Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: not feel well again/not feeling good and today not doing well at all; Tested positive for Covid 28-Apr-2022 / tested positive for Covid after finishing Paxlovid; Sick/started to feel sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feel well again/not feeling good and today not doing well at all), ILLNESS (Sick/started to feel sick) and COVID-19 (Tested positive for Covid 28-Apr-2022 / tested positive for Covid after finishing Paxlovid) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinus disorder (Sinus sufferer for the last 25 years.).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, the patient experienced ILLNESS (Sick/started to feel sick). On 28-Apr-2022, the patient experienced COVID-19 (Tested positive for Covid 28-Apr-2022 / tested positive for Covid after finishing Paxlovid). On 04-May-2022, the patient experienced MALAISE (not feel well again/not feeling good and today not doing well at all). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 28-Apr-2022 to 02-May-2022 for COVID-19, at a dose of 3 pills twice a day. At the time of the report, MALAISE (not feel well again/not feeling good and today not doing well at all) had not resolved and ILLNESS (Sick/started to feel sick) and COVID-19 (Tested positive for Covid 28-Apr-2022 / tested positive for Covid after finishing Paxlovid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2022, SARS-CoV-2 test: positive Positive for Covid.. On 02-May-2022, SARS-CoV-2 test: positive light pink line. Unit: Not Provided.. On 05-May-2022, SARS-CoV-2 test: positive bright red line. Unit: Not Provided.         The patient received 3 Moderna Covid vaccines. 1st dose on -Jan-2021, next dose 6 months later and booster 8 months after. The patient would get another booster when she was better and back home. The patient did not have dates, NDC, lot or expiry for any doses to provide.It was reported that the patient first noticed symptoms Wednesday night or on Thursday morning after midnight and Thursday patient started Paxlovid and took it for 5 days and was doing better. Stated by 02-May-2022, her last dose she was doing better. The patient took a test and the line was a light pink and was excited that it was going in the right direction and went out of town on Tuesday. Stated on Wednesday started to feel sick and Thursday was day 9 from when patient contracted it and that day was Friday. Patient tested the previous day and it was bright red and showed fast, clarified these to be Covid tests. Clarified that these were home Covid tests and when there was no line on the test area that was wonderful and it was negative and any sort of line it was positive. When she first tested it was positive and bright line. States that after finishing the medication the line was barely visible and then yesterday she was back to a strong line and also had symptoms that correlate. The patient tested for Covid on 28-Apr-2022, she was sick the night before but tested that day and then she got Paxlovid and started it that day. States she finished the Paxlovid 02-May-2022 and was feeling pretty good and tested on 02May2022 and the line was light but she felt good. Stated 4May2022 and 5May2022 patient was not feeling good and on that day not doing well at all. Stated she tested for Covid again yesterday 05-May2022 and it was bright red positive.  Company comment: This spontaneous case concerns a 69-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events), approximately 8 months after the third (booster) dose of mRNA-1273 vaccine. Primary doses of mRNA-1273 vaccine, were administered in an inappropriate schedule of vaccination (6 months interval between doses 1 and 2). As per narrative of the source document, three positive COVID tests were performed during the COVID-19 disease, and she received Paxlovid (ritonavir) as treatment. The benefit-risk relationship of the mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-562438 (Patient Link).; Sender's Comments: This spontaneous case concerns a 69-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events), approximately 8 months after the third (booster) dose of mRNA-1273 vaccine. Primary doses of mRNA-1273 vaccine, were administered in an inappropriate schedule of vaccination (6 months interval between doses 1 and 2). As per narrative of the source document, three positive COVID tests were performed during the COVID-19 disease, and she received Paxlovid (ritonavir) as treatment. The benefit-risk relationship of the mRNA-1273 is not affected by this report.