Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arterial occlusive disease, Echocardiogram, Fatigue, Hidradenitis, Hypersomnia
Clinical narrative: HEART ATTACK /open heart surgery and was in the hospital for the surgery; ARTERIES WERE 95 TO 99 PERCENT BLOCKED; ARM HURT; TIRED; SLEPT ABOUT 25 TO 30 HOURS; small bump; COLDS; HIDRADENITIS SUPPURATIVA FLARE; This case was reported by a consumer via other manufacturer and described the occurrence of heart attack in a 62-year-old female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included TOZINAMERAN (BIONTECH-PFIZER COVID-19 VACCINE INJECTION) (batch number EN6201, expiry date June 2021) for prophylaxis and TOZINAMERAN (BIONTECH-PFIZER COVID-19 VACCINE INJECTION) (batch number ER8732, expiry date unknown) for prophylaxis.   Previously administered products included Penicillin. Concurrent medical conditions included diabetes, neuropathy, blood pressure high, allergy to molds, penicillin allergy, drug allergy and drug allergy. Concomitant products included adalimumab (Humira), acetylsalicylic acid (Aspirin (Baby)), metformin, glimepiride, gabapentin, metoprolol, ascorbic acid (Vitamin C), cyanocobalamin (Vitamin B12), atorvastatin, iron, clopidogrel, losartan and amlodipine.   On an unknown date, the patient received Hz/su + AS01B. On 12th March 2021, the patient received the 1st dose of BIONTECH-PFIZER COVID-19 VACCINE INJECTION (intramuscular). On 2nd April 2021, the patient received the 2nd dose of BIONTECH-PFIZER COVID-19 VACCINE INJECTION (intramuscular). On 15th April 2021, unknown after receiving Hz/su + AS01B, the patient experienced heart attack (serious criteria hospitalization and GSK medically significant) and hidradenitis suppurativa. In April 2021, the patient experienced arterial occlusion (serious criteria hospitalization and clinically significant/intervention required). On an unknown date, the patient experienced pain in arm, tiredness, sleep excessive, local swelling and cold. On 15th April 2021, the outcome of the heart attack was recovered/resolved. On an unknown date, the outcome of the arterial occlusion, pain in arm, tiredness, sleep excessive, local swelling and cold were unknown and the outcome of the hidradenitis suppurativa was recovered/resolved.   It was unknown if the reporter considered the heart attack, arterial occlusion, pain in arm, tiredness, sleep excessive, hidradenitis suppurativa, local swelling and cold to be related to Hz/su + AS01B.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was not a tobacco or alcohol user. Concomitant products also included Vitamin D as supplement and Venofer. On an unknown date the patient received Shingles vaccine and her arm hurt, slept about 25 to 30 hours, was tired and had colds. The patient received second dose COVID-19 Vaccine and was tired, slept about 25 to 30 hours after second vaccine of Covid. In April 2021, the patient experienced arteries that were 95 to 99 percent blocked. On 15th April 2021, the patient experienced heart attack and hidradenitis suppurativa flare and the heart attack resolved the same day. The patient had an open-heart surgery or triple coronary artery bypass graft last on 21st April 2021 due to three arteries that were 95 to 99 percent blocked. Approximately, from 15th April 2021 up to 11th May 2021, she was in the hospital for the surgery and she also had a rehab for her heart. The patient had a flare of Hidradenitis suppurativa under her arms without Humira. The patient could now use electric razor and was considering deodorant.  The patient sometimes used antibacterial soap, hibacleanse. The patient stopped Humira therapy for one month during time of heart surgery, following heart attack in May 2021 and risk of infection, she was off of Humira for three months and then restarted it after risk was no longer. In October 2021, the patient received 3rd dose of Pfizer Biontech Covid-19 vaccine intramuscularly. In January 2022, the patient experienced hidradenitis suppurativa flare, in 2022, the hidradenitis suppurativa flare resolved. The patient had great positive response since taking Humira and had only one flare up in Jan 2022 that started as small bump and was all clear. She was tired and slept about 25 to 30 hours after second vaccine of Covid. The patient statute that the fatigue happened when she got colds and she did not get sick often if she slept well when first getting sick. She did not have the expiration date of second dose of COVID-19 vaccination because it was not on the vaccination card. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.