Sex: F
Vaccine: COVID19
Symptoms: Death, Expired product administered, Product storage error
Clinical narrative: Patient 4, has since expired; HCP calling to report that 9 patients received a vaccine that was given past the 30 day BUD; HCP stated that the vaccines were delivered on 27OCT2023 and were placed in the fridge on that same day. They were never stored in the freeze; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (Patient 4, has since expired) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030372) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Completed Pfizer Primary and booster dose.). Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) from 30-Jan-2024 to an unknown date for an unknown indication.    On 30-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On an unknown date, the patient experienced DEATH (Patient 4, has since expired) (seriousness criteria death and medically significant), EXPIRED PRODUCT ADMINISTERED (HCP calling to report that 9 patients received a vaccine that was given past the 30 day BUD) and PRODUCT STORAGE ERROR (HCP stated that the vaccines were delivered on 27OCT2023 and were placed in the fridge on that same day. They were never stored in the freeze). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, EXPIRED PRODUCT ADMINISTERED (HCP calling to report that 9 patients received a vaccine that was given past the 30 day BUD) and PRODUCT STORAGE ERROR (HCP stated that the vaccines were delivered on 27OCT2023 and were placed in the fridge on that same day. They were never stored in the freeze) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  9 patients received a vaccine that was given past the 30-day BUD. HCP stated that the vaccines were delivered on 27-Oct-2023 and were placed in the fridge on that same day. They were never stored in the freezer. The 30-day BUD was 26-Nov-2023 and HCP stated that 9 patients were given vaccines from Dec-2023 until Apr-2024. Out of the 9 filled by the pharmacy, only 7 were administered, three patients were current residents, three patients were no longer residents, and 1 patient had expired.   Patient was deceased, Gone to the Lord.  Vaccine was filled on 30-Jan-2024.  No treatment medication was reported.  This case contains information for the 4th of 9 patients described by the reporter.  Company comment:  This case involves a spontaneous report concerning a 71-year-old female patient who had previously received one dose of the Comirnaty vaccine and had no reported medical history. An expired vaccine, which had been stored in the fridge for 30 days past its expiration date, was administered to the patient. The patient passed away after an unspecified period following the administration of the mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine, which was given at the same time as an influenza vaccine. Cause od dead is reported as Unknown cause of death. It is unknown if autopsy was done. No further information was available in the report. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-766478 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2024: Follow-up received and added patient details, added relevant medical history, added suspect product start date, updated event verbatim, added the new event death and updated narrative. On 02-May-2024: Live follow-up received and added no new significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-766478:Patient 1 out of 9; Reported Cause(s) of Death: Unknown cause of death