Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
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 GARDASIL 9 (dose, route of administration and anatomical location were not reported), that had undergone multiple unspecified temperature excursions. On 12-OCT-2015, the patients received an improperly stored doses of GARDASIL 9 (Lot #: L023230; Expiration date: 28-JUL-2017). It was stated that the vaccines underwent a temperature excursion on 12-OCT-2015 at 46.9 F for 60 min. On 03-NOV-2015, the patients received an improperly stored doses of GARDASIL 9 with following details: lot reported as L03221, expiry date: 27-MAY-2017 which underwent a temperature excursion on 03-NOV-2015 at 47.8 F and at 46.6 F for 30 min lot # L023230; expiry date: 28-JUL-2017 (also reported as 19-FEB-2017) which underwent a temperature excursion on 29-OCT-2015 at 46.9 Farenheit (F) for 60 min, on 03-NOV-2015 at 47.8 F and at 46.6 F for 30 min. On 16-MAR-2016 and 01-JUN-2016, the patients received an improperly stored doses of GARDASIL 9 (Lot #: L023230; Expiration date: 28-JUL-2017). It was stated that the vaccines underwent a temperature excursion on 11-MAR-2016 at 34.9 F for 30 min, on 13-MAY-2016 at 46.6 F for 30 min and on 03-SEP-2016 at 32.2 F for 150 min. On 16-MAR-2016 the patients received vaccines (lot reported as L03221, expiry date: 27-MAY-2017), which underwent a temperature excursion on 09-MAR-2016 at 46.6 F for 30 min. On 08-JUN-2016, the patients received vaccines (lot reported as L03221, expiry date: 27-MAY-2017), which underwent a temperature excursion on 13-MAY-2016 at 46.6 F for 30 min. On 21-JUN-2016 and  28-JUN-2016, the patients received vaccines (lot reported as L03221, expiry date: 27-MAY-2017), which underwent a temperature excursion on 28-JAN-2016 at 46.8F for 30 min, on 17-FEB-2016 at 50.2 F for 30 min, on 18-MAY-2016 at 47.3 F for 30 min.  On 27-JUL-2016, 02-AUG-2016 and 03-AUG-2016, the patients received vaccines (lot reported as L03221, expiry date: 27-MAY-2017), which underwent a temperature excursion on 21-JUL-2016 at 46.8 F for  60 min and on 25-JUL-2016 at 46.9 F for 30 min. Date of administration: 22-NOV-2016, 28-NOV-01-DEC-2016, 05-DEC-2016, 07-DEC-09-DEC-2016, 13-DEC-16-DEC-2016, 19-DEC-2016, 21-DEC-2016 (lot M030380 expiry date 01-FEB-2019): dates of temperature excrusions on 10-NOV-2016 at 46.6 F for 30 min, on 01-DEC-2016 at 46.8 F for 30 min Date of administration: 22-NOV-2016, 28-NOV-2016, 29-NOV-2016, 01-DEC-2016, 05-DEC-2016, 06-DEC-2016, 09-DEC-2016, 12-DEC-2016, 13-DEC-2016, 16-DEC-2016, 29-DEC-2016, 30-DEC-2016 (lot M030380 expiry date 01-FEB-2019): dates of temperature excrusions on 22-NOV-2016 at 47.3 F for 30 min, on 29-NOV-2016 at 51.4 F for 150 min, 21-DEC-2016 at 48.9 F for 15 min. Date of administration: 06-DEC-2016 (lot # M032650 expiry date 31-MAR-2019): dates of temperature excrusions on 10-NOV-2016 at 46.6 F for 30 min; on 01-DEC-2016 at 46.8 F for 30 min Dates of administration: 04-NOV-2016, 08-NOV-2016 (lot # M032650 expiry date 31-MAR-2019): date of temperature excrusions: 03-NOV-2016 at 48.4 F for 30 min Dates of administration: 26-AUG-2016 (lot# M023169 expiry date 13-JUN-2018): dates of temperature excrusions on 21-JUL-2016 at 46.8 F for 60 min, on 25-JUL-2016 at 46.9 F for 30 min Dates of administration: 31-AUG-2016, 06-SEP-2016, 21-SEP-2016, 26-SEP-2016, 28-SEP-2016, 30-SEP-2016 (lot# M023169 expiry date 13-JUN-2018): dates of temperature excrusions on 03-AUG-2016 at 46.6 F for 30 min, on 20-SEP-2016 at 47.7 F for 30 min Dates of administration: 26-OCT-2016 01-NOV-2016 (lot# M023169 expiry date 13-JUN-2018): dates of temperature excrusions on 12-OCT-2016 at 32.9 F for 150 min, on 13-OCT-2016 at 33.9 F for 30 min. Dates of administration: 30-AUG-2016 02-SEP-2016 06-SEP-2016 09-SEP-2016 12-SEP-2016 13-SEP-2016 14-SEP-2016 20-SEP-2016 21-SEP-2016 23-SEP-2016 27-SEP-2016 04-OCT-2016 06-OCT-2016 07-OCT-2016 10-OCT-2016 11-OCT-2016 13-OCT-2016 14-OCT-2016 20-OCT-2016 21-Oct-2016 24-OCT-2016 25-OCT-2016 27-OCT-2016 28-OCT-2016 31-OCT-2016 01-NOV-2016 02-NOV-2016 (lot# M018810 expiry date 28-MAY-2018): dates of temperature excrusions on 03-AUG-2016 at 46.6 F for 30 min, on 20-SEP-2016 at 47.7 F for 30 min, on 04-OCT-2016 at 46.8 F for 30 min, on 17-OCT-2016 at 48.3 F for  60 min, on 18-OCT-2016 at 49.6 F for 210 min, on 19-OCT-2016 at 49.6 F for 120 min Dates of administration: 12-OCT-14-OCT-2016 18-OCT-21-OCT-2016 25-OCT-2016 31-OCT-2016 11-NOV-2016 02-NOV-2016 (lot# M018810 expiry date 28-MAY-2018): dates of temperature excrusions on 12-OCT-2016 at 32.9 for 150 min, on 13-OCT-2016 at 33.9 for 30 min Dates of administration 30-AUG-2016- 02-SEP-2016 06-SEP-2016 08-SEP-2016 12-SEP-14-SEP-2016 19-SEP-21-SEP-2016 (lot# M018810 expiry date 28-MAY-2018): dates of temperature excrusions on  21-JUL-2016 at 46.8 F for 60 min, on 25-JUL-2016 at 46.9 F for 30 min. Dates of administration: 27-JUL-2016 29-JUL-2016 02-AUG-2016 04-AUG-2016 09-AUG-10-AUG-2016 12-AUG-2016 15-AUG-2016 19-AUG-2016 22-AUG-2016 24-AUG-2016 26-AUG-2016 29-AUG-30-AUG-2016 31-AUG-2016 07-SEP-2016 13-SEP-2016 (lot reported as M011840 expiry date 01-FEB-2018): dates of temperature excrusions on 21-JUL-2016 at 46.8 F for 60 min, on  25-JUL-2016 at 46.9 F for 30 min Dates of administration: 27-JUL-2016 28-JUL-2016 29-JUL-2016 02-AUG-2016 03-AUG-2016 04-AUG-2016 05-AUG-2016 08-AUG-2016 09-AUG-2016 10-AUG-2016 11-AUG-2016 12-AUG-2016 15-AUG-2016 16-AUG-2016 17-AUG-2016 18-AUG-2016 22-AUG-2016 23-AUG-2016 24-AUG-2016 25-AUG-2016 26-AUG-2016 29-AUG-2016 30-AUG-2016 31-AUG-2016 20-OCT-2016 (lot reported as M011840 expiry date 01-FEB-2018): dates of temperature excrusions on 06-JUN-2016 at 48.2 F for 30 min, on 03-AUG-2016 at 46.6 F for 30 min, on 17-OCT-2016 at 48.3 F for 60 min, on 18-OCT-2016 at 49.6 F for 210 min, on 19-OCT-2016 at 49.6 F for 120 min. Dates of administration: 26-JUL-28-JUL-2016 01-AUG-2016 13-OCT-2016 20-OCT-2016 26-OCT-2016 27-OCT-2016 28-OCT-2016 (lot reported as M011840 expiry date 01-FEB-2018): dates of temperature excrusions on 13-MAY-2015 at 46.6 F for 30 min, on 12-OCT-2016 at 32.9 for 150 min, on 13-OCT-2016 at 33.9 for 30 min  lot# L037554 expiry date 25-DEC-2017: Dates of administration: 10-JUN-2016 14-JUN-17-JUN-2016 20-JUN-24-JUN-2016 28-JUN-2016 01-JUL-2016 04-JUL-2016 11-JUL-2016 12-JUL-14-JUL-2016 15-JUL-2016 18-JUL-21-JUL-2016: dates of temperature excrusions on 13-MAY-2016 at 46.6 F for 30 min Dates of administration: 09-JUN-2016 13-JUN-2016 16-JUN-2016 24-JUN-2016 17-JUN-2016 28-JUN-2016 29-JUN-2016 30-JUN-2016 01-JUL-2016 07-JUN-2016 08-JUL-2016 11-JUL-2016 12-JUL-2016 14-JUL-2016 15-JUL-2016 18-JUL-2016 19-JUL-2016 20-JUL-2016 21-JUL-2016: dates of temperature excrusions, temperature, duration of excrusions were not reported  Dates of administration: 21-JUL-2016 02-AUG-2016 05-AUG-2016: dates of temperature excrusions on 21-JUL-2016 at 46.8 F for 60 min, on 25-JUL-2016 at 46.9 for 30 min Dates of administration: 09-JUN-10-JUN-2016 15-16-JUN-2016 22-24-JUN-2016 27-JUN-01-JUL-2016 05-JUL-2016 07-JUL-07-JUL-2016 12-JUL-2016 14-JUL-2016 15-JUL-2016 18-JUL-2016 28-JUL-2016: dates of temperature excrusions on 28-JAN-2016 at 46.8F for 30 min, on 17-FEB-2016 at 50.2 F for 30 min, on 18-MAY-2016 at 47.3 F for 30 min  lot# L016429 expiry date 09-AUG-2017: Dates of administration: 06-APR-2016 02-APR-2016 03-MAY-2016 14-JUN-2016 30-JUN-2016 05-JUL-2016 22-JUL-2016 26-JUL-2016 25-OCT-2016; dates of temperature excrusions: on 03-SEP-2016 at 32.2 F for 150 min, on 11-MAR-2016 at 34.9 F for 30 min, on 12-APR-2016 at 32.9 F for 30 min, on 13-MAY-2016 at 46.6 F for 30 min, on 12-OCT-2016 at 32.9 F for 150 min, on 13-OCT-2016 at 33.9 F for 30 min Dates of administration: 11-NOV-13-NOV-2015 16-NOV-20-NOV-2015 23-NOV-25-NOV-2015 01-DEC-02-DEC-2015 07-DEC-2015 08-DEC-2015 10-DEC-2015 19-DEC-2015 17-DEC-18-DEC-2015 21-DEC-22-DEC-2015 29-DEC-2015 31-DEC-2015; dates of temperature excrusions: on 29-OCT-2015 at 46.9 F for 60 min, on 17-NOV-2015 at 46.8F for 30 min, on 31-DEC-2015 at 48 F for 60 min Dates of administration: 03-FEB-2016 23-FEB-2016 11-MAR-2016 14-MAR-2016 30-MAR-2016 12-APR-2016 10-AUG-2016 24-AUG-2016 28-SEP-2016 05-OCT-2016 25-OCT-2016, dates of temperature excrusions: on 03-FEB-2016 at 53.8 F for 240 min, on  09-MAR-2016 at 46.6 F for 30 min, on 17-MAR-2016 at 47.5 F for 30 min, on 06-JUN-2016 at 48.2 F for 30 min, on 03-AUG-2016 at 46.6 for 30 min, on  20-SEP-2016 at 47.7 F for 30 min, on 04-OCT-2016 at 46.8 F for 30 min, on 17-OCT-2016 at 48.3 F for 60 min, on 18-OCT-2016 at 49.6 F for 210 min, on 19-OCT-2016 at 49.6 F for 120 min Dates of administration: 07-DEC-2015 17-DEC-2015, dates of temperature excrusions: on 07-DEC-2015 at 47.7 F for 30 min, on 17-DEC-2015 at 46.9 F for 30 min Dates of administration: 22-JUL-2016 02-AUG-2016 18-AUG-2016 19-SEP-2016, dates of temperature excrusions: on 21-JUL-2016 at 46.8 F for 60 min, on  25-JUL-2016 at 46.9 F for 30 min lot# L048237 expiry date 08-MAY-2017 Dates of administration: 19-MAY-2016, dates of temperature excrusions: on 28-JAN-2016 at 46.8F for 30 min, on 17-FEB-2016 at 50.2 F for 30 min, on 18-MAY-2016 at 47.3 F for 30 min Dates of administration: 16-MAR-18-MAR-2016 22-MAR-2016 28-MAR-01-APR-2016 05-APR-08-APR-2016 12-APR-13-APR-2016 15-APR-2016 18-APR-2016 19-APR-2016 21-APR-2016 22-APR-2016 26-APR-2016 28-APR-2016 31-MAY-2016 04-MAY-2016 09-MAY-10-MAY-2016, temperature excrusions: 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 Dates of administration: 14-MAR-16-MAR-2016 22-MAR-2016 28-MAR-2016 30-MAR-31-MAR-2016 04-APR-2016 06-APR-08-APR-2016 12-APR-15-APR-2016 18-APR-20-APR-2016 22-APR-2016 02-MAY-03-MAY-2016 06-MAY-2016 09-MAY-2016 10-MAY-2016 11-MAY-2016 20-MAY-2016, temperature excrusions: at 32.2 on 09-MAR-2016 for 150 min, at 44.9 F on 13-OCT-2016 for 30 min,  at 44.9 on 11-MAR-2016 for 30 min, at 46.6 F on 13-MAY-2016 for 30 min lot# L044475 expiry date12-MAY-2017 Dates of administration: 26-APR-2016 28-APR-2016 02-MAY-2016, temperature excrusions: at 32.9 F on 12-APR-2016 for 30 min Dates of administration: 28-APR-2016 09-MAY-2016 11-MAY-2016 12-MAY-2016 13-MAY-2016, temperature excrusions: at 47.5 F on 17-MAR-2016 for 30 min, at 46.6 F on 02-MAY-2016 for 30 min Dates of administration: 06-MAY-2016 05-MAY-2016 09-MAY-2016 11-MAY-2016, temperature excrusions: 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 lot reported as L026602 expiry date 19-OCT-2017 Dates of administration: 13-MAY-2016 16-MAY-17-MAY-2016 25-MAY-2016 27-MAY-2016 30-MAY-2016 01-JUN-03-JUN-2016 07-JUN-09-JUN-2016 14-JUN-2016 temperature excrusions: 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 Dates of administration: 16-MAY-2016 17-MAY-2016 19-MAY-2016 23-MAY-2016 24-MAY-2016 25-MAY-2016 26-MAY-2016 27-MAY-2016 31-MAY-2016 06-JUN-2016 07-JUN-2016 09-JUN-2016, temperature excrusions: 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 Dates of administration: 12-MAY-2016 16-MAY-2016 18-MAY-2016 20-MAY-2016 25-MAY-26-MAY-2016 31-MAY-2016 03-JUN-2016 07-JUN-2016 09-JUN-2016 10-JUN-2016 14-JUN-2016 15-JUN-2016, temperature excrusions: at 32.9 F on 12-APR-2016 for 30 min, at 46.6 F on 13-MAY-2016 for 30 min lot# L024993 expiry date 