Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Interchange of vaccine products; Relapse of COVID symptoms on May 16 and positive antigen test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Relapse of COVID symptoms on May 16 and positive antigen test) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1  Batch/Lot No: EN6198  Location of injection: Arm Left  Vaccine Administration Time: 10:00 AM) on 01-Mar-2021, Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: ER8732  Location of injection: Arm Left  Vaccine Administration Time: 10:00 AM) on 30-Mar-2021 and Pfizer / BioNTech (Dose Number: 3  Batch/Lot No: EW0183  Location of injection: Arm Left  Vaccine Administration Time: 10:00 AM) on 05-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) and ATORVASTATIN for an unknown indication.    On 21-Apr-2022 at 10:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2022 at 9:00 PM, the patient experienced COVID-19 (Relapse of COVID symptoms on May 16 and positive antigen test). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (Relapse of COVID symptoms on May 16 and positive antigen test) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: negative (Negative) first negative test was May 9. Consecutive negative tests from May 9 to May 15 (including a negative molecule test ('detect hub') on May 15th. On 15-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 16-May-2022, SARS-CoV-2 test: positive (Positive) on May 16 positive antigen test. On 19-May-2022, SARS-CoV-2 test: positive (Positive) Still testing positive on May 19th.         It was reported that patient still testing positive on May 19th with nasal congestion as main symptom  Company Comment: This spontaneous case of Interchange of vaccine products, concerns a 64-year-old male patient, with previous vaccinations of Pfizer/BioNTech, who experienced the unexpected AESI of COVID-19. The event occurred approximately 25 days after receiving the fourth dose of mRNA-1273 Vaccine (Primary doses and 1 booster - Pfizer/Biontech). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for four days, however 8 days later, the patient had tested positive again for COVID-19. The outcome of the event was reported as not resolved. The patient's medical history of previous vaccinations of Pfizer/BioNTech vaccine, remain as confounders for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case of Interchange of vaccine products, concerns a 64-year-old male patient, with previous vaccinations of Pfizer/BioNTech, who experienced the unexpected AESI of COVID-19. The event occurred approximately 25 days after receiving the fourth dose of mRNA-1273 Vaccine (Primary doses and 1 booster - Pfizer/Biontech). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for four days, however 8 days later, the patient had tested positive again for COVID-19. The outcome of the event was reported as not resolved. The patient's medical history of previous vaccinations of Pfizer/BioNTech vaccine, remain as confounders for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.