Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Lymphadenopathy, Malaise, Nausea
Clinical narrative: generally did not feel good; got nauseous; she had pain radiating from under her breast around to the back on the left side; Raging headache; lymph nodes were swollen under both arms/ they were very swollen; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Raging headache), MALAISE (generally did not feel good), NAUSEA (got nauseous) and CHEST PAIN (she had pain radiating from under her breast around to the back on the left side) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 045A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pulmonary embolism (history of a pulmonary embolism reaction 8 years ago.) in 2013. Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN, ATORVASTATIN and ANASTROZOLE for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Raging headache) (seriousness criterion hospitalization). On 02-Nov-2021, the patient experienced MALAISE (generally did not feel good) (seriousness criterion hospitalization), NAUSEA (got nauseous) (seriousness criterion hospitalization) and CHEST PAIN (she had pain radiating from under her breast around to the back on the left side) (seriousness criterion hospitalization). On 03-Nov-2021, the patient experienced LYMPHADENOPATHY (lymph nodes were swollen under both arms/ they were very swollen). The patient was hospitalized on 02-Nov-2021 due to CHEST PAIN, HEADACHE, MALAISE and NAUSEA. At the time of the report, HEADACHE (Raging headache), MALAISE (generally did not feel good), NAUSEA (got nauseous), CHEST PAIN (she had pain radiating from under her breast around to the back on the left side) and LYMPHADENOPATHY (lymph nodes were swollen under both arms/ they were very swollen) outcome was unknown.            Concomitant medications include medications for cholesterol and high blood pressure. Patient states that had tests performed, but no name or results were provided. Treatment received include preventative shot for blood thinner in case it was "heart attack."  Company comment:  This spontaneous case concerns a 70-year-old female patient, with history of pulmonary embolism in 2013 and hypertension, who experienced the serious (hospitalization) unexpected events of: HEADACHE, MALAISE, NAUSEA and CHEST PAIN. The events of headache and malaise occurred 2 days after receiving a booster dose of mRNA-1273. The other reported events occurred 3 days after receiving a booster dose of mRNA-1273. Patient was hospitalized 3 days after receiving the booster dose, and limited information regarding hospitalization, diagnoses, course and treatment were provided. However, it is known that patient spent one night in the hospital, that unspecified tests were performed and that she received a "shot of blood thinner in case it was a heart attack". Patient's history of pulmonary embolism and hypertension remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70-year-old female patient, with history of pulmonary embolism in 2013 and hypertension, who experienced the serious (hospitalization) unexpected events of: HEADACHE, MALAISE, NAUSEA and CHEST PAIN. The events of headache and malaise occurred 2 days after receiving a booster dose of mRNA-1273. The other reported events occurred 3 days after receiving a booster dose of mRNA-1273. Patient was hospitalized 3 days after receiving the booster dose, and limited information regarding hospitalization, diagnoses, course and treatment were provided. However, it is known that patient spent one night in the hospital, that unspecified tests were performed and that she received a "shot of blood thinner in case it was a heart attack". Patient's history of pulmonary embolism and hypertension remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.