Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient stated his left deltoid was sore for approximately 1 day; administered doses of vaccine which were improperly stored; This spontaneous report was received from a nurse referring to two patients of unknown age and gender.   The patients' pertinent medical history, concomitant medications and drug reactions or allergies were not reported.   On 28-MAY-2019, the two unspecified patients were vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R034249, expiration date was 07-AUG-2020; strength, dosage information, anatomical location and route of administration were not provided) for prophylaxis. No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 50 Fahrenheit (F) for 72 hours. There was no previous temperature excursion reported. Data logger was not involved. No product quality complaint (PQC) was associated with this report.  Follow-up information has been received from the nurse regarding one of the patients on 14-JUN-2019.   It was reported that one of the patients was a 69-year-old male patient. The patient's current conditions included hypertension, pure hypercholesterolemia and type 2 diabetes mellitus. His allergies included allergy to amitriptyline hydrochloride and to perphenazine.   It was reported that from 25-MAY-2019 to the morning of 28-MAY-2019, the refrigerator reached 50 Fahrenheit (F), it was noted that it was unknown the exact length, however, that it was in fact approximately 72 hours. The excursion was reported to the Health Department of the county, which instructed to call the manufacturer. A note was placed on the refrigerator with the instruction to: "Do not use", until cleared by the office manager. The vaccines were moved to another refrigerator that was at the proper temperature. However, the note was not moved. Meanwhile, one of the nurses administered a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine as ordered by the physician. It was reported that the patient received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine on his left deltoid. It was noted that he had not received any previous doses. Later, on the same day, they were told to "discard the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by Merck", so they were wasted as instructed. It was reported that, in the future, they would put a "Do not use" note directly on the vaccines and would have the clinical staff sign a form of understanding of the acknowledgment that they could not use the affected vaccines or medication. Moreover, it was reported that it was later determined by Merck's Medical Team that they did not had enough data to ensure that the patient received the vaccine safely and did not need to be revaccinated.   On 29-MAY-2019, the patient's left deltoid was sore (injection site pain), it was reported that he moved his arm and the soreness "went away" after 24 hours. No other symptoms or side effects were reported.   There was no causality assessment provided between the injection site pain and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  This is one of two reports from the same reporter (information captured in MARRS# 1905USA013178).; Sender's Comments:  US-009507513-1905USA013178: