Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 3 | 021B21A | IM |
Patient was diagnosed with 2 small epileptic seizures; currently experiencing multiple symptoms of the attr-cm condition/Patient mentioned that she is still experiencing a discomfort in her chest with a muscular problem on her left arm; Muscular problem on her left arm; This spontaneous case was reported by a patient and describes the occurrence of EPILEPSY (Patient was diagnosed with 2 small epileptic seizures) and CARDIAC AMYLOIDOSIS (currently experiencing multiple symptoms of the attr-cm condition/Patient mentioned that she is still experiencing a discomfort in her chest with a muscular problem on her left arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A, 033C21A and 057M2114) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Kidney stone (had a large kidney stone on the left side (happened before the covid Moderna shot)) and Myocarditis (might had myocarditis (not diagnosed but it was an assumption by PCP) as some of the symptom's correlates to the condition (happened decade ago).). On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 18-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In February 2024, the patient experienced EPILEPSY (Patient was diagnosed with 2 small epileptic seizures) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CARDIAC AMYLOIDOSIS (currently experiencing multiple symptoms of the attr-cm condition/Patient mentioned that she is still experiencing a discomfort in her chest with a muscular problem on her left arm) (seriousness criterion medically significant) and MUSCULOSKELETAL DISORDER (Muscular problem on her left arm). The patient was hospitalized on sometime in February 2024 due to EPILEPSY. At the time of the report, EPILEPSY (Patient was diagnosed with 2 small epileptic seizures), CARDIAC AMYLOIDOSIS (currently experiencing multiple symptoms of the attr-cm condition/Patient mentioned that she is still experiencing a discomfort in her chest with a muscular problem on her left arm) and MUSCULOSKELETAL DISORDER (Muscular problem on her left arm) had not resolved. Concomitant medication use information was not provided by reporter. 2 of the symptoms for familial and most the symptoms that she had, which she currently experienced, was coming from the attr-cm wild version. The patient was currently on a medication for anti-seizure. The patient wanted to know if there was a potential connection between the Moderna's side effects and the attr-cm side effects. It was unknown if the patient experienced any additional symptoms/events. The patient did not have any additional medical history, concomitant disease or risk factor.; Reporter's Comments: The event Cardiac amyloidosis, reported as multiple symptoms of the "ATTR-cm condition" and Musculoskeletal disorder are considered as not related to the Moderna vaccine given that Cardiac amyloidosis is a genetic disorder secondary to a mutation or instability of the transirretin protein, and the long latency and clinical context for the Musculoskeletal disorder The benefit-risk relationship of the product is not affected by this report.
Medical History/Concurrent Conditions: Kidney stone (had a large kidney stone on the left side (happened before the covid Moderna shot)); Myocarditis (might had myocarditis (not diagnosed but it was an assumption by PCP) as some of the symptom's correlates to the condition (happened decade ago).)