Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain in extremity, Seizure, Syncope, Urinary incontinence
Clinical narrative: it could have been a seizure; Unconscious/Collapsed/ diagnosed her as having a Syncopal Episode; Urinated on self/Wet her pants; Headaches; Feeling light headed; Felt her heart beat faster; Sore arm; This is a spontaneous report from a contactable nurse (patient mother). A 45-year-old female patient received bnt162b2 (BNT162B2, lot number EW0150 and expiration date was not provided), via an unspecified route of administration first dose on 05Apr2021 15:00 at single dose for covid-19 immunisation. The patient's medical history included ongoing Hypertension (Patient diagnosed in her late 30's), ongoing Hypothyroid (Patient diagnosed when she was around 20 years old), ongoing Allergies, ongoing Gastrooesophageal reflux disease (The patient was exposed to a chemical in her 20's that caused this condition), ongoing Birth control, ongoing Allergic to eggs (States patient has never received the flu vaccine due to her egg allergy), and ongoing Allergic to shellfish. The patient's concomitant medications included ongoing levothyroxine at 150 ug, 1x/day for Hypothyroid, ongoing Hydrochlorothiazide at 12.5 mg, 1x/day for hypertension, ongoing omeprazole at 20 mg, 1x/day for gastrooesophageal reflux disease, ongoing losartan at 100 mg, 1x/day for hypertension, ongoing norethisterone (SHAROBEL) for Birth control. On 06Apr2021 13:00, the reporter stated that her daughter fainted at work, lost her urine, and was unconscious and was taken to the Emergency Room. Primary Care Physician told her daughter she should have no problem getting the second vaccine. States that she was not certain if her daughter should get the second shot. It was scheduled for next week. Also, reported that after lunch reporter stated that her daughter fainted in her office at work. She had urinated on herself and was unconscious. Caller was concerned it could have been a seizure. Her daughter was taken to the Emergency Room and they diagnosed her as having a Syncopal Episode. On 06Apr2021, the patient had headaches that continue since these events. The reporter stated that her daughter's doctor told her daughter that the blood work and electrocardiogram done at the Emergency Room were normal. The Emergency Room and her daughter's doctor acted like her symptoms were not serious. The reporter looked at the Vaccine Adverse Event Reporting System website and it said that a syncopal episode is a reportable event. Says that her daughter's doctors did not report this event. Says doctors need to have training on the importance of reporting events. The reporter called the Food and Drug Administration last week but she hasn't heard anything from them. States they told her it could take 5-7 business days. Says she called Pfizer today to see if there was any further information or guidance she could get as she is concerned about her daughter. She says her daughter has her own office so she was in there alone when she collapsed. Someone found her on the floor. The reporter was asking for guidance on administration of the second vaccine dose following a syncopal episode after the first. The patient received her first vaccine dose on 05Apr2021 15:00 and she was fine, she had a sore arm, but went to work the next day (06Apr2021) and after lunch she reported feeling light headed and felt her heart beat faster and went to get up and a colleague later found her on the floor and she had wet her pants. They took her to the ER around 1 pm the day after her vaccination and diagnosed her with a syncopal episode stating that they didn't think it was from the shot. The events syncope, urinary incontinence, seizure, and headache were considered as serious (medically significant) by the reporter. The events syncope, and urinary incontinence caused emergency room visit and physician office visit. The outcome of the events syncope, urinary incontinence was recovered on 06Apr2021.  The outcome of the event Headache was not recovered. The outcome of the remaining events was unknown.; Sender's Comments: Based on the information currently available, a causal association between the reported events and bnt162b2 cannot be fully excluded.Case will be reassessed when additional 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 RAs, Ethics Committees, and investigators, as appropriate.