Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients. The patient's historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patients were vaccinated with an unspecified number of doses of PROQUAD subcutaneously, reported lot number R011217, expiry date 15-OCT-2019, reported lot number R011802, expiry date 21-OCT-2019, (laterality, strength, dose and frequency were not reported) and VARIVAX reported lot number R009411, expiry date 29-MAR-2020, reported lot number R003300, expiry date 01-FEB-2020, reported lot number N035940, expiry date 18-DEC-2019 and reported lot number N034551, expiry date 05-DEC-2019 (laterality, strength, dose, route and frequency were not reported) both vaccines for prophylaxis, following a temperature excursion. The administered doses of the vaccines experienced a temperature excursion of 6°F to 14°F (-14°C to -10°C) for 14 hours 30 minutes and of 15°F to 46°F (-9°C to 8°C) (-6.1°C) for 20 minutes, as recorded by a data logger. No previous temperature excursion was reported. This is a non-valid case due to lack of patient identifier. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information has been received from a registered nurse who is also the vaccine provider, concerning a 12 month old female patient. The patient's illness at time of vaccination included Upper respiratory tract infection (URI), hand, foot and mouth disease and ear infection. Birth defects included plagiocephaly. It was reported that the patient had 3 siblings. Historical vaccines and concomitant therapies were not reported. It was specified that, on 14-SEP-2018, the patient was vaccinated with an improperly stored first dose of M-M-R II, subcutaneously in the left thigh, lot # N025894 (albumin status: rha, expiration date: 19-SEP-2019) for prophylaxis, with an improperly stored first dose of VAQTA intramuscularly in the left thigh, lot # R006210 (expiration date: 22-APR-2019) for prophylaxis, with an improperly stored first dose of VARIVAX, subcutaneously in the right thigh, lot # N035940 (expiration date: 18-DEC-2019) for prophylaxis, and with an improperly stored fourth dose of PREVNAR 13, intramuscularly (IM) in the right thigh. All the vaccines were purchased with public funds and were administered at a private doctor's office/hospital. On the same day, the patient received the other suspect therapy; amoxicillin 400 mg 2 times a day (total daily dosage: 800 mg), orally for ear infection. The administered doses of the products experienced a freezer temperature excursion (not specified) as recorded from a digital data logger which occurred at the time of storage in clinical practice. No patient experiences were reported; however, it was mentioned that an unspecified treatment was administered to the patient. It was confirmed that the patient did not receive PROQUAD, and was only administered the aforementioned vaccines. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA010598: US-009507513-1901USA002753: US-009507513-1901USA002754: US-009507513-1901USA002758: US-009507513-1901USA002755: US-009507513-1901USA002756: US-009507513-1901USA002757: US-009507513-1901USA002763: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002764: US-009507513-1901USA002765.