Johnson & Johnson

Patient received Janssen vaccine around 10:30. He left the observation room feeling fine. once he got at his car and started to drive, he felt shortness of breath and some weakness. Then, he came back to the SR Vaccine site to get help around 10:50. We met him in front of the parking lot, he was having some trouble of breath and weakness. We put him in a wheelchair, brought him back to the Observation area. I asked him to lay down with elevated legs on a chair. He instantly felt better, no more shortness of breath. He did not need to use any Oxygen supply. Also, he drank some water, sit back in the chair and felt better ready to leave with his brother who came to help him just in case. At 11:10 he left the building with orientations about worsening of symptoms and when to call EMS.

severe headache, fever, chills, body aches (including in testicles), severe coughing, nausea, difficulty breathing

Patient reports he had chills and headaches the day after his vaccine. He is reporting SOB at rest that worsens on exertion since having had his vaccine. Pt also reports back pain and chest pressure since the day he got his vaccine

Starting from 04/07/21, Sudden waist and back pain, cannot straighten up the body. When straighten up the body feels breathing difficulties . After 3-4 days there?s a continuous pain in both thigh and the calf, and red marks are spawning on the legs.

Patient reported acute onset of diffuse tingling sensation , light-headed, with cold sweats, blurred vision, and acute complaints of shortness of breath within 9 mins of injection. Shortness of breath was immediate after administration. VS at 11:30 AM T97.4, HR 60, RR 16 BP 88/58 O2 87- rechecked at 95--lungs CTAB Reports a controlled 1600 cal/day diet, OJ and gummy snack given. Patient encouraged to push PO fluids and focused respirations. O2 stabilized at 94-95% on RA VS rechecked at 12:15 PM 96.9 Tympanic, HR 58, RR 16 even and unlabored, BP 98/72 O2 97% Reported feeling better and with appetite, was able to walk around parking lot for several mins to make sure he felt ok to independently leave and opted to depart. A&O x 3. Insight and judgement intact.

Got injected, didn?t hurt much. Was told to wait 15 minutes in case of reaction. They walked away and left me sitting in a chair in a public space with everyone else who was waiting. I texted my wife to check in, when I started tearing up and crying for no real reason, then started feeling nauseous so I closed my eyes. Suddenly I felt like I had been given a shot of adrenaline out of nowhere so I?m just trying to figure out if it?s nerves or a physiological response to something. I?m trying to control my breathing but having a hard time breathing. Then the fever hit. The most intense flash of heat. I was hyperventilating. I couldn?t open my eyes or move or make a sound, I could just sit there struggling to breathe. My phone was in my hand and I couldn?t lift it. I just simply didn?t have the strength or energy to move. At some point I legit thought I was about to die. I managed to angle my wrist so I could check my heart rate with my watch. It was 47bpm. I was fading away but I made myself get control of my breathing and forced myself to take long deep slow breaths. It hurt, and I felt like passing out, but I kept doing it. Fever turned into chills and then I soaked through my jeans and T-shirt in under a minute. I was finally thinking clearly and breathing and getting oxygen. Everyone else near me was fine. Nobody checked on me the entire time including the 3 people who sat there and watched me suffer through this. I told the pharmacist about my reaction and asked if it was normal and didn?t receive any indication that I should be concerned, so I went home since I felt better. It wasn?t until my friend pointed out that this sounds like anaphylaxis that I thought I should report it. So here I am. Hopefully I?ll be okay.

Patient looked normal and relaxed before and during vaccination. About 5-10 minutes after vaccination, patient passed out (fainted) while sitting down in a chair. Moved patient on to floor lying down flat and observed him for a few seconds. Patient was un responsive and appeared to struggle to breath. Asked my staff to call 911 for emergency services, and to bring an Epipen just in case, and started to perform CPR on the patient. The patient gained consciousness in about 15 chest compassions and became responsive. He answered the questions like his name, where he lives etc. As the patient became conscious, responsive and appeared to breath normally, I did NOT administer Epipen. Kept patient in observation and kept him engaged in talking until EMS personnel have arrived. They checked his vitals and blood glucose. In the conversation with EMS personnel, they said he is hypertensive and hyperglycemic. Ems took him to the ambulance by walking him (stretcher wasn't necessary)

I experienced after the vaccine, I got super sick for one to two weeks as if I had Covid again, had a terrible headache that has not gone away. Also have horrible vertigo, feel like I am spinning all the time and it has not gone away. I also had SOB and my heart was pounding for one week. My PCP told me that I should wait it out that it was probably my body revolving against the vaccine and I was prescribed a medication for my headache and vertigo. My ear were also checked with an ENT and I have no inner ear problems. I can say that my symptoms came from the J&J vaccine.

April 17th, felt chest pain and fatigue and shortness of breath. After about two weeks of it, I went to ER on the 26th. I was diagnosed with blood clot on my heart. I spent a week at the hospital Heparin blood thinners and antibiotics - discharged on May 2, 2021. They sent me home with Warfarin regiment. I am still on that. I still have some days where I'm good but some days, I can barely stand and get out of bed due to short of breath, fatigue but not as much chest pain. I think the blood thinners are working. I just have to take it easy and make sure to have some calm days. It could take weeks to months to have the blood clot totally dissolve from the system.

Pt received the Janssen covid vaccine. During the 15 minutes post-vaccination observation period, pt started not feeling well. He experienced dizziness, sweating, swelling of the lips and tongue, and shortness of breath. Pt was non-responsive. Rph administered an Epipen and staff called the ambulance. At this time, pt was becoming more responsive in response to the Epipen. EMS came and checked the pt's vitals. Vitals were within normal range. Pt was not sent to the hospital. EMS advised the family to monitor the pt and call EMS if symptoms worsen. Pt is doing okay.

Pt. was in his dorm, stood up and stated he could breathe, then went unresponsive. A medical response was called and staff arrived to the dorm within 2 minutes. Pt. took a couple of agonal breaths and stopped breathing, no pulse was found and CPR was initiated. Staff and EMTs administered 45 minutes of CPR, narcan and cardiac medications. He was pronounced dead by EMT at 10:45 am.

DIFFICULTY/TROUBLE BREATHING; MIGRAINES; SINUS FLUID BUILDUP FEELING; TASTES SOME KIND OF WATER-LIKE LIQUID IN MOUTH; SNEEZING ON AND OFF; ITCHY NOSE ON AND OFF; STRONG HEADACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced difficulty/trouble breathing. On 23-MAY-2021, the subject experienced migraines. On 23-MAY-2021, the subject experienced sinus fluid buildup feeling. On 23-MAY-2021, the subject experienced tastes some kind of water-like liquid in mouth. On 23-MAY-2021, the subject experienced sneezing on and off. On 23-MAY-2021, the subject experienced itchy nose on and off. On 23-MAY-2021, the subject experienced strong headaches. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from strong headaches, migraines, sinus fluid buildup feeling, tastes some kind of water-like liquid in mouth, difficulty/trouble breathing, sneezing on and off, and itchy nose on and off. This report was non-serious.

After 3 weeks, small rashes along the arms, minor coughing, occasional breathlessness, and mild diarrhea began appearing. Currently about 4 days of these symptoms. The week immediately after the injection, only minor itching about the body and nothing else. This might all just be a delayed response, but I'd like to note this occurred.

Patient reported to the administering pharmacist today that he has been experiencing dyspnea and shortness of breath, which began approximately two days prior to date and time that the event was reported (i.e. beginning on or around July 4th, 2021). Patient states that he has been experiencing dyspnea and shortness of breath both upon exertion (and, even upon minimal exertion ? for example, when walking from car in parking lot into the pharmacy today) and also while at rest. Patient states that he has no known history of dyspnea or shortness of breath similar to the symptoms he is currently experiencing. After contacting the patient?s primary care physician?s office and discussing the signs and symptoms the patient was experiencing with the medical office personnel, the patient was advised by the pharmacist to seek immediate medical attention and report to the nearest hospital emergency department. The patient stated that he would seek immediate medical attention at the local hospital emergency department, as his primary care physician did not have any appointment availability to be able to see him in office today.

Since 7/3/21 patient complains of fever 104.5F, malaise, weakness, rigors, also developed cough and shortness of breath on 7/6/21

Uneasiness/discomfort high up on the left side of the chest, slightly below shoulder. Feeling for a few days. On 5/30, it felt more pronounced and I felt I had difficulty to breathing. Hard to take deep breaths and feel as though I was getting enough oxygen. Was breathing mostly normal by morning. By the time I saw the doctor, only chest uneasiness was still there but not persistent as it once was.

Upon wakening this morning pt reports L arm numbness, tingling and flaccidity. pt walked to kitchen and he began feeling sweaty and hot, the next thing he awoke laying in the floor after passing out . Pt was incontinent of urine during event. He now reports some mild shortness of breath but no acute distress or known injuries from syncope episode. pt advised to go to the ER. Pt's states his wife is on her way home and will drive him to the ER.

Patient reports that as soon as he received he experienced tingling through out the his body - to the tip of his toes; experienced light headedness and slight nausea. Shortly after experienced tightness of throat, though denies having difficulty breathing. Patient described as, "having a knot in my throat." Denies experiencing hives, nor itching, no nasal drainage, no cough. States he waited 50 minutes post receipt of vaccine to ensure he could drive. Reports on 03/17/2021 he again experienced tightness of throat; denies difficulty breathing; states it felt like, "my throat was swollen." Again patient denies having difficulty breathing, no hives, itching, no cough. Advised should he experience difficulty breathing to please call 911 since that could be a life threatening emergency; or nearest ER. Denies tightness of throat today, no shortness of breath, nor difficulty breathing.

vitals were 155/104, HR 59 and SP02 94% at 11:37. Patient was getting ready to leave after waiting 15 minutes. patient walked to bathroom and started with chest tightness and SOB. Chest discomfort is rate 1/10, no HTN hx. Patient has hx of panic attacks. 1141 patient states the SOB of breath is better than it was when he was walking to the bathroom. Vitals were repulled at 157/98, HR 91. at 11:47 patient denies chest pain and SOB at time. patient having full sentence conversations and laughing. kept for 15 minutes and repeated BP last time: 1208 PB at 139/95, HR 88.

The vaccine was administered and within a few hours the patient was noted to be tachypneic and tachycardia RR 30s-40s; HR 130s. ABG done revealing hypoxemia to 57.6, blowing of pCO2 25.6. Lactate 6.6. EKG done revealing sinus tachycardia S1Q3T3; D-dimer 3000s; CTA done revealing a large embolus in the right mainstem pulmonary artery area crossing across midline into the left main pulmonary artery compatible with a saddle embolus. New saddle pulmonary embolism with hemodynamic instability Patient started on levophed to manage hypotension. Started tPA,and transferred to the ICU.

On March 20th I received the J&J covid-19 vaccine shot. Starting on March 21st I begin to experience symptom such as fever, chills and body aches. That lasted for about 2 weeks. The week of April 5th- I been to experience struggling the ability to breathe. I was having serious pain in my left side of my chest and in the lower left side in my back. It was so severe, I went to the hospital on April 8th and at the hospital the Doctors discovered I had blood clots in my lung. I was in the hospital for 2 days. Iam currently on blood thinners inhaler and and oxygen.

Bloody nose Left leg / foot pain Entire left side of body not correct Chest pain Shortness of breath Blurred vision Can't sleep

My patient experienced diffuse urticaria and throat swelling. He was seen in the ER, given IV steroids and released as his symptoms improved after 2 days. He was discharged on Decadron and Benedryl.

5/5/21: "Good morning sorry to bother you had a question about this shot (Janssen Covid19 vaccine). I have been checking in with that website (V-safe App) you gave me no one has contacted me. Monday (5/3/21) I missed work due to me not feeling good and still today (5/5/21) I'm at work but feel like I could fall asleep, no energy, nausea still, and like I haven't slept in weeks even though I get good sleep. My breathing has gotten to the point that it hurts to take a deep breath. I believe this is all due to the shot but didn't know what you thought."

patient experienced sharp pain and problems breathing when going up stairs or standing . none while sitting down.

ABOUT 2 MINUTES AFTER VACCINATION PATIENT SAID HE WAS FEELING WARMTH TO HIS FACE , SWEATY , DIFFICULTY BREATHING STILL ALERT. CALLED 911 AND I TOLD HIM THAT I WAS GOING TO GIVE HIM AN EPIPEN. A FEW MINUTES AFTER THE EPIPEN HE SAID HE WAS FEELING BETTER.

COULDN'T TAKE A DEEP BREATH; FELT COLD; WHOLE BODY ACHY; DIZZINESS; WEAKNESS; CHILLS; EXTREMELY TIRED; NAUSEATED; EYES GOT HEAVY; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type2 diabetes. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. Concomitant medications included metformin for type2 diabetes. On 18-MAY-2021, the subject experienced whole body achy. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced weakness. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced extremely tired. On 18-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced eyes got heavy. On 19-MAY-2021, the subject experienced couldn't take a deep breath. On 19-MAY-2021, the subject experienced felt cold. The action taken with covid-19 vaccine was not applicable. The patient recovered from nauseated on MAY-2021, was recovering from couldn't take a deep breath, had not recovered from extremely tired, whole body achy, weakness, and chills, and the outcome of dizziness, eyes got heavy and felt cold was not reported. This report was non-serious.

It started with wheezing that ive never had in my life, I started and coughing. I went to see the doctor and they put me on inhalers and other medications.

c/o throat tightness after vaccination. No SOB, rash, hives, headache, altered mental status. pt. remain vocal and swallows water with no difficulty. no PMH reported. Allergy to bactrim and pollen. Takes Zyrtec PRN. Assessment WNL. V/S BP 134/72, P62, R 18, O2Sat 98%. Pt. after few mins insisted throat is closing up. Emergency personnel is called to the scene. Epipen is given at 1:28pm. Ambulance called with pt. transported at 1:39pm to hospital for further evaluation. Patient not in distress prior to being transported.

5/21/21 10:00pm shortness breath, chest pain, shoulder pain, jaw pain, metallic taste, fatigue ?mini heart attack? symptoms 5/26-5/27 trouble breathing, fatigue, light headed 5/29 pain in left arm 5/30 night - second ?mini heart attack? symptoms General fatigue, hard to breath, overall feeling bad 6/2 - bruise on arm and lump Extreme headache, fatigue, chest pain, arm pain Emergency room visit = blood clots

Background:41-year-old male reported that he awakened with right lower leg pain intermittently since approx. May 10 2021. Woke on June 10 with increased pain and swelling to RLE. He tried to "run it out" but the pain worsened. In the ER he was noted to have elevated D-Dimer- 1980, ESR of 27, labs otherwise normal. Ultrasound showed DVT. He was started on hydrocodone-APAP and Xarelto. Returned on 11 June with SOB. PE was confirmed. Admitted to ICU Note today states continued swelling and pain to RLE. Considering transfer to hospital for vascular consultation and further management.

The first three days were normal expected side effects, such as fatigue, headaches, and so forth. I felt better after two days. Then on the 6th day, I suddenly broke out in hives, starting with a reaction at the injection site on my right deltoid. The hives continued to progress and get worse over the next few days and started welting. My legs and arms were covered in hives. I became dyspneic which was relieved by using albuterol. Hives reduced from antihistamines. For three days the hives would appear systemically with skin sensations of burning and itching.

Immediate(3-5 seconds) and rapid injection site swelling and redness, bleeding more than usual from a shot, dizziness, full body sweating, rapid heart rate, hives, as well as general body swelling that caused great difficulty in starting an IV. I did not have any significant issues with breathing. They treated me with a IV fluids, an intramuscular injection and IV injection of Benadryl and a steroid that I cannot recall the name of, I apologize.

Patient received Janssen lot#1805020 with expiration of 05/25/2021 at 1420 sitting in upright chair. Vaccinator was notified that he has a history of vasovagal response with needles. This response presents itself as sweating (and possible fainting) and is alleviated by lying down. Client mentioned that previous nurse advised him to smell an alcohol pad to distract and prevent a vasovagal response, as this had worked previously on a glucose check. No medications were disclosed or history of anaphylaxis reported. With this background information, RN offered to have vaccine administered in reclined position, however client refused. RN conferred with co-lead about administration recommendations. Vaccinator then checked in with patient at 1423 to see if patient was okay and patient did not answer the question. RN then felt the client's hand and noticed hand was clammy. At 1425 the reclining chair was brought to the station and patient was transferred into chair, appearing diaphoretic. RN palpated pulse and noted patient was not tachycardia, but RN did note tachypnea and uneasiness. RN then provided distraction and promoted relaxation. Then at 1426 patient reported feeling okay and RN noted patient no longer felt clammy. At 1440 patient was asked if he would prefer if EMS should be called, patient declined and stated that he was able to drive home. Then at 1447 patient left the site appearing well, alert and oriented x3 leaving by self in private car.

Severe leg pain first, then trouble breather. Shortness of breath and tightness in chest. Thought it was severe congestion... delayed going to the ER. Finally went in due to vomiting trying to get breath. Had LAD 90% blocked and blockage in the right leg still in hospital receiving treatment. Will Catheter scope the right leg to very clots and severity.

Patient reports extreme leg swelling on both legs occurring 30-45 minutes after vaccination (04/05/2021) and lasting 7 days. Patient reports shortness of breath which has not improved since vaccination date. Patient contacted PCP and was told to continue monitoring side effects,

Flu like symptoms, joint pain, lungs heavy, pain in lungs, headaches - went to ED and PE was found - admitted to ICU - DC'd 5 days later

HEART PALPITATIONS; FAST HEART RATE; SHORTNESS OF BREATH; SHAKINESS; WEAK FEET; This spontaneous report received from a patient concerned a 42 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: 1808980,expiry: 20/JUN/2021) dose was not reported, administered on 07-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced fast heart rate. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced shakiness. On 07-APR-2021, the subject experienced weak feet. Treatment medications included: paracetamol. On 08-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitations, shakiness, shortness of breath, and fast heart rate, and the outcome of weak feet was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

First 2 days after vaccine I had the expected slight sore arm, some minor headache, some muscle aches. Nothing major that kept me from working or sleeping. Some time after, maybe 3rd or 4th day, I noticed a shortness of breath. This I did not expect since it's not a listed side effect for the vaccine but it is one for Covid. I notice it everyday while sitting/working. It does not keep me from being active (running/yard work) but I notice I'm not 100% healthy feeling. It feels like the shortness of breath is closer to the top of the chest/throat area if that makes any sense. If I breathe deeply it feels like I may want to cough although I don't usually cough from doing so. It's mostly just a constant feeling of a very slight shortness of breath.

on the 2nd i had the shot in the left upper arm .. two days later i woke up to violently upchucking pure water after that i when to hospital and was admited i was told after a ekg that i was haveing a heart attack after that have no recolectiom of anything i wake up to a doc telling ,e it was a bad heart attack and had delovped about 5 blod clots in left lung and microcaditis i have been trying since then for a doc to talk to me but so far i been avoided

Could not get air into lungs, made sugar get out of control, had a seizure and turned purple, passing out , ambulance had to come get me from vehicle and take me to emergency room in the hospital, kept me there for about 6 hours then released me to go home, went to my Doctor next day and he immediately sent me to hospital. I was checked for Blood Cloth due to the signs being there along with other tests I am home however I still do not feel well.

This is to report my side effects since the vaccine shot, because I haven?t heard any of these regarding this vaccine. Lower leg below the knee on the left and right leg varicose veins have constantly burned and ached. Only my right leg had previous varicose veins that would burn ache in the evenings following a day of manual labor. From Friday morning to Monday late night my left temple would randomly throb. Same days either my lower left or right lung would ache or be sore. For about 2 hours everyday same days above I would have a metallic taste in my mouth no matter what I ate or drank. No pain ever severe enough for immediate medical attention

Was having normal side effects including headache, fever, muscle aches which started about 6 hours after injections. Roughly 14-16 hours after the injection (8:30-9am) started getting chest pain and slight shortness of breath. Called my PCP and they told me to go to the ER as the chest pain is not normal. At the ER they did an EKG which came back abnormal and I was rushed into a procedure to check my heart including a catheter, ultrasound, and a few more I will provide below. Outcome after all the test was inflammation which I asked if it could have been in other areas of my body but doctor said it was my chest. My C-Reactive Protein level was double the normal level. They put me on 3 medications, Ibuprofen, one for Gout and Prilosec.

Diagnosed with pericarditis Presented to the emergency department on 7/18/2021 with chest pain (substernal) and does not radiate, but reports heaviness and pressure. The pain was severe at onset. This is exacerbated by exercise but are relieved by nitroglycerine and fentanyl. Family history of CAD. Also reports shortness of breath. Pain onset was abrupt while riding his bicycle. ECG shows diffuse ST selevation in multiple coronary distributions with P depression. Bedside ECHO showed normal heart. EF was ~60%. Hemodynamically stable. Given one dose of Toradol., SL nitro 0.4mg Admitted to the hospital Started on colchicine 0.6mg bid and ibuprofen 600mg tid with plan of 10 days of treatment.

AE: numbness of both arms, fingers, legs and toes Fatigue, dizziness, sweating, skin turned pale, difficulty breathing, numbness on tongue -- 1:20 pm about 5 mins after receiving vaccine Treatment: checked Blood pressure: 117/79 and HR 69. Gave 20ml children benadryl (50mg), water and chocolate bar. 1:30 pm Outcomes: pt stated symptoms gone away around 1:45. numbness on arms and legs gone, dizziness and sweating stopped. pt was able to stand up and walked around and went home

Patient was admitted for Multi drug resistant UTI (for which he has been admitted many times before). Was hospitalized for 3 days while awaiting cultures, hemodynamically stable, with no lab abnormalities. On the day of discharge (sensitivities to UTI came back, pt to be discharged on cefepime, had PICC line) pt got up from bed, sat on the edge of the bed and was being given belongings by the nurse, alert and oriented and in a pleasant mood, when suddenly pt grabbed at his chest and stated "I can't breathe" and became combative and altered when O2 was attempted to be placed on pt's face; then pt had PEA arrest x3 and unable to achieve ROSC.

