chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Internal shingles after both doses/ suspected vaccination failure; Internal shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer (stage 4 unspecified cancer).   On an unknown date, the patient received the 2nd dose of Shingrix (right arm) and the 1st dose of Shingrix (right arm). On 01-FEB-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Internal shingles after both doses/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Internal shingles). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Linked case(s) involving the same patient:  US2023AMR048483   Additional Information: GSK Receipt Date: 29-MAR-2023 The patient was self-reported this case. The patient reported that he received both doses of Shingrix vaccine in 2020 and experienced internal shingles and was still suffering with them after 8 weeks. The patient received Valacyclovir as a treatment and he was on his third regimen of Valacyclovir. The patient reported that the Valacyclovir did not seem to help. The patient had stage 4 unknown type cancer that had been just declared cancer free by his physician since he was getting internal shingles. The reporter gave permission to contact his cancer MD physician. The reporter did consent to follow up. This case was considered as suspected vaccination failure as laboratory confirmation regarding shingles were unknown at the time of reporting. This case has been linked with case US2023AMR048483 reported by same reporter for same patient; Sender's Comments:  US-GSK-US2023AMR048483:Same Report (Vaccines Case)
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Dose1-17-Mar-2021 and Dose2-13-sep-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose1-17-Mar-2021 and Dose2-13-sep-2021) and NO ADVERSE EVENT (no adverse event) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient had never been diagnosed with or tested positive for COVID-19. The patient had no acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included GERD, Vertigo and Schizophrenia. Concomitant products included LANSOPRAZOLE for GERD, CLOZAPINE for Schizophrenia, MECLIZINE [MECLOZINE] for Vertigo.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose1-17-Mar-2021 and Dose2-13-sep-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 (Dose1-17-Mar-2021 and Dose2-13-sep-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 (Dose1-17-Mar-2021 and Dose2-13-sep-2021).    The patient received fourth dose on 12-Oct-2022 and the fifth dose of Moderna Bivalent lot no. 023H22A, route intramuscular on left arm. No treatment medication were reported.   This case was linked to MOD-2023-714206 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: Dermatomyositis
Clinical narrative: vaccines developed Dermatomyositis; This spontaneous case was reported by a consumer and describes the occurrence of DERMATOMYOSITIS (vaccines developed Dermatomyositis) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DERMATOMYOSITIS (vaccines developed Dermatomyositis) (seriousness criterion medically significant). At the time of the report, DERMATOMYOSITIS (vaccines developed Dermatomyositis) outcome was unknown.            Concomitant medications were not reported.  No treatment information was reported Company comment: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected and serious (medically significant) event of dermatomyositis after receiving a dose of mRNA-1273.222, which was the patient's unknown dose of COVID-19 vaccination schedule. Exact onset date for event is not known and dose vaccination date is also unknown therefore the latency cannot be assessed. There is limited information in the case- demographic data, onset dates of the event, vaccination date and consecutive dose number in Covid-19 vaccination schedule, family and medical history, concurrent diseases, concomitant medications, diagnostic workup, treatment and event outcome. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-713514, US-MODERNATX, INC.-MOD-2023-713516 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713514: US-MODERNATX, INC.-MOD-2023-713516:sister case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 16-feb-2023 and administed on 22-feb-2023; No adverse event; 6 adult patients received expired Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 adult patients received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 16-feb-2023 and administed on 22-feb-2023) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-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 22-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 adult patients received expired Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 16-feb-2023 and administed on 22-feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 adult patients received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 16-feb-2023 and administed on 22-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 (6 adult patients received expired Bivalent Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 16-feb-2023 and administed on 22-feb-2023).    Concomitant medication was not provided.  Pharmacist reported that the dose administered after 30-day Use By Date. The vial was intact carton and size was 2.5 ml. The vial was initially stored in refrigerator on 16-Jan-2023 . The vial did not undergo any temperature excursion. Treatment information was not provided. This case contains information for the 2nd patient out of 6 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-717807, US-MODERNATX, INC.-MOD-2023-717810, US-MODERNATX, INC.-MOD-2023-717812, US-MODERNATX, INC.-MOD-2023-717811, US-MODERNATX, INC.-MOD-2023-717809 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717812:Adult Patient 6 US-MODERNATX, INC.-MOD-2023-717810:Adult Patient 4 US-MODERNATX, INC.-MOD-2023-717811:Adult Patient 5 US-MODERNATX, INC.-MOD-2023-717807:Adult Patient 1 US-MODERNATX, INC.-MOD-2023-717809:Adult Patient 3
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator 16-Jan-2023/vaccine administered on 05-Mar-2023; No adverse event; Patient received expired Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 16-Jan-2023/vaccine administered on 05-Mar-2023) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 05-Mar-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 05-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 16-Jan-2023/vaccine administered on 05-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 16-Jan-2023/vaccine administered on 05-Mar-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 (Patient received expired Bivalent Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 16-Jan-2023/vaccine administered on 05-Mar-2023).    No concomitant medications were reported.  Vial size was reported as 2.5 ml The vial was initially stored in the refrigerator 16-Jan-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 4th of 6th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-717807, US-MODERNATX, INC.-MOD-2023-717807, US-MODERNATX, INC.-MOD-2023-717808, US-MODERNATX, INC.-MOD-2023-717809, US-MODERNATX, INC.-MOD-2023-717811, US-MODERNATX, INC.-MOD-2023-717812 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717807: US-MODERNATX, INC.-MOD-2023-717807: US-MODERNATX, INC.-MOD-2023-717808: US-MODERNATX, INC.-MOD-2023-717809: US-MODERNATX, INC.-MOD-2023-717811: US-MODERNATX, INC.-MOD-2023-717812: US-MODERNATX, INC.-MOD-2023-717812:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 16-Jan-2023; No adverse event; Patient received expired Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Jan-2023) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Mar-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 05-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Jan-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 (Patient received expired Bivalent Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Jan-2023).    Concomitant medication was not provided.  Pharmacist reported that the dose administered after 30-day Use By Date. The vial was intact carton and size was 2.5 ml. The vial was initially stored in refrigerator on 16-Jan-2023 . The vial did not undergo any temperature excursion. Treatment information was not provided. This case contains information for the 5th patient out of 6 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-717807, US-MODERNATX, INC.-MOD-2023-717810, US-MODERNATX, INC.-MOD-2023-717812, US-MODERNATX, INC.-MOD-2023-717808, US-MODERNATX, INC.-MOD-2023-717809 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717807:Adult Patient  US-MODERNATX, INC.-MOD-2023-717810:Adult Patient  US-MODERNATX, INC.-MOD-2023-717812:Adult Patient  US-MODERNATX, INC.-MOD-2023-717808:Adult Patient  US-MODERNATX, INC.-MOD-2023-717809:Adult Patient
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 16JAN2023; No adverse event; adult patient received expired Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (adult patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16JAN2023) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-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 13-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (adult patient received expired Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16JAN2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (adult patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16JAN2023) 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 (adult patient received expired Bivalent Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16JAN2023).    No concomitant medications were reported.  It was reported that 6 Adult patients received the expired Bivalent booster dose from 16-Feb-2023 to 13-Mar-2023. 1 Patient received on 16-Feb-2023, 2 Patients on 22-Feb-2023, 2 Patients on 05-Mar-2023 and 1 patient received vaccine on 13-Mar-2023. There were Intact cartons of vial size 2.5 ml. The vial was initially stored in the refrigerator on 16-Jan-2023. The vial did not undergo any temperature excursions.  No treatment details were reported. This case contains information for the 6th of 6th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-717807, US-MODERNATX, INC.-MOD-2023-717808, US-MODERNATX, INC.-MOD-2023-717809, US-MODERNATX, INC.-MOD-2023-717810, US-MODERNATX, INC.-MOD-2023-717811 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717807: US-MODERNATX, INC.-MOD-2023-717808: US-MODERNATX, INC.-MOD-2023-717809: US-MODERNATX, INC.-MOD-2023-717810: US-MODERNATX, INC.-MOD-2023-717811:
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Dizziness, Pain in extremity
Clinical narrative: felt faintish after 2nd bivalent booster vaccine; had pain in legs after 1st bivalent booster vaccine; had pain in chest after 1st bivalent booster vaccine; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (felt faintish after 2nd bivalent booster vaccine), PAIN IN EXTREMITY (had pain in legs after 1st bivalent booster vaccine) and CHEST PAIN (had pain in chest after 1st bivalent booster vaccine) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third 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, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (felt faintish after 2nd bivalent booster vaccine), PAIN IN EXTREMITY (had pain in legs after 1st bivalent booster vaccine) and CHEST PAIN (had pain in chest after 1st bivalent booster vaccine). At the time of the report, DIZZINESS (felt faintish after 2nd bivalent booster vaccine), PAIN IN EXTREMITY (had pain in legs after 1st bivalent booster vaccine) and CHEST PAIN (had pain in chest after 1st bivalent booster vaccine) had resolved.        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 Moderna monovalent vaccine as dose 1 and dose2. It was reported that patient had experienced different side effects after taking vaccine which took several days to overcome.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-024164 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024164:Monovalent Product
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Nurse administered 3rd monovalent vaccine to child that is not immunocompromised; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Nurse administered 3rd monovalent vaccine to child that is not immunocompromised) and NO ADVERSE EVENT (No adverse event) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     The patient's past medical history included Developmental delay.    On 28-Mar-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2023, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Nurse administered 3rd monovalent vaccine to child that is not immunocompromised). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Nurse administered 3rd monovalent vaccine to child that is not immunocompromised) 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 INCORRECT DOSE ADMINISTERED (Nurse administered 3rd monovalent vaccine to child that is not immunocompromised).    Concomitant medication details not reported by the reporter. Nurse reported that a pediatric patient (1-year & 1 month-old) received a 3rd Monovalent Moderna COVID-19 vaccine on 28-MAR-2023. Nurse states that this patient has a diagnosis of Delayed Milestones in Sacral Temple. After administering the 3rd dose for immunocompromised, they realized that they are not sure if the current diagnosis qualifies her for immunocompromised. Nurse was not sure if the patient was immunocompromised, but the 3rd primary dose for immunocompromised was administered on 28-MAR-2023. Treatment details was not reported by the reporter.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; who gave a child Moderna Bivalent Booster dose to an Adult male over 65; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (who gave a child Moderna Bivalent Booster dose to an Adult male over 65) and NO ADVERSE EVENT (No adverse event) in a 60-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 29-Mar-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 29-Mar-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 (who gave a child Moderna Bivalent Booster dose to an Adult male over 65). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (who gave a child Moderna Bivalent Booster dose to an Adult male over 65) 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 (who gave a child Moderna Bivalent Booster dose to an Adult male over 65).    No concomitant medication details was reported. No treatment medication details was reported.
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; A patient was administered with the bivalent vaccine instead of the monovalent vaccine for his 1st dose in the primary series.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A patient was administered with the bivalent vaccine instead of the monovalent vaccine for his 1st dose in the primary series.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.   Concurrent medical conditions included Multiple sclerosis.    On 06-Nov-2022, 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 06-Nov-2022, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (A patient was administered with the bivalent vaccine instead of the monovalent vaccine for his 1st dose in the primary series.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A patient was administered with the bivalent vaccine instead of the monovalent vaccine for his 1st dose in the primary series.) 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 (A patient was administered with the bivalent vaccine instead of the monovalent vaccine for his 1st dose in the primary series.).    No concomitant medications were reported.  Patient was treated for nerve condition at HCP office. The neurological condition has remained stable post vaccine administration.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2023: Live significant Follow-up appended: Product information, event information, narrative updated
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Dose of pediatric presentation administered to adult patient today. Pediatric bivalent vaccine administered as booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Dose of pediatric presentation administered to adult patient today. Pediatric bivalent vaccine administered as booster dose.) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Mar-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 30-Mar-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 (Dose of pediatric presentation administered to adult patient today. Pediatric bivalent vaccine administered as booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Dose of pediatric presentation administered to adult patient today. Pediatric bivalent vaccine administered as booster 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 (Dose of pediatric presentation administered to adult patient today. Pediatric bivalent vaccine administered as booster dose.).    Dosage text for suspect product was reported as additional booster.  Concomitant drugs were not reported.  It was reported that pediatric bivalent vaccine was administered as booster dose to adult patient. No other symptoms were reported.  Treatment medications were not provided.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 6 patients were accidentally administered with 3 different expired lot numbers of monovalent Moderna COVID-19 Vaccine. Patient number 6 was vaccinated on 2MAR2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different expired lot numbers of monovalent Moderna COVID-19 Vaccine. Patient number 6 was vaccinated on 2MAR2023) and NO ADVERSE EVENT (No adverse event) in a 15-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 057B22A) for COVID-19 prophylaxis.     It was unknown patient received  any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 02-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different expired lot numbers of monovalent Moderna COVID-19 Vaccine. Patient number 6 was vaccinated on 2MAR2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different expired lot numbers of monovalent Moderna COVID-19 Vaccine. Patient number 6 was vaccinated on 2MAR2023) 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 EXPIRED PRODUCT ADMINISTERED (6 patients were accidentally administered with 3 different expired lot numbers of monovalent Moderna COVID-19 Vaccine. Patient number 6 was vaccinated on 2MAR2023).    No concomitant medications was provided. No treatment medications was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient didn´t report any side effects.; dose of the Moderna Covid-19 vaccine was administered after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of the Moderna Covid-19 vaccine was administered after the expiration date.) and NO ADVERSE EVENT (The patient didn´t report any side effects.) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 30-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 30-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of the Moderna Covid-19 vaccine was administered after the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (The patient didn´t report any side effects.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose of the Moderna Covid-19 vaccine was administered after the expiration date.) and NO ADVERSE EVENT (The patient didn´t report any side effects.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (The patient didn´t report any side effects.) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (dose of the Moderna Covid-19 vaccine was administered after the expiration date.).    No concomitant medications was provided. No treatment medications was provided.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Accidentally administered with 3 different EXPIRED lot numbers; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers).    This case was created for 2nd patient of the 6 patients involved.  Concomitant medication was not provided. It was reported that 6 patients were accidentally administered with 3 different EXPIRED lot numbers of monovalent Moderna COVID-19 Vaccine. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2023: Follow-up received and added reporter details, patient initials and patients details were added, dosage information added.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: patient has not received their 2nd dose of the primary series so far; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (patient has not received their 2nd dose of the primary series so far) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (patient has not received their 2nd dose of the primary series so far) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (patient has not received their 2nd dose of the primary series so far) 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 ADMINISTRATION INTERRUPTED (patient has not received their 2nd dose of the primary series so far).    