Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTP | DTP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1C891M | OT / LA |
PENTACEL and IPOL were incorrectly administered to a patient and vaccines to be given was suppose to be a Dtap and Polio with no reported AE; extra dose of IPV was given with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from nurse. This case involves a 13 months old female patient who incorrectly administered to IPV (Vero) [IPOL] and pentacel was suppose to be a Diphtheria, Tetanus And Nos Pertussis Vaccine and Polio and extra dose of IPV was given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Hib Vaccine Conj (Tet Tox), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Mrc 5), Tetanus Vaccine Toxoid (Pentacel) for Immunisation on 02-jun-2025. On 02-Jun-2025, the patient received 0.5mL of suspect IPV (Vero), Suspension for injection (lot X1C891M, expiry date 31-Oct-2026, strength standard and frequency once) via subcutaneous route in the left arm for Immunization. On an unknown date, the patient was suppose to received Diphtheria, Tetanus And Nos Pertussis Vaccine produced by unknown manufacturer (lot number, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On 02-Jun-2025, the patient was incorrectly administered with IPV (Vero) and pentacel and was suppose to be a Diphtheria And Tetanus And Nos Pertussis Vaccine and polio with no reported ae (wrong product administered) and extra dose of ipv was given with no reported adverse event (extra dose administered) (latency same day). Reportedly, patient's Hib vaccine was scheduled in October 2025 since it was given last April 2025. Action taken was not applicable. 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.; Sender's Comments: US-SA-2025SA157483:
PENTACEL