Sex: F
Vaccine: COVID19
Symptoms: Aortic aneurysm, Diarrhoea, Diverticulitis, Rheumatoid arthritis, Unevaluable event
Clinical narrative: thoracic aortic aneurysm; rheumatoid arthritis; diverticulitis recurrent; she was brain dead since heart surgery; chronic diarrhea; This spontaneous report received from a consumer by a business partner (Pfizer Inc.) on 13-Jan-2025 was received by Johnson and Johnson Innovative Medicine on 13-Jan-2025 and concerned a 66 year old female patient. The patient's height and weight were not reported. Age at time of vaccination was unknown.  The patient's past medical history included: thyroidectomy and radiation, and concurrent conditions included: giant cell arteritis, polymyalgia rheumatica, hiatal hernia, barrett's esophagus, and diverticulitis.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. Non-company products included: metoprolol succinate (tablet, route of admin not reported, batch number not reported) 100 milligram(s), once daily, administered on Aug-2023 to end date not provided and (tablet, route of admin not reported, batch number not reported) 50 milligram(s), once daily, administered on 2024 to end date not provided, for blood pressure and to beat heart harder.  The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Concomitant medications included: morphine for pain; ketamine for pain., armour thyroid (Started in Summer 2015 after a thyroidectomy and radiation treatment).  On an unspecified date, the patient experienced thoracic aortic aneurysm, rheumatoid arthritis, diverticulitis recurrent, she was brain dead since heart surgery, and chronic diarrhea. (dose series 1)  She had a thoracic aortic aneurysm and stated that this was the reason for her surgery. Stated that she was diagnosed with thoracic aortic aneurysm after having the Covid vaccine. Stated that it was the Johnson Johnson Covid vaccine and she took it in Nov-2020. She had to get it for her job. Her initial prescribing physician is not aware of this. She saw another physician outside of the prescribing physician after her surgery.  The metoprolol tablet was prescribed after the patient's heart surgery. The chronic diarrhea started gradually after her surgery around the clock. She was on metoprolol for 10-11 months and she has had chronic diarrhea in that time frame. She also had a hernia and a problem with her esophagus. She said that within 12 hours after stopping the metoprolol the diarrhea cleared up. They put her on it for her blood pressure and to make her heart beat harder because she had ascending aorta replacement. Her diarrhea started in the clinic right after surgery and stated that was not diarrhea at that time and was just soft and loose stool. Said that she was astonished that she could goto the bathroom because of the pain meds she was taking were morphine and ketamine. The patient's hiatal hernia and barrett's esophagus was prior to use of metoprolol. During the course of the period on the metoprolol , caller also had had diverticulitis 3 times during that period. She only had it once prior to that at age 12 years old. She never had it again until after her heart surgery and that is what made her research it. She said that she was brain dead and said that brain deadness was since having heart surgery.   On 15-Aug-2023 was the date of her surgery and by 18-Aug-2023-19-Aug-2023 she was starting to have diarrhea. This was all while on heavy opioids which usually creates the opposite problem. The diarrhea resolved within hours after stopping the metoprolol. Thinks it stopped in Hours of stopping the medciation in Oct-2024 or around the 01-Nov-2024 and was placed back on Amlodipine and HCTZ. Hindsight is 20/20, she did not put all of this together until last yearuntil she went off of the metoprolol on her own. Unsure if diverticulitis occurred prior to surgery. Does not remember the dates of the diverticulitis, but said that 2 occurred in early 2024 and one of them occurred in Fall 2023 after her surgery. She was scheduled to see a Gastroenterologist and when she stopped the metoprolol Succinate ER, the diarrhea stopped and she did not follow up with the gastroenterologist. The action taken with janssen covid-19 vaccine was not applicable and treatment with metoprolol succinate was withdrawn on an unspecified date.  The outcome of thoracic aortic aneurysm, rheumatoid arthritis, diverticulitis recurrent and she was brain dead since heart surgery was not reported. The patient recovered from chronic diarrhea on an unspecified date.  This report was serious (other medically important condition).; Sender's Comments: V0; Aortic aneurysm, Diverticulitis, Rheumatoid arthritis, Unevaluable event; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.