Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound Covid 19 infection; Vaccination failure; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Rebound Covid 19 infection) and VACCINATION FAILURE (Vaccination failure) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 022C21A, 012M20A and 011L20A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Oxycodone. Past adverse reactions to the above products included Allergy with Oxycodone. Concurrent medical conditions included Hypothyroidism and Hypercholesterolemia.   On 02-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021 at 10:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022 at 10:00 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION FAILURE (Vaccination failure). On 24-May-2022 at 1:00 PM, the patient experienced COVID-19 (Rebound Covid 19 infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 12-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound Covid 19 infection) had not resolved and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment It was reported that patient was rebound with COVID-19 infection, 12 days after completing the 5 day Paxlovid treatment. Patient did not received any treatment. COMPANY COMMENT: This is an spontaneous case concerning a 71-years-old female patient with medical history of Allergy with Oxycodone, Concurrent medical conditions included Hypothyroidism and Hypercholesterolemia, Moderna COVID-19 Vaccine on 1 /2, 1/30, 11/4 of 2021 and 5/24/2022, PAXLOVID from 07-May-2022 to 12-May-2022 for COVID-19 treatment who experienced the unexpected AESI event of COVID-19 32 days after  4th  dose of  mRNA-1273 vaccine. On 24-May-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 71-years-old female patient with medical history of Allergy with Oxycodone, Concurrent medical conditions included Hypothyroidism and Hypercholesterolemia, Moderna COVID-19 Vaccine on 1 /2, 1/30, 11/4 of 2021 and 5/24/2022, PAXLOVID from 07-May-2022 to 12-May-2022 for COVID-19 treatment who experienced the unexpected AESI event of COVID-19 32 days after  4th  dose of  mRNA-1273 vaccine. On 24-May-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.