Johnson & Johnson

3/18/21 ER Triage Nurse Note: "To er via EMS for eval of weakness and dizziness. States he started with sore throat and head congestion last week. Seen PCP Monday 03-15-21. Started amoxil. Took it for 2 days and became dizzy so he quit taking it. Dizziness got worse and came to ER." 3/18/21 ER HPI: 76 y.o. male who presents with c/o weakness cough and fever for the past seven days. Pt report sx are mod better with rest and worse with movement. Transferred to Hospital, dx: pneumonia dt covid-19 virus

Patient presented to this facility on 5/12/21 as transfer from hospital for treatment of acute hypoxic respiratory failure secondary to COVID pneumonia requiring intensive care unit treatment. Patient did receive a J&J COVID vaccine on 4/7/21. Patient was intubated on arrival. Patient was treated with remdesivir, tocilizumab, steroids, and antibiotics. Patient's ARDS progressed. He developed septic shock, recurrent pneumothoraces, and acute kidney injury on chronic kidney disease. Patient did not improve. Patient was transitioned to comfort care on 5/23/21 and patient expired.

According to the family, he had symptoms of weakness, nausea, headache, difficulty breathing beginning May 15, 2021. They spoke with him on Sunday, May 16, 2021 and he was continuing to have symptoms. On Monday, May 17, he called one of his daughters, but she missed the call. The family tried to call him on May 18- and May 19, but they couldn't reach him. A welfare check was initiated on May 20; however, the police didn't enter the residence. He was found dead in his bed on May 21, 2021, with changes of decomposition.

The patient received the Janssen vaccine on 5-29-21 and had previously well controlled asthma. The patient presented to ED on 6-1-21, 6-13-21, 6-28-21, and 7-19-21 with acute asthma exacerbation. On 7-21-21 the patient was admitted into the ED and later ICU with cardiac arrest related to asthma acerbation and pronounced deceased on 7-25-21. Symptoms: - Wheezing -Shortness of breath - Onset following the day after vaccine administration Treatments: - Albuterol/ipratropium nebulizers - Prednisone -Albuterol inhaler

On March 27, 2021 the patient developed some pleuritic chest pain and shortness of breath. he went to the Emergency Department at Hospital.

SLIGHT HEADACHE; CHEST PAIN DUE TO DIFFICULTY IN BREATHING; DIFFICULTY BREATHING; SLOW TO MOVE/LACK ENERGY; SORE ON LEFT SHOULDER FELT LIKE HE WAS PUNCHED IN THE SHOULDER; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced chest pain due to difficulty in breathing. On 19-APR-2021, the subject experienced difficulty breathing. On 19-APR-2021, the subject experienced slow to move/lack energy. On 19-APR-2021, the subject experienced sore on left shoulder felt like he was punched in the shoulder. Laboratory data included: Normal pulse rate (NR: not provided) normal at around 60. On an unspecified date, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chest pain due to difficulty in breathing, difficulty breathing, sore on left shoulder felt like he was punched in the shoulder, and slow to move/lack energy, and had not recovered from slight headache. This report was non-serious.

Three days after vaccination developed symmetric weakness in both legs, myalgia, difficulty walking, dysarthria/dysphagia, along with shortness of breath and right eye drooping. Also recently (4/13/2021) treated with nivolumab/ipilimumab so immune checkpoint inhibitor toxicity is suspected.

Patient was giventhe Janseen covid vaccine on 5/5. Apparently the patient 6 days later was reportedly aggitated had hallucinations and trouble breathing. The patient proceeded to lay down to rest. The patient never awoke.

EXTREMELY TIRED; UNABLE TO STAY AWAKE; WOBBLINESS; SHORTNESS OF BREATH; PAIN AT INJECTION SITE; NOSEBLEED; LETHARGIC; This spontaneous report received from a patient concerned a 77 year male. The patient's height, and weight were not reported. The patient's concurrent conditions included Chronic obstructive pulmonary disease (COPD). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: Unknown) dose was not reported, 1 total dose, administered on 06-APR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported. On 06-APR-2021 (evening), the patient experienced extremely tired and lethargic. On 07-APR-2021 (the day after), he developed nosebleeds. For a long period of time, he felt extremely tired, and he was unable to stay awake. Later, he developed wobbliness. On 17-APR-2021, he was taken to emergency room (ER) and was admitted to the hospital for couple of days. His all tests and assessments were performed which came out clear. He also experienced shortness of breath, and pain at injection site. On an unspecified date, he experienced shortness of breath, and pain at injection site. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nosebleed, had not recovered from extremely tired, wobbliness, lethargic, and unable to stay awake, and the outcome of shortness of breath and pain at injection site was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 2021506688-Covid 19 Vaccine-Unable to stay awake, Wobbliness. 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). 2021506688-Covid 19 Vaccine-Extremely tired. This event is labeled per RSI and is therefore considered potentially related.

bi-lateral leg pain within 1 week of shot. then severe back pain after 2 weeks. difficulty breathing week 3. Admitted to hospital for multiple blood clots in legs & lungs.

Pt developed sudden-onset of severe left-sided chest pain with heavy pressure, shortness of breath and diaphoresis; pt collapsed and had a period of unresponsiveness lasting approximately 10 minutes. EMS was called and noted significant ectopy as well as frequent NSVT on ECG. Pt was transported to the Emergency Department and subsequently admitted for observation.

He got the vaccine, was not able to breath real good and didn't think about it. It got to the point within 2 weeks that he was not able to get up from the chair due to the shortness of breath. By 4/1/21 he was not able to breath very well, but continued to stay home. Then by 4/12/21 he was not able to breath well at all and his wife took him to the ER. In the hospital they did x-rays and found out that his lungs are full of blood clots and both legs have blood clots in them. He was admitted and gave him Heparin drip for the 2 days to get the blood clots dissolved and was also on oxygen for 2 days. He was discharged home yesterday with Xarelto, and was told that he would be on that for the rest of his life, and is on oxygen for sleep and when he's up and around, but if he's resting and feels he's breathing okay he can remove it. They informed him that it would take approximately 2 months for all the blood clots to dissipate, and that he was full of blood clots, and had both legs and both lungs which are quite full.

Acute respiratory failure- bilateral pulmonary emboli. Acute renal injury. New onset of atrial fibrillation. Patient in ICU intubation occurred on 4.18.2021

Patient developed shortness of breath, chest pain 'fuzzy head,' headache, rhinorrhea, diarrhea, and increased fatigue around 3/28/21 had clinic appointment 3/30/21, diagnosed with pneumonia. XR CHEST 2 VIEWS (PA AND LATERAL), TRANSTHORACIC ECHO (TTE) ADULT NON CONGENITAL, EKG 12-LEAD completed. given cefTRIAXone (ROCEPHIN-Equivalent) injection 1,000mg IM, and doxycycline monohydrate (MONODOX) 100 mg capsule PO. was evaluated in ED 4/5/21 CT Abdomen Pelvis with IV Contrast Final Result 1. Positive for extensive acute bilateral pulmonary emboli at the lung bases as detailed in the body of the report. DX Chest Portable 1 View Final Result Mild left ventricular prominence is noted. Small right pleural effusion is seen. Minimal discoid atelectatic changes in the left perihilar region and left lung base. Elevated right hemidiaphragm suggests eventration. Admitted to Hospital 4/5/21, per admission diagnosis: Acute pulmonary embolism (*) submassive likely secondary to covid 19 Per hospital course notes:Patient presented with acute hypoxic respiratory failure and was show to have submassive PE with severe pulmonary hypertension seen on TTE. He should be on lifelong therapy given 2nd VTE and severity. Iwould consider unprovoked (COVID in 11/20 wouldn't count I wouldn't think). He was started on eliquis 10 mg BID x 7 days than 5 mg bid. Given his severe pulm htn on TTE, left atrial pressure normal. We would have outpatient sleep study as well He will need VQ scan to assure no CTEPH. Will have outpatient follow up. We discontinued his aspirin on discharge as well.