PATIENT RECEIVED VACCINE ON 4/4/21. ON 4/7/21, WAS AWAKENED DURING SLEEP WITH SHARP, STABBING PAIN IN LEFT LEG CALF MUSCLE. PAIN LASTED FOR 30-40 SECONDS. FOR THE NEXT 2 DAYS, PAIN IN THIS AREA REMAINED SORE, IRRITATED, AND TENDER. RATED PAIN 1-2/10 IF NOT TOUCHING THE AREA, BUT UP TO A 3/10 WITH TOUCHING THE AREA. IN ADDITION, FELT BREATHING HAS BEEN HEAVIER AND LITTLE WORSE THAN HIS NORMAL BASELINE (BASELINE DUE TO HISTORY OF ANEMIA/LOW IRON), AS WELL AS FEELING BRAIN FOGGY SINCE RECEIVING THE SHOT.

Headache will not go away , shortness of and trouble with breathing , weak after a short time of physical anything , chest pains , veins in legs are showing. These all came on a few days ago and the headache last night was almost unbrarible and i never have headaches

By midnight after my vaccine: Shortness of breath. Three days later around 6:25 am on April 15, 2020: I got out of bed, next moment I recall is of me on the floor. No memory of falling. I was shaking uncontrollably as if my body was getting many commands at the same time but I had no control over it. I could not call out for help. At one point I was biting my right hand but could not make myself stop until my shaking stopped. Bite did not penetrate skin but I had visible bite mark on my hand. I regained control suddenly and just got up slowly and shaken by the experience. Wife then drove me to the ER. Been feeling pressure on my head.

BODY ACHES; THROAT SWELLING; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hereditary angioedema, and atrial fibrillation, and other pre-existing medical conditions included the patient did not have any known allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, metoprolol for atrial fibrillation, and sotalol for atrial fibrillation. On 02-MAY-2021, the subject experienced throat swelling. On 03-MAY-2021, the subject experienced body aches. Treatment medications (dates unspecified) included: icatibant acetate. The action taken with covid-19 was not applicable. The patient recovered from throat swelling on 02-MAY-2021, and had not recovered from body aches. This report was non-serious.

TENDERNESS IN THE CHEST; LUNG INFLAMMATION; COUGHING; SORENESS; TROUBLE BREATHING; THROAT SWELLING; CHEST TIGHTNESS; GENERAL SWELLING; DETERIORATION; DID NOT FEEL WELL; TIRED/FATIGUE; This spontaneous report received from a patient concerned a 43 year old male. 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: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced tired/fatigue. On MAY-2021, the subject experienced deterioration. On MAY-2021, the subject experienced did not feel well. On 07-MAY-2021, the subject experienced soreness. On 07-MAY-2021, the subject experienced trouble breathing. On 07-MAY-2021, the subject experienced throat swelling. On 07-MAY-2021, the subject experienced chest tightness. On 07-MAY-2021, the subject experienced general swelling. On 07-MAY-2021, the subject experienced coughing. On 08-MAY-2021, the subject experienced tenderness in the chest. On 08-MAY-2021, the subject experienced lung inflammation. The action taken with covid-19 vaccine was not applicable. The patient was recovering from tired/fatigue, had not recovered from soreness, trouble breathing, throat swelling, chest tightness, general swelling, lung inflammation, and coughing, and the outcome of tenderness in the chest, did not feel well and deterioration was not reported. This report was non-serious.

PAIN IN STOMACH; SWEATS; REDNESS ON BODY LOOKS LIKE SKIN IS DISCOLORED; CHILLS; FEVER; NAUSEA; BODY PAIN; MIGRAINE; EVERY BEAT OF HEART HURTS; HYPERVENTILATION; COULD NOT GET A FULL BREATH; PASSED OUT'; FINGERS WENT NUMB; GOT A CHARLIE HORSE ON LEG; EVERY SINGLE JOINT AND ANKLES HURTS FOR NO REASON; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 135 pounds, and height was 66 inches. No past medical history or concurrent conditions were reported. The patient's concurrent conditions included migraine The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered, 1 total to right deltoid on 19-MAY-2021 around 10 am for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, around 7 pm patient started experiencing side effects. After 1 hour of shot patient had his heart hurt at every beats, hyperventilation. It lasted for 1 -2 hours. The patient also had fever, chills, nausea, sweats and had not taken any medication, as he was afraid of another side effects, had redness on his body which looked like skin was discolored and was like hives. The patient also had body pain appeared suddenly. The patient also had pain in stomach which felt like nastiest gas cramp patient had ever and it was continuous like a rock blocking in stomach, he did not know if it is pain or gas but was hurting. Patient had migraine which lasted long time and was continuous than he ever had. The patient was fine as he was speaking at the time of reporting. On MAY-2021 (dates unspecified) the patient experienced Charlie on his leg (muscle spasm) for which he stood up and didn't do anything on leg, he was passed out and fingers went numb, felt every single joint and ankle hurt with sharp pain like a stuffed knife (intermittent pain for 3-5 minutes).He could not get a full breath of air, and was breathing really fast. Then patient tried to slow down breathing as he didn't want to be hyperventilated but it happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain, hyperventilation, migraine, pain in stomach, chills, fever, nausea, and sweats, and the outcome of passed out, could not get a full breath, redness on body looks like skin is discolored, got a charlie horse on leg, every single joint and ankles hurts for no reason, fingers went numb and every beat of heart hurts was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210540430-COVID-19 VACCINE AD26.COV2.S --Every beat of heart hurts, Passed out. 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).

High fever, muscle aches, shaking, nausea, shortness of breath. All of these lasted for 18 full hours, and slightly shortened breath is still present 5 days later.

patient was asked to stay in the waiting are for 15 minutes.he went and sat down then he got up to talk to his wife at that time he felt sick and passed out. his breathing was shallow and he was unresponsive for 2 minutes. he was pale. paramedics were called and they came right away and assessed him. he did not need any medical help. he felt fine. they did not take him to hospital.

Woke up the next morning feeling sore at shot site and as the day progressed my body started to ache all over. For the next 2 days after this, I will alternate between having the chills and having intense sweats. On Friday 06/25/2021, I woke up to my chest hurting , I could not catch my breath, it felt like I had a very heavy weight on my chest . I went to the emergency room which is a part of the Hospital. After the initial tests the physician told me with 99% certainty that I had had a heart attack. Soon after this they rushed me by ambulance from hospital to hospital which is about 20 miles or so. They rushed me in and completed an arteriogram within minutes of arriving at the hospital. They confirmed with this test that is was not a heart attack and after several more test, the doctor that I had developed Myocarditis due to the vaccine shot. The admitted me into the hospital on 06/25/2021 for observation and to run more test until I was stable enough to go home. I stayed in the hospital for 1 evening and was discharged on 06/26/2021 at about 1:00 or 2:00 that afternoon. The doctor prescribed several medications for me to take for my heart for the next foreseeable future. On 06/30/2021 I had a visit to my new cardiologist in which he ran several test and stating that I was looking better, but he had ordered an MRI to take place on 07/06/2021 at Hospital. I have a follow up visit for my cardiologist slated for 07/19/2021 in which I will find out more information.

Chills, Sweats, Bad body aches Saturday night through Sunday Morning- Took Tylenol Tiredness- throughout Sunday Chills- Sunday night- Tylenol Monday felt good- Monday night slight temp 99.5 and shortness of breath Took Tylenol Tuesday Feel fine headache and slight shortness of breath.

Within hours I quickly became extremely sore, fatigued, and had difficulty breathing. I was unable to eat until the breathing issues subsided late afternoon Sunday since I felt as though I was choking when I attempted to eat. The fatigue and body pain was pronounced enough for me to have to call off work Monday, but they gradually diminished. I am submitting this on 3/11, and I am still experiencing some body aches though the constant feeling of exhaustion is no longer present.

25 minutes after the vaccine dizzy, breathing difficulty, fast heartbeat. It lasted less than 10 minutes. 20 minutes later dizzy , breathing difficulty. Lasted less than 10 minutes. Next day only breathing difficulty for 2 periods. Not as bad as yesterday when I received the vaccine.

Five minutes after shot started losing consciousness, sweating, hot flashes, trouble breathing, numbness on tongue, seizure ( several minutes) came in and out of consciousness during it, eyes rolled back in head. Arms flailing.

- Arm Sore at injection site from 4-6-21 to 4-9-21 - Passed out at 1:00am 4-6-21, and fell to floor with disorientation. - Severe Chills, uncontrollable shaking of body/teeth, 4-6-21 to 4-7-21 - Feverish 04-6-21 to 4-8-21 - Heart Arrhythmia, causing abnormal breathing and inability to breath and sleep 04-6-21 to 4-7-21 - Dizziness 04-06-21 to 04-09-21 - Food/Water/mouth tastes of metal 04-7-21 to 4-8-21 - Loss of Appetite 04-06-21 to present - Bloating, feeling full when haven't eaten 04-06-21 to present - Brain fog, not able to concentrate - 04-06-21 to 04-09-21 - Excessive sweating 04-06 to 04-08-21 - Tired 04-06 to 4-10-21 - Irritability, 04-09-21 to 04-10-21 - Emotional, crying for no reason sporadically 04-06 to 04-9-21

I felt fine all day and went to bed at 9:30pm. I woke up to my body shaking uncontrollably and I was freezing at 10:30pm. My wife felt my skin and she said I was burning up. Unfortunately our thermometer wasn't working so I don't know my temperature, but I have never in my life shaken so badly with a fever. I couldn't control myself and I was shaking so hard that my muscles were sore from it, but I still couldn't stop. I then began vomiting every 45 minutes or so. This happened for nearly 4 hours until 2:18am. Then very suddenly everything just stopped. No more feeling cold (actually I then felt very warm and couldn't cool off. I was sweating quite a bit). No more shaking. No more vomiting. I did get a wicked headache, but I figured it was due to dehydration and took two Advil. The Advil didn't do anything and I was awake until 5:59am because my head hurt too badly to sleep. Finally I slept for about 4.5 hours. Then I just felt worn out for most of the day on the 10th, and couldn't shake the headache. Then on the evening if the 10th, I started getting a sore throat and a slightly runny nose. I went to bed that way. When I woke up on the 11th (today) I still had the sore throat and slight runny nose. The headache was gone, but I felt tightness in my chest. As I went throughout the day, I've noticed that I'm short of breath with doing most things. I have two young children, so even taking care of them I feel like at times I'm struggling for breath. I'm not in bad shape and am a runner, so my cardio isn't bad. So I was surprised by this.

Chest pains- 8 hours after administration for little less than 48 hours; in addition to migraines, extreme fatigue, shortness of breath and sensitive to light.

Dizziness, Shortness of breath, Irregular Heartbeat Diagnosed with Atrial Fibrillation on 4/13/21 by primary healthcare physician

PATIENT SEEN FOR SOB X 2-3 WEEKS IN ED, CT SCAN SHOWED MULTIPLE PULMONARY EMBOLI. HEMODYNAMICALLY STABLE WITH NO EVIDENCE OF HEART STRAIN, D/C HOME ON XARELTO

Got COVID (Janssen) vaccine shot on April 6th at noon. Felt fine Tuesday and went to bed as normal. Woke up April 7th at 7AM with sharp pains in my left shoulder (same side as shot) and slight shortness of breath, and slight chest pain in the left quadrant of my torso (same side as shot). Proceeded to take Advil and seemed to help a bit. Minor aches/pains and shortness of breath throughout the day until about 8PM. At this time shoulder chest pain became more severe, and breathing became very strained, short, and painful. Pain and breathing kept getting worse and at midnight on Wednesday night thought I was having a heart attack due to extreme chest pain, couldn't breath, lightheaded, dizzy, tingly extremities. My wife drove me to ER at 12:30 AM Thursday.

CHEST PAIN (WHOLE CHEST HAD LOT OF PAIN)/THOUGHT THAT HE HAD HEART ATTACK; SHORTNESS OF BREATH/COULD NOT BREATH; SEVERE CRAMPING IN LEFT SHOULDER AND UPPER BODY; DIFFICULTY IN STANDING; SINUS; THOUGHT THAT HE WAS ABOUT TO PASS OUT; BUNCH OF CLOTS IN THE BOTTOM SIDES OF BOTH LUNGS AND ON THE TOP OF ONE OF THE SIDES; BEGINNING STAGES OF PNEUMONIA ON BOTH LOBES OF THE LUNGS (COLLAPSED); CRAMPING IN CHEST; This spontaneous report received from a patient concerned a 44 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: Unknown) frequency 1 total, dose was not reported, administered to left arm on 06-APR-2021 at 12 noon for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 6-APR-2021 at 12 noon, patient got vaccinated and was fine that day . Next morning on 07-APR-2021, patient woke up with sever cramping in same shoulder which he got the shot in, most pain was in the upper left quarter of his torso to down half way to chest up to the shoulder till the neck . By the end of the day it spread to his whole chest and upper body. Also he had shortness of breath ,could not breath .The cramping and shortness of breath came at same time. He took Advil and went along with his day . He took 3 tablet of Advil 200mg every 4-5 hours all day ( total of 3 dose that day) . By night time the case was progressively worse as the whole chest had a lot of pain . He thought that he had heart attack . He thought that he was about to pass out . He could not stand on his own . So his wife took him to emergency room at mid night at 12:30 am on 08-APR-2021. He stayed there for 5 hours and they did bunch of tests , EKG which rolled out the heart attack .They did Chest X-ray which found things then did D-dimer which its level was very high . They found bunch of clots in the bottom sides of both lungs and on the top of one of the sides. They did ultra sound on the legs which had no evidence of blood clots . They discharged him from the emergency room as they felt that he was ok to be out . After couple of hours after discharge , patient's health care professional wrote for him Eliquis, antibiotic and pain reliver. He was given antibiotic because he had beginning stages of pneumonia on both lobes of the lungs (collapsed) . It was found air sacs in lung with signs of pneumonia in both lobes . He came home and started to monitor his blood oxygen . He stayed in the same position till recovery . He was better each day since last week but still had sinus and cramping in the chest ( very minor but was still there). The lung capacity was very limited to take some steps. Patient stated that he needed a specialist to understand his condition. He had no medical history before that incidence . He was wondering regarding which type of blood thinner was good for this type of blood clots because he read that the regular blood thinners are not good for that type of blood clot which his HCP gave (regular blood thinner). Laboratory data included: Total lung capacity decreased (NR: not provided) lung capacity is very limited. On 08-APR-2021, Laboratory data included: Chest X-ray (NR: not provided) found things, EKG (NR: not provided) rolled out heart attack, Fibrin D dimer (NR: not provided) level was very high, and Ultrasound scan (NR: not provided) no evidence of blood clots. Treatment medications (dates unspecified) included: apixaban, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe cramping in left shoulder and upper body, chest pain (whole chest had lot of pain)/thought that he had heart attack, shortness of breath/could not breath, thought that he was about to pass out, difficulty in standing, bunch of clots in the bottom sides of both lungs and on the top of one of the sides, beginning stages of pneumonia on both lobes of the lungs (collapsed), cramping in chest and sinus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: This 44-year-old male patient reported blood clots of both lungs 2 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The patient denies any medical history/condition prior to vaccination. The symptoms reported were severe cramping of arm that spread to his whole chest and upper body and shortness of breath; the patient thought he had a heart attack, about to pass out and could not stand because of the progression of pain. EKG done at the emergency room ruled out heat attack, D-Dimer was reported to be very high, clots were found in the bottom sides of both lungs and on the top of one of the sides, x-ray showed beginning stages of pneumonia on both lobes of the lungs (collapsed). The patient was prescribed with Eliquis, an unspecified antibiotic and pain reliever. Outcome of the events were not reported. Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

1 day after the vaccine (4/28) - low energy level, achy, tired, shortness of breath 2 days after vaccine (4/29) - shortness of breath after physical activity, irregular pulse 3 days after vaccine (4/30) - back to normal - no symptoms

SHORTNESS OF BREATH; ASTHMA ATTACK; DIZZINESS; EXPERIENCING HOT FLASHES; SORE ARM; SWEATING; PASSING OUT RIGHT AFTER VACCINATION; SLEEPY; LOW ENERGY; WEAKNESS; TIRED; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, penicillin allergy, anxiety, smoker, and alcohol user. 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 12-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included clonazepam for anxiety, and ibuprofen for pain/ and inflammation. On 12-APR-2021, after 5 minutes, the patient started feeling dizzy and passed out. He woke up as nurse pulling his chest hair and nurse was about to give him adrenaline shot. The patient was for his vitals until restabilized and was asked to walk around for sometime. The patient had sore arm. The patient was at facility for 2 hours. On 12-APR-2021, at night, he woke up sweating and experiencing hot flashes as if med going through his body. On 16-APR-2021, the patient was not breathing well at night and woke up with an asthma attack which lasted for about 3 hours and the whole next day. He visited clinic for asthma attack and was prescribed with medicines. He had a week and half of low energy. On 27-APR-2021, the patient stated that he was still feeling sleepy, dizzy and tired sometimes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out right after vaccination on 12-APR-2021, experiencing hot flashes, shortness of breath, asthma attack, and sweating, and sore arm on 19-APR-2021, and had not recovered from dizziness, weakness, sleepy, tired, and half of low energy. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210453787-COVID vaccine-loss of consciousness. 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

Pt had progressive shortness of breath/weakness and fatigue. CT scan did not show PE. CK level was 17000, inflammatory labs were mixed. Rheumatology consult concluded it was myositis related to COVID vaccine. admitted to hospital 4/27-4/30.

Allergic reaction started on 5/30/21 (4 days after receiving the vaccine) - rash on left arm and abdomen, shallow breathing/wheezing a few hours after the rash developed. Patient went to the ED and the rash resolved by 6/1/21.

At 12:30am 04/06/21, I was wakened to a nauseous feeling in my stomach, and on my way to the restroom I passed out. My head hit the floor and that is when I woke up and had Diarrhea. Went back to lay down, and I had trouble the rest of the night breathing with intense arythmic activity. It caused me to not be able to breath as my heart was skipping beats very aggressively. This lasted into the morning of 04/06/21, and did not cease until 7-8pm that evening. Symptoms lasted approx 5 days, and dropped off in severity. Other symptoms included the following the day of the 04/6 -4/10/21: - dizziness - metal taste in my mouth - nausea - mental confusion - fatigue - loss of appetite - severe shakes/chills/sweats

PT STARTED DEVELOPING " DIFFICULTY IN BREATHING" AND DIZZINESS ABOUT 15 MINUTES AFTER HE RECEIVED THE VACCINE. 8:55 HR 61 RESP 16 BP 115/76 OXYGEN SATS 99% ROOM AIR PATIENT WAS BROUGHT TO MED OBS 1 AT 855, HE WAS GIVEN APPLE JUICE AND WATER. ODI WAS WITH PATIENT SINCE HE WAS foreign SPEAKING ONLY 0900 HR 60 RESP 15 BP 108/74 OXYGEN SATS 99% ROOM AIR 0905 HR 60 RESP 15 BP 118/77 OXYGEN SAT 100% ROOM AIR PT WAS FEELING BETTER AND LEFT BY HIMSELF ESCORTED TO EXIT BY STAFF

Patient presented with wife 6/18/2021. Patient requested Janssen covid-19 vaccine. The immunization was administered at 6:55pm. After 7 minutes of sitting in waiting room, patient started to complain of dizziness, "spinning in head", heavy breathing, and sweating. Patient was very sweaty, pale, and uneasy. Patient then fell to the ground with wife next to him, and lost consciousness briefly. 911 was immediately contacted. Patient did not hit his head or other body parts. Patient was able to be picked up and brought back into his seat. He did lose consciousness again in his seat very briefly but was able to speak to me and answer questions as I spoke with 911. He was very pale and sweaty, but answered questions to check for mental status. 911 police and ambulance arrived and checked his pulse, blood pressure, and asked several questions to examine his mental status. Patient declined going to hospital. Patient did walk out with wife, more color apparent on face, and able to answer questions. Patient and wife were advised to stay home and relax post-vaccination and call 911 if symptoms arise.

Flu like symptoms. Stuffy nose, cough, shortness of breath, muscle aches, chills. Numbness in the whole right arm from shoulder to fingertips.

Mach 24 1700-1730 feeling odd with some joint pain in knees. Injection shot pain normal as most injuections. 1900 achy 2000 chills started 2100 fever of 99.8 March 25 0015 sweaty and hot fever of 102.5 entire body aches, joint pains knees and arms. Musclar aches all over felt slight nausea 0700 aches continued fever down 100.2, fatigued slept most of the day. Injection site tender. Drank water ate toast. 1300 fever subsided 98.6 (my normal is 98.2) Took motrin for aches. Rest of day and night slightly achy stiff joints fatigued. March 26 Still achy and stiff. No fever. Took Motrin. By midday had more energy and able to get around and walk. Noticed taking deep breaths was hard to do with out slight pain. Was gone by the 28th.

my husband has asthma and this shot made him very sick. today is day 4 and he still has fever, chills, is perspiring profusely. an hour after his shot was administered, he started to feel cold, shortly after, he was having chest pains, not long after his fever spiked to 104. his side effects were, fever, chills, vomiting, chest pains, perspiring, asthma attaches, sever body aches, head aches.

nausea, faint, migraine, chills, fever, muscle pain, shortness of breath, joint pain, weakness, fatigue, dizziness, heart acceleration, lots of sleep, anxiety, drowsy.

Approximately 15 minutes after receiving the vaccination, my throat became dry and my eyes began watering. It was hard to tell but my throat felt slightly swollen also. I drank some water and a few minutes later things seemed to clear up. Randomly throughout the afternoon I had similar dry/itchy/tingling in my throat but not as strong as the time right after the vaccination. I didn't suspect this was directly related to the virus since I have allergies to grasses, trees, pollen, etc. and take over the counter allergy medicine as needed. At 3:30am today (4/10/21) I woke up having to use the restroom and when standing up out of bed I was extremely dizzy. After laying down in bed the dizziness disappeared. When waking up later in the morning the dizziness/light headed feeling was still present when standing. I also have noticed random strange pinching pain in my legs that only last for 1-2 seconds and sends a quick short pain sensation throughout my body. I have no clue if any of this is related to the vaccination received, but after noticing news articles with issues in a few folks receiving the Janssen vaccine, I decided I would pass this info along just in case.

