Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 1 | MM0534 | IM / LA |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | Mm0534 | — |
Within 10 minutes after administration he noted mental confusion; difficulty walking; inability to speak coherently; This is a spontaneous report received from a Physician from a sales representative. A 77-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 10Feb2026 as dose number unknown, single (Lot number: Mm0534) at the age of 77 years for immunisation. The patient's relevant medical history included: "ASCVD" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "ARMD" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Propofol, reaction(s): "Allergy:Propofol". The following information was reported: CONFUSIONAL STATE (hospitalization, life threatening) with onset 10Feb2026, outcome "recovered with sequelae", described as "Within 10 minutes after administration he noted mental confusion"; GAIT DISTURBANCE (hospitalization, life threatening) with onset 10Feb2026, outcome "recovered with sequelae", described as "difficulty walking"; SPEECH DISORDER (hospitalization, life threatening) with onset 10Feb2026, outcome "recovered with sequelae", described as "inability to speak coherently". The patient was hospitalized for confusional state, gait disturbance, speech disorder (start date: 10Feb2026, hospitalization duration: 10 day(s)). The events "within 10 minutes after administration he noted mental confusion", "difficulty walking" and "inability to speak coherently" required emergency room visit. Therapeutic measures were taken as a result of confusional state, gait disturbance, speech disorder. Clinical course: Within 10 minutes after administration he noted mental confusion, difficulty walking, inability to speak coherently and was transferred to withheld emergency room. Other medications taken within two weeks.; Sender's Comments: Considering a close drug-event temporal association, a reasonable possibility that the events confusional state, gait disturbance, speech disorder are related to the suspect drug pneumococcal 20-val conj vac cannot be excluded. 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.
Medical History/Concurrent Conditions: Age-related macular degeneration; Atherosclerotic cardiovascular disease; Hypertension