17-OCT-2017 Dates of administration: 22-FEB-2016 23-FEB-2016 25-FEB-2016 07-MAR-2016 08-MAR-2016, temperature excrusions: at 53.8 F on 03-FEB-2016 for 240 min, at 50.2 F on 03-MAR-2016 for 90 min Dates of administration: 22-FEB-2016 03-MAR-2016 07-MAR-2016, temperature excrusions: 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, lot# L018351 expiry date 11-AUG-2017 Dates of administration: 20-JAN-2016 01-FEB-02-FEB-2016 05-FEB-2016 09-FEB-2016 11-FEB-2016 16-FEB-18-FEB-2016 22-FEB-23-FEB-2016 25-FEB-26-FEB-2016 29-FEB-2016 01-MAR-03-MAR-2016 09-MAY-2016, temperature excrusions: at 46.8Fon 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 Dates of administration: 14-JAN-2016 15-JAN-2016 20-JAN-2016, 26-JAN-2016 27-JAN-2016 28-JAN-2016 29-Jan-2016 05-FEB-2016 08-FEB-2016 09-FEB-2016 10-FEB-2016 11-FEB-2016 19-FEB-2016 23-FEB-2016 25-FEB-2016 26-FEB-2016 29-FEB-2016 03-MAR-2016, temperature excrusions: at 47.5 F on 14-JAN-2016 for 60 min, at 53.8 F on 03-FEB-2016 for 240 min at 50.2 F on 03-MAR-2016 for 90 min lot reported as L017119 expiry date 10-MAY-2017  Dates of administration: 17-MAY-2016, temperature excrusions: 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 Dates of administration: 25-FEB-2016, temperature excrusions: at 53.8 F on 03-FEB-2016 for 240 min lot reported as L017119 expiry date 10-SEP-2017 Dates of administration: 18-JUL-2016, temperature excrusions: at 46.6 F on 13-MAY-2016 for 30 min lot reported as L016L129  expiry date 09-AUG-2017 Dates of administration: 10-MAR-11-MAR-2016 15-MAR-2016 18-MAR-2016 22-MAR-2016 06-APR-2016 19-APR-2016 05-MAY-2016 09-MAY-2016 16-JUN-2016 22-JUN -2016 temperature excrusions: 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 lot# L007560 expiry date 15-JUN-2017 Dates of administration: 14-APR-2016 28-JUN-2016 temperature excrusions: 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 Dates of administration: 30-NOV-2015, temperature excrusions: at 46.9 F on 29-OCT-2015 for 60 min, at 46.8F on 17-NOV-2015 for 30 min Dates of administration: 17-MAR-2016, temperature excrusions: at 32.2F on 09-MAR-2016 for 150 min, at 34.9 F on 11-MAR-2016 for 30 min lot# L004741 expiry date: 04-MAR-2017 Dates of administration: 08-MAR-2016, temperature excrusions: 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 lot reported as L004601 expiry date: 04-NOV-2016 Dates of administration: 20-APR-2016 29-JUN-2016, temperature excrusions: at 46.8Fon 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 Dates of administration: 16-MAR-2016, temperature excrusions: at 46.6 F on 09-MAR-2016 for 30 min Dates of administration: 19-NOV-2015, temperature excrusions: at 46.9 F on 29-OCT-2015 for 60 min, at 46.8F on 17-NOV-2015 for 30 min Dates of administration: 18-JUL-2016, temperature excrusions: at 46.6 