States that he got the J&J COVID vaccine Thursday 4/8/21 States that he had immediate muscle pain right away and a cough right away Upper chest is painful and he is having trouble breathing Chest pain has started yesterday- reports the pain has gotten worse States that he exercises every day and ran this AM States that today the chest pain has gotten worse and his breathing has gotten worse as well States that he works around chemicals in a woodworking shop but doesn't think that this is the cause of his chest pain Chest pain is located at the top of his sternum States that he feels queasy and unwell over all Advised that with current symptoms that he needs to be evaluated urgently and advised calling 911 if he did not have someone to bring him in. Patient refuses 911 but agrees to be seen in the ER. Will go to his closest ER now.

Chills and joint pain in the evenings from day 3 through day 7. Mild to moderate Headaches from day 3 through day 9. Shortness of breath, twice between day 5 and 7. Chest pain on the evening of day 6, lasted 3 to 4 minutes.

I had mild pain radiating in my arm within 2 minutes of the vaccine. 1-2 hours later I developed unusual and intermittent pain on the volar surface of my wrist. 8 hours after the vaccine I developed chills, severe fatigue, myalgias, loss of appetite, and a fever up to 101. I was bedridden for 36 hours and then the symptoms gradually subsided by day 3. I then developed a sense of chest tightness intermittently for the next 4 days usually at night. I did not have chest pain, but had tachypnea at times with a respiratory rate up to 22/min. At day 7 this resolved.

FINGER TIPS GETTING HOT; FINGER TIPS GETTING NUMB; INSIDE OF LEFT ARM EXCRUCIATING PAIN; COULDN'T WALK DUE TO SWOLLEN ANKLES; COULDN'T WALK DUE TO SWOLLEN ANKLES; SHORTNESS OF BREATHE; HOT AND SWEATY; PAIN ALL OVER BODY; EXTREME CHILLS; REALLY COLD; HEADACHE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced shortness of breathe. On 11-APR-2021, the subject experienced hot and sweaty. On 11-APR-2021, the subject experienced pain all over body. On 11-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 11-APR-2021, the subject experienced extreme chills. On 11-APR-2021, the subject experienced really cold. On 11-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 16-APR-2021, the subject experienced finger tips getting hot. On 16-APR-2021, the subject experienced finger tips getting numb. On 16-APR-2021, the subject experienced inside of left arm excruciating pain. Treatment medications (dates unspecified) included: tramadol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breathe on 11-APR-2021, and hot and sweaty, couldn't walk due to swollen ankles, couldn't walk due to swollen ankles, extreme chills, really cold, and headache on 12-APR-2021, was recovering from pain all over body, and had not recovered from inside of left arm excruciating pain, finger tips getting hot, and finger tips getting numb. This report was non-serious.

On March 13, I received the Johnson & Johnson vaccine at the clinic The pharmacist monitored me for symptoms but there were none right away. I did have a fever and some body aches in the two or three days that followed but those were short-lived. While driving on March 16, I started experiencing some irregular breathing and periods of shortness of breath about three hours after leaving home. I stopped at the emergency room at the Health Center where Dr diagnosed me with an acute pulmonary embolism after discovering a small blood clot in one of my lungs. He prescribed me with Eliquis, which I am still taking today. Their phone number is provided if you have questions. I haven't had too many shortness of breath episodes lately but do not know if the blood clot is still there. I am scheduled to see my hematologist on April 27 to get further updates on this. My hematologist Dr is located in clinic number provided While it has not yet been proven that the vaccine caused the blood clot in my lung, I feel the need to report this in the wake of recent news about the Johnson & Johnson vaccine. My hematologist and primary care physician are both aware that I have received the vaccine but I have not received any further communication from them.

This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, and eye twitches. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced eye twitching. On 13-APR-2021, the subject experienced slight pressure on side of head. On 13-APR-2021, the subject experienced burning sensation in chest. On 13-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye twitching, slight pressure on side of head, burning sensation in chest, and shortness of breath. This report was non-serious.

Patient was doing paperwork when he experienced the worst headache of his life on 4/17 with associated emesis. Patient found to have a Hunt Hess 3 Fisher Grade 3 Subarachnoid Hemorrhage with hydrocephalus s/p EVD, s/p cerebral angiogram on 4/18 negative for aneurysm/AVM. On the evening of 4/20, patient became acutely hypoxic with wheezing for which he required oxygen via 10L oxymask. During 4/21, his oxygen requirements continued to increase with increased work of breathing requiring high flow nasal cannula (HFNC) at 50L/60% + pulmonary congestion on imaging and he was treated with diuresis. On 4/22, oxygen needs increased requiring 70L/100% with worsening imaging. He was then started on steroids, antibiotics were broadened, epoprostenal started in addition to diuresis. On 4/23, patient reports improved breathing and is on non-rebreather. Antibiotics, steroids, and epoprostenal were discontinued as patient showed improvement of oxygenation without clear signs of infection. Of note, patient reports vaping in the past 2-3 months. Patient has also been intermittently febrile. Wife was concerned that these symptoms were possibly related to him getting the J&J vaccine on 4/11. Patient is currently still in hospital on day 6 of admission at this time.

Ten days after vaccination I had an allergic shellfish reaction to a frozen lobster product. Never happened before and I've had other Lobster on the east coast before. I also ate shrimp a few days prior to vaccination with no reaction. I have eaten other Lobster all my life with no reaction. My sinuses and throat closed up making it very difficult to breathe. I didn't know what was happening so I took decongestants and antihistamines then went to the doctor and got injected with a steroid immune suppressor. I now have epinephrine just in case it happens again.

CLOT IN SPLENIC ARTERY; CELIAC ARTERY THROMBOSIS; BODY SWEATING; SHORTNESS OF BREATH; CHILLS; This spontaneous report received from a patient concerned a 45 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: 043A21A) dose was not reported, administered to left arm (left deltoid) around 15:00 to 16:00 on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, after 5 days of vaccination, in the morning, while driving patient had very severe abdominal pain, very hard time breathing, had to get out of the car because of that, patient thought he was going to die, after 5-10 minutes he felt chills and body was sweating. His wife took him to the hospital on same day. At the hospital unspecified tests and CAT scans were done, and found clot in splenic and celiac artery. Patient was hospitalized on 14-APR-2021 for 1 day and was discharged around 3pm the next day on 15-APR-2021. Patient had another visit with a hematologist on 28-APR-2021 in morning, he found nothing wrong with the body. Patient now had to take Eliquis for 6 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, body sweating, shortness of breath, on APR-2021, and had not recovered from clot in splenic artery, and celiac artery thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210456348 - Covid-19 vaccine ad26.cov2.s-clot in splenic artery, and celiac artery thrombosis. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Started with nausea, then it followed. Migrane, unable to talk, unable been awake ,I even fainted I don't know for how long but when I woke up was on the floor and sweating, chills, fever, shortness of breath, tireness, muscle pain and cough. Did not go to the doctor or hospital, I have no insurance. Even until today I still have a light cough and shortness of breath. All this stopped me from going to work for 2 weeks, and unenployment did not pay.

Chest pain/discomfort, Heart Palpitations/Abnormal Heart rhythm, Shortness of breath, Exhaustion, Lightheadedness and dizziness. Symptoms are ongoing and of intermittent intensity. Aspirin daily for chest pain. See below for diagnostic tests ordered.

On 5/13/2021 patient developed a cough in the evening. Patient woke up not feeling well on 5/14/2021, and also had nausea and vomiting. Patient was driving a vehicle when he had a seizure. No prior history of seizures. Drifted off the road, no significant damage to vehicle. Patient post-ictal following seizure, seizure activity was witnessed by bystanders. CT brain showed small subdural hematoma. A CTA chest performed due to hypoxemia and tachycardia at Hospital showed Multifocal groundglass type nodular infiltrates throughout the right lung involving the upper lobe, middle lobe, and lower lobe, minimal left lower lobe patchy infiltrate, as well as patient's known thymoma. These multifocal groundglass infiltrates were not previously mentioned on a CT chest performed on 4/10/2021. Patient was transferred to this facility for evaluation by neurosurgery. Patient was mildly tachycardic, hypoxemic to 88% on room air, and tachypneic. Patient reported decreased sense of taste & smell for 1 month, which he attributed to his losartan use. A covid/flu/rsv PCR on 4/10/2021 was negative, and a viral respiratory pathogen panel with covid PCR was negative on 5/14/2021, as was an antigen & NAAT for COVID on 5/14/2021. Patient was treated with antibiotics and admitted for further management.

Shortness of breath, numb face , tingling arms and legs, tinnitus in both ears, heart palpitations, blurry vision. Still have tinnitus, hearing sensitivity, vison problems and chest pai.

Complained of right lower leg pain and swelling, shortness of breath, sent to hospital for Ultrasound of right lower leg, Ultra sound was positive for a DVT. Was then sent to the Emergency room for evaluation and treat for DVT. Complained of Shortness of breath. CT Scan Angiogram completed and found to have bilateral Pulmonary Embolism

Patient presented to ED on 6/14/21 with 4 day history of cough, malaise and 1 day history of right flank/pleuritic pain. He was found to have a left leg DVT and bilateral pulmonary emboli. He was started on a heparin drip which he tolerated well. He was transitioned from heparin to Eliquis. He has no family or personal history nor other risk factors for DVT or PE; no long travel, no surgery, no immobilization. Hypercoag workup was initiated. He continued to have right sided pleuritic chest pain which improved during his stay. There was some question of possible community-acquired pneumonia, which he was empirically treated with CTX and azithromycin. He had normal WBC, low procalcitonin, and no fever. Patient was discharged home on 6/15/21 on Eliquis with follow up scheduled with primary care provider.

dry mouth , shiver and difficulty breathing and tightness in arms complained (05.10 pm)by patient within 15 minutes of administration( 450pm) . Patient was laid down on floor with raised legs and cold packs applied to face and hands. Bp monitored and benadryl given ( 5.15 pm) . patient was still breathing . BP was high. next 10 minutes patient was feeling better. was seated with elevated legs. Drank water and Ems was called . Bp was at 178/112 pulse 83 Per EMS possibly syncope or initial reaction to the shot.

Symptoms began immediately. I felt an aching pain in my left arm immediately after the vaccination. It then moved to my scapula. It persisted the rest of the day and all day Tuesday. I also felt soreness of limbs (both arms and legs) intermittently for the 48 hours. I had shortness of breath for the next day. I felt extreme fatigue for the next 48 hours. I felt my heart racing off and on for 24 hours, I felt a loss of strength in both arms and legs for the next 48 hours. Monday Night I woke up sweating as I had a fever. The fever persisted off and on for about 24 hours. I was irritable (probably due to not feeling well) for about 48 hours. My wife had to drive me home.

24 hours after the vaccination the patient developed a delayed allergic reaction in the vaccination site (right upper arm). He developed 3 serous filled bulla with the largest measuring 5cm by 2.5cm with surrounding erythema and tenderness to palpation in the area. This was associated with headache, diaphoresis, shortness of breath, substernal chest discomfort, and sensation of throat itching. By 72 hours the bulla had popped and the patient's the only remaining symptom was right upper arm pain.

Since receiving the vaccine, I have developed tightness in my chest and shortness of breath. At times, it has been severe. Feeling like I might pass out, I went to Immediate Care on 04/12. They didn?t identify a cause. On 04/15, I went to my Doctor, who noted wheezing in my upper lungs. An inhaler and pantoprazole were prescribed. At times, it feels like I am having something similar to an asthma attack. The inhaler has helped. Prior to the vaccine, I didn?t have any history of breathing problems, nor does it run in my family.

FOOT NUMBNESS; HEADACHE; FEVER; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 165 pounds, and height was 69 inches. The patient's concurrent conditions included penicillin allergy, smoking, and abstain from alcohol, and other pre-existing medical conditions included no illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced shortness of breath. On 04-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced foot numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from headache, and had not recovered from foot numbness, and shortness of breath. This report was non-serious.

BLISTERS ON RIGHT ARM BETWEEN ELBOW AND SHOULDER; SHORTNESS OF BREATH; BLURRED VISION; ITCHING ALL OVER ESPECIALLY IN RIGHT ARM; FEVER OF 101 F; TIREDNESS; SCAR ON ARM THAT WAS 4 INCHES LONG AND 2 INCHES WIDE; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 225 pounds, and height was 66 inches. The patient's past medical history included umbilical hernia, and covid-19, and concurrent conditions included high cholesterol, non-smoker, and social alcohol drinker, and other pre-existing medical conditions included the patient had no known allergies. The patient had no history of 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: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin calcium for high cholesterol. On APR-2021, treatment medications included: diphenhydramine hydrochloride, oxygen, and paracetamol. Also given unspecified cream for right arm. He wanted help with the scar on arm that was 4 inches long and 2 inches wide. On 12-APR-2021, the patient experienced tiredness. On 13-APR-2021, the Patient experienced blisters on right arm between elbow and shoulder, shortness of breath, blurred vision an itching all over especially in right arm. On 13-APR-2021, the patient experienced fever of 101 F. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the patient experienced scar on arm that was 4 inches long and 2 inches wide. The patient was hospitalized for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blisters on right arm between elbow and shoulder, shortness of breath, blurred vision, itching all over especially in right arm, tiredness, and fever of 101 F on 14-APR-2021, and the outcome of scar on arm that was 4 inches long and 2 inches wide was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210435619-COVID-19 VACCINE AD26.COV2.S-blisters on right arm between elbow and shoulder, shortness of breath, blurred vision, itching all over especially in right arm. 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). 20210435619-COVID-19 VACCINE AD26.COV2.S-tiredness, fever of 101 F. This event(s) is labeled and is therefore considered potentially related.

Patient presented with shortness of breath and generalized body aches on 3/26/21. Patient has had symptoms for 3 days, with new diarrhea as well. No nausea vomiting, positive fever and chills, no loss of taste or smell. He has chest pain that is pleuritic in nature, central lower sternal region. Patient admitted to the hospital setting from 3/26/21 and still in CCU as of today (4/30/21).

Patient received their J&J vaccination on 4/7/2021. The patient's wife tested positive on 4/12/2021. The patient tested positive on 4/23/2021. The patient presented to the ER with a severe progressive cough (starting one week prior), worsening shortness of breath, a high fever, chills, myalgias, and malaise. The patient was diagnosed with COVID pneumonia and ARDS with hypoxia and given Lovenox, remdesivir, and dexamethasone, tessalon, and Brovana. The patient was admitted on the 23rd and continued to decline until their eventual passing on 4/28/2021.

Patient started to feel throat contractions and nausea within 5 minutes of the vaccine. He then started throwing up profusely. Patient was given 25 mg of Promethazine IM within 10 minutes of start of the reaction. He was held in the clinic for 30 minutes and checked on every 5 minutes.

Shortness of breath chest pain severe headache. Multiple blood clots stent placed in one and taking medication now to help with the other blockages.

pt states he started feeling nauseas, developed a headache, and had diarrhea. The next day he had fever, chills, body aches, he was shaking. His headache was getting worse. All symptoms were getting better except the headache. He thought he was feeling better but when he woke up today 4/6/2021 he was SOB and diarrhea was back. Pt has taken Pepto Bismol for his symptoms and will probably need to go to the ER since he is having trouble breathing. He feels like he has had such a bad reaction to this since he possibly has had the covid vax in the past 90 days.

after 10 minutes after vaccination patient said he felt flushing in the forehead, dizzy, had a unsusual taste in mouth, tightness in throat. Patient was given 10 ml of beandryl oral liquid 12.5mg/5ml , monitored . After 5 minutes of oral benadryl administration patient said he was feeling better , his throat was getting better and dizziness was gone. patient was monitored was additional 30 minutes before he left.

PATIENT LOOKED AT WIFE AND SAID I DON'T FEEL RIGHT, AS I WAS CALLED BACK TO THE CAR HIS HEAD BEGAN TO ROLE FORWARDS, THEN IN A CIRCULAR MOTION. HIS EYES ROLLED BACK IN HIS HEAD AND HE MADE A GASP FOR BREATH THEN PASSED OUT. EPI PEN WAS IMMEDIATELY ADMINISTERED. PATIENT BECAME MORE RESPONSIVE, LAID SEAT BACK IN CAR. PATIENT SWEATING , COULD NOW SPEAK TO ME BUT STILL SOMEWHAT DISORIENTED. VERY FAINT PULSE. 911 WAS CALLED AND COOL WET PAPER TOWEL PLACED ON HIS NECK AND OBSERVED UNTIL 911 ARRIVED WITHIN 5-10 MINUTES. PATIENT TRANSPORTED TO ER DUE TO VERY LOW PULSE EVEN AFTER EPI ADMINISTRATION. PATIENT REMAINED AT ER UNTIL 1:30 PM FOR MONITORING. THEY TRULY FELT IS WAS A VASOVAGUL REACTION. PATIENT WAS OUTSIDE WORKING IN YARD AT 6:30PM WHEN I CALLED TO CHECK ON HIM, HAS NO RECOLLECTION OF RECEIVING SHOT OR EPI PEN, JUST SAID HE REMEMBERS MEDICINE FEELING "HOT" GOING DOWN HIS ARM.

SHORTNESS OF BREATH; FULL BODY ACHE; JOINTS HURT; SEVERE HEADACHE; NAUSEA; SENSITIVITY TO LIGHT; LETHARGIC; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 15:25 for prophylactic vaccination. Concomitant medications included benzylpenicillin for drug used for unknown indication. On APR-2021, the subject experienced lethargic. On 02-APR-2021, the subject experienced sensitivity to light. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021 01:15, the subject experienced shortness of breath. On 02-APR-2021 01:15, the subject experienced full body ache. On 02-APR-2021 01:15, the subject experienced joints hurt. On 02-APR-2021 01:15, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, full body ache, and severe headache on 03-APR-2021 09:35, had not recovered from lethargic, and the outcome of joints hurt, nausea and sensitivity to light 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.

Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Medium, Systemic: Seizure-Severe

The morning of 2 April, I woke up with a fever, chills, sweating and an excruciating headache. The symptoms persisted for approximately 10 hours. The following Monday, I woke up with sharp pains across my chest and shortness of breath. I was admitted to the hospital Emergency Room for about 7 hours and subsequently diagnosed with pericarditis. It is unknown if the pericarditis was associated to the vaccine but thought it was a good idea to document here.

I hurt for three days,headache, body hurt, tired, sick to my stomach, sore arm, tired and felt like I had the flu. I then got better. About a week later, I started coughing a lot. My head hurt,but i didn't run any fever. I thought I was having bad allergies from changing weather, but it lasted longer than usual, over a week. I was sore, tired, not really hungry. I feel better now, but I still have this lingering dry cough and it won't completely go away. I still feel sore and very tired. I get a headache every now and then. I thought it was allergies, but it falls into the time period that people are having reactions to this JJ Janssen shot. The cough is annoying. I get short breathed and winded rather easily or more easily now. I thought I'd at least report it.

47-year old male c/o frontal headache since Friday, 4/9/2021. Received his Johnson & Johnson vaccine on Thursday, 4/8/2021. Still having his headache now. 9/10 pressure-like on the frontal head - constant States, "I never had this kind of headache before". 6/10 burning epigastric pain. Also has bodyaches. Has mild dizziness. Denies any photosensitivity, fever, flu-like sx, nausea/vomiting, chest pain, dyspnea, numbness, tingly sensation, slurred speech, back pain, rectal bleeding.

Five minutes after injection I broke into extreme sweating, hot flash, nausea, fatigue and head ache. I was at work and requested to go home early. I fell asleep one hour into my arrival and slept for 17 hours. Up to and including today I am having headaches, pain in my legs on left side only, nausea, lack of sleep and a continued smell similar to dried blood after a injury. I have also have and continue to have shortness of breath and chest pains resulting in two panic attacks within the last three days. This has led me to report this and I have doctor visit scheduled for 4/22. I also reported today based on internet search of reactions.

About 1 week after vaccination, I noted sensations of fullness or bloatedness. It felt like gas trapped in my upper abdomen that could not be relieved by burping. Within 2 days, I began to have pain in lower, left rib cage akin to side cramps/stitch after strenuous running, but persisted the entire day. About 2-3 days later, the pain intensified and spread throughout my diaphragm region (left and right sides). Breathing was somewhat affected, after semi-strenuous activities, such as walking up/down stairs. So, I avoided physical exercise, and took Advil for a couple days to minimize the pain. After another 3-4 days, the pain in the diaphragm region subsided. I have not experienced further discomfort for the past week (today is 4/21/2021). No treatments were sought during this period. I self-researched the symptoms and hypothesize the pain stemmed from a swollen spleen, which might have been caused by an overactive immune system due to the vaccine.

Within 5 minutes, patient was sweating, flushed, and stated that he was about to faint. Patient fainted and was unable to respond to verbal or motor commands. Patient had rapid, shallow breathing. Patient's hands/arms were twitching very slightly. Patient was moved onto the floor and rolled onto his side after he started to gag like he would vomit. Once on the floor, patient regained consciousness within 1-2 minutes and was able to sit up after another 5 minutes. Paramedics arrived and examined him. He left under his own power.

Intense uncontrollable shaking, uncontrollable contraction of all muscles, inability to control breathing, intense very shallow hyperventilation, Inability to speak or answer questions, severe muscle aches, soreness.

FLUSHED; MINOR GOUT SWELLS; SORE ARM/THROBBING ARM; TIRED; SHORTNESS OF BREATH; ANXIETY; DIARRHEA WITH BLOOD; This spontaneous report received from a consumer concerned a 47 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic gout. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205ANA, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAY-2021 vaccination at left arm 16:30 for prophylactic vaccination. Concomitant medications included allopurinol for gout. On 08-May-2021, The patient experienced Shortness of breath shortly after vaccination, but this resolved in 15 minutes. He waited for 20 minutes after getting the vaccine. Patient noted that it could have been anxiety driven. On 08-May-2021 night (10 hours after), patient experienced diarrhea in the middle of the night and progressed to blood in the stool. The patient also very tired. Patient slept for almost 24 hours from Saturday to Sunday night, but now feels better. Patient felt very flushed, also experienced arm super sore for 1 day after vaccination, and throbbing for about an hour. The patient suffers from chronic gout and experienced minor gout swells (unsure if it is related to the vaccine or not) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and anxiety on 08-MAY-2021, and sore arm/throbbing arm, and tired on 09-MAY-2021, was recovering from diarrhea with blood, had not recovered from minor gout swells, and the outcome of flushed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210522256-COVID-19 VACCINE AD26.COV2.S-diarrhea with blood. 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).

Pt called pharmacy and complained about uncontrolled muscle contractions as well as hyperventilation. He feels better now, however he wanted the pharmacy know. I told him to seek immediate attention if he started to feel worse. He stated he was fine at the time.

Increased pain and swelling in left arm - started within 12 hours and continued for 2 weeks Fever over 100 - started within 12 hours and continued for 1 month (fever between 100 and 102) Nausea - within 12 hours (continued for 1 month) Vomiting - within 24 hours (continued for 3 days) / then again 2 weeks out for 3 days) Migraine Headache - started within 12 hours and continued for 6 weeks (and on-going) Labored breathing - started within 12 hours and continued for 5 weeks (and on-going) Low oxygen - started within 36 hours and continued for 1 month) General muscle and body aches and pains (started within 24 hours and continued for 6 weeks (and on-going) Extreme exhaustion and lethargy (started within 6 hours and continued for 6 weeks (and on-going)

03/10/2021 I started feeling fatigued, hard time breathing, got to point I checked my oxygen, almost felt like I had covid. o appetite. Next day It started with pain, body aches, severe, after pain, fever came 102.1, I was doing advil but fever would not break. It was really bad for the first 3 days. Got to point I had to go get covid test at PA in Wharton, had no test, no smell, lasted about a month. Visited Doctor first week in April because Doctor was out due to loss of kids in house fire so it took a while to get in. He had done some blood work earlier in March, my numbers were bad- WBC, and he put me on a antibiotic, Zpack, just in case I did have covid, but I didn't feel any of these symptoms until after I got J&J shot.

Covid-19 Janssen vaccination administered on 5/24/2021 at approximately 1230. At approximately 1247 patient noted to have flat red rash to left side of neck moving towards chest and same rash on left antecubital space. Patient reported feeling hot. Diphenhydramine 50mg IM administered. Patient reported feeling short of breath, epi-pen 0.3mg IM administered. Respirations at 16 per minute, lungs clear to auscultation. Noted bilateral flat rash to underarms, improved with removing clothing from area. Patient symptoms improved. At approximately 1330 patient reported starting to feel short of breath. Patient self administered albuterol inhaler, two puffs. Lung sounds per auscultated expiratory wheezing bilateral upper posterior lobes and right middle lobe, no stridor. Post inhaler lung sounds very faint expiratory wheezing upper posterior lobe, right middle lobe cleared. At approximately 1400 noted rash to bilateral underarms started to return, rash to left side of neck started to raise, noted dermatography to bilateral sides. EMS activated. Perioral edema noted, patient reported starting to feel short of breath, epi-pen 0.3mg IM administered, oxygen at 2L per NC applied. Ambulance on prison grounds at approximately 1412, left grounds at approximately 1429 to Emergency Room for a higher level of care. Treatment at ER not available. Discharged from ER on same date at 2246. On 5/25/2021 at approximately 0215 patient reported pain in jaw, neck and chest. EKG obtained, normal EKG. Follow up scheduled with medical provider.

Patient presented to PCP office on 5/20/21 from residence at group home with C/O body aches, fever up to 100.2, runny nose, sore throat, wheezing, and coughing. Known exposure to COVID-19 at group home. Rapid test done in office positive for COVID-19. Patient admitted to hospital on 05/20/21 and chest Xray positive for ground-glass opacities consistent with COVID pneumonia.

Patient fainted 10 minutes after getting the vaccine, he felt light headed and had seizure like symptoms, and his body was rigid and shaking . He wasn't able to breathe, patient was put on his back and CPR was performed for 20 seconds, and 911 was called. Patient was able to breathe again and felt okay. Patient stated that he didn't eat or drink anything prior, he was given a sports drink and sat back in a chair for 20 minutes after. EMTs showed up and took his vital signs, patient refused to go to the hospital.

Had a raspy throat and nasal itch almost like allergies but more. 2nd day it increased its severity. The third day I was really congested. I felt like my lungs were only filling up half way; I was a little shortness of breath. Mucous buildup and had to cough to clear my throat to breathe. I felt like there was swelling in my throat. By Thursday, I went to get seen by doctor. Dr. noticed little pustules on my lymph nodes and she tested me for strep, negative. QR, inhaler steroid, prednisone for 5 days. Nasal spray to clear the nasal passages, Flonase. I have taken albuterol when needed to help clear up my breathing. I'm still feeling a little congested with sinus drainage, voice a little horse. Note: I did have a Tetanus shot about a month or a little bit more than a month before this vaccine.

Mild reactions including breathing heavy, throat felt swollen while trying to sleep, slight dizziness, some rashes(similar to big mosquito bites). All reactions are mild.

Client reported shortness of breath with gradual onset within 30 minutes of vaccination. Monitored by paramedics and symptoms resolved without treatment.

rapid heart rate, excessive sweating, chills, muscle aches, pain all over body, chest pain. Weakness, brain fog, out of sorts, flu like symptoms, break outs on face, trouble breathing. These conditions have lasted over 5 days so far.

Severe achiness, leading to spasms in legs and particularly in chest wall muscles, causing difficulty breathing. Nausea, vomiting. Headache.

Extremely bad headache, shortness of breath, dizziness lump in throat, chills followed by getting hot flashes and very lethargic and fatigued. Shot was administered at 11:45am on the 9th and by 03:00am on the 10th felt the above symptoms. Today date I am feeling better with minor unsteadiness here and there and a slight pain deep inside the middle of head almost like a headache for a few seconds then goes away, So far so good I think. I did call doctor to note on chart. Thank you!

SHORTNESS OF BREATH; CHEST PINCHING; FAST HEART BEAT; RASHES HAD REDNESS; RASHES AS ITCHY; RASHES ON CHEST AND BACK AS PAINFUL; EASILY GOT TIRED; FELT HEART WAS CONGESTED; COUGH; LITTLE BIT OF HEADACHE; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 150 pounds, and height was 170 centimeters. The patient's past medical history included low platelet, and bypass surgery, and concurrent conditions included rashes allergy, non drinker, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for low platelet. On 31-MAR-2021, the subject experienced little bit of headache. On APR-2021, the subject experienced felt heart was congested. On APR-2021, the subject experienced cough. On 12-APR-2021, the subject experienced shortness of breath. On 12-APR-2021, the subject experienced chest pinching. On 12-APR-2021, the subject experienced fast heart beat. On 12-APR-2021, the subject experienced rashes had redness. On 12-APR-2021, the subject experienced rashes as itchy. On 12-APR-2021, the subject experienced rashes on chest and back as painful. On 12-APR-2021, the subject experienced easily got tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little bit of headache on 01-APR-2021, had not recovered from shortness of breath, chest pinching, fast heart beat, rashes on chest and back as painful, easily got tired, rashes as itchy, and rashes had redness, and the outcome of felt heart was congested and cough was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.

Patient received vaccine at 1:23pm 4/30/21. He came back to the pharmacy at 4:45pm 4/30/21 reporting that his throat and tongue were burning, itchy, and felt swollen. He had excessive thirst and nausea. His symptoms were getting worse during the 10 minutes he were talking with him. The patient refused Benadryl and Epipen at the pharmacy as he wasn't sure he needed it. An ambulance was called and he was transported to the hospital.

DIZZINESS; SHORTNESS OF BREATH; PULMONARY EMBOLISM; This spontaneous report received from a physician concerned a 48 year old male. The patients 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: Unknown) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination. Vaccination site was not reported. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced pulmonary embolism. Laboratory data included: Computerized tomogram thorax (NR: not provided) positive, Ear, nose and throat examination (NR: not provided) negative and Platelet count (NR: not provided) 197. On 04-APR-2021, the patient experienced dizziness and shortness of breath. Full neuro, cardiac, Ear, nose and throat workup and evaluation was negative in Erectile dysfunction and follow up clinics. Patient had a Wells Criteria of zero, and was hemodynamically stable, platelet was 197. Patient started with DDIMER which was 560 and later chest Computerized tomogram thorax was positive for right lower lobe Pulmonary embolus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, shortness of breath and pulmonary embolism was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: -Covid-19 vaccine ad26.cov2.s-Pulmonary embolism. 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).

CHEST PAIN; RIGHT HAND/WRIST WEAKNESS; REDUCED HAND/GRIP STRENGTH; PLEURISY; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non alcohol user, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pleurisy. Laboratory data included: Computerised tomogram (NR: not provided) It was clear, and Fibrin D dimer (NR: not provided) Elevated. On APR-2021, the subject experienced reduced hand/grip strength. On 20-APR-2021, the subject experienced chest pain. On 20-APR-2021, the subject experienced right hand/wrist weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 30-APR-2021, had not recovered from right hand/wrist weakness, and the outcome of reduced hand/grip strength and pleurisy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

Patient taken to hospital after feeling very dizzy immediately following shot. Patient was profusely sweating and felt like he couldn't breathe.

Shortness of breath due to heart failure. Hospitalized on 5/18 heart functioning at 25% being monitored by cardiologist.

LEFT EYE WITH BLOOD SPOT IN THE EYEBALL; PAIN IN THE CENTRAL PART OF THE CHEST; DIFFICULTY BREATHING WHEN DOING ACTIVITIES; HEADACHE; LEFT ARM PAIN WHERE SHOT WAS ADMINISTERED; COULDNT SLEEP THE DAY OF THE VACCINE; BODY TREMBLING; This spontaneous report received from a 48-year-old, male patient The patient's weight was 184 pounds, and height was 74 inches. The patient's past medical history included gallbladder removal. The patient was non-smoker, social drinker (only in holidays mostly), and the patient had no known allergies. The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 14-MAY-2021 around 13:15 to left arm for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the patient experienced left arm pain where shot was administered, body trembling and couldn't sleep on the day of vaccine. On 17-MAY-2021, the patient experienced headache which had diminished, but suddenly they were like stabbing, left eye with blood spot in the eyeball and pain in the central part of the chest, which on occasions varies from right to left with breathing difficulty when doing activities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body trembling, couldn't sleep, and left arm pain where shot was administered on 18-MAY-2021, was recovering from headache, and left eye with blood spot in the eyeball, and had not recovered from pain in the central part of the chest, and difficulty breathing when doing activities. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210555889-COVID-19 VACCINE AD26.COV2.S -Left eye with blood spot in the eye ball. 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.

Pt presented with 1 week of progressive fatigue, dry cough, chest pain, nocturnal fevers. Presented to ER on 5/30/2021, hs troponins were 71 twice. Discharged with advice for symptom management with antipyretics. Symptoms worsened and pt returned to ER, worsening CP and fevers up to 100+F. Repeat troponins 1100 to 1200+, elevated LFTs, diffuse 1mm J point elevation on EKG Cardiac MRI 6/1/2021: IMPRESSION: 1. Patchy subepicardial left ventricular delayed enhancement, greatest in the basal inferolateral wall, compatible with myocarditis. Normal left ventricular size and systolic function. LVEF = 52%. 2. Patchy consolidation in the right lower lobe consistent with pneumonia. Small right pleural effusion. 3. Mild splenomegaly. CT chest RLL consolidation, splenomegaly

OVERALL ACHINESS IN UPPER BODY; LABORED BREATHING; EXTREME PAIN IN JOINTS/PAIN IN RIGHT WRIST/SHOULDER PAIN/ELBOW PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180869 and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced overall achiness in upper body. On 03-APR-2021, the subject experienced labored breathing. On 03-APR-2021, the subject experienced extreme pain in joints/pain in right wrist/shoulder pain/elbow pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from labored breathing, overall achiness in upper body, and extreme pain in joints/pain in right wrist/shoulder pain/elbow pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

SHORTNESS OF BREATH; UNABLE TO WALK; BRUISE IN THE STOMACH; HEADACHE; ARM PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 09041738 expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced arm pain. On 19-JUN-2021, the subject experienced headache. On JUL-2021, the subject experienced bruise in the stomach. On an unspecified date, the subject experienced shortness of breath, and unable to walk. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, had not recovered from arm pain, bruise in the stomach, and shortness of breath, and the outcome of unable to walk was not reported. This report was non-serious.

Day 1 after vaccine patient short of breath. Went to ER. Admitted to Hospital. Was in CHF, sustained MI. Eventually tranferred and underwent 4 vessel CABG and wears Defibrillator vest.

Dizziness start on Sunday, 3/21/2021 and has been present every day since so far. This is abnormal for me. Prior to that, I have been having some problems breathing after getting the vaccine and have been using my Ventolin more often after the vaccine. Also noticed shortly after getting the vaccine, a feeling of liquid in my right ear. the liquid in the ear did go away a day before the dizziness started. Did not consider the ear or breathing issues as possible side effects as I do have asthma and figured the ear was congestion. Not sure if the dizziness and the feeling of liquid in my right ear are related and/or related to the vaccine.

After receiving the vaccine, I sat down to rest and gave me tachycardia with difficulty breathing, my feet were weak with tiredness and cold. Then I drank water and fluids and my heart rate stabilized. Then within 2 hours I had 4 tachycardia events but milder and then normalized.

AFTER ADMINISTRATION OF THE VACCINE, WITHIN 45 SECONDS, THE PATIENT FELL UNCONSIOUS AND I WAS NOT ABLE TO WAKE HIM UP. THE PATIENT SEEMED TO BE HAVING A LITTLE BIT OF LABORED BREATHING AND PERFUSEOULY SWEATING. ADMINISTERED ONE DOSE OF 0.3MG EPINEPHRINE INTO THE PATIENT'S RIGHT MEDIAL THIGH. PATIENT SLIGHTLY REGAINED CONSIOUSNESS. AT THE SAME TIME, EMERGENCY SERVICES WERE CALLED AND THEY ARRIVED PROMPTELY TO THE PHARMACY AND TOOK THE PATIENT TO THE NEAREST HOSPITAL.

Fever 102, pain, chest tightness, chest pain, difficulty breathing, unable to move limbs or sit up, general pain in muscles, joints, bones, acute pain in wrist

1 week post vaccination - patient, not responding to albuterol HFA, called 911, he passed out, was unresponsive, pronounced dead.

I received the J&J vaccine on 3/16/2021 and then flew to watch over my dads house while he went through cancer treatment. I began to have pain in my chest that was getting progressively worse, yesterday I had a very sharp pain when taking a shallow breath. I went to the hospital they thought I had pneumonia, but then saw a blood clot in right upper side, I've had a prior event but that was attached to an injury in 2012. I've not had any other issues.

He got the vaccine, He felt as if he was breathing shallow on the bus to get to work, within 15 minutes of the vaccine. He came home and collapsed due to the fatigue which is not normal for him. About 12 hours later his throat got scratchy, achy but doable. He went to work and had to leave early due to flu-like symptoms, felt feverish. Really bad aches now, and his breathing and heart rate are elevated right now. Achy-like headaches. He did take some Ibuprofen 800 mg and seems to be helping. He has had the typical soreness of getting the vaccine in the left shoulder, but otherwise ok. He also has a stuffy nose, scratchy throat and his eyes are a little red and glassy. He was directly exposed to somebody for 25 hours that was positive for COVID, but nobody else in the car got COVID in January.

Strong pain in the hips. Numbness in the legs. Tingling in the legs.Difficulty to walk. Trouble breathing. Numbness in my left fingers. Pressure on the chest.High blood pressure.

Felt a slight numbness is throat, possible slight swelling in throat- felt this 20 minutes after shot and it lasted about 30 minutes.... 30 minutes after the shot my face turned red and my ears were very red, almost purple , and hot. This lasted for several hours after... At 11:30pm, almost 7 hours after the shot, I started to feel lousy. I started to get body aches and chills. Within 30 minutes they were fairly intense body aches and chills, shaking. At 1:00am I started to feel nauseas . At 1:30 am I started dry heaving. At approximately 2:30 I threw up twice, and the dry heaving and nausea lasting until 4am , when I took an anti nausea pill. I finally fell asleep at 430am. I woke up at 8am and felt tired, and no longer nauseated.

Injection sight pain Chills Muscle Aches - day 2 Headache - Day 2 and 3 Fatigue - Day 1,2,3+ Coughing Lung pain Shortness of Breath Chest Pain

Patient began sweating, hyperventilating and "feeling bad like he might pass out" about 5 minutes after vaccine. He lost color in his face about 2 minutes after and asked if he could like down. Paramedics were called and he was taken for care.

At time of vaccination patient felt fine. Morning after: patient stated he had a fever. At presentation to pharmacy(11:00am) , temperature checked any no fever was present. Patient stated he felt tired and couldn't catch his breath. Patient was encouraged to go home and rest as most of the described symptoms were to be expected. He did not. He reported back to pharmacy after 5:00pm and stated at around 2:00pm he felt dizzy and then went unconscious for a brief time (he did not know exact time frame but stated not long. Again temp was checked and was normal. He stated that his breathing was improving, but he was taking rest of day off.

Pain and swelling in my throat and severe tightness in my chest thirty minutes after the ijection. Severe ringing in my ears, could not sleep at night up to now. Went to ENT yesterday.

Chills after 6hrs, headache after 12hrs, severe headache after 15hrs, dry heaves and shortness of breath after 18 hrs.

Shortness of breath, mild upper back pain, ache behind both knees, bloating and increased bowel movements, mild headache

Within 2-3 hours , felt achy, and fatigued (mild) Next 24 hours felt about the same 36-48 hours later achy, fatigue , Temp 99.4 By 4/10/21 symptoms were more intense Sinusitis began with sneezing, nasal congestion. 4/11/21 still fatigued, muscle aches, nasal congestion wax and waned 4/11/21 rest seemed to help but noticed fatigue through the day, and more nasal congestion 4/12/21 symptoms still about the same. Moderate to severe 4/13/21 lethargy 4/14/21 seemed better but tired easily with activity (nasal congestion. Moderately controlled with DayQuil/NyQuil generic product 4/15/21 Nasal Swab tested for COVID awaiting results Still mod / severe signs of fatigue, muscle aches, nasal congestion , weakness, shortness of breath(at times) Moderate cough of sputum

Patient came in to store 4/16 -- he mentioned the day of vaccine that we was uneasy on his feet that evening. ( did not mentione until 4/16.) HE said around 4/11- 4/12 he has cold sweats, dizziness and some coughing started. He said he started to feel better but noticed 4/16 that he was having a little shortness of breath/congestion -- he is taking mucinex to relieve congestion

Patient felt ok the day of the shot, next day got very sick. Said he felt terrible, felt like the vaccine was going to "do him in." He complained of weakness and shortness of breath. He was dehydrated and worried about his kidney function. Said he had a hard time going to the bathroom with stomach pains. On Mar 31, 2021, said he had fever, but didn't go to doctor. Was taken by ambulance April 3 to ER, admitted that night, transferred to ICU on April 4, on ventilator, proceeded to experience multiple organ failure and died on April 11, 2021

It was reported that patient had been experiencing difficulty breathing, walking and delusions as per his fiancé . Fiance notified Manger that they sought medical attention earlier in the morning on 1-Apr-21 at the Clinic and they refused to evaluate patient beyond performing a PCR swab test so, they went back to their apartment. An SMS notification was sent on 1-Apr-21 indicating that patient was COVID-19 positive which was not seen by patient or fiance who reported the result to Mgmt. on 6-Apr-21. He was contacted by patient's friend and advised him the patient was sick, not able to walk, and having difficulty.

starting have shortness of breath/difficulty breathing and back and chest pain. light headed, pain unbearable. Saturday April 23rd Went to er was treated for kidney stones but they could only find one small one, Was sent home with pain medication. Shortness of breath persisted as did bloody cough and pain in chest and all over. Went back to the er on 4/28 as pain was unbearable (chest pain) once given a cat scan and diagnosed with blood clots in my lungs and then an ultra sound and found a blood clot in my leg (just above knee). It is thought that I was mis-diagnosed on the original trip to the er with kidney stones. I have been put on blood thinners and pain medication and will be following up with my doctor.

BLOOD CLOT IN LEG; SHORTNESS OF BREATH; HEART RATE INCREASED; GANGRENE IN TOE; RIGHT LEG SWOLLEN; RIGHT FOOT SWOLLEN; CHILLS; RUNNY NOSE; FEELING HOT; This spontaneous report received from a patient concerned a 50 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included high blood pressure and diabetes. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number 1802070, expiry date unknown), dose not reported, 1 total administered on 19-APR-2021 for prophylactic vaccination on left arm. Concomitant medications included amlodipine besilate for drug used for unknown indication, empagliflozin for drug used for unknown indication, fenofibrate for drug used for unknown indication, insulin aspart for drug used for unknown indication, insulin glargine for drug used for unknown indication, losartan for drug used for unknown indication, and pioglitazone hydrochloride for drug used for unknown indication. On an unspecified date (reported as 22-MAR-2021; 28 days prior to vaccination), the patient experienced shortness of breath, heart rate increased, runny nose, chills and was hospitalized (date unspecified). He reported that on this past Saturday, 17-APR-2021 (2 days prior to vaccination), he went to the emergency room. He reported that his toenails were coming off, the skin on his toes was coming off, and he had swelling in his right foot and up his leg. He says there was no circulation going to his toe and he was diagnosed with having a blood clot in his right leg. He says he had surgery to open up the arteries in his leg, and also reported gangrene in his toe. The subject was discharged on 21-APR-2021. On 23-APR-2021, the patient experienced feeling hot. He also reported that he may need to have his right pinky (fifth) toe amputated because it has gangrene. He reported that he is going to go back to the hospital, to which he would seek medical attention if he was having issues. Treatment medications (dates unspecified) included paracetamol. When called back due to his vaccination dates being after event start dates, the patient said that his memory is not too good, so he 'had to take his time to remember the correct dates'. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient was recovering from blood clot in leg, and had not recovered from runny nose, shortness of breath, heart rate increased, chills, feeling hot, gangrene in toe, right leg swollen, and right foot swollen. This report was serious (caused hospitalization).; Sender's Comments: V0: This 50-year-old hypertensive and diabetic male patient reported that he was feeling hot and may need to have his fifth toe amputated because it has gangrene 4 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection and 2 days after discharge form the hospital. The patient was hospitalized for shortness of breath, heart rate increased, runny nose, and chills 28 days prior to vaccination. The patient went to the emergency room 2 days prior to vaccination because his toenails/skin on his toes were coming off, swelling in his right foot and up his leg, gangrene in his toe; he reported that there was no circulation going to his toe and was diagnosed with having a blood clot in his right leg; the patient reported he had surgery to "open up" the arteries in his leg. Four days after vaccination, the patient felt hot and reported reported that he may need to have his right pinky (fifth) toe amputated because it has gangrene. The patient is taking paracetamol as treatment. No other details was reported. Based on the lack of temporal association, the causality is considered not related for the events blood clot in leg, shortness of breath, heart rate increased, right leg swelling, right foot swelling, chills, and runny nose. The information available regarding event gangrent of fifth toe and feeling hot precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

Acute onset of dyspnea, predominantly with exertion over 1-2 days. Diagnosed with unprovoked pulmonary embolism diagnosed 2 months after vaccine. No family or personal history, no tobacco use. Up to date on cancer screenings.

