Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Severe Acute Respiratory Syndrome (SARS).; Feeling congested; Felt sick; Weak; Sore throat; Breathing problems; Muscle weakness; Diarrhea; Gets very tired; Muscle soreness; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SEVERE ACUTE RESPIRATORY SYNDROME (Severe Acute Respiratory Syndrome (SARS).) and PULMONARY CONGESTION (Feeling congested) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 002821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PULMONARY CONGESTION (Feeling congested) (seriousness criterion medically significant), ILLNESS (Felt sick), ASTHENIA (Weak), OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Breathing problems), MUSCULAR WEAKNESS (Muscle weakness), DIARRHOEA (Diarrhea), FATIGUE (Gets very tired), MYALGIA (Muscle soreness) and VOMITING (Vomiting). On an unknown date, the patient experienced SEVERE ACUTE RESPIRATORY SYNDROME (Severe Acute Respiratory Syndrome (SARS).) (seriousness criterion medically significant). At the time of the report, SEVERE ACUTE RESPIRATORY SYNDROME (Severe Acute Respiratory Syndrome (SARS).), PULMONARY CONGESTION (Feeling congested), ILLNESS (Felt sick), ASTHENIA (Weak), OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Breathing problems), MUSCULAR WEAKNESS (Muscle weakness), DIARRHOEA (Diarrhea), FATIGUE (Gets very tired), MYALGIA (Muscle soreness) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: found out that she had Severe Acute Respiratory Syndrome (SARS) (abnormal). On an unknown date, SARS-CoV-2 test: (Negative) Negative.         Concomitant product use was not provided by the reporter. Treatment medication included unspecified antibiotic for congestion.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Company comment: Very limited information regarding these events have been provided at this time. No further information is expected. Based on the mechanism of action of mRNA-1273 the event Severe acute respiratory syndrome is unlikely related to the vaccine.       Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected. Based on the mechanism of action of mRNA-1273 the event Severe acute respiratory syndrome is unlikely related to the vaccine.