Johnson & Johnson

Presented to Hospital for dyspnea. Diagnosed with large right sided pulmonary embolism; platelet count 138 T/UL at time of ER visit. Transfer to larger facility for higher level of care on 4/19/21.

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

03/28/2021 to 03/30/2021- Admitted Ip via E/R , Dx: Pneumonia, Cardiomegaly, Small pericardial effusion, Esophageal stenosis (s/p dilation), Small hiatal hernia. F/U with PCP for Hopital F/u on 04/01/2021. Visit ER on 04/03/2021- 04/05/21 04/14/21-ReAdmitted IP via E/R. -Dx: Dx: Chest pain, Pericarditis w/ mod-large Pericardial effusion (s/p pericardiocentesis), Hypokalemia, Pleural Effusion (s/p thoracentesis)

The same night after the vaccine I had shaking violent chills, my teeth were chattering as well. I also was vomiting a lot , I had lots of chills that I could not get warm this went on all night long. The next day I did experience some bad body aches like the flu. The next day after that I slept all day long and tried to hydrate myself back together. Over the next few weeks I noticed how I was running out of breath so fast. I am now suffering from shortness of breath.

CONSTANT SHORTNESS OF BREATH; LOW BLOOD OXYGEN; WEIGHT LOSS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 77 year old female. The patient's height and weight were not reported. The patient's past medical history included covid-19 positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, frequency once total, administered on left deltoid on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. After the vaccine, on 13-MAR-2021 the patient experienced chills, fever and headache. The headache goes go from the left to right side of her head. On an unspecified date, the patient experienced constant shortness of breath, low blood oxygen, and weight loss. The shortness of breath was severe and patient had to take a break every couple 100 steps for rest. On 15-MAR-2021, the patient was hospitalized. Laboratory data (dates unspecified) included: COVID-19 (nr: not provided) positive, oxygen saturation (nr: not provided) low, and weight loss (nr: not provided) 5 pounds and she is down to 86 pounds. The patient was prescribed steroids and nebulizer treatment. The patient had low blood oxygen level. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, chills, constant shortness of breath, low blood oxygen and weight loss was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210442930-covid-19 vaccine ad26.cov2.s -Constant shortness of breath/low blood oxygen/weight loss. 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).

Death 5/15/2021 Causes of death listed on death certificate: 1) COVID 19 pneumonia 2) Acute respiratory failure with hypoxia 3) Pulmonary embolism 4) Paroxysmal atrial fibrillation Other: obesity, hypertension

During the morning hours of 7/14/21 patient became increasingly SOB and eventually went unresponsive, with no pulse or respirations, CPR initiated and EMS transported to Medical center.

developed COVID after vaccine, sx onset 4/21/21, hospitalized 4/24-4/27, treated with remdesivir and steroids, improved, then readmitted 5/2/21 with respiratory failure, required ICU admission 5/21/21, intubated, PEA arrest, passed away 5/24/21.

with several days of receiving the shot the following symptoms occurred: severe headache backache severe pain in your abdomen or stomach pain in your chest leg pains joint pains shortness of breath

Started having muscle pain; I didn't have chills. I was very fatigued - in bed all day. I had a headache and the muscle pains went into my left side and into my left lung and every time I breathed I would get a sharp pain. It went into both of my breasts but worse on left side of breast. This lasted about three or four days. I went to the doctor on Thursday, the 15th. But now everything is cleared up and I feel good. Yesterday, the 22nd I started feeling myself again. Except, I have a tremor that won't go away - I had a slight tremor before the vaccine but now after the tremor it is much worse.

FULLNESS; OXYGEN LEVEL NOT GREAT; TROUBLE BREATHING; NOT SLEEPING WELL; FELT WORSE; RASPING; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, cigarette smoking, thyroid disorder, hip replacement, brain tumor, high cholesterol, alcohol user, dry mouth, anaphylactic reaction from carboplatin, drugged feeling like floating at full strength, and exhaustion, and other pre-existing medical conditions included no thyroid but takes thyroid replacement. The patient experienced drug allergy when treated with moxifloxacin hydrochloride for drug use for unknown indication, and drug allergy when treated with venlafaxine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination. Concomitant medications included salbutamol for copd. On MAR-2021, the subject experienced rasping. On 10-MAR-2021, the subject experienced trouble breathing. On 10-MAR-2021, the subject experienced not sleeping well. On 10-MAR-2021, the subject experienced felt worse. On 15-MAR-2021, the subject experienced oxygen level not great. Laboratory data included: Chest X-ray (NR: not provided) clear, and Oxygen saturation decreased (NR: not provided) not great. Treatment medications included: erythromycin, and fluticasone propionate. On an unspecified date, the subject experienced fullness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing on 18-MAR-2021, and not sleeping well, felt worse, and rasping on 15-MAR-2021, and the outcome of fullness and oxygen level not great was not reported. This report was non-serious.

Patient was discharged from the hospital after massive PE. She went to the hospital at 2am last Saturday. Patient described unbelievable pain from shoulder neck and arms. She could hardly walk to her car. Went to ER. There they ran tests and found many blood clots in lungs. Blood clots had stopped the blood in that area. They were not definitive but said it sounded like that. Got a breathing apparatus after because it's been hard to breathe and she has been shaky. Her shot was administered 04/12 during chemo. Hospital April 24. She was discharged and given a blood thinner and pain medication - Oxycodone & Eliquis.

