Received Dec 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (KINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 4 | UNK | IM / RL |
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | P1A171M | SC / LL |
crying during the injections; Overdose; 18 months old female patient who received fourth dose; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of crying in a 18-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis. Co-suspect products included Polio vaccine inact 3v (Vero) (Ipol) (batch number P1A171M, expiry date APR-2020) for prophylaxis. On 22-JAN-2019, the patient received the 4th dose of Kinrix (intramuscular, right thigh) and Ipol (subcutaneous, left thigh). On 22-JAN-2019, immediately after receiving Kinrix and 1 year after receiving Ipol, the patient experienced crying (Verbatim: crying during the injections), overdose (Verbatim: Overdose) and inappropriate age at vaccine administration (Verbatim: 18 months old female patient who received fourth dose). The outcome of the crying was not reported and the outcome of the overdose and inappropriate age at vaccine administration were not applicable. It was unknown if the reporter considered the crying and inappropriate age at vaccine administration to be related to Kinrix and Kinrix Pre-Filled Syringe Device. It was unknown if the company considered the crying and inappropriate age at vaccine administration to be related to Kinrix and Kinrix Pre-Filled Syringe Device. 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: 11-DEC-2025 The reporter mentioned a female patient who had received the fourth dose of Kinrix along with a separate dose of Ipol vaccine and had cried during the injections. The batch number was not provided, and a request for this information had been made.