Sex: F
Vaccine: COVID19
Symptoms: Drug level, Electrocardiogram, Glycosylated haemoglobin, Laboratory test, Magnetic resonance imaging head
Clinical narrative: Stroke-like episode (NO FURTHER INFO AT THIS TIME); This report was received from business partner, Merck, with assigned Manufacturer Control Number of 2203USA007967.  Information has been received from an investigator concerning a 57-year-old female subject enrolled in a study.  The subject's concurrent conditions included hypertension, chronic anemia, schizophrenia, mixed hyperlipidemia, tobacco user, marijuana use, and multiple lacunar infarcts. Her medical history included a stroke, cocaine use, and acute ischemic stroke. Concomitant therapy included lisinopril (manufacturer unknown) and ^^acetylsalicylic acid (ASPIRINE)^^.  On 05-MAR-2022, the subject was randomized into the study protocol. On the same day at 12:19, she was vaccinated with single severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (mRNA-1273) at a dose of 50 microgram intramuscularly (IM), on her right arm; and at 12:20, with the first dose of pneumococcal vaccine, polyvalent (23-VALENT) (MK-V110) or pneumococcal 15v conj vaccine (CRM197) (MK-V114), or matching placebo, formulation: prefilled syringe, IM on her left arm. ^^The device operator was reported as the subject who had trained for this. Also the device was initially used per the instruction without device malfunction reported, which was also available for return.^^ Both suspect vaccines or placebo were administered as prophylaxis for pneumococcal infection. This was the only reported dose of SARS-COV-2 vaccine (mRNA-1273) and these were the last doses administered prior to the event onset.  The subject had prior stroke in 2019 with initial left (L) hemiparesis. On 19-MAR-2022 at 16:00, the subject experienced stroke-like episode (no further information at this time (Grade 4). The subject started having stuttering symptoms on that day around 16:00 of dysarthria and L hemiparesis, which self-resolved completely around 19:00. On 20-MAR-2022, the subject woke up and was seen by her husband at 07:00 in her usual state of health. Around 11:30, the subject started complaining of headache and was noticed to be limping on her left side and having slurred speech, she initially refused to seek medical help. Around 15:30, she felt lightheaded and generalized weakness. Emergency medical services (EMS) was called, and she was taken to emergency department (ER). On arrival, blood pressure (BP) was 182/132 (unit not reported), "FSG" was 141 (unit not reported), electrocardiogram (EKG) showed normal sinus rhythm (NSR), national institutes of health stroke scale (NIHSS) was 8 for dysarthria, "LUEF" and left lower extremity (LLE) were weakness. Computed tomography brain (CTB) without (w/o) contrast showed extensive periventricular white matter hypodensities, age-indeterminate lacunar infarct in the left gangliopcapsular region, partially empty sella (abnormal), and old appearing/age undetermined right (R) subcortical stroke. Computed tomography perfusion (CTP) with extensive motion articat, no penumbra visible and "TCTA" with no large vessel occlusion (LVO). She was admitted to the hospital because of stroke on that day and downgraded from intermediate care unit (IMCU). On the same day, the subject contacted the site and informed about the stroke that occurred. Stroke like episode was the exact adverse event (AE) term diagnosed in the hospital. On that day, general rephasing chest showed mild diffuse interstitial prominence suggestive of mild edema and/or infectious/ inflammatory process which was accentuated by vascular crowding in the setting of low lung volumes (abnormal). Pertinent laboratory tests were performed: on 20-MAR-2022, cocaine was presumptive. On 21-MAR-2022, magnetic resonance (MR) brain w/o contrast showed extensive involvement of the basal ganglia and the pons with increased T2 signal, this might have represented combined pontine and extrapontine myelinolysis. Extensive chronic ischemic changes of the supratentorial white matter; multiple supratentorial chronic lacunar infarcts; chronic microhemorrhages in the right lentiform nucleus and thalamus; multilevel moderate cervical spinal canal stenosis (abnormal). On 22-MAR-2022, glycohemoglobin was 5.6 (units not provided) (within normal limits [WNL]). On 23-MAR-2022, cholesterol was 209 (units not provided)-high (H). On the same day, chest X-Ray was normal. The subject started new medications at hospital and was later discharged with the same medications. The subject was given amlodipine 10 mg (23-MAR-2022), hydralazine 50 mg (23-MAR-2022) and candesartan 16 mg (24-MAR-2022) for hypertensive care; famotidine 20 mg (23-MAR-2022) for gastrointestinal prophylaxis; furosemide 20 mg (23-MAR-2022) for acute pulmonary edema; and rosuvastatin 10 mg (21-MAR-2022) for dislipidemia. The subject was also given oxygen supplementation, provided via nasal cannula to maintain oxygen (O2) saturation more than 92%. On 24-MAR-2022, the subject recovered from the event and was discharged with the diagnoses of bradycardia, severe sinus hypertensive crisis acute pulmonary edema dyslipidemia multiple lacunar infarcts right thalamic infarction bleeding in brain due to blood pressure disorder. Discharge summary stated the subject discharge condition was "stable" and was discharged with a walker per medical record. She would be followed upped by primary care physician (PCP) in 1-2 weeks post discharge. Records would be requested again in case if more laboratory tests were performed. On 07-APR-2022, the subject came to visit 3. It was confirmed visually and verbally by the subject that she had no need for the walker and was in stable condition. The walker might have been given to the subject just in case, but it was never used. On that day at 11:41, she was vaccinated the second dose of pneumococcal vaccine, polyvalent (23-VALENT) (MK-V110) or pneumococcal 15v conj vaccine (CRM197) (MK-V114), or matching placebo formulation: prefilled syringe, IM on her left arm. The action taken with pneumococcal vaccine, polyvalent (23-VALENT) (MK-V110) or pneumococcal 15v conj vaccine (CRM197) (MK-V114), or matching placebo was reported as dose not changed; with SARS-COV-2 vaccine (mRNA-1273) it was reported as not applicable.   The investigator considered the event to be not related to pneumococcal vaccine, polyvalent (23-VALENT) (MK-V110) or pneumococcal 15v conj vaccine (CRM197) (MK-V114), or matching placebo, SARS-COV-2 vaccine (mRNA-1273), or to the study procedure. The event was considered to be a life-threatening (LT) event by the investigator.   Updated information received from the investigator on 26-JUL-2022 had been captured between double caret (^^).  Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event of cerebrovascular accident is considered unlikely related to investigational vaccines. The evidence is not sufficient to suggest a relationship between the investigational vaccines and the reported serious adverse event. The causality assessment is impacted by the confounding factors such as patient's age, hypertension and hyperlipidaemia concurrent conditions, and stoke medical history which has been described as event's risk factors, with a diagnosis hypertensive crisis and constitutes a more plausible alternative explanation for the event.  Company Comment- No changes to investigational vaccines safety are warranted at this time. Merck continues to monitor the safety profile of 23-valent pneumococcal polysaccharide vaccine (V110) or 15-valent pneumococcal conjugate vaccine (V114). Moderna continues to monitor the safety profile of SARS-CoV-2 mRNA (mRNA  1273) vaccine.  Company Comment: This case concerns a 57-year-old female subject with a medical history of hypertension, chronic anemia, schizophrenia, mixed hyperlipidemia, and stroke, who experienced the unlisted life-threatening adverse event of stroke-like episode (no further information at this time). The event occurred 15 days after the first dose of mRNA-1273 and of pneumococcal vaccine, polyvalent (23-VALENT) (MK-V110), pneumococcal 15v conj vaccine (CRM197) (MK-V114), or matching placebo. The event was reported as resolved. The event was considered unrelated to IP in agreement with the Investigator´s assessment. The event might be explained by the subject's underlying history of Hypertension, hyperlipidemia and stroke. Age is an additional risk factor for the event.; Reporter's Comments: Company Comment: This case concerns a 57-year-old female subject with a medical history of hypertension, chronic anemia, schizophrenia, mixed hyperlipidemia, and stroke, who experienced the unlisted life-threatening adverse event of stroke-like episode (no further information at this time). The event occurred 15 days after the first dose of mRNA-1273 and of pneumococcal vaccine, polyvalent (23-VALENT) (MK-V110), pneumococcal 15v conj vaccine (CRM197) (MK-V114), or matching placebo. The event was reported as resolved. The event was considered unrelated to IP in agreement with the Investigator´s assessment. The event might be explained by the subject's underlying history of Hypertension, hyperlipidemia and stroke. Age is an additional risk factor for the event.