Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood pressure systolic increased, Feeling hot, Interchange of vaccine products, Off label use
Clinical narrative: my SBP went up to 130''s; I had a sensation of heat in my whole body; received the Pfizer booster dose 3 after 2 Moderna doses; received the Pfizer booster dose 3 after 2 Moderna doses; This is a spontaneous report from a contactable nurse (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 3 (booster) intramuscular, administered in arm left on 21Sep2021 16:45 (at the age of 53-year-old) (Batch/Lot Number: FE3592) as single dose for COVID-19 immunisation.  Medical history included hypertension HTN but BP was low that morning, prediabetes, sleep apnoea syndrome, allergies to Sulfa. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included amlodipine (AMLODIPINE) 10 mg 1 tablet po daily taken for an unspecified indication, start and stop date were not reported.  The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Moderna COVID 19 vaccine, dose 1 intramuscular, administered in arm left on 04Jan2021 19:00 (at the age of 53-year-old) (Batch/Lot Number: 025L20) as single dose, dose 2 intramuscular, administered in arm left on 29Jan2021 07:15 AM (at the age of 53-year-old) (Batch/Lot Number: 032L20) as single dose for COVID-19 immunisation.  The patient experienced her SBP went up to 130''s (medically significant) on 21Sep2021 17:00 with outcome of recovered in Sep2021, she had a sensation of heat in her whole body (non-serious) on 21Sep2021 17:00 with outcome of recovered in Sep2021, received the Pfizer booster dose 3 after 2 Moderna doses (non-serious) on 21Sep2021 16:45 with outcome of unknown. The clinical course of events was as follows: Immediately after she received the Pfizer as a booster (dose #3), she had a sensation of heat in her whole body and her SBP went up to 130's. As treatment she took Amlodipine; it was a blessing that she did not take it that morning as her BP was low.  The patient underwent lab tests and procedures which included blood pressure measurement: 130 on 21Sep2021 SBP went up to 130's, Sars-cov-2 test: negative (Nasal Swab qualitative RT-PCR). Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Systolic pressure increased due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided. 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.