Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Illness, Mobility decreased, Nerve compression, Pain
Clinical narrative: Pinched nerve; internal shingles; pain or hurt; not able to get up; Illness; This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (Pinched nerve), HERPES ZOSTER (internal shingles) and PAIN (pain or hurt) in a 62-year-old male 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) solution for injection for Crohn's disease.    No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, 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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced ILLNESS (Illness). On an unknown date, the patient experienced NERVE COMPRESSION (Pinched nerve) (seriousness criterion hospitalization), HERPES ZOSTER (internal shingles) (seriousness criterion hospitalization), PAIN (pain or hurt) (seriousness criterion hospitalization) and MOBILITY DECREASED (not able to get up). At the time of the report, NERVE COMPRESSION (Pinched nerve), HERPES ZOSTER (internal shingles) and PAIN (pain or hurt) was resolving, ILLNESS (Illness) had resolved and MOBILITY DECREASED (not able to get up) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. 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 concerns a 62-years-old female patient with medical history of Crohn's disease that was treated with HUMIRA (ADALIMUMAB), who experienced the unexpected, serious (hospitalization) event of Nerve compression, Herpes zoster and Pain. The event occurred on an unknown date in context to third dose of mRNA-1273 vaccine. The Concomitant medication and treatment details were not provided, and the event outcome was resolving. The medical history of Crohn's disease treated with HUMIRA remains a confounder to the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. Sender's Comments: This spontaneous case concerns a 62-years-old female patient with medical history of Crohn's disease that was treated with HUMIRA (ADALIMUMAB), who experienced the unexpected, serious (hospitalization) event of Nerve compression, Herpes zoster and Pain. The event occurred on an unknown date in context to third dose of mRNA-1273 vaccine. The Concomitant medication and treatment details were not provided, and the event outcome was resolving. The medical history of Crohn's disease treated with HUMIRA remains a confounder to the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.