Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Oropharyngeal pain, Pyrexia, Rash, Rash pruritic
Clinical narrative: Migraine; Vomit; Nose bleed; Headache; There was a faint but strange "dreamlike" feeling when I stood up & some faint distortions of light; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number was unknown), via an unspecified route of administration, administered in Arm Left on 03Aug2021 (at the age of 43-years-old) as dose 1, single for covid-19 immunization at pharmacy or drug store. Medical history included hyperemesis gravidarum (she had a pregnancy complication 10 years ago) from an unknown date and unknown if ongoing. Patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination/post vaccination, the patient had been tested for COVID-19. Patient had excellent health and never needed any hospitalizations or long-term medications. Received Pfizer mRNA vaccine. Ok for about 15 minutes. 03Aug2021 5:18pm started to leave the pharmacy but there was a faint but strange dreamlike feeling when she stood up and some faint distortions of light so she stayed for a bit until she knew it was safe to drive. 7:15pm she experienced the first migraine of her life, it caused her to vomit, and the first nosebleed of her life approximately an hour after the shot. She had to lie down with a wet rage on her face due to the light, so it was hard to say the exact time. After she vomited, she felt well enough to drive to the ER. At 8:24pm arrived at the ER at the hospital so they could check her and analyze what was happening with the nosebleed. Now just headache which she had expected. They took her vitals and admitted her but unfortunately, due to the outbreak, there were over 100 people ahead of her and it was night so after several hours she needed to go home and go to bed so she did a follow up with her PCP the next morning. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Aug2021 (nasal swab), sars-cov-2 test: negative on 05Aug2021 (nasal swab), sars-cov-2 test: negative on 06Aug2021 (nasal swab). No treatment was received. The outcome of events syncope, migraine, epistaxis, vomiting and headache was reported as recovered with lasting effects.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Syncope, migraine, headache, vomiting, epistaxis and suspect drug BNT162B2 cannot be excluded. 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.