJ3270) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gluten Allergy" (unspecified if ongoing); "Pollen Allergy" (unspecified if ongoing); "Allergy to Statins" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09May2023, outcome "recovered" (10May2023), described as "Temporary soreness at injection site"; 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. Therapeutic measures were not taken as a result of vaccination site pain.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna: Dose Number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GJ5342), in right arm and on 15May2023 as dose 6 (booster), single (Lot number: GL2042) at the age of 74 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EN9581), in right arm, on 01Mar2021 as dose 2, single (Lot number: EN6202), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 301558A), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jun2022 as dose 4 (booster), single (Lot number: 058A22-2A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "high bp" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Sep2015, stop date: 19Jul2023; D3, start date: Mar2017; LUTEIN ZEAXANTHIN, start date: Sep2021; LOSARTAN POTASSIUM, start date: Mar2023; FISH OIL OMEGA 3, start date: Mar2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Jun2022, outcome "unknown", described as "Moderna: Dose Number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid treatment from 19Jul2023 to 24Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300264982 same patient, different drug/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300265205 same reporter/patient, different drug/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "Hypertension" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid"; Tetracaine, reaction(s): "Known allergies: tetracaine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment information was Paxlovid from 22Jul2023 to 27Jul2023.  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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Retinal artery occlusion, SARS-CoV-2 test
Clinical narrative: Central retinal artery occlusion (CRAO); Permanent vision loss right eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, on 07Oct2022 as dose number unknown, single; SYNTHROID. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN7206, Location of injection: Left arm, Vaccine Administration Time: 08:00 AM), administration date: 05Mar2021, when the patient was 52-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 26Mar2021, when the patient was 53-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FE3592, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 04Dec2021, when the patient was 53-year-old, for Covid-19 Immunization. The following information was reported: RETINAL ARTERY OCCLUSION (hospitalization, disability, medically significant) with onset 20Nov2022, outcome "recovering", described as "Central retinal artery occlusion (CRAO)"; BLINDNESS UNILATERAL (hospitalization, disability, medically significant) with onset 20Nov2022, outcome "recovering", described as "Permanent vision loss right eye". The events "central retinal artery occlusion (crao)" and "permanent vision loss right eye" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of retinal artery occlusion, blindness unilateral.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizures seeing a neurologist now for it; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Na), for COVID-19 immunization. The following information was reported: SEIZURE (medically significant), outcome "not recovered", described as "Seizures seeing a neurologist now for it". The event "seizures seeing a neurologist now for it" required physician office visit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Human papilloma virus test, Vaccination failure, Weight
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6203), on 15Mar2021 as dose 2, single (Lot number: EN6208) and on 22Nov2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZITHROMAX. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jul2023 at 19:00, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Human papilloma virus test: (29Sep2021) Positive, notes: Her HPV APTIMA positive test; Weight: (unspecified date) 121 lbs, notes: was 121 pounds before this started a week ago. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300265894 same reporter/patient/product, different AE/dose;
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: an issue which may be an autoimmunity Polymyalgia rheumatica; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE ), for COVID-19 immunization; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE ), for COVID-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as "an issue which may be an autoimmunity Polymyalgia rheumatica". Therapeutic measures were taken as a result of polymyalgia rheumatica. The patient reported that he wanted to get his 6th vaccination of Pfizer vaccine but recently had developed an issue which may be an autoimmunity Polymyalgia rheumatica. He'd like to know if there were any contraindications for him taking the vaccine while taking Prednisone or having autoimmune disease.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: Disease Recurrence; have had 5 vaccines. Have had Covid 4 times; have had 5 vaccines. Have had Covid 4 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "have had 5 vaccines. Have had Covid 4 times"; DISEASE RECURRENCE (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence as Paxlovid treatment. Clinical course: Patient had Covid 4 times in May2022, Sep2022, May2023 and currently. Patient added If patient could be of help in any trial, please let patient know. Patient was so grateful for the vaccines and Paxlovid. Patient took it in May2022 and am took it again now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300265595 same patient, different SD/AE;
Age: 36.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Injection site discharge, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Patient had localized reaction at injection site. Area was red, warm, and weeping. Patient reports this developed within 36 hours of administration. Patient went to urgent care and was provided steroid cream which alleviated symptoms within 48 hours. Patient reports that urgent care provider suggested this was a 'robust uptake' and did not believe it was cellulitis. Patient returned for dose 2 of vaccine, subsequently had the same reaction which was treated with steroid cream and resolved. Patient denies any other s/s such as n/v/d, fever/chills, muscle pain.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 34.0
Sex: F
Vaccine: COVID19, CHOL
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 34.0
Sex: F
Vaccine: COVID19, CHOL
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administration error
Clinical narrative: 3rd bivalent dose administered, 2 months after 2nd bivalent dose administered. Vaccine administration error, no known adverse side effects reported.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Not appropriate dose.  Novavax only authorized for 1st booster dose.    No adverse symptoms.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electrocardiogram abnormal, Heart rate increased, Nasopharyngitis
Clinical narrative: rapid heart rate, cold
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Inadvertent administration.  Novavax only authorized as a 1st booster dose, and patient has already received booster dose.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: swollen right arm and red
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient presented to clinic on 08/02/2023 with redness and swelling to left arm. Patient afebrile, denies pain, itchiness to left arm. Per mother she noticed arm on morning of 08/02/23. Dr. diagnosed as cellulitis of arm and 1 gram of rocephin was given in clinic. Dr. also prescribed Sulfamethoxazole-Trimethoprim oral suspension 7.5ml BID for 10 days. Patient has follow up appt 08/03/2023 to see how he is doing after rocephin injection.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Dyspnoea, Gait disturbance, Injection site swelling, Pyrexia
Clinical narrative: My Sons leg was swollen on the side where vaccine was administered.  Fever, vomiting, chills, SOB, wheezing. (My son could not walk after adminstration).
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Vomiting, Wheezing
Clinical narrative: My Sons leg was swollen on the side where vaccine was administered.  Fever, vomiting, chills, SOB, wheezing. (My son could not walk after adminstration).
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lip swelling, Urticaria
Clinical narrative: Presented with hives the morning of 7/29/2023.  Did a video visit with Dr. in my office.  Pictures provided to me that are consistent with hives.  Received Benadryl 25mg twice that day.  Hives subsided a bit.  The evening of 7/29/23 though developed lip swelling.  Woke up on 7/30/23 still with hives and mom gave Claritin 10mg and the hives quickly and immediately resolved and have not returned again.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: 2nd Moderna bivalent vaccine booster was administered on 8/1/23. Moderna vial was moved to fridge on 6/28/23 and labeled with a 30 day expiration on 7/28/23. Technician removed vial from fridge for administration and expiration date was not checked.
Age: 0.83
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine that was administered had expired on 7/26/23 ( 1 week prior) and this was not discovered until after vaccine was given. Called and disclosed to parents.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: There was no adverse event. Wrong vaccine was given: a monovalent dose was given after it was recommended to stop vaccination with the monovalent vaccine and prior to new dosage recommendation for bivalent vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Disease recurrence, Herpes zoster
Clinical narrative: Broke out in shingles on right side (underarm, trunk) approximately 3 days post vaccine.  This has occurred since 2nd COVID Pfizer vaccine. Outbreak milder but in larger area. Second recurrence of shingles 8/2/2023.
Age: 1.25
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt was administered Havrix, Proquad  and Varicella on 7/27/23 @ age 15 months  .  Merck notified as well   manufacturer for ProQuad.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: COVID VACCINE ADMINISTERED PAST BEYOND USE DATE OF 12/17/2022.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperventilation, Hypotension, Loss of consciousness, Pallor
Clinical narrative: Pt was extremely nervous (possible panic attack) about getting the vaccine, then after administration pt reported blacking out, pale skin, blood pressure was low/difficult to take, hyperventilating, tx was sitting and drinking water several minutes. afterwards was able to walk out on his own
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Skin reaction
Clinical narrative: patient with delayed allergic reaction to menveo vaccine -  Left upper arm swelling/redness - rx for prednisolone & cold compress prn will follow up on 8.7.23
Age: 17.0
Sex: F
Vaccine: HPV9, IPV
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Adolescent received HPV and IPV vaccines in first trimester of pregnancy. No adverse reaction occurred to her
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Skin reaction
Clinical narrative: Skin reaction; allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "food allergies" (unspecified if ongoing), notes: Has food allergies; "external allergies" (unspecified if ongoing); "allergic to antibiotics and sulfur" (unspecified if ongoing); "allergic to antibiotics and sulfur" (unspecified if ongoing); "allergies to medications" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, All doses in right arm), administration date: 11Feb2021, when the patient was 76-year-old, for Covid-19 Immunization, reaction(s): "Skin reaction". The following information was reported: SKIN REACTION (non-serious) with onset 2021, outcome "unknown"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "allergy". The events "skin reaction" and "allergy" required physician office visit. Therapeutic measures were taken as a result of skin reaction, hypersensitivity. Additional information: Has a lot of allergies to medications, amongst other things. Also had allergist for majority of the time. Treatment: Lots of things. Patient doesn't want to take another shot if, it is going to bring back the allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Pharmacist confirms no symptomatic events or side effects reported. No additional AE/No PQC. / No adverse event known; Pharmacist called to report a VARIVAX Temperature Excursion. Improperly stored VARIVAX was potentially administered on unknown dates to multiple patients (unknown demographics and number of patients involved unknown at time of call, therefore multipl; This spontaneous report was received from a pharmacist concerning a 19-year-old male patient.  The patient's concurrent conditions were not reported. His concomitant therapies included coronavirus disease 2019 (COVID 19) vaccine. Pre-existing physician-diagnosed allergies, birth defects or medical conditions were none known.  On 03-JUL-2023, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot #W012165 and expiration date on 12-APR-2024, administered subcutaneously (SC) in the right arm for prophylaxis (dose number was not provided). The vaccine was administered by the healthcare professional at a pharmacy, and it was purchased with private funds. It was unknown if there was illness at the time of vaccination.  On unspecified dates, three separate temperature excursions occurred: one up to 12.092 degrees Fahrenheit (F) for 6 hours and 15 minutes, the second up to 13.6 F for 2 hours and 30 minutes, and the third up to 12.1 F for 1 hour, 45 minutes and 5 seconds. The temperature excursions occurred as a result of a reading from a Digital Data logger.    No adverse events were known.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA000909: US-009507513-2307USA011964: US-009507513-2307USA011965: