Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Kidney infection, Lower respiratory tract infection
Clinical narrative: Kidney infection; Chest cold; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection) in an elderly 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 an unknown indication.    No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced KIDNEY INFECTION (Kidney infection) (seriousness criterion medically significant), LOWER RESPIRATORY TRACT INFECTION (Chest cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, KIDNEY INFECTION (Kidney infection) and LOWER RESPIRATORY TRACT INFECTION (Chest cold) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. 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. No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.  The formulation for co-suspect product Humira was reported as "Solution for injection in pre-filled pen". The reporter's causality for the event(s) of KIDNEY INFECTION and CHEST COLD with respect to Humira was not provided. Company Comment: This is a Spontaneous case reported by a consumer, concerning an elderly female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Kidney infection, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalamumab for an unknown indication. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an elderly female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Kidney infection, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalamumab for an unknown indication. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.