Johnson & Johnson

Pt received Janssen vaccine on 4/5/21 and did complain of arm soreness on 4/6/21. Arm assessed small bruising noted. Pt working with therapy on 4/8/21- she was complaining of pain, nsg assessed arm and found the RUE was blue in color and hard to touch. NP made aware, ordered warm compresses as needed to arm. MD assessed pt on 4/9/21 for a poss. UTI- IV Rocephin ordered and adm. Pt had an allergic reaction to IV Rocephin, pt sent to ER for eval and treatment. Pt was adm on 4/9/21 and returned to health on 4/15/21. When pt arrived her entire rt arm/hand is black in blue in color. Per patient and daughter- the bruising continued to get worse day by day after she had received the vaccine

Patient states that one week later - she is experiencing heavy urinary bleeding - fresh, red blood - no pain or irritation.

Mild shivers, then intense dry heaves for about 10 minutes (?) (was in bed sleeping), complete loss of bladder control (never before) when stood up Slept through much of the morning. Was OK after.

Details of Hospital Stay History of Present Illness The patient is a 79-year-old woman with a past medical history of hypertension, hypothyroidism, lumbar compression fracture, hiatal hernia, metastatic adenocarcinoma primary lung to bone and question liver, on immunotherapy pembrolizumab started 12/3/2019, changed to osimertinib, right leg superficial thrombosis, on Xarelto presented to hospital on 3/10/2020 with complaints of 2 months duration shortness of breath, worsened over a 4-day period. She was admitted to the hospital with a diagnosis of acute respiratory failure with concerns of acute PE. For all details regarding the patient's initial presentation please refer to history and physical exam dated 3/10/2021.

Pt w/significant cardiac hx p/w from LTC facility w/increasing confusion, decreased appetite, weakness over 4-5 days. No reported hx of cough, SOB, N/V, fever, or URI symptoms. CXR findings were clear. Ther was concern for dehydration due to worsening renal function. Pt tested positive for COVID-19 (4/24) despite Janssen vaccine (4/7) and pt stating they had COVID in December 2020. Pt admitted for additional management of COVID-19 infection w/acute metabolic encephalopathy, acute on chronic CHF, & AKI. Treated w/dexamethasone & remdesivir. Ultimately discharged 5 days later (4/28).

3/13/21 ER HPI: 83 y.o. female who presents to the Hospital Emergency Department by private auto with her daughter. The patient comes in because her blood pressure at home has been very high. It is actually not reading on her cuff. She has a very dull headache on the left side of her head, but states it is very mild. No chest pain. She might be a little bit short of breath, but not much more than normal. She denies any current neck pain. She states a few hours ago she had a little bit of pain in the left side of her neck that was just brief and then way. On my initial evaluation her systolic blood pressure was around 240. The patient does have a history of anxiety. She states she has had typical anxiety, but nothing new. 3/15 office followup note: Subjective: Patient is 83 y.o. year old female that is here for ER follow up. 2 ER visits over the weekend. BP was elevated into the systolic 200s. Has ringing in ears when BP was elevated On Saturday: Left side of throat dry Left side of face "doesn't feel right", hard for patient to describe When she woke up on Saturday, couldn't see out of left eye, this has improved Says her voice doesn't sound the same, "gravely" She did not tell the ER doctor on Saturday about the neurologic symptoms. In her 1st ER visit she had a chest x-ray which showed no acute disease. Cardiac enzymes were negative. ER doctor increased her losartan dose and gave her p.r.n. clonidine. In the early morning hours on Sunday, she returned to the ER. Blood pressure was elevated again at 208/85. Patient was given sublingual nitro and a Norvasc 5 mg tablet. After the sublingual nitro, blood pressure was 144/84. ER doctor discharge patient with follow-up today.

UTI 3/16/2021-3/20/2021. UTI 4/28/2021. Sensitivity to light 3/24/2021 - current. Blurry Vision 3/20/2021 - 3/24/2021. Partial blindness 4/04/2021 - current. Headaches 3/24/2021 - current. Doctor ruled not a stroke. Stroke of the eye due to blood clot or plaque build up is the highest suspected cause. No previous incidents of this nature had occured.

