Johnson & Johnson

Dizzy, run down two hours after injection. Woke up 4 am then off and on with extreme body pain, sore neck , lower back, right hand and arm. Headache and fatigue at 6:45 am got up with two children (2 yrs and 10 months) ate small breakfast by 9 am I couldn?t get off the couch or stay awake. My head started aching and my eyes hurt, I felt extreme chills two thick blankets weren?t enough to warm me. Extreme fatigue, stomach pain and loss of appetite. I fell asleep and didnt have the energy to walk to my bed until 2:30 pm. It set off my stomach and I was vomiting off and on until around 9 pm. By then I could keep little bits of fluid and food down. Then I was hot. I felt flushed but had no fever. My usual heart rate is 52-54 bpm via Watch while laying down. My heart rate during this hot period laying in bed was 102 -101 bpm. Which is consistent for my workout heart rate. I went to sleep and woke up 7 am with my kids and was well enough to take care of them but not do all my usual chores. I couldn?t bend down or put my head lower than chest or the extreme throbbing headache was back. Still had body aches and fatigue but nowhere near yesterday. It is 11:22 pm Sunday and I feel spent.

I spiked a fever of 101, had joint pain in all joints except fingers and toes, my muscles ached and spasmed a bit and a had an incredibly bad headache.

Janssen COVID-19 Vaccine EUA About 6 hours after receiving vaccine, sudden onset of fever to 101 degrees with chills. About two hours after the fever began, extreme fatigue and muscle and joint pain, and left breast pain began (had the injection in my left arm). The extreme fatigue lasted for about 9 hours, during which time I felt like I could barely walk or move in bed. After the extreme fatigue passed, and for about 24 hours, I continued to experience moderate fatigue, joint and muscle pain, and headaches. A bad headache has bothered me for about 36 hours since the extreme fatigue passed. All symptoms are now clearing up (it is now about 42 hours post vaccination).

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.

"Janssen COVID-19 Vaccine EUA" Onset 8hrs after vaccine, lasted 48hrs. 24hr fever 101- 102 degrees. Severe muscle pain for 48hrs. Severe headache lasting 12hrs from onset of symptoms. Loss of appetite for 48hrs.

About six hours after the shot, I had a fever, headache, exhaustion, nausea, and muscle soreness. These symptoms lasted about 32 hours.

7:30pm 3/14: feeling feverish/flu like 9:15pm: chills starting 10:30pm/ massive chills and body aches. Migraine starting 12:00am 3/15: cold sweats, migraine, nausea, dizziness 3:00am: racing heart beat, cold sweats, migraine, nausea, dizziness 7:00am: lethargy, body aches, headache, chills 10:00am: mild headache, body aches, lethargy 2:00pm: lethargy, shaky, very mild headache 7:00pm: extreme fatigue, shaky. Nausea 7:00am 3/16: massive muscle fatigue, shaky, racing heart 1:30pm: tried to shower, loss of muscle control, very shaky, hard to breathe, body and mind slow

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

Moderate to significant muscle aches in entire body started to develop about 7 hours after the vaccine. Mild headache and moderate mental fogginess started about 8 hours after receiving the vaccine.

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.

Around 4:30PM started having headache and shivering. Around 9PM started having body ache all over.. Continued throughout the night. Next morning at 7AM only headache and soreness of neck continued. All symptoms were gone around 6PM on 3/18/21

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.

Shot at 12pm. Fever started 6pm. Fever rose to 102.7 at 11pm. Fever returned to normal at 4AM following day. Chills, muscle soarness, headache. Mild symptoms and nauseous on day 2. Return to normal day 3.

Janssen COVID-19 Vaccine EUA headache (8/10), chills, muscle pain, fever, nausea, dizziness, weakness, fatigue

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

Day after vaccine, heart beating fast, chest hurt, back aches, headache, dizzy, difficulty breathing. Lasted all day. 2nd day after shot- no symptoms. Theses side effects aren?t told To you at the time of shot. Should be a warning.

On Friday evening after the injection: Within minutes of injection: pain in arm - injection site. Continued for several days afterwards. Within 10 minutes: tongue tingled and went numb. Continued for several days afterwards. Within 20 minutes: upset stomach for the remainder of the evening. Within an hour: Fever, chills, full body muscle aches, fatigue. Slept for several hours over 2 days. Resolved by Sunday evening (roughly 48 hours).

From 5:30-11:30pm: fever, severe chills, breaking out in sweats, could not form fist with hand and severe mental fogginess. 11:30-7:30am: migraine, breaking out in sweats 7:30-8:00pm: migraine, major GI issues, stomach hurt to the touch, mental fogginess

Fever (101) started at 1:22 AM 3/31/2021 and did not break until about mid morning. Also had severe headache until approximately 9 PM 3/31/2021. Pain in joints (especially in both hips) until approximately 6 PM 3/31/2021. Nausea and light headed until 4/1/2021 morning. Very tired (slept all day on 3/31/2021).

Woke up from sleep with fever of 102.7 and shaking in chills. Took tylenol at about 4am because I could not sleep. Fever waned to 101 and came back at 11am at 102 degrees. Started feeling nausea around noon and had body aches in my joints, specifically my hips and left elbow. Took Tylenol again. Fever continued until around 7pm and then it lowered to 99.1. By 8am the next morning all symptoms were gone and temperature was back to normal. The injection site and arm never hurt besides joint pain.

My back started hurting, then my legs aching , starting getting massive chills. Whole body ached. Was really cold. For 2 days whole body ached.

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

I was feeling ok and then all of the sudden I stated feeling bone and mussel ache, chills, mild fever, shivering, tiredness, headache. I had to lay down and remain in bed until next day. Day after felt very ache, no more chills. Very tired and headache

Headache started in the evening progressing to migraine by 11pm or so. General muscle aches and loss of appetite same evening.

NECK PAIN; SICK (AFTER ABOUT 8 HOURS); CHILLS; HIGH FEVER; NAUSEA; 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: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 11-MAR-2021, the subject experienced neck pain. On 11-MAR-2021, the subject experienced sick (after about 8 hours). On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced high fever. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, chills, high fever, nausea, and headache on 13-MAR-2021, and the outcome of sick (after about 8 hours) was not reported. This report was non-serious.

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.

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.

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

Extremely Swollen eye on right side of Body. Pain on right buttocks and back of leg. All over achy. Stuffy and flu like symptoms

Metal Mouth within 15 minutes; 5 hours later sever chills and violent shakes for the next 8 hours; resting heart rate between 96 to 100 bpm (my average resting heart rate if 65-68 bpm) until 18 hours after receiving the shot; no sleep the first night after the shot; intense headache that over the counter medicine could not help nor did meditation; my body was shaking so hard it threw out my hip and muscles in my back spasmed; hard to walk; joint pain in back, arms, and legs; fever up to 102; the following 24 hours after the first day felt like I had COVID with a cold, sinus headache, exhaustion, and body aches. Second night difficult sleeping as well.

J&J one shot vaccine-Dizzy/Nauseous/winded easily/Hot to touch but freezing (no temperature)/Sore upper back and shoulders. Started immediately-then I felt fine until I woke at 3am with more pronounce symptoms

Fatigue, intense full body pain, rapid heartbeat, winded by just walking, diarrhea, loss of appetite, chills, sweats, fever, abnormal headache- shooting pain in back rt side of head Fever broke after about 24 hours. Heartbeat, breathing, chills after 36 hours. Pain and fatigue lasted 48 hours+ Able to eat after 48 hours . Still have headache but not severe.

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.

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.

Had a sore arm within hour of shot (got it at 7:30pm). Felt a little yucky before going to bed. I made sure to hydrate significantly before the shot and after. I woke up at 3am with chills and had them for about an hour. Woke up the next morning at 9am with with medium neck and head pain and feeling a little chilly and out of it. Mild ache in joints and body overall. At 10am I took one ibuprofen, but at 11am (200mg), kept pushing fluids. 11am headache got worse temp 98.7 (slightly high for me, I am usually about 97). Started having some gastrointestinal issues around noon. Felt nausea and sweaty palms loss of appetite. Had a bowel movement (normal in appearance). That all seemed to pass and I felt better, still tired, for most of the afternoon. Arm was sore to the touch and when moving. I managed to eat a few small meals, kept up hydration, and took a nap late in the day. I woke up at 5pm with headache and body aches all over. No appetite again. Had very little to eat, kept hydrating, At 7pm my vision got a little blurry and I had a minor vasovagal episode. Center of vision blurred, got chills and sweaty, nausea, and I had to poop (it was less formed). I rested, cool compress, and raised my feet. It all passed in about 20 minutes. I had major loss of appetite rest of the night (couldn't eat anything), kept hydrating, and went to bed. Slept through the night with no incidents. Woke up at 9am second day and had a small breakfast, though my appetite is still not back. Generally feeling exhausted, but no headache or aches in the body anymore. My arm is still sore. Had some more GI distress (another less formed poop around 11am). My appetite returned by early afternoon on the 2nd day post-vaccine. Still tired and generally feeling "off," especially mentally. Had brain fog all afternoon and my ears felt plugged today. Hard to concentrate on a task.

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.

Constant pinching headache, ears clogged, chills and sweats for two days. From waist down: leg weakness, nerve pain (like sciatica pain), diarrhea and couldn?t control pee twice on the night of the shot. Took Tylenol pm to be able to deal with pain and sleep a bit Feeling better today but leg pain is still strong

I immediately felt dizzy. Within a few hours, I became very tired and lightheaded. Within 12 hours, I had severe muscle aches, chills, headache, and a fever of 102 degrees. The fever and chills lasted 24 hours. The fatigue and light-headedness have continued for 7 days without stopping.

pt developed right hamstring pain approx 1 week after vaccination. Denies headache, abd pain, sob. Scheduled to f/u with PCP today.

(all events/symptoms resolved without treatment) fever (Tmax 102.6) x16hr chills x12hr headache - resolved in <48hr body/muscle aches - resolved within 48hr lightheadedness - resolved within 72hr fatigue - resolved within 72 hr

Pain in right arm immediately after the injection, couldn't move it for 30 minutes, blurred vision, heart palpations (first 30 minutes), throughout the day I felt foggy and strange, by 6pm I had a fever, horrible muscles aches and headache, became extremely nauseous all night and my muscles and joints hurt so bad I was crying (and I've had five kids with a high pain tolerance), fever, and at 6am my fever broke with a sweat. I felt clear headed but exhausted for the rest of the day. My chest has been tight and congested since then. Hard to breath and my voice is rough and raspy. This is ongoing and I still have chest tightness and a raspy voice. On 4/12/21 I started having horrible joint and muscle aches again throughout my body and felt so tired. Horrible headache and stomach pain, bloating and nausea.

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.

About 30 minutes after receiving the J & J vaccine, my left arm, and then left leg began to feel heavy and intermittently tingly (that was not what I consider the adverse event, but I want to give you the full context). Then approximately 40-45 minutes after the vaccine was administered, I was sitting and typing on my computer when out of the blue I felt considerable tightness in neck. The sensation began at the base of my neck and moved upwards across my neck and rose into my head. At that point, it felt like my neck and head were in a vise. That continued while at the same time it felt like there was a great deal of pressure directly on my sinuses. This all continued for 1-2 minutes, at which point the tightness in the necks diminishing until I did not feel it any long. The tightness and pressure in my head lasted another 10 minutes or so. It gradually diminished, before fully dissipating after. The entire event lasted about 12-15 minutes and was very scary, as nothing like that has ever happened to me. Once it was over, I continued to feel heaviness and intermittent tingling in my left arm and left leg for another couple of hours. By the next day the heaviness was gone, but I was a bit congested and had a headache. I didn't know who to report this to until the J & J vaccine administration was halted and it occurred to me that maybe my experience should be documented and reported. A friend found this website for me.

Day 16 post vaccine: significant top of foot/ankle edema with pitting edema also minor swelling up to groin (~1cm larger compared to right up the leg). Right lower leg and F&A also had minor pitting, but not the pronounced swelling seen in the left. Did self MLD massage, elevated and wore compression. Tingling in left leg overnight and felt heavy. Called doctor's office as soon as they opened on Day 17 post. Saw them that afternoon. Swelling had already gone down significantly either on its own or due to compression, elevation, and massage. Practitioner noted pitting edema in both ankles, more pronounced in left. It was not painful or warm, so she ordered a D-dimer test if I still had swelling over the weekend. Since swelling continued to improve, nothing else was done.

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.

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.

shortness of breath No energy Fever 103 for two days, Tylenol didn?t work to break it Full body sweats. I had to change my bed sheets 3 times in four days Body aches Sore in legs, neck and inside of my arms Dehydration The inside of my left arm still hurts and throbs (not where I got the shot)

Within 4 hours of receiving the vaccine on 3/9/21 I felt exhaustion, body aches, chills and headache. About 30 hours later I started to experience extreme leg pain/tremors, severe nausea and an unrelenting headache, lower back pain and continued chills. 6 days after receiving the vaccine (3/15/21) I tested positive for Covid-19 and the symptoms worsened. 8 days after receiving the vaccine I developed a cough and sore throat and trouble breathing. 10 days after receiving the vaccine I went to the emergency room (3/19/21) and received a chest x-ray and diagnosed with covid pneumonia and given antibiotics to treat along with a CT scan. Symptoms started to subside about 2 weeks after receiving the vaccine, although to this day I am still troubled with a lingering headache and constant fatigue. Throughout the duration I relied on Tylenol and Motrin. At the hospital I was prescribed indomethacin and ondansetron for pain and nausea.

Patient stated on 4/15/21 at the pharmacy that she still has a headache and neck stiffness from the vaccine. still taking tyelnol over the counter to treat headache

Chills, fever up to 102.5, headache, fatigue, mild nausea, muscle aches, joint pain, minor shortness of breath, feeling of lightheadedness/dizziness, feeling like my vision was off/blurry and was... crowded, like the edges of my vision weren't entirely 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.

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 .

Later that day I started getting pain in the hip/groin area of my left leg preventing me from putting pressure on it or walking. The acute pain diminshed after about 3 hr and I could walk again but the hip flexor area remained tender and felt like a sore muscle had been pulled for about 3 days. About 5pm I developed really bad chills which lasted about 24 hrs and was really intense about the first 6hr. About 11pm I developed a severe headache preventing me from sleeping which lasted about 9hrs. 4/10 I had occassional chills, the headache had subsided a little but had a nagging tension feeling and I was really fatigued and really wiped out the remainder of that day. My Gynecologist advised I stopped taking my Birth Control for the next month to lower my risk of blood clots.

48 hr fever, 72 hr muscle pains, headache, eye pain ( severe flu symptoms) slight cough with asthma symptoms

8hrs after injection onset of fatigue, Fever with chills, body aches, major lower back aching, nausea, dizziness restlessness. Lasted for 24 hrs. Majority of symptoms have subsided. Random lightheaded and dizzy spells have continued multiple times daily, with occasional nausea.

Stabbing pain sensation ALL OVER BODY in random places each time - legs, chest, head, neck, feet, arms, hands, toes, fingers, inside mouth - everywhere. It?s like someone is stabbing me inside my veins. Nothing helps it. Also loss of bladder control. Pectoral muscle on left side is extremely swollen and painful, my neck hurts so badly at night that I have to sleek sitting up. Please help. My doctor doesn?t know what to do.

Patient first reactions were within the first 3 days of extreme fatigue, shortness of breath, palpitations, and extreme headache of migraine magnitude. Leg pain, heaviness to legs, difficulty to walk was a week after vaccine. Easy bruising and swelling 2 1/2 weeks after vaccine. Palpitations never went away.

My first period after the vaccine arrived 6 days early, which is quite abnormal for me. The day before I couldn't work at my desk due to pain in my low back and hip flexors, which is also abnormal. Then the period was heavier than normal lasted 3 days longer than normal. It looked like there were clots in the blood. I mentioned this experience to a friend, who said several of his female friends also experienced bizarre periods after receiving the JJ vaccine. Was this drug tested on women of reproductive age before being released?

One day after vaccine I missed worked, was in bed all day with fever of 101.8, headache, body aches, abdominal pain etc. On 4.2, I couldn?t breathe after attempting a lower-than-normal intensity elliptical workout (I do 60+ min elliptical workouts 5x/week and 6+ mile walks the other 2 days/week). Following that event I had significant trouble getting a full breath and had dull upper left back pain and very localized pain in upper left abdominal area/lower left rib area that got worse at night. I had a telemedicine appointment with my pcp on 4.14, was Rx?d advair and albuterol. Had another telemedicine with my pcp on 4.16 because breathing and localized pain were more concerning. PCP sent me to the ER. At the hospital ER they found elevated troponin-I and an abnormal ekg (normal chest X-ray and cat scan) and diagnosed me with an NSTEMI heart attack. They transferred me the other hospital where they did more testing. Troponin-t was normal, ekg was determined to be a normal atypical variant. I completed an exercise stress test and the cardiologist determined that I would not have been able to complete the full 15 min with no abnormalities if I?d just had an NSTEMI so they changed the diagnosis to Acute Myocardial Injury. On 4.23 lab results showed troponin-I is still elevated. I still cannot Get a full breath and still have some left back and lower rib pain

- 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.

Fever greater than 101 for 18 hours post vaccination along with muscle body aches. Regular menstrual cycle followed by 2+ weeks of spotting, headaches accompanied with nausea.

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.

Severe muscle and joint pain lasting about 36 hours. 7-7-8/10 on pain scale. Fever of 102.3 lasting for about 8-10 hours. Fever broke early morning Saturday. Sweats and severe chills that caused entire body to shake lasting about 6-8 hours Friday night. No OTC meds helped. Tried Advil and Tylenol. Stayed in bed and waited it out. Decided not to call doctor after reading info booklet on vax saying it was ?normal ? reaction to have pain, fever, sweats and chills. All symptoms were subsided by Sunday evening.

My period was delayed in starting/started about 7 days late and then I had menstrual bleeding for 18 days that was very heavy. This is very irregular for me. I did also have a fever of 102.9, myalgias, chills, and joint pain on 3/31-4/1/21 right after receiving the vaccine

Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: syncope episode, did not pass out, pale,sweating,visual changes-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: vaccine 2:40pm, CC@ 2:55pm, sweating, visual changes, sweating, feeling of going to pass out, cold compress, vitals BP 93/55 pulse 81. slight tingling feeling in hands, pale, laid on floor/feet elevated, monitored and after 30+ additional minutes felt better,sipped some water& walked out of store, advise lots of water/rest/come back or ER if further issues

Feeling very sick since vaccine, night sweats, diarrhea, Dry heaving in morning, loss of appetite, weight loss, flu like feeling, fatigue, aching, lack of concentration, no fever

Later during the night after the vaccine I developed a high fever, body aches for about 24hrs which caused me to sleep the next day. 2 weeks later I developed a bacteria infection in my right eye and possibly bronchitis so I went to the Urgent Care and was treated with Z-Pack and steroids. I feel alot better but I still have a little lingering cough. This past Friday I woke up with a pain in the right side of my neck which got worse so I went to my PCP on Sat who diagnosed me with Carotidynia where he states my corotid artrery is inflammed and was prescribed an antiinflammitant Diclosenac with the intents of decreasing the inflammation.

Was diagnosed with a DVT 3.5 weeks after vaccination. Started experiencing symptoms of DVT 20 days after the vaccine. Symptoms were not atypical and were almost not checked for DVT at ER. Started with twinges in my right leg for several days. Then pain in my back right behind my heart. Then developed sporadic chest pain and heart palpitations. I was afraid to go to the ER because of COVID because my 12-year-old daughter has a heart condition. Then on April 30 mid-day my right thigh began to hurt like a pulled muscle although I had not injured it or pulled it. I couldn't walk on my leg the pain was so intense. My family was very worried about a blood clot because of the Johnson and Johnson vaccine. That night I had really sharp chest pains and my thigh pain was no better by the next morning. I went to the ER told them my symptoms. After the ER doctor examined me he said he was 99% sure I didn't have a blood clot because my pain was in my thigh and there was no redness or swelling. He told me my chest pain was probably due to anxiety. I asked if he would check my leg anyway. Once the ultrasound of my leg was done the DR came back and said I had a DVT. Then I had to have an MRI of my chest which he told me was a lot of radiation. I did not have a PE. They did not prescribe Heparin because they felt the DVT was from the vaccine. So I was giving Eliquis. Since then my family DR has run more tests and I do not have any genetic reason to have the DVT. I do not and have not taken birth control in the past 20 years. I am now on a blood thinner for at least 90 days if not longer and I am continuing to have twinges and chest pain twinges.

4 hours after administration bilateral leg.thigh numbness. Could still walk. 18 hours after administration had severe mid back pain, that limited ability do activities.

MULTIPLE BLOOD CLOTS ON BOTH SIDES OF THE LUNGS/NAUSEA(THREW UP BLOOD TWICE)/BLACK STOOL (WAS LIKE DIARRHEA)/FEVER/OXYGEN WAS ON 80S/; WEIRD TASTE (AWFUL); BONE PAIN/BONE PAIN AS BONES FELT LIKE A GLASS/PAINFUL (ANYTHING THAT TOUCHED WAS HURTING); SORE ARM; POSITIVE COVID TEST (RAPID TEST)/CAME POSITIVE BOTH TIMES; HEADACHE; This spontaneous report received from a patient concerned a 40 year old White and Non Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported,1 total dose administered on 10-APR-2021 on left arm as prophylactic vaccination. Batch/Lot number was not reported and has been requested. No concomitant medications were reported. The patient was not pregnant at the time of reporting. On 10-APR-2021, 5 hours after the vaccination, the patient started experiencing headache. On an unknown date the patient experienced sore arm for about a week. On an unknown date the patient experienced bone pain as felt like a glass, painful and anything that touched was hurting. On an unknown date the patient experienced weird taste that was awful. On 16-APR-2021 the patient tested positive for covid-19 (rapid test) (coded as: suspected covid-19). On 17-APR-2021 the patient was again tested positive for covid-19 (rapid test) on both time tested as positive. On 17-APR-2021 the patient experienced 2 episodes nausea (threw up blood twice) before visiting hospital and at the hospital. On an unknown date the patient experienced black stool (was like diarrhea). On 18-APR-2021 the patient had body temperature 100.8 to 100.9 and went to hospital again there diagnosed with multiple blood clots on both sides of the lungs. On an unspecified date the patient was taken with tums and pedialyte for an unknown indication. The patient was treated with tylenol (for an unknown indication), nausea medicine, steroids, blood thinner and oxygen (for oxygen level in 80s). On 21-APR-2021 the patient was discharged from hospital. The patient was hospitalized for 4 days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. On 26-APR-2021 the patient was recovered from headache. On an unknown date the patient was recovered from sore arm and not recovered from multiple blood clots on both sides of the lungs/nausea(threw up blood twice)/black stool (was like diarrhea)/fever/oxygen was on 80s/, and the outcome of positive covid test (rapid test)/came positive both times, weird taste (awful) and bone pain/bone pain as bones felt like a glass/painful (anything that touched was hurting) was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000179162 The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20210521944.; Sender's Comments: V0: 20210520244-Covid-19 vaccine ad26.cov2.s-multiple blood clots on both sides of the lungs. 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).

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.

The next day after about 24hrs later I felt feverish but did not have a temp. I developed a lower arm pain in the elbow to wrist area which caused me to not be able to use it, it had no strength and hurt very bad which lasted for about 3 weeks and finally went away on its own with no other symtoms.

Headache, severe fatigue, arm pain, loss of appetite, GI upset, low grade fever, light headacheness, back pain,

spinal cord inflammation causing drop foot, reflex deficiencies, back, hip leg and foot pain. Numbness and nerve pain in leg and foot

The side affects: fever, body aches, headache, and flu-like symptoms (chills, sweats) and that lasted between 11:00 am - 03:00 am Tuesday morning. What continued was the extreme body and joint pain. That was probably about a 6 or 7 on the pain scale. That lasted from Monday and then on Thursday and Friday I couldn't sleep because of the pain. I called the doctor because there were things on the news about calling dr. with leg pain. I couldn't bend down and pick up anything. It felt like I had horrible arthritis. Dr said to take Advil and Tylenol if I needed help - that helped when I slept. I have a very physical job that probably made it worse - lifting and pushing - it would be worse.

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.

I started noticing a headache and my neck got really stiff about 5 minutes before I started vomiting violently. I felt better for about 30 minutes after vomiting, but I started vomiting again. I started to have blinding pain in my head. By 6pm, I was having muscle and joint pain so I went to the ER. I tested negative for COVID. I received some IV drugs, but I'm not sure of the name. I was also tested for Lyme disease, but I never received the results. Nothing was confirmed about my adverse event, but it was guessed that I was experiencing migraines. I also received IV fluids. Around midnight I felt better and was released from the ER.

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

BLOOD CLOT IN RIGHT CALF; BLOOD CLOT IN LEFT LUNG; COULDN'T WALK; FATIGUED WHEN WALKING; MUSCLE PAIN; WALKING SLOW / STUMBLING; LEFT CALF PAIN; This spontaneous report received from a consumer concerned a 40-year-old female of unknown race and ethnicity. 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:1808980 00040604, expiry: not reported) dose was not reported,1 total, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. In APR-2021, about a week after vaccination, the patient experienced right calf pain/right lower leg pain and muscle pain. Patient was unable to walk, experienced fatigue while walking and was out of breath/unable to breath and on 20-APR-2021, the patient went to the urgent care (Emergency room) and then to the hospital. At hospital, patient had done Ultrasound Test and found blood clot in right calf (right leg) and in left lung. Patient was unable to breath. At hospital, patient was given with medication for blood clotting. After taking medication, patient was able to take breath. On 21-APR-2021, patient was discharged from hospital with medication to prevent blood clotting. Patient was hospitalized for 2 days. Patient was taking the medication one each in morning and evening. On 02-JUN-2021, patient was still walking slowly, tumbling and was not able to walk. On same day, patient also had a pain in left calf and fatigued. On 03-JUN-2021, patient went to the Emergency room(ER). Laboratory data included: Ultrasound scan (NR: not provided) which showed a blood clot in the right leg and left lung. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigued when walking, had not recovered from couldn't walk and left calf pain, and the outcome of walking slow / stumbling, muscle pain, blood clot in right calf and blood clot in left lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210607546-covid-19 vaccine ad26.cov2.s -Blood clot in right calf, Blood clot in left lung, Couldn't walk. 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). 20210607546-covid-19 vaccine ad26.cov2.s -Fatigue when walking, muscle pain. This event(s) is labeled per RSI and is therefore considered potentially related.

patient started having headache a week after vaccination. Within 6 weeks, patient was found to have headache on the left side of her head, and then developed right sided blurry vision and RUE numbness/weakness. Per EMS, patient was having word-finding difficulty. Last known normal: 19:10 5/17/21. Patient got diagnosed with acute ischemic stroke that required tPA.

On 6/4, started having muscle ache when she woke up. On 6/5, states has bell's palsy (side of face is pulled down, cannot squint right side)

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.

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.

Severe joint pain in right hand started 9 hours after vaccine administered. Slight nausea and severe headache upon awakening at 4:45 am. Slightly elevated temperature (100.1). Currently 25 weeks pregnant.

I got the shot on the first day of my menstrual cycle. About two hours after getting the shot, I experienced excessive bleeding for the next seven hours. For four of those hours I bled through a Tampon every half hour. In addition, to the bleeding, there was a lot of lower back pain, pain in the hips and general pelvic region.

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

So about ten hours after the vaccine, I had a fever and left work not feeling well. I had a fever all day Tuesday and then Wednesday I was nauseas and had muscle pains as well. I have also had sharp pains in my back and shooting into my legs, I cannot get dressed by myself or go to the bathroom. I have not ever had any problems before. It's like a sciatic pain, a back pain. I went to the Dr. Wednesday or Thursday (21st or 22nd of July), I am not sure when. The Dr. can't really do anything for me except take Tylenol. I have an x-ray scheduled, and my next step is Chiropractic work and possibly Physical therapy. I struggle daily just to do my normal daily activities at this point.

Facial numbness on right side Extremely sore joints in the neck, arms, hands, legs, feet Headache Fever

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

Fine the day of the shot (5/6/2021), woke up the next day (5/7/2021) with headache, joint pain, muscle aches, fever, nausea, dizziness and what felt like severe heartburn, frequent urination and stomach pain. As of 5/8/2021 all symptoms have subsided except for let arm still being a little tender, a little sore in left neck and that's it. Everything seems to be fine now

When I woke up the next, I had severe muscle pain for the whole body, chills, nausea, headache, sharp pain to the back of the head. Today (3/10/2021) I don't feel muscle pain for the whole body, chills, nausea but I have sharp pain inside left ears, headache and dizzy.

Fever reaching 102.5, chills, muscle aches 9 hours following vaccination Acute appendicitis - approximately 20 hours following vaccination

fatigue starting 7 PM and continuing to present (1 PM following day) headache, fever and chills 8 PM to 8 AM muscle ache 2 hours after injection and continuing to present treated with ice packs, tylenol, rest

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.

Muscle soreness, 102.7 fever, tiredness, headache. Started around 4 pm day of shot. Took 2 Tylenol at 9:30 pm that night.

fever, fatigue, nausea, sweating, dizziness, runny nose. Started with a fever and fatigue, took Advil for muscle aches, Through the night I had sweating and nausea. I had dizziness upon standing the next day after the vaccine. About 48 hours after vaccine, I developed a burning sensation in my nose and had a very runny, stuffy nose for one day. By day 3 after vaccine, everything went back to normal.

Numbness and tingling in the opposite of arm of injection site. left arm begin to feel heavy after injection

Nose bleed followed by fatigue, muscle aches, headache, and fever. Symptoms started 5 hours after injection and lasted approximately 15 hours.

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.

Severe headache, muscle aches, chills and fever over 100 degrees. Effects started approximately 12 hours after the vaccine was administered and lasted roughly 36 hours.

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!

fever, chills, body aches, headache, fatigue, dizziness for 12 hours headache, fatigue for 36 hours muscle fatigue for 5 days Tylenol for treatment

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.

headaches continuing into 11 days post vaccine liver pain flare up began post vaccine fatigue and muscle aches that began post vaccine

Moderate joint pain, especially in shoulders, elbows, low back and hips. The next day very early in the morning lasting for 2-3 days

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.

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.

Day 1: Ten hours later: exhaustion, body ache, fatigue without being able to sleep, diarrhea, headache Day 2: Extreme body ached and headache Day 3: spaciness and exhaustion Day 4: Joint cracking with movement Day 5: Mild/nothing Day 6: Fever and chills

BODY TEMPERATURE GET LOW; CHILLS; HEADACHE; NAUSEA; DRUG USE VIA UNAPPROVED ADMINISTRATION ROUTE; OFF-LABEL USE; TIREDNESS; MUSCLE PAIN INCLUDING CHEST AND BACK; STOMACH ACHE; DIARRHOEA; BODY ACHES; SORE THROAT; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 158 pounds, and height was 62 inches. The patient's past medical history included rash, vomiting, nauseas, pass out, and tachycardia, and concurrent conditions included non-alcohol user, non-smoker, latex allergy, clindamycin allergy, and hydrocodone allergy, and other pre-existing medical conditions included the patient had no history of drug abuse. the patient did not have acute illness 30 days prior to vaccination. the patient did not have significant family history of diseases or hospitalizations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 18:45 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced stomach ache. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced muscle pain including chest and back. On 12-MAR-2021 18:45, the subject experienced drug use via unapproved administration route. On 12-MAR-2021 18:45, the subject experienced off-label use. On 12-MAR-2021 18:55, the subject experienced body temperature get low. On 12-MAR-2021 18:55, the subject experienced chills. On 12-MAR-2021 18:55, the subject experienced headache. On 12-MAR-2021 18:55, the subject experienced nausea. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Done, COVID-19 PCR test (NR: not provided) Negative, Negative, Negative, Urine analysis (NR: not provided) Done, and X-ray (NR: not provided) Done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, chills, and body temperature get low, and the outcome of stomach ache, diarrhea, sore throat, tiredness, muscle pain including chest and back, body aches, drug use via unapproved administration route and off-label use was not reported. This report was non-serious.

I experienced slight nausea, awake all night, felt like a stimulant to me, fever, chills, sweating, migraines. I felt super tired but my body would not let me sleep. I also had muscle aches and cramps with lower back and leg with a throbbing sensation. This was within 12 hours. About 5 days later, my eye started to hurt, went to se my eye doctor and they found out I have ocular herpes. I am on now on some antiviral eye medication. I could tell after the vaccine I had a viral type infection. I still have not recovered and I will see my eye doctor tomorrow.

Headache - severe Tinnitus Diarrhea Fever 102 Joint pain - hips Muscle pain - whole body Shaking Chills Feeling of dread/hopelessness

First of all the site doing the administration was dirty and no gloves were used. Non sanitary storage of vaccines and bandages. Approximately 10 hrs post injection I had a 101.1 fever, chills, sweats, headache, unbearable joint pain, headache, and nausea. Symptoms are ongoing still now. Fever has broke but other symptoms remain although seem to be lessening 36 hrs later

Chills, "COVID inferno" AKA hot all the time x 5 days, fatigue, dizziness, myalgias (full body), nausea

Upon waking up the next morning (18 hours after receiving the vaccine) I felt very ill. I had a 100 degree fever, chills/sweating, widespread muscle aches, headache, nausea, joint pain, severe fatigue and an overall feeling of being unwell. These symptoms lasted 24 hours, but I am still experiencing nausea and am now experiencing mild dizziness also.

Fatigue, chills, headache, muscle ache. Noon to midnight on 4/3. Took Tylenol and symptoms subsided.

About 45 minutes after I got vaccinated I started to feel a strange sensation (a kind of tingling) in the right side of my head, inner ear, and jaw. Then about 15 minutes later I felt the sensation in the right side of my tongue. The best way I can describe it is similar to the same sensations I feel when the Novakane is wearing off after having a cavity filled. It's Monday (4/12/21) and I can still feel it a tiny bit in my right ear, where my jaw connects (right side), and my right cheek. Hopefully, it will go away when the stiffness in my shoulder goes away. Also, during my 15 minute waiting period I had the same tingly sensation going down my arm to my fingertips, but I was told that some people experience that sensation as the vaccine moves throughout their body. Other than that I experienced the stated side effects.

11pm: Fever, chills and muscle aches 3am: Chills and muscle aches worsen 6am: Weak and short of breath 7:30am: Body begins to tingle, cant really feel hands or feet, trouble breathing, shaking, eyesight worsens, chest tightens, headache 7:43am: Call husband for help, begin sweating a lot 8am: Call 911, begin convulsing, trouble talking, cant see well, trouble breathing, urinate on myself Continue to have convulsions. Taken by ambulance to hospital. Continue to have involuntary contractions, tightening of chest, trouble breathing, bad eyesight, headache. etc. Diagnosed with Dystonic Reaction and Neurologic Problem because of a vaccine complication

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

4/7/21 @ around 2:00 pm - dizziness, headache, "tunnel vision" and felt faint. I drank water, stopped activity (walking) and rested. It passed within about 30 mins. These dizzy spells have reoccured 4 times since then. 4/8/21 @ 2:15 am - fever of 101.8, chills, muscle spasms, extreme muscle aches all over body esp in back and legs, **unable to use my hands freely. My hands became very ridged and I could not open or close them well. I could not hold a glass of water to take a Tylenol. I finally did take a Benedryl and a 500 mg Tylenol. These symptoms lasted until around 5:00 am when I dozed back off. I woke at 7:00 am feeling tired and had a bad headache. My back and legs were still aching but were much better. 4/8/21 all-day - fatigue, bouts of dizziness, and nausea. 4/8/21 @9:00pm - diarrhea for about 4 hours. Stomach pain. 4/9/21 @ around 3:00 dizziness that last about 30 mins 4/10/21 throughout the day - diarrhea and stomach pain 4/11/21 - tired and headache persists. I started to feel more normal. 4/12/21- headache still there. Won't go away. I feel "foggy" and unable to think about things as I normally do. I returned to work today and still feel "yucky". I feel as though I'm recovering from the flu.

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.

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.

Foot heaviness, pain infrequently in right and left pain. rotating pain in the body ( abdominal, leg, arm). Dizziness for 5-6 hours on 04/12/2021. It subsided afterwards. Breathlessness for 3-4 days.

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.

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.

Severe headache (stabbing pain right temple) caused body to sweat from pain night sweats severe joint aches and pain brain fog memory loss dizzy weak vision impairment tiredness fatigue nausea severe rib pain (left side) - hard to breath with it

Fever, Chills, headache, body aches. Severely Stiff neck Severe Headache Locked Jaw-unable to open and close Vomitting

Reaction started with dizziness and weakness in the shower, followed by intense shivering and chills for 1.5 hours. Then I developed a fever of 100.8, which lasted 2 hours. During this time, I experienced nausea and vomiting, along with muscle pains and body aches, particularly in my back and legs. The nausea lasted 5 hours. The muscle pains lasted 8 hours. I also experienced headache and thirst that lasted 10 hours.

Extreme nerve pain in hands and arms. (Neuropathy) This pain is debilitating at times. The pain causes me to be unable to perform daily tasks. The pain dissipates at times and then comes back. Tingling and pain around spine.

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.

Severe back pain and shooting pain down both legs beginning on 4/2/21 Severe shoulder pain beginning on 4/2/21 Migraine headache beginning on 4/5/21 uncontrolled by medication Loss of facial muscle use on 4/7/21. Went to emergency room on 4/7/21 Conditions treated: facial nerve palsy likely in the setting of Johnson and Johnson COVID vaccine, elevated CSF protein, headache, unspecified, parenthesis of hand

Pt states that she experienced low back pain and extreme fatigue after imz but resolved in 24 hours. On Sunday, (4/11/21) which is roughly 3 weeks later pt noticed pain in lower right leg (calf) which was warm and tender to touch. Pt went to urgent care and was immediately sent to ER. Diagnosis was DVT in right lower leg . Pt was administered 2 shots of heparin injection in abdomen and discharged on Eliquis. Pt followed up with PCP on today 4/14/21 and was told to continue Eliquis and to follow up in 1 week for another ultrasound to ensure medication is working.

Increased chest pain & pressure; Increased shortness of breath; increased kidney/flank pain; brief episode of tremors, severe chills

Extreme exhaustion, unable to think clearly, in a dream like state, body ache, muscle weakness and twitching, fever, nausea, vomiting

Monday evening after vaccine - fever over 101, chills with uncontrollable shaking, rapid heartbeat that could be felt within eyes, nausea, muscle aches & pain - including back and left leg Tuesday morning through Thursday - lower fever, pain in leg continued, shortness of breath, fatigue

Dx: Acute DVT of the left posterior tibial vein (distal to popliteal) shown on US, opted for repeat CBC next AM to confirm platelet count stability and US in 1 week to assess DVT progression vs stability Symptoms: Headache, nausea, myalgia, shortness of breath, forgetfulness, leg pain starting from bilateral feet cramping

Immediately after the JANSSEN vaccine I felt tenderness in my jaw that lasted for about two days. My body was sore, my Legs felt like I was having cramps ?growing pains? I also was experiencing allergy/asthma like symptoms that included difficulty breathing and shortness of breath that worsened over time I couldn't speak in full sentences or laugh I was unable to walk 10 steps without gasping for air, after a couple of days of trying to maintain and cope with my theses symptoms. I couldn?t take it anymore, as I was preparing myself to go to the emergency room. I got into the shower the steam from the shower felt like it was suffocating me and I passed out my children took me out of the bathtub and rushed me to the emergency room where I was given several tests that include x-ray, CAT scan, artery bloodwork and vein bloodwork. I was being treated for asthma and given several different breathing treatments and steroids, unable to keep my stats at a decent level and the hard rebound even after continuous treatments, I was admitted because the breathing treatments were not effective. I am still uncertain of the ?actual outcome? the Hospital doctors treated me for an asthmatic episode and gave me directions how to handle my asthma i was prescribed prednisone and referred to my primary that would then refer me to a pulmonologist and cardiologist. At the hospital I was told that there was black spots on my lungs I was told that I was being treated for infection, but then also told it could be pneumonia no certain answer was ever given and i was given and antibiotic and was also told that I needed to see my primary for a way to maintain my asthma. The antibiotics seem to work for a couple of days and again I'm back to having difficulty breathing, shortness of breath, muscle pain soreness and mild lingering headaches. STATUS ASTHMATICUS ASTHMA EXACERBATION ACUTE TRACHEOBRONCHITIS SHORTNESS OF BREATH

BACK PAIN; FEVER; 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, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced back pain. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and back pain was not reported. This report was non-serious.

HEADACHE ELEVATED TO MIGRAINE; SEVERE BODY ACHES; SEVERE FATIGUE; HEADACHE; NAUSEA; FEVER; BONE ACHE IN LOW BACK, HIPS,BONES CONNECTING SPINE; FEELING DISORIENTED; NIGHT SWEAT; DIZZINESS AND LIGHT HEADED; LOSS OF APPETITE; UNABLE TO SLEEP; 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 covid infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 12:21 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) unknown. On APR-2021, the subject experienced unable to sleep. On 10-APR-2021, the subject experienced feeling disoriented. On 10-APR-2021, the subject experienced night sweat. On 10-APR-2021, the subject experienced bone ache in low back, hips, bones connecting spine. On 10-APR-2021, the subject experienced dizziness and light headed. On 10-APR-2021, the subject experienced loss of appetite. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. On 10-APR-2021 15:21, the subject experienced severe fatigue. On 10-APR-2021 16:21, the subject experienced severe body aches. On 10-APR-2021 17:21, the subject experienced headache elevated to migraine. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive, positive, positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to sleep, feeling disoriented, night sweat, headache elevated to migraine, severe body aches, loss of appetite, headache, and fever, and bone ache in low back, hips, bones connecting spine on 12-APR-2021, and had not recovered from severe fatigue, dizziness and light headed, and nausea. This report was non-serious.

? Acute CVA (cerebrovascular accident) Hospital Course/test results: Work up with MRI showed 2 small acute infarcts in R temporal lobe region, and findings which could represent subacute infarcts in L frontal lobe. Neuro deficits now resolved. Neurology consulting. Suspicious for embolic phenomenon. She does also have a IUD to treat her menorrhagia, which may predispose her to clotting. However when we did further research Mirena IUDs were not found to raise the risk for blood clot-related heart attack and strokes but the company does recommend clinical consideration for removal in such situations. We contacted OBGYN oncall physician and spoke to doctor today. From his recommendation is not to remove the IUD at present time because the risk is very low comparing to the higher risk of severe menorrhagia that patient had experienced in the past. Since she will have annual visit with her GYN at OBGYN, patient should have that conversation with her GYN for options. Patient remains stable and symptoms free. Repeated brain MRI and new MRV did not reveal new findings. Her HA resolved on its own. She was initially started statin and full dose of ASA then changed to low dose ASA plus Plavix (21 days) then ASA as monotherapy after. Currently hypercoag panel is still pending. Echo showed no evidence of intracardiac shunting with fair quality and technically adequate study. Neurology recommended outpatient follow up with neurologist and 30 days heart monitor to look for Afib/flutter. Currently her headache is resolved as well R hand weakness/tingling is resolved. She is stable to go home today. A1C is 7.3 while on Metformin (2000mg daily). She may need additional agent to get A1C < 7 as outpatient. Neuro also recommended outpatient sleep study.

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.

The first two days I had a normal reaction with fatigue and soreness. On the second night I developed a severe sinus issue that caused my tongue to turn white/gray and be dry and sore. Frequent diarrhea, headache, sore throat, soreness, low grade fever for half a day and a resulting acid reflux condition. (I have never had acid reflux before) I was tested for Covid and Strep, both negative. Continued lymph node sensitivity for two weeks. 3.5 weeks in, I developed muscle tension, unrelenting, from the back of my head all the way down my spine. I had continued chest pressure and some numbness on my left side in my arm, leg and later my face. No home remedies worked and rarely do I get back/neck/shoulder pain. I was not doing anything strenuous. I went to the ER where they tested me for blood clots (J&J news had just come out and I have a family history) and prescribed valium for the muscle tension which has somewhat helped. I fully recognize that this might be bad luck, a series of unfortunate events after I received my shot. However, I have not been sick all year, I have never had acid reflux issues or pain like this in my neck/back/shoulders previously. The fact that in the 4 weeks after the shot I have not had a single day where I felt normal is a red flag to me. I feel like it is worth reporting in case anyone else has had a similar experience.

BRAIN FOG; MIGRAINE; TIRED; NAUSEA; TINGLING IN HANDS; NUMBNESS IN HANDS; ARM HURT; VERY SHARP STABBING PAIN IN RIGHT SHOULDER; FEVER >103; 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, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced tingling in hands. On 25-MAR-2021, the subject experienced numbness in hands. On 25-MAR-2021, the subject experienced arm hurt. On 25-MAR-2021, the subject experienced very sharp stabbing pain in right shoulder. On 25-MAR-2021, the subject experienced fever >103. On 25-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced migraine. On 26-MAR-2021, the subject experienced brain fog. On 26-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, and nausea on 25-MAR-2021, and fever >103 on 28-MAR-2021, and was recovering from numbness in hands, migraine, brain fog, tired, very sharp stabbing pain in right shoulder, and tingling in hands. This report was non-serious. This case is associated with PQC number: 90000175693.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious

Pain concentrated in lower back making it painful to stand; by Tuesday moved to back of both knees; by Thursday concentrated only in left leg causing throbbing in leg. Still some pins and needles in outside of left foot

Patient is a 41 yo woman with no PMH who presented to an outside urgent care with left flank pain found to have a wedgelike defect in the posterior left lower renal pole suggestive of a renal infarct. She underwent CTA which did not show any embolism, thrombus, dissection. The radiologist did note mild beading of the bilateral renal arteries, however the radiologist at Valley View reviewed the images as well and was not as convinced. Left renal infarct: Given suggestion of mild feeding of the bilateral renal arteries, patient underwent CTA of the chest, head and neck which did not show any other signs of fibromuscular dysplasia. Echocardiogram did not have any thrombus or decrease in function. Patient did not have any arrhythmias on telemetry. Blood cultures were ordered and pending on discharge, but patient did not have any of endocarditis A hypercoagulable work-up including factor V Leiden, protein C, protein S, Antithrombin, lupus anticoagulant, beta-2 microglobulin, anticardiolipin antibodies were all sent and are pending at the time of discharge Discussed the case with hematology at hospital: Most experts treat with 3 months of anticoagulation other evidence is not entirely clear and aspirin 81 mg may be a reasonable choice. In light of the patient's lack of insurance, decision was made to treat with 1 month of apixaban followed by 81 mg of aspirin daily indefinitely Discharged with a short course of oxycodone 5 mg #15

48 hours of fever, chills, malaise, headache Followed by constant dizziness, acute joint pain (knees, ankles, shoulders, and hands), brain fog, fatigue, intermittent headaches, pain in calves, backache, and locking/swollen hands - for ~8 straight days.

Extreme fatigue. Body aches, joint aches, muscle aches. Feeling of being very sick. Chills and nausea

About 9 pm I felt fatigue, I went to bed. I took 800 mg of ibuprofen and 1000 mg Tylenol as a pain medication. I drank a bunch of water and took an Emergen-C. I fell asleep by 10:00. I slept and I woke up - shocked awake around 04:30 am - I was super thirsty. My whole body was really sore and stiff and I had a headache. It was uncomfortable but not unmanageable. I decided to take more Tylenol and Ibuprofen and drink more water again. I got back in bed and was feeling a lot of symptoms - I was really sore in my thigh muscles, lower back, knees and forearms. I had slight chills; I was pretty uncomfortable. I couldn't get back to sleep - I couldn't sleep on my arm with the injection site. This was about 5 pm. I never actually had a fever. But just a lot of fatigue and body aches. For the next day or two - I took 800 mg of ibuprofen and 1000 mg Tylenol every 6 hours. Within 48 hours, the body aches started to subside. I still felt a bit fatigued and I still do feel fatigued to this day. Into the next week, I started feeling like (towards the middle of the week - about the 7th) I was having an urinary urgency feeling. It was a sensation in my lower back like a UTI was coming on. I haven't gotten one in a long time ( I use to). On Friday or Saturday, when I wiped, I was seeing a slight pinkish hue - a trace of blood - in my urine. Decided to take probiotics and Vit C. and I started to feel better. But Sunday morning, I was back to feeling pretty bad. I visited the Urgent Care on Sunday, the 11th. In the visit, they took a urine specimen. Dr. saw blood in my urine from the test. And an absence of nitrates in the urine and she said it wasn't a typical UTI. They decided to culture the urine specimen. Macrobid - 2 times a day for 7 days - antibiotics was prescribed. I felt a little better the second day of taking it, I thought, but it was up and down. Culture showed there was no UTI. Friday, the 16th, I had my annual visit with my PCP, I was feeling okay by this time. But I still had a sensation in my lower back - not a pain but a sensation and I still feel this sensation now (on my left side). She asked me to come back after the antibiotics to take another urine sample. Lab test. I feel some fatigue but I'm doing normal daily life.

NECK STIFF; HEADACHE; NAUSEA; FEVER; EARS HURTS; DIARRHEA; EARS FEEL MUFFLED; EARS RINGING; 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 past medical history included cervical cancer, and concurrent conditions included seasonal allergies. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced ears hurts. On 09-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced ears feel muffled. On 09-APR-2021, the subject experienced ears ringing. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced neck stiff. On 10-APR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.9. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and fever, and had not recovered from headache, ears hurts, neck stiff, diarrhea, ears ringing, and ears feel muffled. This report was non-serious.

4/10 - sore arm, no other symptoms 4/11 - headache 8/10, brain fog, nausea, dizziness, 7/10 neck and back pain, 8/10 exhaustion 4/12-4/17 - low grade headache 3-4/10 4/19 - 8/10 headache, 8/10 exhaustion, extreme weakness on right-side, rapid onset of stroke-like symptoms (Est 815am) to right side (face droop with impaired slurred slow speech, right arm, right leg immobility) facial symptoms resolved quickly (less than 1 minute), complete speech impairment lasting 2-3 minutes, partial speech impairment sustaining through to mid-day, complete right side weakness lasting 3-5 minutes before total resolve and intermittent R-side weakness after transport to hospital. Arrived at Emergency department about 930/10am, most symptoms subsided by time of admission - slowed speech persisted to mid-day. Discharged at 4pm to home. 4/19 - 6/10 exhaustion through most of the day 4/20-4-21 unusually high level of energy 4/21 - back pain and low grade headache return 3/10 4/22 - back pain more intense 4/10, intermittent headache 3/10 - report to CDC 4/26 - scheduled follow up appointment with Neurology

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.

Severe headache, fever, chills, muscle aches, dizziness, vomiting, diarrhea Lasted approximately 33 hours Took Excedrin Migraine and Zofran to treat symptoms

I immediately began to feel my arm asleep, it wastes the ring finger and the little fimger. then i was taking iboprofen ) sr, order to me, the was eors and he gave me diclofenacoy take it 5 day but i star havin ptoblems with my eyes and legs. my my sensory nervous systerm is very devilite. I ca"t smell and I have no Taste this week i did an MRI and x ray

LEFT ARM MUSCLE TENDERNESS STARTING FROM THE LEFT WRIST EXTENDING TO THE LEFT SHOULDER; SORE LEFT ARM AND FEELS OVERUSED STARTING FROM THE LEFT WRIST EXTENDING TO THE LEFT SHOULDER; 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, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in left upper arm for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced sore left arm and feels overused starting from the left wrist extending to the left shoulder. On 14-MAR-2021, the subject experienced left arm muscle tenderness starting from the left wrist extending to the left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore left arm and feels overused starting from the left wrist extending to the left shoulder, and left arm muscle tenderness starting from the left wrist extending to the left shoulder. This report was non-serious. This case, from the same reporter is linked to 20210353764. Version(1) created to amend previously reported information on 15/Mar/2021. Upon review the following information was amended: Labeling of event (sore left arm and feels overused starting from the left wrist extending to the left shoulder) updated to unlabeled from labeled in USPI. Additional information was received from patient on 15-Mar-2021 following information was updated and incorporated into case narrative: Link case added.

First night had chills and fever that lasted about two days Area around right knee swelled quite a lot about two days after shot given with some pain, most swelling has subsided but some superficial veins still more visible than before

HEADACHE; MILD FEVER (98F OR 99F); MUSCLE ACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included hepatitis b, and other pre-existing medical conditions included no known drug allergies and drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 16-MAR-2021 15:00 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced muscle ache. On 17-MAR-2021 23:00, the subject experienced headache. On 17-MAR-2021 23:00, the subject experienced mild fever (98f or 99f). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98 or 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, mild fever (98f or 99f), and muscle ache on 19-MAR-2021. This report was non-serious.

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

Patient reports waking up in the early morning hours with pain in center of chest and between shoulder blades. She felt like her throat was closing up, unable to take a deep breath. Dizziness, feeling faint and heavy arms also reported along with headache. Her husband gave her acetaminophen and shower and ice pack and she returned to sleep. Upon waking in the morning, she felt fatigued and arms ached "like she had been doing push ups" The pain in her neck and chest heaviness persisted. She made an appointment for later in the day with her PCP and was promptly sent to the emergency room for further evaluation. X-rays and labs were drawn.

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

April 10, late evening: fever developed. Most of the night it was 102.2 F. Also, my lying down heart rate was 130, which is 50-60 bpm higher than normal April 11: A fever between 100 and 101 all day. Took a Tylenol in evening. April 12: Fever, headache gone. Just a little tired and fatigued. Then I seemed to have been recovered. April 21-22: Achiness, tingling pain in arms, left back, shoulders. Then this seemed to have abated. April 28-29: Tingling pain in arms, hands, sometime back and feet. I have never experienced these symptoms pre-vaccine so it makes me wonder if it is related to the vaccine

4pm severe peri orbital eye pain and severe headache 4:30p Severe ear pain with light sensitivity 9pm fever, severe chills,with excessive uncontrollable shakes that appeared to look like a convulsion, uncontrollable teeth chattering, hot flashes, diaphoretic , elevated blood pressure and teeth nerve pain, severe body aches and lasting muscle soreness

MUSCLE WEAKNESS; SEVERE HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 120 pounds, and height was 165 centimeters. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug. the patient was not pregnant at the time of report.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced muscle weakness. On 27-APR-2021, the subject experienced severe headache. On 27-APR-2021, the subject experienced extreme fatigue. Laboratory data included: Pain scale (NR: not provided) 7/10 severe headache with a pain level. On 28-APR-2021, Laboratory data included: Pain scale (NR: not provided) 1/10 severe headache with a pain level drops. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, extreme fatigue, and muscle weakness. This report was non-serious.

By 7:50pm the same night I was chilled with a fever of 101.7 it stayed around that temp until about 1:30am. My entire body ached, my joints felt like they were on fire. It hurt to move. By 3am I woke up sweating with a normal temperature. The next morning I felt weak and tired but no fever. Today I still have a headache abd feel a little tired but almost back to normal.

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.

05/06 - some muscle pain and weakness 05/07 - severe persistant abdominal pain from 4:00 pm. Lost appetite. Weakness. 05/07- in the night went to ER

PATIENT DESCRIBED SEVERE MUSCLE TIGHTNESS ON LEFT SIDE OF NECK THAT PERSISTED AT THAT LEVEL THROUGH 5/9/2021 (NO RELIEF WITH MUSCLE RELAXER) AND IS STILL FEELING TO A SMALLER EXTENT AS OF TODAY.

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

3 days after receiving the vaccine I started having a very painful shoulder pain as days passed the pain intensified in severity and I could feel the left side of my face num, my picky and ring finger on my left arm and numbness that went from my neck down to my spinal cord this was accompanied with a burning sensation.

no antibodies shown on spike protein antibody test at day 60. I did have chills, and muscle aches after....so what was injected????

I woke up 6 hours after vaccination and started getting the chills with a fever of 101.3. I took some Tylenol which brought the fever down for a few hours but it later shot back up to 104. I had a headache, muscle pain, and fatigue. On Monday, I got a sharp pain on the side of my head causing my eyes to hurt. I called doctor who said that it sounded like a sinus infection and prescribed me Azithromycin. Days later the doctor called me and I told him that I wasn't feeling better and was referred to take a Doppler test which showed nothing wrong. I went to another doctor that prescribed me Bactrim which cleared up my sinus infection and I felt a little better. I still feel fatigued, have brain fog, and double vision. I went to a neurologist and was given a CT scan. That was two weeks ago and I never heard about the results. I'm scared to drive because I don't know what will happen. The vaccine also threw off my cycle and I have gained so much weight since my vaccination.

I had severe joint pain, headache, nausea, and extreme fatigue. And symptoms that went on for a month were dizziness and brain fog.

Within 2 mins of receiving injection, I experienced full body sweats, deadening of sound, blackness in eyes, lightheaded, unable to hold things in my hands, uneasy stomach, very pale all over, especially face. Talked/deep breathed my way out of fainting. Within 10 minutes all the above symptoms started to lessen. 15 minutes after receiving the injection, the near fainting experience was over and I was comfortable leaving and driving. But the 10 minutes were terrible and I came very close to passing out. My husband experienced the exact same symptoms 2 days later. I will be reporting that immediately following this submission.

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.

RESTLESS LEGS; SPINE PAIN; BACK PAIN; HIP AND KNEE PAIN; FEVER; BODY ACHES; HEADACHE; CHILLS; FLUSHING; This spontaneous report received from a patient concerned a 41 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, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced body aches. On 21-MAR-2021, the subject experienced flushing. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced restless legs. On 21-MAY-2021, the subject experienced spine pain. On 21-MAY-2021, the subject experienced back pain. On 21-MAY-2021, the subject experienced hip and knee pain. On 21-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from restless legs on 21-MAY-2021, and chills on 14-MAY-2021, and had not recovered from body aches, hip and knee pain, headache, flushing, spine pain, back pain, and fever. This report was non-serious.

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

She was having muscle aches, joint aches, was having breast pain and arm pitt pain also went to the different doctors had a fever that last about five days and chronic chest pain.

After the administration she felt tightness in her fingers in the same arm as the injection. It left a few minutes after the injection.

Started feeling weak and headache and thirsty within 15 minutes. Then I felt like cold, low fever, back pain, hip pain and nausea. I wanted to vomit but nothing would come out. After that the headache is very very bad. The situation continued until Sunday around 07:00 pm and then I was better. After that, my hip pain and back pain and headache was still very bad. I went to my family doctor and they gave me to some medicine to help. They gave me a lotion to put on my hip to stop pain, and I had more rest. I am still getting the hip pain and back pain and the headache. Sometimes, I feel much better but sometimes when I feel tired my headache starts again. The headaches are only on the right side of my head.

Started with vomiting , which was severe and very sudden Fever started and was really tired and couldn't sleep had chills and muscle spasm everywhere very severe leg muscle spasm are worse in right leg. Next morning the muscle spasms stopped in right leg and then left leg started hurting really bad became more severe thorough out the day Couldn't walk Pain in the left leg by hip started moving down her leg I noticed that behind my left knee was hurting Pain throughout entire body After a week hip and knee started feeling better Left calf feeling funny Went to doctor the second week Every since shot I have had muscle fatigue Pain in hand Taking Motrin around the clck.

Istated having a pain in the neck later that evening and I started getting headaches, so I went to the doctor 2 weeks later. I normally don't get headaches and I still have them a lot. I was very scared so I went to the doctor.

Immediate dizziness. Arm felt like dead weight. Had trouble driving to waiting area. Within 20 minutes, chest, neck, arms, and face tightened, I couldn?t move my arms, paramedics found blood pressure to be very high. Was light headed for 48 hours after. Almost fell over multiple times. Arms and legs very heavy and tired easily. On 4/21/2021 my leg cramped up and went numb. Week later my chest constricted with same issue from injection day. Went to hospital. Blood pressure again elevated. Concerned of a blood clot, did chest mri and ultrasound of blood vessel in leg. No blood clot found, but new lesions in chest were found and no explanation of leg issues. As of today?s date, no one can figure out why my right leg is numb from mid thigh down, but has major pain and causing me not to be able to walk and go up stairs. Feels like a constant charley horse in my calf with pain radiating through my knee and up my thigh. No injury was sustained. It happened all of the sudden while laying on the couch reading. I?ve seen regular doc, pt specialist, sports med doc, headed to a spine specialist next. No explanation of strange pain and numbness.

Intense, shooting, intermittent pain in/below left inner ear/jaw area that came and went for about 3 days along with a mild sore throat Acetaminophen 500mg seemed to help eliminate for about 2 hours after taking, then didn't help My left inner ear would pop every once in awhile on its own and a dull pain persisted for a couple more days in my inner ear and back of my neck area. Seemed to go away for a couple days, then the right side of my head felt swollen and stuffed--but no mucous or anything. No intense shooting pain, just a constant dull ache in my inner ear that also could be felt on the right side of my face and back of my head/neck area. Lasted for close to a week. Doctor ended up prescribing antibiotics and diagnosed me with sinusitis. All symptoms went away after about 2 days of antibiotics.

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.

Had typical symptoms within 24 hrs - low grade fever (101F), body aches and arm pain. On second day developed mild headache that went across forehead. On 5/15/21, developed right ear pain - pressure in ear and headaches continued. Intermittently the left ear would also have pain. Started developing stiffness on the right side of neck that accompanied the ear pain. Went to urgent care on 5/20/21. Doctor said both ears were visibly full, especially the right ear. Prescribed Azelastine nasal spray. Called PCP in morning of 5/21/21, and was prescribed prednisone for 5 days to control inflammation. Prednisone worked after a few days but was still run down and pain developed in my abdomen and along the right side of back/leg. Went to ER on 5/24.21. Doctors performed tests for blood clots. Was told I was weak and dehydrated and given IV and pain meds. Was negative for blood clots but my IVC was dilated. Pains persisted for about 2 weeks - especially in the right abdomen. Went to cardiologist on 6/4/21 and had a normal EKG but low BP. Doctor believes abdominal pain is gastrointestinal and put me on proton pump inhibitor. I am getting echocardiogram on 6/10./21 to check IVC. Since then most pains have subsided except weak, right sided abdominal pain. The right ear pain is back. Starts in the morning with outer cartilage of ear getting inflamed, followed by pressure/pain in right ear, then pain in right neck. Has been going on for a month now. 100% related to vaccine - came after vaccination and never had before.

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.

Client reported feeling nauseous and dizzy as well as having a headache and "heavy"right arm during the 15 minute waiting period after receiving her vaccine. Client's vital signs taken at 1545 and were BP 108/72, P 89, O2 99% and R 14. Client was given some water and animal crackers. Client was encouraged to drink fluids and stay hydrated. Client continued to report feeling dizzy and tired, but reported her heavy arm had improved. Blood pressure was reassessed at 1600 and was 126/82. PHN encouraged client to rest and stay hydrated and if her symptoms did not improve or resolve she should be seen in the walk in or by a medical provider. Client verbalized understanding. Client left clinic with her husband who was giving her a ride. On 6/18/2021 at 1022 PHN placed call to client to see how client was feeling today. Call went straight to voicemail. PHN requested call back. Client returned call just before 1400 and reported symptom improvement and that client was only feeling tired today.

Thursday pm I began to experience palpitations, indigestion, substernal pain, and back pain between the shoulder blades when breathing deeply. Friday the symptoms continued, particularly in the evening. I began monitoring my blood pressure Friday evening with the electronic arm cuff that we normally use. It is staying abnormally low, ranging between 105/68 - 109/70 on 4 different measures. My normal range stays between 115/78 at the lowest - 130/90 at the highest. Today, all symptoms remain unchanged and blood pressure remains <110/70

14 hours after injection I had normal reactions of headache, nauseous, fever, body ache, but I also had every joint hurt even my knuckles I couldn't bend my fingers neck was stiff I couldn't turn my head and I had the heart palpitations like a racing heart.

Left arm and neck pain. Feels like a deep bone pain, wakes her up at night. Can't sleep on her side because of the pain. Started after receiving the Johnson and Johnson vaccine.

CHEST PRESSURE; FAST HEART RATE; TEETH PAIN; GUM PAIN; JAW PAIN; LOW BLOOD PRESSURE; MUSCLE ACHES; FATIGUE; SLIGHT HEADACHE; This spontaneous report was received from a 41-year-old, female patient of other (unspecified) race. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, non alcohol user, and non smoker. The patient had no known allergies and no drug abuse/illicit drug use. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 2021421A, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 (1 day post vaccination), the patient experienced symptoms of fatigue, muscle aches, chest pressure, fast heart rate, teeth/gums/jaw pain, low blood pressure, slight headache. The patient's doctor had a suspicion of blood clots and hence, on 14-APR-2021, the patient was hospitalized. The patient got her blood work, chest X-ray, electrocardiogram (EKG), and heart monitoring done and results of all tests were normal and she was cleared. No blood clots were found. On 14-APR-2021, the patient was discharged from the hospital. On 15-APR-2021, she felt a little bit better and then on 16-APR-2021 (two days post hospitalization), her symptoms completely subsided. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, fast heart rate, teeth pain, gum pain, jaw pain, low blood pressure, muscle aches, fatigue, and slight headache on 16-APR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210702888-COVID-19 VACCINE AD26.COV2.S-chest pressure, fast heart rate, teeth pain, gum pain, jaw pain, low blood pressure. 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). 20210702888-COVID-19 VACCINE AD26.COV2.S-muscle aches, fatigue, slight headache. This event(s) is labeled per RSI and is therefore considered potentially related.

Joint pain continuing for three months following the vaccine, pain was particularly focused in the wrists, knees, and hips.

shakiness, dizziness, vomiting, muscle weakness, vertigo, difficulty walking, difficulty raising the left foot, muscle aches, fast heartbeat

Stabbing pains in right hip, numbness upper right leg, pain in leg down to knee. After shot got high blood pressure.

Patient was given the Janssen vaccine and within 3 minutes the pt complained that she was lightheaded and dizzy. As I walked out of the pharmacy to see what her reaction was her muscles tensed up and she became completely rigid and stared sliding out of her chair. By appearances it looked like she was shaving a mild seizure, with a blank stare. By the time I got her down on the floor and got her coat off to see if there was an allergic reaction to the site the patient came too and asked me why she was in the floor. At that time she was clamy but knew who she was and where she was. Paramedics were called and while they were here she stated that she was dizzy and nauseous so they ended up taking her to a location hospital to be seen. While there they drew blood as a precaution.

Side effects started with in 7 hours starting with tiredness. Headache within 8 hours. Muscle aches, fever and small bouts of nausea within 11 hours. All side effects lasted about 24 hours after injection of the vaccine.

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

Janssen COVID-19 Vaccine EUA Approx 7 p.m., I noticed moderate pain in my lower back, hips, and legs. Around 7 30, I felt very cold and began covering up with several blankets and turning up the heat. Husband and kids reported the house was not cold at all. Within 15 minutes, chills began and increased quickly to an almost violent state. I was shivering so badly, it became painful and scary. My husband added three blankets on top of our down comforter and sent me to bed. It took approx 15 minutes to warm up, stop shivering, and slow teeth chattering enough to relax and fall asleep. Awoke around 1:30am feeling incredibly thirsty and in desperate need of water. Upon standing, the pain in my body was excruciating which made it extremely difficult to walk. Finally in the kitchen, I took Ibuprofen 800mg and filled a large bottle with water. I began to feel incredibly dizzy and needed help from my husband to get to the couch. It took approximately 2 hours before I began to feel any relief from the ibuprofen. Around 6:30 a.m., about 60 to 65% of the pain had abated and I had finished around 100oz of water. The remainder of the day was spent feeling extreme fatigue and a general sense of unwell. Appetite was poor throughout entire event. This all continued into the evening until bedtime at 11pm. Experienced moderate insomnia overnight, falling asleep around 2:30am. Could not fall asleep due to constantly thinking about the stress of the previous 24+ hours. Upon waking this morning, I feel almost back up to 100%.

3pm: Immediate body-wide, internal feeling that can only be described as "intoxication." Felt loopy & woozy -- not lightheaded or dizzy. Felt as if I were floating to chair. Sat for 20mins, legs weak, odd sensation across shoulder blades & cervical spine. "Slow" & woozy for duration of evening. Physically moved slow, cognitively slowed down, inability to focus. Internal body-wide sensation difficult to define. All very similar to immediate effects I have from alcohol. Passed out (sleep) 9hrs later & woke 100% fine at 8am.

Ten hours later felt achey, then chills, and fever of 101-102 all night with SEVERE joint pain. I have a herniated disc in my lower back and this was severely aggravated by the vaccine. My back and fingers hurt so bad I couldn?t sleep at all. Tried not to take Tylenol finally took some after 3-4 hours and it helped a lot with fever and joint pain. Also had a headache. Fever and pain was gone after 8 hours. Then felt very low energy with a headache all the second day. Third day I felt great except are sore.

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.

Day of Vaccination: Headache started approximately 4:30PM Fatigue and feeling cold began around 5:30PM Chills began around 8PM continued through the night, difficulty sleeping and muscle pain/myalgia began Day after Vaccination: Muscle pain/myalgia, headache and fatigue noted as continued through the following day Following Days: Fatigue noted through today

fever, muscle aches, headache, tylenol within 30 hours I was back to normal with no symptoms or signs

Myalgia, Arthralgia, Fever, NauseaVomiting, photophobia/ "red, tender, chapped lips" Narrative: Other Relevant History:

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

Uncontrollable chills for over 3 hours followed by a few hours of extreme perspiration. Inability to sleep soundly. Fatigue during following day and muscle soreness.

Fever 102, pulse 110, very lightheaded, nausea, severe fatigue, shart muscle pain in my back and neck.

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 .

I received my shot at 9:15AM at 11.5 hours later I began feeling foggy, fatigue and flu like symptoms. I had a slight fever and just stayed in bed the day after. Ibuprofen seemed to help the headaches but not the body aches. No nausea. Within 72 hours I was almost back to my normal self, but still extremely tired, and my neck and back hurt quite a bit. Today marks 13 days. As of 5 days ago I began to get cold like symptoms. Neck and back still extremely uncomfortable, neck barely able to move side to side. I have a bit of a cough with phlegm. Headaches are still happening quite a bit, and still super tired all the time. I feel like I?ve been sick ever since I took the shot, and have to take several days off work.

Vomiting (once at 1 am) Shaking and chills from 1 am until next day ( over 24 hours) Fatigue Joint pain Arm pain

24hr post vaccine: paresthesias, sharp pains, throbbing pains, & a heavy/leaden feeling began in both legs from knees down. Continued nocturnally for 4-5 nights before beginning during daytime hours encompassing both legs & both feet. Spread to left arm on day 5 & then to include right arm a day later. Weakness in all limb muscles. Difficulty walking. Unable to carry heavier items, unable to lift over 5lbs with both arms, unable to move arm from plate to mouth at its worst. All symptoms waxed & waned, Guillian Barre was ruled out due to this. Currently 20 days post vaccine with little relief. Medical care has been sought & is continuing at this time.

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.

about eight hours after receiving the injection, I started to feel strong aching in my muscles and joints (most strongly felt in neck, hands, jaw, inner ear, but also including legs and feet). I also felt chills. My temperature was 98.8 F. Over the course of the next three or four hours, I have felt strong sensations of aching and throbbing in my chest, back, hands, inner ears, and neck. I also felt pins and needles all over but most strongly in chest, back, hands, inner ears, and sides of my neck.

Janssen COVID-19 Vaccine EUA Around 7 hours after receiving the vaccine, began experiencing chills which worsened over a few hours. Experienced sweats, joint pain, light headedness, nausea, and numbness in face and fingers. All symptoms but numbness lasted for around 14 hours. Numbness was off and on. After 14 hours only experiencing achy joints, head ache, fatigue, weakness. Took Tylenol when experiencing the worst symptoms.

Visual aura 3 hours later, headache for 2 days, then at 3 days sudden onset nausea, vomiting, emotional upset then sleepiness, pupils to me seemed very constricted on that day, stiffness of neck for several days and right sided head/ face pain for 5 days difficulty concentrating/ reading.I took ibuprofen for 5 days which helped symptoms

Injection Tuesday at 10am, felt fine until 6-7pm. By 7pm overcome by crushing exhaustion, unable to complete simple meal prep but no appetite. By 8pm, intense shivering, feeling freezing cold. By 9pm, back/neck/leg/arm muscles stiff & cramped, joints achey, terrible headache. By 11pm, unable to sleep due to discomfort of symptoms - temp 100.1, tylenol taken. Poor, intermittent sleep 12-7am. Wed 7am - ibuprofen for sore achey muscles & joints and headache. Ibuprofen helpful, but exhaustion from poor sleep. Had friend come to care for children because I could not do it. Ibuprofen helpful for symptoms, able to nap. Symptoms slowly resolved. All symptoms gone by Thursday morning.

I experienced blisters/ mouth ulcers within 24 hours of being vaccinated and lower back ache + abdomen discomfort (akin to period pain) within 48 hours.

Patient complained of left arm heaviness at 12:44pm. BP was 158/98 Pulse was 101 and O2 saturation was 99. No other complaints at that time. After observation period patient went to the bathroom around 1:00pm and vomited in the restroom. She returned to post vac area where BP was checked (208/124) Pulse (107), O2 saturation (98), and respirations were at 28. No blurred vision, shortness of breath, or dizziness. Due to elevated BP we elected to call EMS for further evaluation. While waiting for EMS BP was taken again at 1:30 pm and it was 170/92 and pulse and apical HR were at 96, respirations at 24, O2 Sat at 97% and pt. reported arm was less heavy but she felt a tingling sensation from her arm to her wrist. EMS arrived at 1:35 and BP was 220/120 and temp was at 97 degrees.

8 hours after vaccine, the chills started. Violent, body shaking chills. It sounded like woody woodpecker when my teeth were chattering against my mouth guard. Then the fever came in. 17 hours after the vaccine, my fever is still at 101. Did not sleep much. Woke up with severe headache and muscle pain. Drank a gallon of water yesterday and 32 oz in the middle of the night. Despite that, I?m still thirsty.

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.

Extreme fatigue, severe neck pain (right side only), nausea. Began at wakeup on 4/7 (6am). The same symptoms and severity lasted all of 4/7, 4/8 and 4/9. On 4/10 (today) I was able to function better but only at 50% of normal rate. Pushed lots of water and slept 18-20 hours 4/7 & 4/8

I experienced headache, pains at the back of my neck, Tommy pains, and dizziness. All lasted for 24 hours. Tommy pains subsided first, about 14 hours. I took tylenol ( over the counter) twice, and felt better. I did contact my primary doctor' s office. I was scheduled for a visit. I was unable to keep the appointment because I was feeling so dizzy that I slept the whole day. The next day, I called the doctor's to let them know I was feeling okay, again. I

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.

fever and chills for <24 hours. Low back pain and muscle pain that started 1 day after vaccine, has persisted for 5 days. Patient had similar symptoms with prior COVID infection in November 2020. Patient has muscle spasms in low back with no associated injury or heavy lifting.

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.

Started with feeling a brick on my chest. Them my ribs hurt. Every breath hurt and I couldn?t take a deep breath. The pain spread all across my ribs and up my chest. It hurt to the touch.

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

Muscle/leg aches. Fever that never exceeded 101.6. Dull headache. Started around 3:30 am on 4/11/2021 and all symptoms completely gone by 10:00 pm on 4/11/2021.

On day 5 I started exp sore arm causing muscle pain. About 16 days I had swollen lymph nodes under both under my arms. I contacted my PCP on 4/5 and as of today 4/12 doing better.

At approx 10 hours post vaccine: High fever (104.5 at height); intense pain in spine Lingering after 12 hour mark through 30 hour mark: General aches; gastrointestinal issues

Burning sensation with tingling and some minor numbness within 5 min, within 15 min started to feel dizzy. spoke with EMT on site and was told I could remain for an additional observation before returning home and that another 5 people had the same symptoms that morning and appeared to be fine after some time. After I arrived home, on or about 10: 45, I ate an egg sandwich and the dizzy sensation faded. However, severe fatigue set in and by 1 PM I went to lie down. On or about 1:30PM, I awoke with severe chills and a fever of 101.5. The Chills lasted from about until about 3AM on April 9th. The fever, however, went down after I took Tylenol at about 8PM. I remained in bed on April 9th until 8AM and proceeded to work from home with fatigue and a headache that would not go away with Advil. By April 10th the a majority of the initial symptoms abated and only a sore left arm with a slight tingling sensation remained. On Sunday, April 11th, my right ankle started to swell and left leg had some pain (behind the knee) . Elevated the leg and the swelling went down on the right ankle and left leg felt better after massage on the 12th.

Thursday 04/08/21 - 1:35 PM Went to Fairgrounds to get the Johnson & Johnson - Janssen COVID-19 vaccine shot with my husband. Both of us wore our masks, walked in together, went through the line together, we both got the shot in our left arms and then set together and waited the 15 minutes before we could leave. A little later at home we were working on some landscape lighting and I felt a bit foggy, light headed and kind of out of it. I was drilling into masonry and the first hole went fine but the second one for some reason just wasn?t going and I touched the drill bit with my fingertip on my left hand to see if it had smoothed out and I knew in my head not to do it and that it should be hot as heck but I didn?t feel anything at all so later that evening when I took a shower my finger was burning and I knew I had burnt it. That evening I begin to feel crippling cold, my fingernail and toenail beds had turned purple and I was shivering violently. I got under a pile of blankets with my dog and tried to slow my breathing I could feel my heart beating in my chest and it felt like the air I was breathing was cold and frosty. I had a 104+ fever that night. My husband got me some aspirin a cold washcloth for my head a popsicle and water to help bring down the fever. And I was able to sleep on and off that night. When I woke up I had a 103+ fever and a tingling and numbness in my arms. Before the fever my arms felt tight and cold and I had a tingle that ran from my elbows to my fingertips. Again it was aspirin cold washcloth and lots of water to drink to try and get my fever down. Friday 04/09/21 Was spent in bed trying to drink water and sleep through it. My arm was sore, not at the injection site but the whole top part of my arm felt like I had been hit by a truck. I had a fever again that evening. Saturday 04/10/21 I thankfully woke up fever free but my arms were tingling. I had to take my husband to the airport that morning at 6:30 AM. I came back home and went back to bed until about nine when I woke up my arms were cold and sore and tingling it seemed to be getting worse in my left arm and I felt shots of electricity from my elbow down to my fingertips. At one point I took a picture because my left arm hurt so much more than the right and my fingertip beds were purple on my left and pink on my right. I took aspirin and took a nap. I couldn?t hold my phone with both hands hands like normal sitting in bed because my left hand goes cold and achy. Woke up worried that both my arms were aching and tingling from my elbows to my fingertips seems to be where it stays the most. Then that pain subsided and my lip started to tingle. After a few hours that stopped but the tingling in my arms is about constant not as strong sometimes, not in both arms sometimes, it seems to almost always be in my left arm and at one point scary enough that I almost went to the ER. Went to bed around 11:30 PM and the tips of the toes on my left side were tingling and it went to the whole leg. Sunday 04/12/21 I woke up with a coughing fit and mucus at around 1:00AM and my right leg with a little tingly at 4:24 AM awake again and coughing woke me had to get a drink and my stomach was buzzing and stopped now just back to the bottom half of my left leg. All of a sudden after a coughing and sneezing fit I got a tremendously sore burning throat out of no where that only lasted about five minutes. I noticed my left arm straining to hold up the pizza box tonight when my right arm had no trouble at all. Then a little later in the day stiffness in the back of my neck. It is a weird strong dry cough and I was scared to go to the ER because my symptoms were so varied and ever-changing I didn?t know what they would do with me and I didn?t want to just get stuck in there for days with him not knowing or making it worse. I told my husband ? It?s so random I?m a little scared no one is going to know what to do with me...?I?ve had issues with allergic reactions and no one being able to diagnose them and me having to figure it out on my own on the Internet that I had Thyroid problems and that I was allergic to the sun for a few years in the past and aloe vera... I didn?t wanna wind up going, them not fixing anything and having a huge bill to pay. But this whole time my body is buzzing and tingling and going through something strange. At this point I am just telling my family I?m okay and what random symptoms I have had since we spoke last. They are on standby to watch my children if I need to go to the ER. The constant buzzing, numbness, cold tingling in my arms is worrisome. Monday 04/12/21 I am use to the numbness and tingling being a constant thing on some part of my body... There are times when I feel fine but I know it won?t last long. We can add an upset stomach and diarrhea to the list. I had a metal taste in my mouth for a little bit today. Both arms legs and my lips have randomly buzzed, ached or tingled. The websites say call 911 for emergency or call your local medical provider for assistance so I called the local ER to see if they could tell me if my symptoms were normal or if it?s something I should come in for and they couldn?t give me any advice... I was told if you feel like you should come in then come in. I had a very strong sharp pain at my elbow of my right arm tonight that made me sit up in bed... Tuesday 4/13/21 My left arm is still sore if people touch me or if I try to sleep on my side like I normally do it hurts trying to hold my phone with both hands my arm still goes cold and achy. So far this morning my arms are both tingling and my left leg and my lips so at this point I just say I?m buzzy. 11:25 AM randomly my right arm decided to feel worse for a change but is back to a low buzz... after a few minutes. I find myself holding them up or lifting them when they hurt it seems to help a little to elevate my arms to my chest. I am just waiting to see what comes out in the media, or to see if this gets any better, or if they learn what to do about it... It isnt over, it hasnt stopped yet.

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

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

I woke up with my Menstrual cycle, 15 days early, the morning after the vaccine and had extreme night sweats the night of the shot. All other symptoms I had were normal side effects.

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.

101.9 Fever (Apr 7 evening to Apr 8 evening) Severe Headache (Apr 7 afternoon to Apr 8 evening) Muscle pain especially lower extremities (Apr 7 afternoon to Apr 8 evening)

Evening of vaccine (Thursday night): chills, headache, aches and pains First day after vaccine (Friday April 2): chills, sweats, dizziness and fuzzy thinking, extreme fatigue, headache, joint pain Second day (Sat April 3): fatigue, headache, aches and pains Evening of the second day (Sat April 3): fatigue, acute pain in my left armpit/swollen glands in my armpit/breast/neck Third day (Sunday April 4): fatigue, headache, armpit pain and swelling radiating to the entire upper left side of my body Fourth day (Monday April 5): fatigue, headache, armpit pain slightly abated Fifth day (Tuesday April 6): fatigue, armpit pain slightly abated Sixth day (Wednesday April 7): neck still stiff, left armpit still very tender Seventh day (Thursday April 8): left armpit tender 8th day (Friday April 9) until now: still tender/sore in and around left armpit, still a bit stiff in the neck

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.

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.

PATIENT EXPERIENCED "HORRIBLE MUSCLE ACHES AND PAINS" SHE CONTACTED DR AND THEY RAN SOME BLOOD TESTS AND TOLD HER SHE HAD "THICK BLOOD" SO SHE STARTED TAKING ASPIRIN LOW DOSE DAILY AND SHE SAID THE PAIN RESOLVED BUT SHE HAD ANOTHER BLOOD TEST ON 04/15 THAT SHE DOES NOT KNOW THE RESULTS OF YET

FEELING COLD; PAIN IN LEFT ARMPIT; PAIN IN LEFT SIDE OF NECK; BODY ACHE; PAIN IN THE INJECTED ARM (LEFT SIDE); ANAPHYLAXIS; 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 covid-19 infection on an unspecified date in MAY-2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 03-APR-2021 around 11:00 a.m. on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in MAY-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) positive, (3.72). On an unspecified date in 2021, Laboratory data included: COVID-19 antibody test (NR: not provided) level of 0.2. On 03-APR-2021, the patient experienced anaphylaxis. It was reported that within 5 minutes after vaccination patient experienced tongue was swollen, throat started closing, throat breaking in hives. The pharmacy called the emergency service, and the consumer was taken to the hospital. On 04-APR-2021, the patient experienced feeling cold, pain in left armpit, pain in left side of neck, body ache and pain in the injected arm (left side). She was treated with routine treatment for anaphylaxis, and she was put on prednisone and Benadryl. It was reported that, the treatment was still on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anaphylaxis, and had not recovered from feeling cold, pain in the injected arm (left side), pain in left armpit, body ache, and pain in left side of neck. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to AER20210409478.; Sender's Comments: V0 20210410075-Covid-19 vaccine ad26.cov2.s Anaphylaxis. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).

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.

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.

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)

PATIENT COMPLAINING OF GENERALIZED JOINT/MUSCLE PAIN, NAUSEA BEGINNING ON 4/9/2021, PATIENT FAINTED ON 4/12/2021 AND HAS COMPLAINED OF LACK OF ENERGY AND INABILITY TO EVEN HAVE STRENGTH TO HOLD HER HEAD UP AS OF CURRENT DATE FROM DAY AFTER VACCINE ADMINISTERED

For abt the first 5 days I was in a lot of pain from elbow to collarbone. It has improved slightly but still experiencing pain in arm w limited mobility. Appears to be in the joint. Feels similar to what I?ve been through w my left shoulder (bursitis, arthritis etc resulting in a scope/surgery)

LUMP ON LEFT SIDE OF NECK; CHILLS; FATIGUE; HEADACHE; FEVER; SHAKING; FLU-LIKE SYMPTOMS; ACHYING JOINTS; 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 hashimoto's disease, seasonal allergies, and certain metal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced shaking. On 10-APR-2021, the subject experienced flu-like symptoms. On 10-APR-2021, the subject experienced achying joints. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced lump on left side of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, flu-like symptoms, achying joints, chills, fatigue, headache, and fever on 13-APR-2021, and had not recovered from lump on left side of neck. This report was non-serious.

GENERALISED ACHING; CHILLS; FEVER ON SATURDAY NIGHT; HEADACHE; FEELING WEAK; PAIN IN KNEES ALTERNATING; PAIN IN RIBS; PAIN IN BACK; PAIN IN LEGS GOING TOWARDS TOES ALTERNATING BETWEEN LEGS; 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 covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain in ribs. On APR-2021, the subject experienced pain in back. On APR-2021, the subject experienced pain in legs going towards toes alternating between legs. On APR-2021, the subject experienced feeling weak. On APR-2021, the subject experienced pain in knees alternating. On 10-APR-2021, the subject experienced generalised aching. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever on saturday night. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, generalised aching, pain in ribs, pain in back, pain in legs going towards toes alternating between legs, and pain in knees alternating, and the outcome of fever on saturday night, chills and feeling weak was not reported. This report was non-serious.

NERVE PAIN IN LEG AND ARM; EAR ACHE; FELT COLD; CHILLS; JOINT PAIN IN KNEES; HEADACHE; PRESSURE IN CHEST; NO SLEEP; 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 penicillin allergy, and restless leg syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced no sleep. On 10-APR-2021, the subject experienced pressure in chest. On 10-APR-2021, the subject experienced ear ache. On 10-APR-2021, the subject experienced felt cold. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced joint pain in knees. On 10-APR-2021, the subject experienced headache. On 10-APR-2021 03:00, the subject experienced nerve pain in leg and arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no sleep on 10-APR-2021, was recovering from nerve pain in leg and arm, and had not recovered from joint pain in knees, ear ache, pressure in chest, felt cold, chills, and headache. 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.

I had severe headaches and very sharp sight on the first day. The next day I experienced a strange leg numbness in the middle of the night. A week later as I was traveling I had a very bad allergic reaction that required me to call 911, as the throat swallowed. I am still experiencing leg pain when I walk. Sometimes the face feels tight also and I?m not sure this is something from the vaccine.

Swelling of joints, especially knees and wrists but every joint in my body is sore. Started in my knees on April 9 then progressively got worse over the weekend. Saw doctor on Monday and they prescribed meloxicam. Went to er on Wednesday because condition wasn't getting better and was in a lot of pain and they prescribed a steroid for 6 days. After 6 days and not feeling any better I contacted both the doctor and the er and never got a response. Very concerned at their lack of concern. Im not a doctor but I'm pretty sure you don't just wake up with severe arthritis after never showing any symptoms? Really just need someone to assist me because I'm not getting better and its becoming extremely debilitating

Left arm pain after receiving J&J vaccine. Pain started immediately after receiving the vaccine and has persisted for 3 weeks now. Pain: muscle soreness in the shoulder. When not moving, pain is level 1. When moving arm, pain level is 5. It's not sharp pain but persistent and annoying.

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.

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.

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.

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.

Aching left heel: April 26, progress into calf with swelling of foot, ankle & calf: evening April 27, dvt found in left leg, pulmonary emboli in both lungs, right worse than left lung, shortness of breathe, tachycardia

notes: times are approximate. I got the vaccine on day two of my period. I moved my arm a lot after getting the vaccine. My arm did not hurt, even though the rest of my body ached. 4-27-21 2:45pm: got the vaccine in my left arm. 4pm: felt fine. slightly more energy, clearer head than usual. this good mood and clear head only lasted a few hours. it ended before other symptoms began. 9pm: minor body aches, but not in arm where I got the vaccine. minor chills, shivering. 10pm: began to feel worse. moderate body aches, chills, dizzy. 10:40pm: suddenly felt much worse. severe chills, shaking, dizzy, then felt very hot, nausea. vasovagal syncope. sudden low blood pressure. did not actually faint since I know how to prevent fainting. took ginger, drank a lot of water, got ready for bed. lying in bed. felt nauseas for a few hours. this was the most uncomfortable symptom. frequent peeing. thirsty, but water went right through me. sweating. could not really sleep, not totally awake either. felt horrible. after a few hours, still lying in bed. nausea mostly went away. headache, muscle pain in jaw and face were the worse symptoms at this time. frequent peeing. thirsty, but water went right through me. sweating. felt like someone had turned the heat up. when I checked, the heat was off. felt like I had a fever for a few hours. 4-28-21 1:45pm: got out of bed. feel better than the previous night, but generally unwell. short of breath when moving. fatigue. 6pm: dizzy, weak. 4-29-21: 3pm: mild headache, feel mildly hot. 4-30-21: 10pm: tense muscles, especially in my face and head. 5-1-21: sore breasts. 5-4-21: hormones feel unbalanced. PMS symptoms, but it is a few days after my period ended. intense negative moods, spotting, sore breasts.

KNOT ON THE BREAST; MOOD SHIFTING; HEART RACING; FELT SICK; VARICOSE VEINS AGGRAVATED; SLUGGISH; FELT HOT; SWEATING; DIZZY; SORENESS IN EXTREMITIES; HEAVINESS IN EXTREMITIES; COLLAR BONE 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 concurrent conditions included varicose veins, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. breast cancer runs heavy in the family. 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 01-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced collar bone pain. On 01-APR-2021, the subject experienced soreness in extremities. On 01-APR-2021, the subject experienced heaviness in extremities. On 02-APR-2021, the subject experienced varicose veins aggravated. On 02-APR-2021, the subject experienced sluggish. On 02-APR-2021, the subject experienced felt hot. On 02-APR-2021, the subject experienced sweating. On 02-APR-2021, the subject experienced dizzy. On 02-APR-2021, the subject experienced felt sick. On 03-APR-2021, the subject experienced heart racing. On 17-APR-2021, the subject experienced mood shifting. On 03-MAY-2021, the subject experienced knot on the breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, sweating, dizzy, and heart racing on 2021, was recovering from sluggish, and varicose veins aggravated, had not recovered from soreness in extremities, knot on the breast, and heaviness in extremities, and the outcome of mood shifting, collar bone pain and felt sick was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Five days after the vaccine I woke up and could feel a lump on my collar bone that was very painful and could move when touched. The pain eventually subsided but the swollen lymph node is still there to date. A week after I noticed another swollen lymph node appeared in my neck and once it became inflammed my face and scalp became very to the touch and my whole mouth got inflammed also. I went to the PCP who prescribed an antibiotic which did reduce some of the inflammation and pain in my face but the enlarge lymph node on my shoulder is still there.

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.

Within 8 hours of the shot experienced: full-body muscle aches. Full body joint pain to the point that I couldn?t move. My body felt like it was on fire. Stomach ache, severe headache. This pain lasted around 14 hours. After that, the joint/muscle pain lingered for about 3 days. The headache for about 3 days. I felt and still feel weak, and have a fuzzy head. My sense of smell and taste still hasn?t fully recovered. I feel fatigue from Covid-19 since I had it in December and this vaccine seemed to make me feel worse all over again.

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

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.

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.

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.

Both feet hurt the day shot. As days go by the pain was in lymph nodes on my shins. The pain started moving up my legs as days passed. Fatigue. Headaches. By may 18th the pain was up to my hips, arms, and hands. My joins felt swollen. Muscle weakness in legs and arms. Difficult to walk.Was admitted to the hospital on the 19th. For 5 days

The day following my vaccine, I became extremely nauseous and fatigued. I was unable to lift my head or open my eyes because of extreme dizziness/nausea for 24 hours. Over the next 2 months, ending around June 11th, I had migraines almost every other day, constant nausea, and a few migraines that lasted 3-4 days. At one point, I needed to go to the ER to get relief from the migraine. This helped for about 3 days before the migraines returned. At 2 months out, the migraines have improved, but I still have very tight muscles and stiffness throughout my body, a symptom that I often get along with migraines.

woke up gasping for breath, difficulty breathing, chest constriction with pain, heart pressure, pulse pressure in shoulders, neck and top of head treated with Cardio Care and Aconitum Napellus 30 C every 1/2 hr to 1 hr depending on symptom expression and walking and staying up right caused improvement of symptoms. Laying down and lack of movement cause symptom worsening, difficulty in breathing and increasing chest & heart pressure

The pain at first was minor So I?ve began to take Tylenol now three months later the pain is horrible as is my right arm from my back shoulder down my back right side up by under my right breast my chest goes like numb /dead for like days its bad. Hurts so bad I can barely sleep

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.

Muscle weakness in Legs, numbness and tingling. Dizziness, difficulty walking. Numbness and tingling in arms. Neurology referral, MRI's. Still being evaluated.

Increase nerve pain and flare ups - uncontrollable Shaking Tingling and pains in arms Cramping in joints unable to move fingers

It started with joint pain on left side at the elbow and wrist. Then it progressed to all-over body aches. Then every joint became achy, even spine and toes. One of the left lymph nodes at the base of the skull became swollen like a golf ball. Then the throat lymph nodes also became swollen. I had fatigue to the point of needing to nap throughout the day; this comes and goes. I have weakness in the hands. Most recently, I have had shortness of breath, even after doing nothing. I have had earaches recently. I tested positive for mono, even though no one in my life has it. This has all been going on for over 2 months now. The doctor says I display some of the symptoms of Guillain-Barre Syndrome. He says that if I display tingling in the extremities, I am to go to the ER. On 7/19/2021, I am going to have my spleen examined, because I have had nausea and pain in that area.

The same day I received the vaccination after 45 minutes I began to drive home I became very fatigue. I also began to experience muscle burning in several parts of my body legs, arms wrist. The 4th day after vaccination I began to have a chronic cough. The cough was so severe I could not catch my breath. I then visited the ER and was given breathing treatments which did not work. I was referred to an Allergist and a pulmonary function test was performed and it was stated my lungs was only performing at 50 percent. I was diagnosed with asthma and a nebulizer is required daily. I can no longer walk from my home office to my bedroom with shortness of breath.

Immediate extreme pain shooting from my shoulder to my elbow. I asked at the waiting area how long the pain was supposed to last and they told me a few weeks. I couldn't use my arm at all for a few hours and for a few days I couldn't do my hair or dress normally. For a few weeks I experienced pain and weakness when doing simple tasks like lifting a glass or buckling a seatbelt. For a few months I have experienced pain when sleeping, jogging, hugging, etc. My arm now feels weaker than before and I avoid using it on a regular basis because of the pain. The pain has evolved from being acute and achey all of the time to mostly aching during use or when moved. Many people initially told me pain was normal would last a few weeks and that I might just be healing slowly. After 6 weeks, I determined that this was likely not normal to be in such pain. Now, 3.5 months later, I am really ready to get answers, as the pain and weakness are lingering and don't seem to be completely healing. My mom, a physical therapist, suspects that the needle might have entered the bursa, and my husband and I have suspected that it might have damaged my rotator cuff.

Lower back pain beginning day after vaccine. Vertigo & nausea beginning days after vaccine, lasting 2-3 days. Fatigue beginning day after vaccine and is improved, but still present. Leg muscle pain and slight swelling beginning 5 days post-vaccine.

Full on flu-like symptoms: body aches, fever, feeling hot/cold, headache, muscle ache, tiredness. Sore arm.

no reaction at first, since then issues with fatigue, joint issue, muscles aches. Then Blood pressure began to rise and jump, has gone as high as 220/120 then it will come down and then bump up again.. Problems producing urine, sometimes empties and sometimes not.

Minor chills Muscle aches tightness Throbbing joint pain in multiple areas. Exacerbated in areas where I already have chronic joint/muscle pain Mid grade fever Severe headache All lasted for 36 hours

brief dizziness followed by onset of chills and muscle aches that lasted for approximately 2 hours. Now, approximately 22 hours later, I am experiencing fatigue, light nausea, headache, and hot flashes.

mild fever (101), chills, muscle aches, headache, fatigue, nausea. Tylenol to reduce fever, and rest. Symptoms gradually improving after 24 hours

Numbness and tingles immediately after shot. Tingly feeling up left side of neck and into left eye. As days go by more numbness and tingling under my arm pit and down my hand into fingers. Feels like I hit my funny bone from the elbow down when using arm repetitively. Soreness of left side of neck.

Fever over 103F, intense chills, extreme muscle aches, tingling in hands and feet for 6 hours. Severe headache for 24 hours. Extreme night sweats for 2 night. Fatigue for 24.hours.

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.

Headache, Myalgia, Arthralgia, Fever, metallic taste in mouth, dry mouth, loss of appetite, photophobia, fatigue Narrative: Other Relevant History:

From 1 to 3 hours after vaccination : uncontrolled crying. From 1 to 4 hours after the vaccination: weakness in legs and arms, unable to raise legs to walk or no strength in arms, I couldn?t hold objects in hand or close hands. About 3 hours after vaccination: numbness in all face like if under anesthesia, and I could barely been heard when trying to speak, no strength to talk other than single words. First 24 hrs extremely sleepy and lethargic the next day.

has stuffy nose, without sinus congestion and no post nasal drip symptoms associated with : severe fatigue, loss of appetite ( drinking good, eating fair) , severe headache upper posterior headache , severe nausea with out vomiting, mild generalize muscle pain with weakness or joint stiffness 1. mild dizziness with out passing out, worst with movement, use walker

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.

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.

I started to develop a headache and extreme fatigue about 4 hours after getting the shot. By 6pm I started getting severe chills and body aches. About 2 hours later the chills were alternating with fever and I could barely stand because I felt so weak from the muscle aches. I was in so much physical pain I didn't sleep at all that night. The fever lasted until late afternoon the next day (about 24 hrs total), and the body aches lasted until late afternoon the day after that (about 48 hrs total).

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.

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

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.

Approximately 13 hours after receiving the vaccine, I woke up in the night with nausea, chills, fever, spinal pain, joint and bone pain, and the worst headache of my life that I could feel in my brain stem and spinal cord. I also experienced confusion and difficulty walking to the bathroom. The headache was not relieved by OTC pain relievers. I had difficulty sleeping and felt restless. I felt the fever ?break? around 5am with profuse sweating. I had to miss work today (I am a nurse myself who was actually working at the clinic when I received my vaccine). It is now 3pm and after taking a sleep aid and sleeping all day, I do feel better, but the headache remains. I had H1N1 about 10 years ago and aside from that, this is probably the sickest I?ve ever been and it is, with certainty, due to the Covid vaccine.

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.

An odd ache here and there during the day, then at night muscle aches all over the body, chills, slight fever, headache, fast heartbeat. No treatment until morning. Took acetaminophen in the morning, helped with the aches. Heartbeat came down on its own by morning.

Five minutes after shot was administered, severe arm pain that lasted for about five minutes. After that, sore arm that night. Next day at 8 AM ,I had waves of nausea and sore neck and body. Around 2 PM ,(24 hours after injection) flu like symptoms started appearing and by 4 PM I had 100° fever and Bodyaches and flu like symptoms that were severe. Around 8 PM the following day from my injection I started to feel better but not fully recovered until 4/9/21. Not one to get sick often and the sickness and tiredness was severe.

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.

my left arm still hurts since Friday - dull ache 1or2 out of 10 pain overnight from 09Apr to 10Apr I was woken up in pain around 3a.m. I was very hot and my body ached all over, my joints and muscles, I also had a bad headache

face and hand swelling, shortness of breath, increased heart rate to 120 BPM, dizziness and nearly fainted. Lasted 3-4 minutes. Was observed, blood pressure taken and was slightly elevated. Symptoms dissipated and was released to go home. Later had lasting headache and muscle pins for approx 18 hrs along with hot flashes. On 4/11/21 I then experienced the same episode lasting over an hour.

Metallic taste in mouth within 3 minutes of Injection lasting overnight,104 degree temperature for 7 hours, severe chills, severe body aches, racing heartbeat , unable to sleep. I currently have low grade fever, body aches, headache, moderate low back pain Me

Fever of 102+, chills, body pain throughout entire body with what I would call "hot spots", left hip and left lower back. Headache that felt like no other I've had primarily on left side above my ear. Vomiting and urination. Fatigue. Weakness. I was on the verge of going to ER called on-call doctor instead. They advised me to try and get through the next few hours. They also ended up calling me in a medication to help with my vomiting. I was sick for a little over 24 hours with main symptoms. Still feel worn down.

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.

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.

Body stiffness, loss of movement, head about to explode, nose bleeding and stuffed, vomit, pain fever.

fatigue began about 5 hours after injection. Then chills about 6 hours after and lasted about 3 hours. Severe muscle, joint and body aches for 3+ hours with chills, then fever of 102 for 6-8 hours. Severe headache in facial area during fever and chills, dizziness, continued low grade fever of 99.8 for additional 12 hours. Stiff neck began after fever was gone and comes and goes. 72 hours after injection, headache in facial area when working on computer, reading or watching tv and some tiredness. Loss of appetite. 800mg ibuprofen given 48 hours later due to headache.

Body aches starting 5 hrs after injection lasting 16 hrs Headache starting 5 hrs after injection lasting 20 hrs Fever starting 8 hrs after injection lasting 11 hrs. Fever spiked at 102 and remained there for 6 hrs. Chills starting 6 hrs after injection lasting 15 hrs. Fatigue starting 8 hrs after injection. I took Tylenol to reduce the fever and to help with muscle aces. I took 2 every 4 hours starting when the fever did 8 hrs after the injection. All symptoms were gone after 24 hrs.

Lightheadedness and exhaustion set in 15-25 minutes post injection. Later that same evening, experienced nausea, muscle, bone, and joint aches as well as chest pain that were much reduced by the following morning. Malaise continued as did symptoms of nausea without vomiting. 24 hours post injection, experienced a low grade fever of 99.6 F (for me, this is a low grade temp). Fever broke after another 24 hours. Experienced severe headaches in the middle of the forehead for 8-12 hours on 3/25/2021, 3/29/2021, 4/3/2021. Experienced difficulty breathing 3/30/2021. Woke up from deep sleep feeling starved for oxygen and a sensation that a deep enough breath could not be taken--the lungs could not expand enough. Respiratory rate seemed slightly depressed. It passed after about 30 minutes with focused effort on taking deep, regular breaths. Fell asleep again and did not consult a medical provider about it. The oxygen hunger / breathing issue did not repeat. Medical professionals were not consulted for any of the episodes described above.

Extreme pain in joint, difficulty waking, and full body aches for 24 hours. Exhaustion and difficulty waking, going on day four. It does seem to be improving each day, though day 3 had dizziness also.

Patient reports that starting on the day of the vaccination, she had a fever as well as pain in both of her legs and pain in both of her arms. The pain in her legs and arms is still ongoing and she reports that her arms feel very heavy and that it is difficult to use them.

Tingling in lower lip, bilateral lower extremity tingling & muscle aches, right forearm with tingling & muscle aches

Awoke the morning after receiving the vaccine (approximately 19 hours post shot) with stiffness in my muscles. Arms, thighs, lower back and neck were all sore when moved. Throughout the next 12 hours symptoms increased in strength and spread to entire muscle system and joints of arms and hips. Throughout the 12 hours I also experienced alternating periods of chills and overheating as well as a migraine. I used an electric heating pad to warm various areas (feet, legs, arms, neck) from hours 30 to 33. I also used tylenol rapid release 500mg at 19 hours and then again at 43 hours. At 43 hours felt symptoms retreating to feel similar to 19 hours in. By 53 hours only slight tenderness in muscles remained. Muscle tenderness was gone at around 70 hours.

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.

Left leg hurting bad, cramping really bad, Charlie Horses, knee hurting and calf muscle area, my sugar levels were a little higher because of the pain for the first 72 hours now just a little elevated

COUGH; CONGESTION; BACK PAIN; FEVER; FATIGUE; NAUSEA; SEVERE HEADACHE; COLD SWEATS; MUSCLE CRAMPS; GENERALIZED PAIN; 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 allergy, and antibiotic allergy, and other pre-existing medical conditions included the patient had allergy to pain medication (except toradol and ibuprofen). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced cold sweats. On 09-APR-2021, the subject experienced muscle cramps. On 09-APR-2021, the subject experienced generalized pain. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced severe headache. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced congestion. On 10-APR-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, muscle cramps, and fever on 13-APR-2021, was recovering from severe headache, and had not recovered from generalized pain, fatigue, back pain, cough, nausea, and congestion. This report was non-serious.

7:00 started chills 9:00 started fever 101.8/chills/fatigue 10:00 fever 103.2 /chills/ fatigue/ headache/ nausea / crazy sweats continues until Monday Morning of the 12th fever drops to 101. 8 Diarrhea started Sunday stays that way until Monday after noon . Puking starts and diarrhea continues until Weds. Headache gets milder everyday still need aspirin to keep under control. Sweats are still happening. Went to hospital Tuesday because my legs felt like lead. High BP

Received the J&J Covid Vaccine shoot on Sunday, April 11th at the Clinic. The night of receiving my shot, I had a migraine and neck pain which resulted in trouble sleeping. When I got up in the morning, I started having severe muscle pain in my thighs and in my calf, mild cramps in the abdomen. The leg pain lasted the entire day with exhaustion, which interfered with my ability to work a full day. When I went to bed later that night, I still had pain behind my left knee and I was worried about if there was a blood clot. I got up the next morning and my legs were still cramping but improved from the prior day. When I saw the news discussing the blood clot issue associated with the J&J vaccine, I felt it was important to contact my Dr. to discuss the leg pain. They did an ultrasound (vascular scan) on my left leg and follow up with my doctor's office walk-in clinic after the scan. My legs were examined and no clots were identified. We discussed things to watch for.

Initially had body aches, chills, and more localized to lower body in general that resolved by next evening with light headache which resolved. Since then off and on feet and ankle aches and pain. Past two days with tingling of left greater than right wrist hand but patient did do yoga 2 days ago and has distribution of carpal tunnel syndrome on left wrist.

Started dizziness on 14th eve neck pain , back pain, fatigue. went to ER. Blood test were taken to check counts and were reported normal. Fluid was injected via IV and advised Meclizine 25 mg. advised pain killers if needed. advised to contact ENT specialist if the condition continues after 2 to 3 days.

Immediate headache which started immediately after the vaccine and continues. Muscle ache and fatigue.

Patient reports: "I received my covid 19 vaccine on Friday April 9th (J&J) and need to report my reactions afterward. Had the usual immediate arm pain after injection along with nausea. Took a Benadryl and napped when got home and woke up 6 hours after injection with a tingling and swollen lower lip and constricted breathing. Took 3 Benadryl in fear of going to hospital and waited it out. Once lip went back to normal as well as breathing went to bed since it was late and slept all day Saturday. Woke up Sunday in agony from lower back pain and tailbone. Now, thurs 4/15 still in extreme pain in my tailbone. Went twice to chiropractor to help and nothing is alleviating the pain and have been practically bed ridden since Sunday. Can?t work, can?t sit, can?t walk can?t stand can?t anything without extreme pain. Been taking ibuprofen everyday and not helping." She had a visit with us on 4/15/2021: "Patient here for extreme pain on her tailbone. She had the Johnson and Johnson vaccine about 6 days ago and about 6 hours later she woke up with a tingling and swollen lip, constricted breathing, and dizziness. She wanted to avoid the hospital, so she took benadryl 75 mg and it slowly resolved her symptoms. These symptoms have not returned since. She was finally able to fall asleep that night and then slept all day the next day. The following day she woke up and experienced extreme pain in her lower back and tailbone. She saw her chiropractor twice this past week, which helped to resolve her low back pain. Per patient her chiropractor noted that her back seemed very inflamed. However, she is still having extreme pain with her tailbone and is unable to sit, stand, bend or work for more than 20 minutes without extreme pain. The only thing that seems to improve her pain is laying on her back with several pillows tucked behind and all around her. However, she is only able to stay in this position for a period of time before her body becomes stiff from immobility. She has been taking ibuprofen 600 mg TID, flexeril PRN, icing and applying moist heat to her back, but none of these measures seem to improve her pain. Lastly she has noticed that when she sits/stands for too long, her buttocks start to spasm. Denies fever, chills, n/v, numbness, tingling, incontinence or loss of bowel/bladder function."

JOINT PAIN; INFLAMMATION OF THE RIBS; VAGINAL BLEEDING/CLOTS; CYSTS ABOVE THE LEFT ELBOW; FATIGUE; ANXIETY (TINGLING ALL OVER THE BODY ESPECIALLY THE WAIST, SHORTNESS OF BREATH, WEAKNESS); BACK PAIN; NECK PAIN; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumer, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies, no relevant medical history prior to the start of these symptoms. 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 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative, Negative. On 2021, Laboratory data included: Biopsy (NR: not provided) Not reported. On 28-MAR-2021, the subject experienced anxiety (tingling all over the body especially the waist, shortness of breath, weakness). On 28-MAR-2021, the subject experienced back pain. On 28-MAR-2021, the subject experienced neck pain. On 30-MAR-2021, the subject experienced fatigue. On 31-MAR-2021, the subject experienced vaginal bleeding/clots. On 31-MAR-2021, the subject experienced cysts above the left elbow. On 05-APR-2021, the subject experienced inflammation of the ribs. On 06-APR-2021, the subject experienced joint pain. Treatment medications (dates unspecified) included: paracetamol, salbutamol, norethisterone acetate, trazodone, and hydroxyzine embonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cysts above the left elbow, and had not recovered from back pain, neck pain, anxiety (tingling all over the body especially the waist, shortness of breath, weakness), vaginal bleeding/clots, joint pain, fatigue, and inflammation of the ribs. This report was non-serious.

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.

JOINT PAIN; LOW GRADE FEVER; 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 tachycardia, bactrim allergy, flagyl allergy, and keflex allergy, and other pre-existing medical conditions included bactrim, flagyl, keflex allergy, when taken hives occurs with one, and c. diff with hospitalization occurs with the other. 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 10-APR-2021 for prophylactic vaccination. Concomitant medications included propranolol for tachycardia. On 10-APR-2021, the subject experienced joint pain. On 10-APR-2021, the subject experienced low grade fever. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, and low grade fever on 11-APR-2021. This report was non-serious.

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.

On April 16th, I started having heart palpitations. Racing of the heart. It?s bothersome when I eat. Pain in the upper back. Discomfort in the chest.

FELT NUMBNESS RIGHT ON TOP OF BUTTOCKS AND ALL THROUGH THE BACK OF HER LEGS; HEAD PRESSURE; DIZZINESS; CHILLS; PAIN IN LEGS; LEGS WERE NOT STRONG ENOUGH FOR HER TO GET UP; HEADACHE; NAUSEA; 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 high cholesterol, and fibromyalgia, and other pre-existing medical conditions included not obese or overweight, not taking medication for high cholesterol or fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced felt numbness right on top of buttocks and all through the back of her legs. On 12-APR-2021, the subject experienced head pressure. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced pain in legs. On 12-APR-2021, the subject experienced legs were not strong enough for her to get up. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 13-APR-2021, and had not recovered from headache, head pressure, dizziness, nausea, felt numbness right on top of buttocks and all through the back of her legs, legs were not strong enough for her to get up, and pain in legs. 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.

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.

constant back pain that started on April 11 presented to ER on April 19 for back pain and abdominal pain, afraid that she has a clot a few days ago, started having shortness of breath and left leg pain that radiates to the left groin

VERY EMOTIONAL; SEVERE BODY ACHE; ANXIETY; SEVERE CHILLS; JOINT PAIN; HEADACHE; FELT FEVERISH; SLEPT MOST OF THE DAY; 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 past medical history included bronchitis, shoulder and hip issue, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, 1 total, administered on 12-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, after midnight the patient had chills and felt feverish. She was very emotional and had body aches, joint pain which was for about three hours. She had slept most of the day next day and had some body aches and headache. She felt better by Sunday 14-MAR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very emotional, severe body ache, anxiety, severe chills, joint pain, headache, felt feverish and slept most of the day on 14-MAR-2021. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and headache, felt feverish, severe chills, severe body ache and anxiety as related and between covid-19 vaccine ad26.cov2.s and very emotional, joint pain and slept most of the day as possible. Company causality between covid-19 vaccine ad26.cov2.s and headache, felt feverish, severe chills, severe body ache, anxiety and slept most of the day was possible. 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.

Mon 4/12/21 - Headaches started and have continued daily. Tue 4/13/21 - Soreness in right calf muscle, continued for 4 days. Headache continued. Wed 4/14/21 - Sharp pain in pelvis (right and left side) same location I experienced pain the day of receiving vaccine. Occasionally felt this pain 2 or 3 times / day for 2 days. Sought medical attention at ED on the advice of our Nurse Call Center. Was evaluated for blood clots, none found on this day. CT scan, ultrasound of both legs, blood tests. Returned home with directions to take Extra Strength Tylenol for headache. Thu 4/15/21 - Shooting pain in random parts of my body, mostly legs and arms. Experienced throughout this day only. As of 4/27/21, 22 days after being vaccinated, I am still experiencing headaches. More noticeable when I am exerting myself - walking outside for 1-2 minutes triggers the headache. Headaches are usually located in the lower back of my head. Before being vaccinated, I would experience less than 1 headache per month, and they go away within the day.

First week after vaccine: fatigue, body aches, congestion, chills, loss of appetite. Ever since vaccine: chronic fatigue, body aches, joint pain, knee pain and swelling, tension and tightness in legs, tension and pain in neck, jaw, and head, headaches.

1st few days expected to be sick. Then the ?pause? so expected to be nervous, but 2 weeks out started the dizziness, panic attack, heart arrhythmia headache, brain fog, muscle soreness and overall unwell feeling. I have lost time at work. The money this is going to cost me out of pocket for ER visits. Wasting peoples time. I meditate have good people in my life, I?ve never had this typ of panic and feeling and legit arrhythmia. On beta blocker. Told to schedule a cardiologist visit. Prob gonna need some anti anxiety meds. There is no help out there for this. Thought doing the right thing to get vaccine. I?m not antivax but this is super upsetting. I?m an otherwise normal healthy social person. I cannot even go to friend house b/c of dizziness racing heart and panic

1. Very sore arm that lasted for 10 days and went away. 2. Fatigue that lasted for two weeks and went away. 3. Loss of appetite that lasted for two weeks and went away. 4. Three weeks after vaccination, I developed extreme back muscle tightness and spasms that have not resolved yet. The tightness runs from the base of the neck on either side of the spinal column down the length of the back. Massage therapy which has proven to be effective for previous issues of muscle tightness was not effective. I have never experienced muscle tightness that went down the entire length of my back it cannot be resolved by muscular therapy.

A week after the vaccine, I started experiencing full body joint pain. I have had joint pain ever since ranging from a few body parts to full body. I have not experienced full body joint pain before this event.

ON 4/30/21 3 HOURS AFTER I HAD THE VACCINE MY BLOOD PRESSURE WENT THROUGH THE ROOF. MY HAND/ARMS WERE SHAKING, I WAS VERY SHORT OF BREATH AND COULD FEEL MY HEART BEATING OUT OF MY CHEST. I WAS DRIVIN HALF WAY TO THE EMERGENCY ROOM THEN SAT IN THE CAR FOR ABOUT 30 MINUTES TO CALM DOWN. THE NIGHT OF 5/4/21 I WAS RELAXING AT HOME AND A LARGE DARK VEIN POPPED OUT IN MY LEFT CALF AND BECAME VERY SENSITIVE. THE MORNING OF 5/5/21 I WENT AND SAW MY PRIMARY DR. HE DIAGNOSED IT AS VERRUCOUS VIENS . THE PAIN AND SENSITIVITY NEVER WENT AWAY. 5/10/21 MY LEGS BEGAN TO HAVE CONSTANT PINCHING ON BOTH MY CALFS AND THIGHS. 5/12/21 THE PINCHING STARTED IN MY ARMS. TODAY 5/14/21 I STILL HAVE PINCHING IN BOTH LEGS AND ARMS IT IS NOT AS CONSTANT BUT STILL PRESENT.

On 04-07-2021- I experienced a lump on my neck and developed pain to both of my shoulders. I went to the ER where x-rays and lab work was done. X-rays showed that my lymphatic glands inflamed. I also experienced a cramps from my neck that radiated upwards to the base of my head. My pain was so intense that I took OTC Tylenol to help with my pain. I went again to the ER eight days later because I was having pain to my heart, chest, neck and shoulders and x-rays again demonstrated lymphatic glands inflamed and was told to take Ibuprofen for pain. To this day I continue to have pain to my shoulders, neck and head but the pain is not as intense as before although the pain is still present daily. I can not work my full 8 hours of work due to my symptoms and can not over-exert myself in performing my daily tasks at work.

By 7:30, I felt drunk. My brain was not functioning normally and had a fever all night. By 7:15 I felt fine, with the exception for random joint pain. The following Friday, April 9th, I had bloodwork done. It felt like I had hit my funny bone. I had shooting pain up my arm and into my neck and down my spine. I thought it was just the blood draw, so I suffered all weekend. My husband made me go to the doctor on Monday. My doctor said I had the same symptoms of a blood clot. They sent me to the hospital for an ultrasound and blood tests recommended, but everything was negative. She told me to just watch out for any changes and it went away after a few days.

PAIN IN UPPER BACK AND ACROSS SHOULDER; FLU LIKE SYMPTOMS; JOINT PAIN; 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 chronic hip pain, sepsis-staph infections collected in right hip, seasonal allergies, nerve pain, alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with promethazine for nausea, drug allergy when treated with azithromycin, and doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. Concomitant medications included gabapentin for chronic hip pain, and nerve pain. On 11-MAY-2021, the subject experienced pain in upper back and across shoulder. On 11-MAY-2021, the subject experienced flu like symptoms. On 11-MAY-2021, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 101.8 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and joint pain on 12-MAY-2021, and had not recovered from pain in upper back and across shoulder. This report was non-serious.

The night I started getting feverish. I rested. On Monday, I called out sick. Monday, Tuesday - it was chills, fever. 2nd day, my legs started having a sensation I've never ever felt - like cramping/charlie horse. I went to work on the third day but I needed to go home. When I came home, my legs were doubled the size. I tried to ride it out by resting. Ever since then, my legs have weird sensations - not cramps but aches. I have never felt this before. Once in a while, when I'm walking, I get cramps. It still hasn't gone away. At the end of the day, my legs will be swollen but not as bad as the third day after the vaccine. I think my platelets are actually too high so I think that is a good thing. Upcoming doctor's appt on July 9 - she is going to do a whole physical with bloodwork.

The first night, in addition to chills and joint pain (my joints were on fire ), I had extreme pain and cramping in my calves from 9pm to 3am. Throughout the next seven days, the lower leg pain and overall fatigue has continued. Each day, between mid to late day, I have to lay in bed and take my foot and massage the opposing calf due to tightness and uncomfortable pain. Each night, the calf pain worsened when compared to the day. I prop my pillow under my knee.

Fever 101 - 8 hours after shot Fever 100 - 24 hours after shot Pain in lymph nodes under left arm - 12 hours after shot Soreness in muscles near shoulder and knee - 8 hours after shot Headache - 6-8 hours after shot Sweats - 12 hours after shot Pain in arm - immediately after shot Dry mouth - 10 hours after shot

Intractable headache beginning 3/13/21, double vision in right eye, blurry vision in left eye, severe pain in right eye, right temple, right side neck, severely elevated blood pressure

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.

At the 2 week mark after taking the vaccine I developed severe backache ,a fever,fatigue and disorientation.

First felt light headed, then my tongue, throat, and neck felt sore within approximately one hour of injection. Then my eyes started itching and it was more difficult to breathe through my nose. Things looked funny/off and I felt off; heavy/like lead and fuzzy and spacey at the same time. My vision was blurry when I tried to look at objects up close - like my phone. I had to blink several times and hold the object further away to see it. By dinner time, around 5:30, I noticed raised bumps on the sides and back of my tongue. To my knowledge, they were not there prior to the injection, but I don?t usually inspect my tongue. I did so around dinner because of how sore, puffy, swollen, and big my tongue felt. It looked splotchy in shades of white and yellow. My throat also felt puffy and swollen. At 3:50 am I woke up and my left eye was puffy and difficult to see out of. I was cold, clammy, and sweating. I had a really bad headache and felt nauseous. I took 2 ibuprofen and went back to bed. Around 7:30 or 8:00 am I got up and moved around. My left eye was no longer puffy and I could open it, but my eyes, nose, and throat were itching so badly that I wanted to scratch at them. My tongue, throat, and respiratory system felt puffy and swollen. I noticed it took much more effort to breathe. I got some water and took a Benadryl. I layed down and put my feet up. I covered up because I was cold. I fell asleep. A few hours later I woke up and could breathe easier. The itching was less intense and my tongue, throat, and respiratory system felt less swollen and more normal.

Lots of fatigue 2 days after vaccine, sharp stabbing pain on left side that afternoon underneath breast, struggling to breathe, went to ER, ER thought it was blood clot in lung, found to have normal lung, take ibuprofen, pain lasted most of the day, more pain when breathing in, pain gradually faded but occasionally flared up for 2 weeks after the first adverse event. Had been having some mild symptoms previous to that, medical people concluded it was inflammation exacerbated by vaccine. Palpitations, rapid heart rate.

I woke up with severe pain in my neck and across my shoulder blades(upper back.) Not long after this, my Fit bit signaled a prolonged period of high pulse. My resting heart rate peaked over 135 and stayed about 110 for 6 hours.

LEFT SIDE OF TONGUE FEELS LAZY AND LINGERING; UNABLE TO PRODUCE WORDS OUT OF MOUTH; NOT ABLE TO SEE DUE TO SWOLLEN EYE; LEFT EYE ALMOST SWOLLEN SHUT; RIGHT SIDE BACK PAIN/KIDNEY-MID LOW BACK RIGHT SIDE; INNER THIGHS BOTH VEINS POPPING OUT; ANAPHYLACTIC SIDE EFFECT; LEFT EYE FELT NUMB/ LEFT EYE PIERCING; HEADACHE; FEEL WEIRD; 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 penicillin allergy (itchy throat/swelling), and doxycycline allergy (throat swells shut and marbles in there). The patient was previously treated with escitalopram oxalate (Lexapro 20mg). The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported,1 total administered on 09-APR-2021 15:30:00 on left deltoid for prophylactic vaccination. No concomitant medications were reported. It was reported that after vaccination on 9-APR-2021, the patient immediately got headache but her left eye felt numb. She waited 30 minute because she had anaphylactic side effects and it felt really weird. The headache and left eye felt numb/left eye piercing while she was driving back (from vaccination center) which lasted for hour and half (short lived and resolved). On 11-APR-2021 she experienced right back pain (that radiates) which lasted for about five days. After that her inner thigh veins all got bright red for 2 days (only inner thigh nowhere else) and she thought she had something on her and tried wiping it off. On 16-APR-2021, she went to the doctor it was about one week from she received the shot, her left eye was swollen almost shut and that swelling lasted about five days. She was not able to see out of her eyes. She was not able to produce a word which was kind of weird for her. After that, the side effect she had, was her left side of tongue felt lazy and was lingering. She went to the doctor 3 days later news of clot came out doctor said those were the side effect of Janssen COVID-19 vaccine and there was nothing to worry about. She was trying to figure out why her eye was so big and performed D-dimer test which came back normal. She attempted Benadryl for 2 days did nothing but made her tired and she stopped taking it. She thought may be those were allergies at that time. She used an ice pack on her eye, so that swelling would go down a little. There was no discharge from her eye it was just swollen. In APR- 2021, Laboratory data included: Fibrin D dimer (NR: not provided) as Normal. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride (Benadryl). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left eye felt numb/left eye piercing, and headache on 09-APR-2021, right side back pain/kidney-mid low back right side on 16-APR-2021, inner thighs both veins popping out on 13-APR-2021, and left eye almost swollen shut (not able to see due to swollen eye) on 21-APR-2021, had not recovered from left side of tongue feels lazy and lingering, and unable to produce words out of mouth, and the outcome of anaphylactic side effect, feel weird was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210624549-COVID-19 VACCINE AD26.COV2.S-Anaphylactic reaction. This event is labeled per RSI and is therefore considered potentially related.

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)

After receiving the vaccine on 3/31, experienced typical side effects noted such as sore arm, body aches, etc. - however two days after felt numbness and tingling in feet and hands which went away a few days later. On 4/14, the tingling in feet returned. Went to ER on 4/16 as tingling/numbness getting worse and progressing upward to legs; evaluated and sent home. Returned to ER on 4/22 as numbness/tingling continued to progress upward, evaluated and sent home. On 4/25, in addition to constant numbness/tingling, started experiencing tachycardia. Resting heart rate as well as heart rate doing simple tasks was high. Also began experiencing difficulty getting a full breath. Woke up 4/27 to worsening breathing and tachycardia, as well as new feelings of adrenaline rushes and Internal tremors throughout the body. PCP ordered Troponin and D Dimer and D Dimer elevated. Back to ER that day - negative Covid test - CT of chest showed no blood clots; sent home. That evening, resting heart rate was high and elevated even while lying down (90-110 bpm). The next day, 4/28, all symptoms continued and worsened as day progressed. Returned to ER and in the way experienced a pre syncope episode - upon arrival to ER blood pressure was 70/30; stabilized and sent home. Continued tachycardia and another pre-syncope episode that evening. Was referred to neurology and had appointment 4/29; all symptoms remained and were increasingly debilitating. Neurologist determined more testing needed, and was admitted to the hospital for observation/testing. Diagnosed with Guillain Barre Syndrome after head/neck/spine MRI and lumbar puncture, which showed elevated protein. Hospitalized for 5 day course of IVIG and discharged 5/4. Started feeling better for a few weeks, although numbness/tingling in legs/feet never went away. The week of 5/17 started feeling burning in throat/nose/chest and returning tachycardia; returned to ER 5/23, was admitted for observation as D Dimer high again - checked for DVT, all clear; testing and suspicion of Postural Orthostatic Tachycardia Syndrome (POTS); discharged 5/25. On evening of 5/30, experienced new concerning neurological tremors and sudden involuntary movements, as well as stiff neck/head. Returned to ER 5/31; evaluated and released. Have continued to experience autonomic nervous system dysfunction, POTS symptoms, tachycardia and bradycardia, constant numbness and tingling in extremities and occasional tingling/numbness in other areas in the body, pressure in head, internal tremors, adrenaline rushes, feelings of burning in throat/chest, suspected reflux; upcoming appointments with an Electrophysiologist and Neuromuscular Doctor for further evaluation. Note - also reported this using v-safe up until the weekly check ins were over

After one week of COVID vaccination, the patient started experiencing a sharp pain on the left side of her chest. The pain didn't go away but slowly spread to neck, back, head and lower side of her body. She didn't think of the vaccine as a potential cause of these symptoms, so started going to acupuncture and got blood and other lab tests. After taking Aspirin on 6/25/2021, she felt a little bit better. She gave Pharmacy a call on 6/30/2021 for the first time to discuss this issue, and I recommended her to see a medical doctor to discuss symptoms and treatment.

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

I had some dizziness, headaches, right side neuropathy. I was also tired all the time. I went to the doctor where my doctor tried looking for other things aside from the pulmonary embolism. A brain MRI was done which came back normal. A thyroid test was done which showed hypothyroidism. I went to a specialist after this where a thyroid ultrasound was done and showed a swollen thyroid. I was diagnosed with Graves? disease. I have never had this before. I am now on methimazole 20mg/day. I had labs drawn to see if dose needs to be adjusted. I was told that it will be about 2 years before it can be determined if that medication is working. I also experience brain fog. I have lost 10 lbs in the past months due to this as well.

head congestion, sore throat, severe cough, chills,low grade fever, lower back pain and fatigue. I had been having these symptoms that started with the sore throat on 6/24 and by 6/30 it was getting worse so I went to Urgent care and received a negative covid and strep test. Diagnosed with sinus infection and double ear infection. Antibiotic and cough syrup given. Felt better by 7/6 or 7/7 and cough nearly gone by 7/12 and returned to office. By 7/6 husband had same symptoms with same start with sore throat and congestion/cough that got worse. Family member visited with inside his home for 2-3 hours reported he became sick around 7/5 or 7/6 and was beginning to feel better by 7/10 when I checked on him. He also had the J&J vaccine he mentioned during that visit.

About 9 hours after the Vaccination (Saturday), I had a low grade fever (101), chills, sweats, lethargy, muscle aches, significant headache. These symptoms lasted through the night. Some symptoms lifted (fever) for 6 hours the next day (Sunday) but all other symptoms still present for a full 24 hours following onset. Fever came back again at night (Sunday into Monday) and extreme lethargy the following day (Monday) with dizziness.

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.

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:

Around 7 pm on 3/13, I developed brain fog, trouble walking, and then fever, severe muscle pain worse in legs, and chills. Most of these symptoms seemed to improve on 3/14, but then on 3/15, I developed new onset of shortness of breath and chest discomfort. On 3/16 around 1 pm the shortness of breath worsened and I went to the emergency room. I felt that I couldn't take a deep breath in and I had chest discomfort on the left side of my chest worse when taking a deep breath. My legs were hurting as well, especially my left leg. I had sinus tachycardia (heart rate 106-120) and increased respiratory rate (rate of 20) with O2 sats 100% on room air. My breathing and heart rate improved somewhat with 1 liter oxygen therapy, 1 liter of IV fluids, albuterol inhaler, and decadron 6 mg orally. It was thought that I had a delayed asthmatic/allergic reaction to the vaccine. I do not have a history of asthma. I was prescribed a Medrol dose pack and albuterol inhaler. My hands and feet are very cold and tingling on 3/18. Shortness of breath and chest pain seems to have improved but not completely gone as of the time of this submission on 3/18.

Fever, chills, headache, muscle and joint pain, fatigue, loss of appetite within 7hours after vaccination. Fever overnight. Felt little better in the morning. Experiencing Severe headache. Given Tylenol 6hrs apart. Ibuprofen in the am for headache.

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.

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.

Last one night and one day: body muscle pain, headache, belly pain, fever, chill. Took Advil for painkilling.

3/11/21 Left side of face went numb, jaw pain, felt like electric bolts through head, involuntary muscle contacting in face (both sides), Jittery, Eye twitching, headache. Ear pain. 3/12 -3/13/21 Face numbness got worse, left side started to droop. Muscle soreness in left arm, headache, tired. 3/14/21 ER visit to rule out Stroke. Diagnosed with Bells Palsey. 3/15-3/17/21 Left side of face still numb, pain/muscle spasms come and go. 3/18/21 Woke up with skin hypersensitive- feels like I have a severe sun burn from my neck to waist area, swollen glands, eye twitching, lips, tongue and throat swelled up. Severe jaw and ear pain, trouble breathing. Face still tingly/numb. Legs became extremely sore and heavy feeling, hard to walk. Called Dr- put on Prednisone (60mg and decreasing) and an anti-viral. 3/19/21 Same symptoms as previous day plus stomach area began to hurt/burning sensation- like all my organs were inflammed. Uncomfortable pain in my right side. Took first dose of meds this am. 3/20/21 Extreme jaw/ear pain, clenching feeling, loss of strength on the left side of my face Symptoms tapered off fir a few days, face numbness decreased and swelling seemed to improve. 3/25/21 Woke up with Skin burning again and glands in neck swollen. Called Dr- placed back on a higher dose of Predisone . At night, throat and tongue swelled up 3/26/21 Tongue and throat swelling, still facial tingling and numbness

Symptom progression: Sudden onset of left trapezius tightening w/ radiation to left posterior neck. Progressed to sinus swelling, right eye pain w/ pressure & right anterior headache & nausea. Tachycardia, tachypnea, chest pressure & tightness, air hunger & angioedema. Treatment 03/30/2021: Epinephrine (Adrenalin) @ 0215 Famotidine (Pepcid) @ 0255 Loratadine (Claritin) @ 0255 Lorazepam (Ativan) @ 0220 Magnesium Oxide (Mag-Ox) @ 0540 Methylprednisolone sodium succinate (Solu-Medrol) @ 0210 Ondansetron (Zofran) @ 0210 Potassium Chloride (KLOR-Con) @ 0356

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.

2:00pm- extremely tired 4:00pm-nauseous and could smell everything and it was horrible 7:00pm-lower extremity joint pain began with no relief from Tylenol or Advil 12:00/midnight-low grade fever of 99.5 8:00am/ day two-still nauseous, exhausted, fever rising-102.7, congestion amd difficulty breathing 12:00/noon-all same symptoms but fever at 103.4 Took a cold shower and put ice packs on my chest and neck to try to break the fever 4:00-fever broke-still 99.5 Currently on day three-nausea ongoing, exhaustion ongoing and vascular if between freezing and having to be under a heated blanket and sweating and wanting to be naked.

1030 shot Administered 1130 sleepiness 1230 jaw tightening 1300 neck sore 1630 neck, along spine, lower back sore 1855 body aches 2045 nausea/ chills/ fever/ headache/ rapid heart rate over 100bpm 2045-0700 rapid heart rate/ fever over 100

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.

Headache onset just over an hour after vaccination. Muscle and joint pain began slowly approx 6 hours after injection and increased to sever muscle and joint pain for 13 more hours. Disappeared entirely 14 hours after beginning.

Headache - started just after midnight ~8 hours after injection Muscle Aches - severe on left side Joint pain - severe on left side/elbow Fever - 102 degrees at 4am Took 2 extra strength Tylenol Headache, aches, pains continued not quite as bad Nausea started around 9 am Vomiting & diarrhea about 10 am Nausea continued most of day until 8 pm or so but no more vomiting. Aches, pains, headache continued all day and into the evening. Fever fluctuated between 98.4 and 102.5. Stayed in bed all day with no appetite, kept eyes mostly closed, but couldn?t sleep more than ~30 minutes at a time. 9pm finally able to eat a little apple and took 2 more extra strength Tylenol. Still headache, Fever, aches, pains when I went to sleep for night but was was able to sleep 2-4 hour increments. 4/4/21 morning ~8 am (about 40 hours post injection) muscle aches and pain improved a lot. Left arm & joint still a little sore. Fever and headache improved. Very weak and tired and no appetite after a day in bed with yesterday?s symptoms.

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

About 12 hours after receiving the vaccine exhaustion set in followed by a low-grade fever, muscle aches and weakness, nausea, white spots on the throat and tonsils, headache, and dizziness.

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.

- Extreme fatigue, starting one hour after shot for more than 48 hours, sleep/rest/Aleve - Painful joints/most noticeable in arms, elbows, ankles, hips, starting one hour after shot for more than 48 hours, sleep/rest/Aleve - Painful muscles in fully body, starting one hour after shot for 48 hours, sleep/rest/Aleve - Dizziness and weakness, starting one hour after shot for 48 hours, sleep/rest/Aleve - Lightheadedness, starting one hour after shot for 48 hours, sleep/rest/Aleve - Swelling of arms and hands, starting one hour after shot for 48 hours, sleep/rest/Aleve - Headache, starting one hour after shot for 24 hours, sleep/rest/Aleve - Decreased mental clarity/slow to process information and speak, starting one hour after shot for 24 hours, sleep/rest/Aleve

ACHY JOINTS; HEADACHE; TIRED; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced achy joints, headache, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy joints, headache and tired was not reported. This report was non-serious.

Had headaches for a few days a little dizziness right hip pain and left shoulder pain the hip has been an all day affair the headaches 9am in the morning a couple days a week the dizziness when I stand up the shoulder pain was for a few nights at about 12 am

Mild to severe headache Moderate to severe muscle aches Fatigue Chills Feeling Ill (like has the flu) Loss of appetite Body weakness Drippy nose

Throat closing, tachycardia. Later fever 100.7, severe muscle aches, shaking chills, headache. Still muscle spasm and pain 8 days later.

onset evening/night of vaccine: major chills, muscle spasms (including isolated spasms in leg and fingers), extreme fatigue (had to crawl, not walk), extreme spinal pains, low-grade fever. Resolved about 36 hours after vaccine onset ca. 12 hours after vaccine: high resting heart rate (irregular heart rate, approx. 140 bpm), tinnitus. heart rate slowed approx. 36 hours post vaccine, tinnitus still comes and goes onset ca. 24 hours after vaccine: vertigo, dizziness, mild nausea: still ongoing.

Headache, dizziness, muscle fatigue, tiredness, fever, brain fog. 24 hour point after injection couldn't even get out of bed. Took fever reducer and started to feel better 36 hour mark. Was dizzy with headache and brain fog until 48 hour mark.

Immediately after getting the vaccine I began to feel very strange with symptoms of light-headedness, dizziness, and lethargy. Around 3-4 hours later is when the real symptoms began. First, an extremely rapid heartbeat. My left arm began to feel numb. And I was seized by an episode of extraordinary fatigue. 6 hours after the shot, I was having muscle and joint pain to the point that I felt like I was being stabbed with knives - particularly in my tailbone, ankles, and shoulders. High fever followed, uncontrollable chills and shivering, intestinal pain, diarrhea, and intestinal cramps. The following day I had a headache and continuing extreme fatigue as well as pain in both arms.

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.

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.

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.

9 hours after I received the shot, I experienced a fever, severe chills, headache and body and muscle aches. I did not experience pain in my arm. These symptoms continued throughout the subsequent 54 hours. Fever was 102 at the highest and chills were on and off. I took advil every four hours during that entire period, which helped, but didn't completely mask these symptoms. This came on suddenly at first.

Fever of around 99.5 (normal temp is 97.1), chills and severe muscle pain first night, extreme fatigue

Severe upper back and neck pain, numbness, muscle pain, soreness in left arm where the injection was placed. Pain lasted for 5 days. Currently experiencing muscle pain in upper left back.

4/2/2021 3PM, Exhaustion and Chills 4/3/2021 8AM, Swollen left foot, painful to walk on 10/10 level of pain. Low back pain left side. 4/4/2021 - 4/15/2021: Exhaustion continues on and off

Dizziness, muscle aches and soreness, random muscle pain in wrist, jaw, lower back, neck. Had to use rescue inhaler once(normally only use before exercise) fatigue Brain Fog

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

Day 8 began having nagging headache that will not go away. It is not the most severe headache I have ever had, but, with the pause due to clots and my age group, I am worried. Has not ended after 24hrs. Pain is in back of my neck.

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.

At approx 11:30pm my wife woke up and ran to the bathroom complaining of extreme nausea, fatigue, and back pain. While I was getting her tylenol she fainted, hitting her head on the floor. When she came to, she started experiencing the chills along with an irregular body temperature. I put blankets on her, gave her water, and tended to her eye. I was able to move her from the floor to the bed within 15 minutes. She fell asleep around 2am. She has been doing better but has been experiencing off & on headaches & nausea. We did not go to the doctor since we do not have insurance.

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.

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.

pt said she had isolated pain above her left elbow around 4/13/2021. the pain is now from her elbow to mid bi-cep. (she had given blood on 3/4/2021) pt saw a provider on 4/19/2021 regarding her symptoms. She was referred for a US. Results were superficial thrombosis left cephalic vein at the level of the mid upper arm extending into the forearm. She had blood work and was told to take Ibuprofen for pain and to stop taking her birth control. Pt will have a FU appt to discuss blood work results.

Muscle and joint aches, headache -- occurred initially (1-2 days), went away completely, then returned 2 weeks after the shot. Still persisting and are unusual. Headache was determined to be related to neck tension -- and has resolved but the strange muscle and joint aches are persisting. Not at all typical in past.

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.

TINGING IN THE RIGHT LEG, MOSTLY IN LOWER RIGHT LEG; NO APPETITE; SEVERE HEADACHE; MUSCLE SORENESS; NAUSEA; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 165 pounds, and height was 162.56 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 16:45 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced no appetite. On 13-APR-2021, the subject experienced severe headache. On 13-APR-2021, the subject experienced muscle soreness. On 13-APR-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) Headache - 9.5/10, Muscle Ache 7.5/10. Treatment medications included: paracetamol. On 14-APR-2021 20:30, the subject experienced tinging in the right leg, mostly in lower right leg. On 15-APR-2021, Laboratory data included: Pain scale (NR: not provided) Headache - 1 to 2.5/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinging in the right leg, mostly in lower right leg, severe headache, muscle soreness, nausea, and no appetite. This report was non-serious.

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.

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.

LEG CRAMPING; HEADACHE; SPORADIC NERVE PAIN/ HEATING SENSATION IN ARM NECK AND FACE; FELT TINGLING SENSATION IN HER ARM, NECK AND FACE/PRICKLING AND TINGLING IN BOTH LEG; NECK STIFF; FACE FLUSHING; PAIN IN LEGS; This spontaneous report received from a consumer concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug allergies. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced sporadic nerve pain/ heating sensation in arm neck and face. On 08-APR-2021, the subject experienced felt tingling sensation in her arm, neck and face/prickling and tingling in both leg. On 08-APR-2021, the subject experienced neck stiff. On 08-APR-2021, the subject experienced face flushing. On 08-APR-2021, the subject experienced pain in legs. On 08-APR-2021, the subject experienced headache. On 15-APR-2021, Laboratory data included: Blood test (NR: not provided) Not reported, CAT scan (NR: not provided) not reported, and EKG (NR: not provided) not reported. On an unspecified date, the subject experienced leg cramping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from face flushing, and headache on 10-APR-2021, had not recovered from felt tingling sensation in her arm, neck and face/prickling and tingling in both leg, and pain in legs, and the outcome of sporadic nerve pain/ heating sensation in arm neck and face, neck stiff and leg cramping was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as 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.

About a month after the vaccine late that night I developed increased leg pain. My hip and knee joint is so inflammed it cause issues with sleeping and I was diagnosed with Versitis in my hip and sent me to physical theraphy

Within 24 hours, normal side effects including, muscle pain and aches; Resolved after 1 day On 4/23/2021, 14 days after vaccine, patient began experiencing loss of appetite On 4/26/2021, 16 days after vaccine midday on 2, patient began experiencing sudden onset of upper stomach pain, heart palpitations 4/29/2021, patient went to ER due to extreme upper abdominal pain and intermittent back pain and intermittent heart racing. Prior to going to hospital, patient was healthy with no prior health issues or diagnoses. She also took baby aspirin, 81 mg several days prior to being admitted, took 2 chewable gas- except tablets and had her glucose checked which was a 96. Patient was not admitted and discharged the same day with a diagnosis of acute pancreatitis. She has had 2 children in the last 3 1/2 years and still nursing a 14 month old and hasn't count alcohol in years. Pain meds prescribed but using them every 8 hours to manage pain and barely eating or drinking, yet pain still persists.

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.

Patient developed neck pain and right shoulder pain the day of her shot. Then the pain started going down her right arm and she developed weakness and paresthesias.

Kidney nephritis. After 6 weeks, I am still currently being treated for this and no ETA has been given on how long the inflammation will last. I start another high dose of steroids tomorrow to help with the inflammation. So far the following medication have been prescribed for the pain in my right side from my paraspinal near my T4 around to the front of my ribcage are: Cipro, Macrobid, 60mg Prednisone, anti-nausea medications, Flexeril, Naproxen ER, and Tramadol.

3/12/21 fatigue, brain fog, chills for about 12 hours as expected 3/16-3/21 extreme fatigue 3/21-3/22 stomach upset, dizziness, severe anxiety and panic 3/27/21 ER visit due to anxiety and panic; prescribed Ativan with no tests run 3/23- present Severe anxiety and panic, depression, heart burn, diahhrea, dizziness, headaches, weight loss of 20 lbs (unintentional), lack of appetite, insomnia, fatigue On 4/16/21 I had my thyroid levels checked. TSH in a October 2020 was 1.42. On 4/16/21 it was 0.21. Ultrasound of thyroid on 4/30/21 showed normal thyroid but 3 measurable calcium deposits on the side of the thyroid that are now being monitored. I have been unable to work on-site in school due to the anxiety and panic. I?ve tried 2 different anxiety meds but unable to take due to side effects.

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.

I had covid in 2/2021 then got the J&J covid vaccine on 3/20/21. The health care provider said it will be fine, after getting the vaccine my knees started to hurt and the pain getting worst every day, went to 3 doctors and emergency room at the hospital, please help no doctor is able to treat me and make the pain go away, they all suspect its from the vaccine. I can provide additional information if needed.

Monday afternoon had a headache, but after waking up on Tuesday after the vaccine constant, Wednesday stiff neck, by Friday all same symptoms, along with not feeling well at all. Went to the local ER at on 04/23/2021, Checked BP and it was high, they did a CT and it looked fine, the ER DR came in and said it was a migraine but I have had migraines before and this was not it. 04/27/2021 went into my primary care dr, BP was still high, and prescribed a water pill called Hydroclorophazide.

More severe Headaches, chest tightness, blurry vision, blood shot eyes, stomach pain, back pain, leg pain (back of knees, dizziness off balance.

In mid-April I began to notice very mild neurological symptoms in my right arm and leg - pins and needles, shooting pain down the extremity, numbness, very slight weakness. I have a history of radiculopathy and lumbar spinal arthritis but no recent history of injury or falls, so I attempted home treatment for a while but when that was ineffective after 2 weeks and symptoms were gradually and slowly worsening, I scheduled an appointment with my physician. I saw my physician on 05/21/2021 and he ordered x-rays (taken 5/26/2021), lab work, and an EMG/neurology consult (scheduled September). After the x-ray, the numbness, tingling, and pain in my R arm and R leg worsened and is now causing significant sleep disruption. Also now accompanied by similar symptoms in my R flank/side and pain in my spine from neck to tailbone. On 05/27/2021, I noticed that the right side of my face appears to be affected as well, with muscle spasm/jerking in my right cheek when I smile broadly. No facial drooping, difficulty speaking or swallowing, or respiratory involvement is noted at this time.

Began with tension, pain and stiffness in left gluteus muscle within 24 hours of vaccine. Moved to severe pain, stiffness, weakness of muscles in right groin and leg. Stiffness, muscle weakness, and pain in right leg that has persisted and has now spread to front of hip. Extreme Difficulty waking, sitting, bearing weight since symptoms began a few days after receiving the vaccine. I hesitate to say this is a permanent disability. I?m praying it gets better, but my mobility has been extremely impaired and I am in constant pain. The issues are spreading in my right hip and entire groin.

SEVERE NERVE INFLAMMATION; RESTLESS LEG SYNDROME; MUSCLE CONTRACTIONS; PAIN FROM HEAD TO TOE, INCLUDES FINGERS, TOES, EYELIDS, CHEEKS, ABDOMEN; SLEPT INTERMITTENTLY 5 TO15 MINUTES AT A TIME; CHILLS; EXTREME BURNING OF MUSCLES; MUSCLE PAIN THROUGHOUT BODY; SEVERE HEADACHE; This spontaneous report received from a patient by a Business partner on 27-MAY-2021 was received on 27-MAY-2021 and concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, and other pre-existing medical conditions included the patient had codeine allergy and no other illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021 23:30, the subject experienced severe nerve inflammation. On 25-MAY-2021 23:30, the subject experienced restless leg syndrome. On 25-MAY-2021 23:30, the subject experienced muscle contractions. On 25-MAY-2021 23:30, the subject experienced pain from head to toe, includes fingers, toes, eyelids, cheeks, abdomen. On 25-MAY-2021 23:30, the subject experienced slept intermittently 5 to15 minutes at a time. On 25-MAY-2021 23:30, the subject experienced chills. On 25-MAY-2021 23:30, the subject experienced extreme burning of muscles. On 25-MAY-2021 23:30, the subject experienced muscle pain throughout body. On 25-MAY-2021 23:30, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe nerve inflammation, restless leg syndrome, and extreme burning of muscles on 26-MAY-2021 11:30, muscle contractions, and muscle pain throughout body on 26-MAY-2021 15:00, and severe headache on 26-MAY-2021 20:00, and the outcome of chills, pain from head to toe, includes fingers, toes, eyelids, cheeks, abdomen and slept intermittently 5 to15 minutes at a time was not reported. This report was non-serious.

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.

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.

Within one minute of receiving the vaccine, I lost consciousness/ passed out. When I came to, it took me awhile to realize where I was and what had happened. I was alone in the room. I eventually realized that I was sweating profusely as of water have been poured all over me, something I have never experienced before. Then I began vomiting violently. I couldn't move because I kept almost passing out and I continued vomiting. The two vaccine workers kept wanting to call an ambulance for me but I didn't see what an ambulance could do for me and it was hard to respond to them. I could not get up or move myself or leave the store by myself. After about a half-hour I contacted my sons to come to the store and help me. When my son's arrived, approximately 15 minutes after all of my Adverse Events began, they helps me out to the car in the parking lot and I continued vomiting violently, even on the drive home. Once at home, I took anti nausea / anti vomiting meds and after an hour or two I could sit up and sip water. By that night, I had fevers and the continued throughout the night along with a migraine like headache. The next day continue taking the anti-nausea meds but I still was not able to move around or eat and I had fevers add headaches severe muscle aches and soreness throughout the day and the next night. For the next several days, I was no longer taking the anti nausea meds and I just constantly felt like I was going to pass out and vomit. It felt like all the blood had been drained from my face. It was hard for me to sit or stand or walk around. I tried to work remotely but even just sitting up in my home to a computer was very difficult. I felt dizzy and light-headed and nauseous constantly. On a Thursday, the 10th, I suddenly became very cold and chilled even though I had not had a fever that day. I laid down on my bed with a blanket to try to warm up but my teeth were violently chattering and my hands and feet were ice cold but profusely sweating like nothing I've ever experienced on my hands and feet. My arms and legs started shaking so badly it was more like Tremors bordering on convulsions. It was a very scary and I would have gone to the hospital but I could not safely drive. This lasted about an hour and after it went away, it never came back. I last had a fever on Sunday, the 13th. It was approximately 101. I have not had a fever for a headache after that day but I still felt light-headed and nauseous until June 18th. I have been feeling basically normal since the 18th. I am hopeful that I will not have any more effects but I'm wondering how and where I should report any others?

Severe headaches turned into sever pressure in my head, face (specifically nose, behind my eyes, and temples.) My ears were pulsating and I was having daily dizziness. The pressure in my face and head was almost unbearable as nothing seemed to help make it go away. I went to my doctor's office for the 2nd time that week. I was feeling extremely anxious because I had been experiencing this head, face and ear pressure for days on end. I saw a PA in my doctor's office and she had me start taking anti-histamines, a low dose decongestant, and said to continue Advil throughout the day. I started the anti-histamines and then started taking Advil 3 times a day just to keep the head pressure at bay enough to function. At this time I had now been sleeping almost completely propped sitting up in my bed for weeks because the pressure in my head and nose area bacame unbearable whenever I attempted to lay down.

I woke up in the middle of the night to a throbbing headache. I got up because continuing to lay down wasn't an option. I took 2 Advil and sat in my living room waiting for it to kick in. I have a history of migraines, but this was unlike any headache or migraine I've ever had. It felt like every vein in my head was throbbing and pulsating. It was even pulsating and throbbing through my face and in my ears. Every time I tried to lay back down it caused tremendous pressure in my head, so I had to sit back up. I wound up staying up all night due to not being able to lay back down. The headache finally subsided by morning.

First night, I had severe chills and sweats off and on throughout the night; including muscle and joint pain that was severe. Fatigue, joint pain and an occasional chill (better then the next day). Monday - Joint pain and occasional chills - those continued for the rest of the week and Wednesday I also had a migraine headache. Friday - severe migraine and vomiting and my doctor sent me to ER. Medication for the Migraine - three different things - one was an IV Benadryl - the others I don't know. That cleared my symptoms up that same day just a couple hours later. I have been fine every since.

Sever joint paint traveling through body hands wrists knees feet ankle fingers neck back. Seems to move around and worse at night. Pain medication does not work. I have been to the ER and ruled out Lime disease, Lupus. Scheduled to see Rhumitoid doctor. Doctors don?t know does not go away.

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

The back of my head and neck were very swollen and sore since I received the vaccine. My fingers and fingertips have been experiencing extreme pain, numbness, and tingling since I received the vaccine. My right hand and arm have been having burning pain, numbness and tingling. The pinky finger on my right hand has hurt the worst and the pain hasn?t gone away.

My shoulder remained in pain as the usual Covid Vaccine reactions. From Day 5 and beyond my arm was extra soar, started losing sensation in my left hand and forearm. Sleeping became unbearable after 10 days. I was unable to tend to normal daily thing slike cooking, dressing myself, shampoo, putting on sunscreen (by that time I was on vacation in Florida). It did not get better. My arm hurt, shoulder, forearm hand, weakness and pins and needs in my hand as well. I booked a doctors appointment for July 16.

muscle aches, palpitations, "feels like heart is accelerating and decelerating", chest pain, nausea, vomiting, has hx of GI upset Referred to see primary physician STAT.

?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.

So I reacted pretty severely to the vaccine. It's almost been 24 hours now, and my symptoms are almost gone. I had, in this order, compounded, with the peak happening about 12 hours afterwards: immediate dizziness about 10 minutes after the shot, nausea started about 30 min, at 4 hours a strong headache that didn?t go away until now, took Tylenol at 7pm, stiffness in the joints, hands, and feet started about 6 hours of shot, at 8 hours pain in the shoulders and neck, at 12 hours cramping all down my back and my hips and low fever. Fever continued until around 6am despite taking more tilt at 2am. Finally got to sleep at 6am. Woke with remaining stiffness and headache at 7:30am. Nausea continued for another 6 hours. Headache continued for another 6 hours. Muscles remained sore due to severe cramping last night.

By 8:30pm, low grade fever, lower back pain, chills, couldn't get hands warm, very tired, heavy legs. No sore arm.

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.

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.

3 hours later, 5:30 pm Heaviness in legs 9 hours later, 11:30pm low fever, chills, aches for 2 hours. Took acetaminophen for relief. Symptoms did not return. 12-27 hours later, until 5pm the next day, sheer fatigue and exhaustion. Mind seemed sharp. No symptoms again until 3 days later, (72 hours), fatigue and heaviness feeling in head and body, headache, thirsty Sleep helped headache go. Drank water. 3 1/2 days later, in morning, woke with dizziness and vertigo like feelings. Stumbled and head fog. Dull feeling still on this 4th day. Muscles weakness in limbs, feeling faint, tightness in head, dehydrated feeling, congested. Drinking water. Sitting. Still working desk job, teacher.

Experiencing muscle weakness in my proximal muscles severe enough to be in a wheelchair. The symptoms began three days after my vaccination. I had COVID-19 (diagnosed Feb. 1st, 2021) and 3 days after my COVID symptoms went away, I had severe weakness in my proximal muscles which put me in a wheel chair for 4 weeks. I was diagnosed as a "long hauler" with Post-Covid syndrome. I had just started walking again on Monday, March 15, 2021 and my vaccine was Friday, March 19, 2021. I asked my neurologist prior to the vaccine if he thought it was safe for me. He assured me that it was. I started experiencing muscle weakness again 3 days after vaccination, which coincidentally, was the same time frame that I experienced these same symptoms post COVID. It appears the vaccine caused a relapse of post-COVID syndrome.

Besides flu like symptoms beginning 12 hours after injection and lasting 24-30 hrs, i woke up with a very swollen lymph node in pectoral/underarm area 48 hrs after injection. Dr ordered ultrasound of site. Determined 2 lymph nodes were enlarged. Prescribed cephalexin 500 mg 2 times a day for 10 days, ibuprofen and warm compresses. After 48 hours on antibiotics has slightly gone down in size.

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.

Fever chills joint and muscle aches headache fatigue beginning about six hours after receiving the vaccine

Woke up with chills the morning after receiving the vaccine. Piercing headaches in temples, all over body aches, mostly in the back and neck. Body felt very fatigued. Nausea. Brain fog.

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.

24 hours after vaccine severe pain in all body joints and muscles. Hurts to walk. Pain in lower back and pelvis, knees, wrists, and ankles. Tiredness, headache, dizziness.

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.

Side effects started approximately 8 hours after receiving shot. First chills, then body aches, then headache and possibly joint pain in knees. 400 mg of Tylenol was taken approximately 15 hours (4:15am) after receiving the shot and symptoms diminished. The next morning I woke with a mild headache, body aches started to return around 10:30am as the Tylenol wore off. Additional 400 mg of Tylenol was taken. General fatigue was experienced the rest of the day. After the 2nd night of sleep I felt fine.

Initially started as nausea and dizziness within 20 minutes of the shot. I started running a fever that reached 100.4 that night. The fever continued the next day and stayed around 100.3 and went down to 99.4. Today (4/9) me fever has subsided. In addition to the what is listed I had, and continue, to have muscle soreness and pain in my stomach. I also have pain in my joints. I have also noticed that my vision is not clear is blurred and that continues. My stomach pain and pain in my legs continue at this moment and I am very tired.

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.

Joint pain by 10 PM on day of injection. By 11 PM Monday rejection severe body chills shaking uncontrollable muscle twitches to the point where I could not speak or walk correctly which lasted for approximately one hour. By the by 8am the next day Fever 99.1 but my baseline temp is 96.7 to 97.1. Headache and nausea started around the time of the fever. I was unable to go to work on fri 4/9/21. Symptoms resolved by about 11 PM Friday 4/9

Fatigue and headache began approximately 8 hours after vaccination. Over the course of the evening my lower back and hip joints began to ache and the headaches worsened. By 10pm the same evening of the shot, I began to get chills and the body aches worsened. The next morning, the headache had lessened considerably and the body aches were mild; chills were completely gone. By noon the next day all symptoms were resolved. Not treatment was sought, I took Ibuprofen and drank tons of water.

Severe headache started at about 12:45am. Vomited. Took 400mg Ibuprofin. Chills started. Fell asleep, but had chills and muscle aches the remained of the might. The following day I was on the couch all day with chills, muscle aches and fatigue. Took a lot of naps. Around 4pm on April 7 I took about 200 mg ibuprofen for another headache (I don't usually get headaches). The muscle aches and fatigue started to ease up by 8-9pm on April 7. Went to bed and woke up feeling myself again on April 8.

myalgias, fever to 101, and fatigue approx 6 hours after administration. Abdominal pain throughout the night. The next day around 3pm the patient developed severe, diffuse crippling abdominal pain, 10/10, while walking in the park. EMS was alerted by her husband because she was unable to get up or move from the spot due to pain. He gave her Pecid AC and by the time EMS arrived she was doing much better.

I reported previously that the day of the shot (that evening at close to midnight) I fainted. I woke up on my bathroom floor. I walked down my hall and saw black dots and felt dizzy with nausea. The next thing I knew I was on the bathroom floor and didn?t remember how I had gotten there. It is Friday and I now am experiencing shooting pains in the side of my head. I also have been experiencing pains in my calf muscles and some chest pains. I am still extremely tired and having abdominal pain. I have contacted my doctor?s office about the fainting but I am going to call Monday to get an appointment to get checked out. I am concerned about possible blood clots.

Starting the day following the vaccine, I had shooting pain (nerve pain) in all of my limbs? both arms and legs. It has been more severe in my legs. The only time I experienced any similar pain was several years ago when I had shingles, except that pain was isolated to one side of my body and only in my arm. This pain is exactly like that except it is bilateral and is happening in arms and legs. I did also have the standard muscle ache post-vaccine, but this shooting pain is in addition to it. The nerve pain peaked about 32 hours post-vaccine and has persisted in my legs through today, which is 4 days post-vaccine. I have only self-medicated with ibuprofen or acedomenophen, which reduces but does not eliminate the pain. No signs of this pre-vaccine. Was feeling totally healthy? to the extent that I exercise daily and ran a half marathon a month ago.

A few hours later, I got a migraine. Over night I got achy and nausea set in. My migraine got worse the next day. Today it is mild but still there. As well as my stomach nausea. I hope to be symptom free by tonight. I also had muscles tighten up. Especially in my legs

Around 10:00 p.m. the same day as receiving the shot, I started to experience intense burning sensation at the base of the back of my neck. It persisted strongly and then body aches and chills started shortly therafter. Now, on the second day, I noticed a feeling of bruising around the same base area of my neck and around the front left collar bone, it feels like a nerve/vein is swollen and tender.

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

When I got the vaccine I fainted. I never fainted before with vaccines. The real problem started a week after I got the vaccine I felt extremely exhausted, and I'm having a hard time getting up from bed in the morning. My symptom is that all my joint hurt so much, my ankles, my wrist, my knees, my hips , my elbows anywhere is a joint its hurts. If im sitting it hurts, if I'm standing it hurts, if im laying down it hurts. Besides that I feel nervous, like I'm shaking in the inside, but I'm not shaking.

Fever 101 F onset approximately 12 hours post vaccination; Concurrent Chills - Duration 5 hours thereafter Fever dropped to 99 and resolved with increased fluid intake Onset 1Hr post vaccine: Inflammation and Regional Pain Left Axial Lymph nodes; difficulty raising and extrnding left arm (heavy feeling) not due to soreness - Resolved 36 hours

Janssen COVID-19 Vaccine EUA Received vaccine at 11 am and at 8 pm I started to feel weak, achy, and feverish. 101 temp. Took Tylenol extra strength rapid release gel caps. Woke up at 11 pm with body aches, moderate/severe back pain, fever 101, nausea. Iced back and neck and called pharmacy at 1:30 am to see if I could take ibuprofen. Took 2 ibuprofen at 2am and that helped subside the back pain, body aches, and fever. Felt tired, achy, nauseous for the next 24 hrs. Felt about 75% better 48 hours later, but still tired and off and on nausea. I also had a mild headache from day 1 - 3 and a dry cough that continues a week later.

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.

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. 9 hours after the shot I woke up freezing cold, all my joints hurt, my muscles were stiff, and I felt disoriented. I stayed in bed for a couple of hours. At 5am I got up with all the same symptoms and took my temp which was 101.4. My head hurt like there was too much pressure in my skull. I ate toast and took some ibuprofen and went back to bed. These symptoms lasted for 10 hours. Then for the next 5 hours I just had a fever off and on and fatigue. 3 days after the shot the gland in my left armpit became swollen. It has gone down in size but still sore 5 days later. I still feel tired too.

Other than feeling warmer than usual within minutes after the injection at 0715 AM I had no other symptoms until 430 PM when I began to develop a headache, muscle aches and joint pain. It came on slowly but by 930 that evening I was shaking uncontrollably for about 3 hours with chills and severe joint pain. My headache grew worse and lingered for several days after as well. I still have a mild headache today (4/13/21) and feel lethargic and almost foggy.

Dizziness/lightheaded, felt hot,hard to breath right after injection. Had lip/tongue tingling, dry mouth, and chest tightness within a few minutes. They had me wait for 30 mins before allowing me to leave. I woke up at 3:30 in the morning with a severe headache, and had stiffness in my neck and trap muscles. I still am having a severe headache, neck/trap muscle pain, dizziness/lightheaded, diarrhea, sweats and I feel like Im having panic attack sypmtoms throughout the day.

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

It gave me Covid symptoms that started about 12 hours after the shot. Body aches, fever, chills, congestion, exhaustion, nausea & dizziness. That mostly resolved after 2 days. Then 1 week later on Saturday, I started having pain in my left leg where I had had RFA of the greater saphenous vein 6 months prior. Leg swelled up got a hard knot. I got dizzy & nauseated. The pain increased, & I went to the ER on 3/21. They diagnosed it as thrombophlebitis. The pain & inflammation has continued for 3 weeks now despite the use of anti-inflammatory meds & support hose. I have also had rapid weight gain of 12 lbs and edema not relieved by lasix. Two weeks after the shot I also started having severe nose bleeds.

MIGRAINE HEADACHE; CHILLS; NOT FEELING GOOD; FEVER; BONES ACHE; DIFFICULTY SLEEPING; This spontaneous report received from a consumer concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and gall bladder disorder, and concurrent conditions included migraine, and cigarette smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 17:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced bones ache. On 10-APR-2021, the subject experienced migraine headache. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced not feeling good. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 10-APR-2021 10:00, Laboratory data included: Body temperature (NR: not provided) 99.4 F. On an unspecified date, the subject experienced difficulty sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, bones ache, migraine headache, and chills, and the outcome of not feeling good and difficulty sleeping was not reported. This report was non-serious.

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.

Fine until next morning. On 4/6, the as to week to get out of bed until 1:30 pm. Took Tylenol and slept most of the day. The following symptoms are still accruing and have lessened about 5% every day, but new symptoms are arising also. Nausea Chills/sweats EXTREME fatigue Dizzy spells Shortness of breath Belching Dull headache General headache Sore joints and stiffness in legs Bloat Bad Bouts of general malaise Fogginess and complete disorientation for 4 days Loss of balance and coordination for 4 days Had to take Off of work until 4/12. Symptoms as of 4/14 Extremely sore legs and calves Clogged ears Heaviness in chest and shortness of breath Tired but not fatigued Less weak Stomach has been upset All over body aches

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

Approximately 30 minutes after the injection I developed a significant headache and nausea. Approximately one hour later if I was in the sun I became overheated, flush and an overall feeling of nervousness, I adapted to these symptoms knowing they would considered normal but I no longer feel these should be considered normal. Around 7pm on Monday I started running a fever that started at 101.1. Between Monday night and Thursday morning it bounced around but stayed between 101.1 and 103.2. It did not go away completely until Thursday morning. At least I hope it is gone for good. On Wednesday around 10am I developed abdominal pain that by 4pm had me sitting by my car unable to continue for about 10 minutes. It was extremely stressful and still to the time of this report is still has not completely gone away. The most concerning for me is the back pain with it. At the time of this report I still have a headache, nausea, abdominal pain with back pain and vertigo. I have contacted my doctor's office and they have made notes but suggested I report everything here. They have started me on baby aspirin and electrolytes as I am also experiencing interment diarrhea.

Patient was seen in ER On 4/14/2021 with a complaint of right anterior hip pain. Patient denied any injury she received Johnson & Johnson vaccine on 4/8/2021 and has been worried about the side effects. Patient endorses a sharp pain which is worse with palpation right over the tibial bone. Right anterior shin x-ray showed no fracture or malalignment no destructive osseous processes or aggressive periosteal reaction. No radiopaque foreign body or soft tissue gas. Patient was discharged home to follow-up with her primary care. On today's visit patient states that she continues to have her right shin pain overall it is getting better she has tried ibuprofen/Aleve, however still worried about Johnson & Johnson vaccine side effects. Denies recent fall or injury. No swelling on exam Duplex ordered

Headache, nausea, dizziness/lightheadedness, blurred vision, muscle and body aches, fever 102.4, increased heart rate and palpitations, shortness of breath.

