Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysstasia, Eating disorder, Fatigue, Gait disturbance
Clinical narrative: High fever of 104.1-105.4 F; severe headache; body aches; difficulty standing, walking, moving; difficulty standing, walking, moving; difficulty standing, walking, moving; difficulty eating/ drinking; nausea; fatigue; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Dec2021 12:30 (Lot number: FJ8762) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [LORATADINE]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 15:45), administration date: 22Jan2021, when the patient was 43 years old, for Covid-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 16:00), administration date: 05Jan2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 12Dec2021 12:30, outcome "unknown", described as "Booster"; HYPERPYREXIA (medically significant) with onset 13Dec2021 03:00, outcome "recovered" (2021), described as "High fever of 104.1-105.4 F"; HEADACHE (non-serious) with onset 13Dec2021 03:00, outcome "recovered with sequelae" (2021), described as "severe headache"; PAIN (non-serious) with onset 13Dec2021 03:00, outcome "recovered with sequelae" (2021), described as "body aches"; DYSSTASIA (non-serious), GAIT DISTURBANCE (non-serious), MOVEMENT DISORDER (non-serious) all with onset 13Dec2021 03:00, outcome "recovered with sequelae" (2021) and all described as "difficulty standing, walking, moving"; EATING DISORDER (non-serious) with onset 13Dec2021 03:00, outcome "recovered with sequelae" (2021), described as "difficulty eating/ drinking"; NAUSEA (non-serious) with onset 13Dec2021 03:00, outcome "recovered with sequelae" (2021), described as "nausea"; FATIGUE (non-serious) with onset 13Dec2021 03:00, outcome "not recovered", described as "fatigue". The events "high fever of 104.1-105.4 f", "severe headache", "body aches", "difficulty standing, walking, moving", "difficulty standing, walking, moving", "difficulty standing, walking, moving", "difficulty eating/ drinking", "nausea" and "fatigue" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 100-103.0 Fahrenheit, notes: the next two days of fever were lower 100-103.0 F; (13Dec2021) 104.1-105.4 Fahrenheit, notes: High fever of 104.1-105.4 F temporal for 2 days; sars-cov-2 test: (07Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of hyperpyrexia, headache, pain, dysstasia, gait disturbance, movement disorder, eating disorder, nausea, fatigue. The patient did not have known allergies. The patient did not receive other vaccine in four weeks. The patient did not have covid prior to vaccination. The patient was covid tested post vaccination.; Sender's Comments: Based on the close temporal association the possibility of causal association between the event hyperpyrexia and the suspect drug BNT162B2  cannot be ruled out. 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.