Johnson & Johnson

Low grade fever and fatigue started around 7:30pm followed by severe chills. Woke up the next morning around 8am with headache that went away after a couple hours. Felt great the rest of the day with slight soreness at the injection site.

Chills, body aches and fever about 7 hours after the shot. I took Tylenol and it made the symptoms more mild. I was fever free at about 11am the next day. My injection site and arm still hurts 3 days later and I have a swollen and sore gland in my collar bone on the same side as my shot was given.

8-10 hours after had aches, 102 temp wouldn?t go down with Tylenol, chills, dizzy (all manageable) 24-30 hours later arm formed warm red lump which has continued to harden and spread. It?s now a very hard lump that is the largest it?s been . I?ve been treating with prescription triderm and it is helping some but when I tried clobetasol the opposite happened and it aggravated the site. This redness , itching, swelling and warm to the touch has been going on since Sunday evening and it is not Wednesday night and doesn?t look better yet.

An hour after getting the injection my left arm started spreading red, the next day I woke up with a terrible migraine, more redness and hives, it feels like a bad sunburn. My skin is red all over my body. I didn?t ever feel pain at the injection site just felt warm as the vaccine spread.

Hives throughout the body, will treat with Benadryl at home but if I don?t see improvement I?ll go in to doctors office for evaluation. Janssen COVID-19 Vaccine EUA

Symptom Onset 3/12/21 4:30pm - 4am Fever of 101.9, muscle pain, joint pain, numbness in fingers, muscle weakness, difficult to move on my own, skin pain, migraine-like headache . 3/13/21 9 am - muscle fatigue, muscle pain, headache, sensitive skin, joint pain, brain fog.

Headache/migraines 3/13 night with limited relief from imitrex. Body aches starting with injection site working down arm to hand, then all joint throughout the night. Unable to sleep with pain. By morning I had a fever. Took two Tylenol and slept. Final helped with aches and fever. 4pm Sunday still have pains in the head when I get out of bed.

5:00 pm 3-9-21 I became instantly exhausted and had fatigue. I got chills and ran a 99.8 fever. I went to bed and about 5 hours later my fever broke and I felt fine in the morning when I woke up. 9:30pm on 3-13-21 I found both of my thighs bright red. It was not itchy, but it was warm to the touch. 7:45pm on 3-14-21 My butt cheeks were bright red and warm to the touch. Then about 30 minutes later my thighs became red. Everything red started itching was raised like hives. I found three dots on my arm and later those spread into large spots of hives. Then over the next 9 hours, a new spot would start, it would spread, then it would itch like crazy. I took 25mg of Diphenhydramine at 8pm. I took another 50mg at 10 when I was having no relief and it continued to spread. At 1:15am both of my hands and wrists had hives and these hurt and itched the most because they were swollen and hard to bend. At 3am both of my feet started to flair up. Finally around 5am the hives stopped. I was not able to sleep through it. I did not ever have a fever, I checked that 4 times. I also did not have trouble breathing or have any swelling on my face. 3-15-21 @ 9:20am I went to see my doctor. All of my vitals were good. All of my hives were gone. He put me on Prednisone in case it came back and at 11am I took 4 pills and went to bed. I woke up 2 hours later and my feet were itching again. My left foot broke out in hives bad. It lasted for over an hour. My toes were hard to bend. 4:34pm on 3-15-21 currently I don't have any hives and I am tired. I thoroughly thought through everything that I have eaten, worn, and used, and I have changed nothing over the past 2 weeks.

- Fatigue (Began 3/13 @ 9pm) - Continued until 3/15 - Headache (Began 3/14 @ 8am) - Continued until 3/15 : Treated with Tylenol - Nausea / Vomiting (Began 3/14 @ 9:30am) - Continued until 10am on 3/14 - Sore Around Injection Site (Began 3/13 @ 4pm) - Continued until 3/14

Headache, dizziness and brain fog initially. Significant arm, shoulder and neck pain on left side. (Injection site). Neck pain continues after two days/seems worse.

Intense Muscle Aches and Weakness Intense Joint Pain Fever Chills with sweating Small rash and intense itching in left arm Headache that made me nauseous

Per HCW, she developed flu-like symptoms on 3/13/21 @ 0720 am. (Approx. 17 hrs post vaccination). Other symptoms include itching to face, headache, fatigue, pain behind the eyes and sore neck muscle. Took Motrin and Benadryl. Per HCW, symptoms worsened. On 03/14/21 @ 03:30am she noted swollen lips, injection site swelling, fever of 102 and shivering. She denied SOB, Chest pain. Had mild nausea and diarrhea (resolved). On 03/15/21, Sought treatment via PCP and was prescribed Alegra 180 mg by Mouth everyday and Ibuprofen 600 mg PO every 4-6 hours. OUTCOME: Began feeling better on 03/16/201 at approx. 1130 am. Continues to have a "knot" at injection site. Intermittent neck soreness and pain behind the eyes.

About 6 hours after receiving the shot I started experiencing skin sensitivity (common when I feel ill), chills, aches in my legs and a slight headache. The chills subsided after about 2 hours, but then my resting heart rate went up to 110-120 bpm rather than the normal 75-85 for me. It felt like my heart was beating out of my chest even though I was laying down in bed. That lasted through the night and I felt back to normal around mid-morning.

After 15 minutes of sitting in the waiting area in case of adverse effects, (which I didn't have any) I went outside and sat in the parking lot for another 10 min. After no side effects, I drove away. Only to have a sudden reaction as I was driving. I've felt dizzy with flu vaccines before and have felt the same symptoms as with the covid vaccine when IV dye was injected for a CT scan 5 months ago. Felt faint/ dizzy, Got severe tachycardia, thought my heart was gonna explode. I drove back in a hurry, scared and confused. I was waiting to be seen, and no one ever came out. Symptoms subsided on their own after 15 min, therefore I just left without notifying anyone. 2 hours after vaccine, my arm looked moderately red and swollen, with minimal pain. 7 hours after getting the vaccine I started with chills and body aches. 8 hours after getting the vaccine I felt feverish and malaise. After taking Tylenol with feverish symptoms (didn't check temp) slept for 2 hours and felt a little better.

24 hrs later - Rapid heart rate (150 resting) exhaustion, Swollen red arm, body aches, low grade fever

I felt light headedness right away. The night that I got the injection, I felt kind of drunk. I felt like I had too much alcohol. I am very sensitive to things. I felt silly - loose - tired. In the night, I had aches and chills - no fever. The next day I felt achy and really really tired. I had a pain at the injection site. That evolved into a left side migraine (the achiness and fatigue and pain from shot) It created tension up my arm and up my neck - and I did get nausea with the headache - on Saturday. Sunday, I felt a little bit better but energy was still low - unusual tiredness; couldn't exercise as I felt a heavy fatigue. On Sunday, I went to a dance class but it was difficult as I was tired. On Monday, I felt a tiny bit better but still fatigued and did another dance class which went a little better. On Monday evening, I felt like I did the night of the injection - a little loopy and "drunk like." Monday night, I woke up with a Fiery, achy, itchy, burning rash on both of my arms and the tops of my legs. If I would itch it, it would exaggerate it. When I woke up the next day - the rash went everywhere in my body - it would come and go in different places - neck, face, down and up my legs and feet and on my butt. Pretty much every spot had the rash at one time or another. It was really bad on Tuesday morning, I called the doctor. Was treated with Benadryl and cortisone cream which helped with the symptoms. Tuesday night, it was excruciating - it was all up and down my legs, arms, neck and face and stomach and rear end and feet. It was very achy, burning and itchy - very intense. It would hurt if I scratched it. Accompanied with really intense fatigue. Wednesday, after taking Benadryl, I woke up and it was a tiny bit better. It was still on my legs, neck and face. Sometimes my arms would flare up and sometimes they wouldn't. Any kind of exertion - like my dance class - would trigger the rash - so I took a break from exercising that week. It started getting incrementally better - very slowly. Still there on Thursday - still fatigued and I was still taking Benadryl. Friday, also. Saturday, it was pretty much gone but it would threaten to come back and I felt itchiness in my legs when I went for a walk. It still feels a little lingering - my legs are itchy. I'm still building back my energy. Incrementally my energy is increasing. Still not 100% there but it's getting better day by day. Note: My history with my skin: I do get flare ups when I get bug bites and when I get poison ivy - I have very sensitive skin.

In addition to the known side effects of extreme fatigue, low grade fever and body aches, I also have right arm pain at the site of injection with right arm swelling, warmth and right axilla swelling and tenderness. The arm pain was began immediately at the time of injection and did initially lessen some for the first 12 hours until it started worsening mid-morning 22-24 hours after the injection. Around 26 hours after the injection the arm pain worsened such that it couldn't be ignored and the axilla pain became very prominent almost worse than the arm pain. Upon inspection I noticed obvious swelling and pain in my right axilla. The right arm and axilla pain has persisted and worsened over the last 2 days to now include upper biceps, upper triceps, lower deltoid, trapezius, clavicular and right lateral breast pain. The axilla and arm swelling has persisted and worsened over the last two days to now include swelling in my upper arm, around my clavicle, my upper chest and upper back. The initial axilla swelling has not decreased any and is more prominent than any of the swelling located elsewhere. Of note, I cannot easily palpate any axilla, clavicular or cervical lymph nodes. If there is lymp involvement the nodes are not appearing to be extremely swollen with palpation exam.

Site: Pain at Injection Site-Medium, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: vasovagal reaction -Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Additional Details: patient started hyperventilationg after vaccine. Was flush and said dizzy. Had patient lay down said getting hot and sweaty. Then said having trouble breathing. Checked pulse rapid. BP was 168/92. Repeated that having problems breathing so called 911. They did EKG-normal, BP was back to normal after I laid her down,elevated feet, put fan on her, gave cold compress and had do breathing exercises. EMT after assessement and refused blood glucose test said probable vaso vagal rxn.

ADVERSE REACTION TODAY: hot, itchy rash on forearms made up of tiny blisters -- > no tx thus far -- > OTHER SIDE EFFECTS: Immediate onset: muscle pain at site of injection Onset about 11 hours post-vaccination: fever, chills, muscle aches, site of injection red and in worse pain, headache Onset about 24 hours post-vaccination: earache off and on Onset about 48 hours post-vaccination: fever spiked at 101.8 Onset about 96 hours post-vaccination: lethargic, headache

Where I was given the injection, I have a large red swollen bump. It's been 48 hours and it seems to be getting larger. It's looks similar to a spider bite.

Chills and body aches, skin sensitivity. Night sweats, headache and ran 101.1 fever. Light nausea. This happened from 1AM until 4AM. Then I felt fatigue the whole rest of the day and had body aches for the next 24 hours.

Fever of 101.8 plus body aches and severe headache on 3/31/21 resulting in inability to work. Sore arm On 4/1/21, mild symptoms, sore arm, mild body aches and mild headache On 4/2/21 same mild symptoms as previous day plus some shortness of breath followed by an asthma attack at 5:30pm. An asthma attack is extremely unusual for me and I haven?t had an asthma attack in 20 years

Janssen COVID-19 Vaccine EUA Developed a headache and sore arm approximately 12 hours after vaccine administered. The headache lasted for 5 days. I currently still have a walnut-sized, firm lump in my arm at the injection site that is still slightly painful (like a mild bruise). The skin surface of the injection site was itchy (like a mosquito bite) on 3/22 and 3/23. My main concern is the continued presence of the lump in my arm.

Around 6 hours after vaccine, I had uncontrollable chills. This led to a low grade fever. I tried to sleep it off, but woke up with my heart racing- My resting BPM was around 120. My skin was super sensitive. I started taking 2 extra strength Tylenol every 6 hours around 5pm, and that helped a little. I couldn't focus on anything- I could basically stare at the wall while my heart was hammering. I finally slept, and woke up soaked in sweat with my fever broken (my fever never got above 99) around 2am, and improved steadily after that.

Generalized itchiness throughout the body including left side of the throat. 25 mg of benadryl administered PO with improvement in symptoms.

Injection site bleeding at time of shot. Second bandaid applied. Dizziness and nausea within 20 mins of shot Shortness of breath (when walking) within one hour Fogginess Extreme fatigue Muscle weakness Arm pain at and around injection site radiating up left side neck area Over 24+ hours later all side effects persists

During 15 min waiting period around 0945 at vaccination site, patient became flushed and had increased heart rate of 106 bpm at rest per patient's Apple iWatch. Provider onsite was notified and immediately evaluated the patient. Instructed patient to remove face mask to allow ease of breathing. Heart rate returned to normal for patient (68bpm) within a couple of minutes. Patient stated she informed the provider that she was feeling better and was cleared to return to work. Patient states that throughout the day, she was mentally "foggy", sleepy, yawning frequently. States at around 1300, she began to itch on her arms, then around 1400 she noticed her arms were blotchy with purple/white rash. In areas where she scratched, she reports the rash was dark red with a bit of orange tint. Reports legs had rash that appeared has hives. Patient also reports that about 1-2 hours post vaccination, she started having chest tightness and shortness of breath. At 1600 she called the clinic and spoke with a medic on the phone. She informed him of her symptoms (chest tightness, shortness of breath and full body rash and hives). She was instructed by medic to report to the nearest ER for evaluation and treatment. Patient states that she did not feel that she needed to go to ER at that time. She states that at 1800 she took Benadryl which did not seem to help the symptoms however she states they did not worsen. She took a second dose of Benadryl at 2200 and fell asleep. Patient states when she woke up this morning at 0600, all symptoms had resolved. She denies any symptoms now except for some minor itching on a couple areas of her wrist, ankle and under arm. No full body rash or hives noted. Denies any further administration of Benadryl at this time, as of 1630 on 7 APR 2021.

At about 5 pm the same day of receiving the shot I started to break out in hives on my chest. Later that evening I started to feel numb from the neck down. I had a hard time walking. My whole body felt sore. I started to run a fever of 101.9. This lasted for about 24 hours.

4 1/2 hours after the vaccination I experienced extreme pain in my upper body all the way through my neck 4 1/2 hours after the vaccination I experienced extreme pain in my upper body all the way through my neck. Then very tired. Around midnight I woke up with an excruciating headache fever chills. Was not able to go to work the following morning go to the headache and bodyaches all over with a stabbing pains in my side. The following morning I woke up with red hives all over my body. The hive started at my neck and went down with my torso around my back and on the inner of my arms. My headache has gone away but I still have the hives

My vaccine was administered at 12:30pm. I waited until 12:55 at CVS after the vaccine to make sure there were no reactions. I also move my arm around a lot after the injection to keep it from hurting. I drove home, at lunch and about 2:45 was hit with a very noticeable headache. I never get headaches and eat healthy and consume about a gallon of water a day. I knew it wasn't from dehydration or being hungry. Headache was in the temple area and made my eyes hurt in the same way they would if you had cried for an extended period of time or were overtired. At 3pm a wave of exhaustion hit me. I was sitting working trying to combat the headache and felt almost wiped out. I got through the rest of my work day (4:30) and went to lay down immediately. I passed out almost instantly until 7 pm. I work up and showered, ate dinner and started to feel a little warm. It should be noted it was an unseasonably warm day and got up to 77, so it was a tiny bit warm in my home. I put on loose fitting clothes and slayed on the couch still with the bad headache and the injection site started to throb so I placed and ice pack on for 20 minutes. I could only stay awake until 8:45 and got in bed. I could not get comfortable for several hours feeling very warm. I tried a fan on high and drinking more water but i felt very warm like how you feel with the flu. I took my temp at 1130pm it was normal. I continued to toss and turn and feel very warm and slightly dizzy, in the sense that I hadn't been able to sleep and with the headache my body was just exhausted. Around 2 am i woke up for more water and got in the shower because I had sweated so much my sheets were wet and my clothes. I got out of the shower around 10 minutes later, changed and got new sheets and got back in bad. Around 330 I felt very hot again and opened the windows and got another ice pack for my arm which was throbbing again. I finally fell asleep after 3:45am. I got up for work at 6am. I felt slightly foggy, and very hot. But no fever. My temp is normally around 97.4-97.9 and it was 98.4. Still normal but I was running warmer than usual. It took a long time to get ready and despite hot water in the shower I was freezing. i got dress and debated going to work. Got in the car at 6:45 and my drive to work is 30 minutes. 1/2 way into my drive I got very sweaty again and went home to change my clothes because they were too warm. Got to work around 7:20 and still felt warm but they take our temps at the door and min was still okay, no fever. I drank a lot of water and ate, and at 8:30 am all of a sudden the exhaustion was gone and I felt normal. I got home form work at 5:30p and took a 3 hour nap and felt normal again.

Sore/swollen lymph nodes on the side of injection, very vivid dreams, restlessness, significant increase in anxiety/panic attacks, hard time falling asleep

started to have hives, pain in feet, hands, bones, itching. took Benadryl, not effective, was started on Famotidine and Zyrtec which controlled hives, came back if missed a dose, started ASA bid on day #10 for pain, was started on oral Pred taper day #15 for persistent symptoms (60mg x 2 day to taper ever 2 days), these symptoms consistent with serum sickness.

Patient reports the night of the vaccine, she had chills and low grade fever (100.7F) that resolved by morning and she was tired for two days. On March 29, 2021, she had discomfort on the left axillary and left upper back areas which help like her "shirt was too tight and rubbing" and the upper back was like a "pinch" and she continues to have this. She developed a rash under her left arm on April 2 in the evening and it continued to spread and erupt across her upper back and chest. April 4, 2021, she developed blisters and it continued to spread down her left arm. She contacted her PCP and MD on April 4, 2021. After describing the symptoms to MD, MD prescribed Acyclovir 800 mg PO 5 x daily x 10 days and gabapentin 300 mg PO TID. MD advised patient that she likely had herpes zoster. She reports she improved 40% with treatment and presented for evaluation 5 days after contacting MD and the diagnosis was confirmed.

Pain in arm immediately upon injection. Extreme dizziness, light-headedness, and a warm flush came over me within 2-3 minutes. Sat down on a chair, put my head between my knees. Wasn't helping so I sat down on the floor cross-legged and put my head to the ground to try to keep myself from fainting. A medic noticed I wasn't doing well and took me to a tent on the other side of the large room to lie down. She asked if I wanted a wheelchair and I declined. I barely made it to the tent to lie down before I would have fainted. Lying down was significantly better than sitting down. After staying prone for about 20 minutes, I was doing better so I left. Immediately after walking outside and feeling cool fresh air I was much much better. Dull headache approximately 19hrs after shot that lasted half a day. 48hrs post shot had tingling and numbness in injection arm that lasted about a day. Injection arm soreness for 3 days total.

Noticeable increase in menstrual cycle- bleeding increased 6-7 hours post injection, and was accompanied by very large clots. (Not normal ) This lasted two days. Intense chills/shivering. Night sweats, nausea. This was the night of the injection. Headache. Everyday since injection. Throbbing in left temple. Muscular pain, left deltoid. This has increased since day of injection. Redness, swelling, pain at injection site that has intensified since injection. (No other indicators of it being an infection. Not warm to touch, no oozing or bleeding or any type of fluid.) Left forearm muscle pain, left wrist pain- almost like a dull ache going down arm.

Almost immediately began to experience nausea and some mild lightheadedness. Within an hour began to feel like I had taken a sedative (reminded me of how klonopin made me feel when I was taking it for anxiety). Sedative type feeling lasted for approximately 4 hours. Headache developed approximately 2 hours after receiving vaccination. Headache and nausea persisted until bedtime. Had major issues sleeping and had night sweats all night. Nausea is gone this morning but headache is still present. Some mild tenderness at injection site that is still present this morning.

I went to bed that night 6 hours after vaccine, and woke up with extreme flu 8 and half hours after vaccine. High fever chills, vomiting, body aches. The next morning 15 hours after vaccine my arm started to hurt so badly I could barely move. The nerves in the injected arm running up and down with shooting and pulsing, lack of feeling in hands and extreme pain through the the arm and shoulder on the injected side. The pain was extreme for 13 days I lost work time. I saw several doctors who sent me on my way. My arm still hurts right now 24 days since vaccine. The pain is not extreme but the nerves still shoot pain and oils and there is often extreme pain by the end of the day.

High fever (103.5) approximately 8 hours after shot, persisting for 3 days at over 101 with Tylenol every 4-6 hours Body aches and chills lasting for 24 hours Nausea and vomiting for 72 hours after injection Diarrhea for 72 hours after injection Bitter taste in mouth and all food tastes bitter ? still persisting as of 4/10/21 Patches of dry skin on left side of face that burn and itch and are flaky. Areas are swollen and hot to the touch? appeared on 4/7/21 and as of 4/10/21 still there.

Patient had covid19 vaccine yesterday in her left arm. Today, she noted some swelling at the base of her neck on the left and it is quite tender to touch. The upper arm is only mildly tender. The vaccine was Johnson and Johnson. She has no breathing difficulties and no trouble swallowing. No fever, chills or myalgia. No chest pain. Acute onset. Stable. She has no evidence of airway compromise or difficulty swallowing. This does not appear to be lymphadenopathy. I want her to monitor closely. Apply ice to area as directed on after visit summary. Acetaminophen for pain. If enlarges with any evidence of airway compromise at all, she must go directly to Emergency Department or call 911. I encouraged her to report this on VAERS site for adverse vaccine reaction. As of 4/11 1:41pm pain at collarbone is same, but swelling is down a bit. Injection site is now very tender/ painful to touch.

Presents to the emergency department with complaints of swelling on the roof of her mouth which has progressively increased since receiving the Johnson & Johnson COVID-19 vaccine 10 hours prior to arrival. Mass on the roof of the mouth which is firm and hard like bone. Treated with IV fluids and medications.

Low fever, chills, muscle aches, headache, nausea, sore injection site, fatigue/exhaustion. Bad for 12 hours, milder for 12 hours. 24 hours total. Symptoms started 8 hours after injection.

At time of injection, dizziness, pain at injection site, pain in right arm fingers, inability to grip with fingers on right arm. Next day swelling of hands and feet. Veins large and visible thru skin more than usual. Continued dizziness. Tylenol taken to deal with pain. 7 days later still minor dizziness. Swelling of feet and hands continues. Pain in right arm. Pain in right hand and unable to grip with right hand.

FRIDAY DAY AFTER INJECTION SEVERE HEADACHE AND BODY ACHES, THEN SUNDAY EVENING LEFT SIDE FROM SHOULDER TO ANKLE HAD BRUISES AND HURT TO TOUCH.

Pt says she has a knot at the injection site that developed day after the injection and hasn't gone away even though it's been a week. According to the patient, she has a family history of blood clots and pulmonary embolisms. She was advised to contact her primary care provider and get the proper diagnostic tests.

Approximately 3.5 inch in diameter injection site reaction that began approximately 72 hours after receiving vaccine. The area is swollen, hot to touch and red in color. The area itches and is very painful when touched. Occasional sharp pains occur and entire left arm is sore after use even for simple tasks such as typing or driving.

left shoulder was the injection site- very swollen, red, the size of a fist, hot to the touch, very sore- a lot of pain. Hot, cold, chills, extreme body aches, blinding head ache, loss of clear site in left eye, vomit, nausea, tired, loss of taste, sores on the inside of mouth.

Janssen COVID-19 Vaccine EUA: twelve days after vaccination patient presents to emergency department with a headache that started seven days prior to arrival. Patient describes headache as different than normal headaches: worse with movement and episodes of dizziness. Patient also has rash/redness on right cheek of the face. Vital signs within normal ranges except blood pressure 141/96 mmHg. Patient admitted to hospital for further testing and management.

Chills, sweating, mild fever (100F), joint aches starting the night of the injection through 7pm the following day. Starting on Saturday (2 days after the injection, I developed a rash on my belly and had diarrhea. Sunday, developed an itchy rash on the tops of my feet and hands, in addition to the belly. Another bout of diarrhea.

Patient reports pain, redness, swelling, itching, and stiffness at injection site. Stiffness most concerning for patient. Did discuss normal and expected vaccine reactions and patient felt this was outside those parameters.

The night of the vaccine (4/10/2021), and the following two days (4/11/2021, and 4/13/2021) I experienced extreme fatigue & low-grade fever (99.6F). On 4/14/2021, the injection site became red, hot, and slightly hard to the touch.

Severe Pain in armpit and swelling in the same area the symptoms started on Monday evening and still occurring. I am taking 2 Ibuprofen every 4 hours to relieve the pain. I am in my 3 day of experiencing this along with a headache.

On Friday after the shot, I felt ok, but my left arm was swollen to the point of taking off my wedding rings because they hurt. The leg pain started on Friday night. Saturday woke up with a groggy head and tired. Sunday I had leg pain, headache, and foggy brain. Saturday into Monday I had night sweats (pouring in sweat) fever, headache, body aches, tired (could not keep my eyes open) I slept all day and could barely move comfortably. Tuesday I was extremely exhausted, leg pain continuing, headache, and weird feeling. The swollen arm is back. Today is Wednesday, almost a week after with leg pain, headache, swollen arm, and weird feeling.

Patient started with swollen injection site 2 and 1/4 inch in diameter. Hurt to touch and hot to touch. Headache, bodyache, severe fatigue, and nausea. On April 13th blood pressure started to rise and was 160/106. Patient decided to go to the Emergency Department and was seen by Dr. She was prescribed ibuprofen, Zofran, acetaminophen. Dr concluded that all symptoms were from the Janssen vaccine.

Janssen COVID-19 Vaccine EUA Chills and muscle aches began 5.5 hours after vaccine and last for about 3 hours. Extreme chills and aches for 1.5 of those 3 hours. Fever rose to 100 degrees and fell within those 3 hours. Next day experienced minor heachache, body aches, fatigue for entire day. 56 hours after vaccine experienced red itchy bumps across stomach and inside elbows.

RASH; This spontaneous report received from a patient concerned a 40 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, expiry date: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. No concomitant medications were reported. On 07-APR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash. This report was non-serious.

On April 8th at 4am, I woke up feeling a strong pain in my heart / esophagus region. I was alone and out of town and didn't know what to do, so I just sat in the hotel bed and waited for morning to come. I didn't know if i was having a heart attack or if it was gas from drinking soda the previous day. I went to work. At work, the left side of my tongue suddenly started swelling and a tingling and numbness set in my upper lip. I was very scared, rushed to the drugstore and bought GasX, Ricola drops (my throat was slightly sore, too) and Allegra 24 hours. I immediately took the Allegra pill but still went to the hospital. When getting to the parking of the hospital, though, the anti-allergic started kicking in and the tongue started getting back to normal, so I went back to work and didn't enter the hospital. I was ok for a while. Hours later, rashes started showing all over my body. Starting in my arms then under my breasts. On the night of the 8th, I even had fever and chills. Still, I had to go to work so it was a real nightmare. I also had diarreah. I then went to the drugstore again and also bought regular and night Advil, lots of water and electrolytes drink, Peptobismol and Benadryl (only Allegra was not enough). The following day, April 9th, the rashes started spreading all over my body, the fever was only being controlled by Advil. I flew back to Miami and was bedridden until the April the 11th. On the night of April the 11th I still woke up with very strong headache and on the 12th spent the day with a headache, but since have gotten better.

itchy rash to arms and legs with throat tightness. Took oral Benadryl, symptoms resolved and did not return.

There was a small rash on my left hand. of which I was applying an ointment. it was perfectly fine until the vaccination but after 2 days, i had a burning sensation and redness on the rash. along with it, I observed pimples/red bumps on my face near the nose too. since then, the rash is flaring up badly and turned red even after applying ointment too.

pt says she had an achy left arm w/ fatigue. Next day she had a low-grade fever and hives on her stomach. She started taking Benadryl per Teladoc. She started getting very dizzy and her hives were moving towards her shoulders and her throat was closing up. 911 was called. She was told her anxiety was very high. She was transported to Hospital ER. She was put on fluids and steroids, (methylprednisolone 125mg, famotidine 20mg, sodium chloride 100ml) They did blood work which showed low platelets. Her rash was bright red and spreading down her arms and her stomach while she was being monitored. She was discharged w/ DX; Acute allergic reaction and given an EPI pen and oral steroids. She has a FU w/PCP on 5/3/2021 to check blood platelets and will go from there.

Onset of chills at 4:45pm, followed by fever of 104 degrees, heart palpitations and tachycardia, red rash on cheeks from fever, severe headache and body ache, random spasms in arms and legs. These symptoms were intense and lasted throughout the night. Headache, muscle aches and spasms lasted three days.

One week post injection I developed a rash a couple inches below where the injection was received that spread down my outer arm (to a little above my hand). Within a few hours the same rash appeared on my other arm the same way. I later realized it was also on my stomach and sides down to my upper thighs. Those rashes were gone within 12 hours or so. I did continue to get small rashes on my inner thighs and small rashes or itchy spots on my lower legs and ankles for a week or so.

INJECTION SITE RED /SWOLLEN/ITCHY /SMALL RASH GROWING INCH BY INCH; This spontaneous report received from a patient concerned a 40 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced injection site red /swollen/itchy /small rash/. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site red /swollen/itchy /small rash. This report was non-serious.

Pt reports that she developed circular itchy rash over the back and the front of chest and trunk on 4/2/21 5 days after her vaccination .The rash also spread to the arms and upper leg .Pt also reports mild wrist pain with no swelling. No headache or blurry vision or dizziness or any calf pain or any bruising noted .Vital stable Exam: rash are multiple circular reddish and scaling visible maculopapular lesions and present over the back ,right neck ,front of chest and small spots on the left arm and the upper thigh .No pai n or fever .

after getting out of shower, I noticed redness on my right thigh. I have noticed redness on my arms and it is very itchy. I have used hydrocortisone cream to help with itching and took allergy medication as well.

Blood pressure 50/40 heart beat 50 fever body spasms eye spasms diarrhea short breath lot headaches skin burning when showering skin very dry and swollen

The day after the vaccine common side effects (fever, chills, body aches, headache). The following day body aches increased, numbness on the left side of my face and right lower leg, hives on my chest, neck and face, debilitating fatigue. Spoke with my PCP and treated hives with Zyrtec and Benadryl. Hives went away quickly. After 5 days of intense body aches, they eased up. The only remaining symptom is the numbness in my face and leg. There is occasionally pain in my leg (feels like nerve pain).

Saturday, April 10th- ? Received Johnson & Johnson / Janssen Covid 19 Vaccine at pharmacy at 10:00 AM o Vial 205A21A ? Had chills and overall yucky/flu like symptoms for that night, Sunday was pretty much back to normal Friday (April 16th) evening- ? Started feeling weird ? headache ? facial area tight/flushed/tick ? Worsened/blurry vision especially in right eye ? Noticed leg bruising, not sure when it?s from ? No appetite Overnight Friday into Saturday, woke up several times covered in sweat Saturday (April 17th) - ? Fatigue, no appetite, headache / blurry vision continued, brain ?fog?/hard to concentrate ? Rested most of the day, went for small walks ? Off / on low grade fever seemingly worse at night and getting out of shower Sunday (April 19th) - ? Fatigue, no appetite, headache / blurry vision continued, brain ?fog?/hard to concentrate ? Rested most of the day, went for small walks ? Bloodshot, tired, red eyes that don?t go away with drops Monday (April 20th)- ? Fatigue, no appetite, headache / blurry vision continued, brain ?fog?/hard to concentrate ? Went on normal 3 mile walk and did fine ? Bloodshot, tired, red eyes that don?t go away with drops Tuesday (April 21st)- ? Fatigue, no appetite, headache / blurry vision continued, brain ?fog?/hard to concentrate ? Went on normal 3 mile walk and did fine ? Bloodshot, tired, red eyes that don?t go away with drops

BUMP ABOUT 2 INCHES BELOW THE INJECTION SITE; LITTLE RASH ON ONE SIDE OF THE BANDAID; SORENESS AT INJECTION SITE AND IT FEELS HOT; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma allergies, non smoker, and alcohol user, and other pre-existing medical conditions included the patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced bump about 2 inches below the injection site. On 09-APR-2021, the subject experienced little rash on one side of the bandaid. On 09-APR-2021, the subject experienced soreness at injection site and it feels hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at injection site and it feels hot, bump about 2 inches below the injection site, and little rash on one side of the bandaid. This report was non-serious.

RED BRUISE ON LEFT ARM; INJECTION SITE WARMNESS; TINGLING SENSATION IN LEFT LEG; INJECTION SITE BULGING; INJECTION SITE REDNESS; LEFT ARM PAIN; FEVER; WEAKNESS; CHILLS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included gluten allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced weakness. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced red bruise on left arm. On 12-APR-2021, the subject experienced injection site warmness. On 12-APR-2021, the subject experienced tingling sensation in left leg. On 12-APR-2021, the subject experienced injection site bulging. On 12-APR-2021, the subject experienced injection site redness. On 12-APR-2021, the subject experienced left arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 11-APR-2021, and weakness on 12-APR-2021, and had not recovered from red bruise on left arm, injection site warmness, tingling sensation in left leg, left arm pain, injection site bulging, and injection site redness. This report was non-serious.

NAUSEA; TIREDNESS/SLUGGISHNESS; BRUISED ARM AT THE ADMINISTRATION SITE; DIZZINESS; FEELS A LITTLE OFF; HEADACHE; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced bruised arm at the administration site. On 04-APR-2021, the subject experienced dizziness. On 04-APR-2021, the subject experienced feels a little off. On 04-APR-2021, the subject experienced tiredness/sluggishness. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 06-APR-2021, was recovering from nausea, dizziness, and tiredness/sluggishness, and had not recovered from bruised arm at the administration site, and feels a little off. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.

4-5 DAYS AFTER VACCINATION, LEFT ARM PAIN DISTAL TO SITE OF INJECTION, NUMBNESS OF LEFT HAND. PAIN IS INTERMITTENT, WORSENING, WAKING PT UP FROM SLEEP LAST NIGHT. PT WAS SENT TO THE ED FOR FULL EVALUATION.

FEEL THE POINT OF INOCULATION; SORENESS OF ARM; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes type 2, and seasonal allergies, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced feel the point of inoculation. On 06-APR-2021, the subject experienced soreness of arm. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness of arm, and feel the point of inoculation. This report was non-serious.

- Injection site pain (burning, stinging) immediately after shot that dissipated within a few minutes, followed by arm soreness that lasted approx. 3 days. -Fatigue late afternoon followed by chills beginning 6-7 hours after injection. Chills became more severe (uncontrollable) as the night progressed and affected the whole body. Layered clothing and blankets, and was still shaking. -Approx. 8 hours after injection, developed a low grade fever (99.9) which progressed into a high grade fever (101.2) by late night. Fever continued overnight, breaking at about 11 am the following day. No medication was taken for the fever. -Overnight experienced join pain and muscle aches, and developed a migraine headache with nausea. Experienced heart racing/rapid pulse and could feel /hear pulsing and whooshing noise in my ears. Was unable to sleep. Muscle and join pain continued and was noticeable for about two days post vaccine. Migraine became a mild headache by mid morning. About 6 pm took a Bayer Back and Body for the lingering joint/muscle/headache issue (24+ after vaccine). -Loss of appetite first few days post vaccine. -Feeling of brain fog, difficulty concentrating, very noticeable during first two weeks. -For two and half weeks following the vaccine, felt bouts of fatigue, muscle aches and joint pain, and occasional whooshing noise in my ears.

On Saturday, April 17 at some point overnight I developed hives. The hives started on my right thigh and left knee area lower back an buttocks. On Sunday, April 18 the hives continued to spread throughout my kegs, then in the evening at about 10PM worked their way to my arms and hands. I woke up with hives on my lower legs and feet face, and stomach. The hives remained until Monday, April 19 and Tuesday, April 20 but continued to lessen as the days progressed. The hives were gone by Wednesday, April 21. I took Benadryl to relieve symptoms.

2 weeks to the day after Janssen vaccine spontaneous outbreak of hives all over body. Required steroid shot and oral burst dose of steroids for 7 days. Hives present for 4 days with continued sporadic itching for several days after.

SHINGLES ON WRIST; This spontaneous report received from a patient via a company representative concerned a 40 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 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 28-MAR-2021, the subject experienced shingles on wrist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles on wrist. 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.

STOMACH FLU; CHEST PAIN UNSPECIFIED; SHORTNESS OF BREATH; EKG SINUS TACHYCARDIA, LOW VOLTAGE PERIODICAL, UNCONFIRMED DIAGNOSIS; DIZZINESS; SLEEPING 14 HOURS; LARGE NODULE AT INJECTION SITE; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; SORENESS/PAIN AT INJECTION SITE; HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 (following vaccination), the patient's area around the injection site was swollen, a large nodule formed, it was red, sore and painful. These local symptoms lasted for a week then disappeared. The patient felt very fatigued, and reports sleeping 14 hours that night. On 10-APR-2021 the patient experienced headache and felt like his head was in a vise around each cheekbone. The fatigue and headache was gone on 11-APR-2021. On 19-APR-2021 the patient had vomiting and diarrhea for about 16 hours. The local symptoms swelling, redness, pain at injection site reappeared. On 19-APR-2021 the patient was very fatigued and took Pedialyte (calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate) to get rehydrated. On 21-APR-2021, the patient visited the emergency room as new symptoms appeared stomach pain, chest pain, shortness of breath and dizziness and her blood work and electrocardiogram(EKG) was done. The health care professional(HCPs) ruled out heart attack and told patient nothing in the symptoms or blood work warranted a scan for blood clots. The patient received anti-nausea intravenous (IV) medication, diagnosis of stomach flu and was sent home. The patient reports that her blood pressure readings were 144/104 and a pulse was 119. The emergency room health care professional instructed the patient to follow up with doctor and discharge diagnosis was made as chest pain unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling at injection site, redness at injection site, soreness/pain at injection site, and large nodule at injection site, had not recovered from chest pain unspecified, shortness of breath, dizziness, and EKG sinus tachycardia, low voltage periodical, unconfirmed diagnosis, and the outcome of stomach flu, high blood pressure and sleeping 14 hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210443030-covid-19 vaccine ad26.cov2.s-Stomach flu. 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).

Two weeks after vaccine swelling of feet and hands begin to turn purple and black and her feet were swollen and numb

Patient reports history of Bell's Palsy that developed end of 2016 and resolved in early 2017 and a history of gastric sleeve surgery in February 2019. No known allergies. Patient reports symptoms that started on 4/8/2021, the day after receiving her vaccine. Patient with ?groggy? feeling that has since resolved, headaches that haven?t resolved rated at a 4-5/10 that are relieved with OTC pain medication, and pain in left arm near injection site along with pain in left neck that radiates to left elbow rated at 4/10 that worsens with left arm abduction and isn?t alleviated with OTC pain medication. On 4/24/2021, patient reported a worsening of headaches rated at 7-8/10 that were eventually relieved by OTC pain medication, chest pain rated at 9/10 described as constant tightness that lasted for about an hour, and LUQ pain rated at 9/10 described as a stabbing pain that was relieved after sitting down/relaxing for about an hour. Patient did not seek medical attention. On 4/26/2021 during patient interview, reviewed the importance of following up with PCP based on her symptoms and patient stated she will be reaching out to her HCP.

I started to notice what I thought was a bug bite. It was not getting bette after a couple of days so i booked a virtual appointment. I was diagnosed with shingles 4/29/21. I?ve never had this happen before. I have had chicken pox when I was a child but never had a flare up before. I am now on anti viral medication as of 4/29/21

Approximately 30 minutes after receiving the vaccination, the patient returned to the pharmacy and stated her upper lip felt tingly and larger than normal and she was having generalized itchy feelings around her face. We gave her diphenhydramine 25 mg and observed her for an additional 20 minutes. At that time, she stated she felt fine and left the pharmacy area.

Itchy armpits, and then cyst developed under left armpit. The cyst is about an inch in diameter. I'm having it removed this week.

--Days 2-3 after vaccine: fever, chills, nausea, loss of appetite, felt like skin on fire; --Days 4 after vaccine: slight reprieve, no fever, still loss of appetite, skin no longer felt on fire --Days 5-6: extreme nausea, vomiting, diarrhea -- Taken by ambulance to hospital on 4/13/21; admitted due to acute renal failure --10 day hospital stay: First 7 days with extremely low potassium and magnesium levels, put on telemetry due to low electrolytes. BP fluctuated up and down. Lactic acid & hemoglobin extremely high upon admission. I have all lab reports if necessary to provide. In fact, discharged with potassium at bare minimum of safety. Released with 3.5 potassium level. --Unable to control nausea: Zofran & Phenergan ineffective. Eventually put on IV Phenergan piggy back through IV with oral Diclegis given every 8 hours, eventually change to every 6 hours. Pain felt in upper right quadrant and lower abdomen due to multiple bowel movements (extreme diarrhea). --Tests performed in hospital showed nothing abnormal: CT Scan, Ultrasound, Endoscopy, MRI with and without contrast --Immediate follow-up with GI doctor on 4/23/21.

KNOT ON ARM INJECTION SITE; SORE ARM; RED ARM; CHILLS; MILD TIREDNESS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 40 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: 204A21A expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced chills. On 28-APR-2021, the subject experienced mild tiredness. On 28-APR-2021, the subject experienced fever. On 28-APR-2021, the subject experienced headache. On 29-APR-2021, the subject experienced knot on arm injection site. On 29-APR-2021, the subject experienced sore arm. On 29-APR-2021, the subject experienced red arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knot on arm injection site, chills, mild tiredness, fever, headache, and red arm, and had not recovered from sore arm. This report was non-serious.

The first few days, I had flu-like symptoms. After I got the vaccine - my migraines became very severe - they would last for days. They became unmanageable and I had to go to ER. I have asthma - it's a lot harder to breathe - this is on and off. It used to be once in awhile I need my inhaler but now I need to use it more. It feels like I'm catching my breath a lot more now.. My rashes went away - but I had had rashes (random places - arms/legs) that came and went for the first two weeks after the vaccine. I went to hospital ER on the 12th of April - because my migraines were so bad that my blood pressure went up to 200 something and they had to clear me to make sure I wasn't having a stroke. I have always had migraines but the only thing different that has changed the severity is the vaccine. I just finished off the steroids' - Progesterone that the neurologist (at ER)(the one that called the cold stroke) prescribed to me. But that didn't really help. I'm waiting for approval from insurance for another medication. Saw another neurologist - after the ER visit.

ANAPHYLAXIS; HOT AND BRUISED SHOULDER; FLUSHING; BODY ACHES; LOSS OF FEELING IN FACE; LOSS OF APPETITE; VOMITING; CAN NOT SLEEP; CAN NOT DRINK WATER; STOMACH FEELS LIKE SODA; SWOLLEN ARM AND SHOULDER; COULD NOT MOVE FINGER; VERY HOT LEFT ARM; LEFT ARM SENSITIVE TO TOUCH; HOT SHOULDER; LOWER BACK PAIN; DEHYDRATED; SORE ARM; RASH; HIVES AND BUMPS AROUND THE INJECTION SITE; WEAKNESS; INJECTION SITE PAIN; HEADACHE; VERY TENDER ARM AND SHOULDER; TERRIBLE NAUSEA; FEVER; LOSS OF TASTE; LOSS OF SMELL; BRUISE ON LEFT WRIST; PALMS TURNED BLUE FROM CLAPPING; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, non-alcoholic, crohn's disease, heart murmur, chronic vertigo, panic attack disorder, depression, drug allergy, fish allergy, and perimenopause, anxiety and other pre-existing medical conditions included patient had no drug abuse or illicit drug, patient is allergic to all the narcotics, passes large clots of blood during menstruation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: unknown) dose was not reported, administered on 06-MAY-2021 13:15 for prophylactic vaccination. Concomitant medication included meclozine for vertigo. After receiving vaccination the first thing she felt like there was hot lava going down her left arm ( where she got injected) and she could not move her finger then that went away after 10-15 minutes later. they told her that symptom was normal and everyone experience the same kind of symptom. She completely lost her appetite, the smell of food made her sick ever since she got the shot. Patient stated her left arm was very hot, sensitive to the touch, bumpy around the injection site and sore. all these symptoms were the same day of her shot (on 6-MAY-2021). since the injection she had the headache and it wont go away and she still has the headache today. her relative was telling her that her shoulder was hot. she had body aches ( lower back pain and everywhere, the pain was moving though her body). the second day everything got worse; her arm where she received the injection her whole shoulder was black it looks like if someone threw brick at her, she had hives and bumps around the injection site. she cannot sleep, she cannot eat and she cannot drink water. she was tired and she was not feeling good. she had anaphylaxis 30 hours, dizziness, loss of feeling in her face, her heart was racing. she took two tablets of antihistamine to manage the anaphylaxis reaction. 30 hours after the vaccination she has dizziness, wheezing, she had flushing , rapid pulse, she was throwing up for hours then she had to take the antihistamine. On an unspecified date patient had weakness. Patient said that her fever gets worse every day. On the day of vaccination (on 6-MAY-2021) her temperature was 99.4, and has checked it 5 to 6 times with the same reading. on 7-MAY-2021 it was 99.6 and on 8-MAY-2021 it was 100.3. she said it felt like both sides of her throat were touching. Patient had barely been able to eat since 6-MAY-2021, but has been able to drink small amounts of water. Patient stated her saliva makes her nauseated. On 10-MAY-2021 she clapped her hands and they turned blue and also developed an egg shaped bump/hematoma on her left wrist after bumping it. She went to urgent care where she was instructed to use ice pack for bump, which gave her no relief. There, she was stuck with a needle 4 times to get blood work because she was dehydrated. Patient stated that her whole body felt like a walking pin cushion and skin was hypersensitive. Urgent care checked platelets and hemoglobin which came back normal. Patient stated her menstrual cycle started on 10-MAY-2021 was different than usual with super heavy, red flow, no clots, and soaked pad in an hour, it was slowed down since but flow was heavy. Urgent care advised this may be normal due to change of hormone during perimenopause. As of today, patient could not smell or taste anything. Patient was taking antihistamines 2 a day. Temperature was normal. Patient stated nausea and vomiting were better but would definitely come back if she stopped taking meclizine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move finger, had not recovered from sore arm, headache, loss of appetite, vomiting, injection site pain, stomach feels like soda, terrible nausea, swollen arm and shoulder, feels like both sides of throat are touching, weakness, bruise on left wrist, loss of taste, and loss of smell, and the outcome of sore body, hot and bruised shoulder, rash, anaphylaxis, flushing, body aches, not feeling good, dizziness, loss of feeling in face, wheezing, rapid pulse, hives and bumps around the injection site, can not sleep, can not drink water, fever, very tender arm and shoulder, very hot left arm, left arm sensitive to touch, hot shoulder, lower back pain, palms turned blue from clapping and dehydrated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210516682-COVID-19 VACCINE AD26.COV2.S-Anaphylaxis. This event(s) is labeled per RSI and is therefore considered potentially related.

Several hours after vaccine, chills through out the night, headache, fatigue , lasted for two consecutive days. Two weeks from vaccine rash, hives all over body. Everyday I have hives. No history of hives or allergies

Bruises to bilateral thighs and buttocks with no history of trauma. Ongoing leg pain although bruising is resolving

I wasn't feeling well, I started having a really bad headache, fever, sore and achy like I had the flu. I started having problems heaviness and shortness of breath. I started getting a rash that turned into hives all over my entire body. I was having feelings of anxiety and overall not well. I'm still getting hives from it. The other clinic I saw was the clinic 5096342913. I still am using an inhaler from the shortness of breath.

within moments red dot, turned to red arm and severe itching, moderate swelling next day, incredible headache, body aches, bone pain, feeling of spine splitting in low back. tylenol every 4 hrs, advil every 4 hours (alternating). low grade fever for 5 days- right around 100F after medication. development of vertigo 5/14/21- question of relationship

HIVES; CONFIRMED COVID-19 INFECTION; LOW GRADE FEVER (100 F); This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient had no known drug allergies. The patient had unremarkable past medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 2D5AZ1A, and expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced low grade fever (100 f). Laboratory data included: Body temperature (NR: not provided) 100 F. Treatment medications included: paracetamol. On 21-MAY-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive (COVID-19), and COVID-19 virus test (NR: not provided) Positive (COVID-19). On an unspecified date, the subject experienced hives. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from hives, and low grade fever (100 f) on 28-APR-2021, and the outcome of confirmed covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000180784; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

FEELING HAZY; RAISED BUMP AT INJECTION SITE; HEADACHE; WATER BLISTERS UNDER NOSE AND TURNED INTO SORES ON UPPER LIP AND UNDER LEFT NOSTRIL AND COMING DOWN TO LIP; FELT HORRIBLE; DISORIENTATED; DIZZINESS; SHORTNESS OF BREATH; TIREDNESS; This spontaneous report received from a patient concerned a 40 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, and expiry: 21/06/2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced tiredness. On 26-MAY-2021, the subject experienced water blisters under nose and turned into sores on upper lip and under left nostril and coming down to lip. On 26-MAY-2021, the subject experienced felt horrible. On 26-MAY-2021, the subject experienced disorientated. On 26-MAY-2021, the subject experienced dizziness. On 26-MAY-2021, the subject experienced shortness of breath. On 26-MAY-2021, the subject experienced raised bump at injection site. On 26-MAY-2021, the subject experienced headache. On 28-MAY-2021, the subject experienced feeling hazy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt horrible, disorientated, dizziness, tiredness, and headache, had not recovered from water blisters under nose and turned into sores on upper lip and under left nostril and coming down to lip, raised bump at injection site, and shortness of breath, and the outcome of feeling hazy was not reported. This report was non-serious.

The husband came to pharmacy to receive his COVID vaccine and informed us of his wife experiencing a possible adverse reaction from her Janssen COVID shot. He said the patient experienced fever of 101 and tingling/sharp prickling of the face the night of the vaccine and the following morning. She took an unknown fever reducer with success. The following day her legs began looking dark and bruised and she was numb and tingling in the legs. As of today (the next day), the bruising (dark color) has reduced and she only has slight numbness and tingling in the legs. He said she had back surgery 3 weeks ago so is unsure of the cause. We informed him that she should be taken to a doctor as soon as possible to rule out the possibility of blood clotting. He acknowledged and said they will discuss immediately when he gets home and either take her to the ER or keep a close eye on her and take her to PCP on Monday morning.

Persisting local swelling, induration, pruritis, and pain. Pain radiates into neck/head, chest, and lower arm. Arm tender to touch. With associated nausea, blurred vision, and intermittent sharp chest pain.

NEUROLOGICAL PAIN; SHINGLES; INJECTION SITE ITCHING; LEFT SIDE INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, oak allergy, and sumac allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A121A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced left side injection site pain. On 01-JUN-2021, the subject experienced injection site itching. On 02-JUN-2021, the subject experienced shingles. On an unspecified date, the subject experienced neurological pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side injection site pain on 22-MAY-2021, had not recovered from shingles, and injection site itching, and the outcome of neurological pain was not reported. This report was non-serious.

SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION. LEFT SHOULDER PAIN POST COVID VACCINE ADMINISTRATION. EXAM IS NORMAL BUT APPEARS INJECTION WAS PLACED INTHE INSERTION OF THE DELTOID OR POSSIBLY SUBACROMIAL SPACE VICE THE DELTOID MUSCLE BELLY BASED ON PHYSICAL EXAM AND SUBJECTIVE COMPLAINT.

Constant headache x10 days after vaccination (HA starting day 1 post-vaccination). Visual changes with aura type arc in middle of visual field lasting 30 minutes prior to resolving spontaneously- this occurred twice after vaccination date with 1st episode occurring at 1 week post-vaccination and 2nd episode occurring at 2 weeks post-vaccination. Facial shingles at V2 dermatome (near Left eye) diagnosed 6/21/21; pending repeat eye exam 7/12/21 to follow this.

Side effects in the first month: hypotension, light headed, felt faint, heart racing, shaking, fever, chills, fatigue, heavy feeling/pressure/pain/tight feeling in chest, difficulty breathing deep, swollen glands in armpits for longer, intense body pain Side effects in 2-4 months after, these symptoms come and go: numb tongue, gastro pain, loose stools, heart racing (seems to be at bedtime), hypotension, feel like body underwater, elevated blood pressure, pressure in chest, tongue sores, tingling in calves, fatigue, feeling faint, eye redness, redness and itchy cheeks (with dry flaky skin), chest discomfort/pain/tightness, foggy thinking Current treatment plan is to raise low blood pressure.

Subconjunctival hemorrhage. Petechiae. Headache. Cardiac insufficiency. SOB. Syncope. Fever. Splinter hemorrhages.

10 days after the vaccine I started experiencing heart palpitations, elevated pulse, anxiety, trouble falling asleep, some hair loss. The anxiety was very pronounced from April 22, 2021 to April 27, 2021 but got better subsequently. The palpitations started on April 22, 2021 and continued almost daily through June 2021

I, patient was vaccinated on March 30, 2021 at the time mentioned above in the form with the Janssen COVID-19 vaccine at a Medical Center hospital, for 24 hours after the vaccination, I am unwell general: (headache, body ache, diarrhea, stomach ache, chills, fever and discouragement), at the hospital they recommended taking tylenol, after 24 hours all symptoms started to improve, then I was able to go back to my work. As the days passed, I began to present discomfort in my legs: (extreme fatigue, pain, swelling, redness and a lot of itching) being the symptoms more severe in the right leg, I also had a headache, chest pain and back. By April 15, 2021, I could no longer bear the By April 15, 2021, I could no longer bear the discomfort and pain so strong and decided to go for emergencies to the Bergen New Bridge Medical Center hospital, where I was hospitalized for two days, on April 15 and 16, 2021, there too. . I was diagnosed with venous thrombosis in my right leg due to the Janssen COVID-19 vaccine. After leaving the hospital, I was prescribed a medicine of (Xarelto) 20 milligrams, for 3 months and 10 days of disability, being able to return to work on April 28, 2021. After 3 months and I finished my medication on July 9, 2021, after 7 days I returned to present the same symptoms that I had presented on April 15, 2021, seeing myself in the obligation to return to the emergency center of the Medical Center hospital, there they gave me medications until July 21, 2021 where I had my follow-up appointment with my general practitioner MD, that day my doctor told me that I had not had any improvement and would have to send me medications again for another month until next month where I will have a follow-up appointment for my illness. Personally I feel that I am not evolving for the better, I feel more and more tired in my legs and the pains and swelling are getting stronger. In advance, I thank you very much for your attention.

De evening that day I started with chills , throbbing head pain I never have headaches so it felt like fluid building up over the back of my head like it?s swelling and later on I had post nasal dripping massively - muscle aches , pain and swelling of half of the left arm that stood for about 1 week and the day after I deceased rash all over my neck, arm ,chest back and hip Since I seem to have nerve pain in my foot and my left hip and lower back and lower left belly muscles aching badly I have had nasal bleedings sitting in front of the tv doing nothing, I am as well bruising occasional in ca 10-15 cm purple bruises without having a injury , I haven?t had my menstruation for a about 3 months Regulare dizziness lately with no previous event or reason

3/6/2021 9:30 pm - nausea 10:00 pm - chills and muscle spasms in stomach and legs and headache 10:30 pm - body aches and 99.2 fever and headache 3/7/2021 5:30 am - 100.1 fever and intense muscle soreness in neck, shoulders, arms, and lower back and headache 8:30 am - 98.9 fever and intense headache 10:30 am - intense headache and muscle soreness near injection sit

Fever of 102 all night, taken with forehead scanner. Highest fever 103. Headache and rapid heartbeat all night. Next day headache. Arm soreness started Two days after the shot and continues, very painful in the muscle and skin is itchy over the injection site.

rash all over upper torso and arms noticed within first couple hours after administration, pt called md and was counseled to take benadryl and watch for further symptoms. Pt states she's fine and no further problems beside the rash.

Woke up with a severe headache, threw up, had chil. A rash on my neck developed that was red, itchy, and scaly and has persisted for 4 days.

Pain at sight immediately that continued for 30min At 7:30pm fever chills constant shaking that subsided at 9:00pm woke up at 10:45pm and can?t stop shaking legs and rapid breathing....still going in at 12;30am as I wrote this

burning and hot arm lt side, metal taste in mouth, headache, dizziness, nausea, high blood pressure, Tylenol for headache, Benadryl, tongue started to burn, lt earache, unwell, weak, chest hurting, can't concentrate, rash on right side of face

Chills, sweating, vomiting, fever (102.4), pain in the left arm at the injection site, headache for 12 hours. Muscle ache, fatigue, nausea, headache, chest pain/tightness 72 hours. Chest tightness, nausea, headache, fatigue, muscle ache, general bad feeling current as of 3-14-21.

Large, raised itchy hives (ranging from dime sized to larger than outstretched adult hand) covering majority of body, including hands and face, lasting for about 36 hours.

Severe headache, fever, chills, extreme fatigue, weakness, loss of appetite, body aches, and pain in arm at and around injection. As a high level endurance athlete, I was unable to get out of bed for 24 hours. Symptoms improved gradually after that. Minor headache continued through 48 hours. Inability to fully exert myself has continued through day 4, although gradually improving each day.

Injection site is hot to the touch and a different temperature than the rest of my arm and body. My mensuration cycle was delayed by a week.

Chills, severe headache and body aches, fatigue. Symptoms began about 11 hours after administration of the vaccine and last about 12 hours from onset. Injection site soreness lasted approximately 4 days.

The day after the vaccination, 3/16, I noticed red irritated skin on the back of my right hand and wrist. It did not itch or feel irritated, just noticed that it was red and thought I might have scratched it on something. The next day, 3/17, I woke up to see that the irritated area now had blisters and I felt a burning sensation in that area. I also noticed a few of the red patches and one blister on the underside of my right forearm. I took Benedryl which seemed to help with the burning feeling. Today, 3/18, it now is less red, but the blisters are still present. It does not burn and I have not taken any more medication for it.

Chills @ 11 hours; fever, violent chills, joint pain and injection site tenderness @ 14 hours followed by copious sweat; fever continued at 100-101 for 38-40 hours; injection site lump, redness and tenderness still in the 4th day.

Low back pain began about 6 hours after shot. Next morning, 12 hours after shot, woke with muscle aches, headache, chills and sweating. Approximately 18 hours after shot, hives began to appear at wrists, thighs. About the same time, diarrhea occurred twice, and severe dizziness occurred. Likely brief loss of consciousness occurred, resulting in fall due to sudden dizziness upon standing. Hives became progressively worse, became severe and full-body. Called doctor, who instructed us to go to ER for IV steroids and additional care.

Day 1 tired. Day 2 - 6 horrible GI symptoms(gas, bloating, diarrhea, acid reflux) Day 8- hives Day 9 bad pain in breast. Ariola starts peeling. Intense pain in butt, hip, knee, shin, & feet. These symptoms have not stopped. Pain keeps me up at night. Also feel somewhat weak! Still experiencing symptoms!

Exactly an hour after recieving the shot, I started horribly itching from head to toe and had a red rash. I took 2 zyrtec. The allergy meds helped but once they wore off I would start itching. Two days after the shot my face got really puffy especially around the eyes. For six days I took 2 Zyrtec in the morning and 1 benadryl at night. After 6 days of the allergy meds I finally was back to normal.

Sharp headache, fever, chills, exhaustion, sleeplessness, mild dizziness, pain at injection site that increases with time

Woke up the next morning with a migraine, had chills and sweats. Extremely tired, nausea, no appetite. It's now Friday still Extremely tired and no appetite. I try to eat then feel nauseous. Left arm is sore.

Chills, headache, muscle ache, neck pain, started 12 hours after injection. It got worse through out the day, could not sleep. Took tylenol, which helped with the pains. Headache came back, chills went away, injections site hurt worse with 22 hours.

She got the vaccine, she was fine, no problems. She woke up, Down's syndrome, and her sister-in-law saw that she was white faced, and looked like she was going to throw up, but said that she was achy and nauseous. She has swelling to the injection site, a small dot. She feels a little warm, but no fever, 97.9. Has not taken anything for her symptoms.

24 Hours after injection - Slight fever (101) and fatigue that lasted for 2 days. Injection site was swollen and much hotter than the rest of my of my arm/body and lasted for 2 weeks.

I have a rash on my torso, chest and back. It is many small red spots - maybe 25 or so. I also have painful pinching nerve pain in my back, neck, spine, hips and joint pain. My joint pain is in my wrists, knees and back.

Janssen-Covid 19- EUA 41 yo Female who recieved single dose of Janseen lot # 180890 at approx 910 this morning. During observation pt had no complaint of any symptoms. Pt returned to work shortly after, pt started to feel itchy on her arms, neck and back. pt also stated more red bumps on face. Pt states possible reaction to shrimp last month but was unaware if it was or not. Pt denied any sob,diff breathing, pt did have rash on arms and shoulders. Fire was activated. pt signed ama with Fire Department.

rash on chest, neck and face started about 24 hours post vaccination. 48 hours later facial swelling and rash continued. Spoke to allergist and did a regiment of Claritin and bendaryl for three days which contained reaction.

Headache one hour after Dry mouth and metal taste right after Fever the next day Severe depression with suicidal thoughts starting the next day and continuing to present Itchy started a few hours after especially on hands Upset stomach a few hours after

Started with chills shortly after getting the injection, which got progressively worse. At 9:30 pm, the evening of injection, chills got worse, along with a headache and muscle aches that started with my shoulders and moved quickly down my body, eventually, ending at my toes. It hurt to move, even my fingers. I took 2 regular strength Tylenol, which helped get me to sleep. I then woke up around 4 am in a puddle of sweat... I took my temp and no fever, but body aches, headache and chills were still prevalent. I spent the next day in bed without moving or eating much - drank a lot of water. Tylenol every six hours. An hour after taking Tylenol, I seemed to be well enough to not be moaning and groaning, but it wore off too quickly and I had two hours of feeling horrible before taking more Tylenol for a bit of relief. I woke Sunday morning around 5 am in another puddle of sweat and severe body aches and headache. I took more Tylenol, went back to sleep and woke around 9 am feeling groggy, but quickly realized that I was feeling 100% better! Just like that. I also had pain at the injection site that for some reason seems to be getting worse today, Sunday (April 4). I do not have swelling or redness. It just feels hot and very very sore and getting worse. Heavy and hard to lift.

PATIENT STATED HAVING HISTORY OF FAINTING. UPON ASKING, PATIENT STATED FAINTING ON THE SIGHT OF BLOOD, AND SHE WAS NERVOUS. WITHIN 5 MINUTES OF THE VACCITATION, PATIENT WAS SHAKING AND WARM/ SWEATING. SHE WAS BREATHING WAS NORMAL. PATIENT SAT DOWN IN A CHAIR, WE GAVE HER SOME WATER AND AN ICE PACK. PATIENT THEN DECIDED TO LAY DOWN AFTER 5 MINUTES. HER HUSBAND WAS CALLED, SHE STARTED FEELING BETTER. SHE STAYED SITTING/LAYING DOWN FOR AT LEAST 30 MINUTES. PATIENTS HUSBAND TOOK HER HOME.

Patient complained of feeling as if something was stuck in her throat and she could not swallow, that her throat felt "fat". As the minutes passed, the feeling of fullness was more pronounced. We offered EPI-PEN and to call 911. Patient wanted 911 only. We called 911, took her blood pressure (188/119). Paramedics arrived within 1 minute. After examination, patient was transported to hospital at 1:30p.m. accompanied by family members. At 3:55p.m., I spoke to her fiancé to inquire about her well being. She was still at ER at 3:55 p.m. She was given Benadryl, EpiPen, and Prednisone. Fiancé said she was breathing better but there was a rash and itching at injection site which was being treated with Benadryl and Prednisone. Fiancé said patient was frustrated at having to be at emergency room.

FEELING SLEEPY; BODY ACHES; HEADACHE; TEMPERATURE OF 101.8 F; SKIN HURTING; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 166 pounds, and height was not reported. The patient's past medical history included covid-19 and concurrent conditions included penicillin allergy, non alcoholic, and non smoker and other pre-existing medical conditions included patient had no drug abuse or no illicit drug usage. The patient experienced drug allergy when treated with cefalexin. 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 25-MAR-2021in right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced skin hurting. On MAR-2021, the subject experienced temperature of 101.8 f. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 25-MAR-2021, the subject experienced feeling sleepy. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin hurting, and had not recovered from feeling sleepy, headache, body aches, and temperature of 101.8 f. This report was non-serious. Version created to amend previously reported information on 25-Mar-2021. Upon review, the following information was amended: Narrative inconsistency corrected.

Got the vaccine at 10:30am on 4/5/21 and felt ok all day. About 10:30pm when trying to go to bed I started having severe body aches, extremely high fever, all over and uncontrollable body shaking (thought I was having a seizure), racing heart, severe headache, very sensitive and sore injection site. This lasted through the night, for a good 6 hours. As of 10:30am on 4/6/21 I still have a very bad headache and mild to moderate body aches and an extremely sore injection site.

Janssen COVID-19 Vaccine EUA. My left arm swelled and a red rash covered my arm. The next day I had hives on my head and itching. Hives appeared on my trunk and legs. Benadryl kept is under control, but I am still experiencing itching and hives but it is decreasing.

Patient received IM injection at 1:00. Patient noted to start having reddened cheeks and rash to chest. Patient stated her front of her tongue feeling tingling. Two 25 mg Benadryl given at 01:18. Patient stated she was breathing ok and able to talk and drink water without any problem. B/P 134/90, 98% O2,80 R. Patient monitored for additional 30 min. Patient admits to decreased tingling sensation to tongue at 1:30. Patient able to talk and drink no slurring of speech or problems swallowing Declined EMS to local hospital.

chills and haigh blood pressure the night of the 7 and the next day on the afternoon, the 9, 2 days after the arm is itchy and red warm and swollen on the area of the vaccine

Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: patient had tingling in the left arm

This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune thyroid issue - hashimoto, and sulfa allergy. The patient experienced drug allergy when treated with doxycycline, and prednisolone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18205018, and batch number: 18205018 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 10:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced tiredness. On 31-MAR-2021, the subject experienced pain to arm. On 31-MAR-2021, the subject experienced injection site stinging. Laboratory data included: Fever (NR: not provided) as high 101. On 31-MAR-2021 18:00, the subject experienced flu like. On 31-MAR-2021 18:00, the subject experienced shivering. On 31-MAR-2021 18:00, the subject experienced body aches. On 31-MAR-2021 18:00, the subject experienced fever. On 31-MAR-2021 18:00, the subject experienced headache. On 01-APR-2021, the subject experienced bump to site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like, shivering, and headache, and chills, and fever on 01-APR-2021, had not recovered from bump to site, body aches, tiredness, and pain to arm, and the outcome of injection site stinging was not reported. This report was non-serious.

On 4-8-21 at approx 2:30am I woke up with chills, nausea and severe diarrhea. I began experiencing severe abdominal pain in belly button as if it were on fire. Hurt to take deep breaths. Developed hives all over body and very itchy. Scheduled phone call with triage nurse at 11:15am and then a follow up call again with my primary care doctor immediately following. At approx 1:22pm my primary care doctor told me to go to urgent care or ER due to concern of me going into anaphylactic shock. Immediately went to Emergency Room and admitted after waiting in waiting room for over 5 hrs. After bloodwork and CT Scan of abdomen my appendix was perforated and needed to be removed immediately. Immediately sent to OR for surgery at 11pm.

Injection site reactions: pain, redness, and swelling, hot skin lasting longer than 6 days General reactions: Headache, fever, nausea, stiffness of the neck, muscle aches, fatigue, fast heart rate, dizziness

I developed what appears to be contact dermatitis around both eyes. Treated with oral steroids, prednisone eye drops, antihistamine pills and drops. Once I stop treatment it comes back

Day of post-vaccination, my shot area bled. No pain, no initial adverse reaction. Second day when I woke up at 5:00am, my arms was swollen, I was in pain for 2 weeks, no fever, I was not in my right sense of mind and I was bruised up on the shot area for 3 weeks. Ice pack, Tylenol and massaging my arm with CBD lotion helped me.

within 4 hours - pain at the injection site, tired, full body chills with uncontrollable teeth chattering, headache, entire body aches of the joints, eye pain. Effects lasted 36 hours then acutely dissipated.

On 3/24 patient received J&J COVID-19 vaccine Started to feel soreness in arm x 2 days, got better, went back to her usual exercise routine (heavy lifting, kettle bells) but then a week after receiving the vaccine, she started noticing some pain in the injection site, R deltoid Feels like a nerve pain. Localized. Feels like a shock sensation. Started lifting weights and has noticed she doesn't have as much strength in that area as well. c/o weakness of affected deltoid muscle Can't lean on the area for a prolonged or put any pressure on it

The day of and the following day, flu like symptoms- fever (102 at highest) chills, sweats, headache, fatigue, restlessness (had to sit and sway at night because my body could not stay still. loss of apatite, nausea, injection site pain. tightness in head, upper back/shoulder and neck on the side of the injection (left). Everything but the soreness of the injection site and tightness in the muscles on that side lasted about 48 hours. The tight muscles and soreness lasted about a week. *** THREE WEEKS AFTER THE SHOT**** Sunday, 4/12/2021 I woke up and stepped out of bed and my left ankle gave out when I stepped down. Internal rotation, weakness in left ankle. It happened again as I walked shortly after. That day I tripped many times due to weakness in that ankle. When I showered and shaved my legs I realized that I had absolutely no feeling in the left lateral part of my lower leg. It felt like I had a novocaine injection in my leg. I could not even feel a pin prick there. By Friday 4/9/2021 I started to have some sensation, but still decreased sensation and weakness in my left ankle even at this moment. ****4 WEEKS AFTER THE SHOT**** My period started Monday, April 5th, 2 days early. By Friday, 4/9/2021 and through the day and night Saturday 4/10/2021, I had such a heavy period that I kept soaking through tampons, pads, and 2 pairs of jeans. I have never blead like that and could not keep up.

Within 24 hours of vaccine, patient felt nausea, dizziness. Severe fatigue and body aches, 102 degree F fever and headache x 3 days. Shortness of breath x 1 day. Redness, inflammation, heat at area of vaccination and "red line" x 5 days. Instructed patient to apply cold compress and take NSAID. Patient believes she was positive for COVID last fall.

With prior vaccines and flu shots, I have either had no side effects or mild. But with the COVID vaccine, I was sicker than sick! I wasn't expecting to miss as much work as I did, nor go to the doctor three times in a week's time. I received it around 11:30am on Thursday, March 18. Around 1pm, my mild headache started to intensify and had ringing in my ears that would repeatedly come and go (still is doing so today, just not as frequent). Around 4pm is when all of the "normal" side effects started?chills, hot flashes, sore arm, and super sleepy. I woke up a couple hours later, with a headache that was WAY worse and was super nauseous. This was close to 10pm. Then, around 11pm that same night, I developed HORRID shooting ear pains and took my first Tylenol. The ear/jaw pain was more than I could stand - had it in both ears, but the right ear was more intense. It felt like I had a lighting rod between both ears and had these intense "zings" that kept going back and forth, like they were playing ping-pong. The painful "zings" reminded me of those felt during an ear infection but WAY MORE INTENSE. My jaw was super tight, as well, with a horribly intense headache. I spent the entire night night doing warm compresses on my ears, taking Tylenol every 4-6 hours, staying in the shower, and lots of crying. It was so bad that I felt the need to go to the ER but didn't feel comfortable driving and didn't want to go the ambulance route?and thought it was pointless because going to the ER for ear pain would leave me there for hours and hours since I didn't feel it would be viewed an an urgent emergency. My goal was to make it through the night and see if I could get into my PCP doctor the following morning. I took another Tylenol around 5am, and I thankfully cried myself to sleep for a couple of hours. When I woke up, I called my PCP but couldn't get in, so I did an online doctor visit through my insurance company. My fever was about 103.06 at its highest during the night but was gone by 3:34pm Friday afternoon (assuming because I was taking more Tylenol than I had been post-online doctor's appointment). Around 7pm Friday evening, I knew I needed to go to the ER or urgent care. I got a ride and was taken to urgent care for my intense ear pain. They gave me a Toradol injection and Tramadol prescription. By bedtime Friday night, the injection was doing its job and made the ear pain and zings were much less intense (didn't get the prescription until a couple days later). On March 20, Saturday night, is when I developed a red, itchy rash on my back and tummy. Over the next couple of days, it was on my chest, arms, legs?pretty much come and was in various places. I called my PCP Monday morning (March 22), left a message, and they called me back to tell me to restart taking my Zyrtec/HCL to see if it would help the itching. It has and am just mildly breaking out at this time. The stinkin' ear/jaw pain returned on Tuesday the 23rd, so I loaded up on OTC ear drops and made an appointment with my PCP for Wednesday, March 24. She saw no ear infection and essentially told me to keep taking the pain meds. I received the vaccine on March 18 and did not return to work until the following Thursday. In retrospect, I should have just missed the remainder of that week, too.

When I first got the shot I noticed it in my throat. I told the nurses they had me wait 20 minutes before I could leave. I felt dizzy but not dizzy enough to not go home. It felt like it went to my stomach, then my head, and then I could feel it in my joints. I drove home from the city. Two hours pass, I notice a rash but I didn't think anything of it due to indoor allergens, springtime plus it went away within an hour. I started to get chills and fever. I had a lack of sleep due to pain throughout the first night. I was waking up feeling like my head was on fire from my ears to the top of the skull area and in front of my face by my eyes too. My eyes felt like they were going to burst. I layed in bed for 24 hours. Day two: pain, tiredness, headache, and sensitivity to light for the next few days. Symptoms come and go for days then wean off. Next, I had issues with anxiety, sleeping, yet being really tired as well coupled with problems sitting still. These are subsiding but still there. I am still very tired today and a bit anxious on April 13th, 2021. I also notice my typing skills, as well as testing skills, are not as sharp as before the vaccination.

Initial reaction was noted on 03/22/21, pt reports she developed GI complaints, nausea, diarrhea which lasted for one day. Then the next day she developed nerve pain, and felt fatigue and exhausted, felt like a recurrence of the shingles, states the neuropathy effected the same area as before, to the left of chest, ribcage, and back. This lasted for 1 week, then had a couple of days where she felt better, then developed a rash to the upper back and shoulder blades on 4/6/21.

P/C from patient. States she took the vaccine on 4/1/21 @ 1:30 PM. When she heard of the issues that were in the news about the vaccine she thought she should call. 4/1/21 Thursday: That evening around 6 PM she started to have a rash. It started on her L arm where she got her vaccination traveled up her neck, covered her face and trunk. It started out as an itchy red rash but became raised hives. It resolved on it's own and on Saturday she did not have the rash anymore. Never had any difficulty with breathing. Her left arm where she received her vaccination still has some discoloration. States on Thursday evening she started having a "brain fog". 4/2/21 Friday: The next morning she woke up and was unable to finish a sentence, states she was confused, "felt like I was on pain medication, like I was drugged". States she was confused, could not think and could not remember anything. Cried all day over nothing. Would tell her daughter something and then immediately ask what did I just say as she couldn't remember what she said. She was working on the graduation hooding ceremony and scribbled all over her papers like a 3 year old and the papers were strewn all over the floor. She reports that she had a mild headache all over her head dull pain and pressure 4/10. Took tylenol but that didn't help at all. Denies having any visual problems, trouble breathing or chest pain. Did have some abdominal dull cramping with nausea and even though it felt like she was going to have diarrhea there was no diarrhea or vomiting . The abdominal pain went away after friday but the nausea stayed through Sunday.She states she got lightheaded if she stood up too fast or turned her head too fast. This just happened on Friday. Denies having any weakness, lack of coordination, or speech issues. She states she was crying and could not stop all day on Friday. She told her boss she was having a mental breakdown and had to go home. 4/3/21 Saturday: Patient states she felt stupid, could not think, could not remember anything she said. States that the horrible headache came on Saturday. It was so bad she had to lay down in a dark room with a wet washcloth over her eyes. The horrible headache.lasted about 1 hour at a 10/10 level. Took some more tylenol but does not think it helped. Went to sleep and when she woke up the headache was still there at a rete of 4/10. She was still nauseate but the crying had resolved. 4/4/21 Sunday: Again, had a severe migraine when she woke up. 7/10, not as bad as the one on Saturday. It lasted a couple of hours and then went back to the 4/10 headache that has persisted at the 3-4/10 level the entire time since she got her vaccination. The headache never stops hurting and stays 3-4/10. 4/5/21 Monday: Had a regular headache 3-4/10. Still felt "loopy" and with brain fog. Went to work on Monday and told her boss about it and that she still says she can't think straight. Her boss has been very supportive and has helped her to complete her assignments to get them in on time. 4/6/21 Tuesday: Still had a headache, It has been continuous ever since Friday. Still taking Tylenol and it doesn't seem to help. Yesterday she even tried Ibuprofen and it didn't help. 4/13/21 Today is day 13 and she still can't think straight. still has 3-4/10 headache, still all over her head. Feels that she still has brain fog, but not as "loopy". Feels like she can remember what she has said better. She called the nurse line at her husband's work.They told her that it was just a reaction to the vaccine. The patient didn't think to report it to the Health Center. She got the vaccine from the Health Center (she asked if employees could get the vaccine and said she would prefer that) She is not pregnant. She has no chronic health conditions and takes no medications routinely She denies being allergic to any medications and states she has taken the Flu shot without any reaction in the past. NOTE: Tested positive for COVID on 2/4/21 and was told it was OK to get the vaccine. She lost her taste and smell and said she felt she had a mild flu for a couple of days. Has regained her sense of taste and smell and has had no residual symptoms. Instructed patient to go to the ER for an exam. She needs a full neuro exam and at least a C_T scan of the head. She would like to contact her Primary Care Provider. States she hasn't seen him for a couple of years but feels like he would want to know. Instructed patient to call me with the outcome of her visit to her PCP or the ER. Patient verbalized understanding of and agreement with plan. Signed by: APRN-CNP on Apr-13-2021 at 04:04 PM Locked by: APRN-CNP on Apr-13-2021 at 04:04 PM

Day 1- out of it, lightheaded Day 2-4 flu-like symptoms, temperature regulation issues, upset stomach Day 2-6 skin flushed, facial skin extremely dry and patchy/scaly- eventually went away Day 2-6 easy bruising- mostly on legs; small fingerprint sized bruises- common for me

Rash/Hives starting the evening of the vaccine. The next morning severe brain fog to the point of not being able to complete any daily task, uncontrollable emotional and mental melt down, severe headache, feeling of being highly medicated, nausea, and stomach cramps. All of the sever symptoms lasted for 3 days after the vaccine. It has been 13 days now and the brain fog is still present, unable to focus on work tasks, and daily headache are still present.

4/6/21 @ 6pm - Severe chills and body aches. Lasted until 4/8/21 4/11/21 afternoon - hives started. By 4/12/21 hives covered both thighs. From 4/12/21 to current time hives have continued on both arms, legs, hands and feet. Treatment includes benadyl and hydrocorisone cream. Benadryl helped on 4/12, but currently taking up to 50mg at a time and is not helping today.

Injection given very high on left shoulder. When injection started?burning pain went through the shoulder and then followed bloodflow down left arm to fingers, back up arm, down left side of back of neck, down the back, down the back of the left leg to foot, and back up to the middle of body before the burning no longer followed a path. Upon standing, I was dizzy, and told the pharmacist, and I told her that something felt wrong. She asked me to wait outside the pharmacy, standing, for 10 minutes. I was shivering and visibly shaking. Immediately after the injection, the burning on the left side persisted for over 30 min, and was over the whole left side of my body. I could not move my shoulder joint without a lot of pain. The pain has gotten worse each day, around the shoulder.....pain in the rest of my body has lessened.

Slight headache day after shot, swollen and sore arm at injection site for almost an entire week. Headache didn?t get better but continues to get worse until treatment had to be sought Continued pain in left calf

March 9, 2021: 3:30am: Woke up with chills and feeling very cold 7:00am: Woke up with fever of up to 103F and extreme fatigue and headache which lasted during the day. To ease the symptoms I took Tylenol every 6 hours. 10:00am: Started noticing hives, first on my left shin and continued to manifest in my torso/back as well as forearms. I called my physician via telehealth and I was advised to take Benadryl as needed. Took Benadryl twice (6 hours apart) and the hives calmed down and eventually went away during the course of the day. March 14, 2021 1.30am: Woke up with itchy hives on my torso and back. Took Benadryl once again. I called my physician and was instructed to take Cetirizine for the next couple of days (10mg at 1x per day). Symptoms subsided. March 23, 2021 4:00am: Woke up with itchy hives on the left side of my torso and across my back and my groin area and upper thighs. Called my physician once again who instructed to take Cetirizine for a course of 2 weeks. No symptoms while taking Cetirizine. Stopped taking Cetirizine on April 2. April 6, 2021 6:00am. Woke up with itchy red patches (with very small bumps) in localized areas of the body (ie on my hand, on my right leg, and areas near my armpits. These lasted a little while with intense itchiness...would subside to just having red patches, and another area of the body would manifest red itchy patches. The above lasted several days as I wanted to see if this would go away on its own. On April 9th, called my physician to advise of the continued itchy patches which seem to come and go in different areas. Advised to take Cetirizine once again for another 2 weeks once a day.

Red welts all over stomach, legs, chest, and bottom that itched just like the spot around injection site. Head aches and fatigue.

Numbness starting from the injection site (upper left arm) and surrounding area, noticed about a week after the shot. Then numbness continued progressing down my upper arm, and into the front of my lower arm. This is accompanied by pins and needles kind of tingling and an intermittent heavy aching feeling along my entire left arm (picture the feeling of dental numbing wearing off). On 4/14/2021, I noticed the numbness is now also in my left thumb. Arm appears to function normally at this time, but worried about the increasing loss of sensation. Went to doctor who performed a complete blood count and recommended monitoring as she felt nothing could be immediately done.

day 1-7 arm wasn't sore it freakin HURT and there was heat and pink color... day 2-7 i had diaheara, nausea/vomiting, chronic headache that my migraine meds wouldn't quite get rid of...biggest concern was it triggered my tachycardia and bp...I had to take alot of extra heart meds during that week due to how hard my heart pounded and worked

immediate redness, swelling post injection. pt continues to have swelling to face and legs, redness to face.

I had light headedness and queasy stomach immediately. 5 hours after the shot I had the same allergic reaction I have to foods that I am allergic to. My throat starts to swell, it?s hard to swallow. I start coughing profusely. Later that evening came the chills, body aches, vomiting, diarrhea. That lasted 3 days. On day 8 I had severe pain down my arm. The same as the pain I had before I had my cervical spine fusion. On day 11 I had severe down my leg. Again the same type of pain I had before having lumbar spine surgery. I?m on day 12 as I?m writing this.

CHILLS; NOT FEELING WELL; MUSCLE ACHES; HEADACHE; FEVER; PAIN AT INJECTION SITE; INJECTION SITE RASH; This spontaneous report received from a consumer concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included environmental allergy, and seasonal allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: not reported) dose was not reported, administered on 12-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced injection site rash. On 12-APR-2021, the subject experienced pain at injection site. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021 17:00, the subject experienced chills. On 12-APR-2021 17:00, the subject experienced not feeling well. On 12-APR-2021 17:00, the subject experienced muscle aches. On 12-APR-2021 17:00, the subject experienced headache. On 12-APR-2021 17:00, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site rash on 13-APR-2021, was recovering from pain at injection site, had not recovered from not feeling well, muscle aches, headache, and chills, and the outcome of fever was not reported. This report was non-serious.

Extreme itching fill body above waist (back, front, arms, face, neck). No rash, just unquenchable itching.

ITCHINESS TO THE HEAD/ITCHINESS THROUGHOUT THE BODY; HIVES THROUGHOUT THE BODY; SWELLING TO THE LEFT ARM; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulpha allergies. The patient experienced drug allergy when treated with bupropion hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978) dose was not reported, administered to left deltoid on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced swelling to the left arm. On 02-APR-2021, the subject experienced itchiness to the head/itchiness throughout the body. On 02-APR-2021, the subject experienced hives throughout the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling to the left arm on 02-APR-2021, and was recovering from itchiness to the head/itchiness throughout the body, and hives throughout the body. This report was non-serious.

No pain at site of injection. (A) Onset around 8:00 pm on day of injection: chills, shaking, fever (no thermometer was available -- legs, stomach and head were very hot to the touch for about an hour, despite strong chills); strong migraine; sensitivity to light, sound, touch; mild body aches. (B) Menstrual cycle began on time about 2 days after injection, but persisted for 3 days longer than usual. Normal bleeding occurs over 2.5 days, but light bleeding occurred much longer than any time in the previous decade. TREATMENT: (A) Tylenol, warm blankets, heat pad; (B) Ibuprofen 400mg, heat pad (normal treatment)

neuropathy on bottom of feet. I felt an intense heat and pins/needles sensation on the bottom of my feet for hours on the night of my vaccine. I couldn't sleep from the pain and heat.

RASH TO BOTH ARMS AND REST OF THE BODY; BUMPS TO BODY AND HIVES; This spontaneous report received from a patient concerned a 41 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced rash to both arms and rest of the body. On 05-APR-2021, the subject experienced bumps to body and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash to both arms and rest of the body, and bumps to body and hives. This report was non-serious.

FLU-LIKE SYMPTOMS; MUSCLE PAIN; FATIGUE; FEVER; NAUSEA; HEADACHE; INJECTION SITE PAIN; DIZZINESS; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced injection site pain. On 09-APR-2021 20:00, the subject experienced flu-like symptoms. On 09-APR-2021 20:00, the subject experienced muscle pain. On 09-APR-2021 20:00, the subject experienced fatigue. On 09-APR-2021 20:00, the subject experienced fever. On 09-APR-2021 20:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, muscle pain, fever, and nausea on 13-APR-2021, and was recovering from fatigue, dizziness, headache, and injection site pain. This report was non-serious.

HEART PALPITATION; MUSCLES SPASM IN RIGHT ARM; BODY ACHE; INJECTION SITE ARM SORENESS; MILD FATIGUE; STOMACH UPSET; TWITCHING IN RIGHT ARM; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced stomach upset. On 20-MAR-2021, the subject experienced twitching in right arm. On 20-MAR-2021, the subject experienced muscles spasm in right arm. On 20-MAR-2021, the subject experienced body ache. On 20-MAR-2021, the subject experienced injection site arm soreness. On 20-MAR-2021, the subject experienced mild fatigue. On 03-APR-2021, the subject experienced heart palpitation. On 12-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Electrocardiogram (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach upset, body ache, injection site arm soreness, and mild fatigue on 23-MAR-2021, and was recovering from twitching in right arm, heart palpitation, and muscles spasm in right arm. This report was non-serious.

CLOSING OF THROAT; HIVES; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included corn allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced closing of throat. On 10-APR-2021, the subject experienced hives. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from closing of throat, and hives on 10-APR-2021. This report was non-serious.

Patient states that bruising started about 3 days after her shot. The bruising started at the injection site, then it spread to her left leg and thigh. She woke up two days ago with bruises on her shin. Her on/off headaches began when bruising started. They intensified when her shortness of breath began three days ago.

Non-urticarial rash on upper body. Fever of 102. Burning/paresthesia in arms/neck/back. Nausea. Chills. Diarrhea. Decreased appetite.

As soon as I took the vaccine shot I had an immediate headache, after taking the vaccine I took Tylenol and slept in the rest of the day. The next day I woke up and my arm was red and swollen. I was running fever, still had the headache and now blurry vision. My entire body was hurting. My left side of my body felt numb and tingling. The next two days the pain became worse. I did not really have an appetite. When I did eat I could barely hold my food down. On Wednesday morning I could barely get out of bed, I also felt extreme pain in my lower legs, stabbing pain in stomach and right lower side. I also had ringing in my ears, more in the right ear. I then notice a bruise on my left leg, that it was not originally there, and was also tender to touch. I went to the emergency room on the same day and I was admitted. I was in there for 4 days, they tested my leg and stated it was not a blood clot, although it look and felt like one. They discharge me and advise me that it was a migraine that was causing all my pain. This was on Sunday, I had a follow up with my PCP on the Friday, however to being in so much pain and shortness of breath, and arm pain I was advise to go to the ER on the Thursday and was admitted again. I was told in the ER I had a blood clot in my right arm and it was most likely from the IV from the previous visit. My blood pressure and heart rate was so high that they put me on medication. No matter the pain medication they gave me, it would not completely take the pain away. They discharge me again on Monday and after me begging them to get run any and all test, they said they found nothing. I'm still in the same amount of pain and same symptoms, still having trouble keeping my food down. The only thing that changed is my left arm is not as sore, however I still have a huge knot and its still warm to touch. I don't know what else to do that is why im contacting the CDC for help. I'm in a extreme amount of pain and pounding headaches. Please help

Next day full body red rash, 103-104 degree fever, deep body aches, skin sensitivity, joint pain, headache, brain fog,lasted 4 days, One week later period started with large chicken-egg sized blood clots, heavy flow lasted 2 days longer than typical period for me. Second cycle after vaccine started 4.22.21 with same very large clots, intense cramping and bloating

immediately after the injection the injection site was sore. The injection site still remains sore 3.5 days later. Approximately 7 hours after the injection (6:45pm), physical exhaustion set in; mental state was wide awake (thinking about everything/mind racing), however. Approximately 1 hour after the exhaustion began, slight fever and chills started. By 9 pm the fever and chills increased to the point of teeth chattering and touch to the body felt raw. Throughout the night, the fever and chills continued. Sleep was mixed with pain in the legs and restlessness, coupled with a mild headache. In the morning, the headache increased, but the chills subsided and the fever had broken (8am); slight nausea. Eating food seemed to keep the nausea at bay; body exhaustion still existed. headache subsided by the evening. no further chills/fever symptoms. 1.5 days for major adverse symptoms. Soreness at injection is still continuing (no discoloration or lump, just soreness). no vomiting, diarrhea, migraine perhaps related, but not sure...my right leg had a broken fibula a month prior, but was ~98% healed. The evening of the injection, that ankle was swollen to the size when the injury first occurred. Earlier that day, the ankle had no visible signs of injury (no swelling, discoloration, etc). In the morning, the ankle appeared as it had the day/week before.

the night of 4/30/21 started to get a slight fever of 100.5. at 2:00am on 5/1/21 i woke straight up with bodyaches, fever of 102.8, headache, nausea, vomited x 3 times, SOB, diarrhea, chills which all lasted till sunday 5/2/21. on 5/2/21 the area of the injection started to itchy, be painful and the become red and swollen with heat, the injection site to this day on 5/4/21 the redness of the site getting bigger and itching and painful more and going up my left shoulder area.

Site: Itching at Injection Site-Mild, Systemic: approximately 0.5cm bulla located at injection site, no sign of infection-Mild

Client complained of numbness of Left upper arm soon after the vaccination up till present. Client still feels there is difference in sensation and skin temp between the two upper arms. Client didn't realize the numbness until family members touched left upper arms and she still noticed pain 3 weeks after 4/5/21. Then she paid attention and realized there was mild numbness of the left arm. She received massage therapy on 5/7 and felt better. She started practicing Yoga for 1 hour twice a week since 4/2/2021 until present, and realized that the sensation and strength are different on both upper arms. The injection (Left) arm has more pain and less strength than the right side.

Jokingly my boss said she had heard if you go the Johnson & Johnson shot is supposed to magnetize your shot site. Again, jokingly we tried it and it pulled my (cotton) cardigan up with magnet. When we got a bigger magnet take off my cardigan on bare skin, magnet actually stuck to my skin. I still have a huge knot on my left arm and where the magnet stuck was actually where the sit was

RED RASH ALL OVER BODY; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. patient had no known medical condition. 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 04-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAY-2021 17:00, the subject experienced red rash all over body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red rash all over body. This report was non-serious.

Raised area of skin, reddish in color, hot to touch, 3cm in diameter, very sensitive to touch, pain upon any contact with objects or breeze lasting 10 days, sensitive to touch for an additional 7 days, but less painful, not hot, then reduced in size, returned to normal color, but still hard tissue at injection site 1 month later. Red rash appeared within 8 hours of injection spreading from injection site over the next 4 days to reach, pink in color, sensitive to touch, measured 10 cm tall by 16 cm in width, remained visible for 10 days and then faded over next 7 days to normal skin color. Burning sensation in shoulders, elbows, knees worse with movement starting 6 hours after injection lasting another 18 hours and then disappeared immediately (24 hours post vaccine). Areas of itching on body starting on back below shoulder blade on left side, spreading to shoulders, arms, waist, torso, neck, face and thighs beginning 24 hours after injection. Red raised blemishes developed over these areas sparsely spaced, raised, hard, itchy, extremely painful when scratched. One on back of arm formed a pustule that was extremely painful if touched. Day 5 visited the doctor about reaction, told to watch and see if symptoms worsened. Symptoms remained the same for the next 5 days and then began to subside. Raised bumps on face, neck, and arms still visible 3 weeks post injection, finally resolving around 4 weeks.

Pain with injection all the way down my arm into my fingers. Arm felt very heavy. Sharp pain in left chest area Lightheaded Tired

The injection spot became swollen, red, itchy and heated. The pain was preventing normal arm movements. The symptoms started to fade on the 6th day after the vaccination.

It first started with fatigue and chills, I woke at 1 am with a slight fever and felt like bone aches in my big joints such as my legs and hips. I had very mild soreness of the injection site. I had a headache the next day. I had a canker sore as well that lasted over a week. Most of the symptoms were gone with 24 hours. I also got diagnosed with breast cancer but I am not sure it is linked with the vaccine.

For 36 hours, fever, nausea, muscle pains, body aches, chills, headache; 6 days after the vaccine, developed full body rash/hives

THE PATIENT CAME TO THE PHARMACY TO BE VACCINATED FOR COVID-19, WITH JOHNSON & JOHNSON, ON FRIDAY, MAY 21, 2021 AT ROUGHLY 2PM. I GAVE HER THE VACCINATION IN HER DELTOID MUSCLE ON HER LEFT ARM. SHE ALMOST IMMEDIATELY COMPLAINED OF DISCOMFORT AND ASKED IF I HAD A COLD PACK. I PROVIDED HER WITH ONE, WHICH SHE USED WHILE WAITING THE 15 MINUTE POST-VACCINATION OBSERVATION TIME. SHE LEFT THE PHARMACY WITHOUT INCIDENT. ONLY A COUPLE HOURS LATER, SHE CALLED THE PHARMACY TO REPORT ERYTHEMA AT AND AROUND THE INJECTION SITE. I DID NOT KNOW AT THAT TIME WHETHER THE ERYTHEMA WAS DUE TO THE COLD PACK OR IF IT WAS A VACCINE-INDUCED RASH, SO I INSTRUCTED HER TO TAKE A DOSE OF ANTIHISTAMINE. AS SHE HAD CETIRIZINE IN THE HOUSE, SHE TOOK THAT. SHE WAS HOME WITH HER HUSBAND. I RECOMMENDED HE KEEP AN EYE ON HER AND IF SHE DEVELOPED ANY ADDITIONAL SYMPTOMS OR WORSENING RASH, SHE SHOULD GO TO THE HOSPITAL FOR EVALUATION. ADDITIONAL SYMPTOMS INCLUDED SWELLING, TROUBLE BREATHING, WHEEZING, CHEST OR THROAT TIGHTNESS, OR HIVES. THOUGH SHE DID NOT EXPERIENCE ADDITIONAL SYMPTOMS, SHE DECIDED TO GO TO UCONN HEALTH CENTER ER IN FARMINGTON. THEY DID BELIEVE THE RASH WAS VACCINE-INDUCED BUT DID NOT FEEL SHE REQUIRED ANY ADDITIONAL TREATMENT AND DISCHARGED HER (I.E., NO EPINEPHRINE). THE PATIENT NOTED THAT HER BLOOD PRESSURE AT THE ER WAS HIGHER THAN "HER NORMAL" AT 152/95. THE FOLLOWING TWO DAYS, THE RASH STAYED THE SAME AND WAS DESCRIBED BY THE PATIENT AS THE "WORST SUNBURN SHE'S EVER HAD". SHE ALSO HAD NORMAL SIDE EFFECTS OF BODY ACHES AND CHILLS/SWEATS. ON MONDAY, 5/24/21, SHE FOLLOWED UP WITH HER PCP. HE AGREED WITH THE HOSPITAL THAT THE RASH WAS VACCINE-INDUCED AND TOLD HER THAT HE DIDN'T WANT HER GETTING ANY COVID-19 VACCINES IN THE FUTURE. HE DID BLOODWORK TO RULE OUT PLATELET ISSUES, WHICH, PER PATIENT, WERE NORMAL; SHE NOTED THAT HER RBC'S AND HEMATOCRIT WERE SLIGHTLY ELEVATED. HER PCP GAVE HER A MEDROL DOSEPAK FOR THE RASH. THE PATIENT IS RECOVERING. I BELIEVE IT IS WORTH NOTING, HOWEVER, THAT THE PATIENT APPLIED THE COLD PACK DIRECTLY TO HER ARM FOR AN EXTENDED PERIOD OF TIME AND DID NOT PROVIDE THIS INFORMATION TO EITHER THE ER OR HER PCP. SHE SENT ME A PHOTO OF HER ARM WHICH SHOWS GENERALIZED ERYTHEMA (THE SIZE OF THE COLD PACK) - THE ONLY PART THAT IS COMPLETELY NORMAL IS THE SKIN BELOW THE BAND-AID. I BELIEVE THE PATIENT CREATED AN ICE BURN BY USING A COLD PACK TOO DIRECTLY, FOR TOO LONG, AND THAT THE UNDER BAND-AID AREA WAS NOT RED BECAUSE IT PROTECTED THE SKIN FROM COLD BURN. I SUGGESTED TO THE PATIENT THAT SHE RUN THIS THEORY BY HER PCP, AS I BELIEVE IT IS IMPORTANT "MISSING INFORMATION", THAT COULD POTENTIALLY CHANGE THE DIAGNOSIS AND ALTER HIS RECOMMENDATION TO AVOID FUTURE COVID VACCINATION. WHETHER OR NOT THE PATIENT CONTACTED HIM AGAIN IS UNKNOWN.

Persistent left shoulder pain and inability to move shoulder that started about 60 hours after vaccine and is still present over 10 days later

Tingly/numbness in right arm immediately with injection. Lasted about an hour. Fatigue and achiness the following day. 4/17-4/19 tingly and soreness in neck and shoulders. Virtual visit with doctor on 4/19 to discuss if symptoms were related to blood clots and/or vaccine. Week of 4/25 extremely swollen and sore lymph nodes. 5/4 -5/6 fever (101). COVID test 5/5 and negative result received 5/7. Fever returned higher (102.9) on 5/8. Virtual visit with doctor 5/10 to discuss fever and fatigue symptoms. 5/13 UTI test. No infection but blood in urine. Off and on fever and extreme fatigue continue along with loss of appetite and weight loss. 5/18 in person doctor visit to check symptoms, another UTI test and bloodwork. Blood work came back normal, UTI normal, still blood in urine. 5/20 X-ray to check for pneumonia (none found) and ultrasound on kidneys and bladder to check for infection, kidneys stones (none found). Also had more blood work done that day to check for mono (had as a teen with similar symptoms). 5/24 confirmed reactivated mono. Symptoms have slowly improved since 5/23. Another test is scheduled for the future to check the blood in urine again.

About ten minutes after leaving the vaccination site, I began feeling a strange dizziness; an internal wobbly-Jello-like sensation. I felt a pin/needle/ stabbing sensation on my left fingers, particularly on the dorsal side of the third and fourth fingers, and in the middle of the tongue. The tongue felt as if was receiving a subtle electric charge that immobilized it with every shock. It lasted about 5 minutes. My vision was blurry. After that, my mind was foggy. At about midnight, flu-like symptoms began sudden, but they were the expected symptoms for a covid vaccine (fever, body aches, sweats, sore throat, severe headache, pain on injection site, etc.) However, the pin/needle/ stabbing sensation was felt throughout the body. It sometimes felt as if a bubble, waves, or something was moving inside of me, in different areas of the body (rib cage, legs, chest, arms, legs, face, and top of the head (like when a baby moves inside of a pregnant woman, without the visible bump). My body, head, and neck felt stiff. Symptoms were milder after 48 hours, on and off, until 4/13/2021 when I felt a sunken feeling, like something dropped inside of me (sugar, blood pressure, blood rush, I do not know). The tense feeling of the body returned. I felt dizzy. Left arm and leg felt tingly. There were palpitations, but I think that it was due to being scared about all the other symptoms. I felt cold and was shivering. The head felt stiff again. I was very thirsty. In the following days, symptoms got milder. On 4/22/2021, at about 4pm, the sunken feeling returned, along with the dizziness, wave or bubble-like sensation through head, face, body. The wave-like sensation flashed across my face, head, and neck intermittently. It was hard to speak, pronounce words, and swallow. The tongue felt numb. It lasted about two hours. I felt exhausted, so I took a nap until 8pm. When I woke up, I felt like nothing had happened, no symptoms until 1:00 am. At 1:00 pm, 4/23/2021, the sunken feeling, dizziness, palpitations, heavy breathing without shortness of breath, cold/shiver, blurred vision, the wave-like sensation, and pokes suddenly returned. The waves were more intense and felt like pressure on the right side of the head and left side of the chest. Went to the Emergency Room. With every wave of sensations, was accompanied by an urgency to urinate. I urinated like 3 times in a span of 30 to 45 minutes (full bladder). Findings were normal but symptoms continued through 4/24/2021, on and off. Each episode lasts anywhere from 1 to 4 hours. Short lasting, mild symptoms returned Monday 04/26/2021, at night, until Wednesday 04/27. However, that Wednesday night, I felt a belt like, tight sensation around the left bicep and neck. It felt as if I was being grabbed by the left arm. On 4/29/2021, around 5:00 pm, I called an ambulance because all symptoms had returned ?full force?, such as sunken feeling, blurred vision, dizziness (like passing out), intense head and left chest pressure (in waves, like having a huge fish or parasite inside the chest and head), numb mouth (like dental anesthesia), hard to speak (hard time sending the message from brain to mouth). It took great effort to speak and felt that I had to decide whether continue speaking or staying conscious. I also had blurred vision with the first sunken feeling. Symptoms continued 2 to 3 times a day. Since 4/29 a feeling of being inside of an elevator, airplane, or earthquake, and the numbness on the left side of chest and arm remain, even when no other symptoms are present. Also, both arms become numb while sleeping, every night, multiple times a night, since 4/29. Since then, I sleep on 3 pillows (two in my head, one on the shoulders to create an angle) to minimize the numbness of the arms and the head/neck pressure while sleeping. On 5/5/21, symptoms began while car riding as a passenger and upper body felt tight. Strangely, symptoms ended when car stopped moving. Later that day, while walking through a department store, nostrils felt uneven, as if the left nostil were breathing cold air while the right was taking warm air. That night, symptoms intensified (the attack). Like all other times, urinating was too frequent while ?the attack? is present. This time, my body felt sore and tired (Flu-like). There was an intense pressure on the right side of the eye and forehead. The neck stiffness was intense. For the past two weeks, ?attacks? have been less frequent, about 2 to 3 times a week, lasting a maximum of 2 hours. The numbness on the left side of the chest and arm continues. The feeling of something moving or pins/needles may appear sporadically throughout the day. At times, they feel like twitches. The woozy feeling of being inside of an elevator remains. Breathing still feels heavy, like trying to breathe with the face in front of a fan. All test results from the 2 ER visits were normal, including the CT scan. A brain MRI, done on 5/5, was also normal. A 24-hour heart monitor also had normal results.

Follow up report to E-report #360127 - I saw my endocrinologist on 4/5/2021 and my Free T3 and THS was higher than it had been (last checked November 2020) was a little off and she increased my thyroid medication. I have a follow up appt with my endocrinologist Dr. on July 6th 2021 to see how Thyroid is doing. On 4/23/2021 I noticed that my feet were purple and they were stinging. I went to the doctor for this issue today and he said it could be from the vaccine or it could be another kind of circulation problem from sitting; or low iron. He says he wants to see me back in a month. No tests were ordered right now but he would do them in a month if it's still an issue. In April, it was just every once in a while that I noticed it and now it's every day. It starts in the afternoon and then by the time I wake up in the morning, it's better. Thyroid recovery is unknown. For the purple feet - No I have not recovered.

Rash all over upper torso that did not itch. I went to a clinic on 6/16/21 and was told that it was probably pityriasis rosea, a common and harmless rash. However, it keeps spreading and is now going up my neck.

PATIENT CALLED ON 07/06/2021 AND REPORTED HAVING FEVER, NAUSEA AND EXTREME FATIGUE STARTING THE NIGHT OF IMMUNIZATION. SHE HAD THESE ADVERSE EVENTS FOR 3 DAYS AND ONCE THESE ADVERSE EVENTS WENT AWAY, SHE STARTED ITCHING ALL OVER HER BODY. SHE HAS BEEN TAKING BENADRYL SINCE THEN BUT STILL THE ITCHING PERSISTS.

11 days after the injection, I noticed a small patch of itchy red bumps on my side, above my hip on the left side of my body. Over the course of the next 2 weeks, the itchy bumps developed into small vesicles which burst and began to scab over, eventually healing but leaving a small reddish purple discoloration on my skin. I had a doctor diagnosed case of shingles approximately 24 years ago with nearly identical symptoms and sensations. I personally believe that rash was a recurrence of shingles.

Initial injection was incredibly painful. I had the normal arm pain that I expected for a few days after but then the pain never went away. I have no history of shoulder pain/injury and had done nothing to cause a chronic injury. I went to to my primary care first and she thought that it was most likely from the the injection. I then went to a shoulder specialist who agreed and prescribed physical therapy. I have been in physical therapy for about 4 weeks with almost no noticeable improvement.

Started with feeling tired around 6pm, woke up at 3:30 am (ish) to wanting to vomit, shivering, high fever over 103, aweful headache, dizzy, breathing feels labored. Now at 12:30 pm, arm is extremely sore at site, chest still feels funny when taking deep breaths, head still aches but not as bad, not quite as tired.

Approximately 6 hours after vaccine, I had a headache, chills and body aches. These continued all night and got better the next morning when I took Ibuprofen. On Sunday morning, a little less than 48 hours after vaccine, I notice certain parts of both arms were itchy. This morning, a little less than 72 hours after vaccine, I am experiencing an itchy rash in several places on my body including torso , knees and arms and legs.

Dizziness, itchy, tightness to inj site on arm, tingles. Symptoms resolved about 15 after observation. Pt was released back to observation area and pt checked out. Pt received the Johnson and Johnson vaccine.

THIS PATIENT PRESENTED TO OUR ED AFTER RECEIVING THE J&J COVID-19 VACCINE AT AN OUTSIDE CLINIC. SHE REPORTED RECEIVING THE VACCINE AROUND 1100. AROUND 1200, SHE REPORTS THAT SHE STARTED DEVELOPING HIVES AND FELT LIKE HER THROAT WAS CLOSING. SHE REPORTED TAKING 1 DOSE OF BENADRYL WHICH DID NOT ALLEVIATE SYMPTOMS, SHE REPORTED CALLING HER PCP AROUND 1400 WHO ADVISED HER TO TAKE ANOTHER DOSE OF BENADRYL. SHE REPORTS THAT SHE DID NOT FEEL IMPROVEMENT IN SYMPTOMS SO SHE ARRIVED TO THE ED AROUND 1500.

Started pretty immediately with feeling overheated like a wave of heat then started feeling unwell or not right then my right hand went numb that was about five minutes after the shot. Told the nurses they took me back in a room took my vitals at that time I started to feel weak like my arms and legs were Jell-O or jelly. I also felt jittery the nurses gave me apple juice and crackers they put me in a private room they check my vitals again my heart rate was elevated and my blood pressure also went up . 02 That?s normalsats normal My feet are they just started to feel numb as well. A doctor came in and checked me out they felt like my exam was normal but they also felt like I might be having a mild reaction around 1500 I started to get itchy but no hives noted I took a Benadryl 25 mg at 1500 around 1515 my feet were still numb but I definitely felt better still kind of felt like my arms and legs were weak but not as bad so after an hour and a half I was allowed to leave and was told to rest for the rest The day and you call or go to the emergency room if I had trouble some side-effects about four hours after the shot my lips did start tingling at home I did check my oxygen saturations and it was normal I look at my lips to make sure that they weren?t swelling the only thing I noticed was that a scar I have on my lip that usually you can?t see was more prominent and you could actually see it my lower back hurts a lot

Immediately got dizzy, had pins and needles in the arm and hand on the injection side also has swelling of the face on that side and itching at injection site. Layer that evening and the next day I had heart erratic heart rate

Red circle around injection site approximately 2 inches in diameter. Vomiting, fever, general feeling of malaise. Patient has Rett syndrome and is severely/multiply disabled. She never vomits and she did twice after vaccine.

Patient identified as high risk in registration. Patient received vaccination and immediately began to develop hives and itching on neck and a mild rash on her face. She took 50mg benadryl of her own. She stated she has had anaphylactic reactions to the flu vaccine, however denied shortness of breath at the time. Staff immediately called EMS. EMS arrived at 1133. Patient was evaluated by EMS. Hives had spread to her arms. She stated she was feeling better. EMS told her she could come to the hospital or not. Patient declined hospital transfer. Patient left stable and feeling well. She stated she would call 991 if anything else occurred.

Day of the vaccine had sore arm and mild nauseous. Next day nauseous continued until mid afternoon and a headache along with chills and mild fever continued for the rest of that day. On the 3rd day a bruise and circle rash/ring appeared along with body aches and mild headache. Sore arm and smaller circle rash still present 1 week later along with mild body aches. While I am feeling ok im not 100% back to normal.

Extreme Skin sensitivity - burning sensation at injection site at time of injection. Extreme skin sensitivity - light tactile, heavy tactile touch painful Extreme temperature sensitivity - feeling very cold, freezing, uncontrollable shaking.

About 7 hours after the vaccine injection I started to feel flu-like symptoms: aches, chills, woozy and slightly nauseous. Within the next few hours the symptoms became increasingly worse, but not different other than the addition of a headache. I took 2 Tylenol to help with the headache and fever. Overnight sleep was difficult due to chills, sweats, fever dreams and aches. The symptoms lessened the next day (24-hours post injection), but still included muscle/body aches, headache, and extreme fatigue. Again took 2 Tylenol to help. Today (48-hours post injection) I'm feeling quite a bit better although still not 100%. Soreness at injection site persists, especially when lifting my arm.

6 hrs after shot was given the following side effects appeared: 100 degree fever, hot flashes/chills, shaking, chest pain, headache, joint aches. Numbness and loss of color in finger tips. Side effects lasted for 24 hrs. Fever broke within 3hrs of onset.

We had a vaccine reaction today at pharmacy 1870. Patient signed up vaccine online. I saw on her form that she had a reaction to vaccine. , and discussed the vaccine reaction with her. She said she had hives to influenza vaccine five years ago, but had influenza vaccines every year since including 2020 without incident. I gave her the vaccine (Janssen) and almost immediately she said she felt tingling in her arm. I had her sit in site of my gatekeeper for the vaccines. In less than 5 minutes, she was swelling and red in the arm and it crossed over to her chest neck and the other arm. She asked for a benadryl tablet and we complied, but the swelling continued to get worse. We immediately called 911 and the paramedics arrived in about 5 minutes. They gave her iv benadryl and transported her to hospital for observation. Employee followed up with patient this afternoon. She had been released from hospital and is doing well. She was very pleased that we called to ask about her well-being.

Pt had itching to back and arms post injection. No respiratory changes, no hives, no rash, no stridor or any other symptoms of an allergic reaction. Pt rested in chair for 45 min then felt better. Declined transport to the hospital.

Patient received Vaccine March 10 at 8am, Couple hours (10am) headache, muscle aches, Low Grade fever 38.4 chills. Lasting for the remainder of the day and symptoms dissipated next morning

Pt complained of SOB, itching, throat swelling and coughing, Pt was given, epi injection, Benadryl and supplemental O2. Vital signs remained stable.

Received vaccine on 3.12.2021; began to have tearing of R eye with erythema on 3.24.2021 at approx 20:30; awakened 3.25.2021 with swelling of R eyelid, inability to blink, R side facial numbness, R side tongue numbness; Diagnosis: Bell Palsy; Rx Prednisone taper, Neurontin, Valacyclovir, moisturizing eye drops, eye patch.

Day of vaccine, I felt like my lymph nodes were swollen. Two days later the injection site started to get deep red. Friday I started to about an inch of so, swell up some. Saturday I had a rash on my arm by the injection site, the top part on my bicep was pretty red and swollen. I didn't take my Humara or Zolar injection. On Sunday the rash got worse and grew in size and really hot to touch, the pain was radiating all the way to my wrist and hurt really bad causing pain when I moved my wrist. It was hard for me to go to sleep so I called the dr and went in . The dr. said it looked less red that what it was and told me to take Ibuprofen 800mg* 3x day. The pain is now in both wrist and hard for to grip stuff and a little hot to touch. You can see the difference in the skin tone where the rash was, it looks bruised.

Once I received injection my arm had a cold sensation and bit of numbness. Injection site sore. Hour after injection became overwhelmed with fatigue. Slept 15hours. Woke feeling lots of discomfort in joints all over some aching more than others but would not always be the same areas. Injection site sore. Mild headache. Still felt exhausted. The second evening was the worst with body discomfort. Fever mild 99.0-100. The next morning woke no joint pains mild headache (forward center) lasted until midday. Symptoms have seemed to dissipate .

Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Additional Details: Patient had a few seconds of syncope after patient came back to consciousness she experienced difficulty breathing that was alleviated by taking off her mask. She was lighted head ed and nauseous while 911 came

Bright red rash started on my neck 1 day after vaccine. It is spreading over my chest, torso, and sides. The rash is becoming brighter and itchy now in the 3rd day. It is not responding to hydrocortizone cream or oral doses of Benadryl.

Described feeling congested upon arrival patient had develop a rash involving face including bridge of nose and neck and chest. Given 50 mg of benedryl and rash improved prior to discharge from vaccination site

Chart note of 3/22/21-" Local, delayed reaction to the COVID-19 vaccine. Discussed the self-limiting nature of this. Recommend treating with ibuprofen (she has tolerated this NSAID well in the past despite her other reactions to NSAIDS), Tylenol, ice, and OTC antihistamines. Provided her with an ACE bandage today to limit mobility of the wrist due to pain. F/u if no improvement in 2 weeks." chart note of 3/29/21-"Patient is a 42 year old female who presents to the office for wrist pain and rash. Both have been going on since covid vaccine. Has been wrapping her wrists intermittently with no improvement. Swelling has decreased in her arm- left upper arm. States had hives bilaterally in the upper arms although patient has chronic urticaria. States all weekend wrists will hurt later on in the night. Will get shooting pain at night. No swelling of her wrists. When pain happens doesn't have full ROM. Does right now. When pain gets worse cant make a full fist. No fever or chills. States will get a charlie horse pain in the right back of the leg. Has been taking the motrin 800 mg tid. Doesn't want to take that much. States has taken it a couple of times, otherwise takes tylenol. Has done ice on the arm not on the wrists. Thinks turning into a worry wart. Johnson vaccine was on 3/16. History of chronic urticaria. Does take zyrtec three times a day. Singluair patient was unable to get her allergy shot this month due to getting the covid vaccine. " A referral has been placed to Rheumatology based on labs.

Major body aches and night sweats at 3am nigfollowing vaccine. Advil worked wonders. Sore and tired starting a few hours after shot but very rough nights sleep. Better next day and Advil has been only treatment.

Patient received her vaccine at 11:30 AM. Immediately after receiving the Jansen vaccine, the patient reported feeling lightheaded as she stood up. She sat in our waiting area for about 10 minutes, and reported that she felt as though her tongue was swelling. We contacted EMS at this point, and provided a dose of Benadryl to the patient at her request. We brought the patient into our vaccine room where she began to break out into hives. She vomited several times. EMS arrived shortly thereafter and checked to see if the patient was experiencing an allergic reaction. EMS took the patient to the hospital. At about 2 PM, the patient called the pharmacy to let us know that she was okay. She said that it was confirmed as an allergic reaction at the hospital. She indicated that she had received a steroid injection at the hospital and was feeling much better. We encouraged the patient to call us at any time if she had any further problems or questions.

Started around 7pm with massive headache and light sensitivity, then by 10pm started running fever that lasted until morning and ranged between 100.7 to 101 F. Fever broke around 4:30am and gradually returned to normal temp by 9am. Since fever started and continue to have: chills, skin sensitivity to touch, nausea, headache, fatigue, and body soreness.

pt stated minor redness/ hives reaction and puffy eyes when she got home but subsided with benadryl . woke up at 130 am on 4/8 with fever of 104 f . fever broke and pt sweated profusely-- had headache and run down feeling most of 4/8. fever is down but still feeling tired

Patient rec'd Janssen COVID-19 vaccine at 0912. Immediately started vomiting. Stated "arm burned all the way to her hand with injection". Reported felt dizzy, lightheaded, hot". BP 98/62. Assisted to cot and side-lying position. Continued to vomit/dry heave. At 0921, pt stated she was "really tired" and couldn't keep her eyes open. Able to answer questions, but not always able to finish sentence. EMS called. BP returned to normal limits within about 5-10 minutes. Patient contiued to dry heave and c/o feeling cold and nauseous, as well as "really tired" until EMS transported her. 4/8/2021: Nurse called patient. Patient stated she "feels foggy today". States her arm is "extremely sore".

Within 7 hours of the shot, I got a fever of 102.3, severe body aches, severe headache, fatigue, dry cough, and shakiness. Now it's 24 hours after the shot, and I have diarrhea, rash on neck, dizziness, weakness, a productive cough, severe body aches, severe headache, fatigue, and temp of 99.9

I had swelling of my arms, legs, feet, face, eyes and throat. I was dizzy and my heart was racing. I had hives all over my body for many hours. I have taken 2 rounds of Benadryl and it starting to go away.

On 03/29/2021 I started feeling sick I then went to the doctor on 04/05/2021 and I was diagnosed with shingles.

I developed hives on the insides of both of my lower legs. This developed approximately 30 hours after I was vaccinated.

PATIENT EXPERIENCING SHORTNESS OF BREATH LATER IN THE DAY THAT EVENING. HIVES DEVELOPED THE FOLLOWING DAY. BENADRYL GIVEN TO PATIENT 04/09/21 FOR TREATMENT OF HIVES. PATIENT ADVISED TO HEAD TO URGENT CARE FOR EVALUATION.

About 3 hours after the vaccine was given, I had chest pains and started running a fever. I had acute lower back pain and felt overall very lethargic. The fever continued through the night and broke around 3am. The next morning I felt okay but by 10am started to run a fever again for the remainder of the day and chest pains and headache/body aches were now VERY present. It is now 5 days after the shot and I?m just starting to feel like myself again. The headaches and overall body aches lasted for days. I also had blurry vision on and off during this time. My husband and I workout every day and eat very well. We?re not overweight and don?t smoke. The injection site is still sore 5 days later. I will complete another form for my husband but he experienced the EXACT SAME reactions....every one of them.

NAUSEA; FEVER; SWEATING; PAIN/INJECTION SITE PAIN; SWELLING/INJECTION SITE SWELLING; HIVES; BODY ACHES; EXHAUSTION; REDNESS/INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 15:00 in right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body aches. On 03-APR-2021, the subject experienced pain/injection site pain. On 03-APR-2021, the subject experienced swelling/injection site swelling. On 03-APR-2021, the subject experienced hives. On 03-APR-2021, the subject experienced exhaustion. On 03-APR-2021, the subject experienced redness/injection site redness. On 04-APR-2021, the subject experienced sweating. On 04-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.9, 99.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and exhaustion on 05-APR-2021, sweating on 04-APR-2021, and hives on 03-APR-2021, was recovering from fever, and pain/injection site pain, and had not recovered from nausea, redness/injection site redness, and swelling/injection site swelling. This report was non-serious.

MILD HEADACHE; MILD PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 11:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced mild pain at injection site. On 03-APR-2021 19:30, the subject experienced mild headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild headache, and mild pain at injection site on 04-APR-2021. This report was non-serious.

Day 2 after vaccination I got a hive like rash all over my body. I went to Urgent Care and was put on Benadryl and Steroids. Today is 3. Some signs of the rash but it has lessen. Some tiredness and sore where the shot was placed. No other side effects so far.

Rash on arms, fatigue, nausea, cough, sporadic sharp pain in stomach and legs, body aches, headache.

1 hour after injection; Jittery/rapid hear rate (lasted for a few hours) Day 2: Extreme body/muscle aches Day 1- present.-pain on injection arm, pain on injection site, redness on injection site, continued swelling of injection site, hot to the touch on the injection site. Day2- present; Fatigue

Redness and swelling on the arm but approximately 2 inches from injection site, headache, fever and chills

Patient reported swelling in both hands, knee and throat that occurred several hours after getting the vaccine. Patient reported associated symptoms of itching of the entire body, body aches, ear ache, and swelling at the injection site. Patient reports improvement of symptoms with the use of Benadryl.

2- 3 DAYS AFTER RECIEVING THE VACCINE, THE EMPLOYEE DEVELOPED A RASH OVER HER ENTIRE BODY WITH EXTREME ITCHING. AS OF 4/12/21 SHE STILL HAD THE RASH.

1st 24 hours: Sleeplessness, headache, all body aches 24 hours: Left side of torso - skin was sensitive 24-48 hours: initial blister rash appears on torso, skin continues to be sensitive and painful on the left side 48- hours: Diagnosed with shingles/herpes zoster, put on Acyclovir, rash spreading on left side back and front; is itchy, painful and blistering

I had a very bad case of Covid in January 2021 and have not regained my taste or smell. I was in bed for 2 weeks and had a prolonged fever up to 105 degrees--so high that I had visual and auditory hallucinations. I had hair loss in the following months and I also continue to be fatigued. I received the vaccination on 4/6/21 around 11am; a slight headache and face flushing occurred about 30 minutes after shot, but generally felt ok. Woke up at 4am on 4/7/21 with chills, extreme joint pain, body aches, migraine headache, and a fever of 101.5 degrees. Took Tylenol around 6am and went back to bed. The migraine headache, chills, body aches, and extreme joint pain continued. I was dizzy and extremely fatigued. Woke up around 9 am and fever was at 102.7 degrees. Joint pain and headache were almost unbearable at this point and I took a hydrocodone. Took temperature around 12 pm and it was 103.5 degrees. Fever continued rising to 104.4 degrees at 2:30 pm. Took another Tylenol and went to sleep. The next day, my fever had fallen back down to 102.5 degrees. I continued with Tylenol to control me fever to around 101 degrees. My fever persisted for 3 days. I still have extreme fatigue, joint pain, burning scalp (which will likely mean more hair loss), zero appetite and weight loss, dizziness, blurred vision, etc. The side effects are exactly how i felt when I got Covid in January.

severe headache, bad bruising, extreme fatigue, very sore muscles, odd sensation in muscles in back bled terribly after injection

Heavy off cycle vaginal bleeding 1 week after normal period accompanied by breast swelling, severe weakness and bruising on the knee (not accompanied by any injury)...off cycle bleeding is not something that has ever occurred before so is highly unusual

4-12-2021 Facial tingling & numbness, tightness/swelling of throat, difficulty swallowing, Given Prednisone 40 mg, 2 Benadryl and 1 Pepcit at ER visit. Prescribed Prednisone 40 mg /5 days, Benadryl & Pepcid for as long as symptoms are present. 4-13-2021 Headache, itchy eyes, sneezing, small red blood blister like areas on arms, chest, back and thighs. When Benadryl wears off throat tightness returns. Visited ER on advice from nurse hotline to check out the red blood blister like marks as she thought it was a new rash type symptom. ER recomended remaining on previously prescribed course of meds and to watch for further symptoms.

4/9/21 = 9pm EST, 102 fever, severe chills, back ache, pain at injection site, minor stomach pain 4/10/21 = 9am EST, headache 4/10/21 = 9pm EST, 101.5 fever, chills, back ache 4/11/21 = 9pm EST, 100 fever

Approximately 5 hours after the injection, I had the following symptoms: Migraine Chills/shaking Muscle aches Fever Nausea Also, approximately one month following the injection, the injection site is sore when my arm moves certain ways. This is still ongoing.

itching all over the body started about 7:15pm on 4/9/2021 and lasted until 4/11/2021 (took Benadryl and it helped ; Saturday 4/10 terrible lethargy (slept 20+ hours), Sunday 4/11 continued lethargy and new onset nausea and vomiting lasting until 4/12/2021 at 6:30pm

On 4/12/21 I was out on a walk and my fingers turned white and cold between both knuckles, on each finger, on both hands, excluding my thumbs. This lasted about an hour to an hour and a half. Today, 4/13/21, while out on my walk my fingers did the same thing but then went numb, this started at about 6:30 AM and is the same right now at 11:00 AM

Janssen COVID-19 Vaccine EUA" Sunday 4-11-2021 woke up with mild itch and Hives on shoulders and face. At 12PM I went to Urgent Care, and was given prescriptions Cetirizine HCL 10 MG Tablets. when i got home, I notice my lips was beginning to swell and forehead with Welt. Monday 4-12-2021 The Hives spread to my arms legs, feet, back and neck....I went to the ER. at 10:37AM I was given by IV the following: dexAMETHasone (Decadron) / diphenhydraAMINE (Benadryl) / famotidine (PEPCID) and Sodium Cloride (NS) I stay for about 4-5 hours. where the Hives on the forehead, shoulders and arm was starting to disappear...I was discharged. with Prescriptions: Famotidine and to continue to take the Cetirizine but 2 times a day rather then once a day that was previously prescribed, and to take Benadryl twice a day within 6 hours. Hives was appearing to decrease by the evening, on shoulders, forehead Tuesday 4-13-2021 I woke up with hives all over my stomach, sides, back and inner thighs. some spots on forehead and welts on neck and face.

I had a sudden, large, spontaneous bruise on the index finger of my left hand with no precipitating incident or injury. It filled the space between my first and second knuckle completely and extended into the finger tip and below the second knuckle. It is only in hindsight that I thought it could be a blood clot, although I am not sure. It resolved on its own with a few days, although I unfortunately don't know exactly when.

Severe Pain at injection site started immediately following vaccination on March 27, 2021. Three days later, I experienced a severe headaches (which has discontinued). However, muscle aches, shortness of breath, leg pain is on-going.

I had a headache the next morning but no other symptoms initially. Then, Saturday evening, just over 24 hours after receiving the J&J vaccine I was sitting in landscape pavers outside in jeans and a long sleeve shirt next to the pool. My husband looked over and said what is wrong with your feet, they are blue. He said that is not good with circulation and you should probably talk to your doctor. Unfortunately I did not take a picture at the time and noted I was a little chilly but would reach out to my doctor if it continued and didn?t think anything more of it until I saw the reports Tuesday morning of them recommending to stop the J&J vaccine. I called my doctors office Tuesday morning and they asked me to come in over lunch to see the doctor. While sitting waiting to see the doctor my feel replicated the situation from Saturday night. My toes were especially blue up through my ankle and the doctor pointed out I had red patches looking like a rash. She also noticed my right leg was worse and more swollen up to just below my knee. We did take pictures that we can share if prompted.

Itchy red rash started on legs and spread to entire body day after shot was given. Went to Dr?s was given steroids and rash Intensified each night.

15 minutes after injection: out of nowhere became extremely dizzy, nauseous, and fainted. stayed on floor, drank water, juice, crackers, tried to get up but was too weak and almost fainted again. sweating profusely and cloudy vision so lied back down. After 1+ hour felt mostly better so left . 30 minutes into my drive home felt sudden onset of nausea, left fingers tingling & numbing with save wave of extreme dizziness. Pulled onto median and called 911. My face started stiffening into a pucker like position and my muscles all through my body stiffened, but weakened with sharp tingling. I couldn't stand so they carried me out of car and took me to Hospital. The rooms were full so I was in wheelchair waiting for room, shaking profusely, blue fingers, nauseous, dizzy and couldn't stand on my own. I was able to go to restroom w/assistance but My muscles were stiffened for 1 hour+ and over and i felt awful. over the course of 5 hours I gained strength back and started to feel better with just mild headache and nausea. They did EKG, blood panel and chest xray which looked ok. Diagnoses as allergic reaction and told me to come back if more issues. The day after shot and every day since have had a headache at base of neck and pressure in cheek/forehead + nauseau + dizziness and extreme tired. Today is 14th and no headache today.

1. Facial Cellulitis - 2 days after shot. Below right eye on cheekbone. Hard, swollen, tender and a bit purplish. Tele-Health Visited with doctor who prescribed antibiotic & probiotic - however suggested I wait to see what happens the next day after using warm washcloth compress before taking antibiotic. Next day swelling had gone down. Antibiotics were not taken as it cleared up in 2 days. Minor scabbing left by day 5. 2. 5 days after shot - Bright Yellow Runny Diarrhea

Immediately after the vaccine (faint, nauseous, dizzy, pain in injection site) 2 hours after vaccine severe headache left arm swelling (injection site) 7 hours after vaccine severe headache left arm swelling and pain (injection site), sweating, fever 1-6 days vaccine severe headache left arm swelling and pain (injection site), sweating, fever, chest pain, hallucinations, nightmares

24 hours post (4/11) n/v, chills, fatigue; 4/14 numbness/tingling R arm (opposite); chest tightness. local site small swollen, red area;

Muscle Seizures 5-6 hours post vaccine. Full body muscle spasms/seizures that lasted 5-6 hours. Ice cold extremities. Violent shakes. Migraines over the course of the following 4 days and a itchy rash over my face, neck and torso that lasted a full 2 weeks.

I broke out into hives and couldn?t stop itching my torso from 600pm to midnight. I took 2 Benadryl at 700pm and still had horrible itching. At 1000pm I took 1 more Benadryl and the itching subsided at midnight. This occurred 6 days after my vaccination.

PATIENT SEEN IN THE EMERGENCY ROOM WITH SHORTNESS OF BREATHE, INCREASED BLOOD PRESSURE, INCREASED HEART RATE, HEADACHE, AND PAIN IN THE NECK/ARM ARM AREA. STILL UNRESOLVED.

Experienced fatigue afternoon of shot, then chills, mild fever and severe migraine. Fatigue, migraine, fever and chills resolved the following day. Rash appeared on back of body, extreme itching and pain every 1-3 hours were unbearable. Severe pain and itching reduced one week after shot. Treated with Steroid cream, Dr confirmed rash reaction was unexplained other than vaccine.

Severe headache, fatigue , twitching eye lid, itchy face, pain in legs , sharp pain in left side of abdomen. Blurred vision (comes & goes). Various muscle spasms, excessive thirst, sores under tongue, ringing in ears.

1 Day of the vaccination: Swelling in the left arm, pain in my armpit and left breast pain and discomfort in the left leg sensation of heaviness, stomach pain nausea, headache. 2 Day: 4 bruises appeared on different parts of my body, 1 on the inside of the arm where I received the vaccine, another on my left breast that was small and two more on my 2 feet right on the instep where the veins are In the following days a lot of muscle pain in my legs that does not let me rest, the nausea has not stopped. So I went to the emergency room on April 17, 2021.

Rash/hives- started 6 days from vaccine. Started in right arm. Took allergy medication and hydrocortisone cream to treat- would clear up. Hives would come back as meds wore off- different areas at different times over the last 3 days. Once I had hives covering me from the neck down to my feet. Took more meds and would go away.

4/8 3:30pm chills, fever, and severe headache started 4/8 8pm fever 102.7, severe headache, left foot and knee swollen, ringing/muffled sound in left ear 4/8 11pm unable to sleep due to headache 4/9 severe headache, fever all day. Unable to sleep 4/10 fever, severe headache, yellow bruising on shin left leg, back pain between should blades. 4/11 fever, severe headache, back pain between shoulder blades. 4/12 low grade fever, headache 4/13 thru currently, random severe headaches (debilitating - need to close eyes, limit light and noise, headache worse when walking)

Woke up the next day at 6 am felt fine and fell back asleep at 730 am until 930 am. Woke up with a pounding headache. Arm started to be really sore and a tight swollen bump at injection site. Severe nausea and dizziness immediately following by 10 am and extremely tired. Now almost 9 days later the lump at injection site is still there and sore. I find this very concerning and uncomfortable. The nausea lasted about 12 hours. The tiredness and dizziness lasted about 7 days. The bad pounding headache lasted all day followed by mild headaches throughout the week.

BODY ACHES; LETHARGY; FEVER; SORENESS AT INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced lethargy. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced soreness at injection site. On 08-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.0 F. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, lethargy, fever, and headache on 09-APR-2021, and had not recovered from soreness at injection site. This report was non-serious.

TINGLING OF THE LEFT LEG; SWELLING; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit usage of drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 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 soreness at injection site. On 12-APR-2021, the subject experienced tingling of the left leg. On 12-APR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling of the left leg, and swelling, and the outcome of soreness at injection site was not reported. This report was non-serious.

all over outbreak on body and face of painful acne for over one week now, hsv1 had since birth but not active for years became painful and active on face for over one week now, extreme fatigue for 2 days following injection

Fever of 103.1, chills, shaking, muscle/ joints ache, fatigue, injection site redness and pain. Hard knot still on injection site 15 days post injection. All Symptoms lasted 48 hours.

SHORTNESS OF BREATH; EARLY MENSTRUAL PERIOD; DIARRHEA; LETHARGY; WEAKNESS; NAUSEA; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke, and concurrent conditions included low iron, egg allergy, and pork allergy. 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 10-APR-2021 for prophylactic vaccination. Concomitant medications included iron for low iron. On an unspecified date, the subject experienced shortness of breath, early menstrual period, diarrhea, lethargy, weakness, nausea, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, diarrhea, weakness, lethargy, shortness of breath, early menstrual period and injection site pain was not reported. This report was non-serious.; Sender's Comments: v0-Medical assessment comment not required according to standard operating procedures.

Sore arm and rash 4/9 within 12-16 hours of shot. Body aches and low fever for 12-24 hours after shot. Eyelid hives and rash start 4/10 off and on thru 4/22. Saw dermatologist on 4/16. Used elidel 4/10-4/16 was ineffective. Was treated with eucrisa. Somewhat effective but rash clears and returns. Painful menstrual period 4/22. Unusual at my age and with an IUD.

ED Course/MDM: -Rash appears as an allergic reaction. The patient is given Solu-Medrol and observed for period of time. She continued to improve and I do feel she can be further evaluated as an outpatient. The patient is placed on a prednisone burst and to continue antihistamines. -The patient will follow up with their PCP and is to return for any new or worsening symptoms. The patient is discharged in stable condition. Final Impression: 1. Allergic reaction

REDNESS AT INJECTION SITE AROUND 12 NOON; PAIN AT INJECTION SITE AROUND 12 NOON; RIGHT HAND SWELLING AROUND 12 NOON; BODY FEELS HOT "LIKE FIRE" BUT WORSE IN THE ARMS/HANDS AROUND 12 NOON; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included weak immune system, penicillin allergy, latex tape allergy, sulfa allergy, bactrim allergy, non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with venlafaxine hydrochloride, and ondansetron. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: 02-MAY-2021) dose was not reported, administered on 13-MAR-2021 around 11:00 AM for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced redness at injection site around 12 noon. On 13-MAR-2021, the subject experienced pain at injection site around 12 noon. On 13-MAR-2021, the subject experienced right hand swelling around 12 noon. On 13-MAR-2021, the subject experienced body feels hot "like fire" but worse in the arms/hands around 12 noon. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at injection site around 12 noon, pain at injection site around 12 noon, right hand swelling around 12 noon, and body feels hot "like fire" but worse in the arms/hands around 12 noon. This report was non-serious.

HYPERSENSITIVITY WITH SKIN; SKIN ON FIRE AND BURNING; EXTREMELY COLD; NIGHTTIME CHILLS; MALAISE; FEVER; This spontaneous report received from a patient concerned a 42 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced hypersensitivity with skin. On 14-MAR-2021, the subject experienced skin on fire and burning. On 14-MAR-2021, the subject experienced extremely cold. On 14-MAR-2021, the subject experienced nighttime chills. On 14-MAR-2021, the subject experienced malaise. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hypersensitivity with skin, extremely cold, nighttime chills, malaise, fever, and skin on fire and burning. 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.

4/2 vaccination. That evening you had HA, nausea. 4/12 Abdominal pressure, with fluid build up. Side was hurting. Face started to get puffy. 4/15 Went to PCM. Given fluid pill. Blood panel to check on my blood clotting issues. As I was poisoned between 2019-2020 with gun powder. Liver enzymes had been going down. *blood panel check every 2 months **still puffy. My fluid is going down.

BUMP ON LEFT DELTOID AREA WHERE RECEIVED THE VACCINE; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 270 pounds, and height was 64.8 inches. The patient's past medical history included anemia, and concurrent conditions included non smoker, alcohol user, and penicillin allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced bump on left deltoid area where received the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump on left deltoid area where received the vaccine. This report was non-serious.

FEELING BAD; SICK; JOINT ACHE; HEADACHE; INJECTION SITE PAIN; SEVERE CHILLS; SEVERE BODY ACHES; TROUBLE REGULATING BODY TEMPERATURE; HOT AND COLD FLASHES; SEVERE BREAST TENDERNESS; INCORRECT ROUTE OF DRUG ADMINISTRATION; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight was 175 pounds, and height was 155 centimeters. The patient's concurrent conditions included drug allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. the patient was not breastfeeding at the time of vaccination. no history of drug abuse. the patient had no illness at the time of vaccination. no history of similar event in the past. the patient had no adverse events after any previous vaccination(s). the patient was allergic to amoxycillin. no pre-existing acute illness prior to vaccination. no history of hospitalization 30 days prior to vaccination. no family history of any disease relevant to vaccination or allergy. The patient was previously treated with amoxicillin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced incorrect route of drug administration. On 08-MAR-2021, the subject experienced severe body aches. On 08-MAR-2021, the subject experienced trouble regulating body temperature. On 08-MAR-2021, the subject experienced hot and cold flashes. On 08-MAR-2021, the subject experienced severe breast tenderness. On 08-MAR-2021, the subject experienced severe chills. On an unspecified date, the subject experienced feeling bad, sick, joint ache, headache, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches, trouble regulating body temperature, hot and cold flashes, severe breast tenderness, and severe chills on 22-MAR-2021, was recovering from sick, had not recovered from joint ache, headache, injection site pain, and feeling bad, and the outcome of incorrect route of drug administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210318992.

LEGS FELT "HEAVY" BILATERALLY, LEFT MORE THAN RIGHT; PAIN IN THE ARM; FEVERISH; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient does not have diabetes, circulation problems, and is not overweight. she is not taking birth control pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pain in the arm. On 12-APR-2021, the subject experienced feverish. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced legs felt "heavy" bilaterally, left more than right. Laboratory data included: Body temperature (NR: not provided) 100.1 (unit unspecified). Treatment medications included: paracetamol. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) UNKNOWN (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish on 16-APR-2021, had not recovered from legs felt "heavy" bilaterally, left more than right, and the outcome of pain in the arm and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425979.

HEAVINESS IN LEGS; MISSED WORK DUE TO THE FEVER; PAIN AT INJECTION SITE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medications prior to the janssen covid-19 vaccine. the patient had no diabetes, no circulation problems, and was not overweight. the patient was not taking birth control pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced heaviness in legs. On 13-APR-2021, the subject experienced missed work due to the fever. Laboratory data included: Body temperature (NR: not provided) 100.1. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from missed work due to the fever, and fever on APR-2021, had not recovered from heaviness in legs, and the outcome of pain at injection site and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425979.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

Next day 04/08/2021 afternoon fever range 100.6.-101.6, extreme fatigue ,vaccination arm location swollen to size of egg- currently size of marble,; pain in wrist by thumb, shoulders and neck . Ongoing from 04/08/2021 to current day, 21 days so far. Verbally evaluated the signs and symptoms prescribed meloxicam 7.5 mg twice a day and headaches, pharmacist states once a day for the meloxicam 7.5. Not resolved currently still having burning and occasional lighting bolt of extreme pain and the marble size knot in the left arm of vaccination location.

8 days after my vaccine, I had to have my appendix removed. Previous blood work (within a few months prior) showed zero issues. Also, I never had an allergic reaction to steri-strips or surgical tape and ended up breaking out in a rash from shoulders to mid-thigh. Finally, I never had cold sores and I had to treat cold sores for 8 days.

That night (Sunday) and all the following day, I had a sick feverish feeling without an actual temperature. Also even three days later, I have a 3 1/2 knot on my arm that is hot to the touch. The feverish feeling did go away by Tuesday.

GLASSY EYES; CHILLS; STOMACH DISCOMFORT; FATIGUE; SWELLING AT INJECTION SITE; LUMP; PAINFUL; REDNESS; WARM; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced lump. On 12-APR-2021, the subject experienced painful. On 12-APR-2021, the subject experienced redness. On 12-APR-2021, the subject experienced warm. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced swelling at injection site. On 21-APR-2021, the subject experienced stomach discomfort. On 22-APR-2021, the subject experienced glassy eyes. On 22-APR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm, and swelling at injection site on 21-APR-2021, and chills on 23-APR-2021, was recovering from stomach discomfort, fatigue, and glassy eyes, and had not recovered from lump, painful, and redness. This report was non-serious.

Swollen cheeks, throat, metallic taste, pain in old scar tissue (surgery at L5-S1) within twenty/thirty minutes of injection Fever/headache/chills/sweating for four nights Hair shedding started 4-14-2021 and continues still

42 yo f c/o acute onset of itchy rash to LUE and neck x2-3d after receiving J&J covid19 vaccine approx 2d prior to onset of sx's; additionally reports mild intermittent ha w/dizziness w/o nv or other sx's x24hrs; Pt states concerns for covid19 rxn; pt states mild improvement in rash sx's after total 3x doses of 25mg benadryl; pt denies any other rashes, cp, sob, dyspnea, abd pain/cramping, vaginal bleeding/discharge, urinary sx's, visual changes, neck pain. Pt denies any ha sx's at time of provider evaluation

Site: Pain at Injection Site-Severe, Additional Details: mild sore arm right after injection. on may 5th, it got worse (to level 8). then calmed down. On May 7th, it got worse again. walking caused lots of pain in shoulder. Patient has been taking ibuprofen 600mg every 6 hours since May 2nd.

PATIENT REPORTS SORE SPOT ON INNER ASPECT LEFT LOWER LIP, LEFT HAND TINGLING (WENT TO ER FOR THIS COMPLAINT 05/05/2021 PRIOR TO VACCINE AND DIAGNOSED WITH CARPEL TUNNEL), ITCHY NOSE AND FACE

Full body rash that subsides with allergy medicine and quickly returns. It is itchy, hot and prickly feeling.

The evening of the vaccine I got a rash on my trunk and a ulcer on my tongue. The ulcer was toward the back of my tongue. I felt drunk. The rash was on my trunk near where my bra is. It was a strawberry rash and I took some Benadryl it lasted three days. A few days later I started to get leg cramps like my legs were tired. On the right leg it went up into my thigh and my hip. It was cramping sensation that was constant and lasted for a week. It helped if I put my feet up it improved. Overall the leg cramps lasted for two weeks. I am recovered right now and the symptoms have not returned.

I had - as soon as she gave me an injection - I felt like it was a little bit hot. I told her that. I knew I had a lot of allergies so I was being careful. Within a minute of sitting down, my right arm became swollen and bright red and felt burning and itchy. And it spread across my chest and went to my left arm. The rash or hives continued up my neck up to my face and that all happened within first five minutes. Immediately after that, I had excessive coughing - couldn't cough up anything. I couldn't catch my breath and my throat started swelling a bit. they gave me 25 mg of Benadryl - capsule over the counter - and the 9-1-1 operator advised not to use the epi- pen. Paramedics came - gave me addition 50 mg of Benadryl - and they took me to the ER across the street and I was administered another 25 mg of Benadryl and also some steroid - Solumedrol - and after receiving these - then these symptoms went away. I continued on Benadryl and prednisone for a few weeks - the very next week - I had a large streak that went from injection site to left chest and I had a second red streak from left chest that ran down to my left arm. For two weeks, that burning fire rash would just come. No rhyme or reason as to when or why - arm, neck, chest, legs and sides. And I'd have to take extra Benadryl every time it would happen and I was still on the high dose of steroids as well. I also had - the next day - 24 -48 hours after vaccine - I had a severe headache and it lasted all day long. And about 24 hours after the vaccine- extreme fatigue, body aches and headache and weakness and that lasted for about three days. Fatigue lasted three to four weeks. Joint aches lasted three to four aches. Headaches have still continued. They have almost been worse actually. I had two headaches that I was so concerned about that would not go away - worst headaches I have ever had: one on May 1 and one on May 9 - and I took Maxalt and some Benadryl - the Benadryl did help a little bit (enough for me to go to sleep). Each headache lasted 12 -15 hours and they were the most severe headaches I had ever had. I didn't have anyone to take me to take me to hospital so I just tried to sleep. I saw my primary care doctor - virtual visit. I took the prednisone for two to three weeks. I still contend with the headaches.

I was diagnosed with shingles a moth later. On the lower right side of my back. Swollen lymph nodes on the right groin area.

ELEVATED D DIMER; ITCHY AND UNCOMFORTABLE RASH ( BOTH LEGS AND RIGHT FLANK); This spontaneous report received from a health care professional concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no other pertinent medical history shared. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number:1805018 and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced elevated d dimer, and itchy and uncomfortable rash (both legs and right flank). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Platelets, white blood cells and red blood cells are normal, and Fibrin D dimer (NR: not provided) weakly positive. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itchy and uncomfortable rash (both legs and right flank), and the outcome of elevated d dimer 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.

Initially I had a red raised mark that was a bit itchy, sore, and hot. That faded after about a week, but it still felt like a bruise. Approximately one month later (I noticed on 5/7/2021) I realized that the same area that had been red/raised/sore/hot/itchy seemed to feel sunken in like an indentation. I measured the indentation area on 5/14/2021 and it was appx 3cm high and 5cm wide. It doesn't seem to be getting larger, but it feels deeper today, 5/18/2021. I can't find any instances of this issue and am starting to worry as it seems to be getting deeper and deeper. It does feel a little sore as well.

It started as soon as I got the vaccine. I had a feeling of heat travelling down my arm followed by a pins and needles sensation. I stayed for 30 minutes and I could feel a strange feeling of pins and needles seemed to be travelling up my neck and into my face. When I saw that my arm was swollen. My arm started to itch and I was taken into the observation area and checked out. I went home and four hours later I felt like I couldn't take a deep breath and I started to get a headache, chills and fatigue. The next day my arm and face were still little numb and I was still having a little trouble breathing. On day four I still felt like I couldn't take a deep breath and my heart rate was erratic. On the fifth day I went to an Urgent Care clinic. My blood pressure and heartrate were a little high. I went to the doctor the next day because they had found some hardening of my heart. After five weeks I still have a little feeling of pins and needles in my left arm and in the left side of my face.

Started off with chills fever around midnight. Body aches severally coughing couldn't breath very well just felt awful. Slept 22 hours very nauseas. Arm felt like I got punched at the injection site, bruise and the arm is still sore.

Injection site immediately, pain and swelling. Starting the next day with onset of rapid symptoms including severe headache, extreme full body muscle aches and chills that felt painful as if had the flu, no fever, then the extreme tiredness hit where i had to lay down and sleep. I had to have my mom come get my young son because i couldn't even stay awake. muscle twitching in my calf muscles and my right thumb pad, post nasal drip started then stuffiness and that smell you smell when you are sick. So i slept hard for about 5 hours and when i got up i felt 80% better. The headache had been so bad when i opened my eyes it was very painful. My arm still is very tender and sore and swollen, but these symptoms were weirdly short lived. The most scary was the sleepiness that i couldn't control.

Numbness, blood count platelets went very low. April 11th. Swollen, migraines, inject in Left arm. Does not usually get side affects. Was given prednisone, did not lessen symptoms.

Swelling of vaccine site resulted in a large disc like lump. Pain and tenderness for over a week. Healed after about 3 1/2 weeks, then left a noticeable indentation in arm where vaccine was given and swelling occured.

Low grade fever for 5 days. Extreme nausea for 24 hours. Diarrhea for 72 hours. 24 hours after the injection the lymph node under my left arm swelled up to about the size of a baseball, it was extremely hot and painful. It stayed that size for 4 days, and then finally started getting a little smaller each day. It's officially been 10 days and I would say that lymph node is about golf ball sized now. I did see my doctor and she said it can be a normal side effect and as long as it's going down not to worry. I also was having pain in my back and the doctor suspected a possible pe, my d-dimer test came back positive twice but my platelets remained in the normal range. The second d-dimer was only 513 and considered barely out of range so we assume whatever clot I had dissolved on its own.

Client was waiting in observation 30 mins when she asked EMTs to check her blood pressure as she was feeling palpitations. First vitals at 1512: blood pressure 158/100, pulse 82, oxygen 98%. PHNs arrived shortly. Client sitting in chair, alert and oriented x4. Per client had reaction to Pfizer first dose and medical team had recommended Janssen as second dose instead. Per client feeling nausea, headache, and palpitations. PHN gave client emesis bag. Client assessed for swelling, flushing, per client no shortness of breath at this time. Retake of blood pressure at 1513: 150/100. Per client history of hypertension, diabetes, thyroid, and took her medications today. No other allergies except Pfizer vaccine. 1515 client reported feeling warmth sensation to throat area and feeling itchiness. Per client it was same reaction to Pfizer vaccine. PHN asked client if she drove, per client had family outside waiting. PHN offered client Benadryl and client accepted. PHN administered 50mg IM on right deltoid at 1519. Vitals: pulse 107, oxygen 98%. At 1522 client stated stronger itchy throat and felt like it was starting to close. No swelling noted, per client feeling tingling around lips. Client stated shortness of breath, unable to take deep breaths. PHN Ae called 911. 1524 pulse 104, oxygen 99%. Per client feeling very dry mouth. PHN kept speaking with client, alert and oriented x4, able to answer all questions in short answers. 1527 pulse 103, oxygen 99%. Client stated feeling warmth in throat area again, began coughing intermittently. Per client new onset of strong headache to occipital area, dizziness and chills. 1531 paramedics arrived and assumed care. Client transported to facility via gurney at 1540.

Cessation of monthly menstrual cycles following vaccination. Cycles were regular prior to vaccination; no other signs of peri-menopause. Cycles have not restarted as of 3 months following vaccination. Abnormal hair loss started about one month after vaccination and is ongoing.

within 15 minutes, I had an immediate headache. Over the next 72 hours, my headache worsened and a firefighter friend came to check my blood pressure. It was 240/110 for the next 4 days. I had not had blood pressure problems before. I also developed a rash on my legs that appeared at hour 26 after the vaccine but resolved after 48 hours of the vaccine. My heart was racing and extreme headache persisted. My cardiologist saw me and put me on a heart monitor and had me record daily blood pressure numbers. On day 18 after the vaccine all symptoms mysteriously resolved. The doctor continued to monitor for 30 days total and then we decided if anything serious were to happen, it would have by then. So monitoring discontinued. I had not blood pressure problems before. Now its somewhat higher but within acceptable ranges (140/90 now)

Bleeding at injection and starting to bruise. Quarter size bruising at injection site (purple and yellow) within 4 to 6 hours of injection; joint pain, muscle aching, fever, lethargy within first 24 hours. Still present but less severe 3 days post injection. Patient's main complaint 3 days post in bruising at injection site and fatigue.

Developed a rash that spread over my torso, from neck to upper thighs. It was red and itchy. Sought treatment from a dermatologist approximately 10 days after the rash started as over-the-counter treatments were not helping. The dermatologist determined it was pityriasis rosea and prescribed Triamcinolone Acetonide cream. I applied the cream topically for 14 days and the rash started to diminish. There are a few dark patches still clearing up but it no longer itches.

First day nothing. Second day: tired; skin all over body was sore (like when you have a fever); headache. Third day: previous symptoms are gone but I have sinus pressure in my cheeks and my teeth are sensitive.

GIVEN THE JANSSEN VACCINE. EUA. THE PATIENT STARTED DEVELOPING A RASH IMMEDIATELY AFTER VACCINATION AND SHE STARTED TO FEEL ITCHY. SHE WAS GIVE 25MG OF BENADRYL ORALLY AND WATCHED FOR 30 MINUTES.

local reaction on left arm, red, warm and 3" red circle, increased HR 100-110 BPM (my normal is about70)

The patient had swelling of the face and hives on her arms and chest. Also itching of the head, eyebrows, and ears. This started 2 days after the vaccine. She had fever and chills the night after the vaccine

Patient developed redness at the injection site and arm and complained of generalized itching. Benadryl 25 mg capsule given. Patient watched for 30 minutes and then left. Patient felt better after receiving Benadryl.

Immediate: intense soreness at injection site 6pm body aches 7pm chills 8pm fever 102.4F 12:30am fever broke, onset of migraine 7am nausea Migraine & nausea intense until 6pm 3/13/21 Mild headache now

I still have a lot of swelling and pain at the injection site and it?s been almost a week. I am also very itchy all over, but there is no rash or hives on my skin.

On-going pain, redness, itching and burning sensation at the injection site as well as stiffness, discomfort, tingling, mild numbness and joint pain, and headache from the day of injection, at the time of writing this report including the days in between injection and reporting. Initial swelling an hour after injection on 3/11/21 was the diameter of a quarter; swelling as of 3/15/21 is approximately 4.5 inches in diameter. The surface temperature of the injection site remains approximately 98.1 degrees. In addition, I am experiencing noticeable numbness and tingling on the left side of my body including facial muscles surround eye, mid face, left hand radiating out to all 4 fingers, left thigh, and left calf. I am experiencing joint and muscle pain on the left side of my neck, left shoulder, left upper arm, left elbow, left hip, knee and ankle.

Skin was red especially face, arms & chest. Body aches . Freezing to soaking wet sweating. Fever 100.2 up & down. Nausea & vomiting. Small Headache & now just muscle soreness & tired.

Fever 102.3, chills, muscle cramps, soreness at injection site, mild cough, fatigue beginning all starting 9 hours after vaccine.

3/9/2021 0800: Took dog outside. Upon coming in, I had sever chills and could not get warm the rest of the day and night. 3/10/2021 0630: Upon waking up, arm was very sore 3/11/2021-3/16/2021: Arm was in various stages of redness, swelling, and soreness 3/17/2020: Arm is still raised at the injection site, soreness has lessened.

5 days after vaccine my skin got very hot, red, irritated and broke out in hives. It's been three days and my skin is still irritated.

Reports Hives (cheeks and neck); tightness in throat. Denies SOB, chest pain. BP: 133/98 HR: 80 Sp02: 100% Refused transport to ER by the ambulance, refusal form signed Seen and cleared by EMS

Knot or bump formed at injection site that is red and warm to the touch two weeks after the injection.

hx of allergy to pineapple. Person started with itching to lips the same feeling she gets when eating pineapple. Urticiaria progressed to arms, legs, no visual hives. Person was given 50mg Benadryl PO by facility. 30 minutes later she was still itching. Person returned to work, but closely monitored.

patient reported feeling itchy on the neck, back, and down the arms approximately 15 minutes after injection.

Herpes Zoster, Right chest and axilla, T2 Dermatome. Mild itching, not painful. Patient noted rash on the chest, axillary lesions found during exam. Patient presented for previously scheduled skin exam and brought up the rash wondering if it was poison ivy.

Day of injection-Extreme pain/heat in arm that traveled up neck. Runny nose, swollen tongue and ears, sweating, general spacey or brain fog feeling for about 10 minutes. Went home and had to take 3 doses of benadryl, over the course of the evening. Didn't warrant my epi pen, I didn't feel. Night of injection-night sweats and pain at injection site and down arm. Next day-fever, chills, joint pain, body aches. Taking tylenol

@7pm on the evening of the vaccination, I developed weakness, severe chills, body aches, muscle pain and a severe headache. @7am on 3/26/21 severe chills subsided but weakness, severe chills, body aches, muscle pain and a severe headache remained. Left arm shot site pain started. @1pm on 3/26/21 muscle pain (left side of body neck, underarm, pectoral, lower back, and calf muscles) as well as shot site pain remained. 3/27/21 - 3/28/21 muscle pain subsided as shot site pain remained and redness of the area and below the area grew. @7am on 3/29/21 Shot site pain and redness of the area and below the area grew even larger. the shape of a snowman: the top (shot site) the size of a nickel. the bottom the size of a golf ball. Area has a knot in the muscle and is hot and extremely tender.

Began to experience itching on back and left side that traveled down legs followed by dizziness. Appeared to be very red in the face as well.

Headache, chills, 100.9 fever at its peak, soreness at injection site, mild nausea, hot flashes, nasal congestion, extreme fatigue

fatigued for appx 24 hours after injection and headache. Left arm swelled and has bump/knot at site of injection. Swelling down a bit but bump/knot still present and sensitive to touch. Also arm and shoulder pain. Have not been able to lift arm all the way w/out experiencing pain in my shoulder. No full range of motion. Still hurts to lay on left arm, or put any pressure.

Developed red rash along left side of face and neck followed by mild pruritis. Then, developed tachycardia with normal blood pressure and mild shortness of breath. Then, nausea and vomiting. Treated with epinephrine .3mg and .5mg five minutes later due to lack of improvement in symptoms. Transported to hospital ER. patient reportedly felt much better by arrival at ER.

Pain in arm 4 hours later. 8 hours later severe headache, chills, body aches. Took 600mg Motrin & 10mg melatonin to help sleep 11 hours after injection. Woke up numerous times throughout the night with night sweats, chills, body aches, leg cramps, arm site pain. Woke up in the morning (21 hours after injection) feeling fatigued but no other symptoms

3:20PM PT NOTICED FACIAL RASH - REDNESS TO CHEEKS, LIPS, NOSE AND CHIN. NO SOB/DYSPNEA. 3:22PM BENADRYL 50MG NO DIFFICULTY SWALLOWING. A/O, W/D, RESP REG WITH EASE.

Metal taste and smell immediately after injection First evening, chills and headache, sore swollen arm Next morning chills and headache, sore swollen arm Second evening, fever 101.4, chills, headache

Chills for about a half hour, fever reaching 102 degrees and headache lasting through the night. In the morning I took ibuprofen which brought the fever down and took care of the headache. The fever did not return, but I took another dose of ibuprofen about 5 hours after the first for a returning headache. Today is the 6th and the pain in my arm (injection site) is still fairly intense and especially to the touch.

The injection site was really sore. Ran high fever and had flu like symptoms for about 15 hours. Then those symptoms stopped but the injection site pain continued. The intensity of the pain grew for about 3 weeks. Then pain extended to neck and shoulder blade. Went to urgent care for the arm/neck/shoulder pain. Took neck X-rays. Given a steroid shot and an another shot I think for inflammation. Prescribed a muscle relaxer.

Within hours of the shot, I began having full body itching and have continued to have itching for several days. Allegra, Zyrtec and Benadryl have offered little relief.

Dizziness immediately following vaccine. Slight headache, moderate muscle aches, severe pain at injection site. It was also swollen with redness, itching, and it was hot. . Never had a fever. I immediately started taking Benadryl every 4 hours. I had really bad nausea (no vomiting) to the point I was unable to eat and lost 7 lbs. I had really bad cold sweats so bad I was drenched with sweat multiple times a day for over a week. I ended up going to the walk in clinic about 5 days after the injection and was given Zofran for nausea. I was also told I had a moderate allergic reaction to the vaccine and any other time they would start me on steroids but they said if I took steroids it would make the vaccine not work. So I was told to continue Benadryl and deal with it. To this day which will be two weeks tomorrow since I received the shot I still have a hard hot lump in my arm, I still break out in cold sweats, and still have a little nausea. Never had wheezing or issues breathing though.

10:00 AM Sore at injection site. 10:40 AM Dizzy and sleepy 10:50 AM vomiting 12:10 AM Ran 99.9 fever 3:00PM Same symptoms swelling at injection site. Took 600 mg Ibuprofen 5:30 PM Same symptoms, swelling from arm to neck. Fever at 100.2. Took 2 Tylenol PM tablets. 8:30 PM Vomiting and same symptoms as all day. L/Side Neck and Left arm sore. Very intense headache. Took 2 Tylenol PM tablets. 3:30AM Same and very sore arm and head ache 11:00 AM

Started with the lower right leg and foot being itchy and red 7 days post vaccine. It then progressed to the right lower leg. After a few hours, the upper legs became red and itchy. It then affected my right arm, a little on my abdomen, and then the right elbow area. Benadryl, a cold shower, and icing the areas made the symptoms go away for several hours, but they returned over night at 3am. Day 8, the symptoms were gone most of the day, but returned in the evening around 8pm. Benadryl taken and iced down the arms and legs. Symptoms subsided. They returned again at 3am and woke me from sleeping. It affected both feet, both legs, both arms, a little on my back and sides.

Severe burning sensation when injected. Extremely sore arm once injection removed. Directed to park car for to be monitored for 15 minutes. Parked the car. Car was in park but still running. Attendant at the clinic instructed me to move my car forward. I put the car in Drive and as I moved forward I lost consciousness. Completely blacked out. Unconscious in the car, the car carried on moving forward and crashed in parked car. I came to once someone tried to wake me up. Presently have no smell and have been very tired with the chills. I was sweating in my sleep, shivering and woke up in a wet bed from all my sweat. The next day I am just weak.

4/3/2021 5 pm shot administered was painful going in. Immediate arm soreness. 4/3/2021 from 11pm - 2am : severe chills, headache, and arm soreness. Took extra strengh Tylenol at 2am and woke up several times in sweat. 4/4/2021 at 8am awoke to a headache and fever of 101.6. Felt weak, light headed and some nausea. No appetite. On 4/4/2021, continued to take the Tylenol ever 5 hours which helped to lessen the fever. Continued to feel week and light headed but also began to see improvements in my appetite. Drank plenty of fluids. Arm soreness still present. 4/5/2021 at 8am awoke to a headache and no fever. Felt dizzy and light headed at times through out the day. Experienced decreased energy or tiredness. Arm soreness sill present. 4/6/2021 awoke to a headache and no fever, at times dizzy and/or light headed. Experienced lack of energy. Arm soreness still present. 4/7/2021 awoke to no headache or dizziness. Energy level close to normal. Arm soreness still present.

Approximately 20-30 minutes after receiving the vaccine left arm became slightly numb, noticeable during the short 10 minute drive home. Within 30 minutes of getting home there was notable numbness in the left arm, especially below the elbow and into the hand with last two fingers being the most affected; numbness was also up into the neck and felt in the left cheek/jaw up to near the left ear and the scalp. This diminished over the course of the evening. The next two days there was lingering soreness in the left neck from where neck meets shoulder and slight tingling in the last two fingers. Ibuprofen 600 mg was taken to assist with any pain, usually in the morning with other medication before going to work. By two to three days after the vaccination there was no more soreness or numbness. While no bruising ever occurred, firm pressure on the site of injection two weeks later is still mildly painful.

elevated HR, lots of anxiety, hives by injection site that went away the next day. high temp of 101 the next morning, headache and whole body hurts.

PER PATIENT: APPROXIMATELY 1 HOUR POST-VACCINATION, A.C. STARTED TO EXPERIENCE NAUSEA, NUMBNESS AND TINGLY SENSATIONS, RASH ON ARMS, LEGS, SWELLING IN ELBOWS, KNEES, CHEST PAIN, CHILLS, SLIGHT SHORTNESS OF BREATH. THESE SIDE EFFECTS PROGRESSED AND WERE WORSE 4 HOURS POST-VACCINATION. THE DAY AFTER VACCINATION, AFTER REGISTERING WITH V-SAFE, A REPRESENTATIVE CALLED A.C. AND TOLD HER TO TAKE 75 MG DIPHENHYDRAMINE. THE REPRESENTATIVE STATED THAT A.C. WAS HAVING A MODERATE REACTION TO THE VACCINE (A.C. DID NOT EXPERIENCE ANAPHYLAXIS). MOST OF THESE ADVERSE REACTIONS IMPROVED AFTER TAKING THE DIPHENHYDRAMINE. TODAY, 2 DAYS POST-VACCINATION, A.C. IS NO LONGER HAVING ANY SIDE EFFECTS AND IS RECOVERED.

chills, fever got up to 103.8, body aches all over, skin all over felt like a sunburn, nausea, vomiting, headache, fatigue, pale, clammy, chest tightness, tachycardia

chills, shaking uncontrollably then skin on fire, sensitive to touch, severe sweating, headache, pressure on chest. rapid heart beat, body aches

Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: called ems and blood surgar and vitals good. she felt better after about one hour and was able to go home.

Reporting a faulty syringe. Patient was poked on the left arm and immediately the vaccine started spilling out upon immunizing. No reactions reported from this site, except minimal injection site soreness after 15 minute waiting period. Patient was given a full dose later due to clinical judgement, patient did not receive the first immunization/dose. Patient was monitored over 15 minutes. Followed up with her and reported minimal soreness on arms.

Bad pain at injection site and swelling starting 1 hr later, and lasting over 1 week. Decr over time but lasting at least 10 days. bad rash all over body, worse on both arms, rash on upper legs as well with rash lasting at least 10 days. Peeling skin both arms, legs, moderate, lasting through day 6. Swelling in face, arms, legs, torso - Severe. Lasting at least 10 days. Dizziness, starting 2 hr, lasting at least 10 d. Weakness - start 2 hr. last at least 9 d

I have hard, hot and red where they vaccinated me My Dr. told me it is cellulitis but I have muscle spasm headache and the left side of my head is throbbing. And the area itches me.

Profuse sweating, light headed, hard to hear, almost fainted within minutes of receiving the shot. Was fanned, given orange juice and a cool towel. After 30 minutes I felt okay to leave the pharmacy. Felt lightheaded the rest of the day and really out of it. Developed a fever later that evening that ran throughout the night. Loss of appetite for 3-4 days. Diarrhea on day 4. Pain in arm at injection site for 4 days.

Ache in arm by injection site in addition to elbow, then wrist area. Pain escalated and got worse after the 1st day into the 6th day. Dull ache is still present after the 9th day. In addition, to ache in elbow and wrist occasionally. Also, got very dizzy on 4/12/21 around 9PM . Not sure if vaccine related. With dull ache around injection site continues.

Fever of 101.7; severe headache; body aches; chills/sweats; extreme fatigue; extreme pain at injection site - all developed within 5-6 hours of recieving vaccination. All syptoms lasted approximately 24 hours, causing missed work. (Used Tylenol to help with fever and pain) The second day, fever, body aches, chills/sweats subsided but extreme fatigue and arm pain lingered for the next 3-4 days.

Chills, fever, body ache, headache, sore at injection site. Lasted for several hours through the night. Better in the morning but lingering fatigue for 24 hours.

04/09/21 @ 2:07 PM - I started itching and tingling all over by body. Heated tingle feeling shooting down from injection site and across shoulder and neck to the right side. Rash on my back and lower back pain. 04/10/21 @ 4:30 AM - I woke up with a pounding headache, body ache to include muscles and joints, and nausea. This was off and on and subsided the morning of 04/13/21 04/10/21 - started have pain and cramps in my left calf and I am fatigue. Both which still continues as of now. 04/11/21 - stomach cramps and diarrhea I have taken Advil and Tylenol. I called the Health Department and doctors office. Was told to take Benedryl.

Normal adverse events right after initial injection: Headache, fever, chills Day 3: Tinnitus - ongoing Day 12: rash (looks like cigarette burns) in multiple locations- ONGOING. Currently one rash on each interior elbow, one on left ankle, one on left upper thigh, one on left glut. VERY itchy. Zyrtec and hydrocortisone being used as treatment.

I got the vaccine in my right arm and 8 minutes after getting vaccine I developed hives to my whole body and a scratchy throat. immediately was taken to my dr office and given benadryl

One week later, the injection site is still red. I have a hard lump at the site which is still painful. And I have tingling in my fingers and foot on my left side. That started immediately after the injection, but I thought that was normal and would go away after 1-2 days.

Immediate pain and tenderness at injection site. Numbness and tingling in right foot, moving up to right calf within 5 minutes. Numbness and tingling in left foot and leg as well within 10 minutes. Started to move to hands and arms and went to the ER. Tingling and numbness in face at 20 minutes. Treated with IV steroids and benedryl, no effect. Did bloodwork and showed hypocalcemia. They gave me an oral calcium supplement, tingling and numbness did not subside until next day. Intermittent tingling and numbness in legs continuing to present, 3 weeks post injection. Bloodwork by PCP on 3/30/21 showed normal calcium and protein levels but decreased GFR and low vitamin D despite regular supplementation of 6000 IU/day.

NODULE ON RIGHT SIDE OF THE NECK UNDER JAW; MILD RASH ON FACE; RASH ON LEFT UPPER ARM AT VACCINATION SITE THAT SPREADS TO ELBOW; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight was 179 pounds, and height was not reported. The patient's concurrent conditions included seafood allergies, alcohol user, and smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A,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 nodule on right side of the neck under jaw. On 06-APR-2021, the subject experienced mild rash on face. On 06-APR-2021, the subject experienced rash on left upper arm at vaccination site that spreads to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild rash on face, nodule on right side of the neck under jaw, and rash on left upper arm at vaccination site that spreads to elbow. This report was non-serious.

The evening of Sunday, March 28 (4 days after J&J vaccination) my skin began itching on my legs, feet and arms and was extremely itchy all through the night and into the next morning. On the morning of Monday, March 29, a red rash appeared on my legs and feet and arms. It would rise up in one area and then move to another area. I was itching uncontrollably and went to a clinic. I had never experienced any kind of skin condition or reaction like that before. The Nurse Practitioner guessed that it was some kind of allergic contact dermatitis, with the inciting irritant unknown, and gave me a prescription for Prednisone to take over two weeks. By the time I got home the rash and itching had moved to my back, chest and stomach. The itching and rash subsided after I took the first couple doses of Prednisone that day. I finished out the prescribed dosage over the following two weeks. I have not had any more rash or skin irritation since March 28-29.

Within 4 hours I experience chills, fatigue and a headache. Within 8 hours I had a fever and slept for the next 24 hours. I broke out in buckets of night sweats. The following 2 days I was generally fatigued and had sniffles. After that I was fine, until Monday night (Day 10). I suddenly experienced a sudden onset of a painful and raised red rash at the base of my spine on my lower back. Within hours it migrated up to my head, face and then to the front of my torso. My eyes and throat closed. I took benadryl with no relief. I called Dr. on Demand and they urged me if the symptoms got worse to head to urgent care/ER. The next day (Tuesday 4.13) I went to the ER where they gave me a steroid shot, and prescribed me predisone and Prilosec to block the histimines. I am still having rash symptoms,itchiness and burning. While I have a history of seasonal allergies they've always been stuffy nose at the most. We had no new dietary introductions or new habits.

I had the normal reactions fatigue, fever, and body aches within 8 hours of the vaccine. However on 4/12/21 I woke up feeling extremely itchy. I broke out in hives and whelps on the front of my neck and chest. It spread across my jaw as well by the end of the day. I was extremely hot and my skin felt like it was on fire. My head was extremely itchy. I took a Benadryl which did help the hives/whelps to clear a little after two doses bower I am still extremely itchy. I can?t stop itching. It?s everywhere to. Legs, arms, back head, shoulders...just everywhere, but no more hives. It is very frustrating. This doesn?t appear to be reported as a side effect and I?m very concerned.

Day 1 - Immediate small hives all over body for 1 hour, flush, fever, shaking, nausea, then hives lef. Day 1 evening - Fever 103, blurry eyes, severe headache, swollen tongue, severe pain all over, all major surgery sites spasming, vomit and diarrhea , hard to breath and blackout. Day 2 - Fever, eyes blurry, Blood pressure spike, headache severe, tongue swollen, severe hives, vomit, and diarrhea, cannot move body, pain increased tenfold Day 3 - Worse than day 2, hives are severe and can barely move body, Blood pressure spike, off to the ER. They admitted me and gave me different combos of steroids, pain killer, lorazepam, etc. to figure out the right combination to keep me steady. Day 4 - evening I was able to go on home care with the correct combination of medication. If my numbers don't stay steady I would have had to go back. During the rest of this time - Severe pain throughout body, fever, shortness of breath. The hives are now just my my skin flushing. Heat flashes. My fever has just gone down to normal degrees today. My Blood Pressure has gone from 175/111 back and forth to normal. My headache is still there and body pain. Hives are now just flushed skin. Swollen Lymph nodes in throat. No more vomit or diarrhea.

Pt called LPHA to report she was seen in the ER on 4/8/21 for a potential blood clot in her left leg. Pt reported she awoke from sleep late 4/7/21 early 4/8/21 with severe pain in her left leg. She reported it hurt so bad she was "screaming". She stated it felt like a "charley horse" and her husband noted a knot in her leg. She went to the ER on 4/8/21 due to the inability to put pressure on her leg and/or walk on her leg. She reports having a CT scan of her chest at the ER and no clots were noted. She stated they did not image her leg at that time and scheduled an ultrasound/doppler for around 4/27. She was prescribed some oral blood thinner, but could not recall the name. She stated she stopped the blood thinner on 4/12/21 after the new reports regarding the J & J vaccine and not using blood thinners to treat. Today she states her leg is purple, black and blue and is swelling more when she is up on it at work. RN instructed pt to call her primary provider regarding stopping the blood thinner and to see if re-evaluation of her leg is needed. Pt also instructed to seek emergency treatment for increased swelling or pain to her leg, headache, abdominal pain, shortness of breath or any other concerns. Pt plans to speak with or see her primary provider today.

Janssen COVID-19 Vaccine EUA My skin (on top and going deeper) felt tingly, prickly, sensitive all over my abdomen. This began the day after the vaccine (4/9). By the afternoon of 4/12, it was feeling more intense. That's when I realized I had a skin irritation on my lower back and stomach. I went to my doctor and it was diagnosed as shingles. My doctor said it was not caused by the vaccine but a stress reaction to the vaccine + normal stress in my life.

Immediate extreme pain in the injection site. Subsided slightly within the first 15 minutes. As the day went on, started feeling more soreness and headache. By 7 pm that night, I was extremely fatigued and nauseated. Pain very bad in my arm that night to where I could not sleep. Each day that has gone on, I have had worsening fatigue, headaches, and an increase in my heart rate, and a decrease in my blood pressure. I've had an increase in brain fog and an increase in sleep issues. The pain in my arm went away after 4 or 5 days.

At 8 hours post vaccination the following symptoms occurred: muscle pain and weakness, 104 fever, pain at injection site, shortness of breath, dizziness, vomiting, diarrhea, tacchycardia, fatigue headache, and profuse sweating. These symptoms continued for 4 days. Three days after vaccination pain in left calf started. Still continues to present day. Hot flashes started with fever have continued, and continue to present day. Hot flashes and night sweats cause to wake at night. Hot flashes continue 12 or more times each day.

SWOLLEN EYES; HIVES IN THE EYES; ITCHY EYES; FEELING JITTERY; CONGESTION; This spontaneous report received from a patient concerned a 43 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: D41A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feeling jittery. On APR-2021, the subject experienced congestion. On 10-APR-2021, the subject experienced itchy eyes. Treatment medications included: diphenhydramine hydrochloride. On 11-APR-2021, the subject experienced swollen eyes. On 11-APR-2021, the subject experienced hives in the eyes. Treatment medications included: diphenhydramine hydrochloride. On 12-APR-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy eyes, swollen eyes, and hives in the eyes on APR-2021, and had not recovered from feeling jittery, and congestion. This report was non-serious.

7 hours after: temperature spiked to 103 within the course of an hour. 8 hours after: chills so severe I considered seeking urgent care, wondering whether they were seizures. 12 hours after: felt some sort of mass move through my heart, wondered if it was a transient ischemic attack; but nothing followed. 7 days after: bridge of nose (only) turned red, almost burgundy, unusually/ strangely/ heavily flushed; woke up with unexplained headaches for 3 out of 4 days that week (and I never get headaches). 12 days after: nose flushing had faded; no more headaches; but routine exercise (even stairs) feels unusually/ markedly more difficult. 4 weeks later: gradually beginning to run/ jog again, slowly improving times/ getting back toward normal cardiopulmonary strength.

INJECTION SITE WARMTH; PAIN/UNABLE TO BEND THE NECK DUE TO PAIN; TIREDNESS/VERY TIRED; SORE/TERRIBLE SORE ON INJECTION SITE; INJECTION SITE SWOLLEN; This spontaneous report received from a consumer concerned a 43 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol use, and other pre-existing medical conditions included the patient had no known allergies and had no drug abuse or illicit drug usage. The patient was not pregnant at the time of vaccination. 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 06-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 injection site warmth. On 07-APR-2021, the subject experienced pain/unable to bend the neck due to pain. On 07-APR-2021, the subject experienced tiredness/very tired. On 07-APR-2021, the subject experienced sore/terrible sore on injection site. On 07-APR-2021, the subject experienced injection site swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness/very tired, and sore/terrible sore on injection site, and the outcome of pain/unable to bend the neck due to pain, injection site warmth and injection site swollen was not reported. This report was non-serious.

The night after I received the Johnson and Johnson vaccine I had 101.7 fever, chills, shaking. The next two days my hands got really dry and the skin peeled off them. 3 days later I fainted.

fatigue, chills, body aches, brain fog, difficulty concentrating, chest pains, earlier menstruation, pain at injection site into arm, back and chest. Sought treatment due to chest pains.

EXHAUSTION; PAIN IN ARM; SCABBY RASH/RASH ON BACK/UPPER AND LOWER ARM/LEG; ITCHY RED RASH ON BACK/UPPER AND LOWER ARM/LEG; This spontaneous report received from a consumer concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and tiny clot in lung. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced itchy red rash on back/upper and lower arm/leg. On APR-2021, the subject experienced scabby rash/rash on back/upper and lower arm/leg. On 09-APR-2021, the subject experienced pain in arm. On 10-APR-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from exhaustion on APR-2021, was recovering from scabby rash/rash on back/upper and lower arm/leg, and the outcome of pain in arm and itchy red rash on back/upper and lower arm/leg was not reported. This report was non-serious.

MINOR ITCHY ON INJECTION ARM; SORENESS ON INJECTION ARM; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A,expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced minor itchy on injection arm. On APR-2021, the subject experienced soreness on injection arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the minor itchy on injection arm and soreness on injection arm was not reported. This report was non-serious.

The night of the vaccine I woke up around 1am with chills and a lot of pain on the vaccine site I could not sleep that night. The next day when I tried to work I couldn't go down the stairs because my legs where hurting a lot. I also had a huge headache I couldn't eat I felt very nauseas. My worst symptoms were my headaches it was a sever headache. On 4/12/2021 & 4/13/2021 I had diarrhea. On 04/1 4/2021 I went to the ER they did blood work they did a heart exam everything came out good and they just said it was just a reaction to the vaccine. I kept drinking Tylenol for my headache. On 4/17/2021 is when I did not feel the headache anymore. Now I just feel very fatigue.

Day after Janssen vaccine: Patient called the Health Department on 4-9-21 at 11:45am to report that last night she reported that her face and lips were "hot" to touch, felt sunburnt, and when applying lotion it burns her face. I encouraged her to use cold compresses to face and if short of breath or swelling of tongue to immediately seek emergency medical attention. Encouraged her to reach out to PCP if rash symptoms worsen. Patient, presented to the ER on 4-16-21 due to rash to her neck, torso, and BUE and pain to her joints. The patient reported that she received the Janssen Vaccine 8 days ago and within 15 minutes of receiving it she became flushed and feeling unwell. The nurse at the vaccination clinic monitored her. The patient saw her PCP 4-15-21 and was started on Hydroxyzine q6. The patient states that she was feeling better, but now her symptoms are increasing with severity. The patient denies that she is currently on steroids and says she does better with liquid steroids. The patient BP was elevated on arrival at 171/107. The patient reports that her BP is high in clinical settings . She had a stress test by Dr that was normal and her PCP is going to have her monitor her BP at home before starting antihypertensives. No other complaints at this time.

I went to the ER Three weeks after the vaccine because had a lot of bruises. I got a few bruises at first on my thighs, inner thighs and ankles. The bruises usually lasted a week and a half. I was getting different bruises at different times on my legs. They were not painful but at night when I lay down my legs were a little numb.

Neuropathy flared up very painful in feet hands and breast ..Right arm has numbness on skin but painful under skin from hand to elbow ..what seems to react like tendonitis .

Nausea, diarrhea, headache, rash on chest, shortness of breath, loss of color in face, dizziness, light-headed, extreme fatigue (could not drive home from site), elevated blood pressure

full body pruritic rash, given prednisone 20mg QD x 5 days, improved by 50%, currently on Ranitidine & Cetirizine, referral given to Allergist

Pain in left arm still persists over a month later.. hard to lift anything.. causing twitching and tingling in my neck and left side of my face. Horrible Severe all-over-body itching three weeks after still persists and is getting worse as of today's date. No rash or any sign of reasoning. Went to an urgent care facility, ran a full CBC, all is healthy as normal-must be from vaccine. Suffering and losing consistent sleep from the itching rages that come and go.

officially one month later and still can not move my arm completely. Major pain. Numbness-sagging to left side of my face. Severe Pruritus all over my body. Urgent Care doctors ran all sorts of testing and can not explain nor help me.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: FAINTING LEAD TO SCRAPE ON FOREHEAD-Severe

I immediately felt sharp pain and burning in my arm while being injected. The burning in my arm lasted for about 20 minutes. I got a severe migraine about an hour after the vaccine that lasted for about ten hours. I broke out in hives all over my body later that night, the same day as the vaccine. I also had intense heartburn. I never get heartburn so this is not normal for me. The following day, I was still having hives and started also having chest pains. I was consistently taking antihistamines to keep the hives under control. On Saturday morning, 2 days after the vaccine, I was still breaking out in hives. My throat also started to swell and I was having a hard time breathing. My heartburn was also getting more severe. I ended up going to urgent care. There I was prescribed 2 stronger antihistamines and prednisone to help with my reaction. I was also given an epi pen. Later that night, I ended up going to the ER as I was having severe chest pain. I have a history of DVT so I was concerned about blood clots. I had several tests done along with a chest CT scan. Thankfully everything came back clear for blood clots and heart attack. The ER doctor could not explain why I was having chest pain and advised me to monitor it and to come back in if it got worse. The following day, I was still needing antihistamines for hives and difficulty breathing. I woke up in the middle of the night with severe stomach pain and cramping. I had intense vomiting and diarrhea. The diarrhea started to have a lot of blood in it. I went back urgent care and they sent me for a CT scan which showed I now had colitis. The bleeding lasted for about 3 days.

Severe pain where the shot was given. Unable to raise arm, unable to sleep on the left arm. 05/26 Fever of 101. 3 05/26 Skin sensitive to touch on whole body, restless body, upper back pain.

Systemic Allergic Reaction 20 minutes after injection. Felt it hit my spine, torso and head felt flush and hives started on torso. Had I not taken the Allegra D that morning and Famotidine 1 hour before the shot, I would have gotten hives all over my torso and face and swelling would have started in my face. I had an anaphylactic reaction but the histamine blocker and anti histamine kicked in after about 10-15minutes and I felt better. Had I not taken the medicine I would have ended up in the Emergency Room. That night I developed Oral Lichen Planus. This became extremely bad and uncomfortable for the next 48 hours. Then it started to heal. It fully went away after 6-7 days.

I have a lasting ache in my left arm and is the reason for the ER visit. The doctors looked at everything and said that I was fine.

Sudden nausea, overall larthagic feeling, very tired. Today, Sunday 5/30/21, symptoms returned strong. I am feeling very bad right now. Injection site stinging and arm very sore.

LEFT THUMB SWOLLEN; LEFT THUMB BRUISED; LEFT THUMB CHANGED TO BLACK COLOR; HEART RACING; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced left thumb swollen. On 07-APR-2021, the subject experienced left thumb bruised. On 07-APR-2021, the subject experienced left thumb changed to black color. On 07-APR-2021, the subject experienced heart racing. Laboratory data included: Diagnostic ultrasound (NR: not provided) Could not find anything, EKG (NR: not provided) Unknown, and Vital signs measurement (NR: not provided) Unknown. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left thumb swollen, left thumb bruised, and left thumb changed to black color on 10-APR-2021, and the outcome of heart racing was not reported. This report was non-serious.

Patient came to clinic yesterday, June 1, 2021. Stated she had a itchy rash to her arms, chest, abdomen, and inner thighs that started the night she received the COVID 19 J&J vaccine. She received the vaccine on 4/8/2021, but did not report the rash until yesterday. She had no other symptoms - No throat tightening, dysphagia, hives, SOB, chest pain, or flushing. On exam she has a dark pink/red, maculopapular, excoriated rash to both forearms, right side of abdomen, and inner thighs. Rash is resolving but has been there for 2 months. She had no PMH and is not taking any prescription or OTC medications.

I experienced very bad stingy in my arm for 5-10 minutes, sore to touch at the site for 2 weeks afterwards.

initial - 20 minutes after shot - 1 quick shot of vertigo but I was already in the car. Next day - headache, tired, low grade fever lasted 1 day. On March 30 & 31 I would have massive nausea. On 4/2 after dinner I started to have chest pain. This lasted into the night and I had cold sweats, nausea, vertigo and went to the ER. CTScan w/contrast was done, chest Xray, EKG was adnormal. Was admitted to the cardiac unit for observation. Was there 24 hours. On 4/4, I was still having the chest pain, went to another cardiologist where I had another EKG, Stress test, blood work. Everything looked good, couldn't figure out why I was having chest pain. Echo was scheduled. The night of 4/6 the vertigo increased drastically where I couldn't close my eyes and go to sleep, went to the dr on 4/7 and that is when it was thought that it was tied to the vaccine. Was put on meclazine for the vertigo as needed. It was then that the anxiety and depression started. By body broke out in Hives, was put on allergy medicine to help with those. Unexplained bruising was occurring on my legs. Was put on a Mediterranean diet which is supposed to help with inflammation. Stopped drinking caffeine and alcohol. The vertigo, anxiety and depression continues. I had an MRI of my brain to see if there was anything showing. Bloodwork was done. Started to experience breast pain, went to my dr, had a mammogram and ultrasound to see if anything was there. Lymph nodes are still swollen, have to go back in 6 weeks. Went to an ENT for the vertigo and he found some of the crystals in my ears, I've never had that before. On 4/29 I had a hair appt where 1 minute after she put the hair dye on my hair, I experienced more vertigo. Still experience the depression and anxiety, hoping that subsides very soon.

04/01/2021 I went to the Emergency Room and was diagnose with pneumonia, I then went back 2 more weeks in a row with symptoms not getting better. My chest stills hurt, headaches getting worse, body aches getting worse, rash, vision is blurry. My doctor has no clue why I'm still having these symptoms. I a 43 YO female that suffer from hEDS,

After shot I became very weak. All my joints hurt, even the joints in my fingers. I had a fever of 101 for 2 days. As those symptoms reduced, I came down with walking pneumonia &a rash has broken out on my stomach (rash is still active 2 weeks after shot)

The morning after the shot I began experiencing itchy neck, that turned really red with small rash, more like rough sand paper feeling. The itchiness and redness stayed for the rest of the day and night. The following morning I noticed the rash spreading to my chest. I went to doctor where I was given Zyrtec. This calmed the itchiness and the redness. I didn't feel any itchiness by the following morning. The rash went away as well, but the roughness of my skin is still partially there. I didn't have any other symptoms, or any reaction around the injection site.

ACHINESS; FEVER; TIREDNESS; ITCHY RASH ON FACE/NECK/RIGHT BELOW/NECK LINE AREA/ AROUND SHOULDERS /CHEST AREA.; This spontaneous report received from a patient via a company representative concerned a 43 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: 205AZIA and expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced itchy rash on face/neck/right below/neck line area/ around shoulders/chest area. On an unspecified date, the subject experienced achiness, fever, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, fever, and tiredness, and itchy rash on face/neck/right below/neck line area/ around shoulders/chest area. on 06-JUN-2021. This report was non-serious.

immediately upon injection she had intense pain at the injection site and brisk bleeding. When the tech applied pressure to the bleeding she nearly fainted due to the pain. She had burning pain down the arm and in the intervening weeks has progressive decreased range of motion suggestive of frozen shoulder

Patient stated that after waiting 15 minutes post injection and leaving, she began to experience throat closing while driving in her car. Patient voiced that she took Benadryl immediately and the reaction began to subside. The patient also stated that he woke up Saturday evening with a large sized knot on her arm where the vaccine was administered. Patient stated that it has since gone down in size but is still fairly large.

Extreme fatigue. Slept most of the time for two days. Got shot at 10:40 AM. Left Arm immediately felt odd---sore, heavy, tingly all the way down to my wrist. By noon, I was asleep. Slept for about 3 hours. Up for 3 hours. Slept for 3. Up for 3. Then slept all night. I had a headache and slept most of the next day. Definitely felt like my body was fighting something. I have an approximately 3 inch diameter circle around injection site that is a red, swollen, hard, lump, It is hot to the touch and extremely sore---at times it itches. I am shocked how big and hard the knot is. Its crazy! I cannot put weight on that arm. Extremely sore. It is now 4 days after the vaccine and the knot does not seem to be getting smaller. In fact, it may be bigger.

I suffered a fever from 3/10/21 at 2am until 3/12/21 at 11pm. 9n 3/13 at 7am I woke up with red blotches all over the tops of my feet and toes and my hair is falling out in clumps. I've also had migraines off and on and brain fog.

Strong and uncontrollable Shakiness by 8:30 PM. 38.5 degrees by 11:30 PM on March 5. Strong headache by the next day all morning till 11:00 AM. Fever around 37.5 degrees. On the afternoon started diarrhea and temp started going down till the 36.5 around 8:00 PM. On Sunday all the symptoms disappeared and started a light pain in the arm, like a hematoma, lasted two days, it was light and I was able to move the arm.

chills, fever, body aches and nausea all lasted 24 hours- tylenol and motrin to treat symptoms hives- lasted a few hours dizzy, headache and tired- lasted 48 hours tylenol and motrin to treat symptoms left arm soreness- lasted 5 days tylenol and motrin to treat symptoms enlarged lymph node left armpit- treated by dr...Doxycycline Hyclate 100 MG 2x a day for 7-10 days, warm compress and motrin to relieve pain. Day 3 of antibiotics starting to feel better.

injection site pain/soreness: immediately during dose until 5 days after tinnitus: 22-36 hr post dose nausea: 22-36 hr post dose joint aches: 22-36 hr post dose tiredness: 36-72 hr post dose low grade fever (99.5 - 100.5 F): 37-72 hr post dose delayed or skipped menstrual period

Dizziness, Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Palpitations, Tachycardia "skin feeling on fire", random pain that moved around body (ankle, knee, calf, hip neck) restlessness. left sided chest pain Narrative: Other Relevant History:

Following day, arm severely sore. 3 days after injection, spot turned red and warm. Hut if anything touched it. Lump and tenderness remaining almost 2 weeks after injection.

Throat tightening and racing pulse almost within one minute. Oral meds: Benadryl, famotidine 40, Zyrtec, and prednisone Developed hives day 5 after injection. Full body itching remains unresolved. Treated with eucerin and hydrocortisone topical cream. 2 visits to ER for iv steroids and normal saline fluids. Epi administered on second visit today 3/20/21 with good relief (best I?ve felt since getting it on Monday) 10/10 migraine today not relieved by oral triptans. Relieved by triple cocktail IV.

I started getting fatigued around 7:00 pm that evening. It was hard to finish walking my dog. I was getting the chills to the point that my teeth were chattering. I couldn't wear a shirt at this point because it felt like sandpaper on my back, but I did not have a rash. I went to bed earlier than normal and woke up around 11:30 with the worst headache of my life. My head was throbbing and pulsating and any little movement made it worse. The bottom of my head hurt, where my head connects to my neck. My lower back hurt. I woke up every 1 1/2 hours in pain, due to terrible headache. After suffering for several hours, I finally took some Aleve at 7:00 a.m. the morning following the vaccine.

Patient reports itching on left side of the body from head to ankle, no hives, no flushing. Cleared by EMS

High fever and severe chills/shaking. Terrible headache and nausea. Sensitive skin - discomfort when touched. Lower back pain. This lasted about 12 hours with headache lasting another 12 hours.

Small pink spot developed below injection site and over the course of 2-3 days the spot grew bigger and was warm to the touch. By Sunday, 3/21, it had started to bruise and turn purple in color. It was a little sore to the touch and was not a raised bump like a hive or welt, and it did not itch. It was flat, round, pinkish in color and grew about 2' in diameter and was warm to the touch. By Sunday and today it was not as sore, but was still the same size and bruised.

I exp redness, itchiness at the injection site. On Tues spoke with school nurse at my employer she put Hydocardizone and measured it to keep track of the sieze. As of 3/25 smaller in size and lighter in color,still exp tender now I'm applying Hydocardizone.

3/14 - Cold feet, headache at 3pm; by 6pm severe chills, nausea, throbbing headache, extreme fatigue 3/15 - 2am woke up drenched in sweat; tired all day; headache; pain and itching at injection site 3/16 - fatigue; pain and itching at injection site itching at injection site still has continued through today 3/25; also today a square rash has developed on my forearm of the arm I received the injection

I developed hives on approximately 50% of my body. Symptoms subsided after 2 Benadryl but have re-occurred on 3/26, around my ankles and on the tops of my feet.

Headache started 3 hours after vaccine was administered. Extreme fatigue, nausea, low grade fever (100.2), extremely sore arm and slight shortness of breath followed. Symptoms lasted 3 days (missed a day of work) and I still have a sore arm 9 days later. If my arm is bumped or touched at all still quite painful.

Reported tingling, numbness, tightness in jaw and redness to bilateral arms. Administered Benadryl 50mg po. Observed for 30minutes with improvement in symptoms. Vitals signs stable.

Patient reported injection site reactions such as pain, redness, and inflammation/swelling that became bigger with passing days since the time of injection 03/26/2021 up to the time when the patient came back to the pharmacy on 03/29/2021. Patient noticed a black line that appeared at the injection site as well as some evidence of bruising. Patient did not experience any fever.

Hives - itchy rash to arms and chest occurred within 5-6 minutes, gave 2 diphenhydramine 25mg tablets, patient denied any SOB. After 30 minutes she stated itch was less, but she was tired. Called HR to allow patient to go home for the day.

As soon as the shot was administered in the deltoid muscle within 3 seconds my axillary node was on fire and I couldn't put my arm at rest. Extremely painful in my armpit. The injection nurse said that is not normal and gave me a sheet to report to the CDC scan code. My entire left arm was on fire within a minute. She had me sit for 30 minutes. I had no other reaction. My arm was subsiding a little bit to toleration. I went home and rested, drank a ton of water. I went to bed and woke up at 2 am in a cold sweat, I felt like I was freezing and could not stop shaking. My teeth chattered. My husband put on many blankets and helped me get warm. He said I was burning up. My muscles were so weak and painful, joints hurt and extreme head ache. I took some Advil and he warmed me up. My left arm was numb up my left side of my neck and my left cheek. I took the day off work. In addition, in the morning I felt like my left leg and foot had minor numbness and prickles. I could walk but it was colder and prickled on the foot each step. The next day I was 50% better and made it to work barely. It took me 3 days to recover from the flu like symptoms. My left arm continued to feel numb and had bouts of prickles and tingling. The muscles were hard to use in my left arm and I really didn't use it at all. Over the course of 2 weeks things have improved. I still have not recovered feeling in my left pinky and ring finger. They are weaker still today. Every morning my left arm is numb for a little while (I don't sleep on my left side) but recovers to about 75% except my pinky and ring finger. My left neck and cheek have a warming prickle feeling every morning for about a half hour. They mostly wake up to entirety. My L foot at the bottom has period/episodic prickles. Daily my left arm is colder and is weaker than before. I am a high school teacher so I don't have to use my left arm very much but it is causing pain and negative sensations and is reducing the amount of use of my left arm.

At 1AM on 4/2/21 I had fever, muscle aches, and headache. All that day I was sick with fever, severe muscles aches, fatigue, and headache. On 4/3 I noticed pain in my right arm, a large knot/ swelling, redness, and itchiness.

At 12h post injection: muscle aches, fever, headache, thirst, unable to sleep, arm sore at injection site. From 12 to 28h post injection these symptoms persisted. At 28h post injection - took 500mg acetaminophen (only time it was taken). At 32h post injection - symptoms improved and slept 10 hours. At 42h post injection - fatigue and lack of stamina (weak and short of breath with exertion). At 48h post injection - some energy level returned At 66h post injection - still fatigue and sore arm

> Post-injection, whilst at the vaccine location, my left arm (site of the injection) felt slightly sore. The pharmacist requested a 15 minute time frame to check for any severe adverse reactions. The soreness was not deemed a severe adverse reaction. > In the evening, around approximately 6:30/6:45 pm, I noticed a slight headache. > Around 2:20/2:30 am, I awoke feeling nauseated and the headache had worsened. I was also experiencing a constant fluctuation of hot flashes / cold chills for several hours. This persisted into the morning, until approximately 8 am. > After lots of hydration, rest, and heachache medicine (Acetaminophen), I felt better; this was around approximately 11:45 am/12:00 pm.

I was fine for the first couple of days, then I developed hives, headache, fever, nausea, sore throat, fatigue, coughing and nasal drainage. My PCP put me on Prednisone and Augmentin.

12:16 shot. 12:30. 15 minutes after shot Heart racing, body tingling, light headed, dizzy. 2:30 same symptoms plus face tight, lips and tongue tingling , tongue swollen, body numb 3:30 same symptoms plus head is hot 4:30 same symptoms plus chest pains 24 hours after shot - most other symptoms are gone. Now fever 100 degrees and body aches, headache

A couple days I developed a rash on my chest which looked like a scarlet fever and over the next few days it spreaded to my lower extremeties, back and stomach area and within a few days it disappeared on its on

Next day Nausea then passing out resulting in large facial laceration (multiple stitches needed), neck injury and concussion

Within the first few minutes I had a flushed red face and pins and needle feeling on top of my head 6 hrs after shot I started with chills and a temp of 101.7 Achy and uncomfortable Insomnia Next day headache and no appetite Day three headache persisted with diarrhea and arm pain at injection site

THERE WAS IMMEDIATE SWELLING FOLLOWING THE INJECTION AND A LITTLE BLEEDING. WELT WAS ABOUT 1.5 INCHES IN DIAMETER AND COLD COMPRESS WAS APPLIED AND A DIPHENHYDRAMINE 25MG TABLET WAS TAKEN ORALLY. OBSERVATION WAS CHANGED TO 30 MIN AND CLIENT WAS ASKED TO REPORT ANY ITCHING OR FURTHER SWELLING. AT 3:50, STILL SWOLLEN AND DIAMETER WAS ABOUT 2 INCHES IN DIAMETER. AT 4:05, SWELLING DIMINISHED SLIGHTLY. AT 4:12, SWELLING CONTINED TO DIMINISH AND CLIENT DID NOT WANT TO CALL A DRIVER AND WAS RELEASED TO DRIVE HOME.

Janssen COVID-19 Vaccine EUA: Immediately after the vaccination my arm was sore and shortly after my right hand was stiff. About 8 hours after receiving the vaccination I began to have extreme chills and a fever that was near 102 F. I had a fever and chills all night and woke up with a migraine. After sleeping most the day from extreme tiredness I woke up to my head feeling very weird and I was acting very sleepy and irritable according to those around me. After 24 hours, most reactions have gone away except for soreness at the injection site and a pain in my right leg.

CLIENT REPORTED ADVERSE REACTION FOLLOWING COVID-19 VACCIANTION THAT WAS SIMILAR IN HER WORDS TO CELLULITIS. AREA AROUND INJECTION ISTE WAS RAISED, RED, HARD, WARM TO TOUCH, AREA MEASURED APPROX. 2"X2: AREA TURNED YELLOW AROUND SITE AND REACTED WTO SUNLIGHT BECOMING 'BLISTERY' TREATED WITH TRIPLE ANTIBIOTIC OINTMENT AND RESOLVED AFTER SEVERAL DAYS

Chills for about 6 hrs Fatigue/ muscle aches for 36hrs Mild Pain at injection site for 36hrs Symptoms went away with bed rest after 36hrs. No treatment required.

Sore arm at the injection sight that moved down the wrist about 6 hours after the injection then into the shoulder area about 12 hours after. 10 hours after injection a sever headache started like my head was put into a vice grip followed by a temperature of 101 and hot and cold sweats for the follow 18 hours accompanied by not being able to keep down water or a sip of 7-up - anytime a tried to eat or drink during the 28 hours I experienced symptoms it came back up with periods of dry heaving.

Tongue whiter than usual with a reddish round patch near back of tongue. A little raw feeling on the reddish patch but not much discomfort. I did not burn my tongue or anything out of ordinary other than shot. I don?t know if it started this evening, but I noticed as I was brushing my teeth before bed. Left arm also still tender at injection site.

Woke up at 2AM on April 12 with severe muscle aches throughout entire body and jaw. Worst pain was in my lower back and neck. Reflux symptoms at 4AM which caused me to take 2 OTC Gaviscon which gave relief. At 7AM experienced a fogginess and severe fatigue. Lack of appetite throughout the day. All symptoms continued throughout the day and that night. Next morning at 7AM muscle aches had subsided except for some aching at injection site. Took two ibuprofen for that pain. Felt foggy and fatigued through time of report at 1:22 PM April 13.

On the 8th of April I got my shot at 1:30 p.m. My my arm was sore immediately when the vaccine was put into my muscle. Around 5:30 p.m. I started feeling muscle aches, headache, and fatigue. Took my temperature and later on that night it was at started having chills around 8:30 p.m. severe muscle pain. It almost felt like there was pain in my bones. Still had a headache loss of appetite. Extreme fatigue. Took ibuprofen and went to bed. Got up the next day on the 9th took some more ibuprofen still loss of appetite, muscle aches, joint aches. Took my temperature had a temperature of 100.6 still cold in very fatigued. I slept a lot. Got my temperature down. On the 10th I still had muscle aches off and on, still fatigued had to rest a lot, injection site hurt, headache too. On the 11th off and on muscle aches, fatigue, loss of appetite, almost like my taste buds were off too. On the 12th less muscle aches ,small headache, still fatigued. On the 13th still fatigued.

I started having an annaphylaxis reaction a short time after i left. At first it was intense all over body itching that felt like it was from the inside out. By the time i got home i was getting red blotchy patches over my face, neck, and chest. I took benedryl which did nothing to subside the reaction. When my chest started feeling tight i went to the emergency room. My lips were itching and puffy. At the er i received treatment for annaphylaxis once and about a half hour to forty minutes before i was to be discharge i had a reoccurance of symptoms and was treated for it a second time and admitted to the hospital. This was from the March 31st clinic held at the fire department.

BODY ACHES; BRAIN FOG; ARM WAS EXTREMELY SORE FROM SHOULDER TO ELBOW; CHILLS; FEVER; CHEST PAIN; HEAD FELT HOT; RACING HEART; BODY TINGLING; LIGHTHEADED; LIP AND TONGUE TINGLING; LIP SWELLING; FACE FEELS TIGHT; WHOLE BODY NUMBNESS; TONGUE SWELLING; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 around 12:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced lip and tongue tingling. On 06-APR-2021, the subject experienced lip swelling. On 06-APR-2021, the subject experienced face feels tight. On 06-APR-2021, the subject experienced whole body numbness. On 06-APR-2021, the subject experienced tongue swelling. On 06-APR-2021 12:30, the subject experienced racing heart. On 06-APR-2021 12:30, the subject experienced body tingling. On 06-APR-2021 12:30, the subject experienced lightheaded. On 06-APR-2021 15:30, the subject experienced head felt hot. On 06-APR-2021 16:30, the subject experienced chest pain. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced brain fog. On 07-APR-2021, the subject experienced arm was extremely sore from shoulder to elbow. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) more than 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, body tingling, lightheaded, lip and tongue tingling, lip swelling, face feels tight, whole body numbness, head felt hot, chest pain, and tongue swelling on 06-APR-2021, and had not recovered from fever, body aches, chills, brain fog, and arm was extremely sore from shoulder to elbow. This report was non-serious. This case, from the same reporter is linked to 20210415021.

On 3/23, I received the vaccine. Within a few hours, my right elbow began to hurt and swell. On 3/24, I could not move my arm due to inflammation and intense pain. The skin was hot to touch. I also had a high fever and severe headache. (The fever broke within 24 hours and the headache lingered for about 48 hours.) On 3/25, the arm swelling started to decrease but was still intensely painful, red, and hot. I treated the arm with ice packs, Advil, and Bio-freeze. On 3/25, I also contacted my PCP by email with my concerns and progression photos of my arm. Another doc responded by having his nurse call me. They denied the reaction could be vaccine related. The nurse insisted on their diagnosis and that I should take antibiotics for a skin infection. I disagree because my symptoms did not match their explanation. On 3/31, I contacted my rheumatologist (due to the inflammation) and they referred me back to my PCP. I am filing this report b/c I believe this was related to the vaccine. Lesser symptoms remain.

on the day of vaccination: rash, redness of face and shoulders and neck, vomiting, extreme fatigue these symptoms continued for 48 hours then I started to feel better on 04/12 around 6pm I started feeling foggy, dizzy and felt like I was going to pass out. I called the neighbor for help. I couldn't communicate, my body was shaking, trembling, I stuttered as I was trying to form words. I was taken to hospital by ambulance. I was unable to speak, I was shaking and my blood pressure went up and down. I was given IV fluids and Ativan for anxiety, dysarthria and altered mental state. As of 04/14 I have memory loss, loss of taste and appetite, extreme fatigue

Janssen COVID-19 Vaccine EUA injection was on Saturday. Injection site became hot and very painful late Sunday. The pain has not decreased over these several days and radiates down to my thumb. Monday the site became raised and has a hard bump under the skin. Tuesday the raised hard bump has a slight peak similar to a mosquito bite and is becoming itchy. Today/Wednesday there has been no decrease in symptoms.

Peristent headache, pain in lower abdomen, tightness of skin in left leg, consistent fatigue, and brain fog. Loss of appetite.

Around 06:00 pm, which was about 9 hours after having received the J&J vaccine, I began having a slight fever and chills. The most pain I had was in the back of my legs. Both of my calves felt as if they had both been kicked and were badly bruised. It was painful to walk for about 48 hours/2 days (Sunday - Monday). That was the first time in my life that I had that kind of pain in my back calves. Never had before from running or walking. Then around 09:00 pm on Tuesday, a reddish dot appeared on the left side of my cheek. I thought it was just a big zit. But the following day, the dot got bigger, and looked like a scratch. On Wednesday, it was definitely a scratch-like shape (2 lines, less than an inch long) and had begun to feel itchy. That was when I had realized that it had the same pus-like dotted features of a cold sore. But oddly, it's not right next to either side of my lips. Instead, it is further down, towards the left side of my chin. It is very rare for me to get cold sores. I can't remember when my last one was, as it was years ago. So I am wondering if this cold sore is due to having received the vaccine. The fever, chills, and leg pain have not returned after those first 2 days.

My arm was immediately sore and was sore for a week. Within a few hours from the vaccine being administered I was tired, hands and feet very cold, chills, headache and a fever. This lasted for 3 days. I was and am still fatigued and it has been 2 weeks since my vaccine. On Friday, April 9, 2021 (8 days after vaccine) I woke up with a sore throat and a swollen gland in my neck on the right side (side of my injection). The sore throat and my swollen gland is starting to subside on Day 14. Throughout these whole 14 days I have had hot and cold "flashes" and while I already have anxiety my anxiety has been much worse (feeling of a pounding heart) since the vaccine. It is not my normal anxiety. On Day 11, Tuesday April 13, 2021 I woke up with a black spot on the right side of my chin closer to my bottom lip. It does not hurt, not raised and it is just a black spot. It is still there on Day 14 and slowly starting to fade but not by much.

Bruised for about 3 weeks, little bigger then half dollar, heat to touch, Painful to the touch, I still have a little lite inside bruise

Day 1 = Chills Day 2 = Body Aches and Fatigue Day 3 = Rash on the Right side of my Face & Left Lower Neck & Chin. I made an appt with my Dr. I went in for a visit and she diagnosed me with a Mild Case on the Shingles (and prescribed me two treatments for it). Further, my Dr. says that I am the 2nd patient she has treated for Shingles shortly after receiving the J & J vaccine.

Dry throat immediately. Sinus pain, ear pain, teeth pain, and neck pain increasing. Injection site pain

About 4 days after the vaccination, I developed a rash, first a large patch on my lower back, followed by other areas, including another large one on my upper left arm (the injection site) and many other smaller ones on my fingers, abdomen, leg, and arms. The rash was initially made up of small clusters of intensely itchy bumps, which would eventually redden and join together. The worst areas also swelled a bit and the skin started to feel dry and began peeling in places. The rash drove me crazy all day and woke me at night. I treated myself at home with o/c antihistamines, anti-itch creams (hydrocortisone, etc.), and ice packs for a week and a half; but the rash did not subside and was continuing to pop up in new places. I had my appt with the doctor on 04/7/21. Due to my allergy to medrol, I was not prescribed oral steroids. I was prescribed doxepin for pm (sleep and itching), o/c Allegra for am, and a steroid cream. The treatment has been effective and the affected skin is healing.

Patient received J&J vaccine 4/1/2021. After she had left arm pain. She continued to monitor, but her arm pain has persisted for the last two weeks. TTP of left deltoid. She now has a feeling of warm in her arm at times. And several days ago started to have tingling in first 2-3rd fingers.

On the day of the vaccine just a lot of heat in the body at night and sleeping hands. Severe legs pain and headache on 4/12/21 Started early in the morning but then disappeared.

patient complained of leg pain and swellin on the 14th of April and was admitted to Hospital on the 16th of April due to pain increasing in severity and affecting ability to ambulate. She later spiked a temp of 100.9. Left forefoot erythematous and warm to touch with large bulla over fourth metatarsal extending to webspace between 4th and 5th toes. Patient is currently in ICU, Intubated and unresponsive.

LOCAL PAIN; NECK, BACK, AND SHOULDER STIFFNESS; This spontaneous report received from a patient via a company representative concerned a 44 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 07-MAR-2021, the subject experienced local pain. On 07-MAR-2021, the subject experienced neck, back, and shoulder stiffness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from local pain, and neck, back, and shoulder stiffness on 09-MAR-2021. This report was non-serious.

NECK TIGHT/SORE; HEADACHE; FEVER; ITCHY; SHAKING ALL OVER; CHILLS; WEAKNESS; MUSCLE ACHE; This spontaneous report received from a patient. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 102 F. On 08-APR-2021 19:00, the subject experienced itchy. On 08-APR-2021 19:00, the subject experienced shaking all over. On 08-APR-2021 19:00, the subject experienced chills. On 08-APR-2021 19:00, the subject experienced weakness. On 08-APR-2021 20:30, the subject experienced fever. On 09-APR-2021, the subject experienced neck tight/sore. On 09-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy, and shaking all over on 09-APR-2021, was recovering from weakness, chills, and fever, and had not recovered from muscle ache, headache, and neck tight/sore. This report was non-serious.

Patient states that she received her Johnson and Johnson vaccine on 4/7. That night she started feeling fatigued, developed a headache, had some body aches and chills that lasted through the following day, then symptoms resolved. One week later on 4/14 she developed severe bilateral joint pain, specifically in bilateral shoulders, elbows, and knees- to the point where she could barely walk. She was also very fatigued and had chills. This lasted through the following day and started to subside, but then noticed small, papular lesions scattered across chest and arms. The lesions are itchy, small- 1-2 mm, and follow no particular pattern. She states that today her symptoms have overall improved other than the small itchy bumps. Denies any headache, abdominal pain, joint pain, fever, chest pain, shortness of breath, or redness/swelling of extremities.

Within 15 minutes of receiving my J&J vaccine, I experienced diarrhea. 12 hours later I ran a temperature of 37.5 and also had chills. On Sunday morning 04-11-2021, I had horribleheadaches and I took a Tylenol but it did not help. On Monday, Tuesday and Wednesday I again woke up with headaches and I felt extremely fatigued. I went to see my PCP who performed blood tests and also did a D-dimme test which the tests came back as being okay. I also experienced a full body rash and was having slight breathing issues. I also went to see an allergist on Monday 04-12-2021 due to my whole body rash, patchy skin, red and white bumps on my forehead. I was also concerned because at the inside of my mouth and upper pallet I had red bumps which lasted three days. I took me a whole week to recover from these symptoms.

Approximately 2 hours after the vaccination I felt very minor side effects (headache / soreness on injection site). The next morning I felt the more intense side effects (fever of 101.1, chills, fever, extreme sweat, loss of appetite, body aches and fatigue). While the majority of the side effects have passed I still have no appetite. I am a very healthy adult that does strength training 4x a week, I typically eat and snack every 3 hours. Since the vaccination day I have no desire to eat and I am down to 2 meals (breakfast and dinner). I am also experiencing headaches and dizziness but this could be from the lack of nutrients. Because I feel dizzy I am forcing myself to eat as I almost fainted during a morning workout and had shortness of breath. This particular morning I had coffee, a protein shake and a banana prior to my workout. I have not read or seen any additional information on the loss of appetite lasting this long and I am getting concerned

NIGHT SWEATS; SWEATS; LEG PAIN; FATIGUE; BODY ACHES; CHILLS; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced pain at the injection site. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced night sweats. On 10-APR-2021, the subject experienced sweats. On 10-APR-2021, the subject experienced leg pain. On 10-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at the injection site on 10-APR-2021, had not recovered from chills, body aches, leg pain, fatigue, and night sweats, and the outcome of sweats was not reported. This report was non-serious.

Fever: Starting 12 hours later, experienced strong chills followed by high fever of 102-103 during the night. Controllable with Advil during the day and most gone by 24 hours after the shot. Rash: By that morning, had a rash that worsened over the next day or two and lasted over a week. Was primarily on my neck, upper chest and right arm. Patches of small red bumps that were quite itchy. Took Benadryl that 2nd night, which provided some relief but not entirely. Tried Allegra 12-hour the following day, with limited relief. On Tuesday 4 days after the appointment, I went to see the doctor and she prescribed Triamcinolone Acetonide Ointment, 0.5%, which offered the best relief. Rash improved though persisted over a week.

TRANSIENT DIZZINESS AND LIGHT HEADED; STOMACH PAIN; SWOLLEN LEGS; LEG PAIN; MIGRAINES /MIGRAINE TYPE HEADACHE TOWARDS RIGHT EYE; HEAVY LEGS; RASH ON BOTH LEGS; DIARRHEA; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no medical history. The patient had 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: 042821A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced rash on both legs. On 06-APR-2021, the subject experienced migraines /migraine type headache towards right eye. On 06-APR-2021, the subject experienced heavy legs. On 12-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced swollen legs. On 12-APR-2021, the subject experienced leg pain. On 15-APR-2021, the subject experienced transient dizziness and light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraines /migraine type headache towards right eye, stomach pain, and swollen legs on APR-2021, had not recovered from rash on both legs, leg pain, transient dizziness and light headed, and heavy legs, and the outcome of diarrhea was not reported. This report was non-serious.

HIVES; FEVER; NAUSEA; COLD; BODY PARTS FELT BAD; This spontaneous report received from a patient concerned a 44 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: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced cold. On 09-APR-2021, the subject experienced body parts felt bad. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, and nausea, had not recovered from hives, and the outcome of fever and body parts felt bad was not reported. This report was non-serious.

Rash all over body and bruising that looks like clotting. I have pictures, went to see my doctor and he was dismissive and mean. I just want to know what?s wrong and how to make it go away.

Day of the shot: Muscle aches, fatigue and chills. The next day, I was feeling better. Day 3, I had migraine headache. Day four I was better. Day five, I broke out in a full body rash - Saturday evening. It started on the right arm and it spread all over my body. It lasted off and on for thirty-six hours. It migrated over my body. I went to the ER, and they said I was having a reaction to the vaccine. She prescribed me steroids, I didn't take them because I was hoping the rash would get better without them. I went to my Dr. the next day - by the time I did see my doctor the rash was getting better so she said I didn't have to take the steroids. I was taking Benadryl from the time the rash started and continued until it was gone. The rash ended on day 7. Once the rash went away, I had fatigue for four days.

Severe bruises on left upper, inner thigh and smaller bruising down the same leg. Bruising on right hand.

Within 24hours pt with fever, myalgia, chills, rigors, weakness and extreme dizziness with headache and episode of syncope. Had waves of flushing in body with central abdominal pain and redness and pale extremities. Abdominal pain "burning" recurrent for 6 days with diarrhea, nausea and vomiting and stools pale. In clinic 4/16/2021 pt appeared greenish/yellowish on day 6 and had weight loss from baseline 4lbs in 9 days when she was last seen. Pt labs done and normal. Night of 4/16/2021 started with palpitations racing heart. 4/17/2021 presented to ER for worsening palpitations with flushing and diaphoresis. Labs CXR normal. send home. Anxiety like symptoms fluctuating. Was given diazepam. 4/21/2021 seen in clinic again feeling slightly better. Still with nausea and also now dysgeusia. EKG normal. palpitations better. 4/23/2021 seen on video appt doing better. able to keep food down but still tired and weak. no longer needing diazepam. Taste improving.

Severe headache the day after injection, body aches, chills, dry mouth, fever, fatigue, dizziness, loss of taste, no appetite, quarter size bruise on L hip. Dr. advised that these are common vaccine side effects and could indicate possible viral exposure otherwise.

My first menstrual period following the vaccine was exceedingly heavy in flow for the first two days, which is atypical for me. Heavy clots of menstrual discharge were observed. It is not yet known whether these side effects will continue for my next menstrual cycle. Lesser effects followed two days after the vaccine with fatigue, sore arm, armpit, and glands in the injection arm. These side effects dissipated by day 3 status post vaccine administration.

The day I received the Janssen vaccine, I had pain at the injection site immediately, which was to be expected. My arm was very sore for over a week. I felt ill at dinnertime but was able to eat. Around 10:30 PM I started to feel like my skin was on fire. It was hot to the touch as well. However, I was freezing and couldn't get warm. My teeth were chattering. I started crying uncontrollably. I have never had tears run so hard down my face. The tears felt like they were burning my skin because my skin felt so hot. I awoke my husband to help me. He wanted to take me to the Emergency Room, but I wanted to wait. My muscles ached terribly. I had to pace back and forth because of the intense pain. My head also felt like it was going to blow off of my body. It wasn't like a normal headache. It felt like I had swelling in my brain. The left side of my head was sore for days afterwards. I then became terribly nauseated. I didn't throw up but felt like I was going to. I also felt extremely dehydrated. I was able to drink some water. It was a very long night. Looking back, I probably should have gone to the ER. My husband worked from home the next day so he could be available if needed. It took a long time for me to fully recover. I woke up exhausted and struggled with fatigue for a while and had extreme exhaustion in the evenings. My ears would turn bright red in the evenings and feel hot to the touch. I still have some fatigue now but am mostly better.

BOTH LOWER EAR LOBES BRUISED; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced both lower ear lobes bruised. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from both lower ear lobes bruised. 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.

Progressively worsening numbness near the injection site starting about 14 days after the injection. Numbness also 'shoots' down the arm and is sporadic. Also had severe stomach pain as well on April 11th with has subsided.

hives with itching starting on R elbow and spreading to R arm, left arm, shoulder. throat tightness. diarrhea x1. took Benadryl. seen in ED on 4/12/21 and noted to have rash on both arms and bilateral posterior shoulders. subsequently seen in clinic 4/13. patient reported that rash had resolved, but then returned a few hours later at lesser intensity. had resolved again by the time of visit. continued treatment with antihistamines. no further reports of rash/itching, etc.

ITCHINESS AT INJECTION SITE; INJECTION SITE ARM FEELS PAIN/SORE/HURTS; This spontaneous report received from a patient concerned a 44 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 was previously treated with nortriptyline for antidepressant, duloxetine for antidepressant, progesterone, and estradiol. 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 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-APR-2021, the subject experienced itchiness at injection site. On 27-APR-2021, the subject experienced injection site arm feels pain/sore/hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site arm feels pain/sore/hurts, and itchiness at injection site. This report was non-serious.

First 2 days: fever 101.5, whole left side pain, abdominal pain, headache, lower right leg pain 3rd day: low grade fever 100.5, lower right leg pain, left arm pain 4th day: lower right leg pain increased along with redness, swelling, red lines, and eventually I couldn't apply weight on my right leg. After visiting Urgent Care hospital, blood clots were found in my small veins.

A week after the vaccination I developed a mild case of shingles -- deep pain along upper back/between shoulder blades, along right shoulder, along right rib. It eventually ran up right side of neck. A few days later blister-like welts appeared along right shoulder/upper back and later right side neck. A lot of pain and burning along right shoulder and neck followed and continued for 3 weeks. Chills and headache also followed for 3-4 weeks. Slowly the blisters opened and crusted over.

pt developed b/l LE edema 1+ pitting edema roughly 2-3 weeks after getting covid vaccine cbc, cmp, trop, bnp were normal during ER visit 4/30 pt complained of "red dots" like rash at first but no petichial rash noted on exam

Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: not hungry, then very hungry but nauseous-Medium, Systemic: Nausea-Medium, Additional Details: Patient arrived to store to show a blister/rash that appeared to be from the bandaid as it was not directly by the injection site. She had made an appointment for store for Janssen/J&J vaccine. After talking to the patient, she thought she signed up for Pfizer, which my store does not carry.

Within 5 minutes, I felt like I couldn't swallow. My tongue got so big that it filled my entire mouth; throat closed. I started choking on my own spit. My hands got really big. I couldn't talk. The pharmacist told my friend to take me to the ER. I could kind of spit out stuff. She took me to Urgent Care. They gave me an epi-pen and instantly my tongue got small. Through an IV they gave me: Prednisone, Benadryl and fluids - by the time the IV was done I felt 90% okay. Four about 4 or 5 days - I would get fat fingers and itching. I would still have trouble swallowing - kind of choked when I swallowed. About 5 days after the event the allergy part was gone. I had three days of an oral steroid I was suppose to take and two weeks of Zyrtec. I did have flu-like symptoms also on the night of the vaccine. I had COVID in December 2020.

Neurological disorientation such as staggered motor function. It has been challenging to walk- extremely noticeable as if you are tipsy on new years eve - Headache in center of forehead that hasn't waned 24-48 hour period of visual abnormalities Extreme pain at injection site since shot and untol now although getting better Extreme Lethargy Shortness of Breath Plugged ears Congestion which went from clear mucus to bright green within an extreme short period of time Dr prescribed augmentin antibiotics ITS NOT COVID 19 I GOT A NEGATIVE TEST 5/5/2021 All over rolling from extreme to mild pains Muscle spasms in places all over the body. A part of my body is always twitching under the skin (not any jerking movements others report ) SEVERE CHEST PAIN Swollen arm at injection site A deep cough not severe and frequent but significant and persistent

Daily facial flushing. Hand and feet swelling turns red and hot, burning pain on body . Every day occurrence since 4/26/21

Gut pain started 2 weeks after my shot on Friday 4/23. I was admitted into the hospital for diverticulitis in which I have never had an episode prior. After 2 scans I still have the infection and have been on antibiotics for 3 weeks now. I also have significant joint pain on my right side which is the side the shot was administered on. My right knee and ankle are inflamed and in severe pain.

At day 9 after receiving the vaccination I started to have extremely itchy skin around mi mid area( thighs). At day 10, I was very dizzy/faint in the am. My eyes felt weird and The skin rash /itch was now at my thighs, hands and feet. In the pm my lips started to swell up and I noticed tiny red spots all around my stomach and back( lower and upper back). At that point i went to the ER.

4 hours after shot experienced extreme fatigue, achy body and headache. 8 hours after shot experienced green colored stool - still had green colored stool up to 36 hours after shot. Injection site still sore 3 days after shot.

6 days following the injection in the left deltoid, it became inflamed being that it is swollen, and warm to the touch. I got that deep down to the bones chill. In addition, my skin on my face, arms, abdomen and legs became hypersensitive, felt like it was burning.

DIZZINES, SYNCOPE WHILE SEATED, FELL INTO COFFE TABLE, RANDOM ABNORMAL BRUISING ON ABDOMINAL WALL AND LEGS.

So within ten minutes of receiving the vaccine, my chest area was completely covered in hives. It started off small and then covered my chest, I walked over to the nurses and they called the EMTs. They checked me and my throat to make sure it wasn't closing up. Within twenty minutes it started to go down (the redness). In an hour I had some tingling all over my body. I spoke with my PCD the day after the vaccine and then physically saw her. Now we are much after the vaccine and I see a neurologist suggested by my PCD, because I have random numbness in my fingertips and body and I also experience a lot of fatigue, very tired regularly. I also had a delayed menstrual cycle for about a week. I also felt cramping on my fingertips and toes.

cycle lasted for 12 days First 2 days was extremely heavy soreness at injection site and it felt numb headache and cough Unsure if the below information is related: I though I had Food poisonous severe cramping sweating

The vial used for this vaccination was opened for the first time on Thursday May 27th around 5 PM with an expiration time set for 6 hours after opening (11 PM on Thursday May 27th). The vial was accidentally not discarded at store closure and was placed back into the refrigerator. The next day Friday, May 28th the patient was administered a vaccine from the expired vial. The manufacturer was called for a recommendation. They stated administering the vaccination at the time period it was given was not studied and for the pharmacist to use their best clinical judgment. After consulting other pharmacists it was determined to not re-administer the dose, but to contact the patient and monitor for infection. The patient was contacted to be made aware of the event that had occurred and reported feeling "achey" with a slightly red injection site but no fever (05/30/21). The patient was advised to call back with the onset of any side effects, and has not called us to date.

Fever of 99.1, along with full body muscle aches on 4 June, treated with 800mg of ibuprofen. Fever of 99.6 along with some muscle aches in arms and legs on 5 June, treated with 800 mg of ibuprofen. Intermittent muscle spasms in arm/shoulder near injection, started early morning of 7 June, has not stopped yet (been 10 hours since it began)

Five hours after the vaccine I started to get chills. When I got home from work I was shivering and I had body aches and I felt really tired. I could barely walk and I felt stiffness and pain in my legs. I went right to bed and I was sweating. My skin was burning all over and I had headaches. I felt better after 24 hours but I was still a little tired. I started to get a rash which was on my right arm and my left and right chest. I went to clinic. The rash was raised red bumps that were very itchy. It covered my whole right arm. The rash got better after I started to use the Triamcinolone cream. I was given. I still have the rash on my arm and my chest after two weeks but it has improved.

Extreme inflammation (swelling, hot to the touch, rash) at injection site and extending four inches below the site.

KNOT FORMED AT INJECTION SITE; KNOT LOOKS BRUISED; SORENESS AT THE INJECTION SITE/KNOT FEELS SORE; This spontaneous report received from a patient concerned a 44 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: 1821286 expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced soreness at the injection site/knot feels sore. On 06-JUN-2021, the subject experienced knot formed at injection site. On 06-JUN-2021, the subject experienced knot looks bruised. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness at the injection site/knot feels sore, knot formed at injection site and knot looks bruised was not reported. This report was non-serious.

Vaccine was administered high and towards the back of the upper left arm. Retired, older lady was giving the shot, she didn't squeeze the arm muscle or check the arm for correct placement. Longer needle than was needed was used. Arm was relaxed during the entire duration of injection. As soon as the injection went in, deep pain was felt down to the wrist and mentioned to those administering the vaccine. They instructed me to move my arm as I left the area. I experienced immediate pain in the shoulder, never had arm muscle pain. Shoulder pain became excruciating over the next 2 weeks. Went to orthopedic walk-in clinic, they took x-rays and diagnosed me with impingement syndrome based off of my symptoms of pain and decreased range of motion. I started physical therapy April 26, 2021 and continue to present. Physical therapy has helped to increase range of motion and build some strength in the shoulder, but specific areas of pain (front and top/outside of shoulder area) continue to disrupt daily activities and interrupt sleep at night.

Patient starting having itching 15 minutes post vaccination, patient forewarned that this would happen as she has had this reaction with the flu shot and pneumonia shot. Patient had already discussed with doctor and he still recommended getting the COVID vaccine. Benadryl 50mg STAT was administered and patient waited another 15 minutes. She was feeling well other than the itching. Recommended that famotidine could also be administered to help with itching, and hydrocortisone cream if a particular spot was more bothersome than others.

Huge bruise formed on my shin after barely bumping into a chair at a dance event for my kids. A friend of mine who happens to be a nurse literally watched it form in real time within 30 seconds of barely grazing the chair. She was concerned with what she saw and wondered at the time if I might be anemic.

The varicose veins in my calves that I've had since my 20's started throbbing and aching. I wasn't that concerned at the time because they do that sometimes during my menstrual cycle. I did find it odd and was frustrated because my entire body, and then varicose veins just ached and I couldn't do my morning runs. The veins in my hands burned and throbbed when I took a leisurely walk around the neighborhood with my husband. I told him at the time it felt like even my skin hurt.

Soreness of arm severe for two days, severe cramping in legs followed by Lacey rash on both legs, severe headaches with heart palpitations, sitting heart rate at 140, felt like my heart was coming out of my chest. Chicken pox rash of chest

HIVES LOCATED ON RIGHT AND LEFT BUTT CHEEKS WERE MILD AND ITCHY; MILD CHILLS; MILD FATIGUE; TINNITUS; BODY JERKING; FELT LIKE SHE WAS FALLING; CLOGGED SINUS FELT SUPER CLOGGED IN BILATERAL EARS; BODY ACHES WERE MILD AND LOCATED IN THE NECK AND SHOULDERS MOSTLY; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 125 pounds, and height was 64 inches. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no history of known drug abuse/ illicit. patient is not taking any medications, reports that patient is healthy. patient is not pregnant at the time of vaccination. The patient experienced drug allergy when treated with azithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced body aches were mild and located in the neck and shoulders mostly. On 13-MAY-2021, the subject experienced tinnitus. On 13-MAY-2021, the subject experienced body jerking. On 13-MAY-2021, the subject experienced felt like she was falling. On 13-MAY-2021, the subject experienced clogged sinus felt super clogged in bilateral ears. On 13-MAY-2021, the subject experienced mild chills. On 13-MAY-2021, the subject experienced mild fatigue. On 14-MAY-2021, the subject experienced hives located on right and left butt cheeks were mild and itchy. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body jerking, and felt like she was falling on 08-JUN-2021, clogged sinus felt super clogged in bilateral ears on JUN-2021, body aches were mild and located in the neck and shoulders mostly on 25-MAY-2021, mild chills, and mild fatigue on 14-MAY-2021, and hives located on right and left butt cheeks were mild and itchy on 12-JUN-2021, and was recovering from tinnitus. This report was non-serious.

Immediately 10 minutes after receiving the vaccination, I started sweating really bad, I got a metal taste in my mouth. The next morning, I woke up with a huge migraine, couldn't concentrate, pain in my arm, and my whole body was just very hot. Over the next few months, I had developed swelling from my toes to my mid-calf, which went into my thigh the next week. It got to where I could no longer fit into my jeans. My whole body turned red. I went to the urgent care, which they immediately sent me to the ER. They did an ultrasound all over my body to test out blood clots, they took blood work. They ruled out having a heart attack and blood clots. They sent me home. A Few weeks later, I was at work and the pants I was wearing were cutting into my abdomen. I went to my PCP; I was so swollen head to toe. He put me on a steroid. PCP did blood work and everything is still going on and they still can't figure out why and having more symptoms on top of swelling. I have been on many different kinds of steroids. Had hallucinations, my PCP told me to go to the ER again. My breasts got super enlarged, the doctor I got at the ER still didn't figure anything out. They did a CT, Blood work, EKG, more ultrasounds. They then sent me to another ER, they did another CT, my brain was smaller than normal, my eyes were in the wrong place. To this day I am still experiencing all of these symptoms.

One month after vaccine was received, an allergic reaction began on 4/27/2021. Symptoms included swollen lips and mouth area, blistering and peeling of the skin on and around the mouth, pain and heat in the agitated areas. The symptoms appeared to be trigged by the use of a Chapstick with SPF but continued for 4 weeks after the initial response. A clean diet, OTC Zyrtec allergy medication in addition to a prescribed Anti-Inflammatory Montelukast prescribed for 4 weeks. A follow up is recommended once the medication regimen is complete and/or if additional symptoms appear.

March 30th at 1:00 fever 100.4, headache, backache, twitching muscles arms and legs, fatigue, sore hot arm, I still have twitching in my arms and legs, still pain in injection site along with what I call a burning sensation. Lower back pain. Some times numbness in fingers

Rash consisting of red bumps on arms, face, between breasts, and a little bit on legs and feet. Also a terrible migraine-type headache on the left side with an unusual (for me) ocular disturbance. The rash seemed to appear first on my left arm, and the rash was worse on my left side (left arm worse than right, left side of face more covered than right). I cannot say exactly when on Saturday I noticed it. The bumps on my face itched terribly. I took Benedryl at night, by Tuesday morning it began to fade. The migraine appeared at approximately 2 PM on Saturday, July 10. I took my usual migraine medication, Sumatriptan. The headache presented with a sudden blurring and sense of pressure in the left eye. This headache and change in vision also persisted until Tuesday morning, July 13.

Erythema Multiforme on both hands and arms. Red bumps run up to about mid-upper arm on both sides. Started Prednisone 10mg and Valacyvlovir 500mg on June 30th. Erythema Multiforme mostly resolved by July 8, 2021

Body feels heavy like lead Very tired Minimal pain at injection site 2:18pm hands twitching and my right eye feels like it's swollen and burning closer to my cheek and then started twitching uncontrollably. Very dry mouth. Moments later body tremors and vomiting. Ended up being taken to the emergency room will elaborate later. Drink Sprite on the way home vomited it up as soon as I walked in the door. Not the feeling of nausea just the vomiting is coming. Took temperature have a fever of 101.0 DAY 2 Tremors while walking Headache Body aches Minimal taste Tingling around eye No real desire to eat Managed to keep some noodles down Today is Day 3 5:00am Still unsteady on feet when walking Still have headache and body aches

Got vaccine at 5:36 pm and during waiting time afterward, she reported around 5;53 pm having generalized tingling then followed by generalized pruritis. Denied and did not exhibit signs of urticaria, angioedema, cough, dyspnea, wheezing, CP, abdominal pain, nausea, vomiting, abdominal pain, lightheadedness, weakness, pallor, tachycardia. Discussed giving her diphenhydramine and she agreed stating she had no previous adverse reaction to this treatment. At 5:56 pm, I gave diphenhydramine HCL 50 mg/ml 1 ml IM in her right deltoid muscle. Around the time of the injection (approximately 5:59 pm, pulse was 76, oxygen saturation 97%, BP 138/90, lungs clear, heart RRR. Within 20 minutes (6:22 pm) of diphenhydramine injection, she reported that the tingling had largely subsided (only remaining in lower legs) and her pruritis was improving. Her pulse was 77, oxygen saturation 96%, and BP 126/82 at that time. She also reported she had not developed any new symptoms (see above). By 6:28 pm, she reported no further tingling nor pruritis and feeling well. We released her at that time as we deemed her recovered from the symptoms. We advised her to call 9-1-1 if the symptoms returned especially with one or more of the above symptoms she had twice denied experiencing. 3/9/21 11:47 a.m. Called to check on status. No answer. Left message.

My injection was on a Monday at 1pm. I had no issues for about a day and a half. On Wednesday afternoon I started having itching and redness on my forearms and top of both hands. Both arms on Wednesday evening were swollen, quite red and sore (a bit of a burning sensation). It almost feels like a bad sunburn at times. I took an antihistamine to help with the itching and swelling and this morning actually put calamine lotion on my arms to help soothe the burning feeling. It is more irritating that painful and nothing needing medical attention but I thought it should be reported.

10 hrs afterwards I had the worst chills I have ever had for 2 hrs then my body was on fire for 2 hrs. I was drenched in sweat had to change my clothes twice and a severe headache. I felt some mild discomfort in my breathing and I was extremely thirsty. All of this lasted about 5 hrs

About 10 minutes after receiving the vaccine, patient reported feeling dizzy, nauseous, and had tingling of her left arm (vaccine was given to the right arm). At the time of event her BP was 142/75, HR 76 and RR 20. Patient was placed in a first aid room and after 15 minutes she reported she was feeling well. She was able to sit up and drink some water. After another 15 minutes she said she felt well enough to leave. She went home with her husband

A bumpy itchy rash started first in my arms and after in wrists and hands so i took 2mg of betamethasone and after 45 minutes another tablet of 1 mg. After 2,5 hours the rash calmed down on the upper part but it started on legs, tighs and foot. I was on fire and to have a bit of relief i put a wet cloth on the skin and i took another tablet of 1 mg of betamethasone and 1 of benadryl allergy. Around 11 pm the rash stopped and the skin became normal. I slept with no problem, but the next morning after 20 minutes I woke up the rash started again in all the body so I took 2 mg of betamethasone and 1 benadryl allergy. I went to the vaccination center but there wasn't any doctor, only a nurse that told me to keep on taking antisthamine and corticosteroids. It calmed down around 12 am and started again in the late afternoon.I took a benadryl, i used the wet cloth and around 10 pm stopped. Night with no problem, but around 9.30am the rash started again so i took 1 mg of betamethasone and 1 benadryl. Around 1 pm calmed down and at 2pm i took 2 benadryl. Around 8 pm i had some itchy spot on the legs but it didnt turn out in rash. Today after 30 minutes i woke up i had some spots on the legs, i took a benadryl and after 1 hour disappeared.

Sunday 3am night sweats, two days of heat rash with welting around my neck. three days of headaches and nausea, four days of brain fog, and eight days of fatigue and sleep issues

?Janssen COVID-19 Vaccine EUA? i Headache muscle aches and chills began at 2200 on day of vaccine, by midnight fever was brought down to 100.5 after taking 800mg ibuprofen. Slept ok, next day temp was 100.2 and headache, muscle aches, nausea continued throughout the day despite rest. Today Tuesday fever and headache are gone, mild muscle aches persist. Vaccine site is very sore.

I woke up nauseated and dizzy in the middle of the night. At 5 AM when I tried to get up for work, I couldn?t walk due to the dizziness and headache. I attempted to shower, but was so dizzy I had to go back to bed. I felt terrible all day - nausea, headache, dizziness, muscle aches, pain at the injection site, and severe fatigue.

Diarrhea, loose stools a few times a day w/o bloody/melenic stools. Nausea w/o vomiting. Urticarial rash.

On march 18 (Thursday)I woke up with fever and muscle pain. But 2 days later I already had fever and my arm were with a " red and hot bump" to much pain and iching..... I went to facility on Saturday at night because I was worst and the doctor told me to don't worry because It is normal when you got a shot but she never looked to my arm. she went into the room only to give me the diagnostic but without look to my arm. The diagnostic were: adverse reaction to vaccine. I already have the syntoms and tomorrow it will be 1 week since I got the vaccine. I don't know it is normal. If you want I have pictures.

Low grade 100.5 fever about 10 hours after vaccination. Fever went away over night. Broke out in hives all over body about 24 hours after vaccination. Have taken Benadryl twice, hives are going away.

About 6.5 hours after injection I started to feel achy, fatigues, and weak. Chills and joint ache started about 8 hours after injection along with fever. Migraine type headache with sever teeth pain/ache. This all lasted until about 3-4am when my fever broke. Highest temp 101. This morning (day after injection) I feel better but still fatigued and weak. Injection site arm still sore.

Patient reports redness, itchiness, and warmth at site of injection a week after vaccination. I told her to apply a cool compress to site, hydrocortisone, and/or take oral benadryl. I also recommended to see her prescriber if site doesn't resolve or worsens after a few days.

12 hours later minor fever an body aches that lasted 12 hours. 30 hours after injection developed extreme hives and welts from hives on top of my feet, both knees, ears and both butt cheeks

I have developed burning of the skin on my ears, nose, lips and chest. My skin peels creating sores with the burning sensation.

Immediately after injection - muscular pain at site and radiating throughout bicep and tricep of left arm Day of injection - 3 PM - slight headache Day of injection - 8:30 PM - chills and headache worsening Day of injection - 10:30 PM - fever of 100.5 and headache with nausea - took 650 mg of Tylenol Day after injection - 7:30 AM - fever finally down to 99.7 and headache with nausea - took 650 mg of Tylenol Day after injection - 6 PM - fever still at 99.5 headache lessened to the point nausea is gone - took 650 mg of Tylenol Day after injection - muscular pain at upper half of bicep and tricep of left arm 2 days after injection - muscular pain at upper half of bicep and tricep of left arm finally beginning to lessen

Patient had a tingling in the rt arm about 15 minutes after the shot. Pain and tingling started to go up her right arm after we had continued to moniter. Initial BP was 137/97, with no history of high BP, pulse was 81,, no breathing issues or swelling or redness. Pt. indicated she stopped feeling pain and just had the tingling. After the 30 minutes she sat with us her BP was 124/97. BP upon leaving was 119/100 before the associate left for the day and still complaining of the tingling but no redness or swelling.

I got the vaccine on Tuesday. That night, I had some slight aches and was warm, but nothing awful. The next day, I was just a bit warm. I exercised on Thursday morning because I felt better (stand up paddling). Then the rest of the day, I was very tired and then Friday and Saturday and Sunday, I was very dizzy, foggy, fatigued, no mental clarity, difficult to hold a conversation and answer questions, no focus. Today, Monday, I still feel like I have a brain fog and am talking very slowly. No focus. Conversations feel tiring.

Started having hives at random times on my wrists and forearms. One time each day Tue, Wed, Thur then Friday morning I woke up with my whole forearm on the arm I got the vaccine covered in hives. After an hour the other arm started having hives then on my stomach. After Benadryl it stopped. Sun morning at 5:00 am I woke up with hives covering from my elbow to my shoulder on the vaccinated arm. I took Benadryl immediately and it did not spread

I had burning with the actual injection. It burned as it went in and went down a small ways into my left arm. The rest of the day I had the normal symptoms- Pounding headache, nausea, horrible body aches (couldn?t lay down or stand to be comfortable). That night around 11:45pm I got up to let my dog in and I started seeing small black dots- blurry vision. I felt nauseas. I ended up falling on the floor. I was able to get up. I then ended up waking up in the bathroom on the floor and had no idea how I had gotten there. My hands were vibrating. I called my husband from work to come help me up. I was able to sleep and didn?t seek medical attention. I am not sure if it was low blood pressure or what could have happened I have never experienced that before. I did contact my doctor?s office this afternoon via (online) but haven?t had a response yet. I have been in bed all day today. - Body aches, nausea, pounding headache

9pm - 7 hours after receiving the shot I was extremely itchy all over and took Benadryl 2am- I woke up unable to move my arms, hands, legs, and feet. I wasn?t able to wake my husband and remained as calm as possible. I drifted in and out of sleep. By 4am I was able to wake my husband. He used our elevating bed to sit me up and gave me ibuprofen and water through a straw (not sure why that was his solution and just thankful I?m here today to type this response). By 6am I had terrible shooting pains in my hands, fingers and then Charlie horses in my feet and calves. That is when the ability to move came back. At that point I was extremely fatigued and exhausted and felt like I had a terrible flu. I was in bed for the next 6 hours clammy and sweaty and in a very achy. 24 hours after the vaccine I was back on my feet. 50 some hours after the vaccine I still have an aching in my hip on my left side and tenderness at the injection site.

Pain and soreness began at the injection site. These symptoms continued. Then burning sensations up and down arm began. It's been over a month and the injection site is numb to the touch, while the surrounding area burns, tingles and is soar to the touch. If I move my arm a certain way, I will get a tingling shock in the area (feels like hitting funny bone). Muscles up and down arm burn after non-strenuous activity.

Within 4 hours post-shot: injection site pain, swelling Approximately 16 hours post-vaccination: moderate muscle aches, headache, tiredness lasting almost 36 hours Approximately 24 hours post-vaccination: low-grade fever 100.8 (treated with tylenol) Approximately 36 hours post-vaccination: sore throat lasting for more than 24 hours (on-going as of this report) Approximately 48 hours post-vaccination: fever 101.7 (treated with tylenol) This report is being made at 67 hours post-vaccination, and at this time I'm still experiencing the sore throat and mild tiredness.

Visited ER as I thought I was having an allergic reaction. Treated with Pepcid, prescribed prednisone and streeted. Visited personal allergy physician 4/9/21. per MD Allergist/Immunologist DXd = systemic immunological vasculitis. Most probably a delayed hyper immune response to my vaccine. Legs, arms and sides covered in innumerable petechial eruptions beginning 6 days post vaccination and 3 days post vaccination side effects (chills, headache nausea) subsided. Eruptions spread consistently for 36 hours and are constant not intermittent. They are hot, painful to the touch, and do not blanch. I?m on 60mgs of prednisone for 5 days (the highest dose given outside a hospital) and then 40 for 5 days and then 20 for 4 days. If I get any mouth nose or eye or interior genital irritation I have to go to the hospital and be admitted for higher dose steroids and constant monitoring. Dr advised this will take weeks to resolve and the eruptions will likely fade slowly and possibly peel.

SOB and chest tightness about 10 minutes after injection and a sharp pain that radiated down my arm starting at the injection site. Took Pepcid 20 mg and symptoms subsided after 10-15 minutes. A few hours later began to vomit, which subsided quickly. The nest day had body aches which only lasted 1 day.

Face, beginning with upper lip and eventually all of face numbness, started about 45 minutes after receiving the vaccine and lasted about 15 minutes. Cheeks felt swollen, like a chipmunk, but no real difficulty breathing, very minor if at all. Facial numbness returned about 8:45pm, less noticeable than before, Random itchy spots on arms, scalp, and face, but no noticeable hives. Taking Allegra

Vaginal spotting 24 hours after vaccination , on 4-9-2021 Headache, arm soreness noted 48 hours after vaccination, lasting ~ 24 hours , noted 4-10-2021 Bruise at site of injection noted on 4-12?may have been present prior to this date but went unnoticed

Almost immediately pain at injection site, tingling down arm and through fingers, dizziness and nausea. Within 5 hours progressed to fever, extreme body pain, headache, dizziness shakiness and feelings of doom.

Janssen COVID-19 Vaccine EUA: During the post-observation period, vaccine recipient developed pruritus, fine raised rash on face, itchy throat, swollen under left eye. She was treated with diphenhydramine by EMS. She was monitored for additional 45 minutes. Then she continued to have itchy throat and felt that throat was swelling. She was transported to the emergency department.

4 afters after - severe chest pain that lasted for 2 hours. 12 hours after, face swelling - started on left cheek/lip and migrated across face. Resolved after 24 hours. Continuing random hives. High fever - 102.5, and all the other effects that are more common.

Injection site arms feeling heavy & painful for approx 45min. Fast heart beat & palpitation more than 1 hr. Redness of my face last for approx hour & half. Feeling tired for two days. On my second week, having pain in my lower left abdomen. Severely painful 1st of April check in to ER Chet pain & elevated high blood pressure Check in Urgent care

Janssen COVID-19 Vaccine On 4/12 I started having a lot of pain overnight, especially the left side of my body. My left hip is hurting really bad, my left arm sometimes hurts. My back is also now hurting. Nothing I take alleviates the pain, I have tried Aleve, Tylenol and Ibuprofen. I am extremely fatigued both day and night now. My bones feel very painful even sometimes down to my feet. While most of my body hurts, the left side seems to hurt more than my right side. When I got the vaccine I felt very "out of body" if that makes any sense, but now I feel very off. I also seem to be bruising easier than I used to before as well.

Within 8 hours post-vaccination: pain, tenderness, and swelling at injection site and pins and needles sensation in lower arm and hand of arm injected (largely resolved by 7 days post vaccination) Within 18 hours post-vaccination: significant headache, exhaustion, fever, body aches, and full body itchiness (largely resolved within 3 days) Within 48 hours post-vaccination: headache, significant itchiness and skin burning sensation over most of body but especially arms, hands, lower legs, neck, stomach, and back (largely resolved by 7 days post-vaccination but persisting less intently in multiple locations) Within 5 days post-vaccination: painful swelling on back of right leg near groin area (unresolved) Within 7 days post-vaccination: dizziness and headache ( lasted approximately 30 minutes and resolved with hydration and food)

Several headaches and swollen, red, hot, itchy, huge bump since injection (March 26 - today). Contact physician Friday, April 9, 2021. She prescribed Medrol dose pack and antihistamine (Benedryl). Hot and redness subsided. Now black, itchy patch and severe headaches.

Patient had a fever for 8 hours post-vaccine on 04/10/2021. On 04/11/2021, patient states fever resolved but then developed swelling around lips, "goose-egg lump on forehead", around 9AM. Swelling has moved from lips to jawline and still present on 04/13/2021. Patient reports having a "chicken pox like rash" on arms, "welt-like spot" on left inner wrist and ankle, and also had itchiness. Patient took cold-medicine hoping that would help with swelling. Patient states rash and welts have disappeared as of 04/13/2021. Patient advised to contact healthcare provider and consider taking Benadryl/antihistamine.

worse headache, neck pain, bodyache, chills, sweats, jaw pain, nausea, upper body rash, dizziness, lightheaded, insomnia,

By 10 pm Saturday- severe joint/body aches, chills, headache ,exhaustion , pounding headache. Sleepy from 4pm Sat til 11:30 sun am Showered on Mon evening, Notice rash on injected arm Tues woke 630am feeling bit better then got exteremely dizzy 830am to the point I was stumbling cause it affected my vision. Became nauseous and had a severe headache Called doctor

Posterior leg bilateral pain (at knees) , sweats, dizziness, sleepiness, lethargic, was unable to go to work, lobe, headache pain in center of head cramps to frontal , vision distortion, anxiety attack, body aches, pain/burning to to appendix area, right leg pain., constipation -loose burning diarrhea (4/13/21) reddish light brown in color, joint pain arm pain collar bone/shoulder, mucous, drink cool water pain to the chest-0wall noted, air bubbles coming up in throat , upper neck, back spasms

Fever at 100, massive headache, crucial body aches, fatigue for 5 days and still not able to go to work. Dizziness and nausea.. the appearance of a clot between my neck and shoulder..

Blistering, itching, and redness appeared on upper left chest area. Kept the area clean and applied vitamin E. Blistering, itching, and redness healed and went away after about a week.

I received the vaccine at approx 930 am, Wed, March 17 (Johnson and Johnson Lot 1805020) at the Facility by Fireman(Emergency Responders). Vaccine was from Health Care. At first, after about 15 minutes I was feeling a little flush, there were light red splotches on my skin (only a couple, very light red - like when i get really nervous and get red splotches on my neck.) I felt a little nauseous and dizzy off an on for about an hour (but i had not had anything to eat or drink yet that day either). The site of the shot was a little sore and warm about an inch or two away from the needle injection site, but not a big deal. That night my right arm (which is where i received the shot) ached terribly, all the way from my shoulder to my fingers. The next day (Thursday, March 18) was the same. Sometimes my left arm tingled like it was starting to fall asleep. This went on the whole next day. Injection site still sore too, and warm. The day after that (Friday, March 19) the injection site was sore (like a sore muscle) and that was it. Saturday, March 20, the same until about midnight. Around midnight my son, and I came upstairs from watching tv and my arm (at my wrist) was aching intensly! I looked down and there was a small lump where one if the veins are. I can see my veins easily here and I am very light-skinned. Son could also see the lump. My arm kept aching so badly! I was messaging the lump over and over. After about 5-10 minutes it went down a little bit, ached a little less, and i left it alone. The next day it looked like i had a bruise on my wrist and hand (where the meaty part of your hand is going to the thumb. The next day, Sunday, March 20th, a neighbor said it could be a blood clot and i took an aspirin. Today, Wednesday, April 14, 2021. Approx 1130am, after getting out of bed, getting some coffee. I was sitting at my desk in my home office, took my medication and took my first sip of coffee. All of a sudden, my chest starting hurting. I cant say where the pain originated, it was in the chest/upper stomach area. It ached a lot, I felt very flush, I honestly cant remember if it were hard to breath, all i could think is "what is this?". I didn't know if i would throw up, burp, pass out. the aches starting migrating, still saying in the chest, but expanding to my lower back. I got out of my chair and tried to move around...it took a good 3-5 minutes before it started to dissipate and I took another aspirin.

DAY 1- two hours after vaccine my right arm and right leg felt restricted, numb and had some tingling in my hand, dull headche, muscle pain and dizziness. Day 2- mild pain at injection sight, muscle pain and general tirednes, dull headache,dizzy, right arm& left arm felt restricted and numbness in right pointer finger. Right leg felt restricted and pain behind the knee. Day 3- dizzy, dull headache, faint, high blood pressure, right arm & leg and left arm felt restricted and numbness/tingling in right hand. Pain behind right knee persisted. Went to ER Sunday early afternoon. Diagnosis is a cerebral venous thrombosis in sinus cavity. Still experiencing general weakness/tired, dizzy/unbalanced.

sever headache. Fevr. Shivering. Dizziness. Body ach. Muscle pain. Joints pain.swelling in the shot area..extreme fatigue.

Still 2 weeks and pain at injection site. Cannot sleep on that arm as it hurts like a muscle was torn

Starting at approx 2100: Severe headache, fever, chills, body sweats, full body ache, bruising at site of injection

Hives and welts not controlled with Benadryl Cream or oral tabs. Went to ER as spread was significant and had IV solumedrol. Hives led up. Within an hour of discharge they started coming back and were not controlled with Benadryl still. Hives were apprearing in new locations and spreading rapidly again. Went back to ER for further treatment.

The first side effect I noticed was hives on the arm of the injection site as well as the arm being painful. I became light headed and very tired after the first hour of getting the vaccine. As the evening progressed I begin to get chills and a fever. My body ached from head to toe. I was nauseous and achy all over. I was feeling sick for the next 24 hours, I stayed in bed and could barley move because my body ached so bad. I had a extreme head ache as well. By the 3rd day I felt much better and only had pain in the arm of the injection site. After day 10 I noticed a lump near my collar bone and assumed based on web searching that it may be a swollen lymph node. It's day 12 and I still have a little tenderness near the injection site and my lymph node is still swollen.

Severe R shoulder/arm pain since injection. Upon receiveing the injection I experienced severe pain in my R shoulder joint, but the nurse told me that was normal. Over the following hours/days/weeks the pain began to radiate up my neck, down my arm and into my scapula and lat areas. My range of motion (ROM) had become severely limited and I began to experience neuropathies in my right arm and hand. I tried all OTC pain relievers which had absolutely no effect. On April 6th, I was in so much pain that I went to an urgent care clinic. They provided me with prednisone, soma and celebrex (upon completion of steroid). In addition, I started myself on gabapentin which was provided in the past. I have one more day of celebrex remaining. While my symptoms are not nearly as bad as they were, they have not resolved. I continue to have pain in/around my R shoulder, neuropathy in my R arm and limited ROM/weakness cross-body and above 90 degrees.

I had a deep purple bruise the size of a quarter on my right arm a few days after taking the Janssen vaccine. I did not injure myself or bump into my right arm so I was baffled about how I got the bruise. I also experienced weird sensations in the muscle of my left calf on two occasions a few days within my vaccine. They felt like muscle contractions and the muscles quivered and I thought I was getting a charlie horse, but they were not painful or unbearable. The quivering lasted about 10-30 seconds. I've never had any sensation like this in my calf before. All of this coincided with me hearing news about the blood clots and deaths associated with the J&J vaccine shortly after I took the jab. Initially, I brushed it off and talked myself out of any connection between the vaccine and my symptoms. I was talking with family & friends recently and they suggested I report my symptoms so that's I why I'm reporting now 11 days after my vaccine.

Not too many adverse symptoms the day of and after vaccine... tired at times and sensitivity to light but continued to eat and helped w energy. Also, warm left side of neck and slight red rash. Not expecting to have leg pain in my calf 6 days later then moved to quad muscle and entire left leg felt achy. CDC at this point said to check out any leg pain. Pain was not severe but bothersome... had STAT ultra sound at ER on day 7, turned out negative for blood clots. Returned to my physicians office day 8... still not feeling right with more of a rash on left side of neck and warm to the touch. Tired and slightly light headed and slight pain in left upper chest. Digestion not the best starting day 5 thru 10. Blood test returned normal for platelet levels but low eosinophils... either allergies or body is fighting the vaccine and creating antibodies (most likely). No known allergies besides maybe skin reaction to Timothy Bluegrass. Moderate headache day 9 and 10 which made me more fatigued (pain on both sides of head above ears and temples)... normally I do not get headaches. Also, loss of appetite or feeling slight nauseous on day 8, 9, and 10 after the vaccine. Now on day 11 and 12.. feeling better but still not quite right. Lightheaded and feeling fullness in head but more energy than day 9 and 10 by far. Never heard of people having symptoms after day 1 or 2 of the vaccine, so obviously I think this should be more documented for patients especially after blood clotting as a possibility 6 days after the vaccine.

The patient received the vaccine on April 7, 2021. Almost immediately after the vaccine, the patient developed some nonspecific complaints of headache, myalgias, arthralgias, fever and chills. The symptoms lasted for several days and then seemed to resolve. She was then at her baseline until approximately April 15, 2021 when she noted that she was becoming bruised. She had multiple ecchymoses on her lower extremities and this has never happened to her before. She apparently began taking aspirin at that time. According to the patient, she took 325 mg of aspirin on April 15th, 16th, and 17th. She did not take any aspirin on April 18th but then on April 19th, she took 650 mg of aspirin. On April 19, she had a telehealth visit. They recommended that she go to an urgent care. She went to an urgent care on the afternoon of April 19. They told her that they were ill equipped to take care of her and then sent her to the emergency department. On arrival in the ED on 04/20/21 she was afebrile. O2 saturation was 99% on room air. Her other vital signs were unremarkable. Her initial laboratory studies were notable for white count of 6.6 with a hemoglobin 15.2. Her initial platelet count was 5,000. Initial chemistry panel was completely unremarkable. She was not having any headache, dizziness, nausea, vomiting, blurred vision or any neurologic symptoms. She thinks that her lower extremities are swollen. She was not having any myalgias or arthralgias. Not having any abdominal pain, nausea vomiting, diarrhea, dysuria, urgency, frequency. . The patient has no other specific complaints.The patient was admitted on 04/20/21.

RIGHT EYE CLEAR LIQUID SECRETION; RIGHT EYE WAS SWOLLEN SHUT; ARM SORENESS; REDNESS OF FACE; SWEATING; This spontaneous report received from a patient concerned a 45 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: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced redness of face. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced arm soreness. On 12-APR-2021, the subject experienced right eye clear liquid secretion. On 12-APR-2021, the subject experienced right eye was swollen shut. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right eye clear liquid secretion, and right eye was swollen shut on 12-APR-2021, and redness of face, and sweating on 11-APR-2021, and was recovering from arm soreness. 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.

Swelling in the face, particularly on the right side cheek close to the nose Painful to touch 10 day course of antibiotics Swelling disappeared after 6 days on the antibiotics

ALLERGIC REACTION; SWOLLEN EYELID; VERTIGO; RASH ON NECK; NAUSEA; EYES PUFFY; ITCHY EYES; EAR CLOGGED; EARACHE; RINGING IN EAR; SLEEPY; TIRED; HEADACHE; This spontaneous report received from a patient via Social media concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and pneumonia, and concurrent conditions included asthma, and high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNNOWN) dose was not reported, administered on 08-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced sleepy. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced tired. On 21-MAR-2021, the subject experienced earache. On 21-MAR-2021, the subject experienced ringing in ear. On APR-2021, the subject experienced ear clogged. On 05-APR-2021, the subject experienced eyes puffy. On 05-APR-2021, the subject experienced itchy eyes. On 12-APR-2021, the subject experienced swollen eyelid. On 12-APR-2021, the subject experienced vertigo. On 12-APR-2021, the subject experienced rash on neck. On 12-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced allergic reaction. Treatment medications (dates unspecified) included: triamcinolone, ibuprofen, ciprofloxacin/dexamethasone, azithromycin, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing in ear, was recovering from earache, and nausea, had not recovered from, swollen eyelid, rash on neck, tired, and headache, and the outcome of vertigo, eyes puffy, allergic reaction, sleepy, ear clogged and itchy eyes was not reported. This report was non-serious.

DVT left leg requiring surgical procedure 04/13/2021. Went to ED on 4/12/2021 with severe leg pain, warmth of area.

No flu symptoms but experienced a lot of pain in the arm injection was given. It has been two weeks since the injection and I have a hard lump under the injection site and it is still tender to the touch. My parents received the injection the same day and neither of them have this issue. I have not seen anyone about this yet as I don't know if this is serious or not, I just keep waiting for it to go away.

I experienced 4 hours later, I developed chills. 04-09-2021, started to have muscle cramping, chills, cramps in the palms of my hands and feet. I stayed in bed and drank OJ, multi vitamins. On 04-10-2021, started to feel bit better, chills went away, still had muscle body aches, cramping in my hands and by Sunday I noticed an aching sensation from my left shoulder to my left elbow, itchiness and also started to experience an aching, itchiness sensation on my back down the back of my leg and calf. I then made an appt with my provider to get evaluated. I had lab work done to check my platelets and a follow up was given to me that all was normal. After a few days, my symptoms got better, I have no symptoms today only a headache and muscle cramping to my shoulder areas these last couple of days.

reported feeling itching, abdominal pain, unusual swelling ( inside mouth upper lip and left side of face), swelling of throat, pain on soles of feet and swelling hands on 4/19, she took an antihistamine and symptoms lessened and went away

I had nausea and generalized malaise, body aches and pretty intense swelling about 6 inches, distal at the vaccination site. I put ice, massaged it and tried to break it up. I talked to my doctor who recommended me to apply light pressure massage. These symptoms lasted for 1-2 days. My left arm is still sore but doing better. I feel anxious due to the side effects the J&J vaccine is having. I do not have the lot # with me at the moment.

INJECTION SITE ITCHY; CHILLS; PAIN/SORENESS IN LEFT ARM AFTER SHORT; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, thyroid problems, and seasonal allergies. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure, and levothyroxine sodium for thyroid problems. On 11-APR-2021, the subject experienced pain/soreness in left arm after short. On 12-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced injection site itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain/soreness in left arm after short, and the outcome of chills and injection site itchy was not reported. This report was non-serious.

DULL PAIN/BURN AT REST; SHARP PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced dull pain/burn at rest. On 07-APR-2021, the subject experienced sharp pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pain in left arm, and dull pain/burn at rest. This report was non-serious.

Dizziness, lightheaded at 12:30 pm, to the point of losing balance. Itchy arm at site of injection. Itchy bumps on arm for days/weeks after at site of injection. Extreme bone and joint pain at 1:00 am following the injection, that lasted for the next few days on and off. Dizzy spells continue sporadically to this date, on and off.

Vertigo, body aches, headache first 2-3 days. Then a few days later major fatigue set in, chest pain, mouth breaking out in canker sores randomly, broke out in hives, rashes on my legs and arms, skin hurts to touch, dizzy, loss of balance, difficulty sleeping, night sweats, blurred vision, double vision this is probably the worst of all the symptoms, I lost my taste for 5 weeks. I have taken anti-viral homeopathic drops because it really felt like I was getting the chickenpox or something...like a nerve pain burning. I have documentation how perfectly healthy I was before this and now I am not.

RECTAL BLEEDING; FELT REALLY BAD; JOINT PAIN; CHILLS; WEAKNESS; RASH ON FACE; HEADACHE; FEVER; PAIN TO RIGHT LUNG; COULDNT SLEEP; BODY ACHES; THROAT PAIN; EAR PAIN; KNEES TO BOTTOM FELT HOT FOR SIX DAYS; FEELS LIKE LEG IS ASLEEP; LOCALIZED HEAT TO RIGHT INNER KNEE; This spontaneous report received from a patient concerned a 45 year old Hispanic or Latino female. The patient's weight was 185 pounds, and height was 63 inches. The patient's past medical history included hypothyroidism, and concurrent conditions included pollen allergy, alcohol user twice a year, and non smoker, and other pre-existing medical conditions included the patient had mecroabenola hitosesiario (in Spanish). The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25/MAY/2021) dose was not reported, 1 total, administered on 25-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced weakness and rash on face. On 25-MAR-2021 patient felt really bad On 27-MAR-2021, patient was menstruating but at the same time she had rectal bleeding but was not sure. That Saturday (27-MAR-2021) she though had abundant rectal bleeding twice. The second episode came two hours after the first one. She also had bleeding on Sunday (28-MAR-2021) but it was mild. Patient had fever, chills, pain to her right lung, joint pain, she could not sleep, She had body aches, throat pain, ear pain, headaches, (took Tylenol as treatment drug with specified dose) and her knees to the bottom felt hot for six days. Now that has resolved except she had localized heat to the right inner knee. It felt like spiders, like her leg was asleep. Lung pain was on and off, can be mild sometimes stronger. The rest of the side effects resolved The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rectal bleeding, could not sleep, body aches, throat pain, ear pain, knees to bottom felt hot for six days, joint pain, chills, rash on face, headache, fever, and weakness on 2021, had not recovered from pain to right lung, localized heat to right inner knee, and feels like leg is asleep, and the outcome of felt really bad was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- Covid-19 vaccine ad26.cov2.s-rectal bleeding. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

FELT RED STREAK UNDER ARM FROM SHOULDER; EAR PAIN ON RIGHT SIDE; HOARSE VOICE; LOOSE STOOLS; HYPERGLYCEMIA; SWEATING; LEFT BREAST BURNING; PALPITATIONS; LEFT ARMPIT BURNING; FELT RUN OVER BY A TRUCK; LEFT ARM SMELLS AND LOOKED LIKE AN AVACADO UNDER THE ARMPIT; TEMPERATURE 99.7-100.4; LEFT ARM DELTOID SORE/LEFT ARM SORE; This spontaneous report received from a patient concerned a 45 year female. The patient's height, and weight were not reported. The patient's past medical history included tick bite, and concurrent conditions included obesity, type 2 diabetes mellitus, hypertension, and anxiety. The patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 to left arm as prophylactic vaccination. Concomitant medications included fluvoxamine for anxiety, furosemide for hypertension, insulin degludec for type 2 diabetes mellitus, liraglutide for type 2 diabetes mellitus, sitagliptin for type 2 diabetes mellitus, and rosuvastatin. On 09-APR-2021, the patient experienced left arm smells and looked like an avacado under the armpit; she also felt run over by a truck. She had a temperature of 99.7-100.4 (unit unspecified) and had pain in left deltoid arm. On 10-APR-2021, the patient experienced palpitations, left armpit burning and left breast burning. On 11-APR-2021, the patient blood sugar was high 258 (unit unspecified) and experienced sweating and loose stools. On 12-APR-2021, the patient experienced ear pain on right side and had a hoarse voice. The patient had done lab tests at her physician's office; her blood sugar was 230 (unit unspecified), had palpitations at 144 (unit unspecified) and blood pressure was 157/95 mmHg. She was tested negative for covid-19 and had a sedimentation rate of 51(unit unspecified); her magnesium was at low level. She also did an unspecified lab test for lyme disease and was negative. The patient was prescribed with Nystatin cream and nystatin powder and she also took paracetamol (Tylenol) with no relief. The patient felt that she had a red streak under her arm from her shoulder and was going back to her urgent care; she also called her endocrinologist regarding her hyperglycemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature 99.7-100.4 on 10-APR-2021, was recovering from left breast burning, left arm deltoid sore/left arm sore, sweating, and felt run over by a truck, had not recovered from left armpit burning, palpitations, hyperglycemia, ear pain on right side, loose stools, and left arm smells and looked like an avacado under the armpit, and the outcome of hoarse voice and felt red streak under arm from shoulder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210425219 -COVID-19 VACCINE AD26.COV2.S-Hyperglycemia .This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

PAINFUL; RED; MOSTLY SWOLLEN; ITCHY AT SITE OF INJECTION; KNOT/BUMP AT THE SITE OF INJECTION; HEADACHE; LEFT ARM HURT; FELT TIRED; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto's (hypothyroidism) condition. The patient experienced drug allergy when treated with montelukast sodium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride. On 05-MAR-2021, the subject experienced left arm hurt. On 05-MAR-2021, the subject experienced felt tired. On 06-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced knot/bump at the site of injection. On 11-MAR-2021, the subject experienced itchy at site of injection. On an unspecified date, the subject experienced painful, red, and mostly swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and felt tired, was recovering from itchy at site of injection, had not recovered from knot/bump at the site of injection, and the outcome of left arm hurt, red, mostly swollen and painful was not reported. This report was non-serious.

POPPED/BURST CAPPILLARIES IN CHEEKS; MIGRAINE; INJECTION SITE REDNESS; INJECTION SITE SORENESS; INJECTION SITE SWELLING; HOT TEMPERATURE; PETECHIAE ON HER CHEEKS AND ARMS; CHILLS; URINE OUTPUT DECREASED; VOMITING, LOSS OF APPETITE/NAUSEA, DEHYDRATION, LOWER ABDOMINAL PAIN, SWELLING IN ABDOMEN; ORAL INTAKE REDUCED; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included immunocompromised, nausea, vomiting, migraine, lupus, drug allergy to tegretol, ritalin, adderall , sporanox, latex contact long term and thyroid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included ondansetron for vomiting, and nausea, and promethazine for vomiting, and nausea. On 28-MAR-2021, the subject experienced vomiting, loss of appetite/nausea, dehydration, lower abdominal pain, swelling in abdomen. On 28-MAR-2021, the subject experienced oral intake reduced. On 28-MAR-2021, the subject experienced urine output decreased. On 28-MAR-2021, the subject experienced petechiae on her cheeks and arms. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced hot temperature. On an unspecified date, the subject experienced popped/burst capillaries in cheeks, migraine, injection site redness, injection site soreness, and injection site swelling. Laboratory data (dates unspecified) included: Blood test (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oral intake reduced, and hot temperature, and injection site redness, injection site soreness, and injection site swelling on 21-MAR-2021, was recovering from vomiting, loss of appetite/nausea, dehydration, lower abdominal pain, swelling in abdomen, chills, urine output decreased, popped/burst capillaries in cheeks, and petechiae on her cheeks and arms, and the outcome of migraine 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.

Occurred over 3 days:nausea, tunnel vision, ringing in the ears, lightheadedness, racing pulse, clamminess but not diaphoresis. Pain, heat induration, redness and itching at injection site. Itching from injection site moving up arm to neck, side of face and hair. Itching to inside of mouth and lips. Feeling of heaviness and weakness to arms and legs. Chest heaviness and increased work of breathing. I wasn?t breathing faster, but I was aware of the fact that I had to work harder to breath. As I said, these symptoms occurred over three days. The Friday I went to the ED at Hospital. I arrived around 14:45 and I think it was somewhere around 20:30 when I left.

HEADACHES; PAIN AT INJECTION SITE; COUGH; LACK OF APPETITE; JOINT AND NECK PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 45 year old female. he patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, non smoker, and non alcohol user, and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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. Concomitant medications included levothyroxine for hypothyroid. On 06-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE (units unspecified), and COVID-19 virus test negative (NR: not provided) NEGATIVE (units unspecified). On 08-APR-2021, the subject experienced joint and neck pain. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced cough. On 09-APR-2021, the subject experienced lack of appetite. On 09-APR-2021, the subject experienced pain at injection site. On 15-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough on 11-APR-2021, lack of appetite on 12-APR-2021, joint and neck pain, and fatigue on 09-APR-2021, chills, and fever on 08-APR-2021, headaches on 18-APR-2021, and pain at injection site on 14-APR-2021. This report was non-serious. This case, from the same reporter is linked to.

Injection given at 2PM I had neck pain and headache at 9PM that evening. At 3am woke up with chills, full muscle aches, headache and felt flu like. At 9am following morning still a very bad headache along with chills and extreme fatigue. By noon headache gone but fatigue an chills continued for several hours. Exactly 3 days later I developed an awful rash started on hands. This rash is extremely itchy an painful at times. The rash is on hands, arms, legs, belly, neck an back pretty much everywhere. My legs started swelling on day 6.

Developed tinnitus in my right ear that has not gone away. Onset of that condition happened around April 26-27. I do not normally have this condition. Also, received allergy shots in each arm since my vaccination, and both have resulted in large welt and subsequent bruising which has not occurred in the past year of having the same injections.

The day the vaccine I had body aches all over, chills and cold. I had those symptoms for three days. Over the next week I got a red spot around the site of the shot which got bigger. It was sore itchy and tender. It grew to the size of two inches in a circle around the site of the shot .I also had a headache for a week that was constant for the whole day. I went to the ER and they just told me to take Tylenol for the pain. My arm was still effected, for two weeks total and it itched toward the last few days. My headache also got better.

Low grade fever and general fatigue beginning 4 hours post-dose and ending 36 hours post-dose. Itchy in torso and both arms beginning 48 hours post-dose and ending 72 hours post-dose.

Shingles - zoster Headache , rush , severe pain , blisters in right side of torax, fatigue, diarrhea, sensitivity to light

Patient says she has lost feeling in hand/tingling in the hand. She also complains of having issues with her right arm when she lays on it, says it constantly feels like it "falls asleep" when she lies on it. She has since then followed up with her chiropractor and will also follow up with PCP.

4/1 J&J Vaccine, exactly 7 hrs later, intense chills, woke up next morning a-okay 4/3 A few min after waking up, itchy wrists (bilateral), then itchy shins (bilateral), last about 20min 4/5(?) Possible tick (on back - couldn?t really see or reach, scratched at it?) 4/10 Back pain/extreme tightness (fascia from back of knee to upper back feels like sheet of hard leather, extremely limited forward flexion, maybe 50% of normal?) 4/11 Painful intermittent scalp spasms over left ear for 2-ish hours 4/17 Hypersensitive mucus membranes 4/18 Right side of face falls down - Bell?s Palsy? 4/19 Weird hard-leather back pain fading 4/20 ?Headache? - actually feels like seizing scalp muscles behind top of ears 4/20 ?Cold? spots on skin, particularly legs 4/20 Painful knot (familiar) mid/upper right side 4/20 Out of breath 4/21 Leatherback returns 4/22 Awake 3am head pain back of right ear down neck 4/22 Awake 3am - I can feel my face! (BP resolving) 4/22 Extreme pain during asana, leatherback, shakey, lightheaded, out of breath, severe brain fog (almost hallucinatory) 4/23 Awake 1am extreme head, upper right back pain 4/23 Cold spots front of thighs above knee and left foot 4/24 Weird right upper arm/shoulder pain (hours after carrying around a dozen-ish 100lb-ish rocks) 4/25 Awake 1am -6am in extreme insanely excruciating pain right arm (upper/outer/upperback-ish) paced house for 5 hrs. Tylenol & vicodan useless 4/25 Period 2 weeks early (prednisone?) 4/28(ish) Starting to feel increasingly yeasty (doxy?) 4/29 Last day prednisone (accidentally took 1 extra day, grr) 4/29 Extreme weakness and pain - right arm utterly crippled, shoulder partially paralyzed??? (acute and continuous still as of 5/19) 4/29 Very off balance 4/29 Very jittery 4/29 Emergency visit with Dr (Grrr.) 4/30 Left bicep totally dead with pain like an ice pick through it, extreme weakness (pain, limited mobility and some weakness continuous still as of 5/19) 5/1 I can see in my notes that I am switching words!?! (left for right) ?someone mentioned to me on May 2(?) that I was switching left for right? 5/3 Dr video appointment 5/5 Brain fog approaching hallucinatory (hard to explain, everything around me slightly ?fun-house mirror-esque?, judgement is vey skewed, not fun!) 5/7 Last day doxy

pt has a "lump" at the site of injection and as of 5/19/2021 has "heat" at the injection site. Has not used any ice/heat to area as of yet. advised to seek md advise if continues or worsens.

RASHES THAT BURN; RED ITCHY RASH; BURNING EYES; BUMPY RASH ON WHOLE BODY EXCEPT FOR FACE AND VACCINATION SITE; FELT VERY HOT ( LIKE HAD A FEVER); FELT TIRED; FELT A BIT QUEASY; MUSCLE ACHES; ACHES AND PAINS; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, non-smoker, fibromyalgia, and allergic reactions to antidepressants, and other pre-existing medical conditions included patient had allergic reactions to antidepressants. the patient had no drug abuse or illicit drug usage. The patient experienced swelling of throat due to allergy when treated with erythromycin, and paroxetine hydrochloride. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included pregabalin for fibromyalgia, hydrochlorothiazide, and naproxen. On 16-MAY-2021, the subject experienced aches and pains. On 16-MAY-2021, the subject experienced felt tired. On 16-MAY-2021, the subject experienced felt a bit queasy. On 16-MAY-2021, the subject experienced muscle aches. On 18-MAY-2021, the subject experienced felt very hot ( like had a fever). On 19-MAY-2021, the subject experienced rashes that burn. On 19-MAY-2021, the subject experienced red itchy rash. On 19-MAY-2021, the subject experienced burning eyes. On 19-MAY-2021, the subject experienced bumpy rash on whole body except for face and vaccination site. The action taken with covid-19 vaccine was not applicable. The patient recovered from aches and pains, felt tired, felt a bit queasy, and muscle aches on 16-MAY-2021, had not recovered from bumpy rash on whole body except for face and vaccination site, red itchy rash, rashes that burn, and burning eyes, and the outcome of felt very hot ( like had a fever) was not reported. This report was non-serious.

I broke out in a rash from my breasts up to my face. I sent my doctor a picture and started to feel like I could not keep anything down and started to have bowl movements that were incontrollable. The rash lasted about three or four days and I've been tired ever since; however, we had a COVID-19 exposure in our house.

LUMP UNDER THE SKIN CLOSE TO VACCINATION SITE; LUMP WAS GOING TO LOOK LIKE A BRUISE; SORE ARM; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced lump under the skin close to vaccination site. On 20-MAY-2021, the subject experienced lump was going to look like a bruise. On 20-MAY-2021, the subject experienced sore arm. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from lump under the skin close to vaccination site, and the outcome of sore arm and lump was going to look like a bruise was not reported. This report was non-serious.

Severe heart palpitations - Palpitations last throughout the entire day and are severe enough that sometimes I can sleep. I had a normal EKG last week. I'm currently wearing a holter monitor. Mild side effects included injection site pain, achiness and tingling legs.

Cyst under right arm pit, Knee/toe/back pain, right arm tingling (falling asleep) at night, red painful bumps on legs, bumps in mouth, tired. Doxycycline started on 09Jul21. X-rays and bloodwork scheduled.

silver dollar size whelp at point of injection raised about 1/16 of an inch with bright redness throughout whelp. Physician ordered antibiotics (unknown) to cover risk of cellulitis.

Received shot around 3:15pm. A few minutes later the area around the injection site got really hot and painful, and then I started getting really hot from the abdomen up to my chest neck and face. I called out for the nurse who came in to check on me and I almost fainted. I stayed at the facility for almost an hour until I was able to leave. I was not anxious or faint feeling before the shot so anxiety did not cause this. Once at home I was really tired. Today, July 13, I have had a fever, muscle aches, chills, headache, stomach issues, and a random numbness and tingling in my lower left leg that I?ve never had before.

Arm was just sore for a couple days after the shot at site of injection. It got better after a couple of days. On Tuesday, July 13 at approx 9:30 pm the arm started hurting just below the injection site and felt warm in that one spot. I had on a tank top and it was cool in the bedroom. It is now Thursday afternoon and it is still sore and warm to touch in that spot and the arm is a slightly weak and sore feeling all over. Not too bad. It is not getting worse, just not any better. I just went to the doctor and she is sending me to have an ultrasound just to be on the safe side to rule out a blood clot.

5/24 - nausea (zofran ODT) resolved 6/03 - nausea / vomiting (Zofran ODT) resolved; increased arthralgia (tramadol w/acet 1000mg QD PRN) improved not resolved, more prominent malar rash (no treatment) with moderate warmth at rash site; fatigue / malaise. (missed 2 days of work) 6/24 - moderate to severe arthralgia to major joints (increased tramadol w/acet to BID/PRN) improved, not resolved; n/v (Zofran ODT) improved but lingered; weakness, fatigue / malaise (missed 2 days of work) 7/12 - n/v (changed to zofran as ODT increased n/v), pain / arthralgia moderate to severe (tramadol w/acet 1000mg increased to TID PRN & methylprednisolone 4mg dose pack); Migraine headache x4 days unrelieved (Imitrex, Aleve, & Acet. rest

a week after treatment started breaking out in hives and face swelling; experience on and off for last two weeks

24 minutes after vaccine administration, patient experienced hives on nose, arms, chest, thighs, back and buttocks. Also experienced dizziness. 12.5 benadryl tablet was administered at 8:03pm. Patient only wanted half of the pill due to drowsiness affects. Patient was able to leave at 8:09 and denied HA. at 8:35pm, patient asked for the other half of the pill which was 12.5mg of benadryl for a total of 25mg of benadryl given for hives. Patient was instructed to inform PCP about reaction. At 9:20, patient said the hives were disappearing.

Severe pain in arm at site of shot. Fatigue. Whole body soreness. Feverish without fever. Loss of appetite Headache

Injection site is still sore, chills, severe head ache and severe body aches lasting for two full days post vaccine

At 3:00 pm the day after I received the Johnson&Johnson COVID-19 vaccine I developed a red, raised, swollen, hot, painful circle 5'' in diameter on my left arm under the injection site. My arm is hot to touch, swollen, and still painful the next day and the circle has spread more and has started to turn purple.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild

Patient experiencing hives and rash on center of chest and face (cheek bone area) patient denies any difficulty breathing

Sore arm (not too bad) next day and for a week All over body itchiness (no visible rash) Resolved with benadryl

Fever, skin irritation/sensitivity, fatigue, brain fog, sore throat, gunky throat, headache. Significantly sore arm (going on 5 days)

Light headed, fever, chills, no appetite, skin sensitive (like crawling but painful), migraine, heart racing, cough, difficulty breathing. Was like when I had Covid, but all in 1 day. Rate rate was 135 when walking and pulse went to 89 only when standing/walking

reported to school nurse on 3/16/21 @ 0900 with "crawling" and itching. Nurse also noted patient to have erythema to upper chest and arms bilaterally. Patient then reported febrile, chills, body aches and sweating on 3/16/21 @ 23:00 and missed work on 3/17/21 due to symptoms. Patient received Benadryl 25 mg 1 tab every 4 hours while at work (09:00 & 13:00), then took Aleve and Tylenol at home for other symptoms (unsure of dosage and frequency)

I got hives and rash on neck to mid thigh. I thought I possibly ate something that could of caused it. By Wed it seemed to be gone and on Fri came back. I started back taking Benadryl cleared it up and on 3/24 appeared again on my arm (both).

my reaction was my left lower eye swollen, itchy after three hours shot. I had a fever, shivering, headache, body ache especially backache the first night, and then just healed up for my eye today.

3/24/2021 2:00 pm red hot to the touch rash on left inside of the arm. Muscle twitches all over. Headache the injection site can not be seen no red marks ect 3/25/2021 11:03 am raised red bumps all over neck,back and both arms that were sore even with clothes on. I took two 25 mg Benadryl at noon and 5 pm...neither dose seemed to help the bumps. No fever (97.7) but I was and still feel hot it is currently 7:23 pm...still have muscle twitches. Ongoing headache that I can not get rid of. The injection site is very red I have pictures if needed

Around four hours later began with a head, heart beat really fast, small fever, extreme nausea and IBS-like symptoms (gas pains and diarrhea), fatigue. The later lasted for nearly a week, but the rest were gone by day 3. I did not see a dr as my fever never got very high and only occurred the first night. The nausea last maybe a day and a half. I am about two weeks out and I seem to be having a gluten skin reaction (dermatitis herpetiformis) and given most of the symptoms I listed could also be celiac symptoms, I was curious if there was gluten in the shot as it was very much like an extreme reaction to gluten that I normally get with celiac. I usually see gluten rashes a couple of weeks to a month after being exposed and I was not exposed to anything during the last few weeks that could be causing it (that I know of). The nurse who gave me the shot did not know if there was gluten in the shot. Hence, I know the first symptoms were definitely related to the shot, but not if the current rash is from the shot (because gluten, this is definitely DH and not an allergy rash). I hope this helps, if other celiacs have also had a hard time.

Received dose at 12:30 pm on Saturday. By 6:30 pm I had severe fever, chills, severe headache, and generalized aches until about 4 am. Woke up around 7 am feeling better. Mild heat flashes until about noon. Felt fine the rest of the day. On Thursday 3/25 around 6pm I started developing hives, itching and red rashes on bilateral lower legs. Thighs, knees, feet and ankles. I waited several hours to see if it would go away and it did not. By 10:30 pm it was much worse. I took a 25mg Benadryl tab. Rash went away. On Friday 3/26 rash and hives, itching and red rashes returned. Both kneecaps very red and hot. It mainly stayed on lower legs until about 5 pm. The rash then started on bilateral arms. I took another Benadryl at 6pm. It is currently 7pm.

Blurred vision dizziness nausea headache arm pain Extreme fatigue low-grade fever and chills. Have knot the size of a quarter on my arm at the injection site along with redness and pain. This was the one shot vaccine.

I have a history of Guillain barre and typically after infections or vaccines I get a relapse of symptoms. About 2.5 hours after my injection I noticed numbness starting at the tip of my toes on my left foot. By 5 hours after same on my right. At 24 hours it was up to the base of the toes. Now 2 days after I have numbness to the balls of my feet. I also have numbness around the injection site. Although this is fairly normal for me. Typically lasts about 3-7 days of progression with 1-2 weeks to resolve. So far the pace is spot on for my history. Nothing out of the ordinary.

Menstrual bleeding (I have not had a period in 3-4 years) Pain and knot at injection site (after 5 days it is worse)

Small red rash on right inside arm last few hours soon after shot, Swelling, red, lump, hot to the touch itching - gets bigger every day causes pain to radiate down left arm at times - reaction is still there on 5 around the jab site on the left arm= started around 11:00 PM on 03/25/2021; 103.7 fever started 03/25/2021 and last about 24 hours; finger extremely and hot and burning lasted about 48 hours. Fingertips still feel like electricity is running through them and fingers/hands still hurt; extremely hungry/thirsty from 03/25/2021 - 03/29/2021; fatigue, pain at base of skull under ears, tinnitus extremely loud and both ears feel like ear ache; During the night of my high fever, lower back where kidneys are started hurting very badly. What is still left of that pain on day 5 is a pain radiating from my lower back down my right leg many times throughout the day (treating with ibuphrophen). Pain around knees, elbows, ankles, and bottom of feet- different than joint pain. All my POTS symptoms are in high gear (tachycardias, very low BP, pain, dizzy, vertigo). If the leg/lower back pain, and left arm problems continue, I will see my neurologist or immunologist. I have reached out to both to make them aware. My husband had the JJ shot same day, same place and had zero side affects.

Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Wrong Route (SC, IM, etc.)

15 minutes after shot: significant, noticeable swelling and pain in injection arm, flushed face, neck, and chest; 30 minutes after shot: swelling in face, discomfort in throat, tingling in limbs, anxiety, heart rate increase. Pretreated with benadryl (25mg) 30 minutes prior (at 3 pm); pretreated with benadryl (25mg) 10 minutes prior (3:20pm). Left pharmacy at 3:45, drove to ER as symptoms were worsening. Waited at ER (not triaged) until symptoms significantly subsided - around 5:15pm. Continued benadryl every 4 hours for 12 hours (tried delaying benadryl at 7:30pm, but symptoms began returning). The reduced to 25mg every 5-6 hours, for 24 hours (symptoms returned without benadryl). Other side effects: Began ~ 7 pm: temperature spikes and drops (hands and feet freezing cold), chills, stomach pain, nausea, extreme headache, extreme muscle pain and joint pain, shooting pain, fatigue. 400 mg ibuprofen every 4-6 hours. first 24 hours very bad, 36 hours reesolved,

Soreness in left arm, but not severe by any means. By 8pm, felt chills. By 10pm, had 99.6 fever. Took one Tylenol 500mg. By 5am, has 100.8 fever. Took two 500mg Tylenol. By 10am, has no fever. Just tired and a little weak. Rested throughout the day and felt better. No more fever since. Feel a little odd numbness on my tongue, but no lost of taste. Still have the odd numbness on the tongue. All other symptoms are gone (still a little sore in the left arm, but not a big deal).

Starting on morning of Day after vaccine, experienced very SEVERE fatigue, headache, and nausea. Also low grade fever with sweats and mild sore throat. Arm was mildly sore at injection site for several days. Headache and fatigue continued for three full days. On 5th and 6th day after vaccine, had diarrhea. Was told by doctor at vaccine event not to take any anti-inflammatories for 3 to 5 days. He said Tylenol was ok. Took Tylenol day after vaccine when adverse effects were the worst and it did not help at all. Finally took Advil on day 4 and it relieved headache. Now 7 days after vaccine still have intermittent headache.

1) pain at the injection site immediately upon receiving the shot and lasting approximately 10 minutes afterward. 2) approximately 2 hours after receiving the shot, I became fatigued for a couple of hours

Flu-like symptoms developed and got progressively worse in the first 12 hours after the vaccine and remained for approximately 36 hours. The flu-like symptoms included muscle aches, nausea, stomach pain including more significant pain in the upper left stomach area, headache and fatigue with difficulty sleeping. I needed to take time off from work due to these side effects and had difficulty performing daily activities. Also experienced pain at injection site that got worse in the first 12 hours and lasted also approximately 36 hours. Minor nausea, stomach pain and injection site pain have continued after 36 hours with ability to return to daily living activities.

Pt received vaccine and had a safety barrier bandaid put on. Seconds later, the injection site started heavily bleeding over and around the bandaid. Rph applied constant pressure using cotton balls to the area for 5-7 minutes. Bleeding had stopped and a new bandaid was applied. Injection site adverse event was then resolved. Pt expected this due to her having a medical condition of anemia and taking subsequent B-12 injections. Pt was observed for 30 minutes and no bleeding re-occurred or was seen. Pt was directed to put ice and pressure on it for further home care.

Hives on arms. Stomach. Lower back. Lasted for 24 hours. Did not take anything. Was not itchy. No shortness of breath. Usually happens when I get sick.

3x3 cm of erythema and mild warmth along moderate tenderness and mild induration at the site of the Johnson and Johnson COVID-19 injection

From 330 until 1030 pm I FELT great, no soreness by injection sight, no signs at all of any side effects BUT by 1030 pm, 7 hours after the shot I was ICE cold, teeth chattering, and could not get warm at all. NO FEVER but major body aches and soreness. AFter the chills wore off I was in a sweat..this pattern of chills, vs soaking sweats continued throughout the night. Add to that dry heaves due to nausea but no vomiting. The dry heaves just added to the muscle pains that I already had. I was in bed until 5 pm the next day, no energy, sore body aches to the point that my skin hurt. still no soreness in my arm at all. I finally had the strength to get out of bed at 5pm took a shower and ate 2 pieces of toast to combat the nausea. Fast forward next day, felt fine and arm was mildly sore at injection sight. SO glad J and J is only one dose.. I would have dreaded a second day like that.

Several days after the J&J Vaccine I had a rash on my face and my lips became very swollen and turned a blueish gray color. Under my top lip there were several large dark red marks that were tender and swollen.

Patient received Johnson & Johnson 0.5ml Covid vaccine IM to left deltoid. While in observation area, patient reported nausea and "tingling throat." BP 170/120, HR 98. Patient began vomiting, observed to be scratching arms. She reported feeling itchy everywhere. 911 called. Patient reported tongue "felt funny" and throat felt tight. Epinephrine 0.3mg administered IM to left thigh at 10:50am. Patient reported almost immediate relief in symptoms after receiving Epinephrine. She was transported to local ED via EMS.

TWENTY-FIVE MINUTES AFTER ADMINISTERING VACCINE PATIENT STARTED TO ITCH AND SKIN TURNED RED. BENEDRYL WAS ADMINISTERED AND PATIENT WAS ASKED TO STAY AN ADDITIONAL 5-10 MINUTES (TOTAL 35 MINUTES) PATIENT STARTED TO FEEL BETTER BUT WAS STILL SOMEWHAT ITCHY AT TIME OF DEPARTURE.

At time of shot, burning in arm as serum was being injected, and extreme dizziness where I almost fell off the chair. Dizziness lasted for a few minutes which created nausea. Sat at site for approximately 25 minutes after shot. Left arm was sore between shoulder and elbow, which was to be expected. Later in the evening, experienced fatigue. When trying to go to bed around 11pm, my left are was throbbing. I did take Tylenol at about 6pm. Throughout the AM hours, sever body aches started, extreme fatigue throughout the following day. Flu like symptoms continued the next day. I had heard of these symptoms for the other shots but not for Johnson and Johnson. Hungry but too weak to actually cook.

PATIENT DEVELOPED RED SPLOTCHES ON NECK AND FACE, COMPLAINED OF ITCHING, GIVEN 2 DOSES OF 25MG BENADRYL ORAL (50MG TOTAL), THEN REQUESTED TRANSPORT TO HOSPITAL VIA AMBULANCE

RASH ON HER LEGS; HIVES; ITCHING; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced itching. On 25-MAR-2021, the subject experienced hives. On an unspecified date, the subject experienced rash on her legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives, and itching, and the outcome of rash on her legs was not reported. This report was non-serious.

Day 1-Day 3:Sore arm, swollen, hot to the touch, red irritation at injection site, tiredness, trouble concentrating. Day 4-6: arm swollen more, hot to touch, irritation at Injection site, mobility of arm impaired. Day 5: massaged arm to get swelling to go down. Day 6: woke up with massive headache and swelling went down. Day 7: broke out in hives that turned into blisters, taken to ER and given prednisone and antihistamine. Day 8-10: arm is black and blue bruised at injection site, small lump at site, continuous rotating hives and blisters with Prednisone 160mg and antihistamine and creams.

Painful injection. Arm immediately went numb. 15 mins later feeling restored. 6 hours later got chills fever muscle aches frequent urination twitching from muscle spasms. Face felt like it was on fire, sweating, headache however body pain was so so bad. My heart rate stayed around 128-130 bpm for 6 hours. Tight chest heard to breathe

April 6: sore at injection site and left shoulder April 7: sore at injection site and left shoulder, headache, fever, chills, muscle aches, fatigue April 8: fatigue, intense pain in left arm- tricep/bicep/armpit area, sore in muscles & joints on left side only including left temple, jaw, arm, hip, thigh, ankle, and toe

Nausea, fever (up to 100.5), chills, body aches, rashes in the lower extremities, diarrhea Took Tylenol and Zyrtec

Dizziness, nausea, uncontrollable shaking lasting for 4 hours, chills, lethargy, barely able to walk, feeling of being on fire, feeling of being unable to catch a breath, dry eyes and mouth, severe sweating, not being able to control leg movements, unusual thoughts, confusion, stabbing pains in different parts of the body, all over aching in joints and muscles, rapid heartbeat.

Lump, swelling, redness itching, soreness and burning in the upper arm surrounding the injection site.

in about 5 hours after the shot, I started having very strong chills, body aches, headache, nauseous, eyes hurt, abdomen pain. Symptoms continued for about 20 hours (bed rest, not capable to do anything). horrible headache at night time. No fever. Felt chills and feeling hot sweating during the night. Took Tylenol 2 times. dull pain in the shot area, pain distributed under arms around breasts. tender breast and nipples on 3rd day (Sun) after the shot. Lost appetite for about 2 days (body weight 3 pounds less).

Almost immediate - soreness at injection site Four hours post injection - nausea lasting approx 6 hours Five hours post injection - vomiting lasting approx 5 hours Five hours post injection - chills, fever, headache, bodyaches lasting 20 approx hours Five hours post injection - exhaustion lasting 2 days Two weeks post injection - painful swollen lump under right armpit lasting 3 days, lump did not completely go away for 7 days, but pain/swelling subsided after 3 days.

Left arm became warm, swollen, painful (cellulitis). Treatment with ice, Tylenol and cephalexin 500mg 1 capsule by mouth four times a day for 7 days

Patient called pharmacy to report she was having numbness, stiffness, and tingling in her arm that starts and stop but dose not seem to go away. She also reported rash under the left eye, right side of the eye. Patient indicated she was going to see her physician for an evaluation.

After, receiving the shot i started experiencing a rash on back of neck, arms and face, which left me dry and itching.

Injection was administered very high on shoulder next to what feels like a bone. As injection was being administered I felt pain on inside upper arm down to wrist. Pain subsided. Day progressed. I used my arm to grocery shop. About 6:30 -7:00pm I noticed stiffness and inability to lift arm with extreme pain in attempts to lift arm. During the night had restless sleep. Had to use other hand to move arm into resting positions. No comfortable position. Saw general practitioner on 4/12/2021. Received a paper with physical therapy exercises. Today, 4/13/2021, Still extreme pain to stretch arm to side and in front. If raising arm overhead with help in range of motion exercises (abduction) cannot lower arm without severe excruciating pain in inner shoulder area. New symptom includes numbness in wrist and forearm.

I received the shot in my left arm and experienced the expected symptoms of a sore arm and tenderness at the injection site the day of the shot and the day after. Yet on the third day when symptoms were supposed to be getting better, I developed severe pain in my upper left shoulder and across the back of my neck into the middle of my back. My collar bone area on both sides was also sore. I did nothing physically to explain this additional pain. It was so uncomfortable that I spent most of day 3 and 4 after the shot laying around while taking Tylenol around the clock. The worst of the pain was gone by day 5 but I continued to have discomfort in my left shoulder for almost another full week so much that if I wore a bra, I would have to take it off half way through the day because it caused so much discomfort with the strap on my shoulder. Everything feels ok now that it has been 3 weeks since my vaccine but the muscle pain and discomfort was very painful and unpleasant way past the listed side effects of the vaccine.

I got a rash on my chest and it progressed to my neck and face. I went to the doctor on 4/7/2021. I was prescribed Methylpred and Clobetasol. I took the medicine as directed. The rash stopped spreading and got better. This morning 4/13/21, the rash is back and spreading .

for approx 24 hours: significant pain in shot arm, fever, aches, chills, migraine/headache. Next 24-48 hours: rash on both arms and chest, swollen hands and continued pain in shot arm.

The day after the joint I had severe joint aches. I had to take some Tylenol. The day after the pain was better but I got a burning rash in both armpits. It was not raised and burned on the right side more. It was a solid area in my entire armpit and very red. I had no soreness around the vaccine site. I used steroid cream and took 50mg of Benadryl. Two days later it was gone.

Fever 102.2 for days. Shortness of breath. Sweating and chills. Severe body aching. Severe fatigue. Severe Pain on injection site (right arm). Lightheaded frequently. Water body retention.

Thursday, 4/8/21: 6:40p: Received vaccination at hospital; 7:00p: Left clinic ( hospital); 7:05p: Center area of chest starts feeling ?tight? and difficult to expand chest, neck felt mildly itchy, tongue felt slightly larger. However, I felt no other symptoms of an immediate allergic reaction: no wheezing or difficulty in breathing, no swelling of my throat, no hives or rashes, no GI issues. Decided to drive back and stay close to hospital in case symptoms worsened; 7:20p: Symptoms did not worsen. Drove back and stayed around downtown hospital in case symptoms worsened; 7:40p: Although chest still felt tight, tongue felt normal again and neck did not itch. Returned home to monitor; 9:30p: chest no longer feels tight; 10:00p: went to sleep with no breathing issues; Friday, 4/9/21: 3:00a: woke up to expected mild fever (100F) and aches (NOTE: did not take any Tylenol or NSAIDS) 12:00p: fever 101F, along with start of headache, fatigue; 5:00p: fever 101.7F, headache and body aches worsen, loss of appetite but drinking plenty of fluids, and urinating, could not stay awake; 10:00p: fever 102.5F, major headache and aches, fatigue, ? finally took Tylenol 650mg; 3:00a: awoke from sleep, temp 99.4F and mild aches, no headache ? took another Tylenol 650mg; Saturday, 4/10/21: 8:00a: awoke with no fever (98.6F), no headache, no aches; 3:00p: temp 99F, mild aches, no loss of appetite, no headache **Have not taken any Tylenol or NSAIDS since then**

Tingling and numbness and cold sensation and warm to touch in legs/ pt started taking 2 tabs of Aspirin81 mg from yesterday/ still have the same symptoms

1 Extensive left upper extremity venous thromboembolism-nonocclusive in the left subclavian, left axillary, brachial and basilic veins 2 Right lower lobe subsegmental PE 3 Mechanical thrombectomy of the left subclavian and axillary veins 4 Bruising all over body

04/08 3:00pm had cold sweats & rapid heartbeat 6:00pm blisters in roof mouth & throat Very tender arm at shot site 04/09 Woke up with arm redness and a few blisters on arm (resembled bad sunburn with blisters) Very sore arm with large know size of tennis ball at shot site Still rapid heartbeat and very tired 04/10 Have been taking benedryl every 4 hrs & the blisters have now went down but now feels like burns. Still very sore arm and tired w/ rapid heartbeat 04/11 Still not feeling well and same symptoms of tired, sore arm, burn like feeling on arms & in mouth and throat as well as rapid heartbeat 04/12 Woke this morning with bad headache and now short of breath with any activity & rapid heartbeat and still arms have red like burns and now skin peeling off. 04/13 Woke up this morning with no change in my symptoms so I called my family doctor. Doctor seen me and advise me sounds like possible allergic reaction and to rest and try to ease off benedryl some and callback if any changes. This eve about 8-9pm I started having very dull pains in left chest area and very short of breath with my rapid heartbeat still there. I went to bed. 04/14 Woke up with intense pain in left chest and pulse was getting high with any activity & short of breath along with cold sweats and feeling worse I have ever felt and had and called my family doctor & he sent me to ER At ER they did many tests and labs and xrays and gave me shots of strong steroids and said pleurisy and that seemed like my body was having an overload reaction to vaccine and would take time but should go away. And said rest and follow up with my family doctor in a few days.

Increased migraines, hives (itching, red spots on body) - still taking Zyrtec for the hives - has not resolved completely

Patient is a 47 y.o. female who is evaluated today for the above concerns. Patient presents with concerns related to possible reaction to the J&J COVID vaccine she received last week. She developed some face tingling/numbness, then felt like her throat was closing - not sure if due to lymph nodes swelling or possible reaction. She thought about going to ED or using epipen, but ultimately did not need to do either. She has been on zyrtec for her allergies which have been really bad too, so was not sure if that could be contributing. Later that evening she developed headache, chills, joint/muscle pains and fatigue which continued through the night and into the next day. She also had burning of her skin, specifically her hands and feet. She continues to have some fatigue, joint/muscle pains and mild headache. She is worried about recent development of potential clotting with J&J vaccine - she has factor V Leiden and is supposed to travel later this week. Headache not described as severe, no SOB, leg pain or swelling or abdominal pain reported. Tachycardia "

I am a runner and run regularly. On 3/23 I was running with friends early in the morning and got a strange cramp in my left calf. I?ve never had that happen before. It was so strong that I had to stop running and walk the last mile home. The strange cramp/pain lasted about 4 days. Then last week my family and I were skiing and I got a sharp pain in the shin of my left calf. Nothing brought it on, it was intense and just started out of nowhere. The pain lasted about 10 minutes and then subsided. It was very strange. That night I had a large bruise. The next morning the bruise was the size of the palm of my hand. The bruise was gone after about 4 days. I don?t know if these are related but I?ve never experienced things like these in the past without something causing them. So after hearing reports of adverse reactions these seemed worthwhile to report. As a side note, I also did get sick during the 24 hours after my shot. My symptoms included intense body aches, headache, sinus pain, sore throat, fatigue, nausea and a fever of 102.4. These symptoms all subsided after 48 hours of my vaccination.

I woke-up on 4/7 with an itchy throat and hives were starting to form on my stomach. As the day went on, the hives were all over my torso and went up to my neck as well. When I have hives on my neck, they usually start to bother my asthma/breathing, and this happened on 4/7 as well. My allergist said to up the dosage of Allegra 24 hours from 2 tablets a day to 4. I also took my Albuterol inhaler to control the wheezing. My doctor also gave me a prescription for Prednisone in case I needed it over the weekend, and recommended I go to the ER if my symptoms got worse. Luckily, the extra Allegra and asthma inhaler calmed by symptoms down. Things calmed down over the weekend and by 4/14, the hives were completely gone and I was not longer experiencing any side effects. I did not need to do any in-person doctor's visits; I just talked to my doctor on the phone. Please note that I also had the 'flu-like' symptoms after the shot as well. I felt great after the shot and even exercised on my elliptical around 7:45 that night. At around 9:00, I had extreme chills, where my body was shaking, as well as sweating. I also had extreme fatigue, a headache, and some body aches as well. I slept for 16 hours that night and felt somewhat better when I got up. By that late that night, all the flu-like symptoms were gone. I took some Tylenol for the headache.

Patches of extreme dryness started inside front lower lip and left and right upper lip where lip touches gums 04/03/21 to present. Pain and ulcer appeared inside lower lip/gum 04/09/21. Dry areas of lip tissue sticking to gums. Red left eye on 04/09/21 for about 4 days. No itching or pain. Joint pain in hands, knees, and ankles starting approx. week after to present. Dry eyes and nasal passages for last week. Saw Dentist on 04/09/21 for dry mouth patches and mouth pain. Miracle mouthwash prescribed. Mouth symptoms improved not eliminated to date.

23 hours after receiving the shot, I had the chills, fever, body aches, headache for about 2 1/2 days. Two weeks later I had a virus that I was to just rest and stay hydrated. A month later, I have been told I have shingles.

Left arm swelling and some bruising. bruising resolved after few days. also some cervical lymphadenopathy and rash x few days, now resolved. patient with residual arm swelling 2 weeks post vaccination.

We got a call from Doctor from ER to inform us that this patient came to the ER today & got swollen arm @ the injection site (left arm). They did the ultra sound & found there's a clot in brachial vein on the opposite arm (right arm). Doctor said they'll give pt Eliquist today.

Within a half hour of injection, I experienced pain in my left leg (thigh muscle mostly). Throughout the day the pain spread to my left hip and left calf. Additionally, I felt like my muscles were ?on fire? on the left side of my body. I also felt a ?tingling? in my body, fingers and toes, leg muscles, primarily on left side. (I assumed at that time that this was ?normal?.) About 11 hours after injection, I experienced extreme muscle pain all over my body, lasting for about 12 hours. (Flu-like muscle pain and the feeling that all of my muscles were on fire.) The following day, I began to feel the feeling of pins and needles everywhere but primarily on left leg, thigh and calf. By Thursday evening (three days following injection), I felt the most severe pins and needles feeling as well as ?itching? primarily in calves and hands and feet. I was so uncomfortable and panicked, I couldn?t sleep. On Friday evening, I felt intense leg pain and ?heat? on left side in both calf and thigh muscle and couldn?t sleep. On Saturday evening and all day Sunday I had a headache which I can?t say was related but caused me great concern. Now, eight days later, most of the pins and needles feeling has subsided but the pain in my left leg (thigh muscle) is at an all time high. Extra strength Tylenol is not helping. I did have a consult with my doctor last Thursday and I called again yesterday and I?m waiting for a call back. (Last Thursday, she agreed that my symptoms were unusual and thought I might need to see a neurologist.) Additionally - my left knee has bothered me and feels like someone hit it with a bat. I?m not sure if this is joint pain? FYI - I have no apparent swelling in legs, no numbness, no trouble breathing and no significant headache today. I never had a fever or chills. The injection site burned for a few days (mild) but was never red.

6 days after I got the vaccine, I noticed a large rash across my torso. I am unsure if the rash was developing prior to when I noticed, but the rash is on my stomach and part of my lower back. I finally visited my primary doctor today and was told the rash is a drug reaction - it is not itchy nor painful. **I am supposed to be on baby aspirin indefinitely due to my heart condition. I have not taken baby aspirin in a few years. But after there were reports of women getting blood clots after getting the JNJ vaccine, I started taking baby aspirin 6 days after I got the vaccine. The rash may have happened before or after I took my first dose of baby aspirin. I stopped taking baby aspirin the following day. Today, my doctor advised me to stop taking all Vits and Supplements. I will be taking Zyrtec and Tagamet for next 10 days, hoping the rash will go away.

significant nausea and abdominal pain, that lasted 3 days, followed by severe severe headaches making me feel unable to think and nearly cried on days 6-12, headaches sometimes still occur, also odd bruise to right size of chin that is not improving, about the size of a quarter.

fever (up to 101.8 degrees), body aches, and chills for 24 hours after vaccine fatigue, pain at site of injection, and pain in underarm radiating through to shoulder blade for 6 days after injection muscle spasms in shoulder and chest on side of injection, 9 days after injection called doctors office once to see if I could take pain medication for aches, and they said yes. have not called since

PAIN IN UNILATERAL THYROID ON LEFT SIDE; MUSCLE PAIN; MILD SORENESS AT THE INJECTION SITE; FATIGUE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced fatigue. On 04-APR-2021, the subject experienced mild soreness at the injection site. On 05-APR-2021, the subject experienced muscle pain. On 14-APR-2021, the subject experienced pain in unilateral thyroid on left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 06-APR-2021, muscle pain on 08-APR-2021, and mild soreness at the injection site on APR-2021, and had not recovered from pain in unilateral thyroid on left side. This report was non-serious.

LUMP ABOUT THE SIZE OF AN ALMOND FORMED TWO INCHES BELOW THE INJECTION SITE; LUMP PAINFUL TO TOUCH; RASH AT INJECTION SITE; LIGHT BRUISE AT LUMP; This spontaneous report received from a patient concerned a 46 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: 1802072, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced light bruise at lump. On 10-MAR-2021, the subject experienced lump about the size of an almond formed two inches below the injection site. On 10-MAR-2021, the subject experienced lump painful to touch. On 10-MAR-2021, the subject experienced rash at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash at injection site, and had not recovered from lump painful to touch, lump about the size of an almond formed two inches below the injection site, and light bruise at lump. This report was non-serious.

SEVERE STOMACH CRAMPS/SHARP PAIN; SEVERE FLUSHING ON EAR, FACE AND CHEST; HIVES; SCRATCHY THROAT; SWELLING ON GROIN AREA; NODULES ON INJECTION SITE; NUMB TONGUE; BUMPS AND RASH ALL OVER HER BODY; DIARRHEA; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mast-cell activation syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 10-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 10-MAR-2021 30 min after vaccination the patient experienced severe stomach cramps/sharp pain. On 10-MAR-2021, 4 hours after vaccination the subject experienced multiple symptoms like severe flushing on ear, face, and chest. hives, bumps, and rash all over her body, scratchy throat, diarrhea, swelling on groin area, nodules on injection site and numb tongue. The patient was expecting to have these side effects since she has mast-cell activation syndrome an took Benadryl which seemed to help, and she did not go to emergency room (ER). The patient would follow up with her PCP. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach cramps/sharp pain, severe flushing on ear, face and chest, hives, scratchy throat, swelling on groin area, nodules on injection site, bumps and rash all over her body, and diarrhea on 10-MAR-2021, and the outcome of numb tongue was not reported. This report was non-serious.; Sender's Comments: MAC- MAC not required per standard procedure as the case assessed as non-serious.

Patient presents with concern for Covid vaccine reaction. Patient states she had the Johnson & Johnson vaccine about 2 weeks ago. Patient reports she had a headache about 1 week ago that woke her up from sleep about 1 AM but resolved by 4:30 AM. Patient denies having a headache since then. Patient noticed some small red dots on her nose today and was concerned when her friend told her this could be from the vaccine. Patient called her PCP who advised her to come to the ED for evaluation for thrombotic thrombocytopenia.

Within first few days of Johnson andJohnson vaccine....swollen lymph nodes, lymphedema. 2 weeks after vaccine...leg pain, bruising on legs (with no injury), peticiae rash on legs. Now after nearly a month...still having random bruising and pain on my body (without injury), still feel very unwell, having feelings of pressure and visible swelling in neck that comes and goes, still having pain. Yesterday a new bruise appeared on wrist with swelling, pressure, and pain.

NUMBING SENSATION; WHOLE ARM FEELS WEIRD; TOP OF THE HAND HURTS; SORE ARM; INJECTION SITE PAIN; FEVER; CHILLS; This spontaneous report received from a patient concerned a 46 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced sore arm. On 15-APR-2021, the subject experienced injection site pain. On 23-APR-2021, the subject experienced numbing sensation. On 23-APR-2021, the subject experienced whole arm feels weird. On 23-APR-2021, the subject experienced top of the hand hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 04-APR-2021, and had not recovered from sore arm, injection site pain, top of the hand hurts, numbing sensation, and whole arm feels weird. This report was non-serious.

SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced sore arm at injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm at injection site on 25-MAR-2021. This report was non-serious.

Approximately 3-4 days following the vaccination I broke out in a rash on both arms. It lasted about 3 days and the itching was controlled with cortisone. Approximately one week after the vaccination I contracted a yeast infection. It resolved with over the counter meds one week later. The site of the injection was a bit sore for two weeks.

After my J&J vaccine, I experienced severe headaches all day starting from 03-16-2021 lasting till 03-17-2021. I had some soreness at the injection site. The headache pain was located on the top right of my head towards the back, above my right ear. I took two Tylenol as well as an Aleve as pain medication. I had an U/S of the right leg to check for main vein in my leg to check for any blood clots. The results of my exam were negative. I have been fine since these symptoms.

Severe body aches, fever, skin felt on fire, headache, leg pain, continued nerve type pain on injection arm and should blade for over two weeks.

LIP SWELLING; HIVES; SEAFOOD ALLERGY; BODY HOT; SORE LYMPH NODES; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, treatment medications included: oxycodone/paracetamol. On 07-MAR-2021 17:00, the subject experienced sore lymph nodes. On 10-MAR-2021, the subject experienced body hot. On APR-2021, treatment medications included: epinephrine. On 13-APR-2021, the subject experienced seafood allergy. On 13-APR-2021, the subject experienced hives. On 20-APR-2021, the subject experienced lip swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore lymph nodes on 09-MAR-2021, had not recovered from seafood allergy, and body hot, and the outcome of hives and lip swelling was not reported. This report was non-serious.

Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Systemic: Pin the throat/ear and back (only on right side) , coughing -Mild, Additional Details: patient complaining of pain in the back on the right side since Day 1. Fever developed on 2nd day, but recovered. Also pain in throat/ear, stuffy nose, and coughing, but minor.

Body turned red. Itching was extremely bad and started at 3:30 on May 4th. Got prescribed Vistaril and a steroid. Back at the ER on the 6th blotchy and red streaks and itching EVERYWHERE. Changed steroid and gave me cream

Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient is fine after 15 minutes observation by the pharmacist. After 15 minutes there is no pain or numbness at the injection site.Patient said that she feels fine. After 3 hours, patient experiencing some mild numbness at the neck and left arm where the patient is injected(left arm).

Extreme tiredness starting 10am 5-7 lasting until Saturday 9am. Chills starting 12pm 5-7 lasting until 5am Saturday 5-8. Low grade fever 12pm 5-7 until 5am Saturday 5-8. Arm pain swelling and redness at injection site 7pm 5-7 ongoing. I had Covid with moderate symptoms April 2020

Shingles diagnosed by dermatologist office- Dr. assistant located on on my right side of my back and around right side up under the right breast.

PAIN IMMEDIATELY AFTER SHOT FROM SITE OF INJECTION DOWN ARM AND INTO RING FINGER, WEIRD NUMBING PAIN, LIKE WHEN YOU HIT YOUR FUNNY BONE BUT THE FEELING DID NOT SUBSIDE FOR A WEEK AFTER THE SHOT.

TREMENDOUS HEADACHE LIKE MIGRAINE; MILD PAIN IN THE INJECTION SITE; MILD ALLERGY; TIGHTNESS OF CHEST; FLU LIKE SYMPTOMS; THROAT FELT FUNNY; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to dust, and acid reflux. 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 tightness of chest. On 08-APR-2021, the subject experienced flu like symptoms. On 08-APR-2021, the subject experienced throat felt funny. On 08-APR-2021, the subject experienced mild pain in the injection site. On 08-APR-2021, the subject experienced mild allergy. Laboratory data included: Body temperature (NR: not provided) 102.5 F. On 09-APR-2021 03:00, the subject experienced tremendous headache like migraine. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tightness of chest, throat felt funny, tremendous headache like migraine, mild pain in the injection site, and mild allergy on APR-2021, and flu like symptoms on 2021. This report was non-serious.

3/28/2021 12:45pm Shot received as part of 1200 had gotten access to. It felt like fire in my arm at the point of the shot and moving down toward my wrist. It was cold and rainy, and I had taken my arm out of my sweater and the sleeve had gotten a little damp. I put my arm back in the sleeve and the cool damp sleeve made my arm feel better while I was observed and then drove home. 3/28 3pm I got home and the arm the shot had been given in was sore ? the aches seemed to move across my shoulders and all over my body. 3/28 10pm ? 7:30 am, Over the course of the evening, the aches seemed to get worse and I developed a headache, so, I took 2 tylenol and went to sleep.overnight I had severe chills. 3/29 7:30 am I took 2 Alkseltzer Cold & Sinus (tylenol and decongestant) and laid back down. Around 9am I had a glass of juice ? I was extremely thirsty and this helped. 3/29 11:30am The headache and body aches continued, but the chills seemed to break with a trade to cold sweat. I took 2 more Alkseltzer Cold & Sinus (tylenol and decongestant) and got up. 3/29 3:30pm The headache and aches continue, I took 2 aleeve to manage the headache and body aches. 3/29 6:30pm the body aches and headache are better but not gone. Cold sweats starting again 7:30 ? 2 more tylenol. 3/29 11:30 2 tylenol for bed ? slept through the night no problem. 3/30 ? 8am: Woke up still achy, but the headache is significantly reduced, started feeling a little dizzy and periodic cold sweat 3/30 ? 6:30 pm still a little dizzy and marginally achy 3/31 ? 8am: mostly back to normal. The spot on my arm is still raised and tender, but in general, I feel like I did before the vaccine, suffering seasonal allergies sinus congestion and headaches. My eyes are very tired, I?m having a hard time pulling things into focus or looking at screens ? the headache on Monday was a migraine complete with severe light sensitivity. Wearing readers with blue light blocking helps my eyes feel better. 4/1 ? arm still sore at location of shot, going to continue using scar cream on bump where shot was given. Eyes still a little weak/tired. 4/3 ? arm finally quit hurting ? still sore, but not actively in pain at site of injection.

The day after the vaccine I woke up feeling achy and lethargic. The following day I got a rash at the injection site. Three days after getting the vaccine I went to Urgent care because I had a rash and my joints were swollen. I had target shaped rashes and blisters all over my body. It was extremely itchy. It was not on my face and upper chest but they seemed to be focused around my joints. My joints were a little achy. I also had pins and needles in my hands and feet. I was given Prednisone for seven days and discharged from the urgent. The rash lasted about seven days. Some of the spots were still scabs at that point. The swelling in my joints and the tingling feeling were resolved in two days after taking the Steroids. I have Eczema and Hashimoto?s disease and pre-existing nerve issues. I was told it was an autoimmune response. I have had problems with my allergies since I got the vaccine which has not happened since childhood. I am also having episodes of food triggered Eczema. It took about three weeks before I was fully recovered but the food triggered Eczema which I have not had problems with for 15 years. It does seem to have settled down a little.

Janssen COVID-19 Vaccine EUA About 3 hours after shot I started to have fever of 100.9. My arm feels bruised to the point where i can't lift it above my head without pain. It also has a small lump right where the shot was given. Day 2 very bad body pain all over and fever of 100.7. Arm still hurts bad. woke up with the worst migraine felt like a elephant was sitting on my head and no amount of asprin made it go away. Later in the day i had some nausea and this very weird sharp pain in my left knee it was like someone was stabing me with a needle every 10 mins. Now here we are on day 3 woke up with stuffy nose very bad sore throat hurts to drink anything. fever still 100 and up. have this weird kind of rash its not red or anything just bumpy on the elbow of the arm that got the shot. still have the migraine as well also the site where the shot was given is itchy.

within 5 hours of receiving vaccine - i started itching all over my body - under my arms, stomach, chest and back of neck were the most inflamed area. this has now lasted for 10 days. I'm also experiencing tightness in my chest. I feel like someone is choking/pressing on my chest from the inside. I also had a fever, massive headache and muscle pains

Two nights after the vaccine on the site, it was the size of a pimple on 04/30/2021. After that day everyday I woke and it grew, inflamed, it was firm lump to about inch and half near injection site, and grew overnight larger it was red, swollen and painful. Called my dr on 05/02/2021 and did not hear back from him at all. The lump ended up being the size of my hand, I placed iced on it, and it has went down. Each day since, I have iced it and it has gone down each day. During this time, my period it was very heavy flow for 8 days, then it stopped then began again 9 days later and lasted 7 days heavy flow again.

FEET DISCOLORATION (PURPLE/BLUE) WHEN SITTING DOWN; CALVES FELT LIKE GOING TO SLEEP; TINGLING IN FEET; YUCKY AND TOXIC FEELING; NERVOUSNESS; HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; FACIAL PUFFINESS; BAD FEELING (FELT LIKE HIT BY TRUCK); LIGHT HEADEDNESS AND DIZZINESS; PUFFY AND SWOLLEN FEET; HAND PUFFINESS; SORENESS OF ARM; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, alcohol use, and non smoker, and other pre-existing medical conditions included the patient did not had 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure. On MAR-2021, the subject experienced soreness of arm. On MAR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced hand puffiness. On 09-APR-2021, the subject experienced puffy and swollen feet. On 13-APR-2021, the subject experienced facial puffiness. On 13-APR-2021, the subject experienced bad feeling (felt like hit by truck). On 13-APR-2021, the subject experienced light headedness and dizziness. On 28-APR-2021, the subject experienced high blood pressure. On 28-APR-2021, the subject experienced shortness of breath. On MAY-2021, the subject experienced calves felt like going to sleep. On MAY-2021, the subject experienced tingling in feet. On MAY-2021, the subject experienced yucky and toxic feeling. On MAY-2021, the subject experienced nervousness. On 25-MAY-2021, the subject experienced feet discoloration (purple/blue) when sitting down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from puffy and swollen feet, and feet discoloration (purple/blue) when sitting down, and the outcome of high blood pressure, shortness of breath, flu-like symptoms, soreness of arm, facial puffiness, bad feeling (felt like hit by truck), light headedness and dizziness, hand puffiness, calves felt like going to sleep, tingling in feet, yucky and toxic feeling and nervousness 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.

45 minutes after vaccine, facial numbness, extreme itchiness on face. 48 hours later intense fatigue, aching, nausea, headache. Symptoms subsided, but then one week after shot, intense back of leg pain (strong cramp-like) on both legs (from buttocks to ankles). Taking ibuprofen/tylenol with no effect.

Developed swollen legs tight and discolored.. had a massage to relieve pressure on Friday.. started noticing Thirsday and at present have very bad vision changes that isn't normal. I also have on and off cheat pains this morning with numbness in my left arm and tingling fingers. Pain move from my right under breast area to left side before subsiding. But vision problem persists with swollen face and headache.

Injection site is red and swollen. Left armpit to upper side of left breast is swollen and hurts when pressed. I received the shot on Sunday afternoon and by Monday morning my armpit was slightly swollen but went away late morning. Today, Tuesday morning the swelling came back and is considerably larger and has not gone away yet.

I felt pain in my right arm (the opposite arm of the vaccine). And my legs and hands hurt with a lot of fatigue; the next day I ate peanuts and peanuts gave me allergy with red spots all over my body. Three days after, I ate peanuts again and it was the same. On May 15, 2021 I went to the Emergency room at Hospital, and was I treated only for my continuing arm pain. I was given Cyclovenzaprine10 MG daily. I have not recover of these reactions and I continue taking the pills.

Patient had a skin reaction possibly from covid vaccine. The following day developed shortness of breath and was sent to the ER

ITCHY WRIST; ITCHY RASH ON LEFT LOWER BACK AND LEFT SHOULDER; HEADACHE; BODY ACHE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies, no known medical conditions and no known current medication usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 07- AUG-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced body ache. On 10-JUN-2021, the subject experienced headache. On 11-JUN-2021, the subject experienced itchy wrist. On 11-JUN-2021, the subject experienced itchy rash on left lower back and left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy rash on left lower back and left shoulder, headache, body ache and itchy wrist was not reported. This report was non-serious.

HUGE BLISTERS ALL OVER TOES AND FEET; FEET HURTING; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included elevated heart rate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. Concomitant medications included losartan for elevated heart rate, and metoprolol for elevated heart rate. On 05-JUN-2021, the subject experienced feet hurting. On 06-JUN-2021, the subject experienced huge blisters all over toes and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feet hurting, and huge blisters all over toes and feet. This report was non-serious.

Fever Sweating Pain in muscles Pain in joints Skin feels hot and sensitive Dry mouth Headache Extreme Fatigue Tremors Inability to concentrate Shortness of breath Sore throat Impaired ability to work

This spontaneous report received from a patient concerned a 46-year-old, mixed race, Hispanic or Latino female. The patient's height, and weight were not reported. The patient experienced brain inflammation, inflammation of spine and pneumonia when treated with influenza vaccine for prophylactic vaccination many year ago, and drug allergy when treated with ciprofloxacin. Patient had not taken any flu vaccine since but taken other vaccines with particular no adverse reactions. The patient was not pregnant at the time of vaccination. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: not reported) dose was not reported,1 total, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, after the vaccination, patient felt dizzy, hence patient kept to the vaccine facility for 45 minutes. On 09-MAY-2021, on next day morning, she felt fine. On same day, she woke up with nausea, fever of 103.9 F, sweating and chills. On 09-MAY-2021, she also had soreness at injection site arm and started developing rash on chest, legs and both arms. She drank lot of water and administered the Tylenol and Advil. Patient took the Tylenol and Advil for first 4-5 days. After administration of Tylenol and Advil, her body temperature was 101 degrees. On 09-MAY-2021, she also had loss of appetite, sores on tongue (Inflamed, red and white) and knees joint pain in first 4-5 days following the vaccination. On 15-MAY-2021, her left side of the face was tingling and numb. She examined herself in mirror and found the left side of face was droopy and patient was drooling. Patient was scared and felt like that was Bell's Palsy. Symptoms disappeared within 18-24 hours. On 16-JUN-2021, patient had a on and off fever (body temperature is 100.9), on and off dizziness, fall because of dizziness, scraping ankle, on and off joint pain, rash, fever blister on lip and face numbness. On 16-Jun-2021, she told that joint pain was much better than when first occurred, rash was only on face and arm at that point and face numbness was much better than when first occurred. On 09-MAY-2021, Laboratory data included: Body temperature (NR: not provided) as 103.9 degrees Fahrenheit. In MAY-2021, Laboratory data included: Body temperature (NR: not provided) as 101 degrees. On 16-JUN-2021, Laboratory data included: Body temperature (NR: not provided) as 100.9 (Units were not reported). 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 loss of appetite, sweating, chills, injection site soreness, and nausea on 13-MAY-2021, was recovering from left side of face numbness, had not recovered from on and off fever, woozy /dizzy /on and off dizziness, rash on chest, legs, both arms and face, fever blister on lip, sores on tongue, on and off knees joint pain, left side of face tingling, face drooping, face drooling, and tongue inflammation, and the outcome of fall because dizziness and scraping ankle was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210634553-COVID-19 vaccine ad26.cov2.s -Face drooping. 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).

SUN REACTIVE; HIVES ON FACE, NECK AND CHEST; SWELLING OF THE FACE; SKIN ISSUES DOWN ARMS; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 260 pounds, and height was 62 inches. The patient's concurrent conditions included heavy plegic migraine, rheumatoid arthritis, and non smoker. The patient experienced drug allergy when treated with amoxicillin/clavulanic acid, moxifloxacin hydrochloride, and oseltamivir phosphate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included adalimumab for rheumatoid arthritis. On 15-APR-2021, the subject experienced swelling of the face. On 15-APR-2021, the subject experienced skin issues down arms. On 15-APR-2021, the subject experienced hives on face, neck and chest. On an unspecified date, the subject experienced sun reactive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of the face, hives on face, neck and chest, and skin issues down arms, and the outcome of sun reactive was not reported. This report was non-serious.

LEFT ARM LYMPH NODE SWOLLEN; ARM IS WARM TO THE TOUCH; REDNESS AT INJECTION SITE; TENDERNESS OF LYMPH NODES; FEVER; BODY ACHES; CHILLS; SORE ARM; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and 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: 1821286 expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported On 24-JUN-2021, the subject experienced sore arm. On 25-JUN-2021, the subject experienced body aches. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever. On 01-JUL-2021, the subject experienced arm is warm to the touch. On 01-JUL-2021, the subject experienced tenderness of lymph nodes. On 01-JUL-2021, the subject experienced redness at injection site. On an unspecified date, the subject experienced left arm lymph node swollen. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, sore arm, and fever on 25-JUN-2021, was recovering from tenderness of lymph nodes, and left arm lymph node swollen, and had not recovered from redness at injection site, and arm is warm to the touch. This report was non-serious.

Headache, chills and body aches at night the same day that I got it and after two days many head itch.

5/25/2021 Feeling of pins and needles in upper middle back and shoulder blades right and left of spine. 06/25 little bumps but thinks it was just scabies. 4/26/2021 Heart palpitation (seems to have a history of it happening once every 2 yrs.).

All over body hives started 3 hrs after receiving vaccine. 2 doses of prednisone, pepcid bid x 5 days, Singulair 10 MG at bedtime. Hives come back when off prednisone. Atarax for itching. Lymph nodes in armpits, elbows. Neck, behind necks all enlarged and swollen. Day # 28 still have hives, swollen lymph nodes. Per doctor has to run course. Not enough data

NUMBNESS IN RIGHT HAND AND FINGERTIPS; TINGLING IN RIGHT ARM AND FINGERTIPS; TINGLING IN LEFT ARM AND FINGERS; DRY MOUTH; COULD NOT EAT MUCH; FELT LIKE A TRUCK HIT; INJECTION SITE WAS RED AND RAISED FOR 3-4 DAYS; BAD HEADACHE; NAUSEA; INJECTION SITE WAS RED AND RAISED FOR 3-4 DAYS; WHOLE BODY ITCHED; INJECTION SITE WAS ITCHY; BIG HARD LUMP AT INJECTION SITE LIKE A MOSQUITO HAD BITTEN; This spontaneous report received from a patient concerned a 46 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced big hard lump at injection site like a mosquito had bitten. On 02-JUL-2021, the subject experienced injection site was red and raised for 3-4 days. On 02-JUL-2021, the subject experienced whole body itched. On 02-JUL-2021, the subject experienced injection site was itchy. On 02-JUL-2021, the subject experienced injection site was red and raised for 3-4 days. On 02-JUL-2021, the subject experienced bad headache. On 02-JUL-2021, the subject experienced nausea. On 04-JUL-2021, the subject experienced tingling in right arm and fingertips. On 04-JUL-2021, the subject experienced tingling in left arm and fingers. On 04-JUL-2021, the subject experienced dry mouth. On 04-JUL-2021, the subject experienced could not eat much. On 04-JUL-2021, the subject experienced felt like a truck hit. On 05-JUL-2021, the subject experienced numbness in right hand and fingertips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site was red and raised for 3-4 days, injection site was red and raised for 3-4 days, bad headache, and nausea on 04-JUL-2021, and tingling in left arm and fingers on 07-JUL-2021, was recovering from whole body itched, and injection site was itchy, had not recovered from big hard lump at injection site like a mosquito had bitten, numbness in right hand and fingertips, and tingling in right arm and fingertips, and the outcome of dry mouth, could not eat much and felt like a truck hit was not reported. This report was non-serious.

ITCHING ALL OVER, DEEP ITCH ON THE HANDS, FEET, STOMACH, HEAD, LEGS; FLU LIKE SYMPTOMS; HURTING ALL OVER/ACHY; MUSCLE ACHES; FEVER (DID NOT TAKE TEMP); NAUSEA; TIRED; SORENESS TO LEFT ARM INJECTION SITE; LIGHT HEADED; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis neck shoulders, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. takes muscle relaxer and med to lose weight.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. Concomitant medications included lidocaine for arthritis. On 16-JUL-2021, the subject experienced light headed. On 16-JUL-2021, the subject experienced flu like symptoms. On 16-JUL-2021, the subject experienced hurting all over/achy. On 16-JUL-2021, the subject experienced muscle aches. On 16-JUL-2021, the subject experienced fever (did not take temp). On 16-JUL-2021, the subject experienced nausea. On 16-JUL-2021, the subject experienced tired. On 16-JUL-2021, the subject experienced soreness to left arm injection site. On 18-JUL-2021, the subject experienced itching all over, deep itch on the hands, feet, stomach, head, legs. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/zinc acetate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, fever (did not take temp), nausea, tired, light headed, itching all over, deep itch on the hands, feet, stomach, head, legs, soreness to left arm injection site, flu like symptoms, and hurting all over/achy. This report was non-serious.

VOMITING; FLU; BODY ACHES; CHILLS; GENERALLY UNWELL; HEADACHE; MUSCLE ACHES; FEVER; NAUSEA; LEFT ARM PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included immunocompromised medical issue, gi upset, and digestive issues, and concurrent conditions included chronic idiopathic urticaria, cigarette smoker, non alcohol user, respiratory allergy, hives, and chemotherapy, and other pre-existing medical conditions included patient had history of drug abuse or illicit drug use of recreational drugs in her college days not recently and had not for a long time. patient has intermittent symptoms. gastrointestinal upset following episode of hives. speculate unrelated. patient had multiple drug allergies, highly sensitive immune system, had respiratory and pre-existing allergy with no known diagnosis. medical diagnosis: chemotherapy injection, 2 injections every 4 weeks. patient was sensitive to pharmaceutical products, and had multiple drug allergies opioid allergy. The patient was previously treated with omalizumab for hives, severe allergic reactions, urticaria, and cortisone for urticaria. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included epinephrine for allergy. On 09-JUL-2021, the subject experienced vomiting. On 09-JUL-2021, the subject experienced flu. On 09-JUL-2021, the subject experienced body aches. On 09-JUL-2021, the subject experienced chills. On 09-JUL-2021, the subject experienced generally unwell. On 09-JUL-2021, the subject experienced headache. On 09-JUL-2021, the subject experienced muscle aches. On 09-JUL-2021, the subject experienced fever. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced left arm pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, headache, fever, and nausea on 12-JUL-2021, flu, body aches, generally unwell, and muscle aches on 13-JUL-2021, and left arm pain at site of injection on 16-JUL-2021. This report was non-serious.

It was the Johnson and Johnson shot. Both my husband and I felt mild flu-like symptoms on the same day and yesterday. Today the site where the shot was on my arm is very red, puffy and hot. My flu like symptoms are still here, very mild

vomitting, nausea, extreme muscle soreness-whole body, extreme joint pain, extreme head ache, skin hurt to touch, fever, extreme fatigue

3/9- 1pm vaccine, injection site discomfort 9pm-chills 10pm-fever (reaching 103.8), body/muscle aches, headache through night and into morning 3/10- 12pm-fever, body aches gone, slight headache remained and tired the next day but continued to improve 3/11- No symptom but arm still sore

headache, muscle aches and pains, night sweats, fever, arm very sore at site of injection 3 days later

soreness at the injection site; muscle aches; chills & shivering; mild fever=99.7; low blood sugar; headache

Pt complaint of numbness and tingling to upper lip area 30minutes after vaccine given. Pt did complete 15+ minutes of observation in the waiting area at the vaccine site. Pt did go to her car then came back into the vaccine site to report her symptoms. O2 @ 2L/min applied. Deep breathing encouraged. No s/s of anaphylaxis occurred. Respirations easy, skin warm and dry. Pt did present with increased anxiety prior to receiving the injection. No worsening of symptoms. Family on site to transport patient home. EMS was on site. No transport to local ER needed.

I discovered patient on the floor at approx. 3:03pm. She was lying face down on the floor next to the chair she was sitting on during her 15-minute observation post-covid19 vaccine. Unknown person turned patient over face-up, Face was clammy and warm/hot to the touch. Pulse was taken (weak). Sweating. Eyes were closed when EpiPen was injected on left thigh through pants. It was decided to inject patient as we did not know what exactly happened, why she was on the floor, and she was unconscious at the time we initially thought to give epi injection. 1 pen injected. Pharmacist called emergency services at 3:05pm. Patient eventually regained consciousness while waiting for the paramedics. She was able to talk and answer questions. She was taken outside the gym on stretcher, but her son met us at the school to pick her up. She declined going to the hospital for further treatment.

Janssen COVID-19 Vaccine EUA- nausea first at 4:45am, followed upon rising by severe joint pain and an extreme migraine. It felt like my bones were made out of glass and someone had taken a hammer to my bones. My face was swollen and red. Unable to sit up. Walk from bed to toilet only. Overall, I would say extreme flu-like symptoms. Temperature 99.6 all day. I could not take the pain any further at 4:20 pm and took 1,000 mg of Tylenol. I finally fell asleep and woke up at 8:30pm and could walk again and my fever had broken. I still don't feel great, but I think the worst is behind me.

Janssen Covid-19 Vaccine EUA 3/13/21 - pain at injection site, brief dizziness. Severe fatigue in the afternoon, then chills and shaking. Slight headache and body ache (back) No fever. Took Tylenol and went to bed at 8pm. 3/14/21 - minor headache, severe fatigue continued. Slept for two hours during day and rested. 3/15/21 - felt pretty much back to normal

On the evening of March 16, 2021, I developed an itchy rash (and possible hives) from my elbows down to the tips of my fingers on both arms and from my knees down to my feet on both legs. On March 15, I had taken a long walk outside, so the rash seems to have followed exposure to sunlight, which is the same allergic reaction I have had to sulfa drugs in the past. So this made me think that potentially my itchy rash/hives could be an allergic reaction to the vaccine, but I'm not sure. I'm just reporting it out of an abundance of caution. I am taking Benadryl and using an anti-itch lotion and cold compresses. The rash/hives are still present more than 24 hours later, but even though the itchiness is bothersome, I don't think it's a severe problem. I am hoping it will go away soon. I plan to let my primary care person know via email, but I don't currently plan to see her about this unless it doesn't go away after a few days or gets worse.

Anaphalatic Shock - Rash / Hives / redness / heat / inability to communicate / swelling of the throat. Epi pen , Epinephrane in Ambulance, Steroids and Benedryl, overnight stay

Immediately broke out in a sweat and was very hot. Didn't think much about it. The staff noticed I was in some distress and kept asking if I was okay to which I replied I thought I'd be fine once I got some fresh air. Left the facility to drive home and didn't feel right, Within 30 minutes, developed chest pains, rash and labored breathing. I recognize the symptoms as the same symptoms I get when I've had morphine, which I now must list as an allergy. This lasted 4 hours, then got better. The next day around 1:00, I became ill again with flu-like symptoms and had to leave work. Headache and body aches mostly. I was ill with these symptoms for a 24 hour period. Hopefully all symptoms have passed, except my arm which is red, swollen, itchy and feverish.

Pain at injection site immediately after injection that lasted for about 30 minutes. Slight headache that started around an hour after injection and lasted approximately 24 hours. Next morning felt muscle aches, fatigue and runny nose. Felt like coming down with an illness. These symptoms lasted approx. 24 hours after injections. Felt completely back to normal again by 48 hours.

The day after I have a fever of 100.6 managed by talking tylenol and advil after 6 hours fever went back up this continued for 48 hours. Tired, headache, Very sore and weak arm. Symptoms worse from 24 hr post shot to 48 post vaccine. Tuesday (3 days post vaccine). A larger red swollen hot area appeared around vaccination site 4" by 3". This area is very sore, swollen and hot to the touch,

Redness , Rash and itching started in right side below chest in stomach area , spread to left side, neck front and back and center of the back spinal chord .

Several hours post injection: itchy hands and chest (no rash) Approximately 20 hours post injection: severe muscle cramps and tingling of hands Approximately 25 hours post injection: blacking out, chest pain, trouble breathing, low body temp (94.9), low B/P (60/40), unable to walk or stand, throat swelling up, dizziness, fatigue, profuse sweating through all clothes. My husband was monitoring me, laid down and elevated my legs above my head, took Benadryl, hydrated, and rested. When I could stand, I took a pure hot shower to warm up. I thought I was going to die. The episode started to lessen about 45 minutes after taking Benadryl and elevating legs. Much better today but still not feeling well.

Hives, wheezing, itching,rash chest tightness and respiratory issue. I was treated at the hospital. Treatment medications were Prednisone, metoprolol succinate, Benadryl.

Day 1: Chills, fatigue, aches, low grade fever (under 100). Day 2: Intense fatigue Day 3: Some fatigue Day 4: Light fatigue Day 5: Sore neck on left side, as if in muscle or lymph node, slight swelling along neck, intermittent recurring rash, extreme skin sensitivity, periodic itching various sites Day 6: Same as above. Last day reported. Symptoms still existing as of writing.

Initial onset pain at injection that lasted for over 24 hours. Fever started within 12 hours. Starting approximately 28 hours following neurological symptoms began and left side in the arm and hand. Experienced numbness and tingling from the elbow down. Sunday morning left hand and fifth finger had tremors that lasted for several hours

Chills beginning at 7 hours after vaccine, 103 degree fever as taken at 11 hours after, body aches, fatigue; normal temp at 17 hours after but fatigue, headache; low grade temperature returned at 24 hours (99.8); arm pain and fatigue still present at 48+ hours

Next day, had mild fever, headache, chills, tired, sore left arm 2nd day after vaccine, developed rash on upper body, itchy, red bumps on torso mostly

low grade fever for 24 hours. moderate headache, light headedness & fatigue for 24 hours. sharp stomach/abdominal cramps for 6 hours. injection site tenderness ongoing.

Headache, chills, low grade fever, tiredness, body aches/pains. Pain at inj. Site. Had all of these symptoms up until 12 noon in 4/5/21

It's been 2 weeks and 2 days since my vaccine and I still have a peach pit-sized lump in my left arm (under the skin). It has gotten much smaller since the vaccination, but it is still there. It only hurts if pressed on. The pharmacist who have my husband his vaccine said I should report the lump in my are to the CDC.