Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Oedema, Pain in extremity, Pericarditis, Respiratory tract infection
Clinical narrative: FIBROMYALGIA; CHEST  PAIN/FELT PAIN AS A BALL UNDERNEATH HER BREAST AND TO BACK/FELT INFLAMED; A BIT OF WATER/FLUID IN HEART OR LUNGS; ADVANCED PERICARDITIS; BACK PAIN; FALL; FEET HURT; RESPIRATORY INFECTION; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included: bacteria in intestine, and concurrent conditions included: fibromyalgia ,GI(gastrointestinal)issues, and penicillin allergy. The patient experienced drug allergy when treated with ranitidine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1805029, expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  After 3 weeks of vaccination, on APR-2021 patient developed respiratory infection and 2-3 weeks after that (5 weeks after vaccination as per consumer) on APR-2021, she developed a very strong chest pain radiating to back. On 11-MAY-2021 she visited her rheumatologist but he refused to treat her as she was experiencing really bad chest pain (consumer stated she was crying of pain non stop) and referred her to urgent care. She then went to emergency room, performed EKG(electrocardiogram) and found it to be normal and was sent home. However, that night she developed pain again and took acetaminophen with codeine, but pain was worst. She then went to another hospital, on 12-MAY-2021, where she was admitted for 2 to 3 nights. It was reported that she was also being followed up at that time for GI(gastrointestinal) issues and that all doctors overlooked her symptoms and attributed them to her fibromyalgia. The patient was discharged on 14-MAY-2021. The patient was hospitalized for 3 nights. The patient reported that she had the chest pain on and off since May and that all EKG she got were normal and doctors said it was just her fibromyalgia. The patient reported that she only went to emergency room and primary care physician for pain episodes, then stopped as they were not of any help. On 12-NOV-2021, she had a fall, and hurt her feet for which she went to emergency room (arrived passed midnight). On 13-NOV-2021, she had scans of her foot, and then complained of back pain. She had X-Rays of her back and then CT(computed tomography) scan of her chest was taken which showed pericarditis and fluid in lungs or heart (patient was not sure). The patient was admitted on 13-NOV-2021 and discharged on 14-NOV-2021. The patient was hospitalized for 1 day. Patient also reported that doctor stated that the (pericarditis/inflammation) had been there for a while. Patient was started on anti inflammatory drugs and anticoagulant therapy. It was also reported that one of the doctors mentioned it could have been due to the vaccine and that she should look into that. Later described pain as a ball she felt with her hand on chest, where her heart was and stated physician attributed it as muscular. The patient also reported she felt the ball underneath her breast and to the back and it felt inflamed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from respiratory infection, had not recovered from chest pain/felt pain as a ball underneath her breast and to back/felt inflamed, and the outcome of a bit of water/fluid in heart or lungs, advanced pericarditis, back pain, fall, feet hurt and fibromyalgia was not reported. This report was serious (Hospitalization Caused / Prolonged).      This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included: bacteria in intestine, and concurrent conditions included: fibromyalgia, gi issues, and penicillin allergy. The patient experienced drug allergy when treated with ranitidine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced chest pain/felt pain as a ball underneath her breast and to back/felt inflamed. On APR-2021, the patient experienced respiratory infection. On MAY-2021, the patient experienced fibromyalgia. On 11-MAY-2021, Laboratory data included: EKG (NR: not provided) Normal. On NOV-2021, the patient experienced advanced pericarditis. On NOV-2021, the patient experienced a bit of water/fluid in heart or lungs. On 12-NOV-2021, the patient experienced fall. On 12-NOV-2021, the patient experienced feet hurt. On 13-NOV-2021, the patient experienced back pain. Laboratory data included: CT scan (NR: not provided) pericarditis, edema, Scan (NR: not provided) unknown, and X-ray (NR: not provided) unknown. Treatment medications (dates unspecified) included: codeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from respiratory infection, had not recovered from chest pain/felt pain as a ball underneath her breast and to back/felt inflamed, and the outcome of a bit of water/fluid in heart or lungs, advanced pericarditis, back pain, fall, feet hurt and fibromyalgia was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20211136233-covid-19 vaccine ad26.cov2.s- chest pain/felt pain as a ball underneath her breast and to back/felt inflamed, advanced pericarditis, a bit of water/fluid in heart or lungs.This event(s) is considered unassessable. The event(s) 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(s). 20211136233-covid-19 vaccine ad26.cov2.s -fibromyalgia. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY