Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound of initial COVID symptoms - sneezing, stuffy nose, positive rapid test on 02-Jun-2022 after two negative tests (27-May-2022 and 29-May-2022)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high and Penicillin allergy. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced COVID-19 (Rebound of initial COVID symptoms - sneezing, stuffy nose, positive rapid test on 02-Jun-2022 after two negative tests ( 27-May-2022 and 29-May-2022).). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound of initial COVID symptoms - sneezing, stuffy nose, positive rapid test on 02-Jun-2022 after two negative tests ( 27-May-2022 and 29-May-2022).) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 29-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 02-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive. No concomitant medications was reported. It was unknown if patient was taking other medications or products within 2 weeks of starting COVID-19 treatment. The patient previously received a unknown COVID-19 vaccine. The patient had a Rebound of initial COVID symptoms of sneezing and stuffy nose, also positive rapid test on 02-Jun-2022 after two negative tests on 27-May-2022 and 29-May-2022. The device date 02-Jun-2022. Company comment:  This spontaneous case concerns a 71yearold, female patient with no relevant medical history reported, who experienced the unexpected, nonserious AESI of COVID19. The event occurred approximately 1 month after the administration of the fourth dose of mRNA-1273 vaccine; the first two doses were administrated in an inappropriate schedule (48day interval). The patient completed a 5-days treatment with Paxlovid for COVID-19 (one month after mRNA1273 vaccine). It was reported that the initial symptoms rebounded, and 8 days after finishing treatment with Paxlovid the patient tested positive (previously she had two negative tests 4 and 6 days before). No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-583085 (Patient Link). Sender's Comments: This spontaneous case concerns a 71yearold, female patient with no relevant medical history reported, who experienced the unexpected, non  serious AESI of COVID19. The event occurred approximately 1 month after the administration of the fourth dose of mRNA-1273 vaccine; the first two doses were administrated in an inappropriate schedule (48day interval). The patient completed a 5-days treatment with Paxlovid for COVID-19 (one month after mRNA  1273 vaccine). It was reported that the initial symptoms rebounded, and 8 days after finishing treatment with Paxlovid the patient tested positive (previously she had two negative tests 4 and 6 days before). No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.