Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Cerebral haemorrhage, Cerebrovascular accident, Computerised tomogram
Clinical narrative: LEFT SIDED WEAKNESS; STROKE; BRAIN BLEED; WEAKNESS; TIRED; SORE ARM; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 200 pounds, and height was 61 inches. The patient's concurrent conditions included: diabetes, non smoker, and non-alcoholic, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with metformin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 25-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included atorvastatin calcium, citalopram hydrobromide, clopidogrel, empagliflozin, famotidine, ferrous sulfate, gabapentin, levothyroxine sodium, meclozine hydrochloride/nicotinic acid, meloxicam, and ropinirole hydrochloride, unspecified Vitamins 11 pills, 3 pills, then 7 pills throughout the day for drug used for unknown indication. On 25-MAR-2021, the patient experienced sore arm for a couple days after receiving the vaccine. On 29-MAR-2021, four days after vaccination the patient experienced stroke and brain bleed, an ambulance was called for where she stated that she had a brain bleed and they gave her Alteplase (tPA). The patient underwent Computed tomography (CAT) scan done in the first hospital. She was taken by ambulance to a second hospital, where she was admitted to the Intensive care unit (ICU) for 4 to 6 days, and then on the regular unit for a couple. The patient was not admitted to the first hospital, she was admitted to the second hospital after testing and unspecified bloodwork. The patient was hospitalized for three months. The patient started getting tired and weak she believed sometime in APR-2021, her memory regarding the whole event was foggy. On an unspecified day, the patient was sent to a nursing home and at the nursing home, she had rehab done for her left sided weakness. They wanted her to stay in the nursing home, but she wanted to go home. The patient ended up staying in the nursing home for all of APR-2021, MAY-2021 and JUN-2021. She had caretakers that came to visit her at home. She was unaware for the reason for the hospital visits, she did not remember much about these events, only what was been told to her. On follow-up visit with a nurse at the end of MAY-2021, where the nurse noted that the brain bleed had resolved. All of the symptoms had resolved, except for residual left-sided weakness. She did not currently have a PCP. She had a doctor that visited her house, who wanted to send her to a cardiologist, but the cardiologist said her heart was clear. This doctor was aware of all of the events that took place, and she stated that the nursing home notified the doctor of everything that happened. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not provided, CAT scan (NR: not provided) not provided. Treatment medications (dates unspecified) included: alteplase. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain bleed on MAY-2021, and sore arm, weakness, and tired, had not recovered from left sided weakness, and the outcome of stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210949921-COVID-19 VACCINE AD26.COV2.S-Stroke, Brain bleed, Left sided weakness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).