Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (MODERNA BIVALENT)) | MODERNA | 6 | — | IM |
mild case of Covid (headache, fatigue and sore throat) after traveling in (withheld country) back in 09/2023; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (mild case of Covid (headache, fatigue and sore throat) after traveling in (withheld country) back in 09/2023) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1) in February 2021, Moderna COVID-19 vaccine (Dose 2) in March 2021, Moderna COVID-19 vaccine (Dose 3) in September 2021, Spikevax (Dose 4) in April 2022, Moderna COVID-19 Vaccine and Bivalent (Original and Omicron BA.4/BA.5) (Dose 5) in September 2022. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Spikevax. In April 2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In September 2023, the patient experienced COVID-19 (mild case of Covid (headache, fatigue and sore throat) after traveling in (withheld country) back in 09/2023). At the time of the report, COVID-19 (mild case of Covid (headache, fatigue and sore throat) after traveling in (withheld country) back in 09/2023) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2023, SARS-CoV-2 test: Positive. At the time of reporting, the patient was 78 years old and had no underlying medical conditions. No concomitant medication was reported. It was reported that the patient tested positive for COVID-19 in September 2023 after traveling in (withheld country). She had mild symptoms of headache, fatigue, and sore throat. The patient received Moderna immunizations in June 2024, September 2024 and the last being a Spikevax booster on 14-Aug-2025. No treatment information was provided.
Test Date: 202309; Test Name: COVID-19 test; Test Result: Positive