Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody increased, Antinuclear antibody positive, Arthralgia, C-reactive protein, Echocardiogram
Clinical narrative: Sjogrens syndrome; Chest pain; Shortness of breath; Pericarditis; A-Fib/ when she went into atrial fibrillation, her heart was beating really abnormal; A major hemorragic stroke; Had a major hemorragic stroke, which left her paralized in her left arm and left leg; Did not receive the second dose; Broke out in a rash; Joint pain, specially on her wrist; This spontaneous case was reported by a consumer and describes the occurrence of SJOGREN'S SYNDROME (Sjogrens syndrome), ATRIAL FIBRILLATION (A-Fib/ when she went into atrial fibrillation, her heart was beating really abnormal), HAEMORRHAGIC STROKE (A major hemorragic stroke), HEMIPLEGIA (Had a major hemorragic stroke, which left her paralized in her left arm and left leg), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath) and PERICARDITIS (Pericarditis) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose). In January 2021, the patient experienced RASH (Broke out in a rash) and ARTHRALGIA (Joint pain, specially on her wrist). On 07-May-2021, the patient experienced SJOGREN'S SYNDROME (Sjogrens syndrome) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization) and PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant). In May 2021, the patient experienced ATRIAL FIBRILLATION (A-Fib/ when she went into atrial fibrillation, her heart was beating really abnormal) (seriousness criteria hospitalization and medically significant), HAEMORRHAGIC STROKE (A major hemorragic stroke) (seriousness criteria hospitalization and medically significant) and HEMIPLEGIA (Had a major hemorragic stroke, which left her paralized in her left arm and left leg) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-May-2021 to sometime in June 2021 due to ATRIAL FIBRILLATION, CHEST PAIN, DYSPNOEA, HAEMORRHAGIC STROKE, HEMIPLEGIA, PERICARDITIS and SJOGREN'S SYNDROME. The patient was treated with METOPROLOL for Adverse event, at an unspecified dose and frequency. On 04-Jan-2021, PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose) had resolved. In June 2021, HAEMORRHAGIC STROKE (A major hemorragic stroke), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath) and PERICARDITIS (Pericarditis) had resolved. At the time of the report, SJOGREN'S SYNDROME (Sjogrens syndrome), HEMIPLEGIA (Had a major hemorragic stroke, which left her paralized in her left arm and left leg), RASH (Broke out in a rash) and ARTHRALGIA (Joint pain, specially on her wrist) outcome was unknown and ATRIAL FIBRILLATION (A-Fib/ when she went into atrial fibrillation, her heart was beating really abnormal) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Echocardiogram: abnormal (abnormal) Fluid around her heart. In May 2021, Heart rate: ab (abnormal) heart was beating really abnormal. In May 2021, Rheumatoid factor: 100 (High) Very high. In June 2021, Echocardiogram: normal (normal) She was ok, no fluid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SJOGREN'S SYNDROME (Sjogrens syndrome) to be related. No further causality assessments were provided for ATRIAL FIBRILLATION (A-Fib/ when she went into atrial fibrillation, her heart was beating really abnormal), HAEMORRHAGIC STROKE (A major hemorragic stroke), HEMIPLEGIA (Had a major hemorragic stroke, which left her paralized in her left arm and left leg), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PERICARDITIS (Pericarditis), PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose), RASH (Broke out in a rash) and ARTHRALGIA (Joint pain, specially on her wrist).    No concomitant medications were provided.  Lab data included ECGs (electrocardiogram) and a bunch of autoinmune disease testing for lupus with unknown results.  Doctor advised patient not to get the second dose, as doctor was afraid of having a worse reaction, so patient did not receive the second dose. The patient was in a wheelchair. Couldn't rule out Rheumatoid arthritis, but stated that patient had Sjogrens syndrome. Patient heart was beating really abnormal and that continued after patient came home, but they changed the medication and got better.  Treatment medications also included unspecified antiinflamatory for pericarditis. Company comment This case concerns a 62-year-old female patient, with no reported medical history, who experienced the unexpected serious events of SJOGREN'S SYNDROME, ATRIAL FIBRILLATION, HAEMORRHAGIC STROKE, HEMIPLEGIA and the expected serious event of PERICARDITIS. The events occurred approximately 4 months after the administration of the first dose of mRNA-1273 vaccine. On 7May2021 she started having chest pain and was admitted in the hospital with pericarditis. They found she had an autoimmune disease and stated that she had Sjogrens syndrome. About a week after, she had a major hemorragic stroke, which left her paralized in her left arm and left leg. PRODUCT DOSE OMISSION ISSUE was considered as an additional event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 62-year-old female patient, with no reported medical history, who experienced the unexpected serious events of SJOGREN'S SYNDROME, ATRIAL FIBRILLATION, HAEMORRHAGIC STROKE, HEMIPLEGIA and the expected serious event of PERICARDITIS. The events occurred approximately 4 months after the administration of the first dose of mRNA-1273 vaccine. On 7May2021 she started having chest pain and was admitted in the hospital with pericarditis. They found she had an autoimmune disease and stated that she had Sjogrens syndrome. About a week after, she had a major hemorragic stroke, which left her paralized in her left arm and left leg. PRODUCT DOSE OMISSION ISSUE was considered as an additional event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.