Symptomtext
5 month old male patient administered expired dose of PENTACEL vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from a Physician via other health care professional via Medical Information (MI) (Reference number- 00607806) and transmitted to Sanofi on 19-May-2021. This case involves a five month old male patient who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation. On 13-May-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6622AB and expiry date: 12-Mar-2021) (Frequency: once) via an intramuscular route in the left thigh for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency on same day). It was also reported that Caller states that a Nurse provided an expired PENTACEL to a patient. Nurse states that on 5/13/2021, another nurse administered a PENTACEL vaccine that was later noted to have expired on 3/12/2021. At the time of report, no adverse event was reported. 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.