Sex: M
Vaccine: COVID19-2
Symptoms: Aneurysm, Back pain, Carotid artery dissection, Coccydynia, Gait disturbance
Clinical narrative: transverse myelitis/his back become inflamed at times which is excruciating; an ICA dissection; They did a scan of his neck after this pain started which showed an aneurysm thing near his ocular nerves called an ICA dissection/He also has pain in his tail bone; sometimes cannot walk; his back become inflamed at times which is excruciating; . They did a scan of his neck after this pain started which showed an aneurysm thing near his ocular nerves called an ICA dissection; numbness in his gels; pain in his tail bone; This spontaneous case was reported by a patient and describes the occurrence of MYELITIS TRANSVERSE (transverse myelitis/his back become inflamed at times which is excruciating) and CAROTID ARTERY DISSECTION (an ICA dissection) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE, Shingles shot, VACCINE and PNEUMOCOCCAL. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE, Shingles shot, VACCINE and PNEUMOCOCCAL.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYELITIS TRANSVERSE (transverse myelitis/his back become inflamed at times which is excruciating) (seriousness criterion medically significant), CAROTID ARTERY DISSECTION (an ICA dissection) (seriousness criterion medically significant), SPINAL PAIN (They did a scan of his neck after this pain started which showed an aneurysm thing near his ocular nerves called an ICA dissection/He also has pain in his tail bone), GAIT DISTURBANCE (sometimes cannot walk), BACK PAIN (his back become inflamed at times which is excruciating), ANEURYSM (. They did a scan of his neck after this pain started which showed an aneurysm thing near his ocular nerves called an ICA dissection), HYPOAESTHESIA (numbness in his gels) and COCCYDYNIA (pain in his tail bone). The patient was treated with VITAMINS NOS (MULTIVITAMIN [VITAMINS NOS]) at an unspecified dose and frequency and GLUCOSE MONOHYDRATE (GLUCOSE [GLUCOSE MONOHYDRATE]) at an unspecified dose and frequency. At the time of the report, MYELITIS TRANSVERSE (transverse myelitis/his back become inflamed at times which is excruciating), CAROTID ARTERY DISSECTION (an ICA dissection), SPINAL PAIN (They did a scan of his neck after this pain started which showed an aneurysm thing near his ocular nerves called an ICA dissection/He also has pain in his tail bone), GAIT DISTURBANCE (sometimes cannot walk), BACK PAIN (his back become inflamed at times which is excruciating), ANEURYSM (. They did a scan of his neck after this pain started which showed an aneurysm thing near his ocular nerves called an ICA dissection), HYPOAESTHESIA (numbness in his gels) and COCCYDYNIA (pain in his tail bone) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: They did a scan of his neck after this pain started which showed an aneurysm thing near his ocular nerves called an ICA dissection.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. It was reported that patient had received 5 doses of the Moderna vaccines. 5th dose was given approximately 6 months ago at a Rite Aid. He had been experiencing symptoms, which he believes are in alignment with transverse myelitis. Patient had a back/spinal injury at work recently as well and had to go through a workers compensation process with them which had been grueling. Patient can feel his back become inflamed at times which is excruciating. They did a scan of his neck after this pain started which showed an aneurysm thing near his ocular nerves called an ICA dissection. He also had pain in his tail bone, numbness in his gels, and sometimes cannot walk. The pain this weekend was number 10. Possibly received flu shot, pneumonia shot, and shingles shot within the 4 weeks prior to his most recent dose.  Company comment: This is a spontaneous case concerning a male patient, around 61-years of age, previously vaccinated with 4 doses of mRNA-1273.222 vaccine and recently received flu, pneumonia, and shingles shot within the 4 weeks of Modena vaccine, who experienced the unexpected serious (medically significant) events of myelitis transverse (AESI) and carotid dissection and non-serious events of Spinal pain, gait disturbance, back pain, coccydynia, aneurysm and hypoaesthesia. The symptoms which the reporter believed are symptoms of myelitis transverse began after the administration of mRNA-1273 .222 (Original/Omicron BA.4/5) vaccine, used as a fifth dose, latency remains unknown. Patient also have had a back/spinal injury at work which led to a neck scan. On it, it was observed an internal carotid artery dissection with and aneurysm near the ocular nerves. Patient was treated with supplements. No further information on clinical course, further investigations and treatment received was available in the report. Symptoms of myelitis transverse developed by the patient were not described. Queries are raised to complete assessment. The benefit-risk relationship of mRNA-1273 .222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient, around 61-years of age, previously vaccinated with 4 doses of mRNA-1273.222 vaccine and recently received flu, pneumonia, and shingles shot within the 4 weeks of Modena vaccine, who experienced the unexpected serious (medically significant) events of myelitis transverse (AESI) and carotid dissection and non-serious events of Spinal pain, gait disturbance, back pain, coccydynia, aneurysm and hypoaesthesia. The symptoms which the reporter believed are symptoms of myelitis transverse began after the administration of mRNA-1273 .222 (Original/Omicron BA.4/5) vaccine, used as a fifth dose, latency remains unknown. Patient also have had a back/spinal injury at work which led to a neck scan. On it, it was observed an internal carotid artery dissection with and aneurysm near the ocular nerves. Patient was treated with supplements. No further information on clinical course, further investigations and treatment received was available in the report. Symptoms of myelitis transverse developed by the patient were not described. Queries are raised to complete assessment. The benefit-risk relationship of mRNA-1273 .222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.