Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19, reoccurring Covid, tested positive a little over a week after testing negative on the 18th and 19th of May., 2022. Tested positive again May 27th, 2022) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z6DZ1A) for COVID-19 vaccination. Concurrent medical conditions included Asthma (mild) and Drug allergy (unknown drug). Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (DAYTIME COLD/FLU RELIEF) from 12-May-2022 to an unknown date for an unknown indication. On 10-Oct-2021 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2022, the patient experienced COVID-19 (COVID-19, reoccurring Covid, tested positive a little over a week after testing negative on the 18th and 19th of May 2022. Tested positive again May 27th, 2022). At the time of the report, COVID-19 (COVID-19, reoccurring Covid, tested positive a little over a week after testing negative on the 18th and 19th of May 2022. Tested positive again May 27th, 2022) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 19-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive. Patient's race was reported as Caucasian. Concomitant product reported was HEB Daytime Severe Cold and Flu. On 13-May-2022. the patient used Pfizer product for COVID-19 treatment. On 18-May 2022, the patient tested negative. The Pfizer product was discontinued on 18-May-2022. On 19-May-2022, the patient was again tested negative. On 27-May-2022, the patient experienced recurring COVID and was tested positive again. No information on treatment medications was reported. Company Comment: This spontaneous case concerns a 40-year-old, male patient with a concurrent condition of mild asthma, who experienced an unexpected, non-serious AESI COVID-19 in association with a 3rd dose of mRNA-1273 vaccine. A 5-day Pfizer's COVID-19 treatment regimen started approximately 7 months post-vaccination with a 3rd dose of mRNA-1273 vaccine. Patient tested negative with COVID-19 twice after completing Pfizer's COVID-19 treatment. A little over a week, patient retested positive with COVID-19. 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 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. Sender's Comments: This spontaneous case concerns a 40-year-old, male patient with a concurrent condition of mild asthma, who experienced an unexpected, non-serious AESI COVID-19 in association with a 3rd dose of mRNA-1273 vaccine. A 5-day Pfizer's COVID-19 treatment regimen started approximately 7 months post-vaccination with a 3rd dose of mRNA-1273 vaccine. Patient tested negative with COVID-19 twice after completing Pfizer's COVID-19 treatment. A little over a week, patient retested positive with COVID-19. 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 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.