BODY ACHES; SHORTNESS OF BREATH; SNEEZING; MUSCLE ACHE; FELT GENERAL TIREDNESS/EXTREME FATIGUE; COLD; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included right sided breast cancer, and torn meniscus surgery, and concurrent conditions included physical therapy. The patient experienced drug allergy when treated with clarithromycin, and cefuroxime axetil. 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 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced cold. On 17-MAY-2021, the subject experienced felt general tiredness/extreme fatigue. On 18-MAY-2021, the subject experienced body aches. On 18-MAY-2021, the subject experienced shortness of breath. On 18-MAY-2021, the subject experienced sneezing. On 18-MAY-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sneezing on MAY-2018, had not recovered from muscle ache, and body aches, and the outcome of shortness of breath, cold and felt general tiredness/extreme fatigue was not reported. This report was non-serious.

This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included ductal carcinoma, and ductal carcinoma surgery, and concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient had no medical history of drug abuse or illicit drug usage. The patient was previously treated with lisdexamfetamine mesilate, and vitamins nos. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 043A21A expiry: 05-AUG-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. Product properly stored from receipt to administration. Concomitant medications included letrozole. On 08-JUN-2021, the subject experienced dry irritated cough. On 08-JUN-2021, the subject experienced sneezy. On 08-JUN-2021, the subject experienced irritated throat. On 08-JUN-2021, the subject experienced dry, raspy and voice changed. On 08-JUN-2021, the subject experienced breathing changed. On 08-JUN-2021, the subject experienced chest irritated and irritation to lungs. On 08-JUN-2021, the subject experienced smell of chemical. On 08-JUN-2021, the subject experienced slight headache.The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry irritated cough, sneezy, slight headache, irritated throat, dry, raspy and voice changed, breathing changed, chest irritated and irritation to lungs, and smell of chemical. This report was non-serious.

Patient vaccinated against COVID-19; received COVID-19 Janssen vaccine on 3/10/2021. Patient developed symptoms last week of March. Called Provider with symptoms and then presented to the hospital (admitted on 4/1/2021). Tested for COVID and found to be positive. 4/1/2021. Patient declined, admitted to ICU on 4/3/2021. Patient died on 4/4/2021. Chief Complaint: HPI: Patient is a 79 y.o. yr. old female who presents today for COUGH (has had cough for a little over a week) and FEVER (on and off for about a week)Patient was seen due to feeling ill for over week. Patient states that she was trying to fight it on her own but symptoms have been progressing. Patient has felt feverish no known fevers. Has had a persistent now worsening cough. Patient is feeling very tired and weak due to being sick for over week. Patient does live alone. Patient is coughing which is productive with sputum. Patient is eating and drinking well. No N/V/d. No loss of taste or smell. No recent ill exposure.; Has had covid vaccine. Patient did get the Johnson and Johnson vaccine over a month ago. Patient is feeling very fatigue; Having feverish/chills. Patient is taking OTC nightquil which is no longer helping. Patient does see oncologist for her CLL. DISCHARGE DIAGNOSIS: 1. Deceased 2. COVID-19 with hypoxia 3. Asthma 4. Anemia DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 HOSPITAL COURSE: Patient is a 79 year old female who was admitted on 04/01/2021 for COVID-19 pneumonia with complications of hypoxia. Patient's symptoms of cough and shortness of breath have been present for approximately 2 weeks. It was noted that 1 month ago she did receive the Johnson & Johnson vaccine. Upon admission patient was treated with azithromycin, Rocephin to cover for secondary bacterial infection. She was not a candidate for remdesivir due to the length of her symptoms. She was started on Decadron, as well as gentle fluids due to tachycardia for approximately 12 hours. During the night of 4/2-4/3 patient progressively declined requiring more oxygen she was transferred to the intensive care unit. Patient was a do not resuscitate continued decline and after exacerbating all treatment options patient was switched to comfort care earlier this evening. Pronounced dead at 6:45 a.m.

Patient was in store and top of chest started hurting and down left arm. Patient states that they called 911 and ambulance took her to the hospital. She was tested and found to have mild heart attack with blood clot in vein of her heart. Had procedure to remove clot was put on blood thinner and is now wearing a heart monitor for the next 30 days. Is on Brelinta for the next 30 days as well. Patient went back to ER on Tuesday night (4/13/21) due to SOB spent 12 hours at ER before being transferred back to hospital. She spent another day and half before discharge diagnosed with fluid buildup.

Resident complained of shortness of breath and stated that it started early in the morning of the 13th of April. Pulse ox at time was 94%. No complaint of chest pain. Lung sounds were diminished. Vital signs were within normal limits. NP was notified and she advised to continue to monitor. The resident stated that the SOB subsided and no further issues were noted.

No side effects after I first got it, it was 2-3 day later I started having rash between shoulders and across hips, hives and itching under the skin, it's been a few weeks now and I've had pain in my breast and some shortness of breath.

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.

Receive vaccination on 4/7/21, on 4/17/21 evening minor chest pain simulating heartburn started, on 4/19/21 progressed to severe pain, went to Emergency Room, where she was admitted the FIRST TIME, several test were done and they could not locate source of pain, Just treated with Morphine for pain; my mother was discharged on 4/21/21 with NO answer to the cause for SEVERE pain, just chest ray showed a SMALL amount of fluid. Upon release my mother continued with mild pain, Until it was unbearable on 4-30-21 Admitted for the SECOND TIME until this present, This time alot of fluid was found outside her lungs, then moved to around her heart causing cardiac unrest AND STILL IN HOSPITAL....A biopsy of the fluid was done before her cardiac unrest and hospital is still waiting for results of Fluid Biopsy.

30 min after vaccination patient felt nausea and started vomiting, chest tightness, trouble breathing, "funky" feeling at chest, sudden movements cause dizziness . pt notified us on 05/11 and symptoms have resolved, pt instructed to monitor for continue symptoms especially related to chest symptoms tightness, SOB, etc and to go to ER if symptoms arose again

after getting the vaccine in morning, later that same evening patient felt sluggish, nauseaus, tired. Daughter finally convinced patient to see a doctor. Md prescribed her a cough medication. She still felt bad for another 2-3 weeks, so she finally went to the emergency room where she diagnosed with blood clots in the legs and the lungs. She staying in hospital approx. 4-5 days before being released.

HYPERTENSIVE CRISIS (HIGH BLOOD PRESSURE); DIVERTICULITIS; BOWEL IMPACTION; DIZZINESS; FEELING FATIGUE; BLOOD PRESSURE FALLS TOO LOW AT TIMES; SOME HEADACHES; SHORTNESS OF BREATH; SOME LEFT NECK PAIN; This spontaneous report received from a consumer (reported as daughter) concerned a 79 year old White and Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included that she had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, frequency time was 1 total administered on right arm on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021 (reported as right away after vaccination), the patient started feeling bad which was further elaborated as feeling fatigue, shortness of breath, and had some left neck pain. On an unspecified date in MAY-2021 (reported as on or about 10-MAY-2021), the patient started experiencing some headaches. The patient went to see her doctor on 17- MAY-2021 for routine checkup and got to know that everything was fine, and her blood pressure was fine at this time. On 06-JUNE-2021, the patient was hospitalized with hypertensive crisis, diverticulitis, bowel impaction, dizziness, and fatigue. The patient was discharged from hospital on 11-JUNE-2021. On 28-JUNE-2021, the patient was hospitalized again for second time for high blood pressure, and she was put on 2 different blood pressure medications (unspecified) including a diuretic (reporter was unsure of the medication names/dosages). It was also reported that the patient feels fatigued at times now when her blood pressure falls too low (date unspecified). The results, units and normal ranges for blood pressure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some left neck pain, some headaches, and bowel impaction, and had not recovered from hypertensive crisis (high blood pressure), diverticulitis, shortness of breath, blood pressure falls too low at times, dizziness, and feeling fatigue. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210743176 - Covid-19 vaccine ad26.cov2.s - Hypertensive crisis, Diverticulitis, Bowel impaction, Dizziness. 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). 20210743176-Covid-19 vaccine ad26.cov2.s - Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.

Vaccine given at 545 PM, pt left the clinic and came back at 623 with complaints of shortness of breath and facial numbness. Vitals were 150/80 97% on RA HR 80 and RR 18. At 630 PM vitals were 115/65 HR 92 100% on RA and RR 18. Pt reported all symptoms had resolved by that time and left the clinic.

Patient was given Jansen Covid vaccine Lot# 1805029 Exp: 5/25/2021 to Left Deltoid at 10:40AM, by Rn. Fact sheet was given to pt before and consent was signed. Pt was escorted to lobby for monitoring per protocol. At 10:55AM pt begin to show signs of adverse reaction and was transported back to exam room via wheelchair by staff. Pt was lethargic, flushed, warm and dry and had c/o SOB. Pt was being accessed by Dr., vitals signs taken by staff at 10:56AM BP was 157/69 HR 67 R18 O2 98% glucose reading 84. Pt was offered juice and staff was attempting to arouse pt. Per provider order pt was given IM Benadry 50mg to right deltoid lot# 070110 Exp: 7/31/2022 at 11:03AM by staff. Vital signs rechecked at that time BP 137/68 HR 68 R 18 O2% 98. Pt fully alert and oriented at 11:20am and was speaking to her daughter, daughter was explaining to patient the events that happened. Pt vital signs recheck for 3rd time at 11:22AM BP 11:10AM HR 59 R 16 O2 98%. Pt was transported to car via wheelchair by staff and was witnessed getting into car with no assistance. Pt's daughter was contacted at 2:30PM by staff to check on pt and was told pt is feeling fine

Pt became SOB and dizzy. Vital signs stable. She was put on O2 and given po benadryl 25 mg; sent to er for persistent sob and later discharged home

Difficulty breathing 3/16/21. Taken by ambulance to hospital 3/17/21. Hositalized and treated for double pneumonia.

Client was alert and oriented after the vaccine but stated shortness of breath due to Sinus issues. she asked a question about using a inhaler and was allowed to do so. Client did state that she has had previous reactions to vaccines and was in the 30 minute observation line. She also reported a history of tachycardia. she felt better after using the inhaler and was monitored by EMS and Dr. Blood pressure was 157/76 pulse 80 RR 20 and 97% oxygen saturation. she was advised to seek medical attention post release if needed.

Patient at clinic to receive Johnson & Johnson vaccine. Patient started complaining of being lightheaded. BP was 112/65, pulse 82, Temp 98.5, O2 sat 99. Patient began having tremors and weakness when standing. Physician evaluated patient. Patient became short of breath when talking. Physician ordered 50 mg Benadryl IM and advised staff to call ER. Patient taken to hospital emergency. A message was left for family to inform them. Member was discharged home same day.

