Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNEA (shortness of breath), COVID-19 (tested positive yesterday with COVID), PAIN (mild body aches), PRODUCTIVE COUGH (productive cough with some green phlegm) and PAIN (severe body aches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 1097K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (symptoms lasted for 2 weeks) in December 2020. Concomitant products included METFORMIN, DULOXETINE HYDROCHLORIDE (CYMBALTA), GLIPIZIDE and LOSARTAN for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (mild body aches) and PYREXIA (felt feverish and that lasted for one day). On 26-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), PRODUCTIVE COUGH (productive cough with some green phlegm), PAIN (severe body aches), FEELING ABNORMAL (Could not lie flat), DYSPHAGIA (couldn't swallow), DECREASED APPETITE (decrease in appetite), PYREXIA (feeling feverish) and FATIGUE (was in bed all of Saturday and Sunday). On 29-Mar-2021, the patient experienced COVID-19 (tested positive yesterday with COVID). 29-Mar-2021, the patient experienced DIARRHOEA (some diarrhea). 29-Mar-2021, the patient experienced DRUG INEFFECTIVE (lack of drug effect). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (some sore throat today). The patient was treated with IBUPROFEN at a dose of 800 mg and PARACETAMOL (TYLENOL) at a dose of 1000 mg. On 14-Feb-2021, PAIN (mild body aches) and PYREXIA (felt feverish and that lasted for one day) had resolved. On 29-Mar-2021, DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. At the time of the report, DYSPNOEA (shortness of breath), COVID-19 (tested positive yesterday with COVID), PRODUCTIVE COUGH (productive cough with some green phlegm), PAIN (severe body aches), FEELING ABNORMAL (Could not lie flat), DIARRHOEA (some diarrhea), DYSPHAGIA (couldn't swallow), DECREASED APPETITE (decrease in appetite), OROPHARYNGEAL PAIN (some sore throat today), PYREXIA (feeling feverish) and FATIGUE (was in bed all of Saturday and Sunday) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related. The other events are in consistence with COVID-19. The event of drug ineffective is assessed as possible. Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Upon internal review on 14 Jul 2021, an event (lack of efficacy) was added at Moderna's request.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related. The other events are in consistence with COVID-19. The event of drug ineffective is assessed as possible.