Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neuropathy peripheral, Product storage error, SARS-CoV-2 antibody test positive
Clinical narrative: COVID-19 antibody test positive; Improper storage of product in use; Peripheral neuropathy aggravated; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy aggravated) in an adult 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.  Concurrent medical conditions included Rheumatoid arthritis.  On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy aggravated) (seriousness criterion medically significant), ARTHRALGIA (Shoulder pain), SARS-COV-2 ANTIBODY TEST POSITIVE (COVID-19 antibody test positive) and PRODUCT STORAGE ERROR (Improper storage of product in use). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy aggravated) and ARTHRALGIA (Shoulder pain) had not resolved, SARS-COV-2 ANTIBODY TEST POSITIVE (COVID-19 antibody test positive) had resolved and PRODUCT STORAGE ERROR (Improper storage of product in use) 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  The patient has started an increase in her neuropathy treatment infusions for the past 11 weeks. Also dealing with shoulder pains in which she was getting injection treatments. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 30 Mar 2021, patient received first dose COVID-19 Vaccine manufactured by Moderna. On 27 Apr 2021, patient received second dose COVID-19 Vaccine manufactured by Moderna.   the reporter's causality for the event(s) of increase neuropathy, shoulder pain and patient had covid antibodies with rinvoq (upadacitinib) was no reasonable possibility. the reporter's causality for the event of improper storage/patient removing the rinvoq pills from the bottle before taking each with Rinvoq (upadacitinib) was a reasonable possibility.  No concomitant medication was provided by reporter. No treatment medication was provided by reporter.  Company comment: This spontaneous case concerns an adult female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral (reported as Peripheral neuropathy aggravated), unknown days after receiving a dose of mRNA-1273 vaccine. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. The event had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Sender's Comments: This spontaneous case concerns an adult female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral (reported as Peripheral neuropathy aggravated), unknown days after receiving a dose of mRNA-1273 vaccine. No information on exact date of the event, detailed clinical course, relevant investigations and treatment was available in the report. The event had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.