Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product label confusion, Product label issue, Product quality issue, Product storage error
Clinical narrative: No additional AE/PQC; The caller stated one of the doses of the product involved with this PQC, that was also improperly stored, was administered to a patient; wrong information on leaflet, there was a leaflet that was laminated with orange letters that stated VARIVAX can  be stored in the refrigerator/ she then went onto Merck's website to check what the recommended storage range was for VARIVAX; wrong information on leaflet, there was a leaflet that was laminated with orange letters that stated VARIVAX can  be stored in the refrigerator/ she then went onto Merck's website to check what the recommended storage range was for VARIVAX; This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.   The pharmacist stated that she received a shipment of varicella virus vaccine live (oka/merck) (VARIVAX) which was unpacked on 20-MAY-2022, and according to the reporter "there was wrong information on leaflet", further described as: "there was a leaflet or form inside the shipment box, that was laminated with orange letters, that stated varicella virus vaccine live (oka/merck) (VARIVAX) could be stored in the refrigerator". The caller stated she then went into Merck's website to check what the recommended storage range was for varicella virus vaccine live (oka/merck) (VARIVAX) and she read that it could be stored in the refrigerator for up to 18 months (product label issue, product label confusion). The caller did not specify or provide any further information about the site she visited other than providing the link (exact site where she had read this information) and confirmed this prescribing information (PI) was not inside the shipment, but that she found this on the internet. The caller stated this shipment was stored in the refrigerator that same day (on 20-MAY-2022). Additional details included: the prescription was dispensed in original Merck vials; there were no other printing issues with the label; label was intact; label did not look like it had been exposed to moisture or increased humidity; carton had no damage; primary label was not affected; there were no issues with the shipment or packaging and the caller confirmed the information was legible. The reporter stated this leaflet or form that was included in the shipment had since been thrown away, so no pictures of the form were able to be sent.   Besides, the caller stated that one of the doses of varicella virus vaccine live (oka/merck) (VARIVAX) vial (involved with this product quality complaint (PQC)) that was also improperly stored was administered to the patient on 23-MAY-2022 (reported as "today") (product storage error) as prophylaxis (strength, route of administration, and anatomical location were not reported; product quantity reported as: 1 (units not provided); lot number u039723 has been verified to be a valid lot number, expiration date: 15-DEC-2023). The diluent used for reconstitution dose was not improperly stored and was not involved in the PQC. No additional information provided to further clarify what the pharmacist read on the leaflet. No additional AE/PQC (no adverse event).