Sex: U
Vaccine: DTAPIPVHIB, IPV, TD
Symptoms: Medication error, Product storage error
Clinical narrative: This case involves an unknown age and unknown gender patient for whom it was reported temperature excursion of pentacel, ipol and tenivac total excursion time was 128.25 hours after receiving DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC], IPV (VERO) [IPOL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product storage error). The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/ IPV(VERO)/HIB(PRP/T) VACCINE [lot UJ466AAA expiry date: 21-May-2022] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect IPV (VERO) [lot T1E872M, expiry date: 10-Oct-2022, Lot: T1D481M, expiry date: 25-Jul-2022] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [lot U6831AA and expiry date: 08-Oct-2022] via an unknown route in unknown administration site for prophylactic vaccination. It was a case of actual medication error due to product storage error [Latency: on the same day]. It was reported "Caller stated the first excursion was on one day in august which was for 47 hours. On 01-Sep-2021 for 18 minutes and the temperature in the refrigerator was 46.1-50.2 degrees Fahrenheit. On 18-Oct-2021 the excursion lasted for 72 hours and the refrigerator temperature was 41.0-41.7 degrees Fahrenheit. On 22-Oct-2021 the excursion was for 1 hour and the refrigerator temperature was 39.7-41.8 degrees Fahrenheit. On 25-Oct-2021 the excursion was for 1 hour and 2 minutes. The temperature of the refrigerator was 39.9-40.9 degrees Fahrenheit. On 28-Oct-2021 the excursion was for 30 minutes and the temperature of the refrigerator was 40.2-40.9 degrees Fahrenheit. On 29-Oct-2021 the excursion lasted for 1 hour and 1 minute and the temperature reached 40.2-41.2 degrees Fahrenheit. On 01-Nov2-021 the excursion lasted for 48 minutes the temperature reached 40.0-40.8 degrees Fahrenheit. On 02-Nov-2021 the excursion lasted for 55 minutes and the temperature reached 39.8-40.7 degrees Fahrenheit. On 05-Nov-2021 the excursion lasted for 57 minutes and the temperature reached 40.9-41.7 degrees Fahrenheit. On 09-Nov-2021 the excursion lasted for 59 minutes and the temperature reached 41.3-42.3 degrees Fahrenheit. All vaccines were involved in the excursion and caller stated the vaccines have been given to patients post excursion. Caller stated she will call back when the patient information is gathered. Total excursion time was 128.25 hours". 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 the 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.