Symptomtext
temperature excursion of pentacel vaccine as temperature reached to negative -40f degrees for 8 hours and 25 minutes with no reported adverse event; patient received pentacel post-temperature excursion with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2023SA137908, 2023SA138048 and 2023SA136956. This case involves an unknown age male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] post-temperature excursion with temperature reached to negative -40F degrees for 8 hours and 25 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included Rototec. On 18-Apr-2023, the patient received a 0.5 ml dose (frequency: once) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) (lot: UJ753ABA; expiry date: 16-Sep-2023; strength: standard) via intramuscular route in the left thigh for Immunization. On 18-Apr-2023 the temperature excursion of pentacel reached to negative -40F degrees for 8 hours and 25 minutes with no reported adverse event (product storage error) (unknown latency) and patient received pentacel post-temperature excursion with no reported adverse event (poor quality product administered) (latency: same day). It was reported, "Human Error: UNKNOWN Does extended stability data cover the excursion? No PRODUCT UNOPENED Caller wanted to know if products were given to a patient would they need to call and revaccinate. The caller reported that since the excursion 3-patients received doses of the vaccines; that 2-of the 3-patients received both DAPTACEL and ACTHIB post excursion; and 1-patient received PENTACEL post excursion." Action taken was not applicable. At time of reporting, the outcome was Unknown for both the events. 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.