Patient presented to ED with nonproductive cough, dyspnea, especially on exertion and orthopnea that had been ongoing for 1 week. D. Dimer >20.00

80y.o. female with past medical history of COPD on 3L O2 at home, Asthma, Arthritis, B12 deficiency, Depression, GERD, Achalasia, HTN and Hypothyroidism presented with a chief complaint of cough and weakness. Patient states that she had the Johnson & Johnson vaccine on March 11th 2021 and believes she got sick from it. Since getting the vaccine, whenever she eats something she begins vomiting for the next 2 days. This has happened to the patient before, as she has a history of esophageal dysmotility/achalasia. Patient began developing a cough and SOB over the last 2 weeks that are getting worse. Patient states that she has no appetite at all and is feeling very weak due to the lack of eating.

Pt received vaccine on 4/8/2021. Pt was diagnosed with COVID-19 on 5/17/2021. Pt was admitted to the hospital on 5/21/2021 for pneumonia secondary to COVID-19.

HEAD "FEELS LIKE IT IS SWIMMING"; WEAKNESS; FATIGUE; FEELING LIKE PASSED-OUT; ACCELERATION OF BREATHING DURING WALKING OR MOVING; UNSTEADY; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type ii diabetic, and hiatal hernia, and other pre-existing medical conditions included patient had no known allergies. patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included darunavir/cobicistat non-company. On 10-MAY-2021, the subject experienced feeling like passed-out. On 10-MAY-2021, the subject experienced acceleration of breathing during walking or moving. On 10-MAY-2021, the subject experienced unsteady. On 10-MAY-2021, the subject experienced weakness. On 10-MAY-2021, the subject experienced fatigue. On an unspecified date, the subject experienced head "feels like it is swimming". The action taken with covid-19 vaccine was not applicable. The patient had not recovered from weakness, fatigue, feeling like passed-out, acceleration of breathing during walking or moving, and unsteady, and the outcome of head "feels like it is swimming" was not reported. This report was non-serious.

Reported to me by patients niece, who developed similar symptoms around the same time: Patient developed cough aches, fartigue and shortness of breath about 8 days after receiving COVID vaccine. After another 10 days of illness was taken to hospital by ambulance as too weak to stand., and died in hospital about 5 days later, on or about 5/22/21

DYSSTASIA; COVID-19; SARS-COV-2 TEST POSITIVE; ASTHENIA; FATIGUE; DYSPNOEA; COUGH; PAIN; ILLNESS; DEATH; This spontaneous report received from a health care professional concerned an 80 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and hypertension. The patient experienced drug allergy in past when treated with ACE (angiotensin-converting-enzyme) inhibitors for an unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: unknown) dose was not reported, frequency time was 1 total administered on left arm on 30-APR-2021 for prophylactic vaccination. Concomitant medications included Amlodipine, Atorvastatin, Bupropion, Escitalopram, Furosemide, Lantus (insulin glargine), Levothyroxine, Metoprolol, Mirtazapine and Pantoprazole for an unknown indication. On an unspecified date in MAY-2021 (reported as about 8 days after vaccination), the patient developed cough, aches, fatigue, and shortness of breath. After another 10 days of illness, the patient was taken to the hospital by ambulance as she was too weak to stand. On 22-MAY-2021, the patient experienced Covid-19, dysstasia and she had her SARS-COV-2 (severe acute respiratory syndrome coronavirus 2) test positive. On an unspecified date in MAY-2021 (reported as on or about 22-MAY-2021), the patient died from unknown cause of death in hospital about 5 days later. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on MAY-2021, and had not recovered from asthenia, cough, covid-19, dyspnoea, dysstasia, fatigue, illness, pain, and sars-cov-2 test positive. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: -covid-19 vaccine ad26.cov2.s. Death, cough, covid-19, dyspnea, dysstasia, illness, pain, and sars-cov-2 test positive. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the covid-19 vaccine ad26.cov2.s. Asthenia , fatigue, This events are labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

FEELING OF "DID NOT WANT TO BE ALONE"; FEELING KIND OF WEAK; GENERAL TIREDNESS; DIFFICULTY BREATHING; SWEATINESS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, tetracycline allergy, and vancomycin allergy. The patient experienced drug allergy when treated with promethazine, carbamazepine, and topiramate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1802068 and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced difficulty breathing. On 24-MAR-2021, the subject experienced sweatiness. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 25-MAR-2021, the subject experienced feeling of "did not want to be alone". On 25-MAR-2021, the subject experienced feeling kind of weak. On 25-MAR-2021, the subject experienced general tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, sweatiness, feeling of "did not want to be alone", feeling kind of weak, fever, headache, nausea, and general tiredness on 26-MAR-2021. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

Weakness loss of appetite 1wk after trouble breathing body hicups heart attack death (almost 2 wks after)

