Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, HIBV, PNC13, RV5
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: adverse event: o; Product storage error temperature too low/ 35.2 F; expiration date: 28-MAR-2021/ date of vaccination(s): 30-APR-2021; This spontaneous report was received from a licensed practical nurse and office manager (other) and refers to a 7-month-old, male patient (one of two twins). His medical history, previous drug reactions or allergies were not provided. No other vaccines were administered within 4 weeks prior. No concomitant medications.  On an unspecified dates, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 doses (dose, strength, route of administration, lot # and expiration date were not reported) for prophylaxis.  On 30-APR-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) dose 3, 2 ml dose, orally, lot # 1660952, expiration date was reported as 28-SEP-2021, however upon internal validation, has been established as 28-MAR-2021 (conflicting data) (expired vaccine used) for prophylaxis (strength was not provided). Other suspect vaccinations administered on the same day for prophylaxis included hib vaccine conj (tet tox) (HIBERIX) (dose, strength, route of administration, lot # and expiration date were not reported), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscularly (im), in left anterolateral  thigh (LAT) lot # TF4EB. Lot # TF4EB is an invalid number for the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB). Lot # TF4EB does not match any Company product as confirmed by Lot Verification team. Expiration date was reported as 29-SEP-2021 (dose and strength were not provided); pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (dose and strength were not provided) intramuscularly, lot # DN4217, expiration date was reported as 30-DEC-2022, in the right anterolateral thigh (RAT); and with diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) im, in the LAT, lot # 4977T, expiration date reported as 05-SEP-2022 (dose and strength were not provided).   The digital data logger (DDL) detected, that the vaccines were improperly stored prior to administration. The reporter stated, that the unit (refrigerator) with the vaccines was making a noise, therefore to prevent a loss of vaccines, on 09-APR-2021, they were transferred to a unit, which had insulin samples in it. Due to the amount of products in the unit, the temperature got down to 35.2 degree Fahrenheit (F) on one day (unspecified) (product storage error temperature too low). When a new unit was available ant the temperature was at acceptable level, vaccines were put in the new unit on 04-MAY-2021. The reporter attached the temperature logs. The vaccines were stored at the temperature below 36 (F) (lowest registered temperature was of 35.2 F) for 480 hours (no previous temperature excursion reported). Adverse event and the patient's response were reported as none (0) (no adverse event). The vaccines was not available for return/evaluation due to the single dose. Operator was trained healthcare professional. All vaccines were used according to the instruction leaflet.  This is one of the six linked reports received from the same reporter. This case is linked with the report # 2105USA002668 regarding sibling case.; Sender's Comments:  US-009507513-2105USA002668: US-009507513-2105USA002966: US-009507513-2105USA002721: US-009507513-2105USA002665: US-009507513-2105USA002516: