Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Prenatal vitamins, indication: pregnancy; No additional AE reported; 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 25-year-old female patient with no immune hepatitis B, anemia and hyperemesis (conflicting information, also reported as no illness at the time of vaccination by the same reporter). There was no information about the patient's medical history provided.  Concomitant therapies included minerals nos, vitamins nos(PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), ferrous sulfate, pyridoxine hydrochloride(VITAMIN B6) and fluconazole(FLUZONE [FLUCONAZOLE]).   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. Medication 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.  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 first 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. Pregnancy outcome was pending and the fetal outcome was unknown at the time of the report. The therapy was taken during the first trimester of pregnancy (maternal exposure during pregnancy). There was no adverse effect reported.  The reporter considered exposure during pregnancy, product storage error to be medically significant reported as important medical event, also reported as the patient had repeat dose of vaccine in the next visit.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2303USA003161: US-009507513-2302USA004804: