Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Adacel reached negative 2.1c from 07mar2022 until 31mar2022 due to temperature excursion due to a refrigerator malfunction with no reported adverse event; medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2022SA143416, 2022SA143406, 2022SA140729, 2022SA140912, 2022SA141394, 2022SA142501, 2022SA142502, 2022SA142504, 2022SA140733, 2022SA141172, 2022SA143721, 2022SA140726, and 2022SA140723.  This case involves a 41 years old female patient who received diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] that reached negative 2.1c from 07-Mar-2022 until 31-Mar-2022 due to temperature excursion due to a refrigerator malfunction with no reported adverse event and medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard with no reported adverse event.  The patient had no other vaccines The patient's past medical history, medical treatment(s), concomitant medication and family history were not provided. Pregnancy: No   On 24-Mar-2022, the patient received a 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (strength: standard, frequency: once, lot C5963AA; expiry date: 18-Jan-2024 and formulation: unknown) via unknown route in the left deltoid for immunization.  Caller reported a temperature excursion due to a refrigerator malfunction for the Product adacel. Due to a malfunction low temperature of  negative 2.1C from 07-Mar-2022 until 31-Mar-2022 was reached (product storage error) (latency: same day, Onset date: 24-Mar-2022). No human error involved. The product was used by/ administered to the patient. This situation was reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard (poor quality product administered) (latency same day; Onset date: 24-Mar-2022).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events  At time of reporting, the outcome was Unknown for 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.  Based on information previously received, the following information [Event, "No adverse event" was updated and replaced by events "incorrect product storage and Poor quality vaccine administered" and Case Classification was updated from non case to Valid with no AE.] has/have been amended