Symptomtext
patient inadvertently receive a Pentacel vaccine at 7 months of age with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare Professional. This case involves a 7 month old male patient who receive 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ384AAA and expiry date 09-Oct-2021) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (not produced by Sanofi Pasteur) ( lot number and expiry date not reported), patient inadvertently receive a pentacel vaccine at 7 months of age (accidental exposure to product). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEP [HEPATITIS B VACCINE]) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE SHANTHA) for prophylactic vaccination. It was a potential medication error case due to accidental exposure to product. The caller stated that a patient inadvertently receive a pentacel vaccine at 7 months of age. See the additional event details field for more info. Additional Description of event Adverse events :The patient was given a pentacel vaccination at 7 months of age. Staff person SH administered 0.5 ml of penticacel in the patient's right thigh. He also received prevnar, Hep B and the Roto virus vaccines on this visit. NP wrote the orders. At the time of reporting, 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 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. There will be no information available on the batch number for this case.