Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 007B21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (The patient had food intolerants.).   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative. On 29-May-2022, SARS-CoV-2 test: positive (Positive) Back to positive with COVID.         No concomitant medications were provided by the reporter. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. On day six after taking five days of Paxlovid the patient tested negative and felt great until day three, days later, the patient then felt horrible with a sore throat very tired and stuffy nose and on day five after the patient finished the Paxlovid the patient felt sicker with a bad cough, stuffy runny nose so took a rapid test, and patient was back to positive with COVID. Device date was mentioned as 30-May-2022.  Company Comment: This spontaneous case concerns a 63-year-old, female patient with no relevant medical history reported, who experienced an unexpected, non-serious AESI COVID-19 in association with a 3rd dose of mRNA-1273 vaccine. Exact onset latency of the event COVID-19 cannot be determined with an unknown event onset date. A 2-dose primary series of mRNA-1273 vaccine was given at an interval of 10 days, and the last dose from that series was given approximately 7 months before receiving the 3rd dose of mRNA-1273 vaccine. A 5-day paxlovid treatment regimen started 6 months post-vaccination with a 3rd dose of mRNA-1273 vaccine. Patient felt great and tested negative with COVID-19 the next day after receiving her last dose of paxlovid. Patient felt horrible with a sore throat, tiredness, and stuffy nose 3 days later. Patient tested positive with COVID-19 five days after completing paxlovid treatment. Event COVID-19 has not resolved. Further details on the medical history, clinical course, diagnostics, and treatment were not reported. The natural course of SARS-CoV-2 may include a brief recurrence of symptoms in some patients which is independent of treatment with paxlovid and regardless of vaccination status. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.   This case was linked to MOD-2022-580235 (Patient Link).; Sender's Comments: This spontaneous case concerns a 63-year-old, female patient with no relevant medical history reported, who experienced an unexpected, non-serious AESI COVID-19 in association with a 3rd dose of mRNA-1273 vaccine. Exact onset latency of the event COVID-19 cannot be determined with an unknown event onset date. A 2-dose primary series of mRNA-1273 vaccine was given at an interval of 10 days, and the last dose from that series was given approximately 7 months before receiving the 3rd dose of mRNA-1273 vaccine. A 5-day paxlovid treatment regimen started 6 months post-vaccination with a 3rd dose of mRNA-1273 vaccine. Patient felt great and tested negative with COVID-19 the next day after receiving her last dose of paxlovid. Patient felt horrible with a sore throat, tiredness, and stuffy nose 3 days later. Patient tested positive with COVID-19 five days after completing paxlovid treatment. Event COVID-19 has not resolved. Further details on the medical history, clinical course, diagnostics, and treatment were not reported. The natural course of SARS-CoV-2 may include a brief recurrence of symptoms in some patients which is independent of treatment with paxlovid and regardless of vaccination status. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.