Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: tiredness; fever; chills; headache; Left arm soreness at injection site/did not hurt right after shot, it was after bed around 01:00-02:00.  It was a little tender; really hot; she did not feel right; This is a spontaneous report received from a contactable reporter nurse (LPN) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 19Nov2021 16:00 (Lot number: FJ1620) at the age of 60 years as dose 1, single for COVID-19 immunization. The vaccine was administered in a pharmacy and not at a military facility. Relevant medical history included: "overweight" and "seasonal allergies"; both has been going on for years. Family history included: "diabetic" (unspecified if ongoing), notes: 2 kids. Concomitant medications included unspecified vitamins. The patient has no prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. The following information was reported: FATIGUE (medically significant) with onset 20Nov2021 08:00, outcome "recovered" (21Nov2021), described as "tiredness"; PYREXIA (medically significant) with onset 20Nov2021 08:00, outcome "recovered" (23Nov2021), described as "fever"; CHILLS (medically significant) with onset 20Nov2021 08:00, outcome "recovered" (23Nov2021), described as "chills"; HEADACHE (medically significant) with onset 20Nov2021 08:00, outcome "recovered" (22Nov2021), described as "headache"; VACCINATION SITE PAIN (medically significant) with onset 20Nov2021, outcome "recovered" (25Nov2021), described as "left arm soreness at injection site/did not hurt right after shot, it was after bed around 01:00-02:00.  It was a little tender"; FEELING HOT (non-serious) with onset 20Nov2021, outcome "unknown", described as "really hot"; FEELING ABNORMAL (non-serious) with onset 20Nov2021, outcome "unknown", described as "she did not feel right". The nurse informed that she did not have a primary care provider and did not have to go to the hospital. The patient informed that the adverse events did not require a visit to emergency room and physician office. The patient underwent the following laboratory tests and procedures: body temperature: unknown results.  Additional information: The patient informed that when she woke up she did not feel right. She was really hot and checked her temperature, it was around 08:00. The chills came after temperature broke in the evening. The left arm soreness at injection site - did not hurt right after shot, it was after bed around 01:00-02:00. It was a little tender, but the next day, it was really sore. The tiredness, fever, headache were all at 08:00. The patient would like to know if it was safe to get second one and also wanted to know if she will get sick again.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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 RAs, Ethics Committees, and Investigators, as appropriate.