Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed with / Tested positive for Covid-19; Diagnosed with / Tested positive for Covid-19; This spontaneous case was reported by a medical assistant and describes the occurrence of COVID-19 (Diagnosed with / Tested positive for Covid-19) and DRUG INEFFECTIVE (Diagnosed with / Tested positive for Covid-19) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 019B21A) for COVID-19 vaccination.     The patient had no allergies to medication, foods and other products. The patient had no acute illness at the time of vaccination and up to one month before.  Concurrent medical conditions included Hypertension and Hyperlipidemia since 04-Nov-2020. Concomitant products included CARVEDILOL PHOSPHATE, AMLODIPINE from 04-Nov-2020 to an unknown date and ATORVASTATIN from 04-Nov-2020 to an unknown date for an unknown indication.   On 22-Apr-2021 at 9:56 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-May-2021 at 4:02 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Jan-2022, the patient experienced COVID-19 (Diagnosed with / Tested positive for Covid-19) and DRUG INEFFECTIVE (Diagnosed with / Tested positive for Covid-19). At the time of the report, COVID-19 (Diagnosed with / Tested positive for Covid-19) and DRUG INEFFECTIVE (Diagnosed with / Tested positive for Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, SARS-CoV-2 test: positive Positive, rapid test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (Diagnosed with / Tested positive for Covid-19) and DRUG INEFFECTIVE (Diagnosed with / Tested positive for Covid-19) to be not related.    The event did not cause the patient to seek medical care. There are no other potential causes. The patient did not experience similar kind of event in past. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 58-year-old male patient, with a body mass index of 40.123 and relevant medical history of hypertension and hyperlipidaemia, who experienced the unexpected non-serious AESI of COVID-19, which occurred 7months and 15 days after receiving the 2nd dose of mRNA-1273 vaccine. It was reported that the patient had the two primary doses with Moderna mRNA-1273 vaccines at an interval of 28 days. Lack of efficacy was noted as an additional event. SARS-CoV-2 Rapid test was positive. Patient did not have any signs, symptoms, clinical course and treatment. The event did not cause the patient to seek medical care. The outcome of event was unknown. The medical history of hypertension, hyperlipidaemia and with body mass index of 40.123 along with the current COVID-19 pandemic remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2022-503639 (Patient Link).; Sender's Comments: This spontaneous case concerns a 58-year-old male patient, with a body mass index of 40.123 and relevant medical history of hypertension and hyperlipidaemia, who experienced the unexpected non-serious AESI of COVID-19, which occurred 7months and 15 days after receiving the 2nd dose of mRNA-1273 vaccine. It was reported that the patient had the two primary doses with Moderna mRNA-1273 vaccines at an interval of 28 days. Lack of efficacy was noted as an additional event. SARS-CoV-2 Rapid test was positive. Patient did not have any signs, symptoms, clinical course and treatment. The event did not cause the patient to seek medical care. The outcome of event was unknown. The medical history of hypertension, hyperlipidaemia and with body mass index of 40.123 along with the current COVID-19 pandemic remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.