Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fall, Fatigue, Feeling abnormal
Clinical narrative: COVID-19 like symptoms; can't walk; still gets tired; short of breath; fell three times at work; didn't feel good at all/ feeling bad/felt "deflated"; no strength; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID-19 like symptoms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (mild case of COVID-19 infection) on 15-Aug-2020 and Difficulty breathing (many years ago he breathed in chemicals from a crop duster and was hospitalized due to breathing problems). Concomitant products included ATORVASTATIN for High cholesterol, TEMAZEPAM for Sleep disorder, Aspirin 325 mg and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FALL (fell three times at work), FEELING ABNORMAL (didn't feel good at all/ feeling bad/felt "deflated") and ASTHENIA (no strength). On 06-Mar-2021, the patient experienced SUSPECTED COVID-19 (COVID-19 like symptoms) (seriousness criterion hospitalization). On 22-Jun-2021, the patient experienced DYSPNOEA (short of breath) and FATIGUE (still gets tired). On an unknown date, the patient experienced GAIT INABILITY (can't walk). The patient was hospitalized from 11-Mar-2021 to 22-Mar-2021 due to SUSPECTED COVID-19. The patient was treated with Rehabilitation therapy for Suspected COVID-19. At the time of the report, SUSPECTED COVID-19 (COVID-19 like symptoms), FALL (fell three times at work), FEELING ABNORMAL (didn't feel good at all/ feeling bad/felt "deflated"), DYSPNOEA (short of breath), GAIT INABILITY (can't walk) and FATIGUE (still gets tired) outcome was unknown and ASTHENIA (no strength) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.         Patient was in the rehab facility, every morning he was given a shot in the abdominal wall for use as a blood thinner. While in the hospital, he had to use a wheelchair initially, then a walker and then a cane. He stated that the second Moderna vaccine had put him in the hospital. On 22Jun2021, he was back to 70% energy. He reported he still gets tired, and short of breath, and could not walk as well as he used to, so he was using a cane.  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: Based on the mechanism of action of mRNA-1273, a causal association between the event of suspected COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.; Sender's Comments: Based on the mechanism of action of mRNA-1273, a causal association between the event of suspected COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.