chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. Initial information was processed along with additional information received from the department on 19-APR-2023. The patient's weight, height, and medical history were not reported. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, 1 total administered on 23-MAR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, 1 total administered on 29-OCT-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 09-SEP-2022, the patient had positive strike on Binex test, the patient experienced sickness for 5 days which was confirmed covid-19 infection, and confirmed clinical vaccine failure (dose number in series 2). The patient reported that, the patient's immunity weaned since patient did not had a COVID vaccine in 2 years. On an unspecified date in SEP-2022, treatment medications included: nirmatrelvir/ritonavir (Paxlovid) for covid-19 infection. On an unspecified date, in SEP-2022, Laboratory data included: SARS-CoV-2 test results showed negative next 2 weeks but QuickVue test showed negative (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on 14-SEP-2022, and the outcome of confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000279481 and 90000279482. The suspected product quality complaint has been confirmed to be voided for 90000279481 (as the reported illness is relevant to efficacy post administration of the booster and no pqc identified for the primary vaccination) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20230438449-confirmed clinical vaccine failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration, Suspected COVID-19
Clinical narrative: GOT COVID; HEALTH ISSUES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got covid, and health issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got covid and health issues was not reported. This report was non-serious. This report was associated with product quality complaint 90000279707.
Sex: U
Vaccine: COVID19-2
Symptoms: Atrial fibrillation
Clinical narrative: AFib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) in an adult patient of an unknown gender 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 ATRIAL FIBRILLATION (AFib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (AFib) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.  Company comment:This spontaneous case reported by a unknown age and gender, with no medical history, who experienced the unexpected serious (medically significant) AESI event of atrial fibrillation, which occurred unspecified days after a dose (dose number nor specified) of mRNA-1273 bivalent BA.4/BA.5 vaccination. At the time of reporting outcome of the event is unknown. No further information for medical history, lab data, concomitant medication, clinical course. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 vaccination is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-719402, US-MODERNATX, INC.-MOD-2023-719297, US-MODERNATX, INC.-MOD-2023-719332 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2023: Upon internal review on 20-Apr-2023, it was identified that previous reports were submitted with incorrect WWID number (US-MODERNATX-MOC20230413000001). Hence, significant correction was performed to update the E2b company number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719402:This case is for Doctor 1 out  of 2 doctors US-MODERNATX, INC.-MOD-2023-719332:This case is for Doctor 2 out  of 2 doctors US-MODERNATX, INC.-MOD-2023-719297:This case is for Doctor 2 out  of 2 doctors
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: little COVID vaccine killed my dad; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (little COVID vaccine killed my dad) in an adult 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.    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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Company comment : This spontaneous case concerns an adult male patient of unknown age with no medical history reported, who died an unknown time after a dose of mRNA-1273.222. Information regarding clinical evaluation, diagnostic tests and autopsy reports has not been disclosed. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.   Reporter did not allow further contact; Reporter's Comments: This spontaneous case concerns an adult male patient of unknown age with no medical history reported, who died an unknown time after a dose of mRNA-1273.222. Information regarding clinical evaluation, diagnostic tests and autopsy reports has not been disclosed. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This literature-non-study case was reported in a literature article and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. The study included adults with age equal to or more than 50 years.  All subjects were divided in two groups, first received RZV vaccine two weeks after booster dose of Moderna vaccine and second group received concomitantly. Both groups received second dose of RZV after two months of first dose. Author concluded that co-administration of mRNA-1273 booster vaccine with RZV was immunologically noninferior to sequential administration and had a safety and reactogenicity profile consistent with both vaccines.  Company Comment: This is a literature non-study case concerning a patient of unknown age and gender with no medical history, who experienced the serious (due to medically significant) unexpected AESI pulmonary embolism.  The event occurred after receiving a booster dose of mRNA-1273 vaccine (dose number and event date not reported). No concomitant and treatment medications were reported. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Optic neuritis
Clinical narrative: Bilateral optic neuritis; Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of OPTIC NEURITIS (Bilateral optic neuritis) and MYOCARDITIS (Myocarditis) in a 40-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.       No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced OPTIC NEURITIS (Bilateral optic neuritis) (seriousness criterion medically significant) and MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, OPTIC NEURITIS (Bilateral optic neuritis) and MYOCARDITIS (Myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  In this report author presented a case of myocarditis and bilateral optic neuritis that occurred in a young healthy patient after the administration of first dose of mRNA-1273 vaccine (Moderna).  Company Comment: This is a literature non-study case concerning a 40-year-old, male patient with no reported medical history, who experienced the serious (due to medically significant) expected AESI Myocarditis and the unexpected serious (due to medically significant) AESI optic neuritis.  The event occurred after receiving the first dose of mRNA-1273 vaccine (date not provided). No concomitant and treatment medications were reported. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: On the back of their card 1st dose on Nov-2021, Jan-2021, Aug-2021, Apr-2022; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (On the back of their card 1st dose on Nov-2021, Jan-2021, Aug-2021, Apr-2022) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046621A) for COVID-19 prophylaxis.     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. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (On the back of their card 1st dose on Nov-2021, Jan-2021, Aug-2021, Apr-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (On the back of their card 1st dose on Nov-2021, Jan-2021, Aug-2021, Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (On the back of their card 1st dose on Nov-2021, Jan-2021, Aug-2021, Apr-2022).    No concomitant medications were provided. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720281 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720281:Product Bivalent
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2023-720289 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product availability issue
Clinical narrative: The caller received the 1st primary series dose (Moderna) and is looking for facilities with the vaccine in stock for her second dose and can´t find one.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT AVAILABILITY ISSUE (The caller received the 1st primary series dose (Moderna) and is looking for facilities with the vaccine in stock for her second dose and can´t find one.) and NO ADVERSE EVENT (No adverse event) 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 first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (The caller received the 1st primary series dose (Moderna) and is looking for facilities with the vaccine in stock for her second dose and can´t find one.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT AVAILABILITY ISSUE (The caller received the 1st primary series dose (Moderna) and is looking for facilities with the vaccine in stock for her second dose and can´t find one.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT AVAILABILITY ISSUE (The caller received the 1st primary series dose (Moderna) and is looking for facilities with the vaccine in stock for her second dose and can´t find one.).    No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: February 2023 patient got COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (February 2023 patient got COVID) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In February 2023, the patient experienced COVID-19 (February 2023 patient got COVID). At the time of the report, COVID-19 (February 2023 patient got COVID) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  It was reported that patient received total 5 doses of Moderna. On the back of card the dates of doses were reported as Jan-2021, Aug-2021, Nov-2021 and Apr-2022.   Treatment medications were not provided.   This case was linked to MOD-2023-720290 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 17-Apr-2023; No adverse event; Bivalent Moderna vaccines that expired on 15-Apr-2023 and was given to one patient on the 17-Apr-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccines that expired on 15-Apr-2023 and was given to one patient on the 17-Apr-2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 17-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) on 12-Feb-2021, Moderna COVID-19 Vaccine (Dose 2) on 13-Mar-2021 and Moderna COVID-19 Vaccine (Dose 3) on 19-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 17-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccines that expired on 15-Apr-2023 and was given to one patient on the 17-Apr-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 17-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccines that expired on 15-Apr-2023 and was given to one patient on the 17-Apr-2023), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 17-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccines that expired on 15-Apr-2023 and was given to one patient on the 17-Apr-2023) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 17-Apr-2023).    No concomitant medications were reported. Vial was initially stored in the refrigerator on 16-Mar-2023. Vial did not undergo any temperature excursions. Patient had not reported any adverse reactions to the vaccine. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) 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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received five Moderna Vaccines. Received on Jan-2021, Aug-2021 and Apr-2022. Booster lot no was mentioned as 04662.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720282 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720282:Product Monovalent
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022.; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022.) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C3) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, 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 13-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022.).    No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The vial was initially stored in the refrigerator on 01-Sep-2022. BUD was reported as 01-Oct-2022. The vial did not underwent any temperature excursions.  No treatment medications were reported.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, 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 13-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-Sep-2022 and vaccine was  administered on 13-Oct-2022).    No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The vial was initially stored in the refrigerator on 01-Sep-2022. BUD was reported as 01-Oct-2022. The vial did not underwent any temperature excursions.  No treatment medications were reported.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 09Jan2023 and vaccine was administered on 10Apr2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jan2023 and vaccine was administered on 10Apr2023) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-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. On 10-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jan2023 and vaccine was administered on 10Apr2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jan2023 and vaccine was administered on 10Apr2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 09Jan2023 and vaccine was administered on 10Apr2023).    The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  The vial was initially stored in the refrigerator on 09-Jan-2023. BUD date was 09-Feb-2023. The vial did not undergone any temperature excursions. No adverse events reported from the patient.  No treatment medications was reported.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; On 15-Feb-2023 Patient received the bivalent vaccine as their first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (On 15-Feb-2023 Patient received the bivalent vaccine as their first dose) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy to nuts.    On 15-Feb-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 15-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (On 15-Feb-2023 Patient received the bivalent vaccine as their first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (On 15-Feb-2023 Patient received the bivalent vaccine as their first dose) 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 WRONG PRODUCT ADMINISTERED (On 15-Feb-2023 Patient received the bivalent vaccine as their first dose).    No concomitant medications were reported.  No treatment information was provided.
