Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arterial occlusive disease, Echocardiogram, Fatigue, Hidradenitis, Hypersomnia
Clinical narrative: Heart attack; arteries that were 95 to 99 percent blocked; tired after covid vaccine; slept about 25 to 30 hours after second vaccine of covid; sickness; In Jan022, the patient experienced HIDRADENITIS SUPPURATIVA FLARE; 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 (Company).  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Oct2021 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 2020 (Batch/Lot number: unknown) to 15Apr2021 at 40 mg (40 mg(citrate free)) and second regimen subcutaneous since 08Jul2021 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg(citrate free)) for hidradenitis. 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); "Opioids Allergy" (unspecified if ongoing); "Blood thinner" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Cholesterol issues" (unspecified if ongoing); "No alcohol use" (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN taken for anticoagulant therapy; METFORMIN 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 taken for anticoagulant therapy; LOSARTAN taken for hypertension; AMLODIPINE taken for hypertension; VITAMIN D [COLECALCIFEROL] taken for supplementation therapy; VENOFER; GLIMEPIRIDE taken for diabetes mellitus. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: 12Mar2021, when the patient was 62 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Single), administration date: 02Apr2021, when the patient was 62 years old, for Covid-19 Immunization, reaction(s): "Arterial occlusion", "Heart attack", "Sleep excessive", "Vaccination site pain", "Sleep excessive", "Tiredness", "Common cold", "Hidradenitis suppurativa", "Tiredness"; Shingrix (Drug: Shingrix (Varicella zoster Vaccine RGE (CHO))( Varicella zoster Vaccine RGE (CHO), unknown, Route of Admin: 1) Unknown, Indication for use: 1) shingles prevention), for Shingles Prevention, reaction(s): "tired after shingles vaccine"; Shingrix, for Shingles Prevention, reaction(s): "slept about 25 to 30 hours after shingles vaccine", "arm hurt"; Shingrix, administration date: Apr2021, for Shingles Prevention, reaction(s): "tired after shingles vaccine and colds". The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "recovered", described as "Heart attack"; HIDRADENITIS (medically significant) with onset Jan2022, outcome "recovered", described as "In Jan022, the patient experienced HIDRADENITIS SUPPURATIVA FLARE"; ILLNESS (medically significant) with onset Mar2022, outcome "unknown", described as "sickness"; ARTERIAL OCCLUSIVE DISEASE (medically significant), outcome "recovered", described as "arteries that were 95 to 99 percent blocked"; FATIGUE (medically significant), outcome "unknown", described as "tired after covid vaccine"; HYPERSOMNIA (medically significant), outcome "unknown", described as "slept about 25 to 30 hours after second vaccine of covid". The patient underwent the following laboratory tests and procedures: echocardiogram: (Apr2021) arteries that were 95 to 99 percent blocked, notes: Showed three arteries that were 95 to 99 percent blocked. The action taken for adalimumab was unknown.  Clinical course: On unknown dates, the patient experienced arm hurt after shingles vaccine, slept about 25 to 30 hours after shingles vaccine, tired after shingles vaccine and colds. in Apr2021, the patient experienced arteries that were 95 to 99 percent blocked, tired after covid vaccine and slept about 25 to 30 hours after second vaccine of covid. on 15Apr2021, the patient experienced heart attack and hidradenitis suppurativa flare. on 15Apr2021, the heart attack resolved. in jan2022, the patient experienced hidradenitis suppurativa flare. in 2022, the hidradenitis suppurativa flare resolved. on an unknown date, hidradenitis suppurativa flare  resolved. pfizer biontech covid-19 vaccine (tozinameran) and shingrix (varicella zoster vaccine rge (cho))  were also considered suspect. The patient had an open heart surgery or triple coronary artery bypass graft last on 21Apr2021 due to three arteries that were 95 to 99 percent blocked. Approximately, from 15Apr2021 up to 11May2021, she was in the hospital for the surgery. None of the events wee side effects of Humira. She also had a rehab for her heart. She had a flare of Hidradenitis suppurativa under her arms without HUMIRA. She had used Penicillin as a past medication. 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 BNT162B2: The reporter's assessment of the causal relationship of the event with the suspect product 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 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. opinion is that there is no reasonable possibility that 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). Company's opinion is that there is a reasonable possibility that the event of colds is related to HUMIRA 40MG/0.4ML(ADALIMUMAB).   Hidradenitis suppurativa (10020041) (Hidradenitis (10020040))  Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per Mfr.(Drug/Vaccine) :  No reasonable possibility  Drug:  PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(Injection)(TOZINAMERAN),EN6201,ER8732,UNKNOWN  Hidradenitis suppurativa (10020041) (Hidradenitis (10020040))  Causality as per reporter (Drug/Vaccine) :  Not Reported  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   Follow-up (11Mar2022): This is a Follow-up solicited report based on information received by Pfizer from Company (Mfr. Control No.: 21K-163-3909371-00 (Company) Via GlaxoSmithKline. A contactable consumer (patient) reported that: Update Information Included: event upgraded as serious and events rearrangement done. Patient's Height and weight updated. New reporter added.  The reporter's assessment of the causal relationship of the events with the suspect product tiredness, sleep excessive was possible and for other events not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.  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