Age: 35.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive and developed minor symptoms; A few days after the course, he started testing positive and Covid again; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive and developed minor symptoms) and COVID-19 (A few days after the course, he started testing positive and Covid again) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Drug use for unknown indication: Pfizer/BioNTech (Dose Number: 3 Batch/Lot No: Unknown. Location of injection: Arm Left.) on 14-Feb-2021 and Pfizer/BioNTech. Past adverse reactions to the above products included No adverse event with Pfizer/BioNTech and Pfizer/BioNTech. Concurrent medical conditions included Asthma and Drug allergy (Allergy to unknown drug).   On 26-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) UNK, took all 10 doses. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive and developed minor symptoms). In May 2022, the patient experienced COVID-19 (A few days after the course, he started testing positive and Covid again). In May 2022, COVID-19 (Tested positive and developed minor symptoms) had resolved. At the time of the report, COVID-19 (A few days after the course, he started testing positive and Covid again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: testing positive and covid again (Positive) testing positive and Covid again. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive and negative (Negative) Negative.         No concomitant medications were reported. It was reported that patient was vaccinated with (2 Pfizer) and boosted (Moderna). He tested positive and developed minor symptoms. That night he started Paxlovid and took all 10 doses. During the course he felt fine and tested negative on rapid tests. A few days after the course he started testing positive and Covid again. Patient was isolating so it was unlikely that he was reinfected. Symptoms developed . It was confirmed that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient had previously received a COVID-19 Vaccine. No treatment information was reported.  Company comment: This spontaneous case concerns a patient of a 35-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19. The date of mRNA-1273 booster vaccination was reported with no onset date; hence latency cannot be assessed. Previously he received 2 doses of Pfizer/BioNTech vaccine (Interchange of vaccine products). As per narrative of the source document, he tested positive and developed minor symptoms and took 10 doses of Paxlovid (ritonavir) as treatment. During the course he felt fine and tested negative on rapid tests, but a few days later he reported testing positive and COVID-19 again. He stated he was isolating, and it was unlikely to be reinfected. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of a 35-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19. The date of mRNA-1273 booster vaccination was reported with no onset date; hence latency cannot be assessed. Previously he received 2 doses of Pfizer/BioNTech vaccine (Interchange of vaccine products). As per narrative of the source document, he tested positive and developed minor symptoms and took 10 doses of Paxlovid (ritonavir) as treatment. During the course he felt fine and tested negative on rapid tests, but a few days later he reported testing positive and COVID-19 again. He stated he was isolating, and it was unlikely to be reinfected. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.