Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Dehydrated; Fell backwards and scraped head; Fell backwards and scraped head; Fatigue; Feeling achy; Fainted; MARKETING PROGRAM NAME NOT AVALIABLE  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-163-4351305-00 (Company).  A 73-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First dose, Route of Admin: Intramuscular), administration date: 20Feb2021, when the patient was 72-year-old, for Covid-19 Immunization; BNT162b2 (Second Dose, Route of Admin: Intramuscular), administration date: 12Mar2021, when the patient was 72-year-old, for Covid-19 Immunization; BNT162b2 (Third Dose , Route of Admin: Intramuscular), administration date: 21Sep2021, when the patient was 73-year-old, for Covid-19 Immunization, reaction(s): "Passed out". The following information was reported: SYNCOPE (medically significant) with onset Apr2022, outcome "recovered" (Apr2022), described as "Fainted"; DEHYDRATION (hospitalization), outcome "unknown", described as "Dehydrated"; FALL (non-serious), HEAD INJURY (non-serious), outcome "unknown" and all described as "Fell backwards and scraped head"; FATIGUE (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "Feeling achy". The events "dehydrated", "fainted", "fell backwards and scraped head", "fatigue" and "feeling achy" required emergency room visit. The action taken for adalimumab was unknown.  Causality as per reporter for BNT162B2 for events dehydration (Dehydration): Possible, Faint (Syncope): Possible, fall (Fall): Possible, Head injury (Head injury): Possible, Fatigue (Fatigue): Not Reported, Ache (Pain): Not Reported.  Causality for Humira (ADALIMUMAB): The reporters causality for the events dehydrated, fainted, fell backwards and scraped head unknown onset, Fell backwards and scraped head unknown onset, fatigue and feeling achy was not reported. Company's opinion is that there is no reasonable possibility that the events of dehydrated, fainted, fell backwards and scraped head unknown onset, fell backwards and scraped head unknown onset, fatigue and feeling achy or related to Humira (ADALIMUMAB).  Clinical course: Solicited report from the consumer of a 73-year-old male with events of dehydration and fainted, fell backwards and scraped head, fatigue and feeling achy with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced dehydrated, fell backwards and scraped head, fatigue and feeling achy. in Apr2022, the patient experienced fainted. In Apr2022, fainted resolved. On unknown dates, Fatigue and feeling achy resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. Patient stated that he was not drinking enough water and went out into the heat. He went to sit and instead fell backwards and scraped his head. He was taken to the emergency room and told he was dehydrated. He adds, because he took his 4th Pfizer booster the day before he was told the booster might have played a role in his fainting. After getting fluids in the hospital, he reported feeling good. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 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