Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified patients. It was reported that since 23-MAR-2018, unknown number of unspecified patients were vaccinated with improperly stored GARDASIL 9, ROTATEQ, VAQTA, RECOMBIVAX HB and M-M-R II (product storage error) (lot numbers and expiration dates were not provided) for prophylaxis. No adverse effects reported. Temperature and time frame was reported as 9 degree Celsius to 25 degree Celsius (9 degree Celsius) for 120 hours. There was no previous temperature excursion involved. A digital data logger was not involved. This is a non-valid case due to lack of patient identifiers. Follow up information has been received from the same reporter on 11-APR-2018. On 21-MAR-2018, 26-MAR-2018, 27-MAR-2018, 28-MAR-2018, 30-MAR-2018, 03-APR-2018 and 04-APR-2018, the patients were vaccinated with GARDASIL 9 at a temperature of excursion 9 degree Celsius for duration of 26 hours. On 21-MAR-2018, 22-MAR-2018, 23-MAR-2018, 26-MAR-2018, 27-MAR-2018, 28-MAR-2018, 30-MAR-2018, 02-APR-2018 and 03-APR-2018 the patients were vaccinated with VAQTA at a temperature of excursion 9 degree Celsius for duration of 26 hours. On 21-MAR-2018, 26-MAR-2018, 27-MAR-2018, 28-MAR-2018, 29-MAR-2018, 30-MAR-2018, 02-APR-2018, 03-APR-2018 and 04-APR-2018, the patients were vaccinated with RECOMBIVAX HB at a temperature of excursion 9 degree Celsius for duration of 26 hours. On 21-MAR-2018, the patients were vaccinated with M-M-R II at a temperature of excursion 9 degree Celsius. On 21-MAR-2018, 22-MAR-2018, 23-MAR-2018, 26-MAR-2018, 27-MAR-2018, 28-MAR-2018, 29-MAR-2018, 30-MAR-2018 and 03-APR-2018, the patients were vaccinated with ROTATEQ at a temperature of excursion 9 degree Celsius. Lot number G9H24 is an invalid lot number. Lot number 2372K is an invalid lot number for hepatitis b vaccine (recombinant). Lot number L594L is an invalid lot number for hepatitis b vaccine (recombinant). Lot number LH3RJ is an invalid lot number for hepatitis b vaccine (recombinant). Lot number N030286 has been verified to be a valid lot number for hepatitis a vaccine, inactivated. Lot number K08421 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Lot number N55860 is an invalid lot number for hepatitis b vaccine (recombinant). Lot number H12345 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Lot number G67891 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Upon receipt of follow-up which was received on 04-JUL-2018, case became valid from non-valid due to patient identifiers. Follow-up information has been received from the registered nurse on 04-JUL-2018. It was clarified that this report professional refers to a 6 month 13 days old female patient. The patient's concurrent conditions, medical history, drug reactions allergies were not reported. The patient's concomitant medications included hepatitis b virus vaccine, pneumococcal conj vaccine and PENTACEL. On 03-APR-2018 the patient was vaccinated with first dose of ROTATEQ (dose, units and frequency not reported) (lot # N032564 and expiration date: 30-APR-2019) orally. It was reported that, ROTATEQ was stored at a temperature that was >8 degree Celsius (C). It was mentioned that the physician and manufacturer notified based on the data received from the global medical, it was determined that the stability and potency of the ROTATEQ could not be supported. A letter was sent to patient's parents to let them know about the situation and appointment has been made to revaccinate the patient with the clinic's expenses. This is one of the reports received from the same reporter.