F on 13-MAY-2016 for 30 minutes lot# L016428 expiry date: 30-JUL-2017  Dates of administration: 29-OCT-2015,  temperature excrusions: at 46.9 F on 29-OCT-2015 for 60 min Dates of administration: 22-OCT-2015 21-NOV-2015, temperature excrusions: at 47.8 F on 22-OCT-2015 for 30 min, at 47.5 F on 02-NOV-2015 for 90 min lot#K006960 expiry date: 19-FEB-2017 Dates of administration: 15-MAR-2016, temperature excrusions: at 46.6 F on 09-MAR-2016 for 30 min lot reported as K004204 expiry date:12-JAN-2017  Dates of administration: 17-FEB-2016, temperature excrusions: at 43.8 F on 03-FEB-2016 for 240 min lot reported as L048231 expiry date: 08-MAY-2017 Dates of administration: 08-MAR-2016 09-MAR-2016 10-MAR-2016 11-MAR-2016 15-MAR-2016 16-MAR-2016 14-APR-2016 18-MAR-2016 30-MAR-2016 31-MAR-2016 04-APR-2016 06-APR-2016 06-APR-2016 07-APR-2016 08-APR-2016 11-APR-2016 12-APR-2016 13-APR-2016 14-APR-2016 15-APR-2016 19-APR-2016 21-APR-2016 26-APR-2016 27-APR-2016 28-APR-2016 05-MAY-2016 04-MAY-2016 06-MAY-2016, temperature excrusions: at 50.2 on 03-MAR-2016 for 90 min, at 46.6 F on  09-MAR-2016 for 30 min, at 47.5 F on 17-MAR-2016 for 30 min, at 46.6 F on 02-MAY-2016 for 30 min lot reported as K006429 expiry date:09-AUG-2017  Dates of administration: 21-JUL-2016, temperature excrusions: at 48.2 F on 06-JUN-2016 for 30 min lot # L014415 expiry date: 25-JUL-2017  Dates of administration: 05-NOV-2015 06-NOV-2015 11-NOV-2015, temperature excrusions: at 46.9 F on 29-OCT-2015 for 60 min lot reported as L006549 expiry date:06-APR-2017 Dates of administration: 13-JUN-2016, temperature excrusions: at 46.6 F on 13-MAY-2016 for 30 minutes lot # K016966 expiry date:10-MAY-2017 Dates of administration: 29-OCT-2015 09-DEC-2015, temperature excrusions: at 46.9 F on  29-OCT-2015 for 60 min, at 46.8F on 17-NOV-2015 for 30 min lot reported as K010215 expiry date: 05-MAY-2017 Dates of administration: 05-NOV-2015, 09-DEC-2015, temperature excrusions: at 46.9 F on 29-OCT-2015 for 60 min, at 46.8F on  17-NOV-2015 for 30 min lot reported as M038380 expiry date:01-FEB-2019 Dates of administration:22-NOV-2016 28-NOV-02-DEC-2016 05-DEC-06-DEC-2016 08-DEC-2016 09-DEC-2016 12-DEC-19-DEC-2016 10-DEC-2016 21-DEC-2016 28-DEC-2016 29-DEC-2016, temperature excrusions: at 32.9 on 12-OCT-2016 for 150 min, at 33.9 on 13-OCT-2016 for 30 min, at 33.9 on 13-OCT-2016 for 30 min lot reported as M011849 expiry date:18-FEB-2019 Dates of administration: 30-NOV-2016, temperature excrusions: at 32.9 F on 12-OCT-2016 for 150 min, at 33.9 F on 13-OCT-2016 for 30 min The digital data logger was involved. 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-009507513-1705USA004380: US-009507513-1704USA008135: US-009507513-1705USA004382: US-009507513-1705USA004377: US-009507513-1705USA004376: US-009507513-1705USA004378: