Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Blood glucose, Blood glucose decreased
Clinical narrative: COVID-19/ tested positive for Covid-19; loss of taste; loss of smell; loss of appetite; loss control of bladder; extreme weakness; Blood sugar decreased; Diarrhea; Vomiting; Nausea; fatigue/ tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19/ tested positive for Covid-19) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leg amputation. Concurrent medical conditions included Diabetes mellitus, Atrial fibrillation and Hypothyroidism. Concomitant products included INSULIN ASPART (NOVOLOG) and METFORMIN for Diabetes, LEVOTHYROXINE for Hypothyroidism, METHOTREXATE, VERAPAMIL, HCTZ, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), SULFASALAZINE, ACETYLSALICYLIC ACID (ASPIRIN 81), FOLIC ACID and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced AGEUSIA (loss of taste), ANOSMIA (loss of smell), DECREASED APPETITE (loss of appetite), URINARY INCONTINENCE (loss control of bladder), ASTHENIA (extreme weakness), BLOOD GLUCOSE DECREASED (Blood sugar decreased), DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea) and FATIGUE (fatigue/ tiredness). On 16-Apr-2021, the patient experienced COVID-19 (COVID-19/ tested positive for Covid-19) (seriousness criterion hospitalization prolonged). The patient was treated with OXYGEN at a dose of 2 liter and DEXAMETHASONE at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/ tested positive for Covid-19), AGEUSIA (loss of taste), ANOSMIA (loss of smell), DECREASED APPETITE (loss of appetite), URINARY INCONTINENCE (loss control of bladder), ASTHENIA (extreme weakness), BLOOD GLUCOSE DECREASED (Blood sugar decreased), DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea) and FATIGUE (fatigue/ tiredness) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood glucose: unknown (Inconclusive) blood sugar levels tumble. On 16-Apr-2021, SARS-CoV-2 antibody test: unknown (Positive) Tested positive for Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is due for his second dose i.e on 19apr2021.  Company Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely for the vaccine and likely due to the COVID-19 infection.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely for the vaccine and likely due to the COVID-19 infection.