Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Eye contusion, Head injury, Hypoaesthesia, Immunisation, Pain
Clinical narrative: fainted; hit head near right eye; a cut and a black eye; a cut and a black eye; shooting pain; numbness on right hand; felt like throwing up; Booster; This is a spontaneous report received from contactable other hcp. The reporter is the patient.  A 41 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 07Jan2022 13:15 (Lot number: 330368D) at the age of 41 years as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient had no relevant medical history. No known allergies, no COVID prior vaccination, no other vaccine in four weeks, no COVID tested post vaccination. Concomitant medications included: ATORVASTATIN; SERTRALINE; LISINOPRIL. Vaccination history included: BNT162B2 (dose 1, lot number: EN5318, Left arm), administration date: 06Mar2021, when the patient was 40 years old, for covid-19 immunization; BNT162B2 (dose 2, lot number: EL9264, Left arm), administration date: 27Mar2021, when the patient was 40 years old, for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 07Jan2022 13:15, outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 10Jan2022 06:00, outcome "unknown", described as "fainted"; HEAD INJURY (medically significant) with onset 10Jan2022 06:00, outcome "unknown", described as "hit head near right eye"; WOUND (medically significant), EYE CONTUSION (medically significant) all with onset 10Jan2022 06:00, outcome "unknown" and all described as "a cut and a black eye"; PAIN (non-serious) with onset 10Jan2022 06:00, outcome "unknown", described as "shooting pain"; HYPOAESTHESIA (non-serious) with onset 10Jan2022 06:00, outcome "unknown", described as "numbness on right hand"; VOMITING (non-serious) with onset 10Jan2022 06:00, outcome "unknown", described as "felt like throwing up". The patient reported that woke up to shooting pain and numbness on her right hand. Pain was extreme that she felt like throwing up. As she got up, she fainted and hit her head near her right eye, which caused a cut and a black eye. The events "fainted", "hit head near right eye", "a cut and a black eye", "shooting pain", "numbness on right hand" and "felt like throwing up" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of syncope, head injury, wound, eye contusion, pain, hypoaesthesia, vomiting.; Sender's Comments: Based on the available reported information, the causal association between the events immunization, syncope, head injury, wound and head contusion and the suspect drug  BNT162B2cannot 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.