Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: UNABLE TO SLEEP; HEADACHE; TIRED; ATRIAL FIBRILLATION/HEARTRATE FAST; HARD COUGHING; ACHES ALL OVER; HIPS HURT; HANDS HURT; CHILLS; FEVER OF 100.6; This spontaneous report received from a patient concerned a 64 year old White, Not Hispanic or Latino female.  The patient's weight was 172 pounds, and height was 177.8 centimeters The patient's concurrent conditions included rheumatoid arthritis, pink eye, no alcohol use, non smoker, osteopenia, and allergy to eye drops, and other pre-existing medical conditions included the patient was allergic to eye drop for pink eye allergic reaction, no history of drug abuse and patient was not pregnant at the time of vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, expiry: /5/2021) 0.5 ml, administered on left deltoid on 07-MAR-2021 15:50 for prophylactic vaccination. Concomitant medications included alendronate sodium for osteopenia, folic acid for rheumatoid arthritis, methotrexate for rheumatoid arthritis, and prednisolone for rheumatoid arthritis. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.6 (unit unspecified).  On 07-MAR-2021, the patient experienced atrial fibrillation/heartrate fast, hard coughing, aches all over, hips hurt, fever of 100.6, hands hurt, chills and tired. On 08-MAR-2021, the subject experienced unable to sleep and headache. On 10-MAR-2021,Laboratory data included: EKG (NR: not provided) Atrial Fibrillation.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from hips hurt, and hands hurt on MAR-2021, was recovering from aches all over, fever of 100.6, hard coughing, chills, headache, tired, unable to sleep and the outcome of atrial fibrillation/heartrate fast was not reported .  This report was serious (Other Medically Important Condition).  Additional information was received from patient on 01 -APR-2021. The following information was updated and incorporated in to the case narrative: person tab (patient middle name, two new reporters, patient email ID), Patient demographic details( height, weight, date of birth, pregnancy information), concurrent conditions (rheumatoid arthritis, pink eye, no alcohol use, non smoker, osteopenia, and allergy to eye drops), Concomitant medications (alendronate sodium, folic acid, methotrexate and prednisolone, lab data (EKG), added adverse event (atrial fibrillation/heartrate fast), updated the event verbatim coughing till hear beating fast to hard coughing, updated onset dates of fever, chills tired and hard coughing).; Sender's Comments: V1.Follow up information received regarding Patient demographic details, concurrent conditions, Concomitant medications,updated the event verbatim, updated onset dates of events. Case has been assessed as serious in the current version with addition of serious event Atrial fibrillation. 20210316350-Covid-19 vaccine ad26.cov2.s-Atrial fibrillation. Follow-up received regarding Clinical Details. 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).