Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Covid-19 for which Paxlovid was given; Dose 1 12-FEB-2021 and Dose 2 3-MAR-2022; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 12-FEB-2021 and Dose 2 3-MAR-2022) and COVID-19 (Covid-19 for which Paxlovid was given) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) from 01-May-2022 to 02-May-2022 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 12-FEB-2021 and Dose 2 3-MAR-2022). On an unknown date, the patient experienced COVID-19 (Covid-19 for which Paxlovid was given). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 12-FEB-2021 and Dose 2 3-MAR-2022) and COVID-19 (Covid-19 for which Paxlovid was given) outcome was unknown.            Company comment: This spontaneous case concerns a 66-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19, approximately two months after receiving the second dose of mRNA-1273 vaccine. The patient was treated with a course of Paxlovid (Nirmatrelvir + Ritonavir) for 5 days; following this, she had rebound COVID-19. Outcome was reported as unknown. Details of medical history, clinical course, further investigation reports, and treatment were not provided. It is noted that the patient received first two doses of mRNA-1273 vaccine at a time interval of 1 year and 19 days (Inappropriate schedule of vaccine administered), which could be a confounder in conjunction with current pandemic situation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-577169 (Patient Link).; Sender's Comments: This spontaneous case concerns a 66-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious of COVID-19, approximately two months after receiving the second dose of mRNA-1273 vaccine. The patient was treated with a course of Paxlovid (Nirmatrelvir + Ritonavir) for 5 days; following this, she had rebound COVID-19. Outcome was reported as unknown. Details of medical history, clinical course, further investigation reports, and treatment were not provided. It is noted that the patient received first two doses of mRNA-1273 vaccine at a time interval of 1 year and 19 days (Inappropriate schedule of vaccine administered), which could be a confounder in conjunction with current pandemic situation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.