Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
She had to take the vaccine (2 doses of Pfizer COVID-19)/She had a baby boy; he had a segmental scrotal hemangioma on R scrotum; This is a spontaneous report received from a Nurse. A neonate male patient was exposed to BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), transplacental, administration details for the mother: not provided as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The mother of the patient was 29 years old. The patient's relevant medical history was not reported. The mother's relevant medical history was not reported. The mother had no concomitant medications. No other vaccine same date. No other vaccine in four weeks. No other medications in two weeks. The mother's vaccination history included: Pfizer covid-19 vaccine (She had to take the vaccine (2 doses of Pfizer COVID-19).), for COVID-19 immunization. The following information was reported: HAEMANGIOMA (congenital anomaly) with onset 11Dec2024, outcome "recovering", described as "he had a segmental scrotal hemangioma on R scrotum"; EXPOSURE DURING PREGNANCY (congenital anomaly), outcome "recovering", described as "She had to take the vaccine (2 doses of Pfizer COVID-19)/She had a baby boy". The event "he had a segmental scrotal hemangioma on r scrotum" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound scan: (26Mar2025) Normal; (26Mar2025) Normal; (26Mar2025) Normal; (26Mar2025) Normal. Therapeutic measures were taken as a result of exposure during pregnancy, haemangioma. Clinical course: Patient's mom had to take the vaccine (2 doses of Pfizer COVID-19). She began working there in 2019. She had a baby boy. He was seen by a pediatric urologist as well as a pediatric dermatologist. He was put on topical timolol and the hemangioma is almost gone at dermatology f/u apt on 26Mar2025. He had a scrotal Ultrasound which was normal and on 26Mar2025 he also had an ultrasound of lumbar spine, kidney, and bladder to rule out lumbar syndrome. All ultrasounds were normal. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event scrotal hemangioma was related to the suspect product event most likely due to patient underlying contributory factors. 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-202500069056 same reporter/drug, different patient/event (mom case);
Test Date: 20250326; Test Name: scrotal Ultrasound; Result Unstructured Data: Test Result:Normal; Test Date: 20250326; Test Name: ultrasound of bladder; Result Unstructured Data: Test Result:Normal; Test Date: 20250326; Test Name: ultrasound of kidney; Result Unstructured Data: Test Result:Normal; Test Date: 20250326; Test Name: ultrasound of lumbar spine; Result Unstructured Data: Test Result:Normal