STROKE; SHORT WINDED; This spontaneous report received from a patient concerned a 78 year old White and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included blood clot in leg around 10 year ago, and concurrent conditions included high blood pressure, social drinker, hole in heart from birth, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on left arm on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, atorvastatin, clopidogrel bisulfate, colecalciferol, escitalopram, finasteride, gabapentin, hydroxychloroquine sulfate, levothyroxine, lisinopril, thioctic acid, ticagrelor and verapamil hydrochloride were drug used for unknown indication. On 12-APR-2021, the patient experienced headaches, which lasted 1 week. On 18-APR-2021, the patient had CT scan (computerized tomography) result was not reported. Patient was sent home for tension headache. On same day, patient had also experienced no energy. On 19-APR-2021, the patient was Hospitalized for MRI (Magnetic resonance imaging) which showed patient had stroke within 5 days and also had plaque around the brain. Patient was started on Plavix and aspirin. On 21-APR-2021, the patient discharged from hospital. On same date, the patient went to cardiologist to have monitor placed where patient had another stroke and patient was readmitted to the hospital. patient was taken off Plavix and started on Lisinopril and placed on heart monitor. On 23-APR-2021, the patient was discharged from hospital. Patient was hospitalized for 5 days. On APR-2021 patient had experienced down hill, short winded and voice was gone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and had not recovered from short winded. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210518146-COVID-19 VACCINE AD26.COV2.S-Stroke. 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

Per Regulatory Authority it is to be reported if patient gets COVID if fully vaccinated. Per MD note 1. Acute hypoxemic respiratory failure: This is in a patient with COVID pneumonia. The patient was placed on supplemental oxygen. The plan is for the patient to use supplemental oxygen with oxygen by nasal cannula up to 6 L and if oxygen saturation falls below 90% on 6 L oxygen by nasal cannula, he will be transitioned to high-flow oxygen. However, if he is on maximal support with high-flow oxygen with oxygen saturation falling below 90%, the patient should be placed on BiPAP and transferred to the ICU. The patient is a full code. 2. COVID pneumonia: This in a patient who apparently received his Johnson and Johnson COVID vaccine 3 weeks ago. The patient started on treatment with remdesivir. He will get steroids. He is prescribed Tessalon Perles and Robitussin with codeine as needed for coughing. He may be considered for potentially other treatments in the setting of his COVID pneumonia, especially if his respiratory status deteriorates. We will closely follow up in the COVID unit after admission. 3. Alteration of mental status and encephalopathy: This in a patient who is hypoglycemic. However, part of his encephalopathy related to his COVID infection and volume depletion. He is being volume repleted and treated for his condition. He will have frequent neurologic checks done after admission. 4. Generalized weakness and deconditioning: This is in a volume depleted patient with COVID. His COVID will be appropriately treated and he will be volume repleted. He will need to work with physical and occupational therapy towards the end of the hospitalization. 5. Congestive heart failure, systolic plus diastolic dysfunction: The patient does not have any evidence of acute congestive heart failure at the moment. However, we will take care to prevent volume overload in this patient, who requires volume repletion in the setting of his volume depletion. 6. Volume depletion: The patient will get another liter of IV fluids after admission at 80 mL per hour as tolerated. The goal is to avoid excessive IV fluid administration in this patient with COVID pneumonia.

Shortness of breath, tired, elevated blood pressure, no appetite, upset stomach, nausiated, blood blister in groin area. soreness in groin area, overall feel bad.

Vaccine was given on 4/1/21. Symptoms started 4/2/21 in the afternoon. Symptoms were described as teeth/gums hurting. At 12:30 am on 4/3/21 his mouth was very swollen and he couldn't talk. Also he had trouble breathing. He went to the ER and was given IV solu-medrol. Patient was sent home 30-40 minutes later with the instructions to take Benadryl PO. In the morning they purchased some benadryl and gave it PO every 4-6 hours all day Saturday, 4/3/21. On Sunday, 4/4/21 at about 5:30 am his gums and lips were swollen again. He made another trip to the ER and was given solu-medrol IV again and PO methylprednisolone for 5 days. At this visit, they also gave lasix IV due to extra fluid around his heart. He was told by the ER provider that he developed congestive heart failure due to the vaccine. Patient followed up with his primary care provider on 4/8/21 and was told that his symptoms of congestive heart failure had resolved. Patient also reported his symptoms of swollen gums and mouth had resolved at this time.

Systemic itching and hives; swelling of lips, inside of the mouth and throat. Seen at ED. Treated with IV fluids and steriods. Released to home after several hours. Physician believes it was from the vaccination and ruled out any other cause(s) for the reaction.