Patient recieved Jannsen vaccine 1 week ago. reported shortness of breath x 6 days. arrived at hospital tested c/o shortness of breath. Currently admitted inpatient positive covid test 5/20/21. patient did note exposure to covid positive person 10 days ago.

After receiving vaccination patient became incoherent, began having difficulty breathing and was audibly wheezing. Skin became extremely pale. Epinephrine was administered and 911 was called. EMS evaluated the patient and patient declined further medical attention.

throat swelling shut, called ambulance, took Benadryl. Currently nausea, burning lower stomach, severe lethargy, hot skin,

PAIN IN THE RIGHT LUNG; DID NOT SLEEP WELL; FELT LIKE ON FIRE; FELT DOWN; CHILLS/FEELING COLD; SWEATY FEVER; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included chemical exposure, and concurrent conditions included morphine allergy, smoker, and chantix allergy, and other pre-existing medical conditions included patient said that the symptoms were similar to what he experienced in 25-JAN-2020, he thinks that he might have had covid back then, he thinks he was asymptomatic and didn't take covid test. The patient experienced drug allergy when treated with varenicline tartrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, one total administered on left arm on 22-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the patient experienced sweaty fever, felt like on fire, felt down, chills/feeling cold and On 23-JUN-2021, the patient experienced pain in the right lung and did not sleep well. Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty fever, on 23-JUN-2021, was recovering from chills/feeling cold, and pain in the right lung, and the outcome of did not sleep well, felt down and felt like on fire was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210651442-Covid-19 vaccine ad26.cov2.s-Sweaty fever. 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).

15-20 minutes after vaccine pain in chest on left side near heart, sharp for 10-15 sec and than tingling constant dull pain, sharp pain happened multiple times since the injection. Went to ER on advice from physician, had multiple tests including blood work, EKG, CT angiogram d-dimer high, did not show heart issues but it did show minimal basilar atelectasis. Currently still having pain and started incentive spirometer.

Patient required hospitalization due to breakthrough infection. He received JnJ vaccine on 4/6/21. Hospitalized from 7/18 to 7/20/21. Below is copied from discharge summary: Hospital Course: Admitted with dyspnea on exertion and had covid infection Patient came with his wife, patient didnt require a lot of oxygen He is now on RA, s/p dexamethason and Ramdesevir Patient echo showed normal EF and no wall motion abnormality Ok to be discharged home and quarantine for 10-14 days.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Loss of feeling on finger for 30 minutes-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild

Patient had arm tingling shortly after injection. Pt stayed in store for about 4 hours after 2pm injection, no redness or swelling noticed. Pt was quite anxious & nervous (but already has severe anxiety). Pharmacist called patient following afternoon, the 11th and patient noted he was doing marginally better but still sounded anxious. Pharmacist called patient on Fri the 12th 5:16p and this was when the patient explained the following: Muscle stiffness on left side & pain down left leg; cranial pain; shoulder stiffness; nasal congestion; some shortness of breath; soreness & fatigue. Patient called back and said he had partial shortness of breath at 7:34p on the 12th. On Sat the 13th at 11am, pharmacist called to check on pt; found him quite agitated & saying, "He feels the shot was botched", noted he had called Janssen to report his issues. At 4:30pm, pt came to pharmacy, looked fine, arm showed no redness, was more subdued in person than on the phone earlier. He said he was feeling better but was not happy with Janssen and wanted the Moderna 2 series shot because he feels Janssen's vaccine wasn't doing what it was supposed to.

Patient had a large pulmonary embolism 3 weeks after receiving the vaccine. Unclear if vaccination was the cause, but giving the timing we are reporting it. The health care proxy also noted some palpable masses on distal L extremity, unclear if related to vaccine or what these are.

I started with rashes (red) on both ankles. then near arm pits. They I started with very itchy eyes which turned to Pink Eye. Addtionally I got very congested, trouble breathing, phelm production. Tired or fatigued. Got back enough and went to the doctor and receive a steroid shot, and eye drops. I am still have issues still.

Pain at site of shot. Hot flashes, chills. Before bed got real hot from waste up. Muscle spasms. twitchs at shot site. Light headed, dizzy, shortness of breath. Shot should have been 2nd dose of pfizer. Pharmacist called the next day and told me to remove Janssen sticker from covid shot record card and said to write in pfizer info.

Patient presented on 4/21 with 2 weeks of generalized fatigue, abdominal pain, and weight loss with multiple lab derangements concerning for acute liver failure. Patient on 4/22 is tachycardic and change in mental status. Acute liver failure likely due alcoholic hepatitis. Cholestatic etiologies will be considered. Acetaminophen toxicity treated with acetylcysteine. Started on methylprednisolone 32 mg daily. RUQ: biliary sludge within gallbladder. No sonographic evidence of acute cholecystitis. Acute respiratory failure secondary to COVID pneumonia. Chest pain and elevated troponins. Alcohol withdrawal on treatment protocol. Sepsis and Community acquired pneumonia. Thrombocytopenia and elevated INR. Macrocytic anemia and AKI.

Patient states that he received Janssen Covid-19 vaccine on 3/31/2021 and was exposed to a covid-19 positive co-worker on 4/2/2021 and tested positive for Covid-19 on 4-10-2021. The patient came to the hospital emergency room via EMS on 4/21/2021 at 0912 complaining of shortness of breath. According to EMS the patient had an O2 saturation of 57% on room air and was place on CPAP, 15 liters, and transported to the ER.

Exactly 11 days after receiving the J&J vaccine my husband developed leg pain in his right lower inner leg, he was taken to the hospital on 04/20/2021 which a ultrasound was completed but resulted no blood clots, no other labs or treatment was performed that day, the next day he developed severe diarrhea and flu like symptoms with continued leg pain and difficulty breathing, He was then rushed to the hospital by ambulance where he was suffering from very low BP 41/31 was the lowest, a line was placed and he was put on pressors to increase his BP. He was transferred to the hospital where he was diagnosed with a flesh eating bacteria in the right leg where the pain was at and Sepsis. He was taken to surgery to debride the right leg and was started on CVVHD because his new kidney was now failing, he eventually was started back on Hemodialysis and taken to surgery 2 more times where he cardiac arrested on the table in surgery and died. A private autopsy is being performed but the preliminary results shows he had multi-system organ failure, including his liver which was NEVER a problem in the past.

Patient was admitted to the hospital on 4/5/2021 for severe AKI with hyperkalemia. Patient had a prolonged hospital course due to kidney failure and AIDS. The patient developed acute respiratory failure on 5/1/21 and was transferred to the ICU, where he was found to be in septic shock. Patient passed away on 5/4/21 at 9:59am

SHORTNESS OF BREATH; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced shortness of breath. On 09-APR-2021, the subject experienced trouble sleeping. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Signs of Pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and trouble sleeping. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Running up a hill and became severely short of breath with significant chest pain in center of chest. Had to lie on the ground to rest and catch breath. Several minutes to catch breath and about 10 minutes for chest pain to resolve. One month later had chest pain in center of chest... went to urgent care... EKG and vital signs showed normal. Two months after vaccine, started having forceful heart beat, lightheadedness, fatigue, pins/needles neuropathy in right foot... Lightheadedness and neuropathy was episodic, sometimes for hours, for a week... Fatigue was worse for a week then gradually eased but remains mild to moderate fluctuating... Forceful heart beat has continued but was worse 3 weeks ago and is always worse lying down and improves when sitting up though can be mildly present sitting up... and continues today. Seeing my primary care doctor to assess. Went to clinic 3 times in last month for this... vitals always normal and one additional EKG normal.

Nausea, vomiting, difficulty walking, unable to eat or drink; unable to clear secretions, difficulty breathing

began 24 hours after injection. Hot to touch round, red rash with a knot under skin. Chills with body temp of 98.6F. Body aches and could not get out of bed for 2 days. Chest tightness and trouble breathing.

Patient was nauseous, and short of breath. Patient had several episodes of vomiting, He stated he had a "tickle" in his throat and felt his airway was obstructed. Pharmacist. administered diphenhydramine 25mg po x2.

FELT BILATERAL LUNG CONGESTION (Lung congestion, Pulmonary congestion) BILATERAL SIDE PAIN (Flank pain, Flank pain) VOMITING (Vomiting, Vomiting) LEFT ARM PAIN (Painful L arm, Pain in extremity) DIFFICULTY BREATHING (Difficulty breathing, Dyspnoea) MISSED WORK TODAY (Loss of personal independence in daily activities, Loss of personal independence in daily activities) PAIN WHEN BREATHS (Painful respiration, Painful respiration) FEVER OF 100 F (Fever, Pyrexia) FATIGUE (Fatigue, Fatigue) This spontaneous report received from a patient concerned a 52 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, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021 (mentioned as yesterday), the symptoms of the patient started, and he missed work today (loss of personal independence in daily activities) and left arm pain (painful L arm) because he was not feeling well. The reporter advised him to contact his primary care provider, but he said he called and they are not able to see him without an appointment also advised him to seek medical attention by going to the emergency room. The patient agrees to go to the Emergency Room. On 11-MAR-2021, the patient experienced bilateral side pain (flank pain) , vomiting, felt bilateral lung congestion (lung congestion), difficulty breathing, fever of 100 F, fatigue, pain when breaths (painful respiration) . Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 100 f, had not recovered from bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, and pain when breaths, and the outcome of missed work today was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever f 100 f and missed work today as possible. Company causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever of 100 f and of missed work today as possible. This report was serious (Other Medically Important Condition).

Uncontrollable shaking/chills and slight breathing difficulty at the same time. I couldn't hold a full glass of water without having the water shake out of the glass. I am in good health, was fully hydrated and exercise on a regular basis. This symptom is not listed on the published symptom list and I had no idea this could possibly be the outcome of the vaccine.

PATIENT GOT THE VACCINED AT 130PM COMPLAINED OF ITCHY THROAT, COUGH AND MILD THROAT TIGHTNESS AT 140PM DOCTOR EVALUATED THE PATIENT , NO RESPIRATORY DISTRESS, TALKING IN FULL SENTENCES. BENADRYL 50MG IM ADMINISTERED AT 203PM. MD EVALUATED THE PATIENT 5 MINUTES LATER AND PATIENT DENIED THROAT TIGHTNESS, ITCH OR COUGH. VS STABLE AT 140PM BP 110/65 HR 80 O2 96% VS AT 223PM 106/64 HR 74 O2 96% PATIENT WAS OBERSEVED FOR HALF HOUR AND SENT HOME WITH INSTRUCTIONS TO CALL 911 IF HE DEVELOPS ANY RESPIRATORY DIFFICULTY. PATIENT VERBALIZED UNDERSTANDING

brief shallow coughing with wheezing and slight inability to catch breath; brought on by episode of laughing- entire experience was singular

I experienced two days later bad earaches for some hours. I also had SOB. Today, I am applying ear drops in my ear due to my ear aches.

Onset with severe headache, nausea, diarrhea, vomiting, shortness of breath, difficulty concentrating from 4/3 -4/8. Went to urgent Care on 4/8 where treated for severe dehydration and stomach aligment. From 4/9 - 4/14 continued to suffer from same symptoms and then began to have heart taching, feeling as if there was a bubble in my chest. Went back to Urgent Care on 4/14 and was again treated for dehydration. Outcome is that no one knows why I have been feeling this way except for that it is a direct result of receiving the vaccine.

SWEATY; BODY ACHES; EXTREMELY THIRSTY; LEFT ARM PAIN/LEGS BURNING; LEFT ARM NUMBNESS; HEADACHE; FATIGUE; LUNG PAIN; LUNG WEIGHT/PINCH IN THE HEART/CHEST DISCOMFORT; This spontaneous report received from a patient concerned a 52 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: 1808609, and batch number: 1808609 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 lung pain. On 24-MAR-2021, the subject experienced lung weight/pinch in the heart/chest discomfort. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced extremely thirsty. On 24-MAR-2021, the subject experienced left arm pain/legs burning. On 24-MAR-2021, the subject experienced left arm numbness. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced sweaty. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lung pain, lung weight/pinch in the heart/chest discomfort, headache, fatigue, sweaty, body aches, extremely thirsty, left arm pain/legs burning, and left arm numbness. This report was non-serious.

INFORMATION TAKEN FROM WEDSS...Patient received the COVID-19 vaccine on 3/17. On 4/14 the patient began experiencing symptoms of COVID-19 which included fever, shortness of breath, cough, chills and congestion. Patient went in for testing on 4/19 with results coming back positive.

Pt presented to ED w/SOB, cough, tachycardic, febrile, and headaches. Pt resides in independent apt w/roommate who tested positive for COVID 04/07/21. Pt developed symptoms on 04/08/21 but was tested negative at the time. Progression of cough resulted in ED visit. Pt received Janssen vaccine on 3/25/21 w/no complications. Was admitted for additional management of acute respiratory failure w/hypoxia due to COVID-19 infection and pneumonia requiring bipap, dexamethasone & tocilizumab. Rapidly escalating O2 requirements required intubation (4/16) and trach/PEG insertion (5/1). On 4/23- developed MSSA pneumonia in which 10 days of cefazolin was given. Pt currently still in ICU.

abdominal pain. The pain was so severe that my knees would buckle and several times if I was holding anything, it caused me to drop it. After about a week, I had an appointment at 4:30 and was scheduled for the next morning at 8:30 to meet with a back and spine doctor for xrays. Xrays were negative. I was then schedule with a neck and hand specialist a few days later. This appointment could not provide a diagnosis. Back and abdominal pain increase and soreness had spread to the stomach and groin. After the news broke of the cerebral blood clots in 6 women. See attached Continuation Page.

I felt shortness and restriction of breath, fever 101, body aches and headache. I have had issues with micro clotting, heart rate is even more irregular, and I was diagnosed as having a TMI. I rode in the ambulance on Mother's day was hospitalized

I experienced dizziness, headaches, SOB, chest pains, diarrhea, nausea, occurred when I am under physical stress. Walking 10ft or up the stairs triggered my symptoms. Once I stopped moving, my symptoms would dissipate. I called my PCP along with a cardiologist up until today. I was tested for blood clots, had complete blood panel, stress test and nuclear stress test. My symptoms are getting better but still have mildly present. My last meeting with the cardiologist, what he saw after the nuclear stress test, that there was a lack of blood flow where to the lower right heart chamber. He said it probably due to a blood blockage or plague and at this time he is trying to figure it out.

cough, malaise and fatigue. He states that he started to have symptoms about 3 days ago with chills, subjective fevers, cough, anosmia. He also had some chest pain that he states was left sided/substernal and felt like squeezing/heavy pain. It started yesterday morning and comes and goes. He has some SOB and he also has had a very poor oral intake.

7/18/2021 Patent presemted to ED with a chief complaint of chest pain for the last 3 days associated with shortness of breath. Refers has been using ibuprofen achieving minimal relief. Received COVID 19 vaccinate in April (Johnson & Johnson). Upon initial evaluation on ED VS: stable. Laboratories revealed elevated creatinine and COVID 19 TEST Positive. EKG: Sinus rhythm, T wave abnormalities. A chest x ray: IMPRESSION: Left lower lung airspace disease. CT angio showed Acute pulmonary embolism, left lower lobe, nonocclusive. COVID-19 infection considered asymptomatic and no treatment required for this. Discharged home on 7/19/21.

Systemic: Fainting / Unresponsive-Mild, Systemic: Patient passed out and recovery after 40 seconds of chest compression-Mild, Additional Details: Patient was seen rocking back and forth in his chair according to 3 observers in the room, then fell back hit his head after observed his face turned pale. 3 Observers rushed over to him, patient was not breathing, unconscious and not responsive, eye ball stiff, sweating but cold. Eyelid peeled back and the eye is responsive to light. Started chest compression immediately and after 40 seconds of chest compression at third round, patient came back. no hx of preexisting condition or allergies note

The day following the vaccine, patient developed SOB and a cough. Came to the ED on 4/13/2021 and was found to have new atrial flutter. Patient continues to be in atrial flutter, has received anti-arrhythmic and rate control medications

SOB, CP, Fever, Nausea, Body aches. Seen in ER for cardiac work up. Labs normal and CT chest normal

Headache Shortness of breath Smart watch indicated Atrial Fibrillation (112 BPM average) on 4/12 at 3:04pm

My uncle unexpectedly passed away during the early morning hours of April 13. He had reported to my aunt that he was having shortness of breath, headaches, and in general not feeling well. She found him sitting up with a clear liquid pouring out of his nose and then he fell over dead.

As pt's PCP office, we became aware that pt was admitted to hospital on 5/3/21 with dx of pulmonary embolism. Per admission note, pt reporting increased shortness of breath x 4 days prior to his admission date. Also noted to have received J&J vaccine on 4/29/21. Pt still currently admitted to the hospital and undergoing treatment for PE.

A 53-yo male patient with a nonsignificant past medical history presented to the hospital with worsening generalized muscle pain, and weakness. Patient reported that he received the Jannsen COVID-19 vaccine 3 weeks prior to admission and symptoms began 8 days later. On the morning of admission the patient also developed pressure-like and pleuritic chest pain. EKG findings showed ST elevations in V5-V6 with depression in aVL. D-dimer was found to be elevated however PE evaluation was negative. Troponins were also found to be elevated. The patient was diagnosed with acute pericarditis and underwent left heart catheterization, selective coronary angiography and left ventriculography. The coronary angiography revealed no significant obstructive coronary artery disease, and left ventriculography revealed normal LV size and function. Patient was subsequently initiated on colchicine therapy for acute pericarditis. He remains admitted at hospital.

on 5/17/2021 pt developed a fever, pain in the left side of his ribs and had SOB. He was brought to Hospital ER. Pt had Chest x-ray, blood work, Doppler on both legs, and CT. His DX was pneumonia, blood clot in left lung and bilateral blood clot in legs. He was admitted and stayed for 5 days.

Patient experienced dyspnea on exertion and lightheadedness shortly after receiving vaccine. He continued with these symptoms until presenting to ER on 6/6/2021 and found to have extensive bilateral pulmonary emboli.

About 2 days after he received the vaccine he had really bad headaches, which he never gets. They lasted for about 2 weeks off and on. Around two or two in a half weeks later he started having adverse pain in his middle back left side area. Stated it was a sharp stabbing like pain then it started radiating from his back around his left side up into his chest left side. Being concerned his doctor ordered a Cath test but everything was normal. We have been to GI, Cardiologist, his regular doctor, pulumonary and ER and they have done blood work, CT Scans and x-rays and can't find out why my husband is still having severe sharp pains throughout. They just keep telling him to try another type of doctor. He stays in constant pain and states his chest hurts and he has difficulty in breathing from the sharp pains in his chest. He never had this type of pain until he got that J & J vaccine. I am wondering if he has developed Guillain-Barre Syndrome because it sounds like some of the same symptoms. I just want him to stop hurting.

I had difficult breathing, I was dizzy, but all my bloodwork shows my red cells decreasing, chest pain, Knee weakness, went to care, 06/01/2021 and I was transferred to hospital and I received a blood transfusion. When I am working I still have shortness of breath.

Patient arrived for COVID vaccine prior to working shift. He stated upon questioning having an anaphylactic reaction to seafood. We requested him to stay in observation for 30 minutes after vaccine administration. He agreed and vaccine was administered. After working approximately 3 hours later he returned to the pharmacy stating he felt out of breath. He didn't know if it was because of vaccine or CHF. Questioning him further, he said he felt a little swollen around neck. He was responsive. Administered 50mg of Benadryl. Instructed him to sit. He had a portable fan. After sitting down, he started to feel better. He remained at the pharmacy and called for transportation home, leaving approximately 1 hour later

Had chills in middle of night. Woke up next morning with cough that developed into asthmatic episode. Couldn't get full breaths even after multiple attempts to use rescue inhaler Proair and stronger inhaler Flovent. Went to ER. Pulse Ox was 90 at admission. After course for Medrol and nebulizer, left hospital at 94.

About 5 days after receiving the injection, I suddenly developed mild shortness of breath, aches, and fatigue. Less than 24 hours later, the symptoms seem to be resolving.

i received the vaccine at 5:30 pm no side affect but at midnight 12:05 I woke u with massive headache around my head and muscles pain with temp and shivering cold i could not sleep all night after also with stomach pain too and at one time i felt short of breath i did not take anything until 12:00noon the day with tylenol and i drank lots of Gatorade, i night sweat a lot and i slept all night after taking another two pills of tylenol 500 mg each, i sweat all night and I woke up good thanks god i feel much better

During the night after the vaccine, woke up and was not able to breathe very well. Also experienced a painful migraine/headache and the left side of my face lost feeling. Still mildly numb today.

