Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Swelling
Clinical narrative: PERICARDITIS; FLUID AROUND LUNGS; MUSCLE CRAMPS; MUSCLE ACHES; HIGH FEVER; UNABLE TO WALK; MYOCARDITIS; TINGLING TONGUE; NUMB TONGUE; FEELING SHAKY; This spontaneous report received from a consumer concerned a 50 years old female. The patient's past medical history included heart races, and face gets red, and concurrent conditions included Hashimoto's disease. Patient had no any other vaccination in the past 30 days and had no any other illness in the past 30 days. The patient was previously treated with doxycycline for face gets red, heart races. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: unknown) dose was not reported, 1 total administered on 05-MAR-2021 at left arm for prophylactic vaccination. Concomitant medications included levothyroxine sodium for Hashimoto's disease. On 5-MAR-2021, patient experienced tingling and numbness in tongue and felt shaky within 2 minutes of vaccine administration. Since 13-MAR-2021, patient experienced fever, extreme muscle ache, and cramps. On 13-MAR-2021, one week after the vaccination patient experienced high fever of 105 F. On an unspecified date in MAR-2021, patient received fluid at hospital and was discharged. On an unspecified date in MAR-2021, patient experienced pain in chest, labored breathing and couldn't walk and was hospitalized for second time. Patient was given IV, steroids, and antibiotics at hospital and was discharged after 1 week. Hospital stated that patient had myocarditis at first hospital visit. On 04-APR-2021, patient experienced High-grade fever (105 F), chest pain, labored breathing and was hospitalized for third time on the same day. Same day, EKG (electrocardiogram) showed fluid around lungs and heart of patient to which the hospital determined patient had pericarditis (labored breathing).  Laboratory data included: Body temperature (NR: not provided) 105 F, COVID-19 virus test (NR: not provided) Negative, and influenza virus test (NR: not provided) Negative. Laboratory data included: Body temperature (NR: not provided) 105 F, and EKG (NR: not provided) pericarditis.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling tongue, numb tongue, and feeling shaky on 05-MAR-2021, had not recovered from high fever, and muscle aches and muscle cramps, and the outcome of myocarditis, pericarditis, fluid around lungs, and unable to walk was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210408993-COVID-19 VACCINE AD26.COV2.S- pericarditis, myocarditis, fluid around lungs, unable to walk and muscle cramps. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210408993-covid-19 vaccine ad26.cov2.s -high fever, muscle aches. These events are labeled per RSI and are therefore considered potentially related.