Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Recurrence of Covid positive test after a negative test four days prior; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Recurrence of Covid positive test after a negative test four days prior) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     The patient had previously received a COVID-19 vaccine. The patient had no drug allergy.  Concurrent medical conditions included Cholesterol high and Drug allergy. Concomitant products included SIMVASTATIN from 01-Feb-1997 to 19-May-2022 for an unknown indication.   On 16-Nov-2021 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2022 at 12:00 PM, received fourth 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 (Recurrence of Covid positive test after a negative test four days prior). At the time of the report, COVID-19 (Recurrence of Covid positive test after a negative test four days prior) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 antibody test: negative (Negative) Negative. On 29-May-2022, SARS-CoV-2 antibody test: positive (Positive) Positive.         Concomitant medication also included statin for cholesterol. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient was treated with Pfizer medication from 19-May-2022 to 23-May-2022 for COVID-19. The patient was tested positive for COVID-19 on 29-May-2022 after having a negative COVID-19 test 4 days prior. Device date was reported as 01-Jun-2022.  Company Comment: This spontaneous case concerns a 64-year-old, male patient, with no relevant medical history reported, who experienced an unexpected, non-serious AESI COVID-19 in association with a 4th dose of mRNA-1273 vaccine. A 3rd dose of mRNA-1273 vaccine was given approximately 5 months before receiving his 4th dose. Patient started a 5-day Pfizer's COVID-19 treatment regimen that started 40 days post-vaccination with his 4th dose of mRNA-1273 vaccine. Patient tested negative after his COVID-19 treatment. A positive COVID-19 test recurred 4 days later. Event outcome of COVID-19 was reported as not resolved. Further details on the medical history, clinical course, diagnostics, and treatment were not reported. Age-related immune system changes could predispose the patient to COVID-19. 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 64-year-old, male patient, with no relevant medical history reported, who experienced an unexpected, non-serious AESI COVID-19 in association with a 4th dose of mRNA-1273 vaccine. A 3rd dose of mRNA-1273 vaccine was given approximately 5 months before receiving his 4th dose. Patient started a 5-day Pfizer's COVID-19 treatment regimen that started 40 days post-vaccination with his 4th dose of mRNA-1273 vaccine. Patient tested negative after his COVID-19 treatment. A positive COVID-19 test recurred 4 days later. Event outcome of COVID-19 was reported as not resolved. Further details on the medical history, clinical course, diagnostics, and treatment were not reported. Age-related immune system changes could predispose the patient to COVID-19. 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.