Received Feb 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | RA |
left lung collapsed due to a small clot like those from birth control pills; pulmonary thrombosis; aphasia; the top of it feels tight. She can press it (even squeeze it) and it hurts a little bit; 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 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "aphasia", "noticed some swelling near her breast underneath the armpit", "the top of it feels tight. She can press it (even squeeze it) and it hurts a little bit", "left lung collapsed due to a small clot like those from birth control pills". The following information was reported: PNEUMOTHORAX (medically significant), outcome "unknown", described as "left lung collapsed due to a small clot like those from birth control pills"; APHASIA (non-serious), outcome "unknown"; BREAST SWELLING (non-serious), outcome "unknown", described as "noticed some swelling near her breast underneath the armpit"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "the top of it feels tight. She can press it (even squeeze it) and it hurts a little bit". Clinical course: The first vaccine that the reporter 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. For the next dose of the COVID-19 vaccine, the same thing happened to her right arm. Now, the top of it feels tight. She can press it (even squeeze it) and it hurts a little bit. Caller would like to get them removed. The caller is 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. Caller is 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.