Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Resurgent COVID symptoms 5/24/21 with positive home antigen test 5/25/21; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Resurgent COVID symptoms 5/24/21 with positive home antigen test 5/25/21) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Coronary artery disease (L-transposition) and Heart block third degree. Previously administered products included for Drug use for unknown indication: Penicillin. Past adverse reactions to the above products included Allergy with Penicillin. Concurrent medical conditions included Congestive heart failure (CHF), Gout, Factor V Leiden heterozygote, Artificial cardiac pacemaker user (Pacer dependent) and Major depressive disorder (MDD). Concomitant products included ALLOPURINOL, METOPROLOL, DABIGATRAN ETEXILATE MESILATE (PRADAXA), EPLERENONE, BUPROPION, MAGNESIUM OXIDE, VITAMIN D3, VITAMIN C [ASCORBIC ACID] and VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]) for an unknown indication.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Resurgent COVID symptoms 5/24/21 with positive home antigen test 5/25/21). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Resurgent COVID symptoms 5/24/21 with positive home antigen test 5/25/21) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     Concomitant medication information included the patient took vitamin b complex (medicinal product name: Super B-Complex).  Company comment: This spontaneous case concerns a 54-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Resurgent COVID symptoms 5/24/21 with positive home antigen test 5/25/21). The event exact occurrence was unknown with respect to the third dose of mRNA-1273 vaccine administration. However, it was stated that the patient took Nirmatrelvir + Ritonavir (Paxlovid) approximately 6 months 12 days after the third dose of mRNA-1273 vaccine administration for treatment of Covid-19.SARS-CoV-2 test was positive as on 25-May-2021. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 54-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Resurgent COVID symptoms 5/24/21 with positive home antigen test 5/25/21). The event exact occurrence was unknown with respect to the third dose of mRNA-1273 vaccine administration. However, it was stated that the patient took Nirmatrelvir + Ritonavir (Paxlovid) approximately 6 months 12 days after the third dose of mRNA-1273 vaccine administration for treatment of Covid-19.SARS-CoV-2 test was positive as on 25-May-2021. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.