Symptomtext
The Patient received a 0.5 mL expired dose of ActHib with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Agency (Reference number- 00653461) and transmitted to Sanofi on 23-Jun-2021. This case involves a 2 month old male patient who received a 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] [lot number: UJ324AA, expiry date: 14-Jun-2021], via an unknown route at the left thigh on 22-Jun-2021, for prophylactic vaccination (expired product administered). On the same day, patient received PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and ROTOVIRIS as a concomitant medications. Medical history, medical treatment, vaccination and family history were not reported. It was a case of actual medication error due to expired vaccine used. (Latency: on same day) At the time of report, no adverse event was reported. At time of reporting, the outcome was of event reported as unknown. 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.