Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On an unspecified date, an unknown number of patients were vaccinated with an improperly stored dose of GARDASIL 9 (lot# N032956, expiration date13-JUL-2020) and (lot# N022583, expiration date 20-JUN-2020) (dosage, frequency and route were not reported) for prophylaxis, ROTATEQ (lot# reported as N30176, expiration date 17-JUN-2019) (dosage, frequency and route were not reported) for prophylaxis and LIQUID PEDVAXHIB (lot# R001085, expiration date 24-SEP-2020) (dosage, frequency and route were not reported) for prophylaxis (Incorrect product storage). The vaccines were stored at a temperature of 0 Celsius degree to 1 Celsius degree for 41 hours. Below 0 Celsius degree for 27 hours. 9 Celsius degree to 25 Celsius degree for 12 hours 30 minutes. Previous temperature excursion were 0 Celsius degree to  1 Celsius degree for 27 hours. The patients also administrated with M-M-R II (lot# N024694, expiration date 08-SEP-2019) and (lot# N031294, expiration date 21-AUG-2019) (dosage, frequency and route were not reported) for prophylaxis (Incorrect product storage). The vaccines were stored at a temperature of 9Celsius degree to 25 Celsius degree for 3 hours 30 minutes. There was no previous temperature excursion. VARIVAX) (lot# R006753, expiration date 06-MAR-2020); (lot# N031001, expiration date 03-NOV-2019) and (lot# N027000, expiration date 28-SEP-2019) (dosage, frequency and route were not reported) for prophylaxis and PROQUAD (lot# R004441, expiration date 12-AUG-2019) and (lot# N035174, expiration date 09-JUN-2019) (dosage, frequency and route were not reported) for prophylaxis (Incorrect product storage). The vaccines were stored at a temperature of -14 Celsius degree to -10 Celsius degree for 2 hours. -9 Celsius degree to 8 Celsius degree for 9 hours 30 minutes. 9 Celsius degree to 25 Celsius degree for 3 hours 30 minutes. Previous temperature excursion were -14 Celsius degree to -10 Celsius degree for 2 hours. -9 Celsius degree to 8 Celsius degree for 1 hour. PNEUMOVAX 23 (lot# N019838, expiration date 16-FEB-2019) (dosage, frequency and route were not reported) for prophylaxis (Incorrect product storage). The vaccines were stored at a temperature of 0 Celsius degree to 1 Celsius degree for 41 hours. Below 0 Celsius for 27 hours for 52 cycles. 9 Celsius degree to 25 Celsius degree for 12 hours 30 minutes. Previous temperature excursion was 0 Celsius degree to 1 Celsius degree for 27 hours. Data logger was involved. No adverse effect reported. No product quality complaint was involved. No further information was provided. Upon receipt of follow-up information it was determined that this case is now valid because patient identifiers were received. Follow up information was received from the medical assistant on 16-AUG-2018 and concerns a single patient among the multiple unspecified patients previously reported. The patient was reported to be 11 year old female patient. On 06-AUG-2018 the patient was vaccinated with second dose of improperly stored  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), lot number R001262, expiry date: 10-NOV-2020 in the left deltoid for prophylaxis (product storage error) at public health clinic or hospital with public funds. The reporter stated that patient did not have any adverse reaction to the vaccine. It was reported that patient did not have any illness at the time of vaccination. The temperature excursion was noted as a result of a reading from a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA007069: US-009507513-1808USA007142: US-009507513-1808USA007151: US-009507513-1808USA007169: US-009507513-1808USA007332: US-009507513-1808USA007336: US-009507513-1808USA007347: