Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| IPV | POLIO VIRUS, INACT. (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | W1C741M | IM |
Extra dose administered She stated they received a dose of Pediarix, and IPOL, so they essentially received 2 doses of the polio vaccine; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of overdose in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included Polio vaccine inact (Ipv) (batch number W1C741M, expiry date 17-NOV-2025) for prophylaxis. On 11-MAR-2025, the patient received Pediarix and Ipv (intramuscular) .5 ml. On 11-MAR-2025, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: Extra dose administered She stated they received a dose of Pediarix, and IPOL, so they essentially received 2 doses of the polio vaccine). The outcome of the overdose was not applicable. 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: 21-APR-2025 The health care professional reported that a patient received a dose Pediarix and IPV (VERO) [IPOL] received, so they essentially received 2 doses of the polio vaccine with no adverse event. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On 11-Mar-2025, the patient received an unknown dose of suspect IPV (VERO) [IPOL] via Intramuscular route in unknown administration site for vaccine dose schedule due and received an unknown dose of suspect diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid not produced by Sanofi Pasteur with (Unknown strength, formulation, lot and expiry date), via unknown route in unknown administration site for Prophylactic vaccination (Immunisation), so they essentially received 2 doses of the polio vaccine with no adverse event (extra dose administered) (latency same day), which led to overdose. The nurse was asked for additional adverse event information, and she agreed to it initially and when she was asked for the initials and date of birth of the patient she asked if this goes back to the patient. Then she declined to provide additional information at the time of her call and states that she would fill out any paperwork that was sent to her.