Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Embolic stroke, Hyperlipidaemia, Inappropriate schedule of product administration
Clinical narrative: embolitic stroke; hyperlipidemia; 1st booster dose - 15Jan2022 and 2nd booster dose - 25Apr2022; This spontaneous case was reported by a patient and describes the occurrence of EMBOLIC STROKE (embolitic stroke) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 010A21A, 019D21A and 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu vaccine (Sep/Oct2021) in 2021. Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Allergy to antibiotic (cipro), Sulfonamide allergy (sulfa drugs) and Prehypertension. Concomitant products included AMLODIPINE and LISINOPRIL for Hypertension.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster dose - 15Jan2022 and 2nd booster dose - 25Apr2022). On 30-Apr-2022, the patient experienced EMBOLIC STROKE (embolitic stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HYPERLIPIDAEMIA (hyperlipidemia). The patient was hospitalized from 30-Apr-2022 to 02-May-2022 due to EMBOLIC STROKE. The patient was treated with EVOLOCUMAB (REPATHA) in October 2021 for Hyperlipidemia, at a dose of Injectable 2x a week every other week; CLOPIDOGREL BISULFATE (PLAVIX) in April 2022 for Hyperlipidemia, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] in April 2022 for Hyperlipidemia, at an unspecified dose and frequency and ROSUVASTATIN in April 2022 for Hyperlipidemia, at a dose of 10 milligram once a day. At the time of the report, EMBOLIC STROKE (embolitic stroke) had not resolved and HYPERLIPIDAEMIA (hyperlipidemia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster dose - 15Jan2022 and 2nd booster dose - 25Apr2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 130/68 (latest reading) and 150/68 (without medication). On an unknown date, Blood test: excellent (before shot) and hyperlipidemia (after shot).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient never had COVID positive test or diagnosis. The third embolitic stroke happened after getting the second booster dose. Patient was admitted at a different hospital for 3 days. The patient still had deficits from the stroke (after the second stroke), had some memory deficits, loss of balance, weakness in legs and tremors in both hands.  Company comment:  This spontaneous concerns a 70 year old male patient, with a relevant history of hypertension, who experienced the serious (hospitalization, medically significant) unexpected adverse events of special interest Embolic stroke, which occurred 6 days after the fourth dose of mRNA-1273 vaccine administration. Inappropriate schedule of vaccine administered was also reported. The outcome was reported as  not resolved.  Patient was admitted at a hospital for 3 days. The patient still had deficits from the stroke (after the second stroke), had some memory deficits, loss of balance, weakness in legs and tremors in both hands. Underlying  history of hypertension and patient's age and gender could be confounders for the event. The benefit -risk relationship of mRNA -1273 is not affected by this report.   This case was linked to MOD-2022-612532, MOD-2022-612571 (Patient Link).; Sender's Comments: This spontaneous concerns a 70 year old male patient, with a relevant history of hypertension, who experienced the serious (hospitalization, medically significant) unexpected adverse events of special interest Embolic stroke, which occurred 6 days after the fourth dose of mRNA-1273 vaccine administration. Inappropriate schedule of vaccine administered was also reported. The outcome was reported as  not resolved.  Patient was admitted at a hospital for 3 days. The patient still had deficits from the stroke (after the second stroke), had some memory deficits, loss of balance, weakness in legs and tremors in both hands. Underlying  history of hypertension and patient's age and gender could be confounders for the event. The benefit -risk relationship of mRNA -1273 is not affected by this report.