Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Hypertension
Clinical narrative: became hypertensive to 175/100/ blood pressure was in the 150's when she arrived at my office (but she is usually in the 130's); dizziness; headache; This is a spontaneous report received from a contactable Physician. A 50-Year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot number: unknown) via an intramuscular route of administration in her right arm on 18Mar2021 at 11:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient medical history included diabetes, hypertension and hyperlipidemia. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was reported that the patient had covid prior to vaccination or not was unknown. The patient had reported no allergies to medications, food or other products. Concomitant medications included enalapril and metformin. On 18Mar2021 at 12:00, the patient became hypertensive to 175/100/ blood pressure was in the 150s when she arrived at the office (but she was usually in the 130s) and experienced dizziness, headache. The patient took suggestions for the adverse event result in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The patient underwent lab tests and procedures which included blood pressure: result: 175/100 (unspecified units) and 150 (when arrived at office) on 18Mar2021 and 130 (unspecified units) on an unknown date. The clinical outcome for the events experienced dizziness, headache and hypertensive was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported Information: Route of administration of vaccine was added as intramuscular, laboratory test value blood pressure was added, vaccination lot number unknown was deleted. Physician Office Visit was checked for all event as per source. The verbatim term hypertensive to 175/100 was changed to became hypertensive to 175/100/ blood pressure was in the 150s when she arrived at my office (but she was usually in the 130s). The lines: patient had not tested positive for COVID-19 since having the vaccination and patient had not diagnosed with COVID-19 prior to vaccination were deleted from narrative and new line: It was reported that the patient had covid prior of vaccination or not was unknown was added. No further information is expected; Information about lot number cannot be obtained updated as No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the limited information in the case and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Hypertension. Also consider a contributory role from the patient's medical history. 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.