Pt received vaccine in her home state, unable to get details of vaccine administration such as date, site, lot #, etc. Per ED MD note : 81-year-old female with reported history of atrial fibrillation found down at hotel room. Patient states she has been on the ground in the room for 3 days, she was found covered in feces. Alert and oriented x4 however intermittently appears confused and has varying history. She does not know how she got on the ground, however denies fall or syncope. No significant current complaints. Slightly tachycardic and febrile, slightly hypertensive, exam without any significant acute findings, no obvious skin source of ulcer or infection, no focal neurological deficits, no pain. Initiated aggressive fluid hydration and sepsis work-up. EKG appears normal with no signs of ischemia or arrhythmia. Labs show slightly elevated troponin, low magnesium, metabolic/lactic acidosis. VBG relatively normal. Urine negative for infection chest x-ray without evidence of pneumonia, no clinical signs or symptoms to identify source of infection. Nothing to suggest meningitis at this time. CT head is negative. Unclear source of fever however empirically treated with antibiotics and fluids. Patient remains hemodynamically stable with no hypotension. She did arrive slightly hypoxic and with increased respiratory rate however clear lung sounds and no indications of heart failure, COPD/asthma. CT chest without evidence of pulmonary embolism, focal pneumonia, or fluid overload. Respiratory status possibly related to compensation for metabolic acidosis that is likely due to lack of fluid intake due to being on the ground. CK is normal and kidney function is normal. Consulted medicine for admission for further evaluation and treatment. Cardiology was also consulted for NSTEMI, agrees with current plan. per H&P 4/28/21: Altered mental status (R41.82): Etiology is not clear. Patient states she had J&J Covid vaccine about 3 weeks ago. Need to rule out cerebral venous sinus thrombosis. Get a CT scan of the brain with contrast. If negative will get CT venogram or MRV and MRI of the head. Neuro checks. Request PT OT and speech therapy evaluation. Check urine drug screen. Check blood alcohol level. Non-STEMI (non-ST elevated myocardial infarction) (I21.4): Start argatroban drip until cerebral vein sinus thrombosis is excluded then we can switch to heparin drip. Start aspirin and statin. Check fasting lipid panel. Monitor on telemetry. Trend troponin. Request echocardiogram. Cardiology to consult. Dr. was consulted from the ER. » Beta-Blocker Ordered: Beta-Blocker Ordered » Aspirin Ordered: Aspirin Ordered » Statin Ordered: Statin Ordered Fall (W19.XXXA): Plan as documented above. Rhabdomyolysis (M62.82): Hydrate and recheck CPK. Elevated liver enzymes (R74.8): Check hepatitis panel. Monitor levels. Fever (R50.9): No clear source of infection. Follow up on blood cultures. CT chest negative for infectious process. Check CT of the abdomen and pelvis.Start empiric antibiotics: Vancomycin and Zosyn. Hypomagnesemia (E83.42): Administer magnesium sulfate. Repeat level in the morning. Diabetes (E11.9): Start sliding scale insulin. Monitor fingersticks. Hypoglycemic protocol. Check hemoglobin A1c. Hypertension (I10): Fortunately patient is hemodynamically stable. We will cautiously start metoprolol. Adjust antihypertensives to optimal blood pressure control. Acidosis, lactic (E87.2): Likely due to profound volume depletion. Rule out sepsis. Hydrate and trend level. VTE: Argatroban. » VTE Prophylaxis Assessment: Risk Level documented as Low Risk Discharge Planning: » Discharge Planning: » Discharge To, Anticipated: Home independently Per Intensivist note 4/30/21: . Another consideration was TTP, however, patient has normal renal function with no significant evidence of microangiopathic hemolytic anemia (no schistocytes on smear). Also does not seem consistent with ITP. Suspect more a result from sepsis given bacteremia Per attending note 4/30/21: Altered mental status (R41.82): Likely septic encephalopathy due to sepsis. No cerebral venous sinus thrombosis. MRI negative for stroke. AMS has resolved. Continue antibiotics. Per attending note 5/2/21: Addendum by MD, on May 02, 2021 09:58:55 (Verified) Discussed with cardiologist, Dr. . Possible need for TEE with regards to persistent bacteremia. We will keep n.p.o. overnight for TEE tomorrow. Repeat blood culture from 4/30/2021 just came back positive for Enterococcus. Suspect endocarditis due to TAVR. ? need for TEE to evaluate the valves (TAVR) more closely. Duration of antibiotics depends on bacterial clearance: To be determined. Get another set of cultures. On Zosyn. per attending note 5/4/21: Enterococcal bacteremia (R78.81): Etiology not entirely clear but suspect GI source or endocarditis. Repeat blood culture from 4/30/2021 is positive for Enterococcus. PCP he is accepting to follow-up for IV antibiotics management: Will arrange home IV infusion through care . Antibiotics end date to be determined: Pending bacterial clearance. Repeat blood cultures pending. Infectious disease specialist following: Patient is currently on Unasyn. Will need 4 weeks of IV antibiotics.

Presented to ER with weakness and tired last couple of days. Left side of neck pain and headache, shortness of breath.

TROUBLE BREATHING; CAN'T STAND; CAN'T WALK; BRAIN FOG; STRONG ODOR IN THE URINE; CHEMICAL SMELL IN NOSE AND MOUTH; CHEMICAL TASTE IN NOSE AND MOUTH; BODY ACHE; SORE THROAT; LOOSING MEMORY; WEAKNESS; HEADACHE; This spontaneous report received from a patient concerned an 81 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced trouble breathing. On 10-APR-2021, the subject experienced can't stand. On 10-APR-2021, the subject experienced can't walk. On 10-APR-2021, the subject experienced brain fog. On 10-APR-2021, the subject experienced strong odor in the urine. On 10-APR-2021, the subject experienced chemical smell in nose and mouth. On 10-APR-2021, the subject experienced chemical taste in nose and mouth. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced loosing memory. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from trouble breathing, can't stand, can't walk, brain fog, strong odor in the urine, chemical smell in nose and mouth, chemical taste in nose and mouth, body ache, sore throat, loosing memory, and headache on MAY-2021, and had not recovered from weakness. This report was non-serious.

Recent J and J vaccine on may 14th and then hospitalized on 5/31/21 till 6/7/21 with new onset rapid afib/new non ischemic cardiomyopathy ef 35%/ elevated inflammatory markers, new pleural effusions/sob-CTA chest neg for pulmonary embolism. , Pt did not have her vaccine card for her lot number. Reports her friend stole her card because she wasn't vaccinated and wanted it so she stole it but reports she has had the J and J on May 14th in her right arm. Pt was transferred to a larger teritary care hospital on 6/3 where she had cardiac cath and was evaluated by the heart failure team and discharged home with home health care services on 6/7/21. Her cardiac catheterization revealed patent 2 vessel bypass grafts/non ischemic cardiomyopathy. Cause for sudden cardiomyopathy and new atrial fibrillation unknown. discharged on amiodarone, entresto, demedex and eliquis.

developed shortness of breath and rehospitalized for unstable angina requiring coronary artery bypass

Dyspnea developed one day after vaccination. Symptoms have persisted until today, when she presented to office

Janssen COVID-19 Vaccine EUA Patient received J&J COVID Vaccine on 3/15/2021 per vaccine card. Patient had an ED Visit on 3/17/2021 for a chief complaint of lightheadedness and was diagnosed with Pneumonia with Chest X-ray showing small bilateral pleural effusions with underlying atelectasis or consolidation. On 4/12/2021, Patient presented to ED as instructed by outside physician for finding of blood clot on CT the morning of 4/12/2021 (Pulmonary emboli at the left upper lobe). The patient had CT scheduled during an office appointment on 4/5/2021. Patient admitted for treatment of pulmonary embolism.

Nausea, vomiting, body aches, episodic low-grade fevers, frequent chills, mild dyspnea on exertion, and sensation of being slightly short of breath, pain in legs, intermittent blurry vision, feeling jumpy.

SHORTNESS OF BREATH; SHARP PAIN IN LEFT ABDOMEN; SHARP PAIN IN UPPER THIGH; HARDNESS AT INJECTION SITE; TENDER ARM; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, fibromyalgia, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced hardness at injection site. On 29-MAR-2021, the subject experienced tender arm. On APR-2021, the subject experienced sharp pain in left abdomen. On APR-2021, the subject experienced sharp pain in upper thigh. On an unspecified date, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp pain in left abdomen, and sharp pain in upper thigh on 15-APR-2021, and had not recovered from tender arm, hardness at injection site, and shortness of breath. This report was non-serious.

Shortness of breath not urgent. recommended patient call physician or get examined by medical facility today.

Patient after taking a nap and applying ice to swollen cheek. Also c/o red swollen tongue and swelling of Rt cheek last night at 2 am. The tongue is no longer swollen but it is still red and her cheek swelling has decreased. She also has a hoarse voice. No Benadryl in the house. Patient urged to go to ED immediately to be evaluated.

Shortness of breath and rushed to ER - they found massive blood clot in both lobes of my lungs. No sign of Deep Vein Thrombosis - seems a mystery. Almost fatal if not gotten to ER so quickly they said. I was in the ICU from 4/7 - 4/10

fever, pancreatic pain, rapid heart rate and breathing. (pancreatic pain was the main symptom that resulted in the patient going to and staying overnight in the hospital)

Admitted with intractable back pain (known compression fracture). Per ED note, patient found to have cough and labored breathing. New onset A fib

Pt presented to ED w/2 week hx of malaise, myalgias, weight loss associated w/dyspnea and dry cough. Found to be hypoxic, in which she responded well with 2L O2. Labs confirmed COVID-19 positive w/elevated inflammotory markers (lactic acid). Pt had received Janssen vaccine (3/31/21). Was admitted for additional management of her acute hypoxemic respiratory failure w/COVID-19 on 4/23/21. Was treated with dexamethasone, remdesivir and empiric antibiotics which were stopped early. Pt ultimately discharged 3 days later w/follow-up scheduled in 3-5 days.

Janssen Covid-19 EUA 3/22 started feeling ill. 4/4 went for nasal swab Covid test 4/9 results negative. 4/12 went to doctor with extreme abdominal pain, shortness of breath, blurred vision. Ran bloodwork. Sent to ER for cat-scan. Results were colitis. Back to ER x3. Finally admitted and put on antibiotics, and fluids. Released home to hospice after 4 days. Died on 4/30 with cause of death, colitis.

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

Bacteremia - strep epidermidis, developed respiratory distress required intubation for hypercapnic respiratory failure. Developed PEA on 3/28 died.

CAT SCAN HEAD - SOMETHING IN HEAD; FEELING LIKE A BLOOD CLOT ON INNER UPPER THIGH OF RIGHT LEG; DIFFICULTY BREATHING; CALCIFICATION OF LUNGS; NUMBNESS IN BOTH FEET AND TOES; DIZZINESS; OFF BALANCE; RIGHT LEG TINGLING/FEELS LIKE WATER RUSHING; FELT LIKE BUGS RUNNING IN HEAD; ELECTRICAL SHOCK LIKE BUGS IN HAIR; SQUEEZING IN FACE; WHOLE BLOOD WAS DROPPING OUT OF BODY; This spontaneous report received from a patient concerned an 84 year old female. The patient's weight was 230 pounds, and height was 66 inches. The patient's past medical history included stroke, and concurrent conditions included atrial fibrillation, allergy to medications, non-smoker, and non-alcohol user. The patient was not pregnant at the time of reporting and the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 05-AUG-2021) dose was not reported, 1 total, administered on 04-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included diltiazem hydrochloride for atrial fibrillation, and warfarin sodium for stroke. On 01-MAR-2021, the patient's laboratory data included Doppler scan and results were normal. On 04-APR-2021, the patient got dizzy right after the vaccination and off balance which exasperated everything. On the same day, the patient experienced tingling in right leg, felt like water rushing, both feet toes were numb, on right side felt like a blood clot on inner right thigh, difficulty breathing, calcification of lungs, felt like bugs running in her head, electrical shock, like bugs in her hair and squeezing in her face. The patient felt like her whole blood was dropping out of her body. The patient described everything comes and goes and one day it was there and another day it was not, then it came back. It was reported that, the patient visited her physician for the tenderness in her leg for possible blood clot issue and she did not know the results. On 29-JUN-2021, the patient's laboratory data included computerised tomogram (CAT scan) of brain and lungs which was abnormal, showed calcification on the lungs and that something was in her head. The patient had visited an ear, nose, throat (ENT) physician, internist, pulmonary physician, and cardiologist and it was made aware that all the side effects were from the vaccination. The patient had scheduled upcoming appointment with gastroenterologist physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 04-APR-2021, had not recovered from right leg tingling/feels like water rushing, numbness in both feet and toes, feeling like a blood clot on inner upper thigh of right leg, difficulty breathing, calcification of lungs, felt like bugs running in head, squeezing in face, electrical shock like bugs in hair, and whole blood was dropping out of body, and the outcome of off balance and CAT scan head - something in head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210728298-covid-19 vaccine ad26.cov2.s -this case concerns a 84 year old female-feeling like a blood clot on inner upper thigh of right leg. 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).

