Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068421A, 012F21A, 030M20A and 013L20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Sulfonamide allergy (Bactrim). Concomitant products included ATORVASTATIN from an unknown date to 06-May-2022, AMLODIPINE from an unknown date to 06-May-2022, TAMSULOSIN from an unknown date to 05-May-2022, CYANOCOBALAMIN (VITAMIN B-12) from an unknown date to 05-May-2022, UBIDECARENONE (CO Q10) from an unknown date to 05-May-2022 and DHEA from an unknown date to 05-May-2022 for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022 at 12:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 15-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: negative (Negative) Antigen test was Negative. On 15-May-2022, SARS-CoV-2 test: positive (Positive) positive and also on the next two days..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stopped Paxlovid after morning dose on May 11, 2022. Antigen test was negative on May 12th. Next test on May 15 was positive and also on the next two days. Symptoms of stuffy nose that diminished when taking Paxlovid returned. Patient still had symptoms today (5/18). Had no fever ever. Patient was tired but not limiting activity though only take wa ks.  Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The device date was reported as 18-May-2022  Company comment-This spontaneous case concerns an elderly male patient aged 78 years, with no relevant medical history reported, who experienced the non-serious unexpected ADR of COVID-19 approximately 44 days after fourth dose of mRNA-1273 vaccine. Patient had received all Moderna vaccines,1st dose on 15th Jan 2021, 2nd dose on 16th Feb 2021, and 3rd dose on 25th October 2021. Time interval between 1st and 2nd dose was 32 days. Patient was being treated with Paxlovid (NIRMATRELVIR, RITONAVIR) for Covid from 6th to 11th May2022, Covid antigen test done next day on 12th May 2022 was negative. Symptoms of stuffy nose recurred with a positive SARS-CoV-2 test after 3 days (15th May 2022), symptoms continued with no fever. Outcome of the event was not resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder and elderly age as risk factor to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly male patient aged 78 years, with no relevant medical history reported, who experienced the non-serious unexpected ADR of COVID-19 approximately 44 days after fourth dose of mRNA-1273 vaccine. Patient had received all Moderna vaccines,1st dose on 15th Jan 2021, 2nd dose on 16th Feb 2021, and 3rd dose on 25th October 2021. Time interval between 1st and 2nd dose was 32 days. Patient was being treated with Paxlovid (NIRMATRELVIR, RITONAVIR) for Covid from 6th to 11th May2022, Covid antigen test done next day on 12th May 2022 was negative. Symptoms of stuffy nose recurred with a positive SARS-CoV-2 test after 3 days (15th May 2022), symptoms continued with no fever. Outcome of the event was not resolved at the time of report. The current pandemic situation of COVID 19 may remain as confounder and elderly age as risk factor to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.