Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19/ Night sweats/ pain/ rhinorrhea/ throat irritation/ illness/ myalgia/ pyrexia/ headache; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19/ Night sweats/ pain/ rhinorrhea/ throat irritation/ illness/ myalgia/ pyrexia/ headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 026L20A and 026L20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    The patient's past medical history included Pacemaker syndrome (Pacemaker Passed out and pulse got down to 32) on 12-Jun-2017 and Sick sinus syndrome (had sick sinus syndrome, ultimate diagnosis) on 12-Jun-2017. Concurrent medical conditions included Obesity (Obesity Confirmed weight loss of 80 pounds was before Paxlovid). Concomitant products included VITAMIN B [VITAMIN B NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) three tabs in the morning and three tabs at night. On 12-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19/ Night sweats/ pain/ rhinorrhea/ throat irritation/ illness/ myalgia/ pyrexia/ headache). The last dose administered for NIRMATRELVIR, RITONAVIR (PAXLOVID) was on 17-Jul-2022. At the time of the report, COVID-19 (Covid-19/ Night sweats/ pain/ rhinorrhea/ throat irritation/ illness/ myalgia/ pyrexia/ headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         No treatment medications were reported.  Company comment: This spontaneous case concerns a 66 year old male patient with multiple comorbidities of pacemaker syndrome, sick sinus syndrome and obesity who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred approximately 8 months 3 days after receiving the third dose of mRNA1273. The patient tested positive for SARS-COV2-test at approximately 8 months post vaccination, he also stated that this was the start of his symptoms. The patient had fever, he also described that his throat was like on fire, had night sweats, runny nose and headache. The patient was treated with Nirmatrelvir and Ritonavir (Paxlovid) for 5 days at an unspecified dose and frequency. 6 days after completion of treatment the patient felt sudden onset of symptoms, he self tested with COVID-19 test kit and he was positive. The patient contacted his HCP and claimed that he had rebound of the disease but this time its milder compared to the previous illness. The patient was prescribed to add vitamin C to his daily regimen of medications. Further details regarding diagnostic test/imaging studies done on the patient were not provided. The patients elderly age and underlying medical history of pacemaker use and obesity may be considered as risk factors for COVID-19. The ongoing pandemic of COVID-19 remains as a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-618090, MOD-2022-618142 (Patient Link).; Sender's Comments: This spontaneous case concerns a 66 year old male patient with multiple comorbidities of pacemaker syndrome, sick sinus syndrome and obesity who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred approximately 8 months 3 days after receiving the third dose of mRNA1273. The patient tested positive for SARS-COV2-test at approximately 8 months post vaccination, he also stated that this was the start of his symptoms. The patient had fever, he also described that his throat was like on fire, had night sweats, runny nose and headache. The patient was treated with Nirmatrelvir and Ritonavir (Paxlovid) for 5 days at an unspecified dose and frequency. 6 days after completion of treatment the patient felt sudden onset of symptoms, he self tested with COVID-19 test kit and he was positive. The patient contacted his HCP and claimed that he had rebound of the disease but this time its milder compared to the previous illness. The patient was prescribed to add vitamin C to his daily regimen of medications. Further details regarding diagnostic test/imaging studies done on the patient were not provided. The patients elderly age and underlying medical history of pacemaker use and obesity may be considered as risk factors for COVID-19. The ongoing pandemic of COVID-19 remains as a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.