Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pneumonia
Clinical narrative: Lung infection; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Lung infection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID  ARTHRITIS).   On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In June 2022, the patient experienced PNEUMONIA (Lung infection) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Lung infection) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. Not Provided          No concomitant products were reported.  In june 2022, the patient experienced lung infection. moderna covid-19 vaccine (elasomeran) was also considered suspect. primary reporter did not have the lot number information, because the information was not available in the patient's file.  The reporter's causality for the event(s) of lung infection with humira(adalimumab) was no reasonable possibility.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a 77 year old female patient with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Pneumonia in about 7 months of receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the second dose with the same vaccine after about 5 months. Inappropriate schedule of product administration was noted.  No information on exact date of the event, detailed clinical course, relevant investigations and treatment of the event was available in the report. The event was resolving. Co-suspect adalimumab could be a risk factor for the event Pneumonia. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-628165 (Patient Link).; Sender's Comments: This spontaneous case concerns a 77 year old female patient with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Pneumonia in about 7 months of receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the second dose with the same vaccine after about 5 months. Inappropriate schedule of product administration was noted.  No information on exact date of the event, detailed clinical course, relevant investigations and treatment of the event was available in the report. The event was resolving. Co-suspect adalimumab could be a risk factor for the event Pneumonia. The benefit-risk relationship of mRNA-1273 is not affected by this report.