Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Asthenia, Body temperature, Bone pain, Cerebrovascular accident
Clinical narrative: I started speaking like I had have stroke; this morning around 10:30 the angioedema came back; I had speech impairment/I started speaking like I had have stroke; Chills; the bone aching and muscle aching; the bone aching and muscle aching; I was soaking wet; I have been weak and sick; I have been weak and sick; Fever; Feeling bad; This is a spontaneous report from a contactable other hcp (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included, hereditary angioedema, hypertension, blood cholesterol increased and diabetes, all from an unknown date and unknown if ongoing. Concomitant medication included metoprolol; hydrochlorothiazide; simvastatin taken for blood cholesterol and metformin taken for diabetes mellitus, start and stop date were not reported. The patient haven't had any vaccine since 2016 until she had this Covid vaccine. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on 01May2021 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 63 years), unspecified flu vaccine and Prevnar 13 and experienced allergic. On an unspecified date, the patient experienced that I had speech impairment/I started speaking like i had have stroke, then this morning around 10:30 the angioedema came back, chills, the bone aching and muscle aching, i was soaking wet, i have been weak and sick, fever, feeling bad. About 5 hours later, nurse stated, she wanted to report a very bad adverse reaction to the Pfizer vaccine, on Saturday she had her second vaccine and 5 hours later she had a really bad reaction and had to call. she had what you call hereditary angioedema (medically significant). The first vaccine she had no problem with it like she just said, 5 hours later she had a very bad reaction to the second one. she had the angioedema, and then she had speech impairment, she had chills and fever of a 101, well the bone aching and muscle aching that was something they already told us that will happen that was side effect but it was on the angioedema with and then she started speaking like she had have stroke (medically significant) and today she had to go to the emergency room she did not go Saturday because she took Benadryl, 50 mg of Benadryl on Saturday her speech came back normally, but then twice later on up unto night she kept coming back. Sundays when she had the fever of 101 when she had up to 24 hours and woke Sunday night and she was soaking wet but she have been weak and sick every since, feeling bad and then this morning around 10:30 the angioedema came back and could not understand anything she was saying and she went to emergency room they gave me solumedrol and Benadryl they set me hold with prednisone and Benadryl.  The patient underwent lab tests and procedures which included fever: 101 on an unspecified date. Regarding lab test nurse stated, they did lab test when she went to the emergency room. Therapeutic measures were taken as a result of all the events included prednisone, solumedrol and Benadryl. The clinical outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information and the plausible drug-event association, a possible contributory role of the suspect product BNT162B2 to the development of the event  Cerebrovascular accident and Angioedema cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.