Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding multiple patients of unknown demographics. Information about patients' pertinent medical conditions and concomitant medications was not reported. On unknown dates (reported as starting on or after 13-JUN-2018), the multiple patients were vaccinated with improperly stored doses of PROQUAD and VARIVAX (dosing details were not reported) for prophylaxis. The vaccines were reconstituted with sterile diluent which was properly stored. The lot numbers of PROQUAD which were involved in temperature excursion were lot# N020011 (expiry date: 13-JAN-2019), lot# N028445 (expiry date: 09-APR-2019), lot# R001540 (expiry date: 15-JUL-2019) and lot numbers of VARIVAX, lot# N020686 (expiry date: 27-JUL-2019), lot# N030406 (expiry date: 30-OCT-2019) and lot# N032743 (expiry date: 20-NOV-2019). The vaccines were exposed to 6 degrees Fahrenheit to 14 degrees Fahrenheit for a time frame of 20 minutes. Previous temperature excursion of the vaccines was from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 20 minutes. Call was not due to data logger. No adverse events were reported. No product quality complaint was involved. Follow-up information was received on 14-SEP-2018. There was no illness at the time of vaccination. There were no pre-existing diagnosed allergies, birth defects and medical conditions. It was reported that the patients were immunized from 14-JUN-2018 to 28-AUG-2018 with PROQUAD and VARIVAX via subcutaneous dose with previous number of doses as 39 and 83 respectively. The patients did not experience any symptoms so far. It was reported that there was a power failure in the office that was lasting more than 15 minutes. It was decided to transport the vaccine to a nearby place with a standalone freezer and power. The vaccine was transported and was located about 2 minutes away from office. The vaccine was transported as recommended but was not monitored with a data logger thermometer. The vaccines at stand-alone freezer were not monitored with data logger. The vaccine was safely returned to the office after few hours and when temperature at the office vaccine freezer was stable. The freezer at the office was always monitored with a VFC data logger. The temperature of the vaccine was believed to have been preserved between 6 degree Fahrenheit and 14 degree Fahrenheit because the vaccine was handled as recommended. The vaccine was not exposed to higher temperature during power failure and the short distance between the office and the other site with power. The event was reported to VFC coordinator after administering several doses of the vaccines previously reported. Follow up information has been received from the medical assistant on 19-SEP-2018. The reporter stated that on 14-JUN-2018, a "power outage" took place effecting the vaccinations PROQUAD and VARIVAX. The vaccinations were immediately moved to an unspecified location with a secure temperature source until the time that the power would be restored. During the dates of 15-JUN-2018 through 28-AUG-2018, 38 doses of PROQUAD and 4 doses of VARIVAX were administered to unspecified number of infant patients (reported as "between the ages of 12 months and 4 years of age"). Patient identification information was not readily available at the time of the call. However, it was reported that that information could be gathered and submitted via fax. To date, there have been no reported adverse events following the administration of the vaccinations. The medical assistant also stated that their state is requiring further clarification that the vaccines that were involved in the temperature excursion on or after 13-JUN-2018 were still viable. The doctor would like confirmation that no further action is required. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA012716.