Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Impaired quality of life
Clinical narrative: Had 3 Strokes; Quality of life has been greatly affected; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021.     This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had 3 Strokes) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Prostate cancer (History of prostate cancer 10 years ago). Concurrent medical conditions included Prediabetes, Hypertension, Benign prostatic hyperplasia, Hernia (Left in wall hernia) and Depression. Concomitant products included AMLODIPINE, LATANOPROST, SERTRALINE, TAMSULOSIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 21-Feb-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had 3 Strokes) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced IMPAIRED QUALITY OF LIFE (Quality of life has been greatly affected). The patient was hospitalized from 23-Feb-2021 to 27-Feb-2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency; ATORVASTATIN for Adverse event, at an unspecified dose and frequency; APIXABAN for Adverse event, at an unspecified dose and frequency; TIMOLOL for Adverse event, at an unspecified dose and frequency and Rehabilitation therapy (Rehabilitation center for 16 days) for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Had 3 Strokes) had not resolved and IMPAIRED QUALITY OF LIFE (Quality of life has been greatly affected) outcome was unknown.            At 10am and had 3 strokes on between 8 am and 9 am. He went to the ER and then the hospital and then to a rehabilitation center for 16 days and then had home health care for 3 weeks when he went home.  Patient went to the emergency room and was hospitalized till 27 Feb 2021 then went to the hospital, was there until 27 Feb 2021, went back home but he was still affected and has not recovered. He lost his right peripheral vision in both eyes, difficulty with his vision, can no longer drive, has balance problems, difficulty walking, shot term and long term memory loss, cognitive problem, his quality of life has been greatly affected, can no longer operate a car. He got on a heart monitor, Ipixiban. Patient had to learn how to walk and speak again for 16 days, speech therapy, physical therapy, occupation therapy for 16 days.  Patient had no history of any heart or stoke related issues.   Company Comment: This case concerns an 80-year-old male patient with relevant concurrent medical conditions prediabetes and hypertension and concurrent use of latanoprost who experienced serious unexpected event of stroke. The event occurred approximately 2 days after the second, most recent dose of Spikevax. Rechallenge was not applicable since the event occurred after the second dose. Patient's concurrent medical conditions and concomitant medication are possible confounders.   This case was linked to MOD-2021-319795 (Patient Link).; Sender's Comments: This case concerns an 80-year-old male patient with relevant concurrent medical conditions prediabetes and hypertension and concurrent use of latanoprost who experienced serious unexpected event of stroke. The event occurred approximately 2 days after the second, most recent dose of Spikevax. Rechallenge was not applicable since the event occurred after the second dose. Patient's concurrent medical conditions and concomitant medication are possible confounders.