Received Aug 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
has had "all 9 COVID-19 vaccines from Pfizer/ contracted the COVID-19 infection 2 months ago; has had "all 9 COVID-19 vaccines from Pfizer/ contracted the COVID-19 infection 2 months ago; This is a spontaneous report received from a Physician from medical information team. A male patient 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 included: "pulmonary fibrosis" (unspecified if ongoing); "pulmonary hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 6 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 7 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 8 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "unknown" and all described as "has had "all 9 COVID-19 vaccines from Pfizer/ contracted the COVID-19 infection 2 months ago". Clinical course: Reporter stated that he is a "very high-risk patient", since he has "pulmonary fibrosis and pulmonary hypertension" and also mentioned that he has had "all 9 COVID-19 vaccines from Pfizer", but that, despite that, he contracted the COVID-19 infection 2 months ago. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2025, outcome "unknown" and all described as "has had "all 9 COVID-19 vaccines from Pfizer/ contracted the COVID-19 infection 2 months ago".; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded for the event vaccination failure (COVID-19). This case will be reassessed upon receipt of additional information.
Medical History/Concurrent Conditions: Pulmonary fibrosis; Pulmonary hypertension