Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Patient received a dose of Janssen COVID-19 vaccine prior to mRNA-1273 vaccination; Initial COVID-19 infection prior to Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) and INTERCHANGE OF VACCINE PRODUCTS (Patient received a dose of Janssen COVID-19 vaccine prior to mRNA-1273 vaccination) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J212A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson (Dose Number: 1, Batch/Lot No: 1805020, Location of injection: Arm Left and Vaccine Administration Time: 02:00 PM) on 10-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson. Concurrent medical conditions included Ankylosing spondylitis. Concomitant products included INDOMETHACIN [INDOMETACIN], LISINOPRIL, OMEPRAZOLE, VITAMIN D3 and GINKGO BILOBA for an unknown indication.    On 12-Jan-2022 at 4:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received a dose of Janssen COVID-19 vaccine prior to mRNA-1273 vaccination). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) and INTERCHANGE OF VACCINE PRODUCTS (Patient received a dose of Janssen COVID-19 vaccine prior to mRNA-1273 vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         The patient did not receive any treatments for the events slight congestion and slight runny nose.  Company Comment:  This is a spontaneous case concerning a 57-year-old male patient with no relevant medical history reported, who experienced unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, which occurred approximately 4 months after receiving a dose of mRNA-1273 as booster dose of COVID-19 vaccine. Patient had received a dose of Janssen COVID-19 vaccine with no reported adverse event, approximately 10 months prior to mRNA-1273 vaccination (Interchange of vaccine products). Patient had a five-day course of Paxlovid treatment for the initial COVID-19 infection. However, 7 days after Paxlovid treatment, patient experienced slight nasal congestion and slight runny nose. Outcome of the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 57-year-old male patient with no relevant medical history reported, who experienced unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, which occurred approximately 4 months after receiving a dose of mRNA-1273 as booster dose of COVID-19 vaccine. Patient had received a dose of Janssen COVID-19 vaccine with no reported adverse event, approximately 10 months prior to mRNA-1273 vaccination (Interchange of vaccine products). Patient had a five-day course of Paxlovid treatment for the initial COVID-19 infection. However, 7 days after Paxlovid treatment, patient experienced slight nasal congestion and slight runny nose. Outcome of the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.