Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product distribution issue, Product storage error, Recalled product administered
Clinical narrative: No additional AEs were reported; The nurse practitioner reported that a patient received improperly stored vaccine on 9/20/2022; shipping delay; This spontaneous report was received from a nurse practitioner concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #W017551, expiration date: 01-JUN-2024 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product storage error).  The improperly stored vaccine underwent a temperature excursion of 77 degrees Fahrenheit (F) for 10 hours without previous excursions. No adverse events were reported.  Follow-up information has been received from the nurse practitioner and referred to a 17-year-old female patient on 02-NOV-2022. No other vaccine used within 4 weeks prior to the date of vaccination of varicella virus vaccine live (oka/merck) (VARIVAX). No adverse event following a prior vaccination. No pre-existing physician-diagnosed allergies, birth defects or medical conditions. The patient's concomitant vaccines (vaccinated on the same day with varicella virus vaccine live (oka/merck) (VARIVAX)) included hepatitis a vaccine inact (HAVRIX) (lot# 3397T) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot# U031051). Upon review of packing slip (and placed into proper storage) and supervision (off site), it was noted that vaccine was to be delivered in by 19-SEP-2022 (considered it was the AE onset date of product distribution issue, but it was earlier than the vaccine start date, so just capture as September 2022 in field). When called Merck, they received stability data for varicella virus vaccine live (oka/merck) (VARIVAX) stored at room temperature for 10 hours. It was reported that varicella virus vaccine live (oka/merck) (VARIVAX) (lot# also reported as W017552 (inconsistent information: previous version reported as W017551), expiration date 01-JUN-2024; route subcutaneous (SQ), site was left arm, dose number 1) was administered after shipping delay and improper storage temperature (product storage error and product distribution issue). The patient received one dose of the vaccine at facility on 20-SEP-2022. No illness at time of vaccination. Manually activated indicated there was stability to support continued use of vaccine with shortened expiration date. Hence, there was a delivery issue, Merck asked a replacement shipment, and the original vaccine that was delivered late was returned to Merck. The patient was notified and did not experience any adverse reaction after the vaccine administration. It was reported called manufacturer discontinued used vaccine. It was reported the events product storage error and product distribution issue were attributable to the varicella virus vaccine live (oka/merck) (VARIVAX) (causality considered as related).