Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Pain in extremity
Clinical narrative: She was very sick; temperature of 104.4; woke up very ill that night with chills; she couldn't get out of bed to get a blanket; she had a little soreness in her arm; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: FK9894) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "She has had reactions in the past to sulfa drugs" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, Single; Lot number: FL9262), administration date: 15Mar2021, when the patient was 64-year-old, for COVID-19 immunization, reaction(s): "she had a little soreness in her arm"; BNT162b2 (Dose 1, Single; Lot number: EL9367), administration date: 22Feb2021, when the patient was 64-year-old, for COVID-19 immunization, reaction(s): "she had a little soreness in her arm". The following information was reported: MALAISE (medically significant) with onset 01Oct2021, outcome "recovered" (02Oct2021), described as "She was very sick"; FATIGUE (medically significant) with onset 01Oct2021, outcome "recovered" (02Oct2021), described as "she couldn't get out of bed to get a blanket"; PAIN IN EXTREMITY (medically significant) with onset 01Oct2021, outcome "recovered" (02Oct2021), described as "she had a little soreness in her arm"; PYREXIA (medically significant) with onset 01Oct2021, outcome "recovered" (02Oct2021), described as "temperature of 104.4"; CHILLS (medically significant) with onset 01Oct2021, outcome "recovered" (02Oct2021), described as "woke up very ill that night with chills". The patient underwent the following laboratory tests and procedures: Body temperature: 104. 4 Fahrenheit.  Clinical course: After her primary series and her first booster she had a little soreness in her arm. Woke-up very ill that night with chills. She couldn't get out of bed to get a blanket. When she finally got out of bed, her temperature was 104. 4. She never gets temperatures.She was frightened because she lives alone so she didn't know if she should go to the hospital or not. She went back to bed hoping she didn't die during the night, and the next day, her fever was gone. She was fine. She thinks it is very significant. She doesn't get sick and she doesn't have fevers. She has never had a reaction to an injection before in her life. She went with a friend, and her friend didn't have problems. She has had reactions in the past to sulfa drugs and something she can't re-member. She doesn't know the manufacturers or information at this time. Patient not visited to Emergency room and Physician office. No Prior vaccinations within 4weeks. Other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI) were not performed.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201201335 Same product, patient, different AEs, different dose;US-PFIZER INC-202201201336 Same product, patient, different AEs, different dose;