Age: 62.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Arterial occlusive disease, Coronary artery bypass, Echocardiogram, Fatigue, Hidradenitis
Clinical narrative: Heart attack; arteries that were 95 to 99 percent blocked; An open heart surgery or triple coronary artery bypass graft; hidradenitis suppurativa flare; tired after covid vaccine; slept about 25 to 30 hours after second vaccine of covid; Arm hurt after shingles vaccine; slept about 25 to 30 hours after shingles vaccine; tired after shingles vaccine and colds; tired after shingles vaccine and colds; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-3909371-00 (Agency).  A 62 year-old female patient received BNT162B2, intramuscular, administration date 02Apr2021 (Lot number: ER8732, Expiration Date: Unknown) at the age of 62 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 2020 (Batch/Lot number: unknown) to 15Apr2021 at 40 mg weekly (40 mg, weekly (citrate free (40 mg,1 in 1 wk))) and second regimen subcutaneous since 08Jul2021 (ongoing) (Batch/Lot number: unknown) at 40 mg weekly (40 mg, weekly (citrate free (40 mg,1 in 1 wk))) for hidradenitis; varicella zoster vaccine rge (cho) (SHINGRIX) (Batch/Lot number: unknown) for herpes zoster. Relevant medical history included: "No tobacco use" (unspecified if ongoing); "mold allergy" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Diphtheria pertussis shot allergy" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Supplement" (unspecified if ongoing); "Cholesterol issues" (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN; METFORMIN taken for diabetes mellitus; GLIMEPIRIDE taken for diabetes mellitus; GABAPENTIN taken for diabetes mellitus, neuropathy peripheral; METOPROLOL taken for hypertension; VITAMIN C [ASCORBIC ACID] taken for supplementation therapy; B12 [CYANOCOBALAMIN] taken for supplementation therapy; ATORVASTATIN taken for blood cholesterol; IRON taken for blood cholesterol; CLOPIDOGREL; LOSARTAN taken for hypertension; AMLODIPINE taken for hypertension; VITAMIN D [COLECALCIFEROL] taken for supplementation therapy; VENOFER. Past drug history included: Opioids, reaction(s): "Known allergies: Opioids". Vaccination history included: Bnt162b2 (Dose 1, Single, Route of administration: Intramuscular, lot number: EN6201,, Expiration date: Jun2021), administration date: 12Mar2021, when the patient was 62 years old, for COVID-19 Vaccination. The following information was reported: ARTERIAL OCCLUSIVE DISEASE (hospitalization) with onset Apr2021, outcome "recovering", described as "arteries that were 95 to 99 percent blocked"; CORONARY ARTERY BYPASS (medically significant) with onset 21Apr2021, outcome "unknown", described as "An open heart surgery or triple coronary artery bypass graft"; MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset Apr2021, outcome "recovered", described as "Heart attack"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "tired after covid vaccine"; HYPERSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "slept about 25 to 30 hours after second vaccine of covid"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Arm hurt after shingles vaccine"; HYPERSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "slept about 25 to 30 hours after shingles vaccine"; FATIGUE (non-serious), NASOPHARYNGITIS (non-serious) all with onset Apr2021, outcome "unknown" and all described as "tired after shingles vaccine and colds"; HIDRADENITIS (non-serious) with onset 15Apr2021, outcome "recovered", described as "hidradenitis suppurativa flare". The patient was hospitalized for arterial occlusive disease, myocardial infarction (start date: 15Apr2021, discharge date: 11May2021, hospitalization duration: 26 day(s)). The patient underwent the following laboratory tests and procedures: echocardiogram: (Apr2021) showed three arteries that were 95 to 99 percent b. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of arterial occlusive disease, myocardial infarction.  Clinical Information: Patient stated, She did not have the expiration date of second dose of COVID-19 vaccination because it was not on the vaccination card. She now can use electric razor and considering deodorant. Sometimes uses antibacterial soap, hibacleanse. She stooped therapy for one month during time of heart surgery, following heart attack in May2021 and risk of infection. She was off of Humira for three months and then restarted it after risk was no longer. She had great positive response since taking Humira and had only one flare up in Jan2022 that started as small bump and was all clear. She was tired and slept about 25 to 30 hours after second vaccine of covid. She took Shingrix vaccine for shingles prevention and had arm hurt after and was very tired and slept for about 25 to 30 hours. This fatigue happens when she gets colds and she did not get sick often if she sleeps well when first getting sick.  Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB). The reporter's causality for the event(s) of arteries that were 95 to 99 percent blocked, heart attack, tired after covid vaccine, slept about 25 to 30 hours after second vaccine of covid and hidradenitis suppurativa flare onset 15Apr2021 with Humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of arm hurt after shingles vaccine, slept about 25 to 30 hours after shingles vaccine, tired after shingles vaccine, colds and hidradenitis suppurativa flare onset in Jan2022 was not provided.  The events of arteries that were 95 to 99 percent blocked, heart attack, tired after covid vaccine, slept about 25 to 30 hours after second vaccine of covid, arm hurt after shingles vaccine, slept about 25 to 30 hours after shingles vaccine, tired after shingles vaccine, hidradenitis suppurativa flare onset in Jan2022 and hidradenitis suppurativa flare onset 15Apr2021 are related to HUMIRA 40MG/0.4ML(ADALIMUMAB). Agency's opinion is that there is a reasonable possibility that the event of colds is related to HUMIRA 40MG/0.4ML(ADALIMUMAB). On 22Jul2021, received updates to patient demographics, medical history, concomitant drug information and narrative description. On 24Feb2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Arterial occlusion, coronary artery bypass and Myocardial infarction which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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.