Johnson & Johnson

March 5,2021 at 3:30 am approximately I woke up trembling severely ( entire body ) and intense internal spasms :, high fever : could not grab or hold bottle of water ; tried to get up and and could not stand trembling so bad : I covered up and it lasted till 7:30 am. Now bad headache and back ache

Onset approximately 12 hours p vaccination. Low grade temp. 99.4 ° (normal baseline 97.3) Chills (mild to moderate) Headache (mild to moderate) Neuralgia (mild to moderate) Tinnitus (moderate) Muscle aches (moderate) Site tenderness (mild) Cough (intermittent)

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

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

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 experienced a seizure lasting 2-3 minutes approximately 1-2 minutes after receiving the vaccine. patient has a history of seizures/epilepsy.

Immediate pain after injection in arm at injection site with some pain moving up in the neck muscle and lower arm. After 24 hours the pain increased and moved into shoulder and neck pain increased. No redness in injection site but muscle pain increased and continued into day three.

Patient is a 61 y.o. female who received the Janssen Covid vaccine Lot# 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: "Feeling funny" "Cold feet" Patient was treated/managed as follows: Vital Signs: 1240pm -BP: 140/76 HR: 94 RR:18 1250pm-BP: 133/88 HR: 82 RR: 18 Pt reports feeling better Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted out to car by Site Lead

Nothing serious but the roof of my mouth and back of my throat felt numb for about an hour and then was tingly. This happened about 30 minutes after the shot. I also was very nauseous the next morning.

Fever for 40 hours, chills, uncontrollable shaking for more than 3 hours, severe nausea for 36 hours, nausea continues now but at a much less severe amount, swollen glands around head and in right arm pit for more than 40 hours, pain in right eye started within 10 minutes of shot and continues now, pain in ankles started about 8 hours after shot and continues now but is becoming much more bearable, joints of toes and joints of a few fingers were painful for about 24 hours, sore arm started about 3 hours after shot and continues now, overall muscle aches started about 8 hours after shot - became much worse within 12-14 hours after shot and became less severe after 30 hours. Overall I felt as if I had a terrible case of the flu. It was very intense. I was unable to sleep the first night due to the severity of symptoms. The second night I sweated a tremendous amount and my fever broke. I am still not over all of my symptoms but I am feeling better.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient about 12-24 hours after shot started to develop a rash on arms/neck and hands. Her arms/hands started to swell and she developed blisters in the mouth and had blisters on her hands and neck as well. She had itching all over her arms and hands and swelling of the arms and hands too. She also felt a warming/hot and burning sensation in her arms and hands too. She has been putting clobetasol and hydrocortisone cream/ointment and Levicyn (compound by Dr.) on the blisters and rash.

Arm soreness at site of injection lasting for several days. A tension headache developed by 2pm the day of the shot. Not debilitating, but obvious. It lasted until late the first night, leaving a feeling of lightheadedness afterwards that was gone by late morning the next day. Some tiredness, but not extreme.

About 5pm after I began feeling achy and fatigued. The next day after I developed the tingly, pins and needles sensation that came and went in both legs, my face, arms and both hand area which I am still experiening today but not as frequent as it was when it began. When it happens its not always in the same spots and doesnt occurs at the same times its as if it alternates and now I also get a hot sensation at the top of my ears periodically which doesnt last very long but it does occur

patient had a hot feeling all over her body and her skin was red. . had no rash, no fever, no lesions. this resolved on its own.

Felt great and then all of a sudden diarrhea started around 11 pm. Went to bed and became extremely cold - teeth chattering, chills and fever at 11:30pm - approx. 8 1/2 hours after injection. After that vomiting, soreness, headache body aches, fever of 100 degrees. When awaking the next morning, still had fever of 99.8, chills, nausea, headache. Finally felt like myself by 3pm on Tuesday, March 16. I am not a chronic complainer. After receiving my flu shots every year for many years, this was the first reaction I've ever had to any immunization - ever.

8 hours after the vaccination, patient felt cold/chills along with ascending body temperature. Then, patient felt hot. Dizziness and fever persisted for almost 12 hours. Patient waking up in the morning felt lose of appetite due to nausea.

Approximately, 11 hours after the shot Severe cold chills, so severe my teeth would not stop chattering. I was shaking so hard my body ached from shaking. Goosebumps, a crazy headache. I thought i was having an anurysm. Not a normal headache. Cold sweats so bad you could just about wring out my sheets and clothes. Nausea, some vomiting. On a scale of 1-10 of these symptoms is was an 11-12. These symptoms changed as the days went on. In the moring of the first night. I was ok. Woke up with a bad headache, still nauseas and still cold but not like at night tollerable. About 5PM day 2 it started all over again, just as severe. Next moring ok. This pattern kept reapeating for 4 days. Food now getting repulsive. No way I could eat anything. On day 5 the symptoms continue now throug the day, however the teeth chattering not happeing and the cold chills a bit less severe. I would say by day 5 on the scale of 1-10 i am now about a 9. This was so horrible for so long. Every single night i would wake up soaked in my own sweat. This is still happening 11 days later. I am still experiencing headaches. I never have headaches. I did not go to a Doctor because i figured what are they going to do, i have to ride this out. Also a strange thing is took my temparture daily and seveal times. Zero temprature. by day 5 I could not get out of bed for 3 days. Day 8 things getting better, still cold chills and headaches but not as bad. Day 9 way better, now getting hungry. Daytime cold chills now gone mostly less headaches. Oddly headaches and cold chills start about 4-5pm and continue through the night. In the morning i wake up with a headache still today.

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

RIGHT ARM SORENESS; 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 type 1 diabetes, and heart disease. 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 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the patient experienced right arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm soreness. This report was non-serious.

I am covered in a severe rash that itches burns and tingles. First RX was a 4mg prednisone pack that did not help from an urgent care facility. I then went to Dr who gave me RX and the next day it was worse again so the current RX is described earlier. It is not getting any worse but I am struggling to not itch. I can not wear clothes for long periods of time and it is quite debilitating Clothes

I couldn?t get warm, cold to the point of shivering for approximately 16 hours. I have fully recovered.

Approximately 12 hours after receiving the vaccine I experienced severe chills and couldn't get warm. I didn't take my temperature. The chills lasted approximately 5-6 hours. The day after receiving the vaccine I experienced fatigue and minor muscle aches.

I received the Jenssen COVID-19 vaccine EUA on April 5, 2021 Around 3:30 am on April 6th, I woke up hot and itching. I had a under the skin rash on my arms and legs with little pin prick spots my tongue was tingling. I took Benadryl. It was better in the morning but still visable and tongue was tingling. I took more Benadryl around lunch time.

SORE UNDERNEATH THE ARM; HEADACHE; EXTREMELY TIRED; 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 (suspension for injection, route of admin not reported, batch number: 1805029, expiry: not reported) dose was not reported, once a total administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced sore underneath the arm. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from headache, extremely tired, and sore underneath the arm. This report was non-serious.

Chills and low grade fever, then within another hour felt light-headed and my body hurt all over - skin was sensitive to even my clothes. Headache started in the front of my forehead by late evening, and I literally couldn't even walk up to my bed. Restless sleeping with all the sweating and chills. Woke up with headache remaining and feeling very "wiped out" and still light-headed. No more chills or sweats the next day, but I was weak for about 48 hours. Honestly - I'm very healthy and getting Covid directly from another person couldn't have been worse than getting the vaccine. :( And I am even saying that as a 35 year professional Research Scientist. Thank you

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.

extreme fatigue mild headache muscle pains nausea and vomiting chills taste confusion loss of appetite eye focus issues dizziness brain fog low grade fever sores on tongue lip blisters (Important to note: still experiencing severe blisters on my lips) low energy and fatigue continues day to day

mild intermittent stomach muscle spasms the following afternoon after receiving the vaccine shot the night before. Same symptoms 48 hours later.

Headache, fatigue, chills, intermittent shooting nerve pain at the left angle of my mandible. I went to work on Tuesday because my work was short staffed but was allowed to go home 3 1/2 hours early. I took Advil every 4-6 hours on Tuesday and half of Wednesday. I came straight home and slept until dinner, ate and then went back to bed and slept until midnight, took more Advil and drank a full glass of water, and slept the rest of the night. Wednesday I felt a bit better, headache not as bad and jaw pain not as frequent, still pretty tired. I went to bed straight after dinner and then felt great on Thursday.

Severe joint pain (like arthritis) in all joints. It is not going away after12 days. Also, severe nerve pain in left side of body. This has never happened to me before.

Chills, Nausea, Headache, Body Ache, Skin Hurt, Left hand pain base of middle finger back of hand Lasted about 5 hours, Headache remained into the next morning. Took Benadryl and Ibuprofen

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.

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.

Day 1 40min in... intense, in-tense....fiery, pain radiates from-injection. Up neck, across shoulders and down back. In.tense. Fiery. Pain. Just over 1hr very intense bone ache. Not muscle. Bone. Ache. Stop for lunch and find extreme bone ache across collarbone. Intense pain. Like i thought I broke collarbone. On walking in, to order lunch, dizzy and blurred vision. Had to sit awhile to dissipate. 1.5 hrs in Finish eating and spend time breathing thru pain. Vision clear, on my way back to work. Intense pain continues adding, now, itchy across shoulders. Through afternoon increased fatigue and itch. Little better at 4hrs. Day 2 utter fatigue. Want to. S.l.e.e.p. Pain now replaces the burn. Every. Where; ache. Ache. Ache. Day3 fatigue on waking. Pain is now in all joints. Knees hips excruciating. Manage 3hrs household tasks before the fatigue sets in to stop. Awake but still pain in joints. Not ache; pain. Hard to move. Spend afternoon cooking and resting. Soooo exhausted. Day 4-2wks arm still sore and swollen and warm to touch. cannot bear weight in left arm. Cannot use arm to drive. swelling down day 15 still cannot bear weight in left arm. pain continues along pathway of injected drug. burn sensation. now day 17 still cannot bear weight in left arm. If I do I get sudden weakness in arm and pain in back of shoulder.

Within first hour: pain at vaccination site, headache and left neck/shoulder ache, worser headache, numbness and tingling on left side of face and jaw (sort of like novocaine?) spreading down left arm, increasing severity of headache, nausea, tiredness. Throughout pm: chills, body aches, decreasing numbness on left side face/arm, increased fatigue. Took 2 acetamenaphen extra strength Throughout night: severe chills, headache, body and muscular pain. Day 2: frequent and severe chills; mild fever (100.8); severe headache, severe joint, muscle, and body aches (like flu), nausea, severe fatigue. Day 3(today): much fewer chills, decreased nausea, some fatigue, increased pain in back along spine and down legs, cont tylenol xs

Within 5 minutes of receiving the shot, I had stomach cramps and felt extremely nauseous. I had periods of nausea and dizzy spells for the following week. I had an extreme migrane the night of the shot and chills throughout the next week. I did not report the symptoms to anyone because I had not heard that these were reactions to this vaccine. After I heard that others were experiencing similar symptoms, I felt I should report my experience.

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.

headache, left body stiffness and pain, left sided weakness (sensation of body drooping). Strong flu-like symptoms

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.

The patient had burning sensations and increased urination symptoms consistent with a possible urinary tract infection prior to the vaccination that took place on 2 April 2021. A urinary culture was negative on 31 March 2021. A few days after the vaccination, the burning pain and urgency subsided but was replaced by increasing lower abdominal pressure and pain. The patient will see a doctor on 14 April 2021. Other effects observed following the vaccination on 2 April 2021 include: headaches, muscle pain, injection site arm pain, sore throat. These effects resolved within 24 hours after the vaccination with exception of the sore throat which is ongoing.

Severe vein pain around ankle/lower calf and knee pain, and some swelling. Severe cramping in both legs.

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.

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.

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

Started on Monday morning at 8:30 am started feeling cold chills. Took 800mg of Ibuprofen and after an hour felt better. When going to bed around 9:00pm I noticed that my skin was soaking wet and that I had a hot feeling. When I woke up in the morning (tuesday April 13, 2021) around 7am I could not fully open my eyes. I looked in the mirror and noticed that my entire face was swollen and was red in different areas. I took some benadryl as I thought this was an allergic reaction and went back to bed. A litter later I started getting cold chills and then hot flashes. Around noon time I took another benadryl. By 2:30 I was not feeling any better and I also had body aches and pains and called my doctor. I was able to get in to the office. I was told that I was having a reaction to the shot and that I was boarder line for the hospital. They gave me a shot steriod shot and prescribed Metheylprednisolon tablets (24) to be taken as directed and to continue to take benadryl. It's now Wednesday morning April 14, 2020 and the swelling has gone down but not fully gone and I have stated on the prescription. I now have redness in my chest area. I still have a some chills and hot flashes.

FEVER; FATIGUE; ARM 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 was not pregnant at the time of this reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: not reported) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced arm soreness. On 04-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness on APR-2021, and had not recovered from fever, and fatigue. This report was non-serious.

SWOLLEN LEGS AND FEET; ACHES AND PAIN IN NECK; LEGS FELTS TIGHT; FEET FELTS TIGHT; ACHES AND PAIN IN HIPS; ACHES AND PAIN IN ARMS; EXHAUSTED DAY AND NIGHT; This spontaneous report received from a patient via a company representative 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: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swollen legs and feet. On APR-2021, the subject experienced aches and pains in neck. On APR-2021, the subject experienced legs feel tight. On APR-2021, the subject experienced feet feels tight. On APR-2021, the subject experienced aches and pains in hips. On APR-2021, the subject experienced aches and pains in arms. On APR-2021, the subject experienced exhausted day and night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the exhausted day and night, aches and pains in hips, swollen legs and feet, aches and pains in arms, aches and pains in neck, legs feel tight and feet feels tight was not reported. This report was non-serious.

Pt reports sharp intermittent pain in right posterior thigh on and off x 3 days, no other associated symptoms. Symptoms are improving gradually with time. Exam remarkable for mild tenderness along right distal posterior thigh medial aspect Advised on supportive care for possible muscle strain CBC and Ddimer ordered due to history of Janssen Vaccine

Fever to 102 degree Fahrenheit from 6pm of the day of shot at 1:15pm, till 4pm next day accompanied by chill, fatigue, body heaviness, Treatment was rest. Recovered by 3rd day. Vaccination shot site of arm extreme soreness the day after the shot for 2 days

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

Johnson & Johnson vaccine -1 dose in left arm. I've been having night time leg cramping in backs of both legs (calf muscles).

ACHE MOSTLY ON THE FACE AREA; CHILLS; HEADACHE; FEVER; 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 non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug use. 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, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced ache mostly on the face area. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 5/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache mostly on the face area, chills, headache, and fever on 08-APR-2021. This report was non-serious.

I felt very jittery felt as if I drank about 16 cups of coffee! Felt a little bit pressure in my heart. Could not sleep on Saturday night extreme anxiety feeling. Extreme hyper active feeling!!! Felt like if I had a surge of energy. Very restless, legs felt jittery! Left lymph node in my neck was swollen and slight headache.

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.

BONE ACHE; BODY ACHES; VERY HIGH FEVER; CRAMPS IN CALVES/LEG CRAMPS MOSTLY INSTEP AND CALVES; MIGRAINE TYPE HEADACHE LIKE STEAK THROUGH THE HEAD; 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 hypothyroid, and seasonal allergy. 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 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced migraine type headache like steak through the head. On 06-APR-2021, the subject experienced cramps in calves/leg cramps mostly instep and calves. On 06-APR-2021 03:00, the subject experienced bone ache. On 06-APR-2021 03:00, the subject experienced body aches. On 06-APR-2021 03:00, the subject experienced very high fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone ache, and very high fever on 06-APR-2021, and migraine type headache like steak through the head, cramps in calves/leg cramps mostly instep and calves, and body aches on 07-APR-2021. This report was non-serious.

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.

Janssen COVID-19 Vaccine EUA Chills, fever and headache for approx 40 hours. Controlled with Tylenol. Fine after that.

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

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.

FEELING WEAK; MUSCLE ACHE; FEVER (101.4 F); FLU-LIKE SYMPTOMS; ACHY BODY; PAIN IN ARM; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced flu-like symptoms. On 08-APR-2021, the subject experienced achy body. On 08-APR-2021, the subject experienced pain in arm. On 08-APR-2021, the subject experienced fever (101.4 f). Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 09-APR-2021, the subject experienced feeling weak. On 09-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever (101.4 f) on 09-APR-2021, had not recovered from pain in arm, flu-like symptoms, achy body, and feeling weak, and the outcome of muscle ache was not reported. This report was non-serious.

DELIRIUM; FLUSHED TO FACE; UNCONTROLLED SHAKING; VOMITING; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of 60 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to latex (adhesives band aids leave a welt on skin), non-alcohol use, and nonsmoker, and other pre-existing medical conditions included patient did not have any history of drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-APR-2021 at 13:00 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of report. On 05-APR-2021 at 21:00, the patient experienced delirium, flushed to face, uncontrolled shaking, vomiting, fever and chills. Body temperature (NR: not provided) at 103.5 F. The patient has received paracetamol for fever. The patient consulted a physician at emergency room and physician suggested her to use alternate paracetamol, and ibuprofen to manage symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, uncontrolled shaking, flushed to face, vomiting, chills, and delirium. This report was serious (Other Medically Important Condition).; Sender's Comments: v0;20210417227-covid-19 vaccine ad26.cov2. s-Delirium. 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

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.

SORE THROAT; SWOLLEN FACE; TINGLING LIPS; FATIGUE; FLUSHED FACE; 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 obstructive sleep apnea, hbp, bipap at night, non-smoker, abstains from alcohol, and seasonal allergies. 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 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included colecalciferol for drug used for unknown indication, duloxetine hydrochloride for drug used for unknown indication, hydrochlorothiazide/triamterene for drug used for unknown indication, loratadine for drug used for unknown indication, metoprolol for drug used for unknown indication, orlistat for drug used for unknown indication, and paracetamol. On 12-APR-2021, the subject experienced flushed face. On 12-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced swollen face. On 13-APR-2021, the subject experienced tingling lips. On 14-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen face, tingling lips, and fatigue on 13-APR-2021, was recovering from flushed face, and had not recovered from sore throat. This report was non-serious.

constantly nauseous,stomach feels bloated,hurts,red dots on arm and neck, hot sweats, all to present date 04/21/21.On 04/08/21 got fever 99.5, body aches & pain,then all of the above stuff to date.

Developed visual loss to 20/800, double vision, oscillopsia, ataxia, dysarthria Symptoms started with difficulty with speech and loss of depth perception on 04/10/2021 (7 days after COVID vaccine shot) Trial treatment with Solu Medrol 1 gm 5 days and Gammaglobulin 0.4 mg /kg for 5 days. No significant improvement except vision went from 20/800 to 20/400

SORE KNEE; SORE THUMB; 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 past medical history included breast cancer, mastectomy, chemotherapy, and radiation, and concurrent conditions included arthritis, cigarette smoker, abstains from alcohol, and chest tightness, and other pre-existing medical conditions included patient received injection for her arthritis in her back last month. The patient experienced drug allergy when treated with codeine, and paracetamol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 18:30 for an unspecified indication. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore knee, and sore thumb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore knee, and sore thumb. This report was non-serious.

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

Day one post vaccination - dull headache, leg pain, abdominal pain, back pain - these symptoms continued for a few days, I started to feel a bit better, did not take any pain reliever medications because I didn't want to mask symptoms. On 4/14/21, 7 days post vaccination, my leg pain in both legs worsened including numbness and a burning sensation in both feet. Back pain continued, arm pain started in both arms with numbness in both hands however the pain on my left side with legs and arms is worse. I've had intermittent shooting pains in my left ear, left jaw, left temple and across the left side of my face. I've also experienced shoulder and neck pain. The abdominal pain is intermittent and mild. On 4/15 - 4/18 the pain in my legs was so bad that it was waking me up at night and my arm pain was occurring more frequently. I decided to go to the ER on 4/18, day 11 post vaccination, due to my concern of a possible DVT or other type of blood clot. The ER physician's assistant did not look at my legs but did several blood tests and other tests.

AT 2:00 A.M.HAD THE SWEATS BURNING UP NEEDED TO TAKE SHOWER TO COOL DOWN THAN HAD CHILLS AND BODY ACHES, AND HEADACHE STARTED, HAD A HARD TIME FUNCTIONING. THIS WENT ON FOR TWO DAYS THEN HEADACHE FOR A WEEK AND LEGS WERE PAINFUL TO WALK STILL ARE HEADACHE GONE BUT PAIN IN LEGS, STILL TAKING ADVIL ITS BEEN TWO WEEKS SINCE THE SHOT.

Extreme swelling 2 weeks after vaccine. A lot of bruising. Left hard very sore size of quarter place on right arm. Blood a lot when injection was done.

weak, loss of Appetite called 911 transported to Hospital 4/21-patient still having issues with eating , patient was dehydrated . went to hospital , got out now

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.

DIZZINESS; FATIGUE; NOT FEELING WELL; ELEVATED PLATELETS; LOW CLOTTING TIME; ELEVATED EOSINOPHILS; LEFT SIDE PAIN STARTING FROM THE LEFT BREAST DOWN TO THE HIP; LEFT FACIAL SWELLING; FACIAL NUMBNESS; LEFT EYE TWITCHING; IMPAIRED VISION IN LEFT EYE; LEFT LEG NUMBNESS; LEFT ARM PAIN; 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 blood pressure, and other pre-existing medical conditions included the patient was not diabetic, not on blood thinners prior to going to the hospital, and does not take thyroid medications. 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 to the left arm, on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced left side pain starting from the left breast down to the hip. On 27-MAR-2021, the subject experienced left facial swelling. On 27-MAR-2021, the subject experienced facial numbness. On 27-MAR-2021, the subject experienced left eye twitching. On 27-MAR-2021, the subject experienced impaired vision in left eye. On 27-MAR-2021, the subject experienced left leg numbness. On 27-MAR-2021, the subject experienced left arm pain. On 29-MAR-2021, the subject experienced elevated platelets. On 29-MAR-2021, the subject experienced low clotting time. On 29-MAR-2021, the subject experienced elevated eosinophils. On 29-MAR-2021, the subject experienced not feeling well. Laboratory data included: CT scan (NR: not provided) unknown, Clotting time (NR: not provided) LOW, Eosinophil count high (NR: not provided) UNKNOWN, MRI (NR: not provided) unknown, Mean platelet volume (NR: not provided) LOW, and Platelets increased (NR: not provided) 10 times above normal. On 30-MAR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side pain starting from the left breast down to the hip, facial numbness, left eye twitching, impaired vision in left eye, left arm pain, and fatigue on 2021, and dizziness on APR-2021, was recovering from left facial swelling, and not feeling well, had not recovered from left leg numbness, and the outcome of elevated platelets, elevated eosinophils and low clotting time 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

ABDOMINAL PAIN; BRUISES ON LEG AND RIGHT ARM; CRAMPING ON LEG; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Lyme disease, shellfish allergy, allergy to an unknown antibiotic, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced abdominal pain. On 12-APR-2021, the subject experienced bruises on leg and right arm. On 12-APR-2021, the subject experienced cramping on leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain, bruises on leg and right arm, and cramping on leg. This report was non-serious.; Sender's Comments: v0-Medical assessment comment is not required as the case is assessed as non-serious.

HIGHER LEVEL OF PAIN (EXTREME PAIN) IN THE SHOULDER AND IN UPPER ARM; LACK OF MOBILITY IN THE SHOULDER AND THE UPPER ARM OF THE INJECTED SITE; FROZEN SHOULDER; HIGHER LEVEL OF PAIN (EXTREME PAIN) AT THE LOCATION OF INJECTION; SORE ARM; LITTLE FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included immune thrombocytopenic purpura, 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: 1805022, 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 sore arm. On 01-APR-2021, the subject experienced little fatigue. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) in the shoulder and in upper arm. On 24-APR-2021, the subject experienced lack of mobility in the shoulder and the upper arm of the injected site. On 24-APR-2021, the subject experienced frozen shoulder. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) at the location of injection. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) Platelet count before the vaccination was 40. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fatigue on 03-APR-2021, and had not recovered from sore arm, higher level of pain (extreme pain) at the location of injection, lack of mobility in the shoulder and the upper arm of the injected site, higher level of pain (extreme pain) in the shoulder and in upper arm, and frozen shoulder. This report was non-serious.

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

On and off symptoms include: light headedness, light weakness/tingle on the underside of my left arm, on and off achey weakness in right hand too. It started on day 12, 13, 15 (up to two weeks after vaccination). Symptoms went away and returned at night on April 27 and throughout the day on April 28, 2021. I was borne with mitral valve prolapse (no work/life restrictions) and wondered if the vaccine has any connection to the mitral valve prolapse.

ARM PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 100 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. 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 13-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up The patient received macitentan (form of admin unknown, oral, batch number: ZE019B0101 expiry: UNKNOWN) 10 mg, 1 time, therapy dates were not reported for an unspecified indication. Non-company suspect drugs included: epoprostenol sodium (intravenous, batch number: MM248M0101 expiry: 30/JUN/2022, form of admin was not reported) 20 mg, frequency, and therapy dates were not reported for an unspecified indication. Concomitant medications included warfarin non-company for drug used for unknown indication, and riociquat non-company. On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of arm pain was not reported. This report was non-serious.

LEG SWOLLEN; CANNOT PUT PRESSURE ON FOOT, WALKS ON TIP TOES; TENDERNESS ON OUTSIDE OF LEFT LEG; PAINFUL KNEE/LEG; 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 blood pressure abnormal, knee disorder, and hand arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate for hand arthritis, and acetylsalicylic acid. On 10-APR-2021, the subject experienced leg swollen. On 10-APR-2021, the subject experienced cannot put pressure on foot, walks on tip toes. On 10-APR-2021, the subject experienced tenderness on outside of left leg. On 10-APR-2021, the subject experienced painful knee/leg. On 14-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No blood clots. On 20-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tenderness on outside of left leg, painful knee/leg, leg swollen, and cannot put pressure on foot, walks on tip toes. This report was non-serious.

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

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.

BOTH LEGS HURT (HAD SHOOTING PAIN/ ON RIGHT LEG) AND BELOW THE KNEE AREA; SWEATING; MIGRAINE WHICH LEAD TO NOT TO SLEEP; ACHINESS ALL OVER THE BODY; CHILLS; NAUSEA FELT LIKE HAD FLU; HEADACHE; BURNING SENSATION; INFLAMMATION OF BOTH LEGS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not do well with drugs generally. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced inflammation of both legs. Treatment medications included: ibuprofen. On 12-APR-2021, the subject experienced burning sensation. On 12-APR-2021, the subject experienced migraine which lead to not to sleep. On 12-APR-2021, the subject experienced achiness all over the body. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea felt like had flu. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) sub normal 97.5. On 12-APR-2021 02:00, the subject experienced sweating. On 28-APR-2021, the subject experienced both legs hurt (had shooting pain/ on right leg) and below the knee area. Laboratory data included: Blood test (NR: not provided) normal. On 29-APR-2021, treatment medications included: methylprednisolone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation, and sweating on 13-APR-2021, migraine which lead to not to sleep on 19-APR-2021, chills on 14-APR-2021, and headache on APR-2021, and was recovering from nausea felt like had flu, achiness all over the body, both legs hurt (had shooting pain/ on right leg) and below the knee area, and inflammation of both legs. This report was non-serious.

Migraine headache for a week, had a MRI of the brain to rule out blood clots. A torn rotor cuff that happened 10 years ago that was a no issue, became very painful and inflamed to the point of needing a Cortisone shot and MRI to see what is going on.

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

on or about 5/4/21 noticed a rash on both legs they had been itchy prior to that, the rest of my body is itchy w a few rash spots present. 5/8/21 noticed my left thumb twitching. As far as Item 20 rash is still still present and the thumb twitching is still present

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

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.

Severe Headache, Triggered Trigeminal Neuralgia, Rash, Fever, Large swelling at vaccine site, Short of Breath

Fatigue, HA and migraine, neck pain, body aches, diarrhea that have lasted 4 days. Pt has taken Tylenol, Meloxicam, and Sumatriptan with mild improvement after medication but HA returns later. Diarrhea has improved. No improvement in body aches or fatigue

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 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.

Hands have turned black inside palms and fingers. The knuckles and base of the palm and wrist looks burnt. Have no feeling in fingers, they feel very numb, If i make a fist ,It's very tight and can feel heart beating in the palm of hands. The black burnt look has moved to both inside and outside of hands

I am filling out this report today because I received a follow up call from the website because I had reported loss work, loss of job, loss of activity and visits to doctors. I received the vaccine on March 12, 2021, I started having arm and shoulders symptoms the day after getting the vaccine but did not feel well that first night while trying to sleep. The symptoms worsened every day, I am in week 11 post vaccination. I have had 22 medical appointments with 3 to PCP, 13 to Physical Therapy who diagnosed left bicep tendinitis and shoulder impingement many weeks ago, 4 to acupuncture, and 1 to xray. This Thursday I finally get an MRI. I lost my job on week 7 after the vaccine, I can barely use my left arm, I live alone, I am exhausted and spend much time chasing a diagnosis or help in resolving this issue. I reported to website every time the link was sent to me. I called the Pharmacy on Day 3 and called Janssen hotline on Day 3 to report a reaction. I wrote to my doctor on Day 5 to say something was not right. By the next day I had an injection site reaction, very hard swelling in my arm, a dark red jagged surface reaction at the injection site now there is a divot there. Feeling very unwell, aches and pains, no fever. I had bad abdominal cramps that night after the injection, diarrhea for days, arm pain with swelling, joint pain in shoulder, knee, and fingers, and a rash across my back, I had to continue to work, typing fast 9 to 10 hours a day, I am a self-employed contractor doing tax technical support and the pain in my arm grew worse daily, I was in tears trying to work. Sitting to type, to read, to drive is the worse. I can dictate into my devices but not rapidly enough for the level of my work. The worse pain in my arm and shoulder is less by avoiding typing and driving but the injury is still there. The pain is constant even without movement.

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.

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

After my first dose I experienced- body aches, left arm soreness and stomach pain which lasted a couple of days.

2 hours after shot I felt weak for 2 hours I started to get an itchy rash the same night and my left arm swelled. The shot location in my left arm itched a lot. I scratched it, it bled. It became a large hole. 3 days later approximately, I start feeling very very tired. It got progressively worse . I then developed " brain fog". I have barely been able to work since then.. I believe I started to recover yesterday but not completely sure yet. I also developed a painful tumor in my right arm pit that lasted for a few days. It has since gone away. It was approximately 3/4 " in size. It developed overnight.

I just really got dizzy to point I felt like my head was swimming. I could not lay on my back, that also cause dizziness. I also broke out in sweats in the middle of the night.

Arm hurt as soon as I got the injection. The next day and every since. I have headaches. Awful neck pain,weakness,tired, coughing, pain in back. Using Tylenol doesn't help much..I will feel fine for a day then it comes back

Five hours after vaccine around 8 PM I started with chills and shakes and then fever. I think I had a fever of over 100. No body aches or anything like that, of coarse there was a little bit of soreness in arm but it wasn't so bad. 3 weeks later is when I started with headache which I recognized as sinus so I started medical treatment I went to see a doctor about a month later on 05/03/2021 and that is when I was put on antibiotics for 10 days and steroids. It ended up going away maybe halfway through taking the antibiotics, about 5 days in using antibiotics around 05/08/2021 I started feeling better.

Bad pain down leg , swollen leg, very sharp pain that move into foot . foot swells everyday since vaccine

pt says she had bad migraines after taking the vaccine. Her left arm is still sore, red and inflamed at the injection site. (it has been months) Then she had itching all over. She took a shower and then noticed she had a bump on chest, then on her arms, and her both legs, stomach, back, and breast. These bumps appear like little blisters and then burst and scar her skin like a cigarette burn. Most are small but there are some larger ones. She says like look the measles. She went to her PCP Dr. She was told she was having a reaction to the vaccine and to come back if it got worse. Pt will reach back out to her doctor for medical advice.

My big toes began hurting really bad. They got hot and reddish. They hurt for about an entire day. I put fungi with extra tea tree oil. That calmed it down. The right foot pain and discoloration completely stopped. On the left foot went to a reddish purple to an opal color. It then varied to a reddish purple again. It is discolored in my toenail. It lightens and gets darker. The pain and discoloration went on for about a week. The pain is gone but the discoloration is still present. The Tuesday after mother's day I cut my finger and received stitches. Along with the stiches I also received a tetanus shot. I received the tetanus shot in my right arm but I developed a painful knot in both my COVID arm and my tetanus arm. I put neosporin and a bandaid and massaged them which helped. The knots are going away but they haven't completely disappeared.

When I received the shot I had no reaction at all not even a sore arm. Within a few days I started getting terrible pains in the calves of my legs. Then a few days later I got a purple line on my right calf that was painful. The next day I had 3 big yellow spots on the same leg. They went away in 2 days which I thought was odd. Next day I got a very large bruise at the vaccine location. After that I started with pains in all of my joints. Ever since then I have been having pains in all my joints. The pain level is not going away and has been getting worse

Complained of tingling in the left arm. Denies chest and shortness of breath. No dizziness or headache. Observed for an additional thirty minutes to the initial fifteen minutes. Patient expressed relief of tingling at end of observation.

After my vaccine, I broke out in a rash, felt like someone was burning me, like if I was burning me alive, hard to explain. It was a rash then the rash turned into these big red mass, these lumps were nasty and I could not sleep for three days. They were on my arms and legs, stomach, back, parts of my face. The rash went away and came back, was on different parts of my body. I went to the ER to get checked out but at the ER they did not do any exams for me, they just told me I had hives. It took 4-5 days for my hives to go away. I still get these little bumps, they are small growing around my back, chest and legs and at the bottom of my legs and body and they do not itch.

PAINFUL RASH ON RIGHT ARM AND HAND, LEFT ARM, LEGS, HEAD,BACK,FACE; WEAKNESS; HEADACHE SO BAD LIKE A MIGRAINE; FEVER; MUSCLE ACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 189 pounds, and height was 64 inches. The patient's concurrent conditions included cancer, thyroid and other pre-existing medical conditions included patient receives steroid knee injection, left knee only every 3 months. 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 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included anastrozole for cancer, ibuprofen for drug used for unknown indication, and paracetamol for drug used for unknown indication. On 22-MAR-2021, the subject experienced weakness. On 22-MAR-2021, the subject experienced headache so bad like a migraine. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced muscle ache. On 04-APR-2021, the subject experienced painful rash on right arm and hand, left arm, legs, head, back, face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weakness, and fever on 26-MAR-2021, and headache so bad like a migraine, and muscle ache on 25-MAR-2021, and was recovering from painful rash on right arm and hand, left arm, legs, head, back, face. This report was non-serious.

As soon as the vaccine was given, I was lightheaded ,dizzy and difficulty walking. My left hand went numb and I felt the vaccine travel through my system. I had to be helped to the 15 minute waiting area where I grew nauseous and continued to feel dizzy and light headed. The paramedics were called but my vital signs were normal. I came home and slept for 12 hours. By Saturday ( 4 days ) after the vaccine, I felt like I was in a fog, couldn't think straight, and my speech become slow. Once I got to the ER, I was having delusions and was convinced my deceased dog was sitting on my lap.

Tingling around nose and mouth. Cold water given, reactions are starting to be relieved after drinking water.

I had leg pain, lymph nodes were swollen on the left side, pain down the right arm and tingling in my fingers, dizzy spells, back and head pain.

Bell's palsy Right. since April 24,2021 He was seen at MEDICAL CENTER, s/p acyclovir, prednisone treatment. pt. states 50% improving It was noted that he had J&J Covid19 vaccine. Pt. advised to report it to Vsafe. It will also be reported to VAERS.

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.

SENSITIVE MOUTH; DIMINISHED TASTE; FOOD TASTED FUNNY HAD WEIRD TEXTURE; SKIN ON MOUTH FELT BURNT OR DEAD; PEELING OF SKIN ON MOUTH; SORE ARM; COVID TONGUE OR WHITE SPOTS ON TONGUE AND BACK OF TONGUE WAS ALSO WHITE; TOP OF TISSUE WAS DEAD OF MOUTH; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 205 kilograms, and height was 63 inches. The patient's past medical history included thyroid cancer, and thyroidectomy, and concurrent conditions included type 2 diabetic, and environmental allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced covid tongue or white spots on tongue and back of tongue was also white. On APR-2021, the subject experienced top of tissue was dead of mouth. On 10-APR-2021, the subject experienced peeling of skin on mouth. On 10-APR-2021, the subject experienced food tasted funny had weird texture. On 10-APR-2021, the subject experienced skin on mouth felt burnt or dead. On 10-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced sensitive mouth. On 11-APR-2021, the subject experienced diminished taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from peeling of skin on mouth on 06-MAY-2021, and sore arm on 11-APR-2021, had not recovered from sensitive mouth, diminished taste, and food tasted funny had weird texture, and the outcome of skin on mouth felt burnt or dead, covid tongue or white spots on tongue and back of tongue was also white and top of tissue was dead of mouth was not reported. This report was non-serious.

Right Hand and Arm feels tingling numbness ichy and major weakness. At times feels as though hand and arm are asleep. Lost functionality in hand at times.

LIGHTHEADEDNESS/DIZZINESS; MUSCLE CRAMPS/CRAMPING IN ARMS AND LEGS; ABDOMINAL PAIN (DESCRIBED AS LABOUR PAIN)/ STOMACH MUSCLES SORENESS; FELT WARM WITH NO FEVER; BURPING; DIFFICULTY IN SLEEPING; CHILLS; SORE ARM PAIN; BACK PAIN; 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 past medical history included bronchitis, and concurrent conditions included diabetes, and bipolar disorder. The patient experienced drug allergy-rash when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: FC 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced back pain. On 07-JUN-2021, the subject experienced sore arm pain. On 16-JUN-2021, the subject experienced muscle cramps/cramping in arms and legs. On 16-JUN-2021, the subject experienced abdominal pain (described as labour pain) / stomach muscles soreness. On 16-JUN-2021, the subject experienced felt warm with no fever. On 16-JUN-2021, the subject experienced burping. On 16-JUN-2021, the subject experienced difficulty in sleeping. On 16-JUN-2021, the subject experienced chills. On 17-JUN-2021, the subject experienced lightheadedness/dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps/cramping in arms and legs, abdominal pain (described as labour pain)/ stomach muscles soreness, and difficulty in sleeping on 16-JUN-2021, and back pain, burping, chills, and sore arm pain on 17-JUN-2021, and had not recovered from lightheadedness/dizziness, and felt warm with no fever. This report was non-serious.

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

4 days after injection patient had localized redness and itching. The area is slightly warm to the touch and whole arm had mild pain. hard to say if infected or cellular allergic reaction. Advised patient to take an oral OTC antihystamine and if signs/symptoms persisted or get worse, to seek medical attention.

Pt's husband came in today (6/26/2021) and reported that ten days after receiving the shot (6/15/21), his wife (the patient) started feeling weak and felt numbness in her legs. She is currently in the ICU being treated. They believe it may have been because of the shot. Blood clot has not been confirmed.

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

Patient states that arm has been sore to use since receiving the vaccine; NO redness, rash, warmth to touch or lump or swelling; she states it is sore upon waking in the morning and the stiffness lesses slightly as the day progresses but is sore all day sometimes she has issues gripping & moving arm front to back but not as much soreness raising arm upwards; she was advised by her prescriber to have pharmacy report

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.

ACHY; CHILLS; TENDERNESS ON TOP OF THE HEAD; SORE ARM; This spontaneous report received from a patient concerned a 60 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced tenderness on top of the head. On 18-JUN-2021, the subject experienced sore arm. On 19-JUN-2021, the subject experienced achy. On 19-JUN-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tenderness on top of the head on 21-JUN-2021, achy, and chills on JUN-2021, and sore arm on 26-JUN-2021. This report was non-serious.

FEELING WARM AND COLD; SEVERE CHILLS(EXTREME COLD); FEVER; MUSCLES PAIN; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was not reported and height was 66 inches. 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced feeling warm and cold. On 25-MAR-2021, the subject experienced severe chills (extreme cold). On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced muscles pain. On 25-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling warm and cold, severe chills(extreme cold), fever, muscles pain, and headache on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210663913.

Initially pain in arm severe and last a few weeks 06/19/2021 got sick with diarrhea, sore throat, earache, nausea felt like had the flu for several days was on a liquid diet of broth no medicines. 07/07/2021 started feel better with still scratchy though, no nausea or diarrhea.

4 months of new arm, shoulder and hand pain following vaccination with swelling and redness for 1month. Entire shoulder girdle burns and aches. Strong inflammatory reaction started on first night with many varied reaction symptoms for 10 days. Arm and shoulder pain remained and got worse daily for months, I now have nerve damage, weakness and loss of function. MRI showed damage, tendonitis, tears and much more, pain was severe for first 7 weeks, then I lost my job, I could no longer type for 10 hours a day. The pain progressed to pronounced weakness and poor coordination. Difficult to sleep for 4 months now. A steroid injection given for chemical bursitis by an orthopedic doctor did not help. Physical therapy, acupuncture and a home TENS unit have helped, progress of injury healing and nerve enervation is very slow. High medical costs. Symptoms are similar to Parsonage Turner syndrome, but two doctors said shot was given incorrectly, low and too deep, so possible SIRVA, or both. I progressively worsened for 4 months, now I am in slow recovery but I fear it will go on for years. This has affected all areas of my life. It has been difficult to get medical care and to care for myself. I live alone, there are so many things I can no longer do. I was self-employed, now I have no income and have lost full use of my left arm.

At approximately the 30 minute mark, patient began complaining of hot and itchy palms. Palms and fingers developed redness and there were faint red areas bilaterally on both arms. Patient's PCP consulted and 25 mg of Benadryl was given. PCP saw patient and determined she was safe to go home.

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

VOMITING (WHEN SHE VOMITS, NOTHING COMES OUT); HAND SORENESS; FEVER; NAUSEA; HEADACHE (FEELS SHE CAN SCREAM); WEAKNESS; This spontaneous report received from a patient concerned a 60 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: 207A21A expiry: unknown) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced vomiting ( nothing comes out). On 09-JUL-2021, the subject experienced hand soreness. On 09-JUL-2021, the subject experienced fever. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced headache (feels she can scream). On 09-JUL-2021, the subject experienced weakness. Treatment medications included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, vomiting (nothing comes out), headache (feels she can scream), weakness and hand soreness was not reported. This report was non-serious.

Strong headache and neck paon after two weeks of vaccination. Burning eyes. Leg pain. Difficulty to focus. Mind foggy. Tested for antibodoes for covid and vaccone resulted negatives after one month of vacconation and then again after 3 monthz. However had high autoinmune response. Headache and neck pain continued. Had N mri and neurologiat evaliation but nothing founf. Headaxhe continued and leg pain and stiffness also. Now also continuous ringing in my ears abd hot ears. Veins in my arm are unusually darker abd more visiblw.

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.

The injection was given into the shoulder joint rather than the deltoid muscle. This has resulted in an inflammatory process that has caused pain and injury to my left shoulder (e.g., tendons, ligaments, bursae, nerves). I now have persistent shoulder and upper arm pain, weakness, and limited range of motion that has worsened in the two weeks following the injection. I am dealing with chronic shoulder and upper arm pain, and am unable to carry out daily activities that were not an issue prior to vaccination. When the symptoms did not subside, I sought medical treatment from my primary care provider on July 15, 2021.

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.

PAIN IN THE LEFT LEG; IMPROVEMENT FROM FIBROMYALGIA PAIN, MUSCLE ACHES AND PAIN WITH 80 TO 90% RELIEF; SOAPY TASTE IN THE MOUTH; MILD NAUSEA WITH ON AND OFF; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood clot in the left leg at the age of 18, and concurrent conditions included asthma, fibromyalgia pain, muscle aches, and pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced soapy taste in the mouth. On 02-APR-2021, the subject experienced mild nausea with on and off. On 05-APR-2021, the subject experienced improvement from fibromyalgia pain, muscle aches and pain with 80 to 90% relief. On 06-APR-2021, the subject experienced pain in the left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the left leg on JUN-2021, and mild nausea with on and off, had not recovered from soapy taste in the mouth, and the outcome of improvement from fibromyalgia pain, muscle aches and pain with 80 to 90% relief was not reported. This report was non-serious.

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.

Sore upper left arm the day of vaccination. 20-26 hr after vaccination pain in left arm spread down to the elbow and unable to lift using that arm. trouble sleeping the evening of 7/21/21 due to pain in arm. Extreme fatigue beginning 3pm day after vaccination. Unable to do any physical activity for more than about 5 min. then had to rest. So tired had to go to bed for the day at 8pm when normal bed time is 10-11pm

First 3 days - headache, nausea, body pain, chills, sweats,fatigue. About 3 weeks to present. Memory loss, brain ?fog? Using the wrong word when speaking. ( not the word I was thinking ? , doing stupid things that I wouldn?t normally do , not thinking clearly. Forgetting where I?m going and what I?m doing with a long effort to recall where I am / what I?m doing.

Bells Palsy, anti viral & steroid for one week. Mostly gone within a week. Lingering numb feeling in cheek.

Mega headache (I get headaches so I know it was bad) about 3 hours afterwards. Really cold and falling asleep about 5 hours after. Next day generally just cold and body tired. No arm pain.

day 1 severe hot and cold flashes bad headache and severe arm pain today could not stand up sat down felt Like I was going to pass out sat on floor bad cold sweats feeling nauseous bad diarrhea

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 shaking / chills for 2 hours ...so much so that I could not get warm and my muscles hurt from shaking so much -headache, body ache , both 24 hours -soreness at sight of injection

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.

4 pm injection 10 pm mind racing unable to sleep 10 pm body ache 2 (scale 0=none 10=worst pain) 11 pm body ache shine bone pain 4 2 am body pain 7 2 am chills 7 3 am uncontrollable leg twitching 10 4 am body pain, fever now twitching 10 7 am body pain, fever, twitching 10 (Still no sleep) 10 am body pain, fever 10 10 am leg twitching 7 12 (Noon) body pain, fever 8 12 leg twitching 4 3 pm body pain, fever 5 3 pm leg twitching 0 6 pm body pain, fever 2 10 pm body pain 1, fever 0

Patient reported prior to administration of vaccine significant history of syncope episodes with previous vaccine injections. Placed in wheelchair prior to administration of vaccine. After vaccine given patient experienced lightheadedness and feeling hot within 1 to 2 minutes placed on cot no respiratory distress or anaphylaxis occurred symptoms persisted EMS on site now feeling better EMS recalled back to site and transported to local hospital.

24 hours after receiving the vaccine I began experiencing adverse side effects that have continued to last (Tuesday-Friday). I've experienced constant migraines, nausea, fatigue, diarrhea since Monday, all of which have caused difficulty with eating and sleeping.

Nausea first for 2 hours then fever that reached 101.9 at 12 hours after injection. Fever and aches and shaking all night. Fever broke at 5:30 am-19.5 hours after injection. It?s 24 hours after injection and fever has broke but nausea has returned. Comes in waves. Extra tired and sick feeling just like the flu.

3/13/21 03:00 am, chills, shakes 3/13/21 04:00 am, fever 102, threw up 3/13/21 07:00 am, dizziness, cold sweats, nausea

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

Approximately 12 hours after injection I experienced extreme body aches. Hands ached, hips ached, back aches, legs and feet ached. Hurt the balls of my feet when I walked. My eyes felt like they had sand paper in them. I did not run a fever but my body felt like I had. I had Flu B January of 2018, my syptoms after Janssen Shot were as severe as Flu B, but the duration was not as long! Approximately 24 hrs after injection I starting experiencing a headache, along with neck and shoulder aches. And I experienced fatigue for 3 days after injection along with the headache and neck, shoulder and back ache. On the fourth day following the injection I only feel tired. Aches, pains and headache are gone.

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.

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.

DOSE AT 12:50 PM, ABOUT 5 PM GOT VERY NAUSEAND LAID DOWN IN BED ABOUT 8:00 PM, WITHIN MINUTES BECAME VERY VERY COLD. WAS VIOLENTLY SHAKING FROM CHILLS, THEN VIOLENT SHAKING WITH MUSCLE TENSION FOR SEVERAL SECONDS THEN RELAXED FOR A FEW MINUTES THEN MORE TENSION. ALL OF THIS ALONG WITH THE CHILLS.I DO NOT KNOW HOW LONG THIS HAPPENED BEFORE I FELL ASLEEP. NEXT DAY WAS VERY TIRED, AND ACHED ALL OVER AND WAS WEAK.

30 minutes post vaccine injection I stood up and felt lightheaded, paramedic on site took my blood pressure was 167/85, minutes later was 163/82. Ekg normal, blood sugar by finger stick 109, oxygen 98%. After 15 minutes BP improved to 137/73. While driving home I felt weak again unable to finish conversation. Walking from car mildly lightheaded, rested in bed. At 2:33 pm BP 105/58 heart rate 78, tired.

itching on forehead and neck, skin slightly pink. Both cheeks red and very warm to touch. began approx 48 hrs after injection. The redness and heat on cheeks intensified through out the night and into the next day. Called my primary care doctor who recommended Zyrtec which eased symptoms. After 48 hours symptoms had mostly subsided.

Patient woke up the day after vaccination on 03/23/2021 with tingling feeling in arm. She felt as if she slept on it wrong. On Thursday, 03/25/2021, her arm was still in pain and she spoke with her doctor. The doctor believed a nerve was hit during the administration of the vaccination. She was prescribed Ultram with a plan for follow-up in 1 week.

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

Around 6 minutes post-vaccination, at 11:35, patient stated feeling a warm sensation radiating down both legs. After 10 minutes, around 11:45 the sensation had completely gone away. Patient reported no pain, dizziness, or nausea. Patient monitored for an additional 15 minutes, with no additional symptoms.

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.

RIB PAIN; VOMITING; HEADACHE; NAUSEA; INJECTION SITE PAIN; NIGHTMARES/VIVID DREAMS; FEELING COLD; FEELS AWFUL; INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; ARM PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included stroke, alcohol use 1-2 glasses per week, non smoker, depression, and sleeping problem. The patient experienced drug allergy when treated with povidone-iodine, and codeine for drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:30 in left arm for prophylactic vaccination. Concomitant medications included fluoxetine for depression, zolpidem for occasion sleeping problems, acetylsalicylic acid for stroke, and atorvastatin for stroke. On 12-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 12-MAR-2021, the subject experienced off label use. On 12-MAR-2021, the subject experienced arm pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021 18:30, the subject experienced feels awful. On 12-MAR-2021 19:00, the subject experienced feeling cold. On 13-MAR-2021, the subject experienced nightmares/vivid dreams. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares/vivid dreams, rib pain, vomiting, feels awful, feeling cold, arm pain, chills, fever, headache, nausea, injection site pain, and fatigue on 15-MAR-2021, and the outcome of off label use and inappropriate route of vaccine administration was not reported. This report was non-serious. Additional follow up information received on 26-Mar-2021.The following information was updated and incorporated into the case: age, medical history, demographics, concomitant medication, route of administration for suspect product, events (inappropriate route of vaccine administration and off label use) concomitant medications and outcome was updated.; Sender's Comments: V1: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.

very sore arm headache body aches chills low grade fever (100.3) All began approximately 12 hours after the vaccine was administered. As of this submission, it has only been approximately 16 hours since I received the vaccine. I am currently experiencing the listed symptoms. Given that, there is no information to provide for Item 21, below.

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.

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

Started after falling asleep. Was woken up by profuse sweating and then sleeplessness. Went to work and felt muscle aches and weakness all over. Then major exhaustion with a bad headache.

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

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

VOMITING; FEELS HOT; FEVER; DIARRHEA; COULDNT SLEEP; CHILLS; MUSCLE ACHES; NAUSEA; This spontaneous report received from a consumer 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: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced could not sleep. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced muscle aches. On 31-MAR-2021, the subject experienced nausea. On APR-2021, Laboratory data included: Body temperature (NR: not provided) under 100. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced feels hot. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, and nausea, had not recovered from muscle aches, chills, feels hot, and fever, and the outcome of diarrhea and could not sleep was not reported. This report was non-serious. Version created to amend previously reported information on 01-Apr-2021. Upon review the following information was amended: Event ranking updated and reporter type changed to consumer/ non health care professional from contact.

Immediate pain at injection, stinging sensation. Lasted for another 20 to 30 minutes off and on. Tingling and numbness of right arm for short periods after shot off and on for about first 15-20 minutes. Slight dizziness for first 15 -20 minutes lasting short periods. Nausea, briefly twice in first 20 minutes. Light-headed for the duration of 30 minute wait-and-watch period. This was the most noticeable for me, besides the intense stinging sensation in my arm. After 30 minutes of being watched in common area, I stood up to leave with my adult children and my legs were wobbly. The nurses made me sit and stay a while longer and brought me a snack. I drank my water I had brought with me. Left after an additional 15 minutes.

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.

CHILLS; ARM SORENESS; JOINT ACHE; LOW GRADE TEMPERATURE; SOME MUSCLE ACHE; SEVERE FATIGUE; 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 hypothyroidism, and hypocholesteremia. The patient experienced drug allergy when treated with metaxalone. 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 30-MAR-2021 around16:30 on right deltoid for prophylactic vaccination. Concomitant medications included ezetimibe/simvastatin for hypocholesteremia, and levothyroxine for hypothyroidism. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced arm soreness. On 30-MAR-2021, the subject experienced joint ache. On 30-MAR-2021, the subject experienced low grade temperature. On 30-MAR-2021, the subject experienced some muscle ache. On 30-MAR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 99.5-100.5. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, arm soreness, joint ache, low grade temperature, some muscle ache, and severe fatigue on 31-MAR-2021. This report was non-serious.

began feeling tired and slightly light headed a few hours after the vaccine. Developed a headache by evening same day(Day 1). Arm very sore. Day 2- still tired with light head and headache, arm very sore. Day 3- tired, light headed, headache, arm very sore. Day 4- tired, light headed, headache, sore arm. Day 5- pounding, splitting, incapacitating headache that required 800mg Motrin to start and 400mg every 5-6 hours, fatigue, light headed, sore arm, felt horrible.. Day 6- Woke up back to normal.

At 4 AM the following day I woke up with a severe headache and fever. I attempted to take 2 extra strength Tylenol which seemed to trigger cyclic vomiting every 15-20 minutes for approximately 4 hours. After this, I vomited once an hour for another 4 hours. I was finally able to sip water and sleep after this. I also took my first temperature once feeling better and it was 99.9F. My normal temp is in the 97s and I?m sure it was much higher during the vomiting. My fever broke approximately 12 hours after the first symptoms. Headache lasted approximately 36 hours and resolved the next day, although a milder one did come back off and on for a couple more days. I did not have much pain in the arm I received the injection in.

on March 25 I had intermittent severe shooting pain at vaccine site. It lasted about an hour. Vaccine site also felt very sore. Arm remained mildly sore but becoming slight more painful each day. with some tingling in fingers the following week. By April 10 muscle sore and painful to lift lift for shoulder adduction at 90 degrees.

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

Burning immediately when the needle entered her arm before the vaccine was injected; difficulty raising her arm and opening the dishwasher since- loss of range of motion and weakness 1 week out.

mild headache, dizziness, nausea, and lack of energy six days after shot... Let's hope this won't last long.

Pt had postmenopausal bleeding starting on 3/30-4/3. Workup with u/s was negative. Pt had burning with bowel movement on 3/29, felt like a "habenero pepper." Also had itching and rash of chest wall, right breast, back. Received her shot in the left arm.

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.

Janssen COVID-19 Vaccine EUA About 1-1/2 hours after injection I became very light headed. I sat down for a couple of hours and it went away. That night I could not sleep. I only had about 3 hours of on-and-off sleep through the night. One time I woke up with severe chills The following day (Saturday) I had a lack of energy and in the afternoon I was running a low grade fever (99.8). Went to bed around 8:30 Saturday night, slept all night and felt fine Sunday morning.

About 24-hours after getting the vaccination I started having pain and discomfort under my left arm. I got the vaccine in my left arm. Feels like a swollen lymph node. A little more than 48 hours after the vaccine I am now starting to feel a little bit of pain and discomfort in my right underarm area lymph nodes.

Patient complains of legs falling asleep at night which started about 7 days ago. Her hands have started almost falling asleep during the day hours the last couple of days. She is currently in between primary care physicians.

Severe headache lasting one day after the vaccine. On the second day @48 hrs strong underarm pain radiating down under left breast, alleviated with Aleve every 12 hrs, lasted for over 1 week @8-9 days, actual bruising underarm pit, and pain and bruising down to the wrist and fingers. Did not seek medical attention.

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 .

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)

Had flu-like symptoms night of shot. Fever and pain, plus arm pain. She thought shot was given rather high on shoulder.

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

Day 3 - Chills, Thirsty, Tired Day 10 - Day 3 through 10 fatigue, with the worse being day 10. Slight headache, slight leg, thigh, shin pain after short walk. Still tired, with slight weakness 3 weeks after vaccine.

It has been a month since getting the vaccine and my arm is still painful to the point of limited movement. The first few days after the shot, I was not concerned about the soreness, I knew it was a normal side affect. But at this point I am more concerned and do feel it is an issue to be reported. This may keep me from getting the vaccine in the future.

Immediately after shot I felt pressure all over my body and my face tingled. The pressure eased off quickly but the tingling lasted until the next day then my face felt like I had been punched. I still have a little face swelling and itching with raised red spots on my face that move around to this day.

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.

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.

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.

Nothing very serious. Cold chills, mild headache, some back and muscle pain, fogginess. All side effects were completely gone within 30 hours after onset.

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

4/12/21 12:30 pm began to feel fatigued, face felt flushed. No fever. Fatigue increased more in the evening. 4/13/21 2:30 am awoke and found entire face swollen and slight tingle in lips. Took Loratadine, Metoprolol and Triamterene/HCTZ and went back to bed. Awoke at 5 am, swelling better, but not gone. Still very puffy above and below eyes. Felt fatigue, no fever, went to work. Felt better by lunch time, swelling almost gone. 4/14/21 Slight sore throat, slight fatigue, no swelling.

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

She got the vaccine and immediately she had brain fever that came on immediately, her brain feels like it is swollen and nothing she does help it. She has an extreme splitting headache to where she feels her brain is going to go out of her head. She has also had numbness and tingling down the right side of her body and into her tongue. She cannot get to feeling better, she just keeps feeling worse. She has taken Tylenol/Ibuprofen, and dr. put her on prednisone and gave her a Z-PA to see if this will alleviate symptoms. Nothing she has taken has helped with it. She feels as though her brain is swollen and that she going down hill. She is a cancer survivor and cannot determine if having that has made her worse. The pressure has gone to her ears, feels like it is going to burn her ear drums up. She also has tinnitus with it as well. She also has tinnitus and the headache that will not go away. She has called her doctor many times and hasn't gotten any results back.

Patient reporting numbness in both arms and legs which began 4 days ago (4/10/2021). Numbness comes and goes and increases in intensity throughout the day. Patient also reports extreme fatigue and headaches that have not resolved since vaccination date (4/5/2021).

Severe headache, Chills, 100.2 fever, body aches, Headache lasting several hours High fever lasting 1 hour Chills lasting 2 hours body aches continue as well as right leg pain 5 days after shot, lasting 3 days. Called doctor, prescribed ibuprofen

On 4/6/21 morning, standing helping sick Dad to shower, I experienced dizzy spell and felt like I was leaning to the left side. Slow to regain balance. Lightheaded after for an hour or so. On 4/9/21 evening, while sitting, I felt my head fog up, my left eye spinning in the bottom, my left arm went numb and fingers tingled, left leg numb (1st episode). Lasted several minutes. Shortly after, I experienced another like the first, Tried to walk to the other room, felt like I was dragging my left leg and left arm. Lasted several minutes. Took baby asprin, Within the hour I had 2 more milder episodes. Reported to my doctor on Sunday. She is scheduling tests for me today.

Within 30 minutes the patient had numbness and tingling in the left arm down to her hand. This feeling progressed to numbness and tingling up into the left side of her face. No redness or swelling anywhere. These paresthesias have persisted for 1 week so far.

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.

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

Intermittent 102° fever with normal temperature of 97.7° three days in a row, cold sore on mouth, migraine, body aches, chills, insomnia.

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.

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

My arm was very sore and 3 weeks later my left arm is STILL very tender at injection site. I was very tired for about a week w ? brain fog? very scattered pertaining to staying on task. I see a neurologist in for headaches and administers Botox for that. I am concerned if I get a headache from the vaccine the Botox will mask it. I did have a bad headache yesterday which is unusual given I get Botox for headaches

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.

Intense pain, hot from injection site, down entire arm immediately after given. Continued pain after two days into two weeks, shooting pains , crawling at injection site,and throbbing, even at elbow and wrist. Arm was also very weak, and still gets tired and throbs . Has been 4 weeks this week-end . Reported to nurse who tod me to see my Dr. which I did this week. No redness at injection site, just soreness, know something was off, according to side effects. Very tired feeling, still, and had some flushed color the first week in my face and like heat flashes for two weeks. Hope to get the normal feeling back in my arm. Not sure ? Maybe a nerve was nicked? But was not like a Bee Sting like tech described it would feel like that day. Had a ruff start.

SHAKING TO THE BONE; RADIATING MUSCLE PAIN; LOW GRADE FEVER; ARM BRUISED FROM INSIDE; DISCOMFORT UNPTO THE SHOULDER; STOMACH PAIN; ARM HURTS ALL THE TIME; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced arm bruised from inside. On MAR-2021, the subject experienced discomfort up to the shoulder. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced arm hurts all the time. On MAR-2021, the subject experienced loss of energy. On 23-MAR-2021, the subject experienced shaking to the bone. On 23-MAR-2021, the subject experienced radiating muscle pain. On 23-MAR-2021, the subject experienced low grade fever. The patient recovered from arm bruised from inside, discomfort up to the shoulder, shaking to the bone, stomach pain, loss of energy, and low grade fever on MAR-2021, and had not recovered from arm hurts all the time, and radiating muscle pain. This report was non-serious.

CHILLS; LOSS OF APPETITE; DIZZINESS; TIREDNESS; MUSCLE ACHE; WEAKNESS; PAIN IN ARM; VOMITING; NAUSEA; FEVER; 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: 1808982, and expiry: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient experienced nausea, fever. On 10-APR-2021 the patient experienced tiredness, weakness, muscle ache, vomiting, dizziness, pain in arm. On 11-APR-2021, the patient experienced loss of appetite and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 10-APR-2021, and dizziness on 11-APR-2021, was recovering from nausea, and pain in arm, and had not recovered from fever, weakness, muscle ache, loss of appetite, chills, and tiredness. This report was non-serious.

FEELING COLD; DIZZINESS; BODY ACHES; TIREDNESS; HEADACHES; 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 pre-existing medical conditions included the patient did not have any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A 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 feeling cold. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling cold, and dizziness, and had not recovered from body aches, tiredness, and headaches. This report was non-serious.

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.

NECK SORE TO TOUCH; EXCRUCIATING BACK PAIN; COULD NOT LIE ON BACK AND ON SIDE; MILD BODY ACHES; BACK PAIN RADIATING TO ABDOMEN; CHILLS BECAME WORSE; HEADACHE; MILD TEMPERATURE; CAHRLIE HORSE IN NECK, SHOULDERS. AND LEGS; DIARRHEA; SLEEPY; STOMACH PAIN; LOSS OF APPETITE; FELT TIRED; DRY COUGH; COULD BARELY WALK; 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 type 2 diabetes, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced could barely walk. On 2021, the subject experienced dry cough. On 28-MAR-2021, the subject experienced loss of appetite. On 28-MAR-2021, the subject experienced felt tired. On 29-MAR-2021, the subject experienced stomach pain. On 30-MAR-2021, the subject experienced sleepy. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced cahrlie horse in neck, shoulders; and legs. On APR-2021, the subject experienced mild body aches. On APR-2021, the subject experienced back pain radiating to abdomen. On APR-2021, the subject experienced chills became worse. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced mild temperature. On 01-APR-2021, the subject experienced excruciating back pain. On 01-APR-2021, the subject experienced could not lie on back and on side. On 02-APR-2021, the subject experienced neck sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciating back pain, and could not lie on back and on side on 08-APR-2021, and cahrlie horse in neck, shoulders. and legs on 01-APR-2021, was recovering from diarrhea, loss of appetite, neck sore to touch, and mild temperature, had not recovered from felt tired, sleepy, headache, mild body aches, stomach pain, and chills became worse, and the outcome of dry cough, back pain radiating to abdomen and could barely walk was not reported. This report was non-serious.

ZAPPING PAIN THROUGH LEGS AND SHOULDERS; CHILLS; LEGS BURNING AND ACHY; SORE JOINTS; 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 past medical history included covid 19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced zapping pain through legs and shoulders. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced legs burning and achy. On 08-APR-2021, the subject experienced sore joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, legs burning and achy, sore joints and zapping pain through legs and shoulders was not reported. This report was non-serious. This parent/child case is linked to 20210420242.

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.

COUGH; SHAKES; CHILLS; FEVER; HEADACHE; 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 pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25/MAY/2021) .5 ml, administered on 07-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced cough. On 08-MAR-2021, the subject experienced shakes. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, shakes, fever, cough, and headache. This report was non-serious.

TINGLING AND BURNING SENSATION IN FEET; WEAK IN THE BODY; TIRED IN THE BODY; FEELING NUMB IN THE HANDS; 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: 042A21A, 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 feeling numb in the hands. On 05-APR-2021, the subject experienced tired in the body. On 08-APR-2021, the subject experienced tingling and burning sensation in feet. On 08-APR-2021, the subject experienced weak in the body. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tired in the body, and feeling numb in the hands, and had not recovered from tingling and burning sensation in feet, and weak in the body. This report was non-serious.

Chills, severe body aches, coughing, spitting up phlegm, feeling cold, couldn?t get in my inhalers, couldn?t breathe good, call my doctor office ( lung & disease) was advise to go the hospital, lasting 2 weeks, took back to back nebulizer treatments, cough medication.

"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."

On 3/21/2021 I woke up with sudden bad left lower back pain that radiated down the lateral left thigh. It continued to get worse as the week wore on. I could not bend over, lie down or sit for very long without severe discomfort. I ended up seeing a chiropractor within the week who has been treating the problem over this past month. X rays were taken. I have been treating it with ice, ibuprofen, and aspirin.

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.

DRY MOUTH; TINGLING IN HANDS; HEADACHE; NAUSEA; INCREASED FATIGUE; 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 past medical history included thyroidectomy, and concurrent conditions included breast carcinoma, and teeth problems. 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, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced dry mouth. On 17-MAR-2021, the subject experienced tingling in hands. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced increased fatigue. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) normal (units unspecified), and electrocardiogram (NR: not provided) normal (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, tingling in hands, increased fatigue, and dry mouth. This report was non-serious.

Headache started 4/11/2021 approx 10:30 - ice packs to top of head, over eyes and back of neck, ended 4/11/2021 approx 1600; Nausea started 4/11/2021 approx 10:30 ended 4/11/2021 1600; Malaise started 4/11/2021 approx 10:30 ended 4/11/2021 ended 1600 sips of water throughout day and nibbled on saltines; photosensitivity (lights brighter than usual) started 4/11/2021 approx 10:30 ending 4/11/2021 1630; Bilateral eye pain started 4/11/2021 10:30 ending 4/11/2021 16:30 pain scale 7 (0 no pain, 10 extreme pain); Hot flashes started 4/11/2021 0800 ending 4/20/2021 0800

HEADACHE; TIRED; RINGING IN EARS; SHAKING IN ARM; PAIN IN BOTH LEGS; This spontaneous report received from a consumer 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced ringing in ears. On 08-APR-2021, the subject experienced shaking in arm. On 08-APR-2021, the subject experienced pain in both legs. On 08-APR-2021, the subject experienced tired. On 09-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 ringing in ears, headache, shaking in arm, and tired, and the outcome of pain in both legs was not reported. This report was non-serious.

No immediate side effects except for a slightly sore arm. Extreme fatigue began 4 days from date of injection and lasted to day 16. Dizziness and nausea began about 10 days from date of injection but were intermittent. Nausea and dizziness finally resolved around day 16. No lasting side effects to-date.

Patient discribed mild headache immediately after. Patient experienced sore arm for about 10 days. Patient started experiencing pain all over a week after the injection. she describes it as a burning sensation though her nervous system and joint pain. Patient also experienced a brain fog a week after her injection. She states that she has trouble putting her thoughts to words. She still feel this reactions on your 17th day.

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

INTENSE HEADACHES; CLICKING IN THE LEFT EAR; PRETTY STRONG SENSATION; NO SENSATION IN BIG TOE AND TOE NEXT TO IT; COULD HARDLY SLEEP; COULD HARDLY SEE; COULD HARDLY HEAR (INAUDIBLE); CHILLS; FEVER; EXTREME FATIGUE; 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 past medical history included viral meningitis, nausea, and headache, and concurrent conditions included clotting. 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 21-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for clotting. On 2021, the subject experienced clicking in the left ear. On 2021, the subject experienced pretty strong sensation. On 2021, the subject experienced no sensation in big toe and toe next to it. On 2021, the subject experienced could hardly sleep. On 2021, the subject experienced could hardly see. On 2021, the subject experienced could hardly hear (inaudible). On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced extreme fatigue. Treatment medications included: paracetamol. On MAR-2021, the subject experienced intense headaches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clicking in the left ear, pretty strong sensation, chills, intense headaches, extreme fatigue, no sensation in big toe and toe next to it, fever, could hardly sleep, could hardly see and could hardly hear (inaudible) was not reported. This report was non-serious.

LOSS OF APETITE; TINNITUS RINGING IN EARS; HEADACHE; LEG PAIN; HEAVINESS; LOSS OF ENERGY; CHILLS; FEVER; TIRED; 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, intramuscular, batch number: 1805022, and batch number: 1805022 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 leg pain. On 06-MAR-2021, the subject experienced heaviness. On 06-MAR-2021, the subject experienced loss of energy. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced tired. On 07-MAR-2021, the subject experienced tinnitus ringing in ears. On 07-MAR-2021, the subject experienced loss of apetite. On 07-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain, heaviness, and chills on 07-MAR-2021, and fever, and headache on 09-MAR-2021, was recovering from tinnitus ringing in ears, and had not recovered from tired, loss of apetite, and loss of energy. This report was non-serious.

CHILLS; PAIN IN HANDS; HEADACHE; VERY TIRED; MUSCLE ACHES; PAIN IN ELBOW; 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 pre-existing medical conditions included patient did not have known allergies. 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 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced pain in hands. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced very tired. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021, the subject experienced pain in elbow. Treatment medications included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-MAR-2021, was recovering from pain in hands, and pain in elbow, and had not recovered from very tired, muscle aches, and chills. This report was non-serious.

TINNITUS; INSOMNIA; CHILLS; ACHINESS DOWN LEFT LEG; NAUSEA; HEADACHE; FEVER; 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 past medical history included degenerative disc, and concurrent conditions included osteoarthritis, non alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with ceclor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 19:20 to left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced achiness down left leg. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 12-MAR-2021, the subject experienced tinnitus. On 12-MAR-2021, the subject experienced insomnia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, achiness down left leg, nausea, and fever on 11-MAR-2021, and had not recovered from tinnitus, headache, and insomnia. 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.

Super Dizzy (2 days), nausea (4 days), tingling throughout body (5 days), fatigue (10 days), Severe body aches. Felt like every bone in my body was broken (4 days)

UPPER SPINE WAS VERY TENDER; COLD SWEAT; COULD NOT STAND UP FROM FLOOR; SEVERE DIARRHEA; FELT LIKE SOMETHING HAPPENED; ARM PAIN; BURNING HEAT OFF BODY; BRUISING AT UPPER SPINE/YELLOW BRUISING DOWN LOWER LEFT LEG; SEVERE PAIN UP NECK AND DOWN BACK; 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 sensitive to antibiotics, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced bruising at upper spine/yellow bruising down lower left leg. On 04-MAR-2021, the subject experienced severe pain up neck and down back. On 04-MAR-2021 14:00, the subject experienced burning heat off body. On 05-MAR-2021, the subject experienced arm pain. On 07-MAR-2021, the subject experienced cold sweat. On 07-MAR-2021, the subject experienced could not stand up from floor. On 07-MAR-2021, the subject experienced severe diarrhea. On 07-MAR-2021, the subject experienced felt like something happened. On 19-MAR-2021, the subject experienced upper spine was very tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper spine was very tender, bruising at upper spine/yellow bruising down lower left leg, and severe pain up neck and down back on 07-APR-2021, burning heat off body on 04-MAR-2021, and cold sweat, could not stand up from floor, and severe diarrhea on 07-MAR-2021, and the outcome of arm pain and felt like something happened was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

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.

Pt called the call center. Reporting cold like symptoms"coughing, body aches, chills, both arms hurting, fatigue" after J&J covid vaccine 4/9/2021. Pt is taking ginger tea for symptoms but no medication. Pt denies emergency s/sx. Urgent Care appt made but pt no showed on4/21/21. New appt scheduled for 4/23/21. COVID test negative on 4/23/21.

FIBROMYALGIA EXACERBATION; SORE GLANDS AT JAW LINE; FEELING LIKE CENTRAL NERVOUS SYSTEM ON FIRE; SPINAL CORD PAIN; VERTIGO; SORE ARM; NAUSEOUS; 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 fibromyalgia, atrial fibrillation, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: (6 or 0)43A(2or Z)(Ior1)A) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fibromyalgia exacerbation. On APR-2021, the subject experienced sore glands at jaw line. On APR-2021, the subject experienced feeling like central nervous system on fire. On APR-2021, the subject experienced spinal cord pain. On APR-2021, the subject experienced vertigo. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced nauseous. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vertigo, sore arm, sore glands at jaw line, feeling like central nervous system on fire, spinal cord pain, fibromyalgia exacerbation and nauseous was not reported. This report was non-serious. The Product Complaint Number was 90000177550 The suspected product quality complaint has been confirmed to be confirmed no PQC was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.

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.

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.

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

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.

Immediately after my J&J vaccine, I experienced soreness to my left arm, fatigue , dizziness and a bad headache. In the middle of the night my headache kept getting worse, my eyes started to hurt really bad and I also broke out in hives. About 6 hours later my headache felt like it wanted to explode. I saw a doctor through Tele-health by who prescribed a 6pk of steroids. Then on Day 6, my headaches came back along with the hives and I felt really tired and the hives broke out all over my body including my crotch and ear canal. He prescribed a 6pk of steroids and I started to feel and get better. On Day9, all of my symptoms were resolved except for the fatigue. To this day I still continue to have fatigue.

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

Was fine after receiving the shot at 11 AM . Then at about 8 o?clock at night I had violently severe chills fever nausea weakness and tiredness. Was unable to perform daily to asks the whole next day.

I have daily headaches since 04/12/2021. Wednesday evening 04/12 I was working and felt a vice like grip on my head. I had acute leg pains in my sleep that evening but not since then. Every day since then I have a headache. It feels like swelling in my brain (and heat) and I'm very upset and unhappy about it. I am a very healthy with no health problems. I don't go to doctor or even have a doctor (except a gyn). The headaches have not subsided and are causing me quite a bit of stress.

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

About 5 pm on 4/13 my right upper calf started having a pain. Its still hurting today. sent me for imaging.

I arrived home and my arm was throbbing really bad and broke out all over with hives (looks like measles).

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 .

pt says she started having constant pain from her left leg from the knee to her hip along with muscle spasms that she has had for the past 3 days. She is taking ibuprofen and muscle rub. Pt will contact a doctor if her symptoms get worse.

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.

Sore arm immediately. Headache, body aches and chills started within 3 hours. This lasted for 2 days. I had an off and on headache for a couple more days.

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

I start of feeling sick in the stomach, headache, muscle aches, feverish. By that night I had chills and the really bad nausea, that I had to sleep on the bathroom. The next day, I barely made it to the bed. I am very weak, still having a headache, body aches and feeling fatigue. The ringing in my ear has gotten worst than it was before.

5/07/2021 I had the shot and immediately I got dizzy when I stood up. That night I encountered fatigue, fever, muscle ache and sore throat. Fever lasted 2 days and fever lasted for 5 days. 5/10 the arm was sore and there was a 6x6? huge rash. 5/24- 5/26 I had a rash that I kept under control with Benadryl. 5/29 my saliva glands began to swell and that?s why I went to the Doctor. The Dr sent me to an ENT and Rheumatologist.

Janssen COVID-19 Vaccine 13 days after receiving her Covid vaccine, the patient stated ?I have been experiencing bad headaches that makes the right side of my face numb and/or painful to the touch. Although I have had headaches in the past, these feel different.? Patient stated that she started noticing these headaches late in the week that followed that administration of the vaccine (beginning on or around 6/4/21) Patient also stated that she began developing stomach aches approximately one week following the vaccine administration (beginning on or around 6/6/21)

Whole left side pain from head to calf. Temp at 104 for 16hrs. Headache, ears ringing, stomach pain, strong pain left leg left side of thigh. Felt like a bus hit my left side. Severe fatigue. Congestion.

Sore throat, tingling on left top of scalp (usual site). Presented as another flare-up of Shingles, but Zoster sine herpete (ZSH). Two days later, I visited my PA, and she immediately started me on Valtrex (1g/3x daily) and gabapentin.

BONES HURTING SEVERELY ALL OVER THE HIPS KNEES ANKLES RIBS ARMS AND BACK; TINGLING IN RIGHT ARM; NUMBNESS IN RIGHT ARM; BODY ACHES LIKE THE FLU; LIPS TINGLING BUT NOT SWOLLEN HAPPENED ONLY ONCE FOR HALF HOUR; SQUEEZING LIKE PRESSURE ON RIGHT ARM FELT LIKE RUBBER AROUND BANDS ARMS AND BLOCKING CIRCULATION; JOINT PAIN; HEADACHE ON RIGHT TOP SIDE OF HEAD; FEVER TEMP HIGHEST 104.1F TO RANGE OF 102F; MUSCLE PAIN; 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 pre-existing medical conditions included patient not tested positive for covid, not aware that has had covid before, ended up in emergency room last fall due to non covid virus. The patient experienced got sick like in vomiting when treated with hydromorphone hydrochloride, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced bones hurting severely all over the hips knees ankles ribs arms and back. On 15-JUN-2021, the subject experienced tingling in right arm. On 15-JUN-2021, the subject experienced numbness in right arm. On 15-JUN-2021, the subject experienced body aches like the flu. On 15-JUN-2021, the subject experienced lips tingling but not swollen happened only once for half hour. On 15-JUN-2021, the subject experienced squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation. On 15-JUN-2021, the subject experienced joint pain. On 15-JUN-2021, the subject experienced headache on right top side of head. On 15-JUN-2021, the subject experienced fever temp highest 104.1f to range of 102f. On 15-JUN-2021, the subject experienced muscle pain. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips tingling but not swollen happened only once for half hour on 15-JUN-2021, and was recovering from tingling in right arm, squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation, numbness in right arm, fever temp highest 104.1f to range of 102f, body aches like the flu, headache on right top side of head, muscle pain, joint pain, and bones hurting severely all over the hips knees ankles ribs arms and back. This report was non-serious.

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

SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; SORE ARM; This spontaneous report received from a patient concerned a 61 year old female of an unspecified race and ethnicity. The patient's weight was 265 pounds, and height was 69 inches. The patient's concurrent conditions included seasonal allergies, non-smoker, and non-alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient was not pregnant at time of report. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, 1 total administered on 06-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced sore arm. On an unspecified date patient underwent through laboratory test included: Antibody test revealed negative (suspected immunological vaccine failure) was reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 08-MAR-2021, and the outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210637750. This report was associated with product quality complaint: 90000183360.; Sender's Comments: V0 ; 20210637986- COVID-19 VACCINE AD26.COV2.S-SUSPECTED IMMUNOLOGICAL VACCINE FAILURE . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

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

Severe Chills and shaking repeated nightly for 5 nights Body aches, vertigo, nausea, headache , muscle cramp at injection site resolved slowly over 3 weeks

04-23-21 - Woke up super dizzy & was unable to get out of bed for about 30 mins after that I had to VERY carefully move around slowly for weeks after that (until mid June) I also had ringing in my ears for most of that time pretty severe at first & still present but better that when I was dizzy. I had not had this before & it is quite unnerving. I have been doing PT for the dizziness & it has pretty much subsided. I have also had pain (no rash or lymph discomfort or swelling) just muscular pain in my upper right arm. This started about a month after the vaccination. It is in the arm muscle NOT the bursa. It happens when I have not moved the arm for awhile & I reach for something, etc.. the pain is not severe but obvious (0 to 10 it is about a 4) & goes down to about a 1 after I move the arm around for 30 seconds or so. I have also had pain & a bit of weakness in my legs & a sharp pain in my left beast (not my chest - the upper left quadrant about 1" below my armpit & 3 inches in the breast tissue. It is a single sharp pain (0 to 10 = 7) and only stays for a few minutes.

25 June 11 pm: Entire body aching -- Up multiple times during the night, general muscle aching and fatigue, some confusion; migraine developed overnight. 26 June, 7 am: Out of bed, short walk, general myalgia, fatigue, migraine, had to lie down. 8:30 am: Slightly longer walk, felt slightly better, able to eat small amount after this. 9:30: Felt nauseated, migraine, fatigue, and myalgia worse. Noon: Brief walk outside, lay back down due to nausea, fatigue, myalgia. 2:30 pm: Nausea a bit better, ate apple, lay back down due to symptoms above. 5 pm: Migraine and nausea slightly better, fatigue and myalgia persist. 6:30 pm: Ate plain lettuce, extreme nausea, and tinnitus; vomited entire quantity; nausea improved. Remained prone rest of evening. 7:30 pm: Mild nausea persists, migraine improving, may be slight decrease in myalgia. 9 pm: To bed, slept well, definite improvement through night, some myalgia persists and occasional tinnitus. Able to drink water throughout.

Day 1: Shot Friday about 530 PM. Waited 30 minutes+. VERY ITCHY skin within minute or more of injection. Skin itched all over, but no rash, no other symptoms. Took usual aspirin & Tylenol before bed. Also began probiotics and elderberry/zinc/C supplements recommended in Covid handout. That night: Slept on other arm, when rolled over in early AM, hurt to press on shot arm. Day 2: Woke up hay feverish - sinuses completely blocked but could breathe through mouth, so airway OK. Moderate headache, all over muscle aches. Took usual aspirin & Tylenol. Skin still itches all over. Took a Zyrtec. Sinuses cleared, muscles and head aches went from moderate to mild, skin itch also from moderate to mild. Took usual aspirin & Tylenol before bed. Day 3: Woke up with sinuses partially blocked and sneezing. Mild headache and muscle aches. Took usual aspirin & Tylenol, and when sinuses wouldn't clear on sitting up and blowing and kept sneezing, took another Zyrtec. Day 4: Sinuses draining so I'm going to try to do without Zyrtec. Body still very achy so taking usual aspirin & Tylenol. Day 5 and beyond: Symptoms gradually subsided without further Zyrtec. Higher than normal tiredness persisted longer than aches and hay fever symptoms. Overall, much milder reaction than I had to a flu vaccine many years earlier, so I'm pleased, but felt VAERS should have complete information.

ENTIRE BODY FEELING HOT AND FELT LIKE ON FIRE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was not reported and height was 64 centimeters. The patient's past medical history included difficulty breathing, and hurting around heart, and concurrent conditions included alcoholic (40s per day beer), and smoker, and other pre-existing medical conditions included the patient did not have any known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced entire body feeling hot and felt like on fire. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of entire body feeling hot and felt like on fire was not reported. This report was non-serious.

Extremely painful when vaccine was injected into my arm! The pain radiated up and into my left jaw. I could taste the vaccine. Before the injection I discussed the fact that I have many allergies and my concern that the form didn?t ask which vaccines I had had anaphlaxic reactions to. My tongue immediately became slightly swollen. By the time I arrived home an hour later, I could barely left my left arm, I was sick to my stomach and almost started to dry heave; it passed in about 10 minutes. My tongue remained swollen until 7:00 pm 6/30/2021. My arm remained extremely sore until 7/01/2021; the injection site still hurts a little as of 07/05/2021.. on 07/02/2021 I had chills until approximately 5:30 pm. I carry Epi-pens should I need to self administer.

So on Friday at 10:30PM On the Friday 25th of June, I had GI issues and a lot of stomach pain. I also had cramping and pain in the back of my legs as well. I went to the DR and she put me on antibiotics, Cipro and something else I cannot remember. I went to the DR on Wednesday the 30th of June. The GI problems have been happening for about 2 weeks. I also saw my cardiologist on 4/8/2021 and he saw I was ok, the pulmonary DR also said my lungs looked fine on 4/26/2021.

My stomach pain started a couple weeks after the vaccine. On May 8, I went to the ER because I had left side abdominal pain. I was prescribe antibiotics and given an IV of antibiotics. On the 12th, I called my doctor again and I was admitted me to the hospital. I still feel weak and have abdominal pain on and off. I am scheduled for a colonoscopy on July 23, 2021.

My gums were inflamed they felt like they were pulling away from my teeth. My gums were discolored. I had cavities and it made the pain unbearable. All my teeth felt loose like they were going to fall out. I went to a dentist but no dentist could prescribe me any medication. It hurt from my ear all the way to center of the jaw. I got some antibiotics from my doctor but soon as I finished the pain would come right back. I did three rounds of antibiotics back-to-back. I went to an oral surgeon and he said the antibiotics were not working and he had to pull two of my teeth. The pain was has been unbearable, it feels like nerve pain. I did have some bloodwork sometime during this but I don't remember when.

Lower leg down to foot had a burning, severe pain. Healthcare professional diagnosed with nerve damage. Currently seeing a Neurosurgeon. Dr.

On 15th of June I began throwing up, couldn't keep food down, major cramping in my stomach, wouldn't go away, chills that lasted until 6/24, I took peptol bispol, tums, ginger, but still cramped and threw up, couldn't eat, slept a lot because of pain. I did stop taking the metrondasel antibotic given for my swallon jawl, kept taking Pennicillin because I'm not allergic. I was very weak, on vacation when this started, couldn't be out in the side much at all, felt like I was going to pass out. Later in week begin having tingling in my feet like they were going to sleep and in my upper legs/hips. I do have stents in my legs that are doing well, so it kind of worried me that they were tingling. On 24th of June, went to my doctor, she gave me Hyoscyamine for pain/discomfort in my stomach and back, also PureGG 25B for probiotic. It's been working ok, but still having stomach episodes of pain and goes to my back like sharp object. Also I've never had heartburn until this sickness, have to have tums and something for pain every once in a while, should've been over all of this by now, but have called the new doctor because I'm not sure what's going on. I'm not a sickly person.

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).

Numbness in fingers and toes - tingling sensation - wrist - hand- finger- feet & toes. Weird headache especially when I sleep.

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.

Janssen COVID-19 Vaccine EUA. Gradual headache late afternoon, followed by neck ache, then muscle aches, Horrible chills and shakes, nausea and throwing up. Muscle aches continued throughout the night and into the morning. Left with some muscle aches, stuffy head today. Tylenol did not help in the evening, so switched to Advil at midnight and that started to help.

While waiting the 15 required minutes after the shot was administered..I experianced a headache and left jaw discomfort. Minor arm pain the first day, I expected that. Did my regular errands and was fine, a little tired. The next day, (Sunday)...I went to church, had a headache, arms aching like mad, arthritic symptoms , legs cramping, joint pain in elbows especially, were off the chain! I returned home and took immediately to the couch, where I had a low grade fever and stayed all day. I had no appetite, no energy to get up except to go to the bathroom.

Patient stated after about 15 minutes after receiving vaccine that her face felt numb, she said it feels like it spread from her arm where the shot was given up into her neck and into her face which was numb and tingly

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)

Intense intermittent itching and redness, mainly on tops of feet and occasionally on wrists and arms. On 7th day, hives with raised red bumps and welts and intense burning itch appeared on lower legs. These gradually spread to upper legs and abdomen over several hours. After taking OTC antihistamine, itching subsided. Rash was gone the following day.

Upper body achy ness & headache. Symptoms started around 5:00 PM & subsided overnight & by following morning headache diminished. Sore upper arm the following Thursday evening,

Patient went to the ER the morning after receiving the vaccine because she reports she was experiencing a severe migraine with ear and eye pain, nausea, vomiting, diarrhea, pain in hands and feet, and muscle spasms that last for 4 days.

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.

My wife got the J&J shot last Wednesday and had the typical sore arm and a little fatigue. On the following Saturday she had a very severe episode of anger at the members of our household and wanted to leave our marriage, sell the house, and said she could not live like this anymore. She slammed doors, yelled and screamed, insulted everyone around her, and would not listen to reason. 3 days later she is calming down somewhat but still has a lot of anger. I have lived with the woman for over 30 years and have never seen anything like this before. She does have her moments and has had mood swings in the past but this episode was exceptional. I think she will be OK in a few more days but I wanted to report this to possibly prevent something similar from happening to others. It is possible this episode was unrelated to the vaccine. It is also possible this is related to her heavy use of Neurontin with Prozac. Let me know if you have questions.

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.

Migraine type headache lasted most of day greater than 12 hours, slight fever 1 degree, chills, ache, lower back pain.

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)

Patient experienced lightheadedness, spots in vision, and shakiness approximately 30 mins after receiving the vaccine. Was monitored for 25 mins with no resolution in symptoms and was sent to the emergency room for additional evaluation.

Starting midday Sunday ( one day after vaccine) I started feeling nauseous and about 2:00 I started throwing up. I threw up until about midnight for a total of 7 times. The night before I had difficulty sleeping. The next morning I felt nauseous again and threw up about 10:00 a.m. I started having diarrhea which has lasted through today (Thursday) and I had lost over 5 pounds in just 3 days and my weight is still over 5 pounds less today because it is difficult to eat much. Sunday I was feeling pain around my lest breast where I had had my mastectomy in June of 2006. That eased up the next day. Feeling stressed because I have bad tinnitus and was worried about a reaction.

Day 11 .. right arm .. red splotchy rash, hot to the touch "Covid Arm" No prior symptoms other than sore arm.

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.

Systemic: tooth sensitivity, could not eat or chew-Severe, Systemic: Joint Pain-Medium, Additional Details: 3/19/21: after work, patient came home and noticed itchy rashes on both ankles\r\n3/20/21: Overnight, patient experienced tooth sensitivity, uncomfortable and painful to chew/eat. 1 top and 1 bottom teeth affected more than the others. Experienced joint pain in hips, hands, and ankles. Patient had history of arthritis\r\n3/21/21: Joint pain continued. Rash on R ankle had a few tiny blisters\r\n3/22/21: Dentist appt where one tooth was extracted. amox & pain med started, rash and pain went away

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.

Around 6pm that day I had trembles very bad started getting n feeling cold could not get warm by the time I came back home I went to bed with all my cloths on and 2 more blankets I had a fever of 103 and was very hot to touch the shakes would not go away. The next day I started feeling a little better still cold and had a very sore throat and runny nose body ached bad very bad friday I feel better but feel like I was hit by a truck

8 pm- fatigue, beginning of headache. 11 pm chills and fever 1 pm body ached and crushing headache. did not sleep. fever went away after 3-4 hours, body aches dissipated over 2nd day, headache lasted until 3rd morning. woke up Sunday feeling tired but headache all but gone. now 3 days later, still have fatigue and a little fogginess. much like when I get over the flu- just weak and tired.

INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; SHAKING; BODY ACHES; SERIOUS DIZZINESS; CHILLS; TIREDNESS; HEADACHE; .This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 110 kilograms, and height was 162.56 centimeters. The patient's concurrent conditions included non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergy. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: UNKNOWN) dose was not reported, administered on 07-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vitamins nos. On MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 07-MAR-2021, the subject experienced off label use. On 07-MAR-2021, the subject experienced shaking. On 07-MAR-2021, the subject experienced body aches. On 07-MAR-2021, the subject experienced serious dizziness. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, body aches, serious dizziness, chills, and tiredness on 14-MAR-2021, and the outcome of headache, inappropriate route of vaccine administration and off label use was not reported. This report was non-serious.; Sender's Comments: V2: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.

Arm became sore on the left arm - I had a lump and my whole arm was like one giant bruise. That lasted about three weeks. I still have a lump but it isn't bruised looking anymore. The incident I went to medical care for - I saw the doctor on 4/2/2021 and he diagnosed I have shingles on my right leg. I thought it was spider bites. I did have the shingles vaccine. It is inflamed and I get nerve pain down my leg. It is very, very sore to the touch. Right now it is kind of dry - like blisters on it. It's a mild case. Doctor put me on Valacyclovir. He put me on it for one week and I have two more days after today.

Fatique, Neck tightness, Chills, Fever 102.3, bone pain fingers/hands, shaking legs, unstable walking.

Began with muscles in legs aching, then a headache, body aches, feeling of being sick, chills. Started feeling better two days after shot, but still weak.

I got the vaccine at around 11am on 6th April. By 8pm the same day I was experiencing very severe chills - I have never felt so cold before in my life, and the evening was not cold.. The next day, 7th April, I woke up with bad aches in various, seemingly random areas of my body: both upper arms, outside parts of both thighs, center of back between shoulder blades. Interestingly all the aches were symmetrical. I had not done any serious exercise to cause these symptoms, just a stroll around the park after getting the vaccine. I also experienced crushing tiredness and had to go back to bed in the afternoon. Today, 8th April at 5:30 pm my left arm at the vaccine site still aches, but all the other symptoms had vanished by the morning. I'm 5' 4" and weigh 114lbs. My husband got the vaccine at the same time and had no symptoms. We are speculating that my smaller size may have contributed to my adverse reaction. He is 5' 6" and weighs 180lbs. In spite of this discomfort I'm so relieved and pleased that we were able to get the vaccine. Thank you!

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.

Initial reaction was flu-like symptoms but more concerning reaction was a bad rash with red small bumps on the same side as the shot was given directly above my left breast that was severely itchy. This rash is just now starting to dissipate but still itches; I used OTC cortisone creme and Benedryl to address the itching. The other major effect involved my left arm. For a full week, the muscle in which the shot was given was extremely sore to the touch and the whole arm ached. I still cannot fully extend that arm above my head without it feeling like an aching weight. Lastly, I had a pain in the center of my back as a hard ache that one week later still has not fully dissipated. It appears to be going away, but has lingered longer than I would have expected.

Four days after I received the vaccine (this week Tuesday), I suddenly felt very dizzy and faintish. I sat down until the dizzy spell passed. I felt very cold and clammy and nauseous. My hands were very shaky. I felt very weak and very tired so I slept the whole day. Today I woke up and felt the same dizziness, very cold hands and nauseous. Both times I had diarrhea. I have never had dizzy spells before so I know this has to be vaccine related.

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

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.

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 rheumatoid arthritis, 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: 042a21a, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced tiredness. On 01-APR-2021, the subject experienced subject could not lift things (strength loss). On 01-APR-2021, the subject experienced pain in arm. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on APR-2021, and had not recovered from muscle ache, pain in arm, patient could not lift things (strength loss), and tiredness. This report was non-serious.

8 hrs after vaccine had fever if 104 and pulse of 125. Very weak and dizzy. This continued until the next morning.Took 1300 MG acetaminophen. Had no effect. Used ice bags, had no effect.

A couple minutes after receiving the vaccine, patient started feeling dizzy and described it as her head feeling heavy, and some weakness. She was offered water and was brought in to the clinic for further monitoring. BP- 164/78. PR- 71. Symptoms did not worsen and it improved after 1 hour, but not totally resolved. BP recheck was 143/62. PR- 76. Patient said she felt better and volunteered to go home. Instructed to go to ER if her symptoms persist and worsen; patient verbalized understanding. Discharged to home after an hour of monitoring.

A few hours after receiving the "Janssen COVID-19 Vaccine EUA" I started to experience the following side-effects: headache, fever, muscle aches, tired and weakness. I also felt a little dizzie. I monitored my temperature thoughout the night; I recorded at 7:54pm 99.7; 9:23pm 99.2; 10:45pm 99.8; and at 6:00 am on 4/9 my temperature was back to normal at 97.5. The muscle ache were gone and the headache was mild. I do still feel a little dizzie and weak.

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

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.

At time of the shot, bright red face, rash, skin warm to touch. In the early evening chills, dizzy, waves of nausea. In the morning: vomit, nausea, chills, headache, dizzy

Numbness on left side of face lasting from 3pm to after midnight on 3/8/21. It subsided on 3/9/21 during the day, but again felt numbness on left side of face at 10:00pm on 3/9/21. Continue to feel nausea, no appetite, and extreme fatigue.

Experienced all common symptoms as well as other I have not heard of. Mental fogginess began at 8 PM (8 hrs after shot) and lasted until late the next evening Chills began at 8:30 PM and continued until early Friday AM. There were also a few instances of hot flashes in between the chills. About 10 hours after the shot the following began: headache (I rarely get headaches), nausea, muscle aches - mostly my quadriceps, low back pain, pain in the back of my neck, general lethargic feeling. These all lasted into Thursday evening, except the low back pain, which lasted into Friday AM. I felt a dull pain in all my back teeth that lasted about a day and was intermittent. See page 2 for more.

WARMTH; ACHINESS; CHILLS; HEADACHE; This spontaneous report received from a consumer 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: 041A21A, expiry: not reported) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced warmth. On 06-APR-2021, the subject experienced achiness. On 06-APR-2021, the subject experienced chills. On 06-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 chills, warmth, headache, and achiness. This report was non-serious. This case, from the same reporter is linked to 20210413415.

beginning the following morning: hot flash followed by chills followed by vomiting. Hot flashes, Chills, Nausea, Vomiting, Diarrhea continued for 48 hours

Same night of the vaccine I had fevers & chills. They were gone after 12 hrs. On 3/18/2021 I stated having stomach problems. I had diarrhea & cramping this was going on & off. Around one week later I went to urgent care because of how much I was cramping. I followed up with my regular doctor & he did some la work. It kept going on & off but it started getting better & today on 4/12/2021 is the first day I started feeling like myself.

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.

2 hours after I received the vaccination, I came down with severe chills. My entire body was shaking and I could not get warm. I got extremely fatigued to the point that I could not get out of bed. I got a severe headache (and I get headaches a lot...this one lasted for almost 10 days). It seemed that every bone and muscle in my body began aching, from head to toes. My fever went up to almost 102. These symptoms continued for a course of four days, except the headache and fatigue (which lasted for approximately 6 days and the headache for 10 days). I alternated Tylenol, Advil and Alleve. They did not help hardly at all, unfortunately. 2 weeks later, I developed lymph node swelling in my right arm pit and alongside my right breast. Today, these lymph nodes are still swollen and are painful to the touch. I experienced pain at the injection site and if I touch it, it is still painful today, but does not ache like it did initially.

Feeling glooomy snd a little foggy in the head since day one. Tightness in my leggs thighs. Feeling warm not fever. Not as much on day 7

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

I started having pain in my left calf on Sunday 4/11/2021. I went to the doctor on the next day, Monday, April 12 at 9am. He sent me to the center where they did an Ultrasound which was positive . I was adviced to go to the Hospital for a CT scan of my lungs and brain. I went to medical center on Monday at 6pm. There I was given an Iodine CT scan. They noticed a small spot of pneumonia. They repeated the Ultrasound of my leg and took a swab for Covid-19. I was given a prescription for Xarelto and an antibiotic , Levaquin, 500mg.. I came home.

Pt was vaccinated at 1630 and then proceeded to the monitoring area for her 30 minutes due to allergy hx. At 1700 pt started to c/o to monitoring RN that she felt tingling in her both her arms and legs. RN provided pt wit diphenhydramine 25mg PO with water. Pt continued to be monitored. No additional s/s of an allergic rxn were noted. Tingling improved and pt was discharged home with son at 1720.

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

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.

She received the Johnson & Johnson COVID Vaccine 3/5/2021 9:30am. 3/6/2021 She reports that she was weak and exhausted and flu like symptoms. Symptoms began on 3/7/21, woke up horizontal binocular diplopia at 8:30am. Has been constant since it started. It is worst when looking to the left and best looking the right. Worse in the distance. No other associated symptoms 3/13/21: Around noon, was just sitting in the chair. She reports that she got a bad headache and then the entire left side of the body from head to toe was numb and burning in the left side face. This lasted all day, but completely resolved by night time. Had never had anything quite like that in the past. She had a headache that started soon before the numbness, that also lasted most of the day. 3/15/21: was seen in ED with reported normal MRI, CT, and EKG MRI brain with a small left pons lesion near the cranial nerve 6 nucleus She was seen by Neuro-ophthalmology Dr. (attending), Dr. (fellow) 3/17/2021 " MRI brain on 3/15/21 did not reveal a structural etiology for diplopia. Differential diagnosis includes microvascular ischemic left 6th nerve palsy versus possibly post-vaccination cranial nerve palsy (received COVID vaccine 2 days prior). Also on the differential diagnosis but less likely, includes myasthenia gravis (she did not have expected abduction saccade slowing of the left eye typical of an ischemic cranial nerve palsy). Thyroid eye disease also would be less likely. We will obtain antibody testing for myasthenia and thyroid eye disease. Today we applied a 10 prism diopter base out prism over her left glasses lens. I instructed her to remove this when appropriate, as I expect her diplopia to gradually improved." 4/7/2021 acetylcholine ab receptor negative, TSI negative, TSH receptor antibody negative, LH/FSH normal,

Onset of dull headache which worsened. Continued worsening into a massive migraine(cluster, light sensitive). After several hours I took a migraine relief OTC medication. The headache subsided with minor headache into the following day.

received Jansen vaccine on 3/31/21 and the following day I had a headache,, achy and tired. I expected this, but a few days later I was still having what I describe as migraine type headaches and at one point I was sweating profusely, dizzy massive headache with not only nausea, but dry heaving so bad I could barely get to my medication and seriously thought it would never subside. I continued with headaches up until today April 14. This is the first day I have not had a headache. I contacted my vascular doctor as I had a blood clot several years ago and he has prescribed Eliquis twice a day for the next 2 weeks. Today marks 2 weeks and like I said, it's the first day I have not had a headache

According to the patiens, she had hives and echiness the next day after receiving the vaccination. Today the 14th of April, she showed up to the pharmacy and complained of severe leg cramps and multiple bruises in her legs and thighs. I advised her to go to the emergency room. She picked up her aspirin 81 mg .

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

4-10 and 4-11 experienced leg pain in left calf. When laying in bed moved up back of upper leg. Tylenol helped but only 3 hours. Took ibuprofen next nigh, helped overnight. Symptoms resolved by morning.

4/14/21 Per Patient, received Janssen vaccine on 3/5/2021, began experiencing headaches on side of face and intermittent sharp left leg pain 3/12/2021, does not usually get headaches and thought related to dental work, 4 tooth implants, evaluated by dentist who said headaches not related to dental work, had been more active, walking with nice weather and thought leg pain might be caused by tick bite, left knee "gave out", husband looked at back of leg and did not see any evidence of tick bite, noticed varicose veins had worsened (more prominent, not red or swollen) and thought should be checked, appointment at center 4/8/21 and is under the care of Dr, has follow up appointment 4/21/2021. Placed on blood thinner Xarelto 15 mg tablets, 2 tablets daily x 21 days, then reduced to 1 tablet daily x 22 days for blood clots. Headaches and leg pain improved after starting medication. Signed up for program 4/13/21 after suggested by daughter.

Very lightheaded while vaccine was injected into my arm. It has never happened with other vaccines. Once needle was pulled out of arm, was not lightheaded anymore. Also muscle in my arm is sore 1 month later and not getting better yet.

Swelling of the lymph nodes in the same arm of the injection for 3 days, used heating pad to sooth. Pain at the injection site for 2 days, used CBD oil around site of injection to sooth. headache, feeling very tired, muscle aches , chills and joint pain for 4 or 5 days. I took 2 Tylenol 325mg 2 different times. I already take Mobic for a slipped disc. Had just had a L3-L4 dorsal epidural steroid injection on 2/25/21. It negated the medicine. My sciatic leg pain is back in full force. I called my PCM for advice. They suggested I inform you.

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

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.

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.

Initial reaction was noted on 8:00 PM 3/17. Jitteriness and fatigue on 3/17. Around 9:00 felt neck pain and it was hard to move her neck. The neck pain was severe 10/10. Still has problems with the neck. Her neck pain has improved but the pain is worse than it was before she had the vaccine.

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.

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

CHILLS; FEVER; MUSCLE ACHES; FEELING TIRED; FEELING WEAK; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included lung transplant, and liver transplant, and concurrent conditions included hepatitis c. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced feeling tired. On 08-APR-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, and had not recovered from muscle aches, feeling tired, and feeling weak. This report was non-serious.

Dizziness approx. 30 minutes after vaccination, spinning sensation 1hr after vaccination. Chills and shivering approx. 5 hrs after-- nausea-vomiting-102 fever, severe muscle, joint and headache. 5 1/2 hrs later. 36 hrs after shot side effects lessen. 72 hrs later weakness and fatigue. Day 4 these symptoms resolve. Five days after vaccine dizziness and muffled hearing in left ear which is unresolved.

FEELS SPACEY; DIZZINESS; PAIN FROM HEAD TO TOE; NAUSEA; DRY THROAT; EYEBALLS WERE HURTING; FEELING HOT; FELT LIKE RUN OVER BY A MACK TRUCK; CHILLS; HEADACHE; HOT SWEATS; STOMACH ACHE / BELLY MUSCLE ACHE; INCREASED GAS; BURPING; SWOLLEN THROAT; THROAT IRRITATION; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced increased gas. On 07-APR-2021, the subject experienced burping. On 07-APR-2021, the subject experienced swollen throat. On 07-APR-2021, the subject experienced throat irritation. On 08-APR-2021, the subject experienced stomach ache / belly muscle ache. On 08-APR-2021, the subject experienced hot sweats. On 08-APR-2021, the subject experienced dry throat. On 08-APR-2021, the subject experienced eyeballs were hurting. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced felt like run over by a mack truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021 03:00, the subject experienced dizziness. On 08-APR-2021 03:00, the subject experienced pain from head to toe. On 08-APR-2021 03:00, the subject experienced nausea. On 09-APR-2021, the subject experienced feels spacey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach ache / belly muscle ache, increased gas, burping, headache, swollen throat, dizziness, nausea, pain from head to toe, chills, hot sweats, feels spacey, throat irritation, dry throat, eyeballs were hurting, feeling hot, and felt like run over by a mack truck. This report was non-serious.

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.

FLU LIKE SYMPTOMS; SWEATING; BODY ACHE; MIGRAINE/HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included stent in heart, and stent in leg, and concurrent conditions included migraine, high blood pressure, gastroesophageal reflux disease, and irritable bowel, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for gastroesophageal reflux disease, and irritable bowel, hydrochlorothiazide for high blood pressure, lisinopril for high blood pressure, metoprolol succinate for high blood pressure, pantoprazole for irritable bowel, and gastroesophageal reflux disease, butalbital/caffeine/paracetamol for migraine, acetylsalicylic acid for stent placed in heart, and clopidogrel bisulfate for stent placed in heart, and stent in leg. On 05-APR-2021, the subject experienced flu like symptoms. On 05-APR-2021, the subject experienced sweating. On 05-APR-2021, the subject experienced body ache. On 05-APR-2021, the subject experienced migraine/headache. On 05-APR-2021, the subject experienced fatigue. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, sweating, body ache, and migraine/headache on 09-APR-2021, and nausea on 07-APR-2021, and was recovering from fatigue. This report was non-serious.

Patient began to experience upper thigh pain approximately 3/16/2021 - 3/18/2021. Can't remember which leg, reports the pain as a stabbing and aching pain. Leg was painful whether walking or not. Rates pain 4-5 on the pain scale with 10 being the worst pain ever experienced. Doesn't recall redness, swelling, or warmth to area of the leg. The pain lasted approximately 2-3 days . Patient did not contact her PCP. Also reports headache to back of the head which lasted around one day. Typically has sinus headaches. Recommended she contact PCP immediately so he/she can follow-up

Dizziness, nausea, leg pain(left), migraines, diarrhea (ongoing),chills, unable to regulate body temperature(ongoing), severe fatigue (also ongoing), difficulty working, inappetince... Spoke with doctor. No help. No treatments.

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.

Reports that she starting having leg pain in right leg. States that it starting out intermittent but has gotten worse. Especially at night. Did have some redness to that leg a couple days ago but has resolved.

CHILLS; FEVER; HEADACHE; SORE ARM; 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 latex allergy, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 12:50 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.9 (unit not specified). On 10-MAR-2021 12:50, the subject experienced sore arm. On 10-MAR-2021 22:00, the subject experienced chills. On 10-MAR-2021 22:00, the subject experienced fever. On 10-MAR-2021 22:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 10-MAR-2021 15:50, was recovering from chills, and fever, and had not recovered from headache. This report was non-serious.

NAUSEA; HEADACHE; INJECTION SITE PAIN; BODY ACHE; ARM HURT; CHILLS; JOINT PAIN; MYALGIA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 125 pounds, and height was 174 centimeters. The patient's concurrent conditions included no alcohol user, and non smoker. The patient experienced drug allergy when treated with tetracycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: 25/MAY/2021) dose was not reported, administered on 10-MAR-2021 11:00 for prophylactic vaccination. Concomitant medications included ascorbic acid/calcium/minerals nos/retinol/tocopheryl acetate/vitamin b nos/vitamins nos/zinc for drug used for unknown indication, calcium carbonate/colecalciferol for drug used for unknown indication, vitamin c for drug used for unknown indication, alendronate sodium for osteoporosis, nebivolol hydrochloride for slow heart down, aloe vera, and chondroitin sulfate/collagen/glucosamine. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced arm hurt. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced joint pain. On 10-MAR-2021, the subject experienced myalgia. On 10-MAR-2021 15:00, the subject experienced nausea. On 10-MAR-2021 12:30, the subject experienced headache. On 10-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, arm hurt, chills, myalgia, nausea, joint pain, and injection site pain. and headache on 11-MAR-2021 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.

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

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.

DIARRHEA; DIZZINESS; FUNNY TASTE; PAIN IN LEFT ARM; HEADACHES; NAUSEA; 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 chronic back pain, preexisting degenerative joint disease, non smoker, and non-alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced funny taste. On 09-APR-2021, the subject experienced pain in left arm. On 09-APR-2021, the subject experienced headaches. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 11-APR-2021, dizziness, and nausea on 10-APR-2021, and funny taste on 09-APR-2021, and had not recovered from pain in left arm, and headaches. This report was non-serious.

Frontal lobe headache to start within a few hrs of vaccine. Back of the head to lower neck headache 8 hrs after. Every tooth in my mouth started throbbing at around 11 hrs and continued for about 5 more hours. Also during that time, waves of nausea but no vomiting, also uncontrollable shivering but I wasn't cold and I wasn't hot but weird shivering. I did not take my temperature as I didn't feel like I had a fever. Around 13 hrs after a stabbing pain in front of thighs like hot pokers started and around 14 hrs thigh pain was still present but then the calves on both legs started to get the same stabbing pain. At around 24 hrs after - headache remained, pulsating teeth stopped, thigh pain stopped but calf pain remained. Headache remained off and on for several days. General brain fog also lasted for about 1 week. The calf pain comes and goes even after 2 weeks. Arm where shot was administered was very tender to the touch for the last 2 weeks. Lastly, I wouldn't say I had shortness of breath but at times I just felt like I needed to stop and force myself to take a very deep breath.

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.

HEADACHE; HOT FLASHES; 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 fibromyalgia, and arthritis. The patient was previously treated with tramadol 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: 201A21A, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 13:40 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride/paracetamol for drug used for unknown indication. On 09-APR-2021, the subject experienced hot flashes. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes on 10-APR-2021, and headache on 12-APR-2021. This report was non-serious.

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

ECZEMA ON HAIRLINE AT THE BACK OF NECK AND BEHIND EARS, ON ELBOWS AND ON FRONT OF THE OF ANKLE/RASH/ITCHINESS/BUMPS/REDNESS; SLIGHT SORE ARM; MILD HEADACHE; KIND OF PRESSURE BEHIND ONE EYE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 150 pounds, and height was 62 inches. The patient's concurrent conditions included non-smoker, non-alcohol user, and overweight, and other pre-existing medical conditions included the patient does not have any medical conditions and not taking any medication, the patient had no known allergies, the patient had no history of drug abuse or illicit drug use, the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced kind of pressure behind one eye. On 06-APR-2021, the subject experienced slight sore arm. On 06-APR-2021, the subject experienced mild headache. On 09-APR-2021, the subject experienced eczema on hairline at the back of neck and behind ears, on elbows and on front of the of ankle/rash/itchiness/bumps/redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight sore arm on 08-APR-2021, and mild headache on 06-APR-2021, had not recovered from eczema on hairline at the back of neck and behind ears, on elbows and on front of the of ankle/rash/itchiness/bumps/redness, and the outcome of kind of pressure behind one eye 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.

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

TINGLING OF FINGER TIPS OF LEFT HAND; HEADACHE; TIRED; ARM PAIN; 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 cat allergy, alcohol user, and smoker, and other pre-existing medical conditions included the patient had no any drug abuse or illicit drug usage and other pre-existing medical conditions included nothing significant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included minerals nos/vitamins nos. On 07-APR-2021, the subject experienced arm pain. Treatment medications included: Tylenol (paracetamol). On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced tingling of finger tips of left hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling of finger tips of left hand on 09-APR-2021, arm pain on 08-APR-2021, headache on 10-APR-2021, and tired on 11-APR-2021. This report was non-serious.

DIZZINESS; HEADACHE; FEVER; TIREDNESS; SHAKING; GENERALISED ACHING; CHILLS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19, 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 17:20 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced generalised aching. On 11-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced shaking. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced tiredness. On 13-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-APR-2021, and was recovering from generalised aching, chills, fever, shaking, tiredness, and dizziness. This report was non-serious.

HAND EXTREMELY COLD; SEVERE CHILLS/TEETH CHATTERED; FREEZING; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included leukopenia, hypothyroid, and epstein barr, and concurrent conditions included unspecified allergies, chronic medical condition, non alcohol, non smoker, arthirits, high cholesterol, gastroesophageal reflux disease, fibromyalgia, food allergy, animal allergy, nickel allergy, and degenerative disc disease, and other pre-existing medical conditions included the patient is on thyroid medication, no history of drug abuse. 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 21-MAR-2021 15:30 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for blood thinner, calcium for general health, fish oil for general health, vitamins nos for general health, levothyroxine sodium for hypothyroid, and fluticasone for unspecified allergies. On 21-MAR-2021, the subject experienced hand extremely cold. On 21-MAR-2021, the subject experienced severe chills/teeth chattered. On 21-MAR-2021, the subject experienced freezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand extremely cold, severe chills/teeth chattered, and freezing on 22-MAR-2021 04:00. This report was non-serious. This case, from the same reporter is linked to 20210342283. Additional information was received from (patient) on 13-apr-2021 .The following information was updated and incorporated into the case narrative; Events details ,disease, concomitant product

FLUSHED; WATERING EYES; SUNBURN-LIKE RASH; CHILLS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd from 911 exposure, asthma, chronic rhinitis, thyroiditis, lipidaemia, codeine allergy, and levaquin allergy. The patient experienced drug allergy when treated with betamethasone, ciprofloxacin, and bupivacaine hydrochloride/epinephrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced flushed. On 10-APR-2021, the subject experienced watering eyes. On 10-APR-2021, the subject experienced sunburn-like rash. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed, and sunburn-like rash on 11-APR-2021, and watering eyes, chills, and low grade fever on 12-APR-2021. This report was non-serious.

SLIGHT HEADACHE; SORE ARM AT SITE OF INJECTION; CRAWLING SENSATION; COLD; 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 sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: 19/MAY/2021) dose was not reported, administered on 06-MAR-2021 13:15 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced crawling sensation. On 06-MAR-2021, the subject experienced cold. On 06-MAR-2021, the subject experienced sore arm at site of injection. On 07-MAR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crawling sensation, and cold on 07-MAR-2021, slight headache on 08-MAR-2021, and sore arm at site of injection on MAR-2021. This report was non-serious.

HOT FLASH; NAUSEA; JOINT PAIN/JOINT BURNING; FOGGINESS; VOMITING; FACIAL REDNESS; METALLIC TASTE; APPETITE LOST; SWOLLEN TONGUE; PAIN TONGUE; PEELING TONGUE; ADVERSE REACTION; LOSS OF TASTE; 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: 04DDZ1D expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced hot flash. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced joint pain/joint burning. On APR-2021, the subject experienced fogginess. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced facial redness. On APR-2021, the subject experienced metallic taste. On APR-2021, the subject experienced appetite lost. On APR-2021, the subject experienced swollen tongue. On APR-2021, the subject experienced pain tongue. On APR-2021, the subject experienced peeling tongue. On APR-2021, the subject experienced adverse reaction. On APR-2021, the subject experienced loss of taste. The dose of covid-19 vaccine ad26.cov2.s was increased. The outcome of the hot flash, nausea, joint pain/joint burning, fogginess, vomiting, facial redness, metallic taste, appetite lost, swollen tongue, pain tongue, peeling tongue, adverse reaction and loss of taste was not reported. 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

My wife has been sick for a few days with a slight fever, chills, weakness and cough. We figured she may have caught the Flu. Today she woke up and had no balance with the other symptoms listed. They went over her symptoms with her and gave her a rapid COVID test , according to their test she was found to be POSITIVE for COVID-19. Just can't understand this as she received her vaccination on the 7th.

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"

Day vaccine was administered to patient the only effective on that date was Tired and drowsiness were experienced. in the late afternoon this condition was only intensified . The next business day was difficult due to a Migraine that was in full force on that Friday. Patient was unable to perform any actions including Work from home. Patient slept for the next 20 hours. Other than sleep no other actions were committed. On that date 3/19/2021 it was noticed that her eyes were sensitive to Light and were also very puffy.. On the Sunday there was little and or no change still sensitive to light and the puffiness was still felt but the eyes were so swollen that it was almost impossible to open them. The Urgent care patient went to on the Sunday was the initial with Healthcare facility

J&J vaccine given on 3/14. Pt states vaccine placement was too high and not given in the muscle. Pt states has permanent nerve damage as a result

VOMITING; FEET AND LEG PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included aspirin allergy, and concurrent conditions included history of blood clot, and chronic inflammatory demyelinating polyneuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included immunoglobulin human normal for chronic inflammatory demyelinating polyneuropathy. On 28-MAR-2021, the subject experienced vomiting. On 28-MAR-2021, the subject experienced feet and leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting and feet and leg pain was not reported. This report was non-serious.

FEVER; HEADACHE; NAUSEA; LIVER PAIN; TIPSY; LIGHT HEADEDNESS; COLD CHILLS; LEFT LEG PAIN; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included hepatitis c, and concurrent conditions included controlled epileptic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included silybum marianum for hepatitis c, bifidobacterium bifidum/bifidobacterium lactis/fructooligosaccharides/lactobacillus acidophilus/lactobacillus casei for immune system, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for nutritional supplement. On APR-2021, the subject experienced cold chills. On APR-2021, the subject experienced left leg pain. Laboratory data included: Pain scale (NR: not provided) pain score 2 or 3. On 09-APR-2021, the subject experienced liver pain. On 09-APR-2021, the subject experienced tipsy. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liver pain, left leg pain, light headedness, tipsy, headache, nausea, fever and cold chills 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 assessed non serious

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.

The day after my J&J vaccine, I experienced left leg and knee pain with numbness sensation. I had a left knee replacement in September 2020. I experience numbness below and above my knee cap. I also experienced bad migraines , arm soreness at the injection site. I called my doctor and he gave me an appointment to see him and he did not think it was related to the vaccine but he was not sure since I do have history of rheumatoid arthritis. Today my left knee and leg still feel numb and I am taking my regular medications as instructed.

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 .

BURNING SENSATION IN THE GROIN AREA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included groin discomfort, and covid 19 infection. The patient was previously treated with steroids for drug used for unknown indication, diphenhydramine hydrochloride for drug used for unknown indication, and antibiotics 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: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 12-APR-2021, the subject experienced burning sensation in the groin area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation in the groin area. This report was non-serious.

BOTTOM EYELIDS ROLLING INWARDS TOWARDS EYES; LIGHT SENSITIVITY TO EYE; EYE RED; ENTROPION IN EYE; PAIN EYE; MIGRAINE HEADACHE; FOGGY FEELING IN HEAD; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 67 inches. The patient's concurrent conditions included codeine allergy, alcohol consumption, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amoxicillin for allergic reaction, and for allergic reaction. On 18-MAR-2021, the subject experienced foggy feeling in head. On 19-MAR-2021, the subject experienced migraine headache. On 20-MAR-2021, the subject experienced pain eye. On 20-MAR-2021, the subject experienced light sensitivity to eye. On 20-MAR-2021, the subject experienced eye red. On 20-MAR-2021, the subject experienced entropion in eye. On 21-MAR-2021, the subject experienced bottom eyelids rolling inwards towards eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy feeling in head on 18-MAR-2021, had not recovered from pain eye, light sensitivity to eye, entropion in eye, and bottom eyelids rolling inwards towards eyes, and the outcome of migraine headache and eye red was not reported. This report was non-serious.

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.

Janssen COVID-19 Vaccine EUA Extreme chills and quaking, despite 3 blankets and two heating pads, occasional jerks of my body -within 7 hours. Lasted 20 hours or more. Fatigue- unable to walk myself to bathroom within 8 hours, lasted two or more days. Very weak. VERY Severe Headache, including facial pain, neck pain, temple pain and eye sockets , stared 7 hrs, lasted two days Severe nausea, I actually thought of food poisoning (but it wasn't). Approx. onset 9 hours. Very painful body aches and muscle spasms throughout my body but especially my Back, underarms, legs, feet. Approx. onset 7 hours. lasted 48 to 60 hour Diabetic Ketoacidosis approx 30 hours after. Wasn't able to eat, blood sugar remained in the 150 to 180 area. Managed to eat 2 TBsp of applesauce to reduce ketones, (which worked) Fatigue unable to work until 5 days later.

DIZZINESS; FEEL LIKE LEGS WERE GOING TO COLLAPSE; 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 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: 205A21A, and batch number: 205A21A expiry: 23-JUNE-2021) dose was not reported, administered on 04-MAY-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced dizziness. On 05-MAY-2021, the subject experienced feel like legs were going to collapse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel like legs were going to collapse, and dizziness. This report was non-serious.

Patient developed left 7th nerve pain and subsequent left sided Bell's Palsy approximately 3 weeks after vaccine administration

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.

Intense pain in left arm 3 days after COVID J&J vaccine. Pain is not at injection site, but below and stops at elbow.

Extreme muscle aches and joint pain throughout the entire body which started in the evening. I did not sleep well with the pain with not being able to lay on my sides as my arms would go numb and I hurt terribly the next day until the afternoon when I took two Advils.

I have MS and I was having some stomach issues and they said it wouldn't be a problem but I ended up in the hospital for 5 days then in rehab. I woke up about 2am after vaccine and when trying to go to bathroom my legs gave out and I hit the floor, we called EMS to get me up and I was really weak. My legs were gone the rest of the night and I couldn't stand my husband had to help me . On the 24th, we called the EMS to take me to the hospital and they sent me to rehab and I got out of there on the 28th to home but I do not have my strength back.

LEG CRAMPS; TIREDNESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 153 centimeters. The patient's past medical history included left ankle injury, and leg cramps, and concurrent conditions included seasonal allergy, social alcohol drinker, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. history of taking birth control medication 40 years ago but she stopped it since then due to severe leg cramps. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included naproxen sodium. On 15-MAY-2021, the subject experienced leg cramps. On 15-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine a was not applicable. The patient recovered from leg cramps on 15-MAY-2021, and had not recovered from tiredness. This report was non-serious.

TINGLING HANDS AND FEET; NUMBNESS HANDS AND FEET; PAIN WITH MOVEMENT; DROPPING THINGS; 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 (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dropping things. On 28-APR-2021, the subject experienced tingling hands and feet. On 28-APR-2021, the subject experienced numbness hands and feet. On 28-APR-2021, the subject experienced pain with movement. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from tingling hands and feet, numbness hands and feet, and pain with movement, and the outcome of dropping things was not reported. This report was non-serious.

Old injuries are flaring up again. In 2010, I dropped a 45-pound Olympic weightlifting bar from overhead onto my foot and fractured 3 bones. That was treated and healed (cast and flexible cam walker). In 2013 I had surgery on my left wrist for Derkervains. That healed up just fine also. All of the sudden, both past injuries have flared up again. I had foot pain so bad that I couldn't walk for a day. An Xray shows no damage. Yesterday, my wrist has flared up and is very painful. I have not seen a doctor about that. My foot is improving. I think it will bounce back. I now suspect that my wrist will also improve. My hypothesis is that the vaccine has challenged my immune system enough that old injuries are flaring up and then calming back down again. It's very odd. I don't know if it's significant, but thought I should report it, in case my experience matters.

Sun I woke in middle of night with pain in thumb. There was nothing there. When I got up few hours later my thumb on left hand had enormous blood blister. Which immediately grew, was infected, and whole hand swelled up. Wednesday night I had same pain under right eye. Again nothing was there. Few hours later my eye was all swollen. I have another Dr appt tomorrow with Dr. I had the emergency room take care of my thumb. That Dr, Dr , a few days later sent me to Dr.

SORE ARM; 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 (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced sore arm. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm on 05-MAY-2021. This report was non-serious.

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.

On 4/27 at 6:30 p.m., I became flushed and my skin felt hot. Next, I began itching EVERYWHERE, my arms especially. I scratched so hard I bruised my arms! My skin turned bright red. I chewed 2 Benadryl, and after about an hour it faded somewhat but I kept itching until about midnight. My family monitored me to make sure I didn't go into anaphylactic shock. The nest day I called my physician's assistant and he said just to monitor it, in case it happened again. It happened again on 5/4/21 at 10:30 p.m. It was not as severe, but I took 2 Benadryl immediately, since I recognized what was happening. I was better by about 12:30 a.m.. I had been in contact with my PA regarding my statins, and he said there wasn't anything they could do but to report it. He didn't think it was the statin that I had been taking, as I had discontinued the statin after the first incident, due to other concerns.

The soreness experienced continued for a week to the day of the shot and on the 8th day until the present became increasingly unbearable. I'm unable to dress myself because the pain in my left arm is excruciating. I can't raise my arm for more than a foot from my side. I've taken ibuprofen and am using ice compresses, but it doesn't help enough. So far I've missed 3 days of work. I cannot dress myself, so I know I can't drive. Please advise. I also massage the sore area to keep my arm from stiffening up.

Approximately 5.5 hrs after vaccination - High fever with severe full body shakes lasting about 3 hours followed by a slight fever of 99.7 for about 16 hours, severe headache lasting about 24 hours, Full body aches lasting about 16 hours, tiredness lasting about 36 hours, moderate headache lasting about 3 days.

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

J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified R56.9 - Unspecified convulsions

JOINT PAIN; SORE ARM; MUSCLE ACHES; HEADACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hit by a drunk driver when was 20, and concurrent conditions included osteoarthritis, and body aches. 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, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced joint pain. On 03-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced muscle aches. On 03-JUN-2021, the subject experienced headaches. On 03-JUN-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, headaches, joint pain, and sore arm, and the outcome of injection site pain was not reported. This report was non-serious.

MIGRAINE ON RIGHT FRONT SIDE; FEELING SLEEPY; LACK OF ENERGY; HEADACHE ON RIGHT FRONT SIDE; FATIGUE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included tested positive for covid-19. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced migraine on right front side. On 10-JUN-2021, the subject experienced feeling sleepy. On 10-JUN-2021, the subject experienced lack of energy. On 10-JUN-2021, the subject experienced headache on right front side. On 10-JUN-2021, the subject experienced fatigue. Laboratory data included: Pain scale (NR: not provided) 7. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on right front side, feeling sleepy, lack of energy, headache on right front side, and fatigue on 11-JUN-2021. This report was non-serious.

Allergic type reaction Itching on face, scalp, arms, legs, torso Started approx. 50 hours after injection Treated with OTC Benadryl, 2 doses thus far Patient continued with milder itching and a tingling sensation, similar to a Niacin "flush" on the skin Continued condition remains after 72 hours after injection

Patient received J and J covid vaccine on 3/7/21. She did not feel well for the next few days and had the following symptoms: headache, fatigue, nausea, body aches, loss of taste. She recovered after a few days and was doing well until 6/11/21. She began having the following symptoms: migraine headache, nausea, dizziness, loss of appetite, blurred vision, weakness, loss of taste, muscle weakness and joint pain. She went to ER on 6/13/21. They did a cat scan and ekg, both came back normal. They did not do a covid test. She then went to her regular Dr. on 6/15/21 and he gave her topiramate. He did not do a covid test. She was off work for a week and returned to work on 6/18/21. She is feeling better now and has worked for the last two days. She came to pharmacy and told me what was happening and she thinks that her symptoms are from the original J and J covid vaccine on 3/7/21 and she is worried that she may have recurring symptoms for the vaccine

For the first two-three weeks I had a feeling that something was not right with my veins on the back of my knees e.g. could not sit for more than a few minutes and had to "walk it off". Once those symptoms were gone I was left with a discomfort or pain in my veins especially when my arms, wrists and my knees are bent and there is no normal flow. The pain is similar to as if you accidentally crashed your vein or if you were a few days hooked up to an IV from the same spot. If feels like a low grade vein inflammation that just does not go away. My veins are in general sensitive to pressure now. I nevere had such symptoms until I took Janssen. I saw the vascular specialist and they ruled out blood cloths or varicose veins problems. Over all blood tests look OK. Yet I am left with this pain and no one knows what this is about. Is this some kind of auto-immune response?.

severe right arm pain over bicep and tricep, limits ROM, sharp shooting pain down arm, wakes her from sleep, no localized reaction, pulses and circulation are normal, pain does not improving with tylenol or ibuprofen.

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

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

Patient reported feeling shakiness and lightheaded after initial vaccine, following 20 minute observation period patient reported feeling more normal, and left. Patient reported this is the first vaccine she has had since childhood.

Right after you received the vaccine on 03/31/2021, it was painful, but I thought it was just a shot pain, put I thought it was extremely painful. On my drive home it kept hurting. Finally on 04/17/2021, I was concerned because that was the time the media was mentioning blood clots from the vaccine. Because my arm, my shoulder hurt, and under my arm still continued to hurt I went into the ER. The doctor did not feel any abnormality in my arm. Till this day I still feel soreness in your arm and shoulder and under my arm. I can't extend my arm or use my arm. I use it cautiously, if I use it. I have had 3 or 4 visits with my doctor and she put me on methylpred 4 mg/ triage pack. It helped somewhat with the pain, but I still had soreness. So she prescribed Methocarban 500 mg. I just took it for 3 days. and it upset my stomach and gave me diarrhea . Now I have an MRI that is scheduled, but I don't know when at this point. I have to see if my insurance will cover it. I'm still pursuing to see why my soreness is persisting.

I am 7 years post-menopausal, and 6 weeks after the vaccine I had a week-long, full-fledged menstrual period. Then for the next five or six weeks, I had 4 or 5 hot flashes every day (I never had any in my 7 years of being post-menopausal). I also had a migraine mid morning every day after the menstrual period. They have lessened now (tapered and mostly stopped by end of June 2021). I also have slight balance problems now, that are still ongoing.

SORE ARM; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1205A21A expiry: UNKNOWN) dose was not reported, administered on 12-JUL-2021 10:45 for prophylactic vaccination. No concomitant medications were reported. On 12-JUL-2021, the subject experienced sore arm. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm. This report was non-serious. This case, from the same reporter is linked to 20210728046 and 20210733974.

headache, left side of face was numb, tingling, weak right leg. this was all within a few days of receiving vaccine. I am now 3 months in, and continue with facial numbness on both sides of face, and weakness in right leg. These symptoms come and go, but I have them frequently. I might be a few days between the symptoms, but they always come back.

I noticed aching in my legs and 3 hours later I woke up and it was worse. I also had chills and shaking, a slight headache, and mild nausea. This continued into the next day (March 7, 2021). It was significantly better by mid-afternoon.

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

Patient state she felt light headed and dizziness and "weird". Patient was sitting at the time and I had the patient lay on the ground to prevent any injury in the event she were to pass out. Due to her stating she felt so hot and "bad" 911 was called and dispatched. Upon arrival the patient was seated. and stated she felt weird to the EMS. She stated she did not want to go to the hospital but was unsure if she could stand without passing out. Vaccine was given around 11:40 am and around 11:50 to 11:54am patient started complaining of not feeling well. EMS arrived within 10 minutes of calling 911. Patient stated she did not want to go to the hospital but would go to the ambulance to be evaluated. EMS stated they could exam her in the ambulance and decide from there if she wanted to go to the hospital.

Eight hours after the vaccine, I awoke with moderate chills and tremors. Eleven hours after the vaccine, i awoke with all-over body aches and a mild headache. I slept 3 more hours and woke up with all of the previous symptoms at once. I felt moderate malaise and these symptoms for 24 hours. I had a sore arm for 4 days.

Patient is a 63 y.o. female who received the Janssen COVID Lot#: 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate 15 of observation: "tingling around lips and left arm" Patient was treated/managed as follows: 1120: BP: 162/80 HR:65 RR: 18 O2: 99% 1130: BP: 160/90 HR: 69 RR:18 O2: 98% Pt reports tingling has completely stopped and feels fine. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to door by RN.

6:20pm Chills with uncontrollable shaking, headache, muscle aches. Took 2 ibuprophen. Went to bed. Headache continued. 9:30pm Started having chills again along with headache and muscle aches. Took 2 Tylenol. Fell asleep. Woke around 11:30pm with a pulse of 112bpm (which normally would have been 58bpm) and a headache. Fell asleep. Woke around 6am with a headache. Got up around 11am. Still feel tired.

Janssen COVID-19 Vaccine EUA Based on the paperwork I received at my vaccination, I am reporting my side effects for your records. I received the dose (1805029) on 3/12/2021 (Friday) at 4:30 in the afternoon. At around 10:30 p.m. I began to feel unwell with chills, shaking/tremors of my hands/arms, and overall aches. I had trouble sleeping through the night due to these symptoms in addition to night sweats (fever). These conditions persisted through the next day (Saturday) and evening (24 hours). I managed to sleep 8 hours and had only a headache the following morning (Sunday). I treated my symptoms by taking Tylenol which was helpful. Hope this helps with your research/records.

Approximately an hour and a half after getting the vaccine, I noticed my hands swelling, then my jaws started aching, then they felt like they were swelling, along with my cheeks going down my neck, then I got a great deal of pressure, swelling, in my ear drums. I was speaking with a friend, who is a nurse, and she told me to take a Benedryl, so I ate a 12.5 milligrams children's chewable diphenhydramine. Twenty minutes later I felt normal again. Later that evening I noticed the palms of my hands were very hot. I did not have any fever. That passed the next evening.

About 5 hours after the injection I started feeling funny. About 6 hours after the injection I had severe chills and shaking / spasms that were so severe I couldn't even hold or drink a glass of water. I believe I was running a high fever and was having trouble keeping the thermometer in my mouth because of the spasms but it did get up to 103.4. By morning, my temperature was down to 99.9 and I continued to run a temperature for 48 hours. My normal temperature is 97.2. I also had for fatigue for about 5-6 days but it was minor.

Patient felt light-headed and dizzy 15 minutes after receiving the vaccine. She also felt like her hand was shaking. Her forehead and cheeks appeared to be red and flushed. Her symptoms did not improve, she was evaluated by the ID physician and was transferred to the ER.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient reported to our store 5457 about a vaccine she got at 5434 last monday. She broke out with a rash the thursday after getting the vaccine and after a few days of vaccine she decided to go to urgent care since the \"burning wasn't stopping\" and it spread to her chest. She was discharged with a script of prednisone and the rash seems to be getting a little better. I will follow up with her in 2 days to make sure it has cleared up.

Received shot on 3/11/2021 felt okay, a little tired. 3/12 extremely tired - no energy, 3/13 felt a lot better but had a little sore throat, 3/14 extremely tired sore throat mucus drainage down throat, 3/15 tired no energy, sneezing, dry cough, 3/16 tired no energy sneezing dry cough. Today 3/17 finally feeling better but still a little tired.

March 13, 2021-1:30pm-Shot administered to right arm-it bled and the nurse had to apply pressure with an alcohol swab. It stopped immediately. 1:40-started feeling a tightness in the muscle in my neck under my right ear Stayed a few minutes longer than the required 15 to see if anything else presented. Mentioned it to the nurse and rep. The rep asked if I was nervous about getting the shot. When I said yes, he said it may just be that. Told me to contact my doctor with additional issues. 1:55-When leaving the parking lot, I felt my lips and nostril on the right side go numb-it felt like when Novocain is wearing off after a dentist visit. As the day progressed, the area under my ear and down my neck got more and more sensitive. My lips continued to feel numb. My injection site was tender and black and blue. When I went to bed at 9pm, I began experiencing lots of pain in my right lower jaw. I took a Tylenol but it didn't alleviate the pain. I called on-call doctor. Since I already had taken a Tylenol, he suggested an anti-inflammatory and warm moist compresses and to contact him again if things worsened. 3/14/21-7:00am-Upon awaking, my jaw pain was virtually gone but the whole area I had had the issue with was very tender to the touch. My lip still felt a bit numb. 3:25pm- It is now 26 hours since my vaccination. I still feel like I had trauma to the right side of my face and neck because it is sensitive to the touch. I also have a continued slight sensitivity of my lips on the right side. My glands on both sides of my neck now seem tender, as well. 3/15/21-3/17/21-I continue to have random pain/tenderness in the aforementioned areas. I also have an aura of tingling in my brain from time to time.

Pain at injection site persisted for ~1 hr; 3 hrs. post vaccine -> mild headache; 6 hrs. post vaccine -> serious migraine with myalgia focused on neck and upper back and chest muscles (muscle knots developed and could be felt) -> slight fever (0.6 degrees F above normal); 7 hrs post-vaccine -> serious chills that shook entire body and would not stop for 30 minutes (similar to the kind I had when I had hypothermia at age 18); 8 hrs post-vaccine -> nausea; I took tylenol then and within 45 minutes everything except headache, myalgia and muscle knots, and nausea went away. Vomited in middle of the night. Felt very drained and tired with myalgia all of the next two days. Majority of symptoms went away after that but I felt as if I was coming down with a cold for the next 7 days - today my nose has been running all day and I have a stuffed head (and I have not had a cold since November 2019). I had a covid test yesterday because I need to accompany my husband for a medical procedure on Friday - that was negative. I have seen no one, gone nowhere, and done nothing different since I received my vaccine than I had beforehand yet I am displaying symptoms normally associated with a cold although I have no fever.

chills for approximately 12 hours, thru the night; back muscular pain for same amount of time. weak.

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.

Just walked in the house from work. Sudden total numbness of left arm. Had hard time speaking, words were slow coming out and were slurred. After about 10 minutes the numbness gave way to weakness. The speech was improving but slurred slightly for another 20 minutes. Checked out by emt's and paramedics, then husband drove me to hospital.

Patient came in to the pharmacy complaining of dizziness and weakness. She was having trouble standing up from seated position and walking in a straight line. Her husband was going to take her to the emergency room after leaving here. I had her smile and it was even. She said that she was ok the day before, but developed these symptoms 2 days after vaccination.

Patient came in complaining that she was having weakness and dizziness. She was having trouble standing up from seated position. She was also having trouble walking in a straight line. Her husband was with her and drove her to the ER after leaving the pharmacy.

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.

Received the J+J Janssen vaccine on Sunday 3/14/21. On Friday 3/19/21 developed bilateral lower leg discomfort and red spots on outer part of shin. On Sunday 3/21/21 noted increase in swelling both feet and lower legs with pain and rash waist down. Patient went to ER for evaluation. Started on prednisone. Dx: Vasculitis On Monday 3/22/21 evaluated by PCP. Follow up blood work and office appointment in 8 to 10 days. Report to VEARS. Awaiting patient call back to complete form. On Wednesday 3/24/21 patient returned call. Reports joint aches, right side decreased swelling, left foot and hand remains slightly swollen. Purple skin discoloration remains on lower extremities but decreased pain. VEARS form submitted.

The shot made my arm very sore for about an hour. When I went to sleep that night, I experienced feeling chilled all night long. It ended by morning. I had one bought of mild diahrea the next morning. Then all was fine.

I exp shaking and headache lasted few hours . I went to the doctor on 3/17 had a UTI(which is not normal for me).

On 3-22 11 days after vaccination), patient presented with lower extremity weakness and uper extremity paresthesias

Slight soreness in right arm. Headache (which lasted 2 days), nausea, muscles aches, fatigue (which lasted 12 hours or so).

severe headache. both inner ears ached. trembling - could not get warm. entire body ached - even my fingers

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

Pain injection site since day of vaccination, still have pain. Slight fever and chills, body aches, fatigue for 12 hours.

At 3 am when I woke to urinate, I was very loopy in the head as if I had not slept at all for 24 hours. Kind of dizzy feeling. The next morning I was very tired. As time progressed, I felt like I HAD to be horizontal. No energy at all. No appetite at all. Took my temperature and was shocked to see it at 101.4º. Pharmacist suggested I take aspirin, which I took one, and then another one several hours later. It did help and reduced the fever to 99º. The following day the temperature remained at 99º but under 100º. (I never took any other aspirin other than the two that I mentioned). The third day I was good to go!

next day felt very tired, was fine 2 days until Monday-Wed got headache-pressure in head, felt woozy, stomach was queasy, very low energy, croupy cough, nose runny, no stamina for long walks Was ok 2 days and then it started again off and on till 3/31. Sometimes stomach felt sick, couldn't eat much. Finally feeling better in stomach but still getting headaches. Still have little stamina and very low energy and headaches make it hard to think, runny nose, croupy cough comes and goes. Teleconference with Dr. on 3/23/2021 Saw family Dr. 4/2/2021. Saw no urgent needs, just noted side effects

Severe headache, chills and fever, muscles aches, muscle spasms. Headache, chills and fever lasted until about 5am 4/2/2021. Muscle spasms lasted until about noon on 4/2/2021 and muscle aches lasted until about 7am 4/3/2021. Took Tylenol which didn't affect symptoms until the second dose.

2 days post vaccine, woke up with a rash to bilateral palms and arms that stop at the shoulder. small maculopap bumbsular from palms to shoulder, skin is sensitive to hot and cold, rash is "itchy and painful," denies skin peeling, took zytrtec with no relief, also complains of low energy/fatigue, appetite is ok, denies fever, approximately 12 hours later noticed rash to abdominal region, same maculopapular bumbs across bilateral upper abdoment, denies shortness of breath

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

Shortly after the vaccine my tongue begin feeling really thick and furry. Moments later my lips began tingling causing me to seek medical attention. My body got really shaky and I got really anxious but after about 45 minutes my body returned back to its normal state. Later that day and up into that Saturday I was very fatigued, nauseous and the body aches were severe.

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.

Janssen COVID-19 Vaccine EUA: 18 hours after getting the vaccine i began to feel dizzy, then got chills and body aches. There was no fever. Very uncomfortable though shivering under blankets in 72 degree weather. I expect the symptoms to lessen, have taken tylenol at 7:30pm and feel a little better now.

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.

Head pounding My entire body muscles felt like I had been beat up. Blankets were difficult move stretching/ spasms were strong and long. Took two pain killers my low back felt so bad I wasn?t sure if I could walk to bed. Rough night still have a bad headache low back ~ hips hurts to bend over.

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.

That evening about 11:00 pm I became extremely cold, teeth chattering , complete body ache , nauseated and had a slight headache. The next morning about 6:30am I had a major headache I can only describe as a migraine times 10. All day and all night. Did not go away at all . The next day it was very very slight and by the evening the headache was gone.

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

last night had leg cramps and then all over body pain that lasted for about an hour. took a shower and the spray stung but eventually pain stopped husband doesnt care and would not take to dr

very sore upper arm for about 1/2 hour after 5 hours quickly increasing fever and uncontrolable shivers for 1 hour after 8 hours fever topped at 101.7 continueing nausia and fatigue the next day with low fever and low appetite continuing nausia and fatigue the third day tinitus the third night lingering fatigue and low appetite the forth day (today)

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).

Immediate moderate pain at injection site. 6 hours post injection: severe body aches, chills, tremors, weakness lasting 36 hours. Generalized fatigue and weakness continuing for 4 days.

Developed right facial droop in the hospital, lead to a new diagnosis of Bell's Palsy (MRI no evidence for stroke, CT no acute abnormality) She has Johnson and Johnson Vaccine and she is currently hospitalized after a fall at home

Johnson-Johnson COVID-19 Vaccine EUA-- on 3/31/21 client presented at clinic 0750 for vaccine, completed paperwork and COVID vaccine administered by guardsman and given time she may leave. She stayed longer due to questions and her sister getting vaccine also. I had to call PCP for sister to get vaccine due to medical issues. I could not get through to PCP informed her I would call her. I called to tell them they would need to call her sister's PCP At about 0846 she stated she was not feeling well. Stated she thinks her right side may be numb-tingling and right side of face. Informed her to go to ER if she thought she was having an allergic reaction or call 911. She stated she was in ER parking lot now. Stated her PCP wanted her to have this vaccine and she is allergic to Epinephrine, informed her to tell ER what she just told me and that she had received the COVID vaccine. At 3:00 PM client called and asked if predisone she got in ER would elevate her BP. She stated ER papers say paresthesia of skin, TIA vs allergic reaction to vaccine, work up TIA symptoms and sent home to follow up with PCP.

SORE ARM; JOINT MUSCLE ACHE; HEADACHE; NAUSEA; DIARRHEA; DIZZINESS; 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at 10:10 in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 10:25, the subject experienced dizziness. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced joint muscle ache. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: bismuth subsalicylate/calcium carbonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 07-APR-2021, and had not recovered from headache, joint muscle ache, nausea, dizziness, and sore arm. This report was non-serious.

Received the shot at 11 am and had felt fine all day. Arm was sore a vaccine site but that's it Then around 10 pm I started to get chills. Within 10 minutes of this I felt violently ill. The chills amd shaking were intense. I began vometing and had severe intestinal issues. This attack came on fierce and lasted until 4 am. I was sweating and shaking at the same time and for at lease 6 hours. My body felt tired and drained. I never expected to be so sick. The following day my symptons had began to go away for the most part, headache and feeling drained continued for a few more hours.

Dizziness, weakness, digestive system issues, loose stools, active bowels actively with gas. 5 minutes after injection I noted pain below both of my ears and visual disturbances. Nausea with the taste of bile in my mouth

Hello, I received my J&J vaccine on 3/31/2021. 11:00a.m. Here is my results: 3/31/21 Day1: Waited 30 mins at site due to the history of Penicillin and Sulfa issues in the past. I had a little itching at the shot site. That went away in about 15 mins. Late afternoon I had a slight headache. 4/1/21 Day 2: Morning was normal. Afternoon I started feeling a little sluggish. I had a little headache. 4/2/21 Day 3: Morning was slow. I noticed that I was tired. Headache was stronger. I took Ibuprofen 400mg. By mid day, I was on the couch the rest of the day. My body was telling me to rest. So I did.

Severe headache unable to go to work for one day Still not up to my normal abilities two weeks later. More fatigue than usual. Right and left leg pain and right arm pain. Possible DVT but not tested have had in the past so feels that way

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.

BAD PAIN ON RIGHT SIDE (TOWARDS THE BACK); SWOLLEN NOSTRILS (INSIDE); Shaking; HARD TO WALK; Fever; Nausea; Chills; JOINT PAIN (KNEES, ELBOWS, SHOULDERS, HIPS, FINGERS, ANKLES); HEADACHE THAT FELT LIKE A SLEDGE HAMMER; SORENESS AT INJECTION SITE; EXTREME THIRST; Loss of taste; LOSS OF APPETITE; SWOLLEN HANDS; Runny nose; EYES CRUST AROUND THE EDGES; 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 covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced extreme thirst. On 03-APR-2021, the subject experienced loss of taste. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced swollen hands. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced eyes crust around the edges. On 03-APR-2021, the subject experienced joint pain (knees, elbows, shoulders, hips, fingers, ankles). On 03-APR-2021, the subject experienced headache that felt like a sledge hammer. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021 22:00, the subject experienced shaking. On 03-APR-2021 22:00, the subject experienced hard to walk. On 03-APR-2021 22:00, the subject experienced chills. On 03-APR-2021 22:00, the subject experienced fever. On 03-APR-2021 22:00, the subject experienced nausea. On 05-APR-2021, the subject experienced swollen nostrils (inside). On 05-APR-2021 14:00, the subject experienced bad pain on right side (towards the back). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 05-APR-2021, and bad pain on right side (towards the back) on 05-APR-2021 21:00, was recovering from hard to walk, joint pain (knees, elbows, shoulders, hips, fingers, ankles), and swollen hands, had not recovered from swollen nostrils (inside), and the outcome of shaking, chills, fever, nausea, extreme thirst, loss of taste, loss of appetite, headache that felt like a sledge hammer, soreness at injection site and eyes crust around the edges was not reported. This report was non-serious.

BLURRED VISION, HEADACHE, CHILLES, SEVERE PAIN IN RIGHT ARM, SHOULDER AND BACK FOR DAYS. STILL HAVING BLURRED VISION AND LITTLE HEADACHES

Patient states that on 4-10-21 she developed a severe pain in her right knee. Patient states that the pain radiates from her thigh to her knee and sometimes down her leg. Feels a tightness in her leg and knee, No noted swelling of discoloration of the area.

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.

Woke up with black eye that began in corner of left eye and progressed down to middle of lower lid, later that day I had sudden onset of throbbing pain on left side of upper gum and cheek area. The pain in mouth would come and go and responded to heat pack and extra strength Tylenol. I also had a headache on the left side of my head. The black eye went away in about three days. The mouth pain went on off and on for about 7 days gradually subsiding in intensity over that time frame. The headache only lasted for a few days. I also felt some pressure behind my left eye.

My symptoms started 03-18-2021 at 11am where I developed chills, was very sleepy that I slept 15 hours straight. I felt very fatigued and my eyes hurt so much and I could not keep them open. On 04-06-2021 I still was not feeling well. I started to have problems with my right side of my face, eyes and mouth which gradually got worse so I went to the hospital. At the hospital they checked me for stroke, performed lab work, did MRI and CT scans and the the doctors came back and said it was Bell's palsy. I again went to the hospital 04-11-2021 but this time due to GI issues with pain. On 04-14-2021 through 04-15-2021, I started to experience neck pain behind my right ear. At the hospital they had prescribed my prednisone 50mg, so I took half for my pain. I still have trouble sleeping and have lots of pain.

TASTE OF MEDAL IN MOUTH AT TIME OF VACCINE FELT FLUID OF SHOT ENTERING MY ARM CHILLS FOR 6 HOURS , NO FEVER NUERLOGICAL SENSAATION IN MY ARMS AND FINGER TIPS THAT CONTINUE SINCE THE VACCINE WAS GIVEN THAT COMES AND GOES. iTS AN ANORING SENSATION MORE THEN PAINFUL.

Headaches, blurry vision right after she took the vaccine. She has history of migraines but these headaches and blurry vision are more frequently occuring.

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

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.

Extreme soreness in right breast and throughout by entire body. Vomited after my shower and felt sick but this only lasted about an hour and a half. After that, I was wore out, which last a few days. Nothing serious other than the vomiting was tough.

Starting on about 3/15/21 I started ?getting very uncomfortable pain in my calf on both legs and it lasted 2 weeks. . I do walk 4-5 5 days a week and never experienced this feeling prior. I put heat on my legs massaged the and also used a rolling pin. I never called my dr did not think of it. Just though it was cramping but blood clots did enter my mind but I thought can?t be I am so active.

RAISED AROUND THE INJECTION; WARM TO TOUCH AROUND THE INJECTION; HURTS TO LIFT LEFT ARM; LEFT ARM SORENESS; REDNESS AT THE INJECTION SITE; 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 hypothyroidism, high cholesterol, outside weeds allergy, eczema, and hives. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 19-JUL-2021) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for thrombolytic event. On 28-DEC-2020, Laboratory data included: Coronavirus test (NR: not provided) Positive. On 08-APR-2021, the subject experienced raised around the injection. On 08-APR-2021, the subject experienced warm to touch around the injection. On 08-APR-2021, the subject experienced hurts to lift left arm. On 08-APR-2021, the subject experienced left arm soreness. On 08-APR-2021, the subject experienced redness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at the injection site, raised around the injection, warm to touch around the injection, left arm soreness, and hurts to lift left arm. This report was non-serious.

Patient advises that she has been experiencing lower back pain, leg painful and swelling on her right foot, a fogginess that "feels like I'm on a conveyor belt", depression, diarrhea and fatigue since receiving the vaccine. Patient also advises that she used to be able to walk her dogs 4 miles a day and now can barely walk them 20 min. Patient also states that the foot that is painful is also a blueish gray in color.

4 1/2 hours of severe body tremors and spasms, accompanied by chills. Followed by severe migraine, bodyaches and fever. Vomiting and diarrhea began approximately 9:00 AM on April 2, and lasted six hours. Extreme exhaustion and weakness continued until approximately 12 o?clock noon on April 3.

I received the vaccine on a Saturday evening and by Sunday morning, I was sick as a dog with flu like symptoms - massive headache, terrible backache (like someone kicked me in the back), chills and fever. Sunday evening in the middle of the night, in bed, I was shaking so badly from chills that I was afraid to get up to get Tylenol. I finally did and I couldn't even focus my eyesight and control my hands as I went to open the bottle of pills that my hands were shaking so badly that I spilled them all over the place. Finally I woke my husband who heated up blankets in the dryer and brought me hot tea. My husband helped me to the bathroom where I vomited. I cannot remember when I was so sick. I missed work that day at my part-time job and the next day at my full time job as a teacher.

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

72 hours later I was hit hard with severe chills, extreme nausea, some vomiting (foam) and diarrhea. Day after vaccine, I had mild symptoms - woke up with mild chills and was very tired - slept most of the day. Following night I had the worst night sweats ever - woke up drenched.

SOME AUTOIMMUNE EFFECTS; Tooth pain; Night sweats; STOMACH BURNING SENSATION; DIFFICULTY SWALLOWING; PRESSURE CHOKING; VERTIGO; Facial pain; SUSPECTED PRODUCT CONTAMINATION; FEVER BLISTER; Foggy feeling in head; DIARRHEA; SEVERE STOMACH CRAMPS; SINUS INFLAMMATION; Sensation of pressure in ear; Injection site lump; CHILLS; FELT ILL; INJECTION SITE PAIN; FATIGUE; This spontaneous report received from a patient. 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 expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, upon vaccination the patient woke up and experienced sinus inflammation, sensation of pressure in ear. On 05-MAR-2021, the patient experienced injection site lump. On 05-MAR-2021, the patient experienced chills, felt ill, injection site pain and fatigue. On 11-MAR-2021, the patient experienced severe stomach cramps and diarrhea. On 22-MAR-2021, the patient experienced foggy feeling in head. On 23-MAR-2021, the patient "believes the vaccine is contaminated", fever blister and facial pain. On 24-MAR-2021, the patient experienced vertigo. On 28-MAR-2021, the patient experienced pressure choking and difficulty swallowing. The patient visited 2 clinics and an ear, nose and throat (ENT) specialist but they were unable to diagnose and they felt there was some autoimmune effects (onset date unspecified). The patient suspected that the vaccine was contaminated based on the news report. On 02-APR-2021, the patient experienced stomach burning sensation. On 04-APR-2021, the patient experienced night sweats. On 05-APR-2021, the patient experienced tooth pain. The patient has been visited two clinic Treatment medications (dates unspecified) included: famotidine for 14 days for pressure choking and difficulty swallowing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach cramps, vertigo on 28-MAR-2021, night sweats on 06-APR-2021, stomach burning sensation on 05-APR-2021, and injection site lump, and injection site pain on 16-MAR-2021, had not recovered from felt ill, sinus inflammation, chills, fatigue, sensation of pressure in ear, tooth pain, foggy feeling in head, pressure choking, and difficulty swallowing, and the outcome of diarrhea, fever blister, facial pain, some autoimmune effects and suspected product contamination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0 This report involves a patient who experienced sinus inflammation, sensation of pressure in ear, injection site lump, chills, felt ill, injection site pain and fatigue next day after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination. Approximately a week later, the patient experienced stomach cramps and diarrhea and 1.5 weeks later she had foggy feeling in head and "believes the vaccine is contaminated", had fever blister, facial pain and vertigo. Approximately 3.5 weeks after being vaccinated the patient experienced pressure choking and difficulty swallowing. A throat (ENT) specialist was unable to diagnose and they felt there was some autoimmune effects. A month after being vaccinated the patient experienced stomach burning sensation, night sweats and tooth pain. Given the close temporal relationship and the nature of the events, the events of sinus inflammation, sensation of pressure in ear, injection site lump, chills, felt ill, injection site pain and fatigue are considered related to the vaccination. The insufficient information precludes a meaningful medical assessment of the remaining events, including "autoimmune effects". The events will be assessed further when additional information is received.

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

24 hours after the vaccine I developed a sharp pain on the inside of my left knee, slightly above the knee cap. There was a soft bump in that area. At work the next day I felt more sharp pains and bumps developing around my knees on both legs. The backs of my thighs were also beginning to burn. I contacted the hotline set up at my work for adverse reactions when I got home from work that night. They were concerned and had me call my doctor. My work is onboard an aircraft and she did not want me to fly again without an ultrasound. I had an ultrasound perform on my left leg and the thigh of my right leg. It was normal. Over the next week I would get stinging , painful bumps and used NSAIDS to help. Approximately six days after the shot the burning sensation on my thighs got worst. It spread for the back of my thighs to the front and then to the calves, arms and shoulders in that order, I started taking Benadryl to release the burning. I went to my doctor who sent me for another ultrasound and blood up. Three weeks after the injection the painful stinging bumps are still happening and the burning is on my legs, arms and shoulders. I am going back to the doctor today and talk about prescribing Gabapentin.

On 4/20/2021 around 1 pm patient called the pharmacy and reported intermittent symptoms of severe headache, a feeling of tingling and pinching, and nausea. She stated the last symptom of HA 4 days before her call. She was instructed by the pharmacist to promptly call her primary care provider to report symptoms and receive instructions.

Severe headache on the left side of my head. Unable to turn my head to the left or to the right. Crackling sound when I move my head. On this day, April 22, my neck movement has improved, I still have a headache and I can still hear my head crack when I move my head to the left or right. and when I look up or down.

HEADACHES/PAIN AT THE BACK OF THE HEAD AND BASE OF THE SKULL 3 EPISODES; MILD NAUSEA EXPERIENCED IT 4 TIMES LAST WEEK AND LAST NIGHT; INCREASED SALIVA/MEDIUM AMOUNT OCCURS DURING NAUSEA EPISODE ONLY; SWEATINESS OCCURRED ONLY AT NIGHT, STATED THAT SHE WOKE UP WITH A WET T-SHIRT IN A COLD SWEAT; CHILLS OCCURRED ONLY AT NIGHT AT THE SAME TIME AS THE FEVER; RIGHT ARM SORENESS; FEVER/FELT HOT; 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 blood clot in leg, and concurrent conditions included hypertension, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included diazepam, and fluoxetine hydrochloride. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6/10. On 01-APR-2021, the subject experienced increased saliva/medium amount occurs during nausea episode only. On 01-APR-2021, the subject experienced sweatiness occurred only at night, stated that she woke up with a wet t-shirt in a cold sweat. On 01-APR-2021, the subject experienced chills occurred only at night at the same time as the fever. On 01-APR-2021, the subject experienced right arm soreness. On 01-APR-2021, the subject experienced fever/felt hot. On 01-APR-2021, the subject experienced mild nausea experienced it 4 times last week and last night. On 03-APR-2021, the subject experienced headaches/pain at the back of the head and base of the skull 3 episodes. Laboratory data included: Pain scale (NR: not provided) 8/10. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweatiness occurred only at night, stated that she woke up with a wet t-shirt in a cold sweat, chills occurred only at night at the same time as the fever, right arm soreness, and fever/felt hot on 03-APR-2021, had not recovered from mild nausea experienced it 4 times last week and last night, and increased saliva/medium amount occurs during nausea episode only, and the outcome of headaches/pain at the back of the head and base of the skull 3 episodes was not reported. This report was non-serious.

FATIGUE; FELT HORRIBLE; SKIN BURNING AND HURTS TO TOUCH/SKIN ON FIRE/PAINFUL SKIN; NAUSEA; CHILLS; DIARRHEA; VOMITTING; LEG HEAVINESS; LEG PAIN/INTERMITTENT PAIN IN HIPS, BACK, DOWN TO MY KNEES; 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 past medical history included covid infection, double lung pneumonia, leg pain, and leg heaviness, and concurrent conditions included arthritis, and fatigue, and other pre-existing medical conditions included patient second shingles shot begins in february. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced leg heaviness. On 2021, the subject experienced leg pain/intermittent pain in hips, back, down to my knees. On 2021, the subject experienced weakness. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced vomitting. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021 16:00, the subject experienced nausea. On 19-MAR-2021 23:00, the subject experienced skin burning and hurts to touch/skin on fire/painful skin. On 20-MAR-2021, the subject experienced felt horrible. On 25-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No clots found. On an unspecified date, the subject experienced fatigue. Treatment medications (dates unspecified) included: calcium chloride dihydrate/fructooligosaccharides/glucose/magnesium chloride hexahydrate/potassium chloride/sodium chloride/sodium lactate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomitting, and nausea on 20-MAR-2021, was recovering from diarrhea, had not recovered from chills, skin burning and hurts to touch/skin on fire/painful skin, leg pain/intermittent pain in hips, back, down to my knees, weakness, fatigue, and leg heaviness, and the outcome of felt horrible 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.

leg pain, used ice pack x >12 hours, when removed had rash, patient, went to ED on 4/12/2021 and diagnosed with shingles

SWELLING RIGHT UPPER ARM; CHILLS; PAIN IN RIGHT AND LEFT LOWER LEGS KNEE TO ANKLES/PAIN IN RIGHT UPPER ARM; HEADACHES; EXTREME FATIGUE; SWEATING; LOSS OF APPETITE; BRAIN FOG; SEVERE STOMACH PAIN; DIARRHEA; COUGH; 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 borderline diabetes, without medication, abstains from alcohol, and cigarette smoker, 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, intramuscular, batch number: Unknown) 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 JUN-2020, Laboratory data included: PCR (NR: not provided) NEGATIVE. On 02-APR-2021, the subject experienced cough. On 05-APR-2021, the subject experienced sweating. On 05-APR-2021, the subject experienced loss of appetite. On 05-APR-2021, the subject experienced brain fog. On 05-APR-2021, the subject experienced severe stomach pain. On 05-APR-2021, the subject experienced diarrhea. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced pain in right and left lower legs knee to ankles/pain in right upper arm. On 05-APR-2021, the subject experienced headaches. On 05-APR-2021, the subject experienced extreme fatigue. On 07-APR-2021, the subject experienced swelling right upper arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach pain, and diarrhea on 05-APR-2021, had not recovered from cough, headaches, sweating, pain in right and left lower legs knee to ankles/pain in right upper arm, extreme fatigue, loss of appetite, brain fog, and swelling right upper arm, and the outcome of chills was not reported. This report was non-serious.

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.

LACRIMATION; MUSCLE CRAMPS; JOINT ACHES; CHILLS; FEVER; HEADACHE; TIREDNESS AND 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 not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced joint aches. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced fever. On 23-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced tiredness and fatigue. On 24-MAR-2021, the subject experienced lacrimation. On 24-MAR-2021, the subject experienced muscle cramps. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.6 F, 100.6 F. Treatment medications (dates unspecified) included: magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps, and headache on 24-MAR-2021, was recovering from fever, and chills, and had not recovered from joint aches, tiredness and fatigue, and lacrimation. This report was non-serious.

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.

SORE ARM; UNEXPECTED BENEFICIAL THERAPEUTIC RESPONSE; 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 left shoulder injury- a "spider fracture" of the "proximal humerus", and muscular pain.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, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced sore arm. On 16-MAR-2021, the subject experienced unexpected beneficial therapeutic response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and the outcome of unexpected beneficial therapeutic response was not reported. This report was non-serious.

I got sick twice. On 03/24/2021 and 04/25/2021. I got sick the day I took the J & J vaccine on March 24th with 104.1* fever, chills, headache, body aches and weakness. I was sick the entire day on the 25th and came out of it on the 26th. I got sick again on April 26th with fever and weakness 100.8*. It started around 11:45 PM. I was sick the entire day on the 26th and came out of it on the 27th.

From patient to after hours provider with c/o head and leg pain after Johnson & Johnson CVD19 vaccine. She states symptoms started 24 hours after vaccine and has not resolved. Patient advised to proceed to the nearest ER for evaluation for potential side effect due to J&J vaccine. Patient states understanding.

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.

LEGS FEELING COLD; BLOOD SUGAR LOWER THAN NORMAL; SHOULDER HEAVINESS; BACK PAIN; ARM PAIN AT INJECTION SITE; TIREDNESS; SLEEPINESS; 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 type 2 diabetes., hypertension, and non smoker, and other pre-existing medical conditions included patient do not smoke. patient has type 2 diabetes for approximately 17 years. patient also has hypertension. The patient received metformin non-company (prolonged-release tablet, route of admin not reported, batch number: Unk) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported and has been requested. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine, atorvastatin, glipizide, hydrochlorothiazide/triamterene, insulin glargine, losartan, and sitagliptin. On FEB-2021, Laboratory data included: Blood test (NR: not provided) Results not specified. On 06-MAR-2021, the subject experienced tiredness. On 06-MAR-2021, the subject experienced sleepiness. On 10-MAR-2021, the subject experienced arm pain at injection site. On 11-MAR-2021, the subject experienced blood sugar lower than normal. On 11-MAR-2021, the subject experienced shoulder heaviness. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021 17:44, Laboratory data included: Blood glucose (NR: not provided) 97 (unit not specified). On 12-MAR-2021, the subject experienced legs feeling cold. On 12-MAR-2021 06:00, Laboratory data included: Blood glucose (NR: not provided) 166 (unit not specified). On 12-MAR-2021 16:00, Laboratory data included: Blood glucose (NR: not provided) 79 (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with metformin non-company was not reported. The patient recovered from legs feeling cold on 12-MAR-2021, was recovering from arm pain at injection site, shoulder heaviness, and back pain, and had not recovered from blood sugar lower than normal, tiredness, and sleepiness. This report was non-serious.

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.

COLD-LIKE SYMPTOMS; COUGH; RIGHT ARM PAIN AT THE INJECTION SITE; FEVER; FATIGUE; HEADACHES; LEFT FOOT NUMBNESS/ NUMBNESS UP TO THE LEFT KNEE; 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 attention deficit disorder, back pain, cigarette smoker, and cough, 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced left foot numbness/ numbness up to the left knee. On 25-MAR-2021, the subject experienced cold-like symptoms. On 25-MAR-2021, the subject experienced cough. On 25-MAR-2021, the subject experienced right arm pain at the injection site. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 2021, had not recovered from right arm pain at the injection site, cold-like symptoms, cough, fatigue, and headaches, and the outcome of left foot numbness/ numbness up to the left knee was not reported. This report was non-serious.

Fatigue and malaise within 3 hours; chills, nausea and vomiting after 11 hours; headache, muscle aches, weakness and nausea/vomiting for 24 hours after the vaccine.

Itching that was like pinpricks all over the body, including the ankle, face, legs, and nose in particular. (No itching at the injection site.) Developed a rash on face. These all developed within 15 minutes of receiving the vaccine. Took a benadryl to be safe shortly afterwards. Itching lasted for approximately 2 days. The rash is still about the same. There was also swelling at the injection site, plus a rash that developed at the site about a day later. Other symptoms, such as fatigue, tiredness, and achiness, seem to be more typical outcomes. Also developed a swollen lymph node under the arm that received an injection. This occurred two days afterwards.

The first symptom was the swollen lymph nodes in neck - that lasted a day and a half. About a week ago, same thing - swollen lymph nodes in my neck (or throat area) - that lasted about a day and a half also. Two and 1/2 weeks later, when I developed the swelling and pain in my paratoid gland in my left jaw. Severe swelling - could barely open my mouth. So I saw DR, on the 19th of March. She prescribed a Z-pak antibiotic and the swelling took about a good week to two weeks and maybe a little longer for the swelling and everything to go away. I was on antibiotic for seven days. Since then I have had no other problems.

NAUSEA; FEVER; SLIGHT ARM PAIN; 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: 180890 expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 99.8. On 02-MAY-2021, the subject experienced slight arm pain. On 04-MAY-2021, the subject experienced nausea. On 04-MAY-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight arm pain on 02-MAY-2021, and had not recovered from nausea, and fever. This report was 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.

Pain in right arm and shoulder. Sometimes it radiates down arm into the elbow and wrist. It is not consistent. Sometimes it is very light, and other times it is very severe. I have also had a great deal of weakness in the right arm since the vaccination.

after her vaccination on 4/2/21, she was tired on 4/5/21. on 4/11, she was achy, had HA, sens to light, stomach, backache, nauseous, bilat sciatic pain, temp up to 102, fatigued, oxygen sat 92%. she had visual hallucinations. she went to ER on 4/15/21.

STUFFED NOSE; FELT TO LAY DOWN AND SLEEP; ARM SORENESS; HEADACHE; FELT VERY FATIGUED; 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 allergies, tachycardia issues, gi issues, esophageal issues, post nasal drip issues, nausea, gerd, acid reflux, and seasonal allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced stuffed nose. On 10-MAY-2021, the subject experienced felt to lay down and sleep. On 10-MAY-2021, the subject experienced arm soreness. On 10-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced felt very fatigued. Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) Abnormal, ECG (NR: not provided) Clear-Normal, and Vaginal biopsy (NR: not provided) Clear. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from arm soreness, headache, felt very fatigued, and stuffed nose, and the outcome of felt to lay down and sleep was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.

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

I experienced usual side effects, fever and chills but the entire reason is that I have swelling and edema in both feet and ankles enough so to concern doctors. I went to clinic on 03-26-2021 for evaluation. They put me on 3 day steroids. I went back to First med which they put me on a 6 day course of medication of steroids. I then went to my podiatrist, of my right ankle, I was scanned for blood clots but no blood clots were found. My exams only identify swelling and edema. I can only take NSAID'S. I have to get up wait a few hours to move. My ankle swelling and edema nerve decreases and my feet hurt so bad when I apply pressure. I had an MRI done as well and I am very upset that they cant find why I can not walk without pain and swelling. My doctors at this point do not what to do for me and I would like some answers. To this day, I am still having swelling and edema to both of my feet and ankles.

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.

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.

5 days after injection developed right sided face and lip numbness, tingling, burning, swelling. Diagnosis: Bells Palsy

ITCH IN LEGS AND ARM; LITTLE POLKA DOTS /FLUID-FILLED BLISTERS (RASH ON ARMS AND LEGS AND LITTLE BIT ON STOMACH); SHARP PAINS FROM SHOULDER TO THE ELBOW/ SORE ARM; SHARP PAIN DOWN TO WRIST/JOINT PAIN; FLUID LEAKING; 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 supraventricular tachycardia, low blood pressure, and osteoporosis, and other pre-existing medical conditions included the patient had taken a natural hormone medication from a compounding pharmacy and also osteonutrients and unspecified medication for osteoporosis. The patient experienced drug allergy when treated with cyclobenzaprine hydrochloride, and tetanus vaccine for drug used for unknown indication, drug allergy when treated with clarithromycin, diazepam, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 08:55 for prophylactic vaccination. Concomitant medications included atenolol for supraventricular tachycardia. On 13-MAY-2021, the subject experienced fluid leaking. On 13-MAY-2021, the subject experienced sharp pains from shoulder to the elbow/ sore arm. On 13-MAY-2021, the subject experienced sharp pain down to wrist/joint pain. On 14-MAY-2021, the subject experienced itch in legs and arm. On 14-MAY-2021, the subject experienced little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach). Treatment medications (dates unspecified) included: calamine/glycerol/zinc oxide, ibuprofen, charcoal, activated, triamcinolone acetonide, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from sharp pain down to wrist/joint pain on 14-MAY-2021, had not recovered from little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach), and itch in legs and arm, and the outcome of fluid leaking and sharp pains from shoulder to the elbow/ sore arm was not reported. This report was non-serious.

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

As the lady jabbed me and started putting the vaccine in my arm, it started burning. It hurt so bad that I wanted to scream. I felt lightheaded and needed to sit for awhile after the shot. The next night I started getting pain in my right arm and I couldn't move it. My nerve endings in my arm, shoulder, and clavicle felt like they were on fire. The lymph nodes under my right arm and neck were swollen. I had three swollen lymph nodes in my neck, but one went down, and I still have two swollen nodes in my neck. My quality of life has suffered because the pain in my arm is so bad.

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

I had a case of shingles. Started with rear upper thigh leg pain. It turned into a right side rash and moved all the way up to my rear - mainly the back side of my leg. It was very severe and painful. The doctor gave me Valtrex (Valacyclovir tablets), Tylenol, and Methylprednisolone. I had some relief after a week, but the rash started to scab up.

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

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

FELT WOBBLY; MILDLY SORE ARM; TEARY FOR NO REASON OR SOBBING (OVER EVERYTHING SEVERAL TIMES A DAY); EVERYTHING HURT HER FEELING; 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 doesn't metabolize alcohol, and menopause, and other pre-existing medical conditions included patient had nothing wrong and had no ongoing medical issues, patient was not on medication of any kind and had not taken any medication after shot. the patient had pms (premenstrual syndrome) (wanted to cry over everything, no anger though). 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 09-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced teary for no reason or sobbing (over everything several times a day). On MAY-2021, the subject experienced everything hurt her feeling. On 09-MAY-2021, the subject experienced felt wobbly. On 09-MAY-2021, the subject experienced mildly sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teary for no reason or sobbing (over everything several times a day), everything hurt her feeling, and mildly sore arm on MAY-2021, and had not recovered from felt wobbly. This report was non-serious.

Began my yearly physical two days after the vaccine, as did my husband. Both of our urine tests showed blood in our urine. Had a second urine test a month later. Still had blood in urine. Also had 3 weeks of diarrhea. That was followed by a vaginal yeast infection. Given a prescription to clear that up. Then my breasts became swollen and painful. It has been ten weeks since the vaccination. Saw a urologist this week there is still blood in my urine. The amount of blood has decreased, but still showing up.

Patient complained of burning sensation immediately after receiving vaccine and progressively worsening arm pain over the course of a few day after vaccine administration. Patient states arm pain did not resolve and was seen at provider's office 6/17/21 stating she has decreased range of motion to left arm and continues with left deltoid pain. X-ray of left shoulder and humerus were ordered along with physical therapy.

I had a really severe sore throat; I lost my voice for awhile. Water on my ears and 101 degree temperature. Runny nose really bad. There was drainage down my throat from runny nose. Feeling really weak and tired. Really deep down in my lungs cough. I was sick for about five days and then went to Urgent Care; Cough medicine and Z-Pak Antibiotic that helped with all except the water in my ears. That hasn't gone away yet so my hearing is a little off. The cough lasted for about two and 1/2 weeks but is gone now. I cough every once in a while, but not bad. I may go back to the Urgent care for my ears.

After the vaccine, I was just tired and a little soreness in arm but not much. Shingles - painful soreness in my upper buttocks/hip area and I felt a bit of bruising when I did my walk - when I looked at it - it looked like a belt and was red. It had a mild case of shingles because I had a Shingles vaccine in May 6th. I took a phone of the shingles and sent it to my doctor and she prescribed an anti-viral medication and I took that through yesterday. That helped to resolve it. It's just now a kind of a dry patchy area.

The night of the vaccine I got hives on my chest which lasted for an hour. The first week after the vaccine I had severe flu like symptoms of fever, nausea and sweats for six days. The next week on 04/15/2021 I started to get pain over my left eyebrow and my Diverticulitis was flared up. My doctor sent me to get the headache checked out because it was very painful. The headaches were there all day every day and localized to the left side over my eyebrow. Migraine medicine made it worse Sumatriptan. The pain persisted but I was checked up for Glaucoma. My Neurologist advised that I take Indomethacin and it worked to relieve the pain. Regular pain killers did not work. It slowly improved over the course of two months. It had been twelve weeks and I am still getting headaches intermittently, It is more like a twinge.

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

At 04:00 pm, excessive fatigue. I was taking my mom shopping and I had to stop and take her home. Just excessive fatigue. 3/26/ 21- I woke up at 01:00 am with chills; freezing and infrequent tremors. I had a bad headache. Body aches. 04:00 am started feeling nausea. I contacted Dr to see what I could take. Got a reply email that recommended not to take anything. I toughed it out and I was in bed all day. I finally ate at 05:00 pm that day for the first time. The nausea and chills subsided with the mild food. But headache and achy body persisted. On 3/27, mild headache and mild body aches - I was a 2 out of 10 for pain. It continued to get better. I have joint pain in the winter when it is cold but I don't have any of that when it's warm. But I'm having joint point this summer. Which is weird and not usual. My joints have never hurt in summer time and spring before but have been this year. My left shoulder is frozen out of the blue at the injection site. It hurts. Have been having foot pain. Shooting pain in my right heal. Communications via email to Dr and Dr said to do heat and ice and sent me exercises to do with feet and shoulder. The shoulder still hurts but it is slowly getting better. I have been seeing Naturopath for hormone/menopause and I have been taking the hormonal supplements a month before the shot.

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

Right after the vaccine - Really bad sore arm for at least a week. I did have chills and aches for maybe a day. My usual joint pain that I experience wasn't worse that usual but I had just gotten cortisone shots a month earlier (March) so it was possible that it was keeping it all under control. But now I've been experiencing pain in joints. My thumb joints are in a lot of pain, very difficult to do almost anything; my lower back is really inflamed - the bones there. Other joints - knees and other joints hurt too but mostly those joints. Had chiropractic care - sometimes that increase inflammation because I'm moving the joints and but also have gotten 7 laser treatments on those joints - which has helped. Another number to call regarding my joint pain history medical records- haven't seen him since March, though -Doctor - who did - - he's not listed as my doctor but he did the cortisone shot and was my doctor before.

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.

Rushed to emergency room with severe, severe pain left shoulder, arm, hand, underarm breast, upper back and midback (left side). Given morphine and nausea and sent home. Still in pain. Rushed back to emergency room exactly a week later with same symptoms plus blisters and rash (still left side). Treated for symptoms of shingles, but no "classic" signs of shingles. Saw primary care doctor on 06/02/2021. Continued the treatment for shingles. Extremely limited function in left hand (holding, etc.) Future doctor visits schedule for August.

Numbness , Tingling in my feet, severe leg cramps and now i can't walk came to the ER on June 22 2021 still here in rehab July 13th 2021

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.

Continued pain in upper left arm where given the shot. Never had pain there before until given the shot. Pain sometimes wakes me up at night. No pain in right arm. Is difficult to get dressed in the morning and loss of strength in the upper arm. Pain started day after the shot in upper arm and has not gone away. Is tender to the touch at the location the shot was given in the arm.

brain fog vision problems, extreme exhaustion weight gain all scar tissue from surgerys is swollen and painful blown up and very visible, ( face is distorted) tingling in hands and feet

severe leg and foot cramps/spasms. every night and sometimes during the day time. toes point downwards like a ballerina's foot, calf muscles get hard and very painful. sometimes my foot shakes when this happens

Every few weeks since the vaccine I experience a sharp stabbing pain at the vaccine site. Another symptom that that began slowly (every week or so) until now when it is several times daily-feeling a prick and then a burning sensation on one of my toes or fingers like a fire ant is biting me. The pain lasts for hours-no red marks. I have also experienced the same sensation on my arms, over ribs, abdomen and legs. I have not spoken to my Dr. about this, but will if the frequency keeps up.

Face, neck, and ears became flushed within 5 minutes of the injection. Remained red for approximately one hour.

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.

Janssen COVID-19 Vaccine EUA Uncontrollable Shakes, fever spiking between 100 and 104, throwing up, pounding headache, aches throughout body

Bad headache, nausea - threw up numerous times until there was no more to throw up. These conditions lasted for about 30 hours, followed by body aches and weakness. Now feeling mostly better two days after receiving vaccine.

Face flushing within 1/2 hour that then subsided within another 1/2 hour. 6 1/2 hours after inoculation, at 7pm, I began to feel unwell. I felt a burning all over my body (especially my back), and body aches, and began a fever which grew from 97.3 (my normal) to a high of 100.1 (+2.8 degrees) within 2.5 more hours (by 9:30pm). Very bad chills and fever. By 9:30 took 1 500mg Tylenol. Little sleep that night. Felt very unwell next day (3/9) including headache. At noon I could get up and get some food. By 1pm fever subsided completely, but temporarily. Fever came back by 4pm, but only to 98.6 (+1.3 above normal). Took another 500mg Tylenol. Night 2 slept well. Woke up 3/10 no fever, headache gone, but balance still peculiar. I noticed the first night that my sense of balance was off.

64 y.o. female who is consulted for possible stroke. Patient reports that she awoke this morning (3/10/2021) at about 4:30 PM with severe spinning dizziness. She reports associated nausea, diaphoresis, blurred vision and bilateral hand numbness and tingling. She denies speech or language problems or weakness. She reports she got a COVID vaccine (Johnson & Johnson) Sunday 93/7/2021) and felt a little "woozy" Monday (3/8/2021).

Beginning around 3 pm on 3/10/2021 I experienced chills. The chills worsened, accompanied by bodily shaking. Around 6 pm I experienced body aches. By 9 pm my temperature was 100.4 and I had a mild headache. By 10 pm my temperature was 100.6. At that time I took two 200 mg ibuprofen. At 4:00 am on 3/11/2021 I began vomiting and felt like I would pass out. Vomiting continued until approximately 9:00 am on 3/11/2021. As the day progressed on 3/11/2021 I began to feel somewhat better. Since 3/12/2021 I have felt sporadic, brief periods of nausea and light-headedness. This continues at this time, 3/14/2021.

Patient received J&J vaccine at 15:01, approximately 10 min later patient reported she felt her tongue was swelling and her face was getting red and hot. Following the reaction protocol patient received 0.5mg of epinephrine IM at 15:26 and was moved to a stretcher. EMS was called, again per protocol. EMS recommended patient be transported to hospital but patient refused. Patient ambulated out of clinic independently and drove home.

Severe headache, overwhelming fatigue, 102.7 temp, massive body ache, left armpit and breast extremely sore

Within 12 hours I became to have severe muscle aches and joint aches. All my joint felt hot, it was bad enough I wasn't able to sleep. I took Ibuprofen to help sleep. I slept most of Friday I has extreme fatigue. On Saturday I has muscle weakness and tingly in my hands, the muscle aches have gone away. I couldn't knit ot fine motor skills, It bothered me. I woke up on Sunday where I had extremes muscle weakness in both my legs. I called my PCP, they were surprised by how the reaction was delayed. They wanted me to get a test for the strength in my legs and sent me to the ER. I wen to the Er they tested for stroke, blood work, scans, they were worried about Guillain Barre Syndrome. I stayed there about 5 hours. Yesterday afternoon the tingly went away from my hands but my legs are still kinda goofy. The muscle in my forearm and thigh feel like my muscle are really sore, like they have been tense

11:00 am - very mild rash on face - 2 spots started at 4:15 pm - peeked at 5:45 pm - temperature 100 degrees, sever chills, violent shaking, bad body aches especially back area, headache. Took Advil which reduced violent shaking, chills and body aches by 6:30 pm. Remained fatigued rest of evening.

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.

Bad headache that Tylenol was able to handle, drained feeling the next day, arm sensitive at site. Fine later next day and into the next no problems.

Extreme fatigue and muscle ache throughout body, fever, chills and shaking, intense headache. Vaccine was administered at 9:30 am. Symptoms began around 3:30 pm and lasted until approximately 5:00 am the next day.

deep sharp pain in the muscle where the shot was administered. along with slight fever and low energy.

9 hours after getting the J&J vaccine I had bad chills. My body was shaking and my teeth were chattering despite being bundled under 3 blankets. It lasted about10/15 minutes followed by a headache and body aches. The headache and body aches continued the next day and was treated with Tylenol.

Bad headache, muscle pain over entire body, chills ,then hot, 101.7 fever. I just slept a lot ,drank lots of water, everything but the muscle ache is gone

Rosacea flare up within 10 minutes of injection. Face bright strawberry red. Entire body became hot and had to fan myself (not a hot flash) Approximately 45 minutes later left ear started tingling and then pain followed and only in left ear. An hour after the shot ( and back home) started feeling tingling in lips and face. Face swelled up and smoothed out wrinkles. Lasted about 2 hours and then subsided. Also metallic taste in mouth during swelling of the face. Metallic taste lasted as long as the face swelling which was about 2 hours. Loose stools and tummy upset which is still going on.

30 minutes after receiving the vaccine- -- hot flashes that lasted 8 hours. Right away after receiving the vaccine-- stiff neck on the left side which after a night's sleep, moved to my right side of neck. No big deal. Tired & 'drunk' after the vaccine which lasted until mid-afternoon the next day. No big deal. The worst of all happened at 3 1/2 days, a rash started in the evening, went to bed, woke up the next day with rash almost everywhere. Red, swollen, & itching like crazy. The next day- Sunday, along with Monday & Tues. was horrid. I am covered from my scalp to the tops of my feet, my crotch hurts, as do my breasts. Used Benadryl cream, aloe vera to no avail.

day after vaccine was extremely tired and both hands were frozen cold, following day woke up with clogged right ear and I had vaccine shot in right arm. by end of day, I was feeling much better and ear was unclogged

FEELING VERY COLD; ACHES AND PAINS ARE ALMOST LIKE SHE GOT HIT BY A TRAIN; CHILLS; INJECTION SITE BURNING; TIRED; 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, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 at around noon on right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced feeling very cold. On 25-MAR-2021, the subject experienced aches and pains are almost like she got hit by a train. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced injection site burning. On 25-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 96-97. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site burning on MAR-2021, had not recovered from tired, chills, and aches and pains are almost like she got hit by a train, and the outcome of feeling very cold was not reported. This report was non-serious.

Pt. received vaccine, no reports of soreness at site, no redness or irritation observed. Pt reports numbness to R upper jaw, numbness doesn't radiate, no redness, no swelling. EMT on site, took VS. BP 125/87, p72, r22, temp 97.9, O2 Sat 100% on Room Air. Lungs CTA, PERRLA, grasps equal. No dizziness reported. EMT offered pt 25 mg tab of benedryl, refused at first then changed her mind and took 25 mg tab of benedryl. Pt immediately reports feeling better after swallowing tab. Pt was instructed to call 911 or go to closest ED if s/s increase or worsen. PT stated understanding instructions. Pt then stated she was fine and got up and ambulated safely with steady gate out of exit.

From March 8 th through March 18, I experienced very severe level 10, out of a scale from 1 to 10, migraine pain and related usual symptoms day and night. I also experienced swelling of a 5 in area ,,soreness and redness ,around the injection site for the same amount of days. I normally suffer from chronic migraine.

Pt received vaccine on 4/1/21. On Sunday, 4/4/21, pt started to have muscle cramps in thighs and all down legs. Were so severe at times she couldn't walk. Muscle cramps subsided by 4/6/21 and pt noticed a knot on each inner thigh. Patient is concerned about the knots and if they may cause a blood clot.

Severe shaking chills, headache, fever, muscle aches that lasted several hours. Taking Advil helped reduce symptoms. These symptoms are typical of those who have taken the J&J vaccine and in fact, if you read the actual stories of the side effects of people who took this vaccine, shared on sites, these symptoms are closer to 100% present rather than the far lower and untrue percentage revealed by the CDC. These symptoms need to be better tracked and people should be forewarned how COMMON these side effects are; they are not rare!

Shot taken with no issues at 9:54am, April 4, 2021. At 5:30pm, same day, became immediate flush, dizzy, barely made it to bathroom, violently vomiting all that was in my stomach. This was followed by severe chills, the shakes and a mild headache. Took (2) Tylenol at the time of the shot, drank many ounces of water all day but still had this issue. Took another (2) Tylenol after vomiting and more water. Went to bed at 8pm. Woke at midnight, 4/5/21, severe headache, now took (2) Advil and slept better until Mon. Morning, 4/5/2021. Experienced two sluggish, low energy days and still have no appetite. What the heck????

Cold, lethargic, achy from around 4-7 pm. Took Advil. About 9pm, MAJOR Chills, aches, fever over 100 . Took Advil around 11, fell asleep around 2am. Following morning , temp back to normal, severe headache.

tingling on left side of face, numbness in left arm, blurry vision. Evaluated by EMS-Refusal to transport.

6-1/2 hours later: Symptoms came on quickly. Hands and feet felt frozen, chills, severe shoulder joint and muscle pain. Immediately had to lay down and took Advil/Tylenol. Could feel the movement of joint pain from shoulders to elbow, hips to knees. Headache. Couldn't navigate stairs safely. In bed or on the couch for 24 hours until 6pm Friday 4/9/2021. Three of us from the same company had the Janssen Vac within a day of each other and all 3 of us had the same adverse reaction. To me, that is not mild symptoms when it debilitated me and kept me from going to work. Most family members have had Pfizer with two shots and had NO side effects.

About an hour or so after the shot, continuing until now, only 36 hours later: A general sense of feeling quite ill, headache, extreme fatigue, weakness and sleepiness, muscle aches over the past 36 hrs since the shot occurred. I have been in bed sleeping off and on feeling ill in waves. I feel less ill for hours at a time, during which I get up out of bed and function relatively normally. I felt completely fine (except for injection site achiness) until about an hour and a half after the shot, after which I went to sleep for several hours after which I felt better. The major symptom is the general feeling of 'being sick'.

I had no pain, swelling or redness in or around vaccine site. In the evening, my right hand and fingers began to swell, The next morning my hand and fingers were throbbing and I could not make a fist. I have iced it multiple times and the swelling is coming down today 4.11.21.

I wasn't sure how to indicate which dose I'm reporting on. It's my second dose of a vaccine but my first of Johnson & Johnson. My first shot for Covid-19 was a Moderna shot, to which I had a bad reaction (immediate and prolonged lightheadedness reported already on this site). My doctor advised me that my second dose should be a Johnson & Johnson vaccine, as per information he had received from the CDC. So, 28 days after the first shot I had the Johnson & Johnson vaccine. I experienced the expected side effects of body aches, chills, headache--no big deal on day 2, but on day 3, I started some lightheadedness, as did my daughter who had the shot the same day. Her lightheaded subsided the next day, but mine continued into day 4 and got worse when it became accompanied by pressure in my head/ears, and it felt like I was talking in a tunnel with echoing. I couldn't function the rest of the day. Today, the head pressure is not there, but the lightheadedness and shakiness are still there. I hope I fully recover from these shots, but I don't have a lot of hope.

Patient experienced numbness in peripheral extremities and lips, headache, hypertension, neck stiffness, tremor, and blurred vision

Arm really hurt for about 15 min., then went away. Intense cold, couldn't get warm with multiple layers of clothes and blankets. Fever. Restless sleep ~ hot, then cold. Sunday am woke with a headache that lingered and felt like I was in a fog ~ dizzy if I turned my head quickly, and then really tired. About 7pm I felt fine.

Patient states that she had ear, cheek bone, some teeth and chin numbness. It started on the car ride home after the 15 minute period of sitting by pharmacy for evaluation. Pt said it was about 25 minutes after vaccine. The numbness was only on the left side of her face. The vaccine was also in the left arm. She said her symptoms had completely resolved after 24 hours.

Nine days after vaccination developed pain and swelling in lower right leg, ankle and foot. Red discoloration of lower leg and purple and blue discoloration on ankle/foot. Went to ER suspected blood clot. Ultrasound and blood work were done. NO blood clot was found.

Vax received Saturday. Entire leg very sore on Sunday. Monday morning woke early with pain in the knee that was replaced. I was unable to straighten leg when lying in bed. I managed to stand up and walk it off, but with pain as severe as in January when knee was replaced. Leg continued to be sore, then Monday night I didn't have the same issue w/bending, but I did wake early with horrible stabbing pains in knee. I treated with Tylenol, Alprozalan & Ice.

Awakened earl y morning 12:00 am of April 9th with horrible pain in left calf of leg. Pain continued throughout the night, until I finally got up and just walked around house to try to get some relief then laid down and try elevating leg on pillows. The pain continued so got u p and walked around more and pain finally subsided enough to get some rest. Then felt like just had a bruise in that area of the leg for a day.

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.

2 weeks post inoculation developed burning sensation/tingling /pain from armpit to thumb; some tingling in thumb - sensation more like nerve pain vs muscle pain. After two days gradually improved. Muscle strength not affected, but movement in most directions elicited sharp pain coursing down arm. Gradually improving to pain over the deltoid near injection site; as of 19 days since initial pain motility much improved but still periodically throbs and sensitive to pressure and certain movements. No treatment except restricting use of arm and time. 10 hrs post inoculation developed chills, myalgia and headache. Chills and myalgia resolved in a few hours; an aspirin the next day resolved the headache. This reaction was not unexpected. Did not have pain at injection site until 2 weeks post injection.

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.

LETHARGIC; HEAVINESS OF HEAD; CRAMPS IN LEGS; ACHEY; GENERALLY FELT LIKE A CRAP; DRY MOUTH; NAUSEOUS; HEADACHE; 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 heart defect. 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 in Left Arm on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced heaviness of head. On 08-APR-2021, the subject experienced cramps in legs. On 08-APR-2021, the subject experienced achey. On 08-APR-2021, the subject experienced feeling bad. On 08-APR-2021, the subject experienced dry mouth. On 08-APR-2021, the subject experienced nauseous. On 08-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 lethargic, nauseous, headache, heaviness of head, cramps in legs, achey, feeling bad, and dry mouth. This report was non-serious.

4/8/21: "Six and a half hours after my J&J vaccine I had started shaking with severe chills. By 8 hours after my vaccine I had impaired coordination, extreme fatigue, and it was laborious to walk. Muscle aches and a blinding headache overnight added to my misery. This morning the headache was painful not blinding and the muscle aches not as intense. Had to return to bed right after eating soup, due to weakness. Chills abated by this morning. Speech slowed this morning while talking on the phone. Have spent the day in bed resting" 4/9/21: "Voice was back to normal by 8:30 pm last night. Slept well overnight - no chills or headache. Feeling stronger this morning - no headache!!! Arm still aches, but that is nothing c

UNABLE TO LIFT WITH LEFT ARM; BODY ACHES; MUSCLE SPASM; DIFFICULTY CONCENTRATING; SEVERE LEFT ARM PAIN; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included ptsd, and concurrent conditions included osteoporosis, gluten allergy, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: 25/MAY/2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: cannabidiol, and paracetamol. On 17-MAR-2021, the subject experienced unable to lift with left arm. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced muscle spasm. On 17-MAR-2021, the subject experienced difficulty concentrating. On 17-MAR-2021, the subject experienced severe left arm pain. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced fever. Laboratory data included: Pain scale (NR: not provided) Described pain 12/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 22-MAR-2021, and headache on 26-MAR-2021, was recovering from body aches, muscle spasm, and difficulty concentrating, had not recovered from severe left arm pain, and the outcome of unable to lift with left arm was not reported. 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

Patient states she developed the typical flu-like symptoms over the first 2 days after receiving vaccine (achy, fatigued, sore arm) and improved after these first 2 days. On day 8 post vaccination, she began to develop a whole body rash that she describes as itchy and irritated. They are still present today 4/14/21, 2 weeks after vaccine administration

4/8/21: "Six and a half hours after my Janssen vaccine I had started shaking with severe chills. By 8 hours after my vaccine I had impaired coordination, extreme fatigue, and it was laborious to walk. Muscle aches and a blinding headache overnight added to my misery. This morning the headache was painful not blinding and the muscle aches not as intense. Had to return to bed right after eating soup, due to weakness. Chills abated by this morning. Speech slowed this morning while talking on the phone. Have spent the day in bed resting" 4/9/21: "Voice was back to normal by 8:30 pm last night. Slept well overnight - no chills or headache. Feeling stronger this morning - no headache!!! Arm still aches, but that is nothing c

reported feeling of warmth over her right after injection and tingling sensation in arm & "anxious & nervous". TX: mask removal ; opened car windows x 4 for air flow; emotional support for anxiety.

Beginning 3/18/21: Initial headache. Fever greater than 103 F. Severe myalgias. Profound fatigue and lassitude. Drenching night sweats. E.R. visit followed by 5 day in patient hospitalization. Discharged from hospital approximately 3/9/21. Symptoms not yet resolved. Patient has persistent fatigue and severe occipital headaches.

Headache. Severe , burning, nerve pain in neck shoulders and both arms . Right arm swollen from elbow to wrists. Went to Dr. on 3-19-21 . Told to return in 3 days if not better. They said pulse was ok so prob not a clot. I had pain for two weeks but did not return. At end of two weeks swelling gone . Still some residual pain in right arm, but not constant.

Metallic taste in mouth 30 minutes after receiving vaccine. I have had a lot of stress (significant other diagnosed with Stage 4 inoperable NSCLC ) and had been attributing the often present headache to that, but they were also accompanied by a butterfly pattern red flush across my nose. Acid reflux which I was attributing to stress or alendronate. Woke in the night 4/12 to severe acid reflux, nausea, headache, flush, thought maybe I was having a heart attack (I have no cardiac/BP issues); then last night, 4/14 about 6 PM, weird numbness tingling in right arm from center of my chest passed in about 5 minutes. Significant Other said I had the pattern flush on face at time of attack which faded as I began to feel better. I have not consistently felt at 100% since vaccination, but I have a lot going on and attributed it to that.

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.

SHARP JABBING PAIN IN BODY; FEELING LIKE STICKING WITH NEEDLE ALL OVER; This spontaneous report received from a consumer 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sharp jabbing pain in body. On 12-APR-2021, the subject experienced feeling like sticking with needle all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sharp jabbing pain in body and feeling like sticking with needle all over was not reported. This report was non-serious.

I've had bad nerve pain in my injured leg and lower back which started above my knee and has now moved down my calf.. I've gone to PT and taken Gabapentin to help ease the pain. I've had it from April 7th through today(April 17th).

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.

For the 1st 10 days it felt like my brain was swollen too big for my skull. Not like any headache I have ever had. I did take some acetaminophen but it didn?t seem to quell the pain. While still at vaccine site I got a weird taste in my mouth, dry mouth and my voice started going hoarse. I stayed a while longer to be watched as I also had itching. I did not go into hives. I had pain in my body from time of injection ? the ?typical? sore arm didn?t set in until day 3-4. I had hot spots all over my body ? but not fever or rash. On 4/11/21 I broke out into a rash on my forehead that lasted about 4 days. What I want to specifically report is I like these zinger/sharp traveling pain from my temples to posterior head. Still having this sensation but not as frequently. They don?t last long but are noticeable at the time they are happening. The only way I can explain the pain is that it felt like when you break a blood vessel in you finger and it really, really hurts for a short while and then pain subsides. I started having these pin prick sensations within the first few days all over my body (arms, legs, back) but the frequency has decreased. Days 2-6 I was just wiped out and rested. I am still feeling lack of energy still today.

When the patient enbered the observation area within a few minutes she fell to the ground and appeared unresponsive. When I arrived I noticed foaming around her mouth and she urinated on herself. No clonal movements noted. Pulse could not be felt so CPR was initiated. She woke up in about 30 seconds. Paramedics called and arrived within 5 minutes. Patient was awake and oriented. When asked she indicated that she had a history of a seizure many years ago. Paramedics transported her to a Medical Center.

Note this is in reference to initial report filed 03/31/2021 - Received Janssen vaccine for COVI-19 in mid-March 2021. Over the next couple of days, became very ill, spent five days experiencing severe headache, disorientation, confusion, neck, shoulder, and back pain together with generalized arthralgias and myalgias. Around the 2nd week post-vaccination began to experience ?numbness and tingling? initially, affecting all fingers and toes; symptoms gradually evolved into ascending paresthesia affecting the upper and lower extremities. (worse in the upper extremities). Neurological symptoms are accompanied by painful electrical-like impulses running along my spine and elicited by flexing my neck (Lhermitte neurological phenomenon). Neurological signs and symptoms prompted me to go to the emergency room. Currently, I am under the care of a neurologist and undergoing extensive diagnostic workup. Present treatment: Glucocorticoids (tapering) and Gabapentin. Among the initial rule out diagnosis, were transverse myelitis, and Guillain Barre. Present preliminary r/o diagnosis: Post-vaccine immune reaction ? No definitive diagnosis yet.

VOMITING; WEAKNESS; CHILLS; HEADACHE; NAUSEA; 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 migraine. 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 12-APR-2021 for prophylactic vaccination. Concomitant medications included topiramate for migraine. On 13-APR-2021, the subject experienced vomiting. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, vomiting, nausea, and weakness. This report was non-serious.

Patient complained of headache, diarrhea, and left arm pain that is ongoing since 4/6/2021. She contacted the clinic on 4/19/2021 with her symptoms. The patient was advised to go the the ER.

Patient was vaccinated on 4/6/2021 and reports that on 4/16/2021, she started to experience joint pains and muscle pain in her arms and legs, feeling fatigued and could barely stand. She reported these on 4/19/21. I advised her to contact her PCP to get evaluated for the signs/symptoms that she is experiencing to rule out anything severe. She did not seem to understand and asked to speak with the manufacturer. She said that she would contact the manufacturer and walked away. When I attempted to contact her again today on 4/20/21, the phone number she provided to us has been disconnected and we have no means of reaching her at this point in time. I am hoping she heeded my advice and contacted her PCP to get evaluated.

Patient stating day after vaccine was administered began experiencing nausea and vomiting and body aches. 4/4/2021 patient states began to experience loss of appetite, fatigue and weakness. Described all food and beverage having an acidic taste. As of today, 4/21/2021 patient states symptoms are still persistent but seem to be subsiding.

Pt has had left upper arm swelling and pain since the vaccine 7 weeks ago. Pt is being sent for imaging of the arm. Results not available yet.

April 2 -3 felt tired and achey and chills April 8 - 10 tingeling of face, left eye hurt. April 11 no energy, left eye watering, lips swelling April 13 more swelling of face - Night of 13 wanted to rip my face off!!! April 14 swelling of eyes, lips, cheeks, hives on face and eyes. Felt miserable Zoom call with Doctor put on Medrol dose pack, Allegra, AM Zyrtec,PM Pepcid AC, purchased Epinephrine, Benadryl during day April April 19 more hives on chest

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.

SORE ARM; 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 moderate to severe chronic plaque psoriasis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.

4-13-21 upon waking up, woke up migraines. took her migraine medication and migraine resolved. phlegm, fatigue, chills. 4-22-21 started numbness to lips and fingers with cold sensation. Reports no changes to color of skin so unlikely there is noticeable perfusion changes however advised to get seen at a HCF for this. spoke with pcp for the migraine.

SORE ARM, AT FIRST ATTRIBUTED TO muscle ache, but later realized it was very specific to injection site, and very intense pain. I was unable to sleep more than a few short spurts the entire night as the pain was so intense. I read online that Benadryl was to be used for the pain, as well as ice. Originally I had used heat, before finding the information online. Nothing seems to help at this point.

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.

My initial symptoms were very minor and occurred the day after I received the vaccine: 99.5 degree fever and very mild headache. But several days later, both legs felt strangely weak from the calves to the feet. I also experienced occasional tingly feelings, pain, and often numbness. It was subtle at first but increased in intensity until April 21. I began to fear Guillain Barre syndrome. I scheduled a doctor's appointment for April 22, but the doctor's office cancelled and told me to go to the ER. At the ER bloodwork was done, which was normal. I was told to follow up with a neurologist if needed. It is now May 2 and my symptoms have slowly improved. It was frightening to have the symptoms for about a month. I was prepared to possibly feel unwell for several days, but expected neither my symptoms nor their duration.

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.

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

FEET AND ARMS BURNING; EYES BURNING; SWEATING; COULD NOT EAT; CHILLS; HEAD FELT IT WILL EXPLODE; EXTREME NAUSEA; FEVER; This spontaneous report received from a consumer 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: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced feet and arms burning. On 05-MAY-2021, the subject experienced eyes burning. On 05-MAY-2021, the subject experienced sweating. On 05-MAY-2021, the subject experienced could not eat. On 05-MAY-2021, the subject experienced chills. On 05-MAY-2021, the subject experienced head felt it will explode. On 05-MAY-2021, the subject experienced extreme nausea. On 05-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feet and arms burning, head felt it will explode, sweating, extreme nausea, fever, eyes burning, and could not eat. This report was non-serious.

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.

Patient experienced soreness stiffnes to left arm, chills and headaches x 3 days. Patient no longer has symptoms.

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 received the vaccine on March 13, 2021. I did not have an immediate reaction, but began breaking out in hives all over my body 24 hours later. I was lethargic, wanted to sleep all the time, and had no energy. This is gradually getting better, but still occurs. I periodically have headaches. After two full months I continue to have regular eruptions of hives on my arms. Prior to taking the vaccine I had no health issues, ran daily, and worked out regularly. I have just recently started walking, but have not been able to run.

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.

Day 3 sudden severe onset of nausea, followed by vomiting and chills. Day 4 nausea and weakness Day5 back to normal- just sore from vomiting

INSIDES SHAKY LITTLE IN THE BEGINNING; HEADACHE; SUBJECTIVE FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety issues, environmental allergy, allergy to bee stings, and anaphylactic reactions. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 208a21a, expiry: 21-JUN-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced insides shaky little in the beginning. On 17-MAY-2021, the subject experienced headache. On 17-MAY-2021, the subject experienced subjective fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from insides shaky little in the beginning on MAY-2021, headache on 18-MAY-2021, and subjective fever on 17-MAY-2021. This report was non-serious.

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.

LIGHT HEADED; FELT COLD; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included full hysterectomy, and concurrent conditions included no alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced light headed. On 19-MAY-2021, the subject experienced felt cold. On 19-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.1 F, 100.9 F, 101.5 F. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fever, light headed, and felt cold. This report was non-serious.

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.

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.

Complaint of cramping in legs on April 26. 2021. Resolved for a short period of time. Earlier in May 2021 Complaint of Left Flank pain with Radiating pain to Left Thigh. Appointment with Orthopod cancelled due to inability to drive with pain. On May 15, 2021 complaint of continued Left Flank Pain Radiating to to Left thigh with burning and discoloration. Unresponsive on May 16, 2021. Pronounced Dead at 1:52pm by County Coroner. Cause of death noted as CV. Nature of death :Natural This is being reported in case another patient complains of these same symptoms. There may or may not be a Correlation with this Death and The Jassen Covid-19 Vaccine

A lump appeared shortly after the vaccination was given and remained for six weeks. After this time the lump started to decline and pain in the arm started. This pain ran all the way down my arm to my fingers from the injection site. At times the pain is unbearable and requires that I take Tylenol and put on a Lidocaine 1% patch.

She got her vaccine, and a couple of weeks after getting it she woke up and she was off. She wasn't dizzy but wasn't herself, felt off. Then she got petechia in both legs and she took it easy, drank a lot of water. She took it easy, but ever since then her energy is not there, she is "zapped". She has changed her whole routine, she is pretty active and now she cannot do much due to the fatigue. She is now really concerned as it is lasting. She feels like she is mentally confused. She could not tell me her address without looking it up first. It has started to subside some the feeling of being off. She feels like that she has no blood in her. She feels like she's out of iron, and zapped of energy. She has not called her doctor.

Migraine, fever & stabbing pains from heart to pelvic bone. It felt like 40+ knives stabbing me for 7 1/2 hours.

For the past six weekends patient gets severe fever of coldness shaking and lies on a full length heating pad to warm up. Then experiences fever of hotness sweating and cannot cool down. Muscle aches, joint aches and hurts to touch the skin and exhaustion. The aches and fever last 4 - 6 hours and the next day all she can do is sleep.

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

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

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

4 hours after vaccination, had numbness of left side of face in the trigeminal nerve region. Later had fever an aches which resolved, but as of 7.2.21, still has numbness in face which is about 2/3 better but still present. Has no facial motor deficits.

Tingling in extremities - it started with my toes and went up to my hands. And continues to present. Doctor visit ER. Have an upcoming visit to Neurologist hopefully. No Treatment as of yet.

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.

Almost immediately these symptoms appeared: Extremely achy joints, swollen index finger on right hand, feet and hands hurt, facial filler in right side of chin dissolved completely. Approximately two weeks after vaccine feet and lower legs have pins and needles feel with nerves tingling. This is a 24 hour a day problem and quite concerning. My joints pop and creak like they suddenly aged and have no lubrication. These are all NEW symptoms/issues. I?m concerned that this is a long term and/or permanent medical issue for me! I WOULD LIKE SOME ANSWERS!!!!!

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.

FALLING MORE AND WALKS WITH A CANE DUE TO WEAKNESS; SORE MUSCLES; BODY ACHES; RUNNY NOSE; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 200.2 pounds, and height was 65 inches. 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 use. patient does not remember the name of the blood pressure medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204a21a, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced runny nose. On 02-JUL-2021, the subject experienced body aches. On 02-JUL-2021, the subject experienced sore muscles. On 06-JUL-2021, the subject experienced falling more and walks with a cane due to weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, sore muscles, runny nose, and falling more and walks with a cane due to weakness. This report was non-serious.

LITTLE BRUISES TO LEFT HAND AND ARM UNDER THE SKIN; TINGLING UP LEG TO THE KNEE LIKE PINS AND NEEDLES/TINGLING ALL UP AND DOWN LEFT LEG; HURTS AFTER A MINUTE OR TWO OF WALKING OR STANDING/IT ONLY HURT WHEN PUT PRESSURE ON LEG; HARD TO SLEEP AT NIGHT; PAIN IS BELOW KNEE ABOUT 3/4 OF WAY DOWN TO THE ANKLE, NOT QUITE ABLE TO PINPOINT EXACT LOCATION; PAIN IN LEFT THIGH; LOWER LEFT LEG PAIN; NERVE PAIN IN LEG ALL ON LEFT SIDE; LEFT HIP BECAME SORE; CYST IN LEFT ARMPIT; 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 related medical history. patient feels normal, super good and fine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced cyst in left armpit. On MAY-2021, the subject experienced left hip became sore. On 25-MAY-2021, the subject experienced nerve pain in leg all on left side. On 25-MAY-2021, the subject experienced lower left leg pain. On an unspecified date, the subject experienced little bruises to left hand and arm under the skin, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg, hard to sleep at night, pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location, and pain in left thigh. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cyst in left armpit on 14-APR-2021, and little bruises to left hand and arm under the skin, pain in left thigh, and left hip became sore, had not recovered from nerve pain in leg all on left side, and lower left leg pain, and the outcome of hard to sleep at night, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg and pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location 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.

DOUBLE VISION; SLEPT THE WEEKEND AWAY; STUMBLING POST-VACCINATION; EXTREMELY TIRED/ TIREDNESS; SHAKINESS/UNSTEADINESS; LOSS OF APPETITE; DIZZY; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 115 pounds, and height was 64 inches. The patient's past medical history included emphysema, and smoker, and concurrent conditions included non-alcohol user, 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, and batch number: 04A21A expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 16:15 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced shakiness/unsteadiness. On 10-JUL-2021, the subject experienced loss of appetite. On 10-JUL-2021, the subject experienced dizzy. On 10-JUL-2021, the subject experienced slept the weekend away. On 10-JUL-2021, the subject experienced stumbling post-vaccination. On 10-JUL-2021, the subject experienced extremely tired/ tiredness. On 13-JUL-2021, the subject experienced double vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision, and had not recovered from extremely tired/ tiredness, shakiness/unsteadiness, loss of appetite, dizzy, slept the weekend away, and stumbling post-vaccination. This report was non-serious.

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.

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.

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.

Bleeding and pain at injection site; Droopy left side of face, pain in upper left jaw, below left eye, upper left arm and left shoulder/neck; Transient headache and pain in left leg with ankle swelling.

On 3/7/2021 after I returned home, I ate broiled, skinless chicken, salad and small amount of corn at 5:00pm. I started having diarrhea about 5:30pm. Later in the evening around 8:30pm, I had more diarrhea. Around the same time I became very, very sleepy and had extreme fatigue. My right arm where I received the shot did not hurt and still does not hurt. Around 6:00pm, my left arm starting hurting in the same spot where I received the vaccine in the right arm. On the morning of 3/8/2021, I ate breakfast consisting of whole wheat bread and peanut butter and weak coffee (my usual breakfast) and had diarrhea again soon after eating. At 3:30pm, I ate broiled, skinless chicken, green beans and small amount of instant mashed potatoes. Around 5:00pm, I had diarrhea again. I have been drinking a great deal of water on both 3/7/2021 and 3/8/2021 as I normally do every day. At 6:30pm, I had more diarrhea. Soon after, I took two imodium gelcaps and hoping they will help the diarrhea. My left arm has become increasingly more sore and hurts in the muscle. No other symptoms.

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.

Began with violent shakes and chills. Migraine type headache developed, followed by nausea feeling, all over sore muscles. This lasted about 12 hours, then slowly started to subside. By second day, nausea gone, headache gone, but very light-headed. On third day, still very light-headed.

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.

I noticed a red rash on my legs, arms, and torso at about 8 pm yesterday, March 12; it is red blotches (no hives) and feels more like a sunburn . There is a burning sensation with mild itching and red blotches/spots. I contacted my physician who recommended OTC treatment at home and advised me to report it to VAERS. It is mild in terms of impact but not expected four days after the vaccination date.

started during dinner, 6pm, hands and feet cold, chills continued and increasingly worse, shaking, muscle spasms, headache, temp 103, vomited, ache muscles. Tylenol had no notable affect. Next day 3/8/21 chills subsided, groggy, headache #7 on pain scale with light sensitivity. Tylenol little affect. A metal taste in my mouth, food didn't taste right. Next day 3/9/21 felt much better. Please note I had hydrated well previous to getting the vaccine.

Around 10-11 hours after the injection, I began to feel body aches and soreness around my neck and upper back. I started getting chilled but was very hot and feverish. I went to bed around 10:00pm and had extreme body aches, shaking with chills and had a fever. I took tylenol around 4am, when my temperature was 100.7. The fever and aches subsided by the time I got up around 7am, but I was tired all day. Took another tylenol around 1pm and started feeling normal, fine. No other issues.

About 4hours after being vaccinated, I started to feel weak. I wen to sleep. Woke up an hour later (9PM) with fever (100.5), HUGE migraine and being nauseous. I threw up, tried to go back to sleep but couldn't because of the migraine and fever. Decided to take 2 Tylenol, but I vomited about 20 mins later. All night, I hardly could sleep at all, so sick I was feeling (and I'm never sick!). No reaction at all on the site of the vaccine, no redness, no swelling at all. All day today (day after the vaccine), I have felt really weak, slightly feverish (though less than last night), with a persistent headache.

WITHIN 2-3 MINUTES OF ADMINISTRATION PATIENT BEGAN TO FEEL WEAK, LIGHTHEADED AND WAS SWEATING. PATIENT WAS EXAMINED AND ALL VITAL SIGNS WERE STABLE. WE SUPPLIED WET CLOTH AND COOL AIR. PATIENT THEN SAID HE THROAT FELT HEAVY AND LIKE SHE COULDNT SWALLOW. PT WAS ADMINISTERED EPI 0.3ML IM INTO R DELTOID. MONITORED PATIENT FOR ANOTHER 15 MINUTES AND TOLD TO GO TO ER FOR FUTHER WORKUP. PATIENT WAS STABLE AT THE TIME OF DICHARGE.

pt stated that after she took the covid vax her arm was red and hurting very badly. Later she felt nauseas, had muscle pain and headache. Temp was 100.4. She took 2 Tylenol and felt some better. By 3/17/2021 she began having more muscle pain in her arms and legs and her arm is still very sore. Pt states she will call her PCP for medical advice.

Janssen Covid-19 vaccine EUA First 24 hours, tired and achy. 36 hours in at bedtime felt shivery and cold for a few hours then hot and sweaty for a few more hours. In the morning I felt fine. Very mild symptoms.

First day developed a headache, and a bad rash on my chest that was very itchy for 2 days, rash was visible for approx. 2 weeks. (took a picture), second day had flu like symptoms, headache turned into a migraine 24 hours after initial headache began. Had joint pain, slight cough and lower back ache as well as headache until Saturday morning 3/13/2021. Took Tylenol at home and got extra rest until all symptoms went away.

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

Patient received Janssen vaccine @ 11:44 am, while in the recovery area @ 12:01 pm, c/o numbness in the left neck area, blurry vision> VS 136/80, 63,20, Sats 99% on RA. 12:05, patient stated numbness was no longer present, VS @ that time: 140/92, 55, 24 Sats remained unchanged. Continued to monitor, final VS check @ 12:10 pm, 152/96, 54, 22 Sat's remain unchanged, no further c/o of discomfort of any kind. DC from recovery @ 12:25, all symptoms resolved, gait steady accompanied by Sister (who was present for vaccine as well).

Janssen COVID19 Vaccine EUA starting Tuesday morning, 3/30/2021 hands and feet are numb and tingling, like the nerves are exposed. went to emergency room 4/1/2021 -- could not reach a conclusion without further testing. Told me to report this and call my doctor to arrange further testing to find out the cause -- CT scans, etc.

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

Felt cold, and chilled after going to bed, and feverish. took temperature and it was 101.8. couldn't sleep tossed and turned most of the night until I took Tylenol PM

Scratchy throat within 2 hours of vaccine inoculation, a raging headache started within 3 hrs of Johnson & Jonson (Janssen) vaccine, massive muscle cramping starting at 1800 and continuing through the night - I drank a gallon of water between 6 PM and 9 PM on 04/06/2021 and then 3 more 1/2 liter bottles during the night. None of it came out in the usual manner -- I had cramping of my left side muscles across my rib cage between 4 PM and 6 PM on 04/06/2021 and then massive lower leg cramps starting at about 10 PM 04/06/2021 lasting until 0300 AM 04/07/2021

Extreme chills, fever (102), body aches, vomiting, diarrhea, extreme fatigue, strange taste in mouth, and headache. This lasted for 8 days and I'm still dealing with the fatigue and lack of energy. I took alternating doses of tylenol and motrin and drank lots of fluids. I had to miss 6 days of work because I was too sick to teach.

Night of shot experienced fever of 101, nightmares and slurred speech. The following day experienced fatigue. By the second day post vaccination memory impairemt. By the third day post vaccination has gait unsteadiness and fell six times. The 4th day post vaccination left arm weakness and could not use arm. accompanied by slurred speech.

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.

When needle came out I felt like my upper arm was filled with lead - very heavy feeling for about 8 minutes. About 2 hours later I felt very fatigued and slept for 2 hours. Woke up at 4:30 am next day (04/08/21) with a raging migraine, unbearable nausea and cold to the bone. Vomited 2 times in the day. After drinking some ginger beer at 3 pm the nausea was gone by 3:30 pm. Migraine gone by 7 pm and freezing cold feeling gone this morning (04/09/21).

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

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.

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

3/18 vaccination 3/19 4am woke up I felt sick I had a HA, Nauseas, dizzy, hard to stand, hard to keep eyes open to even go to the bathroom. I tried to go back to sleep. When I woke up, I took it easy. I did get the chills and sweats thru the day; skin turns really red (MCAS). That symptoms still comes and goes. The chills, regulating body temperature, has flared back up after being dormant for years. 3/30 I saw MD. She wanted to defer for 4-6 weeks after vaccination to see if symptoms were still persisting or leveling out. I have since canceled every sort of appt since then as I don't have the energy. *I am on the very tail end of an opioid withdrawal; tramadol. I have taken for 6 years, 400 mg weened down to 100 mg this last year, down to 12.5.

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.

Experienced very sore calf within 2 weeks of vaccine but thought it was from snowshoeing. Then on April 8 I developed vein inflammation in two areas. An ultrasound on April13 showed two blood clots. One superficial and one dvt

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.

When I was receiving the shot on 4-6-21 it was very painful I could feel it all the way to my elbow and About 2 AM on 4-7-21 I tarted feeling very very cold and trembling and delusional I could not recognize my home I had muscle spams on both legs and fever finally got up and took some Advil put on extra PJ's and socks and turn on the heater finally fell asleep about 4 AM about 8 AM on 4-7-21 woke up with a headache and very very tired lot of pain on my left arm so stayed home from work and rested on 4-8-21 came to work at 7 AM and was seeing everything blurry as the day progressed it got worse finally went home about 3 PM took more Advil and rested some more my left arm hurt me for 6 days and I felt very tired and a bit confused I did not call my doctor or any one at Health Department I just took care of myself

ITCHINESS; HIVES; FEVER; HOT; SWEATY; LIGHT HEADED; SHAKY; NAUSEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced shaky. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021 14:30, the subject experienced hot. On 05-APR-2021 14:30, the subject experienced sweaty. On 05-APR-2021 14:30, the subject experienced light headed. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9 F. On 08-APR-2021, the subject experienced itchiness. On 08-APR-2021, the subject experienced hives. Treatment medications included: diphenhydramine hydrochloride, loratadine, and prednisone. The patient recovered from hot, sweaty, light headed, shaky, and nausea on 05-APR-2021, and fever on 06-APR-2021, and had not recovered from itchiness, and hives. This report was non-serious.

SHINGLES-lesions developed on the left side of my forehead w/ nerve pain to my head and ear. Itchiness to my scalp with left top pf head very warm to touch. Flush feeling to entire face. Woke up with this the Saturday morning after the injection and lacey rash over entire body w/ rash gone Sunday morning with lesions to my left forehead still visible. Lesions began to weep on Monday morning.

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

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!

Severe Joint and muscle aches, fever, chills, loss of appetite, night sweats, severe headache, extreme fatigue. Symptoms started 8 hours after injection and persisted for 3 days. Took Tylenol as needed for fever and pain. Extreme fatigue kept me immobilized for those 3 days.

Taken by ambulance from home to ER on Sunday, March 21, around 7:30 pm. Symptoms were severe head and leg pain, vomiting and diarrhea. X-rays and blood work taken. Given pain medication and fluids. Dr in ER said it could be a virus. Discharged at midnight Monday 22. Followed up with my primary.

POOR CIRCULATION (IN FINGERS, FOOT, ANKLES, ARMS); BLOTCHY RASH WHICH GOES UP THE ANKLE AND LEG ABOUT 2 INCHES; TINGLING DOWN LEFT ARM AND IN FINGERS; LEFT ARM AND FINGERS ARE NUMB; RIGHT ANKLE SWELLS AT NIGHT; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included parkinson's disease. 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, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced poor circulation (in fingers, foot, ankles, arms). On 26-MAR-2021, the subject experienced blotchy rash which goes up the ankle and leg about 2 inches. On 26-MAR-2021, the subject experienced tingling down left arm and in fingers. On 26-MAR-2021, the subject experienced left arm and fingers are numb. On 26-MAR-2021, the subject experienced right ankle swells at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from poor circulation (in fingers, foot, ankles, arms), blotchy rash which goes up the ankle and leg about 2 inches, tingling down left arm and in fingers, left arm and fingers are numb, and right ankle swells at night. This report was non-serious.

Evening of Day 1, shaking chills, fever (100), headache. Went to bed at 9:00, woke at 3am with severe "swelling" I felt like my brain was too big for my skull, my entire face felt swollen. Joint aches, muscle aches, nausea. Nausea has been intermittent thru day 5. Headache continues but not as severe. I still wake up with it every day (this is now day 5). Diarrhea began on Day 3 (watery, every 1/2 hour for 4 hours). fever subsided and returned on Day 3 (100). no fever since but muscle aches, headache and joint aches continue.

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

ITCHINESS; REDNESS OF ARM; SORENESS OF THE ARM; SWELLING OF THE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid problem, mild asthma, sinusitis, seasonal allergies, alcohol use, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug use and the patient had bad allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) .5 ml, administered on 04-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced soreness of the arm. On 04-MAR-2021, the subject experienced swelling of the arm. On 04-MAR-2021, the subject experienced tiredness. On 04-MAR-2021, the subject experienced redness of arm. On 05-MAR-2021, the subject experienced itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness of the arm, swelling of the arm, tiredness, and itchiness, and the outcome of redness of arm was not reported. This report was non-serious.

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.

BODY TWITCHING; HEADACHE; CHILLS; BODY ACHE; UPSET STOMACH; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug or non drug allergy. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and 1805018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced body ache. On 12-MAR-2021, the subject experienced upset stomach. On 13-MAR-2021, the subject experienced body twitching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and upset stomach on 13-MAR-2021, and had not recovered from headache, body ache, and body twitching. This report was non-serious.

april 7, extreme skin tingling all over, only lasted that one night april 12, noticed increased tinnitis, I already had it and it is now louder

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.

Very High Fever followed by aches and pains with congestion then a severe headache like a migraine and ending with 3-4 days of diarrhea

around 1 week before appt (4/16/21) started noticing pain in underside of right arm, gradually worsened and moved into axillae area and in to right chest wall.

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.

FELT TIRED; FLU-LIKE SYMPTOMS (CHILLS AND HEADACHE); SORE LEFT ARM; BOTH HANDS HURTING AS WELL; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced flu-like symptoms (chills and headache). On 12-APR-2021, the subject experienced sore left arm. On 12-APR-2021, the subject experienced both hands hurting as well. On 13-APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms (chills and headache), sore left arm, and both hands hurting as well on 13-APR-2021, and felt tired on 14-APR-2021. This report was non-serious.

ACHY; ARM SORENESS; MINIMAL CALF PAIN; SPLIT SECOND FEELINGS OF NAUSEA; TIRED; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood transfusion, and concurrent conditions included toxic shock syndrome, and neutropenia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1043A21A 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. On 09-APR-2021, the subject experienced arm soreness. On 09-APR-2021, the subject experienced minimal calf pain. On 09-APR-2021, the subject experienced split second feelings of nausea. On 09-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, and the outcome of arm soreness, split second feelings of nausea, achy and minimal calf pain was not reported. This report was non-serious.

I currently have swelling in my hands, pain in my vaccinated arm, bone pain, a bump in my hand like thrombi, burning sensation in my stomach, taste of blood in my throat, leg and joint pain. After I was vaccinated.

DIARRHEA; THREW UP; NAUSEATED; HEADACHE; LUNG PAIN (FELT LIKE LUNGS GOING TO EXPLODE); LEFT ARM PAIN; FATIGUE AND FELT TIRED; LETHARGY; SICK; PAIN DOWN FROM LEFT BREAST TO ELBOW; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pain down from left breast to elbow. On 07-APR-2021, the subject experienced lethargy. On 07-APR-2021, the subject experienced sick. On 07-APR-2021, the subject experienced left arm pain. On 07-APR-2021, the subject experienced fatigue and felt tired. On 08-APR-2021, the subject experienced lung pain (felt like lungs going to explode). On 08-APR-2021, the subject experienced nauseated. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced threw up. On 11-APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: oxycodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from threw up, and diarrhea, had not recovered from fatigue and felt tired, lung pain (felt like lungs going to explode), nauseated, left arm pain, lethargy, headache, and pain down from left breast to elbow, and the outcome of sick was not reported. This report was non-serious.; Sender's Comments: V0: MAC comment not required for non serious cases as per standard protocol

Report pain of the left upper arm. Tingling of left arm, hand and fingers. Numbness in fingertips of left hand began 2 weeks post vaccination. Treatment: None Outcome: No improvement symptom are getting worst. Continues to work does not interfere with ADLs. Advise to follow-up with PCP.

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

NUMBNESS IN HANDS, FINGERS AND FACE; CONGESTION; SORE THROAT; DIZZINESS; CHILLS; WEAKNESS; FEVER; FATIGUE; NAUSEA; HEADACHE; MUSCLE PAIN IN BACK; 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: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced numbness in hands, fingers and face. On 09-MAR-2021, the subject experienced congestion. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced weakness. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced muscle pain in back. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, weakness, fever, and headache on 10-MAR-2021, and had not recovered from fatigue, nausea, muscle pain in back, numbness in hands, fingers and face, congestion, and sore throat. This report was non-serious.

4 days after vaccine couldn't grasp with hands, numbness, tingle throughout arms and hands, loss of balance, now uses a walker, can not sit up alone. Had to have emergency surgery ACDF of C4/5 and C5/6

Right arm sharp pains began within 1 week of receipt of the vaccine. Pain present with laying on the arm. Right arm pain persisted with swelling presenting on 4-26-21.

HEADACHE; RED SPOTS / RASH IN LEFT ARM; KNOT/LUMP IN LEFT LEG; SWOLLEN LEFT ARM; TENDER LEFT ARM; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included deteriorating disc disease (c4 and c5 in spine), pain in hand, tingling in hand, neuropathy, and varicose veins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20/JUN/2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, fosinopril, ibuprofen, metformin, and simvastatin. On APR-2021, the subject experienced knot/lump in left leg. On APR-2021, the subject experienced swollen left arm. On APR-2021, the subject experienced tender left arm. On 19-APR-2021, the subject experienced red spots / rash in left arm. On 20-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knot/lump in left leg, tender left arm, red spots / rash in left arm, and headache on APR-2021, and had not recovered from swollen left arm. 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.

At the time, I had very mild injection site pain and warmth on the site. For a couple of days. On Monday, the 15th, I had the worst flare-up of sciatica that I have ever had in my life. Left leg - it had a tremendous swelling. It was crippling. I am still using a pain. I cried because the pain was so horrific. I was able to get into the doctor early on Tuesday - prescribed Prednisone; hydrocodone; muscle relaxer. None of which touched the pain. I was unable to sleep for three days. I slept upright in a chair. I used an office chair as a wheel chair. I wasn't able to lay down. I've improved but I still can't walk to the mailbox - could walk down there - two houses down but couldn't get back. I am using a cane still. I have to elevate leg on a recliner to sleep so it will help with the continued swelling. There was nothing I did that triggered it.

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.

ITCHINESS; REDNESS OF ARM; SWELLING OF THE ARM; SORENESS OF THE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid, mild asthma, sinusitis, seasonal allergies, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no known drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for thyroid. On 04-MAR-2021, the subject experienced redness of arm. On 04-MAR-2021, the subject experienced swelling of the arm. On 04-MAR-2021, the subject experienced soreness of the arm. On 04-MAR-2021, the subject experienced tiredness. On 05-MAR-2021, the subject experienced itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of the arm, soreness of the arm, and tiredness on 17-MAR-2021, had not recovered from itchiness, and the outcome of redness of arm was not reported. This report was non-serious.

About 4 and a half weeks after getting the J&J vaccine, I began to experience marked symptoms: dizziness and disorientation,, balance problems, bilateral numbness in hands, feet and tip of tongue, awareness of left side of brain, intermittent mild nausea (likely related to dizziness). These symptoms had a sudden onset. I am normally very healthy and active so these unusual symptoms without any illness were quite a departure from my normal health. They have, to date, persisted continually since onset over the past 3 weeks. They are very concerning. Last night I went to the ER to be seen since I could not get an appt. with a neurologist for several months and I am concerned about my sudden change in health status.

Extreme dizziness- ongoing since injection. Weakness, fatigue, blood results show increase in calcium levels and albumin levels. Urgent Referral to ENT in process.

pt experienced flu like symptoms beginning 6-7 hours after receiving the vaccine. She reported headache, body aches, chills, sore arm. Significant bruising the size of a tennis ball appeared 18 hours later around the area of injection and persisted for 10 days.

This was the worsening of a chronic condition - my amount of Carbamazepine I was taking was increased. That failed to resolve the issue so another medication of Baclofen was added. It has helped with my symptoms. I have surgery planned now for this. May 28th will be the date for that.

FELT LIKE LEGS WILL BUCKLE UNDER HER WHEN GOING TO RESTROOM; HIVES; ITCHING; INSOMNIA; DOES NOT FEEL HERSELF; ANXIETY; DRY MOUTH DESPITE DRINKING A LOT OF WATER AS DIRECTED; WEAKNESS; 24 HOUR FLU; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced 24 hour flu. On 06-MAY-2021, the subject experienced dry mouth despite drinking a lot of water as directed. On 06-MAY-2021, the subject experienced weakness. On 07-MAY-2021, the subject experienced itching. On 07-MAY-2021, the subject experienced insomnia. On 07-MAY-2021, the subject experienced does not feel herself. On 07-MAY-2021, the subject experienced anxiety. On 07-MAY-2021, the subject experienced hives. On 08-MAY-2021, the subject experienced felt like legs will buckle under her when going to restroom. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 24 hour flu on 08-MAY-2021, and insomnia, was recovering from hives, and felt like legs will buckle under her when going to restroom, and had not recovered from itching, anxiety, does not feel herself, dry mouth despite drinking a lot of water as directed, and weakness. This report was non-serious.

No problems the remainder of day of injection. Next morning upon awakening, I was very groggy and unable to stay awake. I slept 4 hours past my normal time for getting up. I had no balance and would stagger when standing. My entire body was in muscle and nerve pain. Even my skin hurt. I took 300 mg of Gabapentine which eased my pain. I continued to be off balance the remainder of the day, however, by the end of the day I was much better. I took several 1 hour naps throughout the day.

Patient was non-communicative but sitting still in the chair. Appeared to be in a mild type of seizer temporarily. After a few minutes was able to communicate and was feeling better.

She started itching, got hot, said her tongue felt funny. I sat with her asked her if was ok breAThing short of breath, she said no. I ASKED IF SHE WANTED A BENADRYL AND SHE SAID NO. MY TECH WAS AN EMT AND CAME OUT WHILE I WENT TO GET BLOOD PRESSURE CUFF, WE WATCHED HER AND SHE STARTED GETTING ITCHIER BUT BLOOD PRESSURE WAS FINE. WE CALLED EMS . SHE WAS RESPONSIVE, DIZZY, AND ALERT WHEN SHE LEFT WITH EMS.

-Severe abdominal pain, projectile vomiting, severe diarrhea that lasted for 3 days. - spasms and pain in legs