Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | — |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
she had like a type of palsy; This is a spontaneous report received from an Other HCP from medical information team. A 15-month-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in thigh for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), as dose number unknown, single) for immunisation; hib vaccine conj (tet tox) (ACT HIB), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as "she had like a type of palsy". The patient underwent the following laboratory tests and procedures: Specialist consultation: allergist think there was an egg or animal, notes: component that could have caused the episode. It was unknown if therapeutic measures were taken as a result of paralysis. Reporter was unable to clarify palsy further to include location on body. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event palsy was related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Test Name: allergist consultation; Result Unstructured Data: Test Result:allergist think there was an egg or animal; Comments: component that could have caused the episode.