Sex: F
Vaccine: DTAP, IPV
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccines experienced multiple excursions, vaccine stored at temperature outside the recommended range was administered to patient; vaccine expired on 19-Nov-2018 was administerd to patient on 15-Mar-2019; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA125041, 2019SA125047, 2019SA125008, 2019SA125033, 2019SA125087, 2019SA125072, 2019SA125066 and 2019SA125054 same reporter.  This case involves a 4 years old female patient who received vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and TUBERCULIN PPD (TUBERCULIN PPD) for Tuberculin test received on 15-Mar-2019.  On 15-Mar-2019, the patient received a 0.5 mL dose of suspect IPV (VERO) lot N1K931M, expiry date- 19-NOV-2018 via intramuscular route in the deltoid nos.  On 15-Mar-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to incorrect product storage and expired vaccine used.  This was reported to the MIA- Fluzone Quadrivalent, Daptacel, ActHIB, Pentecel, IPOL, Adacel, Menactra. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad  It was unknown if any adverse event was occurred.   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.  Information on the batch number was requested.  Documents held by sender: none.