Johnson & Johnson

Experienced light headedness and felt shaky few minutes after receiving the vaccine. BP 142/70 O2 sat - 100%

headache started at approx 3pm, debilitating chills with uncontrolled shaking started at 4pm with low grade fever that began to climb. Fever peaked at 104.8 and stayed there for approx 6 hours. Vomiting started around 7pm. Rapid hear rate for approx 4 hours. Pulse was over 120 beats for approx 2 hours with chest pain.

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

Horrendous headache starting 13 1/2 hrs later. Then nausea, and I passed out. Came to and had extreme chills. After the 24 hr mark, just tired and had to stay in bed. Today 3/9, all good.

Severe headache, very tired, muscle aches,fever, short periods of dizziness, several hours of the feeling of pressure on my chest which then was replaced by significant burning sensation, bottoms of both feet were very painful and a wrist that i broke a couple of years ago and a knee which has caused pain in the past were very, very painful.

Patient was sitting in chair when she alerted Medic she was feeing dizzy and lightheaded. Patient had syncope episode lasting approximately 45 seconds. Patient did not strike her head and was placed in recovery position on the floor by two medics. EMS was called to facility. EMS cleared patient to return home with spouse.

Chills at about 8pm on 3/6/2021. The woke with a rapid pounding heart rate just after midnight 3/7/2021. I went to the Hospital emergency room. They ran tests; ekg, blood tests, chest X-ray. They gave me fluids and Tylenol. My heart rate and blood pressure were fluctuating when I first went to the ER but then they went back to normal and I was released around 6:00pm 3/7/2021.

Fever and chills began around 3 am following vaccination at 6:45 PM. Upon arising around 7 am, fainted in bathroom and was dizzy when upright for about thirty minutes. Bruised ribs secondary to falling.

Chills and fatigue for 3 days,fatigue and lightheadedness x10 days. Seen at the walkin 3/15/21 sent to ER for two units of blood. Acute anemia-seen at Hospital 3/15-3/16/2021. 3/24/2021 stool tested and no blood found. Next test is on 4/22/21-endoscopy

Patient experienced a brain hemorrhage and was hospitalized on Monday, March 15. Despite numerous tests, doctors could not find the source or cause of the bleeding. Over time, the bleeding spread to other areas of her brain including her brain stem. Damage from the bleeding was so severe that she would not recover. She passed away on March 24 after being removed from life support.

FLU LIKE SYMPTOMS/ TIREDNESS; COLD SYMPTOMS/ NASAL CONGESTION; RIGHT SIDE NOSE BLEEDS; RIGHT SIDE EAR ACHE; This spontaneous report received from a patient concerned a 60 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to Vectrum, Keflex. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced right side nose bleeds. On 18-MAR-2021, the subject experienced right side ear ache. On 18-MAR-2021, the subject experienced cold symptoms. On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cold symptoms, had not recovered from right side nose bleeds, and right side ear ache, and the outcome of flu like symptoms was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious

Patient reported dizziness and nausea following the administration of vaccine. Patient reported dizziness, lightheadedness, nausea, and exhibited hypertension throughout monitoring period. Patient monitored for a total of 1hr and 30 minutes. Patient received apple juice, water, and crackers during monitoring period. Patient remained alert and oriented during monitoring period. Patient reported feelings of anxiety prior to vaccination. Patient exhibited various blood pressure reading see the following, 121/80 HR 79, 130/87 HR 79, 129/81 HR 82, 140/86 HR 79, 150/86 HR 77, 136/86 HR 76, 170/102 HR 86. Patient final blood pressure reading prior to leaving the facility was 175/102 HR 82. Patient requested transfer to emergency room due to increased nausea, dizziness/ lightheadedness, and hypertension. Patient denied shortness of breath or difficulty breathing throughout monitoring period and prior to transfer.

Approximately 10 minutes after receiving the vaccine, the patient's husband said she was feeling faint. I checked her blood pressure, which registered as 80/60. I offered to call 911, due to hypotension, but when I checked it on her other arm, it was 177/87, which she confirmed was closer to her baseline. Additionally, she complained of nausea and vomited. I then offered to call 911 again, but she said that she was feeling better. I continued to monitor her, and offered to call an ambulance again, She did not complain of any difficulty breathing or chest tightness/pain. I continued to monitor her for twenty minutes, and then she said that she wanted to go home. I offered to call an ambulance again, but she assured me that she felt better and wanted to go home.

for 12 hours fever 102 degrees, severe chills/fever, aches pains, cough, chest pressure, headache, fatigue,...now 48 hours later still fatigue, weakness, aches, cough and do not feel very well

7 hours from vaccine, my heart started palpitating and I started feeling sick. I got in my car to go home from a friends house and started severe chills and called Doctor for fear of heart attack. They told me to go to ER. I continued driving home. Chills got worse. I got in shower with heater on and chills persisted. Drank coconut water and heart palpitations resided. Got in bed and fever spiked to 102 and every bone was inflamed in pain. Nyquil did nothing. After a few hours of severe and unbearable pain I called ER. Headed over to ER at 3:00 a.m. and sat in parking lot. Fever broke at 3:00 a.m. which was hour 14 after vaccine. Other than severe nausea, pain calmed down. Drove home with Tylenol. Took 1,000 mg and finally rested at 4:00 a.m. Woke up at 8:00 a.m. with nausea but pain gone. 24 hours from vaccine, most of the reaction gone. 48 hours out body normal but pain in injection site.

FAINTED; QUALITY OF SLEEP WAS LOW/DID NOT SLEEP WELL; FELT VERY RESTLESS; CHILLS; FEVER (UNKNOWN TEMPERATURE); EXTREME NAUSEA; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history included the patient had several comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978) dose was not reported, frequency 1 total, administered on 03-APR-2021 at left Arm for prophylactic vaccination. No concomitant medications were reported. It was reported that, On 04-APR-2021 at approximately 04:00 a.m. in the morning, the patient experienced chills, extreme nausea, fever (unknown temperature, felt like she had a fever, hot) and she fainted. She also stated that when she went to sleep her quality of sleep was low and poor as she felt very restless. She stated that before fainting she called out to her husband who then carried her back to her bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the quality of sleep was low/ did not sleep well, chills, fever (unknown temperature), fainted, extreme nausea and felt very restless was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210408190-Covid-19 Vaccine ad26. cov2.s-Fainted. 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).

Felt hot within a few minutes after the vaccine, then passed out. The NP on site said she was unable to find a pulse so did 10 chest compressions before I woke up. Called the rescue squad who did an EKG on route to Hospital and once I was in the ER another EKG was performed along with blood work and chest X-ray. Entry was noted as allergic reaction but diagnosis was noted as Vasovagal Syncope, Adult. EKG?s performed along with labs were normal. I have pulled muscles, tendons and ligaments from the chest compressions which were questionable but since that day have experienced tingling in upper body and arms and have felt bad. Went back to my Primary Care Doctor for follow up on March 29 for another EKG. Have had panic attacks from the situation and per Doctor will take 2 months for my chest, muscles, tendons and ligaments to heal. Hard to determine if the way I have felt is from the vaccine or what transacted when I fainted. Today which is April 9, I still feel weak, normally I am very energetic. Just wanted to report as when I saw the news that others had some situations thought best to let you know.

A few hours after the Thursday afternoon injection, my temp shot up and stayed right around 102, my heart rate was 135- just sitting, and my oxygen level was 93%. I shook uncontrollably the first 10-12 hours, and had chills. Tinnitus. Nothing inproved until the middle of Friday night- I sweated through sheets. Still had fever, high heart rate, and up and down oxygen for 18-20 days. My heart rate (I'm on 2 anti-arrhythmia drugs so my rate is rarely above 65) was still high but better by day 22. Fever is also better but not gone. Exhausted.

Pt reported feeling dizzy, blurry vision, chest pain directly after vaccine administration, while sitting in chair, 911 called, , ambulance arrived, pt refused ER transfer. Pt reported feeling better and went home with husband.

Was doing CDC TEXT tracing first week after injection, but new reactions started after tracking completed. Had mild reactions originally. Pain in arm, and fever next day that rose to 100.9. No chills, no major problems, no rash. A couple nose bleeds on second day which were not typical for me. Returned to work on third day. Now on day 10 I'm convinced I'm having a delayed reaction. Still mild but present. Low temp 99.5, headache, fatigue, feeling of not being normal. Not allowed to work today. Reason for report of such mild symptoms is my surprise of this delayed reaction 10 days later. There is a bruise on my injection arm now, opposite side of arm, that also is puzzling, but not really worrisome. Know to monitor for platelet issues.

Chills - severe, mild headache, body aches, high heart rate (124 resting rate) began at 9 hours post injection. Took Tylenol to reduce body ache and chills. Took 5 mg diazepam to lower heart rate. Still chills and body ache at 30 hours post-injection Heart rate has returned to normal range

Woke up with body aches, headache, low grade temperature. Stayed in bed most of day(thu) That evening finally took a couple tylenol because the aching was preventing me from sleeping. Fri I felt better maybe a little tired. Friday evening I started vomiting, and had diarrhea. Fever was at 202 at highest. Brain fog. Had severe chills for a couple hours. Fever hung around 100 most of Saturday. Have slight tightness in upper chest. Occassional dry cough. Occassional diarrhea. Weak. Sunday. Still have occassional diarrhea. Temp has been around 99.5. Weak. But a little more energy. Still have tightness in chest.

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.

Extreme chills where my body would not stop shaking, sweats, muscle aches, nausea, bad headache, tired. Took 2 Tylenol every 4-6 hours to help the headache. It lasted until Sunday morning. My nose felt stuffy when I woke up Sunday morning at which time there was blood in my nose. The rest of the day it was clear but a small amount appeared Monday morning as well. Both sides of my temples are sore to the touch as if they were bruised. Other than that and being weak the other symptoms are gone.

Extreme chills & shaking. Blood pressure hyper (160/90]and hypotensive (90/65), erratic pulse, fever (102.4), headache, nausea.

Good morning, I have the patient in the hospital. We have had to give her 2 transfusion in the last 2 weeks and 2 days. The patient also had a more pronounced stroke system. We read today that people with the systems of low platelets and stoke system need to report. I have called everyone and have had no help. I believe it has to be the health department.

3/22/21: Vaccine administered 4:45 pm. Burning sensation on arms and legs began about 2 hrs later. Achy and feeling cold about 2 hrs after that. Then headache, shaking, muscles quivering, fever, weakness, some itchy spots, increased urination throughout next several hours. Fitbit showed elevated heart rate for several hours. 3/23/21: Nausea and vomiting. Could not keep water down. Very weak/shaky. That night, went to ED. Treated for dehydration and allergic reaction. 3/24/21: Able to tolerate clear liquids. Still weak. 3/26/21: Woke up with rash on both legs (small bumps, not itchy). Added bread to diet. Still weak. 3/29/21: Low grade fever, strong pain in right side of lower back.

1ST DAY=Heachache, Dizzines, High blood pressure, Inflamation of hands. 2ND DAY= High blood pressure, headache, chills 3RD Day: Headache, kidney pain 4th Day: Headache, body ache. 5th day: Heachache, leg pain, can't sleep.

Shortly after the vaccine I fainted which came on quite quickly and upon waking within a minute I felt sick and vomited.

Felt fine for hours while sitting at computer and then I got a feeling that I had never had before in my life. It felt as if there was an elephant sitting on my chest. No real pain. No panting. Just a real heavy chest. It is not heartburn or upset stomach - I know how that feels. It was uncomfortable and notice I got a look of distress in my face. That's when I laid down on the couch with feet up and put my hands above my head towards the floor. After about 1.5 hours, the feeling went away. Haven't had anything else since then.

One week after shot experienced left sided chest pain2/10 progressed to burning in left axils. Fatigue heaviness in bilateral arms and legs. Cold feet. Persistent dull left temporal headache. Felt dizzy and lightheaded in addition on 4/7 went to ER

Developed heart palpitations approximately 10 hours after receiving vaccine. Also insomnia making it impossible to sleep. Palpitations seemed to get better by 11 am the next morning but my heart rate was still elevated ( pulse 106-112). Shortly after that ( around 11:45 am) I became extremely light headed and dizzy and felt like I was going to pass out. I also started to feel nauseous and sweaty. I rested lying down for two hours before hearing back from my doctor's office. I was able to control the lightheadedness and dizziness by lying down. The feeling of passing out / nearly fainting went away. I continued to feel nauseous and my heartrate was still elected. I started to get a headache as well. On the advise of a nurse at my doctor's office, my husband took me to the ER. My EKG was normal . My heartrate was elevated. Due to the overcrowding at the ER that day I was made to wait at least an hour and half for further evaluation. I continued to feel light headed and slightly dizzy. My nausea and headache got much worse . I was finally taken back to a treatment room and received IV fluids, Zofran and Tylenol. My heartrate went back to normal and my headache and nausea improved with treatment and I was discharged around 7pm. I continued to feel very tired and slightly lightheaded that evening. The next morning I was much more nauseous again and still very weak feeling and slightly lightheaded. I have continued to feel weak, very fatigued , unwell and nauseous on and off until today, April 14, which is 6 days after I was vaccinated.

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

Patient reports that she had pain behind her eye. Went to hospital and was diagnosed with having a stroke. Patient states she lost sight in her left eye and is still blind in her left eye. Optometrist states patient will not regain her vision in her left eye.

initial symptoms- rash, itching, elevated BP, headache, ankle swelling ultrasound on 4/6/2021 - bilateral DVT CBC low platelets - 16 thousand CT chest - moderate burden PE Pt. was hospitalized

4/11/2021 @ 3:00p. S/P Administration of JNJ Janssen; the patient reported having a "flushed feeling" and states "I can tell that its getting into my system". BP 150/104 HR 120. Sats 100%. RR 16. Flushed lasted about 30 seconds. After 15 minutes, BP 146/105 HR 104 RR 16. Pt asked to wait additional 15 minutes (totaling 30min). During wait time, the patient was conversating with her husband. There was no signs of acute distress. RR remained within range 14-16. Following wait time, the patient denied flushed feeling and stated "feeling okay". 4/15/2021@4:45pm Pt returned to clinic and stated that she continues to have the "flushed feeling". She reports going to ER the night before for elevated BP. She had a dedicated CTA to rule PE and LE doppler for DVT. According to her. both test were "fine". She did report that her BP was around 200s. She denies hx of HTN and current meds use. She was discharged home with clonidine.

FEELING WOOZY OR DIZZINESS; HEART RACING; FEELING VERY TIRED; HEADACHE; MUSCLE ACHE; ACHY ARM; 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: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced achy arm. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced feeling very tired. On 11-APR-2021, the subject experienced heart racing. On 12-APR-2021, the subject experienced feeling woozy or dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy arm, and muscle ache on 11-APR-2021, and feeling very tired on 12-APR-2021, and had not recovered from heart racing, feeling woozy or dizziness, and headache. This report was non-serious.

Immediate pain upon injection. Rapid heart beat . Sore arm at injection site. Later flu like symptoms: headache, chills, slight fever, body aches Later terrible leg cramps and numbness in both legs which sent me to emergency room 4/12/2021 Continued pain in nerves in arms and legs, muscle cramping. Nerve sensitivity on left side(shot arm) of face

Patient woke up to get ready for work and noticed blood coming out of right ear. Clots were in the blood that came out of the ear.

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.

Six days after receiving the Johnson & Johnson/Janssen vaccine, the patient complained about strong pain in the right arm (same as vaccination arm). She went to the ER on the 7th day after receiving the vaccination and after doing EKG, ultrasound, and CT scan, they found multiple blood clots in her right arm where she receive the vaccine.

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.

Pt has a history of DM2, HTN, HLD, HCV cirrhosis (sp treatment, Child Pugh A), CKD3 with baseline Cr 1.5 who presented to the ER after a syncopal episode and with headaches. She has no history of a positive COVID test. She reported receiving the J&J vaccine on 3/6 and reports headaches since then. She also had a syncopal episode that prompted her presentation to the ED. She underwent MRV of the brain looking for sinus thrombosis. The brain portion was normal but she was found to have a LIJ thrombus. She denies prior history of VTE. It is overall unclear if this thrombus is related the her symptoms, to the vaccine, or completely incidental. Pt was started on a heparin drip in the hospital...

Rapid heartbeat 24 hours severe stomach pain two weeks muscle and joint pain two weeks extreme high blood pressure two weeks. Extreme fatigue two weeks. The vaccine triggered an auto immune response. It triggered a flareup in my body and I was very ill for several weeks. Because of my severe stomach pain and blood pressure soaring my doctor ordered a CAT scan and blood work up. I am now three weeks post vaccine and my body seems to be calming down my blood pressure has returned to normal and the stomach pain has stopped. The extreme fatigue muscle and joint pain is still present but much better.

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.

HIGH BLOOD PRESSURE; PULSE PRESSURE OF 106; FEELING OF FLUSH; DELTOID/SHOULDER SITE SORENESS; 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 concurrent conditions included no-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting, the patient had no known allergies and the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the patient experienced feeling of flush (she stated that it felt like a heat coming through), high blood pressure of 103/101 (units unknown) and pulse pressure 106 (units unknown). She also experienced the deltoid/shoulder site soreness which lasted for 1 to 2 days. On an unspecified date she went to emergency room, she had blood pressure 240/140: high (units unknown) and pulse pressure (units unknown). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deltoid/shoulder site soreness on 13-APR-2021, was recovering from feeling of flush, had not recovered from high blood pressure, and the outcome of pulse pressure of 106 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210430543-covid-19 vaccine ad26.cov2. s-High blood pressure 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.

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.

IDIOPATHIC THROMBOCYTOPENIC PURPURA; This spontaneous report received from a company representative concerned a 60 year old female. Initial information was processed with additional information received from the patient's physician, in response to telephone follow-up, on 26-APR-2021. The patient's weight and weight were not reported. The patient's concurrent conditions included hypertension, hyperlipidemia, and obesity. She was a non-smoker and had no history of acute illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included blood pressure medication, vitamins, and a statin (all unspecified). On 21-APR-2021, the patient experienced Idiopathic thrombocytopenic purpura and was in critical condition. The patient presented with petechiae on her legs. Her platelet count was low, less than 9000 and all other labs were normal. The patient was hospitalized on 21-APR-2021 and the duration of hospitalization was not reported. The patient did not have any clots and she was treated with decadron and Intravenous immunoglobulin. On 22-APR-2021, the patient's and improved the next day with platelet of 30,000 and she was discharged same day. on an unspecified date anti-PF 4 antibodies were performed and were normal. Fibrin D-dimer tests were not performed. The reporter stated the discharge diagnosis was Idiopathic thrombocytopenic purpura which could have been related to recent vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Idiopathic thrombocytopenic purpura. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: This 60-year-old female was hospitalized for immune thrombocytopenia 25 days after receiving the Janssen Covid-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. Concurrent conditions included hypertension, hyperlipidemia, and obesity. She was a non-smoker and had no history of acute illness. Concomitant medications included unspecified blood pressure medication, a statin, and vitamins. Twenty-five days post-vaccination, she developed petechiae on her legs and was found to have a platelet count of 9000; all other labs were normal including anti-platelet factor 4. She did not have clots. She was admitted to the hospital the same day and was treated with dexamethasone and iv immunoglobulin. The next day, her platelet count improved to 30,000 and was discharged. Based on the available information, the relationship with Janssen Covid-19 vaccine is considered indeterminate. Additional information has been requested.

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.

SPORADIC NOSE BLEEDS; LEG CRAMPS IN CALVES LIKE CHARLIE HORSE; CONSTANT HEADACHE; EXTREME FATIGUE; 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sporadic nose bleeds. On APR-2021, the subject experienced leg cramps in calves like charlie horse. On APR-2021, the subject experienced constant headache. On APR-2021, the subject experienced extreme fatigue. 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 constant headache, and the outcome of sporadic nose bleeds, leg cramps in calves like charlie horse and extreme fatigue 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.

Pain at Injection Site-Medium, Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Severe, Additional Details: recieved shot at 3:10pm, patient reported severe arm pain, nausea, blurred vision. 1st bp: 96/66 pulse 64 at 3:34pm, 2nd bp:102/68 pulse 62 at 3:50pm, 3rd bp 122/76 pulse 68 at 4:04pm. advised pt not to drive and left pharmacy around 4:10pm, observed patient for over 30mins due to use of epipen for cipr allergy in past

Patient described intractable vomiting, dehydration, blood sugar over 800. Patient went to hospital and was admitted to ICU for approximately 4 days. Patient has been discharged from the hospital.

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.

I experienced acute onset of dizziness with chest pain, shaking chills, muscle spasms in my legs, headaches and nausea. I went to hospital where they did lab work, 1280 EKG, gave me fluids, and gave me Zofran medication. They also gave me a prescription for meclizine. They also did a Covid test which was negative. I saw my PCP on 04-11-2021 who ordered a chest x-ray and lab work. I also saw my PCP 05-11-2021, because I had a TIA on Sunday 05-09-2021. I still being worked up on lab work, TIA and an MRI has been ordered for next Monday 05-17-2021.

As the 2nd week came I started feeling slightly tired/weak, but going into the 3rd week I felt that my inhaler was filed with pepper spray. On wed going home had bad cough. Then Thursday , left work early, had to go home. On the way there was like a circle of fire going around my heart to include that part of lungs. Had to bed rest till Monday. Dr. at Emergency gave a prescription of Antibiotics and a cough prescription, my son had to pick it up for me. Then a bout a week later I had finished dinner, taking my plate to the kitchen, body/brain completely quit. No time to get dizzy, speak out or say anything. JUST QUIT. My husband said I was in/out for about 10 minutes as he was trying to help me up. Right side of nose/head still has problems.

4/7/21 Chills, Body Ache 4/12/21 Cough , Blood Tinged Sputum 4/16/21 Chest Pain (seen in emergency room - admitted to hospital)

FLUTTERING FEELING AROUND HEART; HOT FLASHES; This spontaneous report received from a patient concerned a 60 year old Not Hispanic or Latino African American female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, menopause and other pre-existing medical conditions included the patient had drug allergies. past unremarkable history. 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, 1 in total administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced hot flashes and On 07-APR-2021 experienced cardiac flutter and fast beating of heart. She stated hot flashes symptoms come and go and sometimes had this feeling after eating peppermint candy, unknown if she had peppermint candy before receiving the Janssen COVID-19 vaccine. Her medical doctor was not yet notified and she had not treated her symptoms with any over the counter medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes and cardiac flutter. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210523500-Covid-19 vaccine ad26.cov2.s -Fluttering feeling around heart. 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 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.

HIGH BLOOD PRESSURE; HIGH PULSE RATE; BODY ACHE; BACK ACHE; HEADACHE; FEVER; 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: 1816027, and batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced headache. On 17-MAY-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 103/69, 102/68, and Pulse rate (NR: not provided) High. On 17-MAY-2021 14:00, the subject experienced high blood pressure. On 17-MAY-2021 14:00, the subject experienced high pulse rate. On 17-MAY-2021 14:00, the subject experienced body ache. On 17-MAY-2021 14:00, the subject experienced back ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, high blood pressure, high pulse rate, fever, body ache, and back ache. This report was non-serious.

I woke up at 5am and when I sat up, I slumped over. I sat up again, stayed for 30 sec, went to the bathroom and when I came back, I experienced severe dizziness. For the next 4 hours, I couldn't move my head and would get a zing right up the back of my neck. When I tried to sit up again, I got really sick to my stomach. After 8 hours, I started feeling better and was able to sleep on either side, but not on my back. When I was on my back everything would start spinning again. By the afternoon of the next day, I was feeling better, but was afraid to move my head too much because I didn't want everything to start up again, so I went to the doctor. My BP was high, so he had me lay on the table. He turned my head and set it off again, so I was miserable again for the next 10 hours. After that, I felt better and was able to get up and function.

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.

HEART RACING; EXTREME DIZZINESS; 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 experienced drug allergy when treated with hydrocodone. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced heart racing. On 17-MAR-2021, the subject experienced extreme dizziness. On 19-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) Not reported. The action taken with covid-19 vaccine was not applicable. The patient was recovering from heart racing, and had not recovered from extreme dizziness. This report was non-serious.

POSSIBLE SMALL STROKE; POSSIBLE TRANSIENT ISCHAEMIC ATTACK (TIA); SUPER DIZZY; THROWING UP; COULD NOT OPEN EYES; WIERDLY AND EXCEEDINGLY THIRSTY; COULD NOT WALK; NUMBNESS IN LEFT ARM; COULD NOT STAND; HEAVINESS IN LEFT ARM; NAUSEOUS; HEADACHE; FELT LIKE HAD CHILLS LIKE ONE GETS FROM THE FLU; This spontaneous report received from a patient concerned a 60 year old White, Not Hispanic or Latino female. The patient's weight was 175 pounds, and height was 65 inches. The patient's concurrent conditions included slightly elevated blood pressure, alcohol user socially and on weekends, non smoker, and penicillin allergy since childhood. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included valsartan for elevated blood pressure, acetylsalicylic acid, and furosemide. On 10-MAR-2021, the patient felt like having chills like getting from the flu, for couple of hours might be, a headache for several days, might be for 3 days. For that the patient took some Advil 200 mg every 6 hours for the first couple of days. Then that passed and felt fine. On 24-APR-2021, around 04:00 in the morning the patient woke up and felt weirdly thirsty, exceedingly thirsty and super dizzy, nauseous thought was having a heart attack and heaviness and numbness in left arm but could still move the arm, however could not walk and could not open eyes until was in hospital. As a treatment Aspirin was given to the patient by husband. The patient was throwing up, could not stand. About 05:30 went to the hospital and ran many tests. Ruled out brain bleed, heart attack, anything cardiac did a CAT scan; bloodwork found that the patient was low in potassium and it was determined that the patient either had a small stroke or a TIA that dissipated on its own. The patient saw her cardiologist and wore a Holter monitor for 10 days. The patient also has an appointment with a neurologist coming up in June and having another CAT scan. Also seeing a vascular neurologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible small stroke, possible transient ischaemic attack (TIA), super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm, and nauseous on 2021, felt like had chills like one gets from the flu on 10-MAR-2021, and headache on MAR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: covid-19 vaccine ad26.cov2.s-Possible small stroke, Possible transient ischaemic attack , super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm. These 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. covid-19 vaccine ad26.cov2.s-Nauseous. This event is labeled per RSI and is therefore considered potentially related.

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

Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tinnitus-Medium, Additional Details: The patient reported left shoulder pain that radiated up her neck, with tinnitus in the left ear and chest tightness that has not resolved since getting the vaccine

Patient was nervous about receiving the vaccine and felt nauseous almost immediately after receiving the vaccine. She felt faint as she walked away and wanted to sit down. After a minute or two she fainted while sitting in the chair. Her husband who had been with her the whole time was able to arouse her after about 20 seconds. She felt as though she needed to vomit but was did not. After a few minutes the patient laid down on the floor. Had a fan positioned at them and had the lights off in our pharmacy's counseling room. After about 30 minutes she was feeling a little better and sat up on the floor and was able to drink a little ice water. After a few more minutes she progressed to sitting up in a chair. At no time did she have any rash, hives, or breathing issues. she said she felt very nervous. About an hour after the immunization the patient felt like things were better and was able to stand up and walk out on her own. she held on to her husband's arm as a back up in case she felt faint again.

Patient became dizzy upon standing and experience left sided weakness. Ambulance was called and patient transported to hospital. Upon exam it was determined the patient had a bleed on the ride side of the brain. After 4 or 5 days she was transferred to Rehab. She was then sent back to hospital after complications. Patient began having kidney problems and was undergoing dialysis. 06/16/2021 patient began having bad headaches, CT scan showed multiple previous strokes(clots). Patient currently still in hospital.

Heart Palpitations going on for almost 3 months now, almost every day, multiple times a day (number of times varies daily). Saw doctor on May 26, 2021. Referred to cardiologist. Saw him on June 8, 2021. He ordered a heart monitor which was applied on June 8th and will be worn through June 22nd. It will be sent out on June 23rd for results. Outcomes and diagnosis will be based on those results.

Redness at the injection site and has swelled and became large over time, about the size of a quarter. Fatigue and dizziness. Severe pain under rib.

Normal side effects at first. 72 hours after shot extreme pain in joints. Pain resolved everywhere but forearms, wrists, and hands. Currently, blood pooling in thumb joints, tenderness in wrists and fingers, stiffness in hands wrists, and forearms. Heat and sense of hardness in veins. Veins sticking out in forearms and thumbs. 13 weeks since vaccination. Primary Care physician unresponsive. Limited use of hands. Psychological despair setting in.

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.

2 weeks after getting the vaccine I experienced a horrible headache that lasted 2 weeks. None of my migraine meds worked on this headache. It was constant, for 2 weeks. It then started letting up, but I woke up with half my face being numb. It starts at my lips and moves up my face to my lower eye lid. My upper teeth are also numb on that side. The left side, When that happened I went to the ER as advised by my doctor (4-12-21). My blood pressure was very high so they treated me for that and did a CAT scan of my head and found nothing. I was sent home. Saw my Neurologist the next day 4-13-21, She ordered an MRI which was done on 4-17-21. Nothing significant was found. I also saw my Primary care doctor that same week. He did bloodwork to rule out auto immune diseases. Bloodwork was good. I also went to see my dentist that week to rule out dental problems. He did an xray and did not think it was dental related. The numbness is still there. It has not gone away

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.

2 days later nausea, vomiting, diarrhea, palpitions, tachycardia, fatigue, general malaise. Still have occassional palpitations.

Rapid heart rate for several hours (about 10). Bad headache which is now a sinus headache on the right side.

Work up at 12:30 a.m. very hot and nauseous. When I tried to stand up I fainted. When I came to I crawled to the bathroom and vomited several times. Continued to run fever for about an hour or so. Then headache began. As of 7:00 I still feel nauseous and have a slight headache.

Severe headache pain in the eyes a lot of pain in the body breast pain the arm swollen and red nausea

I felt no immediate side effects of the shot, but 2 hours later, while sitting calmly, my heart rate suddenly elevated and I began to feel light headed. My home blood pressure monitoring kit provided a reading of 149/99 and a resting heart rate of 108. Normally, my blood pressure is very well maintained with my meds and hovers in the 118/75 range. My resting heart rate is usually below 70. I was going to dial 911 but within 5 minutes, my heart rate began to slow down and I felt better. When I rechecked my numbers at 8 pm, BP was down to 118/80 and resting heart rate was 70.

Received Janssen covid 19 vaccine 3/8/21 at 3PM. Twenty minutes after shot, felt skin flush pass over me and was directed to private area where paramedic took blood pressure and checked for hives. No hives but bumpy skin. Blood pressure spiked to 186/75. No history of such high blood pressure. Waited a while and blood pressure went down, flush and skin bumps subsided, and I went home. Blood pressure erratic in evening but never as high. Next day pulse higher than normal. Took homeopathic remedy. Pulse slowed down a bit. Better by next day.

Patient was observed to be sitting in her chair with head down on knees in 15 minute waiting area after receiving Johnson and Johnson Vaccine. Patient reported light headiness and nausea. Patient was AOX4 and vital signs laying at 11:24 am: HR: 79, O2: 96% RA and Temp: 98.1 F, BP not reading. BP retaken at 11:34 am laying down: BP: 50/29 with thready pulse. Patient denies any chest pain, trouble breathing, itchiness, pain. BP retaken laying down at 11:40 am BP: 95/59 and Heart Rate 71. BP retaken sitting at 11:49 am. BP: 83/49. Blood pressure retaken sitting at 12:06 pm : BP 92/57 , HR: 65. Patient reported she normally runs a low blood pressure. Per Patient stated she feels better, had a snack. As precaution called friend to pick her up.

Janssen COVID-19 Vaccine EUA 3/11/2021 - 8pm very sore lymph nodes under armpits, sore chest muscles - sore all the way around my torse from one armpit to the other. Start getting the chills. Went to bed at 10pm. 3/12/2021 - 12am woke up with VERY Intense headache (forehead area and temples) - never had a headache this bad in my entire life, back of neck very sore, couldn't sleep, relax or focus. 3/12/2021 - 3am Diarrhea and nausea started, mouth very dry, tried to drink water but couldn't due to nausea, Headache still intense, haven't slept since midnight and couldn't relax or focus. In and out of bed, up and down stairs just didn't know what to do. 3/12/2021 - 7am diarrhea and nausea ended but still very intense headache. No sleep since midnight and just kept pacing , trying to sit, tried breathing learned in childbirth, but nothing was relieving the headache or letting me relax and sleep. Husband thought I looked like death. 3/12/2021 - 9:30am I finally broke down and took 2 Tylenol and was able to sleep for 2 hrs. 3/12/2021 - 11:30am body still ached and headache was now tolerable. Able to finally focus and relax. Symptoms were now tolerable as compared to 12am-9:30am, prior to taking Tylenol. 3/12/2021 - 5:00 pm beginning to feel better and eat a regular dinner. 3/13/2021 - 8:00 am woke up and felt 100% normal injection site was never sore or red, didn't have a fever

Severe chills, fever highest 101.4°, Pulse ran 80-100, fell to do that I think I fainted Blood pressure 93/49,94/41,99/50,77/46,92/44,

Janssen COVID-19 Vaccine EUA I developed severe chills (no fever) 8 hours after receiving the vaccine. Taking Aleve helped to ease the chills. For the next 6 days, I had a headache, flu-like symptoms, light-headedness and nausea. Four days after receiving the vaccine, I had a nose bleed, which is a very rare occurrence for me.

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

Janssen COVID-19 Vaccine EUA; at 4:15 a.m. I took a tylenol for the headache I'd had since around 8 pm; ate a few crackers with it; then as I was going back to bed I immediately felt weak/dizzy and then I passed out on the floor. My life partner started calling my name and check my pulse (which he said was strong) ; then I came to but was really dizzy; I was nauseous and vomited for a few minutes; extremely hot/sweating; and after I stopped vomiting, then had a bowel movement (He had to aid me in getting to the bathroom). About 20 - 25 minutes later I felt much better; everything calmed down. I was ultimately able to fall back to sleep.

weakness, nausea, dry heaving, abdominal cramping and headache for a 2 day duration. Abdominal CT showed 5 cm left adrenal mass consistent with acute adrenal hemorrhage. Platelets were 32,000 on admission. On the evening, the patient had a change in mental status; head CT revealed acute subarachnoid hemorrhage and small intraparenchymal hemorrhage.

Chills, 103 fever, nausea, dizziness,aches, headache, fatigue. Came and went within 24 hours. Red face. On and off since vaccine Elevated blood pressure. Ongoing Tinnitus. Noticed last night, getting worse.

Neck and back pain night of vaccine... then 30 hours later Heart Attack (Myocardial infarction); Treatment: blood thinners (TNK and Heparin), Stent in coronary artery. outcome: hospitalization 3 days and then recovery and fatigue ongoing...

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.

Elevated blood pressure 230/170 for over 24 hours. Dry mouth, Feeling of unease. Chilled, Insomnia. Loss of appetite. Joint pain, Headache for 6 days.

While she was in her 15 min wait period post injection she complained of palpitations. HR was 82 on Pulse ox and O2 sat was 97%. Listening to her heart with stethescope she was regular at 82. That night she stated she had hearing and visual disturbances. Saturday morning March 27 2021 she had a severe headache and took tylenol and went back to bed. Sunday still with same complaints.

teeth-chattering chills, excruciating headache, 101 fever, muscle aches, vertigo, diarrhea, fatigue, achy chest with tingly cough, brain fog

HIGH BLOOD PRESSURE; CHEST TIGHTNESS; DIZZINESS; STAGGERING FROM WALKING; This spontaneous report received from a patient concerned 61 year old female patient. The patient's weight was 183 pounds, and height was 167.64 centimeters. The patient's concurrent conditions included high blood pressure, COPD (Chronic Obstructive Pulmonary Disease), thyroid problem, severe arthritis, non-alcoholic user, non-smoker, allergic to ginger (throat closes), drug allergy to sulfur, drug allergy to antihistamines and steroid rash. The patient did not had drug abuse or illicit drug usage. 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 in the left arm for prophylactic vaccination. The patient's concomitant medications included two unspecified BP (blood pressure) medications. On 12-MAR-2021, the patient received covid-19 vaccine and she experienced high blood pressure (180/120 mm hg), her chest got tight, she was dizzy and had staggering from walking. On 12-MAR-2021, the patient took BP medicine directly after receiving vaccine to get BP down. Laboratory data included: Blood pressure (NR: not provided) 180/120 mmHg. On 13-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 152/106 mmHg. On 22-MAR-2021, her BP was still elevated and her other symptoms had resolved. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, dizziness, and staggering from walking, and had not recovered from high blood pressure. This report was serious (Other Medically Important Condition). Additional information received from consumer on 22-MAR-2021.The following information was updated and incorporated into the case narrative: patient demographics (age, weight, height), concurrent conditions (drug allergy to sulfur and antihistamine and steroid rash) event outcome updated (recovered/ resolved for events chest tightness, dizziness and staggering from walking).; Sender's Comments: V1: The follow up information in this version updates patient demographics, concurrent conditions (drug allergy to sulfur and antihistamine and steroid rash) event outcome updated (recovered/ resolved for events chest tightness, dizziness and staggering from walking) and narrative updated. This updated information does not alter the prior causality assessment for the reported event 20210325494- Covid-19 Vaccine Ad26.Cov2.S - Blood pressure high. 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.

61 y/o female received Janssen vaccine @ 2:08 pm, while in the recovery area, @ 2:15 began to c/o feeling flushed and rapid heart rate. 2:15 pm vitals: 128/87, 115, O2 Sats 99% on RA, expressed feeling very anxious stating, "I have a hx of panic attacks". Patient instructed on deep breathing, and posturing to relax from very tensed positioning. 2:20 vitals: 120/103, 130, sats unchanged. Recovery Nurse worked w/patient to continue relaxed breathing, began to calm , HR down to 99 @ 2:25. Remained in recovery until 2:45 pm, last vital check, 112/84, 80 sats 99% RA, feeling more at ease, no further c/o rapid heart rate or feeling flushed, dc from recovery w/Son In Law who drive patient to appoint.

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.

Fainted the next morning and split my chin open- went to clinic and then to ER- needed 10 stitches in my chin and split my lip and needed 2 stitches in my lip

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.

syncopal episode, client had history of syncope with vaccination that was not reported until after the fact.

CHEST REDNESS; EYE ACHE; ELEVATED PULSE; DIZZINESS; DRY SKIN; EXCESSIVE THIRST; ITCHY RASH; HEADACHE; FACE FLUSH/ FACE WAS RED AND BUMPY; TOO HOT OR COLD/ INTERMITTENT FEELING EXTRA COLD(HEAD FEELS HOT AND REST OF BODY FEELS COLD); TINGLY FINGER; FELT LOUSY; BLOOD PRESSURE FLUCTUATION; This spontaneous report received from a patient concerned a 61 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced blood pressure fluctuation. On 12-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 150/84 mmHg. On 15-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 125/85 mmHg. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/91 mmHg, 156/90 mmHg, 142/92 mmHg. On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/88 mmHg, 140/92 mmHg. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 143/89 mmHg. On 23-MAR-2021, the subject experienced felt lousy. On 24-MAR-2021, the subject experienced tingly finger. On 27-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 156/96 mmHg. On an unspecified date, the subject experienced chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, headache, face flush/ face was red and bumpy, and too hot or cold/ intermittent feeling extra cold (head feels hot and rest of body feels cold). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure fluctuation, and the outcome of headache, chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, face flush/ face was red and bumpy, too hot or cold/ intermittent feeling extra cold(head feels hot and rest of body feels cold), felt lousy and tingly finger was not reported. This report was non-serious. This case, from the same reporter is linked to 20210408073.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Left chest pain no MI, PE....acute crisis with clot ruled out CBC showed giant platelets and variant leukocytes which have not been present before

Nausea, chest pain, diarrhea, headache, body aches, and fatigue. Symptoms start the next morning and lasted for 5 days. As of this writing, no symptoms persistent at this time.

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 .

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

Beginning approximately 10 PM (about 8 hours post-injection), I started to have chills (feet were freezing) and was exhausted. Went to bed, and slept most of the night, only waking once to urinate and to drink a small amount (approx 2 oz) of Coca Cola -- I was very nauseous and thought it would help settle my stomach. During the night I sweated profusely. At 8 AM, I woke again and went to urinate. At that time I felt very nauseous, dizzy, and light headed. When I walked about 2 -3 feet to my bedroom, I collapsed on the floor - unconscious. My partner called EMS, they arrived minutes later. By then I was conscious. They transported me to Medical Center Emergency Room, where I remained for several hours. They indicated that my SYNCOPE was a result of dehydration. TODAY, 4/13, news of BLOOD CLOTS has compelled me to report my adverse reaction.

Chills, muscle aches, fever of 102 for 6 hours from 2AM 3/9/2021-, fever of 101 and headache/ muscle aches afterwards to 2AM 3/10/21 -fever broke. Fatigue, muscle aches continued for 3 days. (maybe not associated with vaccine... but hip/leg pain flared and continues as well as sudden fainting and flare of diverticulitis (ER-CTscan 3/28/21)

rapid heartbeat - 96 just to stand up and take a few steps. 148 heart beat to stroll 50 yards, when I normally exercise walk hard with a 100 heart rate. After 3 days of this went to cardiologist. See Item 19. Symptoms lasted for 8 days. Extremely low Blood Pressure

Traveled and reported to family that she was disoriented and having some confusion. Was evaluated at ED, had some electrolyte imbalance and UTI. Once resolved, she continued to have neurological symptoms and was diagnosed with a stroke, including early onset dementia per telephone interview with daughter.

Stroke- hearing loss in right ear, extreme headache left temple lobe, nausea, dizziness, diarrhea, inability to move legs. Hospitalized for 5 days Continued weakness left side of the body

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.

Patient experience flu like symptoms and body aches the same evening after receiving vaccine. On 4/1/21 the patient experienced nausea, high blood pressure, and a headache. Around 7:00 pm that night the patient threw up and became unresponsive. The patient was then transported to the hospital by ambulance. A CT scan showed a brain bleed and the patient was intubated and transferred to another hospital.

Patient states that she developed altered mental status approximately 4 days after receiving the vaccine as witnessed by family and friends. Her mental status continued to decline over 2 week period, at which time she was brought to the hospital on April 13th. At that time, it was determined the patient had suffered an age-indeterminant ischemic stroke with hemorrhagic conversion. No neurosurgical interventions were done at this time as patients symptoms have appeared to improve after observation.

Swelling, tenderness at site. Headache within 5 hours. Muscle aches. Abdominal cramping and back pain all within 5 days (3/10-3/14 )of vaccine.Passed out on 4/10/21 while walking, noted fatigue on 4/8 until 4/13.

severe eye pain left eye 9 days after the vaccine then periorbital swelling and increased intraocular eye pressures and thrombocytopenia platelets 63,000. Saw ophthalmologist who diagnosed idiopathic periorbital inflammation; no fistula or infection seen by mri/mra and carotid angiogram. Patient was treated with prednisone and platelets came up to 130,000 and improvement in pain and swelling and intraocular pressure dropped from 50 to 14.

3/29/21 6 pm - Severe pain lower right leg, ankle, and foot, unable to weight bear on right leg About an hour later I was able to walk a little. Stayed off my feet. Right foot became very cold. 3/30/21 Saw my primary care physician at med center. She sent me for an ultrasound at medical arts. From there I was sent to the emergency room at hospital. I asked the attending physician assistant about a correlation between the blood clot and the Covid vaccine because I had read about it being a concern in other countries. He stated that was a bunch of baloney. Was told to have a repeat ultrasound in a few days and was prescribed a 30 day starter pack of Xarelto and released. 3/30 repeat penis ultrasound of right leg showed the same results. 4/1 appointment with hematologist. Prescribe Xarelto for three months and ordered a repeat ultrasound in three months and bloodwork at that time.

Whether the adverse events were caused by the vaccine is to be determined. We are available to discuss more details if this information can be used to help others from experiencing these reactions. The morning after getting the vaccine, patient discovered that she could not swallow. As her condition worsened, she was taken to the emergency room. Over the past month, patient went to the emergency room 4 times. The last time resulted in extended hospitalization that continues to this day. In addition to the swallowing problem, two other major adverse events need to highlighted. First, on 27 March, while in the hospital, vaginal bleeding started. On 29 March, her doctor, performed a hysteriscopy/DNC finding " "an unexplained blood clot (hematoma)." The second major event was when patient demonstrated significant confusion and lack of memory. On 7 April, she was diagnosed with Metabolic Encephalopathy. Neurologists at the hospital suspected that her MS was reacting to her UTI and once the infection is eliminated her memory should come back. But as of 10 April, she was still having issues including hallucinations. Although she is eating some as of 13 April, she is still very weak and will likely by moved from the Hospital to a rehab facility. She still does not remember much of the last 37 days.

vaccine reaction-passed out. c/o worsening headache and feels tire. states broke out sweat, stomach pain, HA, leg cramping and passed out (for about 30sec according to husband) on Mon. took Advil several days. last Advil 0600. J&J vaccine on 5 Apr. 61 yo f w/spouse c/o ongoing headache w/concerns for single episode of 'passing out' approx 48hrs pta approx 30-45 sec per spouse at bedside; Pt states nighttime episode w/preceding leg crampings, sweating, dizziness, sat on footstool and per spouse passed out but caught by spouse and avoided injury; spontaneous recovery w/o further issue from that episode, spouse denies any post-syncope seizure-like activity/urinary incontinence/tongue biting; Pt and spouse concerned. for cerebral venous thrombosis; Pt has sig hx of prior neurosurgery for posterior/occipital schwannoma around 2017, successfully removed, w/o further findings or complications on f/u (last DEC 2020) to include repeat imaging at that time Pt states has been taking advil OTC for ha but no sig relief at this time; Pt defers need for medications at time of provider evaluation; Pt denies any fevers/ns/chills, cp, sob, palpitations, dyspnea, abd pain/cramping, current nvd, prior syncope, fam hx of MI/SCD/dysrhythmias.

Symptoms occurred 12 hours after shot - approx 2 am. Chills all over body - hands freezing, body aches- whole body, heart racing. After approx 6 hours - developed additional symptoms of a headache - location was back of head and severe teeth and jaw pain on right side of face. Unable to sleep all night. At noon - got up and read vaccine literature to see if I could take anything for the pain. Took Extra Strength Tylenol - 2 00 mg gel caps . Stayed awake for a 1/2 - pain in teeth, jaw and head got got better. Went back to bed for 4 hours. When work up later in the afternoon - felt okay.

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.

Progress Notes - Clinical MD at 4/15/2021 1:30 PM HPI: 61 year old female with IBS presents with concerns about adverse reactions to vaccine which she got on 3/19/21. Patient reports that she felt lightheaded after the vaccine when she was leaving. She got home and felt better but then that night woke up in a delirium which passed by the morning. She had some weakness in her extremities, brain fog, cold feeling, funny GI feeling and fatigue for 3 days and then was fine. Two weeks ago she started to feel that the circulation in her lower legs was cut off with sensation of blood pooling in her legs with associated numbness and tingling. She describes it as what you feel when a tourniquet is applied to your arm. No visible lower extremity swelling, redness and no pain. One week ago she felt like her right hand was not working well and then left hand too. She then felt pooling in her arms like the sensation in her legs.No swelling, redness or pain. She reports she did a hand stand and afterward felt pooling sensation in her lower abdomen which has since resolved but continues to have a prickling sensation that comes and goes. Last night while lying on her back she felt the pooling sensation in her chest and this morning throbbing in head and chest and neck. That is when she decided to come in and be seen. Patient denies severe headache, backache, abdominal pain, shortness of breath, bruises, unusual bleeding or rashes. Patient has not had a physical exam with blood work since 11/9/17.

Presented as a TIA (mini stroke) Had vision issues, difficulty speaking, vertigo, could not walk, passed out and taken to hospital by ambulance . Began at around 10am. Felt like I was dying. Placed on Stroke Unit. Scans and tests all negative for stroke and Drs. thought could be panic attack or TIA. Since then my lingering effects point to TIA, Seemed to clear up around 2pm with gradual improvement through the day. Still experiencing some side effects including tinnitus, memory and word retrieval issues, fatigue, anxiety. DO NOT HAVE PANIC ATTACKS. The only time I have had a panic attack was at 26 after the death of my mother.

My sister, received the J & J vaccine on March 5th. I now know that she was not feeling well for a few days afterwards. She then felt better until day nine after the vaccine. On the evening of the ninth day, she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening. Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning. Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands. She was given platelets, pain meds and admitted into the hospital. Later that night staff felt she wasn?t responsive and a head CT was performed. It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point. During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes. On the morning of the 13th day patient was removed from life support and she passed.

The left hand and foot developed bruising spontaneously at 2 pm, finger went numb and white., with tingling. Skin on hands reddened. These symptoms continue today, the day after, though lessened. Hands remain tingly and redness of skin is ongoing.

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.

Not sure exactly when water retention began, but exactly 2 weeks after vaccine 03-27-2021 during middle of night, I woke to a bloody nose. Got it stopped. Next day felt a bit off but okay. At 9 pm 3-28-2021 had a huge bloody nose, just came out of nowhere. Looked inside was coming from not the nose walls but from way up inside sinus cavity? Tried to get it stopped, nothing worked, and 2 times it came out my mouth. Called our local Emergency room, went in. Blood pressure was at one time 220/110. They gave me 2 sprays of Affrin to reduce blood vessels, and tried to insert a nose plug (cotton gauze) to stop it, wouldn't fit, too small of nasal passage. Administered 2 pills, then drugs through IV then another pill form over 4 hours later blood pressure was still high some numbers while there were 204/94, 188/93 then when released and bleeding stopped 188/86. Next day 3-26-2021 immediately after taking my regular meds bleeding started again!!! So tried to get appointment with my doctor, they were full advised me to go /back to ER. Went about 1:00pm my BP was 181/73 Dr ran tests: EKG normal, Blood tests, good, and chest e-x-ray good. She also tried 2 diff types of meds, oral and iv, then I asked for losartan. and left.

patient came to clinic c/o right lower leg swelling on 4/6/2021, on 4/13/2021 she underwent a doppler us and was dx with right common femoral vein thrombus. her platelets are normal

"Pressure on the chest/ pinching feeling up to my back. My left arm goes numb on and off with a little pain. Headache and dizziness. Vaccine given in the right arm."

Sudden onset of bruise in left ring finger and on left foot, left of big toe, both appeared at once while eating lunch. Left ring finger went numb, white and cold, with bruise appearing on the middle digit. Other finger tips turned pink. Skin turned red onhands with tingling sentation. Right hand blood vessels came to the surface and began to swell at intersections. Skin on rt. hand looked whiter and dry. The sudden onset sent me to the emergency room, the condition began to fade in 3 hours, not completely. The same reaction occured the next day at 12 noon. I took a hot shower and the condition improved followed by extreme tiredness. *At the time of vaccination, & on both of these events I had a stiff neck/red skin.

RLE DVT--Acute, occlusive deep vein thrombosis in the right gastrocnemius vein--started on anticoagulant--apixaban

PATIENT PRESENTED TO OUR EMERGENCY ROOM WITH COMPLAINTS OF DIZZINESS, VERTIGO, AND VOMITING WHICH ONSET WAS ONE DAY. PATIENT REPORTS RECEIVING JOHNSON & JOHNSON COVID VACCINE 2 WEEKS AGO . CTA OF HEAD SHOW POSSIBLE TRANSVERSE VENOUS SINUS THROMBOSIS ABOUT 7MM, PATIENT IS ADMITTED TO ICU FOR FURTHER WORK UP .

PEA Cardiac Arrest tx with intubation, CPR, Epi prolonged mechanical ventilation, vasopressors, IVC filter, PEG, Trach. Now off of mechanical ventilation but still vented

Admitted with high blood glucose, intermittent nausea, decreased appetite. Subsequently found to be COVID1-9 positive. >14 days post vaccine completion.

FLU-LIKE S/S THE NIGHT OF THE VACCINE FOLLOWED BY HA ON DAY 2 AND NOSE BLEED & CHEST DISCOMFORT ON DAY 3. THE PT REPORTS THAT THE CHEST DISCOMFORT LASTED X 1 DAY, BUT THE NOSE BLEED PERSISTED. 12 DAYS POST VACCINATION THE PT WAS SEEN AS PART OF HER ANNUAL HEALTH ASSESSMENT AND STILL C/O MILD HA FOR WHICH SHE REPORTS TAKING APAP.

24 hours after vaccine - fever, chills, and aches. Currently (4/21/21) having chest pains. Doctor appointment this afternoon. He suggested I fill out the adverse reaction page.

HEADACHE; NOSE BLEEDS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, 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: 1805029 and expiry: 25-MAY-2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine besilate/olmesartan medoxomil for high blood pressure, and hydralazine for high blood pressure. On 02-APR-2021, the subject experienced nose bleeds. On an unspecified date, the subject experienced headache. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nose bleeds and headache was not reported. This report was non-serious.

CHEST PAIN IN THE MIDDLE OF CHEST; FELT TERRIBLE; ACHES ALL OVER; EXTREMELY TIRED; TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was not reported and height was 63 inches. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced felt terrible. On 11-MAR-2021, the subject experienced aches all over. On 11-MAR-2021, the subject experienced extremely tired. On 11-MAR-2021, the subject experienced terrible headache. On 12-MAR-2021, the subject experienced chest pain in the middle of chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible headache on 12-MAR-2021, was recovering from extremely tired, and felt terrible, had not recovered from chest pain in the middle of chest, and the outcome of aches all over was not reported. This report was non-serious.

CHEST PAIN; RIGHT ARM PAIN; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 150 pounds, and height was 59 inches. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of 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, administered on 24-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the patient experienced chest pain, right arm pain, headache and was hospitalized (date unspecified). She was en route to MRI and had to hang up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain, chest pain, and headache. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210427406-covid-19 vaccine ad26.cov2.s-Chest pain. 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). 20210427406-covid-19 vaccine ad26.cov2.s-Right arm pain, headache. This event(s) is labeled per Agency and is therefore considered potentially related.

For the past 2 1/2 - 3 weeks I have had a pain in my left leg. Today it was extremely painful so I went into the dr. office and after an examination and ultra sound it was determined that I have a blood clot.

1325- Patient received Janssen vaccine dose at drive through clinic. 1335- Patient?s son reports his mother is not feeling well. Patient able to respond appropriately to questions asked, however her responses were delayed. Patient presented with a blank stare and slow movements. BP 100/80, P 42, 99% RA, R16. EMS requested through 911. Patient denied CP, SOB, HA, N/V. Lungs CTA with respirations easy, unlabored. Radial pulses thready bilaterally. Water given to patient, air conditioning turned on in vehicle. 1339- BP 130/90, P 74, 96%, R18. Patient alert and oriented x3, responding appropriately. EMS arrived, patient verbalized she was feeling better and refused EMS assessment. Patient left in own car accompanied by her son who was driving the vehicle.

Sudden onset of heart palpations that lasted for 1 hour. Went to ER and BP was very elevated. CXR, EKG, blood work ok. Followed up with physician and cardiologist. Placed on additional medicine for SVT and BP. Had stress test, ECHO and nuclear heart scan. Also had a 48 hour holter monitor placed

Patient had severe anxiety over receiving the vaccine. After administration she felt like she was going to pass out, however, did not. Administered cool compress and took blood pressure. She felt better after 10 minutes and was able to leave on her own

3/18/21, Day after Vaccine, drowzy in the morning, around 12:00 p.m. I had a brief period of incoherent speach and a few moments of having trouble putting sentences together. Around 2:00 a moment of temporary blindness in my left eye. 03/19/21 -03/20/21, extreme fatigue, stayed in bed. 03/21/21, fatigue, light-headed, slightly dizzy 03/22/21, right side leg and arm became numb as if asleep. Went to Hospital Emergency. I had a stroke, had a Carotid Endarterectomy at medical center, was in the Hospital for 5 days, two weeks after surgery became seriously enemic and d_Dimers are still elevated THE CONTINUATION PAGE IS INOPT. AND WOULD HAVE LIKED TO EXPLAIN IN FURTHER DETAIL.

About 10 hours after receiving the vaccine I became nauseous and weak. I sat down on a kitchen chair and then passed out, falling to my right onto the floor.

That night, no chills or fever but uncontrollable shaking - 10 pm - 4 am in morning. Starting at 10, as well, body aches - run over by a truck type. My chest was burning like it was on fire - lungs felt like they were on fire. I woke up the next morning, with a little bit of body aches - I slept the entire next day pretty much (the 7th). On the 7th, I noticed that my heart was beating - fluttering- skipping- beating. My left left also swelled up and was red. I had PVCs with pulmonary embolism on that left leg in1996 - when I was doing the chemo. My left leg ached, burned and got red on the 7th. I was going to see the PCP the following week and I was still having issues with the heart but the leg was getting better. It can still swell, burn and get red quite a bit of night because I stand on my legs all day - but the amount of pain and swelling did go down over that week while I was waiting to see the doctor. I had an ultrasound on my leg. And a heart halter to monitor my heart for 24 hours. I do have PVCs. Stress from vaccine caused Herpes Outbreak - that was on the left inner thigh right next to genitals - bumps within four days of vaccine. Created more pain. Took Benadryl for pain - helps with the nerve pain - two days with. I took 3000 mg a day of Tylenol for three days after the vaccine. Have not recovered from the calf and heart symptoms.

My left foot felt very heavy then my left lower leg started to get numb. We all 911 by the time the ambulance came my left arm was getting numb. I was transported in helicopter to regional Hospital I was having a stroke

Pain in right leg in knee area beginning on 4/6/2021. Pain worsened over the weekend. Went to the doctor on 4/14/2021. She sent me for a doppler on my legs where a blood clot was found behind my right knee. I started taking Xarelto that night - 15mg twice daily for 21 days. The pain increased considerable and by 4/20/2021 I could hardly walk. I went back to the doctor that day and she ordered a second doppler study. The blood clot was stable but there was no change. Continued on the Xarelto. Third visit to the doctor on 5/5/2021. Some lessening of the pain by then. Doctor changed the Xarelto dosage to 20 mg. one a day for the next two months. Then we'll schedule another doctor visit and probably another Doppler Study.

right leg pain started 5 days after vaccination. Went to the ER on 5-1-2021 x-rays, ultrasound and blood work done. Diagnosed with a deep vein thrombosis blood clot in the right leg. given Eliquis starter pack 2 tabs 10 mg each twice a day for 7 days, 1 5mg each tabs twice a day, ongoing Tramadol 50mg 1 every 6 hours for severe pain Acetaminophen 500mg 1 every 4 hours for pain Ondansetron 4mg as needed for nausea/vomiting

3/20/2021 @ 1:00 vaccination I sat in a chair for 5 minutes. After, I felt warm, I was flushed. Fifteen minutes later I walked out, driving down road with friend and I said 'something is wrong'; really bad 'metal taste' in mouth, blurred vision, grabbed her arm and said I am going to throw up, I was so dizzy and I said I can't think. My face was drooping, I couldn't say my A,B,C's, and by the time I got to the ER they got me on an IV. I couldn't talk, think, and had the metal taste for a few hours. The dr. said we are going to give you fluids, my BP was elevated for 6 hours 198/130, no clots. BP went down to 178/98, taste started to go down, I was drinking fluids, I was able to talk a little bit. I felt like in a 'bubble', I couldn't think. When I was discharged I had no temp, my BP was normal. *my body reacted to the vaccination. *6 hours my body reacted *body had felt like I was recovering from the flu for 2 weeks *Never ran a temperature

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.

Developed a DVT in left calf on 5/10/21. Suffered a fractured metatarsal bone in left foot on 4/13/21 and a walking boot was prescribed. Foot healed excellently but developed a DVT .

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

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

ACUTE KIDNEY INJURY; UNCONTROLLED HYPERTENSION; ELEVATED SEDIMENTATION RATE; ELEVATED C REACTIVE PROTEIN; ELEVATED LIVER FUNCTION TESTS; DAILY PERSISTENT HEADACHE; This spontaneous report received from a pharmacist concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was reported that, the patient received care at the clinic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) 1 total, dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient had acute kidney injury, uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, elevated liver function tests, and daily persistent headache. The patient visited doctor/healthcare professional office for the events. The patient's laboratory data included blood pressure (not reported), C-reactive protein elevated, erythrocyte sedimentation rate elevated, and Liver function tests elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, daily persistent headache, elevated liver function tests, and acute kidney injury. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210537406-COVID-19 VACCINE AD26.COV2.S-Acute Kidney Injury. 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).

PLATELET COUNT INCREASED; EXCRUCIATING HEADACHE; INTRAOCULAR PRESSURE DECREASED; ANGIOGRAM NORMAL; ARTERIOGRAM CAROTID NORMAL; THROMBOCYTOPENIA; ARTERY BURST BEHIND HER EYE; OCULAR DISCOMFORT; PERIORBITAL SWELLING; EYE PAIN; ACHES AND PAINS; This spontaneous report received from a patient concerned a 61 year old female, ethnicity unknown. The patient's height, and weight were not reported. The patient's past medical history included hypertension, hypothyroidism, and intermittent pancytopenia, and concurrent conditions included metronidazole allergy, hashimoto's disease, and microscopic colitis. The patient was previously treated with metronidazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine, levothyroxine, losartan, rosuvastatin calcium, and ubidecarenone. On 09-Mar-2021, the patient got the vaccine and after few days she had aches and pains (very mild reaction) and went to bed early. The patient thought she was fine. On 18-Mar-2021, 04:00, she woke up with an excruciating headache above her left eye in her eyebrow. The patient wondered if it was an aneurysm and took 2 tablets of extra strength Tylenol and it helped. The patient stated that after every 5-6 hours, excruciating headache came back. The patient had the same headache for over a week. The patient got tested for Covid-19 and it was negative. The patient thought she had sinus problems but had no other symptoms. On 30-Mar-2021, the patient woke up with headache. Her eye was killing her, was sore and swollen, and felt like it was going to burst and her left eye was swollen shut in a couple of hours. The patient narrated it was excruciatingly painful. The patient's husband drove her to urgent care, where ophthalmology tested the pressure: right eye was normal (she thinks it was 18- normal) and the left eye was 51 (normal is 14-19), units unspecified (intraocular pressure decreased). The eye doctor started prednisone and the patient had a CT scan and lab work done. MRI was also ordered but they were unable to do it right away. On unspecified date in Dec/2020 the platelets were 349 in December and came down to 64, which was very low (low threshold was 150) (thrombocytopenia). The CT scan was performed, they thought she had a cavernous carotid fistula and she was scheduled for an angiogram for a further diagnosis on 01-Apr-2021. The angiogram determined she did not have fistula. The patient was admitted to the hospital after the angiogram and on 02-April-2021, MRI was done. All throughout the process, the ophthalmologist, radiologist and internist all thought it was related to the Janssen COVID-19 vaccine. The prednisone started working and the pressure started dropping in her eye. The patient states that doctors think an artery burst behind her eye. After discharge, the patient was taking prednisone which was helping. On the 13th, she was watching television and saw that the vaccine was being put on hold due to the women with clots whose progression matched hers exactly (severe headaches, low platelets, and required attention). She was on prednisone for a month. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) negative, CT scan (NR: not provided) Not reported, and Platelet count (NR: not provided) 64 (units unspecified). Treatment medications (dates unspecified) included: prednisone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrombocytopenia, intraocular pressure decreased, ocular discomfort, periorbital swelling, and eye pain, excruciating headache on 02-APR-2021, and aches and pains on 12-MAR-2021, and the outcome of artery burst behind her eye was not reported. This report was serious (Hospitalization Caused / Prolonged, and Disability or Permanent Damage). Additional information was received on 25-MAY-2021 following information was updated and incorporated into case narrative: Other identification number, patient contact details, events- Aches and pains, artery burst behind her eyes, excruciating headache, Tylenol drug was added, hospital details was added and narrative was updated accordingly.; Sender's Comments: V1: Additional information updated identification number,hospital details,events- Aches and pains, artery burst behind her eyes, excruciating headache,This updated information does not change the causality of previously reported events. 20210502268-COVID-19 VACCINE AD26.COV2.S-Artery burst behind her eye. Follow-up received regarding Clinical Details. 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 20210502268-COVID-19 VACCINE AD26.COV2.S-Excruciating headache. Follow-up received regarding Clinical Details. This event(s) is labeled per RSI and is therefore considered potentially related. 20210502268-covid-19 vaccine ad26.cov2.s-Thrombocytopenia, Intraocular pressure decreased, Ocular discomfort, Periorbital swelling, Platelet count increased, Eye pain, Angiogram normal, Arteriogram carotid normal. 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, UNDERLYING DISEASE

Severe drop in blood presure leading to waterfall stroke and seizure. According to neurologist brain damage is permanent and non reversible.

My allergies have gotten significantly BETTER since the shot. So this is NOT an adverse reaction. Nothing had worked prior and I had suffered for years. I just wanted to report this in case research could be done concerning other uses for the shot. However, I have also had a problem with my heart pounding since the shot - perhaps something with my adrenal glands?

At 1615 client informed EMT she "felt dizzy and her blood pressure was high". PHN arrived at 1618, client sitting upright in chair, alert and oriented x4. Per client has history of hypertension and pre-diabetes. Current medication Losartan and client stated she took medication this morning. Allergies to flu vaccine and cats. Vitals at 1818 by EMT: blood pressure 220/110, pulse 71, oxygen sat 99%. Client denies chest pain, shortness of breath, blurry vision, headache, or nausea. PHN retook blood pressure at 1824: 180/90. Per client feeling palpitations. Dizziness same, denies chest pain or shortness of breath. Vitals at 1826: blood pressure 180/90, pulse 71. Per client palpitations same. RN called 911 at 1830. At 1833 client stated new onset of "feeling sleepy" and "eye heaviness". PHN continued to speak with client, client alert and oriented x4. PHN advised to follow up with provider. Fire Dept and Paramedics arrived at 1839 and assumed care. Client transported to Hospital at 1845.

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).

on April 11, 2021 I experienced confusion and unable to read or say a few words correctly. I ended up calling my Dr who insisted I go to the ER. I was admitted to the hospital and after 2 days and many tests it was determined I had a small stroke.

8 hours after getting the vaccine I started feeling very cold. It came on me all of a sudden. Shaking, shivering, teeth chattering ensued along with generally feeling very unwell. (Similar to how I felt years ago after having surgery) This progressed during the night to fever, chills, extreme body aches, stabbing pains in the head, heart racing, dizziness and nausea. After 12 hours I started to feeling improvement. At the 16 hour mark I am really tired and nauseous but feel like I'm coming back. Probably the worst I've ever felt. We considered going to the ER in the night.

I couldn't sleep, I was very tired but I couldn't sleep. My head was throbbing , felt like it would burst. My blood pressure went up to 170/93. Ached all over rest of body.

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.

started vomiting at 1:30 and I felt really dizzy and confused. My roommate found me on the floor passed out. I am not sure how long I was passed out. I woke up and I was talking gibberish. I was aware that nothing I said was making sense. I went to bed and slept almost 24 hours. I woke up feeling wiped out but I wasn't confused and I was talking normal again. Right arm hurt and is numb. ( right side of my body typically is kind of numb but the right arm seemed more so numb after the vaccine)

The actual injection itself was so painful that I almost passed out. It hurts so badly while the needle was in my arm and when she took it out it was worse. I was in such pain that I began to sweat profusely and apparently I turned white and began dry heaving. This was all within a minute or so. I really thought I was going to pass out. A woman with a tag that said pharmacist came rushing over. She got a reclining chair with wheels, they help me into it and then took me to a recovery room. After a few more minutes of sweating and dry heaving I began feeling better. The pharmacist got me some paper towels so I could dry myself off as I was drenched in sweat. I asked her for a bottle of water. I waited the 15 minutes and came home. They never checked my vital signs. Once I got home, I laid down and slept for 15 hours. I was fine the next day and my arm was never sore. Could the shot have hit a nerve? I?ve never felt such acute pain.

Pt began to have tingling in her tongue within minutes of receiving vaccine. Pt reports allergy to topical benadryl, so benadryl was not administered and two RN's observed patient with Epi on hand should it be needed. BP up to 212/90, HR 126 and 99% on RA. Pt observed by RN's approximately one hour until symptoms resolved and pt returned to baseline.

Patient received covid-19 vaccine at off-site clinic. As she was walking up to the post vaccination waiting area after receiving the vaccine, she suffered what appeared to be an anxiety attack and fainted. She awoke quickly and was monitored by pharmacy staff. She maintained good blood pressure and was fine afterwards.

Flu-like symptoms lasting 3+ days, including lethargy, body aches, light sensitivity/headache, nausea, chest pain

A few minutes after the vaccine my heart began palpatating and I began sweating profusely. My vitals were checked, I was given water and moved to a cooler area of the facility. HR was still elevated but I wasnt feeling as flushed. By 4pm that evening I began having having chills and a fever of 100-100.4 which lasted about 4hrs. Later that evening my HR elevated to 125 with the feeling of feeling I was having a heart attack. By that Wed. my HR was still at 125 in motion and about 75 still so I went to visit my PCP on Thurs and when I arrived the HR was 77 but during the visit it elevated to 125 and blood work was done resulting in my tyroid level elevated and since getting the vaccine my HR had been up and down. When in motion its elevated and when sitting its around 75.

1st day: chills, pale skin, vomiting, loose stool, body aches,, fatigue; 2nd day fatigue, fever not exceeding 100.3, body aches. 3rd day: fatigue. 4th day felt 100% back to normal.

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.

Patient C/O dizziness approximately 10 minutes in the observation BP at 10:45 122/88, 80 HR, 95.7 temp. 11:05 am BP 120/82, 78 HR, 95.7 temp.

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.

Extreme tiredness starting at about 3 hours after the vaccination. Then about 8 hours after the vaccination got really cold, freezing, unlike another coldness I've felt. Feet and toes were especially cold to the touch. Shivering, heart palpitations too. Bloating and stomach ache and nausea. Tiredness continues the day after (today)

Once the shot when in, no asperation done. Then I felt a warmth go around my arm in the area it was given, like someone grabbed my arm. This lasted about 5 hours. Only slight pain in the injection site for 4 days. I also had a rush of warmth and fast heart beat 5 min. after the shot. it lasted about 3 min.

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.

Pt states approx 10 min after injection started with a headache and dizziness. Pt ate something around 0900. Patient was given a granola bar and water. at 1405 BP 171/90, HR 83, SP02 98%, RR 16. Pt states heart is "fluttery", pulse regular. 1416 pt states headache is better. pt denies chest pain or SOB. After sitting up from laying position pt states she was dizzier, repeated BP at 1427, no improvement. Gave pt juice b/c she felt shaky and thinks it's because she hasn't eaten. Had pt rest for 10-20 mins more and then obtained orthostatic vitals, no concern for orthostatic HTN, pt states she no longer has headache or is dizzy. Per pt's visitor her color had returned to normal, pt still feels a little shaky. Pt rested another 5 mins, repeated vitals and pts BP was elevated. Discussed with pt and visitor that due to her hx of HTN and her already being on BP meds, pt should be seen in ER and EMS called. Explained that she should have an EKG done b/c of flutters and HTN along with headache. Educated pt on importance of being seen in ED. Gave pt and visitor time to discuss suggestion, when returning pt states, "Talked to niece who is EMT and said I should be fine if I just went home, rested, ate, and checked BP and took another BP pill (1/2) like suggested with doc before getting ahold of physician. All they'll do in ED is continue to check BP". Advised pt that ED would do more than that. Pt refused EMS and wished to go home. Pt visitor stated that they would watch patient and if anything changed take to ED. Patient left clinic in wheelchair and assisted to vehicle. Pt denies any symptoms that she initially presented with but states she just feeling weak.

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.

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

Fatigue that worsened over 3 week period, weakness in legs, arms that progressed over that time, dizzy foggy brain that progressed, chest tightness/heaviness that became more frequent over time, ending in inability to stay active for normal activities, fever on & off - thought MS exacerbation - symptoms completely subsided by 4/7/21

Janssen COVID-19 Vaccine EUA Severe joint and muscle pain all over the body starting at 7:30 pm. Progressively worsening overnight. Overall weakness, cold shivers, severe palpitations with 136 heart rate in resting position. Initially decreased temperature and then increased temperature to 101. Tramadol for pain and diazepan for sleep taken at night. Felt better by the next day afternoon.

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.

Nausea, headache, stiff neck six hours later. Muscle pain, elevated blood pressure, severe ringing in ears occurred 15 hours (3am) after injection. Saw PCP on 3/25- prescribed blood pressure medication (never taken before) and referred to ENT. Saw ENT on 3/29 and 3/30. Prescribed high dose Prednisone for two weeks. Hearing test shows hearing loss in left ear. Received injection in left arm. Shrill high pitched ringing in both ears with no improvement. See Audiologist on 4/20 for hearing recheck to see if hearing has improved in left ear.

Six hours after the vaccine, I had the chills that quickly turned into UNCONTROLLABLE & SEVERE body shaking, a headache, SEVERE back and neck pain and elevated resting heart rate (96). I took 2.5mg of Ambian thinking that if I could just fall asleep, I would sleep it off. After an hour of non-stop symptoms, I fell asleep for about an hour only to wake up with the severe neck and back pain and headache still present. The body shaking had subsided. The next day, I was tired but fine.

migraine Headache BP 235/110 was getting dizzy, tongue became numb she went to nurse 911 called. she was uncomfortable taking vaccination, For 30 minutes she was ok- tongue numb lips swollen still has migraine TMJ pains Did not get epinephrine. BP is on the "high normal side" 140/90, did not check pulse Oxygen level No rash

Fever 103.2 for 24 hours; Fever 102.1 for next 24 hours; chills for 6 hours; heart racing for 6 hours ; fatigue 1 week; diarrhea 3 days; headache on going; severe bruising to injection site about 1.5 weeks after the injection

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.

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.

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.

Chills, severe aches, pain in my left arm down to my hand , neck, back, chest, keytones due to type 1 diabetes.

I had sudden chest pains and could not breath felt as if i was having a heart attack. It lasted about 1 hour and 50 minutes and then it gradually went away.

Patient's husband called to report that his wife was in the hospital due to a blood clot that formed in her leg. He stated that she was having organ failure. Patient is currently being treated at a local hospital for blood clots that were moving and affecting her organs.

Upon waking 2 days after receiving vaccine, I suffered from excruciating headache that was incapacitating. It did not resolve with aspirin, which prompted me to check my blood pressure. My BP was extremely elevated at 145/85. I then took 1 dose of common "water pill" 25 mg hydrochlorothiazide. This did not bring down BP or resolve headache, 2 hours later I took 20 mg of Valsartan. This also did not resolve headache or lower BP, so I took another 20 mg of Valsartan, followed by another 25 mg of water pill. My BP stabilized later that evening and headache resolved by 8 p.m. This same event occurred 2 more times, the last day being 4/10/21. On that date I was completely incapacitated by excruciating headache. I took 40 mg of Valsartan but headache did not resolve until late that evening.

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.

Within 15 minutes of receiving vaccine, massive headache, slight nausea, flushing of face, rapid heart rate double the normal heart rate for myself (120 beats per minute, as opposed to 60 BPM), heat in right hand. Adverse effects lasted 20 hours after injection. Slight headache on and off from 4/11/2021 to 4/14/2021. Also noted jaw pain, felt like slight swelling around eustachian tubes of both ears.

Got shot a little after 3 pm March 11, 2021. At about 10 pm that evening, had about an hour of chills, no big deal. Then began to get headache with slight fever and the headache got progressively worse, with nausea and rapid heart rate. The headache was so bad I could not sleep at all - the worst headache I have ever had. I took one extra-strength Tylenol at about 10 or 11 am the next day, March 12, which took the edge off the headache. The headache diminished till it was gone by about 8 or 9 pm. The rapid heart rate, along with tiredness, low energy, and feeling jittery continued for several days, then stopped. About 3 or 4 weeks later...there's more BUT FORM WON'T LET ME GO TO CONTINUATION PAGE

12-24 hours after the Covid -19 vaccine the patient had a seizure like event: eyes wide open, moaning, unresponsive for 2-3 mins. Patient had reported occurences of blacking out. These are new events. The patient does not have any history of seizures or seizure like symptoms. Patient was placed in isolation at the hospitial for 03/13/2021 thru 03/16/2021

Persistent rectal bleeding and passing blood and blood clots for 7 days since vaccination. Bleeding occurs with stool and throughout the day, requiring the use of pads.

Sore arm at injection site and then a couple hours later started with fever, then red rash over top of body chest, arms rash felt like a burn, nausea, diarrhea, body aches all over, slight headache, tired- took tylenol ever four hours. Rash lasted until Sunday early evening, headache until Sunday morning, tired and aches lasted until Tuesday. Nausea and diarrhea on and off until Tuesday. Fever until Sunday afternoon. Pain in back rt side. About 1 hour after vaccine - chest tightness felt like asthma coming on, then it went away.

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

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.

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

I called a message that patient had experienced a stroke recently and had also rececived the Jansson vaccine. I called patient, who had reported that it happened on 4/2. She had woke up and couldn't put her robe on. Her left arm was not working right. She also noted that she had drooled. She kept thinking that she was find and got ready and went to work. During work she was typing and found that her left hand was not working still, but still went throughout her day and typed with her right hand. Later that evening when she got home, her husband took her to the ER. There, she reports that her blood pressure was through the roof. She had a CT scan and MRI and labs done and was diagnosed with a TIA. She was started on Plavix, baby aspirin, and was started on a statin drug (couldn't remember the name as that information was at home and she was at work at time of call). She is on a heart monitor for 4 weeks and has follow ups with her outside PCP and cardiologist. Today she states that she is feeling back to normal and has regained function on her left side. She reports that she had a headache at time that had lasted for a while. She also reports that she feels like she was having issues weeks before because her brain felt foggy and just was not thinking right.

N17.9 - AKI (acute kidney injury) R19.5 - Occult blood positive stool E87.6 - Hypokalemia R55 - Syncope

Vaccine administered on right arm on 4/8/2021. Approximately, 12 hours later she began experiencing severe abdominal stomach pain, fever and general malaise (fever and malaise have generally resolved), numbness in her left arm, and elevated blood pressure. She continues to have abdominal pain 7 days after immunization. Advised to go to emergency room out of an abundance of precaution.

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.

Received the vaccine friday then monday has numbness to the tongue , near syncope, dizziness, ems called taken to ER and admitted to hospital for TIA. CT of neck, head, abd done, chest xray, full blood work, echo, results sent to primary care said all test ok

I received the Janssen COVAX on Monday morning, 5 Apr 2021. A week later, on Monday evening, 12 Apr 2021, I experienced extremely painful leg cramps and broke out in a sweat. I felt extremely nauseous, and weak, this was followed by a sever pain in my head that was so extreme that I passed out. After coming to, the pain in my head finally began to subside, along with the leg cramps. My husband indicated that I was unconscious for just under a minute. For the next two days, I had bouts of nausea, headaches, sweats, and was extremely tired. On Wednesday, 14 Apr, after learning of the issues related to the Janssen vaccine, and the symptoms described being what I experienced, I contacted the advice (cont'd)..Additional information for Item 18: Line and was told to go to Emergency Room at the hospital, which I did. I do not feel that they addressed my concerns or the symptoms that I was experiencing, and at no time did they try to determine if it was due to the vaccine. The discharge papers did not even address the "event" and the "symptoms" that I described. They did not take any information down related to the vaccine, lot number, etc., that I had received. They seemed to go through a set routine: blood pressure, blood work, temperature, EKG, and CAT scan. 21. (continued)...Visited Emergency Room, however, was requested by ER to go to Primary Care as follow-up, however, as a Employee we cannot be seen by Primary Care on THIS site. Instead , we have to go on the local clinic to receive care. The issue is that this was a vaccine that I was scheduled by my leadership to receive, with no choice in choosing which vaccine I could receive, and without follow-up care for adverse reactions. The hospital did not indicate to me that I should report this incident, however, I am concerned as a result of the "event" that I experienced, that it should be reported. Furthermore,we should have a choice as to which vaccine we want to receive, just as everyone does. Your form does not allow for input addresses Also, your form does not allow for a phone number. I am out of the country.

I was ill with diarrhea, sick to stomach, blood clots coming out of my rectum for 24 hrs., body aches.

MINOR HEART PALPITATIONS; HIGH FEVER; PAIN AT INJECTION SITE; 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: Unknown) dose was not reported, 1 total, administered on 06-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain at injection site. On 07-APR-2021, the subject experienced minor heart palpitations. On 07-APR-2021, the subject experienced high fever. Laboratory data included: Body temperature (NR: not provided) 103 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor heart palpitations, and high fever on APR-2021, and was recovering from pain at injection site. This report was non-serious.

2 hours after receiving the vaccine, I grew exhausted and had to sleep into late evening and was chilled, had a fever of 101 and developed severe pain and inflammation on the top of my collar bone that was feverish and migrated toward my shoulder region on the same side as my vaccine. Ibuprofen would not help with the pain but helped with the fever. My mind told me that I had things to tend to the next day, but still was forced to sleep off and on for 2 more days. After a week and a half, not only did I have thirst, but also food didn't taste right and was metallic. This lasted for 2 days and finally my taste was restored. The exhaustion lasted off and on for 2 weeks and I just listened to my body. The pain and inflammation on my collar bone has subsided 4 days ago but still have pain in my shoulder when I sleep. On April 5 around 8:30 a.m. a nasty virus hit me out of the blue. I grew week and tired and had to go to bed. I slept all day until around 9:00 p.m. and woke to uncontrollable diarrhea and fainting spell while in the bathroom. I had abominable pain and nausea that last for a half hour and then I returned to bed. The next 2 days, I was week and exhausted but continued with my regular routine. My equilibrium is still affected from time to time.

SPEECH PROBLEM/SLUTTER; LACK OF MEMORY (FORGET THINGS); WEIGHT LOSS; HIGH BLOOD PRESSURE 172/95 SOMETIMES 180; RASH ON HER FACE; CHILLS; PAIN IN RIGHT ARM AND RIGHT LEG; 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, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced speech problem/slutter, lack of memory (forget things), weight loss, high blood pressure 172/95 sometimes 180, rash on her face, chills, and pain in right arm and right leg. Laboratory data (dates unspecified) included: Blood pressure high (NR: not provided) BLOOD PRESSURE 172/95 SOMETIMES 180. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right arm and right leg, weight loss, chills, lack of memory (forget things), speech problem/slutter, rash on her face, and high blood pressure 172/95 sometimes 180. This report was non-serious.

LEFT CHEST PAIN; FELT VERY TIRED; 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. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced felt very tired. On 09-APR-2021 02:00, the subject experienced left chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left chest pain, and felt very tired. 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.

Fever, body aches, headache, chills, tired, vomited bile, weak, high blood pressure, visual changes.

BLOOD PRESSURE INCREASED; DEBILITATING HEADACHES; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included post-menopause hormone replacement therapy (HRT). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAR-2021, the subject experienced blood pressure increased. On 29-MAR-2021, the subject experienced debilitating headaches. On 14-APR-2021 09:00, Laboratory data included: Blood pressure (NR: not provided) 150/85 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood pressure increased and headaches was not reported. This report was non-serious.

I developed a nose bleed about an hour after injection. This lasted for about an hour. My arm was sore for a few weeks, with a red "bullseye". This lasted for 2 weeks.

INCREASED HEART RATE; WEAKNESS; TIREDNESS AND EXHAUSTION; 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: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 04-APR-2021, the subject experienced increased heart rate. On 04-APR-2021, the subject experienced weakness. On 04-APR-2021, the subject experienced tiredness and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from weakness, tiredness and exhaustion, and increased heart rate. This report was non-serious.

HIVES; CHILLS; NAUSEA; FEVER; ACHE; RAPID HEART RATE; RASH ACROSS CHEST; 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 pre-existing medical conditions included had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, Laboratory data included: Antibody test (NR: not provided) negative. On 02-APR-2021, the subject experienced ache. On 02-APR-2021, the subject experienced rapid heart rate. On 02-APR-2021, the subject experienced rash across chest. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced hives. Laboratory data (dates unspecified) included: PCR (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and chills on 04-APR-2021, and rapid heart rate, nausea, and fever on 06-APR-2021, was recovering from hives, and had not recovered from rash across chest. This report was non-serious.

PT CALLED C/O NUMBNESS/TINGLING LEFT ARM FROM FINGERS TO SHOULDER 2 DAYS AFTER SHOT; HAD DIZZINESS FOR ABOUT 3 DAYS; FATIGUE; HAS HX OF HEART FLUTTERS BUT GREATLY INCREASED AND CONTINUES NOW; KNOT IN ARM JUST RESOLVED YESTERDAY

ALLERGIC REACTION; HEART BEAT ELEVATED; FATIGUE; GLASSY EYES; LETHARGIC; RUNNY NOSE; 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 advanced multiple sclerosis, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at her right arm. No concomitant medications were reported. On 14-MAR-2021, the subject experienced glassy eyes. On 14-MAR-2021, the subject experienced lethargic. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced heart beat elevated. On 17-MAR-2021, treatment medications included: loratadine. On an unspecified date, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, had not recovered from glassy eyes, runny nose, heart beat elevated, and allergic reaction, and the outcome of lethargic 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"

SWEATING; INCREASED BLOOD PRESSURE; EXTREME THIRST; SHAKINESS; CONFUSION; MILD HEADACHE; DRY MOUTH; CLAMMINESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 100 pounds, and height was not reported. The patient's pre-existing medical conditions included normally had low blood pressure was at 170/92. 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 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dry mouth. On APR-2021, the subject experienced clamminess. Laboratory data included: Blood pressure (NR: not provided) stabilized. On 18-APR-2021, the subject experienced extreme thirst. On 18-APR-2021, the subject experienced shakiness. On 18-APR-2021, the subject experienced confusion. On 18-APR-2021, the subject experienced mild headache. On 19-APR-2021, the subject experienced sweating. On 19-APR-2021, the subject experienced increased blood pressure. Laboratory data included: Blood pressure (NR: not provided) 170/92 mmHg. Treatment medications (dates unspecified) included: atenolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased blood pressure, and the outcome of extreme thirst, shakiness, confusion, mild headache, sweating, dry mouth and clamminess was not reported. This report was non-serious.

RECURRENT NOSE BLEEDS; WEIRD SENSATION IN HEAD; 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 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: Unknown) 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 2021, the subject experienced recurrent nose bleeds. On 2021, the subject experienced weird sensation in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurrent nose bleeds, and weird sensation in head. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.

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.

Patient was seen in my office by me on April 27th. She reports having left leg pain discomfort which started 3 days after receive Johnson and Johnson COVID vaccine. She denies swelling or any other associated symptoms. I ordered Venous Duplex which was done today and revealed b/l femoral DVT. Patient immediately started on Eliquis .

After injection I too seat to wait 15-20 minutes. Immediately I started to lose peripheral vision and then my hearing....I called for help. They took me in a room to lay down and said my blood pressure had dropped vary low. After an out of doing better I just needed t get home. So another hour passes and I get home, go directly to bed and what seems like a bad flu begins. That night my temperature continues to climb, the aches and headache are horrible. I continue fevers for 3 nights. Feel a little better and then with 2 days it relapse and all starts again. I am in bed for 1 and 1/2 weeks, then stay home due to continued headache, dizziness. After 3 weeks the dizziness continues and I then start getting an aching pain in the back of my left leg. Seeing my doctor on May 11th and hope to discuss.

Patient felt dizzy and fainting 2-3 minutes after vaccine. Her breathing was normal. Pharmacist gave her 5 ml of benadryl ( 12.5mg/5ml). Patient start responding within 1 min, Mean while pharmacy call 911. Paramedics arrived and check all symptoms ,BP and ECG. BP was little elevated and ECG came normal.

VERY LOW TEMPERATURE; VERY LIGHT-HEADED; LIPS WERE COLD; MUSCLE SORENESS; CHILLS; HEADACHE; BODY ACHES /LITTLE SORE; FEELING WORSE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 170 pounds, and height was not reported. The patient's concurrent conditions included depression. 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 06-MAY-2021 13:00 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride for depression. On MAY-2021, the subject experienced body aches /little sore. On MAY-2021, the subject experienced feeling worse. On 06-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced muscle soreness. On 08-MAY-2021, the subject experienced very low temperature. On 08-MAY-2021, the subject experienced very light-headed. On 08-MAY-2021, the subject experienced lips were cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 94 F. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, muscle soreness, body aches /little sore, lips were cold, very low temperature, very light-headed and feeling worse was not reported. This report was non-serious.

Sudden rapid heart rate , sweat , nausea, light headed , almost passed out . Ems was called . vitals returned to normal while in ambulance . No further heart fluctuations. A month later tinnitus has begun . I?m currently being checked by an ENT to find out why . No previous tinnitus issues .

STROKE; RIGHT CAROTID ARTERY BLOCKAGE; This spontaneous report received from a patient concerned a 62-year-old white female, ethnicity unspecified. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, hypertension, hyperlipidemia, and allergy to latex, and other pre-existing medical conditions included allergy to Provaxin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 06-JUN-2021) dose was not reported, 1 in total administered on 06-APR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On 28-APR-2021, the patient experienced stroke. On 10-MAY-2021, the patient was hospitalized. On 11-MAY-2021, the patient was discharged. On an unspecified date, the patient experienced right carotid artery blockage (60 percent). Laboratory data included: CT scan (NR: not provided) stroke, Echocardiogram (NR: not provided) stroke, Laboratory test (NR: not provided) stroke, and MRI (NR: not provided) stroke The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of right carotid artery blockage was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210523342-covid-19 vaccine ad26.cov2.s -stroke, right carotid artery blockage. 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

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.

I came in from outside and sat down and all of a sudden I couldn't tell what year it was. My husband suggested that I check my blood pressure and it was elevated. I went to the ER and had a CT scan and a chest x-ray, no damage was seen. I was sent home because they assumed it was a TIA. I saw my doctor the next day for observation.

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.

I am still experiencing pain at the injection site from when I received the vaccine. I have been experiencing heart palpitations that have been waking me up in the morning as well. I'm not sure if it's from the vaccine, or the nasal spray that I have had an allergic reaction to. My stomach still seems off. I'm not feeling right. I saw Dr. about my allergies and allergic reaction.

BLOOD CLOT FROM GROIN AREA ALL THE WAY TO THE LEG; 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 osteoporosis, osteoarthritis, bursitis, rheumatoid arthritis (RA), migraine headache, anxiety, and cholesterol, and other pre-existing medical conditions included patient had no history of blood clots and no prior heart conditions. On 16-Mar-2021 around 09:00, 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, frequency 1 total, administered on left arm for prophylactic vaccination. Concomitant medications included pantoprazole for acid reflux, citalopram for anxiety, simvastatin for cholesterol, and prn 1371 for migraine headache. On an unspecified date in Feb-2021, the patient mentioned (heart doctor) had done some tests on veins making sure the patient's heart was open and does not have any blood clots. Laboratory data included: Diagnostic ultrasound (NR: not provided) Normal, and Doppler ultrasound (NR: not provided) No blood clots. 7 days later the patient was informed everything was fine and she got vaccinated on 16-Mar-2021. On 07-May-2021, the patient reported that her left leg started hurting. On 09-May-2021, the leg started swelling. On 11-May-2021, the patient was admitted to the hospital with a massive blood clot from groin area all the way to the leg. On 14-May-2021, she was discharged from hospital. The patient was hospitalized for 3 days. The patient stated her doctor will let her know if she can move around more next week, the patient is currently in lot of pain. Treatment medications (dates unspecified) included: apixaban, paracetamol, tramadol hydrochloride, gabapentin, and baclofen. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient had not recovered from blood clot from groin area all the way to the leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210500586-COVID-19 VACCINE AD26.COV2.S-This case concerns with 63 year old female – blood clot from groin area all the way to the leg -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Swelling of the right foot and leg. Went to ER and they performed a doppler ultrasound and found a blood clot in the lower right leg. Prescribed blood thinner. So far, the swelling has gone down

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.

6 days after vaccine after having no symptoms at all I suddenly felt nauseous about 9 p.m. Went to the bathroom and can't remember what happened next as I passed out. Fell hard and knocked shower out of track. Woke up throwing up massively. My husband ran in and helped me. I threw up a lot and had chills. After cleaning up, went to bed and piled on blankets. Woke up again sometime in the 11 to midnight range and threw up once more. Still chilled. About 3 a.m. I woke up and removed all the blankets as I felt okay again. I never found a place to report this in my daily reports as within 24 hours I felt normal again. I am 100% positive this was a reaction to the vaccine. I did not need to seek medical treatment as it passed within 6 hours or so.

CLIENT PASSED OUT 5 MINUTES AFTER RECEIVING THE VACCINE. COLD COMPRESSES WERE GIVEN PRIOR TO INCIDENT TO HELP CLIENT. AFTER CLIEN TPASSED OUT AND CAME TO AND ABLE TO TRANSPORT TO COT, WE LAYED CLIENT DOWN FOR 10 MINUTES. CLIENT STATED SHE WAS BETTER AND WANTED TO GO HOME. HUSBAND DROVE CLIENT TO AND FROM MOBILE VACCINE CLINIC AND WILL CONTINUE TO MONITOR CLIENT AT HOME. CLIENT STATED THIS HAS HAPPENED TO HER EVER SINCE HER FIRST VACCINES IN KINDERGARTEN.

Starting on or about June 16th - slight swelling noticed in left ankle, and left calf. Swelling continued in left ankle and left calf even after ice and elevating foot. June 21st scheduled doctor appointment with orthopedic thinking perhaps leg or ankle injury.

Around the time in May I experienced chest pains, after that I went to get a covid vaccine because my husband had been exposed. My test came back positive. I was also prescribed steroid medication.

My heart started feeling funny. I walk a lot and we usually walk four miles 4 or 5 days a week. I told her my chest felt funny. It didn't funny. It felt like heart was pounding. I waited about a month before I went to doctor - never had it in my life this kind of thing. It beats out of whack ( my heart) - I feel it mostly at rest. If I lie down I can hear heart beating in my ear. It is still occurring. The next step would maybe be to take beta blockers but haven't tried that yet. My doctor can hear it. It's constant - it is always is doing it. When I stop and slow down, I hear that it's beating irregular.

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.

LOW PLATELET COUNT; BRUISING; RASH; 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 non smoker, and sulfa allergy, and other pre-existing medical conditions included patient was born with whole in the heart. The patient experienced drug allergy when treated with loratadine, and atorvastatin calcium 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: 1805022, expiry: UNKNOWN) dose was not reported, one total administered in Left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, three weeks later the vaccination, patient started getting bruising and rash. On June-2021, patient went to doctor who put patient on steroids. Patient had blood work done which showed platelets were down to 7. The patient was given steroids in hospital and the platelets was 39 after patient got off the hospital. Patient was off of them too fast and platelets started to drop down, as of Wednesday 23-JUN-2021 platelet count was 304, week before that was 321 and lowered the dose of steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low platelet count was not reported. This report was serious (Other Medically Important Condition). ,; Sender's Comments: V0: 20210660892-covid-19 vaccine ad26.cov2.s-low platelet count. 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).

Pain and burning on L side (arm, shoulder, neck, face, ear, back), headaches, brain fog, anxiety, twitching, spasms, neuropathy in feet, low appetite, fatigue, weakness, tired eyes, blurry vision, heart palpitation when lying on either side at night, hypo thyroid

Finding of microhematuria on a routine urine dipstick. Repeat urine test confirmed microhemtutria and CBC showed 30,000 platelets. WAs admitted to hospital. No purpura or other signs of bleeding. Was diagnosed as Idiopathic Thrombocytopenic Purpura. Started on steroids with good response.

Fast heartbeat and moderate to severe dizziness began at 3:30 PM on March 6. Fast heartbeat slowed considerably after 10:30 pm. Dizziness is mild to moderate as of 5:00 pm March 7. I am reporting this simply because it said we should make you aware of adverse events with the vaccine.

In the evening I started to feel aches in my eyes and joints. I was having trouble falling asleep. I woke up every 2 hours. My heart bpm went up to 102 in the middle of the night. I know this because my fit bit was vibrating and encouraging me to keep exercising and I was just laying in bed trying to sleep. I finally got up around 2:30 in the morning and took 1 Aleve. I also took my temperature with a forehead type and it was 98.5, so no high fever. I took another Aleve around 7:00 in the morning. Now I am feeling fine. It's now 8:22 a.m. and I am working from home. I just wanted to report that the aches in joints and 102 bpm and unable to fall asleep were my side effects. I feel fine now. I will continue to take Aleve as needed. I have never been tested for Covid. I have never had any symptoms to warrant testing for covid. Since March 13, 2020 I have been fortunate to work for a company that has us all working from home. We are still working from home. i am 63 years old. I shop around 6 a.m. in the morning for groceries to avoid people. I do not go out. I have been very careful.

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.

5-6 hours after vaccine-mild muscle aches, temperature elevated but above 100. About 8 hours after injection, muscle ached and so was chilled but felt ok otherwise. FitBit alerted me that I was earning points for being in my ?active zone? even though I was just watching tv - resting heart rate is 66 (actively exercising, heart rate is usually less than 120) but it was 136+. HR stayed elevated ( Verified HR with pulse oximeter) while I was not doing anything. Took temperature (forehead thermometer) and it was 103F. Took Tylenol. Heart rate slowly went down after Tylenol kicked in and fever came down to 101. Heart rate stayed a little higher than normal and fever lasted 24 hours. By 48 hours, all was well.

I developed a vasculitis rash mostly on my lower right leg. I had a tiny rash of he evening before the shot. That was a Thursday. The shot was Friday night. Monday evening I had a huge rash on my lower right leg and a very tiny rash on my lower left leg.

PATIENT FAINTED AND WAS UNCONSCIOUS FOR A FEW SECONDS ONLY. SHE GAIND CONSCIIOUSNESS VERY QUICKLY. 911 WAS CALLED

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.

Approximately 3 hours after my injection I became very lethargic and my heart began to race. I had fever of 101 and became very weak and tired. I experienced nausea, pain in my upper back and my heart raced for approximately 10 hours. On Tuesday, March 16, 2021 I slept on and off for the entire day and continued to have a fever. My heart rate came down within 24 hours after my injection and the fever came down to normal 36 hours after the injection. I felt weakness for approximately 3 days after the injection. I am currently recovered from all symptoms as of March 22, 2021.

Immediately after receiving the vaccine, stood up and felt dizzy and could feel headache moving to my scalp. At bedtime, around 10:30 pm, I could not fall asleep, was freezing, achy, in and out of sleep. Took temperature at around 2:00 AM. My temp was 102 deg. F, my pulse was at 125 bpm. I could feel my heart rate beating rapidly. Was still dizzy. At around 6:30 AM, my temp was 101.9 deg. F. Stayed home from work. Got out of bed around 2:00 PM. As I went to the restroom during the morning, early afternoon, my temp gradually decreased, my heart rate gradually decreased. Still had headache. Was very fatigued. The next day, my temp was normal, had mild headache and was still fatigued.

PT CALLED ON 3-27 TO REPORT A BLOOD CLOT IN HER EYE AFTER RECEIVING THE VACCINE ON 3-13, STILL PRESENT

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

LOSS OF CONSCIOUSNESS, FAINTED; HEART WAS RACING; DIZZY; VOMITING; CANKER SORE UNDER TONGUE; HEADACHE; NAUSEA; FATIGUE; INFLAMMATION ON LEFT EYE; FALL ON BED; SMALL HIVES UNDER EYE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included seasonal allergies, and codeine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 to left arm as prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, after vaccination, she felt fine all day and night. The next morning she woke up and felt sick. She had nausea, headache, hive under eye. She laid back down and tried to sleep. A few hours later, she woke up to use the bathroom. She was very nauseous and dizzy. She lost consciousness and fell trying to get to the bathroom. She fell on her bed and was uninjured. The paramedics took her to the hospital. She was given medication for nausea, headache, and IV fluids. She gave blood for lab tests and they came back normal. No COVID test was administered. When she felt better, she was released. A few days later, she discovered her tongue was sore and red. She called her primary care physician (PCP). PCP said the red and sore tongue was probably related to allergies. Two weeks later, her tongue was not sore, but still red. They advised her to get a second opinion with another HCP. She was going to visit her allergy specialist.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, fainted, heart was racing, dizzy, headache, nausea, fatigue, inflammation on left eye, and small hives under eye on MAR-2021, and vomiting on 07-MAR-2021, and had not recovered from canker sore under tongue, and the outcome of fall on bed was not reported. This report was serious (Hospitalization Caused / Prolonged). Additional information was received from the patient on 23-Mar-2021. The following information was updated and incorporated into case narrative: Patient's medical history added as seasonal allergies and codeine allergy, Vaccination site as left arm added; Additional events as small hives under eye, fall on bed; lab test of blood work added; Event outcome of loss of consciousness, fainted, heart was racing, dizzy, headache, nausea, and fatigue was updated to recovered/resolved.; Sender's Comments: v1: Follow up information received updates patient's medical history (seasonal allergies and codeine allergy), Vaccination site as left arm; Additional events (small hives under eye and fall on bed), laboratory test (Blood Work); Event outcome (loss of consciousness, fainted, heart was racing, dizzy, headache, nausea and fatigue was updated to recovered/resolved). This updated information does not alter prior causality assessment of reported events 20210323730-COVID-19 VACCINE AD26.COV2.S-headache, nausea and fatigue. These events are labeled and are therefore considered potentially related. 20210323730-COVID-19 VACCINE AD26.COV2.S-loss of consciousness, fainted, heart racing, dizzy, vomiting, canker sore under tongue. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are no information on any other factors potentially associated with the events.

Less than two minutes after J & J vaccine I was unconscious and unable to move my entire body. I could not move my eyelids, mouth, arms, legs...entire body . Upon becoming mentally alert it was more than two hours until I could move all of my body. I was taken by ambulance to an emergency room. IV fluids, potassium, and released 3 hours later.

During the 15 minute observation (post-vaccination), patient fainted. EMS was called and patient was transported.

Patient was getting light headed and fainted but did not lose conscienceness. Patient fell at around 2 feet but was conscience, we had patient lay down and called 9-1-1. I called patient afterward to follow up, as she denied going to hospital, she reports being fine, just a little sore on the head. She most likey had her vasosyncopy

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

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.

less than ten minutes after administration of JJ vaccine, patient started to complain of nausea, palpitations, and a "warm flush feeling", but the patient did not exhibit any signs of visible color change. All of the stated symptoms appeared with rapid onset together over a period of 1 to 2 minutes, then started to reside. Patient was given 25mg diphenhydramine and stabilized. Patient instructed to wait additional 30 minutes in pharmacy and had no additional symptoms and stated she felt ok prior to leaving. Follow up phone call 4/7/2021 and patient stated she experienced no additional or subsequent events/symptoms.

RACING HEARTBEAT; DIZZY; CHILLS; WEAKNESS; HEADACHE; FEVER; MUSCLE ACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced racing heartbeat. On 01-APR-2021, the subject experienced dizzy. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced weakness. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Heartbeats increased (NR: not provided) 144 /min. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 21 BMI. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heartbeat, weakness, fever, muscle ache, and nausea on 02-APR-2021, and headache on 03-APR-2021, was recovering from chills, and had not recovered from fatigue, and dizzy. This report was non-serious.

Patient is found with secondary provider reporting the patient had an episode of syncope and hypotension. Patient reports that she is hot, diaphoreticand dizzy after receiving J&J Vaccine. A 12 lead ECG is completed as noted in chart. Patient's vitals are taken as noted in chart. Patient reports that she is beginning to feel better, patient continues to be monitored by EMS. Patient is found A&O x4, flushed warm and diaphoretic. Patient has no noted neurological deficits, pupils are PERRL. No trauma is noted to patient's face. Airway is patent, respirations are as noted. No JVD is noted, trachea is midline. Patient has equal chest rise/fall, lung sounds are equal bi-laterally. Patient denies chest pain, shortness of breath. Abdomen is soft/non tender. Patient denies abdominal pain, no GI/GU Symptoms are noted. Patient has no deficits noted to extremities, pulses are strong. Patient denies covid 19 concerns, other injuries or illness. 12 lead ECG is taken showing sinus rhythm as noted in chart

Pt experienced vasovagal syncope within 15 minutes of vaccination. Supportive care provided and pt recovered without incidence.

Blood glucose 158 mg/dL; Blood pressure 177/102 mmHg; Heart rate 92 bpm, Sp02 98%; Per spouse her head, arms, and chest hurt; arms have itching and tingling. Client's spouse reports she had a similar reaction and it is "less than last time" and was recommended by her PCP to receive a dose of Janssen instead of a second dose of the Moderna (received 1st dose on 01/16/21 Moderna 013L20A).

woken up by a severe pain in my heart area. Bad Headache shortly after receiving the shot. My Left eye won't stop twitching. Rash on upper chest, nausea, upper chest/lungs area feel like they have a slight burning feeling. Chills, Fever. muscle pain my body feels like a truck hit it.

EXCESSIVE URINATION; VOMITING; INCREASED HEART RATE; CHILLS; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 134 pounds, and height was 176.78 centimeters. The patient's concurrent conditions included supraventricular tachycardia, high cholesterol, thinning bones, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no no allergies/no history of drug abuse/no past history of similar event/no adverse event after any previous vaccinations/ no history of allergy to vaccine, drug or food/ no history of hospitalization in last 30 days, with cause/no family history of any disease (relevant to vaccination) or allergy. the patient was not pregnant at the time of event. the patient was not currently breastfeeding.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 to the left deltoid, on 07-MAR-2021 16:30 for prophylactic vaccination. The batch number was not provided and has been requested. Concomitant medications included fish oil for heart health, pravastatin for high cholesterol, metoprolol succinate for supraventricular tachycardia, and calcium carbonate/colecalciferol for thinning bones. On 07-MAR-2021, the subject experienced excessive urination. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced increased heart rate. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excessive urination, vomiting, increased heart rate, nausea, and fatigue on 08-MAR-2021, and chills on 07-MAR-2021. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment is not required as per standard procedure as the case is non serious

Dizzy ,nausea ,complete loss of consciousness, catatonic, eyes rolled back , rigid total body ,extreme low blood pressure for over 1/2 hour Immediately at vaccine time ... 24 hours later chills , bad headache, nausea vomiting

Light-headiness, chest pain on evening of injection, along with high blood pressure (155/88). High blood pressure lasted through the evening of the injection plus 2 days, with readings decreasing each day. This morning (4/11) was my first (almost) normal blood pressure reading.

At 24 hours post-vaccination, I experienced Dizziness. Nausea. Increased Appetite. Muscle aches/pain. Then Fainted and was out for a few minutes. Then woke up on my own. Still experiencing fatigue and some nausea/dizziness and mild diarrhea. Did not get transported to hospital or recieve medical care.

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.

4/4/21 Swelling below waist, including buttocks, hips, thighs, and knees. Severe itching and pain. 4/7/21 Swelling spread to calves and ankles. Severe pain and itching. PCP prescribed 50 mg Benadryl every 6 hours and was told to go to Urgent Care if symptoms persist. 4/9/21 Went to Urgent Care Clinic due to excruciating pain in legs. Admitted to accompanying ER. Received IV and had blood drawn, showing extremely low platelet levels (37k). Discharged with prescription for antihistamine, steroid, and hydroxyzine HCL. Ultrasound taken but did not show blood clots. 4/11/21 Pain and itching spread to both arms. Extreme pain when standing and walking. 4/13/21 Went to ER. Ultrasound confirmed multiple blood clots. Discharged with prescription for Xarelto.

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.

Head rush and heart palpitations approximately 10 minutes after injection, and nausea. Assisted by EMTs to monitor heart rate, blood pressure , and blood oxygen level. Went into atrial fibrillation and blood pressure steadily rose. 165/99 was one reading I heard them call out.

Initially began with tingling in hands, feet and lower legs, face. Progressed to full body tingling with body ?buzzing? like an adrenaline rush. Increased heart rate and blood pressure. Minor tingling continues through this report. No full body experience in last 24 hours.

She presents to ED on 04/14/2021 with complaints of altered mental status and rash. Patient states that she went to work on Saturday, she is a food server, she started to feel not herself and felt like she ?snapped?. She states that on the way home in her car she was nearly struck by the train crossing barriers. She states that she went home and sat in her recliner on Saturday and did not get up until Wednesday at around lunchtime. She states that she did not get up to eat or drink. She used incontinence pads and depends. She did not get up to use the restroom. She did continue to take her medications. Patient states that she was motivated to get up today because her friends were concerned for her and 1 of her friends came over to take her out for lunch. Elevated D Dimer History of DVT - mild leg pain, no swelling or erythema. No chest pain, cough or SOB. Low suspicion for PE - full dose lovenox - BLE duplex in the morning

1st effect was migraine with left side numbness, woke up at 4 am and was unable to walk correctly. Went to ER 1 and was transferred due to lack of CT Scan, hospital then admitted for stroke. Can also still feel injection site

Within 4 hours and lasting at least 50 hours; Terrible headache, chills, vomiting, tightness in muscles of calves that moved also to shoulder and stomach, swollen fingers, chest tightness and heaviness, diarrhea. Constipation on 4th day lasting through today the 9th day. Fatigue lasted for 8 days. Chest tightness and heaviness lasted for 6 days. Finally feel somewhat normal on 9th day although tongue still heavily coated with white.

In the morning I noticed a pinching feeling in my lower right leg. I called my doctor to check on this. She sent me for an ultrasound of the leg on 04/15/2021. During a follow-up visit she informed me that it was a superficial blood clot and set up a second ultrasound on 04/28/2021 for confirmation that it had cleared.

2 weeks and 2 days after receiving the vaccination I had a blood clot blown from my nose no before issues with a bloody nose and not after it was a large blood clot there was not any continued bleeding before or after. Also where the shot was given is still sore in that area and does not seem to get better this is my right arm I am exercising and not any improvement.

Report received from co-worker of patient. Patient received J&J vaccine on 3/13/21. Patient was at work and collapsed 11 days after vaccination. Was intubated at work site and taken to local hospital - the patient was then airlifted to a Medcial Center. Diagnosed with a brain bleed and subsequently died on 4/6/21.

FAINTING; ABNORMAL HEART BEAT; DIZZINESS; BLADDER CONTROL LOST/URINATED ON HERSELF; COULDN'T STAND UP; NAUSEA; CHILLS; DIDN'T HAVE APPETITE; 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 little asthma, cardiac resynchronization therapy (CRTS), and allergic to red tide. The patient was previously treated with gabapentin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: unknown) dose was not reported, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2020, Laboratory data included: COVID-19 antigen test (NR: not provided) negative (units unspecified). On an unspecified date in MAR-2021, the subject didn't have appetite. On 13-MAR-2021, the patient experienced chills at night. On 14-MAR-2021, morning the patient experienced dizziness, nausea, she couldn't stand up and fainted (dead weight) and she reported that she was a dead weight and she didn't have control of bladder and urinated on herself (she was lying in a pool of urine. Also her heart rate went up to 84 b/p per min after she fainted and lasted for the whole day, next day it came down to 74 b/p. Her normal heart beat were 64 b/m. She was nauseous and dizzy for the past 3 weeks. Laboratory data included: Heart rate (NR: not provided) 84 (units unspecified). On 15-MAR-2021, Laboratory data included: Heart rate (NR: not provided) 72 (units unspecified). Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 64 b/p. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abnormal heart beat on MAR-2021, and bladder control lost/urinated on herself, chills, and nausea, and the outcome of dizziness, fainting, didn't have appetite and couldn't stand up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210420179-COVID-19 VACCINE AD26.COV2.S-Fainted. 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.

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.

Heart palpitations. Left arm numb where received vaccine numb and still is over 2 weeks later. Left forearm and finger pain. Insomnia for two weeks and still have it.

Patient states she received the Johnson & Johnson COVID vaccine on April 3rd. Patient states on April 8th she went to her dentist for cleaning and do not expiring any gum bleeding at this time. Patient states 2 day ago (April 19th) her gums were bleeding so bad that she could not see her teeth and patient states she had a nose bleed as well. Patient also states she was experiencing headaches. Patient presented the the Emergency Department on April 21st . Patient was found to have thrombocytopenia (PLT = 2). Patient was admitted to Hospital on April 21st (as of April 23rd, patient is still admitted). Hematology was consulted for further management of thrombocytopenia. Patient received 2 platelet transfusions, IVIG x 2 doses, and is receiving corticosteroids.

got it April 10th First day fine, second-day urine dark, third-day fog and disoriented sensation in my head and double vision, and periods of weakness in hands (now coming and going), lack of appetite, extreme thirst, no fever, no vomiting, pains in my thighs and stomach, middle back pain, Hips, pelvis, 9th day: calves so painful and tight I could not get out of bed, figures swelled up to the point that I could not put on my finds, 10th day my calves are very painful (like the soreness that is felt after someone punches you) Especially right calf. The batch number is 206a21a if I can read it from my card.

UNABLE TO WALK; GENERALISED PAIN; VASCULITIS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 13-MAR-2021on right deltoid arm for prophylactic vaccination . The batch was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced vasculitis. Laboratory data included: Pain scale (NR: not provided) 2/10. On 13-MAR-2021, the subject experienced generalised pain. Treatment medications included: paracetamol. On 19-MAR-2021, the subject experienced unable to walk. Laboratory data included: Pain scale (NR: not provided) 10/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to walk on 24-MAR-2021, and generalised pain on 13-MAR-2021, and the outcome of vasculitis was not reported. This report was non-serious.; Sender's Comments: Report not required as per standard procedure as case was assessed as non-serious.

Throbbing pain at injection site and entire arm. Unable to move up without assistance. Pain grew more and more intense. Went to urgent care on unspecified date. NP examined me and discovered a lump in my arm. Both the lump and the vaccination site hurt when she pressed on them. She prescribed presdone and gave me a work order for a vascular ultrasound to be performed on my left arm. I went on unspecified date for the scan. It was discovered that a DVT blood clot had formed in my brachial vein in the left arm. I was then prescribed eliquis, 20 mg a day for 7 days and told not to take the predesone. NP called my pcp, his office immediately called me and asked me to come in as they are concerned about the high dosage of the eliquis.

ANXIETY; HEART RACING; STRANGE FEELING IN LEGS; RESTLESS LEG SYNDROME; NUMBNESS AND TINGLING IN LEFT ARM; This spontaneous report received from a patient concerned a 63 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: 206A21A and 205A221A expiry: 01-JUN-2023) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced strange feeling in legs. On 07-APR-2021, the subject experienced restless leg syndrome. On 07-APR-2021, the subject experienced numbness and tingling in left arm. On 13-APR-2021, the subject experienced anxiety. On 13-APR-2021, the subject experienced heart racing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from strange feeling in legs, restless leg syndrome, numbness and tingling in left arm, anxiety, and heart racing. This report was non-serious.

First experience in life of severe chest pain, 2 waves in a row, < 30 seconds. No shortness of breath, no radiating pain, no other symptoms. Admitted for 1 night through ER 4/20-21/2021. Continued to have mild chest pain in hospital and since discharge. Suspected issue is coronary artery spasms. Visit to private Cardiologist scheduled for 5/3/21 for follow up.

Nervous system impairment severe dizziness syncope no balance 12 days as impatient, received solumedrol antivert and 5 doses of IVIG

As soon as I got the shot, I immediately had a metallic taste in my mouth. I had a weird sensation in my nerves in my right arm and a little all over my body. I think the shot may have hit a nerve in my arm. Two weeks after the shot I was very pale, and my stomach was very upset. I had a headache and abdominal pain. I felt very ill so I didn't eat or drink much that day. The smell of food made me throw up and felt really bad for 24 hours. I did not eat much for three days and it helped my nausea and I recovered after four days I still had the unusual feeling all over my body. I got some IV therapy twice and it helped. It did start to fade over time and I finally started to feel normal after a month. I am fully recovered now.

I experienced at 12am after my vaccine, got a spasms, took sublingual medication. Three days after I felt really tired and fatigued. On 04-08-2021, I started to have tachycardia and high blood pressure. I went to the ER where they performed triponents, did a CT scan of my abdomen and a chest x-ray. I still continue with tachycardia to this day.

4/11 11:30 vaccination 11:40 I felt had a head rush and my heart started pounding like it never had before. I reported back to the EMTs on site. They monitored me. After another 10 minutes, I was not feeling better, nauseous. My BP rose and I went into a fibrillation. They transported me at that time to the ER. The Afib went away on its own. It was probably an hour at the mobile clinic and ER ride; by the time I had arrived my afib had resolved on its own. Discharged Heart palpitations over the next few weeks. The following Sunday, I started to feel like I was going back into Afib. By the time I got there, everything was ok. They sent me home with a heart monitor for 48 hours. I will get the information on 5/7/2021. *5/7/2021 follow up appointment with PCM to find results of HR monitor.

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.

Patient was vaccinated on 4/10/2021, with the Johnson & Johnson (Janssen) Covid-19 Vaccine. On 4/14/2021, patient had a stoke and collapsed, falling on her head & face at approiximately 3pm. No signs/symptoms prior to stroke & collapsing. Patient became hospitalized with internal bleeding in her brain and is still unresponsive. ‘Unresponsive' in this case is defined as but not limited to: unable to be mobile / stationary in a reclined bed postion since the incident / no movement of upper & lower extremities / minimal reactionary response in eyes / unable to ingest food by mouth

that night, work from sleep with rapid heart beat, headache, sweating, nausea, took aspirin, drank more water, work just feeling off, slight headache and nausea, and left arm pain, concern of blood clots.

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.

Upon speaking with patient here at the hospital she reports having vaccine on March 31, 2021 and reports experiencing clot that had been previously reported to CDC and she asked that this hospitalization be reported to hospitalization as concerns that it may be related. Patient admitted for possible stroke/TIA symptoms resolving

UPPER CHEST WAS BLACK AND BLUE; CHEST TENDER TO THE TOUCH; CHEST HAD LIKE BROKEN BLOOD VESSELS; CHEST WAS TIGHT; 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 past medical history included veins burning, vomiting, redness, burning sensation, swelling, sick, faint, and anaphylactic reaction, and concurrent conditions included multiple sclerosis, non alcoholic, non smoker, sulfa allergy, and steroid allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. Patient was not pregnant at the time of vaccination. Patient had red light therapy as well. The patient experienced drug allergy when treated with teriflunomide, influenza vaccine, interferon, prednisone, cimetidine, and glatiramer acetate. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin for drug used for unknown indication, losartan for drug used for unknown indication, and ibuprofen. On 28-APR-2021, the subject experienced chest was tight. On 14-MAY-2021, the subject experienced upper chest was black and blue. On 14-MAY-2021, the subject experienced chest tender to the touch. On 14-MAY-2021, the subject experienced chest had like broken blood vessels. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from upper chest was black and blue, chest was tight, chest tender to the touch, and chest had like broken blood vessels. 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.

Hemoptysis, flank pain, bilateral leg pain, headache. Found to have thrombocytopenia of 44, extensive bilateral PEs, and nonocclusive aortic thrombus. Treated with IVIG x 2 days and argatroban. Course is ongoing at ~48 hours since presentation.

Patient went to ER 4/4/21 with severe headache, inability to stay awake. CT scan of the head revealed multiple areas of SAH (unexplained no head injury) and a very large ruptured MCA aneurysm. Patient was COMPLETELY asymptomatic prior to vaccination. The aneurysm was repaired with success but the cerebral hemorrhages kept appearing - unexplained. Cerebral edema became so severe (midline shift up to 9-10mm) neurosurgery ended up performing a burr hole craniotomy to relieve pressure as well as placement of a ventriculostomy. This patient later ended up with severe vasospasms which results in an ischemic stroke of the L frontal lobe. Patient later died in a rehabilitation facility, all of this secondary to the Janssen vaccine. This vaccine should not be administered until further studied. This was a healthy 63 year old woman. Vitals always WNL labs WNL very active, BMI WNL. Absolutely NO comorbidities. A lifelong nurse who raised 2 nurses of her own. These events took place for over a month. The trauma not only the patient has experienced but her family is unforgivable.

The injection did hurt quite a bit more than other injections I have had in the past but it began to feel better and I sat in a chair and was on my phone to send a message, spoke to a stranger who was looking for where to go, and was ok until the feeling of fainting began 10 minutes after the shot. I put my head between my knees but it did not help so I called for help and eventually was helped onto the floor to lie down which began to help. I had vision trouble and hearing trouble and could not speak. I was told my neck became bright red as my face grew white and my hands twitched and my eyes rolled around. I found out later that I had also peed my pants. I have fainted only once before in 1989, and found this reaction pretty frightening although I do not believe it happened as a result of anxiety or fear, the adverse effect itself was frightening and unexpected- not listed on any paperwork I received and was not aware it could occur.

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

04/25 I had an upset stomach and at that point I notice that my blood pressure was really high and I took my blood pressure and it was 190/110 I thought it would go down it didn't on 04/29 I went to urgent care and they did run test and the did prescribe me the L-Prill I started taking it right away and it did take my blood pressure down 50 point they told me to go visit my PD and I ended up going in on 5/3 and they ended up doing a full check up and full blood work. and we talked about some course of action, I talked to them about the allergy medication that I was taking and they told me to stop taking the allergy meds, I felt my blood pressure racing when I went to lay down ( also allergic to wheat ). I determined that when I get into bed there is no reason for my blood pressure to be this high and 10 years ago I had another reaction to allergies meds. so I stopped taking it on 5/03, I still have upset stomach but I think it something that I ate. Since I stopped taking the meds my blood pressure has been yester, yesterday it was 144/71. In general I feel good.

Pain in left shoulder blade, back, shoulders and chest, felt like weight on chest. Adjusted meditation to capsule from tablet, blander diet, stress test. Symptoms decreased.

Headache, dizziness, chills, fever, eye movement, nausea, chest pain, muscle weakness and pain, falls.

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.

ISCHAEMIC STROKE; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female of unspecified race and ethnic origin. The patient's weight and height were not reported. The patient was healthy and had no underlying diseases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the patient experienced headache and fatigue for the first 24 hours. On 16-JUN-2021, the patient experienced ischaemic stroke and had visited emergency room (ER).The patient was treated with TPA and the stroke symptoms were resolved The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ischaemic stroke, and the outcome of headache and fatigue was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210651351, covid-19 vaccine ad26.cov2.s, Ischaemic stroke-This event is considered Un assessable. 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.

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

FLU-LIKE SYMPTOMS; UTERINE BLEEDING; SEVERE BRUISING; TIGHTNESS IN CHEST; STRANGE FEELING IN HEAD; 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 anemic, menopausal since 2006, asthma, and irritable bowel syndrome. The patient was not pregnant at the time of reporting. The patient had a history of steroid shots in shoulders, knees and back. The patient had never experienced any uterine bleeding or bruising after receiving the Kenalog (triamcinolone) in the past. The patient never had any of these symptoms in the past. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid on 26-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: triamcinolone acetonide (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 26-MAR-2021, the patient experienced severe bruising and uterine bleeding after receiving the Janssen COVID-19 vaccine. The bruising and bleeding started after she received a Kenalog (triamcinolone) shot. The patient experienced tightness in the chest the same day she received the vaccine and her head felt very strange like it was not part of her body. On 27-MAR-2021, the patient felt fatigue, flu-like symptoms and fever. The fever lasted for 5 days. The patient also had a headache for 2 weeks. The patient recently observed the bruising which had continued to increase. She reported this to her HCP who did some testing. The patient received a Computerised tomogram head scan which showed no blood clots. She used her Albuterol (salbutamol) inhaler and nebulizer to help with chest tightness which resolved. The patient would receive the test results sometime next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with triamcinolone acetonide was not reported. The patient recovered from tightness in chest, had not recovered from severe bruising, and the outcome of uterine bleeding, strange feeling in head and flu-like symptoms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210702690-covid-19 vaccine ad26.cov2.s-uterine bleeding. 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: CONMEDS-OTHER SUSPECT DRUGS

PATIENT BECAME VERY LIGHTHEADED MOMENTS AFTER GETTING VACCINATED. SHE HAD A HARD FALL OUT OF A CHAIR IN THE WAITING AREA. SHE WAS OFFERED COLD WATER AND COLD COMPRESS FOR NECK AND FORHEAD IN WHICH SHE DENIED THE COLD COMPRESS. SHE ALSO DENIED LAYING FLAT ON BACK ON A BENCH IN THE WAITING AREA AS WELL. I ALSO CHECKED BLOOD PRESSURE AND PULSE VALUES WHICH WERE LOW. SHE SAT IN THE WAITING AREA FOR APPROX 45 MINS. A STORE MANAGER WAS CALLED PER PROTOCOL AS WELL

Pt was moved from vaccine area to observation area to a chair pt then passed out onto a table next to hair eyes wide open non responsive with faint to no pulse. 911 was then called and a dose of epipen given which brought the patient out of the unresponsive state within 30 seconds. Pt was then helped to the floor and observed until ems arrived.

About 5 days after the shot, I was still having a lot of fatigue, but I developed severe headaches, like someone was sticking a knife in my head, and I was having bouts of light headedness. I am a person who never has headaches. Because the issue of the blood clots came about with the J&J, I ended up, because of the severe headeaches had to have a brain MRI to rule out the blood clots. I did not have any. But the headaches were very much a problem and the light headedness. I had to leave area for the summer, and now came to another area. I still was not feeling right. The bad headaches subsided, but I was till getting the lightheadedness with a slight headache after almost every day. II also had a full blood panel done on April 8. It is showing my thyroid is low and now have to be on Thyroid medication. I just had full blood work done in March, and all my blood work was normal. I also have noticed that my arthritis in my hands is exacerbated. And sometimes my feet go numb when I am riding my horse. And in the morning, my arms and legs ache. My BP was a little elevated as well. I never have had high blood pressure. I am 63 years old and have always had great health. Since I had the covid shot, I have had nothing but problems. If I had to do it over again, I WOULD NOT have gotten the shot. I only got it because my daughter was having a baby and insisted even though I had the virus back in October.

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

It began with being light-headed and difficulty walking on March 25th. On April 14 I had my first "seizure like" event as I was going to teach school. I had Upper arm tremors and difficulty speaking and walking. Sent by ambulance to the emergency room. Released later that day and given meds for UTI which was later deemed a misdiagnosis by Dr. Didn't go to work as I continued to have difficulty walking and had headaches and overall weakness. Saw Dr. on April 20th. Had to use wheelchair to attend the office visit and was given blood tests to see what was causing my condition. Had high blood pressure. She also advised me to see a neurologist and heart doctor. ON April 20th had to go back to ER as I had the smae seizure like event!On April 22nd I visited Dr. office (heart doctor). Blood pressure was off on this day as well and I stayed at clinic until it was better. Was given a heart monitor to wear for 24 hours. Heart was fine after wearing the monitor. Visited Neurologist and was given EEG and CT CTA tests. All came back fine.

Patient seemed to pass out. Reported fear of needles. Happened about 13 minutes after vaccine was administered. She wasn't responsive to voice for short time period with a blank stare. Once she snapped out of it, she jerked and then we tried to make her more comfortable. EMS was contacted to verify patient was okay. Patient did not want to go to hospital or ER.

I experienced fever, chills, tiredness, and headache approximately five hours after administration of the vaccine on 3-10-21. Symptoms became severe within 30 minutes thereafter, at which time I experienced difficulty standing. After five hours with no improvement, I used my home blood pressure monitor to check my BP and HR; BP was high for me, 120/90 sustained, and HR varied between 135 and 150, with 143 being the most consistent value after multiple readings. I seemed to be experiencing a "severe allergic reaction" per the instructions I was given and called 9-1-1. I was transported to Hospital, treated in ER, and then admitted to the intermediate care unit. I was discharged to home on 3-12-21.

Janssen COVID vaccine was administered on 3/13/21- patient was screened twice and denied receiving any vaccines in the past 2 weeks. after administration it was noted today (3/15/21) that the patient received the Moderna COVID vaccine (one dose) on 3/4/21. I attempted to reach out to patient to discuss and noted that she is admitted to Hospital for a NSTEMI. Per chart notes patient reported symptoms of fever, nausea, malaise on 3/13/21 after vaccination. The next day 3/14/21 developed syncope and chest pain. Patient reported to emergency room and was admitted with NSTEMI

3/8/2021 - 9 hours after vaccine had severe chills for 4 hours, headache, nausea - stayed in bed for 1 day and then seemed fine. 3/16/2021 - late afternoon - developed swelling in left foot along with rash on both legs from the knee down to toes. on 3/17, swelling on both feet with rash and swelling of left hand.

My blood sugar went to 364 and stayed there all day and then that night it was 267 and then it was the next morning 202 and then it went to normal in the low 100s. Hives in the crook of my right arm. Burning, itchy little red bumps. I couldn't swallow but I think that was from the high blood sugar as my mouth was very dry. I felt like I had a really bad cold, my head felt foggy.

Site: Pain at Injection Site-Mild, Systemic: patient stated \"palpitations\"-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient received Janssen covid vaccine 3/12/21 at 5:04pm to her left arm. Due to patient's response on the screening questions, patient was to be observed for 30 min. At 5:30pm patient complained of numbness to arms and face. At 5:34pm patient state she had palpitations. Rph on duty advised husband to take her to ER asap. For next 3days, rph on duty attempted to call the patient multiple times throughout the day but the phone would go straight to busy signal.

Patient received the vaccine and reported approximately 3 minutes later that her heart was racing. Blood pressure was ~188/90 and pulse was 110. She stated that she does not typically have high blood pressure but that she does have anxiety. She had brought her Xanax prescription with her. She took one tablet of Alprazolam 0.25 mg while here. Several minutes passed and blood pressure was now ~170/90. After 30 minutes of being here, she was feeling much better. Before going home, blood pressure was 158/90 and pulse was 82.

3/17/21-Pattern of red bumps (rash) in a circular pattern, itch and I applied alcohol at 9:30pm 3/18/21-Contacted Physician because of welping that occurred on the site Dr viewed via Zoom session and sent in a prescription of Prednosone (5) pills, suggested benadryl and hydrocortisone cream 3/26- No improvement asked the doctor to prescribe a cream of Triamcinolon Acetonide cream 0.1% 3/26- Visit with Nutritionist and made her aware of the incident relative to Chronic condition of Diabetes Prednosine makes blood sugars high 3/31- Vast improvement of site but not completely clear but shrinking in size

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

Resident had an Anxiety attack, passed out approx 5 minutes after administration. Vital signs were taken, blood pressure & pulse elevated, temperature & oxygen levels okay. Patient was sweating. Approx 2 minutes later, patient became alert & oriented x4. Patient stated that she has a fear of needles. Patient relayed having similar symptoms in the past. Patient has hx of hypertension. No further care given. 911 was called at the time the patient became unconscious. EMS arrived approx the same time as the patient becoming conscious. EMS ran vitals. EMS did not transport. Patient is stable and walking. Patient left location after 30 minutes of monitoring.

Patient reported feeling heart palpitations and fatigue and anxiety Patient provided with water and seen by medical team Patient stated symptoms have resolved and refused medical transport and signed Medical form

Experienced light-headedness, heart palpitations March 31st, 6 days post receiving the Covid 19 (Janssen) vaccine. Pulse rate in the 170 range for around 3 hours. Blood pressure elevated with the systolic in the 150's to to 170 range. Tachycardia noted during Emergency room stay. Labs taken as well as EKG.. All within normal range. Felt some mild tremors to head all the way down to my left foot. This was intermittent and lasted around 20 minutes. Had cardiac monitor applied for 24 hours and saw Cardiologist on April 8th. EKG at this time was within normal range and vital signs all within normal limits. No other symptoms noted since the one and only event on March 31st.

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.

Patient received J&J COVID Vaccine 4/12/21 around 12:05 pm. Patient waited in waiting area and complained to her husband about feeling dizzy and might faint. Pharmacists went to aid the patient and lay her down gently, monitored her blood pressure which was high at the time, once patient sat up her BP decreased, it fluctuated the whole time, EMT was called and once they arrived and monitored her, they said the cause of her fainting was due to her blood pressure. Patient was alert and responsive the whole time. Patient was unsure if she took her BP medicine this morning.

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.

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.

During the night I felt like I had a fever, chills and body aches. And the next morning after I woke up needing to use the restroom, got up but started feeling dizzy and fainted for about 2minutes. EMT was called and once they arrived I began vomiting and my BP was super low. During the transport to the hospital I vomited again and was given antinausea meds. At the ER I was given IV fluids, chest xray, EKG and blood was drawn and I was released after a few hours of monitoring

PULSE RACING; BLOOD PRESSURE WAS UP; FELT ANXIOUS; This spontaneous report received from a patient concerned a 64 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced felt anxious. On 27-MAR-2021, the subject experienced pulse racing. On 27-MAR-2021, the subject experienced blood pressure was up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulse racing on 2021, and had not recovered from blood pressure was up, and felt anxious. This report was non-serious.

3/30/2021: lost consciousness for hours at a time for 36 hours extreme pain in lower back and side 4/10/2021 extreme pain in lower back, down left leg, shin, top of left foot. Could not stand or walk or lift anything without enormous difficulty. Restricted movement. Pain in all joints throughout body. Ongoing.

HEART RACING; SLIGHTLY DIZZY/LIGHTHEADED; ANXIETY; 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 pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced heart racing. On 09-APR-2021, the subject experienced slightly dizzy/lightheaded. On 09-APR-2021, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart racing, slightly dizzy/lightheaded, and anxiety. This report was non-serious.

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.

POTENTIAL DEEP VEIN THROMBOSIS; SMALL BLOOD CLOT; ANKLE CALF BOTH SWOLLEN; This spontaneous self-report was received from a patient and concerned a 64 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included no known allergies and smoker. Other relevant history included no alcohol intake, nor any drug abuse/illicit drug use. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration and dose not reported, batch number: 1805029, and expiry: unknown) administered on 14-MAR-2021 on the left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient had "ankle calf both swollen" indicating potential deep vein thrombosis. She went to hospital emergency room, and "HCP confirmed small clot". The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from "ankle calf both swollen" and had not recovered from potential deep vein thrombosis and small blood clot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a spontaneous report of a 64 year old female who developed a swollen calf and ankle swelling indicating a potential deep vein thrombosis 3 days after receipt of Janssen COVID 19 vaccine. Patient was seen in the emergency room by HCP, who confirmed a small clot. No other medical history was reported but patient was noted to be a smoker, reported as 2x a year. Age increases the risk of deep vein thrombosis, but the there is insufficient other details to make a meaningful medical assessment.

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.

One hour after getting the vaccine,my face and neck swelled,but I had no breathing problems. Then 4 days after vaccine I experienced a strange buzzing feeling in my brain,and Tinitus ring in my ears,with sinus pressure. It lasted less than 10 minutes,and stopped. On the fifth day after vaccine,I noticed High Blood Pressure symptoms,and went to ER. On 8th day after vaccine,I I went to hospital for High Blood pressure again,and was put on medication!

Slight dizziness within 10 minutes after injection. Dizziness continues daily for brief periods with slight nausea. Low body temp - 95.8F average

Subarachnoid hemorrhage on 4/20/21. She began complaining of strong pain that caused vomiting, swelling, and hospital visits from about 3 weeks ago. We thought it was her blood pressure but it was consistently normal. She described it as the worst pain she has ever felt.

CLOTS ON RIGHT LEG; HEADACHE; PRESSURE ON BOTH LEGS; PRESSURE ON HANDS; This spontaneous report received from a patient via a company representative concerned a 64 year old Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient had experienced headache after vaccination. On 27-MAR-2021, the patient began to experience intermittent pain on right leg. On 30-MAR-2021, she experienced headache again and was still having leg pain; she visited the Emergency Room (ER) and was admitted on 30-MAR-2021. On 02-APR-2021, the patient experienced clots on right leg. On APR-2021, a catheter was placed in catheterization procedure and her right leg vein was unclogged of a clot. A second clot did not require removal because the vein had already unclogged itself after medication. The patient was administered unspecified anticoagulants. She was discharged on 5-APR-2021 and was prescribed ticagrelor which was then changed to clopidogrel. On 18-APR-2021, the patient experienced a headache again and feeling of pressure on legs and hands. Patient was advised to visit ER. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from clots on right leg and intermittent pain on right leg on 02-APR-2021, recovered with sequelae from headache on 19-MAR-2021, and had not recovered from pressure on both legs and pressure on hands. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 64 year-old Hispanic or Latino female with history of high blood pressure and diabetes was hospitalized for clots in her right leg 13 days after receiving the Janssen Covid-19 vaccine. Concomitant medications were not reported. On the day of her vaccination, she experienced a headache. Ten days later, she began to experience intermittent leg pain. Three days later (ie, 13 days post vaccination), she went to the emergency room (ER) and was admitted to the hospital. During the hospitalization, a clot was removed via catheterization and she was administered unspecified anticoagulants. A second clot resolved on its own without surgical intervention. After 6 days in the hospital, she was discharged with ticagrelor which was later changed to clopidogrel. She recovered from the clots. Thirteen days after discharge, she began to experience headache and "pressure" in both legs and hands. She was advised to go to the ER; no further information was provided. Based on the limited information, the relationship of the serious events with Janssen Covid-19 vaccine is considered indeterminant. Additional information is being sought.

Department of Health received a call from her sister, in response to a call/letter/text sent out to all recipients of the Janssen vaccine. She stated that her sister received the J and J vaccine on 3/12/21 (confirmed in State vaccine system) at the hospital where she receives her oncology care. She reported the following: "She had a massive stroke on MARCH 27TH, 2021 leaving her paralyzed on the right side with the inability to speak, swallow, or see. She was initially diagnosed with Ovarian cancer approximately three and one half years ago. She was chosen for a study with Pharmaceuticals and her diagnosis was changed to a vary rare form of cancer called clear cell carcinoma which originates in the gynecological area. She did have a previous stroke approximately three years ago, (just after original diagnosis) but she was on a different course of treatment at that time...Oncologists have explained that this most recent stroke event would not be considered a side effect of her current treatment routine. She wanted to bring it to the attention of the health department in case it needs to be looked at more closely by the J&J research/scientific team. She passed away on 4/5/21. Her current treatment consisted of palliative chemo only. " Decedent was a resident but was vaccinated in another state. After the CVA she was brought to the hospital and subsequently transferred to the Medical Center where she died on 4/5/2021. Sister is willing to speak with any investigators if deemed necessary.

4/23/2021 felt rundown & tired. 4/24/2021 flu like symptoms, sore throat, high bp 152/98 . So far no fever if my thermometer is accurate. 97.8.

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.

Two days after my vaccine, on March 23 at approximately 2 AM, I had to call 911 because my heartbeat was rapid and irregular and had never happened before. I was concerned it was a result of the vaccine because it was two days after the vaccine. An emergency vehicle came took me to the hospital and they said I had atrial fibrillation and they had to reset my heart by jumping it. Very frightening.

CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; O2 LEVEL 85%; 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 Crohn's disease, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included vedolizumab for Crohn's disease. On an unspecified date in 2021, the patient experienced flu-like symptoms (fever 100F for about two days, very torturous and unusual headache, body aches). It was reported that the patient spent five days sick in bed. On an unspecified date in 2021, the patient took Tylenol but it did not relieve the pain and nothing seemed to help patient except getting some rest. After the vaccine administration, the patient stayed at home for 14 days, she double-masked, she had not been going out very much. On 11-APR-201, the patient experienced oxygen level 85%, felt ill and went to instant care and did Polymerase chain reaction test (PCR). On 13-APR-2021, the test result came positive. The patients Covid-19 symptoms included cough, fever (100F low grade fever) and oxygen (O2) level 85%. On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 85 %. Laboratory data included: PCR (NR: not provided) Positive. In 2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from O2 level 85%, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210427837-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Patient was driving on 3/24 when her vision became blurry in her left eye. She saw her eye doctor on 4/21 and was sent to a specialist. On 4/23 she was diagnosed with a blood clot in her left eye. She is to begin eye injections for treatment.

I had 3 SEVERE epistaxis episodes 4/16-18/2021 requiring ER admissions. #1-4/16 resolved nose bleeding with nasal clamp, #2-4/17 controlled with nasal tampons and 1 unit of platelets, #3-4/17-18 ENT placed bilateral nasal packing. The packing was removed on 4/23 with no more bleeding so far. I've NEVER had nose bleeds! I was diagnosed with storage pool disease in 1992 which was reconfirmed in 2004. I had excessive bleeding during child birth in the late 80's. I bruise easily and need medication or platelets with major surgery or trauma. No issues with dental or minor procedures. I had a TeleMed visit with Hematology today and well be having labs drawn early next week.

Immediately post injection severe stinging occurred. Three days later night sweats bodyaches low-grade fever diarrhea intense headache which lasted three weeks. Headache and bodyaches continued with night sweats for an additional two weeks.

PULMONARY EMBOLISM/RIGHT SIDED MID BACK PAIN; This spontaneous report received from a health care professional concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease. The patient was previously treated with infliximab for Crohn's disease. The patient experienced drug allergy when treated with infliximab (Remicade). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 31-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included vitamins nos, azathioprine, dicycloverine, and mesalazine for drug used for unknown indication. On 22-APR-2021 by evening, the patient experienced right-sided mid-back pain and shortness of breath and was presented to ED (emergency department) on 23-APR-2021. The patient's pain was sharp and worsened with coughing and deep inspiration; she felt that she was taking shallow breaths. Upon ED (emergency department) presentation, there was no shortness of breath, chest pain, dizziness, fevers, dysuria, or abdominal pain. The patient had reproducible pain on her right mid-back area. There was some mild diffuse tenderness in her abdomen, but it was reported that she always had a tender abdomen due to Crohn's disease. The patient had no peritoneal signs and had no recent travel history. On 23-APR-2021, the CTA (Computed tomography angiography) of chest was done with and without contrast and found out central and peripheral pulmonary emboli in the right lower lobe. The patient had no CT (computerized tomography) evidence of right heart strain. The patient's ground glass opacities within the right lower lobe was somewhat band like in appearance and concerned for early pulmonary infarcts. It was reported that this might also relate to sub segmental atelectasis or less likely an inflammatory/infectious process. The patient had also small right pleural effusion; no acute inflammatory process in the abdomen or pelvis. On 23-APR-2021, the patient's platelet count was 252 k/mcL and was tested negative for covid test. The patient was diagnosed with pulmonary embolism; she consulted hematology/oncology specialist and recommended with initiation of argatroban for treatment of pulmonary embolism. The patient was admitted to inpatient on 23-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism/right sided mid back pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0;-covid-19 vaccine ad26.cov2.s-Pulmonary Embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient reported that she had a history of fainting after receiving other vaccines, so she had her friend drive her and got the vaccine administered in her car. A few minutes after getting the vaccine, the patient appeared to have a vasovagal episode where she stared off into the distance and stopped responding to questions for about 30 seconds to 1 minute before coming to. She reported having some tingling in her fingers and feeling a little weak afterwards. Provided the patient with a wet cloth for her forehead and some candy. Patient was a little shaken up but seemed to be back to normal in a few minutes. Contacted EMS just to be sure, and they checked her pulse and blood pressure, which were a little elevated but within normal limits. Patient said she was feeling better and did not need to go with them to the hospital. After waiting a few more minutes, she reported that she was feeling mostly back to normal and her friend drove them back home.

I started to get Migraines the day of the shot. I was nauseous and I did have seizure which only happens twice a year. My seizures are not always triggered by migraine. I have a history of hives and I get reactions to bites. I decided to get the Johnson & Johnson because it seemed to be a better option. Ten days after the vaccine I had a Migraine that was so bad I had to go to the doctor. When I got there my blood pressure was high. I was given some migraine medicine, but it did not help. The migraine was there for four weeks after the shot. I still got a numbing headache after the shot until five weeks after the shot.

She developed a DVT <4 weeks after receiving the vaccine (first became symptomatic 4/30). She has a potential alternative cause in that she was taking oral estrogen but no other provoking factor.

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

Same day of vaccine around 3:30pm I started to shiver I showed a fever of 99 by 4:00pm I had incontrollable shaking with a fever 104.2 fever and sever headache. I had muscle pain on my back and neck. I had violent vomiting multiple times. I felt asleep and about 2 hours later I woke up and I had an SVT episode where my heart rate was beating was up to 200 by then the fever had gone down to 99. I called the nurse line.. they told me to call an ambulance. I called the ambulance they took me in they immediately put fluids they monitored me for 7 hours and they sent me home afterwards. I slept for 24 hours. Then on 4/27/2021 I had another SVT episode where my heart rate went up to 176 beats per minute. This lasted for 2.5 hours but I did not have to go to the the ER.

3 days after vaccination with COVID-19 Janssen, patient developed acute right leg pain and swelling. She did not present to the office until 5/11/2021. She was sent to the ER which showing extensive acute DVT and bilateral pulmonary embolism.

BOTH LEG PAIN; HIVES / WORSENING HIVES; GASTROESOPHAGEAL REFLUX DISEASE; FELT LIKE HAVING HEART ATTACK; SLEEP INTERRUPTIONS; FLU-LIKE SYMPTOMS; ACHES; NAUSEA; 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 neuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Investigation (NR: not provided) blood clots which were negative. On 24-MAR-2021, the subject experienced flu-like symptoms. On 24-MAR-2021, the subject experienced aches. On 24-MAR-2021, the subject experienced sleep interruptions. On 24-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced felt like having heart attack. On 27-MAR-2021, the subject experienced gastroesophageal reflux disease. On 30-MAR-2021, the subject experienced hives / worsening hives. On 04-APR-2021, the subject experienced both leg pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, aches, felt like having heart attack, sleep interruptions, gastroesophageal reflux disease, hives / worsening hives, and nausea on 2021, and both leg pain on APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

I had oral surgery four days before the vaccine with laughing gas and Novocain which lasted four hours. The morning after the vaccine I felt lightheaded and weird. I had heart palpitations and I was queasy. I started to walk back to my bedroom. The next thing I knew I woke up on the floor after passing out. After that I felt like my body was crumpled and I was disoriented. I could barely walk but I made it to the couch, and I had bumps in the front and back of my head near my ear. I was in a lot of pain and I think I was in shock. My foot was painful, and I saw a foot doctor. I had a doctor?s appointment and they did an EKG and they sent me to a Neurologist. It has been seven weeks I still have dizziness and nausea and it is hard to focus. I also have pain in my knee and my right arm.

Started with severe chills and shakes. Nausea and diarrhea. Severe headache, chills and fever (101.4). Arrived home about 7pm and fell asleep for 3 hours. Blood pressure was up to (159/82). Pulse (120). Unable/no desire to move. Called facility around 11pm with concern instructed to alternate Tylenol and Ibuprofen for fever. Started Tylenol and Ibuprofen around 1am (once I had some delivered). By morning only had a slight headache but was gone by late afternoon. Continue to have fatigue.

Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Anxiety-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Mild, Additional Details: Patient experienced high levels of apprehension and anxiety pre-administration. After 15 minute observation period, pt was visibly anxious and reported a "weird" feeling on her left side, local to administration and radiating from left shoulder. Pt BP was read as 173/109 and 5 minutes later 168/95. Pharmacist advised pt leave site due to perceived anxiety/worry, measure again in an hour, and report to ER/Urgent care if BP still above 120/80. RPh will follow up with pt following day.

Janssen COVID-19 Vaccine EUA: patient presented to outside facility one day after vaccination reporting confusion, vomiting,and abdominal pain. Found to be hypotensive (blood pressure 70/40 mmHg) in DKA with electrolyte abnormalities and ventricular arrhythmias requiring shocks. Patient initiated on blood pressure support, airway protection, insulin, intravenous fluids, antimicrobials, electrolyte management and transferred to this facility for a higher level of care. Patient improved, DKA and shock resolved, electrolytes normalized, and was discharged five days later medically stable.

I had about 20 min of being fuzzy headed. I couldn't remember the names of people I've known all of my life, including my best friend and boss. I couldn't think of a town I had vacationed to. My daughter could tell by looking at me that something was wrong. My nephew took me to the ER. They CT Scan, EKG, COVID test, blood work and took my vitals. My BP was 196/84. They gave me IV meds to decrease my BP. They needed to do an MRI, so I was sent by ambulance. They didn't find anything new and my BP had gone down by that time. I was sent home around 4:30am. I was told to follow up with cardiologist and neurologist. I see the cardiologist on 6/14, but I can't get in with the neurologist until August. I was also instructed to rest and I'm still pretty fatigued, so that's what I've been doing.

HEART BEATING FAST; HEART "SKIPPING BEATS"; ACHING JOINTS/JOINTS HURTING; NAUSEATED; HURTING ALL OVER; DIZZY; COULDN'T SLEEP; STOMACH FELT "BLOWN UP"; NO APPETITE; HURTING "DOWN REAL LOW" IN ABDOMEN; HAD TO URINATE ALOT; SHAKINESS; ITCHING ARM; FATIGUE; WEAKNESS/NO ENERGY; SORE ARM; DID NOT FEEL WELL; CHILLS; BREASTS SORE; SEVERE HEADACHE/SORE SPOTS ON HEAD; UNDER ARMS SORE; SUSPECTED COVID; 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 dental surgery, and left arm broken. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced suspected covid. On MAY-2021, the subject experienced breasts sore. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced did not feel well. On MAY-2021, the subject experienced sore spots on head. On MAY-2021, the subject experienced under arms sore. On 11-MAY-2021, the subject experienced shakiness. On 11-MAY-2021, the subject experienced itching arm. On 11-MAY-2021, the subject experienced weakness/no energy. On 11-MAY-2021, the subject experienced sore arm. On 11-MAY-2021, the subject experienced fatigue. On 11-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced hurting all over. On 12-MAY-2021, the subject experienced dizzy. On 12-MAY-2021, the subject experienced couldn't sleep. On 12-MAY-2021, the subject experienced stomach felt "blown up". On 12-MAY-2021, the subject experienced no appetite. On 12-MAY-2021, the subject experienced hurting "down real low" in abdomen. On 12-MAY-2021, the subject experienced had to urinate alot. On 12-MAY-2021, the subject experienced aching joints/joints hurting. On 12-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced heart beating fast. On 18-MAY-2021, the subject experienced heart "skipping beats". Treatment medications (dates unspecified) included: ibuprofen, naproxen sodium, and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate. The action taken with covid-19 vaccine was not applicable. The outcome of the severe headache, shakiness, weakness/no energy, fatigue, sore arm, itching arm, did not feel well, hurting all over, hurting "down real low" in abdomen, nauseated, dizzy, chills, couldn't sleep, stomach felt "blown up", no appetite, had to urinate alot, heart beating fast, heart "skipping beats", breasts sore, aching joints/joints hurting, sore spots on head and suspected covid was not reported. This report was non-serious.

Chills, pain behind eyes, fever, body aches, nausea, vomiting, diarrhea, chest restriction, bloating, fatigue

Pt given Janssen vaccine per ususal protcol and asked to wait in designated chairs for 15min. After about 7 mins pt came to counter saying she had a pain in her neck and her chest was tight. Pt instructed to sit down, was alert, talking and breathing on her own. 911 was then called so pt could be looked at. EMS arrived on scene and transported pt

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.

Patient became ill after J and J vaccine. She was seen in the ER on 5/1/21. C/o were temp > 100, headache, fatigue and myalgia. She presented to the ER on 5/2/21 with multiple complaints. Since that time she developed cellulitis, elevated LFTs and was seen by GI/hepatology. She developed peripheral edema and has been treated with diuretics. Her h/h dropped and hematology referral made. She did not receive the vaccine at this clinic.

Four days after receiving her Covid vaccination patient started bleeding vaginally. Had blood clots and large amount of blood and it lasted 2 weeks. Patient has been post-menopausal for 10+ years.

Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Diagnosed with "costochondritis" by hospital-Severe

She got her vaccine on Tuesday, just felt a little bit tired and achy. She had a dentist APT on Thursday and they took her BP and it was very elevated, which she normally has a low BP. Said it was 210/109 and thought it was the machine and retook it and it was again elevated at 206/104 (approximate #'s). She has subsequently taken it at home and it was still elevated yesterday was 142/80, then again on left arm was 146/89. The most recent one this morning was 139/90. She is a retired nurse, and knew to take it on the opposite arm. The dentist informed her to monitor her blood pressure. She still has joint achiness from the vaccine and fatigue, not quite the pep that she had prior. She took a diuretic last night and rechecked her BP this morning so her readings are after the diuretic.

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.

Systemic: Stroke-Medium, Additional Details: Caregiver mentioned patient received vaccine on 6/4/21, and was admitted to hospital for a stroke on 6/8/21. Please note this was 4 days after the vaccination, unsure if this is related to vaccine or other health factor. However, have still reported per protocol.

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.

On the same day I got the vaccine and the next day, I had fever, body aches, and malaise; I was in bed for 2 days. I had a lack of energy that was worse than it had been before the vaccine. On or about 4/14/2021, I woke up at about 2:00AM with chest pain, pain in the left shoulder and in the left side of the neck. The symptoms subsided after some time. I had low oxygen saturation levels; I knew this, because I used a pulse oximeter that had been used by my late husband. The low oxygen saturation levels have been ongoing ever since, and I have had periods of rapid heart rate and oxygen levels that are even lower than the low levels I have experienced since the vaccine. I have also had periods of chest pains at times, so my PCP referred me to both a pulmonologist and a cardiologist.

J and J vaccine: 40 min. after shot, my lower lip began to tingle, then went numb, next my upper lip, next nose felt funny. chest felt tight, no wheezing. Was still at Clinic so I went to Urgent care. I used my albuterol inhaler, chest tightness resolved. Treated in UC with solumedrol, famoditine, 1 liter NaCl. My allergist had me on 2 Zytec, and 2 famoditine the day of shot. Went to urgent care 7/5 for neuropathy. Saw neurologist on 7/8/21. Today is 12 days after the vaccination. My peripheral neuropathy is so bad I can't work. I have constant pain in my shoulder girdle, lower back thighs, calves, feet, hands, and visceral. My PCP won't give my any pain meds, my pain is 8/10.

June 2, 2021 became confused, nauseated and dizzy. Kept asking the same questions over and over. Diagnosed with most likely TIA secondary TGA with J and J vac most likely a contributing factor.

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.

Following immunization patient had a fever overnight and feeling of being "hit by a mack truck" which caused fatigue and she had slept it off. Patient had lump that developed behind left knee two weeks after vaccination. She described the feeling of losing the ability to move her left leg and a feeling of a rip when getting out of her boat. She called her chiropractor who told her to get to the ED and stated she likely had a clot. She was seen in the clinic and was taken by ambulance to the hospital and had a surgery to remove a clot she was told was from her left ankle to her left knee. She had a Boston Scientific Wallstent placed (lot number 25506141) and was hospitalized for a week duration. Patient taking Lasix, blood thinner, aspirin, and antibiotic. She was taken off of work for a month duration.

Initially dizzy and lightheaded after the injection, heart racing, lasted about 30 minutes. 24 hours later extremely tired, no energy, sore upper L arm, nausea, no appetite, talking, reading, writing/typing almost impossible. This lasted for 3 days. Developed a migraine headache(had migraines 30 years ago) that lasted for the following 10 days and then just a normal headache for 2 more days. I took Advil and Tylenol without any relief. Called the nurse at physicians office who told me to increase the dosage and to use only Advil. If it got worse to go to urgent care to get Tordal and/or steroid injection. I didn?t want anymore side effects of medication so I just toughed it out. The injection site became the size of a half of a tennis ball, was red and hot to touch. It is now 18 days later and there is still a small knot and tender to touch. Trouble sleeping through the night also started at the time of vaccine and finally stopped last night. I felt like I was in a dark hole for the first 3 days and was then in a fog for a week. I had blurry vision off and on for the first 3 days and then again on day 5.

Janssen COVID-19 Vaccine EUA About 8 hours after the injection, I started having strong chills. About 10 hours after, I started having an incredibly fast heartbeat that lasted for about 10 hours. I tried some breathing exercises to bring it down, but that did not work. I did not seek medical care as it went back to normal throughout the morning of the following day. But kind of scary. Also had a low temperature of 98 on the scanner thermometer. Normal is 96 something.

Janssen COVID-19 Vaccine EUA Chills and fever of 103.1 degrees F, elevated heart rate (average 91 bpm) during the night of 3/6/21; Sneezing, runny nose. Treated with Ibuprofen and symptoms resolved by morning of 3/7/21.

Patient received Janseen COVID vaccine. The first 1/2 of the vaccine was given easily IM to the left deltoid and then the patient complained of severe arm pain, tensed her muscles, and the last 0.25ml was difficult to inject. Then the patient became hypotensive 90/45, dizzy, and felt like she was going to pass out. She was laid in the supine position, given a cool cloth for her forehead and monitored for approx. 45 minutes. Her blood pressure remained 90/60, 96/56 at discharge. Her heart rate ranged from 55-65, regular. Her son came to take her home as we did not feel comfortable with the patient driving. The patient was continuously monitored by the NPs and APCT. She ambulated without difficulty and was discharged home. She was given information for V-safe to report her reaction and advised to follow up in the ER for any SOB, difficulty breathing, difficulty swallowing, syncope, CP, etc.

Shot at 2:00 pm. Chills at 7:00 pm. Violent shaking from the chills that hurt my back & chest. Headache sore throat, dizzy

pt waiting 15min no problem then return to pharmacy 30 minutes later with facial flushing no other symptoms ask pt to wait longer (gave ice pack) took blood pressure which was elevated and bout 45-1 hr later stilled had flushing and arm seemed bit redder gave 10ml benadryl 12.5/5ml and recheck blood pressure which was still elevated. around 5:45 pm pt said she felt fine and decided to go home. to her to keep eye on symptom and follow with er if got worse.

Subject received a Janssen Covid-19 vaccination at the Education Center vaccination site. After administration of the vaccine, the patient was required to ubdergo medical observation for fifteen minutes. At the end of the observation period, the patient had no medical complaint and left the observation. Approximately five minutes after leaving the observation area, the patient returned with a complaint of chest pain. The patient was assessed and treated , a Paramedic assigned to the vaccination site. EMS was requested through the 911 system and the Fire Department responded (Incident # 2021-019703). The patient was subsequently transported to a loca

PATIENT FAINTED AND BECAME UNRESPONSIVE BUT BREATHING WITH PULSE, PARAMEDICS ARRIVED WITHIN FEW MINUTES, PATIENT CALLED FEW HOURS LATER TO INFORM US THAT SHE IS OK AND HER ADVERSE REACTION WAS DUE TO HYPOTENSION.

@1340 client c/o rapid heart rate. Vitals obtained @1341: 114/85, 200 HR, 98% Room air. Called placed by (Site Superivsor) to 911 @1344. Client is AAOX4. NAD. Denies any other symptoms. Repeat vitals @1350: 124/86, 197, 98% RA. Fire engine arrived @1355. Facility completed and EKG, inserted a PIV to RAC 18g, started a IVF bolus of NS 0.9% and attempted the Vasal Vagual Manuver without any import net of heart rate. EMS vitals: 112/74, 192 HR, 19 RR, 100% RA. Ambulance rescue arrived @ 1405. Client agreed to be transported to the hospital for further treatment. Paramedics assumed care @1408. Client left AAOX4. NAD. Skin WNL, Respiratory WNL. No acute changes in condition. Patient transport to ambulance without further incidient. Other staff present RN, EMT, Site Supervisor.

Since receiving the Johnson and Johnson Covid vaccine, my blood pressure continued to go up each consecutive day. On Saturday, March 20, 2021 my blood pressure was 195/95. Obviously my husband took me to ER where I was given a prescription to hopefully lower my blood pressure. The medicine that I was give is Amlodipine. My blood pressure typically runs 120's over low 70's. I know this issue is not listed on your list of side effects. My husband has also experienced the same issue, just not to the extreme that it affected me. His has been up around 20 points.

Shingles- on head, scalp, face - treatment valacyclovir, lost of 10 teaching days, Atrial fibrillation - irregular heart beat, 4 EKG ?s, 1 physicians care facility, 1 emergency room visit, 1 urgent care facility, 1 phone call to family doctor, 1 visit to Dr. cardiologist , suppose schedule of a cardiac stimulus procedure ; treatment apixaban and metoprolol

3-13 developed dizzyness with room spinning, cleared after 1 hour of additional sleep. 3-14 repeat of dizzyness with room spinning, did not clear. Diastolic B/P elevated from 87 to 107 mmHg; Systolic from 143 to 166 mmHg; Tilt Test Positive. Symptoms onset around 0715 hrs and lasted until 1600 hrs when EMS called and taken to Hospital

I felt normal; however, I believe it caused my blood pressure to increase. My husband received his , also, and monitors his BP multiple times daily. His BP continued to rise a little each day and thought our machine was off, Then I took mine about 3 days later and my BP was 158/83- higher than I ever remember it. Usually it is about 118 over seventy something. It was back to about 108 over seventy something 5 days after the vaccine. I wasn't going to report it, but thought someone might want to know.

Patient reported previous nausea after receiving vaccines in the past as well as fainting. Monitored the patient for 30 minutes after her vaccination, and she vomited within 30 minutes. The patient reported she felt well after vomiting and denied needing any further attention or assistance

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

Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Additional Details: uncontrolable shaking. patient stated that benadryl has helped her in the past with this type of reaction. gave benadryl. patient has a history of having reactions to vaccines. 911 was called and brought her to the hospital.

Within minutes of the vaccine shot, began to sweat and was dizzy. Immediate attention by health care professionals at site. Blood pressure dropped severely. Laid on cot to recover. Left after approximately 50 minutes. Driving home, some tongue swelling, went directly to Hospital ER, where they proscribed fluids, Benedryl and observation. Arrived home around 2:30. 24 hours later, still having dizziness and some tongue swelling, headache and weakness.

Within minutes of getting the injection, became faint with a severe drop in blood pressure. Under observation at the site by Health professionals for 50 minutes. On leaving the facility, on the 15 minute drive home, had some tongue swelling and other indications of anaphlyaxsis, so drove directly Hospital ER. They suggested fluids and prescribed Benedryl and waiting nearby. When symptoms did not worsen, left and arrived at home around 2 p.m. Now 24 hours later, still some swelling of tongue and tinnitus, along with site soreness and dizziness.

No Sx immediately after. Joint and bone pain starting 12 hours later with increasing fatigue. Temp low -96.2° with chills (normal is 97°). Slight headache and ringing in ears started about 2pm. I felt like temp was going up, but I don't usually get a temp over 98.8° even when ill. Fever at 100° by 5pm Sat. No "CoVid symp" Eg cough, SOB, GI, loss of smell. Increase fluids. Allergies to PEG in Acetaminophen otc, and NSAIDs. Non critical event at this time.

Burning pain, waves of body Chills, left side neck pain, headache, slight nausea. Had a Blood Pressure check immediately and temperature check (97.1), waited for a longer period at facility to make sure I was OK. blood pressure was extremely high at first reading (I've never had such a high reading in my entire life); blood pressure was within normal limits on second check (127/85), and I was well enough to leave. The chills come in waves, with continued slight nausea.

BLOOD PRESSURE SLIGHTLY HIGHER THAN NORMAL; DIZZY AND LIGHT HEADEDNESS; SWOLLEN ARM; REDNESS; This spontaneous report received from a patient concerned a 65 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 12:20 to right arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced dizzy and light headedness. On 31-MAR-2021, the subject experienced swollen arm. On 31-MAR-2021, the subject experienced redness. On 02-APR-2021, the subject experienced blood pressure slightly higher than normal. Laboratory data included: Blood pressure (NR: not provided) 157/72. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen arm, and redness, and had not recovered from dizzy and light headedness, and blood pressure slightly higher than normal. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

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

On April 7 (six days after the vaccine) my mother experience a sharp pain on her left arm, radiating to her neck, back and finally chest. We went to emergency department, and she had EKG, CT Scan, X-Rays, MRI and blood work and could not find anything. She was discharge but the pain didnt go away. She is still in pain but less than before.

Pt received the Johnson and Johnson shot on Sunday. On monday, she had the "worst headache ever", intermittent chest pain, and left sided facial numbness. Symptoms continue today, was told to present to the ER by her PCP.

Severe nosebleed from right nostril like nothing I have ever had. Video consultation with Dr who Instructed me to pinch the soft part of my nose above my nostrils for about 10-15 minutes. The bleeding lasted for approximately 30 minutes

3/28/2021 at 6:00 a.m. patient reported chest pain to a family member. He arrived at her home at 6:15 and found her slumped to the right in her chair, unresponsive. Patient was taken to our facility via EMS. On arrival, patient could open her eyes but could not talk or move her extremities. She was treated with alteplase 100 mg and flown to a trauma center. She was released on 4/2 and is currently receiving rehabilitation services in our facility; she is expected to return home in 4-5 days.

Got shot at 10:15am. Felt tired mid-afternoon. Got chills early evening. Went to bed with low grade fever, which ramped up quickly. Fever-topped out at 101.4 by 3:00am, body aches, repeated vomiting, repeated massive diarrhea, severe headache -crushing, squeezing vise (in the top 10 worst of my life -including migraines!), bright pink/red fingers and toes, racing uneven heartbeat. Couldn't sleep. In tears from headache pain. In desperation took an 800mg Ibuprofen pill at 4:00am. Finally got to sleep. Woke up 5 hours later. Fever mostly gone. Other symptoms receding, except headache. Took 2 aspirin at noon. Still have minor headache. Yuck!

Suddenly blacked out and fell; mild concussion and soft issue injuries to right side of body; extreme fatigue and nausea.

Patient had slurred speech, headache, pain in the thigh muscles, bloody nose, lost strength in the arms, hands and legs, could not chew or swallow. She was diagnosed with Guillian Barre Syndrome and hospitalized from 04/04/2021-04/18/2021.

The patient presented to the emergency department with altered mental status, dry heaving, and body aches. She was found to have a partially occluding thrombus of the right cephalic vein consistent with venous thrombosis, as well as findings of thrombosis in the anterior segment branch of the right portal vein. She had a d-dimer of 25.77 increased to 35.2, and was thrombocytopenic with a platelet count of 92, which dropped to 36 the following morning. Platelets to present were: 92-36-32-23-19-28. The patient received the Johnson & Johnson COVID-19 vaccination two weeks prior to presentation.

pt says one of her toes on her left foot went completely number. Within a couple of days she started swelling between her left big toe and the toe next to it. Her entire left foot started swelling and then her leg started swelling. She went via ambulance to ER. They did an US of her leg and found 2 blood clots in the back of calve. She was given a RX for blood thinner. She went to 3 pharmacies and could not find it so she went home. She went home and then her right foot swelling as well. She went back via ambulance to ER. She was given blood thinner injection, and IV and took blood work. Pt was admitted where she stayed for 5 days. She was released and prescribed Eliquis. She has to take 20 mg a day for first week and then 10mg a day the following week for 3 months. She still has constant pain and her left foot continues to swell. Pt will have to have another US in 3 months.

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.

Patient called 4/23/21 reporting unilateral (left nostril) nosebleeds occurring each day since receiving the vaccine. She saw PCP and had blood pressure medications adjusted to control hypertension, however, nosebleeds have persisted. I have given her my personal cell phone number to call me immediately and to go to Emergency Room if bleeding worsens or other problems arise such as sudden, severe headache. (Patient states that blood flow contained clots for the first day or two, but has been flowing without clots each day at least and sometimes twice per day. She is able to stop blood flow within 5 minutes by packing nostril each time.) I have instructed patient to make appointment with ENT (Ear, Nose, Throat) Dr.

Patient has leg cramps starting on Monday, April 19th. She went to the hospital at later date. Doctor diagnosed her with leg clot.

4/19/2021: Woke up in the middle of the night with an achy arm. Had this for a week. Went to chiropractor as she thought it was neck trouble. Chiropractor states arm is swollen and see MD. MD sent patient for ultrasound and blood clot confirmed in right arm pit. Patient started on eliquis.

Very high fever for 3 weeks; Shivers; Extreme fatigue; Lethargy; GI problems; Increased level of traponin; Very dark and itchy red rash; Very high blood pressure

This patient was seen in the ER and hospitalized on 4/24/21 after syncope, and was found to have hypoxia and fever. NP specimen for SARS-CoV-2 was positive by PCR Cycle Threshold was 15.4 We are trying to get whole genome sequencing done on the specimen. This appears to be a new COVID-19 case after being fully vaccinated. This is the reason for reporting. She is stable and may be discharged in the next day or two.

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.

At ~ 3:00 pm next day heart palpitations started, Heart would beat normal then a sudden hard beat, It kept this up the remainder of the day till Monday 5/3/21 at around 9:00 am. Most of the weird heart beat was standing or binding over, Sitting position was better.

Heart palpitations, could not stand taken by ambulance to ER; discharged home after 3 hours with prescription for metoprolol, advised to see PCP. Patient went to PCP who referred to cardiologist, scheduled for halter monitor on 05/17/2021, stress test and echocardiogram on 05/24/2021.

Patient Received the COVID Janssen vaccine on 3/9/2021. On 4/11/2021, the patient developed symptoms described as right lower leg weakness (leg "bowed" out, felt, like a "lead" foot). She also complained of right upper arm weakness. She was admitted on 4/12 and determined to have an acute CVA. Her symptoms quickly resolved. She was started on enoxaparin, ASA, and rosuvastatin and discharged on 4/13.

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

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.

Patient presented to ED on 5/12 with complaints on gradually worsening left leg swelling and pain for 3 days, no with difficulty ambulating. Patient reports she received the J&J vaccine 5 weeks prior.

Systemic: syncope-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Patient sat down for more than 15mins after receiving vaccine then walk out side to wait for pick up. While waiting, she got syncope and fell down on the side walk, got a bump on the leftside of her forehead. Pt complained of nausea. She felt better after given some water. She refused to call 911. Patient came back inside and continue waiting for 45 mins when her pick up arrived, she stated feeling better and wanting to leave to go back to her hotel

patient had fainted about 5 mins after the vaccine but then she woke up in about 2 mins . Her husband had laid her flat on the ground. She seem to feel better as she was laying on the ground. at that time the ambulance was en route . i had checked on her pulse/bp . the ambulance had arrived but she refuse to go to the hospital . she had felt better . she did walk out of the pharmacy on her own.

PATIENT FELT ODD AFTER APPROX 10 MINS. HER EYES GLAZED OVER AND IT SEEMED AS IF SHE PASSED OUT FOR A FEW MOMENTS. WE DETERMINED SHE WAS DIABETIC AND HAS HTN. WE ALSO DETERMINED SHE DID NOT TAKE HER MEDS IN THE MORNING PRIOR TO VACCINATION. EMTs WERE CALLED

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.

feeling light headed, nausea, some coughing tightness in chest, some loose stool, lower back ache, weakness, lack of sleep the first night. ate chicken noodle soup, tylenol PM, slept, drank white tea with peppermint tea, sucked, on Ricola drops and EmergenC drops

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Additional Details: LOSS OF URINARY CONTROL

SUBACUTE PULMONARY EMBOLISM IN LEFT AND RIGHT LUNG; DVT IN LEFT CALF; UNABLE TO DRIVE; EXTREME EXHAUSTION; HEADACHE; SHARP SHOOTING PAIN IN RIGHT LEG; 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 patient had no known previous medical conditions and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, once total administered on 06-APR-2021 15:00 in Left Arm for prophylactic vaccination. Concomitant medications included amlodipine, hydrochlorothiazide and losartan for which indication was not provided. On 06-APR-2021, the patient experienced headache while driving back to home and was not sure if it was due to vaccine or traffic conditions. At 18:30, patient got up to walk across the room and felt a strong sharp pain in her right and left leg described as incredible cramping type of pain which her husband had to help sit down to a chair. Patient states that although the pain was in both legs, the left leg felt as though someone had took a knife to her thigh, the pain lasted approximately 15 minutes. On 07-Apr-2021, patient states that she went for a routine doctors visit to her family care physician who wrote her a prescription for routine blood work. On 14-Apr-2021, patient went to get the blood work done and states at this time, she felt extremely exhausted and that due to a bloodwork mix up which required her to drive back to the lab, she was not able to drive back so her husband had to drive her. Around 17-Apr-2021 to 18-Apr-2021 patient had to chase the dog and found that she couldn't catch her breath and that she started coughing. Her daughter who happened to be there asked her why she was coughing and thought that it was not normal and that she should contact her doctor.On 19-Apr-2021, patient called the doctor. On 21-Apr-2021 patient saw the doctor and during examination, patient was instructed to run a D-Dimer test to rule out blood clots. On 22-Apr-2021, doctor stated patient to go to the Emergency Room as the result for the D-Dimer test came positive. The patient was immediately hospitalized where Doppler and CT scan was performed on her and was diagnosed with Deep Vein Thrombosis and Pulmonary Embolism on both the lungs. Patient mentioned that she was treated with Heparin drip from 22-Apr-2021 to 24-Apr-2021 and then she was given Xarelto. On 25-Apr-2021, the patient was discharged from the hospital after 4 days of hospitalization. Patient reports that she was still experiencing extreme exhaustion and that the pulmonologist states that this is the normal course of blood clots and it could take anywhere from 60-90 days for the body to clear up the blood clots. She states she still has bouts of shortness of breath but showing signs of improvement. Patient stated that she was scheduled for another Doppler on 19-Jun-2021 which was recommended by her primary care physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp shooting pain in right leg on 06-APR-2021 ,had not recovered from extreme exhaustion, and the outcome of pulmonary embolism in left and right lung, dvt in left calf, headache and unable to drive was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210550248-COVID-19 VACCINE AD26.COV2.S, The case concerns with a Caucasian female. Subacute pulmonary embolism in left and right lung, deep vein thrombosis in left calf. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

MAIN COMPLAINTS ARE VISION IMPAIRMENT AND HIGH BLOOD PRESSURE SINCE VACCINATION. PATIENT STARTED EXPERIENCING DOUBLE-VISION THE EVENING OF VACCINATION. IT HAS NOT SUBSIDED AND CAUSES CLOSE UP VISION IMPAIRMENT. SHE HAS SINCE RECEIVED PRISM GLASSES TO HELP. SHE NOTES THAT HER BLOOD PRESSURE HAS BEEN ELEVATED AND HER FEET SWELL SINCE THE VACCINATION. CURRENT READINGS ~142/87 MMHG (NORMAL READING ~114/72 MMHG). HER PROVIDER, DR. (LAST SEEN 6/4/21), ADVISED PATIENT TO CHANGE DIET BEFORE BEGINNING MEDICATION REGIMEN.

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.

I had a number of strokes between April and May. As many as 9 of them. Memorial Day, 31st, I went to the hospital ER at 9:00PM. I had a PFO, which is something like Patent Forman Ovale, heart condition, hole in atrium of heart that causes the blood to go from heart to brain. Blood clots to the brain, venous blood gets into the arterial blood. The clots could have formed everywhere but they go straight up the brain. They went through an artery and put a mesh screen over my heart opening and eventually it will help that. It was done through an artery, 15 minute process. I left the hospital the following Saturday. This week (two days ago) I have really bad tinnitus starting in both ears. My hearing is quite disrupted. I don't know how serious it is right now. I am being treated with an anti-cholesterol drug (Lipitor) and aspirin. I still have a little bit of cognitive impairment and physical fatigue. My coordination is messed up. Physical therapy starts the 15th and Speech therapy on the 23rd. I had just gotten a job two weeks before the strokes.

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.

My temperature is usually 96 degrees, but I reached a fever of 98.8 on the morning of 4/10/2021. I felt foggy and very fatigued. Between 4/10 and 4/12, my fever reached 101.1. I had a dull headache and I had bone pain and joint pain; I felt like a walking skeleton. I felt like I could feel every joint connected to every bone. I was extremely sleepy and had no appetite. I was in a neurological fog. The days just went by, and I basically don't remember anything. I went to a cardiologist on 5/2/2021 and had a halter monitor put on; the results indicated an electrophysiological myopathy, second and third degree heart blockage, supraventricular tachycardia. The etiology to all of these is unknown. There was no afibrillation. I wore the monitor for 13 days.

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.

After roughly 4 hours I started to get chills and body aches. I went to bed but could not get warm and writhed in considerable distress for at least an hour. (This was the most uncomfortable I've been since induced labor before the anesthesiologist arrived for an Epidural 28+ years ago.) My temperature fell to 95 before I took acetaminophen and was able to fall asleep.. Now, at 7 hours it's 101.2 and I'm just getting the side effects I expected: weakness, a little nausea.

Janssen COVID-19 Vaccine EUA Approximately six hours after administration of the vaccine, patient experienced sever chills and dizziness. Unable to stop shaking, patient took temperature which registered at 95.4F and then 95.1F at 15 minutes. Patient donned flannel pants, thermal shirt, and oversized hooded sweatshirt and got in bed under flannel sheets, two doubled-over blankets, a bedspread, and quilt. A down-filled king-size pillow was placed on top of patient's torso and a space heater was turned on to highest setting. Patient reports heart seemed to be racing, but did not take BP. Unable to quell the chills, the patient continued to shake, developing very stiff shoulders, neck and back as a result. This continued until approximately 2 am. The next morning, patient's temperature was registering at 99.4F and pulse was 96, but patient did not report chills. General muscle aches and mild headache were noted. At time of this report, patient's temperature and pulse are normal (97.6F and 76 pulse).

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.

10 hours after vaccination I got very tired. Went to bed at 9:30. Had chills. and slight head ache. Woke up around 12:30 with rapid heart beat. My normal resting heart rate is 61(per activity tracker) It was 98 ish. and somewhat eractic. (but not a lot). Also had nausea and diarrhea. Finally got some sleep. Woke up at 7:00am and took 2 aspirin. Today I'm feeling fine. Maybe a little tired.

Janssen COVID-19 Vaccine EUA -Rapid heart 9:30 p.m. ish until approx. 1:00 a.m. (not consistent - on and off) -Body Aches & Chills 9:30 p.m. ish -Fever - maxed at 101.3 (fever through the night - fever broke around 5:30 a.m.) Took Aleve for fever and aches around 10:30 p.m.

I've had 2 nosebleeds within 24 hours of receiving the vaccine. I am 66 and have not had a nosebleed since I was 13.

Symptoms began little after ten hours of receiving vaccine. Symptoms included flu like symptoms of aches , joint pain and fatigue with fever up to 101 lasting 3 1/2 days. Fever broke SUnday night 14th, approx 9:00pm. Awoke Monday the 15th light headed and fatigued but aches and fever gone. Then approximately 5 pm on Monday the 15th started having chest pain, upper right side. By midnight I was being transferred to ER for the chest pains. Released Monday morning the 16th from ER Dx. Possible chest wall inflammation; Followed up with primary care office (not my regular Dr. but with Dr. Have been experiencing internal jittering; agitated cough, upper respiratory issues (but lungs are clear.) ever since I originally had Covid.

First day: I swelled up like the Pillsbury Dough Boy. I had high blood pressure, (which I normally do not have), migraine like headaches for three days and now I have a rash all over my face and arms. The rash is very itchy and annoying.

Flu symptoms, weak, nerve twitching, swelling, fever, chills, nausea, pain, headache, very weak pulse, heart palpitations, malaise, rigor, a horrible experience lasted 36 hours.

At 2:00 am on the morning of March 6, 2021 I woke up with terrible chills, upset stomach and a very rapid heartbeat that continued until 5:30 am. The remainder of the day I had a horrible headache.

WEAKNESS, FATIGUE. SHAKY, DIZZY. HYPERTENSIVE 190/80. REQUESTED TO GO TO THE ER. DISCHARGED HOME AFTER EVAL IN THE ER

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.

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.

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!

I got the shot on Tuesday morning, and then by Wednesday morning I had a bad afib event, and still have afib and am at Hospital. I haven't had an event like this in 2 years. The cardiologist here thinks it's related to the vaccine.

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

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.

presented to ED 3/22/21 with leg swelling that worsened over past 2 days. Diagnosed with Venous stasis ulcers & Thrombocytopenia

HPI Details: a 66-year-old female presenting today for evaluation of high blood pressure. Patient notes that she went to the dentist on March 24 and was having a root canal revised. She was told that she had very elevated blood pressure at that time, 173/81. When they rechecked her blood pressure it had gone up even higher. She was not feeling necessarily bad at that time but did start noticed that she was having some pounding headaches and felt like her heart was pounding out of her chest. She has not really changed activity or diet. She is not on any new supplements or over-the-counter meds that would cause this. The only thing different was that she did receive the Johnson & Johnson COVID-19 vaccine just prior to onset of this. Patient was concerned about her blood pressure running so high, and she is a physician so she did prescribe herself some atenolol. She took a couple of doses of this on March 29 when she received her blood pressure cuff in the mail from online store and was checking her blood pressure and found that her numbers were running quite high, such as 207/107. She contacted our office. I did go ahead and start her on lisinopril 10 mg p.o. daily. This did not make a significant improvement in her blood pressure. We did go ahead and get lab work done. CBC was unremarkable. CMP notable for potassium 3.3 and alk phos minimally elevated at 129. TSH was within normal limits. Patient does bring in a log of her blood pressures with her today. Again these are not really improving significantly with the lisinopril 10 mg daily.

Right lower extremity DVT's and multiple bilateral pulmonary emboli involving main pulmonary arteries with right heart strain

Got the vaccine on Apr 6 Fever and leg pain started on Apr 7 Sever headache, nausea occurred on Apr 11, called 911 immediately and sent to emergency room of hospital The diagnosis is large volume of subarachnoid hemorrhage in the brain. Surgery conducted on April 11 and the patient is still in ICU now

My mom had called saying she's feeling nausea, dizziness, drowsiness and vomiting. We called the emergency services when they arrived she had collapsed. They broke the window and took her to the hospital, upon arrival we were informed that she has got a hemorrhage possible clotting due to high blood pressure. I now know the term is Cerebral Hemorrhage, she has been in ICU on a ventilation machine while they tried to drain the blood and clots. She's currently out of ICU however still complains about headache and back pain. We are informed that she has now developed some blood pressure and diabetes however it could be cleared in the short term. She's at the hospital and unknown how long she would have to stay there.

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.

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.

PT REPORTS NOSE BLEEDS LASTING AN AVERAGE OF 2 HOURS 4/5/21, 4/7/21, 4/8/21, WENT TO THE ER EACH TIME. HAD AN ADDITIONAL NOSE BLEED ON 4/12/21. UNSURE HOW LONG IT LAST BUT PT REPORTS NOT AS LONG AS PREVIOUS BLEEDS. ALSO HAD NOSE SCOPE WITH ENT ON 4/12/21 AFTER BLEED EVENT. PT REPORTS DR DID NOT FIND ANYTHING ON THE SCOPE THAT WOULD CAUSE THE BLEED. SAW PCP 4/15/21 AND HAD BLOOD WORK. NO FURTHER DGN OR TREATMENT

SMELLY URINE; CLOUDY URINE; ABDOMINAL CRAMPS; DIZZINESS; HEART RACING; FEELING COLD; BRAIN FOG; NECK SORE; SOUND IN HEAD/HUMMING NOISE IN HEAD; DID NOT FEEL HUNGRY; FORGETFULLNESS; SHAKING WITH COLD/TEETH CHATTER/CHILLS; SEVERE HEADACHE; FEVER; 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 past medical history included cholesterol, and concurrent conditions included hypertension, non-smoker, non- alcoholic, and sensitive to medications, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. the patient had no known drug allergies. The patient was previously treated with hydrochlorothiazide/lisinopril for hypertension, vitamins nos for drug used for unknown indication, and atorvastatin for cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Blood test (NR: not provided) not reported. On 12-MAR-2021, the subject experienced heart racing. On 12-MAR-2021, the subject experienced feeling cold. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced neck sore. On 12-MAR-2021, the subject experienced sound in head/humming noise in head. On 12-MAR-2021, the subject experienced did not feel hungry. On 12-MAR-2021, the subject experienced forgetfullness. On 12-MAR-2021, the subject experienced shaking with cold/teeth chatter/chills. On 12-MAR-2021, the subject experienced severe headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced smelly urine. On 02-APR-2021, the subject experienced cloudy urine. On 02-APR-2021, the subject experienced abdominal cramps. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) NEGATIVE, Computerised tomogram head (NR: not provided) NEGATIVE, Fibrin D dimer (NR: not provided) ELEVATED, and Head MRI (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling cold, and fever on 12-MAR-2021, and smelly urine, cloudy urine, and abdominal cramps on APR-2021, was recovering from neck sore, and had not recovered from heart racing, shaking with cold/teeth chatter/chills, severe headache, nausea, did not feel hungry, brain fog, sound in head/humming noise in head, dizziness, and forgetfullness. This report was non-serious.; Sender's Comments: : V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious

It started with flu like symptoms, upset stomach, not feeling well according to my husband who was present, fast onset of vomiting and continued to vomit for 24 hours many times, complete loss of memory for 24 hours, this started around 3:00 p.m. on 3/14/21, started to feel better about 24 hours later. Next event, 4/19/21, 7:30 a.m. had a very bad nose bleed with two large clots coming out of my nose. Nose bleed stopped after about 15 minutes.

My symptoms i had sever headache! Once April 1st Hit! Thats Was the day I Had a Heart stroke at store, i don?t remember anything and once i woke up i was at the hospital, and they told me that i had a heart stroke because i had lots of blood clots in my body. And they told me i vomit and peed myself durong the whole situation i went in store

severe fatigue, sore throat, low grade temp off and on post-72 hours, ear pain, lymph nodes swollen under left jaw area, chest tightness and pain upon inspiration for the past 3 days. Reeived Janssen on 4/3/2021. Have white pus pocket on left tonsil for approximately five days

Patient presented one week pos vaccination with 2 days of easy bruising and petechiae. Platelets were 4K. Seen by doctor of hematology. Started on steroids with improvement to 21K and discharged. Came back a week later with presyncope and chest tightness. Platelets again 4K. Treated with IVIG

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.

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.

SWELLING OF LEGS; VENOUS STASIS ULCERS; THROMBOCYTOPENIA; 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 pre-existing medical conditions included the patient has chronic conditions like Patient Medical History of Hyperlipidaemia, hypertension, type II diabetes, coronary artery disease with recent segment elevation myocardial infarction left anterior descending s/p Percutaneous coronary intervention, low ejection fraction 30% from 60% s/p single chamber 6/202. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 10:29 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced swelling of legs, venous stasis ulcers, and thrombocytopenia. The patient on unspecified date was shifted in emergency room and later she was hospitalized. Number of days in hospital the patient was admitted was unknown. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Moderate to severe pulmonary HTN, and Echocardiogram (NR: not provided) worsening EF- 15% from 30%m Moderate MR. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of legs, venous stasis ulcers, and thrombocytopenia. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: A 66 year old female, unspecified ethnicity, was diagnosed with venous stasis ulcers and thrombocytopenia 16 days after receiving the covid-19 vaccine ad26.cov2.s. The patient went to the emergency room for the leg swelling (start date unknown) that was progressing over 2 days. Medical history includes hyperlipidemia, hypertension, and type II diabetes. Patient also has coronary artery disease with recent segment elevation myocardial infarction left anterior descending (STEMI LAD) s/p Percutaneous Coronary Intervention, low Ejection Fraction 30% (from 60%), s/p Single Chamber ICD. Concomitant medications not reported. Smoking history not provided. Echocardiogram revealed worsening EF - 15% from 30%, Moderate MR, Moderate to Severe Pulmonary Hypertension. Thrombocytopenia was reported without a reported platelet count. The patient was subsequently admitted to the hospital for unspecified number of days and was reported to have recovered from all events. Given the patient's extensive medical history, there is a plausible alternate explanation for swelling of legs and venous stasis ulcers, and there is limited information to make a meaningful assessment of the report of thrombocytopenia. Additional information is requested.

1-2 weeks after dose of vaccine, developed nausea, chills, diarrhea. Presented 1 month after vaccine to ED with embolic strokes and new renal failure.

The evening after the vaccine Developed severe abdominal pain and joint pains This lasted about a week Also developed mild rash and itch the day after the vaccine Had extreme fatigue for about a week The second morning developed what appeared to be swollen blood vessels in both forearms This lasted several hours and went away Went To dr and received fluids and vitamin iv

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.

CHILLS; BLOATING; ITCHING TO LEFT LOWER ARM/LEFT UPPER; SWOLLEN AND TENDERNESS TO LEFT AXILLA TOWARDS BREAST; ACHING IN NECK; NECK SWELLING; MASSIVE HEART ACHE; NAUSEA; FEVER 100.6 F; MASSIVE HEADACHE TO FRONTAL AND TEMPORAL LOBES; RINGING TO LEFT EAR/RIGHT EAR; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 117 pounds, and height was 61 inches. The patient's past medical history included pain to arm, inflammation, swollen neck, and fever 102 f, and concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included the patient has no history of drug abuse or drug illicit use. She had a history of severe immune reaction to the Pneumovax (pneumococcal vaccine polysacch 23V) in 2019 which caused excruciating pain to arm and inflammation with swollen neck with 102 F and had to call 911. Paramedics stated stable and not taken to the hospital. The patient also experienced drug allergy when ibuprofen, neomycin, and magnesium sulfate/potassium sulfate/sodium sulfate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered to the left arm, on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the patient experienced ringing to left ear and right ear. On 01-APR-2021, the patient experienced massive heart ache, massive headache to frontal and temporal lobes, rapid heart rate, pain near sternum that radiated downward, sensation of pressure at breast level, neck swelling, aching in neck, gastrointestinal upset, solar plexus, nausea and fever 100.6 F. On the same day, the patient went to urgent care and was given Zofran 4 mg sublingual. They took the lab at the urgent care. On 01-APR-2021, the patient's laboratory data included: Absolute lymphocyte count (NR: not provided) 0.7 (units not provided), Blood glucose (NR: not provided) 106 mg/dL, Body temperature (NR: not provided) 100.6 F, Chest X-ray (NR: not provided) normal, Complete blood count (NR: not provided) normal, Electrocardiogram (NR: not provided) normal, Heart rate (NR: not provided) Rapid, Lymphocyte count (NR: not provided) 11 % (low), Neutrophils (NR: not provided) 81 % (high), and Troponin I (NR: not provided) normal. On 02-APR-2021, the patient experienced swollen and tenderness to left axilla towards breast. On 05-APR-2021, the patient experienced itching to left lower and upper arm. On 08-APR-2021, the patient experienced bloating, pain from gas and increased changing of bowel habits. On 18-APR-2021, the patient's headache reappeared. On 19-APR-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing to left ear/right ear on 06-APR-2021, aching in neck, neck swelling, and nausea on 01-APR-2021, swollen and tenderness to left axilla towards breast, and itching to left lower arm/left upper on 05-APR-2021, chills on 20-APR-2021, and fever 100.6 f on 02-APR-2021, was recovering from massive headache to frontal and temporal lobes, had not recovered from bloating, and the outcome of massive heart ache was not reported. This report was serious (Other Medically Important Condition). Initial information was received on 20-APR-2021, with additional information obtained via telephone follow up from a patient on 21-APR-2021, the following information was updated and incorporated into the case: events added (Ringing to left ear and right ear).; Sender's Comments: V0 : -covid-19 vaccine ad26.cov2.s -Massive heart ache. 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.

Patient received J&J Covid Vaccine at 1:46 pm. At approx. 2:05 pm she stated she had an increased HR (wears wrist monitor) and was light headed. Spoke to patient about if she had previously felt this way after a vaccine and she stated she felt this after her "first covid vaccine". After questioning, she stated that she had received a Pfized Covid Vaccine in February which was not noted in her consent form. She also did not note that she had been hospitalized post-vaccination for a burning sensation and flushing that would not cease. She received the J&J vaccine at the advice of her primary care physician but had not advised pharmacy staff. After discussing it with the patient, it was determine that EMS would be called. EMS came to evaluate patient.

Ultrasound done on 4-30-2021 for pain in calf of left leg and numbness of the toes for 7 days. Result came back positive for blood clot.

Rigors, severe Headache, rapidly increasing temperature (102.5), pulse rose above 130, BP slightly elevated, chestbpressure (no pain). Went to ER at 09:15pm.

NERVE TINGLING IN LEFT THIGH; LEFT LEG PAIN CENTRED IN KNEE; GENERAL WEAKNESS; CHEST TIGHTNESS; 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 low thyroid, penicillin allergy, sulfa drugs allergy, and allergy to mango, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with naproxen. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 42A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chest tightness. On 11-APR-2021, the subject experienced nerve tingling in left thigh. On 11-APR-2021, the subject experienced left leg pain centred in knee. On 11-APR-2021, the subject experienced general weakness. On 10-MAY-2021, treatment medications included: meloxicam. The action taken with covid-19 vaccine was not applicable. The patient recovered from chest tightness, and had not recovered from left leg pain centred in knee, nerve tingling in left thigh, and general weakness. This report was non-serious.

DEATH; BLOOD CLOT; This spontaneous report received from a health care professional concerned a 66 year old White and not Hispanic or Latino female. Initial information received from the health care professional on 05-MAY-2021 was processed with additional information obtained from live follow up with health care professional on 06-MAY-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, diabetes, high cholesterol, non smoker, non alcohol user and other pre-existing medical conditions included no known allergies, no drug abuse or illicit drug use. Lab work was done 3-4 months ago, the results of which were unavailable. 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, 1 total, administered on 10-APR-2021 possibly left arm for prophylactic vaccination. Unspecified concomitant medications were reported. On 28-APR-2021, the patient developed right leg pain and right leg swelling also began around this time as well. On 04-MAY-2021, the patient died from blood clot. An autopsy was not performed. The reporter stated that the patient's death was related to Janssen covid-19 vaccination and blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of blood clot on 04-MAY-2021. This report was serious (Death).; Sender's Comments: V0:20210509157-JANSSEN COVID-19 VACCINE- Death, blood clot - 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.; Reported Cause(s) of Death: BLOOD CLOT

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.

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.

Patient received Johnson&Johnson CV-19 1805018 5/21 on March 9, 2021. Patient began experiencing chest pains and abnormal sensations in chest area beginning April 26, 2021. Patient began experiencing electrical-like abnormalities in both hands and feet that cause severe dysfunction beginning May 7, 2021. Patient developed blood clot behind the retina of right eye as examined by ophthalmologist during clinical visit on May 25, 2021 at 8:15am appointment.

Upper extremity DVT same side of vaccination Left upper arm pain, bruising, swelling Symptoms started approximately 2 days after injection

Approximately 12 hours after receiving the injection, I became weak and tired within minutes. My heart began to have palpitations and my heart rate which is usually in the 50s or 60s shot up to 84. My blood pressure was good at 109 over 74. The palpitations lasted until approximately 5:00 a.m. I did not seek medical attention.

INTERMITTENT RAPID HEARTBEAT AND NOTICE MORE HEART BEATS WHILE SITTING; 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 seasonal allergies, non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. Patient was pretty health and does not take any medication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced intermittent rapid heartbeat and notice more heart beats while sitting. Laboratory data included: Heart rate (NR: not provided) intermittent rapid heart beat. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from intermittent rapid heartbeat and notice more heart beats while sitting. This report was non-serious.

ON APRIL 16, 2021 I WOKE UP AND I COULDN'T SEE OUT OF MY LEFT EYE, I WAITED A WHILE TOO SEE IF MY SIGHT WILL COME BACK AND IT DIDN'T SO I CALLED MY EYE DOCTOR AND MADE APPOINTMENT AND THEY SCHEDULED ME FOR APRIL 23, 2021. A WEEK LATER I WENT BACK TO THE DOCTOR AND HE TOLD ME TOO GO TO HOSPITAL A.S.A.P. THEY TOOK A CAT SCAN AND SAW THE OPHTAQLMOLOGIST IN HOSPITAL THE DIAGNOSIS WAS A BLOOD CLOT IN MY LEFT EYE AND I TOOK A STROKE.

Have developed on-going asthma-like symptoms including cough and tightness when taking deep breaths. Treated with Proair inhaler and decongestants. Recently prescribed steroids and antibiotics

A PINECONE SHOVED DOWN HER THROAT; SEVERE HIVES; RECURRENT URINARY TRACT INFECTION; CHEST PAINS/HEART PAINS; 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 past medical history included anaphylactic shock, anaphylaxis, and urinary tract infection, and concurrent conditions included penicillin allergy, and sulfa allergy, and other pre-existing medical conditions included allergy to 20 unspecified drugs. The patient was previously treated with doxycycline for urinary tract infection. 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, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chest pains/heart pains. On APR-2021, the subject experienced recurrent urinary tract infection. Treatment medications included: doxycycline. On an unspecified date, the subject experienced a pinecone shoved down her throat, and severe hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pains/heart pains, a pinecone shoved down her throat, and severe hives, and the outcome of recurrent urinary tract infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

First 5 days-fever, pain joints muscles lightheaded Since to date- racing heart and pulse. Severe dizzy spells. Intense pain and tingling I n legs.

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.

Developed blood clot in left leg. I was also given Pneumococcal vaccine on 4/12/2021 following covid vaccine.

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.

BLOOD CLOT IN ABDOMEN AND EXTREMITIES; ANEURYSM CLOTS IN THE ABDOMEN; LOSS OF MOBILITY; LOSS OF APPETITE; HEADACHE; 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 past medical history included stent placed on lower extremities few years ago, and concurrent conditions included former smoker, cardiac issues, non-alcoholic and racing heart, and COPD (Chronic obstructive pulmonary disease) and other pre-existing medical conditions included no known allergies and patient does not abuse drug or illicit drug usage On 03-May-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: Unknown) frequency 1 total, dose was not reported, administered on right deltoid for prophylactic vaccination. Concomitant medications included rivaroxaban, and sildenafil. On 04-JUN-2021, the patient experienced blood clot in abdomen and extremities, aneurysm clots in the abdomen, loss of mobility, loss of appetite and headache. The patient though the pain was due to medicines she had for cardiac disorder. The pain worsened to the point she went to her gastro intestinal doctor, who did CT scan which showed aneurysm. Her Doctor called cardiologist who suggested referral to a vascular surgeon. The vascular surgeon discovered more blood clots in the abdomen. The CT scan with contrast and Doppler studies were performed. The patient was on blood thinners for 3-4 months. The medicines were started prior to vaccination. None of the doctors were aware that she has taken the Johnson vaccine. The patient stated that she had all the side effects. On 28-JUN-2021, Laboratory data included: Oxygen consumption (NR: not provided) increased. On 28-JUN-2021, Laboratory data included: CT scan (NR: not provided) CT scan with contrast showed clots in abdomen and extremities. On 30-Jun-2021, the patient experienced aneurysm clots in the abdomen. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Not reported, and Ultrasound Doppler (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in abdomen and extremities, headache, loss of appetite, and loss of mobility, and the outcome of aneurysm clots in the abdomen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210716346-covid-19 vaccine ad26.cov2.s-Thrombosis. 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, UNDERLYING DISEASE

Around 10 minutes after vaccine patient reported feeling dizzy, tired and weak. Patient was still responsive, stated she had eaten breakfast. She then was given water. She then became unresponsive, eyes closed, snoring with head slumped down while sitting. After we realized patient could not be awoken, property manager called 911. While ambulance was on thier way, patient "woke up" but was drowsy and could barely communicate. No epinephrine or diphenhydramine was administered. BP was 130/100. After EMS arrived, patient's partner came in from the car and reported this has happened multiple times at doctor appointments/procedures. Patient was unconscious for around 5minutes. Patient reported she went to the ED but was discharged after a short visit.

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.

Severe pain on my right side under my arm and right half of chest. Went to the ER did CBC w/auto Diff, Comp Metabolic panel, DDimer, Quantitative,Lipene , Quantative, Lipase level, magnesium level, tropinin - 1, UA WITH MICROPSCOPIC and reflex criteria for urine culture Urine culture reflex criteria Rsdiology XR Chest 1 View Frontal EKG/ Cardiovadcular Electrocardiography 12 Lead

Fast heart beat (120 beats/minute) that started at about 8:00 pm on the day of the vaccine and lasted about 7 hours. My normal resting heart rate is about 62 beats per minute. Other mild side effects were some muscle aches and feeling very tired.

Severe pain in hips and lower back like passing a kidney stone, severe bone pain in chest area, could not sleep for 2 nights and then slept 12 straight hours, headache and blood pressure spike on 3/14 resulting in ER trip with bp at 204/100. Anxious and nervous with low appetite.

I woke up on 3/16/21 feeling my heart beating rapidly. I was slight dizzy upon standing from bed. I took my blood pressure at 6:06 -- readings were 112/84 and 120BPM. My usual BPM is between 60 and 75. I meditated and took my readings again at 7:44 a.m.. They were 105/78 and 95 BPM. I verified this on an oximeter.

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.

I got the shot they had to clean up my arm because I was cleaning and put pressure on the arm. I sat for 30 mins. My chest felt a little funny. about 9am my face was really red, I got my BP checked 188/85 Oxygen was good and Dr said to take benadryl and took two right away and I took 2 more after 6 hours, symptoms subsided that evening. My BP stayed high and I felt not good, I had pressure in my chest and some pressure on the left and right side of my breast, BP was 177 at 4pm. I went home to bed I woke up with pressure again in my chest. I went to the Dr and he said come back in two weeks and see how you are, I went in this last monday and he put me on medication for high blood pressure

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

3/11/21: 11:05 AM - Pressure in chest lasting 8 hours; 9:00 PM- chest pressure gone, body chills began; 12:30 AM - fever of 101.3 F; loss of appetite 3/12/21: 8:30 AM - Fever reduced to 99.5 F (no treatment taken) ; attempted normal daily activities; loss of appetite; 6:30 PM- extreme fatigue and dizziness, no appetite, slept 12 hours with night sweats 3/13/21: 8:30 AM -Fever gone, sweats gone; extreme fatigue lasting 24 hours; no appetite 3/14/21: 8:30 AM - Appetite returning, still tired, but functioning some daily routines; slept 12 hours 3/15/21: 8:30 AM - Appetite returned, normal daily activities achieved

Immediate bruise at injection site when received, moderate nose bleed 48 hours after vaccine. Bleeding stopped. No medical attention needed.

Heart rate increased within 5 minutes of having the shot, went from 72 to 114. My heart rate stayed at 109 or more until 10 PM the next night when its slowly went down to a normal heart rate. At 3 am (12 hours after the shot) i had a blinding debilitating headache that lasted until 9pm the next night. It also affected my vision. The headache was so bad i could not concentrate on the simplest task. I was unsure of what i could take for the headache. So, I did not take anything. When i woke up i was very tired and this lasted until the following day. 6am i had a fever of 102.3 this went down to 100.4 at 9:15 pm that night. I also had chills for several hours. 9:20 AM the nausea started followed by vomiting and dizziness. This only lasted for a few hours. I experienced very vivid dreams the night of the shot. I only drank some coconut water all day and could not eat any food. The next day Saturday March 27 i felt better but the fatigue did not go away until late in the evening. Sleeping seemed to help but i could only sleep for 2- 3 hours at the most.

PT SAID HER BLOOD PRESSURE ROSE TO 220/130 1 HOUR AFTER VACCINATION . PT WENT TO ER AND THEY STABALIZED HER AND SENT HER HOME. NO PRIOR BP PROBLEMS PER PATIENT

After receiving vaccine, i started to feel headache then extreme nausea, body aches, dizzy, feeling like i'm going to pass out I went to ER at the Hospital the next day, so so sick

Woke with body aches,102.6 fever,horrible headache. Lasted the whole day after injection. Around 5:30 pm I started feeling whoozy and passed out. Neighbor couldn't bring me around. 911 was called. I started vomiting and very nauseous by 6:00 pm. All vitals were ok by medics. I went in my house,went to sleep and woke the next day fine. Wasn't sure about the passing out and vomiting, nor the fever for the day being normal.

Dizziness, light-headed, nausea, sweating, pale skin. The patient was observed and given water and orange juice for 25-30 minutes. She felt well enough to leave the pharmacy on her own after 25-30 minutes. The patient had a prior history of anxiety prior to receiving vaccinations and was very nervous about getting the vaccination prior to administration. The patients daughter was with her and felt that her symptoms were due to anxiety about getting vaccinated, but later called the pharmacy asking to report the adverse events as being related to receiving the vaccine. It is not known weather or not the symptoms are directly related to the vaccine.

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

HEART PALPITATIONS; DIZZINESS; SHOULDER PAIN; HEADACHE; BODY ACHES; BACK PAIN; This spontaneous report received from a patient concerned a 67 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: 1808978 or 1808928 (unsure), and expiry: UNKNOWN) dose was not reported, administered on left arm on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced back pain. On 01-APR-2021, the subject experienced shoulder pain. On 01-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced heart palpitations. On 02-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, back pain, and shoulder pain, and had not recovered from headache, heart palpitations, and dizziness. This report was non-serious.

Patient with racing heart, trembling within 15 minutes. Blood pressure checked and result was 131/61. Patient complained of dry mouth and Benadryl administered. Patient continued to be monitored and within 5 minutes following Benadryl, heart continues to race, chest heaviness, trembling hands, tongue numbness, tongue swelling, slowness of speech and thought. EpiPen administered to Left thigh. Within 30 seconds, tongue numbness and swelling resolved. 911 was called and responded to check patient. Vitals and EKG were monitored. BP somewhat elevated due to epinephrine. EKG WNL. Patient did not go to hospital.

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.

2 weeks 8 days after vaccine, patient suffered which sent pt to emergency room. Husband states she had a "blood clot" to brain with skull fracture and traumatic brain injury. Transferred to Medical Center, then to long term facility. Has not recovered to date. Husband states unable to speak or move.

Strange odor a few minutes after injection, followed by bitter taste, then nausea and spaciness. Dizzyness, with vision looking 2D and flat by 15 minutes. Told Pharmacist, of spaciness who said stay as long as I wanted. Left at 30 minute point, still spacy and nauseous. Spaciness ended by an hour with nausea off and on. Chest pain - began around 7pm, continued to expand in area of chest, sharp stabbing pain later, pain from just above left elbow to hand and tingling of fingers, pain lower left leg and tingling of left foot. Irregular heart rate at different times. Checked into emergency room at 11:00. IV inserted, placed on continual heart and oxygen monitors, EKGs, chest X-rays (2), blood tests (3). Admitted to hospital sometime during the night. Given IV medications to counteract IV contrast allergy. These medications caused full body shakes, eyesight auras and extreme nausea with gagging. Heart CT taken with IV contrast. Discharged around 3:00 PM.

Severe headaches, A little nausea, Upset stomach, Heart racing, and I think it made my diazepam and the stuff I take for my restless legs stop working. As my tremors from the withdrawals I have from Valium I?ve gotten worse, and my doctor switched me to another medication for restless legs. Cold all the time.

Acute bilateral lower extremity DVT found on venous duplex after reporting new bilateral leg swelling 7-8 days after receiving Janssen COVID-19 vaccine. No prior history of DVT. Brain MRA pending at time of report w/ concurrent history of new/moderate/persistent headache.

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.

My sister suffered a massive stroke with blood clots. Totally paralyzed on right side and limited speech. Unable to function on her own, receiving care at a Nursing Home

67 yo female with PMH of HTN, DM who has two days of left sided numbness that has progressed to left hemiparesis and dysarthria in the setting of having received the Johnson and Johnson vaccine on Wednesday(48hours prior). Patient was found to have a right parietal multifocal parenchymal hemorrhage measuring 19x36x37mm and small right temporal lobe SAH. Subsequent CTA showed thrombosis of the superior sagittal sinus and the right frontoparietal cortical veins as well has nonocclusive thrombus of right transverse and sigmoid sinus. The patient was also noted to have focal seizure of mouth and tongue and was loaded with phosphenytoin. After discussing case with neurology, nuero IR, NSGY and family it was decided to transfer the patient to sunrise for close monitoring and consideration of cerebral venous sinus thrombectomy if she worsens. I had a long discussion with multiple sisters about the risks of anticoagulation with argatroban given the IPH but the necessity given the cerebral venous thrombosis. I also discussed that argatroban is not readily reversible and that heparin is contraindicated if there is concern about vaccine induced thrombotic thrombocytopenia due to possible PF4 ab related to HIT. The patients VITT modified 4T score is 4 and she is intermediate risk for this being VITT. #Right parietal IPH, right temporal SAH and Superior saggital sinus thrombosis with nonocclusive thrombus of right transverse and sigmoid sinus -concern for vaccine induced thrombotic thrombocytopenia given johnson and johnson vaccine 2 days prior -modified VITT 4T score of 4- intermediate -send fibrinogen, d dimer, consider IVIG 1gm/kg per day for two days if high dimer, low fibrinogen and falling platelets -will start argatroban, avoid heparin until HIT ab (PF4) is resulted, if HIT positive avoid heparin -neuro IR consulted for possible IR intervention if worsens -transfer accepted by sunrise ICU, appreciate transfer for IR evaluation -continue phosphenytoin -SBP goal <150 with nicardipine and esmolol gtts -monitor daily fibrinogen, dimer, coags #AKI- monitoring uop and cr, consider renal US if worsens #DM- ISS #HTN- nicardipine and esmolol gtts for SBP <150, target 140 Patient seen, examined, labs and imaging reviewed, agree with resident note

HIGH BLOOD PRESSURE; HEART PALPITATION; SEVERE DIARRHEA; HEADACHE/THROBBING IN THE TEMPLES; TIRED; INJECTION SITE PAIN; VOMITING/THROWING UP; SICK; FELL ASLEEP; 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 adverse reaction to beta blockers, and concurrent conditions included blood pressure, and hypersensitive to drugs, and other pre-existing medical conditions included the patient had adverse reaction to beta blockers. The patient had 15 medicinal allergies and reaction to drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 in total administered at left arm on 03-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: nebivolol hydrochloride (form of admin, route of admin, and batch number were not reported) 5 mg, frequency was not reported, from 2021, and 2.5 mg, frequency, and therapy dates were not reported for high blood pressure; and losartan (form of admin, route of admin, and batch number were not reported) 25 mg, 2 times every 1 day, from 2021 for high blood pressure. No concomitant medications were reported. On 03-APR-2021 (on the day of injection), the patient had injection site pain on the day of injection. On 05-APR-2021, the patient starred to getting tired. On 07-APR-2021 or 08-APR-2021, the patient woke up with heart palpitation, throbbing in the temples and diarrhea. Were on vacation, left and came home, still did not feel good, went to urgent care on 11-APR-2021 and blood pressure was 190/100 mmHg. The patient have had blood pressure before, but had been controlled for years until this. Went to cardiologist twice, gave her another medication (carvedilol) which did not bring it down. Carvedilol increased her blood pressure. She was taking 3.175 in morning and 3.175 at night. The patient was tried another medication Bystolic 5 mg that did not bring it down. Cardiologist said they could not do anything else for patient. Referred to a nephrologist that she was not seen yet. No tests from the nephrologist yet. Kidneys were working fine. Meanwhile went to her primary care 3 times, tried on 2 other medications but blood pressure didn't come down. primary care physician lowered the Bystolic to 2.5 mg because she was getting sick from it. Started Losartan 25 mg morning and 25 mg at night, started getting headache. Last night she started getting headaches and throwing up which she said were side effects of the losartan. She went to emergency room on 09-MAY-2021 blood pressure was 215/105 mmHg and kidney was fine, heart was fine, all tests were good (coded as unspecified lab test) and emergency room physician gave her clonidine 0.1 and blood pressure went really low to 129 mmHg over something and she got really sick. They gave her a prescription of clonidine. Family physician told her to take 1/2 of the clonidine if her blood pressure was over 190. On 15-MAY-2021, the patient went to emergency room again because the heart rate was higher (95 ) usually was 60 and blood pressure was 210 over 99 mmHg. She took 1/4 of clonidine and it did drop it down to 160/79 mmHg. She took 1/4 of Xanax and fell asleep. She woke up with severe diarrhea and threw up. Medications included 1/4 Losartan last night. 20 mg Enalapril (original medication) and Hydrochlorothiazide 25 mg and xanax and blood pressure didn't come down. She was taking a 3 course medication therapy all along. For 5 weeks she had been housebound, tryied different medications, throwing up, diarrhea, and xanax tried to bring it down blood pressure right now 188/ 86 mmHg. The patient had been taking the blood pressure medicine and diuretic and a quarter of the Xanax . Her usual BP was 130/140 over 70 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nebivolol hydrochloride, and losartan was not reported. The patient was recovering from high blood pressure, and the outcome of injection site pain, headache/throbbing in the temples, heart palpitation, severe diarrhea, vomiting/throwing up, tired, sick and fell asleep was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210529638--High blood pressure. 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

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

LEFT SIDED WEAKNESS; HEART PALPITATIONS; DIZZINESS AND FEELING FAINT; UNABLE TO LIFT LEGS TO GO UPSTAIRS; FATIGUE; WEAKNESS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the patient experienced dizziness, heart palpitations during weeding outside, had fatigue and was feeling faint. On 08-MAY-2021, the patient was also unable to lift legs to go upstairs. On 12-MAY-2021, the patient experienced left sided weakness. On 20-MAY-2021, the patient visited the emergency room or department for treatment of the events and this was the second time of weakness. On 20-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not reported, computed tomography scan (NR: not provided) No stroke and no blood clot, Chest X-ray (NR: not provided) Not reported, electrocardiogram 12 lead (ECG) (NR: not provided) Not reported, Investigation (NR: not provided) Not reported, and Magnetic resonance imaging (NR: not provided) No stroke and no blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and had not recovered from left sided weakness, heart palpitations, dizziness and feeling faint, unable to lift legs to go upstairs, and weakness. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000180437.; Sender's Comments: V0:20210544480-Covid-19 vaccine ad26.cov2.s-Left sided weakness. 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.

April 22, about 7 pm, vision was way off, blurry and even lost to the far left in my left eye. Woke up on the 23rd confused, I had a maintenance coming to the house and when they called, I had no idea who they were....thank the Lord they called 911. EMT's came and took me to the hospital where I stayed for 5-days. Diagnosis: Hypertension; Embolic stroke

Approx 16 days following vaccine patient's Sp02 saturation dropped to 70-80% despite being on 6liters O2

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.

PROFUSE SWEATING; FELT LIKE I WANTED TO PASS OUT AND DIZZINESS; FEEL ICKY ALL OVER MY BODY AND FEELING CRAPPY; NO APPETITE; RACING HEART; DON'T FEEL WELL AND ILL ALL OVER; VERY WEAK; HEADACHES; 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 severe nausea, and heart race, and concurrent conditions included depression, penicillin allergy, non alcohol user, and non smoker. The patient experienced drug allergy when treated with ciprofloxacin, erythromycin, and sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 13:30 for prophylactic vaccination. Concomitant medications included citalopram for depression. On 06-JUN-2021, the subject experienced profuse sweating. On 06-JUN-2021, the subject experienced felt like i wanted to pass out and dizziness. On 06-JUN-2021, the subject experienced feel icky all over my body and feeling crappy. On 06-JUN-2021, the subject experienced no appetite. On 06-JUN-2021, the subject experienced racing heart. On 06-JUN-2021, the subject experienced don't feel well and ill all over. On 06-JUN-2021, the subject experienced very weak. On 06-JUN-2021, the subject experienced headaches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from profuse sweating, felt like i wanted to pass out and dizziness, racing heart, and headaches, and had not recovered from don't feel well and ill all over, very weak, feel icky all over my body and feeling crappy, and no appetite. 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.

CHEST POUNDING, HEART RATE SPIKING TO 206 WHILE RESTING ON 3 SEPARATE OCCASIONS, BLOOD PRESSURE AT 160, LIGHT HEADED, EXHAUSTION. DIAGNOSES WAS ATRIAL FIBRILLATION. TREATMENT WAS INJECTIONS TO LOWER HEART RATE AND BLOOD THINNER. PRESCRIBED PRADAXA 150MG X2/DAY AND DILTIAZEM 180MG X2/DAY.

15 minutes after injection, customer complained about metallic taste, tongue slightly swollen with small bubbles on each side of tongue. No difficulty in breathing. We asked to stay 15 minutes more for observation. Had tightness in the chest 5 minutes later. Called 911. Operator asks not to give water/benadryl/epipen. EMT arrived 5 minutes later and assessed. Watch 15-20 minutes later walked her out to car. We checked 6:45 pm still have metallic taste and just little swollen on tongue. Called 3/5/21 @ 2:30pm no more symptoms., only from the JNJ shot. tiredness

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.

Lightheadedness and tachycardia noted 20 minutes after administration of Covid Vaccine. Emergency drugs available. Airway assessment done, vital signs obtained, cold, damp cloth placed on patient's head and neck. Husband requested EMS to transport patient to ER for further evaluation. Patient stable when EMS arrived.

0845 Vasovagal with strong retching - no emesis Initial VS: HR 50's O2 sat 85% Subsequent VS: 110/63-HR 60-RR 20- O2 sat - 98% CBG 150 PMHx: HTN, HLD S: patient felt nauseated, dizzy, "hot all over", anxious O: Awake but unable to answer due to retching. Pale, diaphoretic, cool to touch. Cards: radial pulse thready - apical pulse in 50's RRR, no murmur. Resp: clear to auscultation. No cough or evidence of aspiration. GI: strong retching but no emesis. A/P: 68 y/o female who just rec'd J&J Covid Vaccine was in monitoring lot and found to be diaphoretic and retching - semi conscious.   Vasovagal response - patient recovered VS within 5 min of start of event. Wanted to go to hospital for evaluation. She was alone in her car. Called her dtr to apprise of situation. Authority parked her car and returned her car keys to her prior to transport to hospital.

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.

Developed cough and chest tightness 15 minutes after vaccine. Chest tightness worsened. Vital signs stable. Decreased breath sounds no wheezing no sob Given aspirin, ntg sl, albuterol neb. Transferred to Hospital via squad.

HYPOCHROMIA; HIGH WHITE BLOOD CELLS; DVT WITH INFLAMMATION AND SWELLING OF RIGHT LOWER LEG; RUNNY NOSE; BILATERAL WATERY EYES; LEFT ARM TENDERNESS POST IMMUNIZATION; URINARY TRACT INFECTION; LOWER BACK PAIN; 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 concurrent conditions included baker's cyst, and reflux sympathetic dystrophy. The patient experienced drug allergy when treated with gabapentin, and prednisone, drug intolerance when treated with codeine, and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) once a total dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced urinary tract infection. On MAR-2021, the subject experienced lower back pain. On 10-MAR-2021, the subject experienced left arm tenderness post immunization. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced bilateral watery eyes. On 14-MAR-2021, the subject experienced deep vein thrombosis with inflammation and swelling of right lower leg. On 23-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) confirmed DVT right lower leg, Urinalysis (NR: not provided) Unknown, and White blood cell count high (NR: not provided) 10.35 increased and was previously 9.23 not reported. Treatment medications included: ciprofloxacin for urinary tract infection. On 24-MAR-2021, the subject experienced hypochromia. On 24-MAR-2021, the subject experienced high white blood cells. Additional treatment medications (dates unspecified) included: rivaroxaban for deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and bilateral watery eyes on 12-MAR-2021, and left arm tenderness post immunization on 11-MAR-2021, had not recovered from deep vein thrombosis with inflammation and swelling of right lower leg, high white blood cells, and hypochromia, and the outcome of urinary tract infection and lower back pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210348648-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis. 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).

3/29/21 ER HPI: 68 y.o. female who presents with 3 day history of left anterior chest pain. The pain radiates into her back. Pain has been constant and severe at times. It has no relieving or exacerbating factors. Patient denies fever chills cough dyspnea diaphoresis nausea or vomiting. She denies prior similar history. Patient has taken nothing for the pain 4/2/21 ER presentation - flexed to clinic 4/2/21 Clinic HPI: 68 y.o. female who presents today for suspected shingles vs laceration that is infection on her L posterior back. She was seen in the ER for anterior chest wall pain on 03/29 which had started 3 days prior and then saw Dr. again yesterday for follow-up. He gave her a steroid shot and treated her with oral prednisone. In the ER, patient had elevated D-dimer but this was thought to be from her renal insufficiency. She had no other symptoms that suggested pulmonary embolism. No CT angiography of chest was done due to renal insufficiency.The rest of her workup was negative. Rash broke out the day she saw Dr. but didn't mention it to him at that visit. There was no rash on her anterior chest wall where she was hurting at the time.

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.

5 minutes after vaccine I felt a sharp pain in the middle of my head like a headache and thought it would go away and i got dizzier and dizzier for about 25 minutes, I started getting hoarse in my voice, and my heart rate went up.

Pale, Sweating, Shaking Nausea gave water, cool compress and chocolate had patient stay seated for 3- minutes then remain in store until feeling better Patient felt better and left of her own accord

Next day in afternoon (4/8/2021) while sitting comfortably and relaxed at home, heart started racing. rate 183-160. Paramedics called, gave me 10 Mgs of Cardizem IV push then transported to ER. Rate in NSR by arrival in ER, kept overnight for observation. Toprol. XL started by mouth by cardiologist then discharged home in evening Of 4/9/2021.

Patient reports that the morning following vaccination, she awoke with chest pain and palpitations. She took a nitroglycerin and a baby aspirin, upon which the pain subsided. She was fine for the remainder of the day. The next morning she had chest pains again to a much lesser degree; they resolved in the same manner after treatment. She has been in contact with her cardiologist for a follow-up, unsure if related to vaccination or a flare up of her pre-existing condition.

Headache and nausea started at 10 pm, 9 hours after injection. Over the next several hours, headache worsened, chills set in along with low-grade fever (100) and elevated heart rate. Took Tylenol 500 mg at 4:30 a.m. after not sleeping for hours. Continued taking Tylenol every 6 hours for the next 24 hours for the headache. Fatigue and slight 'brain fog' lasted for 5 days.

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.

Date and time adverse event started: 04/08/21 evening (stroke at home) Adverse events experienced and are they still occurring now: after the stroke they did a number of test, angiogram, CAT scan with and without contrast, MRI Spoke to her doctor who told her husband to take her to the hospital (husband stated she is doing better she is still in the hospital)

19 days after receiving vaccine I had a nose bleed that I couldn?t stop and neither could ER until they packed my nose after four hours of continued bleeding. I never had a nosebleed before and have had one weekly since then.

shoulder and neck tightness and soreness, tiredness lasting to the present date, weak arms, tingling in hands, poorer short term memory and speech, pain below directly below lower sternum

1 week after injection experienced low platelet levels and bruising. Those resolved within another week of time. Patient has also been more tired since vaccine, has been experiencing prolonged sinus issues and has been having sensations of needle pricking all over her body in various places since injection.

BLOOD PRESSURE KEEPS GOING UP; FLU LIKE SYMPTOMS/CHILLS/HEADACHE; 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 concurrent conditions included hypertension, hypokalemia, anxiety, depression, penicillin allergy, non alcoholic, and non-smoker, 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 experienced drug allergy when treated with lisinopril, and ibuprofen 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for prevention. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) 140s (unit not specified). On 09-APR-2021, the subject experienced blood pressure keeps going up. On 09-APR-2021, the subject experienced flu like symptoms/chills/headache. Laboratory data included: Blood pressure (NR: not provided) 156/78 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 120s (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms/chills/headache, and had not recovered from blood pressure keeps going up. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

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.

Patient with "easy bruising" went to PCP who sent patient to ED. Platelet count found to be 9000 when two months prior was 200,000

EXTREME BREAK OUT OF COLD SWEAT; BEE STING-LIKE PAIN; NERVE PAIN; LOW BLOOD PRESSURE; IRRITABLE; RASH TROUGHOUT BODY; CHILLS; SWELLING AT SITE OF INJECTION; FEVER; NO STRENGTH TO STAND UP; ITCHING; BODY ACHES; 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 sepsis, and concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 12:30, in the left arm, for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced no strength to stand up. On 18-MAR-2021, the subject experienced extreme break out of cold sweat. On 18-MAR-2021, the subject experienced bee sting-like pain. On 18-MAR-2021, the subject experienced nerve pain. On 18-MAR-2021, the subject experienced low blood pressure. On 18-MAR-2021, the subject experienced irritable. On 18-MAR-2021, the subject experienced rash throughout body. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced swelling at site of injection. On 18-MAR-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) Low. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 19-MAR-2021, had not recovered from extreme break out of cold sweat, chills, low blood pressure, swelling at site of injection, rash throughout body, bee sting-like pain, nerve pain, and irritable, and the outcome of itching, no strength to stand up and body aches was not reported. This report was non-serious.

PULMONARY EMBOLISM; THROMBOSIS; COR PULMONALE ACUTE/ DYSPNOEA; HYPOXIA; DIZZINESS; COUGHING; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1120494) concerned a 68 year old female unknown ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 14:15 for prophylactic vaccination. Concomitant medications included amitriptyline for sleep, and zolmitriptan for migraine. On 07-MAR-2021 08:30, the subject experienced pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing, and was hospitalized (date unspecified). On 12-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) normal, Blood test (NR: not provided) normal, CT scan (NR: not provided) Pulmonary Embolism, Chest X-ray (NR: not provided) normal, Diagnostic ultrasound (NR: not provided) No blood clots or vein thrombosis, Echocardiography (NR: not provided) Increased pressure on the right side of heart due to blood clots, and Heart rate (NR: not provided) elevated. Treatment medications (dates unspecified) included: oxygen, salbutamol, and rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition); Sender's Comments: V2:Additional version created for MAC update. This updated information does not alter the causality of previously reported events. 20210441745-Covid-19 vaccine ad26.cov2.s-Thrombosis, pulmonary embolism ,Cor pulmonale acute, Hypoxia, dizziness, cough. These events are considered unassessable. These 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.

Patient reported knee pain at the end of march 3/28/2021 she was seen by a doctor on 4/14 and thought to have arthritis prescribed NSAIDS. Patient had no history of arthritis or chronic prescription use or chronic health conditions. She was referred to an orthopedic and when no arthritis was found she was referred to ER to check for a blood clot on 5/10/2021. Patient was diagnosed with a DVT on 5/10/2021 with no previous history of clots or other risk factors known.

4/13/21 - 7pm Developed confusion and amnesia noted by husband. Taken to local ER where tests showed small acute stroke left temporal lobe and previous (3-4 weeks prior) small stroke right temporal lobe. Hospitalized for 2 days. No neurological deficits. No previous signs or symptoms of stroke prior to 4/13. Wt. 137 lbs, ht 5"7; normal sinus rhythm.

Pt said that on the day following the vaccine she felt very dizzy and kept blacking out. Her husband said that she was also mumbling nonsensical things, and started drooling. Today when she called, she had trouble with speaking and she is still drooling. Client suspects that she might have had a stroke or a blood clot, but she have not gone to the doctor because she does not have health insurance.

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.

SWOLLEN AREA BELOW THE SHOT/ SWELLING IN ARM; REDNESS IN PROXIMITY OF INJECTION SITE; SORE ARM; HEART FLUTTER; This spontaneous report received from a patient concerned a 68 year old White (Not Hispanic or Latino) female. The patient's height, and weight were not reported. The patient's past medical history included heart murmur, heart flutter, and severe hives with antibiotics, and concurrent conditions included non-alcoholic, non-smoker, sulfer allergy, and penicillin allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with azithromycin, cefdinir, and ibuprofen. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 30-APR-2021 on left arm as prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the patient experienced heart flutter. On 01-MAY-2021, the patient experienced sore arm. On 15-MAY-2021, the patient experienced swollen area below the shot/swelling in arm. On 15-MAY-2021, the patient experienced redness in proximity of injection site. The action taken with covid-19 vaccine was not applicable. The patient recovered from heart flutter on 30-APR-2021, and had not recovered from sore arm, swollen area below the shot/swelling in arm, and redness in proximity of injection site. This report was serious (Other Medically Important Condition).; Sender's Comments: Covid-19 vaccine heart flutter. 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.

12 hours later after I had the shot my heart was pounding so hard it woke me up. Tried to look up information and couldn't find information about a speeding heart rate. The more I moved around the higher my heart beat got. I ended up calling 911 and they suggested I go to hospital, admitted into the ER. They did a chest x-ray, ran some EKGs and blood work and then was admitted into the cardiac unit. They sent me home and told me to check up with my doctor. Did some more blood work later and a thyroid checkup and everything came back fine.

Initially on vaccine evening 3/19/21 mild sore arm, mild brain fog, following day03/20/2021 headache, tired, second day post vaccine 03/21/2021 no noticeable symptoms . 03/17/2021 first notation of headache,, 03/18/2021 headache continued all day ,03/19,2021 notation of headache setting in early evening , 03/20/2021 notation of tiredness all day accompanied by headache and achy everywhere-joints-muscles. Days following had notation of mild headache/body aches. 04/01/2021-8:30am Extremely Dizzy upon getting out of bed, Strong Panic attack-symptoms subsided with am medications, and reappeared about 11:00am. Strong Panic attack, very dizzy, neck stiff,muscle tightness in shoulders, sysmptoms continued off and on

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

Patient is a 69 year old female who was admitted on 5/27/2021 for CEREBRAL VENOUS SINUS THROMBOSIS. Patient is a 69 year old female "who lives at home with husband. Patient with a h/o DM2, hyperlipidemia, epilepsy followed by Dr. neurology outpatient, hypertension. Patient on keppra and tegretol with some episodes of partial seizures, sensitive to being off medications. Patient was in usual state of health until today. Daughter noticed around 6 PM patient was confused, altered, dizzy, not able to walk, and had left arm weakness. The patient's sister had a stroke in the past and they were concerned for this and so brought her in for evaluation when she didn't improve. Daughter thinks patient might have started having symptoms around 1 PM. Daughter reports patient was not taking her aspirin, and they never picked up the lisinopril that was prescribed for blood pressure in the past. She did have the J&J covid vaccine 6 weeks ago.

Heart pounded heavily starting at 10PM preventing sleep. Continued until 3AM (April 29, when medics arrived). Right side of face flushed. Front of thighs very flushed. Called 911. Medics measured blood pressure at 182/81. BP had always been normal (120/60 or less). Pulse = 84. BP lowered to c. 164/?? while medics were with patient. Patient saw her doctor a few days later. Metoprolol prescribed; started May 12 @25 mg with dosage increased to 100mg over three weeks. BLOOD PRESSURE REMAINS ELEVATED DESPITE MEDICATION 100mg daily. BP ranges erratically 184/81 to 134/66 on medication. BP HAS NOT RETURNED TO NORMAL.

Stroke occurred 4 days after shot administered. Blacked out, right arm limp and of no use. 2 pm 5/17/21. 911 called transported to hospital and then transported/admitted to another hospital. CAT scan and MRI test done. Test show right side of head had stroke, and heart has damage.

FLUSHING ON SIDE FACE AND UPPER THIGH; POUNDING HEART; ELEVATED BLOOD PRESSURE; 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 concurrent conditions included generalized anxiety disorder (gad), high blood pressure, non-smoker, non-alcoholic, penicillin allergy, and erythromycin allergy, and other pre-existing medical conditions included the patient had no known 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: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Blood pressure (NR: not provided) 120/60 mmHg. On 2021, Laboratory data included: Blood pressure (NR: not provided) 140/60 to 165/70 mmHg, 170/70 mmHg. Treatment medications included: metoprolol. On 28-APR-2021, the subject experienced flushing on side face and upper thigh. On 28-APR-2021, the subject experienced pounding heart. On 28-APR-2021, the subject experienced elevated blood pressure. On 29-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 182/81 mmHg, 160/60 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushing on side face and upper thigh, and pounding heart on 28-APR-2021, and had not recovered from elevated blood pressure. This report was non-serious.

LOWER HEART RATE; LITTLE HEADACHE; SORE ARM; POTENTIALLY HELPED SYMPTOMS OF POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME/LESS ADRENALINE RUSH/ LESS NEUROPATHY; 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 concurrent conditions included postural orthostatic tachycardia syndrome, neuropathy, hepatitis c, and adrenaline rush, and other pre-existing medical conditions included patient wore a heart monitor and normally heart rate was in 150 - 160s when play ball. patient can not take certain medications because liver enzymes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a71a, and expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced potentially helped symptoms of postural orthostatic tachycardia syndrome/less adrenaline rush/ less neuropathy. Laboratory data included: Heart rate (NR: not provided) 10 beats lower per minute, 140s, 130s, Low 140s, 156. On 02-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced little headache. On 05-JUN-2021, the subject experienced lower heart rate. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 150s. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little headache, sore arm, lower heart rate and potentially helped symptoms of postural orthostatic tachycardia syndrome/less adrenaline rush/ less neuropathy was not reported. This report was non-serious.

SUPERFICIAL BLOOD CLOT IN RIGHT LEG, UPPER THIGH AND VARICOSE VEINS; This spontaneous report was received from a 68-year-old female patient. The patient's height, and weight were not reported. The patient's past medical history included headache, and asthma. Concurrent conditions included high blood pressure (under control with medicines), diabetes (diagnosed 2 years ago; under control with medicines), tetracycline allergy (caused headache), and allergy to cats, dogs, horses, tree (caused asthma). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1800031 or 1805031, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 03-MAR-2021 for prophylactic vaccination. The patient was on unspecified medications for high blood pressure and diabetes. On 25-MAY-2021 (two and half month after vaccination), the patient noticed tenderness, warmth on touch, redness, and red lines in the upper inner thigh (above the knee) of the right leg. On 31-MAY-2021, the patient went to the immediate care, and the doctor diagnosed her leg as a superficial blood clot in the leg, thigh and varicose vein. Ultrasound was not available so healthcare professional (HCP) recommended the patient to see her primary HCP the next day. On 01-JUN-2021 (Tuesday), the patient went to her primary HCP (internist). The internist looked at patient's leg and confirmed the diagnosis as a superficial blood clot. On 02-JUN-2021 (Wednesday), at 08:45, she went to the vein specialist and the first ultrasound was performed. Once again, a diagnosis of superficial blood clot in varicose vein was confirmed. On 09-JUN-2021 (one week later), the patient returned for a second ultrasound to make sure the clot did not get any bigger and no improvement was noted. The patient was prescribed oral Aspirin 325 mg, 1 tablet, twice a day (BID) by the doctor. On 29-JUN-2021, the patient stated that she felt better. However, on the same day, a third ultrasound was performed by the ultrasound technician who noticed no improvement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from superficial blood clot in right leg, upper thigh and varicose veins. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210666967-covid-19 vaccine ad26.cov2.s -Superficial blood clot in right leg, upper thigh and varicose veins. 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).

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.

About 9 hours after the injection, I experienced chills, increased heart rate, and headache. I began taking alternate doses of aspirin and acetaminophen. By 5 a.m., chills were gone.

Pt went vasovagal after dose of Johnson and Johnson vaccine. This has happened before. She did nit lose consciousness. We slowly moves pt from seated position to lying on the floor. She denied use of a cot and a juice box. We had a cold pack on the back of her neck. Eventually she was able to transfer from the floor to the chair and felt better. We started pts 15 minute observation time after she was stable in a chair. Pt felt better before she left.

The pharmacist jam the needle into my arm to the bone and my arm is still a little sore. I could feel the fluid running down in my arm. Around 5 hours or so after the shot, I was in bed for 2 days with chills/aches/fever, head pounding, and heart racing. Also I did not have an appetite. I am just getting my strength back and willing to trust myself walking.

Slight pain at injection site. Moderate headache. Severe chills with chattering teeth and body shaking. Severe fatigue. Moderate muscle aches. Nausea. Racing, pounding heart. Rate measured at 100 bpm. Continued for approximately 12 hours. Overall weakness. Slight dizziness at height of symptoms.

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

Asymptomatic thrombocyctopenia, platelet count of 41 (with plt clumping on micro) on routine screening 2 weeks after vaccination. Pateint had a normal platelet counter for years up until this draw. Again, no abnormal bruising or bleeding.

Janssen Covid 19 Vaccine EUA Patient experienced sudden onset Dizziness and Nausea following her vaccination. Vitals recorded and the patient was placed in a supine position. Facility contacted and they responded to the location and patient was placed in the ambulance and a 12 lead was completed. At this point the patient felt improved, Hypotension had resolved and the 12 lead was negative. Patient decided to AMA and healthcare facility was contacted for the AMA. Patient was taken home by her husband

Side effects started evening of 4/3/2021 with extreme fatigue, nausea, heart palpitations, slight fever, coughing, chills, stomach cramping, dizziness. Side effects still in progress at this writing.

On the night of the 3/9 at 10PM I had shakes/tremors in both my hands for 24 hours. I was freezing, terrible head aches, and nauseated till , could not get out of bed and was very tired. I could not move till sunday night; 6 days later i started feeling better. I called my pcp on the 16,and the 23 complaining that i had pain in my ccchest anad heart, She said that it was allergies. I called her on the 3/23 again telling her that i still had pain in my chest/heart, She told me that it was allergies and that it was a side affect of the shot.On March 26 a neighbor came over that was a nurse took my pulse and said that i had an irregular heart beat.Called pcps office spoke to Nurse told to come in on3/30. PCP checked my lungs/heart.said nothing wrong. I told her to take an EKG-showed PAC

URINARY TRACT INFECTION; EXTREMELY LOW BLOOD PRESSURE; POSITIVE DIAGNOSTIC TEST FOR COVID; This spontaneous report received from a consumer concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included gastrointestinal infection, and concurrent conditions included dialysis. The patient was hospitalized on an unspecified date in MAR-2021, (a week before vaccination) due to gastrointestinal infection and was discharged approximately on 29-MAR-2021 or 30-MAR-2021. On 31-MAR-2021, the patient had dialysis and was administered the vaccine as well in the dialysis center. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered to left arm on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the patient experienced extremely low blood pressure and was taken to the emergency room. On the same day, the patient was admitted to the hospital and was diagnosed with a urinary tract infection. The patient took the quick COVID-19 test which was negative. The patient took another unspecified diagnostic test for COVID-19 on the same day which was positive. It was reported that, the patient did not have COVID-19 related symptoms (or previous symptoms) and was asymptomatic. Laboratory data included: Blood pressure (NR: not provided) Extremely low, COVID-19 antigen test (NR: not provided) Negative, and COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the urinary tract infection, extremely low blood pressure and positive diagnostic test for COVID was not reported. This report was serious (Hospitalization Caused / Prolonged). The case is associated with Product Quality Complaint number # 90000175206. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210407177 -covid-19 vaccine ad26.cov2.s-extremely low blood pressure, urinary tract infection. 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).

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.

Excessive gas, diarrhea, and belching to the point that I could not sleep and resulted in my chest being sore for a couple days. I did not take anything except some baking soda and water on Thursday (the day after my shot). The symptoms eased up on Thursday night and I was able to sleep.

She fell twice. The second time was due to a blood clot on the brain that led to multiple bleeds under dura and the brain. She needed an emergency craniotomy and is now undergoing acute rehab for speech, PT and OT.

Patient became diaphoretic, pale, and began crying. Slow to respond to verbal commands. Paramedic and NP onsite assisted patient to cot and elevated legs. after 15 minutes, patient walked to observation area and was monitored for 30 minutes without event. VS 116/64, 80 HR, 98%

Left Popliteal DVT Edema, pain, increased warmth Starting Eliquis 10mg po bid x 7 days f/b 5mg bid x 6 months

Complaints of chest pain. She went to ER. She was sent home and said no heart attack. She then had another episode of chest pain on 04/11/21 and went to ER and was sent home and told to see cardiologist.

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.

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.

Two weeks and two days after I was hospitalized for congestive heart failure. Never before diagnosed. I was treated during a hospital stay and then sent home.

ARTHRITIS; PAIN IN HIP; COUGHING BLOOD; BLEEDING NOSE; CHEST PAIN; DIARRHEA; LOST APPETITE; WORSENED PERSPIRATION; LOST 100LBS; 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 penicillin. The patient was previously treated with sulfur for drug used for unknown indication, codeine for drug used for unknown indication, and morphine 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 08:00 for prophylactic vaccination. Concomitant medications included warfarin sodium for drug used for unknown indication. On APR-2021, the subject experienced lost appetite. On APR-2021, the subject experienced worsened perspiration. On APR-2021, the subject experienced lost 100lbs. On 07-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced chest pain. On 09-APR-2021, the subject experienced coughing blood. On 09-APR-2021, the subject experienced bleeding nose. On 10-APR-2021, the subject experienced pain in hip. On 11-APR-2021, the subject experienced arthritis. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) negative (units unspecified). Treatment medications (dates unspecified) included: ketorolac, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 08-APR-2021, chest pain on 09-APR-2021, coughing blood, and bleeding nose on 10-APR-2021, and pain in hip on 11-APR-2021, had not recovered from lost appetite, and worsened perspiration, and the outcome of arthritis and lost 100lbs 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

INCREASED CHEST PAIN; 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 congestive heart disease, penicillin allergy, and sulfas allergy. The patient experienced drug allergy when treated with oxycodone hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced increased chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased chest pain. This report was non-serious.; Sender's Comments: V0:As per standard protocol, MAC comment is not required for non-serious cases

FOGGY FEELING IN HEAD; BURNING IN THE HEART MUSCLE; EVERY BONE WAS HURT; HEADACHE; CHILLS; FEVER; SWOLLEN HEART MUSCLE; CHEST PAIN; URINE COLORING YELLOW ORANGE; BODY ACHE; VOICE WAS HOARSE; This spontaneous report received from a patient concerned a 69 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced voice was hoarse. On APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced swollen heart muscle. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced urine coloring yellow orange. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced foggy feeling in head. On 08-APR-2021, the subject experienced burning in the heart muscle. On 08-APR-2021, the subject experienced every bone was hurt. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, foggy feeling in head, voice was hoarse, fever, chills, and headache on 11-APR-2021, burning in the heart muscle, and every bone was hurt on 09-APR-2021, urine coloring yellow orange on 10-APR-2021, and body ache on APR-2021, and was recovering from swollen heart muscle. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.

Presented with chest pain on April 15, 2021, was evaluated in the ER, and discharged home. Presented again on April 18, 2021, and at that time chest pain is more persistent, therefore patient was admitted. Had serial enzymes performed and was discharged the following day to follow-up with cardiology. Unknown further outcomes beyond this.

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.

The patient got her single shot Johnson and Johnson vaccine on 3/6/2021. Then, on or about 4/22/2021, she began to complaint of dizziness and left-sided weakness. She presented to emergency room on 4/29/2021 and was found to have a stroke via CT and MRI.

passed out in car. felt weak and fell over (according to spouse) syncope. Evaluated by EMS- Transported to Emergency room/department or urgent care.

Patient indicated that she had a stroke the evening of 5/4/2021 after she received the Janssen Covid 19 Vaccination.

Received the Johnson and Johnson vaccine, went to get haircut. Went home, watched TV, and went to bed. Got up to use the restroom and noticed face was droopy and speech was off. Stayed in bed through the night and roommate cam in the morning and took to hospital

Heavy legs approximately 3 hrs after vaccine taken ,heart beating fast. The heavy legs went away after few days but for the next several weeks heavy legs came back & continues more frequently up to now. I went to see my doctor, on May 10, 2021,.,

Patient state that she didn't feel well after the shot. She wanted to sit in the chair at the pharmacy versus standing. She walked over to the chair, sat down, within 5 minutes her husband alerted us that she had fainted and if the pharmacy staff could help her. Staff then proceeded to lay her down on the ground where a cooler was placed under her feet to keep them elevated, a cushion was placed under her head for comfort, and she was given a bottle of water when she became alert. She then rested for a few more minutes before getting up in her chair again. She then got in the chair after 10 minutes, waited another 20 minutes and then felt safe enough to go home afterwards.

ROLLING ACHE IN CHEST; FEELS LIKE FLU; STIFFNESS OF NECK; JAW GETTING READY LOCK AND FEELS OUT OF ALIGNMENT; LOW BLOOD PRESSURE/LOWER THAN NORMAL BLOOD PRESSURE; ACHINESS IN FINGERS FOR LONG TIME; ACHINESS IN SHOULDER ANKLE AND KNEE FOR LONG TIME; NECK PAIN; GLANDS SWOLLEN; 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 temporomandibular disorder, and irritable bowel syndrome, and concurrent conditions included sulfonamide allergy, non alcoholic, non smoker, and controlled high blood pressure. The patient was previously treated with for drug used for unknown indication; and experienced drug allergy when treated with chlorpromazine for drug used for unknown indication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced glands swollen. On 30-APR-2021, the subject experienced neck pain. On 01-MAY-2021, the subject experienced achiness in fingers for long time. On 01-MAY-2021, the subject experienced achiness in shoulder ankle and knee for long time. On 02-MAY-2021, the subject experienced low blood pressure/lower than normal blood pressure. Laboratory data included: Blood pressure (NR: not provided) 112/65, 126/71, 124/84, 120/82, 138/72. On 06-MAY-2021, the subject experienced jaw getting ready lock and feels out of alignment. On an unspecified date, the subject experienced rolling ache in chest, feels like flu, and stiffness of neck. The action taken with covid-19 vaccine was not applicable. The patient was recovering from glands swollen, and neck pain, had not recovered from jaw getting ready lock and feels out of alignment, achiness in fingers for long time, and achiness in shoulder ankle and knee for long time, and the outcome of low blood pressure/lower than normal blood pressure, feels like flu, stiffness of neck and rolling ache in chest 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.

According to hospitalization discharge summary paperwork, patient presented to Hospital with bilateral leg swelling and calf pain shortly after receiving the Johnson and Johnson Covid-19 vaccine.

The weekend after the shot, I noticed deep purple coloring at the top of my thighs, pubic area, arm pits. There are also welts on the top of my thighs, where coloration is more blotchy. After a couple days I realized I was having small episodes of near-fainting. I would have the sensation that I was was going to faint, and it went away without any fainting or dizziness. It was a warning sensation. This occurred 10-15 times a day. It would grab my attention & be gone just as quickly. The same weekend I started with the rash, my anxiety level rose very high. I felt a motor in my chest all the time. Sleeping was very difficult. This anxiety & motor are indicative of a thyroid rage, which I have experienced p

pressure on center of chest...fever....muscle aches....sweating....lack of appetite....fatigue.....sleep problems lasted 4 nights and days

04/13/2021 Began having irregular heart beat, lasted for 3 hours. 04/15/2021 Began having irregular heart beat again, extra and skipped beats. This continued all night. Visited ER It finally subsided on the evening of 04/16/2021

Pain, pain, pain, and blisters, itchy and soreness. I went to the Clinic ER because I was in so much pain in my chest and back and they kept me over night and ran test. I was sent home and returned in a couple of days cause I was still in pain and was diagnosed with Shingles.

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.

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.

Patient seen in clinic on 6-14 and admitted to observation in the hospital setting. Patient was transferred to Medical Center for higher level of care due to hypotension and elevated troponins on 6/15

Cramping began in right leg off & on over 6wk period. Not thinking much of it just older I guessed. Then on June 6th my calf locked up & could barely walk. Later in evening my toes & foot went numb & cold & no feeling. Called Ambulance to take me to Hospital. 6 days of treatment. Many injections & needles.

Patient is a 69-year-old female with past medical history of coronary artery disease status post double bypass on May 2015, hypertension, hyperlipidemia came to emergency room with chief complaint of chest pain going on since Wednesday. She says that initially the pain started after she ate her food and she has history of gallbladder polyp and hence she thought it might be her gallbladder and indigestion and took Tums. Pain was associated with nausea at that time. Her pain recurred next day after eating and she took nitroglycerin after which she felt better. But today she tried to hurt just toast and nectarine for breakfast after that she had pain again in the middle of the chest and this is when she got worried and she came to the emergency room. She denied any shortness of breath or vomiting or diaphoresis associated with the pain. She says that her previous heart attack, she did not have any symptoms. In the emergency room, her troponin was elevated and given EKG findings of subtle ST changes, code heart was called and cardiology evaluated the patient and canceled code heart as her EKG was pretty stable. She received a dose of aspirin and Brilinta in emergency room and was started on heparin drip. NSTEMI. Cardiac Catheterization performed.

2 different events: 1) 20-30 minutes after the shot, I felt dizzy and disoriented, similar to car-sickness, but I wasn't in a moving vehicle; It appeared that the center of the field of vision for my left eye had become blurred. Subsequently, I had a bad headache and body aches, which lasted most of that day and the next day. My vision is still blurred. A visit to my optician on 13 April 2021 confirmed an epi-retinal membrane, which was not present at my previous eye exam. 2) about two weeks after the shot, I experienced severe pain and raised blood vessels in different areas of both my fore arms, hands and fingers, and my lower left leg and left foot. These lasted a few minutes and then subsided. They were severe enough to wake me up multiple times every night. I finally went to my doctor's office on April 26, saw the nurse practitioner who actually watched one of these episodes. She consulted Dr., they were only concerned about my left leg being a potential blood clot; said the other areas were unlikely to cause significant problems, sent me for an ultrasound examination of my left leg on April 27th, which showed no blood clot. The intermittent raised veins and pain continued for another week or so then subsided.

