Johnson & Johnson

Patient received vaccine in the AM of 3/16/21. Patient was in his usual state of health when he went to bed the evening of 3/16/21. He ate dinner normally and his PD was started as usual. There were no overnight complications with his PD and he got up shortly before 8 AM. Mom reports the dialysate from his bag was clear and normal and none of his dwell was retained. She heard a loud thud from the bathroom around 8 AM and the patient was found by his mother having generalized convulsions (bilateral upper and lower extremities) and he appeared to be foaming at the mouth. He did not respond to her and she called 911. The seizure stopped by the time EMS arrived and his initial GCS was 12, and 15 by the time they started transport. He had another seizure en route around 9:30 AM and was given 2.5 mg versed and required bagging. Patient was loaded with Keppra and now has been on maintenance Keppra. Patient has not suffered any additional seizures and is currently undergoing an extensive workup by inpatient neurology team. Vaccine adverse effect currently remains on the differential for inciting event leading to seizure however additional labs are pending to rule out other causes (eg. viruses causing PML). Patient was also diagnosed with multifocal pneumonia and started on antibiotics at time of admission.

Patient received Janssen COVID vaccination on April 6, 2021. Pt had no symptoms initially after vaccination. Pt started coughing up blood and having episodes of dyspnea on April 25, 2021. Pt went to Urgent Care earlier in the day on May 11, 2021 - no medications were given, told he was fine. Pt then went to Medical Center and was found to be pale, diaphoretic, and tachycardic in triage. Pt vitals were temp: 36.6; pulse: 128; respirations: 22; BP: 161/129; SpO2: 97. Hospital medications: carvedilol 6.25mg PO BID, enoxaparin sodium 40mg SQ Q24h, azithromycin 500mg/sodium chloride 250mLs @ 250 mLs/hr IV Q24h, ceftriaxone sodium 2gm/sodium chloride 50mLs @ 100mLs/hr IV Q24h, lisinopril 2.5mg tablet PO QD, metoprolol tartrate 5mg IV Q5MP prn tachycardia. ER disposition: consult for admission Dx: hypertensive urgency, tachycardia, suspected COVID virus infection, bilateral pneumonia

Developed clots in both right and left lungs. Wedge shaped infarction in left lung. Extreme headaches. Pulmonary emboli and plural infusion.

HPI This is a 19-year-old male that presents for complaint of witnessed seizure-like activity. He arrives by EMS. Patient is currently awake alert and oriented ×3. Today, he was out on the golf course with friends. It was a normal day and he returned home. When he got home, he was complaining of a headache to his mother. She gave him Motrin. Mother then heard a noise from the other room and found the patient on the floor unresponsive, displaying tonic-clonic activity, and eye rolling into the back of the head. This lasted for 4-5 minutes per mother. EMS arrived on scene he was postictal. Patient is never had this happen before. He denies any illicit substance, alcohol or medication use. Review of Systems Constitutional: Negative for chills, fatigue and fever. HENT: Negative for facial swelling and trouble swallowing. Respiratory: Negative for cough, shortness of breath and wheezing. Cardiovascular: Negative for chest pain and palpitations. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria and frequency. Musculoskeletal: Negative for back pain and neck pain. Skin: Negative for rash and wound. Neurological: Positive for seizures and syncope. Negative for weakness, light-headedness and headaches. Psychiatric/Behavioral: Negative for confusion. The patient is not nervous/anxious.

FEMORAL DEEP VEIN THROMBOSIS; This spontaneous report received from a physician concerned a 30-40 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions were unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-APR-2021, approximately 20 days after the patient received vaccination, he experienced femoral deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from femoral deep vein thrombosis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A 30-40 year-old man experienced femoral deep vein thrombosis approximately 20 days after vaccination. No past medical history or concomitant medications were reported. There were no details provided, including diagnostic workup. There is insufficient information to make a meaningful medical assessment.

Patient's mother called today and stated that he had a seizure this afternoon at 1:35 PM. She stated that she and her husband are both nurses. She happened to be off today and was home with her son. She stated that the seizure was like a Grand Mal seizure that lasted approximately 5 minutes. She stated that he has had a diabetic seizure before when his blood glucose levels were low. She stated his blood glucose was 71. She said this was different, he had no residual after effects. He was not incontinent of bowel or bladder and he woke up quickly afterwards. About an hour after the seizure he ate and only complained of a headache. She gave him ibuprofen 600 mg and he put an ice pack on his head. She said he is better. She stated that she is a nurse and this really scared her, since it was so different than any other seizure he has ever had. She was thankful she was home. She call his primary healthcare provider and she did not feel he needed to be seen.

