Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient received improperly stored VAQTAvaccination / storage in clinical practice; No side effects or symptoms reported at time of call. No additional AE/no PQC.; This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. For all patients, concurrent conditions, medical history and concomitant medications were not provided.    On multiple an unknown dates, the patients were vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) (strength, dose, route, frequency, lot# and expiration date were not provided) for prophylaxis; and the patients were vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, lot #, and expiry date were not provided); and with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided)  The nurse reported that these vaccines doses were administered on multiple unspecified dates to multiple patients and the vaccines were improperly stored (product storage error). They presented a temperature excursion with a temperature and time frame still unknown. No adverse events were reported. Additionally, it was reported that there were previous temperature excursions and it was because of a data logger. There were unable to provide an outcome at that time due to incomplete data.  Follow-up information was received on 12-JUL-2023.  It was reported that the customer only provided the lowest excursion of all the excursions and not all the data. This is a non-valid report due to the lack of patients' identifiers.  Follow-up information was received from a Physician on 14-JUL-2023. This spontaneous report was received from the vaccine provider referring to a 18-month-old female patient. The patient's concurrent conditions and medical history were not reported.   Concomitant therapy included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), rotavirus vaccine, live, oral, pentavalent (ROTATEQ), varicella zoster vaccin, hepatitis b vaccine and measles vaccine, mumps vaccine, rubella vaccine (MMR VACCIN).     On 06-JUN-2023, the patient was vaccinated with the first dose of hepatitis A Vaccine, inactivated (VAQTA) lot# x003791 and expiration date 01-JUN-2024 in the left arm as prophylaxis (strength, dose, route, and frequency were not provided).  It was reported that vaccine temperature excursion was not viable and occurred from a digital data logger alarm believed to be due to sensory issues. Monitoring temperature with back up logger. Temperature in range, new data logger was in use. It was also reported a storage in clinical practice.  The action taken with the vaccine was reported as "returned, waste in progress". No adverse effects.  This is one of several cases by the same reporter.; Sender's Comments:  US-009507513-2307USA009456: