Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, Product dose omission issue
Clinical narrative: At first they thought they had the flu but diagnosed with covid-19 / started getting very sick had Covid; feel extremely sick / started getting very sick had Covid; Patient never got the second dose/nevrer got the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (At first they thought they had the flu but diagnosed with covid-19 / started getting very sick had Covid) and MALAISE (feel extremely sick / started getting very sick had Covid) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus and Autoimmune disorder NOS.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced MALAISE (feel extremely sick / started getting very sick had Covid) (seriousness criterion hospitalization). On 23-Apr-2021, the patient experienced COVID-19 (At first they thought they had the flu but diagnosed with covid-19 / started getting very sick had Covid) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient never got the second dose/nevrer got the 2nd shot). The patient was hospitalized on 23-Apr-2021 due to COVID-19 and MALAISE. The patient was treated with REMDESIVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (At first they thought they had the flu but diagnosed with covid-19 / started getting very sick had Covid) and MALAISE (feel extremely sick / started getting very sick had Covid) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient never got the second dose/nevrer got the 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use information was not provided.   On 11Apr2021 the patient started to feel extremely sick for about 2 weeks. At first they thought they had the flu and took over the counter medication for that, then went to the hospital were they were diagnosed with covid-19 on the 23Apr2021 and was admitted for 7 days. Patient never got the second dose so they are inquiring whether they should get it now or start over the series.  This case concerns a 63-year-old female hospitalized with serious unexpected events of COVID-19 and malaise, and non-serious product dose omission issue. Event latency 7 days after first dose mRNA-1273. Treated with remdesivir. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Non-Significant follow up; Sender's Comments: This case concerns a 63-year-old female hospitalized with serious unexpected events of COVID-19 and malaise, and non-serious product dose omission issue. Event latency 7 days after first dose mRNA-1273. Treated with remdesivir. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.