Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dizziness, Fatigue, Hot flush, Injection site pain
Clinical narrative: TOE CRAMP; FINGER CIRCULATION ISSUE; DIZZINESS; TINNITUS; HEAD VIBRATING; TEETH VIBRATING/CHATTERING; LEG PAIN; FATIGUE; MUSCLE ACHE; SORENESS AT INJECTION SITE; FEVER, HOT FLUSHES THROUGHOUT CHEST; NAUSEA; CARDIAC FLUTTER; CHEST PAIN; MIGRAINE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included tonsillectomy, car accident, broken 2nd vertebrae, right femur-metal rod, smoker, radiculopathy 5/6, radiculopathy L5, bulging disc L4/L5, and mild degenerative disc disease L5/S1 and concurrent conditions included allergy to latanoprost eye drops, macrobid, bactrium, prednsisone, penicillin, elmiron, crestor, welchol, bentyl, librax, mercaptopur (6mp), lyrica, topimax, nuvigil, cymbalta, budesonide, humira, depakote IV, neurontin and mirena and very sensitive to medication, high blood pressure when in pain, migraines (neck pain, hormones, weather), fibromyalgia, interstitial cystitis, crohns- ileitis, gastritis, acid reflux, spinal stenosis, haemorrhoids, gastric polyp, high triglyceride's, low red blood cell count anemia (d and iron-sometimes), possible mild obstructive sleep apnea, restless leg, cats and dogs allergy, cockroach allergy and dust allergy, and the patient received vaccines: engerix-b, havrix, hep a & hep b. The patient was previously treated with botulinum toxin type for migraine, ethinylestradiol/norgestimate for birth control. The patients diet for IC included no maltodextrin, no sorbitol/sucralose/Splenda/equal, low sodium.  The patient's family history included sleep apnea in brother from 1982-2016, muscular dystrophy in maternal grandmother who was deceased at 70 and the mathernal grandmother also had cataracts, stroke, and diabetes and she took Diethylstilbestrol (DES), the patients mother had interstitial cystitis since 1955, hepatitis C, high cholesterol, sleep apnea, restless leg, died of lung cancer, the patients aunt had fibromyalgia, cataracts, and migraines, her cousin had severe Crohn's, patients paternal grandmother had leukemia and died at 45 years due to suicide, paternal grandfather had breast cancer and died at age of 50 years due to heart disease (heart attack), and her cousin mothers side had history of Crohn's and diverticulitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A) dose was not reported, administered on 03-APR-2021 at 01:15 in right arm for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride and guaifenesin for allergies; lisinopril for blood pressure due to back pain; hyoscyamine, infliximab, loperamide hydrochloride and ondansetron for crohns; oxybutynin, amitriptyline and milnacipran hydrochloride for interstitial cystitis and fibromyalgia; omeprazole and sucralfate for gastritis; butalbital/caffeine/paracetamol, curcuma longa rhizome, fish oil and riboflavin for migraine, ascorbic acid, calcium, folic acid, magnesium, and zinc for vitamins supplements.  On 03-APR-2021, within 10 mins of vaccination at 01:30 the patient experienced toe cramp. On an unspecified date in APR-2021, the patient experienced finger circulation issue, dizziness, tinnitus, head vibrating, teeth vibrating/chattering, fatigue, muscle ache, soreness at injection site, fever, hot flushes throughout chest, nausea, cardiac flutter, chest pain, migraine, and leg pain and visited emergency room on 10-ARP-2021.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 F, Chest X-ray (NR: not provided) unknown, and Troponin (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the toe cramp, fatigue, finger circulation issue, fever, hot flushes throughout chest, soreness at injection site, muscle ache, tinnitus, teeth vibrating/chattering, migraine, cardiac flutter, leg pain, chest pain, head vibrating, nausea and dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Cardiac flutter. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.