Sex: U
Vaccine: DTAP, DTAPIPV, HIBV, TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: After temperature excursion, vaccines were administered with no reported adverse event; temperature excursion due to Refrigerator malfunction, Max/low temperature reached: 31.928 F for a duration of labelled 15 mins with no reported adverse event; Initial information received on 11-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 15 patients and reporter reported temperature excursion due to refrigerator malfunction, max/low temperature reached: 31.928 f for a duration of labelled 15 mins with no reported adverse event and after temperature excursion, vaccines diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], haemophilus type B (HIB)  (PRP/T) vaccine [ACT-HIB], diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] and diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] were administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot number, dosage, strength, expiry date- not reported), also received a dose of suspect haemophilus type B (HIB)  (PRP/T) vaccine Powder and solvent for solution for injection (lot number, dosage, strength, expiry date- not reported), also received a dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (lot number, dosage, strength, expiry date- not reported), and received a dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine Suspension for injection (lot number, dosage, strength, expiry date- not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).   Caller reported,  temperature excursion due to refrigerator malfunction, max/low temperature reached: 31.928 f for a duration of labelled 15 mins with no reported adverse event (product storage error) (unknown latency) on 31-Mar-2023 for vaccines diphtheria-2/tetanus/5 AC pertussis vaccine; haemophilus type B (HIB)  (PRP/T) vaccine; diphtheria-15/tetanus/5 AC pertussis vaccine; and diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine and after temperature excursion, vaccines were administered with no reported adverse event (poor quality product administered) (latency- same day). No human error was involved.  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.