Symptomtext
inadvertently administered both Pentacel and Pediarix instead of the ACT-HIB and Pediarix; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of accidental overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included PENTACEL (batch number UJ844AB, expiry date 02-MAR-2024) for prophylaxis. On 07-JUL-2023, the patient received Pediarix .5 ml and PENTACEL (intramuscular, right thigh). On 07-JUL-2023, an unknown time after receiving Pediarix, the patient experienced accidental overdose (Verbatim: inadvertently administered both Pentacel and Pediarix instead of the ACT-HIB and Pediarix). The outcome of the accidental overdose was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-AUG-2023 The unsolicited valid non-serious case received from a Other Health Professional. This case involved a patient who was inadvertently administered both Pentacel and Pediarix instead of the ACT-HIB and Pediarix with no reported adverse event and patient inadvertently received an extra dose of the dtap and ipv antigens with no reported adverse event. The patient's past medical history, medical treatment, vaccination and family history were not provided. The patient received 0.5 mL dose of suspect diphtheria/tetanus /5 hybrid AC vaccine via intramuscular route in the right thigh and unknown dose of suspect Pediarix not produced by Sanofi Pasteur (batch number, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination, inadvertently instead of the Acthib and Pediarix and received an extra dose of the dtap and ipv antigens with no reported adverse event (latency same day). This suspected adverse reaction report was 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 2001183/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was 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 was to be held liable for the occurrence of this medication error, The suspect Pentacel, dose, batch number and expiry date added and text updated accordingly. The patient received inadvertently Pentacel and Pediarix instead of the ACT-HIB and Pediarix, which led to accidental overdose.