Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
patient was now in ICU with fulminanat lung issues; This is a spontaneous report received from a Physician. An elderly female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), for covid-19 immunization; Covid-19 vaccine (dose 2), for covid-19 immunization; Covid-19 vaccine (dose 3), for covid-19 immunization; Covid-19 vaccine (dose 4), for covid-19 immunization; Covid-19 vaccine (dose 5), for covid-19 immunization; Covid-19 vaccine (dose 6), for covid-19 immunization; Covid-19 vaccine (dose 7), for covid-19 immunization; Covid-19 vaccine (dose 8), for covid-19 immunization; Covid-19 vaccine (dose 9), for covid-19 immunization; Covid-19 vaccine (dose 10), for covid-19 immunization; Covid-19 vaccine (dose 11), for covid-19 immunization; Covid-19 vaccine (dose 12), for covid-19 immunization; Covid-19 vaccine (dose 13), for covid-19 immunization. The following information was reported: LUNG DISORDER (hospitalization, life threatening), outcome "not recovered", described as "patient was now in ICU with fulminanat lung issues". It was unknown if therapeutic measures were taken as a result of lung disorder. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the implied temporal relationship, the association between the event "fulminant lung issue" with BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)) can not be fully 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.