Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram peripheral, Arteriogram carotid, Blood glucose, Blood iron, COVID-19
Clinical narrative: Cerebral artery dissection; COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of CAROTID ARTERY DISSECTION (Cerebral artery dissection) in a 50-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.      The patient's past medical history included Vertigo (lasting about 2 months that she attributed to yoga). Previously administered products included for COVID-19 prophylaxis: SARS-CoV-2 Vaccine (Dose 1) in January 2021 and SARS-CoV-2 Vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with SARS-CoV-2 Vaccine and SARS-CoV-2 Vaccine. Concurrent medical conditions included Hypercholesterolemia and Migraine headache (From 15 years and her migraine episodes were successfully managed with over-the-counter medication). Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE (ASPIRIN CAFFEINE) for Migraine and Pain.   In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced COVID-19 (COVID-19). On 19-May-2022, the patient experienced CAROTID ARTERY DISSECTION (Cerebral artery dissection) (seriousness criteria hospitalization and medically significant). The patient was treated with AZITHROMYCIN on 19-May-2022 for Prophylactic antibiotic therapy, at a dose of 500 milligram; AZITHROMYCIN on 19-May-2022 for Prophylactic antibiotic therapy, at a dose of 250 milligram; CLOPIDOGREL in 2022 at a dose of 75 milligram; ASPIRIN [ACETYLSALICYLIC ACID] in 2022 at a dose of 81 milligram and Surgery (Pipeline Flex embolization device a flow diverter stent placement) for Carotid artery dissection. At the time of the report, CAROTID ARTERY DISSECTION (Cerebral artery dissection) had resolved and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, Polymerase chain reaction: (Positive) for a non-Omicron variant but was asymptomatic   at the time. In May 2022, Arteriogram carotid: non-contrast magnetic resonance angiography was conducted, which showed a focal dissection with luminal irregularity, an   intimal flap, and moderate to severe luminal stenosis of the distal right cervical internal carotid artery and right petrous internal carotid junction. In May 2022, Blood glucose: normal. In May 2022, Blood iron: normal. In May 2022, Serum ferritin: normal. In May 2022, Ultrasound Doppler: Of the cervical carotid arteries revealed no significant occlusive disease of the common and internal arteries. Maximum velocities in the right common carotid artery and the right internal carotid artery were 105/26 cm/s and 66/20 cm/s,   respectively. Maximum velocity was 116/23 cm/s in the left common carotid artery and 109/18 cm/s in the left internal carotid artery. Both the right and left vertebral arteries had normal antegrade flow. The subclavian artery had normal multiphasic flow. On 07-Jun-2022, Angiogram peripheral: confirmed a complex dissection of the petrous segment of the right internal carotid artery, associated with 70% stenosis and a 9-mm pseudoaneurysm..     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.  Company comment: This is a Literature-Non-Study case concerning a 50-year-old, female patient with medical history of mild hypercholesterolemia and sporadic migraines managed with over-the-counter medication, who experienced the unexpected serious events (medically significant and hospitalization) event of Carotid artery dissection.  During the period January 2021 - April 2022, the patient received full SARS-CoV-2 vaccination, including 2 boosters of mRNA-1273 vaccine.                                                                            The patient had a history of severe vertigo for two months two years prior, which she attributed to yoga. In April 2022, she was exposed to SARS-CoV-2 and tested positive on May 9, 2022, for a non-Omicron variant but was asymptomatic. Despite full vaccination and two boosters with mRNA-1273, she developed a severe headache on May 10, 2022, accompanied by right-ear pulsatile tinnitus and vertigo. Her symptoms worsened, leading to an emergency department visit on May 19, 2022, where she was prescribed azithromycin for a presumptive ear infection, which did not resolve her symptoms. On May 26, 2022, a carotid bruit was detected, and subsequent imaging revealed a focal dissection with luminal irregularity and stenosis of the right internal carotid artery. She was prescribed clopidogrel and aspirin and underwent a diagnostic angiogram on June 7, 2022, confirming a complex dissection with 70% stenosis and a pseudoaneurysm. On June 21, 2022, due to continued symptoms, a Pipeline Flex embolization device (Medtronic) was placed via femoral access, which resolved her symptoms. At the latest follow-up, repeat angiography at six months showed complete resolution of the dissection and stent patency. In agreement with author assessment, current COVID-19 is a confounder for the event. Mentioned medical history are risk factors for the event. Further information was requested. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Patient was exposed to multiple people who had tested positive for SARS-CoV-2 while traveling in April 2022. The patient had not had COVID-19 previously and had received the full SARS-CoV-2 vaccination including 2 boosters of the Moderna vaccine between January 2021 and April 2022. On May 10, 2022, she developed a mild, dull headache that became severe the next day. The headache was accompanied by right-ear pulsatile tinnitus and vertigo, which were triggered by supine head  movements. Over the next week, the pain extended to the right side of her neck and was aggravated on exertion. Treatment did not resolve the symptoms. On June 21, 2022, because of continued symptoms, a Pipeline Flex embolization device (Medtronic) a flow diverter stent was placed via femoral access that resolved her symptoms. Repeated angiography after 6 months showed complete resolution of the dissection.; Sender's Comments: This is a Literature-Non-Study case concerning a 50-year-old, female patient with medical history of mild hypercholesterolemia and sporadic migraines managed with over-the-counter medication, who experienced the unexpected serious events (medically significant and hospitalization) event of Carotid artery dissection.  During the period January 2021 - April 2022, the patient received full SARS-CoV-2 vaccination, including 2 boosters of mRNA-1273 vaccine.                                                                            The patient had a history of severe vertigo for two months two years prior, which she attributed to yoga. In April 2022, she was exposed to SARS-CoV-2 and tested positive on May 9, 2022, for a non-Omicron variant but was asymptomatic. Despite full vaccination and two boosters with mRNA-1273, she developed a severe headache on May 10, 2022, accompanied by right-ear pulsatile tinnitus and vertigo. Her symptoms worsened, leading to an emergency department visit on May 19, 2022, where she was prescribed azithromycin for a presumptive ear infection, which did not resolve her symptoms. On May 26, 2022, a carotid bruit was detected, and subsequent imaging revealed a focal dissection with luminal irregularity and stenosis of the right internal carotid artery. She was prescribed clopidogrel and aspirin and underwent a diagnostic angiogram on June 7, 2022, confirming a complex dissection with 70% stenosis and a pseudoaneurysm. On June 21, 2022, due to continued symptoms, a Pipeline Flex embolization device (Medtronic) was placed via femoral access, which resolved her symptoms. At the latest follow-up, repeat angiography at six months showed complete resolution of the dissection and stent patency. In agreement with author assessment, current COVID-19 is a confounder for the event. Mentioned medical history are risk factors for the event. Further information was requested. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.