Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Headache, Heart rate, Pericardial effusion, Pyrexia
Clinical narrative: PERICARDIAL EFFUSION/MASSIVE PERICARDIAL EFFUSION/LARGER PERICARDIAL EFFUSION; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 43year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism, hyperthyroidism, nonsmoker, and no alcohol use, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with cortisone, tetanus vaccine, and bupropion hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805002, and expiry: 25-MAY-2021) dose was not reported, (Dose no in Series: 1) 1 total administered for left arm on 03-APR-2021 for prophylactic vaccination. Concomitant medications included Armour thyroid for hyperthyroidism, and hypothyroidism. After receiving vaccine, On 04-APR-2021, the patient experienced fever, and patient couldn't lift head up (Headache). After 7 days on APR-2021, the patient experienced Pericardial Effusion, 2 months later another larger Pericardial Effusion which ended up in an Emergency room, 2 months after that patient had a massive pericardial Effusion where patient undergone a Pericardial window surgery on 20-SEP-2021 and Laboratory data included: Echocardiogram (NR: not provided) Not reported. The patient was re-hospitalized on 22-SEP-2021 and 14-OCT-2021 for Pericardial Effusion and discharged on 28-SEP-2021.  On 9-APR-2021 and 27-AUG-2021 the patient visited physician office and prescribed with Toradol(ketorolac tromethamine) and Steroids for Pericardial effusion. On 02-JUN-2021 the patient visited Emergency room and prescribed with the treatment drug Colchicine (0.6 mg). On OCT-2021, Heart rate (NR: not provided) Not up. On 11-OCT-2021, the patient visited doctor, Laboratory data included: Echocardiogram (NR: not provided) Clear. On 14-OCT-2021 patient was back to the Emergency room and readmitted the same day and discharged on the 20-OCT-2021. That's when patient put on the Arcalyst, Indomethacin and some Expensive medications. Indomethacin is 25mg three times daily. At this time patient couldn't get heart rate up and couldn't exert myself at all. And patient was seen on 29-OCT-2021 by physician and he was released from bed rest but still have to continue watching exertion, take his medicine and he says he won't be a marathon runner. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 06-APR-2021, and had not recovered from pericardial effusion/massive pericardial effusion/larger pericardial effusion. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211235471-COVID-19 VACCINE AD26.COV2.S-Pericardial effusion. 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.