Age: 80.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive on a Rapid Antigen Home test/ worse cough/ Sneezing/ general malaise/ Swollen glands; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive on a Rapid Antigen Home test/ worse cough/ Sneezing/ general malaise/ Swollen glands) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049LZ1, 012F21A, O22M20A and OO7M20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Product used for unknown indication: Creon. Past adverse reactions to the above products included Allergy NOS with Creon. Concurrent medical conditions included Osteopenia, Hiatal hernia and Depression. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.   On 29-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022 at 8:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 30-May-2022, the patient experienced COVID-19 (tested positive on a Rapid Antigen Home test/ worse cough/ Sneezing/ general malaise/ Swollen glands). At the time of the report, COVID-19 (tested positive on a Rapid Antigen Home test/ worse cough/ Sneezing/ general malaise/ Swollen glands) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 30-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that patient had taken other medications/products within 2 weeks of starting COVID-19 treatment.  On 27-May-2022 5 days after finishing the medication, the patient tested negative for Covid-19 and symptoms were resolving.  No treatment medications were reported.  CC: This spontaneous case concerns an 80 year-old female patient, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred 19 days after the fourth dose of mRNA-1273 vaccine administration. Five days after finishing the treatment course of Paxlovid, the patient tested negative for Covid-19 and symptoms were resolving. However patient reported worse cough, sneezing, swollen glands and general malaise and tested positive on a Rapid Antigen Home test  eight days after finishing the treatment course of Paxlovid.. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an 80 year-old female patient, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19,  which occurred 19 days after the fourth dose of mRNA-1273 vaccine administration. Five days after finishing the treatment course of Paxlovid, the patient tested negative for Covid-19 and symptoms were resolving. However patient reported worse cough, sneezing, swollen glands and general malaise and tested positive on a Rapid Antigen Home test  eight days after finishing the treatment course of Paxlovid.. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.