Age: 72.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP advised that his pharmacy administered a vaccine that was drawn up into syringe and was not used for 20hrs; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP advised that his pharmacy administered a vaccine that was drawn up into syringe and was not used for 20hrs) and NO ADVERSE EVENT (No adverse event) in a 72-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-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. On 19-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP advised that his pharmacy administered a vaccine that was drawn up into syringe and was not used for 20hrs). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP advised that his pharmacy administered a vaccine that was drawn up into syringe and was not used for 20hrs) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP advised that his pharmacy administered a vaccine that was drawn up into syringe and was not used for 20hrs).    No concomitant medication details was reported. No treatment medication details was reported.  It was reported that syringe was drawn on 18-Apr-23 and used on 19-Apr-23.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator 01-Sep-2022, administration of vaccine on 13-Oct-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 01-Sep-2022, administration of vaccine on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 13-Oct-2022, 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 13-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 01-Sep-2022, administration of vaccine on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 01-Sep-2022, administration of vaccine on 13-Oct-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 01-Sep-2022, administration of vaccine on 13-Oct-2022).    No concomitant medication were reported.  BUD was 01-Oct-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: a patient reports that after getting the 2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUAL DISORDER (a patient reports that after getting the 2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 MENSTRUAL DISORDER (a patient reports that after getting the 2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.). At the time of the report, MENSTRUAL DISORDER (a patient reports that after getting the 2nd dose of the Moderna Covid-19 vaccine she only menstruated one more and it stopped.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720348 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720348:daughter's friend's mother
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Cardiac failure, Ejection fraction decreased, Hypotension, Obstructive sleep apnoea syndrome
Clinical narrative: I95.9 HYPOTENSION 10/27/2021 ACUTE RENAL FAILURE, UNSPECIFIED I95.9 HYPOTENSION 10/27/2021 HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY I95.9 HYPOTENSION 10/27/2021 ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Chronic fatigue syndrome, Condition aggravated, Crohn's disease, Gastrointestinal disorder
Clinical narrative: I was having bad gut symptoms a couple of months after dose 4 of Moderna, in June of 2022. I also had a flare out of remission from auto-immune symptoms. Crohn's Disease came on, as well as Migraines and Chronic Fatigue Syndrome, Hashimoto, Thyroid was unregulated. I touched base with my doctors for issues I had previously. My doctors have retired and the doctor I listed is new.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Thyroid disorder
Clinical narrative: I was having bad gut symptoms a couple of months after dose 4 of Moderna, in June of 2022. I also had a flare out of remission from auto-immune symptoms. Crohn's Disease came on, as well as Migraines and Chronic Fatigue Syndrome, Hashimoto, Thyroid was unregulated. I touched base with my doctors for issues I had previously. My doctors have retired and the doctor I listed is new.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: NONE Covid 19 vaccine expired. 02/08/2023  Given:  03/23/2023
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Audiogram abnormal, Deafness unilateral, Ear discomfort, Magnetic resonance imaging abnormal, Vertigo
Clinical narrative: I suffered from severe plugged left ear. I have loss all hearing in that ear. I then starting suffering from vertigo and I still deal with it currently. I saw a doctor in another country.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-muscle specific kinase antibody, Asthenia, Balance disorder, Blood test normal, Cardiac stress test normal
Clinical narrative: Around March of 2022, I began to have fatigue and some balance issues. I had already had some balance issues, but they got grossly worse. The fatigue worsened greatly. It was relieved by short naps, but it was pretty significant. I had an episode where were walking and I couldn't move one of my legs. It wasn't bone or anything, I just couldn't move. That lasted for maybe 3 or 4 minutes. During my daughter's wedding, I had to go lie down because I was so fatigued. The fatigue just kept increasing. The motor control kept getting worse. The exhaustion was increasing to the point where I had to take a leave from work in October of 2022. It just kept progressing. My legs, arms, shoulders, and hands. I've seen 2 neurologists, a pulmonologist, and a cardiologist. Nobody can really figure out what is going on. They can see the weakness, exhaustion, blurry vision, and double vision, which are all pretty significant.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Drug level, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Around March of 2022, I began to have fatigue and some balance issues. I had already had some balance issues, but they got grossly worse. The fatigue worsened greatly. It was relieved by short naps, but it was pretty significant. I had an episode where were walking and I couldn't move one of my legs. It wasn't bone or anything, I just couldn't move. That lasted for maybe 3 or 4 minutes. During my daughter's wedding, I had to go lie down because I was so fatigued. The fatigue just kept increasing. The motor control kept getting worse. The exhaustion was increasing to the point where I had to take a leave from work in October of 2022. It just kept progressing. My legs, arms, shoulders, and hands. I've seen 2 neurologists, a pulmonologist, and a cardiologist. Nobody can really figure out what is going on. They can see the weakness, exhaustion, blurry vision, and double vision, which are all pretty significant.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram normal, Fatigue, Impaired work ability, Magnetic resonance imaging normal, Magnetic resonance imaging spinal normal
Clinical narrative: Around March of 2022, I began to have fatigue and some balance issues. I had already had some balance issues, but they got grossly worse. The fatigue worsened greatly. It was relieved by short naps, but it was pretty significant. I had an episode where were walking and I couldn't move one of my legs. It wasn't bone or anything, I just couldn't move. That lasted for maybe 3 or 4 minutes. During my daughter's wedding, I had to go lie down because I was so fatigued. The fatigue just kept increasing. The motor control kept getting worse. The exhaustion was increasing to the point where I had to take a leave from work in October of 2022. It just kept progressing. My legs, arms, shoulders, and hands. I've seen 2 neurologists, a pulmonologist, and a cardiologist. Nobody can really figure out what is going on. They can see the weakness, exhaustion, blurry vision, and double vision, which are all pretty significant.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Motor dysfunction, Ultrasound kidney normal, Vision blurred
Clinical narrative: Around March of 2022, I began to have fatigue and some balance issues. I had already had some balance issues, but they got grossly worse. The fatigue worsened greatly. It was relieved by short naps, but it was pretty significant. I had an episode where were walking and I couldn't move one of my legs. It wasn't bone or anything, I just couldn't move. That lasted for maybe 3 or 4 minutes. During my daughter's wedding, I had to go lie down because I was so fatigued. The fatigue just kept increasing. The motor control kept getting worse. The exhaustion was increasing to the point where I had to take a leave from work in October of 2022. It just kept progressing. My legs, arms, shoulders, and hands. I've seen 2 neurologists, a pulmonologist, and a cardiologist. Nobody can really figure out what is going on. They can see the weakness, exhaustion, blurry vision, and double vision, which are all pretty significant.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: patient fainted twice the morning after receiving vaccine
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Loss of consciousness, Malaise, Similar reaction on previous exposure to drug, Syncope
Clinical narrative: patient fainted twice the morning after receiving vaccine
Age: 22.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Chronic fatigue syndrome, Dizziness, Fibromyalgia, Infertility female, Migraine
Clinical narrative: CFS/ME Fibromyalgia  Possible POTS I am still in visits regarding my symptoms so we are unsure. I am constantly dizzy unless I am laying down. POS Infertility  Chronic migraines It has taken a long time just to find Dr.s that would try to find out what was going on. Most of them acted as though my symptoms were not real as they felt I was too young to be sick. I finally have Dr.s willing to try to figure this out. So many of my diagnoses are newer and some is still on going trying to figure out my issues. CFS/ME diagnosed in 2016. Fibromyalgia in 2023. I don't have exact dates of others. I am currently in course of trying to get into a rheumatologist to figure out why I am always dizzy and can barely ever get out of bed.
Age: 22.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Mobility decreased
Clinical narrative: CFS/ME Fibromyalgia  Possible POTS I am still in visits regarding my symptoms so we are unsure. I am constantly dizzy unless I am laying down. POS Infertility  Chronic migraines It has taken a long time just to find Dr.s that would try to find out what was going on. Most of them acted as though my symptoms were not real as they felt I was too young to be sick. I finally have Dr.s willing to try to figure this out. So many of my diagnoses are newer and some is still on going trying to figure out my issues. CFS/ME diagnosed in 2016. Fibromyalgia in 2023. I don't have exact dates of others. I am currently in course of trying to get into a rheumatologist to figure out why I am always dizzy and can barely ever get out of bed.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient received  a dose of 0.5ml bivalent vaccine on 4/19/23 that has a lot exp of 6/13/23 and was pulled from the freezer on 3/18/23 with  a beyond use date of 4/17/23