Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: NON RESPONSIVE COMA; LEFT SIDE BRAIN HEMORRHAGE/HEADACHE/HEAD STILL HURTING/SPOKE WITH A SLUR; VERY HIGH FEVER/LIKE ON FIRE; HOT FLASHES/GETTING HOT/SWEATING; NOT FEELING GOOD/WELL; LEFT SIDE OF BODY PARALYZED/LEFT SIDE OF BODY COULD NOT MOVE/CAN NO LONGER WALK; FEEDING TUBE UNABLE TO SWALLOW; BLOOD PRESSURE 200 AND SOMETHING/100 SOMETHING; This spontaneous report received from a consumer concerned a 54year old African American and Not Hispanic/Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, and was taking blood pressure medications(unspecified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180503, and expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced hot flashes. On 10-APR-2021, at 11:00 the patient experienced fever and relieved upon taking fever relievers (unspecified) and had headache. On 11-APR-2021 and 12-APR-2021 the patient again experienced hot flashes and hotness. The patient also had headaches on 12-APR-2021, 13-APR-2021, and 14-APR-2021. The patient was not feeling well and continued taking pain relievers (unspecified) for headache. The feeling unwell was not resolved even in 16-APR-2021, Friday and his fever got worsen and taken pills. On 18-APR-2021, Sunday at 3:00 the patient was so hot that he was sweating in bed, and pillows were wet also feeling unwell and head was hurting badly. The patient was taken to hospital on the same day and confirmed hemorrhage in the brain. The patient's blood pressure was 200 and something/100 something, which was high. The patient had very high fever (like on fire) and experienced slurred speech.  The patient's condition has gotten worse on hospital admission and performed Magnetic Resonance Imaging (MRI) (result not provided). On the same day, the patient was taken for surgery after noticing hemorrhage in the right side of the brain and he went into non-responsive coma. The patient stayed in hospital till 06-MAY-2021 and was sent to rehab center thereafter. On an unknown date, the patient's left side of body paralyzed. The patient was unable to move left side of his body and sent him to rehab excel. On 04-JUL-2021, the patient was again taken to the hospital to get a feeding tube and experienced difficulty in swallowing the tube and again sent him back to rehab excel on 14-JUL-2021. Hemorrhage has been caused likely from the fever. The patient was on speech and physical therapy also he could no longer walk at the time of reporting. In total the patient was hospitalized for 28 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side brain hemorrhage/headache/head still hurting/spoke with a slur, non-responsive coma, hot flashes/getting hot/sweating, not feeling good/well, and very high fever/like on fire, was recovering from feeding tube unable to swallow, had not recovered from left side of body paralyzed/left side of body could not move/can no longer walk, and the outcome of blood pressure 200 and something/100 something was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210763166- covid-19 vaccine ad26.cov2.s- left side of body paralyzed/left side of body could not move/can no longer walk, left side brain hemorrhage/headache/head still hurting/spoke with a slur, non-responsive coma, hot flashes/getting hot/sweating. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE 20210763166- covid-19 vaccine ad26.cov2.s-not feeling good/well, and very high fever/like on fire. This event(s) is labeled per RSI and is therefore considered potentially related.