BODY ACHES; HANDS NUMB; CHILLS AND SHAKING/SHIVERING; VERY ACHY JOINTS; FEVER; HEADACHE; This spontaneous report received from a consumer 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, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F, 102.3 F, 103.3 F. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced hands numb. On 10-APR-2021, the subject experienced chills and shaking/shivering. On 10-APR-2021, the subject experienced very achy joints. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills and shaking/shivering, and hands numb, and had not recovered from very achy joints, body aches, fever, and headache. This report was non-serious.

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 have had body aches and severe joint pain since the day after I got the vaccine. Some days I can't get out of bed. Sleeping is becoming more difficult due to the intense pain in my joints. Knees, hips, shoulders and hands are the worst.

Non stop joint pain in legs. Daily migraine unable to open eyes at times. Seeing silver waves constantly and vision has become worse

initially with headache, diarrhea, stomach ache, nausea, loss of appetite then resolved 2 days later and left feeling tired and nauseated for several days. 5 days later developed tingling in legs and heaviness with change to gait. headache resolved. still with decreased energy level.

NAUSEA; FATIGUE; MUSCLE SORENESS ALL OVER BACK; LOW ENERGY; 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, batch number: 203A21A, and 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 fatigue. On 11-APR-2021, the subject experienced muscle soreness all over back. On 11-APR-2021, the subject experienced low energy. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle soreness all over back on 12-APR-2021, and had not recovered from fatigue, low energy, and nausea. This report was non-serious.

I had all the symptoms of the Flu for 3 days, fever, muscle pains, cough, fatigue, and on the 4th day I started having horrible cramps, felt like labor/contractions, followed by my period, which wasn't due for another 3 weeks. I'm still having a very heavy flow and horrible cramping a week later.

I was hospitalized on April 1 for pyosalpinx of unknown origin (not STD related). Symptoms included fever, chills, fatigue, soreness, abdominal and back pain, and headaches. I was hospitalized for four days, and on IV antibiotics for three of those days, followed by two weeks of oral antibiotics.

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.

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.

On 4/12 I started exp pain in legs shooting pain to my thighs and fatigue. I contacted a friend doctor stated that doesn't sound right might be a blood clotting issue. I went for a visit on 4/13 in the clinic doctor said it seem ok. I was also exp nausea, headache and pain lower left leg. I went to the hospital on 4/14 had Blood Work, Ultrasound (legs) tests results was fine. Also still exp inflammation feeling in my legs a if I have lifted weights and tightness in my calves. I couldn't walk exp muscular pain, stiffness between 4/14-/4/16. I normally have my menstrual 3-4 days for some reason it started over again on 4/10 for 10 days. I'm not sure if this was some sort of hormonal reaction. My normal daily activities have been limited I usually walk every morning with my husband since vaccine not able.As of 4/19 my headache is gone the pain is not as bad in legs.

DIZZINESS; FELT SLEEPY; MODERATE HEADACHE; NAUSEA; FELT TIRED; FEVER; BODY ACHES; MILD BONE PAIN; SENSITIVITY TO NOISE; NERVES ON NECK FEEL VERY TENSE; This spontaneous report received from a patient concerned a 45 year old female. The patient's past medical history included covid-19 infection, and concurrent conditions included high blood pressure, hypothyroidism, low vitamin d level, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no drug or non-drug allergies. 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, route of admin not reported, and batch number: 1808980 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 sensitivity to noise. On APR-2021, the subject experienced nerves on neck feel very tense. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced mild bone pain. On 10-APR-2021, the subject experienced felt tired. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced felt sleepy. On 11-APR-2021, the subject experienced moderate headache. On 11-APR-2021, the subject experienced nausea. On 13-APR-2021, treatment medications included: caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from moderate headache, and the outcome of body aches, fever, mild bone pain, felt tired, nausea, dizziness, felt sleepy, sensitivity to noise and nerves on neck feel very tense was not reported. This report was non-serious.

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.

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.

Shortness of breath for several days, feeling fatigue and week, pain in right elbow Diagnosed Apr. 17 in ER setting: acute segmental and subsegmental pulmonary embolism without acute cor pulmonale Acute thrombosis of superficial vena basilica right arm

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.

Lower back cramping night off vaccine. Back continued hurting for 12 days so went to Orthopedic doctor.

I had the vaccine n Sunday, Tuesday morning I woke up with a very tight feeling across my chest/ rib cage area, particularly on my right side, underarm, under breast area. I also had some weakness in my left arm where the shot was given. The tightness in my chest was not affecting my ability to breath, I was able to go on my usual daily hour-long walk but it was concerning me enough for a call with a Dr. I had spent the day before (Monday) using a wood pellet BBQ so I though maybe the issue was related to smoke. The Dr prescribed a salbutamol inhaler which I have used before for seasonal allergies but that didn't really d anything to help with the tight feeling. The feeling of tightness remained all week (and still does to some extent 11 days later). On the Friday I noticed a small dark spot, approx 2mm, a bit like a blood blister on the back of my right thigh. I have had these before fairly infrequently, and I see a dermatologist once a year for a check up and they are not concerned, and they usually go away on their own. But, the combination of a new blood spot and the continued tight feeling across my chest had me concerned enough to call my regular Dr's office. I was also feeling occasional sporadic aches in my legs in varying places. I spoke to a practice nurse who was very reassuring that she had spoken to many other patients that had also been experiencing chest tightness that had gone on for days after the Janssen vaccine, so after that I felt less concerned about the symptoms. I am still experiencing the tightness in my chest which has affected my shoulders and neck with what feels like muscle tension, and also been accompanied by some mild headaches at the sides of my head. I was pretty anxious about getting the vaccine which is not something I usually struggle with and on the Tuesday after the vaccine I felt particularly irrational and also very tired.

DIZZY; WEAKNESS; MUSCLE ACHE; HEADACHE; FEVER; 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 abstains from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. 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: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included paracetamol. On 17-MAR-2021, the subject experienced dizzy. On 17-MAR-2021, the subject experienced weakness. On 17-MAR-2021, the subject experienced muscle ache. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, weakness, muscle ache, headache, and fever on 20-MAR-2021. This report was non-serious.

WHEN TAKEN DEEP BREATH LEFT PAIN INSIDE OF THE LEFT BREAST (CENTER OF CHEST); CHEST PAIN, SORENESS OF CHEST; LOWER BACK PAIN; SORE ARM; MILD HEADACHE; FATIGUE; MILD ABDOMINAL DISCOMFORMT (SIDE STITCH) ON LEFT SIDE TO RIGHT; 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Blood test (NR: not provided) platelets were normal. On APR-2021, treatment medications included: naproxen sodium. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced mild headache. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced lower back pain. On 17-APR-2021, the subject experienced chest pain, soreness of chest. On 17-APR-2021, the subject experienced when taken deep breath left pain inside of the left breast (center of chest). On APR-2021, the subject experienced mild abdominal discomformt (side stitch) on left side to right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain on 10-APR-2021, when taken deep breath left pain inside of the left breast (center of chest) on 17-APR-2021, and sore arm, and mild headache on APR-2021, and had not recovered from chest pain, soreness of chest, fatigue, and mild abdominal discomformt (side stitch) on left side to right. This report was non-serious.

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

Crushing headaches, dizziness, blurred vision, confusion, anxiety. Muscle pain and stiffness, heart palpitations, loss of coordination. Sinus and jaw pain.

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.

At three AM I woke up with the room spinning, I couldn't focus, felt like I was falling. I had horrible pain in my back. I was sweating and vomiting. My husband carried me to the car and brought me to the ER. At the Er I was given a patch for my back pain, medicine for the dizziness and nausea. The dizziness didn't subside. I couldn't walk. I told them I had gotten the vaccine two weeks before and they said it wasn't related. I was diagnosed with a bladder infection, high blood sugar, and vertigo. I was discharged in the evening but with no improvement. I was not able to focus or walk for days. I saw my OBGYN, he was the only doctor I could see right away and he referred me to an ENT. The ENT can't see me until the end of June. I wasn't able to drive for weeks. I am slowly regaining my balance but still feel waves of dizziness and my eyes can't focus well when I am reading. The back pain is gone. My OBGYN also doesn't feel the dizziness is related.

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.

LOSS OF BLOOD; VOMITING; BACK PAIN; ABDOMINAL PAIN; FEELING WEAK; HEADACHE; BLOOD CLOTTING; COULD NOT MOVE; ONLY COULD DO 5 MINUTES OF WORK; 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 fibroids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070CCHD,expiry: UNKNOWN) dose was not reported,1 total administered on 20-MAR-2021 for prophylactic vaccination to left arm. No concomitant medications were reported. On 22-MAR-2021, the patient experienced blood clotting which lasted for three weeks and resolved as per physician on same day the patient experienced headache which got resolved on 22-Apr-2021. On 18-APR-2021, the patient experienced loss of blood, vomiting, back pain, abdominal pain and patient felt weak. On an unspecified date in 2021, the patient went to hospital, it was also reported that patient was not able to move and could do only 5 minutes of work. Patient got confused between clotting with menstruation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clotting on 12-APR-2021, and headache on 22-MAR-2021, was recovering from loss of blood, feeling weak, vomiting, back pain, and abdominal pain, and the outcome of could not move and only could do 5 minutes of work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: In narrative of source document vaccination date is 20-Mar-2021 and in the structured field of source document vaccination date is 20-Apr-2021. So as per conservative approach, date given in narrative 20-Mar-2021 is taken as vaccination date. V0 20210440392-COVID-19 VACCINE AD26.COV2.S-Blood clotting and loss of blood. 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.

UNABLE TO STAND UP; HEAVINESS IN BOTH LEGS; PAIN IN LEFT UPPER THIGH; HEADACHE; BACK ACHE; 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 past medical history included back pain, and concurrent conditions included irritable bowel syndrome (ibsd) with major constipation, abstains alcohol, and cigarette smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of report. The patient experienced cannot breath when treated with tetanus vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced back ache, pain in left upper thigh, headache. On 01-MAY-2021 and heaviness in both legs. On 02-MAY-2021, the subject experienced unable to stand up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heaviness in both legs, headache, pain in left upper thigh, back ache, and unable to stand up. This report was non-serious.

FLANK PAIN (LEFT); SWELLING (FRONT OF CHEST); LUMP ON LEFT CLAVICLE; NECK PAIN; LYMPHADENOPATHY; PAIN IN ARM; This spontaneous report received from a pharmacist concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 204A21A expiry: 22/JUN/2021) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced flank pain (left). On 03-MAY-2021, the subject experienced swelling (front of chest). On 03-MAY-2021, the subject experienced lump on left clavicle. On 03-MAY-2021, the subject experienced neck pain. On 03-MAY-2021, the subject experienced lymphadenopathy. On 03-MAY-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flank pain (left), swelling (front of chest), lump on left clavicle, pain in arm, neck pain, and lymphadenopathy. This report was non-serious.

Chills 1:00am 5-7-21 until 2am Saturday 5-8-21 Extreme tiredness 6am 5-7 until 10pm Saturday 5-8 Moderate headache 1100 am 5-7 until 9am Saturday 5-8 Muscle aches 100 am 5-7 until 10pm 5-7 Moderate sore arm 7pm 5-7 until ongoing I had Covid with moderate symptoms April 2020

A few hours following vaccination, psoriatic arthritis ?flare? began. 24 hours of feeling feverish. 48 hours of severe fatigue with severe joint pain. Symptoms slowly resolved over the next 48 hours and returned to normal. Psoriatic Arthritis is well managed at this time.

May 10, 2021: heaviness on injected arm May 11,2021: left arm pain, back pain and body pain, left leg cramps and pain, numbness on both hands

4/13/21 Numbness and tingling in feet, moved up legs. Cramping and deep muscle pain with shooting pains up thighs. 4/20/21 went to urgent care as cramping very severe with rapid heart rate. Tachycardia, EKG normal. Labs CBC, BMP, CK normal. 4/25/21 Heart 160, went to ER. Tachycardia, SVT. CT with contrast normal, labs normal. Discharged to cardiology follow-up. 4/30/21 Cardiology appointment. Wearing MCOT monitor 2 weeks 3/5/21 Neurology: EMG normal

Headache, right sided arm and leg numbness, pain in both calves, pain in arm pit which is worse on right side, some center chest pain and extreme tiredness. I have been to ER 3 times as well has PCP once and have follow up with a Neuro.

CONFIRMED IMMUNUNOLOGICAL VACCINATION FAILURE; CHEST PAIN TOWARDS THE LEFT; LEFT SHOULDER PAIN/ PROLONGED JOINT ACHES; FATIGUE; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 133 pounds, and height was 66 centimeters. The patient's concurrent conditions included alcohol use (occasional glass of wine), and non-smoker. The patient was not pregnant at the time of reporting. The patient had no known allergies/no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: 21-JUN-2021) dose was not reported, 1 total administered in left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced confirmed immunological vaccination failure. On 08-APR-2021, the patient experienced left shoulder pain/ prolonged joint aches, chest pain towards the left, and fatigue. On 06-MAY-2021 laboratory data included: C-reactive protein (NR: not provided) normal, CPK (NR: not provided) normal, Electrocardiogram (NR: not provided) normal, Erythrocyte sedimentation rate (NR: not provided) normal, Fibrin D dimer (NR: not provided) normal, and SARS-CoV-2 antibody test (NR: not provided) less than 1 which was negative. On 08-MAY-2021, the patient recovered from prolonged joint aches. The patient had an emergency room visit for left shoulder pain and chest pain towards the left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 29-APR-2021, was recovering from chest pain towards the left, had not recovered from left shoulder pain, and the outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210519849-covid-19 vaccine ad26.cov2.s- confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210519849-covid-19 vaccine ad26.cov2.s- left shoulder pain/ prolonged joint aches, fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.

About 2 hours after receiving shot, I was feeling very run-down and sore. My neck had pressure building at the base. Left work early to get rest. My next day entire head and shoulders were pressurized and shooting pains down neck, through arms, numbing left side of body cramping feet and arms, all triggering anxiety /panic attacks. By Friday I sought help. Urgent care sent me ER because they?d be able to run better tests. ER gave me an Ativan and sent me mental health referral. After a couple more days of trying to rest and get ease, went to different urgent care. Received muscle relaxer for cramping, and appointment for primary care provider. Saw ENT dr for throat, referred to neurologist, had MRI for neck pressure and painful spinal release sensation I feel every morning. Follow-up is end of June. Brain in fog, pressure in head building still daily. Acupuncturist gave me info for this Reporting. Been to acupuncture twice, not improving yet.

I was getting severe pain near my right rib and it moved to my back and chest area. I ended up having to have an emergency gallbladder removal surgery.

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

3/13 vaccination. 3-4 hours later, I started having symptoms to include tickle in throat, post nasal drip. By 11:40 I had a HA, I was very tired, quite a bit of secretion. I continued taking Benadryl every 3 hours. At 2 :30 PM, heart palpitations and angina. My BP was 98/69. I took more Benadryl, drank some fluids. By 4:15, I was getting drowsy and tired, having pain in multiple joints through my body; 8/10 scale, especially in my hands in feet. I took something for pain. My arm was very sore. I had mild to moderate slight cough. By 7:40 PM I took my regular medication. I was having a sudden intense HA and pain in joints was 9/10. I was having stiffness, chest congestion, feeling 'flu like' symptoms, brain fog, and weird pains / electro shock pains on extremities. By 830, my symptoms increased to almost a really bad allergic reaction. I couldn't think well, dizzy, cough, chest congestion and my lungs started to hurt. By 10:30pm, I started to have a low grade fever, pain 9/10, I took Ibuprofen and Benadryl every 3 hours. 3/14 Ibuprofen, slight fever, slight HA, joints were swollen and stiff; 8/10 on pain and stiffness. I had muscle pain and brain fog, could not say words. Dull pain back of head. My kidney area, I felt like it hurt, severe anaphylactic reaction it felt like. I still had photophobia. It continued into the evening. I continued taking the Benadryl and ibuprofen. Around 6pm, I had 101.5 temperature, nauseated, crying, chest congestion. By 10:45, my temp was going up again. Monday I had low grade fever, continued medication. Symptoms continued for a few more days with palpitations, brain fog, pain in lungs and kidneys. I couldn't do anything. By the end of the week, I started to recover. *My PCM knew before I got the vaccine they were on board and knew what was going to happen in regards to my reaction, EKG, I had epi pen, didn't pass out, I decided I was going to stay home. *It took me a good couple weeks to recover to my baseline. But it was pretty tough.

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.

- Very fatigued within 4 hours of injection - muscle / body aches within 7 hours, became worse within 14 hours and ended within 48 hours, especially stiff neck and shoulder pain - Restlessness, chills/shivering, tossing and turning and strange dreams/sleep patterns during first night after vaccine shot - felt very heavy within 12 hours, ended within 36 hours - exhausted within 12 hours, ended within 36 hours - fullness and ringing in ears within 12 hours, ended within 36 hours - low temperature within 12 hours, ended within 36 hours - no appetite for 36 hours - low grade headache started at 12 hours, ended within 40 hours

HAD FEVER, CHILLS, AND BODY ACHES 04/01/21 AND 04/02/21 AND WHEN WOKE UP ON 04/03/21 HAD SEVERE MUSCLE, JOINT, AND BONE PAIN THAT CONTINUED TO WORSEN TO POINT THAT COULD BARELY GET OUT OF BED AND FUNCTION. WENT TO PCP ABOUT 2 WEEKS LATER. GIVEN STEROID PACK AND MALOXICAM AND IS NOW IMPROVING AND ABLE TO FUNCTION WITHOUT BEING IN SEVERE PAIN

Headache, chills, body aches, muscle aches, fatigue. Next day, symptoms worsened. Worsened on third day. No fever. Fourth day nausea. into fifth day. Sixth day vomiting. Seventh day severe diarrhea, pain in shoulder blades. Eighth day severe cramping in intestines, fatigue, back pain and dizziness. Ninth day symptoms continued. Tenth day chills and traveling pain left leg to hip. No medication administered. Went to Emergency Room.

I had a migraine with an aura and soon after the migraine started my neck pain got really bad. The headache wouldn't go away. After 2 1/2 weeks of suffering from the headache, I went to see my PCP. She sent me to the hospital to have a CT scan and that came back negative. My headache cleared up 5 days later. I went on a run and after I returned, my headache with the aura came back. We have found that the running needs to halt. I am still having neck pains, but the migraine has not come back. I am experiencing mild/moderate headaches though. I am now going through physical therapy for my neck pain.

Fever, body aches, joint pain, exhaustion, breast pain, shortness of breath, migraines, cough, chest tightness, diarrhea Ventolin Amoxicillin-clav 875-125mg Azithromycin 250mg dose pack Benzonatate 200mg Cefdinir 300mg Levofloxacin 750mg Methylprednisolone 4 mg Prednisone 20mg

CONFUSED; BRAIN WASN'T WORKING RIGHT; REALLY DIZZY; LEGS COULD BARELY HOLD UP; NO ENERGY; HEADACHE; FEVER; SWOLLEN GLANDS; ACHY; PAIN IN BACK OF RIGHT KNEE/PAIN IN LEFT KNEE; 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 obsessive-compulsive disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 23-JUL-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for fever. On 15-MAY-2021, the subject experienced swollen glands. On 15-MAY-2021, the subject experienced achy. On 15-MAY-2021, the subject experienced pain in back of right knee/pain in left knee. On 15-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 Unit Not reported. On 16-MAY-2021, the subject experienced no energy. On 23-MAY-2021, the subject experienced legs could barely hold up. On 24-MAY-2021, the subject experienced really dizzy. On 25-MAY-2021, the subject experienced confused. On 25-MAY-2021, the subject experienced brain wasn't working right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen glands, achy, and fever on 16-MAY-2021, and confused, and brain wasn't working right on 27-MAY-2021, and had not recovered from headache, no energy, pain in back of right knee/pain in left knee, legs could barely hold up, and really dizzy. This report was non-serious.

I went to the ER 5/25/2021 for headaches, nausea and calves, ankles, and feet swollen badly. Dr, prescribed a fluid pills and the swelling was gone after a couple of days.

5/6 1pm Immediately after shot administered had a small headache but barely noticeable. 5/6 11pm Fever started with body aches. Fever was low and then rose to ~102 for the next 24 hours. During this time for a short period of time, ~1 hr, my throat/back of my mouth went numb. The feeling in my mouth returned. During the fever I was dizzy but not as bad as a Vertigo feeling. (I experienced Vertigo 17 years ago - postpartum.). I also experienced slight stomach pains during this time. 5/8 starting on this day going forward for 2 weeks I experienced headaches, which came on in the evenings, just after work. From around 4pm till 8pm I was in bed daily with headaches. I usually do not get headaches unless................ unless it is my period times. During this 2 weeks I also added 5 lbs of weight, which I believe is water weight. Lately I have consistently been 125 lbs (up from 120lbs since I was a teenager) and I went to 130 lbs in 2 weeks. I feel as I am retaining water weight. Pain in my legs attest to the weight. The headaches ended for a few days and returned yesterday afternoon. I can tell my body is trying to fight this Covid-19 shot. I am hopeful these body changes will subside, weight gain and headaches overtime. Also, during the first 2 weeks after the shot I also experienced vision blurriness. This has since gone away and my vision has been self corrected. I have not gone to the doctors as I viewed all of this associated with the vaccine and normally I am a healthy 45 year old woman otherwise. I haven't needed to see a doctor in over a year. If these headaches and body aches/weight gain continues I will be at the doctors for help. I figured I would give it time to enter and exit my body first. Ibuprofen sometimes worked to lessen the headaches, but not always. You can email me any further questions you have. Thank you.

About ten minutes after the shot I had tightness of the chest and difficulty breathing, An hour later nausea and dizziness. Later that day I experienced muscle aches and joint pain, teeth started to hurt on the right side and jaw was hurting.

THE MORNING AFTER MY VACCINE MY TOES AND LEGS WERE NUMB AND TINGLY AND FELT HEAVY AND FELT WEIRD WALKING. I HAVE NEVER FELT THIS FEELING BEFORE, IT WENT AWAY PRETTY MUCH AFTER A COUPLE DAYS AND THEN CAME BACK A WEEK LATER E VEN WORSE THEN BEFORE AND STAYED FOR AT LEAST 3 DAYS SO I WENT TO URGENT CARE AND THEY SAID IT WAS NOT A BLOOD CLOT AND THEY DIDNT KNOW MUCH ABOUT THE VACCINE. NOW OVER 3 WEEKS LATER I STILL HAVE NUMBNESS IN MY TOES AND LEGS. IT COMES AND GOES, SOME DAYS ARE WORSE THAN OTHERS.

Muscle spasm in the back of the neck Foot pain Left arm pain/unable to use or lift it Pain in the bottom of my foot and neck pain are still ongoing The pain usually occurs around night time

Progressively increasing weakness in arms and legs culminating in the inability to breathe with subsequent intubation. Received IVIG 400mg/kg IV x 5 doses. Tracheostomy placed 6/2/21. At the present time (6/29/21) she remains hospitalized off the ventilator with the tracheostomy. She continues to slowly recover

After my J&J vaccine, my left arm started to hurt and was tired for few days. About three weeks later, my IBS is worse, arthritis is worse, get super tired very easily, just going up the stairs and now have to use my inhaler. I went to the see my doctor two weeks ago, he gave me an inhaler and albuterol and have hoarseness and cough way more often now than before. I can not sing anymore because I get winded. I wish I would not have gotten the J&J vaccine due to my symptoms.

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.

Severe pain in left leg. Couldn't walk. Went to urgent care . Did blood work and x-ray. A week later, severe in right shoulder blade and upper back. Had to leave work. Took pain medication. The next day, woke up with severe pain in right calve, felt tingling in numbness in both legs. Went to ER. Given pain medication. Did Dopler untrasound on right leg to rule out blood clot. Still have severe pain in different locations. Still having numbness and tingling in arm and legs. Went to a neurologist. Feeling discomfort in throat. Feeling aniexty. Can't do activities like before.

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.

Muscle pain (up to 7 days after vaccination) Joints and body pain (up to 11 days after vaccination) Weakness and dizziness (after vaccination until now) Tiredness (after vaccination until now) Chills (after vaccination until now) Headaches (after vaccination until now) I took Tylenol Eye pain (after vaccination until now) A blood vessel burst in my left eye on 7/7/21 and I still recovering from that.

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.

Since receiving vaccination, pt has had subjective intermittent fevers, persistent shortness of breath, dizziness, multiple joint pains, bodyaches and mild leg edema. Currently undergoing lab and imaging evaluation for many other possible causes

7.2.21: patient seen in ED and diagnosed with COVID-19. 7.5.21: Patient returned to the ED due to symptoms worsening. Symptoms included: myalgias, weakness and cough. Hospitalization due to COVID-19 infection. Diagnosed with community acquired pneumonia and hypoxia. Remdesivir started. 7/8: Completed a 4 day course of remdesivir and was discharged home.

COLD; HOARSE AND RASPY VOICE; RECURRENT COUGH; WHEN INHALES PATIENT COULD TAKE DEEP BREATHS,WHEN ABOUT TO EXHALE, FELT LIKE A HAND IN NECK THAT NEEDED TO COUGH TO BE ABLE TO EXPEL THE AIR INSIDE; WEIGHT GAIN; This spontaneous report received from a physician concerned a 45 year old female. The patient's weight was 250 pounds, and height was 63 inches. The patient's past medical history included face swell, and concurrent conditions included cough variant asthma, alcohol use, sulfa drugs allergy manifested by hives, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 180206, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: upadacitinib (tablet, oral, batch number and expiry were not reported) 15 mg, every 1 total, from JAN-2020, frequency was not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 2020, the subject experienced when inhales subject could take deep breaths, when about to exhale, felt like a hand in neck that needed to cough to be able to expel the air inside. On 2020, the subject experienced weight gain. On APR-2021, the subject experienced recurrent cough. On 21-MAY-2021, Laboratory data included: CT scan (NR: not provided) No pneumonia, No significant findings. On JUN-2021, the subject experienced hoarse and raspy voice. On 23-JUN-2021, the subject experienced cold. Treatment medications (dates unspecified) included: mometasone furoate, budesonide/formoterol fumarate, benzonatate, and salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The patient had not recovered from hoarse and raspy voice, weight gain, recurrent cough, and cold, and the outcome of when inhales patient could take deep breaths, when about to exhale, felt like a hand in neck that needed to cough to be able to expel the air inside was not reported. This report was non-serious.

Muscle weakness in both legs 3 weeks after vaccine, sudden onset. Pain in legs at night, tingling in hands. Difficulty walking takes extra effort as if walking through mud. Difficulty climbing stairs. Presently still having symptoms.

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

Headache lasted two weeks took Tylenol Very bad lower back pain lasted a week saw my chiropractor and applied heat/ice Lower back pain lasted another week Applied heat Sciatic Nerve pain lasted 4 days saw my Chiropractor Phlebitis in both legs went to ER Took a prescription medication for a week. Pain and inflammation lasted a month Elevated Blood Pressure has not lowered will see heart doctor on August 19th for evaluation Left eye twitching has not stopped. Left arm goes numb when elevated like when driving or when sleeping on left side. Still ongoing.

Sore underarm and shoulder began on the morning of 03/07/2021 and has continued throughout the day on 03/08/2021. The pain is sharp and persistent. I have been taking Tylenol to relieve the pain.

At around 8 pm on 3/5/2021 started with a severe headache, around 10 fatigue and muscle aches. Unable to get to sleep, around 12am 3/6/2021 fell asleep but kept wake up very hot, No fever but did have sweats. Around 2 am 3/6/2021 headache so severe had to get up and take Aleve. Had throbbing behind eyes and sensitive to light. This lasted till around 9pm 3/6/2021. Had fatigue most of the day also. All symptoms gone on 3/7/2021 except I have had a couple of small headaches on and off till 3/9/2021.

Six hours of projectile vomiting, uncontrollable chills, excruciating headache, muscle and joint pain primarily in lower extremities, fever, fatigue. It has now been 24 hours since the injection and I am still experiencing extreme head pain, muscle fatigue and weakness, nausea an extreme headache

I had minor arm pain after my shot. About twelve hours later I had severe body aches, headache, intense chills with full body shaking. I could hardly move and felt an ache in all my muscles and bones. It was very intense pain. The entire next day I had severe body pain and severe fatigue. I tried to go for a short walk and felt dizzy. Everything hurt. I took Tylenol regularly all day and mostly slept. 48 hours later I was feeling better. Slowly regaining stamina and pain is now diminising.

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.

Shaking chills lasting about 1 hour starting 5 hours after dose Fever to 103 about 6 hours after dose lasting a couple of hours Nausea with intractable vomiting starting 12 hours after dose and lasting 12 hours. Visited immediate care facility and medicated with zofran and fluids. Intermittent mild nausea persisted for about 5 days longer Muscle pain of both lower extremities lasting 6-7 days following vaccine

Fever, chills, muscle pain and body aches started about 7 hours after the vaccine and continued for about 48 hours.

3/25 11 pm. Stiff neck, mild upper back pain, headache. Took ibuprofen and went to bed soon after. 3/26 8 am Awake, symptoms mild. Around 11 am symptoms worsen with mild general joint pain, muscle pain, fatigue, headache. Symptoms improve around 4pm and resolve completely by around 8pm. Essentially felt 'flu like' symptoms (no respiratory signs), not unexpected for this vaccine, but was surprised by how bad the following day was. Did not check for fever.

Nausea, apathy, muscle pain, cold shivers for 24 hours. Fatique after that. Sore throat. Headache 3rd day.

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.

Severe headache, muscle aches, fever, chills, dizziness, sore arm. Body chills started around 1am, by 7:00 a.m., I had headache and dizziness, with extreme fatigue. I almost passed out after breaking out in cold sweat by 8:30 a.m. Started running a fever around 9:30 a.m. Took Tylenol for headache and body pain. Slept until 1:30p.m. Woke with a fever of 101.4 and severe headache. Took more Tylenol and laid back down. By 4:30p.m. I was able to lift my head off a pillow and walk without dizziness. Chills and low-grade fever returned around 6:30pm. Went to sleep. Woke at 7:30 am. No headache, slight fatigue, sore arm. No fever, no dizziness.

I was directed to my seat (if walking into the room, the first table but the 2nd seat). The woman was learning the computer system from a gentleman, and she assured me she just didn't know the computer, but knew how to give a shot. I pulled my arm out of my sweatshirt and pushed my short sleeve shirt up. She did the alcohol wipe, then pinched my arm, I looked away as the shot went in. I felt a horrible pain...not even sure how to describe it, just extreme pain and very achy and said Ow maybe 3 times (I am one that can tolerate quite a bit of pain, and I assumed it would sting, but this was different) as she was injecting me. She apologized. The gentleman said Johnson and Johnson is a little thicker. I said to him that I had never ever experienced this much pain with a vaccine before-never. Again, I am talking about as it was injected. I went to sit down for the waiting area, the gentleman who was handing out cards for reviews asked me about it and I said it hurt so bad, I'd never had a shot hurt that bad. Another worker (female) overheard me and asked me if it was a burning-she had a burning with hers (think she said moderna). I said I would not necessarily say it was a burning, it was pain. As I sat there, I texted my husband and told him how bad it hurt (with the injection) and I've never had a vaccine hurt like that. I started to wonder if it was administered incorrectly? I looked over and the gentleman was now doing the vaccines and she was watching. My husband had Pfizer and he said that didn't hurt at all. I was feeling it up into my neck as I was sitting there. I was trying to rub my arm and neck hoping that would help as well as move my arm around. When we could leave, I asked the volunteer if she had heard of anyone else having that much pain DURING the shot. She said she only heard of maybe one other person that said ow. I left, started to cry in the car because of the pain and experience, then spoke with my husband before I left. I came home and got some ice to put on my arm hoping that would help. I did expect pain in the arm after a shot. Within a couple of hours, I noticed pain going down my arm and into my wrist. I thought maybe I needed to be active with my arm and move it so tried that. I started to notice more side effects of the vaccine as the evening progressed: I had the typical side effects I figured I'd have, achy, joint pain, chills, nauseous, no fever though. I was noticing pain into my neck (occasionally even into jaw), shoulder, scapula area of the back, and left side under the bottom part of my ribs. I was feeling tightness in my chest, too, so I decided to try 2 aspirin to see if it helped with any symptoms. I did have slight dizziness, and a weird sensation in my head-like a zapping? I didn't sleep well, and had to stay completely off of my left side. Thursday, I felt better than that night, but still tired, achy, nauseous, chills, and not 100%. My arm still was really affected...it seemed extremely fatigued as well as painful...the pain was radiating up and down and couldn't raise my arm without it hurting. Around noon I decided to take 2 aleve to see if that would help me at all. It did help with the pain and achiness, but was getting a "nerve-type" pain still up and down my left arm into neck/scapula area down to my wrist and hand/fingers. Still couldn't sleep on my left side. Friday, I was definitely doing better with all the other symptoms, I could abduct my arm more than 90 degrees, so I was excited about that. I did wake up with my middle/ring finger hurting (at the base of that area) and a bit numb so put my hand in and out of a fist. The pain subsided, but the numbness/tingling sensation was still there. I continued to take aleve hoping that maybe there was just inflammation around the nerve causing the issue. Aleve did help, but it still never went away completely. By late afternoon, I was getting concerned if I was permanently affected by this. As I was holding a bowl of food and eating, my left arm was going numb. I was even feeling it into my gluts (sciatica?). Again...all of this was after the shot and only on the side I received the shot. That evening I was able to lay on my left side, but not for long periods of time because it became uncomfortable and arm would go numb. Saturday, I still had the nerve pain and was not in a good spot. It made me sad, angry, scared, and I didn't want to talk about it too much-just wanted my arm and all the different radiating pains I was having to be back to normal. I was feeling it up into my neck, scapula, my side(the rib area I previously mentioned), even into my gluts and down leg near ankle as well as down the arm into elbow, forearm, wrist, and hand, fingers (particularly that middle finger and thumb area). I tried to use my arm as normally as possible thinking maybe I need to just keep it moving, but it would fatigue, especially between shoulder and neck. I tried Ibuprofen on this day. Again, the pain relievers helped some, but didn't take it all away. Sunday I was in a horrible spot mentally and crying throughout the day because of the sensations I was feeling still: up and down the arm, shoulder, neck, scapula, side and still into ankle area. I decided I would call my doctor on Monday. Monday, I woke up and was feeling better overall, but still having the nerve sensations down my arm as well as up into shoulder, neck, scapula and my left side. But everything was not as intense. I spoke to my doctor who said there was a protocol, a number I needed to call. Monday night I took ibuprofen because I started to have a horrible headache-didn't go away completely and still have this morning-not sure if it's related or just a normal headache. Still feeling tingling nerve sensations into forearm and fingers. My shoulder/neck area feels fatigued, but so far not noticing the nerve pain yet, so that's a positive. On Monday, it seemed to get worse as the day went on, so we will see. I definitely feel in hand/wrist/fingers as I am typing now. I know this is a lot, and I think I've captured it. Again, I had none of this pre-shot. The pain during injection is what alarmed me most as I expected side effects after the shot, but not this nerve type issue. For this to be lasting as long as it is concerns me, and the fact that it exhibits on my left side where I got the shot. I am very anxious as it hasn't gotten back to normal.

Chills for about 4-5 hrs and then fever for about 6-8 hrs Joint pain (not muscle pain) in all of body especially hands - had trouble using them - next morning (Friday March 26) and most of the day fatigue - 48 hrs diarrhea - began sat March 27- april 1 (taking pepto still have intestinal issues)

post 8 hours - sore arm, post 9 hours - sore back, hard to take a deep breath, foggy head feeling, post 10 hours - sore legs and overall body aches

Body chills, fever of 101.2, malaise/fatigue, cough, shortness of breath, diarrhea, nausea, headaches, myalgias.

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.

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.

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.

Vasovagal syncope resulting in fall to floor. While on ground pt became rigid. Pt began to come to and was transported to medical via cot and EMS was notified. Pt symptoms resolved and EMS was refused.

MUSCLE PAIN IN BOTH LEGS, HIPS, NECK AND BOTH ARMS; NAUSEA; 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 alcohol use. The patient had no known allergies. The patient had no history of drug abuse/illicit drug use. The patient was not pregnant at the time of reporting. The patient was non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 26-MAR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced muscle pain in both legs, hips, neck and both arms. On 27-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 27-MAR-2021, and had not recovered from muscle pain in both legs, hips, neck and both arms. This report was non-serious.

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

Headache after 4 hours, body and joint aches, fever of over 101 at 3 am and sharp bone pain on shins. Day two fatigue, weakness of muscles and joint pain.

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

I received the vaccine at approximately 1:08 pm. Once administered I was instructed to sit in the auditorium for 15 minutes for observation. During that time I had a few heartrate increases and nausea but nothing out of the ordinary or concerning. After the 15 minutes, I walked out to my car and thankfully my husband had driven because what happened next would have caused an accident. Our drive home is approximately 20 minutes from where vaccine was administered. In the car I began to feel a tingling all over my body that gradually began to feel like ?pins and needles? (like when you sit on your legs for too long and they ?fall asleep?), with the worst of the feeling being in both of my hands. I began opening and closing my fingers to try and get them to feel normal. By the time we pulled into the driveway, my hand had locked up in a weird position and I was no longer able to communicate with them and make them move. They were temporarily paralyzed. My husband opened the door for me because I wasn?t capable of doing so. Once I stepped out of the car, my body began to convulse and shake. We stood there for a few minutes because one, I couldn?t make my body cooperate and two, we didn?t want our children seeing me that way. My husband kept asking me if he should call an ambulance. Of course, he should have but I think he was so scared and shocked that he just didn?t know how to react. I had trouble forming words and sentences at that point and could not tell him to call. I felt pretty calm considering what was happening to me and I could not control myself. My husband decided to walk away from me and coerce me to go to him. I stood there for a few minutes trying to communicate with my legs. Once I took my first step, my body stopped shaking and I started to regain feeling in my hands. I went and laid down for a bit and began to feel a bit better. Around 7pm I was feeling extremely cold. So cold that I put on three layers of clothing and two comforters to try and warm myself. That did not work though, as it was more of a cold from nerve endings than it was from temperature. I went to bed around 9pm but didn?t fall asleep until around midnight. I was feeling waves of cold down my body. Like a skin prickling when you hear a beautiful song and you get goosebumps and your hairs stand up. I woke around 3am to an extreme headache and a fever of 102.6. I took Tylenol and went back to bed. When I woke in the morning, I felt better but had weird and random muscle twitching. For the past few days I?ve been suffering with extreme fatigue which is not like me at all. Even when I?m tired, I can still manage to function throughout the day. Not only have I been tired, my body is weak, my muscles are weak and my joints hurt. I?m hoping this ends soon and doesn?t get any worse. It will be two weeks this Sunday.

Janssen COVID-19 Vaccine EUA I was vaccinated on Tuesday, 4/6--on Wednesday, I had the typical side effects of a sore arm, fatigue and muscle aches. On Thursday, 4/8, my arm was less sore and my fatigue and muscle aches were almost gone, however, I woke up with chest congestion and a cough. No fever but the coughs were painful--it almost felt like I had bronchitis. Nothing dire--I can breathe fine, no fever, I don't feel sick, but I just have this deep cough. When I looked up the side effects, I didn't see cough or chest congestion so I thought I would report it. Today is Friday, 4/9 and my cough seems to be getting better, although it's still there and I don't feel 100% yet.

3 days with migraine headaches, 3 days backaches, extremely rapid heart beats the first night, sweats and chills first 3 days, 3 days of chills. First night Ny Quil and Tylenol to sleep and reduce the fever. I woke up in the middle of the night in sweat, I had to take my thyroid medication to slow down my heart rate. I was having heart palpitations, my heart was beating so fast it woke me up.

Intense pain in left arm during vaccination. Pain and weakness in left arm started immediately. Loss of mobility in left arm - not able to raise arm past shoulder height.

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.

Fever, chills, diarrhea, sweating, muscle pain, fatigue, ringing in ears, pins and needles feeling in hands and feet. Very dizzy on day two accompanied by profuse sweating

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.

Shot at 12:18 Friday afternoon. One hour later increased pain in neck where my cervical issue is a current problem. Around 7:30pm overwhelming fatigue and the beginning of chills and the start of low grade pain in joints throughout my body. I took my medications and was in bed by 8pm. Over the course of the next 6 hours, The chills increased, sweating, fever 99.5, the feeling of my muscles and tendons tightening up and I would have to repeatedly stretch to relieve the accompanying pain, extreme thirst, nausea - at one point vomiting bile. The pain in my joints was around a 7 on pain scale. I could not get comfortable and was writhing from side to side. Around 2am I took a 2nd Hydrocodone for the pain. At 10am I finally took Nurtec for the massive migraine. At 11:30am (about 23 hours after injection) the headache was relieved, the joint pain had significantly decreased. My neck still ached. I was very fatigued and it was with effort to move from the bed to the couch. I slept on and off throughout the remainder of the day. I had no appetite but forced myself to eat yogurt with fruit. It is now 11:44am Sunday. I still have no appetite. With exception of some mild fatigue and loss of appetite, all other symptoms have improved.

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).

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.

12 hours-36 hours after extreme muscle aches, chills, intermittent fever over 100 degrees, pounding headache, fatigue. 36-60 hours after fatigue and muscle aches...especially kidney area/lower back. 60 hours to present muscle pain by end of day and night sweats/chills. I am healthy and rarely get sick. This is not normal for me.

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.

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.

Still a little nausea, very fatigue and foggy, body pain periodically and very cold chills periodically throughout the day. Overall feeling - of consisted unwell feeling all day since the shot. I simply push myself everyday to get out of bed as I have to work. 5 hours after shot ? I felt like all my bones were broken ? severe pain ? Cold chills so bad I was shaking ? Fever ? Nausea ? Migraine ? sensitive to lights ? Could not walk (barely can take 2 steps) ? Severely weak ? Chest tightness and heart racing ? Simply felt I was going to die ? of course I didn?t but it was the worse feeling in life worst than flu symptoms

Approximately three days after vaccine, I experienced a blood clot. This caused an acute ischemic stroke in my left frontal lobe, resulting in muscle weakness and partial loss of use in my right leg.

Fever of 101.7 within 12 hours of the shot. The fever lasted for 24 hours at different temps. Chills and cold sweats for 24 hours. A sever headache that lasted for 48 hours. About a week later, random sharp pains would radiate under my left breast. They didn?t happen before the vaccine but I can?t verify they are occurring from the vaccine.

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 had the J&J vaccine on 4/1/21. I have a history of blood clots. I have tested positive twice. Once back in 2001 when I was pregnant and later on around 2008. I have had these symptoms before, but since I have a rare bone disease and have medical issues I really don't like to complain and just deal with this stuff with the pain pills I have a prescription for. Anyway, yesterday I was feeling a little off. My hands, feet and limbs in general tingling. I had a headache which is rare for me and tried to drink extra water, but by 5pmish came I took a handful of tylenol since I had an after work walk to go on with a girlfriend. After the walk I came home and had a desire to lay down and go to sleep. my leg was starting to go from tingle to burn. i decided that i needed to eat some dinner. after dinner i was struggling with breathing while sitting in the recliner chair watching TV, so I told my other half I needed to lay down, this was around 7pm. Then it was just a crazy leg burn from the back of my knee into my foot. I was describing it as if I someone pour gasoline on me and lite the match and I was burning alive. I took a muscle relaxer and forced myself to sleep. The day after the J&J shot. i had chills and was so cold that mid day when I had breaks during my work from home, i climbed in bed with a heating pad to warm up. the shot also left a scare on my arm, which i found odd since i give myself six injections a week for my bone disease. I tested positive with Covid December 20th, 2020 and it was a rough first week, but after about 10 days I was pretty much back to walking around and feeling better. You're more than welcome to have all of my medical record information, just let me know what you need. My doctor switched over to a different portal that I don't have access to and I haven't talked to her or her office since I had covid back in December and it's still a few hours before her office opens to report this, but I saw this on the news. My leg is still tingling and stiff. Again this is not my first time going through this, so I usually just push through it, but since I saw the news I am reporting it.

I received the johnson and johnson vaccine. I had an abscess tooth and I had taken 4 days of antibiotics. The johnson and johnson shot made me feel dizzy and I got so stiff that I could not walk. I was shuffling my feet to get anywhere. I would fall all on my bad and then gradually move my self by holding onto the head bead to actually get in the bed. This lasted 2 days and I had stopped taking the antibiotic because I felt so ill from the shot. I then began vomiting. My entire body hurt it felt like every cell in my body was transforming and the pain was unreal I was so weak I couldn?t open a water bottle

Severe headache, muscle ache, nausea, tiredness, lack of appetite, extreme thirst, high fever for first 2 days. Could not get out of bed. 5 days later, still moderate tiredness, mild headache.

headache chest pressure severe headaches face pain jaw pain neck pain abdomen pain nausea fatigue all over aching

Arm pain, shoulder pain, numbness, tingling, nerve pain, arm weakness, armpit pain, loss of feeling in fingers, back pain

Had pretty significant muscle aches, tenderness all over, achy neck, headache. Resolved after about 48hrs. The last thre days, 12-14 day after received have severe muscle and joint pain like did after first received. Having to take advil to help relieve and then comes back. I haven?t ever had this type of joint pain or muscle aches like this. It hasn?t gone away. I hurt all over.

Woke up on 4/13 and got out of bed. Left upper left calf was painful when straightening my leg. Has not improved throughout the day. Feels tight and as if strained, but I have literally done nothing but walk or sit at my computer in the last week and cannot pinpoint an activity that would have strained a muscle.

I have had a headache every day since receiving the vaccine. 4 days ago my legs began to feel weak and shaky. At some points it is so bad that I have to sit because they feel like they can?t support me. I have never experienced this before.

Patient developed headache, body aches, fatigue starting a few hours after the vaccine. Over the next week the headache increased with pulsing pain at temples and back of neck. temp 98.5 HR 66. Sat 98%. No focal neurologic deficits on exam 4/15/21 at 9:30 am.

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 "

6 days after receiving vaccine, I experienced an episode where I got extremely hot, sweaty in neck and chest area, dizzy, loss of balance, blurred vision and blacked out for a few seconds. The episode lastly apprx. 4-5 mins. I laid down and fell asleep for about 20 mins afterward and woke up to moderate headache and slight burry vision still on left side. I saw my primary dr the next morning on 4/1/21 and reported issue.

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.

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.

The evening that I took the vaccination I was running a fever body aches and chills the day after taking the vaccination I had the same effects fever body aches chills 5 days after taking the vaccination very sick not feeling well not feeling myself passed out twice at home the sixth day after taking the vaccination I proceeded to work was sent home before I could even get in the building went to ER was treated for an allergic reaction after telling them I was 6 days from vaccination then on 4-9-2021 I was taken by my husband to the ER my entire left side was numb tingling sensation couldn't lift my leg couldn't hold my arm up had no peripheral vision severe headache at the ER I was seen my neurologist and I was told that I had 20 minutes to make a decision whether to take the TPA shot which I chose to take I was released from the hospital on 4/11/2021 I am finally going back to work tomorrow ( 4-21-2021) I am now having more anxiety I've had extreme weight loss I've lost 20 lb since this occurred

BODY ACHES; CHILLS; TIREDNESS; DIFFICULTY WITH WAKING UP; RIGHT SHOULDER PAIN; NOT FEELING WELL; 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: 206A21A expiry: 23/JUN/2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced difficulty with waking up. On 12-APR-2021, the subject experienced right shoulder pain. On 12-APR-2021, the subject experienced not feeling well. On 12-APR-2021, the subject experienced tiredness. On 12-APR-2021 01:00, the subject experienced chills. On 12-APR-2021 06:30, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and tiredness on 12-APR-2021, and difficulty with waking up, and not feeling well, and had not recovered from right shoulder pain. This report was non-serious.

I had reaction right away five minutes afterwards drowsy and metallic taste in mouth and :30 observation and extremely fatigue and a neck pain and 4-5 pain level issue 04/12/2021 04/13/2021. Doctor phone and recommended ER and next day tired and off and fatigue and felt off and went to urgent care 04/16/2021 and fever and blood pressure electro cardio gram and for stroke and heart and stroke and clots and no symptoms for clots results was good and not able to sleep and Friday was extremely exhausted and neck pain and fever and medication. Fatigue and fatigue come and Motrine or Tyler. Still have neck pain and fatigue that comes and go not recovered.

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

ABDOMINAL PAIN; JAW PAIN; FACIAL PAIN; PRESSURE IN LEG; LEG PAIN; BURNING FROM BRA STRAP TO BRAIN; CHEST PRESSURE AND PAIN; NAUSEA; SEVERE HEADACHE; ACHE; SHORTNESS OF BREATH; FATIGUE; 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, and batch number: 038A21A expiry: 21-JUN-2021) dose was not reported, administered on 31-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced ache. On 31-MAR-2021, the subject experienced shortness of breath. On 31-MAR-2021, the subject experienced fatigue. Treatment medications included: paracetamol. On 31-MAR-2021 21:00, the subject experienced severe headache. On 04-APR-2021, the subject experienced burning from bra strap to brain. On 04-APR-2021, the subject experienced chest pressure and pain. On 04-APR-2021, the subject experienced pressure in leg. On 04-APR-2021, the subject experienced leg pain. On 04-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced abdominal pain. On 13-APR-2021, the subject experienced jaw pain. On 13-APR-2021, the subject experienced facial pain. Additional 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 leg pain, and the outcome of severe headache, fatigue, ache, shortness of breath, burning from bra strap to brain, chest pressure and pain, pressure in leg, nausea, abdominal pain, jaw pain and facial pain was not reported. This report was non-serious.

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.

Pt experience severe headache, hypertension, head pressure, muscle twitching of the face, numbness on the right side of the head-temporal area, shortness of breath and left sided chest pressure

That evening at 08:00 pm, I had chills, very slight fever (right under 100 degrees); fatigue. Saturday, I woke up without any of those symptoms but a terrible headache on Saturday morning - I had to go to work. It was severe enough for me to not go to work. Headache remained up until yesterday. The headache was pretty severe on Saturday, Sunday and I went to the doctor on Monday or Tuesday. I went because of the length of time of the headache. No meds were prescribed. They offered a brain scan which I decline based on the Dr's explanation of what the scan really does. Dr told me to take Tylenol. It was a "cluster" headache - the right side of my head towards the low part of my neck. The headache was always at that location. Tylenol was enough to lower my headache from the moderate to a minor. I didn't take much of it. I have not had a headache today for the first time since that Saturday. Muscle pain on my upper chest wall - it felt like I had been bench pressing - that symptom was on Wednesday and Thursday of last week (14th and 15th).

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.

CLOT BLOOD; ACUTE ISCHEMIC STROKE IN LEFT FRONTAL LOBE; PARTIAL LOSS OF USE IN RIGHT LEG; MUSCLE WEAKNESS; 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 amoxicillin and flexeril allergy, and migraine. The patient experienced drug allergy when treated with cyclobenzaprine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:30 on left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, ergocalciferol, iron, and withania somnifera. Approximately three days after the vaccine, on 11-APR-2021 08:20, the patient experienced clot blood. Which caused an acute ischemic stroke in left frontal lobe resulting in partial loss of use in right leg and muscle weakness. The patient had a blood test, CT scan, Carotid artery ultrasound, diagnostic ultrasound, electrocardiogram (EKG) and an MRI, results are unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clot blood, acute ischemic stroke in left frontal lobe, muscle weakness, and partial loss of use in right leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a report of a 46 year old, female patient who experienced a blood clot that caused an acute ischemic stroke in the left fontal lobe 3 days after receiving the covid-19 vaccine ad26.cov.2. Patient's height and weight were not reported. Patient has migraine and allergies to amoxicillin, flexeril and cyclobenzapine hydrochloride. Concomitant medications included ascorbic acid, ascorbic acid/ ergocalciferol/folic acid/ nicotinamide/ panthenol/retinol/ riboflavin/ thiamine hydrochloride, ergocalciferol, iron, and withania somnifera. Smoking history, drug abuse and alcohol intake were not reported. Three (3) days after receiving the vaccine, patient was noted to have a blood clot (unspecified area) that caused an acute ischemic stroke in the left frontal lobe, resulting in muscle weakness and partial loss of use of the right leg. Patient had blood tests done as well as CT Scan, carotid artery ultrasound, electrocardiogram and MRI but the results were not reported. The information provided precludes a meaningful medical assessment. Additional information requested.

This is a continuation from report on 4/8 Pt has worsened symptoms. I went to Gynecologist on 4/19 still exp night sweats.The Gynecologist stated I have high disblasha on my cells I'm scheduled for cervical procedure on 5/17. I went to my physician EKG I'm scheduled on 5/6 Physical Stress test.I also went to dermatologist on 4/22 removed (burned) 9 places on my skin (face,chest stomach) that had abnormal cells.The dermatologist recommend have a upcoming scan for my lymph nodes. As of now my lymph nodes (both sides) are swollen still exp day and night sweats, joint pain and tired. I'm now on high blood pressure medication.Both doctors have stated the vaccine has sent me into "haywire with my immune system".

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.

Patient experienced fever, chills, shivering, vomiting, nausea within the first approximately 24 hours after getting the vaccine. She also started to experience "leg pain" or "tendon pain" in the groin area. All side effects subsided within about 24 hours except the leg pain. It has now been 5 days and she is still having this pain with any movement of the body. If she is resting and sitting still, she is fine.

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.

I had chills, fatigue, headache, and bilateral calf and thigh muscle pain that started about 6 hours after the vaccination and lasted about 36-48 hours. I took Tylenol 500mg after the onset of symptoms and three times a day. The symptoms went away by mid-day on 4/13/2021. Since then, I have been experiencing bilateral calf muscle pain off and on. I also had an enlarged axillary lymph node n the left side (side of vaccination). I reported it to urgent care on 4/18/2021 and was told the muscle pain was unlikely to be a clot since it was bilateral and there was no swelling or discoloration. I was told to hydrate and follow up with my primary care provider if it continues. The calf muscle pain has continued - almost every other day - and responds to Advil. I have an appointment to talk to an MD tomorrow (May 5th)

Fever of 100.8 severe headache very tired and weak severe body aches muscle aches sick to stomach severe chills slightly dizzy

Right arm pain, unable to move this arm when she raises it she gets shooting pain that goes through the entire arm into the neck and also headaches.

Low grade fever, fatigue, sore arm, muscle pain the night of the injection as well as the following day

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

LEG PAIN; TIREDNESS; SORE MUSCLES; SHAKINESS; SORE SHOULDER; This spontaneous report received from a consumer concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatic in leg, sulfa allergy, non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no other health conditions or current medication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced shakiness. On 12-MAY-2021, the subject experienced sore shoulder. On 12-MAY-2021, the subject experienced tiredness. On 12-MAY-2021, the subject experienced sore muscles. On 13-MAY-2021, the subject experienced leg pain. Laboratory data included: Screening test (NR: not provided) Unknown. On 18-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal (Platelet count was normal). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from shakiness, tiredness, sore shoulder, and sore muscles, and the outcome of leg pain was not reported. This report was non-serious.

Within 6 hours, fatigue, headache, vomiting, dizzy, back ache, every joint in body hurt... joints continue to hurt for 3 days, headache anf fatigue still present 5 days later, Dizzy spells, severe stomach pain and back ache continued ...

Have been in remissions from Grave's disease - auto-immune disease - for over a year. I had gone in for a routine blood exam (may 10th) - my Dr (May 11th - routine visit) saw that my thyroid numbers were elevated. Before the shot, I had no symptoms and now I have had symptoms of Grave's disease. I am starting to get tremors and a bit of an elevated heart rate. When I go running, it gets elevated I have to stop. Weight loss.

DIZZINESS; NAUSEA; LOSS OF SMELL; LOSS OF TASTE; JOINT PAIN; 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 covid19, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known drug allergies and had no breastfeeding. The patient had emergency room for an allergic reaction 10 years ago. The patient took an unspecified high blood pressure medication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820095 and expiry: 04-JUL-2021) dose was not reported, administered on 28-MAY-2021 18:30 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On 29-MAY-2021, the subject experienced loss of smell. On 29-MAY-2021, the subject experienced loss of taste. On 29-MAY-2021, the subject experienced joint pain. On 30-MAY-2021, the subject experienced dizziness. On 30-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from loss of smell, loss of taste, and joint pain on 29-MAY-2021, and had not recovered from dizziness, and nausea. This report was non-serious.

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.

Moderate (RA) pain flared in multiple joins approximately 6-7 hours after injection (given on 6/3). This is unusual because I typically do not get pain in a lot of joints at one time. Individual knuckles on fingers, wrists, hip, neck, shoulder, knees and ankles. Morning after injection (approx. 16 hours): joint and muscle aches, low grade fever (99; I typically am at 97.4-97.8), moderate malaise and fatigue. Headache, eyes ached, mild nausea, stomach upset and diarrhea. Could not stay awake. Symptoms subsided greatly 30-32 hours after vaccination. Fatigue persists, but is minor; goes away with short rest.

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.

FELT PARALYSED; DIAGNOSED WITH GUILLEN BARRE SYNDROME; INJURED RIGHT FOOT; NUMBNESS IN FACE; LEFT LEG WEAKNESS; SWELLING IN LEGS; TIREDNESS; FEELINGS OF WEAKNESS; NUMBNESS IN LEFT HAND; This spontaneous report received from a consumer concerned a 46 year old female. The patient's weight was 113 kilograms, and height was 66 inches. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 01-MAY-2021 to left arm for prophylactic vaccination. Concomitant medications included immunoglobulin human normal for guillen barre syndrome. On 01-MAY-2021, the subject experienced feelings of weakness, numbness in left hand. On 28-MAY-2021, the subject experienced tiredness. On 29-MAY-2021, the subject experienced left leg weakness and swelling in legs. On 02-JUN-2021, the subject experienced numbness in face. On 09-JUN-2021, the subject experienced diagnosed with guillen barre syndrome, and was hospitalized. On an unspecified date, the subject experienced injured right foot, and felt paralysed, and was hospitalized on 08-Jun-2021. On 01-MAY-2021, the patient developed numbness in her hand on the left side and felt weak. The patient travelled overseas and had a connection to a country and her husband stated that she started to have swelling in her legs. When she reached her destination, she was admitted to the hospital and was diagnosed with Guillen Barre Syndrome by the neurologist per her husband's recollection. In the hospital she was given Immunoglobulin G for 5-7 days and she did regain some feeling in her legs. Based on patient's husband recollection this may have occurred "maybe tired due to travelling," but when she arrived to the country that was when her left leg weak and requested a wheelchair. The patient then injured her "right foot" in another country, but "she didn't feel it and she requested help because she couldn't walk." per her husband. After she reached her final destination, she felt tired and then she completely fell. It was reported that she could not "control herself and felt paralyzed." On 08-JUN-2021, she entered the hospital and was still in hospital at the time of this report. Her husband states that he "does not know any side effect from any vaccine" that caused this in the past. Lastly, he mentioned "she may have numbness in her face when she reached original country". He also stated that the on 04-JUN-2021, doctors conducted a computerized tomography scan and did not find a blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feelings of weakness, swelling in legs, diagnosed with guillen barre syndrome, numbness in left hand, tiredness, left leg weakness, numbness in face, injured right foot and felt paralysed was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This is a spontaneous report received from consumer concerning a 46 year old female, unknown ethnicity, who experienced weakness and numbness of the left hand on the same day after receiving the Janssen Covid-19 vaccine and was diagnosed with Guillain-Barre Syndrome 39 days after. Patient's height was 66 inches and weight was 113 kilograms. Past medical, previous surgery, current illnesses and medications taken as well as history of allergy, smoking, drug abuse and alcohol abuse were not reported. On the same day as the vaccine was given, patient developed weakness and numbness on the left hand. Patient still travelled. Twenty-eight (28) days post vaccine, patient experienced left leg weakness and swelling on the legs. Patient was noted to feel tired the day before. Thirty-two (32) days post vaccine, patient developed numbness on the face. Computerized Tomography (CT) scan was done and there was no blood clot found. Thirty-eight (38) days post vaccine, patient felt 'paralyzed' and injured her right foot. Patient was brought to the hospital the following day and was subsequently admitted. Patient was diagnosed with Guillain-Barre Syndrome and was given IVIG. Information regarding other potential etiologies was insufficient. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.

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

I woke up on 4th with pins and needles in my hands and I called the doctor's office. They said that I was crazy and nothing was going on with me and call back in a week even though the receptionist at the office had just said they were getting all kinds of calls about it.. For the next week, my hands and my feet were tingling intermittently. I went to the doctor on Friday, June 11th. They did a full metabolic panel - all came back fine. The next morning, June 12th, I felt my face was numb. I called doctor and she said it was anxiety. So my hands were pins and needles. The face numbness was new. I see a naturopath and I told her and she said it was call for concern and she looked at labs and told me to call doctor back and she mentioned that she had seen all kinds of people with these symptoms. My anxiety is super high. I'm not usually an anxious person. I have high blood pressure. I have joint pain in my hands - if I take Naproxen. If I take Aleve the joint pain goes away. I feel like my face is dragging but when I call in the mirror it looks fine. That's the feeling of numbness says my naturopath - and that's the same with my lips. I feel like I have some brain fog and I've been stumbling over words. That happens about once a day. I have a doctor's appt on Friday for blood pressure. I did not have blood pressure before this. Usually my blood pressure is 126/90 (when normal) and it's tracking at 143/103 and 140/100 ever since I had the vaccine.

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).

REQUIRING NAPS ALMOST DAILY; WOOZY FEELING/BROWN OUT; DEPRESSION; DOES NOT FEEL LIKE HERSELF; LACK OF ENERGY; HEADACHE; LETHARGY; HARD TO TAKE A DEEP BREATH; WEIGHT GAIN; METALLIC/NUMB TASTE IN MOUTH; SWELLING; LOWER BACK PAIN; STOMACH CRAMPING; BODY SORENESS; ALMOST PASSING OUT; 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 menopause. The patient experienced anaphylaxis when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 005A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced lethargy. On 15-MAY-2021, the subject experienced hard to take a deep breath. On 15-MAY-2021, the subject experienced weight gain. On 15-MAY-2021, the subject experienced metallic/numb taste in mouth. On 15-MAY-2021, the subject experienced swelling. On 15-MAY-2021, the subject experienced lower back pain. On 15-MAY-2021, the subject experienced stomach cramping. On 15-MAY-2021, the subject experienced body soreness. On 15-MAY-2021, the subject experienced almost passing out. On 15-MAY-2021, the subject experienced woozy feeling/brown out. On 15-MAY-2021, the subject experienced depression. On 15-MAY-2021, the subject experienced does not feel like herself. On 15-MAY-2021, the subject experienced lack of energy. On 15-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced requiring naps almost daily. Laboratory data (dates unspecified) included: Weight (NR: not provided) 16 pounds gained. Treatment medications (dates unspecified) included: caffeine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woozy feeling/brown out, headache, lower back pain, stomach cramping, body soreness, depression, and hard to take a deep breath, had not recovered from lethargy, weight gain, metallic/numb taste in mouth, swelling, lack of energy, does not feel like herself, and requiring naps almost daily, and the outcome of almost passing out 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

First 15 days suicidal and depression. Spoke therapist . Also lots of joint pain and hard to move . Feels really stiff. Diarrhea all day since May 7th .

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.).

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.

I had a 101 fever by 3:00 p.m. that would not go down with fever reducing meds. I had aching joints and lethargy. I had chills and headache. My fever broke around 8:00 p.m. and as of this morning I'm better. It's totally worth it but I was told to report if we have any side effects so that data can be collected

low grade fever 99.9 for 12 hours muscle/body aches for 12 hours tired for 12 hours+ headache for 12 hours

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

Around 10 PM the day of the shot, started experiencing chills, muscle aches, exhaustion and a low grade fever (99.5). Symptoms lasted approximately 36 hours. Treated with tylenol.

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

Exhaustion Headache Dizziness Watery eyes Feels like bronchitis Muscle aches Arm discomfort Radiating pain all Over body Double vision Hazy vision Easily get out of breath Bright yellow urine output Insomnia

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

Received JANSSEN COVID-19 vaccine EUA at 11:10am, March 12th, 2021. In the evening, began to experience extreme fatigue, and in morning of Saturday, March 13th, 2021 began to experience fever, 100.3F, very bad headache, fatigue, and bad muscle aches--aching legs, back. Fever has is gone as of afternoon March 13th, however, still experiencing headache, fatigue, and aching muscles, similar with what I experience when I had influenza B a couple of years back.

2 hours after the vaccine, I started to feel very achy, and had terrible chills. That lasted through the night and I woke up with a slight fever, 99.9. The aches were in my joints and muscles. It actually felt like I was having back labor. I took advil, and I was able to sleep and sweat out the fever. These symptoms were similar to one of my worst Lupus flares. These symptoms lasted until Tuesday, 3/9/21, afternoon. The following Sunday, my joints feel extremely stiff and achy. Not sure if it has anything to do with the vaccine. I took Advil and it seemed to help.

Reynard syndrome episode one of first signs - loss of blood to both hands, cold, resisted attempts to warm whiten skin back up until episode resolved itself within an hour; fever, chills, aches, including intense pain throughout back of neck, throbbing pain rt calf & ankle. Fever and pain abated after 9 hrs. Residual side effects into day two: headache, achy joints, fatigue.

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.

Severe and persistent Joint pain (knees, elbows, wrists, fingers etc.), chills, slight headache and back pain 14 hours after administration. Symptoms still continue 23 hours later. Fatigue as well.

Weakness noticed at 5:30pm. 12:00am awoke with severe, burning body (nerve type) pain. Severe spasticity causing sprain/strain injury to muscles and/or tendons/ligaments. After 1 week pain and spasticity was reduced to arms and legs. Still continues. Treating with Motrin, Tylenol, Tizanidine and steroids to follow this week possibly.

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.

6 hours after shot I began to feel major muscle aches and chills. Within an hour of this onset I had a fever of 102.4 and was wearing 2 coats, had the heat blasting, and was in many many blankets and still chilled. This went on for about 7 hours. Also during this time my heart rate was elevated to about 100 beats per minute (normal is 60-65 for me). and also the hear beat seemed 'loud' like someone was dribbling a basketball in my head (maybe this is a sinus symptom??). After these symptoms subsided I had a splitting headache for several more hours.

raised lumps on legs unable to barely walk due to severe muscle aches starting evening of vaccine. Severe chills and night sweats x two weeks. Numbness, tingling in packages. Almost unable to walk.Gait is affected.

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,

Started with a cramp feeling next to my left shoulder blade, Then the feeling moved up my left side of my neck (like I had slept wrong) and began giving me a headache. Because of this, I was getting nauseous and fever spikes. Then about 3:30am, I had water like diarrhea. After that, I started to feel dizzy (I was fine as long as I still) with cold chills along with being very tired. When I got home, I took some Ibuprofen and took a nap (4 hour nap). Began to feel much better. When I woke up, I felt better but still had a stiffness in my shoulder blade area and left side neck.

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.

