Johnson & Johnson

Tightness in throat after 30 minutes, rash across chest. No previous adverse events to vaccinations previously.

Fever Couldn't talk Sharp join & chest pains Painful to move eyes Fatigue Bedridden- couldn't move on my own Shortness of breath Lasted 7 hours; took 3 Tylenol @ 500mg each; lots of fluids

It felt like I had red hot butter knives in the base of my lungs with intermittent shooting/stabbing pains that started in diaphragm to base of lungs.

first started with severe migraine and chills and then experienced difficulty breathing and shortness of breathe. Had to go to the ER because I was unable to breathe when laying down

12 hours after receiving the vaccine, I woke up in the middle of the night with severe chills, fever-like symptoms, a headache, and aches all over my body. I also was experiencing a heavy chest and shortness of breath. All but one of the adverse events went away after 24-36 hours - the shortness of breath and shallow breathing have persisted up through today. I am very aware of my breathing and how my chest feels tight, like I'm not getting enough air.

Right after shot, within minutes, began mild cough. Persisted throughout next days. Two days later on Friday, suffered major asthma attack with trouble breathing, major coughing. Have had coughing and trouble breathing with more asthma attacks in the following days. Used albuterol nebulizer, asthma inhalers to cope.

On 3/17/2021 I started feeling I felt like I was going to faint. My heart rate started to go up to 135, I felt dizzy, I had cold sweat & it felt a little hard to breath. This symptoms lasted for about 2 days. I had to see the doctor the same date on the 3/17/2021. He sent me to do lab work.

after a couple of minutes of administration of vaccine , patient had difficulty breathing. , became unresponsive. was administered epipen 0.3mg autoinjector , a second dose was administered 5 minutes later. patient became conscious. paramedics took patient to ER

Janssen COVID-19 Vaccine EUA 12 am - 1 am: Chills, shivering, couldn't get warm. Temperature 98.9 degrees F 3:30 am: Woke up feeling very hot. Temperature 100.6 degrees F (Fever). Slight headache/muscle aches, and shortness of breath but those could be due to the fever. Took two 500 mg Tylenol tablets. 7:30 am: woke up due to alarm, temperature back down to 98.6 degrees F. 10:00 am: still feeling a little ache-y, shortness of breath, and tired. No more fever.

In a time span of 40 minutes after been provided with the Jansen vaccine, my tongue began to felt asleep and my throat became to feel very tight. An hour after having been administer the vaccine I took 50mg of Benadryl and went to my nearest emergency room where they provided a decahedron syringe 2 hours after vaccine administration.

4/8/2021 3:00pm, 1 hour after vaccine stomach ache, drowsiness, and dizziness/lightheaded 4/8/2021 8:00pm, 6 hours after vaccine numb tongue, swollen face - allergic reaction -- took 1 25mg Benadryl 4/8/2021 10:00pm, 8hours after vaccine swollen face, throat tightness, swollen face, sore throat- allergic reaction -- went to ER given Pepcid, Benadryl, and steroid -- also prescribed these items for next 3 days. 4/9/2021 6:20am - following morning lips swelling - took 1 25mg benadryl

I had a reaction within 25 mins of J&J vaccine injection- my heart rate quickly went from 100 to 160 which is very abnormal for me and both of my hands were tingling (as were my feet). I felt a little dizzy and it was getting harder to breathe. It lasted for maybe 5- 10 mins and I had to try and do deep breathing techniques which helped a little. It has been almost 5 hours since my vaccine injection and I feel fine.

TACHYCARDIA; SHORTNESS OF BREATH; ACHINESS; This spontaneous report received from a parent concerned a 26 year old female. 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) dose was not reported, 1 total administered on 02-APR-2021 at 10:15 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced achiness. Laboratory data included: Heart rate (NR: not provided) 111 {beats}/min. On 02-APR-2021 20:00, the subject experienced tachycardia. On 02-APR-2021 20:00, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia on 03-APR-2021 20:00, shortness of breath on 03-APR-2021, and achiness on APR-2021. 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.

Had no side effects whatsoever for many hours. Felt completely fine until about 7:30 pm, while I was making my plate of dinner. Felt lightheaded, dizzy, and hot. I began to black out, so I sat down, which helped for a few moments to subside lightheadedness. I was still feeling hot, so I walked a few feet to my back door and sat down on the steps outside to cool off. Within minutes, my vision blurred completely, I saw stars, and completely blacked out. My mother, who was nearby, heard me fall on the steps. She said my eyes rolled back, my body was completely limp, I was not breathing but rather making gurgling noises from my throat. She propped my head up, which allowed me to breathe properly, and I came to. If my mother had not been nearby, I am convinced I would be dead right now. I saw the light, saw the other side, saw my relatives. I have had a near death experience once before, and this was exactly like that.

feeling anxious and tight throat, benadryl 25mg given by mouth, monitored and dischared in stable condition advised to see PCP if necessary

After receiving the Johnson & Johnson vaccine at noon on April 9, at around 11:30 that evening, symptoms of muscle pain and fever began to appear throughout the body. When lying down in the middle of the night, I experienced severe shortness of breath. The above situations lasted for 2 days. It began to ease on April 13, and there are still fever symptoms now.

Vomiting, Blurred Vision, Hard time catching my breath, numbness in arms, chest pressure, ear pain, headache, muscle aches, fever, dizziness for about 3 hours starting at 11:00 p.m. Ambulance was called around 2:00 a.m. taken to Hospital Seen by MD tests: Imaging XR CHEST AP PORTABLE MD Apr 12, 2021 The result is abnormalLab CBC WITH PLATELET AND DIFFERENTIAL MD Apr 12, 2021 The result is abnormalLab COMPREHENSIVE METABOLIC PANEL MD Apr 12, 2021 Lab PT-PTT MD Apr 12, 2021 Lab TROPONIN MD Apr 12, 2021 Lab CKMB W/TOTAL CPK MD Apr 12, 2021 Lab P-NATRIURETIC PEPTIDE, MD Apr 12, 2021 The result is abnormalLab MAGNESIUM MD Apr 12, 2021 Lab ESTIMATED GLOMERULAR FILTRATION RA MD Apr 12, 2021 Lab SARS-CoV-2 RNA RT-HDA MD Apr 12, 2021 Lab POCT PERFORM URINE PREGNANCY MD Apr 12, 2021 Pt seen and examined. Workup ordered. IVB, zofran, pepcid, toradol 15mg iv ordered. Reassess. Magnesium 1.4. repletion ordered. covid19 -ve. Upon reevaluation, pt feels better. VSS. Pt is clinically stable for d\c from ER. D\c to home per d\c instructions Strict d\c instructions and parameters when to RTER d\w pt, all of which pt verbalized understanding and agreement.

Pt given vaccine and 3 minutes later, patient complained of not being able to breath. Epineprine 0.5mg SQ and Benadryl 50 mg IM given

Obtained J&J vaccine on 4/4/21 Signs/symptoms started 4/12 and continue today Has intermittent severe headache that ranges in pain from 2-7/10 Current pain is 2/10 Intermittent abdominal pain that radiates to back Pain is mainly in shoulder blades just under her bra line Hurts when she takes a deep breath in Pain rated at 2/10 current but can range as high as 7/10 at times Denies Shortness of breath or difficulty breathing or speaking, states pain only when taking in deep breathing Sometimes the pain will shoot down her back to her hips Intermittent pain across the front of her upper chest States she does not know how to describe it but it is not severe Sore all over Fatigued Afebrile

I woke up at 3 am Friday with cold sweats and body aches. Took 1000 mg Tylenol. Woke up again at 10:30 am to a fever still and this odd extremity feeling. Felt like I had a compression body suit on and weight of 50 pounds around my arms and legs, Mild shortness of breath. I felt like I was swollen but did not see any. I called my PCP and vaccine line and both nurses said go to the ER. I went to the ER they ran tests. The time of the ER I started getting leg cramping and spasming. Those symptoms continued to the weekend. On Sunday the weight and swelling feeling went away. I still had bad muscle cramping and swelling. I did telehealth on Tuesday with PCP and was given muscle relaxer which helped some throughout the rest of the week. Thursday night I have a temp pf 99.6 and went up to 100.6 on Friday morning. On Friday I became shortness of breath and fatigued. It became difficult to go up and down stairs or walking about 20 ft without difficulty breathing. I now have a lower right leg muscle twitch/spasm that comes and goes. I switched to a different PCP, he ran more blood work on Wednesday 4/21. And discussed the next steps for treatment and monitoring.

Reaction after Janssen vaccine (1805031), in right arm, at 1:20pm 3-16-2021: - Within 15 minutes: nothing - Within an hour or two after: itchy right hand, pulsing in right side of head behind eye, dizziness - About 8pm, onset like a wall: severe anxiety/impending feeling of doom, shortness of breath slightly, increased heart rate, tiredness, muscle aches, sore skin, feeling of sharp pains in ?blood stream?, chills, nausea - 12pm after sleeping for about half an hour: flushing of face, slight shortness of breath, facial swelling and blotchiness, swollen lips, fast heart rate, feeling of impending doom, nausea, tongue swelling, slight difficulty swallowing, nasal congestion, groggy voice, sinuses full of moving fluid, ear pressure, hot with chills, eye redness, achy body and sore skin, feeling of sharp pains ?in blood stream? - 1am, in addition to previous symptoms (peak of symptoms): Fever 101.4 F, puffy feet that hurt, dizziness - 1:30am, after eating a little: temp 100.8 F, puffiness went down slightly and severe symptoms improved a bit. Still chills - 2:45am woke up drenched in sweat and hot, 100.7 F. Chills mostly gone. Nose very stuffy. Eye pressure/pain. Feel improved. Chest feels exhausted. Still body aches but improved. Ear pressure. - 8am: 99.4 F. Feel better mostly overall. Head feels like a cinder block. Eyes and ears hurt. Body aches mostly gone. Pain at injection site. Chills gone. Sweats gone. Skin still sore. - 1pm: 98.3 F. - Only remaining symptom for next couple days is tenderness at the injection site. -Following a few days: completely recovered. no symptoms, back to 100%

At 3 am the night of the vaccine, I woke up with flu like symptoms, including a headache and shortness of breath. Two days later, I had a severe manic episode that lasted for three days (bipolar was well managed with medication at this point and I had not had a manic episode in months). Along with the manic episode, I developed chest pressure and shortness of breath, along with dizziness and a pounding sensation in my chest. Any physical activity or even a sip of coffee sets my heart off. I am still experiencing these symptoms to this day and caused me to lose my job because I am not able to perform the required tasks. I had a premature atrial contraction prior to the COVID vaccine, but it had cleared up and I had been off of the medication for months with no problems. I have been to the doctor's office (primary care physician-4/15/21 and 4/20/21) twice, the emergency room once (4/26/21), urgent care (4/14/21), and now am seeing a cardiologist for this condition (first visit 4/29/21).

My symptoms starting the night I got the vaccine and lasted for 2 weeks after. I had a fever, chills, severe headache, nausea, shortness of breath, muscle aches, fatigue, and pain in my left leg. We ended up going to the emergency room the week after because of fear of blood clots.

103 fever,, dizziness, weakness, unable to walk or lift arms, shortness of breathe , severe headache Stayed at doctors office for 1.5 hours, took ibuprofen to lower temp and had to have my husband leave work to come and get me as I was unable to drive. Woke up in the middle of the night with same symptoms and had to take more ibuprofen

Experienced 2 days of worsening fever, chills, myalgias, mild chest pain, fatigue and malaise. Went to the ER after having a low grade fever, chills, shortness of breath, mild chest pain, and an elevated resting heart rate. Was diagnosed with SIRS as a response to the covid vaccine and hospitalized for observation. Was discharged the next day. Diagnosed with SIRS, possibly due to the COVID vaccine with a secondary diagnosis of asthma.

About fifteen minutes after receiving the vaccine participant was having trouble speaking , tongue was swollen, could barely breathe so she took Benadryl that her family doctor prescribe to her symptoms got worse by midnight so she went to the emergency room at hospital.

I woke up at three AM feeling like I had a fever. I had body aches. The next morning when I woke up I felt like I had a tourniquet on my arms and legs. I was also short of breath. I went to the ER and they checked for blood clots. I started to get lower extremity cramps and muscle spasms. Two days after I started to have some shortness of breath and I was out of breath if I walked any length. One week after the vaccine I ended up wit an ear infection in my right ear. The muscle spasms continued especially in my right lower legs with twitching which lasted for five weeks. Two weeks after the shot my Asthma, which is normally controlled got very severe. My inhalers didn't seem to work. Three weeks after the vaccine my Asthma got worse and I was having trouble breathing. I went to the ER again and there were more tests done. I was prescribed Prednisone, and I took one week off work. After multiple treatments I was prescribed antibiotics and switched my inhaler which helped. I have been trying to do some Cardio activity this weeks and I feel better after six weeks. I don't have to use my Nebulizer as much as I had been.

Leg pain. Started in left leg, moved over into right leg as well. Got xray on left knee- nothing came back. Got ultrasound on leg leg- nothing came back. My legs constantly hurting. Mainly behind my knees, side of my knee, and front of knee . My calves and ankles are also hurting. I feel pain, weaknesses, and throbbing. They are very tired. I visit a sports medicine doctor tomorrow. Also visiting a cardiologist tomorrow. I?ve been having chest pains (which are normal for me prior to vaccine). However, now my heart is feeling like I?m having palpitations. It starts beating faster then normal. I can feel my heart beating now, which I?ve never been able to notice prior. I?m having to catch my breath often, and have to take really deep breaths. This is the first time I?ve ever experienced these heart issues. Visits since vaccine- 2 visits to PCP, 2 visits to urgent care, ultra sound, upcoming sports medicine visit, upcoming cardiologist visit

Racing heart, highest recorded beat was 108, lasted from 7:45 to 8:45 pm Face/throat swelling, I treated with benedryl , lasted from about 8:15 PM to 8:45 PM Vomiting and nausea , I treated with anti-nausea med lasted from 7:15 pm to 9 pm Migraine-like headache , I treated with ibuprofen, started around 9 pm and finally decreased around 4:30 am. I still have a slight headache. Chills - started around 3 pm and lasted until around 6am this morning. Site pain - 10 Am until 3:30 am.

Approximately 2-5 minutes after administration, she became sweaty, loss of color in her face, nausea and dry heaving, dizziness, tingling and numbness in all extremities, stiffness in lower extremities, difficulty talking and ability to catch her breath.

I developed dysautonomia (elevated heart rate, chest pain, and shortness of breath upon standing. also GI distress) on June 12, 2021. I ended up in the emergency room and being admitted to the hospital twice over the next week and a half. I have been trialing medications, wearing compression socks, and drinking a lot of water and eating a lot of salt. My symptoms have improved a little but my doctors believe I will be managing this for life (or at least a while). Prior to this episode, I got the Janssen vaccine which caused me to have tachycardia for about 12 hours within the first 24 hours. I felt fine for a week but the second week I felt very fatigued and couldn't do much other than sit on the couch for the week.

Severe joint and muscle pain to the point of being unable to get out of bed alone. Difficulty taking deep breaths. Deep breaths cause coughing. Severe headache and nausea to the point of having trouble standing without feeling sick. Started with a few hours of getting that vaccine and is still present. Have missed two days of work so far as a result with no symptom improvement so far.

-fatigue, fever, shortness of breath, vomiting, chills, headache Began at 6:00pm (about 9 and a half hours after vaccination, and lasted for about 6-8 hours). -soreness in arm, lump at injection site Continuous (3 days later and still sore).

Nausea , fatigue, weakness, headache , back and Neck pain, pressure behind eyes, headache, fever, intermittent hot then chills, rapid heart rate 110s, and shortness of breath at rest & w/ exertion. Vaccine @ 9:00am 3/13 ?> symptoms progressing at 4:00pm and lasting until next day 3/14 3:00pm

person reported heart racing, SOB, chest tightness. Tachycardia 140-160's. Did remember that she had rxn to unknown medication around age 7. transported by EMS for on site observation

A few minutes after receiving vaccine patient began to have irritation in throat and tightness in the chest. 911 was called. 50 mg of diphenhydramine was given to patient with their consent and denied any allergy to benadryl. Counseled patient that benadryl could cause drowsiness. Patient denied any history of anaphylaxis in the past. The EMTs arrived and took over care. Vitals were good per EMT's. The EMTs escorted patient from the pharmacy. Per the EMTs, the patient was advised to self-monitor at home and seek medical attention if any worsening of symptoms, and they advised the patient not to drive home, and alternate transportation was arranged.

After vaccine patient felt like her throat was tightening up - very shaky. states she is allergic to morphine and felt like this was a similar reaction. Says this reaction is not as fast but she feels it. We were with patient for approximately 30 minutes and she presented as stable. Patient was ultimately transported to a local hospital by EMS

About 1-2 hours after vaccination patient experienced trouble breathing and throat closing. She went to ER and received an epi pen and steroids and states she is much better now.

Remember to prep some pain killer!! I was ok in the first 4h. Didn't feel anything. Then my body started feel a bit lethargic. I went to sleep around 9pm but my body was so pain that I couldn't really fall asleep. The whole body was pain. I didn't have short breathe but I had to breathe heavily to catch myself. Until 2am my arms, legs, face and head started numbing and I couldn't even grab anything. My hand were like sprained. That's when my hunsband has to go buy pain killers for me. He also bought thermometer. I checked my Temperature it's was ~96F. I took ibuprofen and some milk, bread and egg. The pain and numbing was getting off after ~40min after I took Ibuprofen. Then I was able to sleep on bed.

Fever, dizziness, weakness, trouble walking, full body aches, headache, wheezing, difficulty breathing, rapid heartbeat, high fever, cough, shortness of breath, vomiting, heartburn, earaches (pressure in the ear), chills, extreme night sweats

event time started at 06:30pm of 04/12/2021. patient felt over at home. reported headache, increased heart rate, shortness of breath, chill, pain on head, back, leg, right leg numb. with no bleeding

About seven hours post-injection, I started feeling short of breath and chest tightness. I also had extreme nausea, headache, and fatigue. Fatigue continued for about one week. Nausea spells continued for about 2 days.

reports she had dizziness, warm sensation, tongue numbness, decreased appetite, decreased sense of taste, vomiting x1, sore throat, myalgias, and intermittent shortness of breath and chest pain. of note had Covid in December 2020

Female with history of COVID-19 in January presents to ER with 1 day of shortness of breath. Patient reportedly received Johnson & Johnson COVID-19 vaccine last week, states postvaccination she had flulike symptoms for a few days that resolved. States this morning she woke up feeling short of breath. Reports associated feeling of anxiety/possible palpitations. Denies chest pain. Reports resolution of symptoms at this time. Patient reports history of ectopic pregnancy while on birth control pills, currently has hormone positive IUD. Denies smoking cigarettes.

On 03/18/2021 at 03:30AM I had a lot of arm pain from my shoulder to my elbow in my left arm. This lasted until 03/31/2021. On 03/18/2021 I woke up with a headache that would not go away. Next, at about 03:15PM I was not able to walk for about 10 minutes. Then, at about 05:00PM I started menstruating. At 07:00PM I had severe pain in my pelvic area for an hour and a half. At approximately 08:30PM I passed a softball sized blood clot vaginally. I bled heavily through the night. On 03/19/2021 I still had a headache and no energy at all. I continued to bleed heavily all day as well. 03/20/2021 was the exact same as the days prior. 03/21/2021 I was still bleeding heavily throughout the day with no energy. I still had the headache as well. I started feeling dizzy while walking on this day. 03/22/2021 I went to work like normal. I was cold all day. I was still bleeding, headache and dizziness. It was hard to stand for 30 minutes. While climbing the stairs I got very light headed and dizzy. I could not go up the stairs at a normal pace. 03/23/2021 I had the same symptoms all day but I was getting short of breath walking short distances. I still had very little energy and a headache. I also lost all color in my face and hands. I was still cold all day. I noticed some slight swelling in my ankles. 03/24/2021 The symptoms were getting more intense. I was still cold. I finally took some aspirin for the headache because it was very severe. The medication didn't help with it. This routine went on for the next week and the symptoms intensified with each day. Throughout this time I was still passing clots that ranged in size from golf/ping pong ball to baseballs. They were very painful when they passed. The days from 03/25/2021 to 04/01/2021 were all the same as far as how I felt. On 04/02/2021 I woke up with the same symptoms but now I could not stay awake for anything. I slept on and off all day. I only ate one meal a day because I was so tired and I had no appetite. The headache was getting worse as the days went on. The bleeding was still happening. It was not as heavy as the weeks before, but enough to be painful still. I also started having abdominal pain. On 04/03/2021 I was seeing stars when I moved too quickly. My heart rate was elevated with shortness of breath along with the rest of the previous symptoms. My headache however was very intense. 04/04/2021 I still couldn't stay awake on top of all the other symptoms. The dizziness and stars were more frequent. I couldn't move my head without seeing stars. 04/05/2021 I couldn't get warm and I still felt the same way. I called and made a doctor?s appointment for Wednesday the 7th. I had all the same symptoms still and they were getting worse. I had to move in slow motion so I could try to function. 04/06/2021 I woke up drained of all my energy and color. I couldn't shower because of the pain in my body. I couldn't stand because I felt like I was going to fall down. I could barely stand up straight let alone walk very far. I was shaking from being so cold. I had all the same symptoms from the days prior. I was in severe pain. I couldn't sit because of the pain in my abdomen I couldn't stand because of the weakness in my legs. I could barely see anything because of the stars I was seeing. At this point I had no color and I was barely conscious. That is when my family took me to the emergency room.

After the shot I had a pasta lunch and then took a nap for about one hour. When I woke up ( 3-4 hours after the shot) I had a fever. I could tell because I was very hot and sweaty even though my room was air conditioned. I drank water and immediately was nauseous and vomited. I continued to have sweats, chills, and after about another hour body aches set in. My whole body was cramping up and my hands were shaky. I was very short of breath over short movements like to get to the bathroom, I would be out of breath and dizzy. Around 1700 (6 hours post shot) I took Tylenol and continued to take it every six hours. I was able to keep ginger ale and crackers down but didn't eat much else until the next morning. I think the fever broke in the night. The next morning I was just really tired and sore, but much less achy than the day prior. I was able to eat light meals and I stopped taking Tylenol sometime that mid-morning. I felt fine the next day (about 48 hours after the shot).

I began to feel shortness of breath when walking, tightness in my chest, for the same reason any physical effort made me feel like I was short of breath. (The day before I had presented the common symptoms such as fever, chills, arm pain, muscle pain) however this symptom was off the list, at 11:30 in the morning I had to go to an emergency clinic, they checked me with blood test, urine tests, medical exam, electrocardiogram, and chest X-ray. The doctor told me that everything was fine that I could leave. I had to pay a high bill at the hospital. The following 7 days the sensation was disappearing very slowly. However from day 8 it started again, until now on day 13, I still having sensation of shortness of breath when doing physical exercise, it is something that lasts and does not disappear.

Within one week of the vaccine I felt like I had pressure on my chest and chest pain and I was having a problem breathing. I had a cough and I had shortness of breath. I was really tired. I had that feeling of tiredness for one week. The shortness of breath and tiredness lasted two weeks. I used my inhaler when I needed it and after three weeks it feels better and I no longer have any symptoms.

Immediately after the injection I felt light headed. Soon I could not see (very blurry vision) and I could not hear (like drowning in water). I then started to sweat profusely from every inch of my skin. I couldn?t catch my breath. I was handed water and told to sip on it, which proved difficult when my throat started to feel like it was swelling up. After about a 15 minute ordeal, it was like nothing ever happened. The only symptom that remained, was sweat soaked clothes

45 minutes after receiving Janssen vaccine, pt became SOB & complaining of tight chest. BP 120/80 Pulse 110 Pt was transported to Hospital & parents notified.

NARRATIVEPATIENT WALKED IN TO FIRST AID AND COMPLAINED OF NUMBNESS TO THE LEFT SIDE OF HER FACE AND COMPLAINED OF TIGHTNESS TO HER THROAT. PATIENT PUT HERDISCOMFORT AS A 3/10. SHE SAID THAT SHE WAS BREATHING FINE BUT HER THROAT FELT SCRATCHY AND BOTHERSOME. PATIENT WAS GIVEN ROOM TEMPERATURE WATER ANDSHE DID NOT HAVE ANY DIFFICULTY SWALLOWING IT. DR. ARRIVED AND VISUALLY CHECKED THE PATIENT'S THROAT WITH A FLASHLIGHT. PATIENT WAS OFFEREDTRANSPORT BUT DENIED IT. SHE STATED THAT THE NUMBNESS RESOLVED BUT SHE STILL FELT THAT HER THROAT WAS TIGHT. PATIENT CALLED HER MOTHER WHO IS AN RN ANDSHE CAME AND PICKED UP THE PATIENT. AMA FORM WAS FILLED OUT AND PATIENT SIGNED THE AMA.

Initially presented with 5 out of 10 chest pain (substernal, no radiation, no exacerbating or relieving factors), nausea, vomiting, diarrhea, dyspnea on exertion, and fatigue. Further history obtained included decreased exercise tolerance since four weeks prior to presentation (noticeable during runs). She was found to have an abnormal EKG at an urgent care and was sent to an outside hospital emergency department. She ultimately was found to have heart failure with preserved ejection fraction (56%), Stage C, Class III, and myocarditis. The highest suspicion for the etiology of her myocarditis is viral vs. autoimmune (given response to steroids) vs. genetically-mediated myocarditis. She was discharged on aspirin, a prednisone taper, colchicine, metoprolol, and Entresto with cardiology follow-up. Patient discharged with 4 week monitor to monitor for arrhythmia as per EP service. Infiltrative cardiomyopathy evaluation pending as well- plan for SPEP/UPEP, serum/urine protein electrophoresis, immunofixation, and alpha-galactosidase (not sent due to specific tube not available).

Fast heart rate and SOB w/HA and fatigue x 2 days, started 1700 yesterday after receiving J&J vaccine in AM yesterday, reports SOB upon exertion and "long-winded conversation"; denies any dizziness; last dose 325mg ASA with 500mg Tylenol at 0900.

On March 22 2021, I had leg cramps that felt like Charlie horses, I had a fever of 102 and I missed work. On March 24 I went to my doctor because my legs were still bothering me. That same night I ended up experiencing extreme dizzy spells, I fainted. On March 25 called my doctor I told them my symptoms were getting worse, the office made me a follow up appointment for April 2 for dizzy spells and fatigue. My symptoms continued to get worse, I had a tele visit April 5. Then, I started developing a dry cough. I called again that same day 4/5 for shortness of breath and went in to my doctors office 1:10pm. They did a chest xray. April 6th I had another tele appointment for anxiety Because I started developing anxiety from all my symptoms. April 7th I called again I had blood in my urine and back pain, It was very alarming because my last period was & years ago. April 7th I went to an Urgent Care . April 8th it got really bad. I went emergency room, I felt like I had a lump in my throat and experiencing some chest tightness, my pulse was 101 beats per minute, heart 118, BP was 143/106 I presented with unspecified Right Bundle Branch block and I ended up tachycardia, they did a CT scan of my chest. the doctor gave me Valium & Hydroxyzine. At the hospital I started dry heaving and vomiting. April 9th saw a new doctor still very nauseated and I was experienced nausea and heart palpitations, and rapid heart.

4/3/21 - Noticed Skin eruptions on arms and legs 4/11/21 Skin eruptions were getting worse 4/19/21 - began heavy vaginal bleeding 4/20/21 - began feeling dizzy, light headed, hard to breath 4/22/21 - admitted into hospital with Cellulitis, Sepsis, Sever Anemia - discharged 8 days later Red blood count was 5

It was like an adrenaline rush at first, light headed and felt like i was going to pass out- 04/2/2021 Shortness of breathe last for 2 weeks. Given a Steroid Shot- 04/16/2021 Given an Inhaler 04/16/2021

CHEST PAIN; DIZZINESS; SHORTNESS OF BREATH; SHE WAS UNABLE TO MOVE FOR WHOLE DAY; CRAWL TO THE BATHROOM; CHILLS; HEADACHE; FATIGUE; BURNING ARM; BODY ACHE; CHEST TIGHTNESS; LEFT ARM PAIN; LEFT SIDE OF BODY OUT OF IT; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1806025, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced left side of body out of it. On 15-MAY-2021, the subject experienced chest tightness. On 15-MAY-2021, the subject experienced left arm pain. On 15-MAY-2021, the subject experienced burning arm. On 15-MAY-2021, the subject experienced body ache. On 16-MAY-2021, the subject experienced she was unable to move for whole day. On 16-MAY-2021, the subject experienced crawl to the bathroom. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced headache. On 16-MAY-2021, the subject experienced fatigue. On 18-MAY-2021, the subject experienced chest pain. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from she was unable to move for whole day, was recovering from crawl to the bathroom, had not recovered from fatigue, burning arm, headache, dizziness, shortness of breath, chills, left arm pain, and chest pain, and the outcome of left side of body out of it, chest tightness and body ache was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

I started to feel a little intoxicated 20 minutes after the vaccine. After about 30 minutes I had rashes on my face. I was unable to walk in a straight line. I was also very emotional. I took a nap and woke up with a headache, chills and sweating, I had body aches and pain in my back. My skin was hot to the touch. I was nauseous and weak with no fever. The next day I was having shortness of breath and I thought I had blood clots.

Patient felt fine day of shot. Next day started to experience muscle tightening, flulike symptoms, scratchy throat, leg numbness, dizziness, cold sweats, shortness of breath and headaches. She was seeking care today, 7/15. I advised patient to go to hospital.

Janssen COVID-19 Vaccine EUA: patient in clinic to establish care. COVID-19 infection in January 2020. Reports one week after immunization experienced increased heart rate and shortness of breath while on vacation out of state. Patient went to emergency department (ED) and diagnosed with heart arrhythmia. Patient left hospital before heart echo could be performed. Continues to have some shortness of breath at times but no palpitations.

It started about a week after getting the vaccine. I had tingling in my feet and my hands, more prominent on my left side. Like pins and needles. Really hard to remain laying on my back. I cannot breathe. A couple of days back I got really dizzy, I have been really bad nauseous. A couple of days ago my middle finger in my left hand was like a little numb. Yesterday with the doctor they tested my sensitivity and I definitely have less sensitivity in my left side. I have more migraines now. They referred me to a neurologist but I have not seen him yet. The day before yesterday I had really bad pain on my left shoulder, I could not move it so I went to urgent care at 9 am yesterday.

Fever, shakes, severe body aches and sharp pains throughout my body. Nausea and vomiting and constant use of the bathroom. Dizziness, and severe migraine, fatigue and trouble breathing that lasted 2+ hours.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient was extremely anxious when she came in for vaccine informing vaccinator that this was her second appointment because she had cancelled the first appointment due to anxiety of side effects (was worried she \"was going to die\"). She stated that her mouth was slightly numb/itchy and that for a moment it was her whole body. Then stated that her mouth had become dry from being anxious about the vaccine. After giving a dose of diphenhydramine & getting the patient to calm down the rxn subsided

Severe headache, body aches, chills, difficulty breathing, severe muscle aches, heart rate 140, extremely high blood pressure 158/91, dizzy, weakness, fever 103.7, swelling of throat, etc

Difficulty in breathing, shortness of breath, shivering, fast heartbeat, coughing, headache, blocked nose.

Approximately 15 minutes after Janssen Covid19 vaccine administered, Patient reported dizziness to nurse that was monitoring pt post vaccination, nurse stated patient was cold & clammy to touch, pt was crying and reported difficulty breathing. Nurse administered 0.3 mg epinephrine via EpiPen injector. I entered room immediately as epinephrine was being administered by RN. Patient was sitting in chair, crying, and responding to questions when asked. Nurse assisted me in laying pt on the ground. Patient's arms were jerking significantly, caregiver reported this was more pronounced than usual. Per finger pulse ox: Pulse was 132 bpm, O2 Sat 93%, BP ready to be taken when paramedics arrived at scene and took over.

Fever around102F for 3 hours, petered out slowly over the next 8 hours Headache Nausea/vomiting Chills Slight shortness of breath All symptoms resolved within 24 hours of onset

After receiving the shot, I was required to sit down for 15 minutes. About 5 minutes in, I started to become dizzy, my vision started blacking out, my hearing was muffled, I became clammy, sweaty, and experienced mental disorientation. It became harder for me to breathe, but I never struggled to take a breath. I drank some water and waited for the symptoms to subside. I remained seated and these symptoms went away within 5 minutes. After feeling better for about 5 minutes, I felt cold and was shivering. The woman sitting next to me was completely fine after her shot. I've since felt a slight burning sensation on my skin in areas that I have scratched lightly. I'm also experiencing strange feelings throughout my body- specifically my head, leg, and hand. It feels like I can feel something in each area for a bit and then it subsides after several minutes.

Chest Pain, shortness of breath, fever, chills (9:00pm-3:00am) chills, body aches (April 4th-April 5th)

Chest pain, difficulty breathing within 3 hours of shot Body aches, chills within 6 hours of shot Tylenol and advil

Typical side effects of fever, chills, injection site pain began 12 hours after the shot. 24 hours after the shot, my breathing got gradually worse. It was like an asthma attack, but normally my asthma attacks are caused by a sinus infection. This was just shortness of breath and gasping for air. I used my rescue inhaler with increasing frequency over the course of the following week. By March 12, I had to use my nebulizer. I used the nebulizer once on March 12, twice on March 13, twice on March 14, and I finally went to urgent care on March 15 when the nebulizer stopped helping. Urgent care was unable to help due to covid protocols, so they put me on oxygen for 5 minutes and transferred me to the ER. At the ER, by the time I got to the ER, my breathing had normalized. I was given prednisone on site, as well as a prescription for 5 days. I had a chest xray done that returned completely normal.

Dizzy, light headed, blurred vision, weakness, difficulty breathing: these lasted more severely about 2 hours after the vaccination and then got worse again the next day which is when I ended up going to the emergency room. I was given benadryl a steroid and a antihistamine there.

Patient experienced anxiety, SOB, clammy hands, vomiting, sweating, arm numbness. BP 108/77 HR98 R16, then 10 minutes later 103/67 HR82, RR18. Patient stable, released with instructions to f/u with healthcare provider

About 10 hours after my Johnson & Johnson COVID vaccine, I had sever chills, teeth chattering, body tense and aching, and trouble breathing. These were severe symptoms that lasted for two hours.

C/O tongue and throat swelling, chest pain 15 minutes after injection; tachy, BP 132/84; Hx of anaphylactic reaction to bee stings. Carries own epi. Epi and Benadryl given at 30 minutes after injection. 911 called when pt. reported no change in s/s. Was seen in ER and tx with solumedrol.

Fever, throat closing, red hives all over body, swollen eyes, swollen jaw, swollen cheeks, muscle aches

SEVERE shaking all over, difficulty breathing, racing heart, headache, dizziness, muscle pain, and muscle weakness. I just tried to wait it out. The shaking (extremely bad, could not control my own muscles at all and I had to lay on my arms so they wouldn't flail out) and racing heart lasted about five hours. The headache and all over muscle pain finally eased up last night. Breathing aches and I am still experiencing muscle weakness.

I was fine for the most part after the vaccine. The only thing that hurt was my arm at the injection site. I started feeling nauseous about an hour later. Then at about 9:00 pm, I started to feel really sick. I felt very tired and my whole body hurt. I had a low body temperature, 95 degrees. Chills, fever, shaking, nausea. Very SEVERE symptoms. Felt very disoriented. I thought I was going to pass out and faint. Vision blurry and seen white. Pounding headache. Ears ringing. I could hardly walk that night, I was crawling on the floor. I felt out of breath. My heart was beating very fast. My left side of my chest hurt by my ribs. When I did wake up from sleep, I woke up with blood in my mouth and dried blood on my lips.

The week prior to delivery (3/22), I started feeling shortness of breath and a headache. I thought it was just normal pregnancy symptoms. That Friday (3/26), I noticed swelling in my ankles. I am a teacher so I asked my school nurse to check my blood pressure; it was high (for me) around 144/88. She said I should call my OB and let them know. I did, and they said to rest for the weekend and they'd see me on Tuesday for my 29 week appointment. We had a weekend trip planned. We took our son there. The next night, I didn't feel right. My belly felt hard to me and I wasn't feeling my daughter move as much, but soon after, I went to sleep. Our two year old son woke us up crying around midnight, and I noticed that I started bleeding when I went to the bathroom. My husband drove me straight to the emergency room. I was diagnosed with sudden and severe preeclampsia. My fibrinogen levels were 100% indicative of a placental abruption. They called the transport team in from hospital so they could transfer my daughter immediately after birth. At 5:57 am on 3/28, my daughter was born via emergency c-section. She is currently fighting everyday at the NICU in the hospital. On Friday, 4/2 I was readmitted for severe preeclampsia to hospital. My blood pressure was 190/115. I had to receive another round of magnesium sulfate. I was released from the hospital on Sunday, 4/4.

I have shortness of breath. It?s not something that is affecting my life but I have this symptom since I got the vaccine

Janssen COVID-19 Vaccine EUA So after the shot I felt tired is but nothing big, then I went to bed around 9 p.m and I started getting chills, and I was freezing cold even under two blankets. I was wearing a fitbit and then noticed my heart Rate went up to the 90s and fluctuated between 90-110 bpm all night into the next morning. I woke up every 2 hours to a new symptom on top of what I was feeling already. It started with chills, then sweating, nausea and a headache. I had a fever of 99.5 at the highest. And then the last time I woke up at 5 my heart hurt so bad, my whole chest muscle hurt with a sharp pain and It hurt to breath. The next day I had a little headache and my body hurt, and I had cramping in my legs for a few days, but I also started my menstrual cycle on the 13th. The leg cramping continued for a few days but only when I sat on my legs for too long.

FEVER; HEART RACES; SHORTNESS OF BREATHE; CHILLS; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no history of vaccine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heart races. On 25-MAR-2021, the subject experienced shortness of breathe. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced tired. On 25-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart races, shortness of breathe, tired, and headache, and the outcome of fever and chills was not reported. 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.

Fever at first. Then occasional shortness of breath. These have gone away but now have sudden and brief headaches. No treatment.

Got J&J vaccine on Friday at 3pm (April 9) and felt Body aches, Muscles hurt, Stomach hurt, Dizzy, Nauseous , Heart rate fast, Clammy Chills, Didnt sleep, Chest tightness, Upset stomach, Fever, Head hurt, Arm hurts and chest tightness feels in-line with where I got the shot, by Sunday (April 11) Flu like symptoms went away, but still have chest tightness uncomfortable and Feels like i have to cough When I take a deep breathe it it feels tight. Have diarrhea everyday since vaccine Still feel weak and dizzy Most of the flu like symptoms have gone away but chest tightness still concerning When I bend over or lay on my right side feels constricted and tight and uncomfortable. Bilirueben associated with liver is elevated and white blood cell count is low. On Wednesday, April 14th I started to get super congestion, runny nose and sneezing and Eyes a little red. Rashes and Hives that were red, blotchy and bumpy started Wednesday April 14 at 6pm and worse at 9pm. Continues to get worse and hurt throughout Wednesday and Thursday night. Developed all over body, legs felt hot. The hives and blotches would disappear and would then reappear at different areas of my body. Called Nurse Triage line and suggested I treat at home with Benadryl since hospitals had 6 hour wait and were full of COVID positive patients. Unable to sleep Wednesday and Thursday due to hives, very comfortable feeling. Diarrhea on Thursday morning , cough and felt shakey. Noticed on Thursday April 15th, some skin on right foot looked like it was pealing. Thursday night noticed some blotching and hives but not as bad as they were the night before. Friday April 16, No redness on legs at 1130am, but Lips feel dried out and Feel a little dehydrated . Bilirueben associated with liver is elevated still and will need to follow up with Doctore in two weeks. However, when laying on right side or bending down feels like something is stuck un chest and need to cough still, with chest tightness. Still had diarrhea until Saturday, April 17th. Chest is still tight and feels like something is stuck. Sunday, April 18th, went for short walk and felt uncomfortable breathing and not normal. This has not resolved still and does not feel breathing is normal.

-Fever (102) and body aches for 1 day post vaccine (4/6). -On 4/11 at 11pm started having shortness of breath/wheezing and severe dry cough. Reminiscent of asthma attacks I had as a child (but haven't had in years). Used OTC inhaler with no relief. Wheezing died down after about 1.5h after starting and no chest symptoms after that. Headache/fatigue next day (4/12), then fine after that.

CHEST HEAVINESS; CHILLS; SORE ARM; FEVER OF 103F; DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced difficulty breathing. Treatment medications included: paracetamol. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced fever of 103 F. Laboratory data included: Body temperature (NR: not provided) 103 F. On 11-APR-2021, the subject experienced chest heaviness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sore arm, and fever of 103f on 08-APR-2021, had not recovered from chest heaviness, and the outcome of difficulty breathing was not reported. This report was non-serious.

WHEEZING FEELING; WOOZY; HEAD FEELS TINGLY; LIGHTHEADEDNESS; FEELING OF PRESSURE ON HEAD; This spontaneous report received from a patient concerned a 28 year old female. 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) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Batch number was not reported. The company has requested follow-up for batch number. No concomitant medications were reported. On 24-APR-2021, the subject experienced wheezing feeling. On 24-APR-2021, the subject experienced woozy. On 24-APR-2021, the subject experienced head feels tingly. On 24-APR-2021, the subject experienced lightheadedness. On 24-APR-2021, the subject experienced feeling of pressure on head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from wheezing feeling, woozy, head feels tingly, lightheadedness, and feeling of pressure on head. This report was non-serious.

I had nervous sweats, I felt that my throat was closing. Once I got home, I had body aches, fever, and chills. It lasted about three days. I took Dayquil and nightquil

COLIC ABDOMINAL PAIN; LIQUID STOOLS; NUMBNESS SENSATION IN THE LEFT ARM; HEADACHE; DIFFICULTY BREATHING; PAIN IN ARM; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 02-MAY-2021, the subject experienced pain in arm. On 15-MAY-2021, the subject experienced difficulty breathing. On an unspecified date, the subject experienced colic abdominal pain, liquid stools, numbness sensation in the left arm, and headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from difficulty breathing, and the outcome of pain in arm, colic abdominal pain, liquid stools, headache and numbness sensation in the left arm was not reported. This report was non-serious.

Pt admitted to the ED with chest pain one day following the vaccination. Pt described this as subtle at first that increased to wake pt up in pain. Sharp pleuritic pain localized in the center of her chest and slightly in the epigastric region. No prior symptoms previously. Pt has been diagnosed with bilateral pleural effusion, acute pericardial effusion and acute pulmonary embolism.

Patient fainted and stated troubled breathing multiple times once regained consciousness. Epi Pen administered and symptoms resolved within 10 minutes. Patient did not need further medical attention.

Fever, chills, tingling in the lips, throat swelling, hives, high blood pressure, coughing, asthma attack. The lip tingling was within 30 minutes of my vaccine, and continued for 2 weeks. Throat swelling lasted the first week. Hives lasted 1 week 4 days. Coughing started on day 3 and lasted 3 days. Asthma attack happened one time, during the coughing phase. High blood pressure started the evening of the vaccine and has continued. Doctor has prescribed a low dose of blood pressure medication to help combat it. Fever and chills started on the first day and lasted through the second day.

Same day on the vaccine I noticed swelling on the vaccine site. Two days later I started feeling my throat swollen I had my lymph node swollen on my neck & under the jaw line everything was on the left side as the vaccine. It started to become very painful 6 days later I went to the urgent care and they gave me antibiotics to treat it. It was a 2 week treatment once I finished it about 5 days later I had to go again because it started to happen again I went in to get more. Now a couple a weeks ago its starting again but I have not gone to the urgent care anymore I'm just watching it and hoping it goes away. If it does get worst then I will be going again.

I had side effects starting one hour after the vaccine - headache and nausea. Muscle pain started 12 hours after and it spread to my other arm - my entire upper body ached. I was nauseous and peeing a lot for 2 days. I did have a few hives, 2 on my arm and 1 on my face and I had not eaten anything high in histamine. The weather that week was stormy and lousy. On Friday-Saturday, I had an intense bought of allergies (plugged dripping nose) and that is very rare for me, regardless of the weather. By Sunday, I had shortness of breath, nausea, and shaking. I tried eating and playing a game to get my mind off it and that didn't help. Usually with my anxiety, I can just tell myself I'll be okay. I told myself I would be okay and if I got a blood clot I would be perfectly fine. It did not work at all. This kind of anxiety was unlike anything I've ever experienced. Nothing I did helped and it felt like everything was going a mile a minute. I decided to take a benadryl, telling myself that this was just the "impending sense of doom" that happens with food allergies. I slept for 12 hours and felt exhausted when I woke up, like I had just been through something tough. I tried to just move past it, but the anxiety got worse and worse. I saw a doctor 06/23/2021 and have started taking Prozac.

The expected adverse effects of fatigue and head pain began immediately, but that evening chest and left arm pain started. I thought it would end, but the chest pain and palpitations continued daily for the next 2 to 3 months. Afterwards, they would happen on occasion and still do to this date. In the first 2 to 3 months after receiving the vaccine, I would get so winded after walking from the train station or up stairs that I would have to stop. Many times throughout the day I had to stop what I was doing and not only rest but sleep. I was exhausted and felt overwhelming pressure around my heart and increased heart rate daily.

Muscle pain, joint pain, because of muscle pain it hurts to breathe in lower back. Have to take shallow breathes. Can?t sleep the pain is so bad. Still probably better than getting COVID... but darn this sucks.

Chills, fever, heavy breathing, body aches (began around 7PM 3/25/21 lasted until 3/26/21 night when they improved drastically, but did not feel all the way better until 3/26/21 from these symptoms) hallucinations (woke up in the middle of the night when this happened- 1x occurrence) dizziness (ongoing from 3/25/21 night and still continuing)

PATIENT FELT UNWELL AT 1230, BP 124/82, HR 73, RR28 1237 GAVE 25MG BENADRYL IM 1245 PATIENT STARTED TO SHAKE, INCREASED RESPIRATORY RATE, STARTED TO HAVE AIRWAY CLOSURE 1245 EPI PEN GIVEN IN LEFT LEG IN RESPONSE TO SOB, REPORTED NUMBNESS AND SWELLING IN THROAT, INCREASED RESPIRATORY RATE. 1246 PATIENT ABLE TO BREATHE BETTER AFTER EPI 1247 PATIENT TRANSPORTED TO ED FOR OBSERVATION 1257 EMS TRANSPORT TO ED

Patient felt like throat was closing. No stridor or increase work of breathing. Given 50 mg Benadryl with good response and improvement of symptoms. 911 called and EMS arrived and as patient was back to normal and did not want to go to ER the patient was discharged home. 99% O2 BP 102/59 HR 96

Symptoms- extreme fatigue, migraine, loss of appetite, low grade fever, shortness of breath. ALl symptoms lasted 24 hours

Woke up between 10:30 and 11pm night of vaccine administration with full body shaking and shortness of breath. It?s unclear if shortness of breath was a direct result of the severity or the shaking or something else underlying the shakes. Walking or standing for any period of time was nearly impossible. I felt too warm and too cold at the same time and felt myself sweating but also shivering. My temperature was 99.6 (high for me - I?m usually low, around 96-97 on average) which persisted until around 5:30-6am the following morning. A severely painful, throbbing headache was present until well into the next evening. The symptoms of the headache did subside with use of OTC extra strength Tylenol (2 oral every 6 hours, taken twice totally 4 over the course of 24 hrs) but the headache was still felt somewhat even with use of Tylenol. Moderate fatigue was present all of 4/9 and until around mid morning of 4/10. Pain at the injection site was present but only noticed if laying on the affected arm (left) or if the site was accidentally touched. Dull aching at the site was felt on occasion until the following Monday, 4/12. All other symptoms had fully subsided by 4/10. As of today, 4/13, I am symptom free but I have noticed that I am taking deep breaths every once in a while (maybe several times an hour) as if I?m trying to catch my breath/I can?t catch a full satisfying breath. It feels somewhat like breathing through a straw for a few moments and I breath in until a full breath ?catchs?.

Due to the recent update per the CDC and FDA regarding immediate stop to the Janssen Vaccine. Staff is following up with patients whom have received the vaccine within the last 3 weeks to verify if patient has developed a severe headache, abdominal pain, leg pain, or shortness of breath. Patient answered YES to Leg pain (RL) and Shortness of breath; Pt states she is currently using her inhaler to help w/ sx's. Pt was scheduled w/ nurse x triage.

Headache (turned into a migraine), extremely drained of energy, lack of appetite, and felt off all day (4/9/21). The next morning (4/10/21) felt the same as the day before, however, had several episodes where I would get really light headed, dizzy, and nauseous. Went to Home Depot at 2:15pm (4/10) and while there my vision blurred and started to fade, I had ringing in my ears and couldn?t hear out of the right and barely was able to hear out of the left. I got very nauseous and I couldn?t breath. I managed to sit on something and put my head between my legs that helped. Fortunately my step- dad was with me and helped me outside while I could barely see and hear and he stated I was very pale. I was having a hard time talking or being conherent. Once outside the symptoms slowly cleared over about the next 6-7 hours. At 4:45pm my mom decided to take me to the doctor but the walk in had just closed and I went to the ER. They stated I had elevated d-dime and did a chest CT scan to check for blood clots around 7:30pm (I believe not sure exact time) doctor stated they came back clear but when asked if he suspected that the episode and symptoms were due to a dissipated blood clot he would not directly answer it. I overheard him dictating his notes and he started he beloved as such. I have never experienced anything like this before. I still felt drained, headache (migraine), occasionally dizzy, and lack of appetite (4/11/21, 4/12/21) and still currently feel the same drained, migraine, lack of appetite, and occasionally dizzy.

SLIGHT SHORTNESS OF BREATH; BODY ACHES; TINGLING IN INJECTED ARM; FEVER OF 100-102; HEADACHE; This spontaneous report received from a patient concerned a 29 year old female. 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced slight shortness of breath. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced tingling in injected arm. On 13-APR-2021, the subject experienced fever of 100-102. On 13-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100-102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 100-102, body aches, headache, tingling in injected arm, and slight shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

INFLAMED JOINTS; SEVERE BODY PAIN; DIFFICULTY BREATHING; MENTAL CONFUSION; HEADACHE; MUSCLE PAIN; FEVER; SORE ARM; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, bipolar disorder, post traumatic stress disorder, and anxiety disorder, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sore arm. On 13-APR-2021, the subject experienced severe body pain. On 13-APR-2021, the subject experienced difficulty breathing. On 13-APR-2021, the subject experienced mental confusion. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced muscle pain. On 13-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 17-APR-2021, the subject experienced inflamed joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 16-APR-2021, was recovering from difficulty breathing, had not recovered from severe body pain, muscle pain, headache, and mental confusion, and the outcome of sore arm and inflamed joints was not reported. This report was non-serious.

** Backache - As of this visit today, April 21, 2021, pt still has c/o continuous back pains all down her spine since receiving the Johnson & Johnson COVID-19 Vaccine on March 31, 2021. patient continues to report pain in her neck (cervical), thoracic, and lumbar spine. She insists that the cervical pain radiates into both shoulders and down to her arms bilaterally. She states these pains started almost immediately after receiving the vaccine and persists as of today. On a scale of 0-10, patient rates her spine and shoulder pains at 3 continuously. -- I've added methocarbamol 750mg tid for muscle relaxant with ibuprofen 400mg q6h. ** Severe headache - As previously noted in my previous findings with patient she reported having moderate headaches for two days after receiving the J&J COVID-19 Vaccine on March 31, 2021 but she states her headaches have now subsided. *** Other: On my first visit with patient on April 6, 2021, she was very concerned about a sudden loss of hair since taking the J&J Vaccine in addition to the spine pains and bruising. ** Leg swelling - patient reported both leg and hand swelling for 2 days after receiving J&J COVID-19 Vaccine with some new neurologic symptoms as noted below: ** New neurologic symptoms -patient continues to report significant weakness and fatigue. -- Her headaches that were present after receiving the vaccine have subsided after the first two days following the vaccine being administered. -- She reported new numbness x 2 days in both fingers and toes bilaterally with both hands and legs swelling immediately after receiving the vaccine. -- She also reported 2 hours of dizziness immediately after receiving the vaccine on March 31, 2021. -- patient reported a new onset of hand tremors that suddenly came on a week ago Sunday, April 11, 2021 while fishing that lasted for a few hours. She stated that the tremors would come and go for a while. -- patient has been and is currently negative for loss of consciousness, seizures, and migraines. ** Severe abdominal pain - patient initially reported episodic sharp shooting pains in abdominal area on multiple occasions after receiving the vaccine but have mostly now subsided. However, today, April 21, 2021 she reports more abdominal shooting "Sharp Pains" in her RUQ this morning that she rated 3/10 pain, and LLQ "Sharp Shooting" pain last Friday, 4/16/21. She states that the shooting pains last approximately 3 minutes in duration. ** Shortness of breath ? patient has continuous episodic shortness of breath complaints that have persisted since receiving the vaccine on March 31, 2021. Her last episode was again this morning, April 21, 2021 and she also states she is feeling like she is having trouble breathing during the exam today. Her SaO2 is 98% on Room Air during triage. She also reported yesterday, the same at the Clinic. She reported being at work on Monday, April 19, 2021 and became short of breath and had to lay down on the floor to breath easier. patient is a Kindergarden teacher. She also became short of breath Monday evening while at home while cleaning her closet. -- Yesterday, April 20, 2021 at Clinic I added a rescue inhaler for her shortness of breath. ** Petechiae (tiny red spots on the skin) - patient reported a new eruption on her upper back and shoulders after receiving J&J Vaccine. While the red spots are not bleeding, there was a significant notable rash to bilateral shoulders and upper back when I last saw her a week ago on April 13, 2021 at the Clinic. Today, the rash has cleared significantly. She was prescribed TRIAMCINOLONE 0.025% (80GM) OINT,TOP in Urgent Care last week, when I referred her to Dr. in the ER. ** New or easy bruising - multiple new bruising noted today on her left bicep arm. Yesterday, April 20, 2021 at the Clinic, I noted new bruising on lower extremities in addition to the bruising noted the week prior. The bruising started after receiving the J&J COVID-19 Vaccine that I noted in my previous findings last week.

My first side effects were fatigue and feeling ?out of it?, which started about 2 hours after the injection. At 7 hours after my left leg became numb and a little sore. I started to notice a feverish, tingly feeling on my skin and this would last at least 24 hours. These symptoms quickly spread through my whole lower body. The chills and intense body aches started at 11 pm. I woke up at 2 am that night and had a low grade fever 99.9 F. I took 2 pills of Tylenol. The fever broke around 3:30 or 4 am and I slept through the rest of the night. The next morning 3/09, I felt fatigue, slow, and woozy. I still had chills and muscle aches, although the intensity was less. Halfway through the day the chills intensified, the muscle aches became more severe, and my eyeballs felt like they were burning in the back of my head. By that evening, the fever was back and I couldn?t think straight. My legs ached with a pain that I?ve never felt before. I did not have a severe headache, but I felt that if I exerted myself too much I would get one. My partner said I could barely form coherent sentences, and I was so weak I couldn?t sit up straight. I took 2 more Tylenol that night, went to bed and slept through the whole night. The morning of 3/10 I woke up feeling tired but my skin did not have that feverish feeling. I was no longer sick. On 3/11 I woke up and did my normal morning routine. I ate an egg, some of a Nutella stuffed scone, and drank coffee and water. I took my 3 pills, loratadine, omeprazole, and a probiotic, and I had a severe allergic reaction within 5 minutes of taking the pills. For the next 10 minutes my breathing became labored and wheezy. I experienced severe eosinophilic esophagitis symptoms. For the next week, my EoE symptoms were heightened. I had a reaction after drinking a seltzer water, which does not usually affect me. Within 2 weeks I was back to normal and to my knowledge have not experienced any other related side effects.

Patient presented to the emergency department with right-sided pleuritic chest pain-she has a pulmonary embolism on CT angiogram. She was started on heparin and admitted to the medical center. She received her Johnson and Johnson vaccine on 03/04/2021.

Patient had difficulty breathing, fainted, gasping for breath, given epinephrine injection in thigh, started to become conscious and breath more easily, then started vomiting. Called 911 in meantime. Patient taken to hospital.

VBT Positive COVID-19 test 05/22/2021. Symptomatic- Shortness of breath, Transferred to another facility for further workup.

ER- TWO VISITS- 4/10/2021 4/12/2021. I've seen a couple doctors to get follow ups and get stronger allergy medications, I can't recall how many I have seen. I had a rash, difficulty breathing, dizziness, chills, shaking, fast heart rate, throat swelling, extremely fatigue. Still having breathing problems, still getting hives, started allegra and I take it daily, I also have to use my inhaler almost daily, I have never had asthmatic symptoms before this.

Chills and shaking 05/27/2021 Cough, fatigue, pain in legs 05/27/2021-05/30/21 I slept nearly all day 05/31/21- 06/02/21 Difficulty breathing + coughing 06/05/21-06/07/21 Fever, pounding headache, Shortness of breath, pain in arms 06/08/2021 Shortness of breath, pain in abdomen, headache, nose feels like it?s underwater, nauseous 06/09/2021

The first night (same day I got the J&J vaccine) I had a fever of 101.5 degrees, tight chest, mild difficulty breathing, strong body aches, strong chills, a splitting headache, and I couldn't sleep that night. By morning the symptoms were gone except a felt very week and still had a mild headache. The headache got bad again by 10:00AM. And grew worse and worse until it was excruciating. I took 800mg of Advil, a muscle relaxant, and 2 hours later a Norco. Nothing reduced the pain. I stayed up and cried all night. I asked a relative to take me to the ER, but they were unwilling. In the early hours of the morning, it started to reduce. The next day I was weak, and I had a mild headache for the next 2 days.

Developed elevated temp, HA, body aches and fatigue the day after receiving the vaccine. On 5/18, she developed increase in respirations and feeling like she could not take a deep breath. Hx of asthma, she used her inhaler with no improvement.Tried Benadryl with no relief. Felt like she had sinus congestion and nasal congestion, but able to breath through her nose fine. Feels SOB, worse on exertion. She also mentioned some difficulty swallowing. Denies cough/wheezing. O2 sat was 98 or above, even on ambulation. Cervical lymphadenopathy, tongue swelling, and flaring of her right TMJ was noted on . Prednisone was started. On May 20th, pt reported to PCP's nurse that she was feeling better.

Fever, chills and joint pain that lasted 2 days after the vaccine. Severe fatigue and shortness of breath that lasted 10 days after the vaccine.

PATIENT REPORTED TINGLING/PINS AND NEEDLES SENSATION IN TONGUE AND TIGHTNESS OF THROAT. EMS WAS CALLED AND PATIENT WAS TAKEN IN AMBULANCE BY EMS.

Unable to sleep due to level of fever, shaking, nausea and dizziness. Fever, SOB, and dizziness continued until around 10:30 am the next day. Caused a migraine.

11:27am vaccine given 0.5ml R deltoid IM 11:55am patient started complaining of R upper arm pain; reluctant to move arm - cold pack to injection site. 12:05pm patient complaining of shortness of breath; voice changes noted; shaking. 911 called. 12:07pm 1st dose of epinephrine pen given L thigh 12:12pm No improvement noted per patient statement 12:13pm epinephrine pen given R thigh - patient anxious, tearful; reassured by translator. 12:20 paramedics arrived and patient transported.

Patient reported that she had a red, itchy rash on her face and arms. She also reported mild tightness in her throat.

12 hours after injection I was shivering freezing using multiple blankets. When I tried to walk I was very dizzy with blurred vision. I had body aches and a severe headache. My temperature was 104.7 with the thermometer. My breathing was as if I worked out but was just sleeping. I called an ambulance and was taken to health center where doctor took over care.

A few minutes after receiving the shot I began to feel nauseous, almost like being car sick while looking at my phone. I also began to feel tightness in my chest. After my 15 minutes were up I asked the administrator of my shot if it was normal that I felt dizzy/chest tightness. They said it was probably fine and just to monitor my symptoms. I went and sat in my car a few min and I began to feel very strange, it seemed very bright out, I felt weak, and my eyes felt very heavy. I wanted to get home so I started driving but on the highway, my heart beat was very fast and I began to feel like I couldn't swallow. At one point felt as though I might be about to choke so I pulled over because I thought I was going to have to dial 911 as my throat was feeling like it was closing up. I tried swallowing a few times with great effort and after a few minutes the sensation started to lessen. My throat hadn't closed up completely, however it did feel like it had swelled up.

Four hours after vaccine administration , patient started to experience arm soreness, shortness or breath, dizziness, facial numbness, and anxiousness. Patient is to have eaten an estimated 500 calories since 6am in the morning. After providing food, water, Gatorade and ice pack she improved.

-felt extremely fatigued, not able to walk or move for 30 mins after the vaccination -felt a melting sensation -got blood pressure taken and it was normal -extremely faint -tried to slow down breathing with bigger + longer breaths because of the uncomfortable feeling -major nausea after getting up and sitting down again (lasted 2 mins) -nurse said it may be because of low sugar levels, drank coconut water

VS 98 O2, HR 108, BP 132/90 Patient complained of throat swelling mild No increase of work of breathing, tongue or lip swelling, no hives or urticaria, or stridor Given Benadryl 25 mg and responded very well. Was observed and back to baseline in 5 minutes. Observed for one hour.

I've had shortness of breath for the last 3 weeks since I've gotten the vaccine. The day after I've had severe leg pains and sometimes that pain comes but not all the time.

Patient stated after the vaccine she had a fever and was nauseous but all resolved after 24 hours. She woke up today with chest pain/ tightness and stated it is painful to breathe. She was advised to go to the ER.

Shortness of breath (still to this day) Headache Body pain Blister in left side of stomach that resulted in wound. Wound on left lower back with skin coming off from light scratch Severe redness on injection site (left arm) that was hot to touch and lasted for 2 weeks post vaccination.

Shortness of breath, chills, heat flashes, Body aches, headache, sharp leg pain, sharp arm pain, muscle aches, chest pain, joint pain, ear throbbing in left ear, ringing in right ear, fatigue, dizziness.

Difficulty breathing; Hot flashes; Diarrhea; Dizziness; Unable to sleep; Intense Chills; Joint pain; muscle pain; Headache; Nausea; This spontaneous report received from a consumer concerned a 30 year old female. 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, and batch number: unknown expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced difficulty breathing. On 2021, the subject experienced hot flashes. On 2021, the subject experienced diarrhea. On 2021, the subject experienced dizziness. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced intense chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced muscle pain. On 2021, the subject experienced headache. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, hot flashes, diarrhea, dizziness, unable to sleep, intense chills, joint pain, muscle pain, headache, and nausea on 2021. This report was non-serious. This case, from the same reporter is linked to 20210420860.

Resting heart rate of 120 for over 12 hours. It began immediately. Laying down heart rate was between 115-120 I got my injection, a few minutes later my heart was fast, but I left anyway. My heart was fast through the day, but manageable. At night I fell asleep, and woke up 1.5 hours later to a heart rate of 123. I got up to use the bathroom and could barely breathe because it jumped to 140 while walking the 10 feet to the bathroom. My heart stayed that fast until the morning

Shortly after taking the vaccine, I started having some chest tightness, trouble breathing, and was nauseous but thought it was my asthma so I did not report it. It continued to happen and still have more breathing issues than before.

EAR PAIN; EAR SQUEALING; SHARP PAIN ON NOSE; THROBBING PAIN BEHIND EYES; DRY MOUTH; SWOLLEN THROAT; DIZZINESS; BODY ACHES; This spontaneous report received from a patient concerned a 30 year old female. 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: Unknown) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced ear pain. On 25-MAR-2021, the subject experienced ear squealing. On 25-MAR-2021, the subject experienced sharp pain on nose. On 25-MAR-2021, the subject experienced throbbing pain behind eyes. On 25-MAR-2021, the subject experienced dry mouth. On 25-MAR-2021, the subject experienced swollen throat. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ear pain, ear squealing, sharp pain on nose, throbbing pain behind eyes, dry mouth, swollen throat, dizziness, and body aches. 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; TINNITUS; CHILLS; FATIGUE; MUSCLE ACHE; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-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 tinnitus. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tinnitus on 09-APR-2021, and chills, and had not recovered from shortness of breath, fatigue, and muscle ache. This report was non-serious.

The next day I was very fatigue and had body chills and mild fever. On monday I had chest tightness . I was still able to breathe and noticed that this was not normal. I pressumed my day as usual. On Thursday I went to my local urgent care. They performed an EKG, Blood test to rule out infection and blood clots and a chest x ray. All of my test came back NORMAL. My Dr. stated that it was " CHEST WALL MUSCLE PAIN" The CHEST TIGHTNESS WENT AWAY ON SUNDAY. 1 week later from the day of the injection.

Broke out in hives consistently, shortness of breath, throat tightening. Hives are not clearing up. D dimer 1450.

In the ED 3/14/21 Patient states yesterday she got the Johnson & Johnson Covid vaccine. She says that today she started having fevers chills generalized body aches generalized malaise and headache. She says she is otherwise healthy denies any sick significant medical history. She endorses some mild shortness of breath associated as well as some nausea and diarrhea but denies vomiting. IV fluid bolus, acetaminophen and ibuprofen

Covid-19 vaccine given to patient @ 4pm on 5/10/21. Patient started to feel hot within the 15 minute observation period. She claimed she felt well and left coming back to the pharmacy immediately explaining "something was not right." She had trouble breathing, hives, facial swelling, throat swelling, itching, flushing, shortness of breath, chest tightness, throat tightness, anxiety and sweating as well as tachycardia. 911 was called. Epi-pen was provided as recommended by 911 dispatch and per pharmacy Immunization protocol. Fire team arrived and gave the patient O2 and monitored stats. Emergency team arrived and took her to the Emergency room,

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Medium

I felt like I had the flu, I also had tingling , hand pain. and 2 days later I had breathing problems.

Patient was given vaccine, 15 min after receiving the vaccine the patient experienced SOB. Pt stated she has anxiety and asthma. I was going to give her an EPI pen but she denied it. Said she was fine and it was her asthma. I asked if she was experiencing tightness in her chest/throat. She stated no and there was no signs of rash or swelling. Patient took her inhaler and was given water. She was monitored for 15 more min and was fine.

I felt like I could not breath, could not take a full breathe 04/01/2021. Later the same day I started getting a fever, and was very tired. By the next day the fever was high as 102 for a few days with severe fatigue, and short of breathe when walking for 2-3 days after the vaccine. I took over a month to build back up my energy. It took till middle of June till I felt of normal feeling.

Pt states she felt dizzy. EMT got behind pt and pt fell into staff. Pt passed out unconscious with eyes wide open, c-spine stabilized. Jaw clenched shut, held her breath, turned blue, sternal rub performed, jaw thrust maneuver performed. Pt in decerebrate posturing, bladder incontinent during episode. Emergency services called. Pt became alert, hyperventilating, began crying. Staff assisted her to cot. States no previous medical history, no allergies, ate two hours prior to vaccination. VSS, pt continuing to hyperventilate and cry. EMS arrived on site and took over. Placed 20g IV in RAC, drew blood, bgl 122.Pt and all belongings taken to Community Hospital by EMS. Pt was AOX4 GCS 15 at time of tx

Around 8:30p.m. Saturday March 6, 2021 I began to feel chills. I laid down around 9:30p.m to go to sleep. I woke up at 12:25a.m (Sunday March 7th, 2021) with a fever of 104.3 and was experiencing extreme neck and head pain. My hands hurt as if I had arthritis and couldn't make them feel better. I was very short of breath and dry coughing. I took Tylenol and tried to lay back down and was able to go back to sleep around 3:00a.m. I got up at 6:10am and my temp was 101.6. I took Ibuprofen at this point and by 9:30am my temp was 99.8. I was still experiencing a very bad headache and my neck and back were achy. I felt a lot better by about 11:00am, took a hot shower and laid down for a nap around 2:00pm Sunday. When I woke up around 3:15p.m I had spiked yet another fever of 102.0 and was having bad body aches again in my neck and head area and it continued to get worse though my back over the next hour. I was experiencing a dry cough again also but this time it was more constant. It took over 3 hours for my fever to go below 100.0 with alternating Tylenol and Ibuprofen. It finally broke around 7:00p.m. I had a lot of pain in my neck and head the rest of the night. I woke up Monday March 8th, 2021 with a moderate headache but it went away throughout the day. No fever returned Monday. The only time I experienced coughing and shortness of breath was while I had the fever.

Severe constant headache causing lots of pressure. Chills low grade fever body aches fatigue joint pain difficulty breathing at night when sleeping. Difficultly being able to sleep or fall asleep due to excruciating headache and pressure and neck pain

Patient was nervous of taking vaccine then after injected patient started c/o of slight headache, then her head started itching. Reports no shortness of breath, no hives seen , patient was anxious. Patient was not able to take a Benadryl due to driving back home.

Hour 2: numbness in right jaw, numbness in right leg, and abdominal cramping Hour 5: continued numbness in right leg, groin pain Hour 8: chills, shakes lasting 45 minutes), followed by fever for several hours, highest recorded temp of 103.8, took ibuprofen to reduce fever, numbness on right side continued Day 2: numbness on right side, low grade fever, patient stayed in bed and continued taking fever reducers Day 3: numbness on right side, now including arm and back, and abdomen pain brought patient to primary care doctor; strength, pinprick, and vibration tests came back normal. Patient was instructed to return home. That evening patient began experiencing numbness on left side in her ankles, and left calf. Numbness is described as electric pulsation, tingling, and dull feeling. Patient can walk, lift limbs, and control muscles. Patient then experienced breathing difficulties, tightness in chest, sharp pains in chest. Abdomen pain intensified. Mouth numbness and difficulty swallowing. Dizziness grew stronger when patient sat or stood. Day 4: breathing issues and chest pains resolved. Numbness throughout body continued and is described as moving in intensity from one area to another. Often intense in the legs, ?feeling like weights?. Day 5: patient goes to ER seeking answers. ER preforms routine lab work and collects a urine sample to test hydration and electrolytes. Patient shows some signs of dehydration. IV is given. Referred to neurologist.

Severe chills, body aches, low grade fever, slight shortness of breath, mild burning sensation on skin. Lasted for around 3 hours.

Fever, fully body aches, headache, sinus pressure and pain, blackout vision, dizziness, weakness, fatigue, cough to inability to breathe, shortness of breathe, chest pressure and pain, mild left side facial swelling and numbness. Scared to contact emergency services due to cost. Took otc ibuprofen and suffered through night and next day. Slept on and off many hours over weekend. Some improvement but most symptoms still linger.

Progressive Shortness of breath, cough, headache, fever SOB started around 1900 then progressed to moderate/severe by 0430. Benadryl 50 MG PO x 2 doses 1900 and 0440 Albuterol inhaler 1900 Albuterol via nebulizer x2 doses 0430 and 0450 Tylenol 650 MG PO @ 0440

Throat became dry and scratchy during 30 minute wait period in clinic. Patient was kept for an additional 15 minutes, throat felt liek it was closing. The next day, patient had angioedema surrounding bilateral eyes, with more swelling in the Left upper eyelid

Immediate arm pain and muscle cramping around left side of body specifically the diaphragm. Twelve hours past vaccination: Chills, Extreme Body Aches, Muscle Pain, Chest Pain, Shortness of Breath, Headache, Dizziness, Nausea, Extreme Fatigue, Burning Hot but no registered fever.

On 4/5/2021(Monday) patient received vaccine approx. 2pm. Patient noted at 11pm their throat was closing and rash. Patient went to ER but did not wait and decided to take benadryl which help her symptoms. Patient called the Pharmacy 4/9/2021 (Friday) at 6pm and informed us of side effects she was experiencing and stated her throat/skin was itching and hard to swallow . I told her to take benadryl immediately and go to the ER.

difficulty breathing and feeling like "throat is closing" within minutes after being vaccinated. Medics started IV, administered 50mg Benadryl via IV, and transported to ER for further evaluation.

All regular side effects on day 1 + day 2. (Fever, chills, bone and muscle aches, headache). Shortness of breath started the next day on Sunday , extreme, far beyond normal asthma or any asthma attack. Went to urgent care on Tuesday- they said it was likely a side effect of j &J and tested me for COVID, kidney disease other things, all came back negtative. Apparently I wasn?t the first person they had seen with shortness of breath. Blood in cough and spit on Wednesday after 2.5 days of shortness of breath. Dizziness (extreme) throughout and chest pain, sternum hurt, chest tightness. Went to Er. They ran a lot of tests and they too said they had seen others with shortness of breath from j and j. They ruled out many things like pneumonia, a birth control blood clot, any lung diseases with X-rays and blood tests. I was given torkeril to ease the chest pain and tightness which it did. Blood stopped coming up in tissues. Doctor said likely inflammatory reaction to the vaccine in lungs, (I have a piece of paper proving that) and cartilage and sternum., which hurt extremely when he touched it. Blood was likely from burst capillaries from overcompensation from trying to breathe. Recommended I return if more blood came up, which it hasn?t. Shortness of breath has not subsided. I can?t even hold a phone app without being winded. So email back, don?t call.

BODY ACHES; SHORTNESS OF BREATH; LOSS OF APPETITE; SORE ARM; HEADACHE; FEVER; NAUSEA; FEELS VACCINE WAS ADMINISTERED A LITTLE HIGH ON THE SHOULDER; MORE PAINFUL SHOT THAN EXPECTED; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intra muscular and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 11:45 on left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced feels vaccine was administered a little high on the shoulder. On 05-APR-2021, the subject experienced more painful shot than expected. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 05-APR-2021 20:00, the subject experienced body aches. On 05-APR-2021 20:00, the subject experienced shortness of breath. On 05-APR-2021 20:00, the subject experienced loss of appetite. On 05-APR-2021 20:00, the subject experienced sore arm. On 05-APR-2021 20:00, the subject experienced headache. On 05-APR-2021 20:00, the subject experienced fever. On 05-APR-2021 20:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shortness of breath, loss of appetite, headache, fever, and nausea on 07-APR-2021 18:10, and more painful shot than expected on 05-APR-2021, was recovering from sore arm, and the outcome of feels vaccine was administered a little high on the shoulder was not reported. This report was non-serious.

Migraine from hell, lump and redness on arm, feel like I have a cold, fever, and also hard time breathing

Friday 4/9 Shortness of breath Hard to breathe Sore arm Saturday 4/10 Bad headache Sound wheezy MONDAY 4/12 Shortness of breath Left shoulder/chest pain

Extreme fatigue, chills, fever on and off up to 101 degrees. Slight shortness of breath. Started Sunday April 11 at night with extreme fatigue. Monday evening started with chills and fever. Taking Tylenol to reduce fever

PE. Pt was placed on therapeutic Lovenox and supplement oxygen which was weaned off and pt discharged home.

At 6pm, I started feeling nauseous, crampy and then like a ton of bricks I had to lie down. I was shaking uncontrollably with a very high fever and chills for two hours. I couldn't eat. I fell asleep for an hour and woke up feeling terrible- headache, fever, muscle aches, and sweating. The next four days I had a headache and shortness of breath. I am on day 8 now and still feel extremely tired.

Posterior headache, shooting leg pain, short of air, myalgias, muscle spasms, sensativity to touch, decreased energy

The next morning I went to urgent care because I was experiencing really bad chest pains and body aches where an EKG and chest X-Ray were perform and I was released and advised if the symtoms got any worse to come back or got to the ER. For the next week the chest pain persist and got worse. I experienced severe chest pains, struggled with breathing at night, was extremely tired and felt worn out. I had sharp pains throughtout my body so I went to the ER where a EKG and D-Dimer test was perfomed and was advised it was elevated and I left. I went to the ER later that day who checked the D-Dimer who advised it was normal and was I was released from there as well after monitoring. The next day I began having sharp pains in my stomach and diarreah which prompted me to now go to hospital where a CT scan, X-Ray and EKG was perfomed there also which all results came back normal and advised I reach out to a Cardiovascular Specialist for the Chest pains and I have an appointment scheduled for 4/21/21 for further followup on that

LEGS FEEL WEAK; WEAKNESS; NAUSEA; FEELING DIZZY AND DIZZINESS GOT WORSE; MEDICINAL SMELL IN NOSE; BODY ACHE; CHILLS; STANDS AND WALKS AROUND FELT WINDED; LEGS FEELS HEAVY; This spontaneous report received from a parent concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 15:45 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stands and walks around felt winded. On APR-2021, the subject experienced legs feels heavy. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced feeling dizzy and dizziness got worse. On 12-APR-2021, the subject experienced medicinal smell in nose. On 13-APR-2021, the subject experienced legs feel weak. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 11-APR-2021, had not recovered from feeling dizzy and dizziness got worse, medicinal smell in nose, legs feel weak, nausea, body ache, and weakness, and the outcome of stands and walks around felt winded and legs feels heavy was not reported. This report was non-serious.

On March 6, 2021, I received the Johnson and Johnson Vaccination at about 8:15 am. Around 7:00 pm that evening I started to experience the normal symptoms that they had advertised. Yes, I felt like I COVID again for about 48 hours, but nothing alarming. On March 12, 2021, I went to an appointment with doctor due to extreme abdominal cramping and very heavy period. This is not totally out of the norm due to my infertility, but I felt like something was off. I had random abdominal bruising and ruptured cyst pain; which I am still experiencing. She ordered an ultrasound to rule out a mass in my uterus due to the extreme pain and bruising. On March 22, 2021, I woke up at 3:00 am with extreme stomach pain and extreme diarrhea. As the morning went on I began to feel worse and worse. Other symptoms I experienced were; severe headache, shortness of breath, heartburn (I felt like I was having a heart attack), nausea, back pain, and extremely tired. At 6:30 am took me to the ER due to my worsening symptoms. Everything checked out fine and they thought I could have an ulcer, but I wanted to make you aware of these symptoms that I experienced. I still have days that I experience some of these symptoms, but they have been under control and monitored closely.

Saturday 4/10: 3:00 pm- first sign of headache -anxious and fatigued, series of falling asleep and waking up confused 10:41pm: First sign of chills and running ?hot and cold? Sleep was disturbed with intense vivid dreams and waking to sweat and running hot and freezing cold Sunday 4/11: 2:15 pm: Headache, sweating, diarrhea 6:51 pm: experienced confusion, brain fog, muscle tightness all over body Monday 4/12: 8:15 am: Woke up to muscle soreness, brain fog, and stuffy nose with green mucus. Left arm from at injection sight still sore. 8:53 am: Experienced disorientation and concern about safety driving to work 10:53 am: Dizziness and overall feeling of being unwell. Series of running hot and ?clammy? Expressed that everything seemed like a dream-like state. Experienced forgetfulness, confusion and uncertainty. 11:59 am: Ran hot and cold going from sweating to shivering cold. 12:02 pm: Questioned ?what?s real and what?s imagined?, hard to grasp reality. Fatigued, confused and trouble at work concentrating. 12:35- 1pm: Shivering cold, difficulty regulating body temp 2:30 pm: Starting feeling a little better, body temp started to go back to somewhat normal Tuesday 4/13 1:13 am: woke up sweating drenched and anxious, confused and achy. Experienced unusual amount of milky discharge not usually present in between menses. Throughout the day experienced less confusion as before, but still sore and not well overall in general Wednesday 4/14 4:15 am: woke up with major feet cramps, toes curling in without release for over an hour. Intense pain that had not been experienced before with the length of the duration of the cramp in both feet. 7:15 am: Feet cramped on and off, noticed left eye swollen (previously has happened before but not sure reason why). Took a Claritin and drank water to help with the cramping. Experienced immense anxiety about driving vehicle to work due to the muscle spasms now mostly on the left foot. 8:07 pm: Left foot was still cramping up sporadically throughout the day with lingering pain when muscle was relaxed Sleep throughout the night was accompanied by vivid intense dreams and waking up with more cramping in feet, more the left foot now Thursday 4/15 7am: Cramps in feet were still present, decided to check in to an urgent care to check it out 9:30 am: MD Now Urgent care visit- ran urine analysis and blood tests. 10:30 am: Discharged from Urgent care with following diagnosis: Acute cystitis without hematuria, abnormal urinalysis adverse effect of vaccine, initial encounter cyanosis of skin, shortness of breath and protein found in urinalysis. Instructed to immediately get CT angiogram to rule out blood clot. 12: pm Admitted to Mount Sinai Emergency Room-blood work, XRay and IV given. details below Discharged with the following diagnosis: Foot cramps - Primary Local reaction to COVID-19 vaccine Friday 4/16 Subtle and lingering muscle spasm on left food. Experienced chills and consistent headache throughout the day Saturday 4/17 10 pm: Began to run a fever however did not check the temperature. Radiated heat and friend took care of me throughout the night as I sweated with confusion Sunday 4/19 Complete fatigue and tiredness, cramping in the foot seemed to have subsided. Still was running hot throughout the day. Monday 4/20 Took off work due to exhaustion and muscle ache and what seemed to be a fever Thursday 4/23 Followed up with General Practitioner Dr. Franco and was advised to report my experience with the Johnson and Johnson vaccine. Feeling better as of Friday 4/24 with slight fatigue but body temperature seems to be ok. No signs of the lingering cramping in the left foot but still slightly achy all over the body.

after the shot i felt dizzy and blur on my visoin shared with Dr on site she told me these symptoms will go away in three to four days waited for three to four days but symptom got worse i start coughing, runny nose, and chills got negative covid test result and still have the symptoms runny nose, cough and little shortness of breat also pain on my right shoulder and lower back also headach.

Severe migraine headaches, dizziness, painful canker sores on roof of mouth, numbness on right side of body from toes to head, brain fog, light sensitivity, intermittent ringing in ears, nausea, vomiting, fatigue, chills/fever, severe body aches. Went to hospital ER on 4/16/21 - had CT scan, ECG. Returned to ER on 4/17/21 - symptoms had escalated. MRI was performed, she was kept over night for observation. 4/20/21 - back to ER - Abdominal pain radiating to every nerve in body, burning in neck, nausea, throat itchy and closing. Released after more testing. 4/21/21 - Appointment with neurologist who ordered Stat Lumbar Puncture, MRV, MRA, stayed overnight again. Was given and/or prescribed varying drugs to combat pain, swelling, etc.

Got lightheaded intialky. Through out the day I slept b hurt then I woke up short of breath and itchy with a slight rash on my chest. I had but if itchiness in my arms but no sign of rash and she watched me an additional 15 minutes to the original 10. Pharmacist gave me shot in left arm.

Shortness of breath by 12:30am 05/11 2 hours laters chest rash. 12:26pm still some shortness of breath.

I developed shortness of breath about ten days after the vaccine. I felt off when I got up in the morning. I could not finish a sentence without pausing for air. It seemed OK if I was sitting still but if I tried to move I got really short of breath. I went to the ER and they ran tests but they did not find anything. I was discharged and I felt a little better that evening. The following day I still had difficulty catching my breath with activity. On the third day I felt normal with no trouble breathing.

Vertigo within 15 minutes, nausea. Subsided quickly. Within the hour, itchy, swollen throat, flushed, very intense vertigo, shortness of breath. Visited Emergency Room (04/06/2021), treatment was IV fluids, and Benadryl. Told to take Benadryl to within 24 hours, and symptoms did subside. After 24 hours, body aches and chills.

SHORTNESS OF BREATH; BODY ACHES; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced body aches. On 17-MAY-2021, the subject experienced shortness of breath. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches on 16-MAY-2021, and had not recovered from shortness of breath. 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.

Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hyperventilation-Mild, Additional Details: PATIENT FELT DIZZY AND LIGHTHEADED ABOUT 5 MINS AFTER ADMINISTRATION OF THE VACCINE. THEN PATIENT FELT SLIGHTLY BETTER ONLY FOR A FEW MOMENTS THEN NOTIFIED THAT SHE WASN'T FEELING GOOD AT ALL. I TRIED TO HAVE PATIENT ELEVATE HER LEGS UP ON A CHAIR BUT WHEN SHE STOOD UP, SHE IMMEDIATELY DROPPED, ALMOST LOOSING CONSCIOUSNESS BUT I WAS THERE TO CATCH HER AND GENTLY LAY HER ON THE GROUND. THE PARAMEDICS WERE IMMEDIATELY NOTIFIED. PRIOR TO THEIR ARRIVAL, SHE WAS CONSCIOUS AND FEELING BETTER.

- April 3- April 5: fevers over 100 - April 5 - April 11: migraine 24/7 - April 5- April 30: extreme exhaustion, difficulty waking in the morning, completely black out in bed, difficult to breathe when waking up - April 12 - today July 4th: leg tightness/pain and exhaustion easily. Unable to keep up with regular activities without feeling exhausted. Shortness of breath/labored breathing, overall body weakness, unable to talk/walk/breath when it happens. I lie down for hours with an ice pack on my chest. Doctors have ran blood tests, checked for blood clots and everything came back normal. - April 3 - today July 4th: Period has been irregular, ovulation days are unpredictable. Prior to vaccine, I had regular periods and regular ovulation dates.

Patient received COVID -19 vaccine Johnson & Johnson on 7/1/21. On 7/2/21 from an outside facility, patient presented to urgent care with chest pain/tightness, SOB, lightheadedness and fatigue with headache. She was referred to the Hospital ED department for further evaluation. Per ED visit, patient reassessed and feeling better. She felt comfortable discharged home. File this incident for record keeping.

INABILITY TO SLEEP/SLEEPLESSNESS; SHORTNESS OF BREATH ATTACKS; BRUISES ON ARMS AND LEGS THAT SHOW UP OUT OF NOWHERE/ BRUISING BEGAN ON THE LOWER LIMBS AND SPREADING UPWARD; BITTERNESS IN MOUTH; LOSS OF APPETITE; WEIGHT LOSS; DIFFICULTY HOLDING THINGS; FATIGUE/UNABLE TO DO ANY ACTIVITY; CHEST PAIN; NUMBNESS IN ARMS AND LEGS/ NUMBNESS BEGAN ON THE LEFT HAND AND SPREAD TO THE RIGHT SIDE; PAIN IN ARMS AND LEGS; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sjorgen syndrome, familial mediterranean fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and the patient had no known allergies. the patient was not a drug abuse or illicit drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chest pain. On 13-MAR-2021, the subject experienced numbness in arms and legs (numbness began on the left hand and spread to the right side). On 13-MAR-2021, the subject experienced pain in arms and legs. On 17-MAR-2021, the subject experienced inability to sleep/sleeplessness. On 17-MAR-2021, the subject experienced shortness of breath attacks. On 17-MAR-2021, the subject experienced bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward). On 17-MAR-2021, the subject experienced bitterness in mouth. On 17-MAR-2021, the subject experienced loss of appetite. On 17-MAR-2021, the subject experienced weight loss. On 17-MAR-2021, the subject experienced difficulty holding things. On 17-MAR-2021, the subject experienced fatigue/unable to do any activity. On 16-JUN-2021, Laboratory data included: Blood test (NR: not provided) Ruled out clots. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inability to sleep/sleeplessness, fatigue/unable to do any activity, shortness of breath attacks, bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward), difficulty holding things, chest pain, bitterness in mouth, loss of appetite, and weight loss, and the outcome of numbness in arms and legs (numbness began on the left hand and spread to the right side) and pain in arms and legs was not reported. This report was non-serious.

Immediately after the shot was given on Saturday 3/6/21, I felt very nauseas. The nausea continued for the next two days. Body aches, headache, and chills set in same day, in the afternoon. I took Tylenol every 6-8 hours until Monday 3/8/21. Exhaustion, dizziness, and some shortness of breath occurred on Monday 3/8/21. Nausea, headache, and exhaustion is still ongoing but not as intense.

3/6/21 This is a 32-year-old female who is receiving her first Johnson & Johnson Covid vaccine and shortly afterwards developed some throat itching and tightness. She was given a milligram of epinephrine by intramuscular injection by retired emergency physician there and then transported by ambulance here for further evaluation. Says her tongue felt a little swollen as well but she denies any respiratory symptoms. Her voice sounds crackly to her. She denies any pruritus or rashes. She has had multiple allergic reactions to medications in the past but never having to be admitted overnight. One episode however did occur while she was hospitalized and receiving treatment. She has never had to be intubated. She has had isolated urticaria without oral or throat symptoms and vice versa. At this point she says she does feel somewhat better. She is given IV dexamethasone and observed here. At 1 point she complained of it complaint complained of it feeling like a tightening in the back of her throat was worsening. She is given an additional intramuscular dose of epinephrine with epinephrine and on reexamination had no significant change in physical findings or her phonation. This occurred again and she was given viscous lidocaine with minimal improvement in her symptoms. After several hours of observation without objective worsening but continued complaint of feeling increasing tightness in her throat, CT imaging of the neck is performed to assess the soft tissue structures. No abnormalities or indication of significant retropharyngeal or paralaryngeal edema or airway compromise present. Given the possibility of some laryngeal muscle or parapharyngeal muscle spasm as him, she was given Flexeril. After some discussion with her I did indicate to her that I felt it would be safe to return home but offered admission for observation as well. She indicated she was comfortable returning home for continued observation. She will be continued on steroids and antihistamines and is given additional Flexeril by prescription if this does seem to help her symptoms. If no improvement over the next 2 to 3 days and follow-up either with her primary providers through facility or Dr. 3/7/21: Return to ED. The patient is in no respiratory distress. She has no wheezing. On physical exam her throat lips and tongue look fine. I think she is not a had another allergic reaction, rebounded from yesterday. She is not on any type of steroids sinus syndrome with some Decadron. And she is allergic to Benadryl but she can take Claritin if she wants. Her CBC and chemistry were normal. I went back to evaluate her and she still getting fluids and now she is complaining of shooting pain down her left leg from the EpiPen. Again she has this regional complex pain syndrome that could be part of that but there is nothing I can do for this at this time. In terms of her allergic reaction she feels much better her throat feels normal. We will send her out with prescription for Decadron and EpiPen and if she gets worse she will come back and will follow up admit her.

The first day about 10 hours later I got flu like symptoms. I had nausea, chills, stiff muscles- it lasted 14-15 hours. I woke up Sunday morning and had shortness of breathe and have been ever since. I seen my PCP and he sent me for testing to rule out Blood clots and that came back ok, but I'm still having the shortness of breathe. If I get worse he advised me to go to the ER and if im not feeling better to call him in three days.

Patient woke up in the middle of the night with swelling in the face, tachycardia 125-130 bpm, BP 142/90, achy joints, sore throat, labored breathing, chills, nausea, fever 102.7

"increased fatigue, mild cough shortness of breath, headache and then some isolated left leg pain. Patient denies any trauma, any swelling, nonpainful to the touch no difficulty walking or specific joint pain. Patient has no prior history of blood clots or DVTs, not currently on OCPs"

Severe body aches, weird taste in mouth, chest tightness, difficulty breathing, fever, chills, the next day I think I hallucinated during the fever and extreme body aches. Most symptoms lasted 24 hours but the rest of them continued.

At approx 23:31 03 Apr 2021 I experienced uncontrollable shaking and muscle rigidity. This lasted approximately 1 hour where upon I began to experience chills and extreme coldness. Approximately 1 hour later at approximately 01:30 I began to experience a spike in temperature around 101/102 degrees. I began experiencing shortness of breath, cough and congestion with rapid onset of nausea . Around 02:30 I had rapid onset increased heart rate, sweating, and severe headache. This lasted until approximately 07:30 on 04 Apr 2021. Upon waking I continue to experience low grade temperature around 100.4, moderate headache, joint and muscle pain, moderate fatigue and nausea. I took 2 Tylenol arthritis beginning at 08:00 on 03 Apr 2021 and repeated every 8 hours to current time of 17:00 on 04 Apr 2021. I have also taken meloxicam QD in addition to my rescue inhaler Xopenex and Zofran ODT for nausea.

Approximately 5 minutes after her Janssen COVID19 vaccine the patient started coughing and felt her throat tightening. I had her sit down and told her I was giving her an Epinephrine 0.3mg shot. The shot was given in her left thigh and within a minute her throat cleared. I gave her a bottle of water. She said her heart was racing but it eventually slowed down. I asked her if she wanted me to call 911, she felt it was not necessary. Patient sat in our waiting room & checked in on her every few minutes, her symptoms improved. Patient was here over 45 minutes. She wanted to go & felt fine. I told her to call us or go to the emergency room if any problems arise.

Pt received the vaccine where patient started to have Chest Pain, sob, and dizziness. Ems was called to pt's bedside. Pts symptoms continue and patient wished to be seen in ER. EMS took patient as requested.

about 12 hours after receiving vaccine, I experienced EXTREME cold. My body could not get warm. I shook violently all over my body. I took tylenol. Then, I experienced extreme heat and could not get cold. I felt like I had a fever and took some tylenol. I did not take my temperature. I started experiencing chest tightness. It feels funny in my chest like I cannot breathe fully. Everything has gone away except for the chest tightness.

Sudden fever, body aches, uncontrollable shaking (like shivering/chills, but more intense), headache, nausea, shortness of breath about 9 hours after vaccine injection. These symptoms lessened about 4.5 hours after they started, but the headache, fever, and chills lasted into the night. More mild headache, nausea, and sensitivity to light continued the day after the vaccine.

within 5 minutes of immunization: syncope, nausea later that day: feeling winded, lessened syncope and nausea overnight: fever 103 F, chills, body aches, headache continuing through today: occasional, mild lightheadedness, nausea and feeling winded

FEVER, CHEST PAIN THAT HAS NOW LASTED 8 DAYS, SOB THAT HAS NOW LASTED 8 DAYS, CHEST TIGHTNESS THAT HAS NOW LASTED 8 DAYS. HEADACHE

Approximately 15 minutes after receiving the Covid 19 Janssen vaccine, while sitting in the observation area pt c/o of feeling SOB. Vital signs B/P 125/77, HR- 125, RR 30, O2 Sat 98% RA, No c/o pain. Pt consented to be moved to urgent care for further evaluation. Pt observed approximately 1 hour in the Urgent care and seen by urgent care provider. Pt declined breathing treatment and signed out AMA d/t pt stating she felt better and tachycardia resolved. Last V/S documented at 11:39 am were 101/49, HR 114, RR 24O2 Sat 95% RA.

7:00 pm Friday started getting left arm: numbness on whole left side of body, left side of face swelling and droopy. Felt a sharp pain in left arm near basilic vein and started swelling like a ball. Felt shortness of breath and dizzy with blurry vision. Almost passed out when stood up. Was rushed to the ER. Had Sharp pains shooting through left leg.

Received vaccine at 3pm on 4/8 and adverse event happened the morning of 4/9. Leg cramps/pains, dizziness, shortness of breath, weakness, and fatigue. I passed out in the morning at a doctors appointment and took a couple minutes to get back consciousness. All color was drained from my face for hours and had to receive 2 bags of fluid. Still getting dizzy/light headed 5 days out from the vaccine.

Felt extremely faint after the vaccine was administered. Muscle weakness and hyperventilation. Within 6 hours of vaccination extreme fever and chills were experienced along with nausea. The next day I experienced the worst headache of my entire life. I could not think or get out of bed. I also had numbness and tingling in my legs. The headache persisted for 5 days, alone with muscle weakness and nausea. Numbness and tingling were intermittent.

I?m addition to the flu like symptoms (severe cold chills, severe headache, weak/fatigue, fever, body aches and soreness at the injection site). The flu like symptoms were so severe I had to take an ibuprofen to nurse my baby. I, then, experienced tingly, numb legs followed by pain. I got up to try to walk it off and had shortness of breath. Put on compression socks but the restless leg and shortness of breath continued for 3/4 hours.

Janssen COVID-19 Vaccine EUA Patient received Janssen vaccine 4/9/2021. Patient presented to ED 4/14/2021. Patient is a very pleasant 32-year-old female, with past medical history significant for taking bromocriptine for prolactin issues as well as metformin for type 2 diabetes, presents to the emergency department for evaluation of continued headache over the last 1 week. Patient also reports chills, sweats, body aches ever since receiving the Johnson and Johnson coronavirus vaccination 1 week ago. The headache started after receiving the vaccination and has been continuing ever since. It does not fluctuate in intensity. It is caused her blurred vision and difficulty focusing. No tinnitus or hearing loss. No slurred speech, vomiting, numbness or weakness or tingling to the extremities or any facial droop. No history of strokes or aneurysms. She is not on blood thinning medication at all. No upper nor lower extremity swelling or redness. No abdominal pain, nausea, vomiting or diarrhea. She reports the continued subtle shortness of breath and body aches since the vaccination as well. No rapid heart rate, long flights, long car rides, surgeries nor oral contraceptive use. Patient started on heparin drip. Neurologist recommended transferring patient to higher level of care. emergency department physician is willing to accept the patient at their facility. Patient transferred to the facility.

bruising, shortness of breath fever severe headaches joint paint , bloody noses, left leg pain, body aches

The patient presents to Urgent Care today with complaint of fever and dry cough x7 days. She had the J&J covid vaccine on 4/9 and began not feeling well on Saturday. She developed a fever and chills and tachycardic. She said every day since then her fever has been going up and down. She started to vomit on Sunday, last time she vomited was Monday night. She was having diarrhea as well. She denies rhinorrhea or congestion. She denies throat pain. She went to the ED on Tuesday and she was given fluids. She said she felt a lot better on Tuesday when she left the ED. She said now she feels bloated. She does have an appetite but because she feels full she isn't eating a lot but states she drinks 1 gallon of water a day, her water bottle is with her. She is having some sob. She denies chest pain. She has bilateral lower back pain when she is sleeping. She took anti nausea meds which did help. She has been taking ibuprofen.

Severe headache, nausea, diarrhea, tachycardia, shortness of breath, fluid in lower lobes of lungs, elevated O BNP, high temperature >103. Blood pressure increased

DIFFICULTY IN BREATHING; SPLITTING HEADACHE; This spontaneous report received from a patient concerned a 32 year old female. 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: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced difficulty in breathing. On APR-2021, the subject experienced splitting headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from splitting headache, and the outcome of difficulty in breathing was not reported. This report was non-serious.

4/5/21: Office visit for myalgias, headache, and localized swelling/erythema to injection site (left deltoid). Bactrim DS prescribed for possible infection with symptom management. 4/13/21: Office visit for continued myalgia as well as chills, malaise, abdominal pain, N/V/D and dizziness. Decadron 10 mg IM given in office and prescribed prednisone. 4/14/21: ED visit for headache and shortness of breath. CTA chest, CT head, UA, urine pregnancy, D-dimer, Chem 14, and CBC done. Diagnosed wtih episodic tension headache and abnormal CT chest (6 mm ground glass nodule to upper left lung). 4/15/21: Office visit with c/o fatigue, dyspnea with moderate exertion, allergy symptoms, and headaches - follow up from ED for abnormal CT results - informed inflammation, infection - will repeat CT in 3-6 months. Prescribed Z-Pak, medrol pak, and promethazine.

TROUBLE BREATHING; NECK PAIN; BLURRY VISION; DIARRHEA; DIZZINESS; COUGH; FEEL SICK; WEAKNESS; NAUSEA; ALLERGIES; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included she had no history of allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13/JUN/2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced allergies. On 11-APR-2021, the subject experienced cough. On 11-APR-2021, the subject experienced feel sick. On 11-APR-2021, the subject experienced weakness. On 11-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced diarrhea. On 13-APR-2021, the subject experienced dizziness. On 15-APR-2021, the subject experienced neck pain. On 15-APR-2021, the subject experienced blurry vision. On 17-APR-2021, the subject experienced trouble breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, dizziness, neck pain, blurry vision, trouble breathing, cough, allergies, nausea, diarrhea, and feel sick. 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.

Overly tired, shortness of breath, chest pain, leg pain After 3wks of symptoms patient(self) went to hospital and it has been discovered patient has ( self) has a blood clot in Right lung. Patient (self) has no record or history of blood clots. Was treated with heparin while in hospital. Has since been discharged and sent home with a prescription for anticoagulant.

Patient is a 32-year-old female new patient 5 months post partum & currently breastfeeding, with seasonal and perennial allergic rhinitis and history of childhood asthma, referred by the emergency department to discuss anaphylaxis like reaction to the Johnson Johnson COVID-19 vaccination on 4/28/21. She received her vaccine around 2:00 p.m. She began developing itchiness in her palms/soles of feet and scalp that quickly developed into a a welt like rash about 3-1/2 hours after receiving the vaccine while on a walk with her husband; this was shortly followed by facial swelling over her right eye. They made it home and she got in a cold shower to cool down, became dizzy, started seeing spots and had difficulty breathing. Her husband called EMS and she was hypotensive when they arrived. She was given 2 doses of epinephrine (0.2 mg each per ED note) and a dose of Benadryl which helped. Shortly after the 2nd dose, she began having difficulty swallowing, maintaining the ability to breathe through her nose. She was given a 3rd dose of epinephrine and transferred to the ED; during transport an IV was started with an epinephrine drip. She was seen at Emergency Department; she was given IV fluids, solu medrol, tryptase level and had a normal EKG. She was discharged with an epi pen prescription. Tryptase is still pending at the time of her visit. She started a new prenatal vitamin at 11 am 4/28/21. Otherwise, she reports no new foods, medications or topical products. She did eat before going on a walk, pepper jack cheese, wheat thins, and black bean hummus. She is pretty sure she was not stung by a bee prior to onset of symptoms yesterday. Interestingly she reports recent urticarial episodes that occurred in February of 2021. These occurred when she was visiting her in-laws and occurred in the middle of the night, 2 nights in a row during the middle of her visit. She has never had hives previously. She reports no family history of hives or anaphylaxis. She reports no use of new topical products or medications.

Within 17-20 minutes of receiving the vaccine, I felt a burning, hot sensation in my throat. I let paramedics know and sat for about 10-15 more minutes. My mouth and throat became extremely dry and I had a tingly feeling in my feet. I also experienced high anxiety. An ambulance came and proceeded to bring me to the nearest hospital. In the ambulance, I began coughing, which caused tightness in my lungs and moments of needing to cough. My vitals were normal in the ambulance and I was given IV fluids. I arrived at the hospital around 4:30 pm. When checked by triage about 2 hours later, the nurse reported my vitals were normal, and that I shouldn't need epinephrine or lab work. She reported that "hopefully a triage doctor would be able to see me soon." I continued to cough into the evening, and began wheezing from coughing. I waited in the ER waiting room until just before 10pm. Triage could not give a time estimate of when I could be seen. I needed an inhaler or nebulizer treatment long before. I left the hospital after the nurse removed the IV port. At this time, the nurse reported my "rash on my chest was gone," although she did not mention a rash earlier in the evening and I did not notice it (had a jacket on). I did not need to sign or receive discharge paperwork because I was never seen by a doctor. I took Benadryl and gave myself a nebulizer treatment once I got home and all adverse reactions were gone the next morning. I experienced flu-like symptoms the next day.

Approximately 12 hours after injection, I began to experience heart palpitations, heart racing and shortness of breath. This went on for several hours before finally falling asleep. The day following the injection, more and more symptoms began to arise such as muscle soreness, cold/hot sweats, low-grade fever (99.5%), chest pain/pressure, sweating, dizziness/disorientation and a headache. Monday night I experienced the low-grade fever however after going to bed, woke up around 5AM barely unable to stand, very disoriented and upon taking my temperature, I took note that I had a fever of 100.9%. Today, Tuesday May 11th, I am experiencing chest pain/pressure, low-grade fever, headache and am lethargic.

About 2 minutes after receiving the vaccine, while parked, I started getting very light headed, felt dizzy, and my heart starting beating extremely fast, and then slowed down and started beating very very hard, and felt like it was going to pound out of my chest. I then had a warm sensation in my throat and started feeling like it was getting harder to breathe. I rolled down my Window, and looked for someone to wave over for assistance, but there were cars in the way, so I closed my eyes and focused on breathing deep and slowly to see if that would make it any better. After about 5 minutes my heart rate went back to normal, I felt I could breathe normally, and wasn't so light headed anymore. I should have reported this to someone when they told me I could leave, but I wasn't sure if it was an actual allergic reaction. Or if it was just a stress reaction. I felt like I should at least report it here, because I was completely fine before the injection, during the injection, and right after, until about 2 minutes after being parked.

I experienced chest pains, felt like hard time breathing, little cough that felt like an asthma attach but not quite. I've had PE blood clots I went to urgent care on 04-23-2021, where they did CT scans of the chest and upper abdomen and lab work and my exams were negative. I can say today that I have recovered from my symptoms.

My whole body tensed up and I began shaking and my arms and legs pulled up into the fetal position and I couldn't breathe all I could do was stare. It felt like a seizure.

swelling in face swellling in arm swelling in legs swelling in gums, lips, tongue swelling in nose swelling in throat intense pressure behind eyes and in gums (feels like my teeth are shifting from the intense pressure) intense fatigue and purple around eyes relentless palpitations that last 24+ hours entire body swelling 24/7 visible swelling in my lips and tongue for over a month my entire body has become hypersensitive and allergic to things that were previously safe for me like shampoo, conditioner, deodorant, makeup, and toothpaste new things keep happening, but this is where i?m at right now

02:20 Patient received Ist dose of Janssen. 02:24 Patient complained throat felt like it was closing and difficulty breathing, audible wheezing and stridor. Given Epi Pen 0.3mcg IM Right thigh. 911 called. 02:26 Given 25 mg of liquid Benadryl PO. 02:30 BP 140/94 Pulse 96 RR 26. 02:34 EMTs arrived BP now 100/60 Pulse OX 97% Pulse 85. 02:40 Walked out by EMT and Paramedics to the ambulance.

After getting the vaccine I experienced a breathing problem, it felt like my neck was being squeezed.. A month after the vaccine it felt like it was getting worse. I went to the doctor and was told that my lymph nose was swollen.

After the vaccine, my chest started hurting. Doctor mentioned that I had heart arrithmyia. Ever since I had the vaccine I've had chest pains and shortness of breath. Like, if I try to carry something up the stair in my home, I get really winded.

TACHYCARDIA IN 220'S, SHORTNESS OF BREATH, HIVES,DIFFICULTY BREATHING, AIR WAY CLOSURE: occuring approximately 45 minutes after injection. EMS was called and Benadryl was and EPI on hand. Primary care order Epi on hand prior to vaccine appt and Benadryl to be taken.

Chest pain, shortness of breath, fever, chills, headache, body aches, canker sores, and exhaustion within 12 hours of short. Within 24 hours, spotting, continued fever, body aches, sore throat and sinus congestion. Exhaustion, chills, canker sores and sinus pain have continued. Bruising and sore arm

Yesterday I got the Johnson and Johnson vaccine. I was the last appointment, so they observed me for 5 minutes, and I left. After riding in the car for a few minutes, I noticed that I was having a hard time breathing and my throat felt like it was starting to swell. By that time, the clinic was closed, so I went to the emergency room just in case and sat in my car since they didn't allow people to sit in the waiting room because if covid. It started becoming increasingly difficult to breathe, and I was feeling more and more swelling of my throat and tongue. I was having a lot of dizziness, nausea, facial flushing, palpitations, and some mild confusion. I then started getting numbness in the bottom half of my face. Over time, the numbness spread, mostly staying on the left side of my body (face, scalp, lower arms and legs, left side on tongue and inside of mouth). I also started getting a prickling burning pain sensation for brief periods of time where I had numbness. I had decided that if my breathing worsened at all, I would go to the er even though I can't afford it. After about an hour and a half, my breathing started to feel less constricted and like there was less resistance. The swelling in my throat was mostly in the upper throat where I had difficulty swallowing but not as much difficulty breathing. The numbness continued to get worse and was sometimes disappearing and reappearing in the same spot. At 9:30 pm we went to go get some benadryl. I continued feeling less and less swelling and having an easier time breathing. At that point, I went home. Once I was home, my breathing continued to improve and the numbness started to dissipate. In the middle of the night, I started itching and getting widespread hives and getting a sharp burning pricking pain that would last a few seconds in different areas. The numbness also started coming back mostly in my face. I continued to have difficulty swallowing. I am feeling much better today. I still feel some slight swelling in my throat when I swallow, but my breathing is fine. I'm still itchy and occasionally breaking out in hives. Im having mild lower facial numbness. I'm also starting to get the normal side effects of fever, headache, arm soreness, and body aches. I'm taking benadryl every 4 hours.

Facility held offsite vaccine pod on 03/18/2021 and offered Janssen Covid19 vaccine. Pt. had reported past hospitalization due severe allergic reaction to Sulfa drug. She received the Covid vaccine at approximately 11:25 AM and was directed to waiting area where she would be watched for 30 minutes. After 5 minutes, at approximately 11:30 AM, she alerted the waiting area monitor (who was an ER nurse) that she felt her throat was closing up and she was struggling to breathe. 911 was notified. BP was 140/82, P 80. EpiPen 0.3 mg ( Lot # 0FM411 Exp: 01/31/2022) administered left lateral thigh. Transported to local hospital ER. Assessed, treated, and released home

After receiving the Janssen vaccine, patient was admitted to the ED within 8 hours for dyspnea upon exertion and breathing. Labs were all within normal limits (CBC, Troponin, CMP, TSH, HCG). Patient was later discharged for follow up with primary care.

Starting the around 10 pm the evening of my vaccine, March 6, I had chills. When I woke up in the morning I had a headache, muscle aches, slight difficulty breathing with chest heaviness, and fatigue. At 2 am on March 8 I awoke with dizziness and room spinning, sweating, weakness and lightheadedness, and nausea. Later that morning most of the symptoms subsided except for slight lightheadedness. By March 9 all side effects had resolved.

No Epipen given. Patient was hyperventilated. EMS was onsite and transported to hospital in abundance of caution.

Shortly after receiving the vaccine, patient complained of coughing, shortness of breath, neck pain. HR=119 and unable to auscultate blood pressure. C/o warmth and feeling of throat swelling, burning in throat after coughing. Patient was placed on floor initially supine and then onto right side. Bluish discoloration around eyes and lips, and encouraged patient to use her inhaler. Ox reading 98% after a few minutes. EMTs present and took blood sugar, 87 and given dextrose orally followed by water. Patient stated that she had a donut and waffle for breakfast. Encouraged to eat lunch with some protein. Relayed that she had an ablation and tubes tied last week. Received allergy shot recently but not new formulatin. She also mentioned that she received a steroid injection for her migraines.

Tachycardic and anaphylactic shock. Heart beat over 140 out of the blue while laying on couch, throat felt like something was lodged in it, Voice became very raspy, felt out of breath.

Approximately 13 minutes after the vaccine was administered patient reported feeling faint. She was sweaty, shaky, hyperventilating, tingling in her fingers and reported a rapid heart rate. Patient was able to speak in full sentences and answer questions. The pharmacy team immediately called 911. The pharmacist assessed the patients symptoms and determined the patient was not experiencing anaphylaxis as she was not experiencing swelling or throat closure. No emergency medications were administered. The patient layed down on her back and elevated her feet. The EMT arrived within 5 minutes and assessed the patient. Patient was taken to the emergency department.

About 15 to 20 mins after receiving shot, patient experienced difficulty breathing, brief blurry vision and difficulty hearing. Was given some water to drink, and EMT was called. After drinking some water patient felt better. Blood pressure and pulse were checked - both were within normal limits. Patient mentioned not having drank or eaten anything prior to appt. She felt better at the time when EMT arrived about 10 minutes later. EPIPEN administration was not necessary. Mother was present and helped patient home. Adviced patient to get something to eat.

103.5+ temp, uncontrollable shakes, headaches, vomiting for 7 days, cough, difficulty catching breath

"Janssen COVID-19 Vaccine EUA" This writer was having a session with a client and her mother at the playground on 4/8/2021 and writer felt weak towards the end of session. Per mother's report, writer's eyes rolled back into her head and writer was about to fall backwards off the picnic table, but the mother caught writer. This writer was unconscious and then came back alert, but could not see for two minutes. This writer experieced severe abdominal pain and needed to use the restroom right after and had a bowel movement. dehydration (J & J vaccine night before at7pm) headache, difficulty breathing and blurred vision and a fever of 99.4 the next day. This writer was taken to immediate care and an EKG and Urine test was done. This writer was diagnosed with Syncopal Episode and dehydration.

3/22/2021 5pm- Received shot ~10pm- adverse events started.As I was falling asleep, it started with restless legs. Quickly, I was shaking so violently I couldn't control my body. I made it to the shower to try and relax my muscles. My heart was uncontrollable and I had difficulty breathing. 4/4/2021- 4/5/2021 Woke up at night shaking similar to the first time, but not as terribly Low-key nausea and shortness of breath, fatigue, dizziness and weakness have been constant.

PATIENT RECEIVED JANSSEN VACCINE ON 4/9/21. 10 HOURS POST-DOSE PATIENT REPORTS FLU LIKE SYMPTOMS AND 4 EPISODES OF SYNCOPE. SHE THEN REPORTS PAIN IN LEGS AND ABDOMEN. ULTRASOUND OF LEGS WERE NEGATIVE FOR BLOOD CLOTS. TODAY 4/14/21 SHORTNESS OF BREATH HAS NOT IMPROVED AND PAIN IN LEGS IN ABDOMEN HAS NOT IMPROVED. PATIENT IS GOING TO ER FOR EVALUATION.

Lower extremity swelling, leg pain, burning in the ankle, chest pain, shortness of breath, shoulder blade pain

The day after receiving the vaccine, I experienced common side effects of fever, chills, body aches, and nausea, which lasted for 24 hours, and then I felt better. Then, 3 days after receiving the vaccine, I suddenly began to have extreme stomach pain, so bad that I could barely walk or stand up straight. My chest felt tight and I had shortness of breath. I thought about going to the ER, but called my GI specialist instead as I thought it could be related to the Xifaxan I was taking, but the office was already closed. The GI office called the following Monday and said the Xifaxan should not cause extreme stomach pain and to go to the ER if it persists, but by this time I was feeling much better. The severe pain lasted two days in total.

Got my vaccine on Saturday 04/10, today 04/14 I start feeling pain in both of my arms this morning, is a weird feeling like I feel my veins, I had a hearth pain, as soon as I wake up I felt a headache, I had it all day, on the left side of my head and after on the back area, it stoped around 6 pm, in the day I had diarrea, fatigue, pain in my joints, shortness of breath, pain in my arms and in my legs, itchy skin .

SHORTNESS OF BREATH; LIGHT HEADED; NECK PAIN; TACHYCARDIA; BURNING IN THROAT; THROAT SWELLING; NAUSEA; This spontaneous report received from a health care professional concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubes tied, and ablation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported,1 total administered on 07-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021,15 to 20 minutes after getting vaccinated the patient experienced shortness of breath, nausea, light headed, and neck pain and there was a burning inside the throat and swelling started as well. The patient also reported tachycardia at 119. Laboratory data included: Blood pressure (NR: not provided) 98/60, Heart rate (NR: not provided) 119, and Pulse oximetry (NR: not provided) 99. Treatment medications (dates unspecified) included: glucose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, nausea, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210414577.; Sender's Comments: V0: 20210414557-covid-19 vaccine ad26.cov2.s-shortness of breath, light headed, neck pain, tachycardia, burning in throat, and throat swelling. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).

PATIENT SEEN IN THE EMERGENCY ROOM WITH SHORTNESS OF BREATHE, INCREASED BLOOD PRESSURE, INCREASED HEART RATE, HEADACHE, RECTAL BLEEDING AND VOMITTING BLOOD. SYMPTOMS STILL UNRESOLVED.

I was 9 months pregnant at the time of the vaccination. My due date was April 3, 2021. The actual date of delivery was March 20, 2021 by C-section. I gave birth to a son weighing 8 lbs 6 oz. I had no complications during this pregnancy. I left the hospital on March 22nd. On March 25, I was experiencing shortness of breath and a low pulse (35 bpm; my usual pulse is in the 50s-60s). My OBGYN told me to go to the emergency room, where they did a CT scan. The CT scan showed a small pulmonary embolism. I was in the hospital until March 27th, where I was treated with Heparin and then was released with Lovenox injections. I am currently on the Lovenox. After seeing the pulmonologist for a follow-up appointment, he advised me that I would be able to stop the injections after 3 months.

NECK WAS SWOLLEN IT WAS GIVING UNDER CHIN; DIZZINESS/LIGHTHEADEDNESS; RED ITCHY RASH UNDER THE BELLY BUTTON AND NECK; SHORTNESS OF BREATH; LOSS OF APPETITE; TIREDNESS; FEVER; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced neck was swollen it was giving under chin. On APR-2021, the subject experienced dizziness/lightheadedness. On APR-2021, the subject experienced red itchy rash under the belly button and neck. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-APR-2021, had not recovered from red itchy rash under the belly button and neck, and the outcome of neck was swollen it was giving under chin, dizziness/lightheadedness, shortness of breath, loss of appetite and tiredness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425148.

THROAT SENSATION LIKE TICKLE; COUGH; SHORTNESS OF BREATH; LIGHT PRESSURE ON CHEST; FELT LIKE HAVING AN ALLERGY; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included anxiety, and endometriosis, and concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced watery eyes when treated with ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced throat sensation like tickle. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced light pressure on chest. On 10-APR-2021, the subject experienced felt like having an allergy. On 12-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. Laboratory data (dates unspecified) included: Laparoscopy (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt like having an allergy, throat sensation like tickle, and injection site pain, and had not recovered from cough, shortness of breath, and light pressure on chest. This report was non-serious.

Severe headache that lasted 12 days. Tachycardia that lasted 8 days. Resting heart rate would jump from 70 to 115 while sitting and would feel pounding heart and that I couldn?t catch my breath.

SHORT OF BREATH; FATIGUE; HEADACHE; GENERALISED ACHING; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.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, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: ibuprofen. On 11-APR-2021, the subject experienced generalised aching. On 24-APR-2021, the subject experienced short of breath. On 24-APR-2021, the subject experienced fatigue. On 24-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalised aching on 12-APR-2021, and had not recovered from fatigue, headache, and short of breath. This report was non-serious.

Patient received COVID J&J vaccine on 4/6, Presented to ED on 4/27/21 with complaint of 3 days of increasing leg pain and SOB

24 hour normal vaccine reaction (fever over 101, chills, fatigue, etc). Extreme sensitivity to caffeine (no sensitivity experienced before) Shortness of breath and dizziness, feeling of constriction in chest, worst in first week after vaccine also accelerated by caffeine intake. Symptoms lessened after stopping intake of caffeine, but are still present when exercising or stressed in third week. Seem to be lessening over time.

I was very ill on Friday night after receiving the vaccination. Flu-like symptoms, high fever, shortness of breath, pain in my abdomen, horrible headache, nausea, dizziness, loss of consciousness and leg pain (both legs). The flu-like symptoms passed on Saturday, but by Tuesday, April 13 I was continuing to have a terrible headache, abdominal pain and leg pain. I saw my primary doctor on the 13th and was sent over to the hospital for an ultrasound of my leg. No clots were found and I was told to continue trying to recover at home unless it got worse. I was seen at the emergency room on April 14th for abdominal pain, leg pain, dizziness and headache. The nurse told me I was probably hysterical over the vaccination being pulled, and I told him this was not the case. They performed CT (without contrast) on my abdomen and head, then released me with instructions to return if I was worse. By the 16th I was unable to walk as my left side was completely numb. I went back to the ER. I had a CT of my abdomen and head with and without contrast. I had a lumbar puncture and several labs. I was given IV antibiotics for some infection they found in my urine. I was given fluids and pain meds, and my BP was shooting up to 145/94 (which is very high for me), when standing. My vision was blurry and I was unable to remember much of the last week. I was admitted from the 16th through the 20th and had an MRV, 2 MRIs, more lab work and medicine for my headache. I was released on the 20th and the headache was unbearable and I was still numb on my left side, going back to my doctor on the 22nd. He suggested the ER, and the ER admitted me back to the stroke unit. I was released on the 22nd with a diagnosis of a hemiplegic migraine that could cause stroke-like symptoms (ZERO history of headaches previously). I was sent home with a walker and home health services. PT visited on April 30th and ordered two visits per week for the next month. I am unable to walk without a walker. I cannot shower or use the stairs without assistance. My memory is still foggy. I am unable to concentrate for long. I often stutter and can't remember basic words. I have also stopped and forgotten where I am at a given moment. I am on Depakote nightly for the headaches, and they have lessened slightly, but when they flare up it is debilitating and I often vomit. I have instructions to follow up with my primary tomorrow morning and see what the next steps are.

TREMBLING; BOTTOM OF FEET PAINFUL; BAD/SEVERE HEADACHE; EXTREME FATIGUE; SWELLING AROUND MOUTH; SWOLLEN HANDS AND FEET; ITCHY ON THE TOP FEET WITH RED BLOTCHY RASHES; NUMBNESS AND TINGLING SENSATION AT LEFT SIDE OF EXTREMITIES AND BODY; SWOLLEN THROAT; SEVERE SHARP STOMACH PAIN; TINGLING AROUND MOUTH; SEVERE SHARP CHEST PAIN (STERNUM AREA); SORE THROAT; DIFFICULTY IN BREATHING; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight was 130 pounds, and height was 169 centimeters. The patient's past medical history included surgical removal of left ovary and fallopian tube, and cyst in ovary, and concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 7/10. On 10-APR-2021, the subject experienced severe sharp chest pain (sternum area). On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced difficulty in breathing. On 10-APR-2021, the subject experienced tingling around mouth. On 10-APR-2021, the subject experienced swollen throat. On 10-APR-2021, the subject experienced severe sharp stomach pain. On 11-APR-2021, the subject experienced swelling around mouth. On 11-APR-2021, the subject experienced swollen hands and feet. On 11-APR-2021, the subject experienced itchy on the top feet with red blotchy rashes. On 11-APR-2021, the subject experienced numbness and tingling sensation at left side of extremities and body. On 11-APR-2021, the subject experienced bottom of feet painful. On 11-APR-2021, the subject experienced bad/severe headache. On 11-APR-2021, the subject experienced extreme fatigue. Treatment medications included: bismuth subsalicylate, diphenhydramine hydrochloride, famotidine, and ibuprofen. On 12-APR-2021, the subject experienced trembling. Laboratory data included: Fibrin D dimer high (NR: not provided) elevated, and Platelet count (NR: not provided) Normal. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal. On 14-APR-2021, Laboratory data included: CAT scan (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe sharp chest pain (sternum area), sore throat, swelling around mouth, tingling around mouth, itchy on the top feet with red blotchy rashes, and severe sharp stomach pain on 13-APR-2021, difficulty in breathing, swollen hands and feet, numbness and tingling sensation at left side of extremities and body, swollen throat, bottom of feet painful, bad/severe headache, and extreme fatigue on 20-APR-2021, and trembling on 16-APR-2021. 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.

Sts felt fine after vaccination but 1 week later started having severe debilitating fatigue lasting several days. then on the 16th started having SOB, dizziness, feeling out of it, shakiness, eye twitching. Went to Emergency room x3 and was given steriods which helped. Also given inhaler - QVAR which helps but needs it more than twice a day. Was placed on heart monitor and is being seen by pulmonary specialist.

BODY ACHES; HARD TO BREATHE; DIZZINESS; HIGH HEADACHE; LOW HEART RATE; MIGRAINE; This spontaneous report received from a consumer concerned a 33 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced migraine. On MAY-2021, the subject experienced low heart rate. Laboratory data included: Heart rate (NR: not provided) Low. On 07-MAY-2021, the subject experienced body aches. On 07-MAY-2021, the subject experienced hard to breathe. On 07-MAY-2021, the subject experienced dizziness. On 07-MAY-2021, the subject experienced high headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from migraine, and the outcome of high headache, body aches, hard to breathe, low heart rate and dizziness was not reported. This report was non-serious.

Patient stated that she was having problems breathing, sweating and felt tingling all over. She said she felt she had a tight chest. An emergency response was called and the patient blood pressure, pulse and O2 was checked and was normal. She was given an ice pack to the back of the neck and stopped sweating. Upon questioning, she had not eaten anything all day and had only drank some pepsi and milk the day. Within 20 minutes she feeling much better and said she was feeling normal again. She was checked by a provider to make sure everything was ok.

I have been taking Benlysta infusions for 5.5 years and I have never had an allergic reaction until 5/25/21. The only thing different in my body was the Janssen Vaccine. Midway through my IV I started itching, numbness in my fingers, lips, and feet. My face was on fire and my tongue was swelling and I could feel my throat closing. My arms turned red and blotchy and swelled. My nurse stopped the Benlysta and started Benadryl and a saline flush. The symptoms then went away.

I received the Janssen vaccine on 4/8/21 at 12:00 pm. By 5:00 pm that day I began having flu-like symptoms (fatigue, body aches, nausea). These symptoms carried through to the next day (4/9/21). When I woke up at 6:00 am on 4/10/21 I had a rash on the backs of my upper arms and the front of my thighs. As the day went on, the rash progressed to cover my entire body. I went to the ER around 2 pm where I received a steroid injection and was prescribed oral steroids. I was fatigued for the next two days, but was able to return to work on 4/12/21. The rash began subsiding, but overall lasted 2-3 weeks. I completed my seven day prescription of oral steroids on 4/17/21. On 4/18/21 I was very fatigued. On 4/19/21 and 4/20/21 I was extremely fatigued and unable to get out of bed, sit up, or stand up. On 4/23/21 I woke up at 7:00 am with a swollen face, throat, tongue and lips. I returned to the ER where they prescribed me another round of steroids, but a lower dose and a longer duration. I experienced fatigue for 6 weeks after receiving the vaccine.

Pain in arm and neck about 2 hours after injection. Headache fever and severe body aches 10 hours after injection. Headache loss of appetite and severe body pains and soreness over next day stuffy and runny nose. Feeling of sadness and hard to breathe day after injection.

EMT Bustamante noted the client was splashing water on her face and hugging her caretaker in the observation area. EMT Bustamante approached the client and asked how she was feeling. The client reported anxiety to EMT Bustamante at 1:34PM. EMT Bustamante escorted the client and her caretaker outside the building and she was seated on a bench. Vitals obtained at 1:34 PM were as follows: BP 130/90, HR 110, and O2 99%. 2 RN's responded at 1:40PM. The client at that time stated she was having "anxiety." 2 RN's left the scene. At 1:49 PM the client stated she "couldn't breathe." RN responded and provided an emesis bag to the client. The client started using the emesis bag to breathe into. RN counted with the client to slow her breathing down. At 1:50PM the client stated she was "starting to feel better." RN played a 3 minute meditation for the client. At 1:53 PM the client was provided an ice pack on the back of her neck. Vitals obtained at 1:55PM were as follows BP138/82, HR 115, and O2 99%. The client noted frustration about her anxiety and increased heart rate. The client also noted "weakness" in her right arm. At 2:03PM the client received emotional support from her caretaker via a hug. At 2:10 the client stated she was "feeling better and almost ready to leave." The client took 2 puffs of her Albuterol inhaler around 2:12. The client stated she uses the inhaler PRN for a history of asthma. The client also reports a history of anxiety which is not controlled with medication. At 2:14PM vitals obtained were as follows: BP 128/84, HR 127, and O2 99%. The client subsequently stood up and stood underneath a tree in the shade. The client received another emotional support hug, was provided a new ice pack, and continued to splash water on her face. RN offered to call EMS services, and the client declined. RN educated the client and her caretaker of s/s of anaphylaxis, when to seek EMS, and to follow up with PCP regarding anxiety symptoms, and V-safe. The client voiced understanding of this. RN escorted the client out of the vaccination site. The client ambulated unassisted with a steady gait. RN visualized the client entering the vehicle to be driven home by her caretaker at 2:27 PM.

patient reports she received J&J vaccine at local grocery store on 7/7 @ 3 pm. within 2 hours developed shortness of breath, headache, body aches, fever (102.1F), loss of smell, taste "like metal"

Guillain Barre suspected Area Hospital Admitted Admit date: 06/27/2021 Admitting Diagnosis: Worsening generalized weakness-secondary to possible Guillian Barré Syndrome History of Present Illness: This is a 34-year-old female patient that presented at sells emergency department with a medical history of recent upper respiratory infection, obesity, asthma who stated she is short of breath. She has generalized muscular weakness x3 days and per mother's report, the patient was unable to get out of bed and required max assist. The patient had a CT of the head, influenza swab, COVID-19 swab, CBC, CMP, magnesium level, lactic acid, venous blood gas and urinalysis. All imaging and diagnostic lab work were negative and within normal limits. Due to worsening weakness, the ED provider in hospital intubated the patient for transfer to Hospital ICU for further evaluation and treatment.

Had all side effects within 24 hours of vaccine- went to bed with a headache and chills, had body aches and slight nausea the next day. Then it all went away aside from some lingering arm pain. A few days after the shot I had tingling and numbness in all 4 limbs. I also had random sharp pains in my right leg. I woke up Friday morning and my right arm felt like ice cold water was dripping down (but wasn?t). My husband took my blood pressure and it was really high and my chest felt tight. Given that the vaccine was just paused for blood clots we went to the ER. They ran labs and said I didn?t have any clots. Here is the timeline of what happened after: Saturday & Sunday & Monday: Felt normal again Tuesday: Felt short of breath Tingles started to come back Wednesday: Leg and arm numbness Thursday thru the next few days were the worst: Thursday: Random sharp pains, back, thigh, ab Right calf felt a bit swollen and more sensitive Tingling on back of head Tingling in leg and arm High anxiety pain in chest No appetite High blood pressure Friday: Muscle twitching in thigh, sides and random places Random tightness/sharp pain in thigh Blood pressure and heart rate went back to normal High anxiety pain in chest before bed Didn?t sleep well keep panicking awake (not normal) No appetite Saturday: Right calf slightly swollen after walking around Still had muscle twitches and it?s always in the same spot in my thigh Did a teledoc appt which was totally unhelpful High anxiety pain in chest- felt like I was going to pass out at one point and we took my blood pressure in that moment and it was high ?happened after dinner No appetite Note: anxiety is not something I?ve ever had Sunday: Swelling in leg returned Sharp pains randomly A little heavy to breath at times Tension in my head ? felt cold After I ate dinner chest heaviness returned Sensory overload- watching tv couldn?t do. Sound of humidifier plus tv gave me major anxiety. Turned humidifier off and it instantly got better No appetite Next few days Leg feels numb tingly in morning Slightly tingling in my right hand Light headache Some random twitches and sharp pains in thigh still The next month all seemed fine. It wasn?t until I got a small cold that the tingling flared up again. Right leg continues to be a problem-tingling and numbness comes and goes daily. I?ve also had a few episodes of chest tightness out of the blue. Last night I woke up to find my right arm also tingly and numb.

Immediately after vaccine was given patient felt numbness in arm extending from where shot was given to hand. She said her arm was completely numb but had tingling in hand and fingers. Also complained of tightness in chest, shortness of breath. Patient was able to move hand and fingers. Said tightness in chest was like she felt when her back was out of place. Patient reported no swelling in throat. Observed & followed up with patient for 1 hour. Her tightness in chest improved but was still experiencing numbness in arm and tingling in hand & fingers. She was following up with a medical facility.

Mouth and throat tingling and slight swelling, dizziness, rapid heart beat, shaking, difficulty breathing.

Chills at 5 pm, rapid breathing followed by nasea arouns 10 pm, vomited once around midnight, naseau until morning, symptoms revealed in morning

Janssen COVID-19 Vaccine EUA Sunday night 3/7/2021 to 3/9/2021: Fever, weakness, dizziness, swelling left upper arm (where I got my shot) 3/9/2021: difficulty breathing, fast heartbeat

24hr after vaccine I was so tired I could barely function and ended up falling asleep on the floor of my office. When I woke up two hours later I was freezing cold and my body was very achy. I ended up sleeping the rest of the day and night. On Friday I felt fine most of the day until about 10pm at night when I started having diarrhea. Throughout the night it got worse and my body got very hot to the point where I had to sleep naked with fans on me. I?m lightly short of breath, exhausted, and am still having diarrhea now (Sat).

Patient stated feeling like her throat was closing and some dizziness No shortness of breath and patient was able to talk in clear sentences Patient provided with water and symptoms improved Patient seen by medical team, refused medical transport and signed AMA form

Vaccine administration at 1522, at 1533 patient states not feeling well. Took to Emergency Department. Flushing, hives, shortness of breath, throat swelling, tachycardia, dizziness.

Immediately -Dizziness, soon after-mouth itching, Hour later- severe nausea, abdominal pain ,rash,three hours later- facial swelling, tongue swelling, epipen dose 1, trouble breathing on way to hospital and extreme dizziness. Epi dose 2. Arrive at hospital given IV and meds

client is a 34 year old female with history of asthma and allergy to ibuprofen. she started exhibiting apprehension, shortness of breath and difficulty breathing at 10: 40 am; Initial vital signs assessment revealed a blood pressure of 160/102; O2 sat 100%; pulse 82; RR: 20; temp 97.7 F; lung sounds were normal; orbital cavity was in tact without signs circumoral of edema; pt began to have trouble speaking during assessment; pt used her albuterol inhaler and epinephrine IM was given in the left thigh at 10:42 am; Blood pressure at 10: 52 am was 128/92; pulse 84; Pt stated that she felt better immediately after epi was given; EMS was activated at 10: 40 am and arrived at 10:55 am; pt was escorted by ambulance to a local hospital in stable condition.

Patient had fever peaking at 104.5, full body sweats (when no fever was present), exhaustion, light headed/dizziness, micro-blackouts, joint pain, muscle pain, migraines, lacked focus/concentration, and was easily winded while doing every day tasks. Symptoms lasted for 5 days.

Convulsions began about 6 hours after vaccine. With each convulsion I lose ability to speak and struggle to breathe. I cannot control the shaking. I get very dizzy and have had a headache since about 2 hours after the vaccine.

normal post vaccine symptoms 1st 48 hours. fatigue, nausea, chills, headache. On day 4, started feeling even worse, with shortness of breath and vomiting. legs numb and tingling.

Numbness/cold in legs. Numbness in arm and one finger of vaccinated arm. Tightness of throat and upper back pain.

Reported to facility with chest pain, AMS, shortness of breath, elevated Ddimer. Suspected PE, given antithrombolytics, transferred to higher level of care

Pt received vaccination. Pt reports that she started feeling more fatigued and short of breath the week following injection. However, on 09Apr2021 pt had increased SOB and chest pain while shower, went into the doctor. After scan discovered Massive PE. Pt decompensated quickly and required intubation. Upon transfer to medical center, there were complications with ET tube and pt coded and required resuscitation for 6 minutes. Pt recovered and was transferred. Pt had Chest Xray, doppler of Blilateral lower extremities. Confirming PE and also left Popliteal DVT. Pt was on heparin drip which was switched to lovenox for proper anticoagulation. Pt was extubated on the 11th, is recovering. .

Over 2 days of chills and fevers. Over 4 days of feeling lethargic. Headaches for 2-3 days after. Reported chest pain in daily check in. It was not an option so I wrote it in. 2 weeks after the shot I still have mild pain when breathing in and feel like I am winded more easily to the point that even before the vaccine was in the news I made an appointment with my doctor. He did EKG and D Dimer tests. Both came back normal but I still don?t feel myself.

patient admitted 4/23 for a multitude of symptoms and signs suggestive of a multisystem autoimmune inflammatory disorder of unclear etiology. Her past medical history is relevant for mild intermittent asthma, history of recurrent idiopathic urticaria, history of migraine headaches, hypothyroidism on supplemental levothyroxine, history of bipolar affective disorder on antipsychotropic medications (lamotrigine) and ADHD on stimulant medication (Focalin). Notably, the patient received a Johnson and Johnson COVID19 vaccine on 4/10. She reports current symptom onset on 4/17. Symptoms include pleuritic type chest pain, myalgias, arthralgias, diffuse interstitial edema, urticaria and objectively evidence of diffuse inflammation manifested by rising leukocytosis 16,000, CRP 9.3 from 5.7 just days ago, ESR 71 from 34 just several days ago, and new acute hepatitis. Pt admitted to the hospital and hospitalist states "Unclear etiology definitively but the clinical features all developed approximately 1 week after administration of the Janssen/Johnson & Johnson COVID-19 adenovirus vaccine which raises suspicion for this vaccine setting off the disease process" and "Strongly recommend consideration for reporting of possible adverse reaction to the Johnson Johnson vaccine".

Three days the vaccine I got very short of breath with confusion, dizziness and light headed and disoriented. I felt like there was pressure in my chest and I had some brain fog. I felt like I had water in my lungs. My right arm bicep was contracting and twitching. I had Vertigo which made it very hard to sit down without feeling off balance. I was unable to drive. I tried to hope it would pass but I went to the ER on 4/14/2021. The dizziness was getting worse after five days and the pressure on my chest was unbearable. I was advised to drink some water and take Tylenol. My blood pressure was lower than normal. I finally felt better on 4/21/2021. I could finally get out of bed and not feel like I was going to fall down. I could not drive for about two and a half weeks. I still feel a little out of breath and my brain is a little foggy but it has gotten a little better.

Patient began having symptoms of chest tightness and throat tightness 4 hours after receiving her first dose of the Janssen vaccination. Patient went to the ER were she presented with fever, chills, lip tingling, finger tingling and feeling like her tongue was swelling 10 hours after getting the vaccine. Patient received antipyretics and Benadryl and began to feel better. On re-exam patient was still hot to the touch and tachycardic. Patient was diagnosed with a vigorous immune response to the vaccination.

99.7 fever within 4 hours of receiving vaccine. I'm currently breastfeeding and my breasts became inflamed and clogged. 101.5 for the next 3 days. Dizziness, sore throat, shortness of breath, body aches and spasms.

5-14-21 1735: had arm pain from injection, light headedness slightly dizzy 5-14-21 0200 woke up with headache took ibuprofen 800mg 5-14-21 0630 am woke up feeling fatigued and like my body weighed 500 pounds I'm 510 and weigh 160 pounds but started to feel better after moving around so I decided to work out from about 930 til 1030 am 5-15-21 approx 1120 in the am was showering after working out : Lip tingling and numbness followed by lip swelling, slight facial swelling and feeling of throat swelling like need to cough to get something out of throat , heart racing but was a little anxious (no new foods or products and have never been allergic to anything before) took a benadryl 25 mg tablet approx 1135 but felt like throat feeling swollen getting worse so I went to ER. Approx 5 pm 5-15-21 slight fever, muscle aches headache began to worsen lingered through until currently filing report benadryl 25 mh taken 8pm per MD orders to take around the clock for couple of days

I experienced headaches, aches and pain whole body, feels pulsation to my hands, like carpal tunnel syndrome, My whole body feels icky, I had shortness of breath, my doctor thinks I have inflammation and I am now on prednisone medication. Pain in my back and all over and difficulty sleeping. These aches and pain come and go and move to different parts of my bodies and also resting heart rate that comes and goes. To this day I continue to have aches and pain on my body and also still on steroid prednisone medication.

Around 1:30pm on Tuesday April 6th, I was sitting at my desk in my home office, working. I began experiencing moderate chest pain and shortness of breath. These symptoms continued to worsen for the next hour. I had difficulty breathing, and taking a full breath was painful enough to prevent me from doing so. I drove myself to the ER. While waiting in the ER, I began experiencing chills, severe joint pain, and moderate pain generally throughout my body beginning around 4:00pm, which I advised ER staff. While being examined by the ER doctor around 7pm, there was some tenderness noted in my right upper quadrant. My blood pressure was extremely high (205/130) and I developed an intense headache. I was admitted overnight and discharged the afternoon of April 7th. While the chills and pain improved on April 7th, my chest pain and shortness of breath continued for another week or so. The night of April 7th at home, I woke up several times with difficulty breathing and ended up sleeping fitfully while propped up at a 45 degree angle so I could at least breathe mostly normally. The chest pain and difficulty breathing slowly improved over about 10 days until I was no longer experiencing symptoms.

pt. with complaints of throat swelling, feeling of tightness and scratchy, audible expiratory wheezes

I fainted in my backyard on June 9th. I was brought to the hospital by ambulance and had elevated heart enzymes and a problem with my EKG. A subsequent CT scan was done and it was found that I had a massive saddle pulmonary embolism. I was air transferred to another hospital and given a TPA to break up the clot. I was in the ICU for 3 days and then the cardiac floor for 2 days. I also had a bleed where my central line was put in in my groin and a subsequent hematoma. The PE was most likely caused by a DVT in my right leg, believed to be caused because of a dislocated ankle and estrogen-based birth control.

04/12/2021 - Pt received Janssen vaccine at County 07/06/2021 - Patient had COVID like symptoms including: shortness of breath, fever and chills, sore joints. 07/08/2021- Patient went to clinic for COVID19 testing. Patient tested with rapid testing and PCR testing. Patient's rapid test came back positive, patient is still waiting for PCR COVID19 test results.

Numbness in feet that spread to legs, trouble breathing?. Was given inhaler?. Neurologist said it was a mild case of guillain-barré

Patient developed generalized itchiness and nausea 2 minutes after getting vaccine. She has history of food , sulfa, cipro, fluconazole. No rash/hives. Vital signs BP 134/88, Pulse 108, Resp rate 24. EMS was notified and because one team was out transport 911 had to be called. She received epi pen from POD at 1:10AM in Left lateral thigh. VSS. A few minutes later still reported generalized itching and was given Benadryl 50mg PO tablet. FD paramedics on scene and administered IV benadryl, patient became nauseous and dry heaved. She was transported patient to Hospital in the village.

3pm- I got the J&J shot 10pm - went to bed ~11pm - woke up freezing, couldn?t get warm Midnight - burning up/freezing/body ache ~ 2 am - felt like I was burning up and I have been switching ice packs on my head all night, I move slowly when I get up to switch out ice pack because I am slightly dizzy when I stand. 4:30 am - 5pm ice packs have help, but now I have an awful headache. My head feels like it is going to explode, it feels like there is so much pressure. 5pm-10:15am (Current time) - cough, scratchy throat, shortness of breath going up stairs, hot cold flashes, mild headache, still haven't felt hungry.

Was eating dinner (seasoned smoked chicken, broccoli, cauliflower, fries) and soon after, felt my lips starting to swell. I had seasonal allergies occurring that day, so I kept eating a bit longer. My tongue then started tingling. I took a dose of Children's Benadryl (all I had for Benadryl at the time). I then waited about 10 minutes before I felt my throat starting to close. We headed straight to emergency room (5 mins away). By the time I got there, I started to have a little trouble taking breaths. When I got into the trauma room moments later, I became nauseous and dry heaving. They gave me an epinephrine shot, Benadryl, Pepto, and Prednisone. They watched me for a few hours before release. Upon discharge, they provided me a prescription for epi-pens, famotidine, prednisone, and fexofenadine (5-day prescriptions).

Patient complained of dizziness, difficulty breathing, tingling in throat and chest tightness. EMS was called. After several minutes of deep breathing, she stated the breathing was much easier, but the other symptoms remained till EMS arrived on the scene.

Tongue swelling, mouth swelling, throat itching and swelling started almost immediately...two hours later nausea, vomiting, sweating, body aches, fever, chills. Extreme fatigue, slept for over 6 hours. Extreme, intense headache 12 hours later. Fever, chills, body aches for next 4 days. 24 hours after vaccine, hard red lump at injection site, sore and hot to touch. Still swollen and painful 5 days later. Hives and intense itching all over body.

Day 1-shot at 10:17am. No immediate reaction in the 30 minutes waiting period. 14 hours after shot-fever onset just before bed Day 2-fever on/off between 99.9 and 102.4, sweating fever out overnight. injection site is itchy at night Day 3- fever on and off all day, body is achy more than the usual amount. feel weak when sitting or standing. fever breaks by early evening. Arm itches more, starts to swell. Day 4-Still feel a little weak, but the body aches are less. Have shortness of breath. Arm is itchy at night and swells. Day 5-Wake up with shortness of breath and arm more swollen. Left knee hurting-inflammation is up. Day 6-Wake up with left arm tingly numb and it remains the whole day as such, shortness of breath continues. Left knee continues inflamed. Injection site still swelling more. Day 7-Inflammation is down, shortness of breath continues, injection site still swollen and bruising. Day 8 through Day 18-Fatigue, shortness of breath, swollen arm, but the lump in the arm goes down a little each day, like a timed release.

EXACERBATED SIDE EFFECTS OF DAILY MEDICATION; ITCHING; HIVES; SHOOTING PAIN; SENSATION OF COTTON BALL IN THROAT; NAUSEA; SORE ARM AT SITE OF INJECTION; SWOLLEN ARM AT SITE OF INJECTION; WEAKNESS; NUMBNESS IN HANDS AND FEET; ASTHMA; PANIC ATTACKS; his spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included fever, and concurrent conditions included anaphylactic allergy to milk, tree nut allergy, asthma, allergy, and sulfa drug allergy. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered in left arm on 10-MAR-2021 12:43 for prophylactic vaccination. Concomitant medications included dexamethasone, diphenhydramine hydrochloride, epinephrine, famotidine, lisdexamfetamine mesilate, and sodium chloride. On MAR-2021, the subject experienced asthma. On MAR-2021, the subject experienced panic attacks. On 10-MAR-2021, the subject experienced numbness in hands and feet. On 10-MAR-2021, the subject experienced weakness. On 10-MAR-2021, the subject experienced sore arm at site of injection. On 10-MAR-2021, the subject experienced swollen arm at site of injection. On 10-MAR-2021 12:48, the subject experienced shooting pain. On 10-MAR-2021 12:48, the subject experienced sensation of cotton ball in throat. On 10-MAR-2021 12:48, the subject experienced hives. On 10-MAR-2021 12:48, the subject experienced nausea. On an unspecified date, the subject experienced exacerbated side effects of daily medication, and itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma, exacerbated side effects of daily medication, panic attacks, nausea, shooting pain, hives, sensation of cotton ball in throat, weakness, numbness in hands and feet, swollen arm at site of injection, sore arm at site of injection and itching 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.

Severe migraine that caused facial swelling / tooth pain, high fever, chills, nausea / vomiting, sensitivity to light, severe body aches and shooting neck and arm pain in injection site, shortness of breath, inability to hold down fluids or food. On second day, still severe fatigue / having trouble standing and sweats / chills / migraine / nausea. Upper jaw Tooth pain is gone on right side. Symptoms started on right side of body and then spread out. Injection site swelling and pain. Nearly went to the ER, will follow up with my doctor when I can get to the doctor, managing with tons of Advil.

Anaphylactic reaction Swelling in face and throat Passing out feeling Rapid eyelid movement Trouble breathing, trouble swallowing

My first symptoms were heart palpitations and hard to breath for a few hours, low grade fever with aches for 2 days. I?ve been experiencing sudden sharp painful headaches for the past few days.

Fever, chills, and bodyaches for 48 hrs. Then developed covid type symptoms like a runny nose. Got tested for covid sat and it was negative. Went to dr mon and had double ear inf and throat infection. He thinks my body is mimicking covid and causing my body to go haywire. I'm still fatigued. Asthma flared up too

5 hour after vaccine , suddenly couldn?t breath. Oxygen dropped to 84. Difficult breathing for an hour. Chills, body shakes, sweats, nausea . These all lasted 5 days besides breathing . On day 6, breathing got worse . Became short of breath. On day. 11, chest pain, random bruising , continued severe short of breath , head aches. Currently day 16, still short of breath , chest pain, headaches, fatigued

35 y/o and 25 weeks pregnant at the time of vaccination, first time pregnancy, EDD 7/22/201. Received vaccine on Thus 4/8/21 during 9am appointment and felt arm/muscle pain immediately after, slight throat tightness. Waited for 30 minutes due to previous history of allergies and cleared to leave. After first 12 hours, had initial onset of feverish, chills, moderate headache, and fatigue that lasted through 48 hours after vaccine. Friday 4/9/21 evening ~7pm, almost 36 hours after vaccine, woke up from brief nap with profuse sweating, chills, and severe, constant abdominal pain. Symptom was new and never felt previously throughout entire pregnancy. Consulted with L&D who advised to test, hydrate, and monitor symptoms. Severe abdominal pain lasted over 4 hours, only began to subside around midnight. Next morning, pain was not as severe, but was still persisted through Sunday, and began to slowly subside with each day. Telemedicine consult with doctor on Tues 4/13/21 to review symptoms, follow up tests ordered.

Within 15 minute observation period, patient reported not feeling well, feeling dizzy and hot. Patient stated she had been anxious prior to injection, after injection felt a pain in her neck and then did not feel well. Patient was brought by another staff member as patient appeared pale ,hands were clammy, and patient seem to have near syncope where she fell and patient was held by two staff members. This RN went to get vitals machine. Patient seemed to be hyperventilating, vital signs were checked while a provider was called for help. Oxygen was 100%, BP 94/63, HR 45. The doctor came in auscultated heart, patient was drinking water while speaking to provider, HR seemed to be improving to 70s and BP went to 101/67. Patient reported feeling better. The Doctor requested that fingerstick glucose and hemoglobin be checked which were also normal. Patient reported feeling much better after about 5-7 minutes. Patient was stable and sent home with call back parameters. Patient had follow up appointment with provider next day with improvement.

INFLAMED LYMPH NODES; VACCINE SITE INFLAMMATION; MENSTRUAL CRAMPS; ASTHMA SYMPTOMS; EXCESSIVE PERIOD BLEEDING AND LONG PERIODS; SHORTNESS OF BREATH; FELT LOOPY; BODY ACHES; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and concurrent conditions included seasonal allergy. The patient experienced drug allergy when treated with cetirizine hydrochloride. 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 on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: salbutamol. On 08-APR-2021, the subject experienced shortness of breath. On 08-APR-2021, the subject experienced felt loopy. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced excessive period bleeding and long periods. On 09-APR-2021, the subject experienced menstrual cramps. On 09-APR-2021, the subject experienced asthma symptoms. On 10-APR-2021, the subject experienced inflamed lymph nodes. On 10-APR-2021, the subject experienced vaccine site inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt loopy on 08-APR-2021, was recovering from body aches, and had not recovered from fatigue, headache, shortness of breath, excessive period bleeding and long periods, asthma symptoms, vaccine site inflammation, inflamed lymph nodes, and menstrual cramps. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious

3/20 vaccination That evening of vaccination, I had really bad chills and a fever of 102.7. I took some Tylenol. 3/21 fever broke. No chills. Felt almost good as new. 3/22 I started having trouble breathing, almost like I couldn't fully breath in and that lasted pretty much until 4/23/2021. It felt like my chest was clogged, like your nose is clogged. Very uncomfortable. I started with a 'cough', almost like I wanted to cough but I kept it all in. 3/23, or 3/25 Urgent Care telemedicine due to being respiratory. Was prescribed an inhaler with albuterol with steroids. Neither seemed to have an affect. The following week, I took a COVID test; Neg. I went back to urgent care, said my lungs were all clear. Prescribed me 'oral medication' and expectorant with codeine. Didn't have affect until I took the expectorant with the codeine.

LOSS OF SMELL; LOSS OF TASTE; LOSS OF APPETITE; CRAMPING ON RIGHT CALF/SPASMS FOR FEW HOURS; SHOOTING PAIN IN RIGHT HIP; SHORTNESS OF BREATH; CHILLS; BODY ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 35 year old female. 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced loss of smell, loss of taste, loss of appetite, cramping on right calf/spasms for few hours, and shooting pain in right hip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, shortness of breath, shooting pain in right hip, loss of appetite, loss of smell, loss of taste, and cramping on right calf/spasms for few hours, and the outcome of fatigue, chills and body aches 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

Exactly a week after the vaccine I noticed alot of bruising and redness all over my body and I also developed severe headaches and SOB off and on for about 2 weeks so my PCP advised I take a Bayer low dose baby aspirin for 2 weeks to prevent blood clotting d/t to the bruising and redness and I finally was able to stop the aspirin on yesterday

DIFFICULTY BREATHING(LOW OXYGEN); ELEVATED D-DIMER; INABILITY TO MOVE; LOW BODY TEMPERATURE; TINGLY FACE; RED FACE; FELT BAD AND AWFUL; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylaxis reaction, and concurrent conditions included fibromyalgia. The patient did not had previous history of allergy to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1605018,expiry: unknown) dose was not reported,1 total administered on 20-MAR-2021 to the right arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, 20 minutes after vaccination, the patient's felt her face red and tingly and it went away. On 29-APR-2021, nine days after receiving the vaccine, the patient woke up not able to breathe or move and had a temperature of 94 degree F. The patient went to hospital and had low oxygen, an elevated d-dimer and had no evidence of blood clots in CT (computed tomography) scan. The patient was treated in ER (emergency room) with epinephrine, steroids, diphenhydramine (Benadryl) and a unspecified nebulizer and then she could breathe. The patient's physician tested her d-dimer for second time following the patient's visit to the hospital and it was elevated, but not as high. The patient had history of fibromyalgia and mysterious health condition but it was reported that she did not have anything like what she experienced after vaccination and she felt really bad and super awful. The patient was not feeling great, but better and can breathe again at the time of this report; her oxygen level also was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing(low oxygen) on 2021, and red face, was recovering from felt bad and awful, had not recovered from elevated d-dimer, and the outcome of tingly face, inability to move and low body temperature was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210446229- covid-19 vaccine ad26.cov2.s -Difficulty breathing(Oxygen). 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 the way home after my vaccine, I had Chest pain. The next day I felt unusual early the next day and normal symptoms in the afternoon. On the third day I had a slight headache in the morning. I then got a significant nosebleed, and my right leg was painful. On the fourth day I tried to work out and I felt lightheaded and got some chest pain and tightness with shortness of breath. I seemed to bruise easily. I was advised to see my doctor and I went to the ER. I followed up with my doctor and she advised that there were no signs of blood clots.

I developed a cough on or about beginning of May 1, 2021. After accidentally double dosing myself with my ACE inhibitor I went into the ER on 5/11 with light headedness/high heart rate and cough. After multiple tests were done it was discovered that I had a large satellite embolism. in my lung and another one in my left leg.

35 y/o female with past medical history of Migraines and Venous Insufficiency who presents with numbness to left side of tongue, shortness of breath and some difficulty breathing post vaccination. Patient received the J&J vaccination (1 dose). Patient states that she did not mention to registration or nursing staff of her medical history of Venous Insufficiency. Patient denies reactions to previous vaccinations. Patient denies chest pain, itch or rash. NP and Paramedics at bedside. Patient provided with Benadryl 25 mg PO x1 and a bottle of water. Patient vitals within normal limits, 112/73 BP, 75 HR, 97% RA, Resp 12. Patient monitored by the NP over 30 minutes with resolution of symptoms. Patient with improvement of difficulty swallowing and difficulty breathing within 10 mins of Benadryl administration, but tongue numbness didn?t improve until 25 mins post medication administration. Patient was able to eat a protein bar without difficulty (patient requested). Patient last set of vitals also within normal limits, 115/77 BP, 65 HR, 98%, Resp 12. Patient advised on concerning symptoms and when to seek ER evaluation. Patient discharged home in stable condition.

Numbness/weakness in arms - burning at times Extreme itching in arms and legs at times Leg cramps Heart beating hard suddenly just from being still or laying down Pin point pain spots on my spine which started within hours of receiving the vaccine Red dots on legs and arms skin (Petechiae) Shortness of breath climbing stairs, sometimes just walking or sitting Sensation is arm, is like it?s falling asleep, has lasted for hours or days especially right side Throbbing in right ear at times Muscle jumping at times Have experienced extreme itchiness where I have had numbness/muscle weakness Facial numbness around mouth and some involuntary twitching on right side Neck ache - cramps A ton of Floaters in eye site Back pain repeatedly Actual worsening cramps Specific pin point cramps mostly in legs which last for a long time or come and go for several days Pin point pain in chest of left side INSANE HEADACHE Now getting small head aches each day Small spider veins on legs I was a person who worked out basically every day over the last 10 years before the vaccine. I have not worked out one day since, I wouldn?t even try because I?m out of breath just from walking up stairs, leg cramps from doing nothing.

The vaccine overstimulated my thyroid, which produced chemicals, creating sever tachycardia producing 170 BPM's. When my bloodwork was tested, my thyroid levels were over doubled the limits. I also had high blood pressure. Four days after receiving the vaccine I went to the hospital because I was experiencing a fast heart rate, I was extremely shaky (to where I could hardly stand) and I was having trouble breathing. After multiple tests at the hospital, the conclusion is that I have to let all of the thyroid hormones leave my body. So, basically, I'm just waiting.

I got Johnson & Johnson ?Janssen? on May 3. For reference, I have moderate to severe ME/CFS and vestibular migraine. I had COVID in December, was bedridden for two months, and almost recovered to baseline before the jab. Here?s my V timeline: Day 1: May 3 Several mins after J&J: Huge hot flash and vertigo spin that went away immediately 30 mins after: Felt drunk Rest of evening: Extra sleepy Day 2-3: Extra dizziness and fatigue, mostly in bed. Definitely felt like I was fighting something. Day 4: Vertigo attack. Days 5-11: Felt better than I had since before having COVID! Less dizziness, more energy. My post-Covid symptoms such as orthostasis had greatly improved.? My resting heart rate was sometimes in the 70s!? Day 12: ADVERSE EVENT: I felt like I got COVID all over again, but less severe. Nevertheless, my feeling of breathlessness was enough to send me to urgent care. I also had chest pain/heaviness, extra dizziness, and increased heart rate (117 resting). EKG at urgent care showed abnormalities similar to EKG I had in December when I first had Covid. So, I ended up in the emergency room. No clot or heart blockage. Doctor seemed to think either I was having a delayed reaction to the vaccine, or this was somehow Covid related.??? Day 13: Woke up feeling better until I had breakfast and had to poop. After doing that, I got so exhausted I landed back in bed all afternoon. This was another problem I had during Covid.? At least my resting heart rate was more normal, 98. Day 14: ??Vertigo kicks in on top of everything else. Xanax is the only thing that helps my vertigo so I took that and was in bed all day. Day 15: Didn?t sleep well but a little better. Day 16: Chest pain and breathlessness are worse again. They got worse after I took a shower upon waking up.??? Day 51 (Today, 6/22/21): Chest pain and breathlessness are much better. Still have extra dizziness. Resting heart rate is usually between 88-100 now. Orthostasis has improved but not gone.

35 Y female no signif PMH but with OCP (TriSprintec) since at least 2018, family hx of strokes in family members' 40s, daily marijuana use, and recently (10 days ago) seen in clinic for shortness of breath who per chart review was in her usual state of health until 10:30 am today shen she developed R sided headache, slurred speech, and L arm weakness while she was working out at the gym. At the time she was doing light cardio exercise including jumping jacks and lunges. On arrival stroke scale - 3 for facial palsy, left arm drift, and mild dysarthria. CT H demonstrated hyperdense R MCA which corresponded with a filling defect in the R MCA (M2/M3 segment) c/w thrombosis; her CTa neck was normal and there were no e/o hemorrhage. Furthermore, this same CTa showed extensive bilateral PE. An extended stroke alert was called and she was given IV tenecteplase at 1250pm and underwent thrombectomy. 2 weeks ago (6/2) she was seen in clinic for sudden onset shortness of breath, thought at that time by that clinician to be most likely exercise-induced asthma vs less likely ACS. She was advised to use her already written albuterol and had follow up in 2 days (6/4). At that time it was noted she had more SOB with exercises and increased chest tightness that were both relieved with inhaler use. She has a family history of strokes: Maternal uncle and maternal aunt strokes in their 40s Recent surgeries/immobility/travel: No surgeries, no more than a 2 hour car ride Smoking history: Dialy cannabis smoking but no tobacco smoking Age appropriate cancer screen: Yes Family history of cancer: breast cancer in grandmother Baseline functional status Full IADL's and A&O x4. At time of ICU consult, temp 98, BP 140/89, HR 88, RR 18. Patient received: intraop NS, Versed, fentanyl, tenecteplase for thrombectomy Labs notable for All labs wnl 35 y.o female with no significant PMH on OCP presented with shortness of breath and slurred speech and LUE weakness found to have acute right M1 occlusion. She underwent thrombolysis with successful recanalization. Deficits resolved. She was also found bilateral PE and non occlusive DVT. Repeat imaging stable. TTE with evidence of small PFO. Today, she is feeling well, denies shortness of breath or new neurological complaints/deficits. 1. R MCA infarct s/p TNK and thrombectomy 6/14 with no residual deficits - secondary to paradoxical embolism. Appreciate neurology recommendations. Small PFO found on TTE, appreciate cardiology evaluation for closure. 2. Bilateral PE/non occlusive DVT - mildly elevated homocysteine level. Rest of hypercoagulable workup pending. Continue heparin gtt, transition to Pradaxa with Lovenox bridging.

Hard headaches Tiredness Numbness up to this moment 76% Blood clots Short breath up to this moment Chest pain comes and go up to this moment Hard coughing up to this moment Sweating while sleeping at night up to this moment. High blood pressure at the time I visited the ER. Made my Anxiety worse since I took the vaccine.

Per triage nurse, " Pt feeling dizzy and began to cry stated she did not want to pass out, was hyperventilating, given fruit snacks. Pt was helped to the ground, legs were elevated and vitals were taken. Vitals all WNL, oxygen via nasal canula at 2L was applied. Pt was able to answer basic questions, would take a while to answer. Dr. stated that patients vitals were fine and that nursing should keep patient in a calm environment and sit her up. Patient was given juice and fruit snacks, nurse and medic were present on site. Patient unable to tolerate sitting up, medic and nurse transferred patient over to gurney and was taken to ambulance past border."

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild

Post vaccination feeling of breath doom, walking to door to get fresh air. Syncope, fell to floor. No head injury. Post vaccination syncope, brief generalized tonic-clonic movement followed by emesis. Blood glucose 114, BP 120/80, HR90, O2 Sat 96%.

First I felt lightheaded/dizzy, then became nauseous, and my feet and hands were numb and tingling, I felt like my tongue was getting bigger but the primary care dr at the clinic didn't think so. They eventually after monitoring me for awhile sent me down to ER, by then my voice was raspy and scratchy, my lower lip was big, my tongue still felt big. I still felt nauseous. The dr asked me if my eyes are usually swollen and red and I said no. My extremities were still numb and tingling. I got epi and other drugs, zofran, benadryl, pepcid, I think a dose of steroids. The symptoms continued so I ended up getting a 2nd dose of epi. I went home around 5pm. When I woke up that evening to do a neb treatment I was nauseous, my lower lip again big, my tongue felt thick and this time my upper throat felt swollen, I gave myself epi and took myself to ER, they monitored me for 3 hrs the dr was gonna hospitalize me if I got worse, I still felt nauseous and the numbness and tingling feeling in my hands and feet when I left but was not having any airway issues when I left. Not sure if the numbness/tingly is gonna go away in my hands and feet.

within minutes of vaccination : chest pressure, shortness of breath, tachycardia, heavy head, confusion, facial twitching, BP 200/113 EMS called. Benadryl 50 mg IM given according to patient. She refused EMS transport to ER. 3/14/2021 : shivering, diarrhea, severe body aches, fever 101.5F, loss of taste, nosebleed all day, headache 3/16/2021 : I performed a virtual visit for her case. Symptoms mostly resolved except fatigue, loss of taste, and headache.

Patient called the office to mention an adverse event. She states about a minute after receiving the shot, she noticed that her throat became sore and her chest began to hurt. She did not mention anything to the provider and waited the 20 minute waiting period. As she was driving home, she began to develop some shortness of breath and she felt that her throat was started to swell a little. When she got home, she took 1 dose of OTC Claritin and within in hour, she was feeling much better. She did not have to take any other medications and has not had any reactions since the vaccine.

headache, feverish, burning nose, shortness of breath, extreme fatigue, general feeling of illness, loss of appetite, chills, sweating

Fatigue, pain, nausea, trouble breathing, swollen face and neck, trouble concentrating, fever, brain fog/can't think

Patient was vaccinated at clinic at approx 4pm and showed no signs and symptons during required 15 minute observation period. She return to work but began feeling lightheadness, cold sweats. and shortness of breath at 530pm. EMS was contacted at work place and patient was transported to hospital.

started with tongue swelling and then felt like her throat was starting to close in. Placed in Wheelchair and taken up to ED. Gave her 50 po Benadryl on our way up to ED. In the ED was given the following medication Medications Administered During Visit diphenhydrAMINE, 25 mg, IV Push EPINEPHrine Soln 1 mg/mL, 0.3 mg, IM methylPREDNISolone sodium succinate, 125 mg, IV Push sodium chloride 0.9% bolus *, 500 mL, IV Piggyback Medical Decision Making 1249 Tongue back to normal. VS stable. Home. See instructions

Normal side effects until 4/4/21, when chest pressure and paid began at night, with shortness of breath. Appt with Dr on 4/6/21 and was sent for a CTA that confirmed a pulmonary embolism.

After sinus surgery, low grade fever, shakes, chills, muscle pain, headache that did not fit with recovery time from sinus surgery. Dizziness... overreactive immune response. Rapid heart rate. Headache severe, throbbing and not helped by Tylenol or Ibuprofen. Infection from the surgery resolved after antibiotics but symptoms remained. Told I might have a "virus" and my immune system was over reacting. Vitamin B12 shot. Currently taking prednisone but still short of breath and fatigued.

Days 1-4: Headache Days 1-4 of ?feeling off?: Shortness of breath while climbing stairs and/or routine motion -Tightness in chest -Unable to catch breath and increased discomfort Day 4: Tightness in Right calf, back of leg. Feeling like a ?Charlie horse not going away? Day 5: All of the above, drove myself to local Urgent Care where I was instructed to go to the ER

High fever (103.2 highest), blood shot eyes, severe headache (not making sense for 24 hours), ear aches, nausea, sensitive eyes to light/sound, body aches, chills that caused shivering and shaking of the entire body that lasted a few hours, weakness, fatigue, back ache, arm and shoulder pain, chapped lips, gas, cold sore, night sweats, day sweats, leg spasms and pain, shortness of breath and chest pressure and high blood pressure.

On Thursday, April 8, 2021, between 915 and 945 AM, I received the Janssen/Johnson & Johnson single dose COVID-19 Vaccine. As I have had adverse reactions to vaccines in the past, I was advised to wait at the vaccination site for 30 minutes after receiving the vaccine, and I did. Approximately 2 hours after receiving the vaccine in my left arm, I developed a red lacey-type rash all over my body. (This rash still persists today, Tuesday, April 13, 2021 at 3:37 PM and is relieved temporarily with consistent doses of Benadryl capsules, liquid or tablets.) On Thursday night (April 8), after receiving the vaccine, I began to have body aches and to feel fatigued around 7:30 PM. I took 50 mg Benadryl, 500 mg acetaminophen, 800mg ibuprofen and went to bed. I woke around 12:30 AM and was drenched in sweat and my clothes were wet with sweat. I urinated and went back to bed and was shivering uncontrollably from the time I got out of bed until I got back in the bed and bundled up?it was several minutes before the shivering stopped and I went back to sleep. At approximately 2 AM, I woke up to urinate again. I had a terrible headache, like my head was in a vice; my tongue, throat, and nasal passages were very swollen, and it was difficult to breathe through my nose at all. I took an additional 50 mg of Benadryl and a 500mg acetaminophen and went back to bed. On Friday morning I woke to a phone call from work checking on me. I had slept through all of my alarms and it was 8:35 AM. I was unable to report to work that day and went back to sleep and slept for most of the day, only getting up occasionally to get a drink and use the bathroom. That evening I was able to get up and do a few things with the children and run to the grocery store, however, I became very fatigued and went to bed early without eating dinner. On Saturday morning, when I woke up, I realized that I had slept for over 12 hours. I was groggy and fatigued all day and had a nap in the afternoon. That evening I was able to participate in family movie night and was feeling ok until about 10 PM. At that time, I began to feel very nauseated and had diarrhea, even though I had not eaten anything that would upset my stomach. I had intense abdominal cramping and felt like I would vomit if I moved around too much. I went to bed and had to get up to use the bathroom with diarrhea at least twice after the initial symptoms at about 10 PM. On Sunday morning, I woke up after sleeping approximately 10 hours and was able to get up without feeling too fatigued. I did chores and errands and began to feel fatigued in the afternoon and took a nap for about 2 hours. That evening I also had to rush to the bathroom with diarrhea, however, there was no nausea. I went to bed at about 10 PM. On Monday morning, when I woke up, I felt very groggy and did not feel like I had gotten enough sleep. By the evening on Monday, however, I had begun to feel a little less fatigued and more clear-headed. As of Tuesday, April 13, 2021, I have had the red lacey-looking rash intermittently since having the vaccine. I am already on several OTC allergy medications for seasonal allergies and continue to take those medications, however, I have increased my Benadryl intake from 25 mg in the morning to 50 mg in the mornings with 25 -50 mg every 6 hours or so, as well. The rash improves for a short time while I am taking the Benadryl, but it reappears within a few hours after taking the Benadryl.

A few minutes after the injection I felt strange sensations in my arms. About half an hour after the injection started feeling a little dizzy and tightness in chest and throat. Later in the evening I had mild flu like symptoms, chills aches. The following morning was a Sunday and was feeling better but later that day throat started hurting. Throat progressively became swelled and irritated and extremely sore. Flu like symptoms returned. Throat was swelled and to the peak of pain on Monday night. Tuesday morning I was seen at a clinic and it was a little bit better. It started getting better after that but also it has now been a week and a half and throat is still a little bit irritated. I also have brown splotches that appeared on my face either the night of the vaccine or the morning that have not went away.

Immediate head spins, my face got numb and started tingling, my throat started getting itchy and closing up (like when I'm having an allergic reaction), I was trying to talk to the paramedic and couldn't "collect my thoughts", my head was pounding, my palms were sweating, I feel like I was going to vomit. I told them something was wrong , and I was crying. They were telling me I was probably stressed when I was clearly having some type of reaction

Flu like symptoms the day after vaccination. Including severe headache and bodyaches. The following symptoms started about four days after the vaccination? Severe headaches, shortness of breath, difficulty breathing, abdominal pain.

I received the Johnson and Johson Vaccine on April 9th between 10:00 a.m.-10:20 a.m., at 10:30 p.m. that same day my legs and feet started to ache (pain level 3), by 11:00 p.m. my feet and leg (pain level rose to a 6), I drank two 500 ml pain-relieving pills. By 11:30 p.m. (pain level rose to a 9), at that time my pain traveled up to my rib cage, I felt nauseous, felt chills, felt contractions on my stomach and lower back, I felt pain and sensitivity on my skin and caught a fever. Between 12:00 a.m.-2:00 a.m. my (pain level rose to 12), I had a high fever, felt weak, disoriented, lost track of time, started to hallucinate, could not breathe normally, and experienced involuntary and uncontrollable laughter and crying. 911 was called.

I've noticed an out of breath feeling when doing activities that do not normally cause an issues such as going upstairs or walking uphill for a short distance.

Generalized body aches, chest pain, shortness of breath, leg cramping. Reports onset of symptoms as same day as vaccine received. D-Dimer negative. Educated on reasons for urgent recheck.

Pt had right sided chest pain x3 days starting 4/12/21, had a week of cough, fever, "general not feeling well" prior to ER admission 4/15/21. Had CT scan in ER on 4/15/21 - per radiology report a clot and pneumonia noted in RUL of lung. WBC count >22, elevated D Dimer, T Max in ER was 102.2. Was given PO Tylenol, 100mg Lovenox Subq, and IV antibiotics and flown to hospital.

This spontaneous report received from a consumer concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease., 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: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 in the right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chest pain. On 10-MAR-2021, the subject experienced elevated heart rate. On 10-MAR-2021, the subject experienced occasional shortness of breath. On 10-MAR-2021, the subject experienced soreness throughout legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chest pain, soreness throughout legs and arms, and elevated heart rate, and the outcome of occasional shortness of breath. was not reported. This report was non-serious.

I felt drunk, and then had severe pain. My skin hurt, hair hurt, muscles and entire body hurt. Freezing shivers. The severe pain lasted about 36 hours and I had about 2 weeks of fatigue that would come and go. I still have bouts of fatigue and shortness of breath now.

Breakthrough COVID-19 infection in fully vaccinated individual; covid + approx 4/25 per pt (no result avail, no vaccine info avail), worsening fever, cough, chills, SOB for past week;

Blurred vision. Nauseous. Chills. Cold sweats. Mild fever. Sweating. Entire aching body down to my toes. Fatigue. Clouded mind. Extremely tired. Loss of appetite. Mild headache. Loss of concentration. Dizzy. Loss of balance. Chest pain radiating through back to shoulder blades. Quick loss of breath. Rapid heart beat. I continue to take Tylenol every 6 hours until persists as directed by the RN that administered the vaccine. Some side effects have lessened, others have not, and the rest seem to be slightly dissipating.

Shortness of breath, She reports that is feels like her seasonal allergies but was told to talk to a doctor. Advised to use her inhaler that she normally uses for her symptoms and if not completely better needs in person evaluation.

Pain in middle of chest (sternum area), shortness of breath, and coughing. These are exactly same symptoms, though not as severe, when I sick with COVID-19 in December 2020 (confirmed positive via 2 tests). These symptoms manifested on 5/24, two days after severe headache, body aches (joint pain), and chills/sweats following vaccination on 5/22. As of writing this report (5/25), I still have a tightness in my chest, a slight cough, and a headache.

I was taking a shower the night of 04/28/21 and I had a bad pain in my right leg. It felt like it could be a blood clot. The area was swollen and I was in a lot of pain. My blood pressure started getting high and it kept going up. On the way to the hospital, I started getting a headache and shortness of breath. I tried to elevate my leg on the way there. I took an aspirin. I had to sit in the waiting room for 2 1/2 hours and my pain in my leg and headache continued. Once I was taken back, they ran a few tests. I was told that my D-Dimer was elevated which indicates a blood clot. I was checked for a pulmonary embolism and that was negative. I was given a blood thinner because an ultrasound technician was not on duty. I went home at 4 am. I went back for an ultrasound the next day for my entire leg. Everything came back normal. The pain slowly went away.

Patient didn't feel well after receiving the vaccine. We gave her Benadryl; however, her condition was getting worse. She complained her throat is closing, so we gave her Epipen and called 911.

Immediate Site pain, headache after approx. 2 hrs, chills, chest pain, shortness of breath after about 8 hours. Chest pain continuing into next day

Paralysis of the hands, dizzy, numbness in legs and arms, shortness of breath, unable to speak. Sick to the stomach. Went in waves for a few hours

11:30 ? vaccine administration 11:41 ? scratchy throat that progresses into laryngeal and tongue swelling. Increased heart rate (tachycardia) and decreased blood pressure. 11:55 ? laryngeal and tongue swelling worse, now accompanied by chest heaviness and shortness of breath. Also light-headed. Used albuterol inhaler x2. 12:15 ? symptoms gradually decreasing. 12:30 ? took 25mg Benadryl 13:15 ? still some swelling and chest heaviness, took additional 25mg Benadryl.

Dizziness, persistent headaches, muscle weakness, muscle cramps, twitching, tingling, shaking, muscle spasms, blurred vision, double vision, shortness of breath. All of these symptoms have come since my vaccine and haven't gone away. My doctor has been unable to find a cause other than my vaccine

Flu-like symptoms, stabbing chest pain, dizziness, fatigue, rash, and wheezing that developed around 0930 on 3/9.

15 mins after vaccination I began to have a scratchy throat, which gradually got worse and became thick mucus in throat, wheezing, sinus inflammation, fatigue, racing heartbeat. Symptoms became under control after 50mg of Benadryl. Thick mucus lingered until the next day. Increased heart rate leveled off after Benadryl took affect. Fully recovered by the following day.

Patient reported feeling dizzy. She asked for some water, which was provided. Went to check on patient a minute later and her eyes were fluttering and her breathing altered. She did not respond to me. Her pupils dilated dramatically and she slumped over. I called for a nurse and we lowered her to the floor together. Blood pressure was low (around 100/60) Her pupils started to return to normal and she was able to converse with us. Blood pressure increased slightly but was erratic. Emergency service responders made call to take to hospital because blood pressure would not stabilize

Several minutes after injection, radiating pain around the injection site then shooting pain down my arm through my wrist and up through my neck on the left side. About 20 minutes after the injection, tongue and throat started swelling. I was given a liquid cap containing Diphenhydramine HCl 25 mg by someone on site.

PT states chest pain starting 20-30 minutes ago with chest tightness and shortness of breathe radiating through the back (got J/J vaccine 1430). PT states pain has since gotten better (taken broken tailbone medication- oxycodone 5mg at 1900/2000).

I had the expected side effects of fever and chills that evening around 8pm on the evening of the vaccine (3/13/21) and it went away by 1am. The next morning (3/14) I felt a bit tired but still had enough energy to go on my usual 8-mile run. Just when I thought the side effects had passed, I was woken up that night by chest tightness and shortness of breath. I had to go to the ER on the evening of 3/14/21and got discharged around 2am of 3/15/21. They did and EKG and they said my heart and lungs are all in great shape and that this is probably just a vaccine side effect. They said they see it more often in Moderna but I guess it can happen with this one too. I just hope I?m not one of the rare cases that ends up in death. I do have a history of allergies and asthma. I?m feeling better though, though I still feel something different in my chest.

Migraine, chills, body aches, fatigue and malaise for the first 48 hours. Sudden bruise on right calf that had pain only when touched. From Sunday afternoon until Tuesday morning. shortness of breath at times, cold toes and fingers on right side especially, weakness, trouble concentrating or thinking. As of Tuesday morning cough and congestion (like a cold), tiredness and weakness but not extreme like day before. Sore muscles and some edema in legs.

Swelling at site of injection (Left arm-swollen, hard red arm with swelling approx. 6 inches in diameter). Progressed during the night to extend to swelling of all lymph nodes and swelling, hardness and redness from back left shoulder blade to finger tips (on left side only). This began to recede and improve after approx 24 hrs post vaccine and swelling is now contained to area approx 4- 5 inches in diameter from site of injection. Soreness is manageable. Fever present within 8 hours, ranging from 102.5 around midnight to temp of 103 during day on 3/22. Treating with Ibuprofen. Shortness of breath and increased arrhythmia/ rapid heartbeat started around 2 am. Treating difficulty breathing with rescue inhaler, this symptom has improved 24 hrs post vaccination. GI issues (vomiting and diarrhea) began within 2 hours of vaccine. Progressed throughout night but seems to be resolving a bit now, diarrhea has slowed down and now I am just nauseous and have stopped actively vomiting since approx 12 hours post vaccination. Pounding Headache started within 4 hours of vaccine, eyes ache when moved from side to side. Treating with Ibuprofen. Body aches, fatigue and muscle soreness. Treating with Ibuprofen.

Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: Migraine headache

Obtained from patient. Patient is a 37-year-old female with past medical history of asthma, bipolar disorder, history of anxiety and joint pain, came to Emergency Room with above complaints. Patient works as a investigator and getting her first COVID-19 vaccination, Johnson and Johnson. Patient was at work receiving her first dose. After dose, the patient was planned to be observed. The patient is stating that 3 minutes, the patient started getting her tongue started feeling funny. Four minutes into vaccination, patient felt her throat was closing and the patient started drooling. Nurse practitioner immediately gave the patient 2 shots of epinephrine with Benadryl. 911 was called and patient was admitted to the Emergency Room. In the Emergency Room, the patient diagnosed with anaphylactic reaction to COVID-19 vaccination. With the patient's persistent tachycardia, still having symptoms of throat itching, the patient requested to be admitted for further observation.

I went to a community event (held at a church) for the COVID vaccine. After the vaccine, I wanted the 15 minutes and felt ok - just hot. I went out to my car and over the next few minutes - I was getting hotter - My face was extremely hot and flushed, and hives started developing on my arms and chest. They were burning and itching; my skin was hot to the touch. My chest felt tight and my throat felt swollen, but I was able to breathe (breathe felt a little short, but I was able to take a full breathe). I was also dizzy and felt nauseous. I went to the ER, where they treated me for anaphylaxis with Benadryl, Pepcid, Breathing treatment, and a steroid. After about an hour or so I felt fine, and the dr gave me some medications to take over the next few days.

Patient developed an acute allergic reaction with urticaria, respiratory distress, upper airway edema, hypotension. Patient was treated with 0.3mg IM epinephrine, 50mg IV diphenhydramine, 125 mg Solu-Medrol and 1 L of IV normal saline. Patient improved after these interventions and was observed for 3 hours in the emergency department. Due to reaction with #1 Moderna on 28JAN2021 041L20A member opted to receive the 1 dose of J&J with providers approval.

Dyspnea, Sinus Tachycardia, and Rigors. Accompanied by all other normal side effects. Symptoms began at 10pm, and ended around 5am. Treated with cold medicine and acetaminophen.

Immediately after I got it I felt different. Fight or flight response kicked in. My heart started racing and chest felt tighter. It felt like I just ran a marathon. My breathing increased and I felt very dizzy and lightheaded. I stayed in the store and walked around hoping symptoms wouldn't get worse for 25 minutes then left. I had my three small children with me and wanted to get them home. I called my husband who is a physician and told him everything I was experiencing. He told me to stay in the store to see how things went. I then drove home to monitor my symptoms. I had post nasal drip and it exacerbated over the next few weeks. I was on two different antibiotics because it felt like I had a bad ear infection. It never went away. I saw an ENT and my tympanaplasty that I had as a child blew. I have a large hole in my ear drum currently and very dizzy. I am getting a CT of my ear this Wednesday and I will have to have surgery in the next few months for another tympanoplasty.

Janssen COVID-19 Vaccine EUA. Fever at 103.7F (39.7C) at night, fever at 101.7F (38.7C) the second day whole day. Temperature get back to normal at the second day night. Chill, fever, headache, strong muscle pain at back and both legs, nausea, fast breathe. Still feel very tired on the third day, have to lie down after standing for around 20 minute. Get back to normal on the fourth day.

Within minutes I felt hot, then light headed and nauseus. My face turned pale and I felt like I would pass out. I was sweating and trying very hard to take deep slow breaths. The event lasted maybe 15 minutes and it was 30-40 minutes before I felt able to walk out and leave.

throat closing, shortness of breath, difficulty breathing. Given epinephrine and Benadryl with improvement

Within 5 minutes I started to have flank pain on the rightside. Was having a panic attack so couldn't breathe well. Flank pain started spreading to my side and mid to lower back. Then it started in the left side. Then it went across my whole mid back and got extremely stiff. Part of my top lip is numb. Over 4 hours and I still can't breathe properly despite the use of my anti anxiety medicine hours ago. Neck pain. Legs walking in slow motion no matter how hard I tried to push them. Hyperventilating after coughing 2 or 3 separate times. Shooting pain in my back when I lay down. Can't catch my breath laying down.

At 9PM on 4/7, started to experience chills, extreme /migraine level headache, extremely fast heartbeat, extreme shortness of breath, body aches, nausea (vomit and dirrhea), weakness, and extreme tiredness.

Janssen COVID-19 Vaccine EUA Patient complained of dizziness and lightheadedness followed by lip swelling with tingling and "tight throat". Patient evaluated and placed on 2L of oxygen via N/C. At 1619 Benadryl 50 mg was administered orally. At 1623 epinephrine 0.3 mg was administered. Patient transported to ER for observation. Patient observed until 1823 with a final diagnosis of allergic reaction, and discharged with resolution of symptoms and prednisone 40 mg daily x 3.

Very strong leg pain the following day that lasted two weeks. Chest pains and trouble breathing started on Sunday April 4th and continue today.

Side effects started at the 6 hour mark. numbness (with "pins and needles" sensation) in both arms up to elbows, fever of 103.7F, vertigo, dizziness, difficulty breathing, chest heaviness, elevated blood pressure 130/90, elevated pulse. Severe chills and a sensation of skin being on fire. I treated with benadryl, tylenol, and ibuprophen. Day 2 fever continued at 101.0, mental fog, dizziness, severe headache, fatigue, severe hot flashes and intemittent numbness in bilateral fingertips. I treated with tylenol. I also started menstrating 2 weeks early exactly 24 hours after injection. Day 3 I had diarrhea and headaches, fatigue, hot flashes.

Per hospital chart notes, known timeline of events is pieced together as follows: 2021-03-23 - patient received J&J COVID-19 vaccine at Drug Store 2021-03-24 - patient developed myalgias, headache, shortness of breath, and chills - resolved within 24 hours 2021-04-02 - patient developed headache intermittent from right to left side of head for which patient was seen at an urgent care. Patient was prescribed Fioricet (butalbital/acetaminophen/caffeine). 2021-04-05 - patient developed right-sided neck pain 2021-04-06 - patient got tested for COVID-19, resulted negative on 2021-04-07 2021-04-08 - patient seen at Medical Center emergency department for headache and right-sided neck pain that shoots to (2021-04-08 cont.) the head and shoulder, for which patient self-medicated with ibuprofen. Patient reported to ED provider that using ibuprofen nearly relieves headache and makes her functional and had the most improvement the day she visited the ED prior to her visit. Patient received a CT scan of the head without contrast that was unremarkable. Patient was diagnosed with headache and neck sprain and was prescribed ibuprofen 600 mg, take 1 tablet by mouth every 8 hours, and diazepam 5 mg, take 1 tablet by mouth 3 times a day as needed for muscle spasm. 2021-04-12 - patient developed left lower extremity pain 2021-04-14 - patient followed up with Neurologist outpatient as directed by ED provider and was advised to get an MRV and left lower extremity doppler. Patient was prescribed tramadol 50 mg and butalbital/acetaminophen/caffeine (Fioricet) by the Neurologist. 2021-04-15 - patient presented to Medical Center ED before outpatient MRV and LLE doppler could be done due to worsening right-sided neck pain and inability to ambulate comfortably due to lower extremity pain that had been worsening over several days. Upon examination, there is subtle swelling to left lower extremity and doppler revealed multiple DVTs in left lower extremity. CT head without contrast was unremarkable, however, CT venogram of the brain reveals thrombi of the right transverse sinus and sigmoid sinuses, as well as IJ. Patient was initiated on argatroban and admitted to inpatient at the time of this report. "Heparin induced platelet antibody" and "lupus anticoagulant evaluation" tests are ordered and pending.

One week after I received it, I noticed I've had shortness of breath. It's not bad, but it's more difficult for me to breath through my mask, especially when I'm talking. When I've been talking for a while, I can't quite catch my breath. Also, I've slightly lost taste. Food tastes a bit 'off,' and some items even taste bitter. I had cake the other day, and, to my disappointment, it was bitter (my family said it tasted fine. It was just me). Also, for two and a half weeks from the onset of they symptoms, I had intense flu-like symptoms. I felt achy all over and fatigued, which chills. I found it odd because it started so late and lasted so long. The flu-like symptoms are the only things that have subsided.

Patient presented with pleuritic chest pain and exertional SOB for 3-4 days. CT angio of chest revealed subsegmental PE RLL. Patient was stable and discharged home on oral anticoagulant.

body aches, headache, chills, slight fever (100.5), nausea, vomiting. No treatment. Rested and stayed hydrated. Nausea lasted 24 hours. Rest of the symptoms lasted approximately 36 hours. Tiredness, short of breath - lasted for about 60 hours after injection.

Patient reported increased frequency in migraine headaches post vaccination. She normally has 2-4 migraines per week, but has noticed an increase in frequency post vaccination despite an increase in prophylactic migraine meds. Also, patient has asthma and noted increased shortness of breath upon exertion and reports having to use her rescue inhaler more often than normal (up from once a month to twice in 2 weeks).

TIGHTNESS OF THROAT; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and no alcohol consumption, and other pre-existing medical conditions included the patient had no known allergies, not on any chronic medications and is not allergic to any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced allergic reaction. On APR-2021, the subject experienced tightness of throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction and tightness of throat 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

DRY COUGH; CHEST TIGHTNESS; PAIN AT INJECTION SITE; HEADACHE; BODY ACHES; SWEATS; FEVER; CHILLS; FATIGUE; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included stopped birth control pill 30 days ago, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered, on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced shortness of breath. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021 22:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced sweats. On 02-APR-2021, the subject experienced pain at injection site. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced dry cough. On 03-APR-2021, the subject experienced chest tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and headache on 04-APR-2021, sweats, and chills, fatigue, and pain at injection site on 03-APR-2021, and had not recovered from dry cough, chest tightness, and shortness of breath. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

PT called pharmacy complaining of light headed, dizziness, and trouble breathing and asking what to do. She had received the shot about 24 hours ago before experiencing any side effects. Informed pt to seek out her doctor.

The evening I got headaches, chills, muscle, loss of smell and taste. The third day I woke up with swelling like hives and rash around my right eye. I took 10mg of Claritin. The hives spread around the back of my neck and the rest of my body over the course of the morning. Within a few hours it had spread to my chest and my throat felt like it was closing. I had taken Benadryl but it didn't seem to help. I was also fatigued but had no shortness of breath. I had not eaten anything before the hives started. It had been 48 hours after the shot that I was in the Emergency Room, the hives started around 36 hours. I was given Epinephrine 3mg, Prednisone and Famotidine and given steroids for a few days. I have not had any problems since the first three days after the ER visit.

Patient reported feeling sweaty, hot, short of breath and dizzy about 6 minutes after receiving vaccine. MA brought patient back to room to room so she could lay down, and reported that she was very unsteady on her feet. Gave patient water, crackers and an ice pack. She denies prior reaction to vaccines or injection. Denies feeling anxious prior to receiving vaccine. After five minutes, checked on patient, who reported that she felt better. Checked on patient again about 30 minutes after having received the vaccine. She reported feeling fine. Denied any of the previous symptoms at that point

Nausea, abdominal cramps, diarrhea, fatigue, vomiting, shortness of breath, dizziness, headaches (severely for 24 hours, mildly for an additional 24 hours). On the 3rd day of symptoms (6 days post-vaccine) - shortness of breath, fatigue, headaches, dizziness.

I started experiencing skin rash in face and flushing about two weeks after the vaccine about three times and had to take a Benadryl each time for the reaction even while being on Zyrtec on a regular basis. I started having under eye puffiness and body rashes right after these reactions that didn't go away even with regular allergy medication. I then started having a reaction similar to a nut allergy even though I ate something I made at home that had no nuts. I had some swelling on the right side of my face and eye. I also had some minor lip swelling and itching along with throat tightness. I had to take a Benadryl as well with this reaction. I have experienced episodes of this type everyday after eating or just in general and I'm on a high histamine regimen as prescribed by the doctor. I was placed on steroids Prednisone for three days with no results after that. I have episodes where I feel my throat swelled and tightness along with itchy swelled lips, nasal pressure and itchy body. I'm still taking the his histamines as prescribed and Benadryl when the bad reactions occur. I have a epi pen.

Patient received COVID vaccine approximately one week prior to admission. Patient developed acute rhabdomyolysis requiring hospitalization. She developed pain and stiffness in her neck which spread to her back and generalized muscles to the point where she had difficulty moving in the next 12 hours. She did not have difficulty swallowing but she did have difficulty chewing and complained of throat pain. Upon arrival to the emergency room she was unable to lift her legs to get out of the car. In the emergency room she was found to have a CK of 130,000 along with a creatinine of 1.1 and potassium of 6.8 with a calcium of 7.0. She was admitted to the hospital ward and given aggressive IVFs. The following am she was having trouble breathing and was started on BIPAP; the repeat CK level climbed to 543,500. She continued to worsen, developing increased swelling around the mouth and neck. She became anuric with acute kidney injury; and was subsequently transferred to CCC upon which she was intubated and initiated on CRRT.

Jannsen covid-19 vaccine EUA Shortness of breath. Leg swelling. Myocarditis, fluid retention, fatigue, weakness. Heart failure symptoms

I have experienced shortness of breath and I am still receiving treatment and going to the doctor for it.

IN Mid Mar 2021 - recd the j and j vaccine. About 4 weeks later started having pain in the right thigh. Lasted for 5 mins - was a spasm. Intermittent. End april started having pain in the left shoulder - like a knot and then w/ sob / chest pains. Came to er and was found to have a PE. Also then a right LE DVT. Started on heparin -- > argatroban HIT panel was neg. Now on eliquis.

Full body ache/pain, headache, nausea, excessive bruising, shortness of breath, sores in and around mouth

MUSCLE WEAKNESS; FEVER; BODY ACHE; CONGESTION; OXYGEN WENT DOWN TO 86; TROUBLE BREATHING; TROUBLE SLEEPING; VOMITING; HEADACHE; This spontaneous report received from a parent concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, chronic obstructive pulmonary disease, asthma, high blood pressure, non alcohol user, and cigarette smoker. The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine, and prednisolone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered to left deltoid on 12-MAR-2021 around 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced headache 40 minutes after her vaccine and resolved the day after. The patient had trouble breathing during the day of vaccine lasted for one day and the patient had vomiting all day after she got her vaccine and resolved the next day. The patient also had trouble sleeping the day of her vaccination but resolved the day after. On 28-MAR-2021,16 days after the vaccination, she experienced trouble breathing, fever, body ache and congestion. Her oxygen went down to 86. These symptoms lasted for a week and a half and resolved. On an unspecified date, the patient experienced muscle weakness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Oxygen saturation (NR: not provided) 86 %. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen saturation decreased to 86, and trouble breathing on APR-2021, trouble sleeping, vomiting, and headache on 13-MAR-2021, and body ache, congestion, and fever on 07-APR-2021, and the outcome of muscle weakness was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210739940.; Sender's Comments: V0: V0: 20210739000-COVID-19 VACCINE AD26.COV2.S-Oxygen went down to 86. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY

I am a very healthy and active person with no prior medical, mental or emotional history. I exercise, eat well and take care of myself. I am 5'9" and 125lbs and not on any medications. Below are the adverse reactions from the J& J vaccine. 1. Severe Shortness of Breath and Chest Heaviness 2. ER admission April 7 - chest x-ray, vascular ultrasound, EKG, Pulmonary CTA, COVID test in ER. Results all negative for Pulmonary Embolism or cardiac arythmia. 3. Follow up appointments - Follow up primary care, cardiologist and pulmonologist test stress treadmill test, echocardiography, pulmonary breathing test , blood test- ALL RESULTS NEGATIVE 3. Severe symptoms lasted - 8hrs on April 7 4. time course: Vaccine - April 7 Symptoms - April 25 - June 20, 2021 5. Symptoms gradually decreased and officially subsided on June 20, 2021

Immediately began to feel a headache, dizzy and nauseated. The doctor on site had me lie down on the floor. Was starting to feel better so was able to sit up in a chair for about 15 minutes. Another wave of dizziness and nausea came over and was lying on the floor again. It was hard to breathe, but oxygen and HR were good. The doctor tried to give me juice to see if it was my blood sugar going low, but afterward, I still felt dizzy and nauseated. It was still hard to breathe. It felt like something was sitting on my chest. BP was elevated, oxygen levels were good, HR was good but I started to get a cold chill where my teeth were chattering. At that point (about 45 min to an hour) the symptoms had not gone away and the ambulance was called. Was transported to the local hospital where I received a liter of saline and Zofran for nausea. BP was high, but oxygen levels and HR were good. The heart monitor showed no signs of arrhythmia or tachycardia so I was discharged. The doctor believes it was a side effect and not an allergic reaction.

Patient received J&J vaccine at clinic (lot # 1805022). at approximately 1530, patient has a history of anaphylaxis and was being observed for 30 minutes. Approximately 25 minutes into the observation period the patient was noted to be lethargic, weak, was able to answer questions stated that she felt tingling in throat, numbness, tingling in extremities, back pain. Progressed to feeling itchiness and continued lethargy, was not able to answer what day it was. At that point we assissted patient in wheelchair to get on stretcher behind curtain. Patient given diphenhydramine 50 mg x 1 at 1600, patient became more lethargic and given epinephrine 0.5 mg x 1 at 1603. Vitals after epi were sbp 138, HR ?? reported as elevated, and 02 sats 98. 911 was called. Patient was also nauseous once in wheelchair and on stretcher, wretching when transferred to stretcher patients lower extremities began shaking, lasting a few seconds. Patient motioning towards throat as is if having trouble breathing. Patient remained stable until EMS arrived. I t was reported to me that patient had been cleared by her MD to receive vaccine but to be monitored for 30 minutes.

Shooting pain in/ around heart for 3 hours. It started about 2 hours after the shot. Sharp shooting pain that was much worse on deep inhales and when stretching chest open.

11 hours post to injection, fever became elevated to 103°F, mentation became very confused, major aches through out body, elevated breathing and heart rate, some vision impairment

As soon as the vaccine was given I felt dizzy and my right hand and foot got numb and tingling. This was reported to the personnel. The symptoms subsided about an hour later. Around 11pm, I started to have wheezing, chest tightness, and back pain. I have been using my inhaler and nebulizer since last night for the wheezing. I spoke to a doctor through phone who confirmed these aren't normal side effects from the vaccine.

Patient recieved IM injection of the JNJ COVID vaccine in the right arm. Shortly afterwards she became diaphoretic, felt tightness in her throat 'like when I eat shellfish,' experienced tachycardia and left-sided chest/neck pain. The Diaphoresis and throat symptoms resolved with zyrtec and benadryl. The tachycardia persisted for 4 days with even slight exertion. HR was 119 bpm upon follow up with PCM on 26Mar2021.

45 minutes after vaccine administered, patient reports feeling throat swelling. Patient is crying and appears anxious. Patient reports feeling nervous prior to receiving vaccine. Patient able to speak clearly, follow commands, swallow Certirizine and drink water. HR 66 BP 134/76 at 2:40pm. Approximately 15 minutes later, patient reports feeling sore throat and throat swelling resolved. Patient experiencing mild headache also. HR 67 BP 128/78 at 3:04pm. Patient denies respiratory distress. Patient advised to follow up with primary care provider and to call 911 with symptoms worsen or respiratory distress. Patient declined transportation to hospital for further evaluation. Patient taking Uber home.

Face tingling, lips swelling, throat tightening, tongue swelling (moderate anaphylaxis reaction) and rash on neck, chest and abdomen.

Janssen COVID-19 vaccine was administered to patient and the patient immediately reported pain at injection site, change in taste, and trouble breathing. Patient began gasping for air. The patient remained aware and able to communicate. I instructed a tech to call 911 and the operator instructed me to use a dose of epinephrine. After administration, the patient's breathing improved. EMT's arrived and took over care for the patient. I informed them of the time of vaccination and the time of epinephrine administration. The patient was then taken to the hospital to receive additional care.

03/09/2021 13:31 patient stated feeling dizzy and light headed after receiving the Janssen Vaccines. Patient noted hyperventilating, clammy and sweaty. BP 57/37, P 52, RR 22, Temp 97.2 F. Patient stated she felt nausea and stated that she did not have a meal all day and only ate an apple. Patient noted pale in color. Patient vomited partially digested apple. Call placed to EMS. At 13:45 pm Fire Dept. arrived. Patient assessed by EMS. Patient declined to go the hospital . BP 116/89, P 84, R 20. Patient states that she still feels light headed. Patient advised by EMS to seek medical care if she were to get worse. Call placed to patient husband. Patient's husband on his way will continue to monitor.

Patient reported a "tightness in her throat" approximately 5 minutes following injection. Requested and was given water by staff which she swallowed without problem. Patient's color and skin appeared normal on inspection but patient did show significant signs of anxiety. BP and pulse were monitored and were within normal limits for the patient. About 15-20 minutes following report patient was given Benadryl 25mg PO. Patient was monitored for approximately an additional 30 minutes at which time she assured us that she felt fine and her throat symptoms were gone.

Within a hour of receiving the vaccine, I felt left shoulder and posterior neck discomfort. A few hours after, I felt flushed and slightly feverish with generalized body aches. 6-7 hours after the vaccine, I experienced extreme fatigue, extremely high fever that registered as "err" consecutively on the thermometer numerous times (min of 5 times checked), severe headache, worsening body aches, left flank pain, GI upset with nausea, congestion, dizziness and many heart palpitations. The high fever broke around 11pm and my temp was 102 when checked then and I was drenched in sweat. The fever continued to decrease throughout the next 12 hours. The extreme fatigue, severe headache, dizziness , GI upset and nausea continued throughout the day Saturday and most of Sunday. I also experienced burning in my chest that radiated into both shoulders, anterior/posterior neck and between both shoulder blades in my back all day Saturday. The burning has decreased over this past week, but I am still experiencing it with some exertion, but not consistently. Fatigue continues some and SOB at random times.

5.5 hours after getting the vaccine, I had chills (guessing I had a fever) body aches, a headache, joint pain, muscle pain, skin pain, nausea, I was exhausted, felt very emotional (felt like crying), had the constant feeling like I needed to stretch, and I could not get comfortable or lay still. At one point my fever broke, I woke up at 245 am drenched in sweat. The symptoms previously stated all came back about 255 am. I could not get comfortable or sleep but was extremely exhausted. I tossed and turned getting tiny naps here and there until I got out of bed at 8 am (4/8/2021), I was again drenched in sweat, tired, had a headache, was nauseous and food sounded horrible. I could not move around much because of joint/muscle pain and would get random bouts of chills. I had to just lay down all day but was never hungry and did not eat again until that night around 7pm. On 4/9/2021 I woke up at 630am drenched in sweat I was still tired and could not exert myself (just going downstairs made me have to stop and catch my breath) throughout the day I would get random nerve pain in the elbow and forearm of the shot arm. This morning I woke up with the shot site hurting worse, a headache, still tired and drenched in sweat (it was 40 degrees in my house and i had a thin blanket covering me). My appetite is back today but still cannot exert myself.

Received vaccine at 4:10pm on Thursday 4/8/21. 2 hours later, at 6:15pm, I noticed mild tongue swelling which slowly continued to worsen. I pulled out my Epipen but was not having any difficulties breathing and my tongue was only mildly swollen still, so I took Zyrtec at 8pm (which I usually do), and continued to monitor. Zyrtec seemed to slow the progression of tongue swelling slightly but at 10pm, I started having a dry cough and wheezing. I took Albuterol and Benadryl and that worked to stop the tongue swelling. Please note, the reason I don?t use Epi immediately is because I have Reynaud?s and it is contraindicated. So I use other rescue meds first if I can. My O2 sats remained above 95%, so I was not in full anaphylaxis. I did not eat anything or come in contact with anything within those 2 hours that would have caused the allergic reaction, so I am positive it was the vaccine. I also have a red, raised itchy bump at the site.

I started to have a little fogginess around 1 32 o?clock then after that I started having severe pains in my legs and my knees my whole body hurt especially in the legs I could not walk the following day I like was out of breath very winded and mind you I am a very healthy 38-year-old woman I work out on a regular basis I am very active with my kids I am five for 128 pounds it felt like my legs had to be stretched out forever it was the weirdest pain I can?t even describe it also I was very itchy and I looked and I did not have hives it was especially in my hands and my feet but I definitely felt spaced out for two full days I ran a slight low-grade fever I was very fatigued could not do anything I would go to the bathroom and I would have to come right back to bed my arm is sore but it almost just feels like a sore muscleI did take Motrin Tylenol nothing helped I had to sit on a chair with my legs straight out and exercise them because the pain was so intense in my muscles very odd but thanks for having this page and let me tell you my concerns so I?m not sure what kind of reaction I had other than that I was breathing fine I was just so tired and cannot walk because the pain thanks for your time

pt reported- dizziness, shaking, scratchy throat, chest tightness, 'feels unable to breathe'. admin 25mg PO Benadryl capsule, epi-pen JR.

Normal side affects felt: fever, chills, body aches. Felt by 5pm and lasted until the next morning ~0700. After symptoms broke, the feeling of sluggish occurred all next couple of days. Throughout, it seemed like I could not quench my thirst. Additionally, red bumpy rash on my legs (mostly thighs) occurred and itching along with it on legs. Not enough to go to emergency room, but definitely uncomfortable. Took Benadryl to help. Subsided about a week later. At injection site, only bruise which I am guessing was from some abnormal bleeding that occurred at injection. I barely had any soreness in the arm. Lastly, a feeling of inability to take a deep enough breath. A feeling of if I had vicks on my chest type cool feeling when I took a breath. The feeling has lingered until now, but not enough to cause any issue. I can breath, but not full deep breaths. Because it has been getting better every day, I imagine it will subside soon. I will go to doctor if it does not get better.

Have had substantial shortness of breath--as though I've completed a strenuous workout--for two days now. Even though I have kept my activity minimal and have avoided working out since the onset of shortness of breath.

Initially within minutes developed SOB that resolved within 10 minutes then recurred 45 mins later, then self resolved. Within 24 hours myalgias, fatigue. Intermittent pounding heart rate episodic since vaccination. Ongoing lightheadedness which is mildly improving. Abdominal pain described as diffuse soreness of entire abdomen with unknown exact onset but within days of COVID-19 vaccine. Abdominal pain persists x 6 days (to date). Some loose stools. Episodic nausea. reduced appetite.

Work up the next day with my left side swollen . My lips and eyes were very very swollen. My throat was swollen and was wheezing . Had a bad cough . Felt like something in my throat .

Day 1 just normal effects as far as I know heavy eyes, super tired. Day 2 a fever and sorness Every day since then fatigue and shotness of breath when over exerted. Arms and legs feeling heavy. Eyes get really heavy, double and foggy vision comes and goes. Sunday April 11 right arm muscles locked up, tense and tight. Monday April 12 legs feel really heavy, feels like something pulling behind my knee caps.

* Arm was very sore for about the first 10 minutes. Moving it reduced it pretty quickly and was no worse than a minor ache for most of the next day or so. * Had a mild headache before the shot (believe due to not having had caffeine that day yet) * At about 6 pm on 4/10, lost appetite due to mild nausea (just enough to not want to eat but not enough to vomit) * At about this time I noticed I also started to feel a little winded, akin to walking just briskly enough that you have to breath harder than if you're just sitting / resting. It did not get any worse than this however, so I opted to keep a close eye and see if it eased (which it would by end of Sunday, 4/11) * At about 8:30 pm on 4/10, noticed I felt warm, had a fever between 100.4 to 100.8 * Also around 8:30 pm I noticed that pain I normally feel from my herniated discs and pinched nerves (L4/L5 L5/S1) just ACHED and was more painful than normal. * Started feeling tired (I'm usually up until around 1-2 am, and I was ready to go to bed by 9pm on 4/10) Also felt a little forgetful / hard to concentrate on anything * When I went to bed, I noticed that my eyes were very sensitive to the white light from my monitor. This is usually a sign of a painless migraine with auras that essentially blind me for about a half hour. I did not have auras, though my headache was steadily getting worse to the point I suspect it might have actually been a migraine) * At about 12:30 am on 4/11, the headache got to the point where I could no longer ignore it (best I can describe is it felt like someone was trying to peel my skull of like you would an orange) so I took 200 mg of Ibuprofen. I also by this point had a fever of 102, though it would drop to 100.5 or so within a few minutes of taking the Ibuprofen. * At about this point the arm starting aching a lot more, I assume because I wasn't using it while sleeping. It felt like someone had punched me multiple times hard in the same spot. * I felt much better on the morning of 4/11. However as the day continued I felt more and more tired. My temperature was higher than normal but very mild; it stayed around 99.8 for most of the day that I took it. By Monday, 4/12 I felt mostly fine aside from my arm aching worse than it did when I first got the shot. Now on 4/14 its pretty much no longer achy.

Puffy eyes, lips, itching on body, closing of throat. (Anaphylactic type symptoms. ) Swelling at injection site. Extreme fatigue and aches over 6 days later.

Redness to right side of face, right ear complete red, numbness to right side of face, swelling to inside of checks and tightness in throat that started about 10-15 mins after shot was given. Pharmacy gave Benadryl when advised of reaction. 15 mins later family drove me to ER to wait to for the Benadryl to take effect in case ER services were needed. ER services were not needed once Benadryl took effect. I?m at day 14 and still having lingering reoccurring headaches and fatigue.

Feel pain on the stomach, headache, loose of breath and High pulse, causing go on A Emergency yo the Emergency Room.

Around 1am Tuesday, April 6th (the day after the vaccination), developed acute onset fever (Tm 102), chills, extreme muscle aches, profound malaise/fatigue, nausea/vomiting, and diarrhea. Those symptoms lasted about 24 hours and, by midday Wednesday, she was back to her baseline of intermittent dry cough, shortness of breath, and no smell or taste. It wasn't until Sunday, two days ago, that she developed sharp, pinpoint right superior parietal scalp pain that, after a few doses of OTC Aleve, did somewhat improve. Other than two 220 mg OTC Aleve tabs twice daily, she has not been taking anything else for her symptoms other than prescribed asthma/allergy meds. She states that her shortness of breath has been helped from the use of albuterol as needed. Unfortunately, the Aleve has not helped with her chest pain, which she describes as a "constant ache." Initially, patient had some pleurisy, but that has apparently cleared up. No history of CVT, PE, and she does not smoke or take oral contraceptives.

FOGGY FEELING IN HEAD/ SPACED OUT; DIZZINESS; UNABLE TO GET UP; SHORTNESS OF BREATH / WINDED; UNABLE TO STAND; LEG CRAMP; LETHARGIC; GENERAL BODY PAIN; TINGLING IN NECK THAT RADIATED DOWN THE ARMS; WORST MIGRAINE IN THE BACK OF EYES AND NECK; LEG PAIN; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included very healthy and active. 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-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced shortness of breath / winded. On APR-2021, the subject experienced unable to stand. On APR-2021, the subject experienced leg cramp. On APR-2021, the subject experienced lethargic. On APR-2021, the subject experienced general body pain. On APR-2021, the subject experienced tingling in neck that radiated down the arms. On APR-2021, the subject experienced worst migraine in the back of eyes and neck. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced extreme fatigue. On 08-APR-2021, the subject experienced unable to get up. On 08-APR-2021, the subject experienced foggy feeling in head/ spaced out. On 08-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from general body pain, and the outcome of dizziness, foggy feeling in head/ spaced out, unable to stand, leg cramp, extreme fatigue, lethargic, leg pain, shortness of breath / winded, tingling in neck that radiated down the arms, worst migraine in the back of eyes and neck and unable to get up was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious

11:20 AM - GIVEN BENEDRYL 10MG / ITCHINESS AND FULLNESS BACK OF THROAT AND LIGHTHEADED AFTER VACCINE 11:35 - NO CHANGE IN SX, NOT WORSE NO SOB OR GI SX. TALKING COMFOTABLY P -88 RR-18 O2-98% ON ROO MAIR

Immediate arm paining mild dizziness followed by 4+ days of extreme fatigue, mild difficulty breathing, fever, chills, body aches (pain level 5/6), difficulty focusing, vomiting, diarrhea, and an on & off migraine

vaccine 4/9 surgery 5/5 on shoulder 5/10 clinic neg US of leg for DVT due to pain 5/13 PE with increased short of breath and tachycardia

LEG PAIN, ONE WORSE THAN THE OTHER; HEART BEATING FAST; COLD SWEAT; THROAT CLOSING UP; HANDS AND FEET SWOLLEN; BLOOD PRESSURE UP A LOT; BODY ACHE; DIZZY; FELT VERY BAD; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, batch number: 202A21A, and expiry: 31-DEC-2069) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 12-APR-2021, the patient experienced heart beating fast, cold sweat, throat closing up, hands and feet swollen, blood pressure up a lot, body ache, dizzy and felt very bad shortly after vaccination approximately within 5 to 10 minutes. In the 15 minutes of post vaccine observation, emergency services were called and the ambulance/EMTs came and helped stabilize the patient. The patient conveyed when she had arrived home that day after receiving emergency services she did not felt well at all and felt very bad. The patient was still had same symptoms at home that experienced shortly after vaccination, the symptoms did not resolve. The symptoms had lasted for two weeks. On 19-APR-2021, the only symptom patient had was strong leg pain in both legs, one worse than the other and was hospitalized (date unspecified). The patient's legs get swollen still and the pain remained to be intense. The patient's HCP was aware and was monitoring the patient. On 04-MAY-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Results pending to rule out blood clots in the leg. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Cleared, CT scan (NR: not provided) Cyst, but she complained no pain there and Urinalysis (NR: not provided) Cleared. The patient was told to go to clinic and the patient had followed up with clinic, then the patient was told to visit hospital as no appointment. The patient needed to be seen at a hospital and that was when she returned back to hospital a couple days after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beating fast, cold sweat, throat closing up, blood pressure up a lot, and dizzy on 19-APR-2021, and body ache on APR-2021, had not recovered from leg pain, one worse than the other, and hands and feet swollen, and the outcome of felt very bad was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210513962 -covid-19 vaccine ad26.cov2.s-Pain in extremity. This event(s) is labeled per RSI and is therefore considered potentially related.

Many weeks ago (end of March, into April) i noticed I was short of breath, and a few weeks later a cough developed (mid-April). Also mid-April, on April 17, I had a sudden subjunctive hemorrhage happen in my right eye for no apparent reason. There was no injury to my eye and my ophthalmologist told me it would heal in a few weeks. Two weeks ago (beginning of May) a terrible, nearly unbearable headache began. A few days later, I continued to feel strange and began to get more frequently short of breath and my cough worsened. On 5/5/2021 I went to my doctor , Family Medicine, and was then sent to the local hospital, and had a cat scan done of my lungs, around 9 AM. I was I was diagnosed with a Pulmonary Embolism in my right lung, that is so large that it is taking up 2/3 of the lung and its pushing on my heart. I am currently taking Eliquis and waiting to be seen by a specialist. I still have shortness of breath, headaches, and chest pain as a result of my PE.

The next day of vaccine on 03/31/2021 I had a severe headache, nauseas, I had diarrhea. As the days passed I started getting worst and worst I was loosing mobility in my body my husband had to take me to the restroom. On 04/06/2021 is when I went to the Emergency Room. When I got to the hospital I could not breath my ribs hurt a lot & I had horrible back pain. They put me oxygen and gave me fluids but they said I had to get transfer to another hospital and they transferred me on an ambulance. In the other hospital us where they transferred me they kept poking my stomach when I asked them why they kept poking it they told me that it was to stop the blood cloths. I was hospitalized for 5 days. When I was sent home I was still not feeling good I was feeling sick still I've been trying to recover slowly but I am not the same. I'm still in a lot of pain I can't move my arms because of how much it hurts my back keeps hurting a lot as well. I want to go back to normal to how I was I can't do anything I can't even cook for my kids. I now have depression.

rash on face, lip and tongue swelling, muscle pain, trouble breathing when moving. Sinus and ear congestion that didn't respond to normal medication/treatment (pseudoephedrine, antihistamine, nasal steroid spray and shots, oral steroids) and resulted in blocked eustachian tube.

Headache since getting the vaccine that has not stopped. Shortness of breath, chest pain and palpitations with any activity. HR has significant increase with any activity. Headache gets worse after episode of chest pain, sob etc. Pressure headache that is in the front of the head since getting vaccine. Now on a beta blocker to help with Heart rate and out of work since getting vaccine.

I had it was hard for me to breathe, pain in her chest that went to her back; Problems walking and asthma flare ups

Patient had swelling of the tongue, hives, difficulty breathing and was sent to the ER for treatment.

-Chest pressure and pains, difficulty breathing, left side tingles in arm and leg -Inflammation -Severe migraine -Indigestion -Began inside 2 weeks of receiving vaccine. -This is after the initial flu-like symptoms I experienced from day 1 to day 6.

patient after receiving vaccine was waiting in observation monitoring area and started to faint, her eyes rolled a little and then was fine, she was breathing properly but her companion was stating she didnt feel good, that was a little out of air. during time pt never loose conciounes nor fell down. after a while was fine

Shortness of breath, pleuritic R lower chest pain since 6/15. Was seen in ED on 6/16 and diagnosed with right lower lobe pulmonary embolism. Then had OCP discontinued, and was started on Xarelto for anticoagulation treatment. Was discharged from ED 6/16. Returned to clnic on 6/17 and still having symptoms of pleuritic chest pain of right lower chest, however does not have SOB or dyspnea on exertion.

Became almost paralyzed, complete body pain as if someone had taken a baseball bat to my body, extrame neck pain, extreme headache, leg and arm cramps, stomach cramps, nausea, cold sweats, heavy feeling on chest making it hard to breath, hyrovenalating, upset stomach, diarrhea. All symptoms started early morning of the 15th and proceed to get worse as the day went on leaving me bed ridden continuing untill evening of 17th when finally they started to go away. Still feeling beaten up and severe headache morning of 18th.

the last 3-4 weeks I have been experiences tightness in my chest, it's becoming hard to breathe. I went to my doctor for my annual physical and she listened to my heart a little longer than normal but would not hear anything different. My blood pressure is higher post vaccination as well both at doctor office and when donating blood (something I do on a regular basis).

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Additional Details: Patient felt faint immediately upon receiving the vaccination. received instruction to sit down. upon sitting down patient passed out/fainted/ muscle contractions in both hands were observed. 911 emergency services were contacted. patient then taken into ambulance for further evaluation.

Within approximately 2 minutes of receiving vaccine, anaphylactic reaction began. Patient's cheeks became very flush/red, & her throat became itchy and tingly. Within the next minute or 2 she started vomiting. She then felt tightness in her chest, and shortness of breath. Complained of lips feeling numb and "heavy". Dr was present and ordered an IV to be started, and placed patient on oxygen and a cardiopulmonary monitor with pulse oxmeter after she used a ProAir inhaler. Patient was given IV steroid SoluCortef, IV Zofran for the vomiting, IV Pepsid, and IV Benedryl all for the allergic reaction. She also received 500 ml IV fluids. Symptoms lessoned within one hour, and she was observed for another hour and a half on cardiac monitor and pulse ox by nursing staff as well as Dr. Vitals stable throughout event.

3/9- 4:10 pm- Felt extreme nausea, heart racing, pins and needle is hands and legs. The heart rate slowed after 15 minutes. The pins and needles lasted till 6:30pm and the nausea lasted all night. 3/10- 5am- severe headache, pins and needles on and off in hands and muscle spasms in legs. Headache and muscle spasms continued all day. Afternoon body aches and fatigue. 3/11- 5am- slight headache, few muscle spasms in legs- was able to return to work. 3/12- 9am- Began to feel chest tightness and restriction In breathing. Called doctors offices, but had a wait time to get seen for following week. 3/13- 6am- muscle spasms continued in legs on and off through the day, slight headache, but chest tightness barely noticeable. 3/14- 10:00pm- check tightness and shortness of breath begins again; this time more constant. 3/15- 5am- chest still tight, no other symptoms. Go to work walk up 2 flights of stairs and have severe shortness of breath. Really struggling with chest tightness and shortness of breath so make primary care appointment. 3/15- 1:00pm- see primary care- who sends me to the ER 3/15-3:00pm- ER- does chest X-ray, EKG, blood panel- all come back clean 3/15-6:00- ER admits to observe me in their outpatient diagnostic unit behind ER. 3/15-3/16- Hospital Hooked up to heart monitor all night, 2 more rounds of blood work, echo, and another EKG. All normal- still having symptoms.

Shortly after the vaccine on the drive home the injection site got super hot, the arm began to swell and turn red. I developed a fever and my sinuses got really stuffy. I began to throw up profusely which made all symptoms from other issues occur causing me to swell all over and because I couldnt take any meds or keep anything down I went to the ER. While there I began wheezing and experiencing SOB which still is an issue today. I have foggy moments where my brain seems so foggy that I am having issues with my short term memory. I was administered IV fluids, IV morphine and IV ibuphropen to help with the symptoms and was hospitalized for less than a day further evaluation

Deep cold shakes Deep headache, head, neck and shoulder pain left side, undulating Feels "like a giant bit my arm" Upper arm pain, numbness down arm Stiff joints, quads sore Nausea Constipation , lethargy, exhaustion, shortness of breath

I have a history of anaphylaxis, and disclosed that to the medics so they watched me more carefully, which was good, as while I did not experience anything that severe, I did immediately get itchy, turn red and feel quite nauseated. However, after they monitored me awhile, I told them I felt okay to go home. The next day I had the expected mild flu-like symptoms, which I anticipated. However, what?s been atypical is they returned tenfold three days later. This time with a much higher fever (103), severe chills, fatigue, a seemingly never-ending headache, muscle spasms, chest palpitations and suddenly I am experiencing asthma (which is typically seasonal) and am coughing, too. I?m now a week past when I was vaccinated and each day was feel worse, not better. I have had to cancel my clients and hire a sitter to care for my kids as I am too weak and ill to do it. I looked up common reactions and nothing states chest pain and/or asthma, nor that it should last this long. That said, as I am high-risk, I work from home and homeschool both of my young kids. Thus, I have been nowhere aside from the vaccine site. Moreover, my partner, our kids and sitter get routinely tested for me, and everyone is negative. Thus, it appears I am having prolonged, heightened side-effects much more intense than the ?mild? flu-like symptoms otherwise reported, which is concerning. I took no medication prior to receiving the vaccine, either.

DIFFICULTY BREATHING (Difficulty breathing, Dyspnoea) FACIAL NUMBNESS, SAME SIDE THAT INJECTION WAS DONE (Numbness facial, Hypoaesthesia) FELT SWOLLEN THROAT (Throat swelling, Pharyngeal swelling) FELT TIRED (Tiredness, Fatigue) This spontaneous report received from a patient concerned a 39 year old female. The patient's weight was 132 pounds, and height was approximately 63.5 inches (5'3 and half). The medical history included: no family history of disease or no allergies. The patient was not pregnant nor breastfeeding at the time of vaccination. The patient received covid-19 vaccine ad26,cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 07-MAR-2021 10:40 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported. The patient was not ill prior to receiving the COVID-19 vaccine. The patient never had a history of any similar event or adverse reaction to any other previous vaccinations in the past. The patient did not have any pre-existing acute illnesses 30 days prior to vaccinations nor was the patient hospitalized in the last 30 days. The patient never had been tested for COVID-19. The patient did not wait the full 15 minute time frame as she was instructed. One hour after vaccination while driving home with her mother on freeway, the patient began to experience some numbness on the left upper part of her head and then the numbness went down the left side of her face. The patient was having difficulty breathing and described it as if, "someone was on her chest" and lasted 5-6 minutes but the numbness still persisted and went down to her arms and legs. The patient's throat felt like it was swollen. The patient also felt "tired" a day prior to this report (captured as unspecified date in MAR-2021) and slept for a total of 14 hours and "felt better today". The patient had been afebrile since being immunized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from difficulty breathing, had not recovered from facial numbness, same side that injection was done, and the outcome of felt tired and felt swollen throat was not reported. The reporter assessed causality for difficulty breathing and facial numbness, same side that injection as related. The reporter causality for the event of felt tired and Swollen throat was possible. Company causality between COVID-19 vaccine Ad26.COV2.S and facial numbness, same side that injection, felt tired and Swollen throat was possible. This report was serious (Other Medically Important Condition). Additional information was received from reporter on 12-MAR-2021. The following information was updated and incorporated into the case narrative: Patient's medical history updated, the non-serious event swollen throat and details concerning reported events added.

It was reported to me by the pharmacist who was on duty on April 6, 2021 that the patient presented to the pharmacy on April 6, 2021 for her COVID-19 vaccination and was anxious prior to the appointment. The patient stated that immediately after receiving the vaccination, she felt a shooting pain in the injection site. The patient stated that within a few minutes, she felt lightheaded and nauseous. The patient then stated that within 20 minutes, she felt like she was having an asthma attack and had to use her rescue inhaler (albuterol HFA). It was reported that the patient left the pharmacy about 45 minutes after receiving the vaccination and the patient stated she was feeling better. The patient the reported to the pharmacy that the morning of April 7, 2021 that her symptoms of shortness of breath and wheezing returned and she went to an emergency room for treatment. The patient stated that after admission into the ER, the medical staff performed two EKGs and one chest X-ray, which were unremarkable. The patient stated she received treatment with Duoneb because she was wheezing and and treatment with IV methylprednisolone because her throat and tongue appeared swollen. The patient stated she was discharged on April 7, 2021 and was prescribed albuterol solution for nebulization and prednisone 10 mg tablets.

Employee initially c/o headache, body ache but 2 days later developed SOB and was hospitalized for 2 days.

Chills, fever, muscle and joint pain, pain at injection site, exhaustion, headache, nausea, feeling like going to pass out, hard to breathe, fluttery feeling in chest / palpitations

at 9 pm after getting J and J covid vaccine, started getting a fast heart rate aound 130bpm, some shortness of breath and tingling. seen by me in urgent care next day, EKG with juntional tachycardia, sent to ED

2:00pm - headache and body aces started 5:30pm- headache, body aches, low grade fever and chills 5:45pm- was driving with my children and felt a wave of heat, followed by extreme nausea, was able to pull over my vehicle and then fainted. After passing out, I started to seize. Rapid breathing, lost feeling of my arms and legs. Ambulance was called. I was transported to the hospital.

Patient was observed by staff after receiving Janssen COVID19 Vaccination. During observation patient reported: Other: pt reported throat tightness approx. 10" after Janssen Covid-19 vaccine injection, anxious it may be an allergic reaction; pt. moved to stretcher, head down, feet up, oxygen 4L via NC applied, 9:15am Epinephrine 0.3mL administered IM to left glut., BP 130/104, pulse 76, pulse ox 99; 9:20 am ambulance called, BP 128/94-74, pulse ox 99; ambulance arrived at 9:30am, 9:34 am pt. transferred to ambulance stretcher with head at ~90 degrees, patient was continuously monitored by FNP, RN. and CNA -- until patient transferred to ambulance at 9:35am for transport to hospital. Pt. has hx of similar symptoms to PCN.

Racing heartbeat, extreme sweating ( I've had to shower twice since 9pm), chest pains, shortness of breath, muscle tension and spasms

Violent chills, fever, muscle stiffness, muscle pain, sharp nerve pains, mild shortness of breath, stomach upset, frequent urination, fatigue, brain fog

1st night very out of breath. O2 at 93 on sensor at home. Felt better next day. 3/29/21 - went to ER for blood clot in left leg.

POSTNASAL DRIP; DRY COUGH; DIFFICULTY BREATHING; TIGHTNESS IN CHEST; RINGING IN BOTH EARS; DIZZINESS; NAUSEA; FEVER; BODY ACHE; HOT AND COLD SWEATS; JOINT PAIN; CHILLS; This spontaneous report received from a patient concerned a 39 year old female. 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: 201A21A expiry: not reported) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced hot and cold sweats. On 06-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. Treatment medications included: ibuprofen, and paracetamol. On 06-APR-2021 09:55, the subject experienced difficulty breathing. On 06-APR-2021 09:55, the subject experienced tightness in chest. On 06-APR-2021 09:55, the subject experienced ringing in both ears. On 06-APR-2021 09:55, the subject experienced dizziness. On 06-APR-2021 09:55, the subject experienced nausea. On 08-APR-2021, the subject experienced postnasal drip. On 08-APR-2021, the subject experienced dry cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, tightness in chest, dizziness, body ache, hot and cold sweats, joint pain, chills, nausea, and fever on 07-APR-2021, and had not recovered from ringing in both ears, postnasal drip, and dry cough. This report was non-serious.

Immediately when I received the injection, I felt a cool fluid rush around my heart with a moderate discomfort/pain. I reported this to the tech who administered. He didn't seem alarmed & advised I wait 15 mins. I still felt a "coolness" around my chest but otherwise felt "fine" so I was permitted to leave. As the day went on, I felt my chest (lungs & area around my heart) feel tighter & tighter & my breath grew more & more "shallow" like I couldn't take deep enough breaths & I was short of breath. In the evening, it intensified. I was very fatigued (couldn't go up our stairs or talk in complete sentences without feeling "winded"). The tightness in my chest was worse & was accompanied by periodic acute pain in my heart. I also had pain my lower back. I went to the emergency room around 10PM that night. An EKG, blood tests & chest X-ray were conducted. The ER doctor said all tests came back "normal" & they weren't sure what my issue was. I went home & rested. I woke the next morning with the acute pains gone but the tightness still lingered. I did not feel "normal" until almost 72 hours after my vaccine.

started with generalized Headache and sob 5-6 days after vaccination with Janssen. For pain she is being prescribed acetaminophen until labs have resulted. A trial of albuterol nebulizer was given in office for spirometry showing moderate airway obstruction. Patient felt the same shortness of breath she is noted to have petechia at site of blood pressure cuff on the upper arms but states this always occurs.

J&J COVID vaccine on Friday 4/9/21 Fatigue, headache, shortness of breath, chest tightness and a racing HR Symptom onset of these symptoms was yesterday Winded with any exertion Patient denies trouble breathing when she is laying down and resting Reports headaches but not bad Muscle aches Reports tightness in her chest- a dull tightness in her chest Reports some racing heart rate while she is out of bed Advised patient to be seen in the ER today for evaluation of her symptoms

Numbness in hands and feet, also felt numbness in neck and lower part of back of the head. Difficulty breathing, heart palpatations, feeling of needing to pass out multiple times. Nausous for a wee straight, with gastro symptoms. I have lost 10 pounds in the week since I have had the shot. Still having tingling sensations in hands and feet.

Pt experienced anaphylaxis with 1st dose of Pfizer cov19 vaccine, but patient wanted to be fully vaccinated due to losing a family member to Cov19. Patient was instructed by her Md to get the Janssen vaccine instead of the 2nd dose of Pfizer vaccine that was due on 3/28. A few minutes after the injection, the patient became itchy and had increased respiratory rate. Despite using her inhaler and receiving a dose of liquid Benadryl, the patients breathing worsened, and I injected the patient with an Epipen. Patients breathing improved and we monitored her for an hour before releasing her. A follow-up call was made on 4/13 to confirm the patient was stable.

Extremely high fever which included loss of consciousness. Dizzy, blurred vision, chills, and diarrhea overnight. Began about 9/10 hours after receiving shot. Next more body aches and arm soreness continued for 24 hours. 72 hours arm soreness and fatigue. One week later (now) still feel fatigued, short of breath, and experience moments of weakness. Sleep up to 12 hours (haven?t done that in many years) and feel achy in mornings.

DIARRHEA; VOMITING; BODY ACHES / INTENSE PAIN; HURTS TO BREATHE/BREATHING PROBLEMS; FATIGUE; CHEST PAIN/CHEST PROBLEMS; BED RIDDEN; NAUSEA; This spontaneous report received from a patient concerned a 39 year old female. 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: 2216279 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 chest pain/chest problems. On APR-2021, the subject experienced bed ridden. On APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced vomiting. On 07-APR-2021, the subject experienced body aches / intense pain. On 07-APR-2021, the subject experienced hurts to breathe/breathing problems. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from hurts to breathe/breathing problems, and fatigue, had not recovered from diarrhea, vomiting, and body aches / intense pain, and the outcome of nausea, chest pain/chest problems and bed ridden was not reported. This report was non-serious.

Within minutes of shot, on the shot going in - it stung so bad I cried and I have a high pain tolerance > extreme nausea right after the shot was in; I felt short of breath - Heartrate - While standing in line, my heartrate was 75 or 76 and it went up to 130 beats per minute after the vaccine (I have a watch that tells me); my heart was racing. I was putting cold water bottles on my neck to feel better. Heartrate went from 130 to 100 at 45 minutes out. It stayed in the hundreds for a couple of hours. About three hours after shot - I developed itching and hives all over - chest, arms, and tops of thighs. I took Benadryl. The injection site on arm stayed incredibly painful - I couldn't even move my arm. 4/12/2021 - I got in contact with someone from Clinic. They felt like there had been a reaction to vaccine - advised to continue Benadryl. A localized reaction to injection site. First 48 hours bone, muscle, joint pain was extreme - it hurt to be alive. It took a week for that to fade so I could function again. Got in contact with Dr. again 19th. Swollen oval under my skin about 2 -3 inches long at injection site; fatigue and nausea is still there. Ran some bloodwork. Advised to take Benadryl when itching came back. This morning, I called the doctor today 20th - an allergist was pulled in for this conversation as well - I was prescribed to take Zyrtec; Claritin and a prednisone (to prevent reaction from continuing) and also Zofran for the long term reaction to the vaccine. Watch the injection site for any redness and heat (there's none right now). Three days after vaccine, I did get a blistery rash across my neck at my collarbone area, down my chest and under my breast and across my rib cage on front and a little on my back on the back of my shoulders and down along the spine. Additionally there was a flat orangish rash that developed - on my face and nose. And then my skin started peeling off there and it (that flat orangish rash) showed up also on the middle of my chest too right in the middle of the other rash on my chest. That is improving with the medications I'm taking.

Patient C/O shortness of Breath and cramping in lower extremities on 4/14/21. She was sent to local ER for evaluation and was admitted for observation.

Patient felt sudden onset of flushing with palpitations and chest tightness. She also reported shortness of breath and dizziness.

Patient received the J&J COVID vaccine on 4/12/21 and she started feeling COVID symptoms on 4/18/21 (fever, cough, body aches, and dyspnea). She has 3 members of her family who tested positive for COVID. Patient tested positive for COVID as well on 4/18/21. She presented to the ED for worsening symptoms on 4/23/21 and was admitted to the hospital for COVID treatment since she was hypoxic in the ED.

I had to go to the emergency room, high d-dimer (.95), elevated Pro B Type Natriuretic Peptide (152 pg/mL) ---Days 1-2 (12-22hrs post-vaccine) were horrific - fever, body aches, extreme pain everywhere, my eyes hurt so bad I thought I'd lose my vision, I was in so much pain that I couldn't talk to ask for help. Saying they were flu-like symptoms is a euphemism. ---Days 2-9 I was weak and shaky on my legs, easily winded (e.g. breathing hard when doing laundry). Fever returned off and on. ---Days 4-13 It felt like someone was sitting on my chest. ---Day 10 I had a blood draw per my doctors request. ---Day 12 Blood draw results showed high d-dimer, and my doctor told me I need to go to the ER for a ct scan to look for blood clots. ---Day 12 Went to Emergency Department - ct scan showed no clots, but elevated Pro B Type Natriuretic Peptide ---Day 15 Finally started feeling better, but still winded easily, fatigued, dizziness, heart palpitations

04/07/2021 evening clammy, 99.-100. fever, chills, sweats, asthma flare up started, self care of inhaler for relief and lungs constantly hurting, got sick, lethargic, and fatigue. A week later went to the urgent care who referred to the ER. Xray and EKG and observation and waiting for the results and prescribed Phenazone.

My tongue swelled up. My face swelled I had problem breathing. I had a severe headache. My blood pressure went up to 181/119

I had a severe allergic reaction. A minute after the vaccination, my eyelids were swollen and puffy and itchy. I drank some water and couldn't swallow. My throat closed up. My arm was sore, swollen glands, swollen neck, swelling under my breast and underarms. I had blinding headaches and body aches.

About 2 weeks after the vaccine I developed SOB and went to the Urgent Care where I received an irregular EKG so I was transported to the ER and was admitted into the hospital for 3 days. On 5/1 I developed severe chest pains again so I went so I went to another Hospital and was informed that my D-Dimer was elevated and was transferred to a different hospital where I was monitored for 24hrs and was released. I visited the Cardiologist who performed a Stress test which was abnormal so I have another Stress Echo tomorrow but I have never had any heart issues in the past.

Patient felt like she might faint, tightness in chest, tingling in fingertips and like it was hard for her to breathe. Provided water, checked oxygenation with pulse oximeter (100%), elevated pulse at 95bpm, BP-142/95. Through talking and deep breathing patient was able to calm down. Patient reports history of events similar to panica attack but has never been formally diagnosed. After ~10 minutes, patient reported feeling improved, pulse ox remained steady and heart rate within normal limits. Second BP reading 132/80. Patient comfortable to leave clinic without EMS evaluation.

DIFFICULTY BREATHING WHEN LAYING DOWN, SHORTNESS OF BREATH; DIFFICULTY BREATHING ON EXERTION; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, penicillin allergy, and non-smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 04-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure. On 30-MAY-2021, the subject experienced difficulty breathing when laying down, shortness of breath. On 30-MAY-2021, the subject experienced difficulty breathing on exertion. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from difficulty breathing when laying down, shortness of breath, and difficulty breathing on exertion. This report was non-serious.

Started wit a headache numbness in my face difficulties of breathing heart rate was high dizzyniess blood pressure was high numbness on the whole right side of body

Eight hours after the vaccine I got a Migraine and my Asthma kicked up. I had achy joints and muscles and a slight fever. I had a rash on my shoulders, ankles and forearms. It was little spots about six inches. Those symptoms lasted for 36 hours. After that point I had very low Oxygen levels and my Asthma was very severe. My Nebulizer and rescue inhaler were not very effective. It has been almost nine weeks and my Oxygen levels are still lower than normal at 96 or 97. Before the vaccine my Asthma was controlled and I rarely used the rescue inhaler. I use my rescue inhaler once daily. I am using my Nebulizer once daily. Immediately after the vaccine I was using my Nebulizer four times daily. It is still not near the level of control I had before the vaccine.

Janssen COVID-19 Vaccine EUA Per EMT in First Aid area of Vaccine POD Chief Complaint: "I'm having trouble breathing" 11:08 AM B/P 130/88 Pulse 90 Respirations 18 Pulse oximetry 99 % on room air 11:18 AM B/P 128/88 Pulse 86 Respirations 18 Pulse oximetry 99 % on room air Patient reported difficulty breathing, has history of asthma, seated in chair, upright, no tripoding, no accessory muscle usage, denies chest pain, appearing to breath normally, CAO X 4, patient states history of anxiety, presenting with anxiety symptoms, patient coached on breathing, instructed to listen to her heartbeat on pulse ox, cold pack to back of neck, patient declined EMS, counseled on normal COVID vaccine side effects, counseled on symptoms of anaphylaxis, MD present throughout assessment, patient felt better after assessment and left under own power,

The patient came to ED c/o sudden onset constant right anterior chest pain radiating to axilla and lateral neck. Sudden sharp pain 10/10 at rest and worse when supine with associated Short of Breath. Troponin was elevated at 0.18, d-dimer <200. All other lab values were normal. The patient is getting admitted for a cardiac workup and further evaluation.

Lips started itchy at the time of vaccination. Later that day I started having shortness of breathe and racing heart rate. Went to the ER continued to have racing heart rate for 2 weeks. I had cold sweats, fatigue, shortness of breathe. Still having racing heart rate. Had to be put on medication to slow heart rate down.

Symptoms included swelling of both right and left ankles, pain in right leg, shortness of breath 5 days after receiving the vaccine. They put me on oxygen and started administering Lovenox twice a day.