Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypertension, Insomnia, Laboratory test, Malaise
Clinical narrative: pain and I had hear loss; pain and I had hear loss; Dizzy spells/feeling of being fainted; Rash and then swelling; Rash and then swelling; headaches; blood pressure was high; hives; Backache; finger swell up/arm swell up; rashes and the blisters; so sick; couldn't sleep for a while; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 23Sep2021 (Lot number: FF2589) at the age of 45 years as dose 1, single and intramuscular, administered in arm right, administration date 21Oct2021 (Lot number: 320308D) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "kidney cancer" (unspecified if ongoing). Concomitant medication(s) included: POTASSIUM taken for hypertension; HCTZ taken for hypertension; CONCOR taken for hypertension.  The following information was reported: after getting the vaccine, patient was having like dizzy spells and feeling like was going to collapse and kept feeling unwell for a while and then started had 'ring' rash and then swelling, then headaches, pain and had hear loss. Patient went to her nephrologist and after she got the vaccine and she was complaining well, her blood pressure was high and her nephrologist wanted to started her on a new blood pressure medication (Norvasc) and she told her her blood pressure was high because her body is overreacting to the vaccine and when she got a new med that's what happen (Further clarification unknown) but she started her on it anyway. Patient went back to her and was told her pressure is still through the roof. She stated that her body is still overreacting because every day she have to take Benadryl. So, she know her body is still overreacting to the medication because every day she go to work she feel like she was gonna collapse, she couldn't sleep for a while so, she kept taking the Benadryl (Further clarification unknown) but once she stopped taking the Benadryl now she start breaking out in hives everywhere. She could keep going back to different doctors nobody knew what was wrong with her. So, everyone says I don't know what's wrong with you, she was complaining of all this backache, this headache, until she got to urgent care because that was like she can't take the headache anymore, she can't take the pain anymore. So, that's when they started her on Steroids (Treatment) and she had to be on an antihistamine (Treatment) in the mean time until she was able to see a rheumatologist because her finger swell up, arm swell up and it was actually her right arm but the rashes and the blisters started in different parts of body then her right arm but (Incomplete Sentence)." Nurse stated, "After I came from the pharmacy I was taking the Benadryl for a while you know because I, but then I then 'take them' and slept all the time (Further clarification unknown) so, I stopped taking the Benadryl but I wasn't sure what was causing the feeling of being fainted and the rash but I kept going to different doctors and I realized that they did not know it must be my autoimmune system is activated (Further clarification unknown) or I should go to a rheumatologist. So, because everyone kept telling me they don't know why I am so sick every day. So, I was just like okay, but then when my parents confirmed that my uncle went through the same thing (Further clarification unknown) and then I realized that's probably why I was sick, that's when I went to urgent care last week possibly Thursday or Friday." Lab Test: patient had labs done right after she got the vaccine and they were okay. The outcome of events was unknown.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes 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.