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.

SEVERE ABDOMINAL PAIN, BLOOD CLOT IN RIGHT LEG, CONFUSION (CURRENTLY STILL IN THE HOSPTIAL FOR THESE ISSUES)

Developed chest pain over time, went to dr , had blood work done and the D- Dimer results were extremely elevated, dr requested that more tests be done

Began feeling tired on way home at 3 pm, rested in chair until 9 pm, in bed was so cold and shivering even with two heavy blankets. Headache developed, heart was pounding (97 pulse rate), headache was the worst ever. Could not sleep, then got up all night until 4 am , finally got back into bed, slept a little, then got extremely hot and sweaty. Finally slept until 9:45 am, still have headache but not as bad. Heart more normal, pulse 75. My temperature stayed a little below normal, 96.6 degrees.

Extended Spike in blood pressure and heart rate. Went from home by ambulance to the ER. Sent home after six hours. No crisis event but went to my dr. Saw cardiologist 3/12 and wearing a two-week Zio patch to rule out other issues.

Metal taste in mouth Swollen face bright red. Later tinnitus rash on legs and arms a few racing heart beats. Itchy face. Headache Today (3/17) face swells and itches then better headache tinnitus but much better than last night.

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.

Patient lost consciousness and was unresponsive for few minutes. She came to and began to vomit. 911 was called immediately and the area was secured with privacy screens. In the meantime, patient was moved to the ground to lie down on her side. She continued to feel nauseas and out of it. The EMTs arrived promptly and took over, once they arrived.

Severe muscle pain throughout body, legs and arms weak to the point of not being able to walk or get to the bathroom, chest pain, severe head/face pain, dizziness/vertigo, chills, fever, vomiting. Was so bad that I thought about calling 911. 15 hours later - muscle pain remains, head exploding pain, dizzy.

Patient showed up to clinic with Dr's note saying she has allergies but that she should get the COVID 19 Vaccine. Prior to administration, patient appeared anxious and states "I shouldn't have had mayo...I'm allergic to eggs." appx 5 min later, patient appears flushed and c/o chest tightness. Was moved into room to lay down and Dr was brought in along with a total of 3 RNs, 1 EMT-1, etc. MD prescribed 50mg Benadryl IM and patient was sent to hospital via local ambulance. During event, patients BP was elevated, HR 120s, SPO2 96% on 1L O2. Patient was able to speak in full sentences and lung sounds were clear bilaterally.

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.

deep vein thrombosis, swelling, pain in both legs and lower abdomen. warm and red skin. red swollen veins.

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?

Started having chest pain. Went to the ER. Was parked in the ER hallway all night, around 3 or 4 am, her heart rate slowed to nothing and blood pressure dropped to zero. She was admitted to a room. Angiogram showed no blockages, doctor said it was an electrical problem from old age. Installed a pacemaker.

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.

On 3/31/2021 Patient developed blurred vision and excruciating headaches with extreme weakness. Pt went to an urgent care where they found bleeding in brain so they sent her via ambulance to ER at another hospital. She had MRI, CT and blood work. She was admitted into the ICU where she was treated for 3 days and then transferred to telemetry. Pt was discharged to FU w/ Neurologist and Ophthalmologist.

vaccine 3/7/21. 4/9/21 presented in ER with leg pain. dx with dvt. has no prior hx or fam hx of clots. is not a smoker. is on hrt. treating dvt with eliquis.

States she developed leg pain 6 days after shot and didn't think it was anything to worry about until she saw the J&J blood clot news and decided to get checked. Had appt and ultrasound on 4/19/2021 with NP. Found to have two non-occlusive, small blood clots in the right leg.

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.

I felt dizzy 45 mins after having my vaccine and i had a headache for 7 days straight and now it comes and goes. i have had fatigue and my blood pressure shot up and my cholesterol went up after having vaccine and now I am having to be on meds to control it

Patient received vaccine on 11 March and developed a superficial venous cord on same arm extending from the left axillary region beyond the left elbow. US of the extremity is pending to rule out DVT of the upper extremity.

LARGE SPINAL HEMATOMA; PLATELETS DROPPED FROM 14 TO 7; This spontaneous self-report was received from a patient who is a nurse and a 70 year old female. The patient's height and weight were not reported. The patient was not pregnant at the time of event reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: unknown) dose was not reported, administered on right deltoid muscle on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient had a planned surgery (decompression fusion). On 13-MAR-2021, the patient had a horrible pain and magnetic resonance imaging (MRI) scan revealed that she had large spinal hematoma. On 15-MAR-2021, hematoma was drained "(3 units of blood)". At the time of this report, the patient still had a little bump and her platelets dropped from 14 to 7. The patient was discharged on 21-MAR-2021; treatment details were not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from large spinal hematoma, and the outcome of platelets dropped from 14 to 7 was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 This report concerns a 70-year-old female patient who had a spinal hematoma, 3 days after a planned surgery and 4 days after receiving Janssen COVID-19 vaccine. One day after vaccination, the patient had the planned decompression fusion. Three days after surgery (4 days after vaccination), the patient had a severe pain and MRI revealed a large spinal hematoma. Two days after, hematoma was drained ("3 units of blood"). Patient's platelet counts dropped from "14 to 7" (unit not specified). The patient was discharged from the hospital six days later. Although spinal surgery is the risk factor for hematoma, based on the close temporal relationship, the causality for the events is considered plausible for vaccine. Additional information has been requested.

The pt said she developed a blood clot on her posterior hand. I asked her if it was a bruise on the back of her hand and she said it was a blood clot. She said she slapped the bumb/clot and it subsequently went down/away.

On 4/23/21 she presented to the ED with 4 day history of left sided weakness and slurred speech. She was hypertensive on arrival 249/121. In the emergency room labs remarkable for platelet count 92, INR 1.0, glucose 170, GFR 70.7, AST 48, alkaline phosphatase 167, troponin I 0.039. COVID-19 and other viral serologies not detected. CT of the brain showed a small subacute infarct in the right body of the corpus callosum. MRI advised by radiology. Patient received aspirin, amlodipine 10 mg, enalapril 1.25 mg IV then 0.625 mg IV for uncontrolled hypertension. MRI of brain reveals small subacute infarct involving the body of the corpus callosum, and punctuate acute infarct to the posterior left frontal lobe. Angiogram of brain was performed revealing focal severe stenosis of the mid basilar artery, moderate to severe stenosis of the short segments of both intracranial internal carotid arteries and moderate to severe short-segment stenosis of the intracranial left vertebral artery, felt to be chronic and unrelated to current symptoms. She was started on dual antiplatelet therapy: clopidogrel 75 mg PO DAILY and aspirin 81 mg Tablet, Delayed Release (Dr/Ec) 81 mg PO DAILY. It should be noted that lab work reveals Thrombocytopenia chronically from 2011 forward.

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.

Face pain especially jaw bones, headache, sharp shooting pain in right abdomen, icy cold, foot cramps, extremely loud and fast heartbeat for about seven hours followed by moderately loud but still very fast heartbeat for several more hours, urination approximately every half hour throughout the night resulting dehydration.

STARTING AROUND 4/3 she started to experience dizziness, nausea and memory loss. On 04/06 She passed out while sitting in her chair, woke up and began throwing up. Had extreme short term memory loss and low blood pressure. On 04/08 while at her primary care Dr, he suggested a hospital visit with suspicion of possible stroke. Was admitted and released the following day. Dr advised possible mini strokes but could also be dehydration. CBC with differential showed other results than dehydration. Starting around 04/20 she started having chest pains and thought it was heart burn, after medication and another visit to her pcp she was admitted to the hospital again on 04/23. Her troponin levels indicated a possible heart attack. She had a heart catherization and was found to have a healthy heart. Again, her blood pressure has been decreased since, her hgb and hct has also been low with a history of it being high. A high WBC since all of this has started among other unexplained blood results.

Patient received vaccine on 4/10/21. Went to ED, got IV placed due to side effects. Came to clinic on 5/4/21 with right arm pain. Found to have occlusive cephalic vein clot.

I had an event where my blood pressure was very high and the left side of my body became tingly and weak. I went to the doctor and stayed two nights for observation. They ran many diagnostic tests but nothing was diagnosed. I continued to have the tingling and weakness and began to feel it could be a pinched nerve in my back/shoulder. I went to a chiropractor and was treated twice for adjustments to my back, neck area and the tingling, weakness has not occurred again. I am monitoring my blood pressure at home and have a doctor check up scheduled for the end of this month. Confident it was not a medical event due to the Covid vaccine but still following up.

After patient received the vaccine of Janssen I saw a hand shake. When I was going over side effect patient's hand was shaking more. I asked the patient if hand shaking was normal she stated no and she passed out. I was able to her upper body from falling. I asked her husband to hold her and I got an epinephrine 0.3mg Lot # 026a20aa exp 02/22. I injected epi into her left thigh. patient woke up after 20 second but she didn't have any memories what happened

4/30/21: This patient comes in complaining of worsening low back pain. She has a history of severe degenerative disease in his had surgery. She was scheduled to see her neurosurgeon last year however it got canceled due to the COVID-19. Patient states she saw her neurologist on Tuesday and was given injections which significantly helped. She states that her pain has returned however. She has had no trauma. No footdrop. No difficulty with her bowel or bladder. Patient states she only uses Tylenol arthritis at home. 5/1/21:The patient is a 70-year-old female presenting to the emergency department for back pain. She has a history of chronic back pain and states that has been worsening. She was recently seen here for the same complaint. She currently rates her pain 10/10 intensity. She reports that she has chronic numbness and tingling of her bilateral arms/hands and legs/feet. She states that this is also worsening. She denies any changes in bowel or bladder function or perineal numbness. She states that she has been using a walker at home and that she has tried to make an appointment with her neurosurgeon who previously operated on her but that she has been unable to get through to their office. She reports that she only called 1 time on a Friday. She is taking Tylenol at home for her pain and reports minimal relief. She denies any fevers or associated concerns at this time. 5/2/21: This is actually her 3rd visit in less than a week with this complaint. She was seen 2 other times at a outside facility. She states that she had back surgery about 10 years ago at Beaumont. She states she was supposed to see her neurosurgeon last year but this did not occur secondary to COVID-19. Her primary care physician had referred her to a neurologist did some injections ahead some relief of her back pain for a week or 2 but this is since worsened. She states that over last several days she has had increasing numbness and tingling in her feet as well as increasing weakness of her lower extremities as well as some now some new incontinence of urine when she stands up. She today she also complains some chest pain she attributes more from just amount of pain he has from her back. She rates her back pain as a 10/10 intensity. She did have 1 episode of a week or 2 ago where she slipped down and fell on her knee but did not hit her back directly. She did not hit her head. She describes the chest discomfort in her upper abdomen lower chest area. She is nauseated but not vomiting here. She denies any exertional dyspnea or orthopnea prior to this. She has had no recent fever chills. 5/11/21: The patient is an 70 y old female admitted on 5/4/2021. The patient was originally seen by Neurology on 05/07/2021 when she presented with diffuse weakness. She has a history of hyperlipidemia, hypertension and diabetes. The patient at that time described the acute onset of weakness ascending from the feet, then involving the legs and arms also associated with sensory symptoms that started about 2 weeks prior to her presentation. She also had persistent neck and back pain radiating to her arm and legs limiting her ability to walk. On neurologic examination at that time the patient had absent deep tendon reflexes in the lower extremities and trace reflexes at the biceps. She had significant weakness in the lower extremities and mild weakness in the upper extremities. She also had a dysarthric speech. Given the patient's CSF analysis showing protein elevation to 266 with no pleocytosis, wbc's were only for, there was support for a clinical diagnosis of acute inflammatory demyelinating poly radicular neuropathy or such variant. The patient was started on plasmapheresis and has received her 2nd session of plasmapheresis on 05/09/2021. She will have a total of 5 sections, one every other day. The patient also has hyponatremia, this can be seen in about 5% of patients with Guillain-Barre syndrome, we also do see pseudohyponatremia but this is in patients that have received IVIG.

Patient got small blood clot show on skin 4 days after shot, it went away lighter red in 1.2 week, blood pressure went up and down suddently. Sunday was fine, Monday the 26 was fine, went to bed at 9:00 PM. Was not able to wake up, went to ER around 8:30 AM on 4/27 AM by daughter call 911. In ER for 28 hour and found out she got stroke. Pnewnewmia. ER gave antibootic around 3:00 PM, transfer to intensive care, MRI around 7:00 PM 4/27/2021 due to CT scan shown stroke. Lost Vision on right side and parcial on left side due to stroke.

Nausea Feeling sick Low blood pressure Clammy skin Signs and symptoms started 5 minutes after the administering the vaccine. Vaccine administered at 12:22. At 12:27, the consumer complaints of nausea and feeling sick. Consumer remained awake, alert, and oriented. The consumer denies shortness of breath, chest pain, or difficulty breathing. Vital signs checked: BP 80/50 (manually), 86/50 (electronically), heart rate 65, oxygen saturation 94-97%. Consumer admitted taking her cardiac medications 10 to 15 minutes before we arrived for the in-home vaccine administration. The EMS arrived around 1:00 pm, assessed the consumer, BP remains low. At 01:40 pm, the consumer was transported to the hospital by the EMS. NOTE: Consumer states, she took cardiac medication 10-15 minutes before the vaccine was administered. She verbalized, the medication has not been take for a while (about 6 weeks), just resumed medication on 5/14/2021. BP reading 12:28 80/50 manually, 86/50 electronically 12:48 - 60/45 Called 911, fluid offered 12:55 - 161/87 1:00 - 104/54 EMS Arrived 1:05 - 106/54 1:06 - 108/70 1:15 - 77/45 1:40 - Consumer transported to the hospital by the EMS. Consumer remains awake, alert and oriented. Denies shortness of breath, chest pain, or difficulty breathing.

Passed out on a walk and broke my arm falling on the concrete. Have had stomach pains and diarrhea off and on since getting the shot.. very tired

Systemic: Blood Disorder (diagnosed by MD)-Severe, Additional Details: Patient was diagnosed for first Pulmonary Embolism on 05/12/2021 & second Pulmonary Embolism on 05/18/2021

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.

3 weeks after shot, numbness and tingling in right hand 3 weeks after that speech problems, trouble swallowing, loss of use of hand, went to the ER on May 18 with a blood clot in brain causing stroke.

THE PATIENT WOKE UP A MONTH AFTER VACCINATION & COULDN'T SEE OUT OF LEFT EYE, SHE WAS SEEN BY OPHTHAMOLOGIST & WAS TOLD THAT SHE HAD A MILD STROKE THAT PROBABLY ORIGINATED FROM A THROMBUS IN THE CAROTID

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.

I have an auto-immune disease, which I checked on the vaccine form as immuno-compramised. Within a week after vaccine, experienced swollen ankles, muscle at joints pain, heart muscle pain. I already had Covid in Feb 2020, after the normal 2-3-week cold/sinus /coughing in bed watching tv, and was totally fine after. I only got the JnJ shot to go to an event in June requiring it, but wish I hadn't! My natural immunity was probably compromised by the vaccine. Being on Humira for previous 10 years (another mRNA-style maintenance drug), probably complicated/worsened my current post-vaccine symptoms. Humira website says the combo isn't tested yet.

I GOT TIMED OUT WITH ALL THE DETAILS I GAVE ON MY FIRST ATTEMPT. THEREFORE, I WILL GET STRAIGHT TO THE POINT. PATIENT WAS FOUND AFTER 15 MINUTES OF ADMINISTERING THE VACCINE TO BE PALE , COLD SWEAT AND NOT DOING WELL. I GAVE HER SOME WATER AND AT THAT POINT SHE LOST CONSCIOUSNESS FOR APPROX 30 SECONDS. 911 WAS CALLED. SHE COMPLAINED OF HAVING BLURRY VISION AND FEELING MALASE. EMTS AND FIRE DEPT. ARRIVED. HOOKED HER UP TO SEVERAL MONITORS. THE ONLY ONE THAT WAS OF CONCERN WAS HER BLOOD PRESSURE OF ABOUT 84/43. IT WAS RECOMMEDED THAT SHE BE TRANSPORTED AS SHE LIVES ALONE. SHE HAD ONLY EATEN EGGS AND POTATOES AT 11AM AND WAS FOSTERING 3 KITTENS. RAN ERRANDS ON A HOT DAY AND SAID SHE WAS HYDRATED.

HPI 70 y.o. female with pmh of HTN presenting w/aphasia and R sided facial and extremity weakness onset 15m prior to EMS activation. Per EMS, pt may be on anticoagulation, unk meds. LKW 15 minutes prior to activation pt began slurring her speech and spoused noted R facial droop and R sided weakness. Patient unable to provide history based aphasia however cannot yes or no to questions. Pt is no longer taking medications for BP. Patient positive of intracranial hemorrhage.

1. first day swelling and pain 2. queasy, headache for 2 weeks, 3. Blisters reoccurring, 4.Inflammation in joint escalated. 5. Severe Angina (7) times 6. Tendonitis in knee, shoulder, elbow 7. Pressure in Back and hips then spread.

OCULAR MIGRAINE; BLOOD CLOTS AROUND SPLEEN; PLATELET COUNT LOW; BLOOD CLOT IN BRAIN; PULMONARY EMBOLISM; STOMACH PAIN; This spontaneous report was received from a patient and concerned a 70 year old white female of unspecified ethnicity. The patient's height and weight were not reported. The patient's past medical history included pulmonary embolism, high blood pressure, and COVID-19 infection (Nov-2020), and concurrent conditions included non smoker and social drinker. The patient experienced hallucinating and itching when treated with hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total, administered to her left arm on 27-APR-2021 at 11:00 for prophylactic vaccination. No concomitant medications were reported. The patient was sick immediately within 4-5 days, which started with a headache. On a doctor's visit "around May 16th or 26th" she was given a prescription for antacid for acid reflux. On 30-MAY-2021, patient experienced sickness which started with a headache followed by stomach pain, chest pain and vision issues. Vision issues were described as zig zag, and sensitive to light. Patient visited eye doctor on an unspecified date and was diagnosed with ocular migraine. On 01-JUN-2021, the patient had severe headache and severe pain on right side of chest, "crazy stomach ache"/stabbing pains, and coughed up blood. She was hospitalized and found to have a pulmonary embolism and blood clots. She was placed on heparin for 2 days in intensive care. On 01-JUN-2021, laboratory data included nucleated blood cell count, C-reactive protein, sedimentation rate manual, Chest X-ray, lipase, and urinalysis; normal ranges and results not provided for all tests. On 03-JUN-2021, laboratory data included: computed tomography angiogram of abdomen and pelvis, computed tomography angiography of head without contrast, and Heparin-induced platelet antibody; results not provided for all tests. On 06-JUN-2021, laboratory data included: magnetic resonance imaging of brain without contrast; result not provided. On an unspecified date abdominal ultrasound scan found that spleen was surrounded by blood clots. Blood clot was also verified in the brain by CAT scan. Heparin "wasn't doing what it was supposed to do". Additional treatment medication (dates unspecified) included: potassium and XARELTO (rivaroxaban). The patient was discharged from hospital on 10-JUN-2021. As of 22-JUL-2021, platelets were still low, patient experiences headaches occasionally, random vision issues and stomach ache after eating. She continued to take XARELTO (rivaroxaban) and had future appointment for verifying if the blood clots have been resolved. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach pain, and platelet count low, and the outcome of pulmonary embolism, blood clot in brain, ocular migraine and blood clots around spleen was not reported. Patient recovered from chest pain on 7-JUN-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous case describes a 70-year-old white female who developed a pulmonary embolism and was hospitalized 35 days after receiving the Janssen COVID-19 vaccine. The patient has a history of pulmonary embolism, high blood pressure, and a COVID-19 infection in November 2020. During the hospitalization she was also found to have an unspecified blood clot in her brain, blood clots around her spleen, and a low platelet count. She was hospitalized for 9 days and discharged on Xarelto. Test for heparin induced platelet antibodies was performed but result was not provided. The subject's history of pulmonary embolism and COVID-19 infection may have increased the risk for the events to occur. However, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.

Pt developed a rash on her finger that spread to her wrist. Benadryl 25mg was given.. the rash improved. Pt blood pressure elevated 195/113, repeat 207/117. Pt developed nausea and abdominal pain. Pt was transported to the ER

about two hours after injection, I experienced headache, then mild dizziness, then extreme dizziness, then sudden overwhelming fatigue, then swollen eyes and eyelids, then chills and elevated heart rate, with pounding. I had to cancel the class I was supposed to teach, because I would not have been safe to drive to campus. I slept from approximately 2:30 pm on March 8 until 8:30 am today, March 9, all symptoms continuing, with bathroom breaks, a couple of short reports to family members who were watching out for me, and one 2-hour window during which I ate a small meal, went back to bed, and read part of a book. During bathroom breaks I took more antronex, some milk thistle, and some glutathione, which seemed to at least temporarily reduce dizziness and eye/eyelid swelling. At one point I took some hawthorne tincture because I was concerned about the heart pounding. Today I woke up feeling symptom-free, but by 2 pm I was compelled by sudden fatigue to take a two-hour nap. After that I felt better, and I think I am now fine, at 7:45 pm on 3/9/21. I am happy to have gotten the Janssen vaccine, because it is one and done!

Dizziness, passed out and fell backwards onto tile floor. (FIRST TIME EVER) Stopped bleeding from cut on back of head. Severe headache for 3 days. Occasional nausea and lightheadedness.

Pt initially felt palpitations, numbness around mouth and overall unwell. BP was elevated, EMS was called. Pt felt better after 30 minutes and went to an urgent care. Her blood pressure improved and now has follow up with her PCP.

Rapid heart rate that lasted through the night subsided in the morning, severe muscle aches and chills

pt states that after she took the vax upon leaving the clinic she started getting woozy and could feel the medicine going through her body all of the way down to her feet. She felt like her heart rate was up. She sat down to relax before driving home. Pt started taking ibuprofen immediately. The next day her right arm was sore, some fatigue and slight fever. All of her symptoms have subsided at this time.

0910 patient recieved vaccine. 0920 client described feeling woozy & like she had run fast. (hearting racing) Patient alert, talkative, denies swelling of mouth or tongue, no rash, no difficulty breathing. POX 98%, HR 120, BP 194/110. 0926 BP 200/120, Hr137. Called EMS. 0942 EMS brought her to Hospital. 1240 husband of patient called me to say "we are going home. She is doing better. The doctor said he did not think it was an allergic reaction to the vaccine."

Pt got vaccination at waited 15 minutes before leaving. She called me 4 days later to let me know that she fainted approximately 1 hour after getting the vaccination resulting in a trip to er and stiches to her face.

Approximately 10 minutes after receiving the vaccine, she began to feel unwell. Felt dizzy, fell unconscious while sitting in chair. Awoke and began vomiting. No hives. Was diaphoretic. Received IM epinephrine in the left thigh. Within 1 minute was feeling much improved, BP 160/80, oxygen sat 98%. Sent to ER by ambulance and was released within 3 hours.

NECK PAIN; ELBOW PAIN; HIGH BLOOD PRESSURE; LEFT ARM PAIN; SHOULDER PAIN; BODY ACHE; FATIGUE; This spontaneous report received from a patient concerned a 71 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) High. On 12-MAR-2021, the subject experienced body ache. On 12-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced shoulder pain. On 15-MAR-2021, the subject experienced left arm pain. On 16-MAR-2021, the subject experienced high blood pressure. On 27-MAR-2021, treatment medications included: paracetamol. On 01-APR-2021, the subject experienced elbow pain. On an unspecified date, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fatigue on 14-MAR-2021, was recovering from high blood pressure, had not recovered from shoulder pain, and left arm pain, and the outcome of neck pain and elbow pain was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

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.

Beginning evening of vaccination and lasting 24 hours; Fever Stomach pain with diarrhea Headache Chest pressure

From 04/04/21 until now: Bad headache, elevated blood pressure, numbness in face and extremities, dizziness.

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.

Fever, chills, muscle aches, rapid heart rate, pain in rib cage, pain at injection site Lasted for about 48 hours

BLOOD IN URINE; TEMPERATURE WENT DOWN; This spontaneous report received from a patient concerned a 71 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: 841A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced temperature went down. Laboratory data included: Body temperature (NR: not provided) 97.7 F, 96.4 F. On 03-APR-2021, the subject experienced blood in urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood in urine, and the outcome of temperature went down 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.

beginning the day after the vaccine Patient experienced dairrhea, extreme nausea, cramps, coughing and weakness. This persisted for 3 days. Patient suffered a stroke or multiple strokes either 5 or 6 days after administration of the vaccine. She has since died as a result of the strokes.

4/17/21 around 5 pm lost consciousness and did not knowingly awaken until a friend came to her home and said she was sitting on the bathroom floor and responding inappropriately. Pt has no memory of any events that occurred between Sat evening through Sunday morning . Feeling of being in a fog is slowly improving.

low platelet count . Patieint had no previous history of low platelets until 4/15/21. No current symptoms

"I received the Johnson and Johnson Covid vaccine on March 9th. On March 30 I was admitted to the hospital with excessive blood clots in my right leg and right lung. My Pulmonary Dr felt I should report this to you. I did have blood clots last year and recently ( February 8th) had back surgery both circumstances could of contributed to the issue. If you need any further information or have questions please do not hesitate to contact me.

On 4/16/2021 went to the emergency room with high blood pressure that was noted as a "hypertensive emergency". Was admitted into the hospital the next day where a CT scan confirmed that a blood clot in the brain occurred which led to a basal ganglia stroke. After a 5 day stay in the hospital, patient is now in a full time rehab facility to attempt to recover her cognitive and speech skills, while also attempting to regain use of her right hand which is currently not functioning due to the stroke.

Patient exhibited stress and anxiety about receiving vaccination. After administration, she said that the site hurt more than expected and said she was feeling dizzy. Cold wet paper towels were offered to her to place on her face. Next, reported feeling strange, shaky. Leaned forward with head low. Instant cold pack was placed on back of neck. Over next five to ten minutes patient's anxiety increased, as did shakiness. Blood pressure readings were taken and elevated, as was heartrate, but not at hypertensive crisis. Patient could breathe and speak. She contacted someone to assist her with leaving, but when the ETA seemed too long, she agreed to have us contact EMS. Her condition seemed to improve and decline several times before assistance arrived. She expressed concern about the elevated BP readings. A second cool pack was administered until she next reported feeling cold and chilly, with shakiness. She mentioned that her abdomen also felt cold, which was strange. EMS arrived and transported patient approximately 30 minutes post administration.

pt says she had a few episodes of feeling dizzy before having a stroke. Pts right hand became numb, she had some confusion, she was nauseated and had a severe headache several days prior to going to the emergency room. On 3/28/21 her face was dropping on the right side so was brought ER. She was admitted and given CT and multiple test. She was treated for a Stroke and stayed for about 3 days. She was discharged to FU w/ Neurologist next week.

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).

Patient presented 3-4 weeks after receiving the Janssen COVID vaccine with right MCA stroke with mass effect, mild midline shift and right MCA thrombus. Carotid ultrasound showed thrombosis of the right common and internal carotid arteries and right carotid siphon. She was found down, last seen normal 2 days prior to admission. She was not a candidate for tPA given the delayed presentation and unlikely to benefit from thrombus extraction. She was treated with aspirin and atorvastatin and treated for rhabdomyolysis. Patient is currently still admitted to the hospital but transitioning to comfort focused care.

SEVERE CHEST PAIN ON RIGHT RIBCAGE AND LEFT HAND SIDE; This spontaneous report received from a consumer concerned a 71 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's concurrent conditions included rheumatoid arthritis since approximately 14 years, penicillin and IV contrast solution allergy, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, intramuscular, batch number: Unknown, and expiry date: unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included adalimumab (Humira) for rheumatoid arthritis. On APR-2021, four to five days after the vaccination, the patient experienced mild soreness or discomfort initially and progressively worsened over time. Later the symptoms developed into a severe chest pain on right hand side of the ribcage, and it hurt to breath and move; the patient felt relieved only while lying flat. The patient had visited emergency room and physician room for severe chest pain on right ribcage and left-hand side. The patient went to the hospital after 6 to 7 days after the vaccination and got admitted. The patient was put on blood thinner immediately after the admission as the staff thought the patient had blood clot. On performing D-dimer test, the levels showed 3.49 (units unspecified) and was identified that the patient had no clots. The patient was discharged from the hospital on 28-APR-2021. The patient was pain free for 2 days; However, she started experiencing severe pain on left hand side of the chest on the day before reporting. The patient stated that the pain moved over. Rheumatologist suggested the patient to take Ibuprofen for the chest pain. The patient had reached out to her rheumatologist who advised the patient to take ibuprofen for the pain in her chest; However, the patient did not take before chest pain started. It was reported that the patient would be seeing the rheumatologist the next day of the report. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient had not recovered from severe chest pain on right ribcage and left-hand side. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210509152-covid-19 vaccine ad26.cov2.s -severe chest pain on right ribcage and left-hand side.. 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

STOMACH ACHES; GENERALIZED BODY PAIN; ATRIAL FIBRILLATION; HEARTBEAT SPED UP AND THEN SLOWED DOWN/IRREGULAR HEARTBEAT; BRAIN FOG; FEVER; HEADACHE; NAUSEA; This spontaneous report was received from a 71-year-old, White, not Hispanic or Latino female patient. The patient's height, and weight were not reported. The patient's concurrent conditions included Hashimoto thyroiditis, celiac disease, arthritis, autoimmune disease. The patient was diagnosed with atrial fibrillation (Afib) in JAN-2018 and seldom had an episode of Afib since then. The patient had no known allergies and was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (JANSSEN COVID-19 VACCINE) (suspension for injection, route of administration was not reported, batch number: 1808978 and expiry: unknown) dose was not reported, 1 total, administered on 30-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, following vaccination, the patient had an episode of atrial fibrillation almost every day unlike the time before vaccination and her heartbeat sped up and then slowed down (irregular heartbeat). On the same day, the patient experienced brain fog, fever (axillary temperature of up to 100 degrees) and headache. Since the vaccination, the patient's nausea worsened. On 31-MAR-2021, the patient experienced stomach aches and generalized body pain. Due to the ongoing concern of reports of blood clots associated with the JANSSEN COVID-19 VACCINE, the patient's doctor put her on a blood thinner (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach aches, and fever on 09-APR-2021, and headache on 04-MAY-2021, had not recovered from atrial fibrillation, generalized body pain, heartbeat sped up and then slowed down/irregular heartbeat, and brain fog, and the outcome of nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210516760-COVID-19 VACCINE AD26.COV2.S- Atrial fibrillation. 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 GOT DIZZY WITHIN 5 MINUTES OF RECEIVING VACCINE-BECAME UNRESPONSIVE FOR ABOUT 30 SECONDS. SHE CONTINUED TO BE DIZZY/FAINT AND HAD A COLD SWEAT. PT WAS NOT INJURED WITH LOSS OF CONSIOUSNESS. CALLED 911, EMS ARRIVED AND TOOK PATIENT TO THE HOSPITAL. WHILE WAITING FOR EMS BLOOD PRESSURE AND HR CHECKS WERE PERFORMED WHILE PATIENT WAS IN LAYING DOWN POSITION.

Starting -4/12/2021 - initial symptoms cycled through over the first four weeks. Fever, chills, aches, pains, shooting pain in ears (first 9 days); uncontrollable shaking, erratic heart beat (April 17, 18); severe head and neck ache (lasted 2 days), resting pulse 100, head cold, diarrhea, cough, fatigue, weakness, chest tightness, pneumonia (X-ray on 04/30/2021), premature heart beat (EKG on 05/17/2021). As of 05/21/2021, still have heart beat irregularities, weakness, and fatigue.

I am diabetic so symtoms are like low blood sugar..I PASS OUT, SWEAT, COLD, DIZZY, MUSCLE PAINS, CONFUSED, VERY SLEEPY, PAIN IN EUSTACHIAN TUBE , HEADACHE, TOE PAIN,

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 .

BLOOD CLOTS IN BOTH ARMS; NUMBNESS IN BILATERAL ARMS; REDNESS ON BOTH LEGS; SWELLING OF BOTH LEGS; PAIN IN BOTH LEGS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer. The patient experienced drug allergy when treated with hydrocodone, and oxycodone 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: 1805029, and expiry: unknown) dose was not reported, 1 total administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2021, the patient felt numbness on both arms. Numbness got worse and patient went to emergency room. On an unspecified date in 2021, Laboratory data included: MRI brain results of which were pending. On an unspecified date in MAR-2021, a week after the vaccination patient went to emergency room due to redness, swelling, and pain on both legs. The doctor prescribed antibiotics which relieved those symptoms and was encouraged to get blood circulation assessed once patient returned to home. On 17-MAY-2021, patient got hospitalized, and on same day, ultrasound test showed a blood clot in each arm. Patient underwent chest X-ray and a test with and without contrast for the lungs. It was reported that patient was started on anticoagulants and physical therapy. On 18-MAY-2021, ultrasound of legs was negative for blood clots. On 19-MAY-2021, test in a machine with and without contrast to look at lungs (Lung scan) was within normal limits. On 19-MAY-2021, the patient got discharged from hospital. Patient stated that, consulted two doctors if it may have been the Janssen covid-19 vaccine that caused this and doctors said possibly and recommended that patient should report the information. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness on both legs, swelling of both legs, and numbness in bilateral arms, and had not recovered from pain in both legs, and blood clots in both arms. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540231-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOTS IN BOTH ARMS, NUMBNESS IN BILATERAL ARMS. 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's daughter, called and states she is her mom's POA and she stated that she was with her mom when she got the vaccine in the parking lot. About 3 weeks ago her mom started dragging her foot and fell twice, she went to a facility and then was sent to hospital and was hospitalized for about 3 weeks, she has had two mini strokes, she is currently at nursing home. She also provided the name of her mom's PCP.

Extremely high blood pressure and high heart rate and low oxygen levels. Incidents have happened 4-10-21, 4-28-21, 5-22-21 & 6-1-2021

periodic neck stiffness, leg cramps, some rapid heart rate,memory loss, continual itching on torso and head, not energy and sleepiness after a good nights sleep, low energy. I am afraid of long term results. Wish I had not received it

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.

Within 10 minutes of receiving the vaccine, pt reported having tingling to left side of tongue and lips. BP 199/88 and continued to rise over the course of 15 minutes to 239/103. Pt denied shortness of breath, but tingling did not improve so Benadryl 50mg PO adminsitered but offered minimal relief. Pt then began to complain of blurry vision to left eye and headache. EMS called and manual BP was 258/100. Pt transported to local ED and treated. ED physician noted that he felt that this was a drug reaction related to the COVID vaccine.

Patient called Thursday around 2 pm and asked if it was normal to hurt all over. I told her muscle pain could be an adverse effect. The patient then said she felt that her blood pressure was up and felt as though a mack truck was on her chest. I instructed her to go to the ER.

MILD SORE ARM, TIREDNESS, NAUSEOUS WITHIN FEW HOURS. 26 HOURS LATER SEVERE REACTION BEGAN. RAPID HEART BEAT 154 BMP AND A HARD KNOT (BOUT SIZE OF DIME) FORMED IN LEFT PALM (ARM OF SHOT). TOOK FLECAINIDE 150 MG THAT REDUCED RATE TO 90 BPM BY 6 PM THAT NITE. HEART WAS NORMAL BY NEXT MORNING. THE HARD KNOT IN LEFFT PALM STILL REMAINS 10 DAYS LATER.