chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients) 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.     Patient did not report any medical history, conditions, allergy, concomitant diseases, or risk factor (including any previous COVID-19 diagnosis). It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients).    Concomitant drugs were not reported. It was reported that vaccines were administered to 20 patients between 13-Mar-2023 to 05-Jun-2023 past the BUD of 17-Feb-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Treatment medications were not provided.  This case was reported for patient 11 of 20.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) 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.     Patient did not report any medical history, conditions, allergy, concomitant diseases, or risk factor (including any previous COVID-19 diagnosis). It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.).    Concomitant drugs were not reported. It was reported that vaccines were administered to 20 patients between 13-Mar-2023 to 05-Jun-2023 past the BUD of 17-Feb-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Treatment medications were not provided.  This case was reported for patient 14 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case of Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.; No adverse event; Two doses were administered on 05-JUN-2023 after the excursion happened; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.), POOR QUALITY PRODUCT ADMINISTERED (Two doses were administered on 05-JUN-2023 after the excursion happened) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-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-Jun-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Two doses were administered on 05-JUN-2023 after the excursion happened). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.), POOR QUALITY PRODUCT ADMINISTERED (Two doses were administered on 05-JUN-2023 after the excursion happened) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion during 2 days and 11 hours.) and POOR QUALITY PRODUCT ADMINISTERED (Two doses were administered on 05-JUN-2023 after the excursion happened).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Concomitant medication details not reported by the reporter. Maximum temperature reached was 57A°F. This was the first and only excursion. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727790 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727790:patient 1 of 2
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received vaccine after its expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) 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. 014H22A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date).    No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided. This case contains information for the 2nd of 7 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727965 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727965:Master Case of Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received vaccine after its expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) 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. 014H22A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date).    No concomitant medication was reported.  Dosage text reported as unknown. No treatment information was reported.  This case contains information for patient 5 out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-727965 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727965:Master Case of Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received vaccine after its expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) 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. 014H22A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date).    No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided. This case contains information for the 7th of 7 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727965 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727965:Master Case of Patient 1
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 21-May-2023; No Adverse Event; 3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A), PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 21-May-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. 069H22A) for COVID-19 prophylaxis.     Patient did not had any relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 21-May-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-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 21-May-2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A), PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 21-May-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 (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A) and PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 21-May-2023).    Dosage text was reported as unknown. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant information was reported. The vaccine use by date was reported as 18-May-2023. The administration date of 3 vials was19-May-2023, 21-May-2023, 25-May-2023. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-727536, US-MODERNATX, INC.-MOD-2023-727687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727536:same reporter US-MODERNATX, INC.-MOD-2023-727687:same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; vaccine that was given 1 day after calculated beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine that was given 1 day after calculated beyond use date) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 31-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine that was given 1 day after calculated beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine that was given 1 day after calculated beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (vaccine that was given 1 day after calculated beyond use date).    No concomitant medication was reported. It was reported that a vial of vaccine that was given 1 day after calculated beyond use date. Beyond Use date calculated was 30-May-2023 Patient was given 1 dose. No other temperature excursions occurred during storage or transport.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2023: Follow up received contains Non-significant information
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: had Covid-19 the week of May 9, 2023; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (had Covid-19 the week of May 9, 2023) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A T) for COVID-19 prophylaxis.     Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot.    On 30-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (had Covid-19 the week of May 9, 2023). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (had Covid-19 the week of May 9, 2023) 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.   No concomitant information was reported. It was reported that patient wife had mild case of Covid-19 vaccine. Like having the flu for a couple of days and then started to get better. The patient and his wife were prescribed Paxlovid and felt worse after day 1 of the Paxlovid regimen They felt so bad from the Paxlovid worse from Paxlovid than from the Covid-19 infection. Patient and his wife stopped the Paxlovid after 1 day.   This case was linked to MOD-2023-727718 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Report that vaccination 06/02 with expiration date 05/30/Expired vaccine administered 6/2/23 and expired on 5/30/23; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Report that vaccination 06/02 with expiration date 05/30/Expired vaccine administered 6/2/23 and expired on 5/30/23) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     Information related to medical history, conditions, allergy, concomitant diseases and risk factor was reported as not applicable.     On 02-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 02-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Report that vaccination 06/02 with expiration date 05/30/Expired vaccine administered 6/2/23 and expired on 5/30/23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Report that vaccination 06/02 with expiration date 05/30/Expired vaccine administered 6/2/23 and expired on 5/30/23) 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 EXPIRED PRODUCT ADMINISTERED (Report that vaccination 06/02 with expiration date 05/30/Expired vaccine administered 6/2/23 and expired on 5/30/23).    Concomitant medications were not reported.  Patient had expired vaccine on 02-JUN-2023.  Patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2023: Live follow up received is significant. Case was updated. Where the reaction occurred was  updated.
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. 051D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-May-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 26-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine).    No concomitant medications were provided. It was reported that patient did not reported any adverse reactions at this time.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-727939 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727939:Same reporter
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. 051D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-May-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 23-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-727945 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727945:Same reporter
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Poor quality vaccine administered; No adverse event; HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP states that the excursion occurred on 31MAY2023 and the vaccine was administered to 4 patients post excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No relevant concomitant medications were reported.  Ten doses of Moderna, go out of range (46.6 F degrees) for 5 minutes on 31-May-2023.   HCP states that the excursion occurred on 31-May-2023 and the vaccine was administered to 4 patients post excursion.  HCP stated that the vials were stored in a cooler. They were thawed vials and were stored in the refrigerated temperature range in the cooler.  No treatment medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-727913 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2023: Patient, vaccine and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727913:Master case
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; HCP stated they accidentally administered 1 dose of Moderna COVID-19 vaccine Bivalent presentation from dark pink cap on 25 APR 2023 to a 7 months old patient that was not previously vaccinated.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 vaccine Bivalent presentation from dark pink cap on 25 APR 2023 to a 7 months old patient that was not previously vaccinated.) and NO ADVERSE EVENT (No Adverse Event) in a 7-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     It was reported that patient had no known conditions.  Previously administered products included for Product used for unknown indication: PEDIARIX, Rotavirus, PNEUMOCOCCAL CONJUGATE VACCINE (PCV13) and HAEMOPHILUS INFLUENZAE TYPE B (Hib). Past adverse reactions to the above products included No adverse event with HAEMOPHILUS INFLUENZAE TYPE B, PEDIARIX, PNEUMOCOCCAL CONJUGATE VACCINE and Rotavirus.    On 25-Apr-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) .2 milliliter. On 25-Apr-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 (HCP stated they accidentally administered 1 dose of Moderna COVID-19 vaccine Bivalent presentation from dark pink cap on 25 APR 2023 to a 7 months old patient that was not previously vaccinated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 vaccine Bivalent presentation from dark pink cap on 25 APR 2023 to a 7 months old patient that was not previously vaccinated.) 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 (HCP stated they accidentally administered 1 dose of Moderna COVID-19 vaccine Bivalent presentation from dark pink cap on 25 APR 2023 to a 7 months old patient that was not previously vaccinated.).    Concomitant drugs were not reported. It was reported that patient had all the Pediarix, Hib, PCV13. Rotavirus vaccine on the same day. No other adverse events were reported. Treatment medications were not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Headache
Clinical narrative: don't feel very good either; have a headache but not throwing up; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (don't feel very good either) and HEADACHE (have a headache but not throwing up) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 05-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jun-2023, the patient experienced FEELING ABNORMAL (don't feel very good either) and HEADACHE (have a headache but not throwing up). At the time of the report, FEELING ABNORMAL (don't feel very good either) and HEADACHE (have a headache but not throwing up) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: 7 patients in received vaccine after its expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients in received vaccine after its expiration date) 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. 014H22A) 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 EXPIRED PRODUCT ADMINISTERED (7 patients received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 patients received vaccine after its expiration date).    Concomitant product use was not provided by the reporter.  Limited Adverse Event reported on 5 patients of the 7 patients that received vaccine past it expiration date. Information on two patients was collected.  Treatment information was not provided.  This case contains information about patient 6th out of 7 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-727965 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727965:Master Case of Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: We have a pediatric patient that we accidentally gave 2 Moderna bivalent shots. We just wanted to report it. 1. 17Dec2022 2. 30May2023; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (We have a pediatric patient that we accidentally gave 2 Moderna bivalent shots. We just wanted to report it. 1. 17Dec2022 2. 