Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UNK | — |
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | UNK | UNK | — |
| TDAP | TDAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
had like a type of palsy after vaccinations; This serious case was reported by a consumer via other manufacturer and described the occurrence of paralysis in a 15-month-old female patient who received DTPa (DTPa vaccine) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis, Hib UNK (Hib vaccine) for prophylaxis, Pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) for prophylaxis and HIB vaccine conj (tet tox) (Act hib) for prophylaxis. On an unknown date, the patient received DTPa vaccine, Hepatitis B vaccine, Hib vaccine, Prevnar 13 and Act hib. On an unknown date, an unknown time after receiving DTPa vaccine, Hepatitis B vaccine, Hib vaccine, Prevnar 13 and Act hib, the patient experienced paralysis (Verbatim: had like a type of palsy after vaccinations) (serious criteria GSK medically significant and other: Medically Significant). The outcome of the paralysis was unknown. The reporter considered the paralysis to be related to DTPa vaccine, Hepatitis B vaccine, Hib vaccine, Prevnar 13 and Act hib. The company considered the paralysis to be unrelated to DTPa vaccine, Hepatitis B vaccine and Hib vaccine. The company considered the paralysis to be related to Prevnar 13 and Act hib. Additional Information: GSK receipt date: 15-JUL-2025 The reporter reported that the patient who experienced a reaction that resembled a type of palsy after receiving the pneumococcal vaccine CONJ 13V (CR M 197) Prevnar 13, hepatitis B vaccine, HIB (PRP/T) Vaccine (ACT-HIB), and Diphtheria toxoid, Pertussis acellular, Tetanus toxoid vaccine (DTaP). The patient's past medical history, medical treatments, vaccinations, and family history were not provided. The patient received an unknown dose of the suspect HIB (PRP/T) vaccine (powder and solvent for solution for injection), an unknown dose of hepatitis B vaccine produced by an unknown manufacturer via an unknown route and administration site, an unknown dose of Prevnar 13 not produced by Sanofi Pasteur via an unknown route and administration site, and an unknown dose of DTaP not produced by Sanofi Pasteur (formulation not reported) (strength, expiry date, and lot number not reported for all) via an unknown route and administration site, all for immunization. The reporter reported that on an unknown date, the patient developed a reaction that resembled a type of palsy (paralysis) with unknown latency. The patient was followed by an allergist, who suspected that an egg or animal component might have caused the episode. The caller was unable to clarify the palsy further, including its location on the body. It was not reported whether the patient received corrective treatment for the event. At the time of reporting, the outcome was unknown for the event.; Sender's Comments: A case of Paralysis, an unknown time after receiving DTPa vaccine, Hepatitis B vaccine and Hib vaccine, in a 15-month-old female patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.