Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 08-Jun-2022; Administered  expired vaccine to more than 40 patients/ Vaccine was expired on 13-May-2022 and administered on 08-Jun-2022 / Dose administered post the expiration or beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered  expired vaccine to more than 40 patients/ Vaccine was expired on 13-May-2022 and administered on 08-Jun-2022 / Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 08-Jun-2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 034F21A, 040B21A and 036A21A) for COVID-19 prophylaxis.     It was unknown whether patient was diagnosed/tested positive for COVID-19.  It was reported acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.  Concurrent medical conditions included Blood pressure high and Diabetic.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Jun-2022 at 8:54 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 08-Jun-2022 at 8:54 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered  expired vaccine to more than 40 patients/ Vaccine was expired on 13-May-2022 and administered on 08-Jun-2022 / Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 08-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered  expired vaccine to more than 40 patients/ Vaccine was expired on 13-May-2022 and administered on 08-Jun-2022 / Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 08-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Administered  expired vaccine to more than 40 patients/ Vaccine was expired on 13-May-2022 and administered on 08-Jun-2022 / Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 08-Jun-2022).    No concomitant medications were reported.  The health care professional thought that Moderna had an extension like Pfizer, and though it would expire on the 13-Jul-2022 but it was expired on the 13-May-2022 and they realize this on the 08-Jun-2022. On 17-May-2022, vials were initially stored in refrigerator. The vial did not undergo any temperature excursions. The patient did not seek medical care for events. There were no other potential causes for the event.  No treatment medications were provided.   This case was linked to PR-MODERNATX, INC.-MOD-2022-585601, US-MODERNATX, INC.-MOD-2022-586783, US-MODERNATX, INC.-MOD-2022-586792, US-MODERNATX, INC.-MOD-2022-586793, PR-MODERNATX, INC.-MOD-2022-598062, PR-MODERNATX, INC.-MOD-2022-598046, PR-MODERNATX, INC.-MOD-2022-598061, PR-MODERNATX, INC.-MOD-2022-598050 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2022: Follow up contains no new information On 23-Jun-2022: Follow-up received contain significant information include additional reporter details, patient demographics, relevant medical history, suspect product dosage information, event onset time, causality and narrative updated.; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-585601:(Administartion date: 19 May 2022) US-MODERNATX, INC.-MOD-2022-586783:(Administartion date: 26 May 2022) US-MODERNATX, INC.-MOD-2022-586792:(Administartion date: 02 Jun 2022) US-MODERNATX, INC.-MOD-2022-586793:(Administartion date: 07 Jun 2022) PR-MODERNATX, INC.-MOD-2022-598062:MCN PR-MODERNATX, INC.-MOD-2022-598061:Master case PR-MODERNATX, INC.-MOD-2022-598050:MCN Number PR-MODERNATX, INC.-MOD-2022-598046:MCN Number