INCREASING HEADACHE, AND SHORTNESS OF BREATH. Previously frequent bloody nose on 03/30/21, pt is not currently taking any blood thinners, he recently went to the ER on 03/30/21, after the visit the nose bleeding stopped. Pt's wife C/o of edema of the ankles with SOB. C/o severe migraine headaches and back pain. Norco helps the patient with his migraines and pain w/o SEs. Patient has still has SOB on exertion, but it is stable, pt's wife states that he is getting worse, he will c/o of SOB after walking less than half a block. He continues to use 2 L oxygen nasal cannula supplement and his inhalers and nebulizer treatment up to 4-6x a day. No fever and chills. Pt only has occasional cough. When he uses his inhalers, his cough will subside. PATIENT HAS HX OF THROMBOCYTOPENIA, BUT THROMBOCYTOPENIA HAS GOTTEN WORSE AFTER VACCINE.

CONGESTIVE HEART FAILURE; FLUID AROUND HEART; HAD TROUBLE BREATHING; TEETH AND GUMS STARTED HURTING; TEETH AND GUMS STARTED HURTING; GUM SWELLING; This spontaneous report received from a pharmacist concerned a 79 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 for prophylactic vaccination about 1:30 pm in left deltoid. No concomitant medications were reported. On 02-APR-2021, the patient experienced gum swelling, teeth and gums started hurting, trouble breathing. His tongue and throat did not swell. On 03-APR-2021, the patient visited the emergency room (ER) about 12:30am and was given Solumedrol intravenously and was sent home advised to take Benadryl. The patient took Benadryl 4-6 hourly all day on 03-APR-2021. The patient visited the ER again on 04-APR-2021 about 5:30 am with swollen gums again and was informed that he had fluid around heart and given Lasix. Emergency department (ED) HCP told patient that the vaccine gave him congestive heart failure (according to patient) and he was given Solumedrol at ED again and sent home on Medrol dose pack. On Monday 04-APR-2021, the patient visited his primary care physician and congestive heart failure had resolved. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from events of gum swelling, teeth and gums started hurting, had trouble breathing an unspecified date in Apr-2021, and from fluid around heart, and congestive heart failure on 05-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210420579- covid-19 vaccine ad26.cov2.s-Congestive heart failure, fluid around heart, had trouble breathing, teeth and gums started hurting, gum swelling. 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).

it appeared that he had fluid in his lungs during visit to clinic, and they couldn?t determine if it had anything to do with the vaccination.

Patient was hospitalized overnight from 5-9-21 through 5-10-21 for reasons not related to Covid-19, at Hospital; his lab reports show that he tested negative for Covid-19 at this time. He developed shortness of breath on 5-16-21 and was taken to Hospital. Patient was transferred Hospital on 5-17-21 where he was admitted and tested positive for Covid-19. Patient was in the ICU during his hospital stay at hospital and required mechanical ventilation; he was discharged on 6-8-21 to Hospice.

The day after the vaccine, he noticed he didn't feel well. Tired, headache, stomach ache, and shortness of breath. This started out mild and as the week went on got worse. Symptoms were leg swelling, shortness of breath, persistent stomach pain, headache, and chestpain. On 6/24 at 3:30 am he went to the ER where they discovered a large (golf ball size) blood clot in his right lung. He also has been diagnosed with pancreatitis. We have talked to five different doctors and multiple other hospital staff who all say it is a direct impact of the covid vaccine.

Patient caregiver reports that he woke up at 2 a.m. the morning after the vaccine unable to hold his urine which is unusual for him. He also reported extreme acid reflux symptoms whenever he attempted to drink any fluids at that time as well as nausea. This progressed to difficulty breathing at which time the caregiver was alerted and checked his blood pressure. This reading was 88/55 according to the caregiver and the pulse was very high as well but the actual number could not be remembered. The difficulty breathing prompted them to alert emergency medical services where he was picked up and transported to the emergency room via ambulance shortly after for evaluation.

Patient received the COVID vaccine on 5/24/21. On 5/31/21, patient started to experience chills, fever, and cough, which continued to progress until 6/3/21, when patient presented to the ER. He tested positive for COVID in the ER and was noted to be short of breath and satting 88% on room air. Patient was admitted to the hospital on 6/3/21 for COVID treatment (remdesivir and dexamethasone).

