Johnson & Johnson

Patient had anxiety about getting the second shot and had fainted on the first dose of pfizer. After the shot the patient thought she might faint, never did. Patient was hot, anxious and then vomited. 911 was called

On 4/6/2021, Vaccination administered in error to an individual under the age of 18 (age 17 years and 5 months at time of administration). Upon identification of error, both patient and parent notified. Patient experienced injection site pain within 12 hours of administration. At 24hrs post-administration she experienced headache, fatigue, decreased appetite and mild nausea, and body aches. At 30 hours post vaccination her symptoms were improved. Symptoms resolved at 48hrs post-vaccination.

DIZZINESS; PAIN AT INJECTION SITE; VACCINE ADMINISTERED IN PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a parent concerned a 17 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and no medical history. 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 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced pain at injection site. On 10-APR-2021, the subject experienced vaccine administered in subject of inappropriate age. On 10-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and pain at injection site, and the outcome of vaccine administered in patient of inappropriate age and off label use was not reported. This report was non-serious.

First 24 hours: fever, body chills, muscle weakness and sore First 48 hours: entire face broke out in acne and rash across cheeks, jaw, and neck

The area where I received a tuberculosis vaccine when I was 1 year old nd the muscle around and below it became inflamed (slight swelling, redness, itchiness, hot to the touch) 2 days after my covid vaccination in the same arm.

Pt. developed itchy rash on both arms and legs. no respiratory complaint. site of vaccination without any rash. Treated with Prednisone, recommended OTC antihistamine and advised to apply OTC topical steroidal cream on the area.

3-30-21 5:55PM RASH TO LT ARM AT INCJECTION SITE. BENADRYL 50MG PO GIVEN, NO SOB. A/O, PINK, W/D, RESP REG WITH EASE.6:17PM DECREASED RASH NOTED/LESS PINK. 6:21PM HOME WITH PARENTS. AMBULATORY, GAIT BRISK AND STEADY. NO ACUTE DISTRESS. 3-31-21 8:30AM PATIENT MOM STATES 'RASH IS GONE NOW'.

4 hours after vaccine was administered: Fatigue, Trouble Focusing 10 hours after vaccine was administered: temperature rose from 97.4 to 99.0, began experiencing full body ache and chills. 11-12 hours after vaccine was administered: Fever of 102.0°, extreme body ache, headache, and slight nausea 19 hours after vaccine was administered: Fever broke, returned to temperature of 97.2°, intense headache and fatigue for the following hours. 28 hours after vaccine was administered: headache was reduced using ibuprofen, fatigue faded. At time of recording (31 hours after vaccine administration) Symptoms only consist of slight fatigue, slight headache, and pain at injection site.

began with body aches in the knees, took Tylenol and went to bed @9:30pm. Woke up @12:30am with chills, a headache, soreness in the injection site, and body aches in the neck, back and legs. Got up and tried stretching and drinking water. Stoped drinking water when I felt nauseas. Did not throw up. Took Ibuprofen and melatonin before falling asleep about 30 minutes after taking the medication. Woke up @3:00am and chills were gone, only left with pain in the knees and injection site. Wasn?t able to sleep until around 4:45am. When I woke up @7:45 am, I still had slight pain in the knees, I took Tylenol @10:45 am. Pain was on and off throughout the day. I took a hot bath, that helped the pain tremendously. Fatigue throughout the day. After sleeping the day after the shot, all symptoms are gone, only soreness in the injection site.

8pm 3/31/2021 Fever, nausea, fatigue 4/1/2021 Extreme nausea, fever, fatigue, body aches, Heightened symptoms of neurocardiogenic syncope, easily bruising on legs 4/6/2021 Continued agitation of neurocardiogenic syncope symptoms- fainting and nausea

I felt really good until late at night when I got a pretty mild headache, then I started shivering and I didn't stop for nearly an hour. My muscles were very tense and the headache got worse. I took ibuprophen and that seemed to help with the shivering and lessen the headache. It is now the morning after and I just have a mild, but persistent headache and skin sensitivity which I don't know if it's related to getting the vaccine or not.

Woke up Saturday morning with hives all over her body, took some benadryl later went to the doctor and was given steroids.

Local injection site pain and soreness immediately after. Starting about 6 hours later, started feeling nausea, shivers, whole body aches. About half an hour after that, had a bout of vomiting, loss of vision for about 10 seconds after standing up from bed (possibly associated with undiagnosed iron deficiency), and paleness of skin and mucous membranes.

Approximately 8 hours after injection, I woke up after sleeping for an hour with excruciating pain in all of my limbs, especially the injection site. I could not move any of my limbs. Not because of pain, I simply could not move them. I had a fever (temp not recorded, I could only tell because I was burning up.) I was very nauseous, but never vomited. I was shaking very hard and had the chills despite being covered by a blanket and simultaneously burning up. Both of my ankles that I had suffered a running injury to several weeks ago (I have an upcoming doctor's appointment to get them checked out) were pulsing with pain. I developed a minor headache. Eventually I either drifted back to sleep or stayed awake, because I don't remember anything up until around 5am when I was able to get up and take Tylenol and water. All symptoms were gone except for the minor headache.

9:00pm on day of injection 4/2/21: body aches, chills, fever, fatigue. 4/3/21: fever broke, continued body aches and fatigue. 4/4/21 PM: body aches & fatigue gone; injection site reactions start to appear - red, swollen, warm and painful to touch 4/5/21 : injection site reaction continue; redness is spreading - approx. 2 inches in diameter 4/6/21 : injection site reactions continue; a blister-like lesion at site is now present (current situation at time of report)

very stiff neck (day 1-2) and headache (day 2) lasting over 24 hours, extreme fatigue & sleepiness (days 2-3), swelling (day 2-present day) at the injection site longer than 5 days, low grade fever and chills (day 3), cold sore appeared on the right side corner of the mouth by April 4. She was monitored at home. Given Tylenol for the headache, stiff neck, and fever. Given plenty of water when not asleep. For the cold sore looking effect, simple OTC cold sore topical medication

Dizziness, difficulty sleeping, headache, irritable skin, muscle pain, joint pain, disorientation, difficulty breathing, uncontrollable shaking, nausea; most just lasted from evening day of to next morning, muscle aches and sensitive skin lasted for a few days

per patient - about 2 hours after her injection she began to experience itching and hives and tightness in her throat. she sought treatment at the emergency department where she states she was given Benadryl and steroids and discharged after observation.

Very large hives formed on my right shoulder, underneath both of my buttocks, behind my knee, and on my thumb. All of the hives were painful. My thumb swelled up a couple of hours after I noticed the one on my shoulder and thighs, and I watched and felt as my thumb swelled up. The next morning I woke up and they were still there, but no new hives formed.

Fever, headache, sweating, chills, body aches, injection site soreness and slight swelling, started mentrual cycle early for one day, tired

Pt received vaccine, while walking to recovery became dazed, confused, unsteady on feet. Staff held her and guided her to floor to lie down put feet up. MD assessed summized vagal vasal response. No LOC, No SOB. pt did not hit her head. Applied ice to back of neck, gave water for hydration. VS146/84, HR 60 reg, resp 12, SpO2 97% Pt's . Left Deltoid site benign - reddness - swelling -bleeding. Mother was at her side. stated "she has a problem with needles this happens to her". Provided reassurance. Monitored 30 minutes. kept reassessing condition. Pt stated she felt better. Ok'd to exit with family after 30 minutes. 4/10/21 next day tried to contact x 2 to check on condition , no answer left message, no return call back

After about 4 hours of having the shot, I got extremely light headed and nauseous. About the same time I got really bad chills and was shaking aggressively from the cold and got very bad pain in my joints, back, neck and injection site. My skin felt very sensitive and hurt to touch. I took medication and felt a little better but was unable to eat due to the nausea. A few hours later I still had very sensitive skin and nausea but I was very hot and couldn?t cool off. The following morning at about 8am on April 9 I woke up with hives on my ears, back of my neck up to the top of my head and the center of my chest. I still had severe body pains and my hives spread throughout the day to my face, inflating my forehead, nose and lips. I was still unable to eat because of the nausea and I was still taking ibuprofen which usually eliminates my hives. My body pain, nausea and hives stayed consistent the entire day despite taking the proper medication precautions. At about 12:30am on April 10 I checked my temperature at 100.3 degrees. At 2:30am it dropped to 98.9 degrees. The first meal I was able to eat was at about 7:30am on April 10 while take over the counter anti-nausea medication. It?s currently about 5:15pm on April 10 and most of my hives have reduced to redness, my body pain and injection site pain is still consistent and my nausea has barely reduced.

chills, hot flashes, feeling flushed, fatigue, mind fog, pain at injection site, extremely sore muscles

All around 2pm of the day i got the vaccine i got a fever, cold sweats, could not move, was very tired, and it hurt to touch my skin.

Weak, sensitivity, whole body aches, incredible spine and shoulder pains, migraine-type aches, sore throat. Felt these symptoms from about 4:00 PM until about 11:00 PM when I went to sleep. The next morning, 24 hours after receiving the vaccine, my head still ached/throbbed, and my back still felt incredibly awful. My left shoulder was also still very sore. As of now, almost 60 hours after the vaccine, the only symptom still remaining is the very sore shoulder. I cannot extend it fully without immense pain, but it still hurts otherwise.

Dizzy: continuous Nausea: 1 day Hot flashes: continuous Chills: continuous Body aches: continuous Injection soreness: continuous Tired: continuous

She felt totally fine after the shot and many hours after. She felt fine to go to a horseback ride lesson at 4. Half way through the lesson she acutely felt like she was going to faint/nauseous (she had a ton to eat that day, had a bottle of water just before lesson, etc. so she knew it wasnt those kinds of things) and then had a crushing headache with a lot of "pressure behind her eyes", dizziness, and a really "strange" feeling like out of body, bawling crying, and started FREEZING. I got there 15 minutes later and she was under lots of blankets, white as a sheet, freezing, said her spine was sore from the top to bottom... just tons of symptoms. When I got her, she moved to my car and had seat heater on high and I had to put all the clothes from a suitcase I had in my car on top of her bc she was so cold and her skin was burning up. I gave her 3 200 advil and a bottle of water. ½ hour later i had a thermometer and even after that she still had 102.3 fever. She was rambling some nonsense and seemed very disoriented for a while. She went straight to shower and laid on the floor of the shower for ½ hour, took cold medicine, and evnetually went to sleep. In the night she was freezing again and the fever had spiked and she took more advil. The next day she felt much better in the morning and fine by lunchtime. She was VERY sick/uncomfortable with basically every symptom under the sun.

6 hrs after injection developed fever, chills, headache, body aches, fatigue, sent home from work went to bed, temperature 101 degrees F. Symptoms continued through Sunday, fever down between 99-100 degrees F, chills and body aches mild, still fatigue. By Monday morning around 2am hives developed, spread across body, face, lips and ears very swollen, went to walk-in clinic by 9am Monday morning. Patient prescribed prednisone and benadryl for relief of symptoms most likely due to vaccination.

Rash on face, vomiting, fever, nausea, chills, headache Vomiting stopped after 10 hours, other reactions still present 28 hours after vaccination

Adverse event: Day after vaccination, experienced severe dizziness, nausea, and fever. Fell over and experienced loss of vision and loss of control of limbs, difficulty talking. Loss of normal color in skin, instead had greyish/blue tint. Treatment: Cold compress, juice, rest laying down Outcomes: After 10 min of having a cold compress and juice, regained vision and ability to talk. 30 min later, regained ability to move limbs. Still could not stand up without falling over for a couple hours. After 6 hrs, only remaining symptoms were slight fever, fatigue, and some dizziness. After 2 days experiencing fatigue, headache, and dizziness, returned to normal health.

Within 24 hour of the shot I had the typical symptoms, but the following night I broke out in hives while I was trying to sleep. I still currently have some bumps on me.

HARD TIME CONCENTRATING; SHORTNESS OF BREATH.; SEVERE SHAKING; FATIGUE; HARD TIME MOVING; HEADACHE; EYE PAIN; FACE BRIGHT RED; FEELING LIKE BOTOX ON FACE; SEVERE BODY ACHE; ARM HEAVY; NAUSEA; This spontaneous report received from a parent concerned an 18 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced face bright red. On 07-APR-2021, the subject experienced feeling like botox on face. On 07-APR-2021, the subject experienced severe body ache. On 07-APR-2021, the subject experienced eye pain. On 07-APR-2021, the subject experienced arm heavy. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced severe shaking. On 08-APR-2021, the subject experienced hard time moving. On 08-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced shortness of breath. On 12-APR-2021, the subject experienced hard time concentrating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from face bright red, and feeling like botox on face on 08-APR-2021, and nausea on 09-APR-2021, was recovering from arm heavy, headache, severe body ache, and shortness of breath., and had not recovered from severe shaking, fatigue, eye pain, hard time moving, and hard time concentrating. This report was non-serious.

24 hours after vaccine given patient developed red, pinpoint , flat rash on lower legs and forearms; does not blanch; no itch; 7 days later it is still present

NUMBNESS LIPS; FELT COLD AIR IN THE NECK; WEAKNESS IN THE LEFT ARM; INJECTION ARM HURT; MIGRAINE (DIZZY, HEADACHE, NAUSEA, FELT LIKE SOMETHING WAS RATTLING IN HER HEAD, FELT LIKE THERE WAS A HOLE ON HER HEAD); This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021around 10:30 in right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, around 5 pm, the patient was dizzy, and had a headache and her injection arm hurt. On 07-APR-2021, the patient experienced numbness lips, and reported that "felt like something was rattling in her head, felt like there was a hole on her head, felt cold air in the neck", weakness in the left arm, nausea for which she was put on IV. On an unspecified date, the patient experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness lips, injection arm hurt, felt cold air in the neck, and weakness in the left arm 08-APR-2021, and was recovering from migraine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210419870-covid-19 vaccine ad26.cov2.s-Migraine, numbness lips, felt cold air in the neck and weakness in the left arm. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210419870-covid-19 vaccine ad26.cov2.s-injection arm hurt. This event(s) is labeled per RSI and is therefore considered potentially related.

GENERAL MALAISE; FEVER; INJECTION SITE SWELLING; INJECTION SITE REDNESS; INJECTION SITE VERY WARM TO TOUCH; INJECTION SITE HIVES; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight was 230 pounds, and height was 170.18 centimeters. The patient's concurrent conditions included asthma, low thyroid, pollen allergy, sesame allergy, abstain from alcohol and and non smoker. The patient was not pregnant at the time of reporting. 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included levothyroxine for low thyroid. On 12-APR-2021, the subject experienced injection site very warm to touch. On 12-APR-2021, the subject experienced injection site hives. On 12-APR-2021, the subject experienced injection site swelling. On 12-APR-2021, the subject experienced injection site redness. On 13-APR-2021, the subject experienced general malaise. On 13-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) ranging from 99 to 100 degree Fahrenheit. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, injection site swelling, injection site redness, injection site hives, general malaise, and injection site very warm to touch. This report was non-serious.

Janssen COVID-19 Vaccine immediately caused injection site pain which lasted for about a week after gradually getting better. About eight hours after injection, a fever and fast heartbeat accompanied by chills began and persisted for about twelve hours. A few mild and extremely brief feelings of nausea were present as well. After taking Tylenol six hours in, the symptoms started improving and were gone after seven hours. Feelings of tiredness were present for about two days after the first symptoms showed up.

REDNESS AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned an 18 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 08-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 APR-2021, the subject experienced redness at injection site. Treatment medications included: diphenhydramine hydrochloride. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from redness at injection site. This report was non-serious. This parent/child case is linked to 20210450484.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: RECOVERED ABOUT 5 MINUTES AFTER FAINTING. 911 WAS CALLED. PT RECOVERED IN 5 MINS

Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted for a few mins, she came to it after a few mins. Paramedics was called in and the pt was checked out. pt stated that she did not eat allday, her blood presssure was low. she was fine after a few mins.

WIthin 5 minutes of patient receiving J&J covid vaccine, she started to develop a large rash on her arm that was quickly spreading. Patient stated that it was not itchy but hurt. I gave her Children's Allergy Relief 12.5mg/5ml and gave her 10ml. Within 5 minutes the rash was starting to subside already. Patient was kept an additional 5 minutes and felt fine when she left.

Grandmother explained on 5/21/21 that pt had rare sickness called Panda disease that can lead to seizures, twitching, and tics. States pt had to go to ER in the evening after due to severe seizure onset, vomiting, and increased swelling in injection site.

About a week after the vaccine I had welts all over my body. They were like the welts that I had when I had Covid-19 in July of 2020. The welts came and went for a while and they were mainly on my left side. I woke up with them and then they would come and go during the day. They were hard raised welts and it lasted for three weeks. I also seemed to have allergic reactions to some foods. I went to the ER on 04/29/2021 three weeks after the vaccine. The welt on my wrist was very red and swollen and I was concerned. I was prescribed an antihistamine. It helped with the rash and other symptoms.

Sudden sharp pain in the right leg under the knee. Making it difficult to walk and move. Noticed three small bruises in the same area appeared around 1 hour after the pain started. Also some swelling around the area. And the area around the bruises is pale (white) This happens today at 2:30 pm June 24 The vaccine was administered June 21 11:30 am

3 BRUISES IN THE AREA LINED UP VERTICALLY ON RIGHT KNEE AND FEELS HARD TO TOUCH; A LITTLE SWOLLEN RIGHT KNEE; PAIN IN RIGHT LEG SPECIFICALLY BELOW THE KNEE; GENERAL BODY WEAKNESS; A LITTLE TIRED; CHILLS; GENERAL BODY DISCOMFORT; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included motor problems specifically to legs ( weakness in bilateral legs due to being born premature), non smoker, and non alcoholic, and other 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: 1821281 and expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the subject experienced general body discomfort. On 21-JUN-2021, the subject experienced chills. On 21-JUN-2021, the subject experienced general body weakness. On 21-JUN-2021, the subject experienced a little tired. Treatment medications included: acetylsalicylic acid. On 22-JUN-2021, treatment medications included: ibuprofen. On 25-JUN-2021, the subject experienced 3 bruises in the area lined up vertically on right knee and feels hard to touch. On 25-JUN-2021, the subject experienced a little swollen right knee. On 25-JUN-2021, the subject experienced pain in right leg specifically below the knee. Laboratory data included: Pain scale (NR: not provided) 7-8 on a scale of 1-10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general body discomfort, chills, general body weakness, and a little tired on 22-JUN-2021, and had not recovered from pain in right leg specifically below the knee, a little swollen right knee, and 3 bruises in the area lined up vertically on right knee and feels hard to touch. This report was non-serious.

RECTAL BLEEDING; LOSS OF APPETITE; ABDOMINAL PAIN; BODY ACHES; FEVER; INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting and had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered on 28-JUN-2021 early afternoon to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUN-2021, the patient experienced injection site soreness. On 29-JUN-2021, the patient experienced loss of appetite (good 12 hours without eating), abdominal pain, body aches, and fever. The patient also experienced rectal bleeding which started in the afternoon and described as bleeding every time she went; it was like having period but it was not. The patient bled pretty good amount. The patient recovered from loss of appetite and was able to eat dinner. The reporter stated that the patient was feeling pretty good except for the bleeding and that the patient had not had any treatment and had not notified the health care provider. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite on 29-JUN-2021, and abdominal pain, and fever on JUN-2021, was recovering from body aches, and had not recovered from injection site soreness, and rectal bleeding. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210668208-Covid-19 vaccine ad26.cov2.s - RECTAL BLEEDING . 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).

SHORTNESS OF BREATH; CHEST PRESSURE; STOMACH PAIN; BACK PAIN; NECK PAIN; NUMBNESS IN CALVES; TINGLING IN FEET/SKIN FEELS STRANGE; SORE THROAT; BUBBLED EARS/RINGING IN EARS; PALE HANDS AND LEGS; RESTING HEART RATE WAS 99-110; SHOULDER PAIN; RIGHT LEG PAIN; HEAVINESS IN LEGS; CHILLS; PAIN AT INJECTION SITE (DURING ADMINISTRATION OF VACCINE); FEVER; HEADACHE; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight was 153 pounds, and height was 65 inches. The patient's concurrent conditions included positive for lupus anticoagulant factor (anti-phospholipid factor), non smoker, non-alcohol user, latex allergy, rubber allergy, allergic to silicone, and resting heart rate runs high. 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 05-JUL-2021 11:15 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, Laboratory data included: Heart rate (NR: not provided) 99-110, and Oxygen saturation (NR: not provided) 96-99%. On 05-JUL-2021, the subject experienced shortness of breath. On 05-JUL-2021, the subject experienced chest pressure. On 05-JUL-2021, the subject experienced stomach pain. On 05-JUL-2021, the subject experienced back pain. On 05-JUL-2021, the subject experienced neck pain. On 05-JUL-2021, the subject experienced numbness in calves. On 05-JUL-2021, the subject experienced tingling in feet/skin feels strange. On 05-JUL-2021, the subject experienced sore throat. On 05-JUL-2021, the subject experienced bubbled ears/ringing in ears. On 05-JUL-2021, the subject experienced pale hands and legs. On 05-JUL-2021, the subject experienced resting heart rate was 99-110. On 05-JUL-2021, the subject experienced shoulder pain. On 05-JUL-2021, the subject experienced right leg pain. On 05-JUL-2021, the subject experienced heaviness in legs. On 05-JUL-2021, the subject experienced chills. On 05-JUL-2021, the subject experienced pain at injection site (during administration of vaccine). On 05-JUL-2021, the subject experienced fever. On 05-JUL-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 06-JUL-2021, Laboratory data included: Body temperature (NR: not provided) 101.1 F, Heart rate (NR: not provided) 117, and Oxygen saturation (NR: not provided) 97 %. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) high, and Lupus anticoagulant (NR: not provided) positive, slightly high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pale hands and legs, had not recovered from neck pain, and the outcome of fever, pain at injection site (during administration of vaccine), headache, sore throat, chills, heaviness in legs, tingling in feet/skin feels strange, shortness of breath, bubbled ears/ringing in ears, stomach pain, back pain, numbness in calves, chest pressure, right leg pain, shoulder pain and resting heart rate was 99-110 was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.

I experienced an overwhelming amount of itching and right after getting vaccinated I experienced extreme swelling in my fingers my right ankle and underneath my feet. I was told to take Zyrtec. It helped but I still experienced itchiness and swelling. I consulted a dermatologist who diagnosed me with dermatographism and concluded my skin responds to the excessive itching by a trauma response known as petechiae. I also have gained a lot of weight since become vaccinated and rapidly. I have not changed my eating habits.

patient passed out shook a couple times and slid down in the chair then a few seconds later woke up scared and unaware of where she was. She was warm and clammy plus felt like she was going to vomit. All complete symptoms of syncope. I stayed with patient and placed ice pack on her back neck area and offered her a drink of water. after about ten minutes she was completely back to norm and i continued to watch her for 30 minutes. she states that she faints every time she receives a flu vaccine as well. she went home with mother after the waiting period.

TROUBLE BREATHING; A RASH ALONG THE THIGHS LIKE SMALL SPOTS ON THE INNER THIGHS THE SIZE OF HALF DOLLAR WHEN IT FIRST STARTED IT SPREAD DOWN TO CALF TO STOMACH AND TORSO AND UP TO CHEST; NAUSEA; HEADACHE; FEVER SPIKED TO 102 F; BODY ACHES; HEART RATE WENT UP; This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no known drug allergies and patient had no underlying health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 23-JUN-2021) dose was not reported, administered on 02-MAY-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced body aches. On 02-MAY-2021, the subject experienced heart rate went up. On 02-MAY-2021, the subject experienced a rash along the thighs like small spots on the inner thighs the size of half dollar when it first started it spread down to calf to stomach and torso and up to chest. On 02-MAY-2021, the subject experienced nausea. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced fever spiked to 102 f. Laboratory data included: Heart rate (NR: not provided) from 115, 120 to125. On 03-MAY-2021, the subject experienced trouble breathing. Laboratory data included: Body temperature (NR: not provided) 102 F, Below 100 F, and Laboratory test (NR: not provided) unknown. On 04-MAY-2021, treatment medications included: salbutamol. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Unknown, and Laboratory test (NR: not provided) Unknown. Additional treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a rash along the thighs like small spots on the inner thighs the size of half dollar when it first started it spread down to calf to stomach and torso and up to chest, and fever spiked to 102 f on JUL-2021, and the outcome of nausea, heart rate went up, trouble breathing, headache and body aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210755447.

Fever began around 11pm 3/6/21 and went to 102.3 at about 2:00 am 3/7/21. She had chills for several hours during this time. She felt nauseous, had skin sensitivity, a dry mouth and muscle pain, and felt exhausted. No fever this morning but still some skin sensitivity, nausea and feeling tired, muscle pain, dry mouth, and hot/cold back and forth.

Patient received the Janssen Vaccine Covid-19 injection and immediately afterwards asked for a trash can. She immediately passed out and fell forward. She hit her head on the wall and received a cut. We called the paramedics and she was transported to the emergency room at the local hospital.

after administering vaccine patient fainted and was found on the floor of observation area. She was conscious when i ran to her.She said she usually feels nausea after vaccines and feels like this was just her normal reaction. She refused an ambulance and felt like she was ok. We gave her ice water and and ice pack as she bruised her head when she fainted. We continued to monitor her and she kept refusing medical assistance. She had a friend come to drive her home.

Janssen COVID-19 Vaccine EUA woke up with chills, 101 fever, nausea, vomitting, and headache for entire 24 hours after receiving vaccine--took tylenol and symptoms seemed to subside for a bit 36 hours after receiving vaccine a rash appeared on face and neck-appeared as small red speckled dots

Patient began feeling dizzy, warm, and confused shortly after vaccination. The patient was helped to lie down on the floor. The patient remained there for 3 minutes and then pharmacy staff helped patient sit back up. Patient stated she was feeling better and remained in the area for 30 minutes to wait after immunization. I checked in with patient 5 hours after vaccine and she felt fine.

Soon after vaccination, pt developed generalized muscle aches and SOB along with low grade fevers. Pt was admitted to hospital on 3/13/2021 for fever, diffuse myalgia, arthritis, rash, tachycardia, and dsyphagia and got diagnosed with likely serum sickness like reaction after COVID-19 vaccination after all the work up for autoimmune etiology such as vasculitis or SLE came back negative. she's currently getting IV solumedrol 50mg BID since 3/17 (switched from prednisone 40mg daily) with a good response.

5:40pm - vaccine given 5:50pm - patients arm and legs begin itching, slight tingling of the tongue 6:00pm - Diphenhydramine injection given IM/RA 50mg/mL. BP 135/95, O2 Sat 96-97%. Dr was contacted via telephone (and continued on the phone until patient left the facility.) 6:25pm - Patient states that itching of extremities seems to be getting a little better, but tingling of tongue seems to be getting worse and now throat is tingling, voice sounds "raspy". Epinephrine 0.3mg was administered via EpiPen to the left thigh, at the direction of Dr. 6:40pm - Patient was transferred via ambulance to ER for observation.

Exhaustion, headache, fever, chills, nausea, weakness, pain in injection site, pain in joints/muscles (neck and back)

Janssen COVID-19 Vaccine EUA. Symptoms: fever of 103.4, chills, headache, ringing in ears, nausea, sore arm, dizziness (started same day as shot approximately 8 hours after shot) Still felt sick next day with fever of 100 with all the same symptoms that I listed above 1 week later my arm is still sore from injection site

My daughter felt warm to touch. Took her temperature with a digital thermometer. Read 101.1. Gave her 2 Acetaminophen tablets.

Chills, body aches, fatigue, dizzyness, febrile state, malaise, tightness at injection site and pain at touch

hives/rash on lower back and right elbow. didn?t get confirmation until 3:30 that same day there was hives (can?t see my elbow or back, had to have someone else look)

Within a few hours of getting the vaccine started with Flu symptoms of severe body aches, chills, headache, fever. Day 2 a bit better but still low grade fever of 101 degrees, nausea, weak, body aches but not as bad. In the evening around 5pm noticed ears starting to enlarge but didn't think much of it, by morning today at 7:30am I felt my face was swollen and numb on the right side. Now both ears were swollen and the area in my face was red. When I took my temperature on my forehead I was normal however the swollen cheek was 102 degrees. At that point I went to urgent care to get it looked out. Currently at 6:30pm on 4/3/2021 the redness in my cheek has turn back to normal however the face is still swollen but not as bad.

Pain at Injection Site an hour after, at 8pm chills began and very harsh sweating occurred, sweating lasted for two days enough to soak the sheets and underside of scalp. Back and joint pain when waking up and through the day, but could be subsided with ibuprofen.

Pt reported feeling dizzy after receiving IM injection and has (+) LOC less than 30 seconds, unsure if hit head, head atraumatic without abrasions, lacerations, bleeding. Pt was assisted to a recumbent position with BLEs elevated. VS as follows: BP 122/70, HR 78, sats 97% on RA. Pt was given water and snack bar and recovered within 15 mins. She ambulated out of clinic in NAD and was driven home by roommate.

Mother states that she experience vomiting overnight after the shot. She also developed hives the next day with shortness of breath. Mom states she used Benadryl the 1st, 2nd and 3rd of April along with having to use an albuterol inhaler those days as well. She had a vomiting episode on Saturday the 3rd as well. Sunday the 4th, she was having no symptoms as previously reported and is currently asymptomatic.

I got my shot at 1:00 pm and my side effects started to begin at 8:30pm. It started off with a slight headache and body aches with pain in my injection spot. My whole body started to shiver uncontrollably. My body aches focused on my spine and I started to become dizzy and nauseous. Around 4:00 am, the worst migraine, I have ever had that encased my whole head, lasted for about 12 hours with hot flashes. After the migraine, my body and head is sensitive to rapid motion and loud noises.

About 4 hours after injection, I had strong chills that lasted 1-2 hours, a strong headache, full body aching/pain particularly in low back, legs, shoulders, and a 100 F fever. All symptoms except chills lasted throughout the night until now (8:15 AM). Currently have strong lower back pain, weakness in legs, headache, and a sore injection arm.

vaccination with the one dose Covid-19 vaccin Johnson & Johnson at 11:40am. Around 6pm patient began having headaches and a bit of fever. By 9pm patient had high fever, body aches, nausea, head spinning, bad headaches, and very fatigued. Mother gave her some pain and fever medicine. By 10pm she began complaining her chest felt like being squeezed. Mother applied some camphor essential oil on her chest. Seemed to bring a bit of comfort. Mother prepared her few bottles to drink throughout the night. Next morning 6am, patient still had a high fever throughout the day and evening, nausea, headaches, body pains but no more chest squeezing! Friday morning: patient's fever is gone. Yet she still has head aches and tired.New symptoms are sore throat and a blue toenail! Saturday morning: still some headache, sore throat, a bit of pain in the chest between the breasts, her arm where the injection took place is swollen as big as a grapefruit and painful to the touch as well as warm. You can clearly see the spot where the neddle was inserted.

Fast heartbeat within 3 minutes of injection, slight swelling of face and mouth, weakness, numbness and pain of injection site, red rash on arms and legs, difficulty breathing, losing breath walking short distances, 10 hours later I developed muscle pain all over my body, chills, 102° fever, extreme shaking, difficulty sleeping due to muscle pain/aches, and fatigue.

Female pt felt lightheaded and dizzy after receiving vaccine. Did not alert staff and had a syncopal episode, falling out of her chair. EMRs at pts side, pt regained consciousness. She did have a small hematoma on her head measuring approx. 1 inch. Pts vitals were HR 68, BP 116/70, RR12 , sats 100%. Pt sts all symptoms have resolved. She denies all further treatment and/or transport.

Started off with a really bad headache and sore arm. Then began chills, severe headache and nausea. by around 9pm. Developed a fever that even with meds still climbed to 103.3. Was dizzy, whole body aches, and felt like she could not take full breaths during the night and could not sleep most of the night. Saturday 10am the fever was down to 100.9 with a bad headache, body aches, very tired, and some dizziness off and on. Sunday the fever was gone, but still soreness in arm, headache and felt extremely worn down.

Jansen COVID-19 Vaccine EUA The first side effect began at 4/10/21 ~9:00 PM, approximately 6 hours after injection. The very first noticeable symptom was chills. As the night progressed, chills came in cycles while headache and an abnormal sensation in the head became apparent. Throughout the night, there was also a feverish feeling, body aches, periodical sweating, and sore arm at injection site. I?ve experienced all these symptoms (except the sore arm and sweating) while being sick with Covid-19 approximately over a week prior to the vaccination. Symptoms continued until the next day, 4/11/21, and they gradually went away as the day progressed and after taking doses of acetaminophen and ibuprofen. Symptoms completely dissapeared by the evening of 4/11/21.

Patient states received vaccine on 4/9/2021. States she had symptoms of body aches, headache, and sore arm 4/9/2021 -4/10/2021. She noticed a full body rash without itching on 4/11/2021 and slight shortness of breath with rest and exertion on 4/12/2021 morning. Patient took benadryl after speaking to her pediatrician. HR 86, BP 118/82, RR 24 O2 sat 96%. Labs for CBC, CMP, urine dip, and chest xray done on 4/12/2021. Patient given 4m IM decadron injection in clinic and started on zyrtec. Follow up appointment scheduled on 4/13/2021.

That night, around 9 pm - from the time I got the shot until then I was fine. At 9 pm, I came to my dorm and I got hot and woozy. My friend told me that my forehead was puffy (swollen). I laid down and I realized I was really really cold but skin was hot to touch. I think I had a fever. I was shaky and shivery and trembling. I tried to take a nap. Fell asleep for an hour - don't remember that time at all - but my friend told me I went to sleep. My smart watch was telling me my heart rate was 120s and 130s while I was sleeping. I debated whether I should go to the Dr. and I called the school police and they took me to the ER - at 03:00 am on the 8th - and they told me to rest for day and wait it out. I still feel like I have a lot of adrenaline - my watch says that my heart rate is way to high for what I'm doing. It's usually in 70's and 80's but it's in the 120's and 130's every day and I am really shaky with adrenaline. I have had a headache since Wednesday night and it hasn't gone away. If it goes past Wednesday, I will go to my primary care doctor but otherwise no treatment at this time.

Flush immediately after shot Severe sweating evening of shot Severe headache 2 days after shot Lump at injection site 3 days after shot

Dizziness, Headache, Blurry Vision, Fever, Body/ muscle aches, joint pain, unable to drive/ function , and golf ball sized welt at sight of injection

onset of dizziness 1 hour after injection- persisting but lessening 5 days after vaccine at time of this report headache onset within 2 hours of injection, persisted for 2-3 days site soreness onset 3 days after vaccination back pain, hip pain days 2-3 post vaccination

A few hours after I got home from getting the shot, my lower body started to ache super bad. My skin started to hurt like I had rug burn, but I wasn't surprised because that happens to me when I get the flu. My legs and groin region started to hurt more and more and I got the chills. It was extremely bad and I was sort of writhing but I told myself I was overreacting. At around 8 or 9, I decided I would sleep it off and went to bed. At 1:00 am, I got up to use the bathroom and I began feeling lightheaded. I thought I had just stood up to fast so I continued. As I walked, i got more and more dizzy and I couldn't hear well. When I sat on the toilet, I realized I wasn't going to be able to get back up, so I sat and waited. I started to get super hot so I took my shirt off. I finally was able to get up and walked towards the sink but I collapsed before I got there. I started drinking the sink water and ran my shirt under the water and put it on my head to cool off. This really helped so I went back to my room to call my mom. I have never fainted before or come this close to fainting. For the rest of the night I had the worst migrane of my life that gave me aura in my left eye and made my left arm and left side of my face go numb, as well as pulsing in my head. The pain on my skin, and in my legs and head was still there for two days after but it was manageable enough for me to go about my day. I tried to exercize to ease the muscle pain but this did not work.

Experienced a head to toe rash and hives. Joint pain in fingers, wrists, and jaw with slight swelling in the fingers.

LEFT ARM SORE; NAUSEOUS; HEADACHE; TIREDNESS; DIZZINESS; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iron deficient. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZIA, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced left arm sore. On 12-APR-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness, and headache, was recovering from dizziness, and had not recovered from left arm sore, and nauseous. This report was non-serious.

VOMITTED BEFORE LEAVING THE PHARMACY (15 MINUTES AFTER INJECTION) FREEZING CHILLS (6 HOURS AFTER INJECTION LASTING 12 HOURS) MUSCLE SPASMS (6 HOURS AFTER INJECTION LASTING 24 HOURS) MUSCLE ACHES (6 HOURS AFTER INJECTION LASTIN 6 DAYS) SHORTNESS OF BREATH CAUSING ASTHMA SYMPTOMS NEEDING RESCUE INHALER EVERY 4 HOURS (17 HOURS AFTER INJECTION LASTING 4 DAYS) HIVES (17 HOURS AFTER INJECTION LASTING 4 DAYS AND NOW REOCCURING) CALLED PHARMACY MORNING FOLLOWING THE INJECTION TO REPORT PROBLEMS, PHARMACY STATED TO CONTINUE TO USE ADVIL/TYLENOL. CALLED PHARMACY TO REPORT HIVES, PHARMACY STATED TO TAKE DIMENHYDRINATE 50 MG EVERY 4 HOURS PRN UNTIL HIVES DISSAPATE TO GO TO ER IF OBSTRUCTING AIRWAY.

BODY ACHES; SHAKING CHILLS; FEVER OF 101.4F; HEADACHE; NAUSEA; PAIN/SORENESS AT INJECTION SITE; This spontaneous report received from a parent concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mild asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A, 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 body aches. On 12-APR-2021, the subject experienced shaking chills. On 12-APR-2021, the subject experienced fever of 101.4f. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced pain/soreness at injection site. Laboratory data included: Body temperature (NR: not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking chills, fever of 101.4f, headache, body aches, nausea, and pain/soreness at injection site. This report was non-serious.

BURNING NEEDLE IN INJECTION SITE; STOMACH ACHE; FEELING HOT INSIDE; THROWING UP; HAVING THE RUNS; CHILLS ON AND OFF; HEADACHE; This spontaneous report received from a patient concerned a 19 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 03-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 stomach ache. On APR-2021, the subject experienced feeling hot inside. On APR-2021, the subject experienced throwing up. On APR-2021, the subject experienced having the runs. On APR-2021, the subject experienced chills on and off. On APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced burning needle in injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, headache, feeling hot inside, chills on and off, throwing up, and having the runs, and the outcome of burning needle in injection site was not reported. This report was non-serious. This case, involving the same patient is linked to 20210435721.

Had a really bad rash to my feet - all over my body and it was super super painful. I went to a dermatologist on April 15 and was prescribed two meds. I take Hydroxyzine at night and in the mornings - Loratadine - to help with the itching. I'm still a little itchy but my rash has gone away for the most part - it does pop up again sometimes but not as bad as it was. It's not as painful.

Patient has been feeling ill with persisting nausea, headaches, malaise, generalized abdominal pain. She has intermittent shortness of breath with chest discomfort. She is not sure if this related to panic attacks. For the last 3 days she has had left posterior neck pain with radiation of pain to her head and left upper and lower arm. Her left arm feels numb and limp at times. She received the vaccine in her left arm.

Pt's throat and tongue and jaw felt like it was swelling. She had extreme pain in her arm and her hands started swelling. She got a rash on her arms and on her hands. I took her to the urgent care facility and they gave her a shot of Decadron and a shot of Benadryl. They also Prescribed steroids. She was very sick like she had a severe flu. I was very worried as her mother. She was weak and slept constantly. Her arm could barely move and It almost appears as if she had had a stroke. She had brain fog and she wasn't remembering her days like she was missing memory. After five days, the reaction started up again so we took her to the emergency room. They did a variety of tests including a urinalysis, CT of the brain, ECG 12 lead, peripheral venous duplex of her upper arm. Everything checked out OK so they put her on more steroids and sent her home. Pt is still having arm pain a month later but finally feels better.

Patient bleed more than usual when got the vaccine. Has couple of drops fall on the arm. After that patient waited for 30 minutes to check if everything is ok. During waiting patient complained of feeling nausea and getting hot. Patient had some water to drink and after a few minutes patient said she was feeling better. Kept watching the patient for 30 minutes and after that she left the pharmacy area without any problem.

patient started bleeding at the site of injection. During her wait time initial felt hot and was seeing spots. The patient also was sweating and didn't feel well. Patients blood pressure did drop. We gave the patient an ice pack and water. Patient refused 911 and refused Benadryl. We took the patients blood pressure and had the patient wait for 30 /40 minutes after the vaccine. the patient felt better

After vaccine, patient was being monitored for 15 minutes and noticed rash forming around where vaccine was given. Pt. stated it did not hurt or itch and she had no trouble breathing or any other symptoms. Advised pt. to take benadryl if it felt itchy or started having any other symtoms. Advised pt to call MD if they felt or saw any further adverse side effects.

The swelling did not go down and I was left with a huge, hurting, and itching bump. I was told that it was a site reaction. I was instructed to use an ice pack on it for 15 mins every hour or so and to take Benadryl and Tylenol.

Gross motor weakness distally in Left Upper Extremity within 1-2 minutes after receiving COVID 19 (Janseen) injection in left bicep muscle. Pain in biceps muscle with passive elbow flexion. Sensation intact to light touch across all limb. Motor function in Anterior Interosseus nerve, Posterior Interosseus Nerve and ulnar nerve intact in Left hand although weak (relative to normal contralateral limb). Vascular exam normal distally, with strong pulses in radial/ulnar arteries. Patient was evaluated by onsite physician and sent to the Emergency Room via EMS.

About 7- hours after injected, woke up in the middle of the night hyperventilating and unable to move. Sweating and sensitive skin all on the body. Headaches that have been constant for the past week and a half and chest pain

Around 30 hours later, I started to break out in hives and nothing would bring them down. My lips began to swell considerably and it was hard to breath. I went to the Emergency room at around 12am that night for treatment. Months later, my lips swell randomly still and hives sometimes pop up too. They can last from half and hour to three hours and it happens at least once a week

5 hours after the vaccine, I started having a sore arm at the injection sight and a low grade fever of 100.0 with chills and I was uncontrollably shaking. I took ibuprofen at 8:00pm. That night at about 9:00 my fever was 100.8 and I felt extreme fatigue. I woke up at 3:30am feeling both extremely hot and cold with a bad headache and my temperature was 101.5. I took ibuprofen again at 3:30am. I then woke up at 5:15 am with a horrible headache and was very hot and sweating. I put cold compresses on my forehead and back of my neck which helped. The entire night, my arm with the injection site was very painful and stiff to move.

Headache, chills, fatigue, tiredness, blurry vision, and sleeplessness; was not able to fall asleep the night after the dose. Lots of pain and soreness at injection site. Had a severe headache the next morning (relieved with acetaminophen), and had a difficult time seeing up close for about two hours despite using my corrective lenses, which made the headache worse.

The first night I had a severe headache, but it was gone the next day, had no symptoms until yesterday, March 18th, after waking up with a huge rash all over my upper thighs and stomach, and the next day, March 19th, it had spread to my arms, and further down my legs, and is starting to spread to my face. No rash has appeared at the injection site, which led me to believe this wasn't a result of the vaccine, but I have made any behavior or diet changes, and have no known allergies, so the only thing I could think to cause the rash was due to the vaccine. I am not saying at all that this means I regret getting the vaccine, I just thought it would be responsible of me to report these symptoms, in case others were experiencing a delayed rash and was concerned. The rash hasn't caused any distress other than existing, there's no itching or pain from it, it just keeps spreading fairly rapidly.

Patient called pharmacy complaining of tight throat, hives, and itching. All occurred about 36 hours after vaccination. Advised patient to take 50mg of Benadryl 4 hours apart then 25mg every 4 to 6 hours. Patient described a close form of anaphylaxis. Advised patient to proceed to ER if difficulty breathing or symptoms progress. Also advised patient to follow up with PCP if symptoms continue for another 24-48 hours.

Patient complained of itching all over her body within minutes of receiving her COVID vaccine. She also had mildly diffuse erythema along both arms. EMS immediately placed an IV and administered 50 mg of Benadryl IV. She remained in observation for 30 minutes with EMS with some improvement of her symptoms. Patient?s father drove her to ER for further evaluation.

Patient reported flu-type symptoms on 3/15/21 but states lumps in armpits started 3/16. Large lump left axillary area starting on 3/16/21.. On exam he had several small mobile tender axillary lymph nodes in left axillary area palpable. The right axilla had a small single mobile tender node. Both axillary areas had superficial follicular pustules and redness. On the Left axillary there was a larger carbuncle that was red and tender and inflamed consistent with boil. Patient described never having had any rash, bumps, or soreness prior to the vaccine. He was treated with Doxycyline and warm compresses to the left axillae and his symptoms resolved quickly within 48-72 hours.

Was really tired, ran a 100.6 fever, chills, couldn?t get warm. Had neck pain. Had a headache, felt tingling in my fingers, was super sore all over. Soreness at injection sight. Symptoms only lasted 36 hours.

2-3 days following the vaccine, a series of small hives appeared along the left side of body. Specifically on the left shoulder and left hip. They appear as small bug bites and are very itchy. They are hot to the touch and only slightly risen. Additionally, at around 10 hours following the vaccine, I experienced severe muscle aches and chills (but this was listed as a typical side effect).

PINL SKIN LESION; SKIN REDNESS ON THIGH AND UPPER BODY; RINGWORM; This spontaneous report received from a health care professional concerned a 3 decade 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pinl skin lesion, skin redness on thigh and upper body, and ringworm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pinl skin lesion, skin redness on thigh and upper body, and ringworm. This report was non-serious.

Beginning about 3 hours after the injection, I had a headache and a fever. Without fever reducing medication, my fever reached 102.9 degrees. 24 hours after the injection, I still have a fever of about 100 degrees. Also, there is some pain around my injection site and some body aches.

uncontrollable laughing and crying, nausea and vomiting especially when standing, feeling of going to pass out and lightheadedness, very red, swollen, and flushed face and ears, eyes were droopy, barely had feeling in face and had a hard time moving jaw. Extreme back pain and facial pain, feeling of shakiness, face turned white like was going to vomit or pass out. Very cold feeling all over but was drenched in sweat. Very tired.

Elevated heart rate. Fever. Body aches and pain at injection site. Chills, hot cold flashes. Weakness and fatigue

Woke up in the middle of the night with fever and chills. Work up next morning with headache, body aches, fever, chills, really sore arm. At 11AM, checked temperature, and it was 102; Took extra strenght tylenol and she napped for 3 hours. Took another temp at 1PM, and she was back down to 98.4. As of 5PM, about 24 hours after the shot, she is doing much better and is only experiencing injection sight pain.

Patient received vaccine at clinic but unsure as to the time. She left the clinic feeling fine, but shortly after started to develop a rash. EMS was called to assess and felt it did not warrant ED visit, however, she went to softball practice and began to have lightheadedness, trouble speaking, in and out of consciousness, trouble breathing, clammy. A rescue squad was summoned and taking patient. Awaiting further word on her condition

Flulike symptoms -- fever, body aches, chills, abdominal pain, fatigue, headache; onset 6 hours after receiving vaccine, resolved 24 hours after receiving vaccine. HIVES without anaphylaxis -- developed 12 hours after receiving vaccine, still progressing 40 hours after receiving vaccine

Fever for 24 hours - high was 102 degrees. Started 6 after injection Chills - 20 hours on and off. Started 10 hours after injection Sore at injection site - 96 hours. Started 3 hours after injection Dizzy - 2 hours. Started 18 hours after injection

Hives on my arms and stomach developed within 15 minutes of receiving the vaccine at 2:16. I left the facility after 30 minutes because the hives did not get any worse and I did not experience any other symptoms. At home about 8 hours later, I started feeling exhausted, weak, and my body was literally shaking whenever I stood. Overnight, I felt feverish, I had the worst nightmares, and woke up every few hours. On Friday (next day) I felt dizzy whenever I moved, nauseous whenever I stood, and once when I was standing too long I started vomiting. On Friday evening I went to a local ER (all the urgent cares were closed) at my primary care Dr?s suggestion to ensure that I wasn?t having an allergic reaction to the vaccine. The ER determined that the hives were likely an allergic reaction but all other symptoms were reactions due to the vaccine.

At recovery table pt became dizzy, lightheaded, slightly nauseated, pale, diaphoretic. Brought to recovery cot to lie down with feet elevated. Ice pack to back of neck. VS taken 98/60, HR 66 reg strong, rest 16 reg non labored, SpO2 99% no LOC, no SOB, no N/V. Left deltoid site benign - redness - swelling - bleeding. Changed to monitor 30 minutes. Pt stated he was anxious about getting the vaccine. after 15 min pallor, dizziness, diaphoresis and nausea subsided. 2nd set of VS taken 110/72, HR 68 reg strong, resps 16 reg nonlabored. Provided reassurance, provided water for hydration . Vasovagal response to vaccine. pt stated "I feel better" Ok'd to exit after 30 min.

erythema, swelling and induration of left arm measuring 6 by 4 cm- onset a few hours after vaccine administration- similar to Arthus reaction. Patient also has fever and chills. Came to seek medical attention on Day 3. No associated lymphadenopathy.

Nausea the day after vaccination, which went away after a day. Starting two days after vaccination, she started experiencing what she described as severe headaches. The severity of the headaches decreased but did not completely resolve over the week after vaccination. The injection site was sore and remained swollen and painful over a week afterwards. She also said that she started wheezing starting a week after vaccination.

Side effects of the injection site were supposed to go away after a few days. It's been almost 4 days since my injection, and the area is still red and inflamed. The soreness is still present, and the skin around the area feels hot to the touch and tight. Sometimes the area has a slight throbbing to it. Other than that, I feel no other symptoms, but I was a bit concerned with this.

Patient was working and fell on the job due to what was perceived to be a seizure. Paramedics were called, and patient was taken to the emergency room. Initial reports from the hospital are that patient has clotting in the arm around the injection site. Patient is still at the hospital at the time of this report.

Around 5:00 PM after having gotten my shot, I arrived home from a drive down to meet my sister. Precautions were taken, masks were worn, safe social distance was maintained and I have no reason to believe any of the symptoms I experienced upon returning home were related to anything other than the vaccine, particularly since first that is how vaccines work and second one of my friends who was vaccinated at the same time as me at the clinic was going through similar pains. It started as a discomfort in my intestines or possibly just below my stomach in general. I thought my pants were too tight but just in case I let my mom take over driving the rest of the way home. When I got to the house, I had about an hour of usable time left before I went into a complete state of delirium. We're not sure how high my fever actually got before my mom woke up and checked in on me at 9:00 PM, but after having pulled the covers away I registered at 102.5° F. I was screaming in a half-awake and half-asleep nightmare, trying to get someone to come help me and unable to get anyone's attention. I would, as a result, like to insist that it be added to recommendations to not be alone after getting the vaccine! For the whole first night! I believe that I genuinely could have died. My brain was melting for lack of more proper medical terminology, and I stopped being able to understand and speak my own first language in an incredibly confused state. This was entirely a result of two simultaneous factors: Fever and Chills. First, the fever made my skin ache. Wearing any clothing hurt. But once I took off my pants in exchange for some breezy shorts, I was covered in goosebumps and feeling frozen even though it was solidly in the 70s. I claimed under blankets and still couldn't get warm enough. The backs of my thighs were insanely hot in comparison to the fronts of them, so I just warmed my body under 3 layers of blankets trying to get the chills to go away. I did that for about four hours during which time I was basically constantly screaming incoherently.

Vertigo, Headache, Nausea, Extreme Muscle Pain. Right arm was swollen, red, and hot for 5 days after.

6 hours after I got the vaccine I had High fever 102.5 for about 3 days, vomiting and diarrhea as well for 4 days. That went away the. developed Headache and leg pain and abdominal pain for about 4 days. Injection site still hurts

I got diagnosed with Cellulitis at the injection site on my left arm. Arm was swollen, inflamed, tender/sore, extremely hot to touch, and itchiness. Prescribed Sulfameth/Trimethoprim 800/160MG TB. The one pill twice a day for 7 days. Most of symptoms have gone away except for a tender/hard lump and itchiness.

Janssen Covid 19 Vaccine clinic held at(Onsite Employer Services)Lot # 1808980 exp. 6/20/2021 As reported on Episode Note: Client returned to vaccination area c/o lightheadedness, dizzy, warm, chest discomfort. BP 114/74, HR 80 C/o centralized chest pain, pain level 5/10, sharp stabbing pain. "Feels like I swallowed water and it's stuck." Pain began when she walked down from the observation area. 1154- approximate time EMS called d/t continuing chest pain. 1156 BP 122/68, HR 84. continued dizziness, increasing fatigue. Applied ice pace to nape of neck. After ice pack applied, client c/o numbness/tingling of Right arm. Ice pack removed. 1158 Patient requested RN call father. Father notified of client status per client request. 1207 Reports feeling chilled, continued chest pain and fatigue. EMS arrived. Vital and 12 lead EKG completed by EMS. Patient denied transportation to hospital. 1215 EMS left. Patient requested RN to notify father to pick her up from employers. HR met with client to complete incident report. 1219 Father contacted to pick up patient. Client voluntarily walked to main entrance of building with HR contact.

Johnson and johnson covid-19 vaccine eau March 20th - allergic reaction to covid vaccine Johnson & Johnson. Allergic reaction started approximately 2 minutes after receiving shot. It started with itching and redness on my arms and upper chest. After approximately 10 minutes, I knew something was wrong and I signaled an attendant. They immediately brought me over to the EMTs on site, where they looks me over and started drawing up IV Benadryl. In the time it took for them to draw up IV Benadryl and insert the IV, the hives on my chest started to turn into burning and ice sensations intermittently. As soon as they administered the IV Benadryl, the itching redness and hives on my arms went away within a couple minutes, and I was left with only redness on my upper chest. They felt comfortable with me getting a ride to the ER from my dad and not getting emergency transport. At the ER, they gave me pepcid and prednisone. About an hour and a half later, I started developing chest tightness and hives and redness on the side of my face. They decided to administer more Benadryl and start epinephrine. I was discharged a couple hours later. March 22nd - I went back to the hospital, with complaints of severe stomach pain. The stomach pain lasted approximately 24 hours. March 20th to march 26th - I experienced extreme fatigue. I was exhausted to the point where on Wednesday I took a ten minute shower and by the end of it I had to lay down again because I was shaking from exhaustion. Symptoms improved slightly until April 5th where it started taking a turn for the worse. April 5th - I started noticing black spots in my vision that wouldn't go away. They didn't move and they stayed in one spot for hours until I fell asleep and then they'd be gone the next morning. They usually started around 8:00 or 9:00 at night. Sometimes a couple hours earlier. They came every day until Friday April 9th when they did not come. April 5th to present - I also started noticing light-headedness, motion sickness when I stood still or sat in a chair, nausea, neck pain, and periods of muscle weakness in the neck. These symptoms have not stopped. Friday April 9th around 6:45 p.m. I started having a bad migraine, I noticed in the bathroom at work my eyes were dilating over and over and over again rapidly. The pain was very high. I ended up leaving work early and going to the emergency room. While at the emergency room they treated my migraine with a cocktail of Benadryl, toradol, and compazine. It reduced the pain at the time, however it did not take away the migraine. Friday April 9th to present - My migraine has continued from April 9th and is still happening. I have been having severe light sensitivity, sound sensitivity, and trouble reading. The rapid dilation of my eyes stopped April 10th, however my eyes stayed dilated until April 12th. In addition to all of my other symptoms, there are others that I am not as positive are relevant. I have asthma and it has been worse over the past couple of weeks, it it is not usually worse this time of year. I've been also been having quite a bit more light bruising than normal over the past two weeks and over the past one and a half weeks I have noticed red spots all over my skin. I was not sure if these red spots were normal or not because I do have them on occasion however these are darker than normal.

INJECTION SITE PAIN; BODY ACHES; HEADACHE; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 14:00 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced injection site pain. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and dizziness on 10-MAR-2021, and had not recovered from body aches, headache, and injection site pain. This report was non-serious.

Stabbing pain in muscles and skin, severe aches in joints, especially knee pain, jaw locked in open position, hallucinations, nausea, weakness. All lasted for entire night until around 4am. Joint pain, aches, weakness continued for another day. Knee pain continues now.

TWO BRUISE (ONE ON EACH LEG); This spontaneous report received from a consumer concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced two bruise (one on each leg). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two bruise (one on each leg). This report was non-serious.

SWELLING BEHIND HER KNEE, CALF AND THIGH; PAIN BEHIND HER KNEE, CALF AND THIGH; CHILLS; NAUSEA; FEVER; INJECTION SITE PAIN; DIZZINESS; DIFFICULT TIME GETTING UP AND MOVING; HEADACHE/COULD NOT MOVE OR TALK; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, non smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced difficult time getting up and moving. On APR-2021, the subject experienced headache/could not move or talk. On 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced injection site pain. On 11-APR-2021, the subject experienced swelling behind her knee, calf and thigh. On 11-APR-2021, the subject experienced pain behind her knee, calf and thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 04-APR-2021, injection site pain on 03-APR-2021, and headache/could not move or talk on APR-2021, was recovering from nausea, and dizziness, had not recovered from pain behind her knee, calf and thigh, and swelling behind her knee, calf and thigh, and the outcome of difficult time getting up and moving 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.

Lupus butterfly rash on nose and cheeks, headache, hands/fingers - feet/toes tingling, skin itchy and burning

About a week after vaccination I started to feel a tingling, burning, almost itching feeling in my thighs and calves. It is not very uncomfortable but very noticeable.

Patient received vaccine at an outside location Patient developed a rash on trunk, bilateral arms and upper thighs Small round, scattered, reddish, flaky lesions. Itchy. No systemic symptoms.

WORSE ASTHMA; RED SPOTS ON ARMS/LEG/CHEST/CHIN/NECK; CONSTRICTING PUPILS; DILATED PUPILS; SEVERE MIGRAINE; BLACK SPOTS IN VISION; NECK PAIN; LIGHT-HEADEDNESS; NECK WEAKNESS; NAUSEOUS; LIGHT BRUISING ON LEG/ARM; FELT LIKE HIT BY MACK TRUCK; SEVERE ABDOMINAL PAIN; FATIGUE; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: unknown) dose was not reported, 1 total administered on 20-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included omeprazole for abdominal pain. On 20-MAR-2021 two minutes after the vaccination, the patient had allergic reaction started with itching and redness on arms and upper chest. After ten minutes, the patient felt something wrong and consulted onsite EMT(emergency medical technician). Later the redness turned to hives with itchy to burning sensation. The EMT (emergency medical technician) was given intravenous Benadryl to the patient and hives got disappeared and redness remained. On the same day the patient went to the Emergency Room(ER) and stayed around seven hours. Pepcid and prednisone was given to the patient in ER (Emergency Room). The patient experienced chest tightness and warm and again Benadryl administered to the patient. The patient was also given Epipen while going home. On 21-MAR-2021, the patient experienced fatigue. On 22-MAR-2021, the patient had severe abdominal pain with 7-8 on pain scale, the abdominal pain was lasted for 24 hours and went away. The patient has been on Prilosec for the abdominal pain since a month. On 26- MAR-2021, the patient felt like hit by mack truck and fatigue. On 29-MAR-2021, the patient experienced light bruising legs far more easily than usual and had a bruise where she wore watch, but it was not deep bruising. On 05-APR-2021, the patient experienced black spot on vision in both eyes around 18:00-19:00 at night until went to bed, and lasted for 4 days. On 05-APR-2021, the patient experienced lightheaded and motion sickness when sitting or standing still; the patient also had neck pain. The patient's neck weakness was felt like the patient's head was going to fall off. The patient experienced neck weakness about once in a week around 15 minutes and also felt nauseous. On 09-APR-2021, the patient had severe migraine with light and sound sensitivity and had rapidly dilating pupils. The patient administered cocktail of medicine Benadryl, Toradol, and Compazine and this medicines helped the patient little bit with the pain. On 9-APR-2021, the patient experienced trouble reading for 2 days due to the dilatation of the both eyes. On an unspecified date, the patient experienced worse asthma than usual, and red spots on arms, leg, chest, chin, and neck. The spots were darker and shinier than usual. Other treatment medications (dates unspecified) included: Medrol for migraine. The patient had visited emergency room for allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from black spots in vision on 09-APR-2021, constricting pupils, and dilated pupils on 10-APR-2021, and severe abdominal pain on 23-MAR-2021, had not recovered from fatigue, light-headedness, nauseous, neck pain, severe migraine, light bruising on leg/arm, worse asthma, red spots on arms/leg/chest/chin/neck, and neck weakness, and the outcome of allergic reaction and felt like hit by a truck was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210436540-covid-19 vaccine ad26.cov2.s-Allergic reaction. This event(s) is labeled per RSI and is therefore considered potentially related.

Beginning approximately 20 hours after injection, the patient developed urticaria from her forehead to toes, sparing only palms and soles of feet. She is started on a Medrol dose pack today. Taking Zyrtec 10 mg daily (hold Claritin while on Zyrtec) and Benadryl 25 MG every 8 hours as needed for itching.

FEELING COLD/HOT SENSATIONS IN LEFT ARM; RASH ON ARM; NAUSEA; REALLY BAD STOMACH ACHE; DEHYDRATION; NERVE PAIN; FELT COLD RUSH DOWN HER LEFT ARM/ FEEL NUMB FOR A MINUTE/ NUMBNESS FIZZLED OUT; EXTREME ARM PAIN/ BURNING ARM PAIN/ FELT LIKE A REALLY BAD SUNBURN/ ARM SORENESS / ARM BEGAN TO SHAKE/ INNER ARM AND ARMPITS SORE/ FEELING WARM, FUZZY PAIN IN LEFT ARM; INJECTION SITE SORENESS; CHILLS; HIGH FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included born with cleft palate, non alcohol user, non smoker, pollen allergy, and mild cat allergy, 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, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out. On 31-MAR-2021, the subject experienced extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced high fever. On 31-MAR-2021, the subject experienced injection site soreness. On 01-APR-2021, the subject experienced nerve pain. On 07-APR-2021, the subject experienced dehydration. On 10-APR-2021, the subject experienced really bad stomach ache. On 10-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced feeling cold/hot sensations in left arm, and rash on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt cold rush down her left arm/ feel numb for a minute/ numbness fizzled out on 31-MAR-2021, rash on arm, chills on 01-APR-2021, and high fever on 02-APR-2021, was recovering from injection site soreness, had not recovered from nerve pain, and extreme arm pain/ burning arm pain/ felt like a really bad sunburn/ arm soreness / arm began to shake/ inner arm and armpits sore/ feeling warm, fuzzy pain in left arm, and the outcome of dehydration, really bad stomach ache, nausea and feeling cold/hot sensations in left arm was not reported. This report was non-serious.; Sender's Comments: V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

PT STATED SHE EXPERIENCED VOMITTING THE DAY OF THE VACCINE IN THE EVENING. SHE ALSO STATED IT PROGRESSED OVER THE NEXT DAY INTO HIVES AND SWELLING. THE ITCHING/SWELLING/HIVES CONTINUED TO BECOME WORSE TO WHICH SHE THEN VISITED THE LOCAL EMERGENCY DEPARTMENT. THE GAVE STERIODS AND OTHER MEDICATIONS BASED ON THE PATIENTS INFORMATION. AS OF 5/3/2021 WHEN THIS IS BEING REPORTED SHE IS STILL ON A STERIOD AND IS STILL HAVING SYMPTOMS RELATED TO THE HIVES AND ITCHINESS.

Immediately following vaccination extreme injection site pain and soreness. Five hours after vaccine was received a minor headache and chills started, some nausea/loss of appetite was present. Six hours after vaccine was administered headache and chills had progressed to being extreme, extreme muscle and joint aches were felt throughout entire body, nausea was extreme and worse when in upright position, low grade fever was noted, some weakness was present, polyuria, thirst, and minor photosensitivity were all present within seven hours of vaccine being administered. All symptoms were persistent throughout night until 20 hours after vaccine was administered. Muscle aches, chills, thirst, and nausea/loss of appetite persisted for first 48 hours after vaccine was administered. Pain at administration site persisted for 2 weeks after vaccine was administered with limitation to use of left arm. Muscle soreness returns with increased use over extended period of time of left arm still at a month after vaccine was administered.

BACK PAIN; NECK PAIN; BUTT HURTS WHILE SITTING ON THE RASH/BRUISE; INFLAMMATION IN BLOOD; NOT BEEN NORMAL; LEGS HURT; BRUISY ON LEFT BUTTOCK; RASH LOOKING LIKE BLUE/PURPLISH DOTS ON LEFT BUTTOCK WORSENED; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 20 year old. Initial information was processed along with the additional information received on 18-MAY-2021. 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: 1805025, expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, next day after vaccination, the patient experienced bruisy rash on the left buttock. The rash looked like a little blue/purplish dots, it started coming back and worsened. If the patient does anything with impact it comes back. On 04-MAY-2021, laboratory data included: COVID-19 antibody test also called as Abbott Chemiouninesent Microparticles Immunoassay SARS COV-2 IgG test (NR: not provided) no antibodies. The patient experienced confirmed immunological vaccine failure. On an unspecified date, the patient experienced back pain, neck pain, butt hurts while sitting on it if she has rash/bruise, legs hurt, inflammation in blood and not been normal since she got it (unspecified). Laboratory data (dates unspecified) included: Blood test (NR: not provided) inflammation. The patient had been to the hospital and saw like 6 healthcare professionals and nobody knew how to help her/fix it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise on left buttock, back pain, neck pain, legs hurt, butt hurts while sitting on the rash/bruise, rash looking like blue/purplish dots on left buttock worsened, and not been normal, and the outcome of confirmed immunological vaccine failure and inflammation in blood was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product quality complaint number 90000179797.; Sender's Comments: V0: 20210530406--Confirmed 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

20 year old female, approximately 1-hour post-vaccine experienced lightheadedness, dizziness, vomiting x1, diarrhea x1, urticaria, "body on fire." Vital signs: HR: 108, BP 154/64, temp 98.2. Administered epinephrine x 1 dose and transported via EMS to Medical center for further evaluation, treatment.

I had a fever to 102 that carried on to the next day. I had diarreha, chills, body aches, nausea, headache, and a bruise at the injection site.

patient felt very dizzy and faint immediately after receiving the vaccine. She said her arm where she got the vaccine felt numb. her blood pressure was 88/54 HR 60 O2 98 when first checked. her BP was checked every 5 minutes for 30 minutes and was in the range of 88/54 -118/93 her HR was 60-75 and her O2 remained in the 96-99 range. She was given an icepack to put on her arm, a cold towel for her forehead and neck and she lay down on the floor. her feet were elevated the entire time she was lying down. She eventually was able to sit up and said was feeling better. her final bp reading was 118/93 HR 75 O2 99

MIGRAINE; CHEST PAIN; PAIN AT THE INJECTION SITE; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: OU3A21A 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 pain at the injection site. On 19-APR-2021, the subject experienced migraine. On 19-APR-2021, the subject experienced chest pain. On 20-APR-2021, Laboratory data included: EKG (NR: not provided) Normal, and X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 23-APR-2021, chest pain on 22-APR-2021, and pain at the injection site. This report was non-serious.

LESS THAN 5 MINUTES AFTER RECEIVING THE VACCINE, PATIENT FELT VERY LIGHT HEADED. SHE SAW BLACK SPOTS & HER HEARING WAS MUFFLED. SHE SAT BACK DOWN IMMEDIATELY. HER SKIN WAS WHITE WITH A GREEN TONE. BLOTCHY IN SOME SPOTS. SHE WAS ALSO SWEATING WITH CHILLS. WE GAVE HER WATER & RICE CAKES THEN A PEDIALYTE POP. PATIENT FELT BETTER AFTER 3 GLASSES OF WATER AND AFTER 15 MINUTES HAVE PASSED. WE MONITORED HER FOR AN ADDITIONAL 15 MINUTES. SHE LEFT THE PHARMACY WITH COLOR BACK IN HER FACE AND SWEATING HAD STOPPED ADVISED HER TO STAY HYDRATED & SEEK MEDICAL ATTENTION IF NECESSARY

Chills and shivering that resulted in uncontrollable shaking, extreme full body pains especially in lower back that were debilitating, fever, extreme fatigue and weakness, headache, pain and soreness and injection site. All lasted for approx. 32 hrs.

9:30 PM- headache, chills 11:30 PM- projectile vomiting, chills, fever, headache 12:00 AM- projectile vomiting 4:30 AM- projectile vomiting, 101 fever, uncontrollable chills, headache 8:30 AM-headache 11:30 AM-present- lethargic, dizzy, soreness at injection sight

24 hour sickness, but adverse reaction has been a growing red circle on my arm. It is raised, itchy, painful, and hot.

patient was weak and pale . could not sit . low BP 91/44 HR; 43 . sever arm pain on injection site .

24 hours post-injection started with redness and pain to Left deltoid injection site and has gradually worsened with 1.5inch circular area of induration and redness and warm to touch

Patient reported some itching and discomfort in throat about 15 minutes after administration. Denied breathing or swallowing difficulty. Was given 25 mg of diphenhydramine by mouth and in 15 minutes patient reported feeling better

Patient received the Janssen Covid-19 vaccine and after a couple minutes in observation she developed pruritis to both arms and neck. Was given po diphenhydramine 25mg and patient monitored for additional 15 minutes. Pruritis got better after diphenhydramine and patient went home. Was counseled to RTC if experiencing any SOB/hives/rash etc.

I was very sick which is normal but I woke up this morning, 3/24/2021, and have a red splotchy rash on my neck and forearm. My forearm is very itchy.

patient is reporting numbness at injection site. She also has a swollen red arm with a solid lump under the skin.

About 6 hours after I recieved the vaccine, I started to feel relatively sick. I had a bad headache and was achy, which I know were listed as possible side effects. A few hours later, I started to have a severe burning sensation all over my body. It felt similar to the sensation when your skin gets extremely sensitive to any touch, but was magnified 10x over, and was over every inch of my body. There was no rash, and I did not have a chill as though I had a fever, although my skin was warm to the touch. I took 2 500 mg tablets of extra-strength Tylenol, and the symptoms did not improve at all.

At around 10:30pm on the day of the vaccine until I feel asleep after 2:00am, my heart hurt, my whole body ached, I was so cold my skin was red. My head hurt. I felt like I would pass out. Today, 4/1, I feel better but go from hot to cold and still feel aches with my head hurting earlier.

I first started to feel weak and achy around 6 pm. Around 7 pm the body aches started to intensify especially in my lower back and thighs. I started to get chills and had a temperature of 102.8. The next morning I woke up with a low fever of 100 and was very tired and had a headache the rest of the day. My arm at the site of the injection was mildly sore for 3-4 days after the vaccine

Throughout the day my mouth was very dry, no matter how much water I drank. Other than that my first major symptom was mucsle aches and body soreness which started about eight hours after the shot. A couple of hours later I started having chills which felt like I might have a fever, but thermometer said my temperature was normal. The muscle soreness remained moderate throughout the night. About 3am I took my temperature again and found that I had a fever of 99.6. The next morning the fever, aches, headache, and chills remained. The aches continued but lessened in severety by 04/03/2021 later afternoon and the fever had disappeared. Arm of the injection sight remained sore the entire time.

6 hours after vaccine: intense chills, 102° fever for 6 hours, muscle soreness, nausea Day after vaccine 4/3/21: nausea, loss of appetite, muscle soreness, blurry vision, headache 2 days after vaccine 4/4/21: headache, soreness- especially at injection site, loss of appetite 3 days after vaccine 4/5/22: nasal congestion, runny nose, headache, fatigue, dizziness

Injection site soreness immediately after and continuing for days (to present at time of writing). At 12 hours after injection, feeling feverish, chills, crawling skin, full body aches. Feverishness and chills resolved after a night of sleep, and aches and crawling skin continued for one more day. Managed with rest, oral painkillers, and fever reducers.

Around 9pm was very tired with small headache. Went to bed at 10pm and laid there for an hour and a half with my head pounding and burning. I?ve never been able to feel a fever on myself?it was so high. I also had major chills the whole time. I?d get up and hydrate and took 2 Advil around 12:30pm as no sign of sleep was coming. I put ice packs on my hot head for an hour with no relief. Meanwhile my heart rate was steadily above 100 for the whole night until about 4am when my fever went down and I was able to sleep till 7am. I thought I was going to die it was so hot and painful and pounding. In the morning the fever is gone and I am extremely tired. Currently not recommending people get the vaccine.

Janssen COVID-19 Vaccine EUA Headache started around 5:30PM and progressed into migraine by 7:30PM. Full body aches, severe bone pain (low back/neck), sensitive skin, hot/cold flashes, dizziness and sleep difficulties continued all night even after 1000mg of tylenol. Symptoms continue this morning (8:00AM) but to a far lesser degree. On a scale of 1-10, the level of pain was ~8-9, and unrelenting.

Numbness in Left Side of face, so far has persisted for 6 days after the vaccine. Included Left side of mouth, left cheek/cheekbone area, and left eyebrow to midline. Felt like there was lidocaine in my face. Dizziness: still getting bouts of dizziness while sitting down and walking, world feels like its spinning Brain Fog: struggling to maintain train of thought, memory problems Fatigued Feels like there is a knot at the base of my throat, feel it when I swallow liquids, does not inhibit swallowing but is a nuisance Fever- lasted for 3 days Chills- lasted for about 24 hours Muscle pain and aching, soreness at injection site, intense shoulder and neck tension is still present but decreasing Headache- 4 days Ventolin Inhaler needed to be taken twice during the worst of the effects, asthma symptoms, specifically coughing and wheezing, have been continuing but decreasing Felt like vaccine exacerbated asthma symptoms Chest tightness, as though someone is sitting on my chest(not one of my usual asthma symptoms)

Body aches, dizziness, insomnia related to the pain, nausea, weakness, restlessness, headache, injection site pain, chest pains.

About 7 days after my vaccination, I started to develop a rash on my arms 2 inches below my vaccine site. After about 15 minutes it started on the other arm. Then 15 minutes later, it started showing up on my leg. It was very itchy, swollen, but I took Benadryl and went to sleep. I woke up and the rash was gone.

Headache that evening and that lasted for about two days. Around 11 PM that same night of vaccine - I had chills but no fever. The second and third day I was super fatigued. Everything was okay after that but a week and a half later I was receiving severe stomach pain and a little blood in my stool. That is what brought me to the ER on 23rd when I had the blood in my stool . I had a rash on the back of my thighs and I had swollen lymph nodes on each side of my neck that started after that. I went to ER again last weekend and that ER was at another location - no tests were done there. They told me to take OTC Tylenol. I still have the swollen lymph nodes and the rash is getting better not completely gone.

Pt received vaccine. sister had vaccine same day and had immediate reaction. Mother stated she has problem with needles. MD suggested to have sister wait to monitor for vagal vasal response. Pt did complain of dizziness, No LOC, No SOB no N/V. Applied ice to back of neck, gave water for hydration. VS128/78, HR 68reg, resp 12, SpO2 98% Pt's . Left Deltoid site benign - reddness - swelling -bleeding. Mother was at her side. Provided reassurance. Monitored 30 minutes. kept reassessing condition. Pt stated she felt better. Ok'd to exit with family after 30 minutes.

CHILLS; HEADACHE; INJECTION SITE SORENESS; CHEST PAIN; SORE ARM; FATIGUE; SLIGHT FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's weight was 190 pounds, and height was 158.49 centimeters. The patient's concurrent conditions included smoking, and alcohol user, and other pre-existing medical conditions included patient was not pregnant at the time of reporting and has no history of illicit drug abuse and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 16:30 to left arm for prophylactic vaccination. Non-company suspect drugs included: amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate ( form of admin, route of admin, and batch number were not reported) 15 mg, 2 times every 1 day, therapy dates were not reported for an unspecified indication; and drospirenone/ethinylestradiol ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chest pain. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced slight fever. On an unspecified date, the subject experienced chills, headache, and injection site soreness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, slight fever, and chest pain, and the outcome of sore arm, headache, chills and injection site soreness was not reported. This report was non-serious.

Janssen COVID-19 Vaccine EUA- Had a 101 degree fever (with headache, body ache, and shaking) the day after vaccination, and a 99 degree fever (I'm usually about 96.5 degrees) the next two days. Left arm has gotten progressively sorer over three days and is currently (3 days in) swollen and feverish feeling in an area the size of a baseball around the injection site.

Extreme chills and ultra hypersensitive skin. Extreme lethargy and pain in arm. I bundled up in many layers and laid in bed with the house thermostat set to 72. Chills and sensitivity have not abated in the 2 hours since onset.

Night one, feverish and chills. Day two, swollen and tender. Day three developed into a red bump the size of a dime and pain and swollen. I iced it. And took ibuprofen. Day four the redness has welted and increased in size to a 50 cent piece. Still hurts and feels hot, sometimes it tingles. Still taking ibuprofen.

Swelling of under eye. Right eye significantly more swollen than left eye. Puffiness and redness. Took a Benadryl and swelling subsided. No itching of eye.

Immediately (a minute or two) after receiving the vaccine: lightheadedness, nausea, nearly fainted, vision started going blurry/black, sweating for about 5-10 minutes. Stayed seated until it mostly passed, then went outside for fresh air and to cool down. Put a cold rag on forehead/back of neck for half hour following symptoms. Drank water at soon as possible. For the next 36 hours after receiving the vaccine: sensitive skin, muscle weakness, tiredness, headache, body aches (including the sight of injection), chills, hot flashes. Took Advil every few hours to reduce pain, kept lights off, laid in bed to rest.

PATIENT EXPERIENCED DIZZINESS, FEELING HOT, SCRATHY THROAT, FEELING ITCHIY AND LIPS TURNED BLUE WITHIN 2-3 MINUTES OF ADMINISTRATION. ADMINISTERED EPIPEN. PATIENT FELT BETTER. EMT TOOK PATIENT TO THE HOSPITAL. I CONTACTED THE PATIENT SHE IS OK AND WAS SEND HOME AFTER THE HOSPITAL.

Patient stated that she had history of dizziness after she received birth control shot ( six years) ago, but she has been getting flu shots and felt fine. No known drug allergies per patient. On 04/04/2021, patient received her first J&J covid vaccine from one of our technician, her skin stated turn crimson. The technician reported to the on duty pharmacist. The pharmacist then found patient sat on a chair sideway and was unresponsive. A immediate 911 call was made. In the meantime, Patient sat up and was able to answer questions appropriately. Patient declined to call ambulance. Patient's BP was 135/86 and P was 48. We observed patient for an additional half hour until her ride came. Pharmacist also counseled patient to have some benadyl at home and seek PCP for medical evaluation. The pharmacist checked back patient twice after she left and she felt fine.

- weakness in my body - muscle aches - headaches - fever of 101.3 lasting for almost a full day after - confusion -chills - soreness around injection site - redness around injection site (all the above lasted almost 24hrs, from 7pm the day of the shot until the next day around 7pm) I also have a hardness under the skin at the injection site that has persisted a week after. It?s a hard lump, shallow and it?s sore to the touch, it used to be hot and red, now it?s just tough.

Fever, headache, nausea, chills, loss of appetite, achy right knee, soreness at injection site, exhaustion

BODY ACHES; SORE ARM AT INJECTION SITE; This spontaneous report received from a parent concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced sore arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm at injection site, and body aches. This report was non-serious.

SWEATING; RASH ON NECK; SORE ARM; This spontaneous report received from a patient via a company representative concerned a 21 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sweating, rash on neck, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating, rash on neck and sore arm was not reported. This report was non-serious.

PAIN IN BOTH ARMS; HEADACHE; CHILLS; PAIN IN INJECTION ARM; FEVER; PAIN IN VEINS; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included thrombosis, and concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of report. The patient was previously treated with rivaroxaban for thrombosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pain in veins. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced pain in injection arm. On 18-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced pain in both arms. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, pain in injection arm, fever, and headache on 19-MAR-2021, had not recovered from pain in both arms, and the outcome of pain in veins 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.

Upon receiving the vaccine, I immediately fainted (vasovagal syncope). I was unconscious for ~15-20 seconds. My apartment-mate who came with me for the shot laid me down on the floor until I could sit up again without feeling dizzy (~15 min). I also had pretty serious bruising at the injection site for ~9 days following the injection and my arm was swollen and painful (although this is a pretty normal side-effect).

Fatigue, chills, shivering starting 15 hours post vaccination Significant pain around injection site (clothing brushing on injection site causes sharp pain) Redness and swelling around injection site Redness and swelling extending 2 inches in one direction from injection site

A lot of bleeding at injection site when given the shot. The day of began 102 degree fever. Severe chills. Body aches. Sore throat. Fatigue. Swollen arm. Pain in arm. Nausea. Lasted about 5 days. 3 weeks later still have tingling and pain in right arm.

Yesterday pt reported sore arm, swollen/red arm, body aches, fever (102F), headache, difficulty swallowing, palpitations, shortness of breath, gets winded walking around. This was when she spoke to triage nurse. Advised to go to Urgent Care or ED and follow up with PCP Dr.

PATIENT FELT FEVERISH AROUND MID-NIGHT ON THE DAY OF VACCINATION, BUT WENT TO SLEEP. SHE WOKE UP AROUND 5AM ITCHING, EXPERIENCING RASH FROM GROIN TO ARMPIT, NOW SPREAD UP TO HER NECK, FACE, NOSTRILS, EARS AND SCALP. HER LIPS ARE SWOLLEN AND EYELIDS AS WELL. NO SWOLLEN TONGUE YET BUT SHE SAID HER THROAT FELT A LITTLE FUNNY.

21yo Active Duty female Navy Sailor currently deployed to UAE reports to Fujairah Detachment medical clinic with c/o bottom lip swelling x 96hrs, which began about 24 hours post receiving the J&J vaccine on 16May21 in Jebel Ali, UAE. Pt denies any pain, tingling, or numbness but does report a throbbing sensation in the lip. Pt denies any dyspnea, SOB, dysphagia, or difficulty eating/drinking. Pt states there is also a blister like red spot on the middle of the lip. Pt denies any fever, body aches, fatigue, n/v, or other skin lesions. Pt denies any history of cold sores/herpes labialis. Pt denies having anything like this from a vaccine in the past. No history of medication, food, or environmental allergies. Pt also reported HA, stomach ache, and feeling weak for 24 hours after vaccination then resolved, but lip then swelling began and persisted prompting medical evaluation. Provider prescribed 25mg Benadryl which significantly decreased the lip swelling over the following 6-8 hours.

Fever lasting over 24 hours Pain and swelling at sign of injection lasting over 48 hrs Chills Headache lasting over 48hrs Fatigue

Date of vaccination (4/28), fever of 102 F, resulting in loss of sleep. A week later (5/03), singular hives began to appear on arms and legs, resulting in loss of sleep. Much worse the next day (5/04)- clustered hives accompanied with burning rash all over arms and legs. Benadryl anti-itch cream only enflamed them more. Vomited the next morning (5/05) and made an appointment with healthcare clinic, despite hives and rash subsiding overnight. Doctor ruled vomiting as an effect of prescription medication, but rash and hives as a result of a reaction to the vaccine. Next day and the day after,(5/06-5/07), had a few single hives appear on body. Haven't had any more appear since then, and I've felt fine.

SEVERE MIGRAINE; FLU LIKE SYMPTOMS; STOMACH PAIN; ARM SORENESS ON THE SURROUNDING TISSUE AROUND THE INJECTION; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, severe depressive disorder, generalized anxiety, alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included sertraline for antidepressant, ethinylestradiol/norgestimate for birth control, and salbutamol. On 25-MAY-2021, the subject experienced arm soreness on the surrounding tissue around the injection. On 26-MAY-2021, the subject experienced severe migraine. On 26-MAY-2021, the subject experienced flu like symptoms. On 26-MAY-2021, the subject experienced stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe migraine on 26-MAY-2021, and flu like symptoms, stomach pain, and arm soreness on the surrounding tissue around the injection on 27-MAY-2021. 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

The first week widespread hives on arms/back/legs for 2 up to 7 hours at a time. After the first week random locations of arms/legs. hives are itchy and spread when itched. React to Benadryl. This has been ongoing nearly every day for 2.5 months since 4 days after vaccine.

Itchy rash appearing within 15 minutes of the incident. I was unable to observe a visible rash, but she says it was there. Spread over the next 15 minutes. Stable and patient notes not as itchy anymore.

PT complained of localized itching on her inner side of the left arm, after receiving the vaccine. RN Administeres 50MG of Benadryl and the outcome was that the PT stated she was fine and she wasnt experiencing anymore itching.

The patient stated they were fine for the first 15 minutes after the injection, but as they were getting up to leave I could see her color was not good and I made her continue waiting . I got out an ice pack and put on the back of her neck and she leaned forward on another chair to try to get the blood to her head. She started breathing heavier and complaining of her stomach hurting and not feeling well. She was sweating and crying. We called 911 and laid her on the floor with a cushion under her head until they arrived. The patient continued to cry and complain of stomach pain and could not open her eyes. She also had no strength to stay upright. Her blood pressure was elevated at 163/100. The patient was taken by ambulance to the hospital.

Rash across chest and neck (about three minutes after the shot, went away an hour later), fever 103.5 by 3pm that day, nausea and vomiting by 8pm, panic attacks and night sweats throughout the night and the following day. Fever wouldn?t break with Tylenol for two days. Cramping in left calf to present day.

Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Sweating-Medium

30 minutes after vaccination in R deltoid had rash, fine red not raised on right forearm. Given benadryl 25 mg po. within 5 minutes developed subjective tachycardia/ and shortness of breath and felt light headed. Rash on forearm improved some with benadryl. Given one epipen at the time 911 was called. She felt short of breath, she was not audibly wheezing. EMT took her to the local hospital. She was always alert and conversant.

First experienced soreness at injection site after receiving the vaccine. Then at around 6:00 I began feeling pain/aches all over my body as well as chills. Around 9:00pm I got a headache. Chills went away a few hours later but the aches were extreme and persisted until around 2:00pm on the March 17. Also experienced fatigue.

Immediately after being vaccinated, patient's face and eyes began to swell and became red. Patient denied itching or shortness of breath, itchy throat. Patient given 50mg benadryl at 1900. Patient then complained her throat was itchy and her voice was becoming hoarse. She continued to deny shortness of breath. EMS was called at 1908. EMS arrived at 1920, evaluated patient. Patient found to be stable and was given option to go to the hospital via EMS or go home. Patient decided to go home with her friends.

arm soreness within 12 hours persisting for 3 days. Fever after 1 day. Headache still occurring after 4 days. Swelling and redness at injection site after 2 days and continuing growth. On day 2, size of dime. Day 4 (today) size of tennis ball.

Originally, I started with random muscle aches in my left shoulder then it went down my back (a few hours after receiving vaccine). Then slightly fogginess and at night the muscle pain became worse making it difficult to sleep and started getting cold flashes. Once asleep around 12:30 I started getting muscle aches that felt like they were burning and in random spots on body along with a headache and would get random cold and heat flashes. Kept yelling out in pain all night and increased tremors in hands. Boyfriend noticed I had a fever as well and gave me ibuprofen around 3am since pain was unbearable and was difficult to sleep. Almost took me to the hospital due to the intense pain.. In morning slightly better but still frontal lobe pain and aches throughout body with raised heart rate. Cannot do much or else aches get worse including headache.

Severe chills, tremor approx. 6 hours after injection(8 PM). Initial episode of chills/tremor lasted roughly one hour before calming. Recurrent chills of lesser severity followed for approx. 4 hours after, on and off. Fever ranging from 99.4-101.0 followed. Skin sensitivity akin to "feeling like a sunburn", muscle ache, and brain fog followed the next 30 hours.

Left deltoid area - swelling and redness - diameter larger than 1/2 dollar coin. No lymph node swelling of affected extremity. Patient states hurts to lift arm/sore (uncomfortable) - constant pinching feeling. Soreness causing discomfort with dressing.

Patient has significant swelling, redness and pain at injection site. Also reports headache, chills, fatigue, muscle aches

Initial arm pain in injection spot for about 10 minutes. About 5 hours after vaccine, developed headache. About 7 hours after vaccine, developed convulsing chills. Throughout the first night after vaccine alternated between chills and hot flashes. About 15 hours after vaccine, still had headache and sore/tired eyes. Headache lasted for about 48 hours in all. Arm with injection site sore for 48 hours. Ibuprofen did not help with headache or arm pain.

Fever and chills (8:30pm-2:00am next day) Nausea / vomiting (3-4am next day) Extreme back pain (mostly lower back) (2am-7am next day) Red, hot, itchy rash on left side of back / abdomen (I just noticed at 11pm day after, not sure when it began) Extreme fatigue and mental fogginess (8pm day of - still continuing 11pm day after)

when my shot was inserted into my arm it felt like the whole inside of my arm from shot injection cite to my wrist was constricting, I was in a lot of pain. woke up at 2 am with a searing headache, felt like I was going to throw up, my arm throbbed at my injection cite, I had a lot of diarrhea. got maybe 2 hours of sleep that night

Muscle pain, fever, and headache the day after the vaccine was administered and this lasted 2 days. Also I got inflammation in the injection area which is red, inflamed and causes a lot of pain as much as the movement of the arm as the touch of the area. It's like a "bump". This effect originated since the same day that vaccine was applied to me and even 6 days later I still have this symptom or adverse event in my left arm which is where I received the "shot."

I had a mild fever Saturday morning, fatigue, and my arm was sore for a few days at the site of injection.

Fever (103F) started at 8pm alond with chills and sever headache. Muscle aches and skin sensitivity also occurred with fever. Fever broke at 3am then started again at 8am. Tylenol taken every 6 hours for Fever.

~3PM Immediately after injection - intense pain at site of injection. Several minutes after injection - lightheadedness. ~10PM - sudden overwhelming full body symptoms. Started with lightheadedness, fever, headache, and nausea. After laying in bed, the headache became extremely painful/throbbing. Full body aches (back, neck, legs) began. Ears got sensitive to sound, eyes got sensitive to light. Stayed in bed experiencing pain until ~1 pm the next day. After taking aleve around 11 am, the headache and fever subsidized, but the remainder of symptoms still persist.

20 YO FEMALE CONSCIOUS AND ALERT WITH A GCS OF 15 COMPLAINING OF HAVING ITCHING AND HIVES TO THE LEFT FOREARM. PT WAS JUST GIVEN HER COVID 19 SHOT. PT DENIED CHEST PAIN, N/V/D, SHORTNESS OF BREATH, BLURRED VISION, DIZZINESS. PT HAD A PATENT AIRWAY WITH EQUAL CHEST RISE AND FALL. PT HAD SOME HIVES TO THE LEFT FOREARM. PT HAD NO DIFFICULTY BREATHING OR RASH ANY WHERE ELSE. PT HAD NO OTHER DCAPBTLS, HEENT WAS UNREMARKABLE. PT VITALS WERE TAKEN AND RECORDED. PT WAS GIVEN 50 MG OF BENEDRYL PO BY EMT. PT WAS OFFERED TRANSPORT TO THE LOCAL HOSPITAL FOR FURTHER EVALUATION. PT REFUSED

Pt had very terrible pain in the back of her hips and lower back beginning at 3am the night she got her vaccine, similar pain to menstrual pain/cramping. Pain was severe enough to cause her to cry; it lasted for 1-2 hrs and then she took tylenol and was able to fall back to sleep. riday morning when she woke up, pain was barely there, some achiness. Then symptom completely gone over 1-2 days. She also noticed left face/hip with raised red areas that looked like she had been bitten by ants on 4/2 (day after receiving vaccine). This rash was gone in one hour and no symptoms since.

Fever, chills, sweating, nausea, headache, pain at injection site, fatigue. Symptoms started a few hours after the injection and have continued for at least 24 hours. I still have symptoms at the time I'm filling this out.

Day After Injection: fever, chills, nausea, dizziness, light sensitivity, migraine, muscle aches, itchiness by injection Day two: swollen injection site, severe itchiness, muscle ache, dizziness Day three: 04/10/21 severe itchiness, redness size of golfball

My daughter got the shot at 1 pm on the 8th of April, 2021. (My daughter & I both got the shot at the same shot at the same time). By 11:00 pm my daughter started complaining with feeling dizzy. She kept saying she felt like she was going to throw up, meaning she was nauseated. She was complaining with her bones hurting. We both got these symptoms at the same time. We both stayed in and out of the shower letting the shower water just run on us. I had to give her ibuprofen because she complained of a mild headache & the pain all over her body. She couldn?t sleep at all. She cried. It had her scared. I fully believe she?s having an allergic reaction to the Janssen shot. I have fully read the Janssen ?fact sheet?. My daughter was having hot flashes & cold sweats. She has ongoing symptoms & it?s been 2 days since receiving shot including fever. She was having what I thought heart palpitations. We both swelled up causing our bodies to feel tight. We both were healthy before receiving the shot. We?ve never had covid nor tested positive. We are currently going to receive a check up by a doctor. The side effects of this medication is dangerous & doesn?t compare to flu like symptoms.

About 9 hours after receiving the Janssen vaccine on April 9th, I started feeling ill. I had a fever of 102, difficulty walking/moving on my own, intense nausea, numbness in my left arm for about 2 minutes, and I spontaneously got my period (which was very regular up until then). I took Tylenol, went to bed, woke up with a 100 degree fever but feeling much better, and it soon dropped back to 98 degrees. Today, on April 13th, I started having pain in my left arm and leg. Specifically, in my left bicep (not the injection site) and my left thigh. This pain does not feel like muscle soreness, but almost like a knot? I'm not sure how to describe it, but I find it odd the pain in my arm increases a bit when I walk/move.

In addition to the common side effects of muscular pain, strong headache, chills, instead of nausea, there were vomits, two times. After 4 to 5 hours of the vaccine shot in the left arm, the area was swollen, red and painful. The adverse event different than reorted one is that the day after, a bruise appears and still in pain.

Janssen COVID-19 Vaccine EUA. Vaccine burned while being injected and for about 4 hours afterwards. Arm hurt for a good week after as well. Had a small red raised bump at injection site for about 6 days. Have not had a period for 4 years due to my birth control, got my vaccine on 03/30/2021 and then started a brown and clotty period on 04/01/2021. Period last about 9 days and seems to be gone now besides an odor. Had undescribable cramping in abdomen. Had some type of stomach bug (fever, vomiting, diarrhea) on 03/27/2021 that lasted about 72 hours. Then had another episode of diarrhea on 04/04/2021. Currently having bad headaches and right thigh cramps. Blood pressure and temperature seems to be running higher than my normal still.

103.5F fever, severe chills/sweats, joint pain, myalgia, eye pain, neck pain, headache, injection site pain, weakness, light headedness, axillary lymph node swelling and pain. still experiencing eye pain and lymph node pain

Janssen COVID-19 Vaccine Immediately following the shot and lasting for about 48 hours, arm pain at the site of injection. Starting at 10:30pm on the day the vaccine was received, had chills (came and went for about 12 hrs), neck pain, back pain and headache (all lasting about 24 hrs). About 24 hrs after the vaccine, had heart racing/palpitations lasting 20 minutes.

Several hours after the vaccine I noticed abdominal pain located in my lower back, primarily on the left side. I also had a pounding headache (not a migraine), and other body aches. Over the next several days (Thursday night through Saturday, 4/1-4/3) these symptoms persisted along with mild dehydration and constipation. The aches I treated with ibuprofen, and I used a mild, natural laxative to try to poop. The constipation was relieved by pooping, but it was much less than my normal amount of stool, and it took a couple days to fully abate. I also noticed that I wasn?t sweating very much/at all until about a week after I received the vaccine, which was very worrying. I attempted to drink plenty of water during all of this, though I can?t be sure I succeeded. I think my menstrual period may have happened during this week, maybe starting on the Tuesday falling the vaccine, but cannot remember for sure. Constipation and dehydration are unusual for my period, though the pain is not. There was soreness in my arm muscles around the vaccine site, but it was consistent with what I feel from any other vaccine, and only lasted a day. All discomfort ceased about a week after the vaccine.

pt reported had vaccine on wednesday, on thursday started feeling sluggish, flu like symptoms, friday started itching and achy arm, saturday went to urgent care with blister at injection site, urgent care filled out online form and gave pt benadryl. today tuesday, pt felt better, blister went away, still little achy arm but better.

Injection site (arm) pain, headache, fatigue, full body chills, fever of 101.3, vomiting, diarrhea, lightheadedness, pale face, dizzy. Lasted about 3 days. Tylenol was taken every 6 hours to help with fever and arm pain.

Dizzy and nauseated when standing, Shivering beginning two hours after symptom start, Headache, Muscular pain at site of injection, mental inhebriation (brain felt drunk) getting increasingly worse. Three hours after symptom start unable to keep balance while standing, shaking in blankets. Next day, fever of 100.4 at 9am down to 99 by 12pm (after nsaid at 10am), fatigue, trembling, stiff neck

Almost passed out about 6 minutes after injection 5 days later I developed a face rash - still have face rash today

I was achey/fatigued/chilled/feverish the day of, since I got it in the morning, and felt decent the next day. That following Sunday/Monday/Tuesday I had a moderate headache. 4/11 I had a severe headache and started feeling achey in my torso/mid region, especially when I breathed/coughed. 4/12 the headache was more moderate, but the aches were a lot worse, and I felt some mild dull pain in my lung area when I breathed. I woke up 4/13 with a very swollen and puffy face, and the aches are still here. I?m normally very active jogging and in the gym, and I haven?t felt anywhere close to normal - fatigue and aches go hand in hand. 4/14 I had a very swollen face, continued aches and abdominal pain. I went to urgent care 4/14. 4/15 face swelling went down a little, moderate headache, continued aches and abdominal pain. 4/16 (today) face swelling was down more, continued aches and abdominal pain. Fatigue every day and reduced activity levels and work.

per patients mother: pt had complained of dizzyness right after leaving clininc. Mother was driving, she said that about 5 minutes later pt started getting hot flashes and had developed a rash across chest, decided to drive to hospital on the way there she progressively got worse she started to complaine of chest tightness/pain. once at ER she double over from severe stomach pain-said it felt like she had to go to the bathroom. Mom said that things quickly worsened. She started to have throat swelling. Epinepherine was administered and IV benedryl, pt stayed in ER and was observed for several hours. Mom reports they were sent home around 4pm and around 7320pm that night pt started feeling tightness in her chest and difficulty breathing mom gave epinephirine and called 911. EMT's transported her back to ER. She was stablized and sent home. pt continued to have these episodes of Chest tightening and difficulty breathing resulting in several more visits to the ER and one over night stay. Last visit to the Hopsital was on 4/15/21

SORE THROAT; BURNING EYES; BODY ACHES OR BODY WAS PAINFUL TO THE TOUCH; MIGRAINE; NIGHTMARES THROUGHOUT THE NIGHT; DIZZY; FEELING COLD; SHAKING; CHILLS; INJECTION SITE PAIN; FEVER OR BODY WAS BURNING UP LIKE A FURNACE; FELT FATIGUED; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included 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, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 15:50 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches or body was painful to the touch. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced nightmares throughout the night. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced feeling cold. On 09-APR-2021, the subject experienced shaking. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced fever or body was burning up like a furnace. On 09-APR-2021, the subject experienced felt fatigued. On 09-APR-2021 19:00, the subject experienced burning eyes. On 10-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning eyes, nightmares throughout the night, dizzy, chills, fever or body was burning up like a furnace, and felt fatigued on 10-APR-2021, was recovering from injection site pain, body aches or body was painful to the touch, migraine, and sore throat, and the outcome of feeling cold and shaking was not reported. This report was non-serious.

Janssen COVID-19 Vaccine EUA 8pm 3/8/21: Nausea, vomiting, chills began; slept for 10+ hours 8 am 3/9/21: Fatigue, nausea, headache; noticed petechiae on arms and abnormal bruising on legs 8 am 3/10/21: Blurry vision, headache (unlike usual throbbing headaches, consistent pain on top of head), lightheaded/dizzy 10 am 3/10/21: Asked friend to drive me to ED at Hospital; Labs were drawn showing platelet count of 42K and I was released from ED and told to follow up with Hematologist

minor soreness in near injection site (within fifteen minutes of injection, continuing for several days) severe chills, causing whole body shivering (eight hours after injection, for approximately forty-five minutes) interrupted sleep (nine hours after injection, then ten hours after injection) hot flashes (nine hours after injection, then ten hours after injection, each for approximately ten minutes) body aches (ten hours after injection, lasting until twenty-four hours after injection) elevated heart rate, hovering around 130 bpm while walking, standing, and sitting (ten hours after injection, lasting for approximately thirty minutes) dry heaving (ten hours after injection, lasting for approximately ten minutes) joint pain (ten and a half hours later, lasting until twenty-four hours after injection) mild fever of up to 100.7 (eighteen hours later, lasting until twenty-four hours after injection) Body aches, joint pain, and fever were successfully resolved with a dose of Tylenol, administered about twenty hours after injection. All other symptoms resolved on their own.

In the evening after getting the vaccine, around 5 hours after the injection, I had severe nausea, vomiting, fever, intense chills and fatigue. In the following week I experienced pain around the injection site and fatigue along with issues with my menstrual cycle. Since getting the vaccine, I've had issues with cramps and spotting including today.

4/2 vaccination 4/8 severe HA, leg, arm, lower back pain, chest pain, diarrhea, bad anxiety with shaking 4/9 PCM (NP) appt; CT scan of abdomen and blood panel 4/10 felt worse, nauseous. Diarrhea continued 4/11 At 11PM, pain right side of neck, to jaw, and toes turned purple. 4/13 PCM; vit D prescribed as they were extremely low, extra strength Tylenol release for leg and arm pain, ordered a D-dimer for possible blood clot. Doppler for right leg. COVID; neg 4/17 chest pain was extremely severe. Radiated to L arm. Went back to ER. EKG, CT Scan, BNP. All normal. Stated probably really bad heartburn. 4/19 Prilosec. I called my dr on 4/22 to follow up. They told me to keep eye on BP as been elevated thru this whole thing. 4/22 My chest, arm and leg pain with HA are still present despite Tylenol and Prilosec. My PCM said to come back in . She prescribed Prednisone and Pantropical and did a blood test to check for inflammation which was normal. I have been taking both medications since Tuesday. *My HA still present. My right side still has pain and I still have chest pain.

SEVERE CHEST PAIN RADIATING TO LEFT ARM; HEARTBURN; NECK PAIN IN RIGHT SIDE RADIATED TO JAW AND EAR; PURPLE TOES; FEELING WORSE; LOSS OF APPETITE; NAUSEA; CHEST PAIN; LEG PAIN; HEADACHE; ABDOMINAL PAIN; LOWER BACK PAIN; DIARRHEA; SEVERE UNEXPLAINED ANXIETY; SHAKING; LOW GRADE FEVER; ARM PAIN; COLD FINGERS / COLD TOES; LOW VITAMIN D; ELEVATED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced low vitamin d. On APR-2021, the subject experienced elevated blood pressure. On APR-2021, the subject experienced cold fingers / cold toes. Laboratory data included: Pain scale (NR: not provided) HEADACHE (6 on pain scale), RIGHT LEG PAIN ( 5 ON PAIN SCALE), CHEST PAIN (3 ON PAIN SCALE). On 02-APR-2021, the subject experienced arm pain. On 02-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99 F. On 08-APR-2021, the subject experienced abdominal pain. On 08-APR-2021, the subject experienced lower back pain. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced severe unexplained anxiety. On 08-APR-2021, the subject experienced shaking. On 08-APR-2021, the subject experienced chest pain. On 08-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced loss of appetite. On 09-APR-2021, the subject experienced feeling worse. On 09-APR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) NORMAL, and CT scan (NR: not provided) NORMAL. On 10-APR-2021, the subject experienced neck pain in right side radiated to jaw and ear. On 10-APR-2021, the subject experienced purple toes. Laboratory data included: COVID-19 virus test negative (NR: not provided) NEGATIVE. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) LOW VITAMIN-D. On 14-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) NEGATIVE. On 15-APR-2021, Laboratory data included: Ultrasound Doppler (NR: not provided) normal. On 16-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) NEGATIVE. On 17-APR-2021, the subject experienced severe chest pain radiating to left arm. On 17-APR-2021, the subject experienced heartburn. Laboratory data included: Blood test (NR: not provided) NORMAL, CT scan (NR: not provided) NORMAL, and EKG (NR: not provided) NORMAL. Other relevant diagnostics included: Mono test on 10-apr-2021 result - negative D-dimer test for blood clot on 13-apr-2021 result - normal l. On 19-APR-2021, treatment medications included: omeprazole. On 26-APR-2021, Laboratory data included: Blood test (NR: not provided) NORMAL. Additional treatment medications (dates unspecified) included: paracetamol, pantoprazole, and prednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and shaking on 15-APR-2021, loss of appetite, and nausea on 12-APR-2021, and arm pain, and low grade fever, had not recovered from headache, leg pain, severe chest pain radiating to left arm, and chest pain, and the outcome of abdominal pain, lower back pain, severe unexplained anxiety, neck pain in right side radiated to jaw and ear, purple toes, low vitamin d, elevated blood pressure, cold fingers / cold toes, feeling worse and heartburn was not reported. This report was non-serious.

20 minutes after administering, patient complained of hives and itching. Benadryl was administered. 30 minutes after administration, patient complained that throat was closing up and having difficulty breathing. EpiPen was administered in right thigh and paramedics call. Paramedics accessed patient and patient refused to go to hospital. Patient left facility on their own.

Headache tiny bit of nausea sore arm at injection sight...at 4 am on the 13th I went to the ER because I suddenly couldn?t breathe

Episode of apparent vasovagal syncope a few minutes after receiving the vaccine. This was witnessed by myself. She appeared to have loss of consciousness and collapsed onto the pavement striking her posterior head on the pavement (fortunately, she did not strike it with great force). She regained consciousness within 2-3 seconds. She had a small "knot" on her posterior scalp, but no break in the skin. No other apparent injury. She initially complained of a headache, but this resolved over the course of about 10 minutes. She initially was mildly diaphoretic and had a rapid pulse and mild hypotension, but these also resolved over the course of several minutes. A chemical ice pack was applied to the posterior scalp and neck. She had a completely normal neurologic and musculoskeletal examination. She was provided oral fluids (water and kool aid) and a snack (chewy granola bar) and kept under close observation by medical personal for about 30 minutes. Transport to the emergency room via ambulance was offered, but declined. Her boyfriend was called and came to drive her home after she had made an apparent complete recovery. Both he and she were extensively counseled regarding signs and symptoms to be on the lookout for that would indicate the need for further medical evaluation and they both expressed complete understanding and agreement. Of note, she reported that she has had episodes of syncope in the past when having blood drawn for laboratory tests, but decided not to disclose this to on site personal prior to the vaccination thinking she would probably not have a problem.

2 days after receiving the Janssen vaccine, pt begain with pruritus. No visible marks, no changes in meds or health or diet. Scratching body to point of significant scratch marks and scabs. Also multiple ecchymotic sites on body, some at sight of scratch marks, others scattered. Continues to today w the pruritus and bruising.

Itchy red rash started Sunday morning (5/30/2021) at 11am on left upper arm. By 3pm it was on my right upper arm. At around 9pm it spread to both lower arms within the hour. Tuesday morning (6/1/2021) about 2am rash on arms was almost gone but started on both legs.

Patient had site redness, fever, and swelling. She went to ER and was diagnosed with cellulitis and placed on antibiotic therapy (cephalexin). Now site is improving well.

Patient received her vaccination in her left arm. (Janssen Covid-19). About 1-2 minutes after vaccination, the patient began to black out for about 10-15 seconds. She woke up and water was provided. 911 was called and the patient began to black out again for about 10-15 seconds. She refused medical attention from 911, and began to drink more water and electrolytes. She remained on site for 30 minutes for observation. She stated she was dehydrated and has a history of fainting after vaccines and piercings. She did not disclose this information prior to vaccination. A follow up call was placed on 07/28/2021, and the patient stated she was feeling much better and only experiencing slight pain at the injection site.

12 hours after my shot my fever reached 102.5 and hasn?t been below 100.5 since then. Extreme body aches and chills, headache. Swollen and red injection sight

Syncope - fainted in observation area. Laceration above left eyebrow (2 cm x 2 cm) and on bottom lip. BPs 111/79 (pulse 104), 113/81 (pulse 98), O2 sat 100%.

Woke up in middle of the night freezing while being super hot to the touch. Realized I probably had a fever.

Woke up the next morning with a major migraine, suffered from body aches and fatigue, a slight fever (100.2), chills, and a lasting headache. Also pain at injection site. Janssen COVID-19 Vaccine EUA

The injection was painful going in. No other symptoms on the day-of. The following day, the injection sight was painful to the touch. I had body and muscle aches in my full body including neck, back, abdomen area, legs, and arms. I had a headache most of the day. I had the chills throughout the full day and had on and off nausea. I was extremely tired and stayed in bed almost all day. 2 days after the vaccine, all of these symptoms were gone except the injection sight is still slightly tender 4 days later.

Arm is sore where injection happened. Later in the day after the injection I got chills and feverish. Had nausea and body aches all night and through to the next morning. Also experiencing diarrhea and dry mouth.

My adverse reaction was about 24 hours of severe flu like symptoms. I received the vaccine Friday afternoon 3/12, and around midnight that night (so 3/13 technically) I developed flu like symptoms. I had a mild fever, severe body aches, severe headache, nausea, fatigue, etc. For the entire day of 3/13 I was pretty much bed ridden. Around 5pm on the 13th I took Tylenol and felt a little better and was able to eat something and fall asleep that night. I woke up on the 14th with just a sore arm where I received the shot.

Severe migraine started 4 hours after shot Uncontrollable chills began 6 hours after shot, accompanied with intense leg/ pelvic region aches and pain Nausea and vomiting Following morning: occasional stabbing pain to the head, slight dizziness, continued leg/ lower back/ pelvic aches, full body skin tenderness (like the skin had been over exfoliated)

Around 10pm on 3/26, I got a slight headache, but I am not sure if it was due to screen time or a vaccine side effect. Per the clinician that administered the shot, I took 2 tabs of Tylenol (one normal adult dose) with water and went to bed. At 1 am on 3/27, I woke up incredibly sore all over but especially in my joints. I was shivering badly and woke up in a tightly curled fetal position. I was unable to lie still or warm up. I eventually went back to sleep and woke up at 5 am, this time with extreme nausea and threw up everything I had eaten the day before. This went on for a couple of minutes. I was still shivering constantly and sore and achy everywhere. Especially in my knees, shoulders, and lower back. At 6 am, I was still awake and while I still had chills, my face felt hot and I took my temperature twice. First getting 100.74 then 100.86. Slept deeply for the rest of the night. At noon on 3/27 I woke up with no nausea, body aches but only in my joints but with general soreness everywhere (like after a good workout) and a temp still in the 100.7 degree range. I took 2 Tylenol tabs at 2pm. At 4pm, I only had slight body aches, a headache, and a slight brain fog left and my temp was at 98.7, so no more fever. No further problems showed up and when I woke up at 9 am on 3/28, I felt absolutely fine other than soreness at the injection site and a little chest tightness which last for about 2 days, through 3/30.

Events: Injection site pain (mild) occurred at time of vaccine administration. Headache (moderate), chills (severe), fever (moderate), and fatigue (moderate) happened about 10 hours afterward, continued for about 14 hours, and caused disruption in sleep and normal activities. Treatment: Water and Tylenol. Outcomes: Everything resolved by 24 hours after vaccine administration except for mild pain in the vaccinated arm.

I had a red and hard spot after the vaccine that kept getting bigger. I was seen by my primary care doctor, sent pictures to my dermatologist, and went to the Emergency room. The spot was ichy and painful. There was a bruise of different colors. It was spreading and I am going back to the Doctor today. I am on antibiotics for 10 days, taking this doxycycline pill two times daily. Furthermore, every 6 hours I have been taking benadryl and applying ice.

~4 hours after injection - chills, no fever, general malaise, arm pain at injection site, took 2 extra-strength Tylenol (500mg each) ~9 hours after injection - fever of 102.4 degrees Fahrenheit, intense chills, intense headache ~10 hours after injection - fever of 103.1 degrees Fahrenheit, intense chills, intense headache ~11 hours after injection - fever of 103.1 degrees Fahrenheit, intense chills, intense headache took 2 extra-strength Tylenol (500mg each) ~12 hours after injection - fever of 101.5 degrees Fahrenheit ~13 hours after injection - temperature of 99.8 degrees Fahrenheit, took 2 Advil (300mg each) ~48 hours after injection - intense headache

Painful injection. Localized pain around injection site and general arm soreness. Soreness did not extend beyond arm. Headache morning after. Neck soreness morning after. Heavy fatigue and sluggishness.

Swelling that increased in size over six days to form a rounded triangle. Bruising around injection site. On day six, brusing started to appear at edges of triangle. By day eight, brusing remains but swelling is now half the triangle's size and hard to the touch

Started with a slight fever and fatigue, evolved to intense chills and feeling very cold, got a 102.5 fever from midnight ~ 8am, milder fever until ~7pm day after vaccination. At the same time as the fever an intense headache started and lasted until ~ 10am. In that afternoon pain in the joints and muscles of the legs started and lasted all afternoon and early evening. Fatigue lasted until ~ 48h after vaccination. Muscle pain at the injection site started directly after vaccination and is still ongoing.

Received Janssen COVID-19 Vaccine EUA. Had blurred vision, nausea, red rash on arms ,neck and face. I took hydroxyzine 25mg

Approximately 5 weeks pregnant, estimated due date December 11, 2021. Symptoms after vaccine include; pain at and around injection site through right shoulder, tiredness and fatigue, chills, headache, nausea, intense dizziness and feeling faint. Pain symptoms started within 1 hour after injection, all other symptoms approximately after 8 hours.

FACIAL IS SWELLING; SLURRY WORDS; DIZZINESS; SWOLLEN TONGUE; HARD TO TALK; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history. The patient had no known drug allergies at the time of reporting. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 about 1 hour and 30 minutes ago (as reported) on for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the patient experienced facial is swelling. On 05-APR-2021, the patient experienced slurry words. On 05-APR-2021, the patient experienced dizziness. On 05-APR-2021, the patient experienced swollen tongue. On 05-APR-2021, the patient experienced hard to talk. On 05-APR-2021, the patient experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from facial is swelling, slurry words, dizziness, soreness at injection site, swollen tongue, and hard to talk. This report was non-serious.

Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Weakness-Mild, Additional Details: only welt at injection site

Symptoms of a fever (full body ache, sensitive skin, headache) started around 5:30pm on 4/9. (No temp taken.) 600mg of Ibuprofen was taken around 8:30, by 10:30 fever symptoms were reduced and only a strong headache remained. 4/10 3:30am-- woke up in extreme pain associated with a fever (actual temp 99.6 F). 600mg of Ibuprofen was taken at that time. 7:30am--600mg of Ibuprofen was taken 1:30pm--fever symptoms started to return, 600mg of Ibuprofen was taken. 8:30pm--fever symptoms were returning but not at strong. 600mg of Ibuprofen was taken 4/11--no more fever symptoms, general arm soreness at site of injection. 400mg of Ibuprofen taken at 8am

After an hour and a half, there was significant swelling below site of injection as well as blotchy rash; some itching. Next morning, awoke with log grade fever (99 f), diaphoresis, intermittent nausea, and extreme fatigue/body aches. At times, felt disorientated while trying to complete mundane tasks.

At about 5 hours after receiving the vaccine at around 5 p.m., I developed a pounding headache. As the night continued, if I moved my head at all it would cause severe pain and a pounding headache. Additionally, I experienced shooting pains through my neck and back, I became extremely hot to the touch, yet I felt freezing cold and could not stop shivering. Then I developed severe aching and tingling from the top of my head to the tips of my toes, with excruciating lower back pain and I could feel my heart beating very fast. My entire body was tense and sore. These symptoms did not alleviate for 12 hours and I could not fall asleep due to the discomfort I was in. I finally was able to fall asleep at 6 a.m. after the aching/tingling/pain/hotness subsided (about 12 hours after side effects started).

Painful injection but fine for the majority of the day. Started feeling muscle fatigue around 4pm, with upper body aches, stinging eyes, and nausea by 6pm. Fever of 102, and progression to full body aches and headache by 8pm in addition to the aforementioned symptoms that continued throughout the night. Fever lowered to 99 and only minor body aches by mid morning on the 12th. Headache continued throughout the day with low grade fever. I predict that I will feel 100% better within 48 hours.

Woke up in the night due to fever. When I woke in morning I had headache and nausea. Couldn?t sleep on right arm. Symptoms lasted until 8:00 pm the following night. My arm is still puffy and red and sore. I have a rash on injection site. Also bled when I got the vaccine which hasn?t happened before.

patient received her J & J covid-19 vaccine on 3/14/21. She is a Pennsylvania school teacher, on 3/15/21 she developed a fever of 105F, headache, body aches, and vomiting. She was seen in the ED and d/c to home without labs. On 3/27/21 she started with unexplained bruising. Was seen by PCP 4/12/21 for unexplained bruising throughout her entire body and dizziness and CBC revealed a platelet count of 5,000. Patient was immediately advised to go to the ER for further evaluation of her symptoms.

Body chills, high 102 fever for about 10 hours, fatigue, body shakes, severe headache, redness of skin (likely due to high fever)

At injection site was no effect, only a scab, however approximately 2 inches below injection site is a 2 inch diameter bruise that did not disappear after 5 days. The area was also red and swollen, with a "hard lump" underneath that is painful to touch. Affected area also felt hot. After a week since injection, the skin around the adverse area became dry, with mild skin flakes forming. The bruise and pain growing as time went on. At home treatment included an ice pack for 15-20 minutes daily for 2 days. 1,000 mg of over the counter Tylenol Acetaminophen daily for 4 days. Adverse effect ended after 10 days since injection date. Currently only a very mild pain when lifting right arm up. Area no longer is painful to touch.

Started feeling nausea and vomiting that night and fever and chills. Vomited/diarhea the next day. Rash developed on arms, legs, back within 72 hours. Rash was not itchy or raised. It was just reddened.

8 hours post shot extremely cold, chills, severe body aches, severe headache, hives, skin felt on fire

3 hours after vaccine (12:45pm) had hives on face and had difficulty breathing. Later that night (7:00pm) ran low fever morning of next day had fever of 106.5° f (4:30am).

Hives covering body that last multiple days (have not left) ease with Benadryl but return. shortness of breath (wheezing).

Hives, SOB, throat closing 3 hours after vaccine, used inhaler with some relief, following AM had chills, fever to 104 and sore throat. + strep test in ED. She rarely uses inhaler.

swollen gland by her jaw stinging sensation at the sight of vaccination dizziness abdominal pain SOB

Reaction on the skin started 12th March 2021 until the end of March. I had pain, itching and rash. I had blisters all over my body.

The day of vaccination and day after I was suffering from very severe head aches that caused me to not be able to look at screens or light during that time. I noticed on Sunday I began developing some redness on the tops of my hands. On Monday morning my hands began getting a rash on the knuckles and tops of my hands. I also noticed that since being vaccinated my nipples have been erect and are tender. Today my hands are no longer displaying a redness to them but they are still itchy and the skin feels dry like Eczema, something I never have had before in my life.

I developed a moderate headache 3-4 hours after receiving the vaccine that became more painful over time. At 8 PM, I developed a rash on the left side of my face, neck and chest that lasted through the night and into the morning (about 12 hours). The rash did not look like hives, but it was itchy and blotchy red patches. I also spiked a 101 degree fever that lasted until the morning (about 12 hours).

I received my vaccine April 11th at 3 p.m and began to have a fever around 9 p.m. My fever did not go away until the next evening. On April 12th I had a fever and woke up with red little dots around my eyes. At night the fever went away. The following day April 13th I felt my chest tight and had shortness of breath throughout the day. I also had stomach pains at times. April 14th and 15th (today) my chest still feels tight and I get tired very easily. My arm is also still very sore and sensitive, I have a little bump where the vaccine was put in.

After the vaccine, the whole body has been allergic and itchy, and the skin will appear red rash when scratching.

ITCHING; SWELLING ON FACE; BURNING SENSATION; HIVES; RASH; BUMP; FEVER; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 (NR: not provided) Positive. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.4 F, 98.8 F. On 09-APR-2021 02:00, the subject experienced body aches. On 09-APR-2021 02:00, the subject experienced chills. On 09-APR-2021 02:00, the subject experienced fever. On 15-APR-2021, the subject experienced itching. On 15-APR-2021, the subject experienced swelling on face. On 15-APR-2021, the subject experienced burning sensation. On 15-APR-2021, the subject experienced hives. On 15-APR-2021, the subject experienced rash. On 15-APR-2021, the subject experienced bump. Treatment medications included: cortisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on 10-APR-2021, and itching on 16-APR-2021, was recovering from hives, rash, swelling on face, and bump, and had not recovered from burning sensation. This report was non-serious.

Injection site is still swollen about 2 weeks later. It?s very hard and hurts a little with pressure. Sometimes I still get random shooting pains throughout my body that I didn?t get before my vaccination.

Shortness of breath while at rest sitting upright, lasting a few minutes in the evening on 4/27 Petechiae on inner left leg appeared exactly 3 weeks following vaccination on 4/28

Fever, dizzy, sore throat, fatigue, minor rash, sore at injection site, muscle aches especially in legs, headache

Immediately after receiving the shot I began to have fairly intense pain at injection site. It continued in waves. I began to walk around the store for the allotted 15 minutes. I began to feel very dizzy and faint. My ears began ringing and I didn?t feel well. I stumbled back to the pharmacy to ask for help. At this point I was also feeling like it was very hard to breathe. I explained all these symptoms to the pharmacists on duty and they told me to just sit down. After sitting down I still felt faint but suddenly felt the need to vomit. I stumbled to the bathroom where I collapsed in front of the toilet and passed out twice, striking my head and throat on the bowl. After awaking I was very disoriented and felt very hot and clammy. The pharmacist then came and found me and told me to once again sit down and continue waiting. After sitting down for about 5 more minutes I began to feel less dizzy and was having an easier time breathing. I left the store as the pharmacist was ignoring me and didn?t seem concerned about my symptoms. After arriving home I was tired and week and very very cold. I noted my body temp was lower than usual. I took a nap and then these symptoms continued for about 24 hours. I am now feeling much better.

Onset approx 24 hours following vaccine for COVID. All over urticaria, symmetric on all extremities, buttocks and a little on trunk. No oropharyngeal swelling, dyspnea, angioedema, or other severe symptoms. Treating with Benadryl and Pepcid. Deferred steroid treatment for now.

I had a red, hard, spot on my arm that lasted over two weeks. I also had a bruise that was changing colors. My arm was painful and the redness was spreading. I was given antibiotics for ten days afterwards. My mother also had a rash at the injection site, and was given same shot as me on same day. The lot number for my shot is 1808609. I have many pictures of the reaction if you want me to upload. Furthermore, the doctor said that my reaction would be aligned with a "moderna" reaction but is NOT typical of a J and J reaction (which is the shot that I had received and obtained a record of receiving from the Pharmacy). I got an ultrasound and blood test around two weeks after vaccine, no blood clot found.

ITCHING ON WRISTS, FOREARMS AND ANKLES; RASH ALL OVER BODY; This spontaneous report received from a patient concerned a 23 year old female. The patient's weight was 152 pounds, and height was 61 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: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced itching on wrists, forearms and ankles. On 04-MAY-2021, the subject experienced rash all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash all over body, and itching on wrists, forearms and ankles. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

April 16 th she started getting blotches on face and arms and upper thighs. It would itch and burn. A few day later she got itching and burning in the mouth. They have come and gone . Patches of bumps on hands and feet.

Lower back pain started at approx 4:30. Muscle soreness through rest of body. Then skin began to feel tingly most everywhere, not painful but more so sensitive to touch? I feel physically fatigued. When I move too fast my ears start to ring in and out for a few times before settling. Headache.

Patient was very nervous about getting the covid vaccine. She sat for 15 minutes and after about 8 minutes she said she thought she was having a panic attack and felt hot. Tech administered vaccine and sat with her the whole wait time since she was nervous. Held an ice pack on her neck when she stated she felt hot. The 15 minute timer went off and she still felt nervous so she continued to sit. Rph also was present once the ice pack was given. She had a dry heave at about 12 minutes. After 20 minutes we moved her to the floor she said she was seeing light flashes. She was sweaty and hot. BP was taken at 420pm 162/109 and 98 pulse. Asked pt if we could call an ambulance, she felt she didn't need one. We got lead from Division 1, also suggested an ambulance and this time pt said ok. Now BP taken was 157/109 and pulse 108. Patient felt a dry heave and we put her on her side. Ambulance arrived and put pt on a stretcher.

I have an extreme fear of needles and we thought that the dizziness came from that and the nauseous came from that as well, that night I had a tough time sleep because my arm was so painful and over the next several days my arm had became inflamed and red we noticed that my sugar had started climbing. So I was kinda okay Monday still kinda sick and nauseous at 6:00 am that morning I started to throw up and I threw up at 6 times my mother had to call 911 and I was taken to hospital in the squad my sugar was 501 I was dka, I had to go without food and water for over a day. I had complications with the insulin and the shot was causing my sugar to rise and there were complication. I was not able to lay on my left for a week longer maybe a little longer. I think my shot was infected it started to leak white goop as well. I was on an insulin drip for a while, my pump was not working so I had to stay longer until a new pump came. I went into the er Tuesday morning and came out Thursday morning

About 8 hours after receiving the vaccine, my body started hurting, I got intense chills, and I became exhausted. 13 hours post vaccine, I had a fever of 101.6, I began vomiting, I was sweating, I was trembling, and had diarrhea. The vomiting lasted for about 2 hours. Also, I was vomiting up small amounts of blood. About 24 hours post-shot, my entire body was sore, I still had chills and sweats, I had a fever of 101.2, fatigue and a headache. Day 2 after the shot, I was still extremely fatigued and sore. Day 3, I began to feel better. I was still fatigued, but the only soreness was in the arm that I got the vaccine along with some redness around the injection site. I also had no fever. Day 4, my injection site was a little sore, I was slightly fatigued, and a small rash was on one of my arms for most of the day, but then the rash faded.

The first day, I was in a lot of pain all over my body, the normal aches and flu-like symptoms. I was in so much pain that I cried. Because I have fibromyalgia, my doctor advised that I go to the hospital because it hurt to touch my skin. I was sent to the ER a week later because my symptoms had lasted so long, I had a persistent headache, and they wanted to check for thrombosis.

Rash all over body within 1 hour of the shot, Severe Lower Back pain Rash got worse and trouble breathing day after the shot

The pt say she broke out on her arms like her blood vessels had been broken in both arms and she now says her lymph nodes are swollen and bruised ase well as her abdomen. The pt did go to her md and her blood work was fine and her Md who is Dr. said it's possible it could be from the vaccine.

EYE SENSITIVITY; FEVER; INJECTION SITE SORENESS; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 23 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced eye sensitivity. On 15-JUN-2021, the subject experienced fever. On 15-JUN-2021, the subject experienced injection site soreness. On 15-JUN-2021, the subject experienced headache. On 15-JUN-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 16-JUN-2021, and had not recovered from injection site soreness, headache, eye sensitivity, and tiredness. This report was non-serious.

Janssen COVID-19 Vaccine EUA Headache (mild) starting at 1:45 pm 3/6/21, became moderate at 7:00 pm, lasting until ~11:30 pm Chills (severe) starting around 7:00 pm, lasting until 10 pm Palpitations starting around 9 pm, lasting until 11:45 pm Mild injection site pain starting 1:30 pm, still occuring (12:15 pm on 3/7/21)

Symptoms started around hour 2 with nausea, injection sight was not sore but had some discomfort below injection site. Continued to have nausea. Had chills in the middle of the night, chills started around 1-2 am and was gone by morning. Woke up with body aches and very tired/fatigued. By hour 18 had diarrhea. Still having fatigue and body aches.

Extremely weak, extremely tired, slight headache, nausea, chills, pain on the inside of my face, sore joints (shoulders, knees, ankles, feet and toes), sore muscles, minor soreness on injection site, eye pain/soreness

Normal amount of tenderness at injection site. After about 9-10 hours, I started feeling fatigue and body aches. Several hours later, the body aches turned into a full fever and headache. Fever did not break until 6am the next morning, and body aches and fatigued continued through the full next day.

Came down with a 100.2 degree F fever the night I got it, which went away after one dose of tylenol. The following night I did have a low grade fever of 99.3, which also went away after one dose of tylenol. I have had muscular soreness, and am now developing a small, itchy, red patch at the injection site. I will fill out another adverse form if it gets worse.

About 22.5 hours after vaccine: lips swelled, waited about 6 hours for swelling to go down when they did not, took an all-day allergy pill before bed, lips appeared and felt normal the next morning About 38 hours after vaccine: face rash, red and splotchy in two spots, extremely itchy, applied cortisone cream immediately, redness persisted a little less than 6 hours

6 hours after my shot I had a high fever, and for the next 24 hours I had a fever on and off, muscle aches, no appetite, moderate to severe pain at injection site with redness and swelling, and fatigue. I took generic Tylenol around 6:30 the day after my shot which improved my condition

At 2 am, approximately 8 hours after receiving the vaccine, I became very dizzy. I work night shift and I needed to sit down. I started getting the sweats. After sitting for a few minutes, I tried to stand up and was very dizzy again. I immediately sat back down as I thought I was going to pass out. 30 minutes later, I had a nasty headache, the chills, pain in my knees and lower back, and neck pain. Also, I had pain at the site of the injection. I felt very nauseous. These symptoms persisted from hour 8 to 44 hours after receiving the shot.

Immediately after vaccine shot: burning sensation at the site of injection for a few minutes Approximately 2 hours after injection: body aches, specifically in my upper back Morning of Tuesday 3/23 (6:15AM): Woke up with a minor headache and upper back aches Tuesday 3/23 Afternoon (11AM): headache slightly worsened, body aches slightly worsened and spread to include both my upper and lower back, 100.7 degrees Fahrenheit fever, chills, had a slight cough that lasted about 2-3 hours Tuesday 3/23 evening: headache worsened to a migraine, body aches worsened and spread to include my neck, upper back, and lower back, stiffness, 100.7 degrees Fahrenheit fever, chills, fatigue Tuesday evening at 9PM: Fever broke and my temperature returned back to normal, all other symptoms remained Wednesday (3/24) Morning (6:15AM): woke up with minor upper back aches

After about 6 hours of receiving the shot, I woke up with uncontrollable chills, and hot flashes in between, where my chest, back and face felt hot but hands and feet were ice cold. I had a fever of 99.9 and had a headache across the front of the face and nauesa. All of this lasted together for about 6 to 7 hours. During this time I took Tyenol, used cold compress, wrapped up in blankets and sipped on water. After the chills and hot flashes subsided I continued to feel fatigue,and had head and body aches for the next 18-24 hours. During this time I continued with Tyenol and fluids. In all it last about 36 hours before I felt like myself again.

extreme tiredness beginning three hours after injection and lasting for five days total. Fever 24hours after injection and lasting for 2 days. Injection site swelling, redness, hotness, itching and lump beginning 24 hours after injection the redness, and swelling disappeared after seven day but the hotness, lump and itching are persisting and have not fully gone away two weeks after vaccination. Sever body and muscle aches 24 hours after injection and lasting five days.

The patient described burning sensation as the vaccine was going in followed by numbness of the right arm and start of a migraine on the same side. The patient was told to put ice pack on the arm. The arm seemed to be experiencing localized injection site reaction. She was informed to take acetominophen when arriving at home and ibuprofen later to help with pain and inflammation

Brain fog; chills & shaking; skin feeling raw; headache; brain zaps; fatigue; sore muscle; slight bruising at injection site

At around 9:15 PM I started to feel nauseous and got out of bed to go to the bathroom. While using the bathroom I felt a very strong chill come over my whole body and started shivering and got directly back into bed and wrapped myself up in a thick blanket. For 45 minutes I laid wrapped up and was shivering constantly. At 10 pm I was brought extra blankets and a heating pad but moving to get situated caused dizziness. It was about 10:30 when the shivering stopped. I was able to sleep but got up to go got the bathroom around midnight and my entire body was drained of energy and I felt that I could barely stand and walk on my own. I was dizzy and my head hurt as well. I could barely hold my arms up to look at my phone briefly. Between 11 PM and 2 AM I had 5 or 6 high heart rate alerts (over 120) according to my Apple Watch but I did not wake up to them. In the morning (Sunday 4/4/21) around 9-10 am my head still hurt and my body was very achy and I felt very hungover. All day I continued to feel achy almost with a bad cold or a minor flu. Today has been better but I have still felt pretty drained. I?ve had continuous arm soreness in the arm I got the injection - but nothing too severe. 15 minutes after my vaccine on Saturday 4/3/21 I took 600 mg of ibuprofen and around midnight of that night I took 2 of pain relief PM acetaminophen (1000 mg of acetaminophen total snd 50 mg of diphenhydramine HCI total)

Was fine for about 8 hours, outside of a little soreness in arm. Then I started feeling cold chills, and had to lie down in bed for the rest of the day. Slight fever also occured and intense body aches. However, these slowly subsided after taking tylenol at about 6PM. I slept through the night and outside of feeling a little lethargic the next day, I was back to normal.

High fever, extreme dizziness, nausea and vomiting, diarrhea, feeling cold then hot, sweating, headache, extreme body aches, pain at injection site. This occurred after 5 hours after the vaccine.

Extreme lethargy, hives, large amount of swelling and redness at injection site that is still persisting, headache, tinnitus, nausea, runny nose, dizziness, itching

The night after I got the shot I had a pulsating migraine, a fever of 103.9, really bad chills and was extremely nauseous and weak. Here it is 6 days later and I have developed a rash all over my body. On my back, my legs, my arms. It is very red and very itchy.

Patient received her Janssen COVID vaccine and was sitting in a chair in the conference room when she slumped over in her chair and became unresponsive. Patient had just received her one dose Janssen vaccine and was sitting in a chair approximately 3-5 minutes after receiving the vaccine. She began to slump over in her chair and was unresponsive. Two RNs responded to assess the patient. Patients feet were elevated and ice packs applied to her neck and axillary areas. Patient was breathing and had a pulse. Patient responded to her name once and then passed out again. Patient was unable to respond after this. Her eyes were open. Patient was lifted into a wheelchair by three nurses and brought to a private area. Patient was warm and sweat was running down her face. Her sweater was removed and ice packs again were applied to her neck and axillary area. Patient continued to have a pulse and was breathing. EMS was called. Patient slowly began to come around and could answer questions after about 5 minutes of being unresponsive. She was confused and had no memory of what had occurred. She reported feeling light headed and seeing spots in her vision. She continued to feel light headed. EMS assessed patient. Vitals were stable and blood sugar was WDL. Patient reported feeling much better. She denied feeling light headed or dizzy any longer. She was able to answer all questions asked. Patient did not want to go to the hospital and refused transport to the hospital via ambulance. She was observed for an additional 20-30 minutes at which time her boss arrived to pick her up. She was educated on calling 911 if she began to feel light headed or dizzy again. Patient verbalized understanding. She was walked to the car by an RN.

Rashes all over body that began at 7:30am today. Changed clothes but rashes come back with a prickling feeling

PATIENT'S PARTNER HAS TOLD ME PRIOR TO VACCINATION SHE WAS ANXIOUS/SCARRED TO GET THE VACCINATION. THAT SHE "MAY" PASSOUT. I SPOKE WITH THE PATIENT AND SHE EXPRESSED BEING NERVOUS, BUT SHE WANTED THE SHOT. DURING THE SHOT I SPOKE WITH HER AND EVERYTHING WAS GOING OK. AFTERWARD SHE SAID SHE WAS FINE AND I LET HER SIT IN THE VACCINATION CHAIR FOR ABOUT 5 MINS. SHE THEN WALKED TO THE FRONT OF THE STORE WITH HER PARTNER TO SIT DOWN. SHE HAD A COLD LEMONAID BOTTLE. AFTER ABOUT 10 MINS I HEARD A FALL. PATIENT HAD FALLEN OUT OF THE CHAIR AND HIT HER LEFT CHEEK ON THE WINDOW SILL. THERE WAS A LITTLE BRUISING. I OFERED TO CALL EMS, BE SHE DECLINED. I GOT A BAG OF ICE AND RAG FOR HER TO APPLY TO CHECK AND TO HELP COOL HERSELF. I ALSO BROUGHT A FAN FOR HER USE. AFTER ABOUT ANOTHER 15-20 MINUTES HER PARTNER ANNOUCED THAT SHE WAS OK AND THEY WERE LEAVING

All over hives on extremities including head and shoulders. Received a round of hydroxyzine which helped after five days all hives gone but still have some rash and itchy spots in scalp. My skin is still sensitive and I only take half s pill at night for itchy spots.

Chills (4 h after vaccination, might last for 6 h) Nausea (just after vaccination, last about 1h) High fever (10 h after vaccination, might last for 3 h, about 102F) headache (12 h after vaccination, last for a day, I took ibuprofen after the fever to relief the headache) fatigue (the second day, last for 3 days) rash (the second day, last for 1 day) canker sore ( the second day, last for a week) short of breath (the third day, last for 2 days)

Initial injection was recieved with arm extended out and raised in car window. Really painful injection. Several seconds after vaccine injected I felt a wave of chills on my body and immediately started profusely sweating. Seconds after that i then began to get extremely dizzy, blacking out, trying to stay conscious for a personnel to walk by and after a few moments the feeling slowly lightened up minus the excessive sweating and chills. Personnel then told me it was just anxiety and brushed it off. I have never had a reaction like this from a vaccine before so this experience was unsettling.

First day there was a red line going under the site an hour after injection. 2-4 th day there was bruising, swelling, warm to the touch, and a red area underneath the injection site. Visited a MD (seeked out help after results worsening) and he stated it was due to a vessel being punctured during injection (not due to vaccine) which caused the bruising at the site and the redness/swelling is due to the vaccine. It?s on day four now and the bruising is healing but the redness and swelling is still consistent. MD cleared me of no infection but stated if redness grows (or fevers) to seek out help again.

At around 10:30 AM on 3/29/2021, I began to notice some irritation and phlegm build up in my throat, as well as some tingling and numbness in my face. This lasted for approximately 30 minutes before subsiding. At around 8:00 PM on 3/29/2021, I began developing a fever and somewhat severe body aches that lasted until the morning of 3/31/2021. I also developed a somewhat severe headache on the morning of 3/31/2021 that lasted through 4/1/2021. The injection site was tender to the touch from the evening of 3/29/2021 until 4/2/2021, and my arm was also very sore during this same time frame. I also noticed unusual exhaustion from the evening of 3/29/2021 until 4/5/2021. During 3/29/2021-4/1/2021, I was taking Tylenol Extra Strength (1 pill every 6 hours or so) to help alleviate symptoms, but it only helped for about 3 hours in the 6 hour interval.

Within 5 hours of shot: slightly raised body temperature, chills, extreme fatigue, headache and muscle ache. Raised body temperature and chills lasted for about 14 hours. Fatigue, headache and muscle ache for 30 hours. After 30 hours: sore left arm (where shot was administered)

Joint and bone pain in legs, right shoulder 12 hours after vaccine. Decreased pain, increased fatigue 24 hours after vaccine. Mild pain at site of injection.

Got the shot at 9:20am on Saturday (April 10th). By the time I sat down to do the 15min waiting period before I could leave. My arm from the back of my shoulder all the way down to around my thumb joint in my hand ached so bad. By around 3pm on the same day, I started to feel really tired and had a pounding migraine. By 4:30p I started to get really cold and everything started to ache. By 6p I was feeling hot but at the same time cold and shivering. My head was pounding. Every muscle ached all over my body, and by every muscle I mean even my eye muscles and pelvic floor muscles. My face had so much sinus pressure that it felt like it could explode. My skin, all over my body, was so sensitive that it hurt to the touch. On top of my skin being sensitive to the touch, off and on my skin would tingle, including the inside of my mouth and tongue. My lymph nodes were swollen enough in my neck that my throat ached. I was mentally confused and shaking. Everything got bad enough I started crying and hyperventilating. I felt sick to my stomach and felt digestive pain. My entire body felt so heavy. By the time it got to around 8p, my mom finally took my temperature, which at that point I had already been taking Tylenol all day and was no longer shivering, and I had a temperature of 101 degrees F. I finally went to bed around 9p. I was thirsty but my stomach felt sick. I still ached and woke up around 10 times throughout the night either feeling too hot or cold or hurting so bad. At 4am I took a Tylenol because it everything hurt bad enough to able to fall asleep. The next day. I mostly better. I was still tired and a little achy and my lymph nodes under my arm pits were swollen. At this point my lungs felt strange. Harder to breathe than normal. I was starting to cough. The day after that (today) I have felt fairly normal except I?m coughing and my lungs still feel a little strained. No more aches or fever or anything like that though.

Patient fainted shortly after receiving dose on 4/10. Patient did respond shortly afterwards and was given juice and a ice pack. Continued to monitor for some 30 plus minutes prior to releasing. Called patient around 5PM same day, patient sounded great and was doing well. Note: Patient has a history of fainting upon vaccine admin. but did not indicate to provider prior to administering vaccine. Patent called at moms request on 4/12 at 9:54 am and indicated she noted upon waking 2 hives in crevasse of arm which spread to all over body. Advised patient to call MD office for guidance and speak to live person. Spoke to doctor's office whom indicated they would address hives condition and then advise provider this provider.

Within 5 minutes of receiving the shot I fell incredibly nauseous, staying nauseous for two full days and then periodically off and on. It has been 6 days since the vaccine and I have random muscle and joint pains, leg pains, nausea, and still have an extremely hard painful lump in my arm. The worst of symptoms is over.

Sharp chest pain that was attributed to heartburn/acid reflux from 1 day after injection until present (04/08/2021-04/13/2021). Fever and chills 1-2 days after injection (04/08/2021-04/09/2021) Muscle pain at injection site 0-3 days after injection (04/07/2021-04/10/2021)

Body aches, fever, tired, injection site soreness, and slight breathing difficulty - these symptoms lasted around 24 hours. Injection site sorness lasted around 5 days.

Muscle and body aches sharp pains throughout body swelling at injection site short bouts of numbness and tingling in right arm from elbow down to fingers headache joint pain

Patient experiencing visible rash on cheecks/face, and down chest. No SOB or distress. Able to swallow water. Hr 77 O2 94 BP 133/105 Liquid Benadryl 50 mg 20 ml administered 11:37, patient had improvement. Offered medical transport. Patient declined due to improvement. Patient departed at 12:00 pm. Pt in passenger seat, mother driving. Instructed to go for further evaluation if symptoms reappear/worsen.

I was running on the treadmill and all of the sudden my feet started tingling. I got off the treadmill to try to massage my feet. Then, I felt nauseous and vomited. After vomiting I could not move and I had very hard time walking. I noticed that my face had swollen, my throat was closing, and my vision was blurry. I also broke out in hives. Once I could get mobile (about two hours after the adverse reaction started) I took a Benadryl and that helped ease the swelling.

6 hours after injection: chills, body ache, mild headache, loss of appetite, injection site soreness 11 hours after injection: chills, severe body ache, severe headache, fever of 101.2F, loss of appetite , injection site soreness 13 hours after injection: 350mg of Ibuprofen taken day following vaccine: slight headache, fatigue, injection site soreness, additional 350mg of Ibuprofen 2nd day following vaccine: only injection site soreness

The night I got the vaccine 3/10 my arm was sore just like any other vaccine I?ve received. Two days later, I woke up and noticed a welt on my arm that was about two inches in diameter. It was itchy and painful. I could not lift my arms up. By noon it had doubled, and the slightest touch was unbearable. The ?Covid arm? was also hot in temperature. That night, it was at its worst at 5 inches in diameter and it was even more swollen. It stayed that way for three more days before it started to go down. A week after my vaccine a bruise developed where the welt was. Two weeks after my vaccination it was still bruised and swollen. It felt like a tide pod when I touched it. My mom encouraged me to go to urgent care. So on 3/26/21, I went to urgent care and was told it was a cyst. My arm is currently still squishy at the welt and bruised. I have an appointment on 4/19 at my dermatologist for further care.

Site: Pain at Injection Site-Mild, Systemic: Blood Disorder (diagnosed by MD)-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: blood clots in stool-currently under care of primary care physician for clot formation investigation-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Medium, Additional Details: patient reported blood clots in stool on 4/11/21 and 4/12/21. Patient was flushed, dizzy and faint after clot was found. Patient has no significant history of hemorriods or colorectal conditions.

Report hair falling out 2 weeks post vaccination and bruising of the right and left arm -noticed on 4/15/21 1 month and 6 days post vaccination. Report of chest pain 1 month 6 days post vaccination described as a pinch lasting 2 minutes. Denies SOB, leg swelling, headache or blurred vision. Treatment: Instructed to see primary care doctor

Patient administered Covid Johnson & Johnson vaccine at Pharmacy. Patient c/o swelling to the left arm, dizziness, throat itching, body aches, coughing at night, chills and sweats since receiving the vaccine. Patient states she took Benadryl without relief. Patient seen by provider at a Community Health Center and prescribed Clindamycin HCl 300 mg capsules and instructed to follow up with PCP in 2 weeks for cellulitis.

Flu like symptoms- Fever (102 degrees) started ~ 10 hours post shot lasted 48 hours, chills, body aches, headache Rash resembling Livedo, or blood clots of the skin first notices 2 days after shot was received but may have started earlier. Condition has not worsened but livedo is still present as of 4/17/2021. Went to doctor about it and was told as long as it does not get worse not to worry.

6 hr after shot: intense chills 8-10 hr after shot: migraine (then took Tylenol) 12-24 hr after shot: lethargy, aches, migraines 48 hr after shot: lethargy, cold sore on left side of mouth, and beginning of rash on left eye 72 hr after shot: singles rash (diagnosed by ophthalmologist) on left eye, including discharge, pain, redness, and swelling

VOMITING; FEELING HOT; RED ARMS; FEVER 102.6F; HEADACHE; SHAKING VIOLENTLY; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to latex. 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 16-MAR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021;03:00 a.m, the subject experienced shaking violently. Laboratory data included: Body temperature (NR: not provided) 102.6 F. On 17-MAR-2021, the subject experienced feeling hot. On 17-MAR-2021, the subject experienced red arms. On 17-MAR-2021, the subject experienced fever 102.6f. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021 03:00 a.m, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red arms on MAR-2021, and had not recovered from vomiting, shaking violently, fever 102.6f, headache, and feeling hot. This report was non-serious.

NECK PAIN; BODY ACHES; BURNING SKIN; POSSIBLE SINUS INFECTION; POSSIBLE DOUBLE EAR INFECTION; FAST HEART RATE; SHORTNESS OF BREATH; SPLITTING HEADACHE; FATIGUE; DIZZINESS; VISION CHANGES; POOR SLEEP; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vasovagal syncope, postural orthostatic tachycardia syndrome, atypical asthma, ehlers-danlos syndrome, attention deficit hyperactivity disorder, hallucinations, and no allergies or reactions to previous vaccination. The patient experienced drug allergy when treated with hydrocodone for drug used for unknown indication, and drug allergy when treated with salbutamol. 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 10-MAR-2021 13:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: levosalbutamol. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced vision changes. On 10-MAR-2021, the subject experienced poor sleep. Laboratory data included: Blood pressure (NR: not provided) 102/60 mmHg, and Pulse rate (NR: not provided) 72 pm. Treatment medications included: paracetamol. On 10-MAR-2021 22:00, the subject experienced splitting headache. On 10-MAR-2021 22:00, the subject experienced fatigue. On 10-MAR-2021 23:30, the subject experienced fast heart rate. On 10-MAR-2021 23:30, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced possible sinus infection. On 11-MAR-2021, the subject experienced possible double ear infection. On 11-MAR-2021, the subject experienced burning skin. On 11-MAR-2021 03:00, the subject experienced neck pain. On 11-MAR-2021 03:00, the subject experienced body aches. On 11-MAR-2021 07:45, treatment medications included: atenolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and splitting headache on 11-MAR-2021, and dizziness, and vision changes on 10-MAR-2021, was recovering from fatigue, burning skin, and possible double ear infection, had not recovered from fast heart rate, possible sinus infection, body aches, and neck pain, and the outcome of poor sleep 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.

I am currently breastfeeding and my infant had an upset stomach the day after I received the vaccine. I got a headache approximately 6 hours after receiving vaccine. I got uncontrollable chills for about 2 hours. My headache lingered for approximately 3 days. My injection site was sore for approximately a week.

Itch started around stomach area, first thought it was a bug bite. Eventually hives started spreading all over the chest, back, under the arms, thighs, and now my hands and neck. Was not sure if this was caused by the vaccine until 5/1. Found out that this was a rare non-severe symptom, and that's when I started taking allergy meds (Benadryl) for Antihistamines and it has relieved the itch temporary. Does not stop the spread of the itchiness.

Thursday, 05/20/2021 02:05PM received Janssen 0.5mL to left deltoid IM injection. 04:55PM Noticed a pin needle like rash on my chest, stomach, and neck. 05:00PM Took 50mg of Benadryl. 05:40PM Took another 50mg of Benadryl due to rash being more present on my chest, stomach, and neck. Itching began on the neck behind the ears. 05:50PM Noticed difficulty/restriction to swallowing. 06:20PM Checked into a facility. Waited an hour to be seen by a provider, Dr. He states only an acute reaction without examining my body of the rash; only examined my back & inside my mouth. I informed him that my rash was on my chest, stomach, neck, now my arms, and top of my thighs. He provided Prednisone and dismissed me. (I will be filing for malpractice) 08:00PM- Got home, still have rash with some difficulty swallowing. Friday, 05/21/21 06:00AM- Rash seems to subside and throat is fine, but swollen. 09:00AM While at work, coworker mentions my face is red. Rash came back to my arms and is now on my face. I took 50mg of Benadryl. 03:00PM Left work early since I could not take another dose of Benadryl to drive home. 03:20PM Rash has spread to whole entire body except lower than the knee. Took another 50mg of Benadryl. 09:00PM Took 25 mg of Benadryl went to bed. Saturday, 05/22/21 07:00AM Rash is more noticeable and red. Everywhere on the body, swelling to ears and throat. Took 50mg of Benadryl.

I experienced fever, chills, headache, fatigue, muscle aches, nausea, and pain at the injection site. Symptoms have lasted for 36 hours and are ongoing. Tylenol was used to treat symptoms.

Patient Presented with body aches and fever, which persisted for 24 hours. Patient presented with left arm redness at injection site, two days post injection, and showing improvement. The doctor prescribed conservative therapy, hydration, and over the counter Tylenol as needed. The doctor will continue to follow up daily with the patient for two weeks post injection.

Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: severe pain and swelling at injection site-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Symptoms mostly local to injection site but more severe and longer in duration than most, site of injection was inspected and appears to have been given in a proper location

BRUISED EASILY; PAIN NEAR DIAPHRAGM; DIFFICULTY BREATHING AND SHORTNESS OF BREATH; CHEST PAIN; HEADACHE; INJECTION SITE PAIN; SENSITIVE SKIN; CHILLS; FEVERISH; TIRED; This spontaneous report received from a patient concerned a 24 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: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced sensitive skin. On 23-MAY-2021, the subject experienced chills. On 23-MAY-2021, the subject experienced feverish. On 23-MAY-2021, the subject experienced tired. On 23-MAY-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 98.7. On 24-MAY-2021, the subject experienced pain near diaphragm. On 24-MAY-2021, the subject experienced difficulty breathing and shortness of breath. On 24-MAY-2021, the subject experienced chest pain. On 24-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced bruised easily. The action taken with covid-19 vaccine was not applicable. The patient recovered from sensitive skin, chills, and feverish on 24-MAY-2021, was recovering from chest pain, pain near diaphragm, and headache, had not recovered from difficulty breathing and shortness of breath, and injection site pain, and the outcome of tired and bruised easily was not reported. This report was non-serious.

Pt received janssen Covid 19 vaccine 518pm. Pt went to the waiting area chairs and within 2 minutes she was losing consciousness. Myself and another customer were able to lower patient to the floor (did not hit head). She lost all muscle tone, consciousness and bladder control (urinating on herself/floor). Sternal rub was able to get the patient to regain consciousness. Took blood pressure at 522pm and was 152/95 with pulse of 95. Arm was hot to touch and patient was sweaty. Placed a cold pack on injection site and fanned pt until EMS arrived for evaluation. EMS loaded pt on a stretcher and took to ambulance to evaluate heart rhythm.

ACHES; HAD A FALL; HAD A BRIGHT RED BRUISE; FEVER; This spontaneous report received from a patient concerned a 24 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 and 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced aches. On 02-JUN-2021, the subject experienced had a fall. On 02-JUN-2021, the subject experienced had a bright red bruise. On 02-JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: amoxicillin/clavulanic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, aches, had a fall, and had a bright red bruise. This report was non-serious.

Patient said she is experienced cramping and aching at injection site along with pain when lifting up her arm.

On 06/12/21 patient received the Janssen COVID-19 vaccine at the mass vaccine event approximately 15 hours prior to arrival to the ED. Patient reports at approximately 2300 hours (12 June 21) she awoke with hives around her mouth; however, went back to sleep. Just PTA to the ED (0358 hours) she reports awakening with dyspnea, facial swelling with worsening facial rash into her hairline, throat feeling tight and difficulty swallowing. Patient arrived to ED where she received Epi 0.3 mg SQ, Benadryl 50 mg IV, Solu-Medrol 125 mg, Famotidine 20 mg IVPB with improvement in symptoms. Patient was observed for greater than 4 hours in the ED without sequela or further intervention required. D/C with RX: Benadryl, Zyrtec, Prednisone taper, and an Epi Pen and instructions to f/u on Monday 14 June 21.

Pt stated she went to ER the day after the vaccination (on 6/22/21) complaining of headache, fever, rash, and shortness of breath. She went to the ER a second time on 6/24/21 again complaining of shortness of breath. In pharmacy she stated she was concerned about blood clots because she has family history with them. She was prescribed albuterol inhaler and prednisone. She has an appointment to see her primary care physician.

The first day I?d say about 3-4 hours after getting the vaccine I noticed a headache, was also fatigue, and slightly dizzy (pretty common side effects.) as the days went on I noticed that the headaches would not go away, they did with taking Ibuprofen and Tylenol, but would return 4 hrs after taking. Monday (6-14-21) I really noticed that my neck was stiff feeling, I was getting really bad random bruises on my legs, I would get really ?airy? feeling in my head, dizzy, my heart would start racing, and my hands would get really sweaty, I also felt hot even in colder temperatures. Made an appointment Monday (6-14-21) to get bruises checked out thinking it was from something unrelated, Tuesday (6-15-21) I made an appointment to make sure I didn?t have the blood clot they did a full work up, and noticed that my blood sugar was abnormally low (58) I do not have a history myself of diabetes or ever been suspected of being prediabetic. Tuesday (6-15-21) was definitely the worst of it. Later on in the day while I was working I was seeing black spots out of the corners of my eyes, I could hardly stand, I could hardly breathe (felt like a horrible panic attack,) my heart was beating so fast I felt like it was going to burst, my hands were extremely sweaty and I felt like my body was shutting down, I had a horrible headache, I could barely drive, and when my mom was taking me to the ER, I could barely lift my arms up. Went home as my blood sugars were then fine and I was feeling okay. From that day forward I noticed that at 6:30pm every night I would get these same side effects. Saturday (6-19-21) the pattern finally broke, I no longer felt like I was dying (I wish I was exaggerating.)

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: Patient described feeling nauseas about 10- 15 minutes after vaccination then patient fainted. Patient regained alertness a couple minutes after fainting but was still weak and unable to get up. Paramedics came and patient was found to be hypotensive after 15-20 minutes patients blood pressure restored and she was at full alertness and paramedics signed her release.

Woke next morning with rash and itching on front lower neck and upper chest. Buring sensation to touch. Rash still present w/o change >72 hours. Recommended taking antihistamine and if no result trying topical steroid. Outcome pending

- Low grade fever for 72 hours w/ high of 100.5°F. Nausea for 36 hours w/ abdominal cramping after eating for 72 hours. Diarrhea one day after vaccination and again 4 days after vaccination. Extreme fatigue for 48 hours. Headache that came and went for 72 hours. Chills/clammy-ness for 96 hours. Muscle/joint aches starting two days after vaccination and continuing until 4 days after vaccination. Chest tightness starting 2 days after vaccination and continuing 5 days after vaccination. Runny nose/sinus inflammation starting day after vaccination and continuing for 5 days after vaccination. - Pain in injection site for 48 hours. - Symptoms were debilitating for 48 hours and were manageable after that point.

I woke up noticing a slight headache, but I figured it was from poor sleep the night prior. I noticed after breakfast that I felt really cold and felt an internal shiver, especially in my chest. My fingers and toes were ice cold even with a sweater, blanket, and a warm tea. I noticed my skin starting to feel tender and I felt very fatigued. I wanted knew I needed to eat so that I could take ibuprofen, but I experienced a loss of appetite. I had a mild cough, but I felt too tired to even cough. I rocked in a chair in the sunlight outside for about 15 minutes and still felt cold. When I took my oral temperature after coming inside, I was reading 99.9. I took 400mg of Ibuprofen by 1130 and layed down to rest. Bundled in 3 layers, I felt the shivering couldn't stop. My headache got worse and my skin was tender to the touch. I was able to sleep for approximately 3 hours and I woke up drenched in sweat. I took my oral temperature again and was at 101.1. I drank some more water and tried to sleep some more. When I woke up around 4:30 pm, I felt a lot better. My temperature went down to 97.8 and I had a boost in energy and appetite. I no longer had a headache and I had only mild muscle aches. By the next morning, I felt completely normal again.

Fever of 102 degrees for 16 hours ongoing. Chills. Headache. Lower back pain. Fatigue. Injection site pain. Using 440mg of naproxen sodium po every 6 to 8 hours to relieve symptoms. Fever does not break with naproxen administration.

Janssen COVID-19 Vaccine EUA 1:15 pm shot received 1:30 pm left facility 6:00 pm horrible headache 11:00 pm body burning up, fever, and chills along with pain at injection site, headache, tiredness, whole body muscle aches, and nausea. This lasted until 7:00 am, took DayQuil, was able to sleep after taking it, but still feeling side effects. 1:15 Woke back up, headache, pain at injection site, tiredness, whole body muscle aches, nausea, temp of 98.4 degrees f. Took DayQuil again.

PATIENT RECEIVED J&J VACCINE ON 3.11.21 AND NOTED RASH AND SWELING OF THE FACE AND EXTREMITIES ON 03.12.21. PRESENTED TO THE EMERGENCY DEPT FOR EVALUATION ON 03.13.21. PATIENT WAS TREATED INTHE EMERGENCY DEPT WITH DECADRON 4 MG IM INJECTION AND BENADRYL 50 MG BY MOUTH. AT DISCHARGE FROM THE ER TO HOME THE PATIENT WAS GIVEN A PRESCRIPTION FOR MEDROL DOSE PACK.

I woke up less than 24 hours later feeling very achey and fatigued. My body ached all day the day after and I had a bad head ache. My arm that the shot was in, hurt to move but was bearable. The injection spot is inflamed and raised and the arm muscle still had a deep ache almost a week later.

Fever, chills, body aches, headache, could not get warm, weak; next day upper back aches, tight chest, left arm pain, sore injection site/very slight bruising

Injection site pain, body aches, headache, dizziness, nausea, and tiredness. Injection site pain started immediately after vaccine given and continued until now (approx. 24 hours later) . Body aches, headache, dizziness, nausea, and tiredness started about 8 hours after injection and continued until now (approx. 24 hours later)

Shortness of breath, sinus swelling, swelling in face, minor irritation of throat, warm, red skin on face and neck, dizziness Onset roughly an hour after injection, slow, progressive intensity of symptoms until roughly 11:30pm, at which point arrived at Emergency Department Treated with benadryl and prednisone in ED. At about 10:30am the following day, breathing clear and even,, no swelling or irritation in face or throat, some lingering redness and heat in face, second dose of prednisone administered at ~11:30am, symptoms continued subsiding.

Body chills began around 9:30pm night of injection. Fever of 99.8 the following morning before work. Spiked at work and was sent home early. Red mark on arm noticed Thursday evening. Was marked and it grew over the last 2 days.

Approximately 7 hours after receiving the single dose of the Janssen Covid-19 vaccine, symptoms such as muscle aches, fatigue, and fever set in. Symptoms rapidly worsened over the next few hours, with the fever reaching a max temp of 103 degrees Fahrenheit. This required monitoring and the use of ice packs to keep the fever under control. Muscle aches were severe, and were particularly prominent in the lower back region and the injection site. Fever remained in the 100-103 degree range for the duration of the night and by the next day, temperature returned to around 98 degrees.

I received the Johnson & Johnson COVID-19 vaccine at 8:30AM on Friday, March 26. The only symptoms I experienced until that evening were mild soreness at the injection site, mild stiffness/soreness in my left arm and my neck, and mild body aches. At 6:00PM that day, I was driving and experienced sudden-onset nausea and dizziness. I experienced tunnel vision and my vision began to black out. I was able to pull off the road and began retching and dry heaving. I also experienced tingling/numbness in my lips and then in my right hand, each of which lasted for about a minute. The nausea lasted for 5-10 minutes, after which it dissipated and I started experiencing chills. After returning home, around 9:30PM I experienced a severe headache and a return of sudden-onset nausea. I also experienced tingling/numbness in my right hand again, which disappeared after about 5 minutes. I retched and dry heaved again, and I took two Advil. The nausea passed and I was able to go back to sleep. The next morning, the nausea had completely disappeared, and the only lingering symptoms were a mild headache and mild stiffness/body aches.

3/25/2021 8:00PM: first sign of muscle aches 3/26/2021 12:00AM - 4:00AM: woke up with intense muscle aches, headache, fever, swollen fingers, slight heart racing, mild shooting pains in stomach 4:00AM: muscle aches became more mild 5:00AM: still awake; took Tylenol 6:00AM: still awake; Tylenol reduced symptoms; pushed fluids (alkaline water and Liquid IV) 6:30AM-7:45AM able to sleep; still felt mildly achey and very tired 10:45AM: ate a typical breakfast of oatmeal 12:30PM: muscle aches worsened, headache, slight stomach pains; took another does of Tylenol - symptoms decreased. Still tired. Ate typical lunch. 3:30-5:45PM: Napped + snack 6:30PM: third dose of Tylenol. Minimal symptoms. Ate typical dinner 3/27/2021 Slept through the night. Only lingering symptom is mild soreness in left shoulder (injection site).

?Janssen COVID-19 Vaccine? Approximately 5 hours after recieving the vaccine I started feeling extremely tired and cold despite the climate being warmer than usual. I went to sleep and woke up shivering, i was cold but my body was burning to the touch. My body ached and I had a headache and nausea. My eyes hurt whenever I moved them. These symptoms persisted until 9:18, I took 2 tylenol pills and started feeling better. Today is my third day, my eye pain has not gone and I still feel tired but what is bothering the most is the eye pain whenever I look anywhere or move my head.

Chills (lasted 2-3 hours) accompanied by a fever (lasted 2 days treated with Tylenol), tachycardia, lightheadedness, keep being either too cold or too hot, no diarrhea but more frequent trips to the bathroom. as of morning of the 3rd day post-vaccine, I am well with the exclusion of soreness of the muscle of the injection site which is still pretty intense

About 4 hrs later, I had a headache and neck ache. Around 8hrs after injection, I grew ill with a fever, severe muscle and joint aches, nausea, and the headache worsened into neck pain. I have had a bit of anxiety and all around emotional swings. I felt foggy and "off" at this time, like my head isn't clear. There has also been constant aching at the site of injection in my left arm.

During day of vaccination (recieved at 10am) Painted injection site, being unable to use that arm. Progressed to severe body aches, severe fatigue, nausea, vomiting, constipation, sciatica starting to act up with muscle cramps and back pain. The next day symptoms continued at the same levels causing work missed.

Fever over 102, whole body aches and weakness, nausea and vomiting, headache, sore throat, injection site pain that radiates into a sharp pain across my back. These symptoms are not mild like everything online says and were way worse than expected. I don't remember the last time I was ever this sick.

4/5 9 pm vomited 4/6 2 fever and chills body aches 4/8 noticed a bumpy rash on my upper back with no breathing issues

Received a call from Lead RN, patient received J & J vaccine @ 1555, patient walked over to the observation area and sat down. At 1600 patient told her wife she was feeling light headed, patient slumped over in chair and fell off the chair hitting the gravel pavement. Per RN patient lost consciousness for a few seconds, small laceration noted to the side of her head. EMS called at 1602, arrived at 1610, evaluated by EMS, per patient she does not want to be transported to the hospital. Patient left site with wife at her side, in stable condition.

I had gotten a red hot and itchy rash all over my body. I did not change anything in my routine and I am not allergic to anything that I am aware of. The rash has since come and gone

Arm was sore in injection site immediately after injection and has remained sore. Started getting a headache around 6/7pm. Headache got worse and started getting muscle aches all over body around 8/9pm. Skin was very sensitive and tender to the touch (eg touching my arm or brushing up against something). Fever started around 9pm, went up to 101.4°F. Had chills. Trouble sleeping. Now 7:30am the next day and still have body aches and severe headache, but don?t feel as feverish. Finally took 2 extra strength Tylenol tablets around 7:30am so hopefully that will help.

The first symptom was a pounding headache which got progressively worse and was also the longest lasting symptom. Fever of 102.5 degrees. Fever lasted approximately 12 hours, and included heavy chills and sweating. Extreme fatigue, weakness, and dizziness. Metallic taste in mouth. Body aches, and especially soreness in the left arm (injection site). Loss of appetite. By 24 hours after the vaccine injection, almost all symptoms were gone, but soreness in left arm persisted. About 26 hours after the vaccine, I had extreme acid reflux which lasted a few hours. In the two days since the vaccine I've experienced a ringing in my left ear.

I received my shot at approximately 8:40 a.m. I had pain at the injection site immediately, but it wasn?t super severe pain. At approximately 3:30 p.m. that same day of the shot that I received, I started experiencing flu like symptoms such as severe aches throughout my body and hot flashes. My body was also significantly shaking as I would randomly become very cold and achy when I wasn?t having hot flashes. I also had a severe headache. Slight pain on the injection site, but not horrible. The day after the shot, I feel weak and nauseous.

Within a day, redness and swelling approximately 1 inch to the left (medial) of injection site. No pain directly at injection site. Affected area approximately 1in x 1 in. Area has slowly increased in size. On 4/11 (4 days after vaccination), redness , soreness and swelling persist with affected area increasing to approximately 2in x 3 in.

Facial lymph nodes swollen ~2 hours after injection, body aches ~5 hours after injection, skin sensitivity to touch (felt like overactive nerves), fever ~1 day after injection. Symptoms completely cleared after 3 days.

Around 6pm I started to get a really bad headache and all I wanted to do was lay down because I was getting very tired. About an hour later my entire body was aching and I couldn't stop shaking with chills. I couldn't move or turn in my bed without my entire body just hurting. Even the blankets and clothes I had on were hurting my body. I tossed and turned throughout the night. At midnight I woke up to use the bathroom and my face and eyes were hurting. Once I got into my bathroom and looked in the mirror, my face was a little swollen and my eyes were a little puffy. My forehead and cheeks were a little red so I took my temperature and I was running a fever of 102.

Difficulty breathing, severe chest pain, trembling, migraine, severe body aches, tingling and numbness in fingers, chills, fever, ear pain, stomach pain, sensitive senses, pain at injection site, fatigue.

My skin is hot and Inchy torso and up worst is my arms both injection and none injection chest and upper back feels like a sunburn light dull constant pain warm to the touch skin but feels just like I got sunburned

Allergic reaction, hives on face and neck, eye and face swelling , all beginning the night of 4/10 and continuing

Initial injection site pain and almost passed out but did not. All body chills and shaking at 11, followed by fever, all over aching through 8Apr with focus on lower back. Injection site soreness through 8 Apr.

arm pain, large bump formed at injection site. red and hotness at injection site. Bump at injection site has remained for more than two weeks. Night of vaccination I experienced 99.3 degree fever, headache, chills, some joint pain a week later

ALOPECIA RESULTING IN COMPLETE HAIR LOSS ON HEAD OCCURRING APPROXIMATELY 4 DAYS AFTER RECEIVING THE VACCINE. PATIENT ALSO REPORTS BURNING SENSATION ON SCALP.

SEVERE MIGRAINE; SWELLING ON SITE OF INJECTION; SORENESS ON SITE OF INJECTION; This spontaneous report received from a patient concerned a 25 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced severe migraine. On 08-APR-2021, the subject experienced swelling on site of injection. On 08-APR-2021, the subject experienced soreness on site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe migraine, and had not recovered from swelling on site of injection, and soreness on site of injection. This report was non-serious.

RED SPOT PAINFUL/RED/SWOLLEN AND HOT TOUCH; ARM SORENESS; ACTIVITIES OF DAILY LIVING AFFECTED; This spontaneous report received from a patient concerned a 25 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 expiry: 20-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced activities of daily living affected. On 06-APR-2021, the subject experienced arm soreness. On 07-APR-2021, the subject experienced red spot painful/red/swollen and hot touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red spot painful/red/swollen and hot touch, and the outcome of arm soreness and activities of daily living affected was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

About a week and a half after vaccination, I have a rash on the back of my neck under my hairline. It?s itchy and bumpy. I don?t know ignore related to the vaccine or not, but it?s not normal for me to get rashes and I haven?t come into contact with any known allergens. I haven?t changed my soap or anything like that.

On the evening of 4-18-2021, I noticed the palms of my hands and feet were extremely itchy. Lotion did not relieve the itch I eventually put ice on them so I was able to sleep. I woke up 4-19-2021 and felt itchy all over but no noticeable rash. I took my last antibiotic pill around 9 am. By 2:00pm I started getting small ?hives? on my arms. By 4pm my arms were covered and my chest and neck had began to break out. By the time I reach the urgent care (4:45pm) my back and stomach, and upper legs had become affected also. I received a steroid shot in the muscle of my buttocks. I got home around 6pm and put cool towels on my legs and eventually the rash was almost completely gone. I woke up 4/20 around 6am with the chills and goosebumps all over feeling cold, but sweating like crazy. The rash/hives had came back and even worse/covering more of my body than before. I am now taking Prednisone 2x per day for the next 7days starting 4/20 11am

Hives x 12 days, started on day of vaccine. Used triamcinolone. Recommended fexofenadine twice daily until clear. Test for other sources with PCP.

Peristent induration and erythema at the vaccine site 3 week after vaccination. improved without intervention.

It has been just over 2 weeks now and I have continued pain in my arm around the injection site. I had no other effects from the vaccination except for some fatigue the following 6 hours after vaccination. I had severe arm pain for 5 days after injection where I could not move my arm. Today I still feel pain lifting it over my head.

BRUISE ON BOTTOM OF RIGHT LEG; TINGLING IN LEGS; SWELLING OF LEGS; UPSET STOMACH; BODY ACHES; CHILLS; EXHAUSTION; HEADACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ADHD, and hay fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. Batch number was not reported and has been requested. On 10-APR-2021, the patient experienced upset stomach. On 10-APR-2021, the patient experienced body aches. On 10-APR-2021, the patient experienced chills. On 10-APR-2021, the patient experienced exhaustion. On 10-APR-2021, the patient experienced headache. On 14-APR-2021, the patient experienced bruise on bottom of right leg. On 14-APR-2021, the patient experienced tingling in legs. On 14-APR-2021, the patient experienced swelling of legs. Laboratory data included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in legs, and swelling of legs, and upset stomach, body aches, chills, exhaustion, and headache on 11-APR-2021, and had not recovered from bruise on bottom of right leg. This report was non-serious.

Shingles - rash and itchiness around right breast that spread to back over 2 days. Blisters formed in 5 days. Started taking antiviral Valcyclovir on 4th day from rash onset. Pain intensified on day 4.

Had the worst cold sore/ herpes outbreak ever. it spread to my genitals, went to doctor and confirmed its still HSV1 and not HSV2. also spread to the inside of my mouth and nose. skin was sloughing off the inside of my nose and the roof of my mouth.

VERY BAD DIARRHEA; UNABLE TO TO MOVE HER ARM; FELT COLD; BODY ACHES; CRAWLING SKIN SENSATION; SWEATING; FELT SICK; HEADACHE; SORE ARM; DIZZINESS; RED FACE; FLUSHING OF FACE; ITCHY FACE; DID NOT FEEL GREAT; BURNING PAIN IN UPPER LEFT ABDOMEN; NODE/SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ehlers-danlos syndrome, and other pre-existing medical conditions included no breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced burning pain in upper left abdomen. On MAY-2021, the subject experienced node/swelling at injection site. On 03-MAY-2021, the subject experienced dizziness. On 03-MAY-2021, the subject experienced red face. On 03-MAY-2021, the subject experienced flushing of face. On 03-MAY-2021, the subject experienced itchy face. On 03-MAY-2021, the subject experienced did not feel great. On 03-MAY-2021, the subject experienced sore arm. On 04-MAY-2021, the subject experienced body aches. On 04-MAY-2021, the subject experienced crawling skin sensation. On 04-MAY-2021, the subject experienced sweating. On 04-MAY-2021, the subject experienced unable to to move her arm. On 04-MAY-2021, the subject experienced felt cold. On 04-MAY-2021, the subject experienced felt sick. On 04-MAY-2021, the subject experienced headache. Laboratory data included: Pain scale (NR: not provided) 4/10. On 05-MAY-2021, the subject experienced very bad diarrhea. Laboratory data included: Pain scale (NR: not provided) 6/10 (headache worsened). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red face, flushing of face, and itchy face on 03-MAY-2021, and crawling skin sensation on 05-MAY-2021, was recovering from unable to to move her arm, had not recovered from dizziness, sore arm, felt sick, body aches, headache, burning pain in upper left abdomen, very bad diarrhea, and node/swelling at injection site, and the outcome of sweating, felt cold and did not feel great was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509350.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

C/O arm numbness. Color of both arms=, pink and warm to touch. Able to move arm. After 10 minutes complained of left wrist and fingers numb on L arm. Able to move digits of fingers. Left hand slightly cooler than right, and color the same. Denies any other symptoms. Bandaid at site of injection indicates given in deltoid. After 20 minutes, symptoms did not improve and patient willing to go to hospital ER.

Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Pain and swelling on right arm and right calf-Medium, Additional Details: The pain and swelling were on the opposite side of where pt got injection. They were not at the site of injection.

BRUISE ON LEFT LEG JUST ABOVE KNEE CAP CREASE AND RIGHT THIGH A COUPLE INCHES BELOW THE BUTT AROUND 2-3 INCHES IN SIZE, DARK-PURPLISH, RIGHT LEG MORE BLUE AND THE LEFT LEG MORE PURPLE THAT HURT LIKE A NORMAL BRUISE AND NOT SWOLLEN; RED DOTS ON LEFT LEG FROM UPPER THIGH TO JUST BEFORE THE KNEE CAP; This spontaneous report received from a patient concerned a 25 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: 042821A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced red dots on left leg from upper thigh to just before the knee cap. Laboratory data included: Blood test (NR: not provided) Normal. On 16-MAY-2021, the subject experienced bruise on left leg just above knee cap crease and right thigh a couple inches below the butt around 2-3 inches in size, dark-purplish, right leg more blue and the left leg more purple that hurt like a normal bruise and not swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red dots on left leg from upper thigh to just before the knee cap on 14-MAY-2021, and had not recovered from bruise on left leg just above knee cap crease and right thigh a couple inches below the butt around 2-3 inches in size, dark-purplish, right leg more blue and the left leg more purple that hurt like a normal bruise and not swollen. This report was non-serious.

GENERAL FATIGUE; HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumption (socially, about once per week), non smoker, and grass, tree and pollen allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 19-MAY-2021, the subject experienced general fatigue. On 19-MAY-2021, the subject experienced headache. On 19-MAY-2021, the subject experienced injection site pain. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from general fatigue, and injection site pain, and the outcome of headache was not reported. This report was non-serious.

About a week and a half after receiving the first and only dose of the Johnson and Johnson Covid-19 vaccine, I developed small bruises (Petechiae) on my chest and arm. I decided to consult my doctor just in case. My doctor did a blood draw and ran a CBC panel. The next day I was rushed to the ER as my platelet count was reported at 7. By the time I got to the ER my platelets had dropped even further to a count of 2. I was treated inpatient for 3 days 2 nights. At this time I was diagnosed with IPT (Immune Thrombocytopenia Purpura). It was treated with two rounds of IVIG (Intravenous immunoglobulin) and 75 mg of Prednisone daily (which I have been slowly tapering off of since). My platelets restored to a non-critical level and have continued to hold steady ever since.

I have sincehad random purpura bruises covering my legs and arms. These bruises are occuring without any injury. Each morning I wake up to 1-2 new bruises. Older bruises are healing but very slowly.

My shoulder was sore for the first day or two after the vaccine, which seemed normal. But instead of getting better, it got worse. It wasn't exactly at the site of the injection, but higher and closer to my neck. It became painful to lift my shoulder to my desk to type. On April 15, my shoulder was hurting a lot and my fingers became numb during the day. It was significant enough that I went to an urgent care facility . The NP I saw indicated the thought that the inflammation in my shoulder was compressing on the nerves, leading to the numbness I felt and by then had spread up most of my arm. I also indicated that moving my arm was painful. She instructed me to take ibuprofen, 600 mg, 2x per day and see if that helped. I did that for about 2 weeks, but that much ibuprofen in my system actually caused me issues and I had to stop taking it. My shoulder becomes tired and sore, making it nearly impossible to function on a daily basis. It causes immense pain and OTC pain medications do not provide relief. I have used heat and cold, which provide temporary relief at night, but by about 1 or 2 p.m. each day I am in immense pain. Using the shoulder to type at a desk or sitting in my car with the arm pushed forward accelerate the pain each day.

Episode lasting 30 minutes on 5/22/21: Distorted vision Numbness in both arms Lightheadedness Sensitivity to light Headache Lasting 6 hours: Fatigue From 5/21/21-5/28/21: Symptoms similar to shingles - skin sensitivity above ribs around torso. Nerve pain/?shocks? 10-20 per hour in same area above ribs circling around entire torso. Fatigue.

All of the following side effects occurred for 36 hours following my vaccination: Extreme fatigue; headache; fever; chills; night sweats; nausea; vomiting; dizziness; blurred vision; weakness; muscle aches throughout entire body; pain at injection site (only experience 24 hours after injection)

25 year old female with prior history of syncope was at public vaccine clinic when she syncopated 9 minutes s/p receiving her 1-time IM dose of J&J COVID-19 vaccine in her L deltoid. When she syncopated, she fell forward while sitting in a chair and hit her head on concrete. She suffered a 1cm superficial laceration on her L frontal scalp. There was a brief moment of generalized seizure-like activity that lasted for about 10 seconds. After this, she woke up and was able to sit up. Patient appeared anxious. She was alert and oriented x 3 once she was up with a GCS of 15.

I started feeling sick at 8pm, headache and body aches and the severe pain at injection site. At 10pm I had become dizzy and short of breath and started shaking. Shortly after I started losing feeling in my hands and then could not feel them at all. This is when I was taken to the ER and admitted for three days. I had a fever as well.

I have developed a large knot in my arm and red fevered area the size of a baseball. It is getting bigger throughout the day. Ice does not help the swelling. Very tender to touch and hard to lift my arm for basic tasks.

10 hours after the vaccine: fever, chills, body ache, diarrhea, abdominal cramps, light headedness. Treatment: electrolytes and paracetamol. Symptoms resolved after 24hours 9 days after the vaccination: headache, fatigue Treatment: ibuprofen 10days after vaccination: fever 100.8, chills, body ache, skin sensitivity, fatigue, & mild headache. Treatment: Paracetamol

Client received Pfizer in January and had a significant reaction, including hives for several days and a chest pain with a subsequent diagnosis of cardiomyopathy. She consulted with her provider who recommended that she try to take some Miralax to see if she had a reaction, which she did, including swelling of her face/lips. She states that her provider then recommended the Janssen as a second dose instead of the Pfizer. Client received the vaccine at 12:12 pm, noticed two small hives on her left forearm a few minutes later, and then reported that she did not feel well at 12:20 pm. She was placed on a cot with a BP reading of 130//72, P -88, O2-99%. She took some oral Benadryl that she brought at 12:30 pm. She reported that her face felt "funny" and she felt hot, but started to feel better when she laid down. 12:40 pm BP 118/76, P-82, O2 98%. Client reported that her throat felt a little scratchy, but that she was also very anxious. 12:50 pm Client reported that she started to feel better. 12:52 pm O2 98%, P - 80. 1:00 P- 85, O2 99%. Client felt well and left with her father.

Began overnight after injection. Bodily fatigue, flu like symptoms, soreness and pain at injection site, headache, loss of focus, inflammation and red filled circle about 1inch diameter at injection site. Have been taking ibuprofen 600mg as treatment.

June 1st: My finger tips were beginning to turn purple. It started on my left hand index and middle finger. Then it spread to my pinky, then following the same route on my other hand. I went to my GP and he had suspected Raynauds but wanted to refer me to a Vascular doctor since it seemed a little odd to see a Raynauds case in June. The next day I was able to see a Vascular doctor. He diagnosed me with a possible embolism and put me on Eliquis and recommended a cardiac workup which I scheduled right after that appointment. The doctor mentioned that if it does not get better to give him a call within the 2 week window of my recheck. A week and a half in it was not getting better, I called the office and he mentioned to go to the ER . June 17th: I went to the ER and explained my situation. Seeing my symptoms they admitted me. They started a Heparin drip IV to keep me on the thinners and ran a whole cardiac workup included an enormous amount of bloodwork. I spent less than 24 hours in the hospital because my cardiac workup was normal, bloodwork did not show any signs of emergency. In the hospital I saw the doctor on call, Vascular, Hematology/Oncology, Diabetic Educator, & Cardiologist. They discharged me with Xarelto to start and told me to see a Rhematologist. Every doctor there suspected a Rhuematoid issue. After being discharged I made an appointment with PA on July 1st. Upon arrival she ordered what had to be 10 or more vials of blood which included some Rhematoid testing as well as a special panel called Avise which narrows down the Rhematoid issues. While we waited for that bloodwork she then put me on Amlodipine 5mg once a day. In between that I went to do the check up with the Vascular doctor that I saw in the hospital and he said that it is not a vascular issue. At my recheck with PA, My bloodwork showed my thyroid number was elevated. She ordered a thyroid ultrasound in which I am still waiting to get done. All of the Rhematology bloodwork showed no diagnosis. She then raised my Amlodipine to 2.5mg in the morning and 5 mg at night as well as Nitroglycerin Cream to put on the top of my hands 3x a day if needed. I have been taking that medication and the cream as well and nothing seems to be helping. On my left hand specifically I have ulcers forming from the beginning of this ordeal. They are getting extremely worse and larger. The pain and inflammation that comes and goes in all of my fingers are unbearable. No medication that any doctor has given me from the beginning to now has helped me.

All periods (starting 24 May) have been predominantly blood clots; atypical to see any. Sudden onset of banana allergy. Itchy ENT, swollen/watering eyes, full-body itch.