Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. From an unspecified date in April 2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 and PNEUMOVAX 23, both for prophylaxis (dose, route of administration, lot # and expiration date were not reported for the suspect therapies). It was reported that the vaccines were exposed to a temperature of - 1.9 (degrees C) Celsius degrees. The time frame was not provided. It was stated that previous multiple excursions occurred (no details provided). No adverse effects were reported. It was unknown if the call was made because a digital data logger. No product quality complaint (PQC) was involved. Follow-up information has been received from the medical assistant on 14-NOV-2017. From 06-APR-2017 to 08-NOV-2017, the unspecified patients were administered the following improperly stored doses of GARDASIL 9 with lot number M035486 and expiration date of 05-JUN-2019, lot number N003703 and expiration date of 29-OCT-2019, lot number N018273 and expiration date of 17-JUN-2019, lot number N013695 and expiration date of 21-MAR-2019,  lot number N019923 and expiration date of 28-APR-2019 for prophylaxis (dose, route of administration were not reported) and PNEUMOVAX 23 with lot number M042599 and expiration date of 17-JUN-2018, lot number reported as N005508 and expiration date of 19-OCT-2018, lot number N003997 and expiration date of 20-OCT-2018, lot number N010106 and expiration date of 15-NOV-2018, lot number N020502 and expiration date of 08-FEB-2019 for prophylaxis (dose, route of administration were not reported). No adverse effects were reported. The vaccines were exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. There was no previous temperature excursion. A "data logger" was involved. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C, 15 minutes; -1.2 degrees C, 15 minutes; -1.0 degrees C, 15 minutes; -0.8 degrees C, 15 minutes; -0.4 degrees C, 15 minutes; -0.2 degrees C, 1 hour; 15 minutes. Lot number N005508 is an invalid lot number for pneumococcal vaccine, polyvalent. Follow-up information has been received from physician on 21-MAR-2018. The reporter the patients received the PNEUMOVAX 23 with lot number M037669 and expiration date 09-MAY-2018, lot number N000508 and expiration date unknown. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifiers and lot number information were reported. Follow-up information has been received from medical assistant on 03-MAY-2018. This report refers to an patient of unknown age and demographics. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # N019923 expiry date: 28-APR-2019) for prophylaxis. This is one of several reports received from the same reporter.