Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound COVID. 1st positive on 5/5/22, negative on 5/14/22 symptom free for 7 days, on 5/16/22 started with hay-fever like symptoms for 3+ days, tested Positive again on 5/19/22; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound COVID. 1st positive on 5/5/22, negative on 5/14/22 symptom free for 7 days, on 5/16/22 started with hay-fever like symptoms for 3+ days, tested Positive again on 5/19/22) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012f21A and 0011A21A) for COVID-19 vaccination.     Concomitant products included ALENDRONATE SODIUM from 05-May-2022 to an unknown date for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound COVID. 1st positive on 5/5/22, negative on 5/14/22 symptom free for 7 days, on 5/16/22 started with hay-fever like symptoms for 3+ days, tested Positive again on 5/19/22). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 05-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound COVID. 1st positive on 5/5/22, negative on 5/14/22 symptom free for 7 days, on 5/16/22 started with hay-fever like symptoms for 3+ days, tested Positive again on 5/19/22) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2022, SARS-CoV-2 test: positive (Positive) 1st positive on 05-May-2022.. On 14-May-2022, SARS-CoV-2 test: negative (Negative) Negative on 14-May-2022. On 19-May-2022, SARS-CoV-2 test: positive (Positive) Tested Positive again on 19-May-2022.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking other medications within 2 weeks of starting COVID-19 treatment. Patient tested 1st positive on 05-May-2022, took Paxlovid on 05-May-2022 for 5 days, negative on 14-May-2022, symptom free for 7 days. On 16-May-2022 patient started with hay-fever like symptoms for 3+ days, and tested Positive again on 19-May-2022.  Company Comment: This spontaneous case concerns a 66-year-old, female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred six months after receiving the third dose of mRNA-1273 vaccine. Patient has completed the primary vaccination with mRNA-1273 with the last dose taken approximately 8 months prior to the current dose. It was reported that patient developed COVID-19 (with a positive SARS-CoV-2 test) and was treated with Nirmatrelvir, Ritonavir (Paxlovid) for 5 days.  She recovered from COVID-19 and remained asymptomatic for 7 days. COVID-19 test taken nine days after the event onset showed negative result. Two days after recovery, she experienced hay-fever like symptoms. A repeat COVID-19 test was performed and yielded positive result. The clinical course, diagnostic investigations, and treatment details after recurrence of symptoms were not reported. 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 the unexpected, non-serious adverse event of special interest of COVID-19 which occurred six months after receiving the third dose of mRNA-1273 vaccine. Patient has completed the primary vaccination with mRNA-1273 with the last dose taken approximately 8 months prior to the current dose. It was reported that patient developed COVID-19 (with a positive SARS-CoV-2 test) and was treated with Nirmatrelvir, Ritonavir (Paxlovid) for 5 days.  She recovered from COVID-19 and remained asymptomatic for 7 days. COVID-19 test taken nine days after the event onset showed negative result. Two days after recovery, she experienced hay-fever like symptoms. A repeat COVID-19 test was performed and yielded positive result. The clinical course, diagnostic investigations, and treatment details after recurrence of symptoms were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.