Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: received the second primary dose of the Moderna COVID-19 vaccine from a pre-dawn syringe that was left at room temperature for 27 hours; 1st primary dose: Moderna, administered on 14Mar2022 and 2nd primary dose: Moderna, administered on 07Jul2022; vial was first punctured*: 06Jul2022 at 10:03 AM and administration of vaccine*: 07Jul2022 at 1:52 PM; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (received the second primary dose of the Moderna COVID-19 vaccine from a pre-dawn syringe that was left at room temperature for 27 hours), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st primary dose: Moderna, administered on 14Mar2022 and 2nd primary dose: Moderna, administered on 07Jul2022) and EXPIRED PRODUCT ADMINISTERED (vial was first punctured*: 06Jul2022 at 10:03 AM and administration of vaccine*: 07Jul2022 at 1:52 PM) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 060A22A and 045L21A) for COVID-19 prophylaxis.     It was unknown that patient had ever COVID+ test or diagnosis in the past but did not get COVID-19 within past 90 days.  Previously administered products included for Product used for unknown indication: Gardasil (1 dose) on 14-Mar-2022 and Gardasil (1 more dose) on 07-Jul-2022. Past adverse reactions to the above products included No adverse event with Gardasil and Gardasil. Concurrent medical conditions included Latex allergy. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 14-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jul-2022 at 1:52 PM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st primary dose: Moderna, administered on 14Mar2022 and 2nd primary dose: Moderna, administered on 07Jul2022) and EXPIRED PRODUCT ADMINISTERED (vial was first punctured*: 06Jul2022 at 10:03 AM and administration of vaccine*: 07Jul2022 at 1:52 PM). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received the second primary dose of the Moderna COVID-19 vaccine from a pre-dawn syringe that was left at room temperature for 27 hours). At the time of the report, PRODUCT STORAGE ERROR (received the second primary dose of the Moderna COVID-19 vaccine from a pre-dawn syringe that was left at room temperature for 27 hours), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st primary dose: Moderna, administered on 14Mar2022 and 2nd primary dose: Moderna, administered on 07Jul2022) and EXPIRED PRODUCT ADMINISTERED (vial was first punctured*: 06Jul2022 at 10:03 AM and administration of vaccine*: 07Jul2022 at 1:52 PM) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 20-Jun-2022. The vial was first punctured on 06-Jul-2022 at 10:03 AM. The vial was stored in room temperature post puncture. The vial did not undergo any temperature excursions. The Total amount of time the vial was exposed to room temperature range was 27 hours. The AE did not cause patient to seek medical care. The patient did not experience similar event in the past.