Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Herpes zoster, Myositis, Pulmonary embolism, Weight decreased
Clinical narrative: Multiple pulmonary embolism; Myositis; Shingles outbreak; some form of dermatitis; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Multiple pulmonary embolism) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064H21A, 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No previous allergy and COVID diagnosis was reported.  Concurrent medical conditions included Hypertension, Hypothyroidism and Chronic back pain. Concomitant products included PREDNISONE, APIXABAN (ELIQUIS), AZATHIOPRINE (IMURAN [AZATHIOPRINE]) and ACYCLOVIR [ACICLOVIR] for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Multiple pulmonary embolism) (seriousness criterion medically significant), MYOSITIS (Myositis), HERPES ZOSTER (Shingles outbreak) and DERMATITIS (some form of dermatitis). The patient was treated with Rehabilitation therapy (In rehab over the last 6 months) for Dermatitis. At the time of the report, PULMONARY EMBOLISM (Multiple pulmonary embolism), MYOSITIS (Myositis), HERPES ZOSTER (Shingles outbreak) and DERMATITIS (some form of dermatitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: 70 ib (Low) 70 Ib.         No treatment medication was provided.  Patient was 4 ft tall and 4 inch.  Company Comment: This spontaneous case concerns a 71-year-old, morbidly obese (BMI 51.807), female patient with concurrent hypertension, hypothyroidism, and with concomitant use of prednisone, who experienced the unexpected, serious (medically significant) adverse event of special interest Pulmonary embolism which reportedly led to choking episodes, and the non-serious events of Myositis, Herpes zoster and Dermatitis. The events occurred on an unspecified date after receiving three doses of mRNA-1273 vaccine. The patient also reported enrolling in rehab for 6 months after being diagnosed with an unspecified type of dermatitis. There is limited information provided in the case on the clinical course of events, diagnostic procedures conducted, and treatment details. Additionally, the reported concomitant medications of unspecified indications could have been taken as treatment for the reported events: prednisone or azathioprine for myositis, apixaban (Eliquis) to prevent succeeding thromboembolic episodes, and acyclovir as treatment for the herpes zoster. The patient's morbid obesity and pre-existing hypertension and hypothyroidism could be considered as risk factors for the pulmonary embolism; while intake of prednisone could be a confounder to contracting the herpes zoster and the occurrence of myositis. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old, morbidly obese (BMI 51.807), female patient with concurrent hypertension, hypothyroidism, and with concomitant use of prednisone, who experienced the unexpected, serious (medically significant) adverse event of special interest Pulmonary embolism which reportedly led to choking episodes, and the non-serious events of Myositis, Herpes zoster and Dermatitis. The events occurred on an unspecified date after receiving three doses of mRNA-1273 vaccine. The patient also reported enrolling in rehab for 6 months after being diagnosed with an unspecified type of dermatitis. There is limited information provided in the case on the clinical course of events, diagnostic procedures conducted, and treatment details. Additionally, the reported concomitant medications of unspecified indications could have been taken as treatment for the reported events: prednisone or azathioprine for myositis, apixaban (Eliquis) to prevent succeeding thromboembolic episodes, and acyclovir as treatment for the herpes zoster. The patient's morbid obesity and pre-existing hypertension and hypothyroidism could be considered as risk factors for the pulmonary embolism; while intake of prednisone could be a confounder to contracting the herpes zoster and the occurrence of myositis. The benefit-risk relationship of mRNA-1273 is not affected by this report.