Patient was vaccinated in her home (COVID J&J) on 3/8. Vaccinator obtained consent and confirmed throughout the process that patient as at baseline since patient was nonverbal and bedbound. Later that same day she experienced an emergency and was take to the hospital and subsequently admitted to ICU. She died on 3/10, family present, on comfort care. Per HPI, "Patient is a 85 y.o. female with advanced dementia (non verbal, wheelchair bound at baseline), chronic aspiration, recurrent UTIs, voiding dysfunction currently self-straight cathing, has suspicious bladder and gallbladder masses (being worked up), has right sided hydronephrosis, BIBEMS for acute hypoxemia, difficult to bag en route, ED had difficulty intubating and so performed cricothroidotomy. Patient had brief PEA arrest due to hypoxia. ED provider noted "excessive pulmonary edema in airway, unfavorable anatomy, and airway swelling." Suspected insult stemming from J&J COVID vaccination reaction.

Patient received Johnson and Johnson vaccine at approx 1:30 pm and passed away on 11:03 pm - May 24, 2021. Was told around 10;20 pm, the patient was experiencing trouble breathing, cold, clammy, non-responsive .

Patient sitting in chair passed out sternal run performed lowered to floor sternal rub performed again responsive breathing shallow lost bowels pulse weak ammonia salts used and EMS called

BLOOD CLOTS IN BOTH LUNGS. SHORTNESS OF BREATH. UPPER BACK PAIN. WEAKNESS. SWEATING AND COLD. NO COLOR IN FACE -- GREY. LOSS OF EYE SIGHT -- STARTED WITH BLURRED VISION.

swelling in throat, very similar to previous vaccination Patient received Moderna # 1 on Jan 15th had difficulty swallowing, tingling on tongue and jitters Patient was recommended by PCP who also consulted H to receive the Janssen Vaccine. Vaccine clinic spoke with ID specialist and looked at recommendation and decided to proceed with vaccinating patient

Extreme pain occurred in left thigh on 4/25/2021, went to ER. Was diagnosed with spontaneous bleed in gluteus muscle. Sent home from hospital 4/28/2021. Pain reoccurred 5/5/2021 and was again admitted to the hospital. Doctors unable to determine exact site of bleed. Stopped blood thinners to allow bleeding to stop and leg to heal. Inserted IVC filter on 5/9/2021. Had to go to to a rehab facility from 5/11 to 5/19. Saw doctor on 6/21 who ordered an MRI to be sure of no blood clots. Found out on 6/23 that there were blood clots in the lungs and was sent to the ER. Admitted to the hospital again. Had to stay until they could take out the IVC filter which was done on 6/28/2021 and she went home on 6/29/2021.

vomiting, shortness of breath, hospitalized, chart shows she suffered from blood clot, hospital has extensive records from tests

DIARRHEA; STOMACH PAIN; BACK PAIN; COUGH; SHORTNESS OF BREATH; RUNNY NOSE; CHILLS; FEELING TIRED/ FATIGUE; FEVER; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcers, blood count are always high, allergies to pain medication, and cigarette smoker, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: 23-JUN-2023) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced back pain. On 13-APR-2021, the subject experienced cough. On 13-APR-2021, the subject experienced shortness of breath. On 13-APR-2021, the subject experienced runny nose. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced feeling tired/ fatigue. On 15-APR-2021, the subject experienced diarrhea. On 15-APR-2021, the subject experienced stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 15-APR-2021, was recovering from feeling tired/ fatigue, diarrhea, stomach pain, back pain, cough, shortness of breath, and runny nose, and the outcome of fever was not reported. This report was non-serious.