30May2023) and NO ADVERSE EVENT (no adverse event) 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 17-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-May-2023, 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 EXTRA DOSE ADMINISTERED (We have a pediatric patient that we accidentally gave 2 Moderna bivalent shots. We just wanted to report it. 1. 17Dec2022 2. 30May2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (We have a pediatric patient that we accidentally gave 2 Moderna bivalent shots. We just wanted to report it. 1. 17Dec2022 2. 30May2023) 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 EXTRA DOSE ADMINISTERED (We have a pediatric patient that we accidentally gave 2 Moderna bivalent shots. We just wanted to report it. 1. 17Dec2022 2. 30May2023).    Concomitant medication details not reported by the reporter. It was reported that a pediatric patient that accidentally received 2 Moderna bivalent shots. They just wanted to report it. First vaccine was administered on 17-Dec-2022 and second vaccine was administered on 30-May-2023. Treatment details was not reported by the reporter.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; second Bivalent in Jan2023 for some reason they got the second bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (second Bivalent in Jan2023 for some reason they got the second bivalent booster) and NO ADVERSE EVENT (No adverse event) 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.     HCP reported the patient did not say what health conditions they had.    In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, 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. In January 2023, the patient experienced EXTRA DOSE ADMINISTERED (second Bivalent in Jan2023 for some reason they got the second bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (second Bivalent in Jan2023 for some reason they got the second bivalent booster) 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 EXTRA DOSE ADMINISTERED (second Bivalent in Jan2023 for some reason they got the second bivalent booster).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Concomitant medication details not reported by the reporter. HCP reports a patient received their first bivalent somewhere in sep-2022 and then second Bivalent in Jan-2023 for some reason they got the second bivalent booster when it was not approved at that time. Treatment details was not reported by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient had nausea,felt nauseous; Patient had vomiting; Patient was dizzy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NAUSEA (Patient had nausea,felt nauseous), VOMITING (Patient had vomiting) and DIZZINESS (Patient was dizzy) in a 74-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.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (All other boosters). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.    On 05-Jun-2023 at 3:00 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jun-2023 at 3:00 AM, the patient experienced NAUSEA (Patient had nausea,felt nauseous), VOMITING (Patient had vomiting) and DIZZINESS (Patient was dizzy). At the time of the report, NAUSEA (Patient had nausea,felt nauseous), VOMITING (Patient had vomiting) and DIZZINESS (Patient was dizzy) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient has taken some motion sickness pill to try and helped for his symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2023-727955 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727955:Same reporter(Wife's case)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; vaccines administered past the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 037A22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Nov-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date.) 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 (vaccines administered past the expiration date.).    No concomitant medication was reported. It was reported that the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max -24C and Min -23C The following doses/Lot numbers were impacted. Trade Name Moderna Bivalent Lot AS7140C Received 9/2/2022 CDC Expiration 5/7/2023 Report Type EXP Date of Administration 5/8/2023 doses 1 Trade Name: Moderna COVID-19 Vaccine Lot: 037A22B Received: 5/19/2022 CDC expiration 10/31/2022 report type EXP Date of administration 11/15/2022 doses: 1 Moderna COVID-19 Vaccine Lot 060H21A received: 12/27/2020 CDC expiration: 3/28/2022 report type: EXP 4/11/2022 doses: 13 Moderna COVID-19 Vaccine Lot: 083B22A received: 11/15/2022 CDC expiration: 2/28/2023 report type: EXP administration date:4/5/2023 doses: 3. HCP doesn´t have any patient identifiers. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Live Follow up received contains No NewInformation
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; vaccines administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-May-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 08-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date).    No concomitant medication information was provided.   It was reported that the vaccines were stored in a standard freezer (15 degree Celsius to -25 degree Celsius). Their temperatures were Max -24C and Min -23C The following doses/Lot numbers were also impacted, Moderna COVID-19 Vaccine Lot: 037A22B Received: 19May2022 CDC expiration 31Oct2022, Date of administration 15Nov2022, Moderna COVID-19 Vaccine Lot 060H21A received: 27Dec2020 CDC expiration 28Mar2022, Administration 11Apr2022, Moderna COVID-19 Vaccine Lot: 083B22A received: 15Nov2022 CDC expiration: 28Feb2023, administration date:5Apr2023  HCP doesn´t had any patient identifiers.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-728242 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728242:Same reporter (Lot number 083B22A)