Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: On Day 5 had Lingering dry throat; On Day 9 had Congestion; On day 9 had Sinus pain; Tested positive and on day 8 started testing negative/ tested Extremely positive on Day 10; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive and on day 8 started testing negative/ tested Extremely positive on Day 10), DRY THROAT (On Day 5 had Lingering dry throat), NASAL CONGESTION (On Day 9 had Congestion) and SINUS PAIN (On day 9 had Sinus pain) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) 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: 1 Batch/Lot No: Ew0151 Location of injection: Arm Left Vaccine Administration Time: 01:00 PM) on 07-Apr-2021 and Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: Ea8736 Location of injection: Arm Left Vaccine Administration Time: 11:00 AM) on 30-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech.   On 11-Nov-2021 at 8:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 28-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive and on day 8 started testing negative/ tested Extremely positive on Day 10). In May 2022, the patient experienced DRY THROAT (On Day 5 had Lingering dry throat), NASAL CONGESTION (On Day 9 had Congestion) and SINUS PAIN (On day 9 had Sinus pain). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive and on day 8 started testing negative/ tested Extremely positive on Day 10) outcome was unknown and DRY THROAT (On Day 5 had Lingering dry throat), NASAL CONGESTION (On Day 9 had Congestion) and SINUS PAIN (On day 9 had Sinus pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2022, SARS-CoV-2 test: positive (Positive) the first day of my  positive test and ran the full series.. In May 2022, SARS-CoV-2 test: negative (Negative) started testing negative on day 8. and positive (Positive) tested extremely positively on day 10.         No concomitant medications was reported.  It was reported as, the patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. on 28-Apr-2022 the patient was tested positive and on same day patient took Paxlovid and by day 5 did not had any symptoms and on day 8 patient was tested negative. On day 9 patient had congestion and sinus pain and patient tested extremely positively on Day 10.  The causality of the events with co-suspect Paxlovid was not provided.  Company comment: This spontaneous case concerns a 31-year-old male patient with history of interchange of vaccine products, who experienced the unexpected non-serous, SARS-CoV-2 test positive, 168 days after receiving a dose of mRNA-1273 vaccine (taken as 3rd dose). The patient experienced the non-serious symptoms Dry throat, Nasal congestion and Sinus pain and had a positive test on two occasions on 8th and 10th days. He was started on NIRMATRELVIR, RITONAVIR (PAXLOVID). Details of clinical course and investigation reports (imaging) were not provided. The outcome was reported as unknown. Approximately a month later, he was tested negative for Covid-19. Eight months prior to the Moderna dose, the patient had taken two doses of Pfizer / BioNTech Covid 19 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 31-year-old male patient with history of interchange of vaccine products, who experienced the unexpected non-serous , SARS-CoV-2 test positive, 168 days after receiving a dose of mRNA-1273 vaccine (taken as 3rd dose). The patient experienced the non-serious symptoms Dry throat, Nasal congestion and Sinus pain and had a positive test on two occasions on 8th and 10th days. He was started on NIRMATRELVIR, RITONAVIR (PAXLOVID). Details of clinical course and investigation reports (imaging) were not provided. The outcome was reported as unknown. Approximately a month later, he was tested negative for Covid-19. Eight months prior to the Moderna dose, the patient had taken two doses of Pfizer / BioNTech Covid 19 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.