Age: 78.0
Sex: M
Vaccine: COVID19-2, COVID19, FLUX
Symptoms: Impaired driving ability, Insomnia, Mental impairment, Posture abnormal, Road traffic accident
Clinical narrative: Mild diastolic dysfunction; Trivial tricuspid regurgitation; Atrophy and chronic microvascular ischemic disease; Inferior infarct; Basilar artery stenosis; needed to relearn how to keep balance; needed to relearn how to remember; Left pontine ischemic stroke/ was confused not thinking straight/ was confused not thinking straight / needed to relearn how to think/ during night time caller could hardly walk / gait issues   / needed to relearn how to walk/; Right bundle branch block; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ISCHAEMIC STROKE (Left pontine ischemic stroke/ was confused not thinking straight/ was confused not thinking straight / needed to relearn how to think/ during night time caller could hardly walk / gait issues   / needed to relearn how to walk/), BUNDLE BRANCH BLOCK RIGHT (Right bundle branch block), MYOCARDIAL INFARCTION (Inferior infarct), BASILAR ARTERY STENOSIS (Basilar artery stenosis), BALANCE DISORDER (needed to relearn how to keep balance), MEMORY IMPAIRMENT (needed to relearn how to remember), DIASTOLIC DYSFUNCTION (Mild diastolic dysfunction), TRICUSPID VALVE INCOMPETENCE (Trivial tricuspid regurgitation) and CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE (Atrophy and chronic microvascular ischemic disease) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:No known conditions, It was reported patient had no significant medical problem.  The patient's past medical history included Appendectomy, Hip arthroplasty and Knee arthroplasty. Family history included Heart disease, unspecified (cousin). Concurrent medical conditions included Non-smoker (Never), Abstains from alcohol and Penicillin allergy.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 microgram. On 15-Dec-2021, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In 2021, the patient experienced ARTHRALGIA (shoulder pain). On 20-Dec-2021, the patient experienced BUNDLE BRANCH BLOCK RIGHT (Right bundle branch block) (seriousness criterion hospitalization) and CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE (Atrophy and chronic microvascular ischemic disease) (seriousness criteria hospitalization and medically significant). On 21-Dec-2021, the patient experienced DIASTOLIC DYSFUNCTION (Mild diastolic dysfunction) (seriousness criterion hospitalization) and TRICUSPID VALVE INCOMPETENCE (Trivial tricuspid regurgitation) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ISCHAEMIC STROKE (Left pontine ischemic stroke/ was confused not thinking straight/ was confused not thinking straight / needed to relearn how to think/ during night time caller could hardly walk / gait issues   / needed to relearn how to walk/) (seriousness criteria hospitalization and medically significant), MYOCARDIAL INFARCTION (Inferior infarct) (seriousness criteria hospitalization and medically significant), BASILAR ARTERY STENOSIS (Basilar artery stenosis) (seriousness criteria hospitalization and medically significant), BALANCE DISORDER (needed to relearn how to keep balance) (seriousness criterion hospitalization) and MEMORY IMPAIRMENT (needed to relearn how to remember) (seriousness criterion hospitalization). The patient was hospitalized from 20-Dec-2021 to 22-Dec-2021 due to BALANCE DISORDER, BASILAR ARTERY STENOSIS, BUNDLE BRANCH BLOCK RIGHT, ISCHAEMIC STROKE, MEMORY IMPAIRMENT and MYOCARDIAL INFARCTION. The patient was treated with ACETAMINOPHEN (oral) at a dose of 650 milligram every six hours; ASPIRIN [ACETYLSALICYLIC ACID] (oral) at a dose of 81 milligram once a day; ATORVASTATIN CALCIUM (LIPITOR) (oral) at a dose of 80 milligram at bedtime and FAMOTIDINE (PEPCID [FAMOTIDINE]) (oral) at a dose of 20 milligram twice a day. At the time of the report, ISCHAEMIC STROKE (Left pontine ischemic stroke/ was confused not thinking straight/ was confused not thinking straight / needed to relearn how to think/ during night time caller could hardly walk / gait issues   / needed to relearn how to walk/), BUNDLE BRANCH BLOCK RIGHT (Right bundle branch block), MYOCARDIAL INFARCTION (Inferior infarct), BASILAR ARTERY STENOSIS (Basilar artery stenosis), BALANCE DISORDER (needed to relearn how to keep balance), MEMORY IMPAIRMENT (needed to relearn how to remember), DIASTOLIC DYSFUNCTION (Mild diastolic dysfunction), TRICUSPID VALVE INCOMPETENCE (Trivial tricuspid regurgitation) and CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE (Atrophy and chronic microvascular ischemic disease) outcome was unknown and ARTHRALGIA (shoulder pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2021, Bacterial test: Trace  unit:- HPF  reference range:- none. On 20-Dec-2021, Basophil count (0-0.10 thousand per cubic millimetre): 0.10 thousand per cubic millimetre. On 20-Dec-2021, Basophil percentage (0-3 %): 0.8 %. On 20-Dec-2021, Bilirubin urine: (Negative) unit:- mg/dl  reference range:- Negative. On 20-Dec-2021, Blood chloride (98-107 millimole per litre): 104 millimole per litre. On 20-Dec-2021, Blood potassium (3.5-5.1 millimole per litre): 4.1 millimole per litre. On 20-Dec-2021, Blood sodium (136-145 millimole per litre): 138 millimole per litre. On 20-Dec-2021, Blood urine present: (Negative) reference range:- Negative. On 20-Dec-2021, Carbon dioxide (20-30 millimole per litre): 24 millimole per litre. On 20-Dec-2021, Chest X-ray: Heart size is normal. Pulmonary vascularity normal. No other pneumothorax, consolidation, effusions or nodules. Degenerative changes in the thoracic spine.. On 20-Dec-2021, Computerised tomogram: Right common carotid, cervicaiiCA and proximal ECA demonstrate contrast opacification with no occlusion, flow limiting stenosis, or intimal flap to suggest dissection. Left common carotid, cervicaiiCA and proximal ECA demonstrate contrast opacification, with no occlusion, flow limiting stenosis, or intimal flap to suggest dissection. Vertebral arteries demonstrate normal course to the level of the skull base and show no occlusion, flow limiting stenosis or dissection. Relatively diminutive right vertebral artery which enhances to the occipital condyle level No flow limiting stenosis or anomaly of the great vessel origins. No concerning asymmetric neck soft tissue abnormality. Multi-level cervical degenerative disc and articular pillar arthropathy is present. Developmental non-fusion posterior neural arch of C 1 .. On 20-Dec-2021, Electrocardiogram: Normal sinus rhythm Left axis deviation Right bundle branch block Inferior infarct , age undetermined No previous ECG available for compari. On 20-Dec-2021, Eosinophil count (0-0.70 thousand per cubic millimetre): 0.30 thousand per cubic millimetre. On 20-Dec-2021, Eosinophil percentage (0-7 %): 3.7 %. On 20-Dec-2021, Glucose urine: (Negative) unit:- mg/dl  reference range:- Negative. On 20-Dec-2021, Haematocrit: 40.8 %. On 20-Dec-2021, Haemoglobin (13.7-17 g/dL): 13.8 g/dL. On 20-Dec-2021, Lymphocyte count (0.50-4.80 thousand per cubic millimetre): 1.80 thousand per cubic millimetre. On 20-Dec-2021, Lymphocyte percentage (19-48 %): 25.2 %. On 20-Dec-2021, Mean cell haemoglobin (27-33 pg): 31.3 pg. On 20-Dec-2021, Mean cell haemoglobin concentration (32-37 g/dL): 33.7 g/dL. On 20-Dec-2021, Mean cell volume (81-98 fL): 92.9 fL. On 20-Dec-2021, Mean platelet volume (6.0-11.1 fL): 8.8 fL. On 20-Dec-2021, Monocyte count (0-.80 thousand per cubic millimetre): 0.60 thousand per cubic millimetre. On 20-Dec-2021, Monocyte percentage (0-12 %): 8.9 %. On 20-Dec-2021, Neutrophil count (1.60-8.50 thousand per cubic millimetre): 4.40 thousand per cubic millimetre. On 20-Dec-2021, Neutrophil percentage (40-74 %): 61.4 %. On 20-Dec-2021, Nitrite urine: (Negative) reference range:- Negative. On 20-Dec-2021, Platelet count (150-400 thousand per cubic millimetre): 161 thousand per cubic millimetre. On 20-Dec-2021, Protein urine: (Negative) unit:- mg/dl  reference range:- Negative. On 20-Dec-2021, Red blood cell count (4.20-5.60 million per microlitre): 4.39 million per microlitre. On 20-Dec-2021, Red blood cells urine: <1  unit:- HPF  reference range:- 0-5. On 20-Dec-2021, Red cell distribution width (11.5-14.5 %): 13.4 %. On 20-Dec-2021, Specific gravity urine: 1.005  reference range:- 1.000-1.030. On 20-Dec-2021, Urine ketone body: (Negative) unit:- mg/dl  reference