Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall, Pneumonia, SARS-CoV-2 test, Scan
Clinical narrative: pneumonia; weakness generalized; fall; This spontaneous case was reported by an other health care professional and describes the occurrence of PNEUMONIA (pneumonia) and ASTHENIA (weakness generalized) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product CORIANDRUM SATIVUM, FOENICULUM VULGARE, GLYCYRRHIZA GLABRA, MATRICARIA RECUTITA, VERBENA OFFICINALIS (INFUSION DIGESTION) for Merkel cell carcinoma.    The patient's past medical history included Pneumonia on 27-Feb-2020, Merkel cell carcinoma on 13-Jun-2018, Pneumonitis on 14-Feb-2021, Heart failure on 14-Feb-2021, Pneumonia from 02-Apr-2021 to 06-Apr-2021, Atrial fibrillation with rapid ventricular response from 02-Apr-2021 to 06-Apr-2021 and COVID-19 on 02-Apr-2021. Concurrent medical conditions included Congestive heart failure since 1992.   On 13-Feb-2020, the patient started CORIANDRUM SATIVUM, FOENICULUM VULGARE, GLYCYRRHIZA GLABRA, MATRICARIA RECUTITA, VERBENA OFFICINALIS (INFUSION DIGESTION) (Intravenous) 500 mg every four weeks. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, CORIANDRUM SATIVUM, FOENICULUM VULGARE, GLYCYRRHIZA GLABRA, MATRICARIA RECUTITA, VERBENA OFFICINALIS (INFUSION DIGESTION) (Intravenous) dosage was changed to 500 mg every four weeks. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, CORIANDRUM SATIVUM, FOENICULUM VULGARE, GLYCYRRHIZA GLABRA, MATRICARIA RECUTITA, VERBENA OFFICINALIS (INFUSION DIGESTION) (Intravenous) dosage was changed to 500 mg every four weeks. On 22-Apr-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and ASTHENIA (weakness generalized) (seriousness criterion hospitalization). 22-Apr-2021, the patient experienced FALL (fall). On 28-Apr-2021, ASTHENIA (weakness generalized) had resolved. At the time of the report, PNEUMONIA (pneumonia) had resolved and FALL (fall) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Scan: abnormal (abnormal) Patchy areas in lungs. On 02-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's medical history of pneumonia, pneumonitis, congestive heart failure and COVID-19 infection are confounders.   This case was linked to MOD-2021-276986 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's medical history of pneumonia, pneumonitis, congestive heart failure and COVID-19 infection are confounders.