FEEL SLUGGISH; BREATHING KIND OF HEAVY, OUT OF BREATH A LITTLE BIT; DEHYDRATED; TEMPERATURE 98.8; ARM SORENESS; LIGHTHEADED, DIZZINESS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate asthma, penicillin allergy, and egg and chicken allergy, and other pre-existing medical conditions included that patient got flu shot in 2011 and had fever afterwards, but usually never gets fevers. patient had allergies (took shots as kid) and stated some complaints "could be pollen". The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 at10:15 in right arm for prophylactic vaccination. Concomitant medications included loratadine. On 29-MAR-2021, the subject experienced lightheaded, dizziness. On 29-MAR-2021, the subject experienced arm soreness. On 30-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F, 97.1 F. Treatment medications included: paracetamol. On 30-MAR-2021 20:00, the subject experienced temperature 98.8. On an unspecified date, the subject felt sluggish and experienced breathing kind of heavy, out of breath a little bit, and dehydrated. The action taken with covid-19 vaccine was not applicable. The patient recovered from temperature 98.8 on 31-MAR-2021, had not recovered from arm soreness, and the outcome of feel sluggish, lightheaded, dizziness, breathing kind of heavy, out of breath a little bit and dehydrated was not reported. This report was non-serious.

ELEVATED BLOOD PRESSURE; CHEST PAIN; SHORTNESS OF BREATH; VOMITING; NAUSEA; HEADACHE MIGRAINE; This spontaneous report received from a consumer concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and tension headache, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered to left arm, on 02-APR-2021 13:40 for prophylactic vaccination. Concomitant medications included atenolol for high blood pressure. On 02-APR-2021, the subject experienced headache migraine. On 03-APR-2021, the subject experienced elevated blood pressure. On 03-APR-2021, the subject experienced chest pain. On 03-APR-2021, the subject experienced shortness of breath. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced nausea. Laboratory data included: Blood pressure (NR: not provided) 180/110 mmHg, and EKG (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, chest pain, shortness of breath, vomiting, headache migraine, and nausea on 03-APR-2021. This report was non-serious.

4/6/21 - got bloody nose at 10:00 A.M, which would not stop. Nose still bleeding 2 hours later, got dizzy, so lied down. Vomited blood and could not stop the bleeding. Went to the ER at 2:00 PM, to have them stop the bleeding 4/6/21- E.R. - Fainted n the lobby while waiting. Taken back to room and given IV and gave multiple tests. E.R. doctor put packing in nose to slow bleeding. Still The Diagnosis was Epistaxis and Vasovagal syncope, and advised to follow up with my doctor and otalaryngologist. 4/8/21- Nose bleeding finally cam to stop in the evening, but had fatigue, weakness, irregular heartbeat, and shortness of breath 4/9/21- ENT and Allergy removed packing, completed nasal scope. Nose still felt like it was stuffed with blood clots until 4/13/21

WET MUCUS IN MOUTH; MOUTH WITH FOUL ODOR; MOUTHFUL OF WHITE THICK FLUID; FEELING OVERALL SICK; FATIGUED; FEVER; COULD NOT CATCH BREATH; COUGH; CHEST PAIN; CONGESTION; TACHYCARDIA; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included head injury, and concurrent conditions included cannot read/see very well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805829, expiry: UNKNOWN) dose was not reported, administered to left deltoid on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 21-MAR-2021, the subject experienced congestion. On 21-MAR-2021, the subject experienced tachycardia. On 21-MAR-2021, the subject experienced chest pain. On 21-MAR-2021, the subject experienced cough. On 21-MAR-2021, the subject experienced could not catch breath. On 21-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99-100. On 22-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102. On 28-MAR-2021, the subject experienced wet mucus in mouth. On 28-MAR-2021, the subject experienced mouth with foul odor. On 28-MAR-2021, the subject experienced mouthful of white thick fluid. On 28-MAR-2021, the subject experienced feeling overall sick. On 28-MAR-2021, the subject experienced fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, chest pain, could not catch breath, and fever on 23-MAR-2021, and feeling overall sick, and fatigued on 31-MAR-2021, and had not recovered from congestion, mouth with foul odor, cough, wet mucus in mouth, and mouthful of white thick fluid. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

SHORTNESS OF BREATH; HEADACHE; This spontaneous report received from a patient concerned a 54 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 and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and headache. This report was non-serious.

Multiple pulmonary embolisms in bilateral lungs with lung infart, superficial blood clot in the right groin area, significant right abdominal pain, shortness of breath, low oxygen saturation levels admitted 3 days in the hospital. 36 hours of Lovanox injections followed by transition to Eliquis 10 mg twice per day, respiratory exercises, oxycodone given for pain Pain has diminished in lower right lung area, clotting appears to be under control

Patient presented to ED on 4/22/2021 with non-productive cough, mild shortness of breath x 10 days. Acute onset chest pain x 1 day. Chronic bilateral leg swelling, but worsening leg pain. Hx of DVT and PE, not on anti-coagulation.

I was admitted to the ER on 4/12/21 with dizziness, lightheadedness, vertigo, some auditory issues, shortness of breath, swelling/puffiness of legs and feet, unusual coldness in extremities, and some minor pain in chest. CT-Scan revealed DVT in left leg and PEs in both lungs. Was given two shots of heparin over a 24-hour period and then Xarelto 15mg (oral) the following day.

1 week post vaccine developed SOB and cough petechiae to bilateral lower and upper extremities and back

After administering the Janssen vaccine the patient began to have dizziness and difficulty breathing. The patient's airway did not completely close up as he was able to respond and talk to me. Called 911 and administered 10mL (25mg) of Diphenhydramine and gave the patient a bottle of water. He was already worked up as he was scared of needles. He continued to breath better but still had difficulty. The EMT arrived in under 5 minutes as they were already on a call close by and was rerouted. EMT administered breathing treatment and took vitals and eventually took the patient to the hospital as a precaution. (Technician administered vaccine)

Patient received Janssen vaccine on 5/11/21 @ Pharmacy, noted 12 hours after the vaccine had headache, body aches, and chills. The on 5/17/21 woke with a head to tow rash. Went to ED and was treated with Prednisone and antihistamines. 5/19/21 noted chest and head congestion, shortness of breath and return of rash on his back only. Patient referred to see provider 5/19/21 to rule out covid infection and discuss the treatment of symptoms.

Experienced severe headache, leg pain, shortness of breath. Was admitted to Hospital on 4/11/2021. Discharged 4/12/2021. Follow up w Primary doctor

BREATHING DIFFICULTIES; CONSTANT COUGH; LUMP IN THE THROAT; FEEL LIKE HE IS DYING; SWALLOWING DIFFICULTY; AIRWAY BLOCKAGE; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced breathing difficulties. On 01-APR-2021, the subject experienced constant cough. On 01-APR-2021, the subject experienced lump in the throat. On 01-APR-2021, the subject experienced feel like he is dying. On 01-APR-2021, the subject experienced swallowing difficulty. On 01-APR-2021, the subject experienced airway blockage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breathing difficulties, constant cough, lump in the throat, feel like he is dying, swallowing difficulty and airway blockage 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.

After receiving , approx. next day, patient noted shortness of breath which worsened over the course of a few weeks. Right leg began to swell with some chest pain approx. 2 days before admission. He presented to ER, CT Chest Protocol showed multiple pulmonary thromboemboli, distal left and right main pulmonary arteries and several segmental branches. and had right heart strain. Venous Doppler of right leg revealed complete occlusion of multiple veins. He was admitted to hospital for anti-coagulation.

My heart has been pounding hard with some pain. Shortness of breath. Coughing. Pain in left chest. Breast bone hurts

High fever, weakness, chills, nauseous. Started at 10am. Was hyperventilating trying to vomit but couldn't took Pepto-Bismol. Fell asleep about 3pm woke up at 630pm soaked from fever breaking. took temperature then was 101.7. Still have fever of 100.7 at 10am 3.7.21

I took the shot at 10:50, first early side effects where mild burning sensation in the legs couple of hours after the vaccine, later pain in the legs in the afternoon. At night I had a mild fever, chills, body aches (everywhere) unbearable headache (still going on 24 hours after the shot), pain at the vaccination site (left shoulder, still strong after 24 hours), pain in the lungs (I sneezed a couple of times). I took Tylenol every 4 hours, but did not improve, only brought the fever down a bit. Today after 24 hours, I still have headache, muscular aches, and fatigue.

Patient was complaining of a weight on his chest and difficulty breathing including gasping for air. BP was 136/90 and Epipen was administered. Following epipen breathing improved

severe lethargy, shortness of breathe and fatigue (potential blood clot), went to PCP and prescribed Eliquis and Prednisone; however, written documentation said that he had no prior history of clotting prior to the vaccine.

Approximately eight hours after receiving the shot, I started getting a headache, body aches, and chills (April 3rd, 8 p.m.). I went to bed and had severe chills and body sweats for the entire night. The primary symptom to report is that my heart raced all night. It felt like it was beating at about 140 to 150 Hz or higher. When I woke up in the morning, it felt like my chest had been pounded on all night. The pain was in my sternum area. The headache and body aches took a little over a day to go away. The chest pain took a couple of days to die down. On April 12th, I walked my dogs in the morning and felt out of breath, which isn't normal for me. In the afternoon, while working at my desk at home, I started getting more and more severe chest pain and then started getting dizzy and felt weak. I drove myself to the local ER and they tested me for a heart attack. All tests came back negative. They suggested going to another facility to get checked for clots or to make an appointment with a cardiologist. The next day, after talking to a doctor friend, he suggested going to the ER facility to get imaged for clots and to get fully checked out. No cardiologist appointments were available till the next week. I went to the ER facility and was there for seven hours getting tested. They came back and said all test results were negative and that my heart looked fine. They did not have any suggestions for what might be causing the pain in my chest.

Patient received Johnson & Johnson (J&J) Janssen COVID 19 vaccination on 3/31/21. Follow up telephone call was done to patient to assess for warning signs of blood clots. Patient reports new onset of shortness of breath 3 days after receiving the J&J COVID 19 vaccination and severe headaches. Patient denies any other symptoms of abdominal pain, leg pain or swelling, backache, petechiae, or new or easy bruising. Patient was given the following recommendations to seek medical care at the nearest emergency department. Patient states he is going to make a medical appointment with his primary care doctor at a local clinic in the town he lives in. Patient was advised due to the symptoms he is experiencing that he should seek medical attention for the symptoms he is having due to the warning signs of a type of blood clot that is occurring in the J&J COVID 19 vaccination.

Developed transient SOB on 4/16 that resolved on 4/18. Developed left leg pain and swelling on 4/19. LE ultrasound revealed extensive DVT. Does report a 4 hour plane ride 4 weeks ago.

Flu like symptoms x 5-10 days, back/pleuritic pain the following 5 days, SOB x 3 days later, finally went to ER dx with DVT, and PE

The patient states he had some side effects from the Janssen vaccination. He had some shortness of breath (trouble breathing) starting the evening of 5/28/21 (day of vaccination). He also had some fever. Both were "tolerable". He did not need to seek any care from MD. He says adverse effects lasted for 2 days then resolved.

Johnson & Johnson COVID Vaccine EUA J&J Dose 4/9/21 NOT COVID POSITIVE 5/25/21: The patient is a 55-year-old male presents to the emergency department via EMS today after calling 911 with acute shortness of breath and being found unresponsive and pulseless at home, subsequently requiring cardiopulmonary resuscitation on route to the ED. the patient has a past medical history significant for gout, which he takes indomethacin as needed, and recently went to another state in March. His significant other reports that COVID-19 infection went throughout the house in December, although he did test negative, they believe he had it due to his symptoms. He did have that Johnson and Johnson COVID-19 vaccination at the beginning of April of this year. Apparently the patient was speaking with the 1st responder right up until for minutes prior to EMS arrival and when fire department arrived on the scene the patient was found unresponsive, pulseless, and apneic, and subsequently they performed 1 round of CPR administering epinephrine and Narcan, when the patient regained a pulse. The patient lost a pulse again, requiring subsequent CPR and airway tube was placed. The patient arrived in the ED at 10:02 a.m., epinephrine was administered x7 rounds, patient was intubated with a 7.5 ET tube, Lucas device on patient, at 1053 the patient was awake, opening his eyes, squeezing nursing staff hand. At 10:59 a.m., nursing staff reported patient trying to pull his ET tube out. The patient received at least 1 hour 15 minutes CPR including time on scene, on route to ED, and in ED. At 11:10 a.m. patient's O2 saturation decreased to 79%, patient became diaphoretic with decreased responsiveness. At 11:13 a.m., cardiology was at the bedside. The patient's laboratory studies were significant for platelets 44, INR 1.2, CO2 16, AGAP 24, glucose 475, BUN 17, CR 1.55, ALT 248, AST 274, ALP 123, mg 2.9, lactate 15, troponin negative, 1st ABG: PH 7.11, pCO2 39.4, base excess -17, PO2 46, HC03 12.6, O2 saturation 100%. EKG showed right bundle-branch block with ST elevation in lead 3, V1, V2, V3, and V4 leads with ST depression in 1, aVL, and lead II. Limited stat bedside echo showed akinetic septum and hypokinetic right ventricle. The patient was taken to the cath lab. Dr. completed a pulmonary arteriogram and found bilateral massive emboli subsequently undergoing thrombectomy. Patient was on epinephrine, norepinephrine, IV fluids, heparin, and propofol. The patient was seen postprocedure in the intensive care unit while mechanically ventilated and sedated. The patient's sedation was stopped and the patient woke up, moved all extremities, and followed some commands. The patient's significant other was at the bedside. He is currently on norepinephrine at 20mcg/min, epinephrine 20mcg/min, heparin per PE protocol after receiving bolus in CCL, propofol 25mcg/kg/min, and IV NS fluids. The patient's wife reports that he has a history of chewing tobacco, but quit over 20 years ago. She believes that he has a family history of blood clots in his sister's and maybe his dad, but she is not completely sure about that. 6/8/21: 56-year-old man who called EMS with complaints of acute onset shortness breath, was found unresponsive, apneic and without a pulse on arrival of EMS. ACLS protocol was initiated, he was brought to the emergency department where CPR was continued with Lucas device. He was intubated, required administration of 7 rounds of epinephrine, a total of 1 arm 15 minutes of resuscitation was required prior to return of spontaneous CT circulation. Cardiology was emergently consulted, he was taken to the cath had last cath lab with only mild nonobstructive CAD noted. He then underwent pulmonary angiography with the finding of saddle pulmonary embolism as well as bilateral main pulmonary artery thrombosis. He underwent mechanical thrombectomy of the right and left main pulmonary trunk, right upper middle old and lower lobe pulmonary artery, left lower lobe pulmonary artery. Therapeutic anticoagulation was initiated with IV heparin then transition to oral Eliquis. He was treated with empiric antibiotic therapy for presumed aspiration pneumonia. Tunneled hemodialysis catheter was placed secondary to legal Rhea and acute kidney injury, renal replacement therapy was initiated with CRRT. Clinical response was favorable, he was subsequently extubated and transitioned to intermittent hemodialysis. He was assessed by Physical and Occupational therapy and recommended for acute rehabilitation placement. His been discharged today in stable medical condition to continue hemodialysis as scheduled per Nephrology at the acute rehabilitation unit.

Day one was headache as expected and right arm pain. Day two I had bad headache (9) joint pain in my shoulder and hips, loud ringing ears. shortness of breathe, left lung pain. This repeated for three days so I tested by BP and found it to be 160/130. Past day 3 I started with adrenaline spikes where heart would race up and I felt like hulk and blood pressure spikes out of the random. 5/24/21, I saw my family doctor and since my BP was so random high and then low she did not want to give me meds since it could drops too low at time. For my difficulty breathing and lung pain she gave me an prescription inhaler. As of today I still have the ringing left ear, shoulder joint pain like a pin stuck in it and unable to raise over my head without using my left arm to support, high BP on average 140/132. 167/151, 126/89, 122/91,110/87, 126/84 are some examples. These at the lowest is 10+ point higher than my normal range of 120s over 70s. Headache continues but may be due to the higher than normal BP.

SHORTNESS OF BREATH (FEELING CONSTRICTED BUT NOT COMPLETE LOSS OF BREATH); LEFT NECK LYMPH NODE SWELLING (NOW DECREASED IN SIZE, STILL PALPABLE AND INFLAMED); FEELS HYPOSTATIC; LIGHT HEADED; FEELING BACKED UP; CLOUDINESS IN URINE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included fever, tinnitus, and drug induced hypertension, and concurrent conditions included autoimmune disease -psoriatic arthritis, and other pre-existing medical conditions included the patient had experienced many adverse experiences with other vaccines/medications in the past. the patient had received steroids that resulted in bright pink torso and was aware about the steroid allergy. the patient thinks he had covid-19 back in december because he loss his sense of smell for 2 to 3 weeks. patient received a vaccine 10 years ago that gave him a fever for 10 days straight. The patient experienced hypertensive when treated with salbutamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04A21A, and expiry: 05/AUG/2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced cloudiness in urine. On 21-MAY-2021, the subject experienced shortness of breath (feeling constricted but not complete loss of breath). On 21-MAY-2021, the subject experienced left neck lymph node swelling (now decreased in size, still palpable and inflamed). On 21-MAY-2021, the subject experienced feels hypostatic. On 21-MAY-2021, the subject experienced light headed. On 21-MAY-2021, the subject experienced feeling backed up. On 01-JUN-2021, Laboratory data included: Blood test (NR: not provided) all clear. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 111/63. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath (feeling constricted but not complete loss of breath), left neck lymph node swelling (now decreased in size, still palpable and inflamed), feels hypostatic, light headed, cloudiness in urine, and feeling backed up. This report was non-serious.

I started to suffer from a numbness in my left hand that radiated into a deep pain and increasingly became intense. That pain radiated up to my shoulder and into the left quadrant of my chest. I started experiencing shortness of breath and a hypersensitivity to the heat. I went to Hospital ER and they ran a bunch of tests. I was diagnosed with a blood clot in my arm. I was given Eliquis. I was on that medication for about 2 weeks and after my second week of being on Eliquis, I started to suffer from the same symptoms. I decided to go to the Hospital. When I went there they admitted me and ran through blood tests to check for a heart attack or stroke or anything relating to the pain I was experiencing. Now I am back home and I am still taking Eliquis. As of today, I am still experiencing the symptoms. The symptoms are mild, but it's still scary. I would like to add that I have had an increase in dietary intolerance.

trout closing , chills , high fever, bells palsy , ringinging in right ear , very sensitive to noise, smell and taste off, dizziness, nauseousness

So roughly a week after my vaccine, I started having acid reflux and wheezing and a ringing in my left ear as well. I went to see an ENT and he prescribed a medication which was to help reduce swelling in my esophagus, I do not remember the dates or the medication name I am sorry, I am in the field right now not home. He also told me to refrain from chocolate, caffeine, carbonated drinks and those things. Doing that has helped with those. The ringing in my ear he addressed as well and I went to an audiologist and they told me I had Tinnitus. Since then I have been fitted for hearing aids and that has helped the Tinnitus a little bit.

PAIN OF THE LEG AND ARMS; WEAKNESS OF LEGS AND ARMS; DIZZINESS/ FEELING LIGHT HEADEDNESS; TINGLING AND NUMBNESS OF THE LEG AND ARMS; BREATHING DIFFICULTY; TINGLING AND NUMBNESS OF THE LEG AND ARMS; REDNESS OF THE RIGHT HAND; DVT, BLOOD CLOT, IN THE LEFT LEG; SWELLING OF THE RIGHT HAND AND LOWER PART OF THE ARM/ LEFT ARM SWOLLEN; This spontaneous report received from a patient concerned a 55-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: unknown) dose was not reported, one total administered on right arm on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the patient woke up in morning and experienced swollen right hand and the lower part of his arm. On the same day in the evening, nurse (from country jail) gave antibiotic due to redness and swelling of the right hand. On 18-JUN-2021, the patient experienced feeling light headedness, dizziness, continue to feel worse, breathing difficulty, weakness of legs and arms and continue to feel worse throughout the weekend. On 21-Jun-2021 on the afternoon, he took the last dose of antibiotic and noticed swelling went down. On the same day in the evening, he was taken to the hospital emergency room (ER) from the jail due to continued pain and tingling of the arms and legs, swelling, and blood pressure spike. Lab work was done, unable to finish the computer tomography (CT) scan of the chest due to left arm intravenous (IV) line blew out and dye went to the left arm. He was discharged back to the jail and left arm was swollen but was fine the next morning (22-JUN-2021). On 22-JUN-2021, he again returned to the hospital ER to get a chest CT scan but unable to perform the chest CT scan due to unable to get an IV line started. Laboratory work done from the night before resulted elevation of the d-dimer. Ultrasound performed on both legs and deep vein thrombosis (DVT), blood clot, was found on the left leg and no blood clot on the right leg. ER health care professional (HCP) prescribed blood thinner Xarelto (rivaroxaban 15mg) the first 3 weeks and fourth week started 20mg. (He was on his nineteenth dose at the time of reporting). After discharged from the ER on 22-JUN-2021, he was discharged from the county jail due to the current medical conditions. On same day at 17.47, he went to the local ER near home due to same symptoms, swelling and tingling of the arms and legs. ER HCP reviewed the medical records from the prison and agreed with the diagnosis of DVT from the above hospital ER visits. On 25-JUN-2021, he went to see his primary physician. HCP reviewed the medical records and verified the DVT on his left leg. HCP ordered the chest CT scan, ultrasound of both arms, and more blood work. On 27-JUN-2021, CT scan of chest resulted negative finding. On 01-JUL-2021, ultrasound of the arms resulted negative as well. On 09-JUL-2021, follow-up visit with primary physician, confirmed DVT and requested him to continue Xarelto for 3 months. He ordered the spine x-ray due to the pain and tingling of the arms and legs to find out the cause. Primary HCP follow-up appointment scheduled for 17-SEP-2021, Comprehensive Metabolic Panel (CMP), D-dimer test, ultrasound of the left leg due to DVT, B-12 test for the numbness and tingling of the legs and arms ordered to be completed prior to the follow-up appointment on 17-SEP-2021. HCP ordered X-ray of the spine. Tingling and numbness of the arms and legs are still severe at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness/ feeling light headedness on 25-JUN-2021, was recovering from breathing difficulty, and had not recovered from DVT, blood clot, in the left leg, swelling of the right hand and lower part of the arm/ left arm swollen, weakness of legs and arms, tingling and numbness of the leg and arms, tingling and numbness of the leg and arms, redness of the right hand, and pain of the leg and arms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210725185-covid-19 vaccine ad26.cov2.s-DVT, Blood clot, in the left 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).

