Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she had symptoms and tested positive/could not sleep last night because she had the sore throat; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (she had symptoms and tested positive/could not sleep last night because she had the sore throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01F21A and GA8851) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In 2022, the patient experienced COVID-19 (she had symptoms and tested positive/could not sleep last night because she had the sore throat). At the time of the report, COVID-19 (she had symptoms and tested positive/could not sleep last night because she had the sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: positive positive.         Concomitant product use was not provided by the reporter. It was reported that, the patient took her second dose of Moderna on 26-Feb-2021 for which the lot number was provided as 023M20A or OZ3MZOA.   Reporter stated that they were both vaccinated and he came down with light cold and tested positive. Stated that a day or so ago that she had symptoms and tested positive. Stated that she took the morning then evening dose and could not sleep last night because she had the sore throat. Stated that he is not sure if it was from Covid or a response from the medication. Clarified that both received the Moderna three doses.  No treatment information was provided. Company comment: This is a spontaneous case concerning a patient of an unknown age with no medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date the next year after the third dose of mRNA-1273. The patient could not sleep because of the sore throat and was tested COVID-19 positive. The patient was treated with Paxlovid. The outcome of the event was unknown at the time of the last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-589457 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2022: Live Follow-up received contain significant information include relevant history details updated, new event updated. On 16-Jun-2022: Upon internal Review on 01-Jul-2022, significant correction was performed to remove tracking only classification and Moderna vaccine was updated from historical vaccine to suspect vaccine.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age with no medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date the next year after the third dose of mRNA-1273. The patient could not sleep because of the sore throat and was tested COVID-19 positive. The patient was treated with Paxlovid. The outcome of the event was unknown at the time of the last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.