Age: 73.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: stroke/He only has one artery in his left neck. His right artery is blocked; His right arm still hurts and is swollen; His right arm still hurts and is swollen. He can't put his arm over his head; His right eye ball and right side of his face hurts; It's hurting his neck and shoulder parts to push out of bed; His right eye ball and right side of his face hurts; He hit his knee on the dresser; It's hurting his neck and shoulder parts to push out of bed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke/He only has one artery in his left neck. His right artery is blocked) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8091965) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    Concurrent medical conditions included Bleeding (stomach bleeding), Hypercholesterolemia (cholesterol), Iron deficiency (iron), Blood pressure high, COPD and Allergy to chemicals (allergic to sulfa and acid stuff). Concomitant products included IRON, ACETYLSALICYLIC ACID (ASPIRINA-G), FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), PANTOPRAZOLE, LISINOPRIL, PREGABALIN, TAMSULOSIN, VENLAFAXINE, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), TRIAMCINOLONE, ROSUVASTATIN, AMLODIPINE and LOPERAMIDE for an unknown indication.   On 06-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke/He only has one artery in his left neck. His right artery is blocked) (seriousness criterion medically significant), PERIPHERAL SWELLING (His right arm still hurts and is swollen), PAIN IN EXTREMITY (His right arm still hurts and is swollen. He can't put his arm over his head), FACIAL PAIN (His right eye ball and right side of his face hurts), NECK PAIN (It's hurting his neck and shoulder parts to push out of bed), EYE PAIN (His right eye ball and right side of his face hurts), JOINT INJURY (He hit his knee on the dresser) and ARTHRALGIA (It's hurting his neck and shoulder parts to push out of bed). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke/He only has one artery in his left neck. His right artery is blocked), PERIPHERAL SWELLING (His right arm still hurts and is swollen) and PAIN IN EXTREMITY (His right arm still hurts and is swollen. He can't put his arm over his head) had not resolved and FACIAL PAIN (His right eye ball and right side of his face hurts), NECK PAIN (It's hurting his neck and shoulder parts to push out of bed), EYE PAIN (His right eye ball and right side of his face hurts), JOINT INJURY (He hit his knee on the dresser) and ARTHRALGIA (It's hurting his neck and shoulder parts to push out of bed) outcome was unknown.            The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient had dose 1 on 15Feb2021 (lot-029L20A), dose 2 on 20Mar2021 (lot-036A214), dose 3 on 12Dec2021 (lot-077C21A) and dose 4 on 28Apr2022 (lot-004M21A).  The patient had all the side effects after taking the shot. The patient had a stroke. The right side of the patient's body doesn't produce anything. The patient only had one artery in the left neck. The patient's right artery was blocked. They did not tell that Spikevax contains all this stuff. The patient shouldn't have gotten that shot. The patient hit the knee on the dresser. The patient's right eye ball and right side of the face hurts. His wife was scared because the patient had only one artery on the left side of his neck to pump the blood. The patient's right arm still hurts and was swollen. The patient can't put his arm over the head. They put ice on it. It's hurting the neck and shoulder parts to push out of bed. No treatment medication was reported.  Company Comment: This is a spontaneous case concerning an elderly male patient with a history of Hypercholesterolemia, Blood pressure high and COPD, who experienced the serious (due to medically significant) unexpected, AESI event of Cerebrovascular accident, together with other non-serious events, which occurred on an unknown date after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine, received as the fifth dose of COVID-19 vaccination schedule. It was reported that the patient had a stroke. The right side of the patient's body doesn't produce anything. The patient's right artery was blocked. The patient hit the knee on the dresser. The patient's right eyeball and right side of the face hurts. The patient's right arm still hurts and was swollen. The patient can't put his arm over the head. They put ice on it. It's hurting the neck and shoulder parts to push out of bed. The mentioned medical history remains as confounders. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning an elderly male patient with a history of Hypercholesterolemia, Blood pressure high and COPD, who experienced the serious (due to medically significant) unexpected, AESI event of Cerebrovascular accident, together with other non-serious events, which occurred on an unknown date after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine, received as the fifth dose of COVID-19 vaccination schedule. It was reported that the patient had a stroke. The right side of the patient's body doesn't produce anything. The patient's right artery was blocked. The patient hit the knee on the dresser. The patient's right eyeball and right side of the face hurts. The patient's right arm still hurts and was swollen. The patient can't put his arm over the head. They put ice on it. It's hurting the neck and shoulder parts to push out of bed. The mentioned medical history remains as confounders. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.