Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 12-APR-2017 from the office manager regarding a unknown number of unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates starting on or after 11-JAN-2017 the patients were administered improperly stored doses of GARDASIL 9, RECOMBIVAX HB, ROTATEQ, or VAQTA (all lot #'s and exp dates unknown) (doses not specified). Excursion details: Names of vaccines involved:  GARDASIL 9, RECOMBIVAX HB, ROTATEQ, or VAQTA Temperature: 47 degrees Fahrenheit to 77 degrees Fahrenheit Time frame: 839 hours Previous temperature excursion? No Was call due to "data logger"? No No adverse effect reported. The action taken is not applicable and the outcome was not reported. 12-APR-2017 Note AE update. Office manager called to report that time conditions for evaluation were incorrect. Time reported is 48 hours. Temperature: 53.4 degrees Fahrenheit (47 Fahrenhit to 77 Fahrenheit) Time Frame: 48 hours Previous temperature excursion? No Was call because of a "data logger"? No No adverse events reported. 12-APR-2017 Additional information received. The primary reporter called to provide the lot numbers and expiration (exp) dates for the improperly stored and administered vaccines. GARDASIL 9  (lot # M032650, exp 31-MAR-2019), RECOMBIVAX HB (lot # M042322 exp 21-FEB-2019), ROTATEQ (lot # M040271 exp 30-APR-2018; M038846 exp 26-APR-2018; M032636 exp 06-APR-2018; M017558 exp 27-FEB-2018), VAQTA (lot # N003194 exp 28-OCT-2018; M038572 exp 11-MAR-2018; M047658 exp 28-OCT-2017) (doses not specified). No further information was provided. Follow-up information was received on 12-APR-2017 from the office manager. VAQTA ( lot # M038572, exp 11-MAR-2018) had temperature excursion 20-JAN-2017 thru 26-JAN-2017 for 168 hrs at 52.3 degrees; 07-FEB-2017 thru 26-JAN-2017 for 336 hours at 46.9 degrees; and 27-FEB-2017 thru 28-FEB-2017 for 8 hrs at 46.4 degrees. The vaccine was administered in February 2017; VAQTA (lot # M047658 exp 28-OCT-2017) had a temperature excursion 16-FEB-2017 thru 21-FEB-2017 for 144 hrs at 49.5 degrees Fahrenheit (F); 27-FEB-2017 thru 28-FEB-2017for 8 hrs at 46.4 degrees F; 10-MAR-2017 thru 12-MAR-2017 120 hrs at 46.6 degrees F; 14-MAR-2017 thru 15-MAR-2017 for 48 hrs at 53.4 degrees F; and 20-MAR-2017 thru 21-MAR-2017 for 48 hrs at 53.4 degrees F. The vaccine was administered March 2017. ROTATEQ (lot # M032636 exp 06-APR-2018) had a temperature excursion 20-JAn-2017 thru 26-Jan-2017 for 168 hrs at 52.3 degrees; 07-FEB-2017 thru 21-FEB-2017 for 336 hours at 46.9 degrees; and 27-FEB-2017 thru 28-FEB-2017 for 8 hrs at 46.4 degrees. The vaccine was administered in February 2017; ROTATEQ (lot # M038846 exp 26-APR-2018)  had a temperature excursion 16-FEB-2017 thru 21-FEB-2017 for 144 hrs at 49.5 degrees Fahrenheit (F); 27-FEB-2017 thru 28-FEB-2017for 8 hrs at 46.4 degrees F; 10-MAR-2017 thru 12-MAR-2017 120 hrs at 46.6 degrees F; 14-MAR-2017 thru 15-MAR-2017 for 48 hrs at 53.4 degrees F; and 20-MAR-2017 thru 21-MAR-2017 for 48 hrs at 53.4 degrees F. The vaccine was administered March 2017. RECOMBIVAX HB (lot # M042322 exp 21-FEB-2019) had a temperature excursion 16-FEB-2017 thru 21-FEB-2017 for 144 hrs at 49.5 degrees Fahrenheit (F); 27-FEB-2017 thru 28-FEB-2017for 8 hrs at 46.4 degrees F; 10-MAR-2017 thru 12-MAR-2017 120 hrs at 46.6 degrees F; 14-MAR-2017 thru 15-MAR-2017 for 48 hrs at 53.4 degrees F; and 20-MAR-2017 thru 21-MAR-2017 for 48 hrs at 53.4 degrees F. The vaccine was administered March 2017. GARDASIL 9 (lot # M032650, exp 31-MAR-2019) had a temperature excursion 16-FEB-2017 thru 21-FEB-2017 for 144 hrs at 49.5 degrees Fahrenheit (F); 27-FEB-2017 thru 28-FEB-2017for 8 hrs at 46.4 degrees F; 10-MAR-2017 thru 12-MAR-2017 120 hrs at 46.6 degrees F; 14-MAR-2017 thru 15-MAR-2017 for 48 hrs at 53.4 degrees F; and 20-MAR-2017 thru 21-MAR-2017 for 48 hrs at 53.4 degrees F. The vaccine was administered March 2017. Additional information has been requested.