Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
pulmonary thrombosis; nausea; lower back pain; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 2024SA301951 (Sanofi). A 34-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (hospitalization, medically significant), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "lower back pain". The patient was hospitalized for pulmonary thrombosis (start date: 04Oct2024, discharge date: 06Oct2024, hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of pulmonary thrombosis, nausea. Clinical course: Patient is taking Apixaban (Eliquis) for pulmonary thrombosis; Prochlorperazine edisylate (Prochlorperazine) and Ondansetron hydrochloride (Zofran) for Nausea and not reported for rest of the events. Hospitalization for 2 days from 04Oct2024 to 06Oct2024 for pulmonary thrombosis. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pulmonary thrombosis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.