Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, Hepatitis B antibody negative, Product storage error
Clinical narrative: prenatal vitamin: Pregnancy; non-immune to Hepatitis B; Nurse reported RECOMBIVAX HB was administered after a temperature excursion to a patient on Feb 13, 2023. No further information provided. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): RECOMBIVAX HB (W03; This spontaneous prospective pregnancy report was received from a registered Nurse referring to a 28-year-old female patient with no illness at the time of vaccination. There was no information about the patient's current condition and medical history provided.  Concomitant therapies included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid(ADACEL), minerals nos, vitamins nos(PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and acetylsalicylic acid(ASPIRINE).  Last read on 10-FEB-2023 at 16:15, where current temperature was 37 (units not provided), with min and max of 36 and 41 (units not provided). Total time out of recommended storage temperature was approximately 72 hours. Upon discovery, medications placed in bag with "Do Not Use." Moved to different refrigerator which was within range.  Thermostat of Side A fridge adjusted to lower temperature. Supervisor aware of the issue. Pharmaceutical Companies contacted to determine viability of vaccines. Patient's Providers made aware of situation. Risk Management made aware. Safety Officer made aware. Facilities Work Order placed for fridge inspection.  Upon review of temperature log, min and max temperatures were out of range on 13-FEB-2023 as well. Management not made aware until 14-FEB-2023, at 9:40. On an unknown date, the patient was vaccinated with first and second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On an unspecified date, the patient experienced no immune hepatitis B ( Hepatitis B antibody negative).  At 9:40, on 14-FEB-2023, the temperature alarm went off on the Side A refrigerator. The digital readout on data logger at that time read 35(units not provided) for current temperature, with min and max temps of 25 (units not provided) and 35 (units not provided) respectively. Data logger located in center of fridge with probe in glycol.   On 14-FEB-2023, the patient was vaccinated with an improperly stored third dose of   hepatitis b vaccine (recombinant) (RECOMBIVAX HB), thimerosal free, intramuscularly, lot # W036194, expiration date reported as 23-MAY-2025, but upon internal validation established as 29-SEP-2025, in the left deltoid for prophylaxis (Product storage error). On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known and could not be calculated. No prenatal tests or results were reported. The pregnancy outcome was pending and the fetal outcome was unknown at the time of the report. The therapy was taken during the third trimester of pregnancy (Exposure during pregnancy). Outcome of no immune hepatitis B ( Hepatitis B antibody negative) was unknown. The reporter considered exposure during pregnancy, non-immune to Hepatitis B, Product storage error to be medically significant reported as important medical event, also reported as the patient had repeat dose of vaccine.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA004804: US-009507513-2303USA003160: