Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Headache, Syncope
Clinical narrative: headches; syncope episodes; fall; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 31-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 01, Lot: EK9231, Expiry Unknown, Route: Intramuscular), administration date: 29Dec2020, when the patient was 29-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 02, Lot: EL3249, Expiry Unknown, Route: Intramuscular), administration date: 19Jan2021, when the patient was 29-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 03, Lot: EW0176 , Expiry Unknown, Route: Intramuscular), administration date: 15Oct2021, when the patient was 30-year-old, for COVID-19 Immunization. The following information was reported: FALL (non-serious) with onset Sep2022, outcome "unknown"; SYNCOPE (medically significant) with onset 22Sep2022 at 06:30, outcome "unknown", described as "syncope episodes"; HEADACHE (non-serious) with onset 22Sep2022 at 13:30, outcome "not recovered", described as "headaches".  Clinical information: Caller states that, She received the Bivalent booster last week Thursday. This morning, after a good night sleep, she was getting ready for work and experienced a syncope episode. This is the first time this has happened. She basically has been resting throughout the day and is also having headaches. This is occurring 1 week out from the day that she got the booster. She doesn't have any stressors, she is not diabetic, she does not have low Blood pressure, she does not have low Blood sugar, she is well hydrated, she doesn't know why the syncope episode and headache happened. The Syncope episode happened today at 6:30AM. The headache also started today, after her fall, she rested and woke up, and since then she has had a headache, the headache has been since 1:30PM.   Causality: For syncope it is Unknown because she didn't have any precipitating factors, she doesn't know if there have been other cases that have been reported 1 week out of receiving the vaccine.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on possible temporal association the causal association of suspect drug BNT162b2, BNT162b2 omi ba.4-5  cannot be excluded for reported events -Syncope, Headache and Fall. 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