Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Vial initially stored in refrigerator on 10Feb2022, and vaccine administered on 24Mar2022; 30 days from the onsite of temperature excursion / possible temperature excursion incidence; 1 dose administered after 30-day Use by Date / Possible expired product administered; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered after 30-day Use by Date / Possible expired product administered), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 10Feb2022, and vaccine administered on 24Mar2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (30 days from the onsite of temperature excursion / possible temperature excursion incidence) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Patient had not ever been diagnosed with or tested positive for COVID-19. Acute illnesses at the time of vaccination and up to 1 month before were none. Chronic or long-standing health conditions were none. Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event were none.     On 24-Mar-2022 at 2:43 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Mar-2022 at 2:43 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered after 30-day Use by Date / Possible expired product administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 10Feb2022, and vaccine administered on 24Mar2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (30 days from the onsite of temperature excursion / possible temperature excursion incidence). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose administered after 30-day Use by Date / Possible expired product administered) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 10Feb2022, and vaccine administered on 24Mar2022) had resolved and PRODUCT TEMPERATURE EXCURSION ISSUE (30 days from the onsite of temperature excursion / possible temperature excursion incidence) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (1 dose administered after 30-day Use by Date / Possible expired product administered) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 10Feb2022, and vaccine administered on 24Mar2022) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (30 days from the onsite of temperature excursion / possible temperature excursion incidence).    No concomitant medications was reported.  It was reported Number of doses/vials administered included for 3 patients, one on 17-Mar-2022 and two on 24-Mar-2022, 30 days from the onsite of temperature excursion.  On 24-Mar-2022, the patient received 1 dose of mRNA-1273 (Spikevax) 0.25 ml. This vial was administered more than 30 days after the vial was first removed from frozen storage (IQ-Feb-2022) Courier.  The courier delivered the vial to site within hours. The courier reported to health staff that the temperature was around 01-degree C. staff immediately refroze the vial, and administered the  dose to this patient on 24-Mar-2022---42 days from 10-Feb-2022.  The patient did not report adverse reaction, no positive COVID test, nor COVID disease up to today 25-Apr-2022. Please note that upon my request, Moderna Inc, manufacturer for Spikevax, had completed an investigation (Case ID CEA-2076) on the Viability of this Lot 069H21A following this " possible temperature excursion incidence". On 7-Apr-2022 Moderna Inc, has determined that: "Analysis of the vials associated with your storage excursion is complete. The vaccine administered  on or before March 24, 2022, from lot number 069H21A maintained the activity necessary to protect  against the SARS-CoV-2 (COVID-19) virus at time of administration."  No treatment drug details was reported.   This case was linked to MOD-2022-531748 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: Significant Follow-up received, Reporter postal code, Patient Details, Suspect coding, vaccine details, causality, added, outcome and narrative updated. Event onset for Expired vaccine used corrected.