Symptomtext
adverse experience; revaccinated; Temperature excursion involving, PEDVAX HIB, RECOMBIVAX HB, VAQTA, GARDASIL 9, and ROTATEQ; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 4-month-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 20-DEC-2021, the patient was vaccinated with an improperly stored doses haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # U003873, expiration date: 15-APR-2023, which have been verified to be valid lot numbers for haemophilus b conjugate vaccine (meningococcal protein conjugate) administered in left thigh and with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (lot # 1821803, expiration date: 26-JUL-2022 (also reported as 25-JUL-2022), which have been verified to be valid lot numbers for rotavirus vaccine, live, oral, pentavalent (strengths, doses # and exact doses were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion of below 36?F (30.4?F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination (inappropriate schedule of vaccine administered). The outcome of the event of ill-defined disorder was reported as resolved on an unknown date. The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown. The reporter considered the event of ill-defined disorder to be important medical event (medically significant). This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-2201USA000582: