Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Jaundice, Peripheral ischaemia, Renal disorder, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19), JAUNDICE (Jaundice), PERIPHERAL ISCHAEMIA (Limb ischemia), VASCULITIS (vasculitis) and RENAL DISORDER (Had other problem with renal but not specified) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 939905, 030A21A and 010M20A) for COVID-19 prophylaxis. Concurrent medical conditions included Hypertension and Non-smoker. Concomitant products included HYDROCHLOROTHIAZIDE, OLMESARTAN, ATORVASTATIN CALCIUM (LIPITOR) and VITAMIN D3 for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jul-2022, the patient experienced JAUNDICE (Jaundice), PERIPHERAL ISCHAEMIA (Limb ischemia), VASCULITIS (vasculitis) and RENAL DISORDER (Had other problem with renal but not specified). On 04-Jul-2022, the patient experienced COVID-19 (COVID-19). In July 2022, COVID-19 (COVID-19) had resolved. At the time of the report, JAUNDICE (Jaundice), PERIPHERAL ISCHAEMIA (Limb ischemia), VASCULITIS (vasculitis) and RENAL DISORDER (Had other problem with renal but not specified) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2022, SARS-CoV-2 test: (Positive) Positive. In July 2022, SARS-CoV-2 test: (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of Covid-19 vaccination. The Moderna covid-19 vaccine administered in deltoid muscle. On 03-Jul-2022 patient had symptoms as cough, headache and congestion. It was reported that it took 6 days before the SARS-CoV2 antigen test became negative from diagnosis. It was unknown whether patient had pre-existing diseases worsened during the SARS CoV2 infection. It was unknown if the patient had SARS-CoV2 antibodies at diagnosis. Patient did not display clinical signs at rest indicative of severe systemic illness and multiorgan failure. Patient did not require hospitalization and supplemental oxygen. The events did not require initiation of new medication or other treatment or procedure. Company comment: This spontaneous case concerns a 68-year-old, male patient with current medical history of Hypertension, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 75 days after the administration of fourth dose of mRNA-1273, the third dose of mRNA-1273 was administered approximately 5 months prior, the initial two doses of mRNA-1273 were administered approximately 8 months prior to the third dose, the interval between the two doses is 28 days. It has been reported that the patient had cough, headache and nasal congestion. Details of clinical course and treatment were not provided. The event has resolved at the time of the report. The patient's current medical history of Hypertension could be a confounder to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 68-year-old, male patient with current medical history of Hypertension, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 75 days after the administration of fourth dose of mRNA-1273, the third dose of mRNA-1273 was administered approximately 5 months prior, the initial two doses of mRNA-1273 were administered approximately 8 months prior to the third dose, the interval between the two doses is 28 days. It has been reported that the patient had cough, headache and nasal congestion. Details of clinical course and treatment were not provided. The event has resolved at the time of the report. The patient's current medical history of Hypertension could be a confounder to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.