Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Arthralgia, Asthenia, Chills, Dizziness
Clinical narrative: Anaphylactic reaction; dizzy; itchiness in the throat; tired; weak; fever; her throat was very very sore with Laryngitis; her throat was very very sore with Laryngitis; body aches; joint pain in both knees and left ankle; tightness in the throat; having issues with breathing; chills; This is a spontaneous report from a contactable Nurse (patient) and a consumer. A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiration date: 30Jan2021) via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Relevant medical history included asthma, sickle cell disease. Concomitant medications were reported as none. The patient previously received pneumonia vaccination at the age of 42 years old on an unspecified date in 2012 for immunization and experienced swelling; received first dose of COVID vaccine BNT162B2 at the age of 50 years old on 22Dec2020 for COVID-19 immunization and experienced dizzy (she did feel dizzy after the first vaccine dose but that subsided). The patient had an anaphylactic reaction to the vaccine. She did not get any clear information as to reporting, somebody gave her a number for somewhere and she went through some questions. She confirmed that the anaphylactic reaction happened after the second dose. The Anaphylactic Reaction happened the same day after the getting the vaccination on 09Jan2021, it gradually worsened throughout the day, she felt dizzy immediately after the vaccine. For this second dose after she experienced itchiness in the throat, by afternoon she felt very tired and weak she laid down, took a temperature and she did have fever, then around 6 o clock she took some tylenol. Eariler that morning, when she felt the itchiness in the throat, her throat was very very sore with laryngitis. She had some body aches but that was expected. She also had onset of joint pain in both knees and left ankle. She had to go to the ER twice, she went in the morning on 10Jan2021, they sent her home, with the Epipen, she felt better with tightness in the throat. Later on that after noon late evening she felt the same thing and started itching in the throat and at night time she went back to the ER on 11Jan2021 around 4 or 5AM in the morning, she went a second time to the ER, they gave steroids and Benadryland directed her to take it every 6 hours, she was still having issues with breathing, it was better, her fever was off and on and the chills. She was still in pain and it was not subsiding. She was not admitted into the hospital, she was sent home both times. During the First ER visit they did labs but nothing that brought anything to her attention. She had had No Positive tests for Covid, and no antibody tests. She had had issues with vaccines in the past but not to this extent. The outcome of the event anaphylactic reaction was not recovered, while other events were unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Anaphylactic reaction and other reported events due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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.