Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No other information given at this time.; Medical assistant calls to report a temperature excursion/ The product were administered; This spontaneous report was received from a medical assistant, referring to an unknown number of patients of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 09-NOV-2021, the following vaccines experienced temperature excursion, and then on unknown dates, they were administered to unspecified number of patients: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (formulations, strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported; lot numbers S007811, S029457 and S005248, expiration dates reported and validated as 14-MAR-2021, 19-SEP-2021 and 20-FEB-2021, respectively to each lot number), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (formulations, strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported; lot numbers 1621929 and R025729, which has been verified to be valid, expiration dates reported and validated as 06-DEC-2021 and 18-JUN-2021, correspondingly to each lot number), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (formulation, strength, dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported; lot number R014263, which has been verified to valid, expiration date reported as 26-JAN-2021, but upon internal review it was established as 26-MAR-2021), and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (PFS)  (strengths, doses, vaccination schemes frequency, routes of administration and anatomical sites of vaccination were not reported;(lot numbers S005856, S029542 and T020638, which has been verified to valid, expiration date reported and validated as 03-DEC-2020, 10-JUN-2021 and 26-FEB-2022, respectively to each lot number), all the vaccines were administered as prophylaxis. The vaccines administered experienced a temperature excursion above 47 degrees Fahrenheit (F) for a time frame of 3 hours. There was a previous temperature excursion above 47 F (47.4 F) for 1 hour and 20 minutes, 47 F (46.7 F) for 50 minutes and 47 F (47.6 F) for 40 minutes, as recorded by a data logger. No additional adverse events were reported. At the reporting time, some of the lot numbers had expired, but were not expired at the time of the administration, neither the lot numbers had expired at the time of the report.    This case has been considered non-valid due to the lack of patients' identifiers.  Follow up information has been received from the medical assistant on 01-APR-2021. The reporter provided patient's identifier and this report was concerning a 4-year-old patient of unknown gender. On 08-MAR-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S039309 with expiration date 31-MAR-2018. The excursion date, temperature and duration were not provided.  This case has been considered non-valid due to the lack of patients' identifiers.; Sender's Comments:  US-009507513-2103USA005178: