Reporte zur Charge UJ260AA

Symptomtext

a patient received a Pentacel vaccine which was exposed at the actual temperature of 22.7 degrees Fahrenheit, which rendered it unsuitable for use with no Adverse event; Initial information regarding an unsolicited valid non-serious case received on 06-Jan-2021 from the other health care professional. This case involves a 4 months old female patient who received a 0.5 ml second dose of QUADRIVALENT INFLUENZA VACCINE [FLUZONE] which was exposed at the actual temperature of 22.7 degrees Fahrenheit (lot number: UJ559AB, expiry date: 14-May-2021), via an unknown route at left vastus lateral on 29-DEC-2020 (Product storage error). The patient's medical history, medical treatments, vaccinations and family history were not provided. List concomitant or no other vaccines not asked. It was an actual medication error due to product storage error temperature too low (latency: same day). At the time of reporting, the patient had no adverse event. Description: Caller advised previously reported temperatures on inquiry: 00408503 were incorrect. The lowest temperature reached was 22.7 degrees F. Also advised PENTACEL was given to patient, wants to know how they should proceed. Should we re-vaccinate the patient who received Pentacel. He provides Adverse Event (AE) information: It is noted that 408503 did not contain AE information, as the reason documented in that case for the temperature excursion was a technical malfunction of the refrigerator. Additional Description of event: The facility initially reported a temperature excursion of 32.5 degrees Fahrenheit and were cleared to immunize based on that temperature. However, on further review, it was discovered they made a mistake and the actual temperature the vaccines were exposed to was 22.7 degrees Fahrenheit. During that time period, three patients received vaccines that were actually unsuitable for use. The patient received a dose of Pentacel after the vaccine was exposed to a temperature excursion of 22.7 degrees Fahrenheit, which rendered it unsuitable for use. Emergency Room/Doctor visit and date 29-Dec-2020. Administering physician Vaccine was administered by a nurse. Product used: Used. First time product used: No and Still using product: No. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.