chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th December 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:16-FEB-2023 Reporter's Comment: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient. The reporter stated that below temperature excursion had happened in October. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient,which led to incorrect storage of drug. The onset date for incorrect storage of drug was earlier than vaccination date, so onset date was not captured in the case.  This was 1 of 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023026693:Same reporter US-GSK-US2023026694:Same reporter US-GSK-US2023026695:Same reporter US-GSK-US2023026696:Same reporter US-GSK-US2023026698:Same reporter
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old male patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient. The reporter stated that below temperature excursion had happened in October. The vaccine administration Facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient, which led to incorrect storage of drug. This was 1 of 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023026692:Same reporter US-GSK-US2023026694:Same reporter US-GSK-US2023026695:Same reporter US-GSK-US2023026696:Same reporter US-GSK-US2023026698:Same reporter
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old male patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient. The reporter stated that below temperature excursion had happened in October 2022. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient, which led to incorrect storage f drug. The onset date for incorrect storage of drug was earlier than vaccination date, so onset date was not captured in the case.  This was 1 of 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023026692:Same reporter US-GSK-US2023026693:Same reporter US-GSK-US2023026694:Same reporter US-GSK-US2023026696:Same reporter US-GSK-US2023026698:Same reporter
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter was a healthcare professional. The reporter reported that the patient received Havrix vaccine that had been in a below temperature excursion and was not considered stable and it was administered to the patient. The reporter stated that the vaccine below temperature excursion was happened in October. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The Havrix vaccine temperature was exposed below temperature excursion, which led to incorrect storage of vaccine. This case was 1 of 6 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023026692:Same reporter US-GSK-US2023026696:Same reporter US-GSK-US2023026695:Same reporter US-GSK-US2023026693:Same reporter US-GSK-US2023026694:Same reporter
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received HAV (Havrix) (batch number 84853, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 15th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter called to report that the day before reporting an expired dose of Havrix was administered to a patient. The reporter consented to follow up via email but requested for name not to be captured in database. Additional Supportive Information: The expired dose of Havrix was administered to a patient, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 07/26/2019, didnt get the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th July 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter called and stated that he received the first dose of Shingrix but did not follow up and get the second dose.  The reporter stated he plans on getting the second dose as soon as possible.  The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received 3 doses; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 9372K, expiry date 5th August 2024) for prophylaxis.   On 15th February 2023, the patient received the 3rd dose of Shingrix. On 15th February 2023, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 17-Feb-2023. Reporter's Comment: The nurse reported that a patient received three doses of shingrix. The reporter consented to follow-up. Additional Supportive Information: Patient received 3rd dose of Shingrix than the recommended schedule, which led to extra dose administered.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: MENSTRUAL CYCLE DYSREGULATED; This spontaneous report received from a consumer concerned a female 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced menstrual cycle dysregulated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of menstrual cycle dysregulated was not reported. This report was non-serious. This case, from the same reporter is linked.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death, Thrombosis
Clinical narrative: STROKE; BLOOD CLOT IN CHEST; DEATH; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. 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, expiry: UNKNOWN) dose was not reported, 1 total, administered on an unspecified date in APR-2022 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 16-MAY-2022, the patient died from unknown cause of death 3 weeks after his first janssen jab. On an unspecified date in 2022, patient had a stroke the day after the jab and a blood clot was found in patient's chest at the hospital. On an unspecified date, the patient was hospitalized for unspecified days. It was unknown whether an autopsy was performed or not. It was reported as, "My grandpa passed May 16, 2022 3 weeks after his first jab. He had a stroke the day after the jab and a blood clot was found in his chest at the hospital. He chose on his own to go home and pass away in peace." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 16-MAY-2022, and the outcome of stroke and blood clot in chest was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20230248250-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20230248250-stroke. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20230248250-Blood clot in chest. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: He also had some mild lightheadedness and felt a little flushed after the second shot; He also had some mild lightheadedness and felt a little flushed after the second shot; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (He also had some mild lightheadedness and felt a little flushed after the second shot) and DIZZINESS (He also had some mild lightheadedness and felt a little flushed after the second shot) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 prophylaxis.     The patient's past medical history included Stroke in 2001. Previously administered products included for Product used for unknown indication: Influenza shot. Past adverse reactions to the above products included No adverse event with Influenza shot. Concomitant products included LOSARTAN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FLUSHING (He also had some mild lightheadedness and felt a little flushed after the second shot) and DIZZINESS (He also had some mild lightheadedness and felt a little flushed after the second shot). At the time of the report, FLUSHING (He also had some mild lightheadedness and felt a little flushed after the second shot) and DIZZINESS (He also had some mild lightheadedness and felt a little flushed after the second shot) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 18-Nov-2021, the patient received third booster dose of Moderna monovalent vaccine of batch number 069F21A. On 18-Aug-2022, the patient received fourth booster dose of Moderna monovalent vaccine of batch number 011B22A.  No treatment medications was reported.   This case was linked to MOD-2023-710973 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: have been suffering adverse effects from the Moderna vaccine/injured by your product; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (have been suffering adverse effects from the Moderna vaccine/injured by your product) in a  patient of an unknown age and 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 IMMUNISATION REACTION (have been suffering adverse effects from the Moderna vaccine/injured by your product). At the time of the report, IMMUNISATION REACTION (have been suffering adverse effects from the Moderna vaccine/injured by your product) had not resolved.            No concomitant products reported. No treatment products reported.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Prostatic specific antigen, Therapeutic response unexpected
Clinical narrative: his blood test revealed that the "PSA" value was reduced by 40 percent after getting MODERNA COVID 19 vaccine; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (his blood test revealed that the "PSA" value was reduced by 40 percent after getting MODERNA COVID 19 vaccine) and NO ADVERSE EVENT (no adverse event) in a male 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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (his blood test revealed that the "PSA" value was reduced by 40 percent after getting MODERNA COVID 19 vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (his blood test revealed that the "PSA" value was reduced by 40 percent after getting MODERNA COVID 19 vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prostatic specific antigen: reduced by 40 percent.         No concomitant medications were reported.   It was reported that, the patient's blood test revealed that the prostatic specific antigen (PSA) value was reduced by 40 percent after vaccination. The patient had requested additional injections, now that the Bi-valent formula was in use, and they noticed PSA leveled out.  According to the patient the mRNA vaccines, specifically the original Moderna formulation might be effective in controlling or combating prostate cancer.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: reported excursion on 14Feb2023; Product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023) and PRODUCT STORAGE ERROR (Product storage error).    Concomitant product use was not provided by the reporter.  One of the medical assistants reported excursion on 14-Feb-2023 previously. Now they are following up to see if the 6 doses administered to children during this time need to be revaccinated or not.   Maximum temperature was 1.8 C. Storage at time of excursion was freezer. Excursion duration was unknown for each day starting on 01-Feb-2023 and continued until 14-Feb-2023. HCP can confirm it was not out of range the entire day.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-711958, US-MODERNATX, INC.-MOD-2023-711977, US-MODERNATX, INC.-MOD-2023-712035, US-MODERNATX, INC.-MOD-2023-712046, US-MODERNATX, INC.-MOD-2023-712062 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711958: US-MODERNATX, INC.-MOD-2023-711977: US-MODERNATX, INC.-MOD-2023-712035: US-MODERNATX, INC.-MOD-2023-712046: US-MODERNATX, INC.-MOD-2023-712062:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Overdose
Clinical narrative: No adverse event; Dose 3 (1st monovalent booster) was 0.3 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of OVERDOSE (Dose 3 (1st monovalent booster) was 0.3 ml) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 32030BD) for COVID-19 prophylaxis.     It was unknown if patient was ever been diagnosed with/ tested positive for COVID-19. It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before or chronic or long-standing health conditions or patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination and/or at the time of the adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 01-Dec-2021 at 9:54 AM, the patient experienced OVERDOSE (Dose 3 (1st monovalent booster) was 0.3 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (Dose 3 (1st monovalent booster) was 0.3 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for OVERDOSE (Dose 3 (1st monovalent booster) was 0.3 ml).    Patient administered the Dose 3 of the vaccine at 09:54 am on 01-Dec-2021.   No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2023-704660 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose-1 administered on (11-03-2021) and Dose-2 administered on (15-11-2021); This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 administered on (11-03-2021) and Dose-2 administered on (15-11-2021)) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 prophylaxis.     It was unknown if patient ever diagnosed or tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination and up to one month before. It was unknown if patient had any chronic or long-standing health conditions.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 administered on (11-03-2021) and Dose-2 administered on (15-11-2021)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 administered on (11-03-2021) and Dose-2 administered on (15-11-2021)) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 administered on (11-03-2021) and Dose-2 administered on (15-11-2021)).    No concomitant medication information provided.  No treatment information provided.   This case was linked to MOD-2023-704537 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Patient had received dose 1 on 31-Mar-2021 and dose 2 on 8-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received dose 1 on 31-Mar-2021 and dose 2 on 8-Dec-2021) and NO ADVERSE EVENT (no adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 1822811 and 042A21A) for COVID-19 prophylaxis.     It was unknown that the patient ever been diagnosed with or tested positive for COVID-19. It was unknown that the patient had acute illnesses at the time of vaccination and up to one month before or any chronic or long-standing health conditions.    On 31-Mar-2021 at 2:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Dec-2021 at 12:05 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 08-Dec-2021 at 12:05 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received dose 1 on 31-Mar-2021 and dose 2 on 8-Dec-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received dose 1 on 31-Mar-2021 and dose 2 on 8-Dec-2021) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received dose 1 on 31-Mar-2021 and dose 2 on 8-Dec-2021).    Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination or at the time of the adverse event were unknown.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2023-704595 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was first punctured on 11Feb 2023 and administration of vaccine on 14Feb2023; No adverse event; Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (vial was first punctured on 11Feb 2023 and administration of vaccine on 14Feb2023) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female 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.     Patient's health history was unknown. It was reported that there was no diagnosis. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 14-Feb-2023 at 5:15 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 14-Feb-2023 at 5:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured on 11Feb 2023 and administration of vaccine on 14Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (vial was first punctured on 11Feb 2023 and administration of vaccine on 14Feb2023) 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 (Expired vaccine used) and PRODUCT STORAGE ERROR (vial was first punctured on 11Feb 2023 and administration of vaccine on 14Feb2023).    No concomitant medication were reported.  Facility administered a vaccine more than 12 hours post puncture to a patient. The vaccine was punctured on 11-Feb-2023 and was in refrigerated storage. Bivalent vaccine 6yrs and older. Individual vial of 5.5 mL. The vial was initially stored in the refrigerator on 11-Feb-2023. The vial was first punctured on 11-Feb-2023 at 9:06 PM. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range for more than 12 hours. No treatment information was provided by the reporter.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received Bivalent Moderna COVID-19 vaccine booster instead of the 2nd Primary monovalent dose; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent Moderna COVID-19 vaccine booster instead of the 2nd Primary monovalent dose) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax (Dose 1 andFirst Primary monovalent dose (Lot# 083B22A & Exp. Date: unknown)) on 23-Jan-2023. Past adverse reactions to the above products included No adverse event with Spikevax.    On 21-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-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 (Received Bivalent Moderna COVID-19 vaccine booster instead of the 2nd Primary monovalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent Moderna COVID-19 vaccine booster instead of the 2nd Primary monovalent 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Bivalent Moderna COVID-19 vaccine booster instead of the 2nd Primary monovalent dose).    Concomitant medication was not provided.   Treatment information was not provided.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 17-year-old patient presented to their pharmacy stating that he received a First primary dose of Moderna COVID-19 vaccine with a Bivalent Booster instead of Monovalent at another facility; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (17-year-old patient presented to their pharmacy stating that he received a First primary dose of Moderna COVID-19 vaccine with a Bivalent Booster instead of Monovalent at another facility) and NO ADVERSE EVENT (No adverse event) in a 17-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.    On 27-Jan-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) 1 dosage form. On 27-Jan-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 (17-year-old patient presented to their pharmacy stating that he received a First primary dose of Moderna COVID-19 vaccine with a Bivalent Booster instead of Monovalent at another facility). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (17-year-old patient presented to their pharmacy stating that he received a First primary dose of Moderna COVID-19 vaccine with a Bivalent Booster instead of Monovalent at another facility) 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 (17-year-old patient presented to their pharmacy stating that he received a First primary dose of Moderna COVID-19 vaccine with a Bivalent Booster instead of Monovalent at another facility).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications were reported. No treatment details were reported.
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Product storage error; no adverse event; reported excursion on 14Feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in a 20-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jan-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023), PRODUCT STORAGE ERROR (Product storage 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (reported excursion on 14Feb2023) and PRODUCT STORAGE ERROR (Product storage error).    Concomitant product use was not provided by the reporter.  One of the medical assistants reported excursion on 14-Feb-2023 previously. Now they are following up to see if the 6 doses administered to children during this time need to be revaccinated or not.   Maximum temperature was 1.8 C. Storage at time of excursion was freezer. Excursion duration was unknown for each day starting on 01-Feb-2023 and continued until 14-Feb-2023. HCP can confirm it was not out of range the entire day.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712044 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Feb-2023: Live Followup recived included non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712044:
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Moderna Bivalent booster dose was inadvertently administered on 17-Feb-2023, instead of second Monovalent primary series dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster dose was inadvertently administered on 17-Feb-2023, instead of second Monovalent primary series dose) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     It was reported that patient had no known allergies and did not had any COVID test. It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (1st Monovalent primary series) on 25-Jan-2023. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On 17-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-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 (Moderna Bivalent booster dose was inadvertently administered on 17-Feb-2023, instead of second Monovalent primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster dose was inadvertently administered on 17-Feb-2023, instead of second Monovalent primary series 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna Bivalent booster dose was inadvertently administered on 17-Feb-2023, instead of second Monovalent primary series dose).    It was reported that patient received 1st Monovalent primary series dose on 25-Jan-2023 lot number 074B22A on the same facility. No adverse reaction was reported by the patient with administration error. No concomitant information was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time; One of the medical assistants reported excursion on 14Feb2023 previously.; Maximum temperature: -1.8 C Storage at time of excursion: freezer Excursion duration: unknown for each day starting on 01Feb2023 and continued until 14Feb2023; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time), PRODUCT TEMPERATURE EXCURSION ISSUE (One of the medical assistants reported excursion on 14Feb2023 previously.), PRODUCT STORAGE ERROR (Maximum temperature: -1.8 C Storage at time of excursion: freezer Excursion duration: unknown for each day starting on 01Feb2023 and continued until 14Feb2023) and NO ADVERSE EVENT (no adverse event) in a child female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time), PRODUCT TEMPERATURE EXCURSION ISSUE (One of the medical assistants reported excursion on 14Feb2023 previously.), PRODUCT STORAGE ERROR (Maximum temperature: -1.8 C Storage at time of excursion: freezer Excursion duration: unknown for each day starting on 01Feb2023 and continued until 14Feb2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time), PRODUCT TEMPERATURE EXCURSION ISSUE (One of the medical assistants reported excursion on 14Feb2023 previously.), PRODUCT STORAGE ERROR (Maximum temperature: -1.8 C Storage at time of excursion: freezer Excursion duration: unknown for each day starting on 01Feb2023 and continued until 14Feb2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712044 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Feb-2023: Follow-up received contains additional no new information was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712044:
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the fridge on 16-Jan-2023, vaccine administered on 21-FEB-2023; No adverse event; they accidentally gave a bivalent booster dose which was 5 days beyond the BUD to a patient today; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they accidentally gave a bivalent booster dose which was 5 days beyond the BUD to a patient today), PRODUCT STORAGE ERROR (vial was initially stored in the fridge on 16-Jan-2023, vaccine administered on 21-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H221) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: ATORVAGEN [ATORVASTATIN] (no longer taking) in May 2022 and ALMACOR [AMLODIPINE] (no longer taking) in May 2022. Past adverse reactions to the above products included No adverse event with ALMACOR [AMLODIPINE] and ATORVAGEN [ATORVASTATIN]. Concurrent medical conditions included Hypothyroidism (On Hydrochlorothiazide and levothyroxine for hypothyroid.). Concomitant products included HYDROCHLOROTHIAZIDE and LEVOTHYROXINE for Hypothyroidism.    On 21-Feb-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 21-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they accidentally gave a bivalent booster dose which was 5 days beyond the BUD to a patient today). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the fridge on 16-Jan-2023, vaccine administered on 21-FEB-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they accidentally gave a bivalent booster dose which was 5 days beyond the BUD to a patient today), PRODUCT STORAGE ERROR (vial was initially stored in the fridge on 16-Jan-2023, vaccine administered on 21-FEB-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they accidentally gave a bivalent booster dose which was 5 days beyond the BUD to a patient today) and PRODUCT STORAGE ERROR (vial was initially stored in the fridge on 16-Jan-2023, vaccine administered on 21-FEB-2023).    Pharmacist called to report that they accidentally gave a bivalent booster dose which was 5 days beyond the BUD to a patient. The date the vial was initially stored in the fridge was on 16-Jan-2023.  Pharmacist called an hour after the administration and patient had not reported any adverse event.  No treatment drug was reported.