Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 3 | UT7695NA | IM / RA |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past; tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past; This spontaneous case was reported by a physician assistant and describes the occurrence of DRUG INEFFECTIVE (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) and COVID-19 (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UT7695NA) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Previously administered products included for COVID-19 prophylaxis: Moderna. Past adverse reactions to the above products included No adverse effect with Moderna. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRUG INEFFECTIVE (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) and COVID-19 (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past). At the time of the report, DRUG INEFFECTIVE (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) and COVID-19 (tested positive Covid by about 48 hours ago maybe a little less/ which I have taken in the past) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient was not allergic to any previous vaccination, medications, food or other products and had no other diagnosed illness/medical history/chronic health conditions. The patient did not receive any other vaccine on the same date as suspect vaccine. Patient was not taking any other medications within 2 weeks prior to the event onset nor received any other vaccines within 4 weeks prior to the first dose administration of the suspect vaccine. Event did not require emergency room visit nor physician's office visit. Infection from COVID occurred over a year after vaccination. There was no predisposing factor, and no culture analysis was performed and also no other relevant test(s) performed. No treatment was received for the adverse event.; Reporter's Comments: Company Comment: The benefit-risk relationship of product is not affected by this report.
Test Name: COVID-19 test; Test Result: Positive