Symptomtext
patient inadvertently received a dose of PENTACEL after having already received a dose of Pediarix, with no reported adverse event; Initial information received on 20-Aug-2021 regarding an unsolicited valid non-serious case from an other health professional and consumer/ non healthcare professional via Media information (under reference 00733710). This case involves a 6 months old female patient who inadvertently received a dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL [VERO]) after having already received a dose of DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) [extra dose administered]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration for prophylactic vaccination. On 04-Aug-2021, the patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On 20-Aug-2021, the patient received a 0.5 ml dose of suspect PENTACEL (lot UJ458AA and expiration date: 21-May-2022) via intramuscular route in the left thigh for prophylactic vaccination. It was an actual medication error due to extra dose administered (same day latency). It was reported "Caller states that a patient inadvertently received a dose of PENTACEL on 20-Aug-2021 after having already received a dose of Pediarix on 04-Aug-2021. Caller asked if the patient was at risk for any adverse events because of the close proximity of the two doses and stated that she realized that today's dose would not count as a valid dose in the series". At time of reporting, it was unknown if the patient experienced any adverse event and the outcome was unknown for the reported event. 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.