Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Seizure
Clinical narrative: Seizure; Feeling cold; Feeling hot; Genital rash; Sweating; Fever; Chilled; sickness; Feeling unwell; Head cold; Nausea; Cerebral disorder; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4236950-00 (AbbVie).  A 55-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for hidradenitis; diphenhydramine hydrochloride (BENADRYL); guaifenesin (MUCINEX). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose, intramuscular), administration date: 17Mar2021, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (2nd dose, intramuscular), administration date: 07Apr2021, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: MALAISE (medically significant) with onset 14Jan2022, outcome "recovered", described as "Feeling unwell"; NASOPHARYNGITIS (medically significant) with onset Jan2022, outcome "not recovered", described as "Head cold"; CHILLS (medically significant) with onset May2022, outcome "unknown", described as "Chilled"; FEELING COLD (medically significant) with onset May2022, outcome "unknown"; FEELING HOT (medically significant) with onset May2022, outcome "recovered"; PYREXIA (medically significant) with onset May2022, outcome "unknown", described as "Fever"; GENITAL RASH (medically significant) with onset May2022, outcome "unknown"; HYPERHIDROSIS (medically significant) with onset May2022, outcome "unknown", described as "Sweating"; ILLNESS (medically significant) with onset May2022, outcome "unknown", described as "sickness"; CEREBRAL DISORDER (medically significant) with onset 2022, outcome "unknown"; NAUSEA (medically significant) with onset 2022, outcome "recovered"; SEIZURE (medically significant), outcome "recovering". The patient underwent the following laboratory tests and procedures: chills: 110, notes: chills of 110. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of malaise, feeling hot (ice pack). Additional information: Causality as per reporter per BNT162B2 (event-assessment): Seizure, Migraine, feeling unwell (Malaise), Cerebral disorder: Not Reported; Feeling cold, Feeling hot, Genital rash, Sweating, Head cold, Nausea, Fever: Possible.   The reporter's assessment of the causal relationship of "seizure", "feeling unwell", "cerebral disorder", "head cold", "nausea", "chilled" and "sickness" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "feeling cold", "feeling hot", "genital rash", "sweating" and "fever" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events seizure", "feeling unwell", "cerebral disorder", "head cold", "nausea", "chilled" ,"sickness", feeling cold", "feeling hot", "genital rash", "sweating" and "fever" Cannot be excluded  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