Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Intervertebral disc protrusion
Clinical narrative: Herniated disc; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC PROTRUSION (Herniated disc) in a 74-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 UPADACITINIB (RINVOQ) for Arthritis rheumatoid.    No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2022, received third 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) (Oral) at an unspecified dose. On an unknown date, the patient experienced INTERVERTEBRAL DISC PROTRUSION (Herniated disc) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INTERVERTEBRAL DISC PROTRUSION (Herniated disc) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication information provided. On an unknown date, the patient experienced Herniated Disc. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality for the event of HERNIATED DISC was not provided. Agency opinion was that there was no reasonable possibility that the event of Herniated Disc was related to RINVOQ (UPADACITINIB).  Action taken with RINVOQ  was unknown.  No treatment medication information provided. Company comment: This spontaneous case concerns a 74-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Intervertebral disc protrusion. The exact date of onset was not specified in respect to the administration of a dose of mRNA-1273, hence latency could not be assessed. The third dose of mRNA-1273 was given approximately 7 months prior to the two initial doses of mRNA-1273, the interval between the two doses is approximately 7 months. The event Inappropriate schedule of product administration was also reported. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.; Sender's Comments: This spontaneous case concerns a 74-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Intervertebral disc protrusion. The exact date of onset was not specified in respect to the administration of a dose of mRNA-1273, hence latency could not be assessed. The third dose of mRNA-1273 was given approximately 7 months prior to the two initial doses of mRNA-1273, the interval between the two doses is approximately 7 months. The event Inappropriate schedule of product administration was also reported. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.