Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; A HCP called to report a TE for the vaccines with 16 different current excursions beginning 04/22/2024 and were identified "sometime last week" (06/10/2024-06/14/2024); This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. Concomitant medications included sterile diluent(STERILE DILUENT).         On an unspecified date in 2024, the patients were vaccinated with improperly stored  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) Albumin status: rHA lot # W028734 with expiration date 08-SEP-2024; measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) Albumin status: rHA lot # X018570 with expiration date 05-JAN-2025; and varicella virus vaccine live (Oka/Merck)(VARIVAX) lot # X018954 with expiration date 13-JUL-2025; all as prophylaxis (strength, dose, route of administration and anatomical location were not reported for the suspect vaccines). It was reported that 16 different excursions began on 22-APR-2024 but were identified "last week" between 10-JUN-2024 to 14-JUN-2024. It was stated that "some vaccines had been administered to patients and the remaining vaccines are isolated from patient use at this time. The healthcare professional was unable to provide specific patient or administration details and the details of each excursion were unknown at this time. No additional adverse event (AE) was reported.  This is a non-valid case due to multiple unspecified patients.  Follow up received from medical assistant on 25-JUN-2024.   On 23-APR-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W028734 with expiration date 08-SEP-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X010531 with expiration date 11-APR-2025 (exact dose, dose number, route and site of administration were not provided). On 24-APR-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W035041 with expiration date 24-MAY-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X010531 with expiration date 11-APR-2025 (exact dose, dose number, route and site of administration were not provided). On 26-APR-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W035041 with expiration date 24-MAY-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X018954 with expiration date 13-JUL-2025 (exact dose, dose number, route and site of administration were not provided). On 01-MAY-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W035041 with expiration date 24-MAY-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X010531 with expiration date 11-APR-2025 (exact dose, dose number, route and site of administration were not provided). On 06-MAY-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W035041 with expiration date 24-MAY-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X010531 with expiration date 11-APR-2025 (exact dose, dose number, route and site of administration were not provided). On 07-MAY-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W035041 with expiration date 24-MAY-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X010531 with expiration date 11-APR-2025 (exact dose, dose number, route and site of administration were not provided). On 13-MAY-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W035041 with expiration date 24-MAY-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X010531 with expiration date 11-APR-2025 (exact dose, dose number, route and site of administration were not provided). On 14-MAY-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W035041 with expiration date 24-MAY-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X010531 with expiration date 11-APR-2025 (exact dose, dose number, route and site of administration were not provided). On 20-MAY-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W035041 with expiration date 24-MAY-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X018954 with expiration date 13-JUL-2025 (exact dose, dose number, route and site of administration were not provided). On 21-MAY-2024, the patients were vaccinated with improperly stored  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W035041 with expiration date 24-MAY-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X018954 with expiration date 13-JUL-2025 (exact dose, dose number, route and site of administration were not provided). On 24-MAY-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W035041 with expiration date 24-MAY-2024 (exact dose, dose number, route and site of administration were not provided). On 28-MAY-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W028734 with expiration date 08-SEP-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X018954 with expiration date 13-JUL-2025 (exact dose, dose number, route and site of administration were not provided). On 04-JUN-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W028734 with expiration date 08-SEP-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X018954 with expiration date 13-JUL-2025 (exact dose, dose number, route and site of administration were not provided). On 05-JUN-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W028734 with expiration date 08-SEP-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X018954 with expiration date 13-JUL-2025 (exact dose, dose number, route and site of administration were not provided). On 11-JUN-2024, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W028734 with expiration date 08-SEP-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X018954 with expiration date 13-JUL-2025 (exact dose, dose number, route and site of administration were not provided). On 14-JUN-2024, the patients were vaccinated with improperly stored  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W028734 with expiration date 08-SEP-2024 (exact dose, dose number, route and site of administration were not provided) and with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X018954 with expiration date 13-JUL-2025 (exact dose, dose number, route and site of administration were not provided). On 15-JUN-2024, the patients were vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X018954 with expiration date 13-JUL-2025 (exact dose, dose number, route and site of administration were not provided). The vaccines were stored in temperature above 9 Celsius degrees for various ranges of time and between -14 to -10 Celsius degrees for various ranges of time (product storage error).   Follow up information has been received from a physician on 16-JUL-2024. A 4-years-old male patient with no adverse event following prior vaccination. On 26-APR-2024, the patient  was vaccinated with improper storage first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot # W035041, expiration date 24-MAY-2024, in the left arm; first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # X010531, expiration date 11-APR-2025, in the left arm; and first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), batch # 5AY2J, expiration date 10-JUN-2024, in the right arm, all vaccines for prophylaxis (quantity dose and route for all vaccines were not reported). The temperature excursion occurred as a result of a reading from a Digital Data Logger.  This case was previously considered no-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient's identifiers were provided.; Sender's Comments:  US-009507513-2407USA010406: