Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder (Autoimmune disorder with biologic treatment (Humira).). Concurrent medical conditions included Allergy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) outcome was unknown. Not Provided          No treatment drug details was reported.  The patient was taking other medications or products within 2 weeks of staring COVID-19 treatment. The patient previously received a unknown COVID-19 vaccine. The patient had a COVID rebound staring on day 7, with symptoms including sore throat, headache, earache, swollen glands in neck, cough, nasal congestion and chest congestion. The device date 26-May-2022.  Company comment: This spontaneous case concerns a 40-year-old female patient with relevant medical history of Autoimmune disorder (unspecified) on Humira (Adalimumab), who experienced the unexpected non-serious AESI of Covid-19, approximately 3 weeks after the 4th dose of mRNA-1273 vaccine. The patient was started on a course of Paxlovid (Nirmatrelvir + Ritonavir) for Covid-19. A week after starting Paxlovid, the patient developed earache, swollen glands in neck, cough, nasal congestion, headache and chest congestion. The outcome was reported as not resolved. Details of clinical course, investigation reports and further treatment were not provided. The current pandemic situation of Covid-19 could be a confounder. Medical history of Autoimmune disorder on treatment with Humira could be a risk factor. Prior to the fourth dose, the patient has received the primary regimen of mRNA-1273 plus third dose (all 4 doses of mRNA-1273). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 40-year-old female patient with relevant medical history of Autoimmune disorder (unspecified) on Humira (Adalimumab), who experienced the unexpected non-serious AESI of Covid-19, approximately 3 weeks after the 4th dose of mRNA-1273 vaccine. The patient was started on a course of Paxlovid (Nirmatrelvir + Ritonavir) for Covid-19. A week after starting Paxlovid, the patient developed earache, swollen glands in neck, cough, nasal congestion, headache and chest congestion. The outcome was reported as not resolved. Details of clinical course, investigation reports and further treatment were not provided. The current pandemic situation of Covid-19 could be a confounder. Medical history of Autoimmune disorder on treatment with Humira could be a risk factor. Prior to the fourth dose, the patient has received the primary regimen of mRNA-1273 plus third dose (all 4 doses of mRNA-1273). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.