Adverse Event Reporting

VAERS ID 2547987
Gender Unknown
Age
StateCode MI
Pharmaceutical Company MODERNA
Lot Number 042H22A
Number of vaccinations
Vaccinated 2022-12-28
Onset 2022-12-28
Condition
Symptoms
  • No adverse event
  • Expired product administered

Current Illness

Preexisting Conditions

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Write-up

No adverse event; Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.
Dose administered >12(US) hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.
Dose administered >12(US) hours post puncture) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .
222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.
4/BA.
5)) (batch no.
042H22A) for COVID-19 prophylaxis.
No Medical History information was reported.
On 28-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .
222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.
4/BA.
5)) (unknown route) 1 dosage form.
On 28-Dec-2022, after starting mRNA-1273 BIVALENT .
222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.
4/BA.
5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.
Dose administered >12(US) hours post puncture).
On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event).
At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.
Dose administered >12(US) hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
For mRNA-1273 BIVALENT .
222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.
4/BA.
5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related.
No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received Expired Bivalent booster beyond 12 hours post puncture.
Dose administered >12(US) hours post puncture).
Concomitant product use was not provided by the reporter.
On 21-Dec-2022 2.
5 ml vials were initially stored in the refrigerator.
On 27-Dec-2022 at 2:30 P.
M, vial was first punctured.
On 28-Dec-2022 11:30 A.
M vaccine was administered Vial was exposed to room temperature (8° to 25°C or 46° to 77°F) for 21 hours.
Vial did not undergo any temperature excursions.
Treatment information was not provided.
; Sender's Comments: US-MODERNATX, INC.
-MOD-2022-693180:Master case (patient 1 of 1)