No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 16-Jan-2023 and was administered on 22-Feb-2023; No adverse event; Adult patient received expired Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 16-Jan-2023 and was administered on 22-Feb-2023) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-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 22-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 16-Jan-2023 and was administered on 22-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 16-Jan-2023 and was administered on 22-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 (Adult patient received expired Bivalent Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 16-Jan-2023 and was administered on 22-Feb-2023).    No concomitant information was reported. Suspect product dosage text was reported as additional booster. The 2.5 ml vial was initially stored in refrigerator on 16-Jan-2023 and did not underwent any temperature excursions. No treatment information was provided. This case is reported for adult patient 3 out of 6 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-717807, US-MODERNATX, INC.-MOD-2023-717810, US-MODERNATX, INC.-MOD-2023-717812, US-MODERNATX, INC.-MOD-2023-717811 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717812: US-MODERNATX, INC.-MOD-2023-717810: US-MODERNATX, INC.-MOD-2023-717811: US-MODERNATX, INC.-MOD-2023-717807:
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 16-JAN-2023 and was administered on 16-FEB-2023; No adverse event; Adult patient received expired Bivalent Moderna COVID-19 vaccine booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine booster), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-JAN-2023 and was administered on 16-FEB-2023) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-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 16-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine booster). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-JAN-2023 and was administered on 16-FEB-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine booster), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-JAN-2023 and was administered on 16-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 (Adult patient received expired Bivalent Moderna COVID-19 vaccine booster) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-JAN-2023 and was administered on 16-FEB-2023).    No concomitant medications were reported. Dose was administered after 30-day Use By Date. Vial size was reported as 2.5 mL. The vial was initially stored in the refrigerator on 16-JAN-2023. Vial did not undergo any temperature excursions. No treatment information was provided.  This case was reported for patient 1 of 6.   This case was linked to US-MODERNATX, INC.-MOD-2023-717808, US-MODERNATX, INC.-MOD-2023-717809, US-MODERNATX, INC.-MOD-2023-717810, US-MODERNATX, INC.-MOD-2023-717811, US-MODERNATX, INC.-MOD-2023-717812 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717808:same reporter US-MODERNATX, INC.-MOD-2023-717809:same reporter US-MODERNATX, INC.-MOD-2023-717810:same reporter US-MODERNATX, INC.-MOD-2023-717811:same reporter US-MODERNATX, INC.-MOD-2023-717812:same reporter
Age: 69.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator 21-FEB-2023, BUD 23-MAR-2023 and administration of vaccine 30-MAR-2023; No adverse event; HCP states that a dose was administered inadvertently to a patient today after the 30 day beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that a dose was administered inadvertently to a patient today after the 30 day beyond use date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21-FEB-2023, BUD 23-MAR-2023 and administration of vaccine 30-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 69-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. AS7173B) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On 30-Mar-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that a dose was administered inadvertently to a patient today after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21-FEB-2023, BUD 23-MAR-2023 and administration of vaccine 30-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that a dose was administered inadvertently to a patient today after the 30 day beyond use date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21-FEB-2023, BUD 23-MAR-2023 and administration of vaccine 30-MAR-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 (HCP states that a dose was administered inadvertently to a patient today after the 30 day beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 21-FEB-2023, BUD 23-MAR-2023 and administration of vaccine 30-MAR-2023).    No concomitant medication were reported.  HCP stated that a dose of the Moderna COVID-19 bivalent vaccine was administered inadvertently to a patient after the 30 day beyond use date. HCP was looking for viability assessment of this invalid dose that was administered to the patient. Bivalent product (BUD 23-MAR-2023) Vial size was 2.5 mL. The vial was initially stored in the refrigerator on 21-FEB-2023. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Vaccine administrators gave a bivalent dose as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Vaccine administrators gave a bivalent dose as a second dose) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Mar-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Mar-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 (Vaccine administrators gave a bivalent dose as a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Vaccine administrators gave a bivalent dose as a second 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 (Vaccine administrators gave a bivalent dose as a second dose).    The concomitant medication was not reported by reporter. The patient's first Moderna dose was given on 09-Dec-2022 batch number Unknown for COVID-19 prophylaxis. The pharmacist stated one of the vaccine administrators gave a bivalent dose as a second dose yesterday 29-Mar-2023. He called and reported it to unknown, who was the federal partner. One of the things he was told to do was to call Moderna and get guidance for what they should do for the patient. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The treatment medication was not reported by reporter.