Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pruritus, Wheelchair user
Clinical narrative: Neuropathy damage from surgeries; patient is in a wheel chair; Itching everywhere; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy damage from surgeries) in a 45-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 ATOGEPANT tablet for an unknown indication.    The patient's past medical history included Surgery (multiple surgeries back, hip, legs. Most of the patient's leg is metal). Concurrent medical conditions included Itching all over. Concomitant products included OMALIZUMAB (XOLAIR) for Itching all over.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ATOGEPANT (unknown route) 60 mg once a day. In November 2021, the patient experienced PRURITUS (Itching everywhere). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy damage from surgeries) (seriousness criterion medically significant) and WHEELCHAIR USER (patient is in a wheel chair). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy damage from surgeries) and WHEELCHAIR USER (patient is in a wheel chair) outcome was unknown and PRURITUS (Itching everywhere) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient started taking Qulipta (atogepant) this past weekend. On 07Nov2021 or 08Nov2021 the patient started itching everywhere. The patient did not talk to her HCP about stopping the medication. the patient stated the Qulipta has not been in her body that long and it has not been out of her body that long. Since stopping the Qulipta the itching has gotten better.  Treatment information was not provided.  Company Comment: This case concerns a 45 year old female with relevant medical history of itching , Reported to have multiple surgeries in the back , hip and legs ( some with metal) , Neuropathy from the multiple surgeries, who experienced non-serious unexpected event of pruritus and wheel chair user which occurred on an unknown date  after vaccination with two doses of mRNA-1273 ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the events has not completely recovered. Atogepant ( Qulipta ) was taken by the patient approximately 7 months after the vaccination with the 2nd dose of Moderna Covid 19 vaccine and reported as Co-suspect drug for this case. The medical history of itching of the patient can be considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 45 year old female with relevant medical history of itching , Reported to have multiple surgeries in the back , hip and legs ( some with metal) , Neuropathy from the multiple surgeries, who experienced non-serious unexpected event of pruritus and wheel chair user which occurred on an unknown date  after vaccination with two doses of mRNA-1273 ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the events has not completely recovered. Atogepant ( Qulipta ) was taken by the patient approximately 7 months after the vaccination with the 2nd dose of Moderna Covid 19 vaccine and reported as Co-suspect drug for this case. The medical history of itching of the patient can be considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.