On May 25, 2021, I experienced sudden onset of shortness of breath. 911 was called and resuscitated me then transported me to medical center where I experienced several episodes of cardiac arrest and resuscitation. I was taken to the cardiac cath lab where it was discovered I had significant blood clots in all of my lung lobes (expect the left upper lobe). The doctors were able to remove the clots. I spent a week in the ICU sedated on a ventilator then moved to a medical floor for about 5 days, then moved to Inpatient Rehabilitation for a week. I am continuing to recover at home.

Extreme fatigue--slept for over 24 hours after receiving vaccine Shortness of breath Dizziness Irritable diarrhea the first day Had to leave work the next day as dizzy and unsteady and diarrhea

Pt. walked to the front of the Pharmacy from the post vaccination waiting area (4 feet) asking for help because he was dizzy. He was sweating and having shortness of breath. Pt. was taken to the seat where he fainted. Pt. was laid on the floor with his legs up in a step. He gained consciousness in less than 1 min. Pt was pale. Pt. was given an alcohol swab to smell. 911 was called. First responders took his blood pressure again and blood sugar. Uncle's pt. was called and came to the Pharmacy to pick him up to avoid pt. having to drive his car back home.

severe chills all night went away around 6 am. Vomit with dry heaves at 1:15 am last round at 5:30 am. Very severe at times. Shortness of breath started in the afternoon or the 6th of March, lasted for 14 days. Cramps in my legs periodically still get them not as often now. Still don't have the same energy I had before the shot. I still tire easily.

Patient received Jassen vaccine 4/10/21. 4/11/21 began with symptoms of fever, headache, chills, nausea, vomiting, and diarrhea, loss of taste and smell. 4/15/21 he presented to ED with symptoms of fever, chest pain and pressure, shortness o breath, myalgias, headache, tachypnea, tachycardia, hypoxia. Was given IV Decadron, DuoNeb and albuerol in ED. Inprovment seen, but patient continued with tachypnea and difficulty breathing. He was admitted to ED with a diagnosis of COVID 19 , asthma exacerbation and elevated Troponin at 31.52 (Ref Range 19) . During admission, glucose levels were labile, requiring adjustment to routine insulin regimen and Glucovance for hypoglycemia. An Echocardiogram was ordered due to elevated Troponin levels on admission. Echocardiogram 4/19/21 showed a density in the right atrium. Cardiology recommended a cardiac MRI. Patient was transfered to Hospital 4/19/21 for elevated care and evaluation, with diagnosis of

Patient started having leg cramping on 4/13/2021, presented to the emergency department on 4/18/2021 with increasing shortness of breath and chest pain.

I started having bad headaches the day after the vaccine. A few days later I saw blood in my stool. I have experienced blood in my stool seven times up to this point. I have been feeling slight numbness in my biceps and calves. I have also been very sleepy and fatigued. Another thing is also pain around my rib cage area. I have also experienced some shortness of breath.

The patient is a 56 y.o. male who presents to the Emergency Department with cough and SOB for 2-3 days. The patient states he was vaccinated with the johnson and johnson COVID-19 vaccine two weeks ago. He denies any vomiting diarrhea, fevers, leg swelling, or chest pain. The patient additionally denies being around any sick contacts or any recent travel. The patient is a 56 y.o. male evaluated for cough and SOB for 2-3 days. Possibility of pneumonia. I have lower suspicion for PE, however his oxygen saturation is less than 94%, so we will obtain a D-dimer. I have lower suspicion for ACS. Will also check COVID swab to rule out COVID despite recent vaccination.

Tight chest, shortness of breath, long & steady dull pangs for 3 weeks until I went to the Urgent Care for a diagnosis. On April 5, 2021, I went from the urgent care to the ER to having a catheter inserted into my wrist at local hospital, because they thought I was having a heart attack. Turns out I have myocardial bridging of the left anterior descending (LAD) artery. I am not in pain, thankfully, but these symptoms persist. Are they being magnified by the vaccine? No one seems to know. What I do know is that since receiving the vaccine I feel this tightness in my chest and it's not going away.

BLOOD IN THE STOOL; SHORTNESS OF BREATHE; TINGLING IN THE FINGERTIPS AND THE TOES; SORENESS IN THE RIBCAGE NEAR THE HEART/LEFT CALF SORENESS; PUMPING SENSATION IN RIGHT SIDE OF HEAD; TIREDNESS; RIGHT ARM SORENESS; COUGHING; LIGHT HEADEDNESS SENSATION; HEMORRHOIDS; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient had no relevant medical history and was not on regular medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, once total administered on 01-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. Patient reported that, he received the vaccine on 01-APR-2021. Approximately 2 days after he coughed and felt lightheaded and noticed some lights around his eyes. Approximately 7 days after patient noticed a list of symptoms including a pumping sensation in the right side of his head, left calf soreness, soreness in the ribcage near the heart, a tingling sensation in the fingertips and toes (but not at the center), sense of tiredness, shortness of breath, blood in stool that he referred to repeatedly as clots, right arm soreness (although the injection was given in the left arm). Patient called his doctor twice and was told to go to the hospital. Patient went to the hospital on 04-MAY-2021. Arrived at 12 PM and discharged at 11 PM approximately. Conducted a chest x-ray, took a blood sample twice, and put some stuff on patient's chest. Patient was discharged on 04-MAY-2021 and given a prescription for Motrin 800 mg taken three times per day as needed, and for cyclobenzaprine 10 mg taken twice a day as needed for spasms. Patient decided not to take these medications as he was unsure if they were pain medications and felt apprehensive. He main concerns seemed to be the pumping sensation in the right side of his head and the blood in his stool which he repeatedly referred to as a clot. His family doctor is aware of the situation and says he thinks its hemorrhoids. He refers to the clot as darker red in colour and also mentions that there is regular red blood in stool alongside the darker clot. Patient notices this about 3 times per week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, and light headedness sensation on 03-APR-2021, was recovering from right arm soreness, and had not recovered from pumping sensation in right side of head, soreness in the ribcage near the heart/left calf soreness, tingling in the fingertips and the toes, tiredness, shortness of breathe, blood in the stool, and hemorrhoids. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210526242-covid-19 vaccine ad26.cov2.s -blood in stool . 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).

My health was great before my vaccine. I was able to have a normal full day five days out of the first 60 without health issues. This week I haven't had one day where I haven't had something going on. I woke up day after vaccination and started feeling feverish, but going into bad chills, extreme headache, a different kind of headache than my migraines, abdominal had pain, heart rate and breathing, heart rate was elevated, breathing not normal, out of breath, deep pain right thigh at bone, did not bruise. I called cardiologist 03/25/2021, about thigh, thought it might be DVT, I followed up 03/29/2021 since I did not hear back, we spoke on the 30th, I had very high blood pressure, doc presumed I had a tress fracture of right thigh bone and that other things were related to my chronic intro viruses. I saw my infectious disease doctor on April 13th he said this could be a major conflict with either current viruses, meds taking in conjunction with vaccination. All of my major lymph nodes were inflamed. I do have non Hodgkin's lymphoma, but they told me it is slow growing. Visited ER on 04/14/2021. Dr met me there.

Janssen COVID-19 Vaccine EUA. Fatigue, hypersomnia, painful white blisters on tongue and in throat, laryngitis, headache, difficulty breathing (more severe than pre-vaccine) Started 5 days after vaccination. Symptoms have not subsided 17 days after vaccination.

headache, upset stomach, fever, chills, (usually right after the fever broke), loss of desire to eat, shorness of breath, started 1 hr after shot, at this time when entering this, still have fever and loss of desire to eat, and chills . I fell like I had a mild cold with no nasal discharge.

After receiving COVID vaccine, patient reported Shortness of Breath, dizziness, loss of appetite, headache and chest pain. On 05/19/2021, patient exhibited right sided extremity weakness. Upon ED evaluation, was found to have suffered a TIA.

RIGHT MIDDLE AND BASILAR SEGMENTAL PULMONARY EMBOLISM; CHRONIC PULMONARY ARTERIAL HYPERTENSION; DILATED PULMONARY ARTERY; SMALL LEFT PLEURAL EFFUSION; PHLEGM; This spontaneous report received from a physician concerned a 56 year old male The patient's weight was 125 kilograms, and height was 175.2 centimeters. The patient's concurrent conditions included alcohol user, smoker, obstructive sleep apnea, asthma, tobacco abuse, high blood pressure, morbid obesity, and general pain, The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 vaccination to left arm for prophylactic vaccination. Concomitant medications included salbutamol for asthma, acetylsalicylic acid for general pain, and atenolol for high blood pressure. It was reported that about 2 weeks ago in MAY-2021, the patient started to experience shortness of breath at rest and on exertion, pain in the left side of his chest, cough, and phlegm. The patient saw his family care provider who referred him to an orthopedic physician. The patient visited physician's office for treatment of the events. On 18-MAY-2021, the patient was hospitalized with a diagnosis of pulmonary embolism. The remarkable laboratory testing results were: D-dimer of 1,716 ng/mL, chest Computed tomography (CT) angiogram showed right middle and basilar segmental pulmonary embolism without evidence of heart strain, troponin of 103 was normal, chest X-ray showed chronic pulmonary arterial hypertension, dilated pulmonary artery, and small left pleural effusion. The patient's heart was fine, had no evidence of heart failure. The patient remained hospitalized currently treated with heparin drip, Lasix, and methylprednisolone. As of 19-MAY-2021, the patient remained hospitalized and was improving since a day prior to this report. The pain and shortness of breath were better. The patient never had this problem in the past. The reporter stated that vaccination was only identifiable change in the patient's normal routine/therapy. The patient also underwent imaging CT and echocardiogram without mention of specific results. Laboratory data included: Computed tomography (CT) scan (NR: not provided) Not Provided, and Echocardiogram (NR: not provided) Not Provided. Laboratory data included: COVID-19 virus test (NR: not provided) Negative, Computed tomography (CT) angiography (NR: not provided) pulmonary embolism without evidence of heart strain, Chest X-ray (NR: not provided) chronic pulmonary arterial hypertension, Fibrin D dimer (NR: not provided) 1, 716 ng/mL, Stress test (NR: not provided) Normal, and Troponin (NR: not provided) 103 normal. Treatment medications included: heparin, methylprednisolone, and furosemide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from right middle and basilar segmental pulmonary embolism, and the outcome of dilated pulmonary artery, small left pleural effusion, chronic pulmonary arterial hypertension and phlegm was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210537813-covid-19 vaccine ad26.cov2.s-right middle and basilar segmental pulmonary embolism, chronic pulmonary arterial hypertension, dilated pulmonary artery, small left pleural effusion. 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 stated that after vaccine he could not breathe, throat was swollen and he gets dizzy every day.

Progressively worse chest pain, beginning with left side moving to entire chest. Progressively worsening shortness of breath.

4/11/21 pt with pleurtic chest pain and worsening hypoxia. chest x-ray w/ bilateral pulmonary infiltrates. covid pcr + 4/11. pt admitted to hospital on 4/7 for alcohol withdrawal, minimal o2 requirements on admit. on 4/10 pt with low grade temperature and 02 requirements were increasing then, started on azithro 500mg daily x 3 days, patient did have chest ray that day with bilateral opacities.

After 4th day of receiving J&J Covid Vaccine to present, I have dull headache, fogged brain, equilibrium seems off, slight loss of balance, increased heart rate of 170-190 BMP, my normal rate is 70 BPM, I took 25Mg of Metoprolol which brought my rate down to 70 BPM. I have increased wheezing and feeling shortness of breath, whereby having to using my albuterol inhaler quite often and I also took 20MG of Prednisone after which my breathing has improved.

Became short of breath a few days later, diagnosed with bilateral pulmonary embolism on 3/10/21 at Medical Center

Patient called the Facility COVID-19 Nurse Holtline with post-dose vaccine related symptoms or guidance. He stated he just received the J&J covid vac Pt msg re: pause which prompted him to think of ongoing sx he has been experiencing after covid vac. ?sob few days after vaccine, nausea, vomiting, fatigue, congestion, muscle aches (sx on/off since 4/1/2021)

Some weeks after vaccination I started feeling shortness of breath. When I walked from the parking lot to my work desk it was hard and when I arrived at work my co-workers could hear me grasping for air, I felt winded, and it never happened before. Also, another episode when the elevator broke down I could not go the flight of stairs without having to stop and catching my breath. Since the weather is better I decided to start walking in the park for exercise but I realized I did not have the strength nor the capacity to breathe. I amafraid at night because sometimes when I lay down I can't breathe.

Diagnosed with COVID infection on 4/13/2021. in ICU on 4/18 with severe hypoxemic respiratory failure

Patient received the COVID 19 vaccine on 4/2, he developed symptoms of COVID on 4/10, he tested positive for COVID on 4/13. He was admitted to the hospital on 4/17 for acute respiratory failure. On 4/20, he was diagnosed with a pulmonary embolus.

On Wednesday the 21st he came home and was tired. It got gradually worse on the 22nd. Was also feeling rib pain on the right side. Was a little bit short of breath. Went to the ER on 4/23 and they gave him IV fluids and pain medications. Put him on Tylenol, Naproxen, and Eliquis. States today 4/26 he is feeling a little bit better.

COUGH; WHEEZING; FATIGUE/ FEELING RUN DOWN; This spontaneous report received from a patient concerned a 57 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, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced fatigue/ feeling run down. On an unspecified date, the subject experienced cough, and wheezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue/ feeling run down, and had not recovered from cough, and wheezing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

This is a 57 year old male, received the Janssen COVID-19 vaccination on 5/4/21, at clinic in Jail, approx 10 minutes post vaccination, patient developed throat tightness, difficulty breathing and swallowing. He was immediately assessed by this writer, EMS activated as code. Given epi-pen to left thigh at 11:23, 50 mg of IM Benadryl to right deltoid at 11:25. Patient reported improvement in his throat tightness, shortness of breath and difficulty swallowing post epi-pen administration. Patient was sent to the ED

History of Present Illness: Patient has a history of sinus problems. He was schedule for sinuplasty and had preoperative evaluation on 04/21/2021 with WBC 5.8, Hb 15.5, PLT 193,000. He had J&J covid vaccination on 04/27/2021. He underwent sinuplasty on 05/05/2021. Subsequent to his surgery he was having headache. He had some nasal discharge with blood. He took tramadol but had persistent pain. His symptoms were worsening up with some weakness of his right upper extremity. Was having generalized fatigue and weakness. He states he was getting short of breath with a flight of stairs. He had decreased appetite. He was given Vicodin for his headache with some improvement. He noted discoloration and bruising with pain pain in his left internal thigh area. Was noticing some changes in his vision but no loss of vision. He presented to the ED on 05/11/2021 and laboratory showed WBC 8.7 Hb15.2, PLT 6,000, segs 77%, lymphs 9%. He had no dark colored urine. INR 1.4 PTT 33, immature platelets 30.2. His bili was 2.1. He was treated with dexamethasone 40 mg. There is tiny focus of restricted diffusion in the both cerebellar hemispheres measuring up to 0.4 cm white matter left cerebellar hemisphere of left parietal junction measuring 0.5 cm compatible small lacunar infarcts. Chronic paranasal sinusitis. Patient described minimal blood with flushing his sinuses. Patient was ultimately transferred to Hospital after 3 days (on 5/11) for further acute care management given the multiple clots and bleeds associated with severe thrombocytopenia.

DIZZY; HEAD SPINNING; NOT FEELING HIMSELF; HYPERVENTILATING; SWEATING; WEAK; NAUSEA; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 235 pounds, and height was 61 inches. The patient's concurrent conditions included smoker, and abstains from alcohol, and other pre-existing medical conditions included patient took water pills twice a day. patient had history of illicit drug use. The patient was previously treated with oxycodone hydrochloride/paracetamol. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for drug used for unknown indication, ergocalciferol for drug used for unknown indication, and metformin for drug used for unknown indication. On 10-MAY-2021, the subject experienced dizzy. On 10-MAY-2021, the subject experienced head spinning. On 10-MAY-2021, the subject experienced not feeling himself. On 10-MAY-2021, the subject experienced hyperventilating. On 10-MAY-2021, the subject experienced sweating. On 10-MAY-2021, the subject experienced weak. On 10-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from weak, dizzy, nausea, head spinning, not feeling himself, hyperventilating, and sweating. This report was non-serious.

5 days after dose had pain in left calf. On May 8th went to the hospital with pain under my left rib cage. It was determined by testing that I had a blood clot in left leg and one in each lung. There was also heart arrhythmia. I was given blood thinners for the clots which I am still taking. I was also given medication to help with high blood pressure and to help with heart beat.

Initially I experienced severe headache, fatigue, fever, tight chest and short breath and swelling in my hands such that I couldn?t get my ring off. I am still experiencing varying degrees of headache and fatigue that is at times preventing my working.

headache front and back and neck, face feels flushed and hot, slight cough, breathing is slightly labored, chest feels tight. Some body ache's. Tylenol given.

extreme version of COVID 19 symptoms: extremely hard to breathe only able to take short breaths; vomiting; dry-heaves; coughing; no appetite; fever; cold sweats; chills; lethargy; tired; no energy 15 lb weight loss. This continued from Mid May to June 10, 2021.

Vaccine on 6/7/2021...after about 1 to 2 weeks, tingling hands, swelled foot, some infrequent shortness of breath, some slurring of words, unusual stutter, abdominal pain, pressure in chest front to back, soreness at shot location, later - a very high blood glucose reading. 6/25/2021 - glucose reading of 225, HBA1c reading of 8.8%! Later diagnosed with LADA because of glucose readings, AND because lifestyle is vegan vegetarian and active workouts, AND no prior high glucose readings. subsequent tests for auto immune, negative.

Fatigue, stomach bloating, shortness of breath, nerve problem-shaking, rash, was provided antihistamine by healthcare professional.

Patient admitted with worsening numbness and weakness 2 weeks after vaccination; Neurology consulted and patient diagnosed with acute inflammatory demyelinating polyradiculoneuropathic form of Guillain-Barré syndrome and underwent plasmapharesis. Patient continued with progressive weakness difficulty with swallowing and choking on food as well as progressive loss of voice. Patient subsequently developed acute respiratory failure, transferred to critical care and was intubated.

ABOUT 4 HRS AFTER SHOT(THAT FRI. NIGHT), LIGHTLY FEELING WEAK, GRADUALLY OVER THE NEXT 6 HRS WEAKNESS STRONGER 3 FULL DAYS. MONDAY MORNING WEAKNESS EVENED OFF. TUESDAY MORNING FEELING SICK,WEAK, NAUSEA, SHAKY, HARDER BREATHING, COUGHING, WIERD TASTE IN MOUTH, DRY MOUTH, LIGHT HEADACHE, SLEPT VERY HEAVY, SWEATY

3/24/21 ER HPI: 58 y.o. male who presents with shortness of breath, palpitations, chest pressure, and hemoptysis. Patient has known history of atrial fibrillation and coronary artery disease. Patient reports he was out in his yard approximately 1 hour ago this evening picking up some items when he bent over and started feeling palpitations. Patient states the palpitations caused a pressure in the center of his chest. He then became short of breath. He then states he got into a coughing fit and coughed up some blood. Patient states he knew something was not right so he told his wife to bring him to the ER. Currently here in ER patient continues to complain of palpitations and trash pressure. Patient currently gives his pain as 6/10. It is nonradiating. Patient reports shortness of breath but denies any lightheadedness, dizziness, nausea, vomiting, or diaphoresis. Of note, patient reports he has been having acid reflux and belching tonight. He states his wife had given him two Pepcid earlier.

About 30-45 minutes after the vaccine was administered, I began to experience a thickening of the mucus in my throat and some slight+ wheezing, perhaps an increase in heart rate. This lasted for about 10-15 minutes. Next day very mild flu symptoms and lack of energy--this continued through the following day but milder.

Raw throat and bronchial on morning of April 2. Felt pretty good on April 3. Night of April 3, woke up with temperature of 100, severe aches and starting to cough up phlegm. Have had fever til current date/time. Now am coughing up yellow crud and mu lungs are starting to hurt. I don't see the lung stuff in the adverse effects and am concerned I should get tested for COVID.

After a week (7 days) I noticed I was short of breath and my heart was racing most of the day. I had my blood pressure checked for several days by the school nurse. The readings were very high 158 over 102 at the start of school and 168 over 104 at the end of the day. This was constant for a week before I went to the cardiologist for a check up. The doctor prescribed Amlodipine Besylate 5mg on March 26, 2021 to lower my blood pressure. It took roughly 10 days to get my blood pressure down to 140 over 85.

SOB/wheezing began 7 days after Janssen Covid vaccine. Patient found to have a PE and COPD exacerbation.

3/26 office appointment: New onset right and left sided chest pain with associated shortness of breath, fatigue and intermittent lightheadedness. Labs drawn. CT scan showed Scattered small occlusive and nonocclusive emboli within small distal pulmonary artery branches bilaterally. Started on apixaban. Has appointment with Hematology on 4/29

BODY ACHES AND BODY SORENESS; DIFFICULTY IN BREATHING; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, non smoker, colitis, seizures, diabetes, and cholesterol, and other pre-existing medical conditions included the patient had no known drug allergies, not allergic to any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:30 for prophylactic vaccination. Concomitant medications included azathioprine for colitis, lamotrigine for seizures, zolpidem for sleeping, meclozine for vertigo, amoxicillin, atorvastatin, hydrochlorothiazide, infliximab, olmesartan, ondansetron, potassium, potassium chloride, propranolol, and venlafaxine. On APR-2021, the subject experienced body aches and body soreness. On APR-2021, the subject experienced difficulty in breathing. On APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches and body soreness, difficulty in breathing and tired was not reported. This report was non-serious.

After my J&J vaccine, about 2-3 days after I developed flu like symptoms, chills and headaches. On the 6th day after my vaccine, I developed a lump on the right side of my throat which progressively got worse. I also experienced diarrhea which lasted three days. I went to see my PCP, Dr. who ordered a CT scan of my neck. The CT scan demonstrated I had an ulcer in my throat located in my larynx box. MY PCP doctor then referred me to an ENT doctor, Dr. The ENT doctor gave me antibiotics and a shot in my arm. My throat kept getting worse and the ENT doctor have me reflux medicine and Prednisone and Bactrum medication. Today I woke up feeling much better although the pain and swelling to my left side of my throat and ear has gone down but I still have a sore throat and ulcer and is being treated with medicine.

