Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Vaccine was administered on 10-May-2022 but was expired on 16-Apr-2022; Excursion duration was 3 hours and 31 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 10-May-2022 but was expired on 16-Apr-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion duration was 3 hours and 31 minutes) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 014F21A, 023M20A and 013M20A) for COVID-19 vaccination.     It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. Chronic or long standing health conditions at the time of vaccination and one month prior was unknown.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 10-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 10-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 10-May-2022 but was expired on 16-Apr-2022). In May 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion duration was 3 hours and 31 minutes). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 10-May-2022 but was expired on 16-Apr-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion duration was 3 hours and 31 minutes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine was administered on 10-May-2022 but was expired on 16-Apr-2022) to have an unknown relationship. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion duration was 3 hours and 31 minutes).    The reporter's occupation was given as clinic manager. Prescriptions, over the counter medications, dietary supplements or herbal medicines being taken at the time of vaccination and or at the time of adverse event was unknown.  The patient was administered 2nd booster dose on 10-May-2022. It was reported that vials were initially frozen and then thawed out at room temperature on 10-May-2022, at the time of the excursion vials were under frozen storage, Maximum temperature was 22.1 degrees F. Vials were then stored in freezer.  Visual inspection noting any vaccine state change was reported as no thawing. Proposed desired use by Date was 16-Apr-2022. Number of vials/doses impacted were 9 vials. It was reported that expiration date on the back of the box was 16-Apr-2022 but there was another expiry date written on the lid as 07-Jul-2022, according to which vaccine was administered. No reactions were noted while in the clinic nor after vaccine. The event did not cause the patient to seek any medical care. The patient had not experienced a similar event in the past.  No treatments were reported.    Most recent FOLLOW-UP information incorporated above includes: On 10-May-2022: Follow-up received updated No New Information On 13-May-2022: Follow up received significant information: updated report type from invalid to spontaneous, updated reporter contact details, added patient demographics, updated patient notes, added dose 1, 2 and 3 information, updated dose 4 details, added partial date for event product temperature excursion issue (from initial), updated reporter causality, updated narrative.