Extreme lower extremity swelling and pain. Evaluated in PCP office on 04/22/21, ultrasound of right LE was negative for blood clot. Patient?s symptoms worsened and PCP referred patient to ER on 04/16/21 and CT of cheat revealed 3 clots in the lungs. Patient was admitted to hospital and stated on heprin therapy. Still currently inpatient awaiting approval to transfer for inpatient rehab due to decreased endurance and bilateral lower extremity pain which is affecting ability to ambulated without assistance.

This 82 year old male hospice patient received the Covid shot on 3/6/21 and went to the ED on 4/6/21 and was admitted on 4/6/21 with respiratory distress, acute hypoxemic respiratory failure, anasarca, atrial flutter, hypothyroid and died on 4/15/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Patient with advanced parkinson's, dysphagia, on G-tube feed received J&J vaccine on 6/9 per wife, developed fatigue/general weakness, developed fever, admitted to hospital for aspiration pneumonia/sepsis/acute respiratory failure.

After vaccination that day, patient was too tired to get out of bed to do his evening walking exercises. On 6/10/2021 3:00 am, patient unable to support himself on the commode and was put back to bed. Next couple of days patient was too weak to get out of bed. 6/14/21 1:00 am, patient became very congested and unable to remove fluid in his lungs, wife called medics and patient was admitted to hospital for 2 days with pneumonia. 6/16/21 7:00 pm, patient discharged from hospital. That night, patient became very congested despite continuous suctioning through the mouth, patient experienced respiratory distress and lungs congested with fluids, 2:30 am medics was called and paramedic performed invasive deep suctioning of lungs via his nose on way to the hospital, upon arrival at hospital they performed another deep suctioning of lungs before sending patient to the ICU. 6/21/21 4:00 pm, patient discharged from hospital in stable condition, doing physical therapy and occupational therapy at home.

developed bilateral swelling and cough/subjective shortness of breath. Found to have bilateral DVT with likely several PEs (not confirmed). Patient started on SQ Lovenox.

Initially admitted for hip fracture and tested + for Covid. His admission was prolonged due to worsening COVID-19 pneumonia. Given his underlying COPD and requirement for supplemental O2, he was started on Dexamethasone 6mg daily for a 10 day course on admission, which is to be continued after discharge. He had Remdesivir added for 5 days as well as CAP coverage with Ceftriaxone and Azithromycin for 5 day course. His oxygen requirements increased from 3L to 6LCT

7/24/21: past 3-4 days, patient had low energy, decreased appetite, drinking very little, and more confused than his baseline. Patient weak and breathing quickly, so came in to ED. found to be COVID positive. Diagnosed with: COVID-19 pneumonia, acute hypoxic resp failure, shortness of breath, acute encephalopathy. Note: patent previously vaccinated with COVID-19 vaccine in April 2021. 7/27: patient still admitted at the time of this form submission.

Daughter reported that on 4/13/21 pt had increased weakness and difficulty breathing, taken to ER for x-ray of lungs, small amount of fluid noted. On 5/11/21 Pt with weakness, shortness of breath, increased edema in lower extremities, taken to ER, admitted to the Hospital with Pneumonia. Pt now home on Hospice.

Started experiencing numbness in feet, weakness in legs, shortness of breath around 6/22. Fell on 6/24. 7/2 shortness of breath increased and weakness in legs. Had trouble walking from living room to the car. Don't have exact date, but on 7/5, 7/6, or 7/8 had trouble walking from living room to the kitchen due to shortness of breath and weakness in legs. Doctor prescribed rehab and started 7/12.

patient states he developed shortness of breath and weakness in lower extremities 1-2 weeks after the injection ,progressively becoming worse

Rapid decline in ability to perform respiratory gas exchange and build up of carbon dioxide in the blood to life-threatening levels, ultimately leading to death. Rapid decline began about 2 weeks after receiving vaccine. Death would likely have occurred on 5/6/2021 or 5/7/2021 but for hospital intervention via use of a BiPAP machine. Patient had been exhibiting more mild, non-COVID respiratory distress for some time, back to at least late 2020, and likely at even lower levels for several years prior. Signs and symptoms included shallow breathing, extreme fatigue, difficulty or inability to lie down, occasional lightheadedness, etc. Oxygen saturation levels in April, as measured by a pulse oximeter, ranged from about 87%-96%. On May 6, it measured 65% just prior to ER visit.