Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: possible rebound covid; 2nd dose administered more than 35 days; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (possible rebound covid) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 35 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Hashimoto's disease, Aortic aneurysm, Obesity and Drug allergy (steroids.). Concomitant products included LEVOTHYROXINE from September 2018 to an unknown date and PROPRANOLOL for an unknown indication.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In November 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 35 days). On 26-May-2022, the patient experienced COVID-19 (possible rebound covid). At the time of the report, COVID-19 (possible rebound covid) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 35 days) outcome was unknown. Not Provided      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.  The patient previously received a COVID-19 Vaccine.  The patient had severe runny nose, congestion and some labored breathing started again a few days after completing paxlovid treatment.  No treatment information was provided. COMPANY COMMENT: This is an spontaneous case concerning a 51-year-old female patient with medical history of Concurrent medical conditions included Hashimoto's disease, Aortic aneurysm, Obesity and Drug allergy, Concomitant products included LEVOTHYROXINE, PROPRANOLOL, RITONAVIR (PAXLOVID) for COVID-19 treatment from 17 to 21 May, 2022,  mRNA-1273 on June and November, 2021 (1st and 2nd doses) who experienced the unexpected events of COVID-19 (AESI) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION  unknown days after 2nd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 51-year-old female patient with medical history of Concurrent medical conditions included Hashimoto's disease, Aortic aneurysm, Obesity and Drug allergy, Concomitant products included LEVOTHYROXINE, PROPRANOLOL, RITONAVIR (PAXLOVID) for COVID-19 treatment from 17 to 21 May, 2022,  mRNA-1273 on June and November, 2021 (1st and 2nd doses) who experienced the unexpected events of COVID-19 (AESI) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION  unknown days after 2nd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.