SINUS ACTING UP; HOT FLASHES; LEG CRAMPS; LOOSE BOWELS; DIFFICULTY IN REMEMBERING; SWELLING INSIDE THROAT; ACHINESS ON SIDES OF NECK; DIZZINESS; NOSE BLEED; ACHINESS ON INSIDE OF LEFT ELBOW AND RIGHT KNEE; NAUSEA; TIREDNESS; MUSCLE ACHES; BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA; SHORTNES OF BREATH; FEELING OF BLOOD RUSHING TO HEAD; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfonamide derivatives, non-steroidal anti-inflammatory drugs (NSAIDs), sulfa antibiotics, penicillin, and cephalexin, asthma, and dry eyes. 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, 1 total dose administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 06-APR-2021, the patient felt rush of blood to her head almost causing her to pass out. On 07-Apr-2021 (in morning), she developed muscle aches, shortness of breath, a nosebleed one and hot flashes. She experienced trouble while remembering which was never a problem before. She developed leg cramps, loose bowels (for 1 week), swelling in her throat, achiness on both sides of her neck, dizziness, nausea if she ate something that did not agree with her, tiredness and an unusual blood stain in her underwear near the groin area (but not the private parts). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood present on underwear near the groin area, nose bleed, and achiness on inside of left elbow and right knee on 07-APR-2021, feeling of blood rushing to head, sinus acting up, leg cramps, swelling inside throat, and achiness on sides of neck, loose bowels on 14-APR-2021, dizziness on 11-APR-2021, and nausea on 09-APR-2021, was recovering from muscle aches, and had not recovered from shortness of breath, hot flashes, difficulty in remembering, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid-19 vaccine ad26.cov2.s-BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA. This event is considered unassessable. The event 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.

86 yo Female, in wheelchair, accompanied by granddaughters,had Janssen Covid19 Vax in Larm 10:28am.10:30 adverse reaction of feeling tired,weak/nauseous. Not diaphoretic. 10:32 V/S HR73,BP120/65,RR26/02%97%. Shallow breathing. 1034 EMS called as Attendee still symptomatic. 10:39am V/S HR77,BP130,RR16,02%99%.Attendee stated she felt better. 10:48am EMS arrive took V/S HR68,BP153/83,RR16,02%97%.Monitored Attendee.EMs offered to take Attendee to ER. Attendee refused. EMS left 10:57am. Attendee sat, rested. Had snacks and drinks offered by grandaughters.11:09am V/S HR66,BP150/70,RR19,02%99.Attendee and grandchildren educated on home discharge/adverse reason instructions.Discharge to home at 11:15am with granddaughters.

Patient presented to hospital on 3/11 with shortness of breath. History of chronic oxygen dependency at night. Became more sob over last several days and was not able to make it to md appointment. Had a recent abnormal stress test. Family states she was febrile at home. Was low on oxygen level on 2LNC, placed on non-rebreather and then BIPAP. Positive for Rhinovirus. Chest xray showed bilateral lower infiltrates. Patient detiorated through the night and was intubated and placed on vasopressors for septic shock. Patient was made DNR and family refused hemodialysis. Family then made decision to withdraw care.

Janssen vaccine given on 3/9/2021; Admitted to the hospital on 3/16/2021 for COVID-19 infection, pneumonia, new onset a-fib, and COPD exacerbation.

Hallucination, shortness of breath, dizziness, weakness, leg edema and low oxygen level. Patient sent to hospital for evaluation and treatment.

SHOULDER PAIN; MALAISE; HEADACHE; OUT OF BREATH; RED CHEEKS; FEELING COLD; CHILLS/SHIVERING; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation, leaky valves, pacemaker, and latex allergy. The patient experienced drug allergy when treated with ibuprofen, levofloxacin, prednisone, tramadol, and tramadol hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180029, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included latanoprost for glaucoma, alprazolam, amlodipine, apixaban, and flecainide. On 15-MAR-2021, the subject experienced feeling cold. On 15-MAR-2021, the subject experienced red cheeks. On 15-MAR-2021, the subject experienced chills/shivering. On 16-MAR-2021, the subject experienced out of breath. On 16-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced malaise, and shoulder pain. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Urine analysis (NR: not provided) Unknown, and X-ray (NR: not provided) Unknown. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, out of breath, shoulder pain, malaise, and red cheeks, and the outcome of chills/shivering and feeling cold was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as 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.

VERY RAPID BREATHING; FEELING WEAK; EXHAUSTED; BLEEDING AT THE SITE OF INJECTION; WRONG INJECTION TECHNIQUE (INSTEAD OF TAKING THE SYRINGE IN AND PUSHING IT IN THEN INJECTING THE FLUID INTO ARM, ADMINISTRATOR JAMMED THE WHOLE SYRINGE, INJECTED THE FLUID AT THE SAME TIME); DIFFICULTY STAYING AWAKE FOR MORE THAN TWO HOURS; ITCHING AT THE SITE OF INJECTION; STRESS; VERY WEAK LEGS; PAIN AT THE SITE OF INJECTION; This spontaneous report received from a patient concerned an 89 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 07-AUG-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced bleeding at the site of injection. On 14-MAY-2021, the subject experienced wrong injection technique (instead of taking the syringe in and pushing it in then injecting the fluid into arm, administrator jammed the whole syringe, injected the fluid at the same time). On 14-MAY-2021, the subject experienced difficulty staying awake for more than two hours. On 14-MAY-2021, the subject experienced itching at the site of injection. On 14-MAY-2021, the subject experienced stress. On 14-MAY-2021, the subject experienced very weak legs. On 14-MAY-2021, the subject experienced pain at the site of injection. On 13-JUL-2021, the subject experienced exhausted. On an unspecified date, the subject experienced very rapid breathing, and feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty staying awake for more than two hours, and itching at the site of injection on JUN-2021, and very weak legs on 28-MAY-2021, was recovering from bleeding at the site of injection, and pain at the site of injection, had not recovered from very rapid breathing, and exhausted, and the outcome of stress, wrong injection technique (instead of taking the syringe in and pushing it in then injecting the fluid into arm, administrator jammed the whole syringe, injected the fluid at the same time) and feeling weak was not reported. This report was non-serious.