Sudden Body Temp Drop, severe leg cramps, head ache, joint pain, high temperature, lost consciousness, stomach pain

RECEIVED J&J/JANSEN INJECTION ON 3/09/21. WHEN I WOKE UP THE NEXT MORNING MY LEFT KNEE WAS VERY SWOLLEN AND PAINFUL. I DID ICIING/HEAT, STRETCHING AND MOTRIM WITH ELEVATION. ON 3/21/21 I WENT TO URGENT CARE BECAUSE MY KNEE WAS STILL HURTING. THEY GAVE MY A X-RAY (JUST SHOWED EFFUSION), KNEE SLEEVE AND SOME MORE MOTRIM. TODAY IS 3/30/21 AND MY KNEE IS STILL IN THE SAME CONDITION. WENT TO A ORTHO CENTER WERE THEY DRAINED FLUID FROM MY KNEE AND GAVE ME A CORTISONE INJECTION. PREV AND AFTER INJECTION I DID NOT SUFFER ANY INJURIES TO MY KNEE. I'VE NEVER HAD KNEE PROBLEMS

Fever, chills, fatigue lasted a day. Then vertigo started with back of neck dull pain. Vertigo still ongoing

Day one, feeling very cold, chills, trembling, achy joints, headache. After the chills passed low grade fever for the rest of the night. Buzzing in my ears, headache. Day two, buzzing in my ears and headache passes, fever leaves. Start feeling discomfort in the middle of my back and middle of my chest, later became nauseous. The discomfort in my chest/ribs lasted about 9hrs. Both days very tired, little stamina.

Janssen COVID-19 Vaccine EUA Strong headache, strong pulsating (debilitating) pain in the neck area, 100ºF fever. Lower back pain. 9am one 500mg Tylenol pill. 3pm three 200mg Ibuprofen. Pain subsided and is under control with medicine. I did not report this to my doctor.

BODY ACHES MOSTLY IN THE JOINTS AND ESPECIALLY THE ANKLES; COULD NOT SLEEP- WOKE EVERY 15 MIN; CHILLS-FREEZING; JOINT PAINS WRISTS, SHOULDERS, HIPS, KNEES AND ANKLES; FEVER; SEVERE POUNDING HEADACHE; This spontaneous report received from a patient concerned a 47 year old. The patient's weight was 130 pounds, and height was 62 inches. The patient's concurrent conditions included percocet allergy, seasonal allergy, gluten allergy, alcohol use, nonsmoker, bile salt malabsorption -gi condition, anxiety, and vitamin d deficiency, and other pre-existing medical conditions included the patient reported no other relevant medical history. the patient had no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 to Left Arm for prophylactic vaccination. Concomitant medications included loratadine for allergies, sertraline hydrochloride for anxiety, colestipol for bile salt malabsorption, colecalciferol for vitamin d deficiency, and vitamins nos for vitamin d deficiency. On 06-MAR-2021, the subject experienced body aches mostly in the joints and especially the ankles. On 06-MAR-2021, the subject experienced could not sleep- woke every 15 min. On 06-MAR-2021, the subject experienced chills-freezing. On 06-MAR-2021, the subject experienced joint pains wrists, shoulders, hips, knees and ankles. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced severe pounding headache. Laboratory data included: Body temperature (NR: not provided) 103 degrees F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep- woke every 15 min, joint pains wrists, shoulders, hips, knees and ankles, and severe pounding headache on 08-MAR-2021, and chills-freezing on 06-MAR-2021, and had not recovered from body aches mostly in the joints and especially the ankles, and fever. This report was non-serious. Additional information was received on 30-Mar-2021. The following information was updated and incorporated into the case narrative: Reporter email, Patient demographic details( age, height, weight), age at time of vaccination, Patient history (seasonal, gluten allergy, alcohol use, nonsmoker, anxiety, vitamin d deficiency), events(could not sleep, joint pain, headache) Product batch no, therapy start date and end date, Concomitant medications.

I WOKE UP SUNDAY MORNING TO PAIN IN MY BACK AND CHEST. I CALLED MY DR THEY WANTED ME TO CALL 911 INSTEAD I DROVE TO THE HOSPITA. THEY STATED SOUNDS LIKE A HEART ATTACK. THEY DID BLOOD TEST AND EKG'S. DIDNT FIND ANYTHING. I AM STILL HAVING PAIN. THEY WANTED ME TO STAY FOR ADD'L TESTING AND I DIDNT. CALLED MY FAMILY DR WILL BE GOING THERE TOMORROW.

First my extremities - fingers and toes became very cold like ice. I was concerned about my circulation amd wanted to move around but then had trouble because my muscles began today hurt. Then later in the night I developed a fever of 101.6 along with chills and muscle aches and headache. I had a fever off and on and was feeling very ill throughout the next day and the fever did not break until Saturday morning

Left side of neck and upper left chest tightness/pain, migraine for 2 days, racing heart, sweats, nauseous, extreme fatigue, ringing in the ears (which still has not gone away)

Fever of 102F and chills/shivering treated with cool bath, cold compresses and ibuprofen. Headache treated with ice packs. Shortness of breath, treated with inhaler. Muscular aches, swelling at injection site. Fever decreased to 101.5F until ~5:00am where it rested at 99.5F until ~4:00pm. Raising slightly now ~5:00pm

1 hour later - perception off driving 3 hours later - light headed/ soreness 7 hours later - Every joint ached painfully 8 hours later - fever (high of 103.2) before Tylenol & Advil 19 hours later - slight fever 100.4 before Advil 21 hours later - feeling off/confused 25 hours later - achy / tired

Upon receiving the shot, I immediately felt lightheaded, not dizzy or vertigo but just detached from my surroundings. I felt spacey. I felt like that for the rest of the day. I took Tylenol as the clinic recommended. Then after I went to bed later that evening I developed a headache that woke me up around 3:00am. I was very uncomfortable, experienced chills and was sore all over like I had worked out hard. I also experienced joint pain which I don't normally have. I still feel rough this morning and running a slight fever of 100F. I just wanted to report my side effects.

On night of vaccine (4/6) she reported severe body aches and fatigue. On 4/7, she also had her ears and collar bone hurt. Then 4/8, She had numbness to forehead and back of head with shoulder pain.

Around five hours after shot I felt what I would describe as brain fog and light headache, by the evening I was aching, chilling and had 101 fever. Aches in my muscles and joints as if I had Rocky mountain spotted fever again. That is what the side effects reminded me of. This went on for over 48 hours. I have never been so sick. Very nauseous by next day. Also fell to the floor from nearly passing out the following morning. Took a minute for the light headed To pass. Arm pain still today. It was very scary and seemed to be a very serious reaction. Friday after noon finally started feeling better. The other strange part of this is that my daughter and best friend and I received the shot together in the same lot number and every one of us was deathly ill with the same symptoms. I am the only one with the fainting spells. Still feel fatigued today. And shoulders and left arm injection site still sore and achy.

Hi I had been given vaccine at 12:30 pm Had very unusual burping non stop till Later that day around 8 pm I got chills Fir about few hours I got tightness of the head Then my body started to hurt , like my bones where braking , kidney very fast filled up with urine I had to pee very often Then I felt like every molecule of my body was burning that was for few hours I couldn?t sleep The burning was all over body Though I didn?t take temperature I didn?t sweat Was unusual burning not topical of high fever It?s all stored by 2:30 am I have noticed that I got skin allergy Rash on my fingers And also they are swollen Like as if my body has holding liquid

HEADACHE; MUSCLE ACHE; CHILLS; FEVER; PULSE RATE INCREASED; This spontaneous report received from a patient concerned a female of unspecified age. 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 31-MAR-2021 17:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced pulse rate increased. Laboratory data included: Fever (NR: not provided) 99-102.7 F. Laboratory data (dates unspecified) included: Pulse increased (NR: not provided) 130 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, muscle ache, chills, fever and pulse rate increased was not reported. This report was non-serious.

Patient called on 4/10/2021 to make aware that she had her vaccine on wednesday (4/7/21) and symptoms have continued. Patient states that Thursday (day after shot) she experienced diarrhea, weakness and muscle aches. The patient states that she has not developed a fever. Thursday she was in bed all day with "flu-like symptoms" and Friday she was weak and only able to shower and go back to bed. Today (4.10.20) she was able to go to work but she is lethargic and still having GI symptoms.

Approx. 9 hours after the vaccination, I began to feel achy in my neck, shoulders, and upper back. Within approx. 30 minutes, I was having extreme chills, some slight stomach cramping, and the neck/upper back aches became very intense. It felt like a case of the flu, but worse. I did not experience vomiting. I took 600mg of Ibuprofin at about 10:00pm Those symptoms ended at approx. 12:30am on 4/8/2021. I was quite exhausted all day on 4/8/2021. Throughout the day on 4/8/2021, I felt lightheaded and a bit dizzy. That symptom lasted for just that day only. I continued to feel tired through 4/9/2021. I now feel completely recovered.

Tuesday 2pm-Jansen vaccine administered . Tuesday 8pm-Violent chills for 2hours followed by what felt like hot flashes and sweating, extreme joint and muscle pain. Wednesday 6am- awake w fever 101.5, horrific headache and body aches. Can barely walk to bathroom to get aspirin. Fever breaks late morning but still feel terrible, Sleep all day. Thursday am- extreme diarrhea, fever 99.5. Took aspirin and Pepto bismol Fatigue all day Thursday pm- pain and swelling at injection site. Feels like a Hard mass about 3.5 inches in diameter and raised. Extremely painful, even clothes against it causes pain that feels like a bad burn. It is now Saturday late Pm and arm is still swollen and extremely painful to The touch. Wondering if I should get it looked at. Awoke next morning w 101.5 fever Horrific body aches and headache, Exhaustion Lasted until evening (slept most of the day) extreme fatigue into following day, diarrhea and 99.5 fever two mornings later.

4/8 @ 12:00 pm - headache 4/8 @ 11:20pm - cold chills to the bone , fever of 102.0 for 3 hours, headache, could not sleep 4/9 all day - body temp of 100.1, cold chills, sweating, bones aching, skin hurting when touched, headache, dizzy and off balance when standing to walk, could not sleep 4/9 @ 2:30pm - fever of 102.3 for 6 hours 4/10 all day - headache 4/11 all day - slight headache

Weirdly despite a right arm injection - left arm ache and left thigh muscle spasms started a few hours afterwards. At 7pm heavy sweat and slight fever. During course of evening nausea, neck, shoulders and lower jaw severe ache by morning. Small sores (the little bubble kind) similiar to mild food allergy broke out on inside bottom lip only and passed only when soreness left lower jaw near late afternoon. Felt better by 5pm. Slight muscle aches in left arm, shoulders & tiredness remained through following day April 2. As of today, 4/12 - I'm having the heavy flow menstral cycle of a freaking teenager. Not fun. I'm accustomed to a very light period at my age not the uteras ripping heavy flow of those first 20 years. Hoping this is a one time deal.

Thursday afternoon at 11:16 I received the Janssen vaccine and started feeling jaw pain, neck pain, chest pressure shortness of breath and extreme nausea at around 7am on Saturday.

Woke up 1145pm freezing shivering my whole left side from my neck to my foot was bothering me my left arm is extremely sore all the way to my hand then after freezing I sweat through my pajamas on april 12 7 am I called out of work I was still extremely uncomfortable in pain with headache dizziness nasua weekness neck and body pain throughout my left side and a low grade fever very tired.

Later that day of the vaccine I woke up about 11pm with a fever, all joints hurting, my eyes were hurting and flu like symptoms which continued throughout the night. I was extremely thirsty which caused me to consume over 60 ounces of water overnight. Woke up about 7am and went to prepare coffee and blacked out. When I woke up I was on the floor and had a bursted nose and EMT was called. I was transported to the ER where I was administered IV fluids, EKG and CBC were done but clear and I was diagnosed as severly dehydrated. I was released about 5hrs later but the consistant feeling of constant thirst has remained even still today. I have also had a lingering headache also.

Started feeling tired so I laid down. While laying down and as time progressed, my head started aching very bad, my arm that received the shot started hurting, I had chills, joint pain, it hurt to touch my skin, off balance when trying to walk, some nausea but I could eat some, I felt pen sensation poking areas in legs but mostly my abdominal area. Overall a feeling of ratchetness, pain, and misery. Next morning I woke with the headache and sore arm but I felt MUCH better. By Monday, all I had was sore arm and slight headache. Now, today, Tuesday, I have small headache, some coughing, sore forearm and thigh (really weird because this just started). Overall I feel good and I am glad that Saturday is over!

spoke with the patient in regards a feeling she has a sensation or feeling on the side of her ankle. she is not sure if its from the vaccine or not , she also explained she donated blood plasma on Friday , and she was dehydrated. told the patient to seek medical attention ASAP or go to Er. spoke with her doctor, team and she said she will call her today , to schedule her to come in this evening for a check up. patient confirmed dr called her to be seen this evening

Initial symptoms was exhaustion and nausea around 12:00 pm. . Headache, chills and trouble breathing followed. Symptoms worsened as the day progressed. I triggered a high heart rate alarm on my watch while sitting and dozing about 6:00 pm. I ended up in bed at 6:30 that night and slept off and on with fever, chills, headache and throbbing arm pain until 7:00 am 4/9/2021. I had to use my inhaler during the night to help breathe but do not remember the time. The next day I was much better with the exception of tiredness, nausea and headache throughout most the day. I have pretty much fully recovered on Saturday 4/10/2021 with only tiredness continuing to bother me as of the this report. I am sleeping more than usual. I did not notify the clinic of my reaction as they were closed over the weekend.

4/09/21 6:00pm Site pain and swelling 4/10/21 1:00pm Fever 101.5, site swelling, facial flushing, weakness 4/10/21 4:00pm Fever 102.2, site swelling, joints pain, increase heart rate (124 heart rate) 4/10/21 7:00pm Fever 102.0 site swelling, joints pain, lower back, hip & wrist pain/sore, lung congested, increase heart rate (98 heart rate) - took tylenol 4/10/21 11:00pm fever 99.1 heart rate 89, site pain & arm weak, thrifty 4/11/21 1:00pm arm sore, weak and numbness with use, site swelling 4/12/21 10:00a arm sore, weak and numbness, site swelling 4/13/21 1:00a arm pain with extended numbness 4/13/21 11:00p arm soreness, arm weakness and numbness

Leg pain; Charlie horses in both legs & severe headache & fatigue. Leg pain started the evening I received my injection around midnight. It has lasted for over a week. Let pain continually through out the day & Charlie horses at night in both legs more my left and as the week progressed in my feet as well. Severe headaches on the right side of my head beginning started around 48 hours after the injection. Throbbing, stabbing pain radiating down my temple, side of head down my neck and into my shoulder blade. Rest, lots of fluids & migraine medication at the highest dose allowed to take.

I had the vaccine on Wednesday. On Saturday, I woke with up my equilibrium being off ( kinda like when you're on a ship ) and pretty intense back and joint pain. By Saturday night, my equilibrium was a little better but I still had back pain. I went to see the doctor and was advised to take Advil. By Sunday, my equilibrium was better and there was a reduction in back pain. Each day the back pain has gotten better.

24 hrs of fever, aches and pains, chills. could not get out of bed. Day 3 fever blister occurs. Day 7 still feel very tired, headache, heavy arms/ legs. I just do not feel like myself. Slighty blurred vision and brain fog.

I had chills - severe- all night long. Couldn't sleep. Muscle joints and muscles were hurting me and fatigue. Next day, fatigue and muscle and joint soreness. It continued for almost three weeks. The third week I got calf pain that was very painful. I went to Urgent Care. It lasted until the next day (so for two days total). When I woke up on the 6th it was gone like it wasn't even there. The third day after the vaccine, the injection site started hurting - but not swollen or anything. The muscle at the injection site still hurts - the pain comes and goes. I did get an iron transfusion (march 8th) before the vaccine - I had a doctor's pass to take the vaccine.

Patient states that she had acute onset of left arm weakness, numbness, difficulty speaking and slurred speech that started at 22:50. Patient was seen as a code stroke, was FANG?D +. Patient underwent MRI and MRA of the brain which showed multifocal small acute infarcts along the right frontal and right parietal lobes, as well as punctate acute infarcts in the right occipital lobe. No evidence of intracranial bleeding. Also noted a filling defect in the right carotid bifurcation causing severe stenosis of the right ECA origin and moderate stenosis of the right ICA origin. Patient was not given TPA, and was started on heparin drip and admitted to the ICU. Patient did receive the Johnson & Johnson Covid?19 vaccine on 4/9. Patient also complained of right ear and right jaw discomfort, pain behind L eye and L aura, as well as burning discomfort of the back of her tongue for the past two days Started on heparin drip initially and then converted over to argatroban drip based on CDC guidance. No IVIG given as platelets are > 500

Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Right leg pain-Medium, Systemic: Joint Pain-Mild, Additional Details: Patient states she is suffering from right leg muscle pain that started on 04/01/2021. She saw on the news about the Johnson & Johnson vaccine being paused so she is wondering if her pain is a result of her vaccine .She has an appointment to see her doctor tomorrow on 04/15/2021.

Chills: uncontrollable shivering for 2 hours (started 6 hours following vaccine) 103.6 fever max (fever varied) lasted 9 hours (started 7 hours after vaccine) Muscle/joint aches lasting for 16 hours (started 11 hours after vaccine) Severe migraine: extreme sensitivity to light and forehead pain lasting for 22 hours ( started 12 ish hours after vaccine) All symptoms disappeared in order of appearance 34 hours after vaccine.

Headache and general tiredness began 30-45 min after shot. Muscle soreness (injection site, rib muscles, leg muscles, back muscles and neck muscles) began soon after. By 6pm, muscles had become painful. I had chills but no measurable fever. I got in the bed but unable to sleep due to muscle pain and discomfort. Hip joints and back began to ache. Fever and chills worsened over the next several hours to measurable with highest at 102F. I took 1000mg tylenol generic which did not lower fever but fever did not rise higher. Throughout the night, I experienced calf muscle cramps and foot cramps, stomach pains, joint pains, inability to sleep, worsening injection site soreness and armpit soreness (likely lymph node soreness). Once in middle of night I may have felt chest tightness but I even doubted that I really experienced it as I had been thinking about all the AEs I was experiencing. Symptoms continued through night. Next morning, developed a cough so I made appointment to get a COVID exposure test at 1pm on 13th April because I had flown in plane on 10th April. Cough could have been due to allergy type post-nasal drip because of high pollen in area. By late Tue evening, I felt better. Headache had resolved and muscle symptoms improved. Now (3:45pm on 15th April) I am still experiencing lymph node/armpit soreness and general inability to focus, think clearly. I feel like I am in a fog. I emailed a message to my physician and reported this through VAERS

The evening after the vaccine was administered I experienced severe pain in my right leg (4/10 at 7:30pm). The pain occured in the groin and knee area and mostly through the thigh. I took 1000mg of Tylenol and it helped resolve the pain. The following day (4/11) I experienced the same leg pain and continued with Tylenol which helped. Monday I had dizziness and almost fainted so I went to the ED to get examined (4/11). I have a family history of blot clotting and carry the prothrombin gene mutation so I'm aware of issues with leg pain and get evaluated. The pain has continued over the week and is now in my left leg with mild pain. Visited walk in clinic to have a follow up on 4/15 and they administered a Covid test.

Had a sore arm after injection, within two weeks became very ill, shortness of breath, arms and legs feeling heavy, feeling dehydrated went to hospital and received IV fluids, received J&J has diarrhea, and extreme fatigue

WEAKNESS IN LEGS; HEADACHES; SEVERE CHILLS; FEVER; HANDS AND FEET WERE NUMB; DEHYDRATION; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent condition included multiple sclerosis. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 dehydration. On 10-APR-2021 16:00, the subject experienced hands and feet were numb. On 10-APR-2021 16:00, the subject experienced fever. On 10-APR-2021 16:00, the subject experienced severe chills. On 11-APR-2021, the subject experienced headaches. On 12-APR-2021, the subject experienced weakness in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hands and feet were numb on 11-APR-2021 15:00, and fever on 11-APR-2021, was recovering from dehydration, and had not recovered from weakness in legs, and headaches. This report was non-serious.

BODY ACHES; TINNIUTS; HEART RACING; TACHYCARDIA; DIZZINESS; SWEATING; CHEST TIGHTNESS/CHEST PRESSURE; BRUISING AT INJECTION SITE; HEADACHE; MYALGIA; FATIGUE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to bees.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 01-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced sweating. On 01-APR-2021, the subject experienced chest tightness/chest pressure. On 01-APR-2021, the subject experienced bruising at injection site. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced myalgia. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021 14:00, the subject experienced tinniuts. On 01-APR-2021 14:00, the subject experienced heart racing. On an unspecified date, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, sweating, chest tightness/chest pressure, bruising at injection site, myalgia, and fatigue on 04-APR-2021, dizziness on 01-APR-2021, and headache on 03-APR-2021, was recovering from heart racing, had not recovered from tinniuts, and the outcome of body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

Charley horse (dull) left leg, sore arm (like punched) Neck pain, excruciating stomach pain for 45 minutes-1 hr that just went away. Mild headache

At 6 A.M on 4/10/2021 (the day after the vaccine) I woke up with a pounding headache. Similar to a hangover. I had chills, muscle aches up and down my legs, fever, extreme fatigue and hot flashes. Site of injection was not sore at this point. Throughout the day I felt weak and could not keep my eyes open for longer than 20 minutes. I fell in and out of sleep and took two aspirins every six hours. The headache went from very bad to a dull constant headache that lasted for three days. When the muscle aches in my legs subsided on 4/10 they then moved to my buttocks muscles. I could not keep my eyes open but kept waking up with chills, headaches, body aches, hot flashes and fever. On 4/11/2021 I woke up feeling better but still had a headache. I felt weak and tired. Symptoms eventually got better throughout the day. I did not feel any soreness in my arm until day three and four. Headaches subsided on day three.

Persistent pain in both legs the day after the vaccination. Legs felt heavy and painful for approximately 24 hours. It started the morning after the vaccination.

12 hours after vaccination, a really bad headache woke me up in the middle of the night. I also had fever (normally, my body temperature is below standard) and my joints hurt me. I took acetaminophen. Next morning, after light breakfast I took more acetaminophen mixed with ibuprofen and went to sleep. I kept alternating both medications every 4 to 6 hours and I got better in the next 36 hours.

Within first 2 hours: dizziness Between 1-7pm: Faster heartbeat Nausea Soreness in sacrum Lower intestine and vagina sore/tight On/off sore throat & metallic taste similar to when sick in December At 8:15pm: Chills Fever - temp 99.3 (normal is 97.5) Heels sore 10:20pm - Fever - temp 100.4 4:30am - Fever - temp 101.2 9:30am - Fever - temp 99.6 12:30pm - Temp back to normal at 97.5 Minor, dull headache for 2-3 days after Then, starting on around April 8, I have been feeling, and still feel today: soreness in my left heel, inflammation all over my body, slightly faster heartbeat, sensations in gland areas of my body (lips, neck, groin, etc), headache that comes and goes.

Unusual headache x4 weeks radiating from the forehead with R facial numbness with dizziness and neck stiffness. These symptoms were severe and intractable for the first week, and then gradually decreased in severity and frequency. At 6 weeks, symptoms have all resolved except R facial numbness. Numbness includes the forehead, cheek, and jaw.

Immediately had flu symptoms the same night as vaccine that went away within 2 days. HOWEVER, twenty-one (21) days later, both eyes were extremely painful to move. Then I lost vision in right eye with extreme blurriness & partial blind spots resulting in a diagnosis of Optic Neuritis by Ophthalmologist and Neurologist. Confirmed optic Neuritis on MRI scan. Twenty-four (24) days later, numbness in legs, feet and right arm started. Hard to walk up and down stairs. Twenty-six (26) days later, extreme pain in in muscles and skin along with tingles all over and numbness. Weakness and Chest pain. Flu like symptoms without fever ie: aches, pains, skin pain, confusion. Dizziness, feeling of being extremely anxious and out of sorts in space. Had to complete round of Steroids and numbness and tingles got better, but did not dissolve. After completion of IV steroids, thirty-four (34) days later all symptoms returned full force and worsening. Checked into ER 4/10 and admitted into hospital. Have not been able to complete normal routine or work level since March 27th due to neurological disturbance and symptoms. Two (2) Eye exams, 3/30/21 confirming swollen optic nerves. MRI 3/31/21 Blood work 4/2/21 CoVid Test 4/9/21 Negative Hospital: April 10-12th. MRI Extensive Blood work Spinal Tap Neuro-Opt exam Outcome pending and further treatment pending results.

LACK OF APPETITE; HEADACHE; SYSTEMIC PAIN AT THE INJECTION SITE; TINGLING IN LEFT ARM DOWN TO FINGER TIPS; ACHING BONES/ACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 127 pounds, and height was 164 centimeters. The patient's concurrent conditions included hypertension, non-alcoholic, and non-smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A2221A 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 tingling in left arm down to finger tips. On 06-APR-2021, the subject experienced aching bones/ache. On 06-APR-2021, the subject experienced systemic pain at the injection site. On 07-APR-2021, the subject experienced lack of appetite. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching bones/ache on 07-APR-2021, and lack of appetite, and headache on 08-APR-2021, and had not recovered from tingling in left arm down to finger tips, and systemic pain at the injection site. This report was non-serious. This case is associated with PQC number: 90000175947, 90000175948. The suspected product quality complaint has been confirmed to be voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

FELT LIKE THERE WAS NO CIRCULATION IN THE ARMS; ARMS WERE WEAK; ARM NUMBNESS; CONSTANT TINGLING IN THE ARMS; PAIN TO TAIL BONE; FEELS LIKE PRESSURE TO THE AREA; NUMBNESS IN THIGHS; DIFFICULTY IN STANDING FOR LONG PERIODS OF TIME; TINGLING IN THIGHS; BOILS THAT WITH PUS ON STOMACH AND UNDER THE STOMACH; ITCHY RASH ON THE STOMACH, LEGS, AND BUTTOCK; MUSCLE ACHES; FEVER; MILD HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced muscle aches. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced mild headache. On 18-MAR-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 103 F. On 21-MAR-2021, the subject experienced boils that with pus on stomach and under the stomach. On 21-MAR-2021, the subject experienced itchy rash on the stomach, legs, and buttock. On 01-APR-2021, the subject experienced numbness in thighs. On 01-APR-2021, the subject experienced difficulty in standing for long periods of time. On 01-APR-2021, the subject experienced tingling in thighs. On 06-APR-2021, the subject experienced pain to tail bone. On 06-APR-2021, the subject experienced feels like pressure to the area. On 10-APR-2021, the subject experienced arm numbness. On 10-APR-2021, the subject experienced constant tingling in the arms. On 12-APR-2021, the subject experienced felt like there was no circulation in the arms. On 12-APR-2021, the subject experienced arms were weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from boils that with pus on stomach and under the stomach, and itchy rash on the stomach, legs, and buttock on 21-MAR-2021, muscle aches, and mild headache on MAR-2021, fever on 20-MAR-2021, and injection site pain on 23-MAR-2021, had not recovered from numbness in thighs, difficulty in standing for long periods of time, tingling in thighs, pain to tail bone, arm numbness, and constant tingling in the arms, and the outcome of felt like there was no circulation in the arms, arms were weak and feels like pressure to the area was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

FELT LIKE FAINTING; BODY ACHES; BILATERAL HIP PAIN; LIMPING; CHILLS; This spontaneous report received from a patient concerned an 47 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 no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced felt like fainting. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced bilateral hip pain. On 09-MAR-2021, the subject experienced limping. On 09-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient was recovering from chills, body aches, bilateral hip pain, limping, and felt like fainting. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Fever, chills, shakes, burning sensation, body and backache, headache day of vaccine. Migraine day 2. Muscle pain x 10 days. Fatigue Day of vaccine x7 days. Alteration of smell day of vaccine to current date.

FAINT; NAUSEA; RIGHT SHOULDER BACK PAIN; LEFT CHEST PAIN; DIZZINESS; RIGHT HAND NUMBNESS; COULD NOT MOVE; WEAKNESS; FEVER 102-103 F; BODY ACHES; SLIGHT HEADACHE; FELT LIKE HAVING AN ALLERGIC REACTION/FELT LIKE HIT BY TRUCK; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included pneumonia. 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: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient had a slight headache. On 10-APR-2021, the patient got off at midnight and felt body aches and upon waking up she could not move. On the same day, she felt like hit by a truck and experienced dizziness, right hand numbness, fever of 102-103 Fahrenheit and weakness. The patient took Bayer aspirin (acetylsalicylic acid) and Tylenol (paracetamol). The patient's headaches were excruciating and came and went and some she had all day. The patient also felt like having an allergic reaction. On 12-APR-2021, the patient had left chest pain and right side of her up shoulder back pain upon taking a breath. On 15-APR-2021, the patient had nausea and visited emergency room and had blood test, chest X-ray and electrocardiogram and everything was normal. The patient was treated with unspecified anti-inflammatory medications, Toradol (ketorolac tromethamine) as intravenous, and they advised to visit a heart doctor. On 17-APR-2021, the patient was faint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left chest pain, fever 102-103 F, faint, right shoulder back pain, and right hand numbness, had not recovered from slight headache, weakness, nausea, and dizziness, and the outcome of body aches, could not move and felt like having an allergic reaction/felt like hit by truck was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: :20210436128 -covid-19 vaccine ad26.cov2.s -faint, bodyaches, left chest pain, dizziness, right hand numbness, could not move, right shoulder back pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210436128 -covid-19 vaccine ad26.cov2.s -weakness, fever 102- 103 F, nausea, slight headache, allergic reaction. This event(s) is labeled per Agency and is therefore considered potentially related.

LOWER BACK PAIN; UPPER LEG PAIN; INNER KNEE PAIN; BRIEF SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 130 pounds, and height was 160.02 centimeters. The patient's concurrent conditions included asthma, allergic to reglan, non smoker, and non alcohol user, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for pain in extremity. On 10-APR-2021, the subject experienced brief shortness of breath. On an unspecified date, the subject experienced lower back pain, upper leg pain, and inner knee pain. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) No clots were found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brief shortness of breath, and had not recovered from upper leg pain, lower back pain, and inner knee pain. This report was non-serious.

Fiery burning in both big toes, far worse in the left one. Left toe is swollen, red, at joint just below the joint.

The shot was given very high on my shoulder and was extremely painful. My range of motion was limited, but I thought it was normal because all people report pain, but then a few days later my whole shoulder really started to hurt very badly so that it was even waking me up if I rolled over on it at night. It was very, very sore. I thought I might have injured myself somehow, but recently I was told that some people have this strange shoulder reaction that can come later, so I figured I should report it. It's been two months now and the intense pain is gone, but I still do not have full range of motion in my left arm. It still hurts if I try to raise my arm straight up. I don't know if it pierced my bursa or what happened. The pain is deep around the joint of the shoulder.

Joint and muscle pain - through back especially and shoulders that still persists Nausea, loss of appetite x1 wk, diarrhea x 6 weeks, still having some GI issues

SWOLLEN ANKLES/BOTH THE LEGS; PAIN IN ANKLES; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included bleeding after first baby, blood transfusion, dnc after a month for second baby, and heart surgery to get water out of heart, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. medical history include hormone pill ,thyroid pill. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride, loxapine, and quetiapine fumarate. On 15-MAY-2021, the subject experienced swollen ankles/both the legs. On 15-MAY-2021, the subject experienced pain in ankles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen ankles/both the legs, and pain in ankles. This report was non-serious.

DIARRHEA; EXTREME FATIGUE; MUSCLE ACHE; This spontaneous report received from a patient concerned a 47 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: 203A21A and expiry: 31-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced diarrhea. On 15-MAY-2021, the subject experienced extreme fatigue. On 15-MAY-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, extreme fatigue, and muscle ache. This report was non-serious.

Immediately felt dizzy & vertigo-ish, w/in 30mins I had to lay down, violent migraine, pain behind eyes , radiated through neck, upper back, shoulder. Felt better the next day, then one week later migraine persisted & all covid symptoms returned at an alarming rate. Fatigue, fever, hot/cold sweats. Freezing & burning up at the same time. Migraine w/vertigo, loss of taste, no appetite, restlessness, brain fogged , short term memory loss, blurred vision, ringing in ears. Vertigo/migraine also worsened w/change in weather, before rain, or a drop in barometric pressure, or increase in humidity, or a cold front coming in. Any drastic temperature change outside seems to prompt or increase the migraine/vertigo, dizziness.

Sickness like the flu at first. Later in March, severe headaches, visual auras, sense of smell change. Continued on while April begin neck pain and severe nerve pain in right arm. Later in April, vision problems in right eye began. May, right arm completely numb, right eye vision problems, balance problems, right leg issues, memory problems, word retention problems. MRIs and x-rays by neurosurgeon in May showed collapsed disc in C5/C6 for no reason (no accident, no trauma) impinging the flow of spinal fluid. Continuing visit to neurologist and another MRI for suspected TIA. Treatment - multiple medications for nerve pain; surgery scheduled to replace collapsed disc and possible other disc (C4/C5) in June; 2nd MRI scheduled to review brain tissue last week of May.

4/18 vaccination. Evening I had sore arm. 4/19 I woke up and felt like I was run over by a truck. Slight fever, flu like symptoms, coughing. I stayed in bed, drank fluids. The extreme fatigue started and progressed to a week later that I was beyond tired. I started to take xanax for the high anxiety. But I could tell the difference between medication tired and tired, lethargic. Joint and body pain started in my neck and shoulder area and it started moving down my body. I went to my regular clinic, in tears, as I was in so much pain. They gave my muscle relaxers and prednisone. My BP was really low; 80/50's. 5/11 I saw my PCM recently and my Dr. stated it was a flare up caused by something. It was a possibility caused by vaccination but unsure. The Dr. wanted to give me a compound medication to help but its not covered by my insurance.