Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non-valid report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent conditions, concomitant medications and past therapies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # N017686, expiry date: 02-FEB-2020) (lot # N021572, expiry date: 01-MAY-2020), VAQTA (lot # N019924, expiry date: 02-SEP-2018), M-M-R II (lot # N010495, expiry date: 31-MAR-2019), PNEUMOVAX 23 (N010105, expiry date: 15-NOV-2018), VARIVAX (M047662, expiry date: 02-DEC-2018), ZOSTAVAX (N025701, expiry date: 16-DEC-2018) for prophylaxis whose dose, route and site of vaccination were not reported. It was reported that all lots of VARIVAX, ZOSTAVAX and M-M-R II were reconstituted with improperly stored sterile diluent (MERCK) (N004801, expiry date: 09-JUL-2019). The above administered vaccines and the sterile diluent used for reconstitution had undergone an unknown temperature excursion for an unknown time frame which was noted from a data logger. It was unknown if there were any previous temperature excursions. No adverse effects reported. There was no product quality complaint (PQC) involved. Follow-up has been received on 27-APR-2018 from a registered nurse. The reporter informed that, there was multiple temperature excursions for the PNEUMOVAX 23 (N010105) as follows, on 19-MAR-2017, temperature excursion was from 0.64 degrees Celsius (C) to -0.54C, on 16-MAR-2018 0.99C, on 15-MAR-2018 0.69C, 0.03C, on 14-MAR-2018 -0.83C, 0.5C, on 12-MAR-2018 -0.16C, on 10-MAR-2018 -0.37C, 0.53C,on 08-MAR-2018 -1.52C, -0.42C, on 05-MAR-2018 0.17C, on 28-FEB-2018 -0.02C, on 27-FEB-2018 -1.09C, on 14-FEB-2018 8.76C, on 08-FEB-2018 -0.67C, -0.61C, -0.27C for the duration of 8.75 hour (h) below 0, 19 cycles, 1407.25 hours from 0 to 1C; for VAQTA (lot # N019924): on 19-MAR-2018 0.64C, -0.54C, 16-MAR-2018 0.99C, on 15-MAR-2018 0.69C, 0.03C, on 14-MAR-2018 -0.83 C, 0.50C, on 12-MAR-2018 -0.16C, on 10-MAR-2018 -0.37C, 0.53C, on 08-MAR-2018 -1.52C, -0.42C, on 05-MAR-2018 0.17C, on 28-FEB-2018 -0.02C, on 27-FEB-2018 -1.09C, on 14-FEB-2018 8.76 C, on 08-FEB-2018 -0.67C, -0.61C, -0.27C; for GARDASIL 9 (lot # N017686) on 19-MAR-2018 0.64C, -0.54C, 16-MAR-2018 0.99C, on 15-MAR-2018 0.69C, 0.03C, on 14-MAR-2018 -0.83C, 0.50C, 12-MAR-2018 -0.16C, 10-MAR-2018 -0.37C, 0.53C, on 08-MAR-2018 -1.52C, -0.42C, on 05-MAR-2018 0.17C, on 28-FEB-2018 -0.02C, on 27-FEB-2018 -1.09C, on 14-FEB-2018 8.76C, on 08-FEB-2018 -0.67C, -0.61C, -0.27C for 8.75 hours below 0; 19 cycles, 1407.25 hours from 0 to 1C, 0.5 h at 26C or warmer; for M-M-R II (lot # N010495) on 19-MAR-2018 0.64C, -0.54C, on 16-MAR-2018 0.99C, on 15-MAR-2018 0.69C, 0.03C, on 14-MAR-2018 -0.83C, 0.05C, on 08-MAR-2018 -1.52C, -0.42C, on 05-MAR-2018 0.17C, on 28-FEB-2018 -0.02C, on 27-FEB-2018 -1.09C,on 14-FEB-2018 8,76C, on 08-FEB-2018 -0.67C, -0.61C, -0.27C for 8.75 hours; below 0; 19 cycles, 1407.25 hours from 0 to 1C, 0.5 h at 26C or warmer. Follow-up information was received from the registered nurse on 21-SEP-2018. On 21-SEP-2018, a phone call was placed to registered nurse regarding a temperature excursion case she had reported on for GARDASIL 9, VAQTA, M-M-R II, PNEUMOVAX 23, VARIVAX and ZOSTAVAX. The telephone call went straight to voicemail. A message was left requesting that the registered nurse return the call. Additionally, a request was made for patient identifiers and dates of vaccination. This case was considered non-valid as no patient identifiers were reported. Follow up information has been received from a health professional on 27-SEP-2018 refers to a male patient of unknown age. On 08-MAR-2018, the patient was vaccinated with improperly stored GARDASIL 9 lot # N017686 (expiry date: 02-FEB-2020) or N021572 (expiry date: 01-MAY-2020) for prophylaxis. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifiers were reported. This is one of the several reports from the same reporter.