Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dermatomyositis, Encephalitis viral, Ovarian cancer metastatic
Clinical narrative: Found ovarian cancer in lungs; stroke; viral infection in her brain; Approx. three weeks after 2nd dose, the patient developed dermatamiyositis; This spontaneous case was reported by a consumer and describes the occurrence of OVARIAN CANCER METASTATIC (Found ovarian cancer in lungs), CEREBROVASCULAR ACCIDENT (stroke), DERMATOMYOSITIS (Approx. three weeks after 2nd dose, the patient developed dermatamiyositis) and ENCEPHALITIS VIRAL (viral infection in her brain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 011620A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In March 2021, the patient experienced DERMATOMYOSITIS (Approx. three weeks after 2nd dose, the patient developed dermatamiyositis) (seriousness criterion medically significant). On an unknown date, the patient experienced OVARIAN CANCER METASTATIC (Found ovarian cancer in lungs) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant) and ENCEPHALITIS VIRAL (viral infection in her brain) (seriousness criterion medically significant). At the time of the report, OVARIAN CANCER METASTATIC (Found ovarian cancer in lungs), CEREBROVASCULAR ACCIDENT (stroke) and ENCEPHALITIS VIRAL (viral infection in her brain) had not resolved and DERMATOMYOSITIS (Approx. three weeks after 2nd dose, the patient developed dermatamiyositis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient was perfectly healthy before vaccine.  Approx. three weeks after 2nd dose, the patient developed dermatamiyositis, later found ovarian cancer in lungs, but couldn't find it in ovaries, had chemo for 9 weeks and now at the time of reporting has had a stroke or viral infection in her brain.  It was unknown if the patient experienced any additional symptoms/events.  Company Comment: This spontaneous case concerns a 53-year-old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant) event of dermatomyositis after a dose of mRNA-1273 vaccination, which was described as 2nd dose in COVID-19 vaccination schedule. Latency cannot be calculated however it was provided, that event occurred app. 3 weeks after vaccination. The patient has also experienced unexpected, serious (medically significant) events of Ovarian cancer metastatic (reported as ovarian cancer in lungs), cerebrovascular accident (AESI) and Encephalitis viral which occurred after the same vaccination, however, due to exact events onset dates unknown latency cannot be calculated. Previously, the patient has been vaccinated with mRNA-1273 as a 1st dose of Covid-19 vaccination schedule, doses were administered 36 days apart. The course of event started with dermatomyositis app. 3 weeks after 2nd dose vaccination; metastatic ovarian cancer was diagnosed in lung with no primary ovarian cancer being identified. After 9 weeks of chemotherapy cerebrovascular stroke or viral encephalitis was suspected. Dermatomyositis could be considered as clinical manifestation of ovarian cancer which combined with chemotherapy also could contribute to central nervous system complications (cerebrovascular accident or viral encephalitis). No further details regarding clinical course, etiologic and diagnostic work-up, concomitant medications, concurrent diseases, accompanying circumstances and risk factors, treatment are available in the report. Dermatomyositis outcome was unknown while outcome of the rest of events was not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.