Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Renal impairment, Vaccination site pain
Clinical narrative: ABNORMAL KIDNEY FUNCTION; SWOLLEN LYMPH NODE AFTER VACCINATION SHOT; EXPERIENCED ACHINESS AFTER SECOND VACCINATION; This spontaneous case was reported by a consumer and describes the occurrence of RENAL IMPAIRMENT (ABNORMAL KIDNEY FUNCTION) in a female patient of an unknown age 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) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced RENAL IMPAIRMENT (ABNORMAL KIDNEY FUNCTION) (seriousness criterion medically significant), LYMPHADENOPATHY (SWOLLEN LYMPH NODE AFTER VACCINATION SHOT) and VACCINATION SITE PAIN (EXPERIENCED ACHINESS AFTER SECOND VACCINATION). At the time of the report, RENAL IMPAIRMENT (ABNORMAL KIDNEY FUNCTION) had not resolved and LYMPHADENOPATHY (SWOLLEN LYMPH NODE AFTER VACCINATION SHOT) and VACCINATION SITE PAIN (EXPERIENCED ACHINESS AFTER SECOND VACCINATION) had resolved.            Concomitant Drugs Not Reported. treatment information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. 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 reported by a consumer, concerns a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, ( medically significant) AESI of Renal impairment (abnormal kidney function) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events. It was reported that the patient took Adalimumab (HUMIRA) injection for Psoriatic arthritis, which could be considered as a confounder. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, ( medically significant) AESI of Renal impairment (abnormal kidney function) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events. It was reported that the patient took Adalimumab (HUMIRA) injection for Psoriatic arthritis, which could be considered as a confounder. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.