Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nucleic acid test, SARS-CoV-2 test
Clinical narrative: Initial covid symptoms 5/10 (positive NAAT (Cue) test 5/11), started paxlovid on 5/11. Symptom free by 5/14/ Mild cold-like symptoms starting again 5/22, positive antigen test 5/23.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial covid symptoms 5/10 (positive NAAT (Cue) test 5/11), started paxlovid on 5/11. Symptom free by 5/14/ Mild cold-like symptoms starting again 5/22, positive antigen test 5/23.) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen (Dose No 1; Batch No 201A21A; Location Arm Left.) on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with Janssen. Concurrent medical conditions included Allergy. Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 16-May-2022 for COVID-19 treatment.    On 14-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, the patient experienced COVID-19 (Initial covid symptoms 5/10 (positive NAAT (Cue) test 5/11), started paxlovid on 5/11. Symptom free by 5/14/ Mild cold-like symptoms starting again 5/22, positive antigen test 5/23.). On 14-May-2022, COVID-19 (Initial covid symptoms 5/10 (positive NAAT (Cue) test 5/11), started paxlovid on 5/11. Symptom free by 5/14/ Mild cold-like symptoms starting again 5/22, positive antigen test 5/23.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, Nucleic acid test: positive (Positive) positive. On 20-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 23-May-2022, SARS-CoV-2 test: positive (Positive) positive.          No treatment information was reported.  The patient had initial COVID symptoms on 10-May. He was symptom free on 14-May. Mild cold-like symptoms started again on 22-May.  Company comment: This spontaneous case concerns a 44 year-old male patient, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred 178 days after a dose of mRNA-1273 vaccine administration, given as the second dose. Patient was previously vaccinated with a dose of Janssen COVID-19 vaccine, with no adverse events reported, 220 days prior to the administration of mRNA-1273 as second dose (Interchange of vaccine products). Patient was started on Paxlovid and was symptom-free after 3 days. Eight days later, mild cold-like symptoms were reported by the patient. Patient again test positive for Sars-CoV-2 the day after. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44 year-old male patient, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred 178 days after a dose of mRNA-1273 vaccine administration, given as the second dose. Patient was previously vaccinated with a dose of Janssen COVID-19 vaccine, with no adverse events reported, 220 days prior to the administration of mRNA-1273 as second dose (Interchange of vaccine products). Patient was started on Paxlovid and was symptom-free after 3 days. Eight days later, mild cold-like symptoms were reported by the patient. Patient again test positive for Sars-CoV-2 the day after. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.