Age: 81.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Computerised tomogram head, Head discomfort, Nausea, Thrombotic stroke
Clinical narrative: clot to the back left side of his brain/ Major stroke, Facial droop, he was repeating the word yes in his native language, right side slouching; he started to feel like he had butterflies between his ears; he felt a little bit nauseous; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOTIC STROKE (clot to the back left side of his brain/ Major stroke, Facial droop, he was repeating the word yes in his native language, right side slouching) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57144B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.  Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.  The patient's past medical history included Right heart failure and Heart valve operation (heart valve surgery). Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.  On 06-Sep-2022 at 4:00 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 06-Sep-2022 at 6:00 PM, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) at an unspecified dose. On 07-Sep-2022, the patient experienced NAUSEA (he felt a little bit nauseous). On 08-Sep-2022, the patient experienced HEAD DISCOMFORT (he started to feel like he had butterflies between his ears). On 09-Sep-2022, the patient experienced THROMBOTIC STROKE (clot to the back left side of his brain/ Major stroke, Facial droop, he was repeating the word yes in his native language, right side slouching) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 09-Sep-2022 to 13-Sep-2022 due to THROMBOTIC STROKE. The patient was treated with POTASSIUM for Nauseous, at an unspecified dose and frequency and Surgery (Performed a thrombectomy where the clot was removed in whole.) for Thrombotic stroke. At the time of the report, THROMBOTIC STROKE (clot to the back left side of his brain/ Major stroke, Facial droop, he was repeating the word yes in his native language, right side slouching), HEAD DISCOMFORT (he started to feel like he had butterflies between his ears) and NAUSEA (he felt a little bit nauseous) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram head: showing a major stroke, and a clot to the back of the left side of his brain.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.  Patient had received 4 doses of the Moderna COVID-19 vaccine by intramuscular injection. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form (lot number 013A21A, expiration date unknown). On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form (lot number 036A21A, expiration date unknown). On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form (lot number D13H21B, expiration date unknown). Patient administered the flu shot with his bivalent booster dose. On Friday 09-SEP-2022 patient felt like his right side was slouching. He was trying to smile with a facial droop, and he was repeating the word "yes" in his native language. He was then taken to the emergency room. While in the ER they were unable to administer stroke medicine. Performed a thrombectomy where the clot was removed in whole before being transferred to another hospital. Patient was admitted from Friday night to Tuesday afternoon before being transferred to a rehab center. Patient had been undergoing physical, occupational, and speech therapy. Patient was currently taking anti-stroke medicine. Prior to the events of 09-SEP-2022, patient was examined by his cardiologist on 05-AUG-2022. The contact had also spoken with his doctors who state he was not at risk for a stroke prior to his stroke. Patient had done blood work at his house and saw his doctor on the Monday prior to these events. Reporter had reported these COVID-19 safety events. Reporter had filed an injunction with the pharmacy. Reporter believes her father took these shots against his will.  Company Comment: This spontaneous case concerns an 81-year-old male patient with medical history of heart failure and heart valve surgery, who experienced the unexpected, serious (hospitalization and medically significant) event of thrombotic stroke (AESI) three days after the fourth dose of mRNA-1273.222. The patient describes that he had his right-side face drooping, with repetitive speech, for which he was taken to the emergency department. A head CT scan showed "a "major stroke," and a clot to the back of the left side of his brain", for which a thrombectomy was performed. He is currently undergoing physical, occupational, and speech therapy, and taking anti-stroke medication. The medical history of heart failure and heart valve operation, along with patient's age and concomitant administration of the influenza vaccine, could be risk factors for the event. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an 81-year-old male patient with medical history of heart failure and heart valve surgery, who experienced the unexpected, serious (hospitalization and medically significant) event of thrombotic stroke (AESI) three days after the fourth dose of mRNA-1273.222. The patient describes that he had his right-side face drooping, with repetitive speech, for which he was taken to the emergency department. A head CT scan showed "a "major stroke," and a clot to the back of the left side of his brain", for which a thrombectomy was performed. He is currently undergoing physical, occupational, and speech therapy, and taking anti-stroke medication. The medical history of heart failure and heart valve operation, along with patient's age and concomitant administration of the influenza vaccine, could be risk factors for the event. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.