Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Transient ischaemic attack
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Ministroke) in an adult 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 Psoriasis. Concurrent medical conditions included Psoriasis. On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Ministroke) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating), PRURITUS (Itchy), PAIN (Generalized aching/ Body ache), IMMUNISATION REACTION (Body did not took Covid vaccine well/ vaccination adverse reaction), PAIN IN EXTREMITY (Painful feet) and ARTHRALGIA (Pain in knee). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Ministroke), HYPERHIDROSIS (Sweating), PRURITUS (Itchy), PAIN (Generalized aching/ Body ache), IMMUNISATION REACTION (Body did not took Covid vaccine well/ vaccination adverse reaction), PAIN IN EXTREMITY (Painful feet) and ARTHRALGIA (Pain in knee) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. The patient had some pain in knee and feet, sweating and itches, patient's body did not took Covid vaccine well and suffered body ache and ministroke with possible hospital visit. The reporter's causality for the events of mini stroke, pain in knee, pain in feet, sweating, itches, body ache and body did not took well Covid vaccine was not provided and the opinion was that the events of mini stroke, pain in knee, pain in feet, sweating, itches and body ache are not assessable and there was no reasonable possibility that the event of body did not took well Covid vaccine was related to Humira 40mg/0.4ml(adalimumab), 80mg/0.8ml(adalimumab). Treatment information was not provided. Company comment: This spontaneous case concerns a unspecified age male patient, with no relevant medical history, who experienced unexpected serious (medically significant) AESI event of Transient ischemic stroke, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. Patient experienced had some pain in knee and feet, had sweating and itches, patient told that his body did not took Covid vaccine well and patient also suffered from body ache. At the time of reporting outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a unspecified age male patient, with no relevant medical history, who experienced unexpected serious (medically significant) AESI event of Transient ischemic stroke, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. Patient experienced had some pain in knee and feet, had sweating and itches, patient told that his body did not took Covid vaccine well and patient also suffered from body ache. At the time of reporting outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.