Patient flew from city to city through another city on Tuesday 3/16/21. He had a reaction on the flight where he coughed for 1.5 hrs and was hot in the airplane. He could not go to work and was required to get Covid tested on 3/18. Still coughing and having trouble sleeping (laying down). Rapid Covid test negative on 3/18. PCR test results negative on 3/21 from hospital. He continued to grow weak and cough from 3/16-3/21. At 3am on 3/22 he called and said that his feet were 2X their size and having difficulty breathing. Taken to hospital via ambulance. When transfered to ER bed, Dr said that he lost pulse. They intubated and got his pulse back. Died at 5:15am. Autopsy said cardiac arrest. Dr said that they could not maintain a heart beat. He asked me if the patient had a history of blood clots? No he did not ever has a blood clot that I know of. He had a chest xray post mortem showing fluid in his lungs from low circulation of blood.

HEADACHE; SOMETIMES LOOSE MEMORY; HIGH BLOOD PRESSURE AFTER VACCINE; DIFFICULTY BREATHING; FEELING ABNORMAL; LOOSING WEIGHT; VOMITING; MY TONGUE WAS SWOLLEN; POOR APPETITE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included blood pressure abnormal, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known allergies or drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1200287383 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sometimes loose memory. On APR-2021, the subject experienced high blood pressure after vaccine. On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced feeling abnormal. On APR-2021, the subject experienced loosing weight. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced my tongue was swollen. On APR-2021, the subject experienced poor appetite. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fatigue, sometimes loose memory, high blood pressure after vaccine, poor appetite, nausea, vomiting, loosing weight, and feeling abnormal, and the outcome of my tongue was swollen and difficulty breathing was not reported. This report was non-serious.

DIDN'T SLEEP WELL; BODY ACHES; FATIGUE; HEADACHE WITH NO FEVER; FELT LIKE NOT ABLE TO TAKE DEEP BREATH; FELT LIKE HEAVY WEIGHT ON CHEST; This spontaneous report received from a patient concerned a 58 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, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced felt like not able to take deep breath. On MAY-2021, the subject experienced felt like heavy weight on chest. On 11-MAY-2021, the subject experienced didn't sleep well. On 11-MAY-2021, the subject experienced body aches. On 11-MAY-2021, the subject experienced fatigue. On 11-MAY-2021, the subject experienced headache with no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from didn't sleep well, body aches, fatigue, and headache with no fever, and the outcome of felt like not able to take deep breath and felt like heavy weight on chest was not reported. This report was non-serious.

BLOOD CLOTS IN LUNGS; NUMBNESS IN HANDS AND FEET; SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 58 year old white male. Initial information was processed along with the additional information received on 11-MAY-2021 The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right deltoid on 09-APR-2021 around 13:00 for prophylactic vaccination. No concomitant medications were reported. After receiving the vaccination on 09-APR-2021, the patient went home and slept for 6 hours. One week after vaccination, on 12-APR-2021 the patient experienced swelling in hands and feet. Two weeks after, on 19-APR-2021 the patient experienced numbness in hands and feet. On 21-APR-2021, the patient went to the emergency room (ER) and was given the tests, laboratory data included: Blood test (NR: not provided) unknown, CAT scan (NR: not provided) blood clots in lungs, and EKG (NR: not provided) unknown. The patient experienced blood clots in lungs and was hospitalized. On 22-APR-2021, laboratory data included: Sonogram (NR: not provided) results awaiting and will get records on wednesday. As of 22-APR-2021 the patient was started on blood thinner. Treatment medications included: apixaban (Eliquis) 2 a day. On an unspecified date in APR-2021 while in the hospital the patient was on oxygen (unspecified indication). The patient was discharged on 22-APR-2021 and the duration of hospitalization was 1 day. The patient was released with a prescription of Eliquis for 3 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in hands and feet, numbness in hands and feet, and blood clots in lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210518013 -COVID-19 VACCINE AD26.COV2.S- Blood Clots in lungs . 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).

HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; PAIN CONTINUES ALL OVER BODY; HIP PAIN; LEFT KNEE DISCOMFORT; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sickle cell trait. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: Unknown) dose was not reported,1 total administered on 05-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021(10 days later), the patient experienced left knee discomfort and hip pain, for which patient visited primary doctor, who referred him to an orthopedic. Orthopedic prescribed meloxicam; however, the patient took ibuprofen daily instead of it . On an unspecified date, the patient experienced pain all over body for which patient took oxycodone hydrochloride/paracetamol but discontinued due to constipation and for constipation patient took casanthranol/docusate sodium, then patient checked blood pressure and it was found 148/106 mmHg (high) so patient visited to emergency room where patient firstly checked for covid -19 test which was negative. For high blood pressure patient took amlodipine 10 mg daily. The patient took paracetamol for unknown indication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain continues all over body, and the outcome of left knee discomfort, hip pain, shortness of breath and high blood pressure was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210532847-COVID-19 VACCINE AD26.COV2. S - High blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Sudden onset arrhythmia while walking at normal pace indoors. Past experience with occasional SVT (more than 5 years ago since last) seemed consistent. Past successful mitigations did not stop episode which lasted approximately 3 1/2 hours. Some minor dizziness and slightly out of breath under non-stationary conditions (consistent also with prior events).

Johnson and Johnson Vaccine, shortness of breath, elevated blood pressure, elevated temperature, increased heart rate, decreased kidney functions, blood clots in both arms and jugular vein, slurred speech, severe pain in right side, fluid in right lung and around heart. Admitted to MICU from emergency room. Intubated for 12 days. Chest tubes both sides, central line, Hickman Catheter. Discharged and admitted to hospital. Currently home receiving outpatient therapy.

BLOOD CLOT IN LUNG; BILATERAL FEET AND HAND NUMB; BILATERAL HANDS AND LEGS SWOLLEN; SLEPT FOR 6 HOURS AFTER SHOT; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 285 pounds, and height was 56 inches. The patient's concurrent conditions included high blood pressure, depression, diabetes, flea bites allergy, peanut allergy, alcohol consumer, non smoker, heart disorder, nerve pain, mood disorder, fluid retention and pain. He had no known drug allergies. He 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: 207A21A, expiry: 23-JUN-2021) dose was not reported, 1 in total administered to right deltoid on 09-APR-2021 for prophylactic vaccination. Concomitant medications included hydralazine 25mg BID (twice a day) for blood pressure, metformin hydrochloride 500mg BID for diabetes, Baby Aspirin (acetylsalicylic acid) EC (enteric coated) for heart disorder, escitalopram 10mg daily for mood disorder, gabapentin 100mg TID for nerve pain, and celecoxib 200mg 1 tablet a day as needed for pain. olmesartan medoxomil 40mg daily for blood pressure, amlodipine besilate 10mg daily for blood pressure, furosemide 40mg daily for fluid retention, potassium chloride ER (extended release) 20 Meq TID (thrice a day) and metoprolol succinate ER 50mg daily for an unknown indication. On the same day vaccination, the patient slept for 6 hours after shot and was tired. On 16-APR-2021, the patient experienced bilateral hands and legs swollen. On 19-APR-2021, the patient had bilateral feet and hands numb. On 21-APR-2021, he went to the emergency room (ER) and was hospitalized. He had following test done. Covid-19 test and EKG (electrocardiogram) results not provided, sonagram of legs showed no blood clots, computerized tomography (CAT) scan found blood clots in lungs. He was put on IV fluids and oxygen. He had blood clots in lungs, he could not specify if both lungs had it. He was discharged the next day without oxygen. He was put on Eliquis (apixaban) 5mg BID for 3 months. He was hospitalized for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours after shot, and tired on 09-APR-2021, had not recovered from bilateral hands and legs swollen, and bilateral feet and hand numb, and the outcome of blood clot in lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210554313- COVID-19 VACCINE AD26.COV2.S- blood clot in lung, bilateral hands and legs swollen and bilateral feet and hand numb. 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).

Injection recieved 4/10/21, a-fib started 5/16/21. Admitted to hospital 6/19/21 with sepsis syndrome in the mechanical cardiac valve, leukipenia, thrombocytopenia, encephalopaty, acute kidney injury, respiratory failure, tachycardia, new onset afib. Patient is currently still hospitalized and declining in status- on ventalator

(4/19) Began experiencing discomfort in right side (bottom of rib cage) when getting in/out of bed; no other symptoms. (4/30) Rapid fever onset with chills from 98.6 to 102.7 within four (4) hours; increased pain in right side; . Seen at urgent care: blood pressure normal; elevated heart rate (130); sub-normal SpO2; urinalysis negative; chest x-ray negative; COVID test negative. Referred to ER. (4/30) ER: increased pain; no coughing or symptoms beyond extreme chills/fever; two additional COVID tests negative; extremely high white cell count (25K), CT showed small pneumonia on right side. Treated with multiple antibiotics and released. (5/1-5/7) Continued elevated (99-100F) fever; occassional lethargy; no coughing or other symptoms. (5/8) Temperature normal; occassional lethargy; no coughing; increased pain on right side at night. ( through 7/10) increasing pain on right side; present constantly but worse at night; radiates front to back on right side below rib cage; no other symptoms. (5/12,6/23,7/1) Follow-up visits with PCP; additional chest x-ray negative; CT scheduled for 7/14.

Bells Palsey 02May2021 Low grade fever and fatigue 12May2021 Breathing issues started 14May2021 Covid 19 Positive Test 15May2021 Covid related pneumonia 19May21 Hospital admitted 19May2021 to 24May2021 Tingling in fingers and toes started 30Jun2021 to present.

Leg pain 24 hours later, fever pneumonia, congestive cardiac failure, dialysis access dysfunction, post vaccine fever, hyperkalemia, anemia, vomiting, weakness, hypoxia, hypervolemia; Pt rcvd J & J and next day seen in ER with leg pain, N, V, diarrhea and shortness of breath. Mult stool antigens neg. Lactic acid and WBC elevated. Initial fever resolved as did hyperkalemia and hypervolemia state after urgent dialysis.

When patient woke up the morning after the vaccine (given on 7/19; symptoms started 7/20), he experienced tingling feet; body aches; shortness of breath; chest tightness.

COVID-19 RELATED PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ASTHMA AGITATED; BURNING SENSATION IN FINGERS; TINGLING OF FINGERS AND TOES; BELL'S PALSY; This spontaneous report received from a 58-year-old male patient. The patient's height and weight were not reported. The patient's concurrent conditions included high cholesterol, high triglycerides, mold allergy, alcohol use (6 to 8 beers in the weekend) and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 07-AUG-2021) dose was not reported, 1 total, administered on 08-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the patient started experiencing bell's palsy. His mouth was dropping on the left side and he didn't have any feeling or nerve feeling on that area of mouth. His eyes and rest of the body was fine. He visited the physician. On an unspecified date in MAY-2021, Laboratory data included: CT scan result was Negative and Blood test was Negative. Patient was given a Steroid shot as treatment and it resolved. On 12-MAY-2021, he experienced low grade fever, fatigue and kind of illness. On 15-May-2021, he visited hospital with breathing problem and coughing. In the hospital patient was tested positive for covid-19 (suspected clinical vaccination failure). The chest X-ray showed that the lungs were clear. On 19-MAY-2021, he again had trouble breathing and was unable to breathe despite trying hard and was hospitalized for 5 days. Patient had another X-ray and was diagnosed with a COVID-19 related Pneumonia. He was put on Remdesivir and oxygen as treatment. Laboratory data included: Oxygen saturation was around 80. After 3 and half days, he was able to breathe on his own and was taken off oxygen. On an unspecified date in MAY-2021, while at hospital, patient experienced asthma agitated and was prescribed prednisone also. On 24-MAY-2021, he was discharged from hospital for 5 days. Non-company suspect drugs included: tyrosine (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from JUN-2021 for mental alertness. Since 29-JUN-2021, he experienced tingling in his fingers and toes. He reported that the physician had put him on D-Tyrosine for last one month and has experienced the event since then. On 08-JUL-2021, he stopped the supplement as the physician had asked him to stop but still have the event and symptoms were getting worse. On JUL-2021, he experienced burning sensation in fingers. He stated that it was not all the finger and toes in general but noticed more issue on the left side than the right side. The left side was worse for the toes but for the fingers issue progressed from right index to his left hand. At the time of reporting, He had tingling and burning sensation in both hands and was continuing and not getting any better. Physician was aware but did not prescribe him any medication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bell's palsy, suspected covid-19 infection, covid-19 related pneumonia and asthma agitated, had not recovered from tingling of fingers and toes, and burning sensation in fingers, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000185884. The suspected product quality complaint had been confirmed to be not voided.; Sender's Comments: V0: 20210727746-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure.. 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: SPECIAL SITUATIONS V0: 20210727746-covid-19 vaccine ad26.cov2.s-Bell's palsy, Covid 19 pneumonia. 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). V0: 20210727746-covid-19 vaccine ad26.cov2.s-Asthma aggravated. 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

Individual called LHD to report adverse reactions to vaccine including, SOB, dizziness, weakness, vomitting, headache and chills lasting 8 - 10 hours.

The patient is a 59 y.o. male with a hx of COPD who presents to the Emergency Department with SOB. He received the COVID vaccine on 3/18/2021 and has felt bad since then. Patient has experienced increased SOB and a productive cough with yellow sputum.. He experienced fevers for 2 days after receiving the vaccine but has not had any since then. He is on 4-5 liters oxygen at a time. He experienced some diarrhea today but took a laxative. He denies blood in stool, dysuria, or urinary symptoms. Patient reports some body aches. He is on chronic pain medications for back and leg pain. He has not been on any steroids or antibiotics recently.

SWOLLEN LIPS; SWOLLEN THROAT; DIZZINESS; FLUSHED FACE; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight was 194 (unit unspecified), and height was 71 inches. The patient's concurrent conditions included gout, alcohol use, non-smoker, cipro allergy, high cholesterol, and high blood pressure, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 08:00 in left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, febuxostat for drug used for unknown indication, losartan for drug used for unknown indication, pravastatin for drug used for unknown indication, probiotics nos for drug used for unknown indication, selenium for drug used for unknown indication, vitamin d nos for drug used for unknown indication, and calcium. On 08-MAR-2021, the subject experienced swollen lips. On 08-MAR-2021, the subject experienced swollen throat. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced flushed face. On 08-MAR-2021, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lips, swollen throat, dizziness, and flushed face on 08-MAR-2021, and flu-like symptoms on 10-MAR-2021. This report was non-serious.

On 4/14/2021 patient woke up with stomach cramps and diarrhea. states he could not walk, and had no energy from dehydration. patient states he had SOB. Patient has emergency alert system, so he pressed the button and an ambulance took him to the ER.

BODY ACHING; COULD NOT MOVE; TROUBLE BREATHING; SWEATING; SLEEPY/SLEEP MOST OF THE DAY AND NIGHT; NO ENERGY; FELT TIRD; HEADACHE IN THE BACK OF HEAD; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included knee replacement, and concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug allergies and no abuse or illicit drug usage. 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 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sleepy/sleep most of the day and night. On MAR-2021, the subject experienced no energy. On MAR-2021, the subject experienced felt tird. On MAR-2021, the subject experienced headache in the back of head. On 09-MAR-2021, the subject experienced trouble breathing. On 09-MAR-2021, the subject experienced sweating. On 09-MAR-2021, the subject experienced body aching. On 09-MAR-2021, the subject experienced could not move. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, body aching, and could not move, had not recovered from trouble breathing, and headache in the back of head, and the outcome of no energy, sleepy/sleep most of the day and night and felt tird was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious

o 2-Apr-21, developed fever, chills, nausea, and diarrhea which he was managing at home. o 5-Apr-21 performed a PCR swab at Hospital and received positive results on 6-Apr-21. o 8-Apr-21 developed difficulty breathing and notified his Mgmt. who called for an ambulance. He was transported to Hospital and later to Hospital. o SOB on exertion. Receiving vitamins, P and antibiotics. O2 via face mask. Stable condition was the report provided to his wife from Hospital. o 14-Apr-21 condition deteriorated and he was intubated and placed on the ventilator o 15-Apr-21 was transferred to Hospital

I woke up the next day with a fever , the fever went and then I had trouble breathing with congestion I went to urgent and went on antibiotic the congestion cleared up then I had extreme tiredness for 3 days I am still having trouble with my left arm and cannot reach it above my head the energy level has returned to normal around Thursday and Friday of last week but the rotation of the left arm is still difficult

THROAT SWELLING; BODY ACHES; STOMACH ACHES; CHILLS; DIZZY; SEVERE HEADACHE; FEVER; INJECTION SITE BLEEDING; MILD SHOULDER PAIN; INJECTION SITE "BUBBLED UP"; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included many surgeries post traumatic car accident, and concurrent conditions included a lot of scar tissue on shoulder (at injection site), and high blood pressure.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A2114, and expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced injection site bleeding. On 18-MAY-2021, the subject experienced mild shoulder pain. On 18-MAY-2021, the subject experienced injection site "bubbled up". On 19-MAY-2021, the subject experienced dizzy. On 19-MAY-2021, the subject experienced throat swelling. On 19-MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced stomach aches. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced severe headache. On 19-MAY-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site bleeding, and injection site "bubbled up" on 18-MAY-2021, and mild shoulder pain, was recovering from severe headache, throat swelling, fever, chills, and body aches, had not recovered from dizzy, and the outcome of stomach aches was not reported. This report was non-serious.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: Patient became unresponsive with gasping but remained with normal pulse, pt came to within a minute

normal side effects the next day tried and feel exhausted. Aches and pain on to the second day. On the third day, I was getting winded just walking around the house. Pulse up to 130. Walking around Walmart I was a little head and short on breath.

patient seen in clinic 5/26 for severe head ache, chest pain, diaphoresis, subjective fever and chills, SOB. Transferred to ER elevated troponin, transferred to other Hospital where he underwent cardiac cath and diagnosed with NSTEMI.

"Janssen COVID-19 Vaccine EUA About 7 minutes after the patient received Janssen covid-19 vaccine, he started complaining about his throat feeling tight and difficulty breathing. I quickly give him one dose of epinephrine 0.3mg on the right thigh and about five minutes later he recovered. I requested to call 911 but the patient declined. I asked him to wait longer but he left .

PT had the J & J Covid shot on April 10. four days later he started having symptoms of dyspnea. pleuritic chest pains and headaches. HE NEVER had these symptoms before. He wanted to tough it out to see if he would improve, but this was not happening so he came to the emergency room and saw me on June 1. He was hypoxemic at triage with an 02 sat of 89% on RA. On ABG he had a PaO2 of 50 on RA. I performed CTA of the chest, and venous dopplers of the legs. No PE, no DVT, no pneumona, Had no fever, no elevated WBC and No infectioin,. Pt was admitted. Inpatient work up had normal Coronary arteries, Echocardiogram had an Systolic Ejection Fraction 70 % , Had negative respiratory pannel. No infectious agents identified. High resolution CT scan of the Scan of the chest , Demonstrates ground Glass opacites in the lungs. End Result was pt diagnosed with ATYPICAL pneumona discharged on Levaquin and two liters of oxygen by nasal Cannula

Patient stated that his breathing becomes shallow when resting or seeping. Patient is afraid to go to sleep.

Pt was hospitalized from 6/3-6/7 for severe hypercalcemia and diagnosed with diffuse metastatic renal cell cancer. He received his J and J vaccine on 5/14/21 and reported "everything went to downhill" with development of nausea, constipation, weight loss, weakness, poor appetite resulting in hospitalization with new severe hypercalcemia and acute functional decline and dx with metastatic renal cell cancer. pt was dx with a bladder tumor 3/19, underwent TURP with bladder biopsy and fulguration and cyctoscopy on 5/19/21. Prostate bx reveals benign nodular hyperplasia, bladder bx revealed urothelial dysplasia felt to be pre neoplastic. Urine Cytology from 4/14/21 negative for high grade urothelial cardinoma. with pamidronate treatment, lasix and ivf and calcitonin his hypercalcemia improved and he was discharged to follow up with oncology and urology as out pt. He has since been readmitted on 6/22/21 with recurrent hypercalcemia and progressive decline. biopsy with I.R. of left renal mass confirmed RCC, biopsy of LN was non-diagnostic. per urology: Given the small size of the renal mass, it would be surprising if this was truly metastatic RCC, this could be metastatic urothelial carcinoma given his history of high grade T1 disease, although the primary site and the urinary tract has presumably been eradicated of disease, metastatic disease prior to initial tumor eradication in the bladder remains a possibility.

patient experienced lower back pain, nausea, dizziness, tightness in chest, asthma symptoms patient went to see the primary doctor and was evaluated

Patient called on 6/29 around 10:30 am stating that he has muscle aches, no energy, and trouble breathing since 5/21 (2 days after his vaccination). Pharmacist advised patient to see a doctor immediately since he is very trouble breathing and to rule out any infection or other issues related or not related to vaccine.

Patient had stated that he tended to pass out after giving blood. After shot was given pharmacist stayed with patient in case something happened. Patient almost immediately said he didn't feel right. Patient started to lose color and was very hot. Pharmacist got up and stayed next to patient. Patient slowly lowered his head and started to breathe heavily. Pharmacy technician then came over with a cool towel to place on patients head. The pharmacist couldn't tell if patient had in fact passed out because patients head was down and pharmacist was holding patient in place so he didn't fall. The pharmacy tech was asked if patient passed out and she saw his eyes were open. Patient then asked how long he was out for. That was for a total of roughly 5 seconds. Patient then stayed at pharmacy for around 45 minutes. He regained his color and his body temp returned to normal. He did say he was drowsy but felt he was fine to go home. Patient was called later in the day and he said he was drowsy but feeling much better.

I did not feel well for several days following the injection. I was tired and had a headache. However as the days went bye I stopped exercising and did not feel like working or even leaving the house. On the night of May 24 I began to have the worst headache of my life, my heart was beating irregular. By the morning of the 25th I got up and passed out. I was sweating, heart pounding, nauseous, chest pain, shortness of breath, pain in my shoulder blades.