Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid with the home antigen test; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid with the home antigen test) and DRUG INEFFECTIVE (Lack of drug effect) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 treatment: Paxlovid from 06-May-2022 to 11-May-2022; for Product used for unknown indication: Codine. Past adverse reactions to the above products included Allergy with Codine; and No adverse event with Paxlovid. Concurrent medical conditions included Type 2 diabetes mellitus, Primary biliary cholangitis and Diverticulitis. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METFORMIN, URSODIOL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 09-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021 at 7:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021 at 6:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022 at 4:00 PM, the patient experienced COVID-19 (Tested positive for Covid with the home antigen test) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for Covid with the home antigen test) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive for Covid with the home Antigen test..         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The Patient took full course of Paxlovid which started on 06-May-2022 until 11-May-2022 for the Treatment of COVID-19. The Patient started feeling better the following week. The Patient started getting very runny nose and headache on the 13-May-2022. The patient had full blown symptoms and started to feel a bit better. At the time of reporting, the patient still had very runny nose, aches and minor cough.   Company Comment: This spontaneous case of Drug ineffective, concerns a 69-year-old male patient, with a relevant medical history of Type 2 diabetes mellitus, Primary biliary cholangitis and Diverticulitis, who experienced the unexpected AESI of COVID-19. The event occurred approximately 15 months and 4 days after receiving primary and booster doses of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, however the patient had cold symptoms and tested positive again after 2 days of completing Paxlovid treatment. The outcome of the event was reported as unknown. The patient's medical history of Type 2 diabetes mellitus, Primary biliary cholangitis and Diverticulitis, 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 Drug ineffective, concerns a 69-year-old male patient, with a relevant medical history of Type 2 diabetes mellitus, Primary biliary cholangitis and Diverticulitis, who experienced the unexpected AESI of COVID-19. The event occurred approximately 15 months and 4 days after receiving primary and booster doses of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, however the patient had cold symptoms and tested positive again after 2 days of completing Paxlovid treatment. The outcome of the event was reported as unknown. The patient's medical history of Type 2 diabetes mellitus, Primary biliary cholangitis and Diverticulitis, remain as confounders for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.