Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. The patients received a multiple improperly stored doses of PEDVAXHIB (doses, routes of administration and anatomical locations were not reported), that had undergone multiple temperature excursions. The following details were reported: Vaccines with lot#L042836 expiry date 24-AUG-2018, were administered on days 04-APR-2016 06-APR-2016 07-APR-2016 12-APR-2016 14-APR-2016 15-APR-2016 10-MAY-2016 12-MAY-2016 13-MAY-2016 16-MAY-2016 18-MAY-2016 19-MAY-2016 20-MAY-2016 23-MAY-2016 24-MAY-2016 26-MAY-2016 27-MAY-2016 31-MAY-2016 02-JUN-2016 03-JUN-2016 06-JUN-09-JUN-2016. Those doses undergone temperature excursions at 47.5 F on 17-MAR-2016 for 30 min, at 46.6 F on 02-MAY-2016 for 30 min, at 47.8 F on 16-MAY-2016 for 60 min, at 52.5 F on 25-MAY-2016 for 210 min, at 48 F on 26-MAY-2016 for 60 min, at 48.2 F on 06-JUN-2016  for 30 min. Vaccines with lot# M001813 expiry date 14-OCT-2018, were administered on days 25-MAY-2016 01-JUN-2016 09-JUN-2016. Those doses undergone temperature excursions at 46.8F on 28-JAN-2016 for 30 min, at 50.2 F on 17-FEB-2016 for 30 min, at 47.3 F on 18-MAY-2016 for 30 min. The patients received also vaccines (lot#M001813 expiry date 14-OCT-2018) on 08-JUN-2016 26-JUL-2016, which were undergone temperature excursions at 48.2F on 06-JUN-2016 30 min. Vaccines with lot# M001811 expiry date 04-NOV-2018, were administered on days 06-JUN-2016 13-JUN-2016 21-SEP-2016 12-OCT-2016 19-OCT-2016 01-NOV-2016 07-NOV-10-OCT-2016 28-NOV-2016. Those doses undergone temperature excursions at 48.2 F on 06-JUN-2016 for 30 min, at 47.7 F on 20-SEP-2016 for 30 min, at 46.8 F on 04-OCT-2016 for 30 min, at 48.3 F on 17-OCT-2016 for 60 min, at 49.6 F on 18-OCT-2016 for 210 min, at 49.6 F on 19-OCT-2016 for 120 min, at 48.4 F on 03-NOV-2016 for 30 min, at 47.3 F on 22-NOV-2016 for 30 min. The patients received also vaccines with the same lot#, on 29-JUL-2016 10-NOV-2016 21-NOV-2016 which were undergone temperature excursions at 46.8 F on 21-JUL-2016 for 60 min, at 46.9 F on 29-JUL-2016 30 min, at 46.6 F on  10-NOV-2016 for 30 min, at 46.8F on 01-DEC-2016 for 30 min. Vaccines with lot# M001811 expiry date 04-NOV-2018, were administered also on days 07-JUN-2016 26-MAY-2016. Those doses undergone temperature excursions at 46.8F on 28-JAN-2016 for 30 min, at 50.2 F on 17-FEB-2016 for 30 min, at 47.3 F on 18-MAY-2016 for 30 min. Vaccines with lot reported as L04836 expiry date 24-AUG-2018, were administered on 08-JUN-2016 31-MAR-2016 05-APR-08-APR-2016 13-APR-15-APR-2016 19-APR-2016 -20-APR-2016 22-APR-2016 26-APR-2016 29-APR-2016 02-MAY-2016 04-MAY-2016 06-MAY-2016 09-MAY-10-MAY-2016 13-MAY-2016 18-MAY-20-MAY-2016 23-MAY-25-MAY-2016 01-JUN-2016 08-JUN-2016. Those doses undergone temperature excursions at 46.8F on 28-JAN-2016 for 30 min, at 50.2 F on 17-FEB-2016 for 30 min, at 47.3 F on 18-MAY-2016 for 30 min. Vaccines with lot# M001814 expiry date 15-OCT-2018, were administered on 13-JUN-2016 16-JUN-2016 20-JUN-21-JUN-2016 24-JUN-2016 27-JUN-2016 29-JUN-2016 08-JUL-2016 13-JUL-14-JUL-2017 18-JUL-2016. Those doses undergone temperature excursions at 46.8F on 28-JAN-2016 for 30 min, at 50.2 F on 17-FEB-2016 for 30 min, at 47.3 F on 18-MAY-2016 for 30 min. Vaccines with lot#M001814 expiry date 15-OCT-2018, were administered also on 13-JUN-2016 14-JUN-2016 16-JUN-2016 20-JUN-2016 21-JUN-2016 22-JUN-2016 24-JUN-2016 28-JUN-2016 30-JUN-2016 01-JUL-2016 07-JUL-2016 11-JUL-2016 12-JUL-2016 14-JUL-2016 15-JUL-2016 18-JUL-2016 19-JUL-2016 20-JUL-2016 25-JUL-2016 26-JUL-2016 26-AUG-2016. Those doses undergone temperature excursions at 48.2 F on 06-JUN-2016 for 30 min, at 46.6 F on 03-AUG-2016 for 30 min. Vaccines with lot# M001814 expiry date 15-OCT-2018, were administered also on 26-JUL-2016 28-JUL-2016 01-AUG-2016 03-AUG-2016 08-AUG-2016 10-AUG-2016 12-AUG-2016 15-AUG-2016 17-AUG-2016 18-AUG-2016 29-AUG-2016 01-SEP-2016. Those doses undergone temperature excursions at 46.8 F on 21-JUL-2016 for 60 min, at 46.9 F on 25-JUL-2016 for 30 min. Vaccines with lot# M006710 expiry date 06-DEC-2018, were administered on days 27-JUL-2016 02-AUG-2016 05-AUG-2016 08-AUG-2016 09-AUG-2016 11-AUG-2016 16-AUG-2016 18-AUG-2016 19-AUG-2016 23-AUG-2016 24-AUG-2016 24-AUG-2016 25-AUG-2016 29-AUG-2016 30-AUG-2016 31-AUG-2016 01-SEP-2016 02-SEP-2016 06-SEP-2016 08-SEP-2016 11-SEP-2016 13-SEP-2016 15-SEP-2016 19-SEP-2016 20-SEP-2016 21-SEP-2016 23-SEP-2016 26-SEP-2016 29-SEP-2016. Those doses undergone temperature excursions at 48.2 F on 06-JUN-2016 for 30 min, at 46.6 F on 03-AUG-2016 for 30 min, at 47.7 F on 20-SEP-2016  for 30 min. Vaccines with lot# M006710 expiry date 06-DEC-2018, were administered also on days 09-AUG-2016 18-AUG-19-AUG-2016 23-AUG-24-AUG-2016 26-Aug-2016 29-Aug-2016 30-AUG-2016 31-AUG-2016 06-SEP-2016 08-SEP-2016 16-SEP-2016 19-SEP-2016 21-SEP-2016 15-SEP-2016. Those doses undergone temperature excursions at 46.8 F on 21-JUL-2016  for 60 min, at 46.9 F on 25-JUL-2016 for 30 min. Vaccines with lot#M020100 expiry date 07-MAR-2019, were administered also on days 02-SEP-2016 09-SEP-2016 13-SEP-2016 12-SEP-2016 14-SEP-2016 19-SEP-2016 20-SEP-2016 30-SEP-2016 04-OCT-2016 05-OCT-2016 06-OCT-2016. Those doses undergone temperature excursions at 46.6 F on 03-AUG-2016 for 30 min, at 47.7 F on 20-SEP-2016 for 30 min, at 46.8 F on 04-OCT-2016 for 30 min. Vaccines with lot#M020100 expiry date 07-MAR-2019, were administered on days 08-SEP-2016 13-SEP-2016. Those doses undergone temperature excursions at 46.8 F on 21-JUL-2016 for 60 min, at 46.9 F on 25-JUL-2016 for 30 min. Vaccines with lot# M006709 expiry date 16-DEC-2018, were administered on 20-SEP-2016 and undergone temperature excursions at 46.8 F on 21-JUL-2016 for 60 min and at 46.9 F on 25-JUL-2016 for 30 min. Vaccines with lot# M025192 expiry date 21-MAR-2019, were administered on days 07-OCT-2016 11-OCT-2016 12-OCT-2016 18-OCT-2016. Those doses undergone temperature excursions at 46.8F on 04-OCT-2016 for 30 min, at 48.3 F on 07-OCT-2016 for 60 min, at 49.6 F on 18-OCT-2016 for 210 min, at 49.6 F on 19-OCT-2016 for 120 min. Vaccines with lot# M027882 expiry date 14-APR-2019, were administered on days 24-OCT-2016 27-OCT-2016 28-OCT-2016 01-NOV-2016 02-NOV-2016 03-NOV-2016 07-NOV-2016. Those doses undergone temperature excursions at 48.3 F on 17-OCT-2016 for 60 min, at 49.6 F on 18-OCT-2016 for 210 min, at 49.6 F on 19-OCT-2016 for 120 min, at 48.4 F on 03-NOV-2016 for 30 min. Vaccines with lot#M032149 expiry date 18-APR-2019, were administered on days 23-NOV-2016 29-NOV-2016 30-NOV-2016 01-DEC-2016 06-DEC-2016 13-DEC-2016 18-DEC-2016. Those doses undergone temperature excursions at 46.6 Fahrenheit (F) on 10-NOV-2016 for 30 min and at 46.8 F on 01-DEC-2016 for 30 min. Vaccines with the same lot as above, were administered also on the following days: 29-NOV-2016 02-DEC-2016 05-DEC-2016 06-DEC-2016 07-DEC-2016 08-DEC-2016 09-DEC-2016 12-DEC-2016 13-DEC-2016 14-DEC-2016 15-DEC-2016 16-DEC-2016 19-DEC-2016 20-DEC-2016 21-DEC-2016 29-DEC-2016 30-DEC-2016. Those doses undergone temperature excursions at 47.3 F on 22-NOV-2016 for 30 min, at 51.4 F on 29-NOV-2016 for 150 min, at 48.9 F on 21-DEC-2016 for 15 min. The digital data logger was involved. There was no adverse event reported. The product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004383: US-009507513-1705USA004379: US-009507513-1704USA008135: US-009507513-1705USA004381: US-009507513-1705USA004382: US-009507513-1705USA004377: US-009507513-1705USA004376: US-009507513-1705USA004378.