Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electroencephalogram abnormal, Heart rate increased, Hypertension, Magnetic resonance imaging, Mental status changes
Clinical narrative: POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME; ANXIETY/AGITATION; FAST HEARTBEAT'; VERY HIGH BLOOD PRESSURE; SKIN RASH ON FACE AND SHOULDER; This spontaneous report received from a consumer concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included kidney transplant, and concurrent conditions included blindness, and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. Concomitant medications included olanzapine for confusion, and anxiety, and tacrolimus. On 15-MAR-2021, the patient experienced fast heartbeat, very high blood pressure. On 15-MAR-2021 and skin rash on face and shoulder. On 16-MAR-2021, the patient experienced anxiety/agitation, confusion and diagnosed with Posterior Reversible Encephalopathy Syndrome. Patient was hospitalized on 22-Mar-2021.Reporter seems that the vaccine partially triggered an adverse effect of patient anti-rejection pills tacrolimus and they took her off on 23-Mar-2021 probably Reporter said that could have caused the Posterior Reversible Encephalopathy Syndrome , but reporter was not sure. Patient was on antirejection medication from May 2020 to March 2021. Transplant was working perfect. Seems like after shot it might have triggered something to go wrong. It was a terrible thing, as it affected her mentally. The kidney function is still very good. The patient had two MRIs since March 22 and Posterior Reversible Encephalopathy Syndrome  had not changed very much. Patient still having some mental difficulty. The skin rash has resolved, just a little bit like acne. On 23-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, ECG (NR: not provided) Normal, and MRI (NR: not provided) POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME, On MAR-2021, Laboratory data included: MRI (NR: not provided) POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME. The patient was discharged on 29-Mar-2021.The patient was hospitalized for 8 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heartbeat', very high blood pressure, and skin rash on face and shoulder on 2021, was recovering from anxiety/agitation, and had not recovered from Posterior Reversible Encephalopathy Syndrome. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000179808.; Sender's Comments: V0- 20210532749-Covid 19 vaccine-This case concerns with 33 yr old female.  Posterior Reversible Encephalopathy Syndrome. 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, Conmeds- other suspect drugs. 20210532749-Covid 19 vaccine-Anxiety/agitation, fast heart beat, very high blood pressure. 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). 20210532749-Covid 19 vaccine-Skin rash on face and shoulder. This event(s) is labeled per RSI and is therefore considered potentially related.