Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid symptoms improved but then returned/positive again on 12-May-2022/tested negative again on 14-May-2022/Symptoms returned on 16-May-2022 and tested positive again) in a 44-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Drug allergy. Concomitant products included SERTRALINE for an unknown indication. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-May-2022, after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Covid symptoms improved but then returned/positive again on 12-May-2022/tested negative again on 14-May-2022/Symptoms returned on 16-May-2022 and tested positive again). At the time of the report, COVID-19 (Covid symptoms improved but then returned/positive again on 12-May-2022/tested negative again on 14-May-2022/Symptoms returned on 16-May-2022 and tested positive again) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative on 11-May-2022. On 12-May-2022, SARS-CoV-2 test: positive (Positive) positive again on 12-May-2022. On 14-May-2022, SARS-CoV-2 test: negative (Negative) tested negative again on 14-May-2022. On 16-May-2022, SARS-CoV-2 test: positive (Positive) tested positive again. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. It was reported that day 0 was 01-May-2022. COVID-19 symptoms improved but then returned the day after completing Paxlovid on 11-May-2022. Tested negative on 11-May-2022, but then positive again on 12-May-2022. Symptoms improved and tested negative again on 14-May-2022. Symptoms returned on 16-May-2022 and tested positive again. It was reported that the patient was still feeling ill. No treatment was received. Company Comment: This spontaneous case concerns a 44-year-old, female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred on unknown interval after receiving an unknown dose number of mRNA-1273 vaccine. Patient was diagnosed to have COVID-19 on unknown date and was treated with Nirmatrelvir, Ritonavir (Paxlovid) for 6 days. Her COVID-19 symptoms improved, and COVID-19 test turned negative after completion of treatment. However, a day after recovery she developed episodes of recurrence of COVID-19 symptoms and positive COVID-19 test after negative result. At the time of the report, the event has not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 44-year-old, female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred on unknown interval after receiving an unknown dose number of mRNA-1273 vaccine. Patient was diagnosed to have COVID-19 on unknown date and was treated with Nirmatrelvir, Ritonavir (Paxlovid) for 6 days. Her COVID-19 symptoms improved, and COVID-19 test turned negative after completion of treatment. However, a day after recovery she developed episodes of recurrence of COVID-19 symptoms and positive COVID-19 test after negative result. At the time of the report, the event has not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.