Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hypertension, Investigation, Rash macular
Clinical narrative: Hypertension; Tachycardia; Extreme flushing to face and neck; glowing red; took her pulse and it was 145; Persistent head to toe macular erythematous Rash; Dull Headache; This is a spontaneous report from a contactable healthcare professional (patient).  A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered on the left arm on 21Apr2021 13:12 (Batch/Lot number was not reported; Expiration Date: 31Jul2021) as 1st dose, single for covid-19 immunisation. Medical history included fibromyalgia (diagnosed more than 20 years ago), bladder cancer (diagnosed 13 years ago the first time, 8 reoccurrences and has been cancer free for 2 years, cancer free for 2 years), multi drug allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities, diabetes, and obesity. Concomitant medications included lisinopril, levothyroxine, and oxazepam. No vaccines received within 2 weeks. In 12 minutes after the injection on 21Apr2021, while she was still sitting in the parking lot, patient developed tachycardia on and extreme flushing to face and neck on 13:20.  They were as red as being in the sun.  She was aware of tachycardia first.  Then she looked in the mirror and was glowing red. Patient was observing in parking lot and took her pulse and it was 145. Persistent head to toe macular erythematous rash occurred next.  They took her to the ER about 20 minutes after the injection. In the ER, she was given 25mg of Benadryl IV and 125 mg of Solumedrol IV.  When both of those wore off the next day, the generalized rash came back on Thursday (22Apr2021).  The rash was persistent but not as flushed looking as before. When they got her into ER, the first blood pressure reading was 198/117, which was within 20 minutes of injection. Hypertension was experienced on 13:30. Her blood pressure usually was fairly low and was back to normal now. She had one reading of 124/76 to 170/something. Her normal range is anywhere between 150-170/70-80's. She is on Lisinopril. The other morning when it was 124/76, was just a fluke. That was an unusually good reading. They did a regular panel of lab work when she went to the ER. They did not tell her that anything was abnormal.  She asked them to run an A1C, but they told her they could not. They did a chest film, EKG, placed IV to give medications, but no fluids given. Her doctor said not to get second dose of the vaccine.  She had it at the hospital and they had reports of other people with a rash. The patient considered the events tachycardia, extreme flushing, macular erythematous rash and hypertension were medically significant while for headache was non-serious.; Sender's Comments: The reported events were possibly causally related to the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship.  This case will be reassessed should additional information become 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.