I was walking in the airport and I just fell for no reason. I went down slow. I was able to get up on my own, but I have no idea what made me fall. I went to my daughter's house and I was trying to climb the stairs to get to her place, but I couldn't even bring my leg up to step on the first step. I had to physically pull myself up the stairs by my arms. I felt like I lost my strength. I lost control of my bladder. I went to the doctor to have a urinalysis done and there was not an infection. I also lost my balance and would often have chills. Anytime I would start walking it would feel like I was drunk with how I couldn't walk straight. I felt fatigued during this time as well. During time that I would try to speak, I would say something in a sentence that had nothing to do with the topic of conversation. I was thinking I may have had a stroke, but when I went to the doctor and had a CT scan, a brain MRI and blood work done, everything came back normal. All of this lasted three weeks and then just all went away. My doctor diagnosed me with post COVID viral illness, but I never had COVID. She said it's similar to a viral meningitis.

On the morning of admission, patient had another episode. She was sitting at the kitchen table and then slumped forward unconscious. She has no memory of the episode. Daughter is unsure how long she was unconscious for. She was taken to the ER via ambulance. Head CT in the ER showed only age-related changes. Chest x-ray showed an increase in infiltrate. Influenza test negative. Rapid COVID-19 test negative. Urinalysis only had 2+ leukocyte esterase. White count of 3.3. Cardiac enzymes negative. BNP normal. remains hospitalized at Hospital - inpatient

BLURRY VISION; UNCONTROLLABLE SHAKING; JAW PAIN; PAIN ON LEFT SIDE NEAR KIDNEY; FELT BODY HOT/BODY BURNING HOT; DIZZY; PAIN IN BONES ALL OVER BODY; FREEZING COLD; CHILLS; PAIN IN LEFT ARM WHERE INJECTED; HEADACHE; FEVER; This spontaneous report received from a patient concerned an 84 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, and hypothyroidism, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism, and insulin for type 1 diabetes. On 11-APR-2021, the subject experienced blurry vision. On 11-APR-2021, the subject experienced uncontrollable shaking. On 11-APR-2021, the subject experienced jaw pain. On 11-APR-2021, the subject experienced pain on left side near kidney. On 11-APR-2021, the subject experienced felt body hot/body burning hot. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced pain in bones all over body. On 11-APR-2021, the subject experienced freezing cold. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced pain in left arm where injected. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from uncontrollable shaking, and chills on 11-APR-2021, jaw pain on 12-APR-2021, and felt body hot/body burning hot, freezing cold, pain in left arm where injected, headache, and fever on 13-APR-2021, was recovering from blurry vision, and pain on left side near kidney, and the outcome of dizzy and pain in bones all over body was not reported. This report was non-serious.

On 2/27/21, pt had new onset chest congestion, exhaustion and shortness of breath, but no fevers (measured at home) nor orthopnea. Visited primary doctor who urged her to visit ED. On ED visit on 3/4/21, she was found to be in afib RVR (heart rate to 170s) that was refractory initially to dilt push, dilt oral, dilt gtt. On 3/7/21, stroke alert was called because of new right arm dis-coordination, and on 3/8/21, MR brain showed an acute right cerebellar artery infarct (which did not leave deficits). Prior to the vaccine, pt had absolutely no symptoms of heart failure or cardiac diagnoses. She was hospitalized from 3/4/21-3/13/21, 3/18/21-3/23/21 for afib RVR, congestive heart failure, and acute kidney injury which required dilt and diuretics. However, she was later hospitalized on 4/8/21-4/11/21 again for afib RVR, congestive heart failure and acute kidney injury. Finally after continued outpatient amiodarone, she returned to normal sinus rhythm. Patient has shared that she has never experienced such drastic health changes in her life and these frequent hospitalizations occurred after her Janssen shot.

BLE EDMEA/PAIN, GAIT DISTURBANCE, GENERALIZED WEAKNESS PRESENTED TO ER ON 5/1/2021 SYMPTOMS STARTED ON 4/30/2021. SHE WAS FOUND TO HAVE BLE DVT. NO EVIDENCE OF CT PE. REPORTED HAD J&J COVID VACCINE ON 4/6/2021. RECENT HOSPITAL ADMIT FROM 4/28/2021 TO 4/30/2021 WITH ACUTE RENAL FAILURE AND ACUTE CYSTITIS. PT ADMITTED TO MED SURG FLOOR. CALL REC'D FROM PROVIDER NOTIFIING OF RECENT COVID VACCINE AND NEEDED VAERS REPORT COMPLETED.