Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Carotid artery aneurysm, Computerised tomogram, Headache, Lymphadenopathy
Clinical narrative: Cavernous, something or other, aneurysms bilaterally; right eye turned bright red; headaches are a burning sensation from her temple to her scalp which feels like her hair is being pulled or her skin is burning; terrible headaches; lymph nodes on chest and armpit were swollen/lymph nodes are swollen to "pea size."; This spontaneous case was reported by a patient and describes the occurrence of CAROTID ARTERY ANEURYSM (Cavernous, something or other, aneurysms bilaterally) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 0JIF21A, 027B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer, Fibromyalgia and Migraine.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient experienced OCULAR HYPERAEMIA (right eye turned bright red), SKIN BURNING SENSATION (headaches are a burning sensation from her temple to her scalp which feels like her hair is being pulled or her skin is burning), HEADACHE (terrible headaches) and LYMPHADENOPATHY (lymph nodes on chest and armpit were swollen/lymph nodes are swollen to "pea size."). On an unknown date, the patient experienced CAROTID ARTERY ANEURYSM (Cavernous, something or other, aneurysms bilaterally) (seriousness criterion medically significant). In April 2022, OCULAR HYPERAEMIA (right eye turned bright red) had resolved. At the time of the report, CAROTID ARTERY ANEURYSM (Cavernous, something or other, aneurysms bilaterally), SKIN BURNING SENSATION (headaches are a burning sensation from her temple to her scalp which feels like her hair is being pulled or her skin is burning), HEADACHE (terrible headaches) and LYMPHADENOPATHY (lymph nodes on chest and armpit were swollen/lymph nodes are swollen to "pea size.") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: elevated 3 weeks ago and decreased to only one of inflammatory markers being slightly elevated after 2-4 weeks. On an unknown date, Computerised tomogram: Cavernous, something or other, aneurysms bilaterally. On an unknown date, Magnetic resonance imaging: Cavernous, something or other, aneurysms bilaterally. On an unknown date, Mammogram: mammograms for her lymph nodes on her chest which showed she did not have breast cancer or tumors and mammograms for her lymph nodes on her chest which showed she did not have breast cancer or tumors. On an unknown date, Red blood cell sedimentation rate: elevated 3 weeks ago and decreased to only one of inflammatory markers being slightly elevated after 2-4 weeks.         Concomitant product use was not provided by the reporter.  About 1 week after last booster dose, the patient started having terrible headaches that only subsided for 30 minutes to 2 hours before coming back. At the same time, her right eye turned bright red and her lymph nodes of her chest and armpit on the left started swelling. The patient's lymph nodes were swollen to pea size. If touched those bumps in the right place, the patient would jump and they were clustered as 2-3 nodes together. Her right eye cleared up after 2 to 2.5 days. The headaches were a burning sensation from her temple to her scalp which felt like her hair was being pulled or her skin was burning. She thought those were like her previous migraines prior to vaccination, however they had different characteristics. They had prevented her from functioning and limited her ability to drive. She took 2 migraine cocktail infusions, and trigger point injections to the back of her head. The patient spoke to her primary care doctor and neurologist.  Company Comment : This spontaneous case concerns a 75-year-old female patient with relevant medical history of breast cancer, fibromyalgia and migraine, who experienced unexpected, serious (medically significant) event of Carotid artery aneurysm which occurred at an unknown time with regards to the mRNA-1273 vaccination. Around 1 week after the patients'  last booster dose, she experienced recurrent headaches that was described as burning sensation from the temple to her scalp, and would only subside for 30 min to 2 hours, along with her right eye turning bright red. She also noted that the lymph nodes on her chest and armpit on the left started swelling to "pea size." The right eye cleared up after 2-2.5 days. Her headaches prevented her from functioning and limited her ability to drive. She has taken 2 migraine cocktail infusions, and trigger point injections to the back of her head. She consulted with her primary care doctor and neurologist. They stated that her headaches may be due to inflamed vessels from the temple running through the scalp. The magnetic resonance imaging and computed tomography done showed "Cavernous, something or other, aneurysms bilaterally." Mammograms were also done for her lymph nodes on her chest which showed she did not have breast cancer or tumors. She has also had an elevated erythrocyte sedimentation rate and C-reactive protein, which were elevated 3 weeks ago. The outcome of the events was reported as unknown. The relevant medical history of breast cancer, fibromyalgia and migraine can be contributory factors to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75-year-old female patient with relevant medical history of breast cancer, fibromyalgia and migraine, who experienced unexpected, serious (medically significant) event of Carotid artery aneurysm which occurred at an unknown time with regards to the mRNA-1273 vaccination. Around 1 week after the patients'  last booster dose, she experienced recurrent headaches that was described as burning sensation from the temple to her scalp, and would only subside for 30 min to 2 hours, along with her right eye turning bright red. She also noted that the lymph nodes on her chest and armpit on the left started swelling to "pea size." The right eye cleared up after 2-2.5 days. Her headaches prevented her from functioning and limited her ability to drive. She has taken 2 migraine cocktail infusions, and trigger point injections to the back of her head. She consulted with her primary care doctor and neurologist. They stated that her headaches may be due to inflamed vessels from the temple running through the scalp. The magnetic resonance imaging and computed tomography done showed "Cavernous, something or other, aneurysms bilaterally." Mammograms were also done for her lymph nodes on her chest which showed she did not have breast cancer or tumors. She has also had an elevated erythrocyte sedimentation rate and C-reactive protein, which were elevated 3 weeks ago. The outcome of the events was reported as unknown. The relevant medical history of breast cancer, fibromyalgia and migraine can be contributory factors to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.