Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects; One patient who received the ROTATEQ lot # R022224 that had undergone temperature excursion; This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Their medical history, concurrent conditions and drug reactions or allergies were not reported. Concomitant medication included sterile diluent.   On unspecified dates since September 2019, these patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (strength, dose number, dose, route, anatomical location, lot # and expiration date were unknown) (product storage error). It was reported that varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced temperature excursion with a total time in the range of 15 degrees Fahrenheit (F) to 46 degrees F (-9 degrees Celsius (C) to 8 degree C)  (-3.1 C) for a timeframe of 2 hours and 28 minutes. Previous temperature excursion was reported as (-10 C) and total time in the range of 6 degree F to 14 degree F (-14 degree C to -10 degree C) for 1 hour and 47 minutes with multiple excursions. It was also reported that Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion at a temperature (17.4 C) and total time and highest temperature was above 47-degree F/9 degree C with multiple excursions for a time frame of 6 hours and 43 minutes. Previous temperature excursion was also reported. The call was due to digital data logger. No additional adverse effects were reported.   Follow-up information has been received from the medical assistant on 26-NOV-2019.  Lot # and expiration dates of the vaccines were updated. It was reported that varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R021098, expiration date: 23-JUL-2020; lot # R018933 and expiration date: 02-JUL-2020) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R028531, expiration date: 02-APR-2020) experienced temperature excursion with a total time in the ranges of -9 degree C to 8 degree Celsius (-3.1 C) for a timeframe of 2 hours and 28 minutes. The previous temperature excursion was reported to be -10 C with total time in the range of -14 degree C to -10 degree C for a timeframe of 1 hour and 47 minutes. Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R022224, expiration date: 29-MAY-2020) also experienced temperature excursion with total time and highest temperature above 47 degree F/9 degree C (17.4 C) for a timeframe of 3 hours and 30 minutes. The previous temperature excursion was reported with a total time and highest temperature above 47 degree F/9 degree C (14.8 C) for a timeframe of 3 hours and 13 minutes. The call was due to digital data logger for all the vaccines.  Follow up information has been received from the medical assistant on 21-MAY-2020.  The reporter mentioned that no patients had received Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) or Measles, Mumps, Rubella and varicella virus vaccine live (Oka/Merck) (VARIVAX) that had undergone temperature excursion.   The reporter mentioned that a 6-weeks-old male patient, with no concurrent conditions, medical history and concomitant medications  reported, received on 02-DEC-2019, a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ)(dose, route of administration, anatomical location not reported; lot # R022224, expiration date: 29-MAY-2020) which had undergone temperature excursion for prophylaxis.  Additional information is not expected.