Severe thrombocytopenia (<2000) 8 days after vaccination resulting in widespread petechiae Hospitalized for IVIG and corticosteroid treatment with slow rise in platelets to 58,000 then discharged. Seen by me in clinic 4 days after discharge and repeat platelet count again <2000 and re-admitted. Bone marrow biopsy was reassuring and he was started on high dose prednisone (150mg/day) to be tapered over the next 6 weeks Discharged 5/1/2021 with follow up with me 5/5/2021 and follow up with hematology 5/7/2021

Acute pericarditis. 4 days of worsening substernal chest pain. Diffuse ST elevations on ECG. Large pericardial effusion on CT and ultrasound. Troponins negative. ESR and CRP elevated. No previous history of viral illness or autoimmune disease. Treated with course of Colchicine and Indomethacin with close Cardiology follow up outpatient. Patient otherwise afebrile and hemodynamically stable.

High respiratory rate with shallow breaths, Rash on chest, Tachycardia, Altered Mental Status . The Patient that was suspected to have an adverse reaction. EKG displayed no abnormalities, IV was placed in patients L Arm and provided 1,000 ML of Normal Saline, and administered supplemental O2 via simple mask. An Epinephrine Auto Injector 0.3mg was also injected into the patients L thigh. Determination to transport to local treatment center was made by provider. Patient arrived at Medical Center approx. at 2245 and further evaluated there. Patient was then transferred to Level 3 Trauma facility to Hospital around 0100, 17 March. Admitted to the ICU for further evaluation. Update- Patient will be admitted until 18 Mar 2021. It was noted by Hospital Patient had a sever anaphylactic reaction.

Unknown if the vaccine has any correlation to event. Patient was found unresponsive and not breathing on 4/11/21 @ approximately 3:45 PM outside on the grounds of the campus. A rented scoter was next to him. There was no sign of trauma. 9-1-1 was called and CPR initiated by passerby (there were no witnesses). He remained unresponsive and was intubated when the paramedics arrived. He was transported to hospital where he was pronounced dead.

Pt received vaccine at 1130 on 4/10. Per report of others reported feeling fine at 2300 4/10. Went to bed. Awoke at approx 0100 4/11, reported not feeling well, vomited, returned to bed. Found by housemate at appox 2100 4/11 unresponsive. Declared deceased with rigor mortis by EMS. Pt in custody of the coroner for autopsy.

24 HOURS AFTER THE VACCINE HE BEGAN HAVING HIGH FEVER, AND VOMITING. HIS FEVERS BECAME HIGH TO 103.7, HAD DIFFICULTY BREATHING, PRESENTED TO THE LOCAL ER, AND HOSPITALIZED. CT SCAN SHOWED NO PULMONARY EMBOLISM, BUT HAD SIGNS OF PNEUMONIA. COVID-19 TEST WAS NEGATIVE. He was hypoxic, requiring oxygen.

21 y.o. male with no significant PMHx who received the Johnson and Johnson vaccine 4/10/21 found to have extensive LLE DVT (extending above inguinal ligament). Pt was transferred to OSF for catheter directed thrombolysis. He was given 10 mg Eliquis prior to transfer. Pt reports acute onset of LLE pain the evening of 4/16 with progressive pain over the weekend and development of LLE edema/redness 4/18. Left leg mildly more edematous than right. Foot pink/warm, sensorimotor intact. No skin discoloration. Pt denies recent surgery, prolonged immobility or known family history of clotting disorders.

My son Fell out at work after shot was given. He had a seizure, he lay unresponse on floor until medics were called. He noe has a blood clot in brain & has had 3 more seizures.Patient drives a fork lift & drives a truck he is nolonger able to do either.

FEVER; ANAPHYLACTIC REACTION (PASSING OUT/ COULD NOT BREATH/ SWOLLEN LIPS AND FACE); LIPS WERE DROOPING TO THE RIGHT SIDE OF FACE; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma (as a child), non-alcoholic, and cigarettes smoker. The patient experienced drug allergy when treated with Tamiflu (oseltamivir phosphate). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown, NDC number: 59676-0580-15) dose was not reported, 1 total administered on 14-MAY-2021 at 10:00 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, as soon as the patient got the shot (within the 15 minutes of wait at the pharmacy), he had an anaphylactic reaction. It was further reported that he could not breath, his lips and face started to swell and then he passed out. The patient was taken to ER (emergency room) and his doctor gave him EpiPen (epinephrine) shot, Medrol (methylprednisolone), Benadryl (diphenhydramine hydrochloride) and IV (intravenous) fluids. The patient's lips were drooping to the right side of his face even after taking the medications. The patient stayed at the ER for 6 or 7 hours then was sent back to home on the same day. On 15-APR-2021 (reported as Saturday), the patient had fever. On 16-MAY-2021 (reported as yesterday from the date of reporting), the patient was much better, and his drooping lips was there a little bit but not as bad. The reporter did not have patient's vaccination card (for lot number or expiration date). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction (passing out/ could not breath/ swollen lips and face) on MAY-2021, and was recovering from fever, and lips were drooping to the right side of face. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210532244-COVID-19 VACCINE AD26.COV2.S-ANAPHYLACTIC REACTION. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). 20210532244-COVID-19 VACCINE AD26.COV2.S-LIPS WERE DROOPING TO THE RIGHT SIDE OF FACE. 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).

after receiving injection, pt. sat in chair @ about 0918 pt. fell to ground, noted having tonic clonic seizure like activity lasting about 15 seconds, pt. .placed on his side. After about 15 seconds, pt. became arousable, awake alert and oriented, noted to have "chipped tooth" and slight bleeding in his mouth. Pt. states has hx. of syncopal episodes after receiving injections. Denies any history of seizures. Team alert was called and Pt. was taken to ED for further evaluation

Patient received J&J IMZ at 9:45 am. After receiving dose was sitting in waiting area for 10 minutes. Patient then lost consciousness and fell off chair. Patient bump head on floor and had mild case of tonic clonic seizure for approximately 6 seconds. Patient came regained consciousness within 1to 2 minutes.911 was called in and EMTS arrived for assistants. Taking patient out in stretcher. Patient did not have any alerts or allergies noted on PQCF form to alert of any issue

Small blood clot in my left lung. Treatment includes 5 mg dose of Eliquis blood thinner twice a day.

At roughly 6 days after vaccination my body developed Hives head to toe. Roughly 18 or so hours after initial hive development I sought treatment for a anaphylactic reaction in my throat and face area. I received a steroid and a Pepcid to calm it down, and was given an epi pen and sent on my way. The following now two plus weeks since then I've had episodes of dizziness, shortness of breath and headaches that seem to be constant. There has been almost no relief from these symptoms, however the rash has completely resided. I've taken an Aspirin in the mornings to deal with the headaches but strenuous activity seems to bring these on much more prominently.

Pt walked over and sat down in waiting area. Within 2 minutes he lost consciousness, fell out of his chair, hit his head on the floor. this lead to bleeding/ bump on left eyebrow. Pt was hot, sweaty, clammy, and pale. he laid on floor with feet raised for a few minutes. He felt better in about 15 minutes, parents arrived to drive him home.

PATIENT BROUGHT TO ED DEPARTMENT: HISTORY LIMITED TO PATIENT MENTAL STATUS CHANGES. PATIENT PRESENTS TO THE ED AFTER BEING FOUND ROLLING AROUND ON GROUND OUTSIDE OF APT. COMPLEX. SEVERAL HOURS INTO PATIENT STAY, HE BEGAN DROOLING. PATIENT HAD A RIGHT-SIDED FACIAL DROOP. CT ANGIOGRAM ORDERED WHICH SHOWED A THROMBUS IN THE LEFT MCA. VACCINATION OF JANSSEN VACCINE APPROX. 1 WEEK PRIOR TO PRESENTING PER PATIENTS MOTHER. UNKNOWN WHERE HE RECEIVED VACCINATION. PATIENT DIAGNOSED WITH ACUTE CVA

24-year-old male patient with no past medical history received Johnson & Johnson Covid vaccine on April 7 presented to ED with abdominal pain and was found to have portal vein, splenic vein, superior mesenteric vein thrombosis. Patient was also found to be thrombocytopenic he was admitted to the stepdown unit placed on bivalirudin. Patient remains hospitalized at the time of this report.

After administration, pt went shopping with his wife and kid. While shopping within the store, pt reports he fainted, fell down to the ground on his forehead and sustained a deep cut injury right above his left eye. He was bleeding profusely, first aid was rendered and his wife drove him to the ER

Patient came to Pharmacy today for his J&J vaccine along with his wife who also received her vaccine as well. After I administered the vaccine, the patient got light headed and I asked him if he would like to lay down. Before he could respond, the patient collapsed off his chair hitting the side of the plastic trash bin in our patient care room. I caught him before he hit the ground. I asked if he could hear me after saying his name a few times, no response. I assessed his subjective vitals and could tell he stopped breathing. Called for Pharmacy resident to grab and administer an epi pen. Patient responded within 30 seconds of epi pen administration and started breathing again. Proceeded to call emergency services, first responders arrived within 5 minutes and administered IV fluids and oral ondansetron. Patient left with the ambulance and will follow up tomorrow to make sure everything is ok.

Thrombocytopenia resulting in undetectable platelets that improved with 4 days of dexamethasone and IVIG with improvement in gum bleeding and petechial rash of bilateral lower extremities

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Weakness-Mild, Additional Details: patient was nervous and was hesistant about needles just prior to vaccination. as soon as the vaccinnation was done, patient became tense and seizure like activity for ~10 seconds, then he became coherent and was sweating/ pale/ feverish. Gave the patient water, ice packs, and offered to call 911 once he was coherent. Patient refused and then called friend to take him home.