Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (also an administrator) referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. From 10-FEB-2016 to 25-OCT-2016, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route unknown; lot number L025738 with expiration date 14-AUG-2017) for prophylaxis. From 31-AUG-2016 to 25-OCT-2016, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route unknown; lot number L048848 with expiration date 09-AUG-2018). No adverse effects were reported. Multiple previous temperature excursions were reported. Data logger issue was not involved. The temperature excursions and time frames were as follows: On 01-MAR-2016, the vaccine was exposed to temperature excursion of 10.3 Celsius degree (C) for 107 hours. On 13-MAY-2016, the vaccine was exposed to temperature excursion of 9.3 C for 0.75 hour. On 29-JUL-2016, the vaccine was exposed to temperature excursion of 8.8 C for 1 hour. On 02-AUG-2016, the vaccine was exposed to temperature excursion of 8.2 C for 1.75 hours. On 26-AUG-2016, the vaccine was exposed to temperature excursion of 9.3 C for 1.75 hours. On 29-AUG-2016, the vaccine was exposed to temperature excursion of 8.2 C for 2 hours. On 30-AUG-2016, the vaccine was exposed to temperature excursion of 8.3 C for 2.25 hours. On 31-AUG-2016, the vaccine was exposed to temperature excursion of 8.3 C for 2.25 hour. On 31-AUG-2016, the vaccine was exposed to temperature excursion of 8.4 C for 2.25 hour. On 01-SEP-2016, the vaccine was exposed to temperature excursion of 8.4 C for 3.75 hours. On 01-SEP-2016, the vaccine was exposed to temperature excursion of 8.2 C for 2 hours. On 16-SEP-2016, the vaccine was exposed to temperature excursion of 11.5 C for 1 hour. On 16-SEP-2016, the vaccine was exposed to temperature excursion of 9.8 C for 0.75 hour. On 16-SEP-2016, the vaccine was exposed to temperature excursion of 8.3 C for 5.7 hours. On 18-SEP-2016, the vaccine was exposed to temperature excursion of 8.5 C for 21.5 hours. On 19-SEP-2016, the vaccine was exposed to temperature excursion of 8.5 C for 1.5 hours. On 20-SEP-2016, the vaccine was exposed to temperature excursion of 8.4 C for 16.75 hours. On 20-SEP-2016, the vaccine was exposed to temperature excursion of 8.4 C for 3 hours. On 21-SEP-2016, the vaccine was exposed to temperature excursion of 8.6 C for 23.75 hours. On 22-SEP-2016, the vaccine was exposed to temperature excursion of 8.5 C for 17.75 hours. On 29-SEP-2016, the vaccine was exposed to temperature excursion of 12.1 C for 167.75 hours. On 30-SEP-2016, the vaccine was exposed to temperature excursion of 9.1 C for 1.75 hours. On 30-SEP-2016, the vaccine was exposed to temperature excursion of 14.8 C for 1.5 hours. On 11-OCT-2016,  the vaccine was exposed to temperature excursion of 9.4 C for 1.25 hours. On 11-OCT-2016,  the vaccine was exposed to temperature excursion of 9.1 C for 1.75 hours. On 13-OCT-2016,  the vaccine was exposed to temperature excursion of 8.5 C for 5 hours. On 17-OCT-2016,  the vaccine was exposed to temperature excursion of 8.5 C for 104.25 hours. On 18-OCT-2016,  the vaccine was exposed to temperature excursion of 8.4 C for 3.5 hours. On 19-OCT-2016,  the vaccine was exposed to temperature excursion of 8.7 C for 19 hours. On 19-OCT-2016,  the vaccine was exposed to temperature excursion of 8.2 C for 3 hours. On 20-OCT-2016,  the vaccine was exposed to temperature excursion of 8.2 C for 7.5 hours. On 20-OCT-2016,  the vaccine was exposed to temperature excursion of 8.2 C for 4 hours. On 21-OCT-2016,  the vaccine was exposed to temperature excursion of 8.4 C for 11 hours. On 21-OCT-2016,  the vaccine was exposed to temperature excursion of 8.1 C for 1.25 hours. On 21-OCT-2016,  the vaccine was exposed to temperature excursion of 8.1 C for 2.5 hours. On 22-OCT-2016,  the vaccine was exposed to temperature excursion of 8.3 C for 11 hours. On 22-OCT-2016,  the vaccine was exposed to temperature excursion of 8.1 C for 5.75 hours. On 24-OCT-2016,  the vaccine was exposed to temperature excursion of 8.6 C for 46.25 hours. On 24-OCT-2016,  the vaccine was exposed to temperature excursion of 8.2 C for 2 hours. On 25-OCT-2016,  the vaccine was exposed to temperature excursion of 8.7 C for 18 hours. On 25-OCT-2016,  the vaccine was exposed to temperature excursion of 8.3 C for 4.25 hours. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005442: US-009507513-1703USA005443: US-009507513-1702USA008550: