Received Feb 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
left lung collapsed due to a small clot like those from birth control pills; left lung collapsed due to a small clot like those from birth control pills; aphasia; noticed some swelling near her breast underneath the armpit; This is a spontaneous report received from a Nurse from medical information team, Program ID. A 79-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMOTHORAX (medically significant), PULMONARY THROMBOSIS (medically significant), outcome "unknown" and all described as "left lung collapsed due to a small clot like those from birth control pills"; APHASIA (non-serious), outcome "unknown"; SWELLING (non-serious), outcome "not recovered", described as "noticed some swelling near her breast underneath the armpit". Clinical course: The patient was a retired nurse calling for herself as she took her first covid shot on her left arm and had a reaction and next shot is on her right arm and had the same reaction, and now unable to fit on her coat. The first COVID-19 vaccine she had was some years ago and she had aphasia. Her left lung collapsed due to a small clot like those from birth control pills. Then, a few months later, she noticed some swelling near her breast underneath the armpit. It doesn't go away. Patient was asking if she can get the next shot on her hip or she will do it by herself as she knew how to do it. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events pneumothorax, and 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. ,Linked Report(s) : US-PFIZER INC-202500039797 same patient/drug, different event/drug dose.;