Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19/fever/Stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19/fever/Stomach ache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hypercholesterolaemia. Concomitant products included SIMVASTATIN for Hypercholesteraemia, LISINOPRIL for Hypertension, ACETYLSALICYLIC ACID (ASPIRINE), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and MONASCUS PURPUREUS, SILYBUM MARIANUM (RED YEAST PLUS) for an unknown indication.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2022, the patient experienced COVID-19 (tested positive for COVID-19/fever/Stomach ache). In January 2022, COVID-19 (tested positive for COVID-19/fever/Stomach ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         Caller stated that the patient started Lisinopril and Simvastatin a year apart as patient's health was not good until patient started gaining weight from a couple of years. Caller believed that the patient started Simvastatin last year or the end of the year before. Caller also stated that the patient was having red yeast as doctor told him and was taking for long time. Caller was not sure about the vaccination dates and stated that the first dose may be on 01-May-2021. It was reported that the patient recovered fast and was not having any cough or other symptoms. It was also reported that patient did not received any treatment other than good food and rest.  No treatment medication information was given. Company Comment: This is a Spontaneous case concerning a 58-year-old male patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as tested positive for COVID-19/fever/Stomach ache). The event occurred approximately 7 months after the administration of the second dose of the mRNA-1273 vaccine in a correct dose interval between two primary doses, although no booster dose was detailed in this case. Relevant tests were performed: Rapid testing positive for COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious.; Sender's Comments: This is a Spontaneous case concerning a 58-year-old male patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as tested positive for COVID-19/fever/Stomach ache). The event occurred approximately 7 months after the administration of the second dose of the mRNA-1273 vaccine in a correct dose interval between two primary doses, although no booster dose was detailed in this case. Relevant tests were performed: Rapid testing positive for COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious.