Johnson & Johnson

Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Fainting / Unresponsive-Medium

Shortness of breath, fatigue, dizzy, aches. 1 week out and still have listed symptoms. May be improving slightly but not gone

Headache and neck stiffness within 15 minutes of vaccine and lasted for a couple days. The days after vaccine I had extreme tiredness and felt like I had a bad cold with a lot of coughing and shortness of breath. I was coughing up a lot of mucus. The cold like symptoms are still ongoing, 2 weeks after the vaccine, but are less extreme. 8 days after the vaccine I started to have pain at the injection site. My upper hurt if I touched it. Twelve days after the vaccine my upper arm hurts if I raise my arm and if I shake my inhalers to use them. This seems like a muscle pain from the injection site to my shoulder.

Sensitivity started within four hours of dose. Autistic sensitivities to maximum. Scrambling of all senses including proprioception to the point of not being able to move from standing or sitting. By hour seven, all sensory inputs were too overwhelming to do anything but shut down and sleep. 911 was not an option because they don't let you sleep, and ERs are overwhelming already, before maximizing all inputs. 7.5 mg hydrocodone for overwhelming pain and sensitivity, allowed sleep. On waking, sensitivity was lessened, but the pain started, 18 hours after the vaccination. Emotional lability for three days. Average aching of arm and injection site were not above expected levels. "Brain fog" and lack of ability to articulate (another autism symptom) started within that first seven hours, and diminished over next ten days. Not yet gone as of today Dry mouth; overproduction of thick 'chunky' mucus that wouldn't cough out, treated with guaifenesin, lasted three days. Shortness of breath and cough associated with that mucus also diminished after three days. Not completely gone ten days later. Excessive thirst, onset two hours after vaccine, lasted two days. Hyperalert (can't sleep without drugs), hyperactive despite weakness, and hypervigilant (extreme startle reflexes) lasted three days as well. Sleep was achieved with hydrocodone and THC. All over body pain, feelings of immune mobilization (coming down with) for two days were not above expected levels. No fainting or other collapse at time of injection, or later. Knowing that severe over-stimulation is exacerbated in a medical setting, it was decided not to seek medical support for three days of systemic symptoms that would have easily merited hospitalization.

Patient reports shortness of breath, fevers, chills, diffuse myalgias along with right-sided back and chest pain since receiving the COVID vaccine. Symptoms began a few hours after receiving the vaccine. She reports localized pain to the injection site but denies redness or swelling. She reports she had fevers for 2 to 3 days, highest being of 101. She presented to the ED on 4/10/21 because of worsening shortness of breath with mild cough and pain in her back. This is exertional along with pleuritic. She reports she has overall improved from the myalgias but is generally not feeling well and continues to have dyspnea.

Starting the 10th, patient has had bad headache, severe muscle pains more than usual, SOB more than normal and severe fatigue. She thought it would go away but the symptoms got worse with each day. No fever. She had been taking Ibuprofen and Tylenol around the clock. Symptoms had not improved Also had been nauseated since Monday 4-12-21. The site was sore and her arm felt heavy and she could hardly lift it.

Report she got the vaccine on 4/10/21 and started having achiness, fatigue shortly after. 3 days later pt developed diarrhea (watery), cough, SOB. Reports SOB worse with exertion, talking.

Patient presented to ER with diffuse rash over body and minimal shortness of breath. Patient received Janssen Covid vaccine the day prior. Patient also on last day of antibiotic regimen (nitrofurantoin) for urinary tract infection.

elevated blood pressure, slurred speech, expressive aphasia, blurred vision,headache,shortness of breath confusion.

Pt received her 1st and only needed dose of the Janssen COVID-19 vaccine on 4/2/2021. After the 2 weeks needed to be considered fully vaccinated, She presented to the ED with cough, SOB, and chest discomfort on 4/17 and was diagnosed with COVID pneumonia. She was treated but not admitted.

All symptoms for up to 10 days after vaccination: pain at injection site; muscle aches around neck/shoulders; chills; malaise; stuffy nose/sinus problems; blood while blowing nose; all over body aches; excessive sneezing; watery eyes; brain fog; tongue/gum swelling; shortness of breath; throat tightening; acne; fleeting stomach pain; sore sternum.

3/16 vaccination 4/4 extreme HA, tired, High BP, dizzy. 4/6 went to the ER. Shot for headache. Tramadol for HA if got worse. I took Tylenol. I saw PCM on Friday Meloxicam 7.5 1 per day. Will go to 2 tablets per day if continues. Not consistent HA as of yet. Scheduled echocardiogram on 4/29/2021 *Usual BP runs 115-120 range. Never had issue with BP. Knee replacement sx 12/1/2020 and no issues with BP then. Since vaccine my BP has been in the 150's. My BP has been consistently high since vaccine. Lowest has been 141 on 4/12/2021. I feel like I am out of breathe.

This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 143 kilograms, and height was 65 inches. The patient's past medical history included shingles vaccine, and concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-202113:30 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced heart thumping hard in chest. On 06-APR-2021, the subject experienced foggy feeling in head. On 06-APR-2021, the subject experienced shallow breathing. On 06-APR-2021, the subject experienced violent chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced excruciating headache. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced nausea. Treatment medications included: paracetamol. On an unspecified date, the subject experienced eye running d/t the pain, couldn't stand the light and sound, pure misery, burning up, and full body shaking/came on like a train wreck. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.6 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart thumping hard in chest, and violent chills on 07-APR-2021, shallow breathing, fever, and excruciating headache on 08-APR-2021, and body ache on 09-APR-2021, had not recovered from fatigue, and foggy feeling in head, and the outcome of nausea, full body shaking/came on like a train wreck, eye running d/t the pain, couldn't stand the light and sound, burning up and pure misery was not reported. This report was non-serious.

SHORTNESS OF BREATH; FATIGUE; This spontaneous report received from a patient concerned a 60 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 and normally had to take anti-histamines in the spring. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included levocetirizine. On 13-APR-2021, the subject experienced shortness of breath. On 13-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and fatigue. This report was non-serious.

I took 1 Benandryl about 1 hour before the injection of the vaccine prior to leaving my home. My son took me as I would anticipate some type of reaction given my history. J&J was the one my doctor recommended in hopes that I could handle the response better and only need 1 dose. I had options to get pfizer or moderna, but my dr wanted J&J so I waited several weeks longer to get this one. Within 10 minutes of having the injection, my ears swelled up, and felt like I was on a bad plane and could not burst clear. Then my throat on left side, the same side I got the shot swelled. My face was full of red and rash and my son mentioned he was concerned how I looked. I told him my symptoms and then took another Benadryl before we left the store. I told the pharmacist that I was having a reaction, they wanted to call 911-I said please no. I am used to having reactions and would want to see if I can manage it with Benadryl at home. I came home and took my Alegra (as I take my alegra at night before bed to help with congestion). Going forward every 2-3 hours I would take another benadryl rotating the time frames and slept as much as possible. It took several hours for the swelling to subside, longer than I was used to. Over the next several days, I would have times when my ears, throat would swell, my face would be red and rashed, especially at night my face will get red, rash and ears and throat swell late at night. It waxes and wains depending on how I feel. After the main allergic reaction of 12-24 hours later, I stared with the COVID symptoms, fever, chills, body ache, the joints that I have trouble with hurt so much more (knee, foot, arms, hands) I was so thankful I did not catch COVID. I don't think I would have survived. On Friday, March 19, 2021 was the first day I started to feel better except for the late night episodes of allergic reaction. I take Alegra or when needed Benadryl. It seems to lower my swelling response.

Patient presented to the ER on 4/16/21 for dyspnea and wheezing, diagnosed with acute COPD exacerbation/chronic bronchitis and discharged home. Pt presented to ER 4/22/21 with worsening symptoms and was admitted to the hospital for acute kidney injury, dehydration and COPD exacerbation.

SWELLING ON THE SIDE OF LEFT NECK; DIFFICULTY SWALLOWING; HANDS AND FEET FREEZING FOR A LONG TIME; CHILLS AND SHIVERING; SUSPECTED FEVER; HEADACHE; NAUSEA DRY HEAVES; DEHYDRATED; THIRSTY; QUATER SIZE KNOT IN LYMPH GLAND AND SWELLING; FAST HEART BEAT; THROAT TIGHTNESS; ACHYNESS JOINT PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 190 pounds, and height was 155.44 centimeters. The patient's past medical history included covid-19 infection, and concurrent conditions included alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, copd, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin, and other pre-existing medical conditions included the patient had no illness at time of vaccination. the patient had no past history of similar events. the patient had no pre-existing acute illness in 30 days prior to vaccination. the patient had no hospitalization in last 30 days prior to vaccination. the patient had no family history of any disease or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for drug used for unknown indication, budesonide/formoterol fumarate for drug used for unknown indication, and for drug used for unknown indication. On 30-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On MAR-2021, the subject experienced dehydrated. On MAR-2021, the subject experienced thirsty. On MAR-2021, the subject experienced quarter size knot in lymph gland and swelling. On MAR-2021, the subject experienced fast heart beat. On MAR-2021, the subject experienced throat tightness. On MAR-2021, the subject experienced achyness joint pain. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea dry heaves. On 17-MAR-2021, the subject experienced suspected fever. Laboratory data included: Body temperature (NR: not provided) 99.4 deg. On an unspecified date, the subject experienced swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time, and chills and shivering. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, had not recovered from quater size knot in lymph gland and swelling, and the outcome of swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time and suspected fever was not reported. This report was non-serious. Additional information was received from patient on 16- APR-2021. The following information was updated and incorporated into the case narrative: Patient age group, medical history(alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, COPD, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin), events( chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, quarter size knot in lymph gland and swelling), outcome updated, causality; Sender's Comments: This case was non serious

I woke up from almost like a pop in my brain and fluid started pouring down my throat and I started choking. I woke up and was able to spit some of it out. It was clear and also tinged with blood. It stopped once I stood up. I immediately thought my brain was leaking. I told my daughter about this the next day. My balance was off and I had a weird flapping in my head for the next few days. As well as a headache. A few days after I heard about the blood clots. I am not 100% sure if it was from the shot but it was literally hours from when I received it. It was very scary.

DIFFICULT TO SLEEP; SHORTNESS OF BREATH; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 60 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: 23-JUN-2021) 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 flu-like symptoms. On an unspecified date, the subject experienced difficult to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, and shortness of breath, and the outcome of difficult to sleep was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.

CHEST PAIN; SHORTNESS OF BREATH; TROUBLE FALLING ASLEEP; HOT FLASH; EXTREME FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 60 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included progesterone for prevent breast cancer, and estradiol for prevent osteoporosis. On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced trouble falling asleep. On 18-APR-2021, the subject experienced hot flash. On 18-APR-2021, the subject experienced extreme fatigue. On 18-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chest pain, and shortness of breath, and the outcome of extreme fatigue, trouble falling asleep and hot flash was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.

Itching, rubbing, nausea, dry heave, stridor, heavy breathing, cough, swelling of uvula Given Benedryl - Patient declined EpiPen, EMS and ER. Remained tired and itchy for the rest of the day.

Patient developed cold symptoms with heavy drainage on 4/15/21. Patient took a whole package as directed but continued to get worse. Used Vicks Vapor Rub and took a couple doses of sinus medication after the Coriidin was gone. Started severely hurting with difficulty breathing and chest pain on 4/27/21. Went to The Hospital on 4/28/21. Was diagnosed with pneumonia, pulmonary embolism in left lower lobe pulmonary arterial branches. Patient was admitted. Patient placed on Rocephin 1 gram IVPB daily and azithromycin 500 mg IVPB daily. Patient was started on therapeutic dosing of Lovenox and then transitioned to Eliquis 10 mg BID for 7 days then 5 mg BID. See hos.

Fever,coughing,sob,severe weakness over 4day perios,went into resp distress,unable to raise up became no strength

Patient experience shortness of breath, hives, itching approx 8-12 hours post vaccination. No reaction reported within 4 hours post-injection

4/6/2021 vaccination. Within an hour, I had hives .5", and spread to smaller all over body. I had a hard time breathing. I was fine for the first 15 minutes. I started to get itchy, neck started to hurt. My head was all broken out. All down my legs. An hour or 2 later is when it started to itch really bad. Burning going down my arm. I went to work and worked rest of the day, hard time breathing. I had major stomach ache. I couldn't eat. The HA kicked in and had asthma attack. Fever started; 102. Stomach cramps. HA was severe for quite a while. Seven days later, I called my doctor. 4/13/2021 Saw PCM; Pneumonia and sinus infection. Put on upper respiratory medication; Sefedna. *Migraine for 12 days, became a HA for almost a whole month. 102 FEVER lasted 7 days vomiting for 2.5 weeks body aches, chills, teeth chattering; first 2 days extreme fatigue 4/12 or 4/19 (?); COVID + *still experiencing muscle and joint pain *felt like breathing bleach whole time

HEAVY BREATHING EVEN IF JUST TALKING/SHORTNESS OF BREATH; HEADACHES; HEAVINESS IN CHEST/FEELS LIKE SOMEONE IS SITTING ON MY CHEST; This spontaneous report received from a patient concerned a 60 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 02-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 heaviness in chest/feels like someone is sitting on my chest. On 02-APR-2021, the subject experienced heavy breathing even if im just talking/shortness of breath. On 02-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy breathing even if just talking/shortness of breath, and the outcome of headaches and heaviness in chest/feels like someone is sitting on my chest was not reported. This report was non-serious.

Patient asked if she could get an inhaler for her asthma filled while she was waiting after her vaccine. It was determined that the patient had not had any medications for asthma filled in over 3 years. We contacted two pharmacies that she normally used. Patient then said she was having asthma like breathing - and that she's been having issues but had not seen a PCP in a long time. I then called the Police dept and asked for EMT to come to our site; patient kept saying she didn't want us to call 911. EMT arrived, gave her oxygen, and patient was refusing to go to the hospital. She then changed her mind and decided to be transported to the Hospital. While these events happened after vaccination, it is likely that patient's issues are from not treating her asthma.

Janssen COVOD-19 Vaccine EUA. I had a fever, terrible headache, muscle aches, tired, chills, soreness in upper abdomen and not being able to take a very deep breath. These lasted for a little over 24 hours, but I still have some tenderness in upper abdomen and cannot take a deep breath.

I woke up Wednesday and I felt like I was hit by a train. I felt like a wet dish rag hanging on the sink. Everything hurt, even taking a step, I just felt bad, tired like the flu but no respiratory issues. By the 14th I started getting short of breath, couldn't walk without SOB, my legs started to swell, joints were sore, I felt tired. Went to the doctor and my blood pressure was high, I was prescribed medication for my blood pressure and fluid pills. It hurt just to brush against the skin on my calf. An ultrasound revealed 4 blood clots in my left calf. Went to the ER at . Hospital in and sent to hematologist Dr. and there were no findings.

Anaphylactic response noted at 0955: Audible wheezing and dyspnea-Epipen 0.3mg administered to Left outer thigh. 0958 911 called. 1005 EMT on scene. SaO2 96 Room Air and HR 112. Taking sips of PO fluids (water).1015 Decreased audible wheezing 2LNC Sao2 98 and HR 115 States "feeling better".. 1020 Room Air SaO2 98 HR 111. States feeling better. Without audible wheezing. Spoke with Dr and gave report. Patient encouraged to go to hospital now but she refused. Explained risk of rebound respiratory event for next 6 hours. Patient acknowledged understanding but still refused transport to ER. 1025 Room Air SaO2 98 HR 105 Talking Alert Drinking water Offers no complaints. States she "feels better". Still refusing transport by EMT to hospital. Stated she does not regret having vaccine. Stated she "wanted to get the vaccine." No Chest pain No dyspnea. 1030 Signed AMA (a copy scanned into chart). Walked out of clinic with escort. No complaints. No dyspnea. Advised to call 911 immediately if any adverse effects. Verbalized she understands risks and recommended treatment needed. Called patient at 1412 and left VM inquiring about her and asked she return my call.

I had trouble breathing for two days and had a sore arm within 5 minutes of having the injection. And pain in my left leg is still ongoing.

Heart rate seemed much higher than normal. I felt pressure on my chest, especially on the upper right side of my chest, all day. Breathing was also more difficult than normal. These symptoms lasted all day and were very concerning, but they seemed to have subsided by the next day (Monday May 17th), so I did not seek medical attention. On Monday May 17th, I had a headache from the time I awoke and for hours thereafter. But that went away shortly after I took an aspirin. This is my third reaction event to this vaccine. The first was a headache 3 days after the vaccine. The second was severe vomiting 3.5 weeks after the vaccine. This increased heart rate, chest pressure, difficulty breathing, and headache is the third event.

cardiomegaly, with significant bilateral lung abnormality. in addition, pulmonary edema with extensive bilateral multifocal pneumonia

Patient started coughing, and said that her throat was tingling. She said it was getting hard to breath. Staff gave her some water and took vitals. 1:30 BP 130/92, 81. 1:35 Denies throat tingling. 1:36 reviewed when to seek medical attention and if she reacts after she leaves here. BP 113/77, Pulse 57. 1:41 Patient states she feels fine, no tingling in throat, and no coughing. patient leaves Health Department.

The evening after the vaccination, it triggered my asthma. I consulted my doctor and started breathing treatments (levoalbuterol) twice a day. At 5 days post vaccine, the asthma improved but I came down with a very sore throat and also noticed a enlarged lymph node. It was so painful I could not talk or eat. I was tested for strep and was negative. I was prescribed budesonide to calm down the inflammation and I took cough drops. I am still suffering from sore throat but it getting better. Right below my jaw line, I have an enlarged lymph node that is sore to the touch. I am having difficulty swallowing, talking and eating. I am still having these symptoms.

Get tire extremely fast when walking daily Shortness of breath daily Swollen ankles daily Headaches every morning when I wake up Pressure in left eye often Body was cold the night of the vaccine

Sore throat and headache. Runny nose, sneezing and Productive cough next. And Had a fever once and 02 went down to 95 and then to 92 and then back up. I got Tylenol (took it around the clock - until the week after the hospital due to headaches); Vit D; and I took herbal teas Ginger/Turmeric and water. I had Telehealth visit the whole time. I went to ER when 02 went to 92 and I couldn't smell. I couldn't lay down - had to sit up due to not being able to breathe. I couldn't bend down without being out of bed. I still was short of breath for about three weeks after. Fatigue lasted that long, too. They gave me some (Received Oxygen for breathing at ER). My sense of smell has now returned - not sure when. I'm back to going to gym now - I can walk around and not get out of breath.

FAINTING; BLURRED VISION; SHORTNESS OF BREATH; CHEST PAIN; HEART POUNDING/PALPITATIONS; FASTER HEART RATE; DIZZINESS; CANNOT SLEEP; FEELING SICK; SEVERE ALLERGIC REACTION; SEVERE PERSISTENT HEADACHE; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non-smoker. The patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: 28-JUL-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient experienced severe allergic reaction and had visited the doctor first who then had sent the patient to the emergency room. Laboratory data included: Blood tests (NR: not provided) not reported, Head scan (computerized tomogram head) (NR: not provided) not reported, Heart scan (cardiac imaging procedure) (NR: not provided) not reported, and chest magnetic resonance imaging (NR: not provided) not reported. The patient was released after two hours. The patient felt sick, severe persistent headache, and blurred vision for which she had visited the ophthalmologist and had not found anything wrong. The patient also experienced fainting, shortness of breath, dizziness, chest pain, pounding heart and palpitations all the time especially at night. The patient also had faster heart rate of about 112 beats per minute and was unable to sleep. The reporter stated that the patient would wake up three or four times at night and to distract her, she would eat something to settle her down just a little bit and then the heart rate would go to 90 or 85 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, severe persistent headache, blurred vision, shortness of breath, dizziness, heart pounding/palpitations, faster heart rate, cannot sleep, severe allergic reaction, fainting, and chest pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210664089-covid-19 vaccine ad26.cov2.s-fainting. 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).

11:30PM - Chills late that night and up for an hour for them - went to go to bed with a lot of clothes and lots of blankets but I fell asleep. Morning they were gone. Slightly after that, I had some fatigue but nothing major. I was pretty normal. Then I noticed a few weeks later some swelling under my arms - lymph nodes swollen. I was very aware that they were touching. That seemed to last for a couple of months. I have just become aware the last few weeks that those symptoms with the swollen lymph nodes are gone. About 6 weeks to two months ago - I have been getting pounding heart and a bit of difficulty breathing. May be related stress. It comes and goes and then about a month ago I started a stress reduction supplement protocol and started doing meditation but they were still there and so I went to the doctor. She did an EKG and general physical and she didn't find anything that showed up abnormal with heart. The heart pounding and the breathing issues I'm still noticing.

My head hurt really bad shortly after injection and continued for at least 2 weeks, trouble with body shakes, also had trouble when taking walks with urinary isues, and exusted climbing stairs, caused pressure in my chest which is still there. Finally did Ultrasound of heart because of the pressure in chest, it came back ok. Having alot of junk in throat daily, constantly trying to clear it, I have to use fexofenadine daily instead of ocasional with Asthma flair ups., with shortness of breath it almost fells like emphysema, very sensetive to all smells worse then before.

LEFT EYE COVERED WITH VASELINE MUCOUS; DOUBLE VISION; FOGGY VISION/ EYE GLASSES DON'T WORK AS WELL FOR LEFT EYE; MUSCLE SPASMS; WATER RETENTION; DISCOMFORT; CRACKLES IN LUNG; SLEEP FOR LONGER THAN 2 TO 3 HOURS; WEIGHT GAIN; RIGHT FORE ARM BRUISE; BACK PAIN AND PRESSURE; BACK FREEZING UP; PAIN AT THE DIAPHRAGM; FELT SLEEPY; FELT REALLY HOT IN NECK; HEART BEATING REALLY FAST; FELT REALLY WEIRD; SWOLLEN AND RED FACE/ PUFFING UP LITTLE BIT; TROUBLE BREATHING; UNWELL FEELING (GROSS AND CRAPPY); ALLERGIC REACTION; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 150 pounds, and height was 64 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included caller stated that she does not have any chronic medical conditions. she takes 2-2.5 mg ativan daily, she stated this is half of the dose she was on 1 year ago. Patient had no any drug abuse/ illicit drug use. The patient experienced drug allergy when treated with medroxyprogesterone acetate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. Concomitant medications included diazepam, ketorolac tromethamine, and paracetamol. On 27-MAY-2021, the subject experienced felt sleepy. On 27-MAY-2021, the subject experienced felt really hot in neck. On 27-MAY-2021, the subject experienced heart beating really fast. On 27-MAY-2021, the subject experienced felt really weird. On 27-MAY-2021, the subject experienced swollen and red face/ puffing up little bit. On 27-MAY-2021, the subject experienced trouble breathing. On 27-MAY-2021, the subject experienced unwell feeling (gross and crappy). On 27-MAY-2021, the subject experienced allergic reaction. On 10-JUN-2021, the subject experienced back pain and pressure. On 10-JUN-2021, the subject experienced back freezing up. On 10-JUN-2021, the subject experienced pain at the diaphragm. Laboratory data included: CT scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, Laboratory test abnormal (NR: not provided) unknown, and Pain scale (NR: not provided) 9/10. On 08-JUL-2021, the subject experienced right fore arm bruise. On 09-JUL-2021, Laboratory data included: Spine X-ray (NR: not provided) could not find anything in the series. On an unspecified date, the subject experienced left eye covered with vaseline mucous, double vision, foggy vision/ eye glasses don't work as well for left eye, muscle spasms, water retention, discomfort, crackles in lung, sleep for longer than 2 to 3 hours, and weight gain. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 8-10/10, and Water retention (NR: not provided) gained 25 pounds. Treatment medications (dates unspecified) included: lorazepam, succinate sodium, methylprednisolone, methocarbamol, naproxen sodium, and methylprednisolone sodium succinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen and red face/ puffing up little bit, and trouble breathing on 27-MAY-2021, and left eye covered with vaseline mucous, double vision, and foggy vision/ eye glasses don't work as well for left eye, had not recovered from back pain and pressure, back freezing up, pain at the diaphragm, right fore arm bruise, water retention, and weight gain, and the outcome of felt sleepy, felt really hot in neck, heart beating really fast, felt really weird, unwell feeling (gross and crappy), crackles in lung, sleep for longer than 2 to 3 hours, allergic reaction, muscle spasms and discomfort was not reported. This report was non-serious.

Could NOT breathe, Afib increased, could not walk 15 feet without stopping, gasping for air at night when trying to lay down, major edema in legs and feet - this lasted approximately 2 weeks. Then returned on 6/17 & 6/18.

CHEST X-RAY; ELECTROCARDIOGRAM; NUMBNESS IN RIGHT ARM; TINGLING IN RIGHT ARM; COMPUTERISED TOMOGRAM; ULTRASOUND SCAN ABNORMAL; HYPERTENSION; SKIN SENSITISATION; ARTHRALGIA; PAIN; FATIGUE; PERIPHERAL SWELLING; DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; GAIT DISTURBANCE; FEELING ABNORMAL; DYSPNOEA; INFLUENZA LIKE ILLNESS; MALAISE; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (ID: 1331063) concerned a 60-year-old female. The patient's height, and weight were not reported. The patient's past medical history included degenerative disc disease (neck surgery (four discs repaired), and knee replacement, and concurrent conditions included fibromyalgia, and arthritis. The patient had no known allergy and current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAR-2021 15:00 at right arm for prophylactic vaccination. Concomitant medications included diclofenac, ibuprofen, oxycodone hydrochloride/paracetamol. The patient woke up and felt like she was hit by a train (feeling abnormal) and felt crappy for next 3-5 days, everything was hurting (malaise), even taking a step. She experienced gait disturbance, patient felt bad, tired like the flu (influenza like illness) but does not had respiratory issues. On 12-MAR-2021, she had dyspnea. Patient started symptoms shortness of breath, could not walk without SOB (Shortness of Breath), her legs started to swell (Peripheral swelling/edema), joints were sore/pain (arthralgia), she felt tired (fatigue). On 23-MAR-2021, she visited doctor with high blood pressure (hypertension) and edema, she was prescribed medication for blood pressure and fluid pills (unspecified). Four days later, her legs were swollen bigger, and the PCP switched the medication. It hurt to brush against the skin on her calf (skin sensitization). The patient was diagnosed 4 blood clots (thrombosis) in left calf by ultrasound scan. She ended up in the emergency room the following day, and Computerized tomogram scans were performed and they found pulmonary embolisms in the lower lobes of both lungs. The patient was also diagnosed with electrocardiogram, computerized tomogram, Blood test and chest x-ray. Laboratory data included: Computerized tomogram (NR: not provided) pulmonary embolisms in the lower lobes of both lungs, and Ultrasound scan (NR: not provided) 4 clot on left calf (abnormal). She has been taking Xarelto ever since. In JUN-2021, she said that she began feeling tingling numbness in her right arm, from her elbow to her fingertips. It tingles most of the day and wakes her up at night. Patient was on blood thinners. Laboratory data (dates unspecified) included: Blood test (NR: not provided) unspecified, Chest X-ray (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) not reported. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from feeling abnormal, had not recovered from deep vein thrombosis, skin sensitization, peripheral swelling, pain, malaise, influenza like illness, hypertension, gait disturbance, fatigue, dyspnea, arthralgia, chest x-ray, computerized tomogram, electrocardiogram, and ultrasound scan abnormal, and the outcome of pulmonary embolism, numbness in right arm and tingling in right arm was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20210538232. Additional information was received from patient on 13-JUL-2021. The following information was updated and incorporated into the case narrative: reporter details (first and last name, address, city, zip code, office, email address), Updated disease start date (degenerative disc disease and knee replacement), Events added (pulmonary embolism, numbness in right arm and tingling in right arm), updated event (thrombosis to deep vein thrombosis), Updated event onset date (deep vein thrombosis, ultrasound scan and computerized tomogram) updated lab dates(ultrasound scan and computerized tomogram), updated lab result(computerized tomogram), Added vaccination time and treatment drug(Xarelto) and vaccine facility details (vaccine facility name, city and military information) Upon review following information was amended: Removed partial date (2021) of event Electrocardiogram and lab test (chest x-ray, electrocardiogram and blood test). Additional information was received from patient on 13-JUL-2021. It was determined that (20210538232) was a duplicate of this case. All relevant information regarding this case will be submitted under (20210556305); Sender's Comments: V1-20210556305-Covid-19 vaccine ad26.cov2.s-PULMONARY EMBOLISM and DEEP VEIN THROMBOSIS. Follow-up received regarding Other Information: reporter details, disease start date, Events added, updated event (thrombosis to deep vein thrombosis), event onset date ,lab dates,lab result, vaccination time , treatment drug and vaccine facility details . 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). 20210556305-covid-19 vaccine ad26.cov2.s-Thrombosis, ultrasound scan abnormal. This events are considered unassessable. The events has a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Fatigue, tired, dizziness, palpitations, shallow breathing, lack of energy, diarrhea on 5th day after the vaccine shot

Patient with 2 Emergency Department visits after vaccination. (3.19.21 & 3.22.21) 3.19.21: Symptoms: Patient had the J&J vaccine on Tuesday, and felt fatigued on Wednesday. Today she is more short of breath than normal and states she has chest pain. Daughter has suggested an ambulance, but patient, who is A&O X 3, declines. Daughter will bring to ED for evaluation. 61-year-old female with history of asthma, sleep apnea, environmental allergies, and hypertension presents emergency department complaining of shortness of breath and cough that started this morning and midsternal chest tightness rating at a 7/10. Sent home with prescriptions to manage cough, inhaler and steroid burst. 3.20.21 Office Visit: Patient states Wednesday 03/17/21 morning cough and mild fatigue started. Thursday 03/18/21 patient had shortness of breath with exertion x2 days. Yesterday 03/19/21 patient went down the stairs and was having severe shortness of breath. Patient felt like she couldn't get enough air in. Patient was seen in ED 03/19/21 and prescribed cough medicine. Patient states cough is constant with intermittent coughing fits. Patient was tested for COVID-19 while in ED and results were negative Shortness of breath is still present, but is better after ED visit. Patient states she feels 50% better today 03/20/21. Patient has been using inhaler and prednisone. Patient is needing to move slower to compensate for shortnbess of breath. Cough is present still. Cough is deep and dry. Yesterday 03/19/21 cough was productive. Today 03/20/21 patient is getting a small amount of phlegm out and it is white in color. Denies fever. No known exposure to COVID-19. History of asthma, not much relief currently with inhaler. When shortness of breath is present, it takes patient about 20-30 minutes to recover. Intermittent wheezing with mild wheezing present currently. Tightness in chest is present and coughing makes it worse. Patient had COVID-19 in April of 2020. Any treatment So Far: ED visit, Inhaler, prednisone, and prescribed cough medicines 3.22.21: Mon Mar 22, 2021 1722 This is a 60 year female presents for evaluation of shortness of breath. Some been going on for about a week now. She was just seen in the emergency department 3 days ago for same complaints. At that time she had a cardiac workup that was unremarkable. On initial evaluation here today she appears in no acute respiratory distress. She has normal room air oxygen saturations. Complete blood count shows a slight leukocytosis of 11.93 which may be elevated secondary to her current prednisone use. About 4 positive relative normal limits. Troponin was normal as was her proBNP. COVID PCR was not detected. CT angiogram thorax was negative for PE, pneumonia or other acute process. Patient is notified of these findings. She otherwise is discharged home with instructions follow up closely with primary care physician.

By 6pm, I started feeling feverish, with chills, nausea, chest pains and abdominal pain. I also experienced headaches and my fever got up to 102.5. I went to the ER and they gave me fluids. I was told it was a reaction to the vaccine, but my paperwork said upper respiratory infection. My cough started out dry, I had SOB, weakness, fatigue, diarrhea and joint pain. My PCP put me on a steroid and an antibiotic Keflex (500mg, 3 times a day). I get lightheaded just walking around the house. I'm still experiencing SOB, fatigue and the cough. Today is the first day that I could get up an move around. I'm fine when I first wake up, but I eventually feel depleted.

Patient received the vaccine on 3/23/21 and developed symptoms of COVID on 4/5/21 (abdominal discomfort, heartburn, shortness of breath, and cough). On 4/8/21 she was admitted to hospital with COVID and is currently on supplemental oxygen.

Severe - Chills for 12 hours, horrible neck/back pain, hallucinated, whole body ached & felt like I couldn't move, extremely tired, shortness of breath for 1/2 day, no energy, rash, runny nose & sore throat, tingly sensation on extremities (still occurring), ringing/piercing sound in my ears, headaches. It has been over 3 weeks and I still don't feel energetic & like myself.

40 minutes after receiving shot, patient was home and felt swelling of the tongue, slight difficulty breathing. She called 911, EMS did full evaluation on her (vitals included) and said maybe she was just having an anxiety attack. EMS instructed her to take Benadryl. Patient did not want to. Patient called pharmacy and explained symptoms to me, the pharmacist who administered the shot. I told her it sounds like it was related to the vaccine and that I would report her reaction to VAERS. I told her it might be a good idea to take Benadryl.

Mild tingling in tongue, felt "funny allover", itching, mild shortness of breath, difficult shallowing, hives, swelling in arm (right administered 75mg of Diphenhydramine oral 10 minutes apart, symptoms leveled out until assisting to restroom, needed assistance ambulating to and from toilet felt dizzy and weak, itching in arm became unbearable, itching all over became severe, administered patient's epipen, called EMS, patient was responsive when sent in ambulance to ER.

Forty minutes after the shot, my mouth, lips, neck, gums, and tongue became numb and I had difficulty swallowing. This came on immediately. I started having shortness of breath and chest tightness. I acknowledge that the shortness of breath could have been due to panic, but the allergic reaction came first and was most definitely real. I also have muscle twitching on my left hand, which started after the shot. I've had it now for 28 hours. I got the shot on my left arm.

Very strong chills during the night, the next day weakness. Inappetence, excessive sleepiness, headache. place of the vaccine inflamed with pain and itching it is been five days and it's still swollen and painful, from day 4 throat swelling with pain, place of the vaccine inflamed and pain. I have taken antiallergy, ibuprofen, cortisone cream in the place of the vaccine, and cold and hot

extreme pain on left side of face, throat, and neck. swelling in throat that caused fair amount of difficulty in breathing, talking and swallowing received epipen at urgent care on 04/09/2021 as the doctor felt I was having an allergic reaction to the covid vaccine and was told to go to the emergency room. was given IV of benedryl and pepcid. had a CT with contrast do to feeling of having something lodged in my throat. sent home with perscriptions for steroids and pepcid. still having symptoms though they are less severe

Shortness of breath, stomach issues, muscle aches and pain, headaches, rapid heart rate, nausea, vision problems.

Felt crippled unable to walk excruciating pain (bone next to tailbone on left side) Shortness of breath Couldn't hold urine Felt perfectly fine until the morning of 3/20/21 (lasted 2 weeks-until I begged DR. to provide anti-inflammatory, 5% lidocaine patch to treat this, and I did not want continue to take my Percocet (from previous facture event) that the Dr. recommended.

Had injection on March 31, 2021. Very sore arm with soreness and stiffness in the neck for a few days. On April 8th woke up very dizzy, had to lay back down for a little bit. On April 10th woke up not being able to take a deep breath without a very bad pain in my back (it felt like my right lung) same issue the 11th, and 12th. This pain was not severe unless I took a deep breath. I was able to go about my daily activities. Today April 13th still a little tight in my lung but do not have the pain in my back that I had the last few days.

Chills, severe headache, fatigue, dizziness, lack of appetite, nausea, anxiety. On 4/9/2021, I started to feel a pulsating feeling on my upper head and felt anxiety. It felt like I could not reduce my stress by taking deep breaths and letting it out slowly which was unusual because this usually works.

Approx 5 Minutes post vaccination : Severe Headache lasting approx 10 minutes, slight throat tightening, acceleration of heart rate that lasted about 15 minutes but continued intermittently for the first day post vaccination. Leg pain (aching) that lasted for 4 days. I struggled to think...as though I was in a fog ...for example it took me along time to think of an answer to a question I was asked. This lasted for 2 days. Severe tiredness 6 hours post vaccination, I slept for 2 hours then insomnia the first evening. Nausea beginning 6 hours post vaccination then rolling nausea that continued 6 days .

The patient presented 3 weeks post injection with cardiac arrest from home. She had a 1 hour downtime. The day previous she had worsening leg swelling and SOB +DOE. Post arrest she was diagnosed with massive PE. She was treated for PE with thrombolytics and improved hemodynamically. She unfortunately at this time has anoxic brain injury.

101 fever for 12 hours. Chronic headache that has not resolved to date, ongoing chills since vaccination, unresolved insomnia, intestinal discomfort, and intermittent shortness of breath.

Right after shot, did not feel anything that morning till around 5pm I started to feel feverish, headache, tired. My arm never got sore or swollen. AFter 5pm till, the feverish feeling and hot cold got worse as time went by and I started shaking uncontrollably - pretty severe. I took Tylenol early hoping to stop the achy feverish and shaking but did not seem to help. THis went to till about 1am or 2am when I could finally lay down and try to sleep. The shaking had stopped. I did take more Tylenol and drank some herbal chamole type of hot tea. I could not sleep that night. Next day I was exhausted, body aches and still had some feverish feeling. By the way, took my temperature and it was normal. Then on Wednesday, I believe is when I had a huge episode of diarrhea (came on sudden). I kept calling and talking virtually to the doctor telling him all of what was going on. The next day I the feverish feeling and body aches and being tired kept happening - adding headache getting worse. I kept taking Tylenol. Seem to help some but did not take the pain away. EAch night , I could not sleep due to the headache. I started to feel better but then on the weekend, I had that headache and tired feeling. The headache was getting stronger and it circled my whole head and both shoulder and around my neck. It scared me because I felt at times that my throat was getting smaller. I could still swallow but it was so strange. I kept putting heat packs and ice packs and taking Tyelnol. I know that on Thursday or Friday the week, the doctor told me if I wanted to to go get tested for Covid and I did. I was tested negative on both the quick test and the other test that takes longer. I had that headache, sinus tension pressure for quite a few more days. Overall it took 7 days. I had to take off most of the week from my telework job because I could not function. I also did not eat much and drank lots of water during this time. It seem to go away and then about a week later, I got this painful diarrhea out of the blue and went to see an urgent care doctor. They tested me for blood, urine, and stool and they were negative. I was also having pain on my left side. Then it seem to go away after I was on the BRAT diet for a few more days. Then the diarrhea happened again the next week or so. This week, as of yesterday, I got a very strange throbbing pain in my left hand and not sure where that came from. It can be extreme at times. I tool Tyleonol but the pain is still there. Also, during this time and before the shot, I got a trigger finger issue on my right index finger. I don't think that has anything to do with the vaccine. Please note I have been told my doctors and I know this for a fact, my body is super sensitive to food, meds. I don't usually get the flu shot because of that. Today I am experiencing the left hand pain and now metal tasting in my mouth. I am about 5 weeks out from the vaccine. I wish I had never taken it. I pray nothing more will happen in my body If I have left anything off it is because I did not write this down when was happening. I really thought I was going to die one night because of the pressure I was having in my head, neck and shoulders. I have a little bit of a headache now and told my PT doctor that if I needed to know, I could get a brain or some kind of scan to see if I am hainvg any issues. I am going to bring this up to my virtual call today.

Headache since shot with fluctuating intensity Extreme fatigue since 4/1/21 Cough since 4/5/21 (asthma) Dizziness since 4/11

patient was diagnosed with bilateral pulmonary emboli within 3 weeks of vaccine administration, developed dry cough within 1 week of vaccine that progressed to worsening shortness of breath.

Patient received vaccination without noted reaction. On 04/10/2021 patient was transported to hospital via ambulance c/o shortness of breath. Patient was diagnosed with pneumonia. Patient refused admission and returned home with prescriptions for inhalers, steroids, and antibiotics. Patient claims on 02 at home prior to event. Patient also c/o left leg pain (unspecified) but has not sought medical care. Patient treated at Hospital. Patient was advised to follow with her PCP for leg pain.

right after the vaccine in the pharmacy my throat felt like it was closing. and medicine taste going down my throat , pharmacist said no big deal. I went home 4 hours later i had fever and shakes and convulsions and my right finger were numb and my right leg and right low side hurt. My neighbor call the pharmacy and they said its normal to work thru. april6 pain in side was unbearable and i went to the doctor. had a ct scan and they put me on antibiotics.I had had headache for 15 days now. I don?t know how i am going to pay mymedica bill for a free covid vaccine.

Bilateral pulmonary embolism. She had chest pain, SOB, tachycardia in 130s. . Presented to ED. CTA positive for bilateral PE with Left popliteal DVT. She was treated with systemic TPA and heparin. She is still hospitalized.

Fingers on left hand began tingling around 30 minutes or so after shot. While riding home in the car, both the numbness, heaviness feeling in my arm and the tingling worsened. Then a strong sensation went up the left side of my neck and into the left side of my face where my face started tingling. That was so powerful and unexpected it caused me to gasp and grab the side of my neck. My husband turned the car around and we returned to the hospital where they took the information and had me sit for a while checking back a few times. My arm, fingers, neck and face continued to feel numb and heavy with my face and fingers tingling. After no improvement and some escalation as it ebbed and flowed, I had an April 12 appointment with Dr at Medical Center. Some blood work was done afterwards. A PT appt. is set for April 29th. It has been more than two weeks now and unfortunately, the numbness, heaviness and tingling continue.

A few minutes after the patient received dose 1 of the Janssen Covid-19 vaccine, the patient started having trouble breathing, her throat felt "swollen and thick", was shaky, had itchy hands, and her lip was swelling. Her blood pressure was 174/86 and her pulse was fluctuating in the mid-high 80s. I administered 1 tablet of diphenhydramine (25mg) and 1 dose of the 0.3mg epi-pen. After about 7-10 minutes, she said her symptoms started to level out and were no longer getting worse. Her lip swelling started going down by the time EMS arrived. I continuously checked her blood pressure, heart rate, and heart rhythm while waiting for EMS to arrive and take over her care. They took her to the closest emergency room for continued monitoring.

Insomnia, muscle aches and weakness. back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breath and chest pain.

Insomnia, muscle aches and weakness. Back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breathe and chest pain.

With in 10 minutes of the injection my thoart closed, my lips swelled and I was having trouble breathing. Benaydyl was given and an Epipen was used, I was taken by ambulance to the local hospital ER where an IV was started, steroid was injected. I was kept several hours for observation and sent home. The following day I had attacks of itching and rashes as well as occasional numbness in my lips, by Thursday evening it was worse, returned to a different hospitals ER at 2am Friday morning, more steroid was given and I was observed, and sent home with an prescription for an epipen as well as steroids. Continued to take Benadryl often taking two with in a half hour, Monday May 24 went to my own docotor, as I had a new reaction of pressure in both ears with pressure in my cheeks and around the back of my head. She give me a prescription for additional steroids and is still monitoring me as I am still reacting.

Patient presented to PCP on 05/18/2021 office from group home with C/O cough, runny nose, lethargic, fever, lungs rattling, uncontrollable shaking. Patient had a seizure the night before and had been having weak spells and coughing and fever since that time. Patient admitted to hospital on 05/18/2021 and chest Xray showed pneumonia. Patient tested for COVID-19 on 05/21/2021 after learning of potential exposure at group home and result was positive.

the patient came back med opts 1 shaky, warm, and slightly sweaty. she said her tongue was itchy and had slightly labored breathing. Patient also said she was diabetic and was given apple juice. Vitals- TIME: 4:37 HR: 116 RESP: 14 BP:168/100 SP02: 94%

Patient said that she is experiencing extreme fatigue and chronic pain in her hip back neck. she can hardly walk. She stated that she falls asleep any where. She has a strange feeling in her chest. She is experiencing breathing complications. She has a hard time drinking water without choking. She stated that she has a high tolerance for pain, but this pain is unboreable. She stated that she was taking walks and now she can barely walk to her car without loosing her breathe.

SYNCOPE/COLLAPSED; FELL DOWN; TREMBLING; HYPERVENTILATED; BLOOD PRESSURE WAS VERY DOWN; COULD NOT TALK; HIT HEAD; HIT HAND; HIT ELBOW; BUMP ON HEAD, ELBOW, AND HAND; HEADACHE; This spontaneous report received from a patient concerned a 61 year old Hispanic or Latino 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2076A21A, and expiry: unknown) dose was not reported, frequency 1 total, administered on 07-JUL-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 07-JUL-2021, after receiving vaccine, the patient felt dizzy and could not talk. The patient fell down and hit her head, hand, and elbow. Paramedics were called to help the patient and she was taken to emergency room (ER). The patient was informed that her blood pressure was very down, she was hyperventilated and was trembling. On the same day, the patient felt fine and experienced headache after going home and noted bump on her head, hand, and elbow because of the fall. The patient was diagnosed with syncope/collapsed. Laboratory data included: Blood pressure (NR: not provided) Decreased, and Laboratory test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from syncope/collapsed, trembling, hyperventilated, blood pressure was very down, and could not talk, and the outcome of fell down, hit head, hit hand, hit elbow, headache and bump on head, elbow, and hand was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:- 20210718537- covid-19 vaccine ad26.cov2.s-syncope/collapsed. 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).

I sat in a chair for 15 minutes after getting my vaccine. One minute after sitting down, I had a headache, and I never get headaches. The headache got worse and worse. I had lunch, and I still had the headache afterwards. I then went home, and the headache got even worse. At about 2 AM, I got out of bed and tapped my head in the hope that it would help the headache and it didn't. I then started to get a fever. The following morning, I had a full-blown fever, and I still had a horrific headache. I ended up having the headache for a whole week. With my fever, the temperature was 102; I didn't take anything, because I thought it would run its course and allow my body to get used to the vaccine. I eventually took two acetaminophen tablets, and it only reduced the temperature by one degree. I then took Advil, which also reduced it by one degree. The day after that, I had hives all over from the knees up, even in my crotch, eyes, and ears! I called a doctor, who prescribed me heavy-duty steroids. I was on steroids for 6 days . On the 4th day, I began to show signs of improvement. On the 9th day, the hives started to clear up, the headache began to subside, and the fever was gone. I had terrible fatigue for a while afterwards. Now, I'm trouble breathing. I always feel winded whenever I do any activity. Before the vaccine, I was very high-energy and had no trouble with fatigue or windedness.

Chills Fever of 101.8 Nausea Muscle Aches Fatigue Trouble Breathing Dizziness Symptoms gradually subsided over 24 hours. Used a rescue inhaler for the breathing troubles, took extra strength tylenol for the fever. Slept for 18 solid hours from 9pm on March 7th till 3 pm on March 8th - had been napping most of the day before 9pm.Fever and fatigue were the last symptoms to resolve.

Patient arrived to the outpatient vaccine clinic for her scheduled appointment. Immediately after receiving the vaccine, the patient felt chest pain, dizziness, and passed out. She had swelling of the tongue, lips, eyes, and throat. Patient was admitted to the hospital and treated for anaphylaxis with epinephrine, benadryl, famotidine, methylprednisolone, Duoneb and tylenol. Patient is currently still in the hospital but her condition is stable.

Janssen COVID-19 Vaccine EUA I received the single dose at 10:40. In approximately 11 minutes I started to experience shortness of breath. I thought it was my N95 mask so decided to head to the car after my 15 minute wait period was completed. After sitting down in the car I started the following symptoms: shortness of breath, rapid heart rate, swelling of face, dizziness, weakness. I sit in the car for approximately 15 minutes then headed home. I had a driver (thank goodness). I continued to have symptoms and what felt like elevated blood pressure (I did not have access to a pressure cuff). After resting at my driver's house for about 5 hours I felt better and headed home. The next morning the symptoms were less but still present. In addition I had a slight rash on my stomach that wrapped around my back. After approximately 48 hours all of the symptoms subsided. My blood pressure had returned to normal also. All swelling went down.

One week after my vaccination, I had what I thought was an asthma attack. I used my inhaler and it eased the symptoms for a short while, but I had to use it again a short time later as my breathing was a bit labored. My chest tightened up and it was hard to take deep breaths. From that date on, I have had tightness in the lungs and it hurts to breath deeply. It is getting so I am tired now after having this issue for the past 10 days or more. It seems to come and go and is not constant, but it does happen every day since March 10, 2021.

I just started having problems breathing, I couldn't catch my breathe and heart rate went sky high. I ended up going to the ER, they have me some steroids and breathing treatments, monitored my heart rate for three hours. I stayed in the ER for 4 hours and discharged me. The next day I was feeling a little week but breathing better and heart rate was back down to normal. I have a cough that's lingering a dry cough.

Anaphylactic reaction 10 mins after shot - drop in blood pressure, swelling of lips and upper palate and throat. Treated with epi-pen. Symptoms subsided with some residuals for about 90 minutes.

Day 1: Received vaccine @ 2pm and about 15 minutes later lymph nodes in neck started to swell with right greater than left swelling. Notified nurse and told to wait another 15 minutes and contact if difficulty breathing. Took 25 mg benadryl orally, Symptoms remained the same. At 2:30 left vaccine site. At 2:35 took another Benadryl due to tightness in throat. No change in breathing, Swelling in Lymph nodes increased. No change in breathing. Went to bed for a few hours. Upon waking felt achy all over. Day 2: The next day about 20 hours after the receiving the vaccine felt chilled, increased body aches, feverish, temp 102.4. Treating with Tylenol and Benadryl, warm showers to try and decrease chills and fluids. Day 3 increased body aches and now mild headache, temp continues 100.2 treating with Tylenol, additional fluids.

The Pt presents with swelling of her lips 20 minutes following injection of 1 dose Janssen vaccine to the left deltoid. The Pt states that she has had anaphylaxis in the past to Macrobid, Sulfa, Amoxicillin. She has an Epipen at home but states that she has never had to use it because her symptoms develop slowly. In the past she has driven herself to the ER where she has received breathing treatments and observation. Pt denies swelling of the eyes, tongue, throat tightness, difficulty swallowing, itching of the skin, SOB, CP, nausea or vomiting. She also denies dizziness, lightheadedness, or vision changes. The Pt also has a Hx of meningioma and SVT s/p ablation. Suspicion for anaphylaxis high due to lip swelling, wheezing, and previous episodes of delayed onset anaphylaxis. Pt drove herself today so IM injection of diphenhydramine was delayed. Upon recheck Pt?s wheezing was unchanged and lip swelling had not progressed further. Due to past episodes of SVT and no progression of current symptoms, epinephrine was on stand by but not administered. Care was transferred to EMS. Care was transferred to EMS and Pt was transported to the hospital.

Injection site bruising, rash, with creeping red rash that continued to broaden each day. Swelling, itchiness. Minor wheezing (Day 2 or 3) Extreme fatigue (Day 1, 2, 3).

Chest palpitations vomiting fever breathlessness rash on neck and face thickening of tongue palate lips blood pressure 174/106 spike tiredness headaches aches since Friday I had called nine times to this number

Client received the COVID vaccine (Janssen, Lot# 1808980) at 11:30. EMT observed the client sitting with her head in her hands and alerted RN, then all responded at 1140. The client complained of shortness of breath and dizziness. Upon assessment, the client was pale, diaphoretic, and clammy, and her skin was cool and dry. The client stated that she is anxious about needles and vaccinations, and that her mask was making her feel "claustrophobic." The client was encouraged to practice deep breathing and her vital signs were obtained: blood pressure of 96/76, respiratory rate of 12. The client stated that she did eat breakfast that morning at 0930 and was offered some water to drink. . Per the client, she has a medical history of hypothyroidism and the only medication she takes is levothyroxine. The client also stated that she tends to have lower blood pressure and "110/60 is normal" for her. The client was alert and oriented. At 1145, the repeat vital blood pressure for the client was 97/63. She stated at this time that she felt like she was going to pass out, and was transferred to the reclining chair. At 1150, the repeat vital signs were as follows: blood pressure of 118/80, heart rate of 78, respiratory rate of 16, and pulse O2 reading of 95%. At 1155, repeat vital signs were as follows: blood pressure of 112/74, heart rate of 78, respiratory rate of 14, pulse oximeter reading of 96%. At this time, the client's color returned to normal and they were no longer clammy. At 1207, the client's blood pressure was 110/72, their heart rate was 73, their respiratory rate was 8, and their pulse oximeter reading was 97%. The client stated they "feel great" and left the facility at 1210, ambulating with a steady gait to their car, where they were driven home by an acquaintance.

03/08/2021 (Symptoms began 45 minutes after shot): sore arm down to fingers, stuffy nose, watery eyes, headache, light headed, slight balance issues, malaise, no appetite, slight nausea, tight chest, arm soreness down to fingers became worst & was accompanied by arm swelling which included the fingers, 2 hives, tingle around mouth & nose, asthma feeling progressed to shortness of breath upon exertion, slight face swelling, Temp 102, chills. 03/09/2021 same symptoms as 03/08/2021 but minus the hives & the addition of the following symptoms: Temp 101, shaking so bad from chills couldn't hold anything, runny nose & eyes, extreme fatigue, small chest pain, skin cold like had been in freezer, lips & fingers slightly purple. 03/10/2021 same symptoms as 03/08/2021 & 03/09/2021 but minus the hives, slight face swelling, servere chills, lips & fingers barely purple & the addition of the following symptoms: Temp 100. 03/11/2021 symptoms include: Temp 99.7, sore arm down to fingers, stuffy nose, watery eyes, headache, slight balance issues, malaise, no appetite, slight nausea, tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue, & small chest pain. 03/12/2021 symptoms include: Temp 98.7, sore arm down to fingers, slight headache, slight balance issues, malaise, no appetite, slight nausea, slight tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/13/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, no appetite, slight nausea, slight tight chest, slight shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/14/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight appetite, slight nausea, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021- 04/10/2021 symptoms include: Temp 97.7 (my normal), fatigue & slight malaise at times.

almost two weeks later my arm is still very sore at injection site. the next morning after the vaccine when i was at work i had to leave my classroom because i felt sick. i felt nauseated, sweaty, light headed, short of breath and my heart was pounding like i had been running a marathon. i thought i was gonna have a heart attack. i HAD to go outside for fresh cool air and sit down. i was also applying a cold compress, drinking cool water and taking very deep breaths i was able to return to work in about 15 minutes. i continued to feel nauseated for the rest of that day and the next.

Shortness of breath, difficulty breathing, difficulty speaking, chills, violent shaking, left kidney pain , headache, Coughing body aches, fatigue, confusion, difficulty sleeping ,loss of appetite, weakness , burning in my lungs

Woke up at around 5am to severe chest pain and difficulty breathing (shortness of breath). The condition continued through out the day requiring me to sit in a way that it would alleviate the pain and reduce the shortness of breath.

Day one: soreness at injection site, mild achiness and headache, brief episode of intense coughing/wheezing Day two: slight lightheadedness, episode of vertigo and nausea. All totally resolved by the end of day 2

Pain of lower extremities; SHORTNESS OF BREATH; WEAKNESS OF THE UPPER ARMS; WEAKNESS OF LEGS; Chills; Fever; VIBRATION SENSE ON BOTH LEGS; Chest tightness; STIFFNESS/TIGHTNESS OF LEGS; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced vibration sense on both legs. On 09-MAR-2021, the subject experienced chest tightness. On 09-MAR-2021, the subject experienced stiffness/tightness of legs. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 16-MAR-2021, the subject experienced weakness of legs. On 23-MAR-2021, the subject experienced weakness of the upper arms. On 04-APR-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced pain of lower extremities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, chills, and fever on 10-MAR-2021, and had not recovered from vibration sense on both legs, shortness of breath, weakness of legs, weakness of the upper arms, stiffness/tightness of legs, and pain of lower extremities. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as Non serious.

About two weeks ago, I started with a stuffy nose, SOB and I had a cough that was producing phlegm. I had to increase my oxgen to daily use.

Tightness in throat, breathing problems, used my albuteral inhaler 2x, coughing, very itchy all within 10 minutes of the shot. I was taken back to a separate room and seen by paramedics.

Patient described having trouble breathing . She said it felt as bad as collapsed lung she had in the past.

Leg Pain: Bilateral; heavy and achy especially to lower legs. Having generalized weakness and lack of energy. Associated sx: sob with rest/exertion; worse with exertion and dry cough. Onset of sx over Easter weekend and continued without improvement. Reports she had her COVID19 Vaccine (J&J, March 20). Onset of sx approximately 15 days from J&J COVID vaccine. Further c/o increased edema to BLE. Usually wears her stockings but cannot tolerate them d/t pain. Reports family hx of CHF in mom. She further has a hx of varicose veins. Tx: labs and imaging - see below.

Some minutes after the injection I started feeling a burning sensation under my bra (around my chest), and it was hard to breath and then I started feeling it in my throat and then my lips started tingling, I also had a headache that started. I alerted the person at the vaccination site saying something was not right and then they called the paramedics who took my vitals and said my heart rate and blood pressure was extremely high. They gave me a shot of Benadryl and oxygen because I was feeling shortness of breath. They kept me until about 11:35 in observation when I felt myself again. The headache, nausea and body aches stayed for about 2 weeks but all other symptoms subsided.

The day after having been vaccinated with Johnson & Johnson/Janssen COVID19 vaccine (04/11/2021), my mother started to feel intense pain, swelling, tenderness and cramping in her legs, especially her right leg, to the point that she couldn't walk. By the fourth day after the vaccine her right leg was completely swollen, twice as big as its normal size, the pain was unbearable and she experienced fatigue and shortness of breath. I took her to the ER on 04/14/2021

severe Headache started the next evening along with sore throat, cough, sweating, chills, pounding/throbbing in the ears, trouble breathing, elevated heart rate symptoms persist through today 4/15/21

10 minutes after shot i started to feel tingling and numbness in my chest which traveled to my neck and into face. Began having a dry cough, went to nurse to as if normal, she said no, she started monitoring me. Still had cough, then became light headed and nausea. She gave me 25 mg of Benadryl, coughing continued, breathing became rapid, then I was given shot of epi, I became dizzy again and couldn?t complete a sentence. Words were slurred, heart beat racing. EMT?s were called. Received another shot of Benadryl. It did not counteract anything. Received another shot of epi. Had uncontrollable shakes and hard to breathe or speak. Was difficult to get BP reading due to shaking. Finally got reading of 196/99. EMT listened to heart and lungs. Said all was good. Taken to ER for monitoring of heart, Lungs and BP. Was there for approximately 2 hours u til shakes and BP were good.

colonic necrosis 62 yo woman history of prior L occipital CVA and DVT on Xarelto presented to Hospital on April 6 with mental status changes. Patient was noted to be in severe metabolic acidosis, renal failure and shock. Chest x-ray showed interstitial infiltrates and she tested positive for SARS-CoV2. She required intubation and mechanical ventilation. CT brain showed encephalomalacia and atrophy, no new changes. She was transferred on April 8. She was given IV bicarb for persistent metabolic acidosis. Initially she was only treated with steroids, then antibiotics were added for fever and persistent hypotension. She started to spike fevers up to 40. Abdominal CXR ordered prior to MRI, showed possible pneumatosis. A follow up CT April 13 abdomen/pelvis was done which shows colonic pneumatosis, with air in the SMV, portal vein, air in the liver. No thrombocytopenia; platelets on April 13 were 310k, as low as 260 on April 8.

FEELS SPACEY; DIZZINESS; PAIN FROM HEAD TO TOE; NAUSEA; DRY THROAT; EYEBALLS WERE HURTING; FEELING HOT; FELT LIKE RUN OVER BY A MACK TRUCK; CHILLS; HEADACHE; HOT SWEATS; STOMACH ACHE / BELLY MUSCLE ACHE; INCREASED GAS; BURPING; SWOLLEN THROAT; THROAT IRRITATION; This spontaneous report received from a patient concerned a 62 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 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced increased gas. On 07-APR-2021, the subject experienced burping. On 07-APR-2021, the subject experienced swollen throat. On 07-APR-2021, the subject experienced throat irritation. On 08-APR-2021, the subject experienced stomach ache / belly muscle ache. On 08-APR-2021, the subject experienced hot sweats. On 08-APR-2021, the subject experienced dry throat. On 08-APR-2021, the subject experienced eyeballs were hurting. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced felt like run over by a mack truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021 03:00, the subject experienced dizziness. On 08-APR-2021 03:00, the subject experienced pain from head to toe. On 08-APR-2021 03:00, the subject experienced nausea. On 09-APR-2021, the subject experienced feels spacey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach ache / belly muscle ache, increased gas, burping, headache, swollen throat, dizziness, nausea, pain from head to toe, chills, hot sweats, feels spacey, throat irritation, dry throat, eyeballs were hurting, feeling hot, and felt like run over by a mack truck. This report was non-serious.

HA, Itching all over, Rash (shingles like around neck), Itching ears, Swollen legs, Shortness of Breath

RAISED RED MARK IN THE AREA OF SHOT; AREA OF SHOT HURT; HEADACHE; TIREDNESS; PAIN IN THE NECK; BITTER TASTE IN THE MOUTH; NASAL DRIPPING; DRIPPING BACK OF THROAT; SWELLING OF TONGUE; SORENESS OF BODY; DIFFICULTY IN BREATHING; PAIN IN RIGHT ARM; CHILLS; SHOULDER HURT; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip surgery, and knee replacement, and concurrent conditions included atrial fibrillation, hypertension, diabetes, gastrooesophageal reflux disease, rheumatoid arthritis, multiple myleloma, egg allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not had any drug abuse or illicit drug use. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, metformin for diabetic, torasemide for diuretic, omeprazole for gastrooesophageal reflux disease, pantoprazole for gastrooesophageal reflux disease, amlodipine for hypertension, eplerenone for hypertension, sodium perborate monohydrate for hypokalemia, paracetamol for rheumatoid arthritis, atorvastatin, and ubidecarenone. On 08-APR-2021, the subject experienced pain in the neck. On 08-APR-2021, the subject experienced bitter taste in the mouth. On 08-APR-2021, the subject experienced nasal dripping. On 08-APR-2021, the subject experienced dripping back of throat. On 08-APR-2021, the subject experienced swelling of tongue. On 08-APR-2021, the subject experienced soreness of body. On 08-APR-2021, the subject experienced difficulty in breathing. On 08-APR-2021, the subject experienced pain in right arm. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced shoulder hurt. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced raised red mark in the area of shot. On 12-APR-2021, the subject experienced area of shot hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bitter taste in the mouth, nasal dripping, dripping back of throat, swelling of tongue, and difficulty in breathing on 08-APR-2021, and chills on 12-APR-2021, was recovering from raised red mark in the area of shot, and area of shot hurt, and had not recovered from headache, pain in the neck, pain in right arm, tiredness, shoulder hurt, and soreness of body. This report was non-serious.

MUSCLE SPASMS; STIFF NECK; TIGHTNESS IN THROAT; MUSCLE TWITCHES; HEAVINESS IN LIMBS; LOW GRADE FEVER; ARM PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm pain. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced stiff neck. On 08-APR-2021, the subject experienced tightness in throat. On 08-APR-2021, the subject experienced muscle twitches. On 08-APR-2021, the subject experienced heaviness in limbs. On 08-APR-2021, the subject experienced low grade fever. On 12-APR-2021, the subject experienced muscle spasms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff neck, and heaviness in limbs on 10-APR-2021, had not recovered from low grade fever, injection site pain, muscle spasms, arm pain, and muscle twitches, and the outcome of tightness in throat was not reported. This report was non-serious.

SHORTNESS OF BREATH; LIVER SPOTS; RASH LEFT THIGH; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included oxygen for copd. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced liver spots. On 11-APR-2021, the subject experienced rash left thigh. Laboratory data included: O2 saturation (NR: not provided) 97 %. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, had not recovered from rash left thigh, and the outcome of liver spots was not reported. This report was non-serious.

1 week post vaccine had 1 day with a sore throat and runny nose. Developed right calf pain 04/19/2021. Presented to ER on 04/25/2021 w/ a 2 day history of shortness of breath and some chest tightness worse with exertion, with worsening symptoms at time of ER visit. Admitted for observation with "Pulmonary embolism without acute cor pulmonale and Acute respiratory failure with hypoxia"

MIND FOGGY; SHORTNESS OF BREATH; HEART RACING; UNABLE TO MOVE AROUND; CHILL; FATIGUE; FEVER; MUSCLE PAIN; VERY RED VEINS ON RIGHT LEG LOWER PART/RED VEINS ON LEFT ARM LOWER PART BETWEEN WRIST AND ELBOW; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and other pre-existing medical conditions included patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced very red veins on right leg lower part/red veins on left arm lower part between wrist and elbow. On 06-APR-2021, the subject experienced shortness of breath. On 06-APR-2021, the subject experienced heart racing. On 06-APR-2021, the subject experienced unable to move around. On 06-APR-2021, the subject experienced chill. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced muscle pain. Laboratory data included: Pulse rate (NR: not provided) 92 /min. On 16-APR-2021, the subject experienced mind foggy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chill, fatigue, fever, and muscle pain on 08-APR-2021, was recovering from shortness of breath, and unable to move around, and had not recovered from heart racing, mind foggy, and very red veins on right leg lower part/red veins on left arm lower part between wrist and elbow. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.

Hives, rash, slight difficulty breathing, partial reduction in taste, fatigue, headache. 2 rounds of prednisone, benadryl, zyrtec

Per NP; "Patient is a 62 y/o female with hx of HTN, DM2, Asthma, severe obesity, being seen in the COVID vaccination clinic for their 1st COVID vaccination. After the vaccination they noted symptoms of tongue tingling and throat tightness approximately 20 minutes after vaccine administration. Denies facial, tongue or throat tightness, difficulty breathing or shortness of breath. Patient allergies: PCN and Sulfa Patient was moved to the aid station and evaluated. Vaccination provided today was Janssen Hx of reaction to vaccination in the past:denies Patient was given Zyrtec 10 mg PO Able to take PO water without difficulty Plan is to observe, will reevaluate Patient was advised to take diphenhydramine at home if continued or recurrent symptoms and to follow up with their primary MD. Strict return precautions to ED were discussed in detail. Diagnosis VACCINE ADVERSE REACTION, INIT (primary encounter diagnosis) Plan: CETIRIZINE 10 MG ORAL TAB Dispo Home Condition Good"

COMPUTERISED TOMOGRAM; ELECTROCARDIOGRAM; LABORATORY TEST; PULMONARY EMBOLISM; X-RAY; PAIN ON THE RIGHT-HAND SIDE UNDER MY RIBS; MYALGIA; ULTRASOUND SCAN; LUNG COLLAPSED; FLUID IN THE BOTTOM OF HER LUNG; This spontaneous report received from a patient via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) and concerned a 62-year-old female patient. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, and penicillin allergy. The patient had no current illness. The patient had no heart problems, no pulmonary problem and diabetes. The patient experienced drug allergy when treated with paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included levomilnacipran hydrochloride for depression, and quetiapine fumarate for depression. On an unspecified date in APR/2021, little more than a week after single-dose coronavirus vaccine at hospital facility the patient felt general malaise and minor pain in her right side. The patient had shortness of breath, and she looked anxious and her heart rate was very fast. The vital signs were not stable. The physician suspected that patient had developed pulmonary embolism blood clots in her lungs. When combined with her vitals, the doctor knew it was an emergency. The patient also began to feel mildly ill. She was experienced general malaise, soreness on her right side, and while she was not struggling to breathe, it hurt when she took a deep breath, her right-hand side, like under her ribs, she felt some pain. It was not a bad pain, not enough to take anything for it but just noticed it. The symptoms seemed minor, and at the time. It was reported that by 21-APR-2021, she still was not feeling well and decided to make an appointment at the urgent care center. The patient visited emergency room or department/urgent care facility for treatment of the events. The patient soon learned she had developed blood clots (pulmonary embolism) in both lungs due to the vaccine, a doctor at the hospital told her. One of her lungs also had collapsed. She had developed blood clots in both lungs due to the vaccine, she was there for 10 hours (undergoing tests). The patient underwent a computerized tomography scan and an X-ray. They did everything and got the results of the CAT scan, with pulmonary embolism in both lungs. They immediately gave her some blood thinner and was as hospitalized (date unspecified). It was reported that she would spend five days in the hospital. According to the doctors this was from the vaccine. The patient was also experiencing the pain on the right-hand side and also started getting myalgia, muscle aches just in different parts of her body. The patient's legs also felt weird. So they rushed her down and gave a sonogram in her legs to check for deep vein thrombosis. The pain on her right side grew worse for a day or two, and she was treated with morphine. The doctors surmised the patient had fluid in the bottom of her lung, which her body eventually absorbed. The patient was still on a blood thinner and continued to recover. Laboratory data included: Heart rate (NR: not provided) very fast, and Sonogram (NR: not provided) Not provided. On an unspecified date in APR-2021, Laboratory data included: Computerised tomogram (NR: not provided) pulmonary embolisms in both lungs, Electrocardiogram (NR: not provided) Not provided, Laboratory test (NR: not provided) Not provided, Ultrasound scan (NR: not provided) Not provided, and X-ray (NR: not provided) Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pulmonary embolism, had not recovered from computerised tomogram, electrocardiogram, laboratory test, ultrasound scan, and x-ray, and the outcome of myalgia, fluid in the bottom of her lung, lung collapsed and pain on the right-hand side under my ribs was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). Additional information was received from company representative via social media on 18-MAY-2021. The following information was updated and incorporated into the case narrative: patient's city added, events added (pain on the right-hand side under my ribs, myalgia, lung collapsed, fluid in the bottom of her lung), CT scan result updated, lab data updated (Heart rate and Sonogram).; Sender's Comments: V1: The follow up information in this version updates Patient's city, events (pain on the right-hand side under my ribs, myalgia, lung collapsed, fluid in the bottom of her lung), CT scan result updated, lab data updated (Heart rate and Sonogram). The follow up information received in this version does not alter the causality of the previously reported events 20210514298-COVID-19 VACCINE AD26.COV2.S-fluid in the bottom of her lung, pain on the right-hand side under my ribs: These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210514298- COVID-19 VACCINE AD26.COV2.S-myalgia. This event is labeled per RSI and is therefore considered potentially related. 20210514298-COVID-19 VACCINE AD26.COV2.S-Pulmonary embolism, computerized tomogram, electrocardiogram ,laboratory test, ultrasound scan, X-Ray: These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Started with weakness, then shortness of breath, multiple syncopal episodes. Bilateral popliteal DVT, multiple bilateral PE's with no other risk factors. Symptoms started approximately 2 weeks ago. Hospital admission date was 5/26/2021. Obstructive shock from PE, required ICU care, vasopressor therapy, and EKOS therapy, IVC filter. Improved from shock after EKOS therapy, no longer need vasopressors. Heparin infusion post EKOS therapy. Will be going home on oral anticoagulation when appropriate for discharge. Shock liver as a complication from the obstructive shock.

fever, dizzy, headache, severe pain throughout body for 24 hours, screaming pain could feel vaccine going through entire body tiredness hoarseness, heavy breathing 6 weeks after vaccine

Loose BM's in the evening of the vaccine and the next morning, turned to Diarrhea. Subsequently during that time, it was intermittent diarrhea. It was either very soft or very watery. I noticed I was having more shortness of breath that usual. It's common for me to have some shortness of breath but this was more. That went on for a month or so. I happened to see Pulmonary Dr because of my normal appt.

Rash and hives on entire face - took Benadryl, but that did not help Around 1:00 AM on 6/1/2021 - went to Emergency Room - lips were tingling and throat was closing up They gave me dexamethasone sodium phosphate injection 10 mg & famotidine 20 mg Rash cleared up on 6/3/2021 My known allergies are allopurinol and iodinated contrast media - IV dye

I had a very bad headache and soreness at the site of the injection for a couple of days after the shot. Since then, I have felt tired and out of breathe. I also felt some angina. I had a cardiology exam and no problems were found.

62 YO female presents to the ED on 6/4 with complaints of non productive cough, chest congestion, post-nasal drip, nasal congestion, chills, SOB, sinus pressure, and sore throat. Denies fever. COVID rapid test results back negative the same day. Vitals were stable and pt was discharged with COVID-19 diagnosis. She is s/p J&J vaccination on 5/11.

Sharp chest pain on 5/16/21 and 5/17/21 that caused me to catch my breath it lasted for a couple of minutes, then it stopped. The same thing happened 5/18/21 and 5/19/21 but because it was not as severe I did not seek medical attention.

Wheezing; cough; similar symptoms to a cold but more attributed to asthma. Prednisone to treat - two week course - I had saw two different doctors and they gave me two different dosages. The first one was two pills a day for five days. The second was six pills for seven days and then tapered off. Codeine with cough syrup and Singulair, as well, to treat. It's been two weeks and I'm just now hearing my voice kind of get back to my normal tone. Still having symptoms but milder.

After receiving the vaccination I started experiencing a dry cough and problems breathing 3 months after. I visited the ER for the severe symptoms and was tested for COVID 19 to ensure I did not have another variant. I tested negative.

Patient presented with fatigue and SOB starting about a week after vaccination. Was admitted to hospital SOB. No evidence of TTS. Progressive ARDS and death in 2 weeks after admission. Microbiology negative. No aetiology identified.

Half hour after injection my throat felt tight and my OPPOSITE arm hurt. About 1:00 am I got so chilled I couldn't get warm, I did not take my temperature because my thermometer goes under my tongue and I was afraid I would break it cause my teeth were chattering so bad. The next day I felt very weak and nauseous. Then I discovered I had a rash at the top of my legs. My left breast was very sore I felt like someone punched me. Today is Monday and I still have diarrhea.

Around 430pm my right upper began to get red also my chest began to get red (blotches) I began to feel my heart racing also slight tightening in my throat approximately a half hr later all symptoms went away.

Patient presented to clinic for Covid-19 vaccine. Patient started complaining of chest pain 5 minutes after vaccination. Patient denied shortness of breath, but states the pain worsened with deep breathing. Patient denies other complaints or symptoms. Vital signs stable and work of breathing normal. RN auscultated lung sounds, upper lobes clear bilaterally. Blood sugar 227. Patient states she has diabetes and hypertension. Patient kept closing her eyes, RN encouraged patient to keep her eyes open, but patient kept stating, "I'm tired." RN notified provider, provider in to assess patient. Per provider, patient to go to ED via EMS. Patient's husband notified and arrived to clinic to be with patient. RN contacted EMS and report given.

Fatigue, aches, nausea, cotton mouth, headache, wheezing, loosing voice, and arms and legs feel heavy. Called doctor the next day (the 16th) for medical advise, was told to drink coffee and take tylenol due to aspirin allergy.

19 hours later I got cold and started Wheezing 20 hours later slight chest pressure after taking ventolin inhaler

Saturday after shot: felt fine afterwards; no soreness in arm, no other effects. Sunday after shot: started feeling lightheaded/dizzy in the evening; headache Monday -- Friday: fatigue, muscle ache, lots of congestion (nose/lungs) and deep bronchial cough, intermittent headache, intermittent low grade fever -- unable to work. Saturday-today after shot: still fatigue but better; congestion better as well--still congested but cough is relieved (saline nasal rinse helped a lot); no headache; no fever

March 4 - J&J Covid Vaccination March 5 - Woke up feeling terribly under the weather; sinus inflammation/chills/fatigue/pressure in ears/pain in teeth (upper back molars), swollen glands - just plain "ill" Week of March 8 - See above, the same March 9 - Appointment at Primary Care Clinic due to March 5th symptoms and a 1-day bout of diarrhea Diagnosis ?cold, sinus issues? - try Mucinex/Tylenol / Covid Test = Negative Mid-March: fever blister appears for a few days and ringing in my ears (noise) increases. Fever blister lasts about 4 days. Week of March 15 - Same Symptoms as March 5 plus another 1-day bout of diarrhea Sunday, March 21 - stomach cramps / diarrhea - chills/overwhelming fatigue - same sinus issues as March 5 Week of March 22nd - equilibrium is off and starts to become an issue - 3 nights of vertigo but not severe during that week. Last vertigo attack was in 2018. March 28th - sinus situation the same, diarrhea again, start Pepto Bismol regime based on past microscopic colitis issues Mucus is thin and clear, just started to discharge. March 31st - Schedule another appt at Primary Care Clinic due to ?status quo? - this doctor thinks inflammation and prescribes prednisone (2) 20 mg for 5 days - Covid Test / Strep Test / Influenza Tests = Negative March 31 - April 4 / Prednisone: Visibly more stuffed up. Tooth/nerve pain increased from a 3 to a 7; didn't take the final days dose. After stopping my head felt numb. Vertigo stopped; equilibrium still off. Increased tinnitus and increased pressure/burning under my eyes and around my cheekbones. April 5 - 6 - New symptom appeared approximately a week ago; tightness in throat, difficulty swallowing. Still experiencing tooth nerve pain (sinus cavities). Woke up soaked the last 2 nights. Noticed increased difficulty concentrating "brain fog".

Pt developed throat discomfort. Was given benadryl 25 mg po x1. BP 153/69, HR 65, O2sat 100%. Respirations appeared normal. Also reported arm pain radiating up to left side of face and tight chest pressure. Was given 2 puffs of albuterol inhaler. Pt stated throat felt better at this time. Repeat BP 135/59, HR 64, O2sat 99%. Pt felt shaky and cold, possibly from albuterol. Pt stated chest tightness subsided but still continued to have weird sensation in her arm up to her jaw area and throat was still feeling funny. Repeat VS 123/61, HR 61, O2sat 100%. Was taken to ER via W/C. Pt c/o being dizzy and throat was tightening up again on the way to ER. Was given solumedrol in ER. Discharged home. Feels better but still has some left throat swelling, improved with steroids, antihistamine. Airway unaffected. Chest tightness/pressure resolved.

DIZZINESS; FACE SWELLED; THROAT CLOSING; CHEST TIGHTNESS; ITCH IN EAR; HEART BEAT RACING; WHEEZING; WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non alcoholic, penicillin allergy, and sulfonamide allergy, and other pre-existing medical conditions included the patient had anaphylaxis with tetanus booster shot 4 years ago. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: unknown) dose was not reported, administered on 31-MAR-2021 at 12:18 p.m. vaccinated on left arm for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy, and fluticasone propionate for allergy. On 31-MAR-2021, the subject experienced dizziness. On 31-MAR-2021, the subject experienced face swelled. On 31-MAR-2021, the subject experienced throat closing. On 31-MAR-2021, the subject experienced chest tightness. On 31-MAR-2021, the subject experienced itch in ear. On 31-MAR-2021, the subject experienced heart beat racing. On 31-MAR-2021, the subject experienced wheezing. On 31-MAR-2021, the subject experienced weakness. Laboratory data included: Blood pressure (NR: not provided) Unknown. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, face swelled, throat closing, chest tightness, heart beat racing, wheezing, and weakness on 31-MAR-2021, and had not recovered from itch in ear. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious

Patient called clinic 4/13 to report having been seen by PCP and in ER twice since vaccination. She reported onset of headache and fatigue day of vaccine. She reported later feeling short of breath and having a decreased tolerance of activity. She stated she had an elevated heartrate and "neurological symptoms", but did not specify. She reports still feeling off at this time 4/13 and having appointments scheduled with a Vascular surgeon and neurologist in the near future. I am doing the reporting as the vaccine was given by Public Health staff, but this is the first notification we have received of the her potential adverse reaction.

On March 8th received the J&J shots, March 9, 10th & 11th was extremely nauseous in the morning. On the 12th had severe chest pains which I chalked up to a very bad case of heart burn. On March 24th, while driving I had two major (what I thought at the time) was panic attacks...body started shaking, heart was beating like crazy, couldn't catch my breath, felt like I was going to pass out or die. Had to pull over twice to calm myself down. (From what I read this could be a sign of a blood clot but I am not a doctor.) Had minor heart burn until April 5th....which ironically was the end of my 28 days until the vaccine fully kicked in. Just reporting what happen. I feel fine now.

Chills, shivering, short of breath, vomiting for 15 minutes, chills for an hour and sweating after that, headache. After vomiting I took a Benedryl and than extra strength Tylenol at night.

Date and time of adverse event: 24 March, 2021 3hrs after started arm sore, muscle lakes, fatigued, fever, shortness of breath. All symptoms resolved except shortness of breath, getting better. List all vaccines given on the date listed (including how vaccine was given and where (body site) vaccine was given: Patient states she started to experience symptoms 3 hours after she received her vaccine. Sore arm, muscle aches, fatigue, fever, shortness of breath. All symptoms resolved except shortness of breath which is continuing to improve. She is just calling to report her symptoms, so no one else will take this vaccine.

PROFUSE SWEATING; SHORTNESS OF BREATH; EYES SENSITIVE TO BRIGHT LIGHT; FEELS AWFUL; PHOTOSENSITIVITY; SICK TO STOMACH/NAUSEA; This spontaneous report received from a patient concerned a 63 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, route of admin not reported, batch number: 1808978, expiry: not reported) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced profuse sweating. On 29-MAR-2021, the subject experienced shortness of breath. On 29-MAR-2021, the subject experienced eyes sensitive to bright light. On 29-MAR-2021, the subject experienced feels awful. On 29-MAR-2021, the subject experienced photosensitivity. On 29-MAR-2021, the subject experienced sick to stomach/nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from profuse sweating, shortness of breath, eyes sensitive to bright light, feels awful, photosensitivity, and sick to stomach/nausea on 29-MAR-2021. This report was non-serious.

Had Janssen vaccine on 4/9 and within a day developed subjective fevers and dyspnea which progressed until admitted to Hospital on 4/11 and promptly intubated for respiratory distress. Found to be in sepsis and ARDS with multiple negative COVID tests including an extensive respiratory viral panel, we have failed to culture any bacteria from multiple sputum cultures, Legionella antigen and HIV negative. Have been treating as ARDS 2/2 atypical pneumonia, possible aspiration (although no aspiration event reported) with hospital course complicated by VAP. Concern remains for possible reaction to Janssen vaccine. Still admitted to ICU at Hospital.

HIGH BLOOD PRESSURE; HEAD AND NASAL CONGESTION; LOSS SENSE OF TASTE; SOFT STOOLS; BACK AND SIDES ARE HURTING; GOING TO THE BATHROOM 4-5 TIMES PER DAY; SOMETIMES NO STOOL; ACID BUILDUP; FELT WEAK OCCASIONALLY; PHELGM BUILDING UP IN THE LUNGS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperacidity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included calcium carbonate for acid buildup. It was reported that on 09-APR-2021 evening, the patient started to feel some lightheadedness and congestion. She noted that the lightheadedness happened here and there. She had head and nasal congestion and had snot coming out the nose. She felt like her head was about to explode. There was sort of a snap, crackle, and pop in the head. Her back and sides were hurting. She was going to the bathroom 4-5 times per day, sometimes with no stool, and other times with soft stool.She noted some phlegm building up in the lungs. Coughing was noticeable. She also felt weak occasionally. She had a loss sense of taste. She also had acid buildup and took Tums occasionally but did not take on 13-APR-2021. She had noted high blood pressure and heart rate, but they had gone down due to blood pressure medicine. She had exercised in an attempt to reduce her symptoms. She did not had a healthcare professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high blood pressure, had not recovered from head and nasal congestion, weakness, loss sense of taste, going to the bathroom 4-5 times per day, and acid buildup, and the outcome of soft stools, back and sides are hurting, sometimes no stool and phelgm building up in the lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210423813- Covid-19 vaccine ad26.cov2.s-Phelgm building up in lungs. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

63yr old female called into call center, stated she received J&J vaccine Friday 4/16 (external site; not with county), and today noticed swelling on her left calf, and 4/10pain above her left knee. Pt denied emergency symptoms at the time of call. Stated sunday night she felt her throat ""a little tight."" Drank water and felt better. Denied swelling of face, lip and throat at time of call. Pt denied SOB, pain/tenderness on calf, petechiae, new/easy bruising, abdominal cramping, backache or headache. Pt stated only other symptom she felt was on Friday 4/16 evening, a slight headache after the vaccine. did not experience any other symptoms. Pt Advised to call 911 or arrange for immediate transport to the closest ED. Pt verbalized understanding and agreed.

DIFFICULTY BREATHING; DIZZINESS; SEVERE HEADACHES; This spontaneous report received from a consumer concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included enlarged heart, and poor lung function. 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 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 difficulty breathing. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headaches, dizziness and difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non-serious.

itchy throat, heaviness in throat, headache onset lungs clear bilaterally, denies SOB or difficulty breathing, BP 136/90

SOME DAYS SHE DID NOT USE HER LEFT ARM; LEFT ARM WEAK; JOINT PAIN; CHILLS; FATIGUE / TIRED; HEADACHE; FEVER 101F; MUSCLE PAIN; SHORTNESS OF BREATH; DRY COUGH; BRAIN FOG; ALL SHE DID WAS SLEEP FOR 2 WEEKS; RACING HEART RATE; DIZZINESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 150 pounds, and height was 175.26 centimeters. The patient's past medical history included covid-19 infection, and concurrent conditions included non-smoker, alcohol use, sulfonamide allergy, high blood lead level, and neurological problems, and other pre-existing medical conditions included the patient had no known allergies and no food allergy. the patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with ciprofloxacin, clindamycin, erythromycin, and nortriptyline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced racing heart rate. On 06-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced dry cough. On 09-MAR-2021, the subject experienced brain fog. On 09-MAR-2021, the subject experienced all she did was sleep for 2 weeks. On 09-MAR-2021, the subject experienced left arm weak. On 09-MAR-2021, the subject experienced joint pain. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fatigue / tired. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fever 101f. On 09-MAR-2021, the subject experienced muscle pain. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced some days she did not use her left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart rate on 17-MAR-2021, dizziness on 04-APR-2021, and joint pain, chills, and fever 101 F on MAR-2021, was recovering from dry cough, fatigue / tired, headache, brain fog, left arm weak, and muscle pain, had not recovered from shortness of breath, and the outcome of all she did was sleep for 2 weeks and some days she did not use her left arm 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.

SHORTNESS OF BREATH (WORSE UPON EXERTION); ELEVATED HEART RATE; DIZZINESS; CHEST PAIN; WEAKNESS; FEVER; MUSCLE ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, allergy to plavix, and compazine allergy. The patient was previously treated with for drug used for unknown indication; and experienced drug allergy when treated with amlodipine 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced shortness of breath (worse upon exertion). On 13-MAY-2021, the subject experienced elevated heart rate. On 13-MAY-2021, the subject experienced dizziness. On 13-MAY-2021, the subject experienced chest pain. On 13-MAY-2021, the subject experienced weakness. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced muscle aches. On 13-MAY-2021, the subject experienced headache. On 13-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, muscle aches, and headache, and had not recovered from shortness of breath (worse upon exertion), elevated heart rate, dizziness, weakness, fatigue, and chest pain. This report was non-serious.

25 March 2021 – Woke up with severe pain, left chest, breathing was fine, however, it was very painful to breath, laugh, cough or sneeze and walking. It was painful to roll out of bed each morning at least for a week or so. I live with the pain/discomfort for a few days, thinking it would get better. 30 March 2021 – I called my PCP, who had no appointments, I ask the appointment person to have someone from her office call me. They call back later in the day and said that the dr was fully booked and ask if I was willing to see someone else, answer was yes. see continuation page

Extreme high fever Chills Headache Muscle pain Weakness Short of breath Chest pain Rapid heart rate Fever and chills went away after 4 days, all other symptoms continue I have had pulmonary function testing, and more appointments scheduled

On the 21st, my rib muscles on left side - spasms - hard to breathe or take a deep breath. About month ago left foot and left hand - was start to numbness - moving up my calf a little bit - doctor thought it was a nerve impeachment. About two weeks ago, Breathing with rib muscles are starting to be better - it's not gone however. The last couple of days, I have had a little numbness in my right foot and then it went away.

pt says she started having pain all over her body. The pain from her knees down to her feet was horrible. The left arm hurts and has tingling numb feeling in the hand. She gets episodes of being light headed and SOB. She gets sharp pains in her head like something is pinching her on the inside of the brain and is a very strange feeling. She went to see her PCP about 10 days after taking vaccine and was referred to a Neurologist Dr. She was told it looked like nerve inflammation and was prescribed Neurontin. The medicine helps but has side effects and makes her feel bad. She has a FU appt next week.

I had no regular symptoms, but a few days later I sat down in my chair and it felt like someone shot me in the stomach, I took oxycodone, it kept getting worse and I dealt with it for a week. I started getting pain in my kidney and went to the ER because of the pain and the pain level on a scale of 1-10 was a 8-9 at all times. I couldn't' breathe and was rushed to the hospital. I have portal vein thrombosis and have three blood clots in my stomach. I tried to figure out what to do to relieve the pain, I couldn't eat or during and was on IV's. I was in so much pain to even eat a cracker, they kept me at the hospital. While in the hospital they did a CAT scan to see if it was diverticulitis and found out that I had 3 blood clots, they also did the dye or contrast. I spent days in the hospital and was transferred to the hospitals skilled nursing facility so that they can watch me because of the clots. I was told that the blood clots could burst in the vein.

BLOOD CLOT IN ARM; HARD TIME BREATHING/COULDN'T BREATH; HIGH FEVER; This spontaneous report received from a a 63-year-old female patient of unspecified of race and ethnic origin and her daughter via a traditional media and via a company representative. The patient's height, and weight were not reported. The patient's concurrent condition included diabetes. The patient never tested positive for coronavirus disease (COVID). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, and expiry date: unknown) dose was not reported, 1 total, administered on 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 an unspecified date, in APR-2021, shortly after the vaccination, the patient experienced a high fever. A day later, the patient had a hard time breathing/could not breath and was rushed to the hospital (date unspecified). The patient also developed a blood clot in her arm. The doctors told the patient's kids that the patient might not recover. In a hospital bed, the patient spent 21 days on a ventilator. The patient was recovering in the hospital in the last month of MAY-2021 and was expected to leave the rehabilitation facility by the end of JUN-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, hard time breathing/couldn't breath, and blood clot in arm. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20210619186-COVID-19 VACCINE AD26.COV2.S-Blood clot in arm, Hard time breathing/couldn't breath, High fever. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Started noticing shortness of breath upon exertion; I was also having some Malaise. Some dry/brittle fingernails some of the classic symptoms of anemia. March 30 when you gave blood my finger stick hemoglobin was 12.5 and usually it is 13.4 or 13.5 (in December 2020). I went to see Dr on April 19th and they drew labs. Iron supplement Fergon to take for one month. May 24th re-drew my blood and hemoglobin was back up to 13.4. Stopped Fergon on June 4th per doctor's recommendation. My symptoms have gone away since I've taking that iron. I will get blood drawn again August 2021.

Shortness of breath, weakness, heart palpitations. and got diagnosed with both bronchitis and pneumonia.

Instant right fingertips numbness, Breast itch and have for days, the numbness in fingertips have not gone away. Shortness of breathe on and off. Headache the evening and next day after the shot.

extreme shortness of breathe, irregular heartbeat, fatigue, loss of bladder control, shooting pains, muscle ache, tightness in chest

Patient developed hives the day after receiving the vaccination 3/6/2021. Hives come and go, very itchy. Continues to have sporadic hives on 3/10/2021. She is using Benadryl PRN. Recently prescribed prednisone for Hives. She also had a swollen throat day after receiving the vaccination without difficulty swallowing. Took Benadryl PRN, this has since subsided.

Respiratory tightness in chest for five days. Took Benadryl three times a day for five days. It eased the tightness in chest.

Within a few hours of receiving the vaccine, I started feeling nauseated. Since the day I took the vaccine, my appetite has been nonexistent. A day later, I felt very tired and confused. I received the vaccine on Monday and I woke up in a panic on Wednesday morning. My heart was racing, palms were sweaty, I felt like I couldn't breathe and it seemed like I was having a panic attack when I woke up. From that point forward, I fell into a deep depression. At first I didn't connect it with the vaccine, but I kept feeling nauseated and then wondered if it was connected. The depression became unbearable and I felt suicidal by the next week. I finally contacted my doctor's office and had a telemed visit where I explained that I had the J&J vaccine the week before and these symptoms presented themselves afterward. The doctor put me on Zoloft and I HAVE been treated for depression in years past with that; however, I had not taken depression medication for about 8-10 years until this. Likewise, because my doctor put me on an anti-depressant, she also wanted me to see a counselor--which I have done. The medication is helping somewhat but I still don't have an appetite. I don't know if the vaccine had anything to do with the depression, but I wanted to report it just in case others have had similar symptoms.

NO medical intervention required. For reporting purposes ONLY. Within about five minutes, throat swelled but not to the point of concern. Don't remember reactions to previous vaccines but not surprised considering allergies. Left side of face felt strange but didn't look any different when a selfie was taken. Sometime during the afternoon/evening, experienced a headache of short duration. Approximately six hours after shot, experienced chills and low grade fever. Simply went to sleep. Better the following morning, though very tired. Probably unelated rough itchy patch on RIGHT arm the day following vaccine. Went away with no treatment.

63 yo female patient complaining of a "tightness in her throat" Pt states she had multiple allergies. Pt given benadryl. No swelling to mouth or tongue noted. Pt denies any shortness of breath. Vital signs wnl. Pt stated she would sit and wait for awhile to see if she began feeling better. Pt advised she did not want to go to the hospital.

extreme shortness of breath after one week and admitted to hospital with blood clots in both lungs and a collapsed lobe in right lung within two weeks

Beginning the following morning after my vaccination, at approximately 8:30 am, I began having severe stabbing chest pains. Feeling as though I was being stabbed dead center of my chest and it came out my back. I had trouble breathing or felt like it hurt more when I tried to take a deep breath. This was very severe for about 2 hours then eased off and was off and on for about two days. My arm did not get sore until the third day after my vaccination and remains sore still. I?ve experienced a headache in severity ranging from a nuisance to temple throbbing since the day after vaccination. I have taken my naproxen for the chest pain and headache. I ran a temp of 99-100 occasionally but never for a long period of time. I?m still experiencing some chest pain occasionally but nothing as severe as the first two days.

On Wednesday, March 24th approximately 4:00 PM I started having severe chest pain, shortness of breath and tingling in my face. After about 40 minutes of severe chest pains and shortness of breath and tingling in my face I took 2 81 mg baby aspirin called 911 was advised to take two more 81 mg baby aspirin. Transported to ER.

Nausea, headache that increased to monstrous proportions throughout day and lasted 3 days; severe joint and muscle pain., incoherent thinking process, fatigue, some dizziness. Presently have shortness of breath. Surprisingly, injection site only hurt the first day.

Pt c/o slight tightening of the throat that occurred @1535. No itchiness. Pt advised to take deep breathes and drink water. Pt speaking in clear full sentences. No apparent distress. Pt notified and shown vital signs stable. Closing of the throat worsened. Pt requested epinephrine due to "closing of the throat." Epinephrine given at 1554 pt stated throat opening and breathing effortless. Vital signs taken please review. 1613 pt states closing of the throat has not gone away but feels better. Pt speaking in full clear sentences alert Nurse supervisor, Chief Doctor, were notified. Dr. assessed pt and 911 was called at 1620. Pt transferred @ 1632

feeling of closing of the throat. Pt came in for covid vaccine. Answered no to screening questions. Was given Janssen single dose. Pt asked MA, what an allergic reaction looks like. I stepped in and told pt. hives, swelling/ closing of the throat, and feeling like you can't breathe. Pt stated @ 1535 that she felt her throat was closing up a little and that breathing was getting difficult. Pt was speaking in clear full sentences w/o difficulty. I told her to take deep breathes and drink water. I assessed her, she was warm and dry and no apparent swelling of the throat, no itchiness or dryness of the throat. MA brought in BP machine, vital signs were stable. O2 was at 95%. Pt has asthma. I wanted to seek a second opinion on pts well-being, MA went to seek provider that had seen pt prior to vaccination. As MA went to get nurse, I continued to talk to pt about her status. I asked if the feeling was getting better or worse and pt said it was staying the same. Pt was not in distress and speaking in clear full sentences. I told her if her status worsens I have an epi pen to help her breathe better. MA came back 5 minutes later w/o provider and pt stated her throat closing as she had her hands on her throat and was worried. MA did not realize the urgency of the situation and went back to get the nurse. During this time I asked pt if the feeling was getting worse and pt said yes. I told her I have the epi pen and thats when pt requested I administer it to her. I administered the epi pen at 1554. One minute later Nurse comes in to assess pt. Pt is calm and speaking in clear full sentences. MA takes vital signs and BP is elevated and O2 is at 99%. I inform the nurse that I administered epi and she advised to keep pt for observation, she left to see another pt. Pt was calm and speaking in clear full sentences A&O X4 and stated that the feeling was better. At 1610 Pt stated that her throat was feeling the same closing feeling as before the epi pen. I messaged my nurse supervisor, at 1612 about pt and she proceeded to bring Dr. for assessment. Dr. assessed pt and told me to call 911. Pt was not in distress and speaking in clear full sentences. Fire dept. came and took over the situation approximately 8 minutes later. Pt requested to be taken to Hospital.

Started morning after with terrible headache, pain in the eyes, nausea and sore arm. Few days later felt tightness in the chest, shortness of breath and a cough started. Feeling unwell. Continued and went to urgent care. Covid 19 test negative. continued to feel the worse and went back again to urgent care. Same symptoms with nausea and headache on and off. another covid test negative and chest xray. looked ok. Continued with the same symptoms and went to Primary Care Cough worse and pain in chest. Blood work done. Looked ok. Woke up with terrible headache at 3am. Went to the ER. IV ,Blood work ,ct scan, ekg. No real answersBP elevated. Still struggling but cough improving.

Fever, Headache, Nauseous, Severe Pain All Over, Extreme Tiredness, Shortness Of Breath. Swelling Of Both Feet. Onset - 9 Days Out. Still Ongoing 12 Days Out.

6-8 hours following the vaccine, the patient developed a severe head ache, SOB and fatigue. Patient took an unknown OTC medication, this did not help her symptoms. Her headache receded on 04/08, and her symptoms improved, but never fully resolved (per patient's son).

BODY HURTING; LEGS DID NOT SUPPORT; FEELING TIRED; PAIN IN RIGHT SIDE CHEST; PROBLEM BREATHING; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and diabetes, 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: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced problem breathing. On 10-APR-2021, the subject experienced pain in right side chest. On 17-APR-2021, the subject experienced body hurting. On 17-APR-2021, the subject experienced legs did not support. On 17-APR-2021, the subject experienced feeling tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, body hurting, problem breathing, legs did not support, and pain in right side chest. This report was non-serious.

LIGHT HEADEDNESS; SWELLING IN FACE; SWELLING IN THE THROAT AREA; THYROID PROBLEMS; BALANCE PROBLEMS; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included colon cancer, sinus problems, neck injury, jaw virus, and hashimoto disease and concurrent conditions included allergy to hay fever, allergy to cleaners, allergy to rubber gloves, steroids allergy, and allergy to some chemotherapy medications, and other pre-existing medical conditions included 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced fever. On an unspecified date, the subject experienced light headedness, swelling in face, swelling in the throat area, thyroid problems, balance problems, body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thyroid problems, light headedness, swelling in face, fever, chills, balance problems, body aches and swelling in the throat area was not reported. This report was non-serious.

2021-04-23 Patient presents to the ED with right-sided mid-back pain and shortness of breath starting 2021-04-22 evening. Pain is sharp and worsens with coughing and deep inspiration; she feels that she is taking shallow breaths. On ED presentation, no shortness of breath, chest pain, dizziness, fevers, dysuria, or abdominal pain. She does have reproducible pain on her right mid-back area. There is some mild diffuse tenderness in her abdomen, but reports that she always has a tender abdomen due to Crohn's disease. No peritoneal signs. No recent travel. Patient was found to have pulmonary embolism. Hematology/Oncology specialist was consulted and recommended initiation of argatroban for treatment of pulmonary embolism. Patient was admitted to inpatient.

Taken to directly to the ER from the site SOB Headache Chills Chest pain Dry hives Faintness Aching legs Heavy feeling in chest Vertigo following day Increase HR-as though heart was pounding in my chest

5/3/21 Pt presented to ED with a 3 day history of feer to 103.5, sore throat, SOB and N/V. She had a known exposure to a household member(s) with COVID. NP swab was positive for SARS-CoV-2, Otherwise her labs were unremarkable. CXR showed subtle streaky opacities in left lung base. She had no oxygen requirement and was discharged to home with a referral for monoclonal antibody. 5/6/21 Patient received infusion of BAM+E. During the infusion she was noted to be SOB and O2 sat was 90%. She was sent directly from the infusion center to the ED. HOSPITAL COURSE: patient is a 64 y.o. female with shortness of breath from infusion clinic after getting antibody for covid. Pt was found hypoxia. Pt has been treated with Remdesivir, decadron and supportive care. Pt recovered very well Pneumonia due to COVID-19 virus Acute hypoxic respite failure secondary to above. -Was admitted on May 6, SP remdesivir and IV diuretics -05/11 improving respiratory failure, current on 6 L NC, continue supportive care, ID continue following up -05/12 pt is on 3 L NC without shortness of breath. Pt's CRP trending down 18.3. Pt will be discharged home with home oxygen. She will continue taking 4 days of decadron. Follow up with primary care physician. Return to ER for worsening symptoms or other concerns.

BLOOD CLOT IN BRAIN; BLOOD CLOT IN RIGHT LUNG; BLOOD CLOT IN STOMACH AND NECK; This spontaneous report received from a patient concerned a 64-year-old, female. The patient's height, and weight were not reported. The patient's past medical history included tendonitis in right shoulder, surgeries on right shoulder and concurrent conditions included arthritis in right shoulder, non-smoker, abstains from alcohol, and seasonal allergies, and other pre-existing medical conditions included the normal wear and tear on her body at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total, administered on 04-MAY-2021 at the right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The Patient reported that on 04-MAY-2021, after vaccination, she began feeling unwell with a low grade fever, her highest body temperature was 102F. She experienced headache that she initially felt on the right side of her head but could not determine the source for sure. On 14-MAY-2021, she coughed up blood, but she didn't think anything of it and continued her normal routine then on 15-MAY-2021, she coughed up more blood but it had some phlegm in it, so she went to the ER (emergency room) on 18-MAY-2021. She received a Computerized axial tomography (CAT) scan of her chest which showed blood clots in her right lung. She got a secondary CAT scan and blood clots were found in her stomach, brain and in her neck. She was admitted to hospital on 19-MAY-2021. The Patient was reportedly hospitalized for 6 days and was supposedly discharged on 24/May/2021. For treatment, she was receiving an Intravenous (IV) blood thinner but later changed to an oral blood thinner. She was also receiving Tramadol for pain. She was receiving other medications when first admitted but could not recall specific names. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in brain, blood clot in right lung, and blood clot in stomach and neck. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210546778-covid-19 vaccine ad26.cov2.s- blood clot in brain, blood clot in right lung, and blood clot in stomach and neck. This events are considered unassessable. The events 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 events.

35 minutes after injection experienced dizziness, shortness of breath, tingling of lips, tongue, fingers and toes. Went to nearest Emergency room, 8 minutes away. Treated with IV Solumedrol, Benedryl, and Pepsid. Stabilized and discharged after 2 hours. Minor symptoms for 2-3 more days. Back to normal now.

COULD NOT SWALLOW HER FOOD DUE TO NAUSEA; COULD NOT BREATHE VERY WELL; NIGHT SWEATS; RIGHT ARM AND LEG BEGAN TO HURT; CHILLS; HEADACHE; TIREDNESS OR FATIGUE WAS UNGODLY; NAUSEA; VERTIGO-LIKE FEELING; PASSED OUT ON FLOOR; CHEST PAINS HERE-AND-THERE NOT CONSTANT; This spontaneous report received from a patient concerned a 64 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included colitis, non alcohol user, smoker (2 cigarettes per day), allergy to penicillin cause chest pains and swelling, allergy to sulfa cause chest pains and swelling, and medication sensitive. The patient had no drug abuse or illicit drug use. The patient experienced sick when treated with influenza vaccine (flu shot), chest pains and swelling when treated with codeine, and naproxen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, 1 in total, administered at right arm on 13-MAY-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient could not swallow food due to nausea and could not breathe very well (difficulty in breathing) and fatigue was ungodly. On 13-MAY-2021, the patient had tiredness, headache, nausea, night sweats and chills after took the vaccine. The right arm and right leg began to hurt. Tiredness was not gone away and Lightheadedness here-and-there. The patient had chest pains here-and-there, that was not constant. The patient felt like she had vertigo and passed out on her floor twice last week in MAY-2021 and on 04-JUN-2021. The Lightheadedness and dizziness presented again on 04-JUN-2021. A chill was come-and-go. The right arm and leg pain have resolved on 04-JUN-2021. She was not reached out to her primary care provider for medical advice. Patient mentions that she was medication sensitive. The patient had tendency for low blood pressure, but her low blood pressure was fine at 120/80 mmHg. The patient took Norco for pain and occasionally took Zofran for nausea. The patient had history of colitis and these medications help her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats, and right arm and leg began to hurt on 04-JUN-2021, had not recovered from tiredness or fatigue was ungodly, chills, vertigo-like feeling, headache, chest pains here-and-there not constant, passed out on floor, and nausea, and the outcome of could not breathe very well and could not swallow her food due to nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210612160-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passed out. 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.

Six hours after the vaccine I got chills, headache, stomach upset and swelling in my lower face and throat. I had body aches all over my body but no fever or pain at the injection site. Those symptoms lasted for ten days. I went to ER. I was given medication for the nausea and pain. The chills were a little better by then. The medication helped with everything but the headache. The headache is constant at the back right of my head. I then get other head pain at the same time in my temples on the left. It is a sharp shooting pain. I get flashes of light in my eyes and my eyes start twitching at the sides. I also get pain at the top of my head on the left hand side on occasionally which comes after the temple pain. I sometimes get head pain on the right side with deep concentration. I have recently started to get tremors in my right hand. Sometimes the headache wakes me up at night. I wake up every day with a headache and it has been thirteen weeks. I can not drive or concentrate. I have seen a neurologist but I am still having trouble scheduling scans. I have tried some prescription pain medication and it did not work. I have taken two courses of steroids.

Patient had complaints of dizziness and swollen throat. Patient stated that after she received the flu vaccine she passed out and has passed out before after the administration of previous vaccinations. BP: 110/76, HR: 87, O2: 95%, temp: 97.9 The healthcare team remained with the patient during this time. Patient remained alert and oriented with no breathing or swallowing difficulties. After 10 minutes the patient stated that the swelling feeling of her throat resolved. Vital signs taken again, BP: 110/80, HR: 80, O2: 95%, Temp: 97.9 Patient asked if she could stand up, no dizziness per patient. She remained with us an additional 15 minutes and then was walked to her vehicle in which she performed with no difficultly.

Janssen COVID-19 Vaccine EUA Per POD First Aid provider syncope episode, complaint of tingling to lips and difficulty breathing, patient experienced a syncopedic reaction when returning from bathroom, was unconscious for 1 minute, complained of dizziness, odd taste in her mouth and difficulty breathing. 12:15 PM B/P 150/82 Pulse 68 Respirations 16 Pulse ox 98% 12:20 PM B/P 122/72 Pulse 64 Pulse ox 100% Benadryl administered @ 12:20 PM, patient transported to A Medical Center for evaluation.

Day after vaccine: chills so hard I had charlie horses; bones ached; nauseous and diarrhea In May, Telemed visits to Dr. sneezing, sore throat followed by coughing. wheezing, tightness of chest, shortness of breath, tired, nauseous. All COVID tests came back negative. Blood test - no antibodies, no COVID, Seeing a heart Dr. for continued shortness of breath and pressure on my chest. Had stress test and echo test.

On 3rd day after vaccination, pain began in left pectoral region on left side. Pain heals settled in intercostals of left rib cage. This has caused difficulty in taking a deep breath. No congestion, coughing, or vomiting. Just pain with inhalation. Pain can be palpated in ribs, level 6 and 7. Somewhat better today, March 17.

Severe Spasms in all muscles from feet all the way up through back, lasting for up to 10 seconds and occuring every 10 to 15 minutes. I felt as if my entire body was frozen during the spasms. Had a very hard time breathing. Called 911, no fever, taken to emergency room. Was given an injection of ativan and it relieved the spasms. I slept the rest of that night and woke up very sore in all muscles for 5 days after.

Patient vaccinated by EMS on 3/29/21, EMS notified clinic that patient was taken to the Hospital for a stroke on 4/1/21

Fever, chills, whole body stretches, headache, joint pain, very tired, This will take a day or two to not feel tired. and a little heavy breathing.

^ hours after injection my arm was aching. Then Head ache set in by 7pm. pain with neck and head and fever progressed quickly. by 9pm it was 103.7 By 11:00pm my fever was 105.4. By midnight it was 105.9 I took Vicks NyQuil because it was the only pain med that had Tylenol in it. Fever reduced to 105.4 by 2:30 am fever was at 104.5 and I felt safe to try and sleep and not die. A nurse friend was telling me to go to the emergency room. I applied and Ice pack to my splitting headache and eyeballs felt like they were going to pop out. also Icepack to neck. ate a popsicle. I hydrated emencely before the shot and All day with the shot. I kept moving my arm and it was fine after a few hours. THE FEVER SITUATION WAS QUITE FEARFUL AND STRESSFULL. My throat felt a "little" tightening. I swallowed every few minutes to make sure it did not progress. I had Benadryl on hand just in case. I slept from 3:00am until 9:30 am. My morning fever was between 103.7 and 104.5 It was 102.4 at 3:00pm it is 8:45 pm and my temp is 202.2 now. head ache is at 50% of yesterday.

SOB, WHEEZING, ELEVATED HR, EPI X1. Evaluated by EMS- Transported to Emergency room/department or urgent care.

Fever 101.3 chills, splitting headache, wekness, sore throat, dizziness, slight swelling of throat and tongue. Took two benadryls and four ibuprofens.

left knee swollen: x-ray done on 3/15/21, showing nothing wrong, doppler test done on 3/19/21- no blood clots, MRI done on 4/14/21, waiting on results: shortness of breath started on 3/12/21 and lasted about 3 weeks.

anaphylaxis, severe face swelling, throat closing, arm swelling, headaches, ongoing dizziness, equilibreum issues, aches, stomach issues, rash on face, neck, torso and both legs, nausea ongoing, tingling sensations. 8 benadryl in first 30 min. kept me there for one hour - almost two weeks out and still not fully resolved (very dizzy, severe headaches, some swelling remains)

On 4/10/21 to Urgent Care. Found blood clots in my lungs and Pneumonia, Clots removed at Hospital on 4/11/21. Hospitalized until 4/13/21. Treatment - blood thinners (enoxaparin, heprin and steroids), azithromycin, Advair disk, albuterol, Spiriva, Symbicort Outcome: Still trouble breathing, slow moving and sore from the incesion.

65-year-old female presenting with reaction to the Johnson & Johnson Covid vaccine. Received vaccination in her home, about 5 to 10 minutes later, developed redness and swelling of the face. Thought she had some stiffness of the tongue and tightness of the throat. No chest pain, shortness of breath.

Patient admitted 4/12/21 with fatigue and abdominal pain. Found to have UTI but no definite sepsis, and acute renal failure. Treated with iv antibiotics and iv fluids. Over next 48 hours developed worsening encephalopathy and thrombocytopenia. MRI/MRA/MRV showed no acute findings. Hyperammonemia noted, with no known Hx of cirrhosis; US did not show portal vein or hepatic vein thrombosis. Encephalopathy worsened, no clear etiology; EEG just showed generalized encephalopathy. Renal function worsened. Patient became obtunded and was intubated 4/16/19. Platelet nadir of 31k. Dialysis started. Left common femoral DVT developed. Patient had DIC type picture. Respiratory failure worsened, hypotension developed, patient passed away 4/20/21. No clear etiology of encephalopathy and thrombocytopenia identified, unclear if related to J&J vaccine received 2 weeks prior.

On Sunday night, 04/11/2021 around 7:00pm, patient stated she started getting sick to her stomach. She complained of headaches and fatigue. At midnight she vomited, couldn't lay down and symptoms lasted all night. She complained of back pain too. she noticed blood in her urine with a clot of blood in it and had shortness of breath. She vomited twice. In contact by phone with her daughter at the time. Patient refused to go the the emergency room or call her physician. She has a cardiologist who is her primary care physician.

DIARRHEA; THREW UP; NAUSEATED; HEADACHE; LUNG PAIN (FELT LIKE LUNGS GOING TO EXPLODE); LEFT ARM PAIN; FATIGUE AND FELT TIRED; LETHARGY; SICK; PAIN DOWN FROM LEFT BREAST TO ELBOW; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 06-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 pain down from left breast to elbow. On 07-APR-2021, the subject experienced lethargy. On 07-APR-2021, the subject experienced sick. On 07-APR-2021, the subject experienced left arm pain. On 07-APR-2021, the subject experienced fatigue and felt tired. On 08-APR-2021, the subject experienced lung pain (felt like lungs going to explode). On 08-APR-2021, the subject experienced nauseated. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced threw up. On 11-APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: oxycodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from threw up, and diarrhea, had not recovered from fatigue and felt tired, lung pain (felt like lungs going to explode), nauseated, left arm pain, lethargy, headache, and pain down from left breast to elbow, and the outcome of sick was not reported. This report was non-serious.; Sender's Comments: V0: MAC comment not required for non serious cases as per standard protocol

LEFT RIB CAGE PAIN; MUSCLE TIGHTNESS; DIFFICULTY BREATHING; COUGH; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune hepatitis. The patient experienced drug allergy when treated with erythromycin, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:50 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cough. On MAR-2021, the subject experienced difficulty breathing. On 14-MAR-2021, the subject experienced left rib cage pain. On 14-MAR-2021, the subject experienced muscle tightness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left rib cage pain, and difficulty breathing, and the outcome of cough and muscle tightness was not reported. This report was non-serious.

The patient was given Janssen vaccine @ 11:38am. She stated she had anaphylaxis reaction before after colonoscopy was not sure exactly what from. Made sure this vaccine didn't have PEG in it. Asked her to stay for 30 minutes after vaccine so I could monitor her. Around 12:10pm she said her mouth felt like anaphylaxis may happen. Asked her if she felt like she could swallow she said yes gave her (2) 25mg diphenhydramine. Had her sit and took her blood pressure which was BP 202/101 hr 70 I asked her if maybe she was anxious she said no she was very calm. Around 12:20pm she said felt throat was closing like before told partner to call 911. Got out Epi pen 0.3mg but she had her own administered 1 dose in right thigh. Shortly after EMS arrived and took over. The whole time she was awake and alert and responsive. Spoke to her around 4pm she was just leaving ER and said she was doing better.

I received the Covid vaccine on 3/9/2021 and was exposed to the Covid virus around March 31. I tested positive for Covid on 4/6/2021. I had runny nose, low grade fever thinking it was seasonal allergies until April 5 when my temperatures was 102. My Granddaughter tested positive on April 5 and so did her mother. I immediately notified my Doctor that I was positive and his office immediately made arrangements for me to be given Monoclonal Antibody Therapeutics. I was hospitalized January 2020 with shortness of breathe, pulse ox 72, temperature 104. At that time I was told I had a virus of some kind but the Doctor in the hospital was not sure what kind.

patient apparently had taken Johnson Johnson COVID-19 vaccination that the was about 4 days ago. And since the that time patient had been having increasing shortness of breath patient denies any history of any fever chills denies any chest pain in. Of of the by the time patient had presented to the ER patient was hypoxic and was having respiratory of difficulty patient was initially put on a non-rebreather observe mask

On the way home I had neurological symptoms, tongue and lip tingling, nauseated. The smell of Lysol spray made me not be able to breath. Made me dizzy and nauseous. It was like an LSD trip. It like being on a roller coaster, It continued all the way home. I could see all the timbers and bright green colors. Neck was stiff and it crawled up my head to my temples. It was like someone was holding my head. About 3 days later after vaccine my throat started to close and we headed to ER. I took turmeric and ginger to the ER as well as Benadryl. The symptoms subsided before we reached ER so I didn't seek care. I took vitamin E and fish oil 2X everyday after vaccine for 10 days following vaccine.

Right away, they were watching me because I felt like my throat was tightening up a little bit. My blood pressure sky rocketed. Then I was okay after awhile. They pharmacist said to take some Benadryl when I got home if I needed it. He knew I had taken Claritin D earlier. I was okay though. But the next morning, I was so exhausted I could barely get out of bed. The next day, I was still really tired. On Sunday morning, 10th, it hit me - I woke up at 04:00 in am. Nauseous; light-headed; gastro-intestinal issues; extremely ill. I called my brother in and was afraid to be by myself. I could barely move around to even get water or go to bathroom. I got through it somehow that day and on Monday I was just maybe a little but that isn't saying much - still severe. By Tuesday, I called the pharmacy - I was so light-headed I thought I was going to pass out and they told me to go to ER and someone took me and doctor said he was seeing a lot of this. Gave me IV fluids. It was difficult to stay hydrated - they gave me paperwork on what to drink to stay hydrated - Pedialyte - anything that had water in it. I drank Essentia Water, too. I couldn't stay hydrated and I was so light-headed (kept feeling like I was going to pass out) that I could have gone to ER again two days later. Doctor said take it easy - he said my body was busy making antibodies. That light-headedness for about a week - but I couldn't drive for two weeks because of it - was still so dehydrated. I had a strange sensation - like I was outside my body - I couldn't think straight. I was feeling pain in my back by my kidneys and went to my doctor.

pt stated about 4 hours after taking the vax she had a terrible headache. pt laid down but when she got up she had very sharp pains shooting from her toes up to her legs. pt said she had a stabbing pain in her left mid thigh. This episode lasted about 15 minutes. the next day she went to a routine exam but her PCP did not seem to think there was anything to worry about. pt had to have blood test 10 days later. She stated she was so tired she could barely get to the lab to get the test. The following weekend on 5/17/2021 she started having SOB and a coughing spell. On 5/19/21 she called to make an appt w/ PCP on 5/21/21. She saw a different physician and she was ordered a D-Dimer test. On 5/22/21 the pt got a phone call stating she needed to get to an Emergency Room since the lab test proved she had a blood clot. She went to ER. They did a US Doppler and CT of lungs. She had 2 pulmonary thrombosis. One in left lung and one in right lung. She had one DVT in left calf. Pt was admitted. She was given heparin IV for 3 days. She was then put on Xarelto and discharged on 5/25/2021. she has to take Xarelto for 90 days and scheduled to have another US on 7/19/2021 to see if the clots are dissolved.

Immediate extremely strong metallic taste in mouth. Tongue and lips a little puffy. Very inflamed lymph nodes in neck. Metallic taste went to gums, and I could feel the metal taste scallop across my teeth, from left to right. Felt a sweaty sensation on top of head, like I had a bowl on top of my head. Metallic taste started going down my throat. Soft palate swollen causing gagging due to uvula touching my tongue. Could feel the sensation on my head inching its way down my head. It stopped at the hairline above my ears, which made me think that I was getting in feeling in my hair follicles and not a sweaty sensation. Stayed 70 minutes at site. Metallic taste mostly gone. I was told to pick up some Benedryl. As soon as I took it I felt a strong pounding in my ears. When eating dinner I could feel a slight constriction while swallowing. The next morning the lymph nodes in my armpits were extremely sore. Neck lymph nodes stopped being sore Saturday, but are still a little swollen. Lymph nodes in arm pits were better on Sunday, but are still sore if pushed on.

Total Mouth Thrush includes swollen tongue, palate, gums..adverse event happened for 2 consecutive weeks ...stuffy nose, difficult breathing

Adverse reaction to a J & J vaccine. Reaction was described as an anxiety attack, happened 5 min later after a vaccine. Had chest tightness, felt like throat was closing for ~1 min, took vitals, gave water, left with friend, walking on her own.

Two weeks after vaccination, developed fatigue, low platelets (30,000), pain in thorax (ribs - tenderness/pain bilaterally, variable location - worse with standing up, not related to breathing), shortness of breath - developed epistaxis.

C/o shortness of breath and feeling hot momentarily after receiving the covid vaccination. States throat itchy but transient. Educated regarding anaphylactic reactions and airway closing. States that it was only for a minute or two that she felt something. Encouraged to wait 45 to 60 minutes to insure that she will not have further sxs. VSS: 132/70-t8 pulse and regular, 98% oximeter reading

Taking a shower and starting having severe shortness of breath, got real weak and it lasted about 45 mins. Could barely walk. Went to the ER got admitted and they couldn't find anything. She had to walk with a walker, body and joint aches. Walks very slow now, balance is off and she get lightheaded

June 14, I had the vaccine. June 25, I started having muscle aches, severe headache and sore throat. This continued through the next week along with being extremely tired. July 5, I went to the ER due to severe chest pains (I have NEVER had chest pains before). They sent me home that same day. By July 7th, I felt like my heart was seizing and went back to the ER this time also with shortness of breath and a fever. I was admitted on July 7th and discharge on July 9th, with diagnosis of Pericarditis--a SIDE EFFECT OF THE VACCINE. I am now currently on sick leave as I cannot work. I was told by medical staff to report this so that is what I am doing.

OUT OF BREATH, SHORTNESS OF BREATH; HEADACHES; FELT DIZZY,FELT LIKE SHE WAS GOING TO PASS OUT; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, temporomandibular joint disorder, deviated septum, and jaw pain, and concurrent conditions included low blood pressure (110/50), tooth problems, penicillin allergy, celery and avocado allergy, and allergy to animal products. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced felt dizzy, felt like she was going to pass out. On 06-APR-2021, the subject experienced out of breath, shortness of breath. On 06-APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 110/50 (low). Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches on 30-JUN-2021, was recovering from felt dizzy, felt like she was going to pass out, and had not recovered from out of breath, shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.

Extreme shortness of breath. Initially 1 day a week for 15 min. Then every other day, then every day, then twice a day. Length of attacks now ranges 15min-all day.

Janssen eua Very slight dizziness afterwards, and then very heavy feeling in chest, hard to breathe about 45 minutes later, and then hives about an hour later. Next day very slight feeling in the injection area, muscle aches, still have heavy chest and breathing issues, but not as bad as yesterday. I took a Zyrtec tablet around 6:00 p.m. on 3/9/21. Also used CPAP during the night. Oops, forgot to add CPAP and Zyrtec to medication list, I use CPAP nightly and Zyrtec 1xd at night time. I also had a resting pulse of 111 with fast heartbeat. My blood pressure was 136/84, my oxygen was down to 93.

RASH ON THE LOWER RIGHT ARM THAT WENT TO THE LEFT ARM AND UPPER PARTS INCLUDING ABDOMEN, BREAST, AND FACE. ( ONLY UPPER EXTREMITIES ) SEVERE ITCHING, SHORTNESS OF BREATH,

Approximately 10 minutes into the patient's 15 minute after vaccine monitoring time, she reported redness of upper extremities bilaterally. Patient taken to emergency medical area of public health vaccine clinic where she then reported numbness/tingling to the lips, Patient started to experience a "funny feeling in legs/feet", hives on chest and lower extremities. Blood pressure was 226/139. IV established LAC 20 gauge with EMS/Fire called. Patient transported to Campus via EMS. Patient contacted on 04/02/2021 via phone to obtain patient's current status: patient stated she was kept in hospital ER for 6 hours, developed further rash to face and back,felt really cold/freezing, and had shortness of breath while at hospital. Patient states she was given pepcid, prednisone, benadryl while at hospital; had lab work-CBC w/ diff, CMP, chest x-ray, 12 lead EKG. Patient discharged home with prescriptions for an Epi-Pen, benadryl, prednisone and pepcid. Patient reports she has a raspy voice, itchiness, some chest tightness, throat feels "a little tight like you are starting to come down with something" and headache that started morning of 04/02/2021.

Immediate pain at injection site as expected , as well as fever, headache, chills, fatigue. Towards evening these symptoms worsened. (not adverse). I hardly slept. (all these not worrisome to me) I'm so glad my vaccine provider warned me that with underlying conditions, the vaccine could make them flare up. Which they did. In the morning I had widespread pain all over. Severe headache, and shortness of breath. Because I already have near emphysema hypoxemia oxygen levels, I checked my Oximeter and my blood oxygen was in the dangerously low 70's. It stayed there until I put my oxygen concentrator on. Monitoring oxygen levels all day, I was able to keep it in the 80's to 90's, which helped. 40 hrs after injection , symptoms already fading away. All my adverse events were related to underlying conditions responding to the inflammation of the immune response. I feel protected, glad I had the oxygen handy, and I feel great about the J & J vaccine!

Janssen COVID-19 Vaccine EUA Immediate dizziness, vertigo with nausea, dry mouth, shortness of breath, headache and increased blood pressure. Later at night I had a low grade fever with achiness and headache. The flu like symptoms resolved by morning but I continue to have vertigo and intermittent nausea and my BP was still high in the morning around 9 am but came down by 12:45 to my normal range. Paramedics at the site did a BP, pulse ox, blood sugar, ECG . Everything was normal except my BP which was 180/90. This morning it was 167/98 and 168/97. No treatment. Saw my doctor's partner at 1:00 today and BP was back to my normal range but I still have mild vertigo and intermittent nausea. Doc gave me some exercises to do for the vertigo and did not seem to think that it was related to the shot, but since the paramedics said they had seen a LOT of the same reaction yesterday to the J&J shot and two sites in other cities shut down for the same reactions, nobody will convince me that it was anything but the shot. I expected the flu like side effects but never dreamed it would cause my BP to spike and the vertigo.

SWELLING IN ARM; SWELLING OF FACE; TINGLING OF BODY; THROAT STARTED TO CONSTRICT; LEGS ARE ITCHY; SHAKY FEELING ALL OVER; RASH ON TORSO; CHILLS; KILLER HEADACHE; LITTLE BIT OF NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination, vaccinated at the left arm at 12:00 PM. No concomitant medications were reported. On 01-APR-2021, the subject experienced swelling in arm. On 01-APR-2021, the subject experienced swelling of face. On 01-APR-2021, the subject experienced tingling on face. On 01-APR-2021, the subject experienced tingling of body. On 01-APR-2021, the subject experienced throat started to constrict. On 01-APR-2021, the subject experienced legs are itchy. On 01-APR-2021, the subject experienced shaky feeling all over. On 01-APR-2021, the subject experienced rash on torso. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced killer headache. On 01-APR-2021, the subject experienced little bit of nausea. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling of face, tingling on face, tingling of body, throat started to constrict, chills, shaky feeling all over, and little bit of nausea, and had not recovered from swelling in arm, rash on torso, legs are itchy, and killer headache. This report was non-serious.

Patient presented for Covid vaccination. She had multiple allergies with history of anaphylaxis including to other vaccines. Patient insisted her PCP wanted her to get J & J vaccine. Patient received vaccine at 12:20 AND AT 12:30 C/O of losing voice and feeling like she was reacting. EPI 0.5 given subq at 12:30. BP 138/80; HR 60 and regular. At 12:38 symptoms were getting worse with raspy voice and feeling SOB. Second dose of Epi 0.5 given subq. BP 130/84; HR 64. EMS called. Arrived at 1300 and patient was transported to hospital.

Began to experience shortness of breath which got worse and worse, until I couldn't walk across a room without being totally out of breath.

High blood pressure day of vaccine Shortness of Breath continues, but better Pain in upper shoulder for a month following

Shortness of breath and tightness of chest for a week and several palpitations. Autoimmune response similar to Hashimoto's attack with severe inflammation in heart and body, migraine headache, fever, chills, body aches intermittently over three weeks. Hands and feet hurt three weeks. Could not make a fist.

Woke up at 6 a.m., Friday April 2, feeling buzzing feeling in right arm, right leg, and feeling of swelling on right side of throat, rapid heart rate. Duration of feelings lasted for approx. 1 1/2 hours. In general felt strange. On April 13, developed bothersome headache, had to take tylenol to alleviate. On April 14, developed bothersone headache, had to take tylenol to alleviate. On April 15, developed bothersome headache, had to take tylenol to alleviate.

HARD TIME BREATHING; SUSPECTED SINUS INFECTION; FELT BAD AND MISERABLE; LEFT ARM HURTS WHILE PRESSING INJECTION SITE; DIFFICULTY LIFTING LEFT ARM; MUSCLE ACHE; SEVERE INFLAMMATION ALL OVER THE BODY; PAIN EVERYWHERE; JOINT ACHE; TENDON ACHE; SLEPT FOR 6 HOURS THROUGHOUT THE DAY/SLEEPINESS; DRY COUGH; INJECTION SITE WAS RED; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and other pre-existing medical conditions included patient has type-a blood group. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced injection site was red. On 07-MAR-2021, the subject experienced severe inflammation all over the body. On 07-MAR-2021, the subject experienced pain everywhere. On 07-MAR-2021, the subject experienced tendon ache. On 07-MAR-2021, the subject experienced slept for 6 hours throughout the day/sleepiness. On 07-MAR-2021, the subject experienced dry cough. On 07-MAR-2021, the subject experienced joint ache. On 07-MAR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced difficulty lifting left arm. On 07-APR-2021, the subject experienced left arm hurts while pressing injection site. On an unspecified date, the subject experienced hard time breathing, suspected sinus infection, and felt bad and miserable. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Unknown, EKG (NR: not provided) Normal, Erythrocyte sedimentation rate (NR: not provided) indicated inflammation, and Fibrin D dimer (NR: not provided) indicated inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours throughout the day/sleepiness on 07-MAR-2021, had not recovered from severe inflammation all over the body, pain everywhere, joint ache, left arm hurts while pressing injection site, hard time breathing, dry cough, muscle ache, and tendon ache, and the outcome of difficulty lifting left arm, injection site was red, suspected sinus infection and felt bad and miserable 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.

On 04-01-2021, I started to experience fever, chills and terrible headaches. I also developed pneumonia. A chest x-ray was done which demonstrated ground glass opacities. My breathing was also bad. I also have an enlarged heart. I also do not have any blood clots. I did not have problems before the J&J vaccine. To this day I still have headaches that come and go. I do not know if the J&J vaccine attributed to my symptoms and my doctor is till monitoring me.

about 6 days after taking vax she had nausea and vomiting. On 4/11/2021 she had SOB and cramping in her stomach. She went to ER. They did blood work, EKG and Chest-X-RAY. She was told that she did not have the blood disorder that people with the blood clots have after taking the vax. She was released and told to FU w PCP. She still has some nausea that comes and goes and does not feel back to normal.

BRADYCARDIA; RAPID ATRIAL FLUTTER; RAPID ATRIAL FIBRILLATION; TACHYCARDIA; SHORTNESS OF BREATH; DID NOT FEEL WELL; This spontaneous report received from a patient concerned a 66 year old white and Hispanic or Latino 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: 1805031, and expiry: UNKNOWN) dose was not reported, once total, administered on 10-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On 10-MAR-2021, patient had echocardiogram and the rhythm was normal. On 29-MAR-2021, the patient experienced rapid atrial flutter which became rapid atrial fibrillation and had tachycardia and shortness of breath. On same day patient was hospitalized for monitoring and On 30-MAR-2021, the patient developed bradycardia. It was stated that patient was bouncing between tachycardia and bradycardia which he never experienced before. Also patient stated that if symptoms doesn't resolve he had to have cardioversion procedure. On 31-Mar-2021, patient got discharged from hospital. It was reported that patient's medical doctor was aware about the adverse events and cardiologist does not know about the administration of vaccine. It was also reported that clinician who administered the vaccine to patient advised to take Motrin. Treatment medications (dates unspecified) included: Motrin(ibuprofen) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid atrial flutter, rapid atrial fibrillation, shortness of breath, tachycardia, and bradycardia, and the outcome of did not feel well was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210424129-Covid-19 vaccine ad26.cov2.s-Atrial fibrillation, Bradycardia and Atrial flutter. These events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Patient presented to hospital with four days chest pain, dyspnea on exertion and weakness. Work up revealed an acute submassive pulmonary embolism without evidence of deep vein thrombosis in bilateral lower extremities.

She been feels ill slightly ill ever since the shot. Always short of breathe. Now she died of a blood clot / heart attack while at night in her chair.

SHORTNESS OF BREATH; HEAVINESS IN CHEST; HEADACHES; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 135 pounds, and height was 162.56 centimeters. The patient's concurrent conditions included non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage and no medical history. The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042AZ1A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced shortness of breath. On 02-APR-2021, the subject experienced heaviness in chest. On 02-APR-2021, the subject experienced headaches. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown, and Ultrasound chest (NR: not provided) unknown. On 16-APR-2021, Laboratory data included: Stress test (NR: not provided) negative/false positive. On 05-MAY-2021, Laboratory data included: CT scan (NR: not provided) results awaiting, and Scan with contrast (NR: not provided) not definitive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heaviness in chest, shortness of breath, and headaches. 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.

On May 27th, I had an episode of double vision and light headedness and my blood pressure was up. Not quite confusion but just strange. They thought it might be a mini stroke - so I had an MRI or MRA - showed vascular changes but showed no acute stroke and carotids were okay. Also did an EKG with some changes and a repeat EKG - and that one seemed like a normal EKG. I had an echocardiogram - on Tuesday; Coronary CT on Wednesday and radiologist called my primary care doctor and said there was a "broken glass" opaqueness (opacity) of left upper lobe. This Wednesday with the chest x-ray, I'm concerned - I have been short of breath and tired lately - just not feeling good. On May 28th, I started Lisinopril for blood pressure and also started aspirin. My blood pressure is still fluctuating. I'm waiting for a lung CT to be scheduled - Pulmonary function study to be schedule and that's a couple of weeks out. I haven't had another episode of double vision. Fatigue and short of breath and I have had some diarrhea. I had had some weird GI stuff all winter long but it restarted (diarrhea) 2 weeks ago. I hadn't had it for four months or so.

Instant headache and pain shooting down arm and side while being injected, sick feeling and light headed right as I was leaving the facility. Within 4 hours I was struggling to do anything. I was tired and felt and nauseated, light headed and felt like i was hit by a truck. The bottoms of my feet hurt and I had stabbing pains so bad in my knee joints I could barely walk without assistance. I felt very ill for about a week after the shot but the headaches continued constantly for over a month but aren't daily anymore even though I still have them, and the fatigue was getting worse and still is a problem to this day. Once I was feeling a bit better my right knee started to give out and my left knee was cracking. Since I got that vaccine on 3/6/21 I have had back to back problems. Below is a quick list of these things that have occurred by dates: 3/30/21 - Constant headaches since the vaccine and ear pain and throat issues. 4/16/21 - Right knee giving out on me that started shortly after vaccine and gotten worse. X-ray and physical therapy ordered. 4/22/21 - Shortness of breath, back pain, constant fatigue. Blood work that showed elevated D-dimer then chest x-ray and ct-scan ordered. 4/26/21 - Ultrasound for nodule found on ct-scan. 5/4/21 - Biopsy done of mediastinal mass. 5/11/21 - Physical done for surgery. 5/24/21 - Surgery to remove mediastinal mass, right side of thyroid, two parathyroids and lymph nodes. 6/1/21 - Follow-up for surgery. When I asked why this happened, the doctor said we may never know but the biopsy of the right thyroid nodule result showed thyroiditis, Autoimmune/Hashimoto's, and that my immune system attacked my thyroid. The doctor said she tested me for that in 9/20 and it was negative. 6/2/21 - Left knee pain. About 4 days after my surgery on 5/24 i turned towards the door and heard a loud pop in my left knee. It had been crackling since the vaccine but wasn't giving out like the right one. I couldn't walk on it at all and was using crutches. 6/9/21 - Mri on left knee showed medial and lateral meniscus tears. Referred to Ortho Dr. 6/28/21 - Test thyroid levels post op. TSH levels high. Referral to Endocrinologist. 6/30/21 - Left knee treatment, cortisone shot in knee for now to help with pain and inflammation so I can function and physical therapy. Since then my 4th toe on my right foot has been numb for almost two weeks. I am scheduled for numerous future physical therapy appointments and doctors appointments. Then to make matters worse I just heard 2 days ago that J&J is having more issues and mentioned autoimmune and wondered could that be what caused all of this? I regret getting that stupid J&J vaccine. I expected it to he the Pfizer because that is what was there 2 days before I got my shot. I told the person I didn't want it and she got someone in charge to talk me into it. I should have walked out of there and I am mad at myself for caving to this woman. If J&J says we need a booster I will refuse to take it. I don't know if the vaccine was what triggered all of this but I find it quite odd that all of this started almost immediately after I got that vaccine. Not only to me but also to my sister who got it at the same time. She fell within 30 minutes of getting that vaccine and 3 more times that day, and has had and is still having numerous problems that mimic mine, such as issues with her feet and legs. She struggles to walk and is having issues with her thyroid among other things that she wasn't having a problem with prior to the vaccine. This is just the short version of all I have been through. Any questions feel free to contact me.

On 3-10-2021, Covid Vaccine administered IM L deltoid at 12:15 PM. At 12:25 PM Pharmacist was notified patient symptoms of head and face tingling and throat swelling. BP 165/90 pulse 68 at 12:28PM. Patient described s/sx rapidly developing and described severity as 10/10 with difficulty breathing. Epinephrine (Epipen) administered in R thigh at 12:30PM. By 12:34 patient described symptoms as already decreasing to a 7/10 severity. EMS arrived, assessed patient. Continued improvement with no residual effects. EMS dismissed patient to care of her husband without further follow up needed.

Fever on the night of vaccination. Body aches that felt like every bone in my body hurt. Tylenol did not control the fever. Body aches lasted three weeks. Fever lasted about 4 days. No appetite, diarrhea. Sill lack of appetite and run down and nothing tastes good. The fatigue is lingering. The breathing and low oxygen levels are still causing problems since the first dose.

Shaking chills, headache, subjective fever, stuffiness starting 6 hrs after Johnson and Johnson vaccine Noted bumps day after vaccine around a superficial vein along L lateral forehead associated with soreness. She had some hyperventilation which also subsided Had HA for 2 days. No clear vision changes, wears contact Had R ear redness briefly but also resolved

15-20 minutes after the injection, I started feeling a tightness in back of my throat; I broke out in cold sweat. I started getting dizzy and very whoozy. I felt my vision starting to close in. I thought I was going to pass out. I got the attention of the person across me to get an attendant and they brought me a chair with wheels. Two people got me up (and I'm not a big person) - they were worried I was going down and I was taken to exam room. They said I was white as a sheet. She checked my eyes and throat a few times and checked my blood pressure. It was lower than normal but she didn't seem really concerned about it - 104 over 60 something which is low for me. She gave me water to sip. She gave me very cold compresses to put on my forehead. They watched me pretty good. She had the epi-pen ready. She watched me and I sat in there and nurse came in a quite a few times to check me for about an hour. About an hour later the tightness went away and I started feeling myself again. We went home. I went to sleep. I woke up at night to go to bathroom and I was still a little woozy but I didn't fall. Next day, I just didn't feel well. My left arm was starting to hurt - was no swelling; it was a little red at injection site. It hurt just a little. I was woozy. My eyes couldn't focus as well. I felt out of it. I drank a lot of water and took a nap. Yesterday, I felt pretty decent but still woozy somewhat. I tried to run errands with my husband - just wasn't quite right. Today, much better but I'm not quite myself yet. Just a little wooziness - weird feeling. Yesterday, I did feel a soreness in the back of my right calf muscle. It wasn't warm to the touch or swollen. I don't have it anymore, it went away. It could have been a muscle thing from the first day of the vaccine when I got home and I got up and almost fell down. I do still have some achiness in joints. Especially in my knees - which isn't normal because they are replaced.

Prior to vaccination, the patient stated that she was nervous, but seemed relieved and okay directly following the vaccination. Following vaccination, patient became restless during the 15 minute post-vaccination window about 2-5 minutes after receiving the vaccine. She initially presented with uncontrollable shaking/bouncing legs, palpitation, sweating, and shortness of breath (though this was very brief. Patient remained coherent and oriented to time/person/place. The shaking and palpitations subsided after a couple minutes and resumed towards the end of the 15 minute waiting period, accompanied by nausea. 25 minutes post-vaccination she appeared to have stabilized, and we assisted the patient to her room nearby at her request to allow her to lie down while being monitored. After returning to her room, she very quickly ran to her sink due to her nausea, then after a minute of attempting to vomit, she collapsed and appeared to have briefly lost consciousness. EMS was called and the patient was rolled onto her side to prevent choking in the event of emesis. Patient remained responsive, but was weak and clammy with a weak pulse and breathing. After the firefighters came, a search of the apartment found the previously listed medications. Additionally, the patient experienced a seizure-like episode lasting 15 seconds in duration. Once the EMT came, they assessed her and monitored her in the ambulance; they reported that her condition appeared stable, her vitals were strong, and transported her to Hospital for observation/testing.

Extreme body and mind agitation, thought psychosos (first night after shot) Chest pains in left side (first night after shot) Pain spot inside of left elbow for 9 days Shortness of breath for first 2 days with intermittent recurrences for next 7 days Achy, dizzy, headache, fever, & fatigue starting evening after shot, lasting 2 days with intermittent recurrences for next 11+ days

Shortness of breath, hypertension, hypoxia, tachycardia, lips and fingers turn blue, high fever, rash, hives, joint pain, whole body aches, left lower leg burning, artery blockages, infection, weakness, dizziness, tunnel vision, sweating, headache, new onset atrial fibrillation with rvr All of the above symptoms first occurred 30 minutes after injection of vaccine The atrial fibrillation occurred 6 days after injection Left lower leg started burning 15 days after injection The artial blockages and thrombus 18 days after injection by medical diagnosis due to instantaneous shut off of blood to left leg

The patient received the vaccine on 3/31/2021. On 4/7/2021, patient developed weakness that continued until 4/14/2021. Patient also developed shortness of breath on 4/14/2021. The patient presented to the ER for weakness and shortness of breath. Patient had labwork, EKG, and an Xray. Troponin, BNP, and D-Dimer were elevated. Sodium was low. Chest xray showed congestive heart failure. Pt required intubation and then coded. Cardiac life saving procedures were started but the patient succumbed to death. Patient death pronounced per MD.

4/20/21 ER HPI: 67 y.o. female who presents with complaint of shortness of breath since yesterday night when she went to bed and describes it as heaviness associated with lower chest pain both back and front. Patient says shortness of breath is worse with lying down and with activity. Patient also complained of cough that is nonproductive. No fever or chills, no nausea vomiting and no abdominal pain. Patient has been off her Coumadin is since for 04/09/2021 for back injection for back pain. Patient said the the shortness of breath is similar to the last time she had blood clot.

RASH RESEMBLING A SUN BURN; DIARRHEA; BODY ACHE; CHILLS; FEVER; ASTHMA; RESTLESS LEG SYNDROME; MIGRANE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with cortisone 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: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced asthma. On 08-MAR-2021, the subject experienced restless leg syndrome. On 08-MAR-2021, the subject experienced migrane. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced rash resembling a sun burn. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asthma, and migrane on 08-MAR-2021, and restless leg syndrome, body ache, and fever on 09-MAR-2021, had not recovered from rash resembling a sun burn, and diarrhea, and the outcome of chills 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.

12 hours after vaccine started to have congestion, hives/welts (50-cent piece size) on head, neck and chest, itching, difficulty breathing, "bronchial asthma-type symptoms", GI cramping, throat felt like it was closing. She is still having difficulty breathing, congestion, itching, and hives are still present.

SORE THROAT; SHORTNESS OF BREATH; MYALGIA; FATIGUE; HORRIFIC HEADACHE; HORRIBLE PAIN IN CHEST LIKE HEART ATTACK; BONE WRACKING DRY COUGH; METALLIC TASTE IN MOUTH; FELT DIZZY; FELT LIKE HIT BY DUMP TRUCK; BODYACHE; NOT FEELING WELL; AGITATED; URINATING A LOT; BILATERAL EARACHE; WAS TOO SICK; HEART RATE WENT UP TO MORE THAN 80 BPM; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 66.7 kilograms, and height was not reported. The patient's past medical history included tachycardia, atrial fibrillation, left periorbital ecchymosis, dry eyes, trouble focusing, headache, nausea on right side of chest, felt like gas bubble and emesis, possible post concussion symptoms, voice hoarse/raspy voice, chronic laryngitis, flare up of hemorrhoid, constipated over a weekend, increased heart rate, nontoxic uninodular thyroid goiter, atherosclerosis of aorta, fatigue, papillary thyroid cancer, right thyroid lobectomy, deep vein thrombosis, gerd, melanoma of skin, dyspnea, deep vein thrombosis, sinus pain, tooth pain, treatment non compliance, pharyngitis, stroke, vertigo, and influenza like illness, and concurrent conditions included non-smoker, no alcohol use, asthma, cerebral palsy, qt prolonged, chest pain when tired, diabetes mellitus, chronic kidney disease stage 3, hypertension, congenital nystagmus, hearing loss, hypothyroidism, and diabetes, and other pre-existing medical conditions included the patient had no history of abuse or illicit drug usage. The patient was previously treated with phenoxymethylpenicillin, guaifenesin for sore throat, calcium carbonate, famotidine, simeticone, promethazine, cefalexin, diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid for prophylactic vaccination, salbutamol, ciclesonide, and polymyxin for red eyes; and experienced drug allergy when treated with atenolol, ciprofloxacin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 04-APR-2021 11:15 for prophylactic vaccination. Concomitant medications included disopyramide phosphate. On 10-MAR-2014, Laboratory data included: Factor V Leiden mutation (NR: not provided) negative, and Prothrombin mutation G20210A (NR: not provided) HET Abnormal, coagulation. On APR-2021, the subject experienced heart rate went up to more than 80 bpm. On APR-2021, the subject experienced agitated. On APR-2021, the subject experienced urinating a lot. On APR-2021, the subject experienced bilateral earache. On APR-2021, the subject experienced was too sick. On APR-2021, the subject experienced bodyache. On APR-2021, the subject experienced not feeling well. On 04-APR-2021, the subject experienced metallic taste in mouth. On 04-APR-2021, the subject experienced felt dizzy. On 04-APR-2021, the subject experienced felt like hit by dump truck. On 05-APR-2021, the subject experienced horrible pain in chest like heart attack. On 05-APR-2021, the subject experienced bone wracking dry cough. On 05-APR-2021, the subject experienced horrific headache. On 09-APR-2021, the subject experienced fatigue. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 20-APR-2021, the subject experienced sore throat. On 20-APR-2021, the subject experienced shortness of breath. On 20-APR-2021, the subject experienced myalgia. Laboratory data included: Anion gap (NR: not provided) 10 mEq/L, B-type natriuretic peptide (NR: not provided) 64 pg/dL, BUN (NR: not provided) 26 mg/dL, Blood pressure (NR: not provided) 214/91 mm Hg, Body temperature (NR: not provided) 97.8 F, CO2 (NR: not provided) 26 mEq/L, Chloride (NR: not provided) 102 mEq/L, Creatinine (NR: not provided) 0.92 mg/dL, Differential white blood cell count (NR: not provided) Normal, Glomerular filtration rate (NR: not provided) more than 60 mL/min, Glucose (NR: not provided) 328 mg/dL, Hematocrit (NR: not provided) 42.9 %, Hemoglobin (NR: not provided) 14.9 g/dL, Lab test (NR: not provided) Normal (no blood clots/thrombocytopenia), MCV (NR: not provided) 91 fL, Nucleated red cells (NR: not provided) 0 kilo per microliter, Oxygen saturation (NR: not provided) 98 %, Pain scale (NR: not provided) 1 (units unspecified), Platelet count (NR: not provided) 190 kilo per microliter, Potassium (NR: not provided) 4 mEq/L, Pulse rate (NR: not provided) 81 beats per minute, RBC count (NR: not provided) 4.73 million per microliter, Respiratory rate (NR: not provided) 18 (units unspecified), Sodium (NR: not provided) 138 mEq/L, Troponin I (NR: not provided) more than 0.02 ng/dL, WBC count (NR: not provided) 7.3 kilo per microliter, and X-ray (NR: not provided) Aortic atherosclerosis. Treatment medications included: hydralazine. On 20-APR-2021 17:34, Laboratory data included: Blood pressure (NR: not provided) 190/100 mm Hg, Body temperature (NR: not provided) 36.6 degree celsius, Glasgow coma scale (NR: not provided) Eye opening:4, Verbal response:5, Motor Response: 6, Total Coma Score:15, Oxygen saturation (NR: not provided) 97 %, Pulse rate (NR: not provided) 74 bpm, and Respiratory rate (NR: not provided) 16 (units unspecified). On 28-APR-2021, treatment medications included: prednisone. Additional treatment medications (dates unspecified) included: estradiol, levothyroxine, paracetamol, verapamil hydrochloride, salbutamol, diphenhydramine hydrochloride/lidocaine/nystatin, budesonide/formoterol, guaifenesin, benzonatate, chlorhexidine gluconate, ipratropium, aciclovir, fluticasone, montelukast, hydralazine hydrochloride, fluticasone propionate/salmeterol xinafoate, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste in mouth on 05-APR-2021, felt dizzy on 20-APR-2021, felt like hit by dump truck on 16-APR-2021, was too sick, and shortness of breath, and horrific headache on 19-APR-2021, had not recovered from bone wracking dry cough, horrible pain in chest like heart attack, sore throat, and bilateral earache, and the outcome of heart rate went up to more than 80 bpm, myalgia, not feeling well, fatigue, urinating a lot, agitated and bodyache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious

5-3-2021: at 11:54 am got J&J Covid-19 vaccine at Pharmacy. No anaphylaxis or other severe reactions within first four hours. By 8:00 pm began feeling fatigued and generally warm. No nausea or vomiting. By 11:00 pm developed diffuse soreness of left deltoid at injection site, mild chilling, muscle aches, T 98.8. Then developed severe shaking chills and profuse sweating, generalized, systemic burning sensation, nausea, light-headedness. This reaction lasted through the night, about 8 hrs. I spent 5-4-2021 in bed, and started feeling a bit better by 7:00 pm. By the next day felt very weak, light-headed and tired, and a little short of breath with movement. By 5-8-2021 felt pretty much back to normal, but tired. Arm soreness resolved. Reported reaction to my MD.

TEETH WERE BLUE THAT HAD FILLINGS; HAIR LOSS; FATIGUE; DIFFICULTY FUNCTIONING; RACING HEART; BLURRED VISION; SHORTNESS OF BREATH; SLICK FINGERS; LACEY RASH TO ARMS, HANDS, LEGS, AND CHEST; SEVERE HEADACHES; CHILLS; RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast surgery, tonsillectomy, pulled chest wall muscle, rib separation, and eye surgery, and concurrent conditions included penicillin allergy, environmental allergies, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm pain. On 08-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced severe headaches. On 15-APR-2021, the subject experienced lacey rash to arms, hands, legs, and chest. On 18-APR-2021, the subject experienced blurred vision. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced slick fingers. On 20-APR-2021, the subject experienced racing heart. On 25-APR-2021, the subject experienced difficulty functioning. On 25-APR-2021, the subject experienced fatigue. On 01-MAY-2021, the subject experienced hair loss. On 10-MAY-2021, Laboratory data included: C-reactive protein (NR: not provided) Elevated, and Sonogram (NR: not provided) normal. On 24-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 03-JUN-2021, the subject experienced teeth were blue that had fillings. On 08-JUN-2021, Laboratory data included: C-reactive protein (NR: not provided) Normal, and Complete blood count (NR: not provided) Normal. On 09-JUN-2021, Laboratory data included: Panoramic dental X-ray (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, difficulty functioning, and shortness of breath, right arm pain on 04-APR-2021, chills on 11-APR-2021, and severe headaches on 14-APR-2021, was recovering from lacey rash to arms, hands, legs, and chest, and fatigue, had not recovered from hair loss, teeth were blue that had fillings, and slick fingers, and the outcome of racing heart was not reported. This report was non-serious.

From the April 4, 5, 6 I felt very dizzy and out of it. When I got home on the 4th of April I had a metallic taste in my mouth and I started to feel pain in my chest. On my right side, center of my chest and the left side of my chest is where I felt pain. It was the worst pain I felt in my life, I took Tylenol. I called my doctor the next day 4/5/21 and she told me take off for 2 days per protocol for J&J vaccines. I did have a fever on 4/5/21On the 7th of April I had to stop working because my headaches were so bad. The doctor ordered new nebulizer kits for me, I was just using those. My doctor told me not take anything else except for Tylenol. I was having trouble breathing so I went to ER on the 20th of April, they ran tests (xray, blood). Since the ER visit, I have not been able to work full time. I have been feeling very unwell, breathing issues and a bad cough. I have been sick again since 6/2/21, I was given antibiotics and I have also been prescribed prednisone. The prednisone has made a huge difference, I was able to start working more. Once off the prednisone, I started to feel bad again. Since getting my COVID 19 vaccine, I have not been able to work a full work week.

LEFT ELBOW STIFFNESS; JOINT PAIN; LEFT ARM SORENESS AT INJECTION SITE; LEFT ELBOW MUSCLE PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 200.4 pounds, and height was 67.5 inches. The patient's concurrent conditions included asthma-like attacks, palpitations, anaphylaxis-like reactions, formaldehyde allergy, and cat dander allergy, and other pre-existing medical conditions included patient had a 98 squares test on her back & breathing test. Pin sticks on arm to check for other allergies. The patient experienced drug allergy when treated with nickel, and fluoxetine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma-like attacks, epinephrine for palpitations, metoprolol for palpitations, and loratadine. On 21-JUN-2021, Laboratory data included: Imaging procedure (NR: not provided) Normal. On 09-JUL-2021, the subject experienced shortness of breath. On 11-JUL-2021, the subject experienced left elbow stiffness. On 11-JUL-2021, the subject experienced joint pain. On 11-JUL-2021, the subject experienced left arm soreness at injection site. On 11-JUL-2021, the subject experienced left elbow muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath on 09-JUL-2021, and left arm soreness at injection site on 12-JUL-2021, and had not recovered from left elbow stiffness, left elbow muscle pain, and joint pain. This report was non-serious.

Within 2 minutes of receiving vaccine funny sensation in my mouth Very mild Only lasted few minutes never reported. Within 1 hour of receiving the vaccine numbness tip of my tongue. At around 0630 started with restlessness, sob, coughing which kept getting worse, stated losing my voice. Went to urgent care and given injection of solumedrol, and back to back doses of duo neb treatments Released. At 0400 next day started again with SOB, coughing, Resolved with duoneb treatment 4 to 5 hours later started again with SOB and coughing Resolved with duoneb treatment. No further episodes

Within minutes of receiving the Janssen vaccine, patient c/o dizziness, difficulty breathing, and feeling like her throat was closing. Her breathing was labored, shallow and fast RR high 30s, 93% RA, HR 120s. Lungs sounds with poor air entry, no wheezing. No rash, injection site unremarkable. Pt disclosed extensive history of allergies and h/o anaphylaxis needing Epi. States that current symptoms feel like previous anaphylaxis events. Called Code. Administered Epinephrine IM L thigh and within 2 minutes patient felt better, vital signs improved to HR 121, 99% RA, 170/86 speaking in full sentences. Allergy fellow and ED team arrived and patient was transported to ED alert and responsive in NAD.

Pulmonary embolism with acute Cor Pulmonale/hypoxia I had shortness of breath, dizziness, coughing. I had Covid test on 3/12/21 that was negative. Went to Urgent Care on 3/12/21. Gave me an albuterol inhaler which was not effective in relieving symptoms. I wasn't improving, so went to emergency room at the hospital on 03/18/2021. I was admitted to hospital and placed on oxygen and kept overnight. I was also given Xarelto. I am at home and on Xarelto.

She is on Hospice for her COPD. After she received the shot her leg and shoulder pain/ache increased to an 8/10 (usually a 2-4/10) and was constant when it usually is intermittent. Her breathing is worse and she is maxing out her inhalers and needing many more doses of her rescue morphine than usual (usually 2.4 ml of 20mg/ml Roxanol used in a week and last week was 7.5ml). She has not been taking it for the pain for fear of med interactions. She has increased her Tylenol use from 500mg qd to 3000mg qd. Her tremors are worse and she is taking her propranolol for tremors 20mg BID instead of her usual 10mg BID. Her body sweats have gone from 1 time a week to 1-2 times a day. No fevers noted.

HEAVY BREATHING/SHORTNESS OF BREATH; MILD CHEST PAIN; INCREASED FATIGUE; ITCHINESS TO RIGHT LEG; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included hospitalisation, and blood transfusion, and concurrent conditions included cardiac blockage, non smoker, non alcohol user, and low hemoglobin (3/10), and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered to left arm on 18-MAR-2021 15:00 for covid 19 prevention. Concomitant medications included fexofenadine hydrochloride for drug allergy. On 18-MAR-2021, Laboratory data included: Blood test (NR: not provided) not reported. On 18-MAR-2021 15:00, the subject experienced itchiness to right leg. On 19-MAR-2021, the subject experienced heavy breathing/shortness of breath. On 19-MAR-2021, the subject experienced mild chest pain. On 19-MAR-2021, the subject experienced increased fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchiness to right leg on 18-MAR-2021, and had not recovered from increased fatigue, heavy breathing/shortness of breath, and mild chest pain. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Patient with mild shortness of breath for the past month. Travel a week ago. Received vaccine 03/29/21. Admitted on 04/11/21 for increased shortness of breath. CT angio showed extensive segmental pulmonary embolii. Patient doing well and discharged to home on 04/12/21 after being placed on Lovenox then transitioned to Eliquis.

4/08/2021 @1200 - diarrhea, tired, weak. At 1700, extreme muscle achiness. At 2300, severe headache, temp 102° F, chills, sore mucous membranes in mouth, tachycardia (110-120/min), Respiratory expiratory wheezes. Took Tylenol extended release 650mg po. Drank grape juice & 7up. Diarrhea twice during night (4/09/2021) 0100 - 0600. Very sick. By 0700 on 4/09/2021 symptoms slightly better. Still had temp of 100 °F, O2 Saturation 94%, Took Tylenol every 6 hrs x 3 daily on 4/09/2021 thru 4/11/2021. Didn't feel better til 4/11/2021.

BONE PAIN; HARD TO SLEEP; BAD FLU; BOTH SIDES OF THE BACK HURT; SHAKING; HARD TO BREATH IN MIDDLE OF THE NIGHT; BOWL MOVEMENT WAS VERY GROSS AND SMELLY; PAIN IN HIP; MUSCLE SORENESS; SLIGHT HEADACHE; FEVER; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood thinner, and stroke, and concurrent conditions included grass allergy, tree allergy, and yellow paint allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced bone pain. On 08-APR-2021, the subject experienced hard to sleep. On 08-APR-2021, the subject experienced bad flu. On 08-APR-2021, the subject experienced both sides of the back hurt. On 08-APR-2021, the subject experienced shaking. On 08-APR-2021, the subject experienced hard to breath in middle of the night. On 08-APR-2021, the subject experienced bowl movement was very gross and smelly. On 08-APR-2021, the subject experienced pain in hip. On 08-APR-2021, the subject experienced muscle soreness. On 08-APR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 09-APR-2021, and fever, was recovering from muscle soreness, bone pain, bad flu, both sides of the back hurt, pain in hip, and hard to breath in middle of the night, had not recovered from shaking, and bowl movement was very gross and smelly, and the outcome of hard to sleep was not reported. This report was non-serious.

STUFFY NOSE; DIARRHEA; FAECES HAS REALLY BAD ODOUR; MIGRAINE-LIKE HEADACHE; CHILLS; INJECTION SITE PAIN; PRESSURE IN THE CHEST; RIGHT BREAST (FROM CENTER OF CHEST) UNDER THE ARMPIT STILL FEEL DISCOMFORT; HEART BEATING FASTER; FELT LIKE HEART WAS JUMPING OUT OF THE CHEST; STOMACH PAIN/SHARP PAIN; FELT THE URGE TO GO TO THE BATHROOM; REDNESS OF THE FACE; PAIN IN THE JAWS (BOTH SIDE); FELT LIKE HAVING A HEART ATTACK; PAIN SHOT UP TO RIGHT SIDE OF NECK TO SHOULDER AREA, THEN ELEVATED TO THE EARS; HARD TO BREATHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included x-ray dye allergy, prednisone allergy, amoxicillin allergy, non alcoholic, non smoker, fibromyalgia, and lymphedema in the legs, and other pre-existing medical conditions included the patient had allergy to an unspecified pain medication. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:15 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced pressure in the chest. On 10-APR-2021, the subject experienced right breast (from center of chest) under the armpit still feel discomfort. On 10-APR-2021, the subject experienced heart beating faster. On 10-APR-2021, the subject experienced felt like heart was jumping out of the chest. On 10-APR-2021, the subject experienced stomach pain/sharp pain. On 10-APR-2021, the subject experienced felt the urge to go to the bathroom. On 10-APR-2021, the subject experienced redness of the face. On 10-APR-2021, the subject experienced pain in the jaws (both side). On 10-APR-2021, the subject experienced felt like having a heart attack. On 10-APR-2021, the subject experienced pain shot up to right side of neck to shoulder area, then elevated to the ears. On 10-APR-2021, the subject experienced hard to breathe. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021 13:00:00, the subject experienced migraine-like headache. On 13-APR-2021, the subject experienced stuffy nose. On 13-APR-2021, the subject experienced diarrhea. On 13-APR-2021, the subject experienced faeces has really bad odour. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beating faster, and chills on APR-2021, redness of the face on 12-APR-2021, and pain in the jaws (both side) on 11-APR-2021, was recovering from migraine-like headache, pressure in the chest, and hard to breathe, had not recovered from stuffy nose, and diarrhea, and the outcome of stomach pain/sharp pain, injection site pain, felt like heart was jumping out of the chest, felt the urge to go to the bathroom, faeces has really bad odour, pain shot up to right side of neck to shoulder area, then elevated to the ears, felt like having a heart attack and right breast (from center of chest) under the armpit still feel discomfort was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.

I became very short of breath, both actively and at rest. Thinking it was stress related, I waited a few days for it to pass. When it did not I reported it to FNP and she sent me for labs including a D-dimer. The results were abnormal and she sent me for a CT Chest w/contrast.

About 1 week in a half later after the vaccine I felt very tired and felt like I couldn't breath. I went to the Emergency room they did lab work & a CT scan and that's when they seen I had a blood cloth in my lungs. I got admitted I was hospitalized for 2 days and they also gave me oxygen to take home when I was released. I am currently still on oxygen and I still feel very tired I can't do a lot of things because I get tired right away. I also have back pain and I have to continue paying for my medication something that was not in my budget.

fierce "flu like" symptoms onset approx 6-8 hours post-injection; too ill to rise from prone position for 8+ hours, insomnia and breathing difficulties throughout, violent vomiting ("dry" heaving). Slow restoration of strength, gastric upset for 60 hours (initial severe diarrhea, stomach upset). Since then (15 days) weakness, malaise, persistent minor headache.

Patient was waiting in waiting area after receiving Jenssen vaccine. After about 15 minutes, another patient who also received Jenssen came to inform me that her friend was having difficulty swallowing. Patient was not able to speak English so her fried translated to her. She was able to talk and responding to her friend's questions. I gave her Benadryl liquid to see if it resolves. After 5 minutes or so she complained of having chest tightness and having hard time breathing. I immediately gave her EpiPen 0.3mg injection in left thigh. After few minutes patient said he is feeling better with chest tightness but still having feeling of throat closing. at this time, I had one of my tech call 911 and provided another EpiPen injection (about 5 minutes after the first one). Police showed up in approximately 5 minutes. EMT showed up 10 minutes after them. Patient was conscious the entire time. When EMT took her, she was feeling better but still complaining of difficulty swallowing. Management was informed about the incident

RED SPOTS UNDER SKIN ON CHEST AND ARMS; CHILLS; TOO TIRED; INJECTION SITE PAIN/ ARM AT INJECTION SITE HURTS; INJECTION SITE REDNESS; HEADACHE; FEVER; SHORTNESS OF BREATH; NERVE PAIN EVERYWHERE; PAIN IN LUNGS WHEN TALKING OR MOVING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included fluticasone furoate for covid-19. On 10-JUN-2021, the subject experienced shortness of breath. On 10-JUN-2021, the subject experienced nerve pain everywhere. On 10-JUN-2021, the subject experienced pain in lungs when talking or moving. On 10-JUN-2021, the subject experienced chills. On 10-JUN-2021, the subject experienced too tired. On 10-JUN-2021, the subject experienced injection site pain/ arm at injection site hurts. On 10-JUN-2021, the subject experienced injection site redness. On 10-JUN-2021, the subject experienced headache. On 10-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.3 F. On 14-JUN-2021, the subject experienced red spots under skin on chest and arms. Treatment medications (dates unspecified) included: salbutamol sulfate, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 11-JUN-2021, was recovering from shortness of breath, and injection site redness, had not recovered from nerve pain everywhere, injection site pain/ arm at injection site hurts, red spots under skin on chest and arms, and headache, and the outcome of pain in lungs when talking or moving and too tired was not reported. This report was non-serious.

Vaccinated in March, began having some mild shortness of breath and fatigue around mid April which she attributed to allergies. Fatigue and shortness of breath continued to worsen and she began having some lower extremity edema. She saw her family physician at the time, Dr., who did an EKG in the office which was normal, and recommended that she follow up with Cardiology. In May the shortness of breath and fatigue worsened and she began having pain between her shoulder blades. She saw the Dr. He did a cardiolyte stress test which was reported as negative, and an echo which showed a mild pericardial effusion and they recommended a

Patient c/o throat closing, SOB, and chest pain within minutes after receiving the vaccine. Her vital signs showed tachycardia, increased respirations, and elevated blood pressure. She had a hard time speaking in full sentences. She does have a history of anaphylaxis to certain medications. She was administered epinephrine auto injector IM and brought to the emergency department by rapid response team.

Client complained of feeling dizzy with chest discomfort following vaccine. She also complained of a lump in her throat with swelling. and a headache. Client was able to talk without gasping. She was monitored by EMS and Dr.who administered an Epi pen 0.3ml at 17.20 pm At 17.33 pm blood pressure was 136/77 with heart rate of 93. Client was transported to EMS observation van and monitored by DR. . Dr administered several medication intravenously following IV insertion by EMS. Solumedrol 125mg, Benadryl 50mg and pepcid 20mg. Client was transported to Hospital. Her husband was advised that client needed to receive further vaccines in the office of an Allergist for observation

Patient reported history of adverse reaction to Flu Vaccine in the past and now reporting Shortness of Breath post 15 mins after vaccine administration. Patient transported to local ER for further evaluation.

Extreme racing of heart for 2 hours starting about 45 minutes after injection. Slight asthmatic cough for one week. Brain fog for one day. Heart irregularities still occurring two weeks later.

headaches, body aching pretty much all over, high fever,chills,shivering,cold,nausea,, loss of appetite,diarrhea,very week,disn?t care about anything, could barely move, uncontrollable loud with moaning fast heavy breathing all onset approzimately 7.75 hrs after the injection and sum lasted for very approximately five hours, some lasted very approximately 14.75 hours abd some lasted very approximately 18.75 hours

As soon as she injected the vaccine into my arm I immediately felt a burning sensation go down the inside of my arm to my wrist. It lasted about 5 minutes. I felt fine the rest of the day. The next day I developed a burning sensation in my tongue, mouth throat and chest. Then weakness in my chest and dificulting breathing. It is Saturday April 10, 2021 and the symptoms still come and go. The burning sensations mostly at night. The chest weakness and breathing issues seem to be in the morning and when I exercise. These symptoms are not as bad as they were initially but still present. I am unable to get an answer when I ask if the burning down my are is normal when getting a vaccine. No one else that I have talked with has experienced this symptom. I emailed my doctor she suggested taking tylenol.

I experienced two days later, nausea and fatigue and headaches in the frontal lobe and around and behind the eyes. On day 3-4; racing pulse ad felt breathless. I also felt fatigued, with shooting pain to my right arm. This pain comes and goes. I also have brain fog. My leg pain comes and goes. I have migraine headaches with fatigue, cough, nausea and sputum. I went to an acupuncturist which has helped a lot and will be going tomorrow for another session.

Took Covid shot March 6 (J&J). Since then has felt fatigued and achy. No fever but has had joint pains. Feels SOB with walking. Feels it is worse since the shot. Having pain in the back of the neck, and her hands and knees are swollen (but not red or hot). Feels this is worse than it was before. Taking furosemide but swelling not going away. Taking spironolactone and potassium. Takes furosemide 4 days a week. No N, V, but has had diarrhea since taking vaccine. She says her husband has had very similar symptoms.

pt says on the 6th day she woke up w/ a headache and nauseated. She started vomiting and took Medizine which seem to help. On 4/11/21 she started having cramps in her stomachs like a spasm and SOB. She went to hospital ER. They did blood work and Chest X-Ray which came back negative results. She was told she did not have the same blood disorder as the other people who have had blood clots after taking the vax. She was told she had blood in her urine but had no infection. She will FU w/ PCP in June. Pt says her only symptoms now are some nausea and still does not feel normal.

CONSTANTLY CLEARED THE THROAT; FELT KIND OF SWOLLEN THROAT; A LOT OF COUGHING; NUMBNESS IN LEFT ARM; TINGLING IN LEFT FINGERS; SHARP HEADACHE; TWINGE OF PAIN IN LEFT SIDE OF TONGUE; LIGHT HEADEDNESS; BURNING SENSATION AT ADMINISTRATION SITE/ TENDERNESS AT INJECTION SITE; LEFT-SIDED NUMBNESS THAT SPREAD FROM HER JAW, FACE TO TOP OF HEAD; LEFT SIDED FACIAL NUMBNESS LASTED FOR AT LEAST 5 HOURS DESCRIBED IT AS WAS SIMILAR TO DENTAL ANESTHESIA, BUT MORE EXTENSIVE; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, and concurrent conditions included seasonal allergy, vision damaged, and sensitivity to alcohol, and other pre-existing medical conditions included azithromycin allergy (headache, rash, hives, swollen lips, tongue and throat , breathing problems, chest pains, raises blood pressure), sulfadiazine allergy (headache, rash, hives, swollen lips, tongue and throat), omnicef allergy (headache, rash, hives, upset stomach), cefdinir, clonidine allergy (headache, rash, hives, upset stomach), cipro allergy (headache, rash, hives, upset stomach), aspirin allergy (upset stomach), cortisone allergy (feels like shards of glass), lisinopril allergy (cough), amlodipine allergy (swelling of legs &feet), hydrochlorothiazide allergy (headache, upset stomach). The patient experienced drug allergy when treated with amlodipine, acetylsalicylic acid, azithromycin, cefdinir, ciprofloxacin, clonidine, cortisone, hydrochlorothiazide, lisinopril, cefotaxime sodium, and sulfadiazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 14:05 to left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) Positive (units unspecified). On 06-MAR-2021, the subject experienced left-sided numbness that spread from her jaw, face to top of head. On 06-MAR-2021, the subject experienced left sided facial numbness lasted for at least 5 hours described it as was similar to dental anesthesia, but more extensive. On 06-MAR-2021, the subject experienced allergic reaction. On 06-MAR-2021 14:25, the subject experienced light headedness. On 06-MAR-2021 14:25, the subject experienced burning sensation at administration site/ tenderness at injection site. On 06-MAR-2021 15:05, the subject experienced twinge of pain in left side of tongue. On 06-MAR-2021 15:15, the subject experienced sharp headache. On 06-MAR-2021 16:00, the subject experienced constantly cleared the throat. On 06-MAR-2021 16:00, the subject experienced felt kind of swollen throat. On 06-MAR-2021 16:00, the subject experienced and had a lot of coughing. On 06-MAR-2021 16:00, the subject experienced numbness in left arm. On 06-MAR-2021 16:00, the subject experienced tingling in left fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from constantly cleared the throat on MAR-2021, and and had a lot of coughing, numbness in left arm, burning sensation at administration site/ tenderness at injection site, and sharp headache on 06-MAR-2021, had not recovered from light headedness, left sided facial numbness lasted for at least 5 hours described it as was similar to dental anesthesia, but more extensive, left-sided numbness that spread from her jaw, face to top of head, tingling in left fingers, and twinge of pain in left side of tongue, and the outcome of felt kind of swollen throat and allergic reaction was not reported. This report was non-serious.

HIGH BLOOD PRESSURE; INCREASED HEART RATE; HEART PALPITATIONS; SHORTNESS OF BREATH; CHEST TIGHTNESS; TIRED; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressures, and increased heart rate, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. 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: Unk) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced tired. On 08-MAR-2021, the subject experienced heart palpitations. On 08-MAR-2021, the subject experienced shortness of breath. On 08-MAR-2021, the subject experienced chest tightness. On 10-MAR-2021, the subject experienced high blood pressure. On 10-MAR-2021, the subject experienced increased heart rate. Laboratory data included: EKG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, heart palpitations, shortness of breath, chest tightness, high blood pressure, and increased heart rate. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

patient vaccinated at another location. approx 7 days post vaccination was admitted to the hospital for increasing shortness of breath and leg pain and swelling.

HAD LITTLE WEAKNESS AND TIREDNESS SINCE NEXT DAY AFTER TAKING VACCINE ON 4/7/2021 ON 4TH DAY, MORNING, 8.00 AM, 4/11/2021, WHEN I CHECKED AFTER WAKING UP, PATIENT WAS NOTICED NOT RESPONDING, NOT BREATHING, NO HEART BEAT. 911 WAS CALLED AND ARRIVED AT 8.20 AM. THEY TRIED VARIOUS MEASURES FOR 1 HOUR, AND THEN THEY CONCLUDED THAT THE PATIENT IS NO MORE.

Patient received the vaccine on 3-20-21 at the clinic and was admitted to Hospital on 4-6-21 with Covid-19 with Acute Respiratory Failure, Pneumonia, and right femoral DVT. She was intubated on 4-7-21 thru 4-21-21. She is in our facility receiving therapies to recover from illness.

Patient stated her throat started tingling and she thought it was feeling like it was ready to start closing and she usually takes Benadryl. Administered 25mg of liquid Benadryl. The patient waited 30 minutes and stated she felt fine.

Resident went into respiratory distress during early am of 6/7/2021. Pulse ox dropped to 56%. Resident sent to Medical Center and admitted with Respiratory Failure.

69 YO female received one dose of J&J vaccination on 3/12/21. 4/8: Patient complaint of epigastric abdominal pain almost nightly since March 12 (coincided with her COVID vaccination) described as 10/10, crampy and without radiation. CT abdominal and pelvis with contrast showed infiltrating mass in the left hepatic lobe concerning for intrahepatic cholangiocarcinoma with reactive adenopathy. Additionally, left mid ovarian vein thrombus found. No thrombus in the renal veins or IVC. 4/28: Venous duplex demonstrated bilateral leg acute DVT. Eliquis was started. 5/7: Pt underwent laparoscopic biopsy/paracentesis. Eliquis was held 2 days prior to laparoscope...5/11: Pt presented to hospital with complaints of generalized weakness, fatigue and leg pain. CTPA showed bilateral PE. Pt received heparin drip and was switched back to Eliquis on discharge. Echocardiogram on 5/12 noted mobile round mass in RV junction, right atrial mass; presumed to be a thrombus. Pt additionally with elevated troponin, determined to likely demand ischemia related to PE; EKG without any acute changes. Discharged on 5/24. 5/27: Patient started on chemotherapy with gemcitabine/cisplatin for metastatic intrahepatic cholangiocarcinoma. 6/4: Presented to the ED again due to worsening dyspnea and home pulse ox readings in the 70s. CT chest showed moderate burden of bilateral obstructive pulmonary emboli with no overt RV strain. EKOS and clot retrieval was contraindicated d/t thrombocytopenia. Was noted to have demand ischemia, and transitioned from eliquis to heparin gtt. Vascular was consulted for eval of her ischemic right foot, and deemed that it needed amputation, but would be a high risk surgery. 6/8: Patient was transferred to this reporting institution for second opinion requested by the family. Upon arrival, patient was found to be obtunded and hypotensive requiring heated high flow nasal cannula and vasopressor with norepinephrine. Code status was deemed DNRCCA/Do not intubate per family. Bedside ultrasound was concerning for an LV mass. Cardiology and Vascular surgery were consulted and recommended that the foot be amputated as well, but requested further workup with ECHO and CTA chest/abdomen/pelvis to further evaluate the LV mass. During admission workup, she was incidentally found to be COVID PCR positive. She was started on DEXA-ARDS prednisone dosing, remdesivir, and placed in enhanced droplet isolation. Her hospital course was complicated by acute hypoxemic respiratory failure due to pulmonary emboli, COVID-19 infection, and underlying malignancy requiring heated high flow nasal cannula. Empiric cefepime was started to treat any underlying superimposed pneumonia. Due to extensive clot burden with limb ischemia, as well as + COVID, she was systemically anticoagulated with a heparin drip despite her thrombocytopenia. She was intermittently given platelet transfusions in order to keep platelet count >30. TTE was obtained on 6/11 which showed large masses in right ventricle and right atrium, vegetations on mitral valve, aortic valve, and tricuspid valve, and probable mass in IVC. She also developed AKI with oliguria related to shock and critical illness. Medical oncology was consulted and she unfortunately was not a candidate for further chemotherapy at the time due to critical illness, as well as ischemic limb. (If further treatment was pursued, she would need a left leg amputation, then would require 4-6 weeks of recovery before additional chemotherapy could be given.) She slowly became more encephalopathic and had increased oxygen requirements, requiring continuous heated high flow nasal cannula. Goals of care were discussed with her family. Given her advanced cancer, it was decided to transition to comfort-focused care. Her code status was changed to DNRCC. Symptoms were controlled with IV pain and anxiety medication. She expired on 6/13/2021 at 0225.

Within 1 week of receiving Covid Vaccine, patient developed extreme lethargy, severe shortness of breath, lightheadedness at times, oral sores and swollen gums, dysphagia. At 3 months out now, all symptoms have continued with no signs of improvement.

Took Benadryl 50mg prophylactically prior to vaccine. 5 min after shot experienced heart racing, mild air hunger and SOB. 15 min after symptoms started to subside. At 30-36 min later felt normal.

BREATHING GOT WORST; ANKLES SWELLING; HANDS SWELLING; SORE THROAT; TONGUE SORE; FEVER; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included heart attack, and concurrent conditions included copd, bad heart, and pneumonia, and other pre-existing medical conditions included the patient had no history of allergy to vaccine, drug, or food and no past history of similar event.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced ankles swelling. On MAR-2021, the subject experienced hands swelling. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced tongue sore. On MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, and Investigation (NR: not provided) UNKNOWN. On 29-MAR-2021, the subject experienced breathing got worst. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from breathing got worst, and the outcome of sore throat, ankles swelling, hands swelling, tongue sore and fever was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.

Patient presented to the ER on 4/10 with complaints of SOB. She has been SOB for a few days prior to admission. She is on 4L of oxygen at home. In the ED, WBC was 36.9, lactate 2.4. Admitted for acute on chronic respiratory failure with hypoxia. Possible trigger of COPD exacerbation could be COVID vaccine. patient also positive for 3/4 SIRS criteria on admission. She did test positive for COVID in February but did not require hospitalization. On 4/11, CTA showed tiny LLL PE. Eliquis began. Possible adverse event r/t clotting disorders after JJ vaccine?

J&J vaccine 3/15 and on 4/2/2021 I thought I pulled a muscle and my leg started swelling, but my right leg only. I thought it would go down and my leg and foot started swelling up and my foot got really cold. I went to the hospital on 4/11 and they said it was a DVT and they checked my lungs and said I had small blood clots in my lungs as well. They put me on Eliquis to keep my blood thinned out.

Pt had Johnsons and Johnsons vaccine Pt presented to the ER with shortness of breath and left leg pain. She had a CT and ultrasound that showed a PE.

04/04/2021 - Significant shortness of breath when I went for outdoor walk around lake; 04/09/2021 - Awoke in cold sweat with blinding headache - checked in with work saying I was out for day at 04:12 am, took Aleve, and slept for the rest of the day. Slept for most of weekend

Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.

BLACK TOE; STUBBED HER RIGHT SMALL TOE; SEVERE HEADACHE; CHEST PRESSURE; CHEST PAIN; SORE ARM; NECK PAIN; MUSCLE ACHES; EXTREME TIREDNESS; SHORTNESS OF BREATH; HEAVY AND TIRED EYE; MULTIPLE BRUISE; BLURRED VISION IN LEFT EYE; FUNNY EYES; COUGHING; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 in march 2020, and concurrent conditions included migraine on the right or left side of her head, and sinus problem. he 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, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included mecobalamin. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced heavy and tired eye. On APR-2021, the subject experienced multiple bruise. On APR-2021, the subject experienced blurred vision in left eye. On APR-2021, the subject experienced funny eyes. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced extreme tiredness. Laboratory data included: Platelet count (NR: not provided) Normal. On 08-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced chest pressure. On 10-APR-2021, the subject experienced chest pain. On 14-APR-2021, the subject experienced stubbed her right small toe. On 14-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced black toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, and chest pain on 11-APR-2021, and heavy and tired eye, blurred vision in left eye, funny eyes, coughing, black toe, stubbed her right small toe, sore arm, severe headache, muscle aches, and extreme tiredness on APR-2021, had not recovered from multiple bruise, and the outcome of shortness of breath and neck pain was not reported. 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.

feeling bad & nauseous in morning during physical therapy. Asthma flared up. Used rescue inhaler AM, used again in 3 hours, then in two more hours used nebulizer. Eventually falling asleep for about an hour. Woke up and still needed rescue inhaler when trying to perform any tasks.

Swabbed positive for covid after coming into hospital for SOB and chest heaviness and upper GI bleed blood loss. Stated previously positive 4.16.21 but record not in system.

I was fine up until the 5/21. As I was leaving work, I got a horrible headache. I had a fever, coughing, congestion, wheezing, irritated throat--it felt like I had COVID. My lasted from 5/21-5/23. It never got over 100, but I never get fevers. I had a tele-med visit on 5/24 and she had me take antibiotics for a week, but they didn't work. On the 5/28, I spoke with her again and she wanted to see me again in a week. On 6/1, she had me take another round of antibiotics that helped a little, so I was able to return to work part-time. I got a Rocephen injection on 6/7 and that finally helped. I was then able to return to work full time. Currently, I am still experiencing some throat irritation and coughing, but I'm much better. I'm taking some cough medicine that she prescribed as needed.

Patient reported J&J COVID vaccine receipt on ?4/28. Symptoms of headache with visual disturbances and abdominal pain began less than 2 weeks later. She presented to the ED about 4 to 5 weeks after the vaccine with chest pain, abdominal pain, and hemoptysis. Work up identified right sided central and bilateral segmental pulmonary emboli, with splanchnic circulation thrombosis of the upper segment of the superior mesenteric vein, splenic vein, main portal vein, and intrahepatic portal veins, as well as dural sinus thrombosis. The patient was thrombocytopenic with elevated heparin pf4 antibody. She was initially started on heparin, but transitioned to argatroban and IVIG, with resultant increase in platelet counts over the course of her stay. She was also started on Diamox 250 BID for increased IOP. The patient was hypoxic on room air, requiring up to 4L of oxygen during her stay, but was down to 1L at the time of discharge. She was discharged on rivaroxaban for continued anticoagulation.

~ 30 days after vaccine, Pt developed increasing dyspnea. Treated with PO prednisone taper x 8 days with some improvement, however symptoms worsened off prednisone and she presented to ED on 5/3/21. Found to have multifocal PNA with significant peripheral eosinophilia. Treated with PO Abx and steroids again. Repeat CT in 6/21 shows worsening multifocal PNA with peripheral eosinophilia again. Admitted to hospital, bronchoscopy performed with results c/w chronic eosinophilic PNA. Started on IV steroids - > PO with significant improvement in parencyhmal lung disease.

fever ,swelling of face and throat, red rash all over upper body. intestines swelled. epipen, benadryl, prednisone starting at 4pm. still taking benadryl and prednisone

I became dizzy, nauseous, sweaty, and rapid breathing about 10 minutes after receiving the vaccine. I was given an EpiPen injection and taken by ambulance to a local ER

She developed symptoms of right lower leg pain 4 days after receiving the vaccine. It then progressed to right chest pain, tachycardia, and shortness of breath. She was diagnosed with a DVT and PE.

Pt complained of tinging, heaviness in tongue. No drooling. No CP has some shortness of breath. No wheezing. Pulse ox 96% on RA. HR-78/min Lungs were clear. Pt given Benaydryl 25mg 1 tab by mouth. Pt given solumedrol 40mg IM pt showed improvement in signs and symptoms. BP 120/80

Developed shortness of breath and chest pressure on 3/25/2021. Went to the emergency facility where EKG revealed a 3rd degree heart block. Transported via EMS the same day where further cardiac workup was performed. On 3/26/2021 I underwent implantation of a dual chamber cardiac pacemaker. I was discharged home on 3/27/2021.

Patient had her Johnson and Johnson Covid 19 vaccine on Friday April 9, 2021. Prior to the vaccine patient displayed no noticeable signs of deteriorating health. Over the next two days, friends of the patient attempted to contact her with no success. Finally after several hours of no contact, the grandchildren of the patients friend went to her apartment and found the patient lying on the couch unresponsive. When the patient was found, her leg was swollen. She was cold and not breathing. She passed away after receiving the Johnson and Johnson vaccine.

Thyroid swelling Difficulty breathing--one week post vaccination Sore throat abdominal pain Swelling of face Constipation All started one week after vaccination

No events immediately following injection. Six days later I started to experience an allergic reaction for some unknown reason with red welts over body, swelling. and itching. On the 7th day, my tongue and throat started swelling and I went to Urgent Care. I was treated with prednisone and epinephrine on 4/18/21 and released. Prescription given for 5 days of prednisone. No further symptoms after 4/18/21. Physician recommended I file a report with VAERS.

BLOOD CLOT INSIDE THE BUMP (INJECTION SITE); WHEEZING; HIVES ON NECK; BLADDER INFECTION/ABDOMINAL PAIN TO GROIN; BLADDER INFECTION/ ABDOMINAL PAIN TO GROIN; INJECTOR PULLED THE NEEDLE BACK AND PUT IT IN AGAIN; COULD HARDLY WALK; COULDN'T TOUCH THE ARM; REDNESS IS STILL AS BIG AS A BASEBALL; NAUSEA; VOMITING; HALLUCINATIONS; DIARRHEA; This spontaneous report received from a consumer concerned a 71 year old white (Hispanic/Latino) female. The patient's height, and weight were not reported. The patient's past medical history included bladder infection, and concurrent conditions included high blood pressure, high cholesterol, and asthma/ bronchitis/ get asthma attacks often. The patient's other pre-existing medical conditions included that she had no history of heart attack or pain. The patient's family history included that her mother had bladder infection and lady part infections. 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: 202A21A and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 10-APR-2021 around 10;00 AM for prophylactic vaccination on right arm. No concomitant medications were reported. On 10-APR-2021, the patient almost passed out after she got the shot (vaccination), they (vaccine facility) had to take her out to the car, and she could hardly walk. The patient reported that injector pulled the needle back and put it in again (Wrong injection technique). It was reported that right after injection when she turns around her arm was big as baseball, mushy, swollen and it was painful (injection site). The mushiness was going down, but it was still mushy. The patient's arm was hard as a marble, redness was still as big as a baseball and she could not touch her arm. On 20-APR-2021, the patient had bladder infection/abdominal pain to groin and had infection from lady's problem and further stated it as bladder infection. The patient think that the bladder infection was not because of the Janssen vaccine. On 21-APR-2021, the patient experienced hives on the neck and she applied Benadryl cream on it. The patient went to her physician on 22-APR-2021 (Thursday) and Nurse looked at her arm and said that it was perfusion and there was blood clot inside the bump. The patient's physician told her to take Benadryl and put ice and heating pad on it. The patient reported that she was already putting ice packs 3-4 times a day and heating pads 3 times a day. The patient also showed her hives to her physician and she was told to keep putting Benadryl on it. The patient had a follow up with her physician on 03-MAY-2021 for her arm checkup. On an unknown date in APR-2021 (reported as first night), she could see penguins walking around, marching up the stairs on first night (Hallucinations) and then no more penguins after the first night. On the same first night, the patient experienced nausea, diarrhea, and vomiting. On an unknown date, the patient experienced wheezing and she thinks that her wheezing was not related to the Janssen Covid-19 vaccine. According to patient her wheezing is related to her asthma. The patient did not have any trouble sleeping since she was taking the Benadryl. The patient stated that she could move her arm up and down, but she was scared to do so. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinations, bladder infection/abdominal pain to groin, diarrhea, vomiting, and nausea, and the outcome of almost passed out, hives on neck, couldn't touch the arm, blood clot inside the bump (injection site), wheezing, could hardly walk, injector pulled the needle back and put it in again and redness is still as big as a baseball was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and wheezing, and bladder infection as not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210452551-covid-19 vaccine ad26.cov2.s- blood clot inside the bump (injection site), hallucinations. 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).

I originally had breathing problems in January. I couldn't catch my breath. My Oxygen was very low and I was hospitalized overnight. I was treated and released the next day. It reoccurred two weeks before the vaccine and COPD was ruled out. Two weeks after my vaccine I had breathing problems again. I went to Urgent care again with breathing problems and released after treatment. I am scheduled to see a pulmonologist and I am not sure if it is related to the vaccine. I was sick in March of 2020 and I am not sure if it was Covid-19. It seemed to be a mild disease. I have three episodes since I got the vaccine and all tests have been negative for definitive lung disease.

On drive home anaphylactic reaction (trouble swallowing, swollen tongue), went to Emergency Room, treated with benadryl. Returned to ER a week later with new symptoms, severe headache, nausea, tightness in chest, trouble breathing .

Janssen COVID-19 Vaccine EUA Ten weeks ago I had A LOT of nasal mucous draining into my mouth during the night, couldn?t breathe, coughing. This went on for 4 days, so I went to the GP, took a COVID and Strep Test, both negative. I had and still have: a very difficult time swallowing any food or drinking water because I have a very irritated throat when I breathe, with throat pain going from the bottom of my neck up to my ear (earache). I?ve lost 7lbs. over the last ten weeks, 5?5? 93lbs. GP suggested an ENT. ENT did an XR Esophagram, CT Sinuses Fusion wo contrast and a CT neck soft tissue w contrast/creat. Everything OK. Sending me on to a swallow therapist on June 30th.

Patient' husband stated patient started having severe itching, slight rash on arms and legs, shortness of breath approximately 45-60 minutes after receiving the vaccine. Patient told husband it was like she could taste the shot. Patient took Benadryl and used her Albuterol MDI at home but according to husband refused to go to a doctor. No symptoms presented during 15 minute waiting period after the patient received the vaccine.

Patient complained of shortness of breath, general weakness, dizziness, chest pain which she specifically described as ?angina.? Patient stated symptoms lasted for about 30 minutes then resolved. No medications administered in response to event.

Extreme lower back pain and shortness of breath. Breathing exercises for lungs and over the counter acetaminophen for body aches Outcome symptoms still the same.

Many lasting for 2 weeks - pain, nausea, diarrhea, extreme weakness and fatigue, dizziness, fever and chills, cold sweats,, headache, brain fog, dyspnea on exertion, dry mouth. Medicated with Tylenol, bananas, oatmeal and herbal tea. Documented on pdf form, but unable to use "continuation page", so added sheet that unable to attach. Will try again to upload and send separately to this. NO forms given to me at pharmacy for reporting anything. I called several times and left messages, but no return call. Sent email, but response saying unable to help at this time. Very frustrating as I continued having severe symptoms and unable to get help. Finally feeling better enough today to send form.

ER 3/17 HPI: 72 y.o. female who presents with generalized weakness and not feeling well. Patient states that she had her 1st dose of COVID-19 vaccine about a week ago and since then has not felt well. She denies fever or chills, she denies any arthralgias or myalgias, she has had some nausea and vomiting but none in the last couple of days. There has been no diarrhea. There have been no urinary symptoms. 3/22/21 Inpt Admission hpi 72 y.o. female who presents with shortness of breath and hemoptysis. Patient has known history of COPD and also has a history of squamous cell carcinoma of the lung that is in remission. Patient reports she has noticed increasing shortness of breath for the past several weeks. She states the got worse around the noon time today. Patient reports she began having some hemoptysis today. Patient denies any chest pain or palpitations. Patient denies any fevers or chills. Patient denies any sinus congestion or nasal drainage. Patient denies any headaches, myalgias, or loss of sense of taste and smell. Patient does report a 4 day history of intermittent diarrhea. She denies any nausea or vomiting. Patient has had COVID-19 vaccination. Of note, patient's family reports she has lost 10 lb in the past 30 days. 3/30/21 Deceased

Received vaccine at approximately 1040. Patient then went to the self monitoring area where approximately 5 minutes later stated she felt "slight puffiness in lower lip and tingling on tongue". Patent was removed from the self monitoring area and brought to our First Aid room. Vitals remained stable BP 138/70 HR 80 and respiratory rate 16. After 5 minutes within the First Aid area patient stated " the tingling and puffiness of lower lip is extending to the back of my tongue and throat". EMS was called and patient was transported to SVMC ED.

My blood has been very thin since I got the vaccine. I did not take my Warfarin one day before the vaccine and then two days after on the advice of my doctor. My INR level was over seven without takin my Warfarin for the three days. was It is now down now to 4.5 and I am still withholding my Warfarin for two days and then taking it for three days. I am going to continue monitoring my INR and withholding the Warfarin if needed as advised by my doctor. I have also been very short of breath since the vaccine. I have also been diagnosed by Nuclear MRI with a lung condition. My MRI taken three weeks after the vaccine result listed Matched Ventilation/perfusion defect in the left lower lung. I am still very short of breath after three weeks I am on Oxygen now. I had shortness of breath before the shot but it was not as bad as it has been since I got the vaccine.

FAST HEART RATE; BLOOD CLOT IN BOTH LUNGS; ACHY; LOW ENERGY; VERY WEAK; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on left arm on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included pregabalin(Lyrica) for fibromyalgia and bad back. The patient reported pregabalin makes her gait off. On 13-MAR-2021, the patient felt okay. On 14-MAR-2021, the patient experienced achy, low energy, very weak, headache, fever of 100 degrees fahrenheit. Laboratory data included: Body temperature (NR: not provided) 100 F. On 13-APR-2021, she had wellness visit. The patient had a fast heart rate. Laboratory data included: Heart rate (NR: not provided) 144 (units unspecified). So immediately her electrocardiogram was taken and she was hospitalized for 2 days in emergency room by ambulance and started running tests. The patient had a computer tomography with dye contrast and it showed blood clots in both lungs. She had many tests, echocardiogram and X-rays. Treatment medications (dates unspecified) included: continuous oxygen via nasal prong (3.2 litre down to 2 litre), warfarin sodium(Coumadin), blood, whole, and rivaroxaban(Xarelto). The patient stated once she had rivaroxaban she felt "free". Currently also had 2 intravenous and taking blood regular. She was also on physical therapy. The therapist came in and made her walk across her room twice according to therapist she did not need oxygen. The patient currently had 2 IV's and taking blood regular. The patient will be discharged with or without the oxygen. The patient has machine on her chest with all kinds of wires. She don't know about her oxygen saturation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, low energy, very weak, headache, and fever on 15-MAR-2021, had not recovered from fast heart rate, and the outcome of blood clot in both lungs was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).; Sender's Comments: V0: This is a 72 year old female, unspecified ethnicity, who experienced tachycardia and was noted to have blood clots in both lungs 32 days (around 1 month) after receiving the COVID-19 vaccine ad26.cov2.s on the left arm. Patient had Fibromyalgia and is maintained on Pregabalin (Lyrica). Patient's height and weight were not reported as well as history of smoking, allergies or drug abuse. One day after receiving the vaccine, the patient experienced fever, headache, weakness and pain, which resolved. During a wellness visit after a month from the vaccine, tachycardia was noted and an EKG was done. Patient was immediately brought to the ER, where the CT Scan (with contrast) showed blood clots in both lungs (detailed result not reported). Other tests done were also not reported. Patient was subsequently admitted in the hospital and was discharged after 2 days. The information provided is insufficient to show that the vaccine is causing the event; hence, this is assessed as indeterminate per WHO causality classification of adverse event following immunization. Additional information requested.

Patient is a 73 y.o. female who presents today with multiple complaints worsening shortness of breath, cough, weakness, headache, nausea, and diarrhea. Symptoms began with a cough 3 days prior. She went to dialysis on her usual time. Sent to ER to be evaluated due to cough. Positive COVID-19 4/27. Other family members positive. Patient became progressively more weak, short of breath that she was unable to go to dialysis today. She has had poor intake with intractable nausea and diarrhea. Audible gurgling. In ER, potassium elevated and chest x-ray with congestion consistent with overload. Nephrology intending on dialysis today while inpatient. Due to poor respiratory status now requiring oxygen typically only at night. Decadron added. Not a candidate for remdesivir.

Client during TC, expressed through the telephone Spanish Interpreter, received the J & J COVID 19 vaccine, in left arm, on 3/14/2021. After receiving vaccine had slight soreness at site, and on 3/27/2021 started having left sided facial droopiness, difficulty swallowing, talking, fatigue, SOB and weakness, around 10:00 am. Per Client, children called 911, and was transported to Hospital. Per Client, was treated at hospital and informed by medical personal, that she probably experienced a stroke. Client was not admitted to hospital, sent home the same day, and instructed to follow up with PCP. Per Client, on 3/29/2021 followed up with PCP, and on 5/12/2021 had a MRI procedure and due to fo

Person died on 5/7/2021 with death note stating acute respiratory failure with hypoxia, thrombocytopenia.

Blood spots under skin in arm vaccination given in. Shortness of breath, chest pain, headaches, tiredness

Pt admitted on 7/10 for dyspnea and chest pain. Pt received COVID J&J vaccine on 4/6/2021. Pt was given oxygen ~1.5 days and received dexamethasone and acetazolamide. On 7/14/21, Pt currently on room air. Possible reason for AHRF multifactorial of COVID, acute on chronic anemia and HF exacerbation with severe valvular disease.

Stated that 45 min after vaccine when walking to car, began having SOB, felt like she was breathing through cotton and then sand. Increased her prednisone to 20 mg per day. Day 3-4 became dizzy, weak, developed a rash with itching. SOB continued Day 8 SOB is getting better and weaning down to 8 mg prednisone

Initially had stroke-like symptoms on left side, now resolved. Continues to have extreme weakness and SOA with any exertion.

3 weeks post vaccination patient developed chest pain and shortness of breath. Was able to tolerate symptoms, then had radiation treatment and developed more shortness of breath. Was transported via EMS to hospital where an xray and MRI were completed and showed multiple blood clots in her lungs. Venous Doppler was also completed and blood clots were found in her legs. She was subsequently admitted to hospital.

04/07 evening uncontrollably shaking tingling headache nausea Treated at ER released 3:00 am 04/08. Headaches tingling all day advised to take Tylenol. Advil 04/09. 12:00 am. Face burning mouth throat body tingling prickly heart pain trouble breathing. 2:00 went to ER. Admitted for observation. Given blood thinner copious medications Released 2:00 pm 04/09.

DIARRHEA; NO APPETITE; CHILLS; JOINT HURTING; FEVER; ACHES; FLU LIKE SYMPTOMS; SHORTNESS OF BREATH; DIZZINESS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, severe bronchitis, arthritis, bad back, and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 06-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 104 F. On 07-APR-2021, the subject experienced aches. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced no appetite. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced joint hurting. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, shortness of breath, diarrhea, no appetite, and joint hurting on 12-APR-2021, flu like symptoms, dizziness, and chills on 11-APR-2021, and fever on 10-APR-2021. This report was non-serious.

Myasthenic Crisis. Hospitalized. Immediately after shot got headache/still have it. Extreme tiredness day after shot which continued throughput. Got Short of Breath around day 9. Was sent to ER by ambulance from Urgent Care. Was close to being intubated.Was in SICU 7 days, then 2 days regular hospital room. Am still very tired and weak and short of breath with weak diaphragm and will ho back to ER if no improvement.

Patient developed shortness of breath the day after the vaccine and was diagnosed with bilateral pulmonary embolism and DVT and had to be hospitalized.

Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26.

EXPELLED PEA SIZED MUCUS BOLUS WITH BLACK CENTER WHEN COUGHING OR BLOWING NOSE; UNEXPECTED THERAPEUTIC BENEFIT; TIRED; GASTROINTESTINAL TRACT PAINFUL; BLURRED VISION; THROAT SWELLING REQUIRING MOUTH BREATHING; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19/covid cough, and concurrent conditions included migranes, osteoarthritis, irritable bowel, constipation, reactive asthma, malaise, exhaustion, brain fog, migrating joint pain, disturbed sleep pattern, mold allergy, pollen grass allergy, raynaud's syndrome, alcohol use, memory disturbances, non smoker, sulfonamide allergy, tetracycline allergy, barbiturate allergy, and penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of drug abuse or illicit drug usage. the patient increased the use of normal nebulizer from sporadically to daily for months that caused a trip to the emergency room in apr-2020. The patient was previously treated with butalbital/caffeine/paracetamol; and experienced cut off vital organs to brain shut down blood vessels when treated with cimetidine for migraine, and low blood pressure when treated with pethidine hydrochloride, tachycardia when treated with oxycodone hydrochloride/paracetamol, and throat swelling when treated with capsaicin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included epinephrine. On 09-APR-2021, the subject experienced blurred vision. On 09-APR-2021, the subject experienced throat swelling requiring mouth breathing. On 10-APR-2021, the subject experienced gastrointestinal tract painful. On 11-APR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced unexpected therapeutic benefit. On 20-APR-2021, the subject experienced expelled pea sized mucus bolus with black center when coughing or blowing nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, and throat swelling requiring mouth breathing on 09-APR-2021, and tired on 12-APR-2021, was recovering from unexpected therapeutic benefit, had not recovered from gastrointestinal tract painful, and the outcome of expelled pea sized mucus bolus with black center when coughing or blowing nose was not reported. This report was non-serious.

Patient presented to the Emergency Room via EMS with lip, palette, and throat swelling and tingling, itching, and hives. The patient was treated with epinephrine x 2 doses and diphenhydramine. The patient began having symptoms soon after receiving the Johnson and Johnson COVID 19 vaccine.

Paitent presented to the office for followup to a hospitalization for presumed viral pericarditis. Upon evaluation the patient had persisting tachypnea and orthopnea, She was referred for a stat echocardiography and found to have significant pericardial effusion with tamponade. From the echocardiography department, she was referred urgently to the emergency department and taken urgently to the cardiac catherterization suite where she underwent fluoroscopy-guided pericardiocentesis with drainage of about 360mL of bloody effusion, Pericardial drain was left in place. In total it apperas that approximately 400mL of fluid was removed over the course of the patients hospitalization from the pericardial catheter. The catheter was removed on the afternoon of 05/12/2021 without difficulty. On the date of discharge it was noted that she had mild increase of dyspnea, a chest x-ray was obtained which revealed a right pleural effusion and a questionable infiltrate in the left base. The patient did not endorse any symptoms of cough and she had no wheezing and clinically did not have evidence of infectious pneumonitis at the time of discharge.

73 yo female, had reaction 1 hour after Pfizer Covid-19 vaccine 1/21/21- facial swelling, redness and respiratory symptoms- seen at ER, no epi given. Discussed with allergist, determined that receiving Janssen as an option (with risk involved), advised 1 hour observation in clinic. Pt received Janssen vaccine today. After 30 mins, pt complained of SOB, dry cough and sensation of losing her voice. Pt transported to ED with RN.

Four days after receiving vaccine I experienced severe shortness of breath and passed out. In the next week I had 3 more syncope episodes after severe dyspnea. Went to the emergency room and in hospital was diagnosed with stage 3 heart block with LONG pauses (one was 23 seconds). I needed an emergency pacemaker. I was also diagnosed with atrial fibrillation. Eliquis and Bisoprolol added to my medications. I also was diagnosed with pneumonia of unknown origin and unknown type (viral vs. bacterial). Speculation is I aspirated when I passed out.

3/8/21: Immediate dizziness lasting all day. Headache, fatigue/lethargy all day. Intermittent chest pain/tightness, throat tightness, gas, fever, chills. 3/9/21: Gas, loose bowls, tired, but otherwise pretty good. 3/10/21: Still tired and mildly dizzy all day. In afternoon, chest pain/pressure with any exertion, even climbing the stairs in my home, Chest discomfort stopped when I stopped the activity. 3/11/21: Chest discomfort, mild dizziness and tiredness continued this day. 3/12/21: Chest pain gone. Sore throat started in evening. 3/13/21: Sore throat all day. Runny nose for about 10 minutes. 3/14/21: mild tiredness in afternoon.

chronic diarrhea, unresolved shortness of breath after exercising, unresolved Followed up with doctor and maintains nonrelated to vaccine

The patient had already received a dose of Moderna vaccine on 01/28/21- Lot #030L20A The patient tolerated vaccine well during observation period. No signs/symptoms of adverse reaction. Assisted Living Facility reported on 4/9/21 that the patient was seen at ER the night of immunization with increased shortness of breath and was diagnosed with COVID-19 and released back to facility

74-year-old female with cardiac risk factors presents with exertional dyspnea over the past 3 days. Patient had low oxygen saturation 81% at the doctor's office which came up to 89 with rest. Patient placed on oxygen here in the emergency department. Patient does not have symptoms at rest. Patient does not have any calf swelling or pleuritic pain. Patient's D-dimer is elevated therefore CT angio of the chest was obtained which shows large, central pulmonary embolism with evidence of right heart strain.

She is a 74-year female with history of morbid obesity, OA on chronic opioids, T2DM, CKD 3, HTN, and hypothyroidism who presents with 10 days of worsening fatigue and trouble ambulating. She reports that she started feeling unwell about 10 days ago with a sore throat and pain radiated to her left ear. She had trouble swallowing due to the pain and was generally tired, thinking she had strep infection or ear infection. Her sore throat resolved as did her ear pain, however her fatigue worsened and had trouble walking due to weakness. Felt like she had trouble functioning at home, soshe presented to the ED. In the ED, she is hemodynamically stable, satting low 90s on room air. Labs are significant for mild hyponatremia 133 and bump in creatinine 1.84 (previously 1.44). Found to be Covid positive, and CXR with possible right lower lobe infiltrate. Currently, reports feeling tired with poor appetite and body aches though no shortness of breath, chest pain, nausea. She has been eating foods that taste good to her, not following diabetic diet and sugars have stayed appropriate. Denies any sick contacts or leaving the house. Of note had her Covid vaccine (J&J) 3/22 in her house, and does not know where she contracted Covid.

Immediately felt dizziness and dry mouth. Then within 2 hours felt extremely nauseated and fatigued. For two days I felt shortness of breath and fatigue for 4-5 days. The nausea lasted for over a week and then by the 4th day, diarrhea set in, which is now finally resolving after two weeks in.

On the night of my vaccine, 04-06-2021, I experienced chills all night long. I also had a terrible headaches, SOB, chest pain. I also experienced light headiness which lasted one week. I went to see a doctor on 04-13-2021, who performed x-rays of the chest, did lab work and did an EKG which the tests came back normal. To this day I still have light headiness, nausea and light-headiness.

patient came in for routine physical exam on 4/12. had gotten J/J vaccine on 3/17. husband reported onset of dyspnea a few weeks prior, eg starting some time after her vaccine. worsened significantly 2-3 days prior to her physical, but she refused to go to hospital. was found to be hypoxic at her routine physical and sent by ambulance to ED, had large saddle PE requiring thrombolysis, left leg DVT. was in ICU. now home off oxygen on anticoagulation.

Patient received Johnson and Johnson Vaccine around 4/1/21. Patient presented to the emergency department today with chest discomfort and shortness of breath. CT scan results: segmental pulmonary emboli within the superior segment of the left lower lobe and lateral basilar segment of the right lower lobe. Patient does have a history of PE 10/2020 with obvious insult of immobility post gastrectomy and was treated successfully. Patient was not on anticoagulants prior to arrival today.

SHORTNESS OF BREATH; STOMACH CRAMPS; HEADACHE; LEFT ARM SORENESS; TIREDNESS; WORSENING OF FLUTTERING OF HEART; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight was 266 pounds, and height was 62 inches. The patient's past medical history included concussion in 2019, spinal injuries, anaphylaxis shock after medicine took for bone and swelling, and concurrent conditions included non alcohol user, non-smoker, and reaction to iv dye, fluttering of the heart, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient was previously treated with steroids for swelling. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered one total, on 08-APR-2021 in left arm for prophylactic vaccination. Concomitant medications included roprinolil, atorvastatin, lisinopril , propranolol , salbutamol sulfate(inhaler) as needed, oxybutynin, and paracetamol as needed, all drugs were used for unknown indications. On 09-APR-2021, the patient experienced worsening of fluttering of heart, tiredness. On 10-APR-2021, the patient experienced left arm soreness. On 13-APR-2021, the patient experienced headache. On 17-APR-2021, the patient experienced stomach cramps and recovered on 21-APR-2021. On 19-APR-2021, the patient experienced shortness of breath. It was reported that patient had experienced shortness of breath before shot but not as often. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from stomach cramps on 21-APR-2021, and was recovering from headache, worsening of fluttering of heart, left arm soreness, shortness of breath, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: v0:20210447945: covid-19 vaccine ad26.cov2.s -Worsening of fluttering of heart. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

Patient received J&J vaccine 5/8, developed SOB 2 days ago, came to hospital last night and found to have pulmonary embolism and thrombocytopenia

Sore arm right away and then went to a sore muscle like normal the next day and was sore for three days. What happened next, I had gone to ENT for my ear (5th) and he put me on heavy dose of Prednisone (6th). Following Tuesday, I was on Prednisone for ear. I was already really achy by then. On the third day after the Prednisone I fatigue, headaches and neck pain but I didn't have any other pain. I still couldn't hear though. I was on this for almost 4 weeks and from them I started like I was having a hot flash and then I would get cold; sore throat; headaches heavy bones and achy muscles; earaches; fatigue; dizziness like you wouldn't believe. They were cyclical - I'd have them for a couple days and then for about a half a day I'd be a bit better and then it would start up again. The fatigues and dizziness didn't change when the other symptoms seemed to be a bit better. My hearing didn't start to clear until I went to see the 2nd ENT which was a couple of weeks down the road. I do not have the stamina I had before the vaccine - I'm not sleeping well at night and I'm always short of breath at any exertion. It is improving but it's slow. Again, the symptoms I experienced during cyclical times: Cold symptoms, runny nose, sore mouth, ringing in my ears was horrible; dizziness and short of breath - cyclical for three weeks. The Prednisone took away all my cramps and pain in my joints that I had before the vaccine. Currently: My heart feels like it's going 100 miles an hour at night in bed - chest discomfort at night. Legs blue in the shower. The week of the 28th, I was done with the Prednisone and then all the pain came back and more. I can't take an inflammatory - the pain is still there and my usual cramps came back.

5 min after shot was given: warmth, nausea, dizzy, feeling of passing out, throat closing up, pins and needles in face and fingers/hands/forearms, red face and chest, and weakness. Second day, nausea, stomach cramps, dizziness.

After getting the vaccine I came home and I fell asleep for a couple hours and I woke up very sick to my stomach and vertigo really bad. I was coughing a lot and I could not breathe and it was terrible. I was also tired and my muscles were sore. I made a doctor's appointment and I was waiting on the car and I tried eating some chips and I could not taste them. Then they let me in the hospital and I had a Covid test done and it was positive. That happened in 04/09/2021. They gave me a medicine for vertigo and an inhaler, Ibuterol and a medicine to control wheezing in my lungs

Terrible pain affecting all joints; arms, back, shoulders, neck; collar bones, etc Out of breath; fatigue easily; difficulty getting out of chair; walking, doing yard work, interrupted sleep due to pain. this is arthritis , psoritic type with severe aching/pain. Have been referred to rheumatologist. Initial psoriasis flare=up 5 days after injection.

death 4/24/2021 causes of death listed on death certificate: 1) Pneumonia Due to COVID 19 2) Acute Respiratory Failure with Hypoxia 3) COVID 19 4) Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Severe pain in right back, right groin, hip and upper leg. Blood clot in right lung. Placed on heparin (IV medication) by healthcare provider. Transferred to a rehabilitation hospital after being hospitalized for 5 days. Currently has home help by nurse, provided blood thinner. Unable to walk.

Client received the Janssen dose lot # 1808980 and expiration date 6/20/21 at 11:01AM. At 11:16AM client had already waited their 15 minutes and reported to EMT that she was having shortness of breath and anxiety. Vitals were taken : Oxygen: 97%, Blood Pressure: 130/80, pulse=75. Client reports to EMT s that she has a history of bradycardia and anxiety. Client reports medications are amlodipine 5 mg, Irbesartan 50 mg, Aspirin 81 mg PO, inhaler for asthma. Client also reports that on January 8th of 2021 she tested positive for COVID-19. PHN was notified at 11:28AM of client's symptoms. PHN arrived to find client sitting upright and alert and oriented x 4. Since client had shortness of breath reported PHN offered 9-1-1 but client declined, stating she was already feeling better. PHN advised client to stay an extra 30 minutes since she had a reaction. Client reports she thinks it is because she forgot to take her inhaler dose this morning. Vitals were taken: respiration rate=20, Blood pressure 130/70 and oxygen 96% and pulse 55. Client then reports she also has a history of high blood pressure. Client reports that earlier she felt a little lightheaded but did not report to EMTs. At 11:31AM vitals were blood pressure: 146/80, oxygen:97%, pulse: 65 client reports she no longer had shortness of breath, no dizziness no headache, no blurred vision and no chest pain. Gave client water bottle. At 11:41AM vitals were pulse:70, blood pressure: 130/80, oxygen: 97%- client reports no shortness of breath and "feels great." PHN advised client of emergency precautions and to follow up with provider. At 11:46AM: blood pressure: 132/90, oxygen: 98%, pulse: 68. At 11:50AM client left facility with steady gait.

Patient developed chills and fatigue Saturday and Sunday (April 3rd and April 4th) . Patient developed diarrhea and lack of appetite Monday, April 5th. Patient was reported to be bedridden Wednesday, April 7th. Patients husband stated hat patients eyes were halfway closed, experiencing shallow breathing, and had a soft pulse. Husband call 911 while instructed to do chest compressions until EMTs arrived on site. First responder were reported to perform resuscitation efforts on the patient for 35 minutes until transporting the patient to the hospital.

Sudden onset of very rapid heartrate lasting 15 minutes or more and including shortness of breath and dizziness and feeling of being light headed. In the 4 days following I had several subsequent similar episodes multiple times per day, but not lasting as long as the first one. Perhaps lasting a few minutes to about 5 minutes. Sometimes I also had a low grade headache.

within 10 days I had severe breathing problems that lasted about 4 days, had test that revealed blood clots in my lungs about a week after

Day of vaccine I didn't feel bad, just felt queasy later, I was tired the next day. I don't know when the SOB started but it continued through the month of March. I thought it was an exacerbation of my chronic issues, by Sunday 4/4/20221 I coughed up blood, and on Monday I went to the hospital and had a CT scan and was told I had a pulmonary embolism and a clot in my leg. Now I'm on an injectable blood thinner for the rest of my life and I was told it would take 3-4 months to resolve the blood clots.

Patient came to ED with complaints of syncopal episode. passed out, hit her head, felt mildly short of breath with ambulation.

TIGHTNESS OF CHEST; SHORTNESS OF BREATH; VOMITING; COUGH; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included myasthenia gravis, and penicillin allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced tightness of chest. On 16-MAY-2021, the subject experienced shortness of breath. On 16-MAY-2021, the subject experienced vomiting. On 16-MAY-2021, the subject experienced cough. On 16-MAY-2021, the subject experienced nausea. On 16-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from tightness of chest, shortness of breath, cough, nausea, fatigue, and vomiting. This report was non-serious.

75 y/o female w/ PMH significant for COPD, diabetes, GERD, HLD, HTN, CAD, CVA who presented to the hospital ED on 4/2/21 for fever, dyspnea. Pt reports being exposed to COVID 1 week ago, her entire family at home had it. She called her PCP and was placed on multivitamins and prednisone taper when she became symptomatic ~3/27/21. Throughout the week, pt had worsening dyspnea, worse with exertion, as well as dry cough, fevers and chills. Reports her temperature was 102 at home. Pulse ox was 85% at home and pt was instructed to come into the ED. On arrival, O2 82% on RA and pt having some respiratory distress. Patient was intubated and placed on full vent support, but could not be extubated. Patient's diabetes continued to be uncontrolled because of IV steroid. Patient's lactic acidosis improved with IV hydration. Patient continued to be difficult to extubate because of COVID pneumonia with ARDS. Family opted for the patient to be transitioned to hospice care and comfort care. Expired on 4/26/2021.

Mother suffering from sarciodosis, however was improiving until she recieved the Johnson and Johnson vaccination. She became very weak, very hard to breath . She was admitted to the Hospital and stayed for about two weeks. Since released from the hospital she never got her strength back and lost more weight. My mother passed away 5/28/2021.

SHORTNESS OF BREATH; MALAISE; FEVER; This spontaneous report was received from a 75-year-old female patient via a physician. The patient's height, and weight were not reported. The patient's concurrent conditions included pulmonary arterial hypertension and sinus infection due to seasonal allergies. The patient received macitentan (OPSUMIT) (tablet, form of administration:10 mg, oral, batch number was not reported) 10 mg, daily, from 23-JAN-2020, frequency was not reported for pulmonary arterial hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the patient experienced fever which was treated with Tylenol (paracetamol). On 12-APR-2021, her fever returned and was accompanied by shortness of breath and malaise, following which she was hospitalized in the afternoon. It was reported that the patient had a possible reaction to the vaccine. At the time of report, the hospitalization status was provided as 'current'/'not resolved'. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of the malaise, shortness of breath and fever was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210440876-covid-19 vaccine ad26.cov2.s -SHORTNESS OF BREATH. 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, UNDERLYING DISEASE 20210440876-covid-19 vaccine ad26.cov2.s -MALAISE, FEVER. This event(s) are labeled per RSI and is therefore considered potentially related. 20210440876-OPSUMIT-SHORTNESS OF BREATH,MALAISE,FEVER. This event(s) are considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS

DIZZINESS; PALPITATIONS; DIFFICULTY BREATHING; JOINT PAIN IN BILATERAL SHOLDERS; MUSCLE ACHES; WEAKNESS; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 123 pounds, and height was 67 inches. The patient's past medical history included laminectomy of l4 & l5, urinary mesh insertion, and removal of urinary mesh, and concurrent conditions included chronic obstructive pulmonary disease, thyroid problems, urinary incontinence, mold allergy, alcohol, and occasional smoking, and other pre-existing medical conditions included the patient has allergy of different plants and prilosec (difficulty breathing & swallowing). The patient had correction of urinary mesh in 2009 and 2010 and did not have history of drug abuse or illicit drug. The patient experienced difficulty breathing and swallowing when treated with omeprazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2020, Laboratory data included: BUN (NR: not provided) UNKNOWN, CBC (NR: not provided) UNKNOWN, Thyroid function test (NR: not provided) UNKNOWN, and WBC (NR: not provided) Elevated. On 29-APR-2021, the subject experienced dizziness. On 29-APR-2021, the subject experienced palpitations. On 29-APR-2021, the subject experienced difficulty breathing. On 29-APR-2021, the subject experienced joint pain in bilateral sholders. On 29-APR-2021, the subject experienced muscle aches. On 29-APR-2021, the subject experienced weakness. On 29-APR-2021, the subject experienced tiredness. On 29-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, palpitations, muscle aches, weakness, tiredness, headache, difficulty breathing and joint pain in bilateral sholders was not reported. This report was non-serious.

On Apr 17, 2021 I had COVID symptoms of cold like symptoms, then a night of chills and coughing, followed by aches then weeks of what I thought may be allergies, but not feeling good. I continued to cough, but thought it was attributed to GERD. I wasn't thinking it could be COVID because I had been vaccinated. By May 18, I was having trouble breathing as it was painful to inhale. I thought I might be having a heart attack so went into the emergency room at Hospital. I tested positive in ER. No heart problem. There were also at least 5 blood clots found in my lungs. It felt like what I imagine it would feel like if my ribs were broken and I was trying to take a deep breath. I continued to have difficulty inhaling because of the pain of doing so into the next day (19th) and part of the 20th. I was administered oxygen and pain meds for the first day. I was put on Eliquis, which I am ordered to take for 6 more months. I was released from ICU on the 20th, which appeared to be a quick turnaround. I still have no energy, lack of clarity of thought, and easily out of breath a month later. In the hospital, I had no fever. The only time I think I did was on April 19th when I had the chills and cough.

DIFFICULTY BREATHING; SWOLLEN ANKLES ON BOTH SIDES (MORE NOTICEABLY AFTER THE VACCINE); LEAKAGE/GOING TO THE BATHROOM CONSISTENTLY; HEADACHE; TIRED; HARDLY SLEPT; DEHYDRATED (THIRSTY/DRY MOUTH); DRY RIGHT DOWN IN THE THROAT; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included lung cancer, kidney infection, headache, swollen ankles, difficulty breathing, and leakage, and concurrent conditions included neuropathy, diabetic, and high blood pressure, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient's all medications were held at the time of vaccination. The patient was previously treated with oxygen for difficulty in breathing; and experienced drug allergy when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with naproxen sodium, chlortalidone, carvedilol, lisinopril, losartan, morphine, prednisone, tiotropium bromide, and rashes when treated with cobalt. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included paracetamol for headache. On MAY-2021, Laboratory data included: Allergy test (NR: not provided) Not reported. On 09-JUL-2021, the subject experienced dehydrated (thirsty/dry mouth). On 09-JUL-2021, the subject experienced dry right down in the throat. On 09-JUL-2021, the subject experienced hardly slept. On 10-JUL-2021, the subject experienced difficulty breathing. On 10-JUL-2021, the subject experienced swollen ankles on both sides (more noticeably after the vaccine). On 10-JUL-2021, the subject experienced leakage/going to the bathroom consistently. On 10-JUL-2021, the subject experienced headache. On 10-JUL-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dehydrated (thirsty/dry mouth), swollen ankles on both sides (more noticeably after the vaccine), leakage/going to the bathroom consistently, difficulty breathing, hardly slept, headache, tired, and dry right down in the throat. This report was non-serious.

SUSPECTED CLINICAL VACCINATION FAILURE; PULMONARY THROMBOSIS; MENTAL IMPAIRMENT; COVID-19; COMPUTERISED TOMOGRAM THORAX ABNORMAL; COUGH; DYSPNOEA; NASOPHARYNGITIS; PAIN; PAINFUL RESPIRATION; ANTICOAGULANT THERAPY; ELECTROCARDIOGRAM; FIBRIN D DIMER; INTENSIVE CARE; SARS-COV-2 TEST POSITIVE; CHILLS; MALAISE; ASTHENIA; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1421473) concerned a 75 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included osteoarthritis, seasonal allergies, and hypothyroidism, and concurrent conditions included mild cold, and Gastroesophageal reflux disease (GERD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808078, and expiry: UNKNOWN) frequency 1 total, dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, colecalciferol, compounded hormones, esomeprazole magnesium, fexofenadine hydrochloride, fluorometholone, fluticasone propionate, thyroid, vitamins nos, and zinc. On 17-APR-2021, patient had COVID symptoms of cold like symptoms, then a night of chills and coughing, followed by aches then weeks of what patient thought may be allergies, but patient was not feeling good. Patient continued to cough, but thought it was attributed to GERD. Patient wasn't thinking it could be COVID because patient had been vaccinated. Patient experienced pulmonary thrombosis, nasopharyngitis, and mental impairment and was hospitalized on unspecified day. By 18-MAY-2021, patient was having trouble breathing as it was painful to inhale. Patient thought patient might be having a heart attack so went into the emergency room at Hospital. Patient was tested positive in emergency room (ER). Patient had no heart problem. There were also at least 5 blood clots found in patient's lungs. Patient felt like what patient imagine it would feel like if patient's ribs were broken and patient was trying to take a deep breath. On 18-MAY-2021, patient experienced suspected clinical vaccination failure. Patient continued to have difficulty inhaling because of the pain of doing so into the next day 19-MAY-2021 and part of the 20-MAY-2021. Patient was administered oxygen and pain meds for the first day. Patient was put on Eliquis, which patient was ordered to take for 6 more months. Patient was released from ICU on the 20-MAY-2021. Patient still have no energy, lack of clarity of thought, and easily out of breath a month later. In the hospital, patient had no fever. Patient thought that the only time patient thought was on 19-APR-2021 when patient had the chills and cough. patient was hospitalized for 3 days. Laboratory data included: Computerised tomogram thorax abnormal (NR: not provided) Not Reported, Electrocardiogram (NR: not provided) Not reported, Fibrin D dimer (NR: not provided) Not reported. On 18-MAY-2021, laboratory test included, SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19, asthenia, chills, computerised tomogram thorax abnormal, cough, dyspnoea, malaise, mental impairment, nasopharyngitis, pain, painful respiration, pulmonary thrombosis, anticoagulant therapy, electrocardiogram, fibrin d dimer, intensive care, sars-cov-2 test positive and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This report was associated with product quality complaint: 90000185984. The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed, a manufacturing related root cause could not be identified, based on the PQC evaluation/investigation performed. Additional information was received from Consumer Complaint Vigilance Organization on 16-JUL-2021. The following information was updated and incorporated into the case narrative: Investigation result added.; Sender's Comments: V3: In this version following information was updated and incorporated into the case narrative: Investigation result. This updated information does not alter the causality of the previously assessed events. 20210705031-COVID-19 VACCINE AD26.COV2.S -19- Pulmonary Thrombosis, Mental Impairment, Covid-19, Asthenia, Chills, Cough, Dyspnoea, Malaise, Nasopharyngitis, Pain, Painful Respiration. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210705031-COVID-19 VACCINE AD26.COV2.S -Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS 20210705031-COVID-19 VACCINE AD26.COV2.S -19- Computerised Tomogram Thorax Abnormal, Anticoagulant Therapy, Electrocardiogram, Fibrin D Dimer, Intensive Care And Sars-Cov-2 Test Positive . 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).