range:- Negative. On 20-Dec-2021, Urine leukocyte esterase: (Negative) reference range:- Negative. On 20-Dec-2021, Urobilinogen urine: (Negative) unit:- mg/dl  reference range:- Negative. On 20-Dec-2021, White blood cell count (4-11 thousand per cubic millimetre): 7.1 thousand per cubic millimetre. On 20-Dec-2021, White blood cells urine: 1  unit: HPF reference range:- 0-5. On 20-Dec-2021, pH urine: 7.0, reference range:- 5.0-9.0. On 21-Dec-2021, Alanine aminotransferase (11-55 international unit per litre): 15 international unit per litre. On 21-Dec-2021, Albumin globulin ratio: 1.1 [1.1-1.8]. On 21-Dec-2021, Angiogram: Unremarkable CT Angiogram of the neck.. On 21-Dec-2021, Anion gap: 10.0 millimole per litre. On 21-Dec-2021, Aspartate aminotransferase (5-34 international unit per litre): 29 international unit per litre. On 21-Dec-2021, Blood albumin (3.4-4.8 gram per decilitre): 4 gram per decilitre. On 21-Dec-2021, Blood alkaline phosphatase (40-150 international unit per litre): 82 international unit per litre. On 21-Dec-2021, Blood bilirubin (0.2-1.2 mg/dl): 0.4 mg/dl. On 21-Dec-2021, Blood calcium (8.4-10.8 mg/dl): 10.1 mg/dl. On 21-Dec-2021, Blood chloride: 104. On 21-Dec-2021, Blood cholesterol: 188 mg/dl 04:31 and 188 mg/dl. On 21-Dec-2021, Blood creatinine (0. 72-1.25 mg/dl): 0.99 mg/dl. On 21-Dec-2021, Blood glucose (70-105 mg/dl): 117 mg/dl and 118 mg/dl. On 21-Dec-2021, Blood magnesium (1.6-2.6 mg/dl): 2.1 mg/dl and 2.1. On 21-Dec-2021, Blood osmolarity (275-300 millimole per kilogram): 277 millimole per kilogram. On 21-Dec-2021, Blood potassium: 4.1. On 21-Dec-2021, Blood sodium: 138. On 21-Dec-2021, Blood triglycerides (7-150 mg/dl): 106 mg/dl. On 21-Dec-2021, Blood urea (8-26 mg/dl): 13 mg/dl and 13. On 21-Dec-2021, Chest X-ray: No acute consolidation or pneumothorax.. On 21-Dec-2021, Echocardiogram: Normal LV systolic function and wall motion with an ejection fraction of >55%2., Mild diastolic dysfunction, TraceTR, No pericardia! effusion, Negative bubble study.. On 21-Dec-2021, Glomerular filtration rate: 73 ml/min/1.73m2 and 89 ml/min/1.73m2. On 21-Dec-2021, Glycosylated haemoglobin: 5.7 % <=6.5. On 21-Dec-2021, High density lipoprotein: 5, 04:31, 38 mg/dl 04:31 and 38 mg/dl. On 21-Dec-2021, Lipoprotein (a): 129 mg/dl. On 21-Dec-2021, Low density lipoprotein: 129 mg/dl <=100. On 21-Dec-2021, Magnetic resonance imaging: Seen along the left side of the pons there are areas of restricted diffusion punctate areas approximately 5 mm each 3 in total, in the superior anterior portion. No other areas of significant restricted diffusion. Moderate increase prominence of the CSF spaces. There are mild bilateral subcortical and periventricular white matter high T2 signal likely representing chronic microvascular ischemic change. There is no midline shift. There is no cerebellar tonsillar herniation at the foramen magnum. No mass lesion or abnormal fluid collection. Intracranial flow voids are normal. Sinuses unremarkable. Mastoid air cells are patent. Orbits unremarkable. Evidence of acute infarction along the left anterior superior pons. Atrophy and chronic microvascular ischemic disease.. On 21-Dec-2021, Non-high-density lipoprotein cholesterol: 150 mg/dl. On 21-Dec-2021, Platelet count (150-400 thousand per cubic millimetre): 161 thousand per cubic millimetre. On 21-Dec-2021, Protein total (6.4-8.3 gram per decilitre): 7.5 gram per decilitre. On 21-Dec-2021, Total cholesterol/HDL ratio: 5. On 21-Dec-2021, Troponin (0.010-0.033 ng/mL): 0.010 ng/mL. On 21-Dec-2021, Very low density lipoprotein (1-40 mg/dl): 21 mg/dl. On an unknown date, Blood pressure measurement: 152/84. On an unknown date, Heart rate: 66(Peripheral). On an unknown date, Oxygen saturation: 97 %. On an unknown date, Respiratory rate: 15.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient also reported that he could not write or speak well /   needed to relearn how to write, speak/ he could not write or speak well / needed to relearn how to talk/ Slurred speech/ CVA / Possible stroke/diagnosis for this patient was a stroke/ needed to relearn how to drive/ Atrophy/ acute infarction/ ischemic disease/ Left pontine ischemic stroke / was confused not thinking straight/ was confused not thinking straight / needed to relearn how to think/ during night time caller could hardly walk / gait issues.  No concomitant medications details were reported.  Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  After 1st and 2nd dose patient only experienced shoulder pain. After 1st booster, on 20-Dec-2021 during night time patient could hardly walk, patient was confused not thinking straight, patient could not write or speak well, next morning patient's wife insisted to go to the hospital and called an ambulance very late at night and ended up in ER, patient was in the hospital during 3 days and he had to do exercises to recover, relearn to write, speak, walk, and currently it was still very hard to control body functions.  It was reported that Patient woke up shortly after midnight on December 20, 2021 with slurred speech and difficulty walking. He was hesitant to go to the hospital but Inpatient eventually presented late in the day on December 20, 2021. I discussed the case with the emergency room physician. he had also reviewed the admission note along with the patient's data in the EHR. Patient had remained stable without progression of deficit or new neurologic symptoms. CT scan of the head reviewed including actual imaging and is unremarkable. CTA of the head and neck shows a small right vertebral artery that ends at approximately the skull base. To my review I believe there is also a mid basilar artery focal area of stenosis on the CTA. MRI is completed and reveals a left penetrating artery distribution infarct in the pons. But is otherwise unremarkable. Carotid ultrasound was unremarkable. Laboratory noted. Cholesterol 188 LDL 129. No modifying .factors. Obviously high severity. At the time of emergency head was atraumatic, normocephalic. normal dentition, eyes were normal conjunctiva and lids, CVS Heart, RRR. No murmur. Palp pulses all extremities and no edema. Neck was palpable carotid pulses. No bruits. No masses. Chest had breath sounds bilateral, normal respiratory effort, ABD was soft, nontender, plus bowel sounds, Skin was warm, dry with no rash, Psych was appropriate mood and affect, Musculoskeletal was Minor arthritic changes. No gross joint abnormalities. Mental status was Oriented times three, normal short-term memory with recall after distraction. Remote memory was intact. Attention and concentration were normal. Speech normal with no aphasia. Receptive and expressive language function was intact, including vocabulary. Mood was appropriate. Fund of knowledge was good with knowledge of current events. Cranial Nerves: PERRLA. Full visual fields and adequate acuity. Full extraocular movement and conjugate gaze. Sensation of face and muscles of mastication were normal. Symmetric face with normal movement. Hearing intact bilaterally. Palate moves well and symmetrically. Normal shoulder shrugs. The tongue had normal movement. Mildly dysarthric. Motor: Symmetric but mildly and diffusely weak in major muscle groups in all four extremities. Bulk and tone normal. Sensory: Intact to touch, temperature, position. Reflexes were one plus and symmetric. Coordination or Cerebellar were No nystagmus. Good extraocular movements. No deficits in extremities. Gait or Station was Unsteady gait, nonspecifically.   Patient was taken by ambulance to the Emergency Room, treated, than admitted to the Hospital on December 21, 2021. He was diagnosed with having suffered a severe ischemic stroke, he would like all those records. On 15-Dec-2021, just 6 days earlier he had his 3dr Moderna vaccination, booster shot, and for influenza. No one told me that the stroke could have been caused by one or both vaccinations. He believe it should had been reported to government authorities. He was severely injured. He needed to relearn how to walk, talk, write, speak, keep my balance, drive, think and remember. He received Home Medical services for approximately 2 months. He still had serious problems and poor perception when making a left-hand turn resulted in a car accident which totaled my 2010 car. No one was injured.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 78-year-old male patient, with no relevant medical history, who experienced the unexpected and serious (due to hospitalization and medically significant) events of Myocardial infarction (AESI), Cerebral small vessel ischemic disease (AESI), Basilar artery stenosis, and Ischaemic stroke (AESI), and the unexpected and serious (due to hospitalization) events of Diastolic dysfunction, Tricuspid regurgitation, Bundle branch block right (AESI), Balance disorder and Memory impairment, which occurred within the first week after the third dose of mRNA-1273 vaccine. Influenza vaccine was administered the same day, and remains as a co-suspect product. Patient started 5 days after vaccination with slurred speech, he could hardly walk, he was confused, not thinking straight, he could not write or speak well and had difficulty walking. He was admitted to hospital, where several studies were performed. Patient was hypertensive with a blood pressure of 152/84. MRI of brain showed acute infarction along the left anterior superior pons, atrophy and chronic microvascular ischemic disease. Echocardiogram showed mild diastolic dysfunction, with normal left ventricle function and wall motion, with an ejection fraction of >55%; trivial tricuspid regurgitation was present. ECG revealed left axis deviation, right bundle branch block and inferior infarct. Troponin was normal (0.010 ng/mL). Computed tomography angiography of the neck was unremarkable. Chest x-ray showed no acute consolidation or pneumothorax. He received treatment with acetaminophen 650mg every 6 hours, aspirin 81 mg daily, Lipitor 80 mg once a day and Pepcid 20 mg twice a day. Patient was discharged after 3 days. He had to relearn how to walk, talk, write, speak and keep his balance. He received Home Medical services for approximately 2 months. He still has serious problems and poor perception. Patient´s underlying elderly age could be a confounding factor for the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2023: Live follow-up received contains additional no new information. On 31-Jan-2023: Follow-up received contains additional event information, lab data, Patient information, Reporter details, treatment details were updated.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 78-year-old male patient, with no relevant medical history, who experienced the unexpected and serious (due to hospitalization and medically significant) events of Myocardial infarction (AESI), Cerebral small vessel ischemic disease (AESI), Basilar artery stenosis, and Ischaemic stroke (AESI), and the unexpected and serious (due to hospitalization) events of Diastolic dysfunction, Tricuspid regurgitation, Bundle branch block right (AESI), Balance disorder and Memory impairment, which occurred within the first week after the third dose of mRNA-1273 vaccine. Influenza vaccine was administered the same day, and remains as a co-suspect product. Patient started 5 days after vaccination with slurred speech, he could hardly walk, he was confused, not thinking straight, he could not write or speak well and had difficulty walking. He was admitted to hospital, where several studies were performed. Patient was hypertensive with a blood pressure of 152/84. MRI of brain showed acute infarction along the left anterior superior pons, atrophy and chronic microvascular ischemic disease. Echocardiogram showed mild diastolic dysfunction, with normal left ventricle function and wall motion, with an ejection fraction of >55%; trivial tricuspid regurgitation was present. ECG revealed left axis deviation, right bundle branch block and inferior infarct. Troponin was normal (0.010 ng/mL). Computed tomography angiography of the neck was unremarkable. Chest x-ray showed no acute consolidation or pneumothorax. He received treatment with acetaminophen 650mg every 6 hours, aspirin 81 mg daily, Lipitor 80 mg once a day and Pepcid 20 mg twice a day. Patient was discharged after 3 days. He had to relearn how to walk, talk, write, speak and keep his balance. He received Home Medical services for approximately 2 months. He still has serious problems and poor perception. Patient´s underlying elderly age could be a confounding factor for the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.