Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Carotid artery occlusion, Cerebrovascular accident, Dementia, Depression
Clinical narrative: Passed out; carotid clogged arteries/ carotid arteries clogged; neck pain; blood clot exploded; stroke; wiped out; headache; psoriasis is coming back; bone pain; body hurt; depressed; feeling of dementia; 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-163-4390777-00.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen from 2019 (Batch/Lot number: unknown) to 2021 at 40 mg (40 mg, (1 in 2 wk)) and second regimen since 09May2022 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg, (1 in 2 wk)), all subcutaneous for psoriasis. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Alcohol use", start date: 2015, stop date: 2022; "Tobacco use" (unspecified if ongoing); "depression", start date: 2021 (unspecified if ongoing), notes: He had depression last year 2021 because his grandson died on his birthday. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol; VITAMIN D [COLECALCIFEROL] taken for nutritional supplementation; CALCIUM + MAGNESIUM taken for supplementation therapy. The following information was reported: DEPRESSION (non-serious) with onset 2021, outcome "not recovered", described as "depressed"; DEMENTIA (medically significant) with onset 2021, outcome "not recovered", described as "feeling of dementia"; PAIN (non-serious) with onset Feb2022, outcome "recovered" (May2022), described as "body hurt"; BONE PAIN (non-serious) with onset Feb2022, outcome "recovered" (09May2022); PSORIASIS (non-serious) with onset Apr2022, outcome "recovering", described as "psoriasis is coming back"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant), outcome "recovered", described as "Passed out"; CAROTID ARTERY OCCLUSION (hospitalization, medically significant), outcome "recovered", described as "carotid clogged arteries/ carotid arteries clogged"; NECK PAIN (hospitalization), outcome "not recovered"; THROMBOSIS (medically significant), outcome "recovered", described as "blood clot exploded"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "recovered", described as "stroke"; FATIGUE (non-serious), outcome "unknown", described as "wiped out"; HEADACHE (non-serious), outcome "not recovered". The events "passed out", "carotid clogged arteries/ carotid arteries clogged" and "neck pain" required emergency room visit. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of carotid artery occlusion.Clinical course: An adult male with events of Passed out, Carotid clogged arteries, blood clot exploded and Stroke and non-serious feeling of Dementia, wiped out, Depressed, Bone pain, body hurt, Psoriasis is coming back, neck pain and Headache with Humira 40MG/0.4ML (Adalimumab).The patient has other concomitant therapy of multivitamins wiped out. On unknown dates, the patient experienced Passed out, Carotid clogged arteries, blood clot exploded, Stroke, wiped out, neck pain and Headache. In 2021, the patient experienced feeling of dementia and Depressed. In Feb2022, the patient experienced Bone pain and body hurt. In Apr2022, the patient experienced Psoriasis is coming back. On 09May2022, the bone pain resolved. In May2022, the body hurt resolved. On unknown dates, Passed out, Carotid clogged arteries, blood clot exploded and Stroke resolved. Pfizer BioNTech Covid-19 Vaccine was also considered suspect. According to the patient, a few weeks after his Covid-19 vaccine he felt neck pain, passed out and he was brought to the emergency room and was hospitalized on unknown date. Per patient, physician informed him that he had 50% of his carotid arteries clogged. Patient unable to recall diagnosis that was provided by physician. He was given Cholesterol pill unknown name. Per patient Humira was discontinued because of insurance issue. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Change History: On 12May2022, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The events of "Passed out", "Passed out, Carotid clogged arteries, blood clot exploded", "feeling of dementia", "wiped out", "depressed" and "headache" were added. The event of "Bones hurt" was amended to "Bone pain".  The reporter considered "passed out", "carotid clogged arteries/ carotid arteries clogged", "neck pain", "blood clot exploded", "stroke", "feeling of dementia", "wiped out", "depressed", "bone pain", "body hurt" and "headache" related to BNT162b2. The reporter's assessment of the causal relationship of "psoriasis is coming back" 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.  Causality for Humira 40MG/0.4ML(Adalimumab): The reporter's causality for the event(s) of Passed out, Carotid clogged arteries, blood clot exploded, Stroke, feeling of Dementia, wiped out, Depressed, Bone pain, body hurt, Psoriasis was coming back, neck pain and Headache with Humira 40MG/0.4ML (Adalimumab) was no reasonable possibility. MFR opinion was that the events of Passed out, Carotid clogged arteries, blood clot exploded, Stroke, feeling of Dementia, wiped out and headache are not assessable. MFR opinion was that there is no reasonable possibility that the events of depressed, Bone pain, body hurt, Psoriasis is coming back and neck pain are related to HUMIRA 40MG/0.4ML (Adalimumab).  Causality: Passed out (Loss of consciousness), Carotid artery occlusion, Thrombosis, Stroke (Cerebrovascular accident), Dementia, Fatigue, Headache Causality as per reporter (Drug/Vaccine): Not Related, Causality as per Mfr.(Drug/Vaccine): Not assessable and Depressed state (Depression), Bone pain, General body pain (Pain), Psoriasis flare-up (Psoriasis), Neck pain (Neck pain) Causality as per reporter (Drug/Vaccine): Not Related ,Causality as per Mfr (Drug/Vaccine): No reasonable possibility  Causality for Pfizer Biontech Covid-19 Vaccine: Passed out (Loss of consciousness), Carotid artery occlusion (Carotid artery occlusion), Thrombosis, Stroke (Cerebrovascular accident), Dementia, Fatigue, Depressed state (Depression), Bone pain, General body pain (Pain), Neck pain, Headache Causality as per reporter (Drug/Vaccine): Possible and Psoriasis flare-up (Psoriasis), Causality as per reporter (Drug/Vaccine) :Not Related  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 cannot be totally 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.