Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Chills, Feeling cold, Feeling hot, Genital rash
Clinical narrative: This is a solicited report received from contactable reporter (Consumer). The reporter is the patient. Other Case identifier(s): 22K-163-4236950-00. A 55-year-old female patient received BNT162b2 (BNT162B2), on 13May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for hidradenitis; Acrivastine (BENADRYL [ACRIVASTINE]), (Batch/Lot number: unknown); guaifenesin (MUCINEX), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First Dose, Intramuscular), administration date: 17Mar2021, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (Second Dose, Intramuscular), administration date: 07Apr2022, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (Third dose, Intramuscular), administration date: 11Oct2021, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "Seizure", "Migraine", "Feeling Unwell", "Feeling Cold", "Feeling Hot", "Cerebral Disorder", "Genital Rash", "Sweating", "Head Cold", "Nausea", "Fever", "Chills", "Sickness". The following information was reported: FEELING COLD (medically significant) with onset May2022, outcome "unknown"; FEELING HOT (medically significant) with onset May2022, outcome "recovered"; GENITAL RASH (medically significant) with onset May2022, outcome "unknown", described as "Genital rash / broke out/sweated a lot in private area"; HYPERHIDROSIS (medically significant) with onset May2022, outcome "unknown", described as "Sweating/sweated a lot in private area"; CHILLS (medically significant) with onset May2022, outcome "unknown", described as "chilled / chilled of 110"; PYREXIA (medically significant) with onset May2022, outcome "unknown", described as "fever"; ILLNESS (medically significant) with onset May2022, outcome "unknown", described as "sickness"; MIGRAINE (medically significant) with onset 2022, outcome "recovered"; SEIZURE (medically significant) with onset 2022, outcome "recovering"; CEREBRAL DISORDER (medically significant) with onset 2022, outcome "recovering"; NAUSEA (medically significant) with onset 2022, outcome "recovered". The patient underwent the following laboratory tests and procedures: Chills: (May2022) 110, notes: chills of 110 (as reported). Therapeutic measures were taken as a result of migraine, feeling hot, nausea, they were resolved with ice pack. The reporter's assessment of the causal relationship of "seizure", "migraine", "cerebral disorder", "nausea", "chilled / chilled of 110" and "sickness" with the suspect product 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/broke out/sweated a lot in private area", "sweating/sweated a lot in private area" 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: A causal association between administration of BNT162b2 and the onset of Feeling cold, feeling hot, Genital rash, Sweating, nausea, fever, chill and Sickness cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. Other events represent intercurrent medical conditions and unrelated to bnt162b2. Linked Report(s): US-PFIZER INC-202200763019 Same reporter, same patient/vaccine, different dose and event.