Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Cerebrovascular accident
Clinical narrative: Stroke mostly affected right hand; Anxiety; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke mostly affected right hand) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4782590) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ill-defined disorder, Bone marrow biopsy (Bone marrow biopsy and diagnosed with leukemia) on 01-Jan-2021 and Tonsillectomy (Patient's concurrent condition ). Concurrent medical conditions included Platelet count increased since April 2020, Acute myeloblastic leukemia (Acute myeloblastic leukemia) since January 2021, Allergic reaction to analgesics (Opioids allergy), Motor dysfunction (Under Physical therapy treatment), Walking difficulty (Under Physical therapy treatment), Strength loss of (Under Physical therapy treatment) and Drug allergy (Hydrocodone bitartrate/acetaminophen allergy). Concomitant products included VENETOCLAX (VENCLEXTA) for Acute myeloblastic leukemia, HYDROCODONE BITARTRATE, HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) and ACETAMINOPHEN for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke mostly affected right hand) (seriousness criteria hospitalization and medically significant). In 2021, the patient experienced ANXIETY (Anxiety). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke mostly affected right hand) was resolving and ANXIETY (Anxiety) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown if patient was enrolled in COVID-19-vaccine trial.  On 01-Mar-2021, patient had a stroke and was taken to the hospital. The stroke mostly affected patient's right hand which was the dominant hand. patient stated that, there was some suspicion that the stroke was related to the Moderna Covid vaccine. On 20-Oct-2021, patient had difficulty to write because of stroke, patient had anxious. On 01-Nov-2021, patient had been working with therapy for a couple of months and thought that patient hand was improving but still did not had dependency and patient could not write well with right hand.  The patient stated that, patient was on an unknown medicine used to treat the patient for a condition where the patient had excessive platelet production in Apr 2020. However, despite receiving medication for the excessive platelet production, Patient was not making progress with the hemoglobin. Then on 01- Jan-2021, patient had a bone marrow biopsy where patient was diagnosed with leukemia and was doing physical therapy due to losing some motor function and strength, and not being able to walk. Treatment medication was not provided. The reporter's (non-health care professional, global introspection) causality for the events of Anxiety, Difficulty/could not write well with right hand, and Stroke mostly affected right hand with Venetoclax film-coated tablet was reported as not provided.  The other manufacturer's causality for the events of Anxiety and Stroke mostly affected right hand with Venetoclax film-coated tablet was reported as no reasonable possibility.  The other manufacturer's alternative etiology for Stroke mostly affected right hand with Venetoclax film-coated tablet was more likely related to increased risk from underlying Acute Myeloblastic leukemia in this elderly age patient, confounded by use of co-suspect COVID vaccine and for Anxiety was more likely related to stroke with underlying Acute Myeloblastic leukemia in this elderly age patient.  Company Comment: This is a Spontaneous case reported by a patient, concerning an 89-year-old male patient, with relevant current condition of acute myeloid leukemia with platelet count increased, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of Cerebrovascular accident, which occurred 41 days after the first dose of mRNA-1273 vaccine. The stroke mostly affected patient´s dominant right hand, which was treated with therapy. 8 months after the stroke, patient´s hand was improving. No information disclosed about diagnostic tests performed or other treatments received. At the time of the report, the event was resolving. Patient´s elderly age could confound the case, and underlying acute myeloid leukemia with platelet count increased could be a contributory factor for Cerebrovascular accident. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.    This case was linked to MOD-2022-662687 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2022: Follow-up document contains updated patient demographics.; Sender's Comments: This is a Spontaneous case reported by a patient, concerning an 89-year-old male patient, with relevant current condition of acute myeloid leukemia with platelet count increased, who experienced the unexpected and serious (due to hospitalization and medically significant) AESI of Cerebrovascular accident, which occurred 41 days after the first dose of mRNA-1273 vaccine. The stroke mostly affected patient´s dominant right hand, which was treated with therapy. 8 months after the stroke, patient´s hand was improving. No information disclosed about diagnostic tests performed or other treatments received. At the time of the report, the event was resolving. Patient´s elderly age could confound the case, and underlying acute myeloid leukemia with platelet count increased could be a contributory factor for Cerebrovascular accident. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.