Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033k21-2a, 0JJC21A, 024M20A and 025L20A) for COVID-19 vaccination. The patient had reported medical history as only minor. Concurrent medical conditions included Sulfonamide allergy (Sulfa medication). On 22-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-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. In May 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 29-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative after sixth day. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. The patient was not taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had completed a five day course of Paxlovid started after the second day of symptoms. The only side effects of medication were diarrhea and metallic taste. Patient had tested negative after sixth day. Seven days after completing Paxlovid patient woke up with headache nasal congestion and cough. Patient had retested and had a positive test again on 05-Jun-2022 at 06:00. Device Date was reported as 06-Jun-2022. Company Comment: This spontaneous case concerns a 66-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious AESI Covid-19 around 1½ months after receiving a fourth dose of mRNA-1273. She was treated with Nirmatrelvir/Ritonavir (Paxlovid) then tested negative.  However, approximately 7 days after Paxlovid completion, she had headache, nasal congestion, and cough; and tested positive again for Covid-19. The ongoing Covid-19 pandemic could be a contributory factor. The benefit risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 66-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious AESI Covid-19 around 1½ months after receiving a fourth dose of mRNA-1273. She was treated with Nirmatrelvir/Ritonavir (Paxlovid) then tested negative. However, approximately 7 days after Paxlovid completion, she had headache, nasal congestion, and cough; and tested positive again for Covid-19. The ongoing Covid-19 pandemic could be a contributory factor. The benefit risk relationship of mRNA-1273 is not affected by this report.