Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Hypertension, Throat tightness
Clinical narrative: blood pressure went from normal to 190; feeling her chest tight; couldn't breathe; black spot in her eyes; just a tightness in her throat; sugar is very high; This is a spontaneous report from a contactable nurse (patient). An 80-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 02Mar2021 (Batch/Lot Number: EN9809; Expiration Date: 30Jun2021) as a single dose for COVID-19 immunization. Medical history included diabetic, asthma, allergy, sugar, and thyroid (disorder). The patient also stated that she has a lot of allergies. She was allergic to bees and allergic to bunch of things and many more things. She had her thyroid removed. Concomitant medications included levothyroxine (LEVOTHYROXINE, 100 ug) taken for thyroid (disorder), start and stop date were not reported; metformin (METFORMIN, 100 mg) taken for her sugar, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE, 12.5 pill), taken as diuretic, start and stop date were not reported. The patient reported that she had a very bad reaction from the vaccine, which was 20 minutes her blood pressure went from normal to 190 and she started feeling her chest tight and couldn't breathe (all on 02Mar2021). She also had a black spot in her eyes (02Mar2021). The patient reported that the events started the minute after she got the shot. She was sent to the hospital on 02Mar2021. When she was in the hospital, her blood pressure went up to 244, it is the highest. Her chest was going to have an asthma attack but she didn't develop an asthma attack it was just a tightness in her throat (02Mar2021). She was a day and half in the hospital, trying to get her blood pressure down which went down somehow that she still have over 200 blood pressure. When paraphrased the above concern she stated, "Yeah absolutely want to know what kind of result or what kind of the side effect you are going to have." The patient also stated at the time of report, "I still have my blood pressure is still 200 and my sugar is very high too (unspecified date in Mar2021), is that part of the after effect of the vaccine because I didn't have that before." The patient was hospitalized from 02Mar2021 to 04Mar2021. Therapeutic measures were taken as a result of blood pressure went from normal to 190 (hypertension) and couldn't breathe. The patient stated her doctor put her in the double medicine for the blood pressure. When probed for if patient was still experiencing issue, she stated "No, as soon as I came home I took Benadryl". The patient reported that her breathing improved as soon as she took Benadryl and her chest is probably clear now. As treatment, they gave her blood pressure pills. They gave her Pravastatin 20 mg. Outcome of the event blood pressure went from normal to 190 and sugar is very high was not recovered. Outcome of couldn't breathe was recovering. Outcome of the other events was unknown.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the events 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.