Johnson & Johnson

The injection site is swollen with redness, very painful to touch and painful to move. There is also lingering pain after any moment of the arm or anything touches the injection site. I also have some itchiness on the injection. The pain has gotten wores today (Monday 3/8) which is more than 72 hours after I received the vaccine Friday (3/5) morning.

Significant body aches and pain all over body, fatigue, headache, injection site pain the night after getting the vaccine

Tightness in throat after 30 minutes, rash across chest. No previous adverse events to vaccinations previously.

I had my J&J COVID vaccine on Monday 3.8.21 On Monday night I developed a fever of 103 which lasted all night despite Advil and Tylenol. I had diarrhea, injection site pain and severe shaking. On 3.11.21 I have developed a very red swollen injection site which is large and extremely painful to the touch. My fever did go away at around 3AM on 3.11.21 but still have the body aches. This was not listed in my possible side effects this far out and some side effects were not even listed in my hand out

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Additional Details: Within 10mins of vaccine, pt seem to have a mild seizure for less than 30sec. Pt had no hx of seizures, on no current medication. Pt recovered, and within 1-2mins she passed out. She was warm. She woke up within 1min, then started to vomit. Called emergency services. She felt better after throwing up. When ambulance arrived, she started to have tingling sensation on her finger tips. States she felt better. EMT advised her to go to the ER. Pt decided to go to ER to get checked up. Let with ambulance.

Janssen COVID-19 Vaccine EUA 12:15pm (3/10/21)- initial injection 12:20pm- excessive bleeding from arm 6:45pm- chills, inability to get warm, headache 7:45pm- low grade fever (100.3F), took Tylenol Overnight- inability to sleep, constant chills and sweating, muscle aches, felt very horrible 2:30pm (3/11/21)- fever breaks, only arm is still sore

Janssen COVID-19 Vaccine EUA. Mild body aches and chills. Injection site tenderness. Three 200 mg ibuprofen taken around 10 pm relieved symptoms

Janssen COVID-19 Vaccine EUA. Fever 3/14 from 7:30pm-11:30pm. Fever 3/15 6:30-7:30am. Headache 3/14 starting at 7:30pm-3/15, ending at 9:00pm. Fatigue starting 3/14 at 6pm. Arm pain at injection site.

- Pain in injection site on left arm - redness, swelling (knot), warm to touch (still continuing, worsening) - Mild nausea for over 36 hours (still continuing) - Headache for less than 36 hours - Minor body aches for less than 36 hours - Slight chills on second day

experienced a rash on the neck area Recommendation: please contact your doctor and notify him of your symptoms, you could take benadryl to help alleviate the rash near your neck, but if you do experience any difficulty breathing please go to the nearest emergency room

30 minutes after leaving the site, got a mild reaction where my face got tingly and red but then it subsided but then 4 hours after receiving the vaccine I began getting a low grade fever (100.6) by 5pm that same day, I began having flu like symptoms, body aches, headaches, fatigued, chills, sweating and fever had risen to 101.7. Took ibuprofen to help with the symptoms but fever kept rising. By 8pm., fever was at 102.9, headache worsen, sweats throughout the night and felt dizzy. Next morning 3/18, fever was low grade by 7am (100.4) by 9AM, fever was gone, felt tired, with mild body aches and moderate headache and felt exhausted the rest of the day. Symptoms are getting better with rest.

Pt. vaccinated @ approx. 1445. 1448- brought to first aid station by medic in wheelchair stating that her lt arm was slightly itchy and her tongue "was tingling". Pt. AA&O x3. Lungs clear to auscultation bilaterally. Pt. had fine macular red rash over top of left lateral and anterior arm that spread medially across the upper portion of her chest. Stated that rash was faintly itchy. BP- 140/78-HR- 112 R - 22. Pt. placed in supine position for 15 minutes. Lungs remained clear. Rash fading to light pink at 15 minutes and tongue no longer tingling. Pt. able to call home and speak w/o difficulty. Pt. placed in sitting position for 10 minutes. 1505- BP-134/76 - HR - 80 r - 16. Pt. able to stand w/o difficulty @ 1515. Lungs clear bilaterally and rash no longer visible on Lt arm and only faintly pink on her chest. Pt. stated that she "feels normal" and is not dizzy or lightheaded. BP-130/78 HR- 80 RR- 16. Pt. escorted to her car my medic and sent home in stable condition.

Nausea day 1 accompanied with loss of appetite and hot flashes, Day 2 rash and itchiness at injection site, chills while sleeping, muscle aches, headache, fatigue, Hot flashes after chills went away

pt develped delayed local reaction at the site of injection measuring 6 cm by 9cm. Erythematous and pruritic as well as tender.

I started to lose mobility in my left arm the evening of my vaccine appointment. The following morning, I could not raise my arm at all. The pain in my upper left arm (where the vaccine was administered) has been severe for more than 48 hours. It is extremely painful to the touch. I can use my left hand, but cannot function/cannot perform necessary daily work and school tasks due to the loss of mobility. I have been in extreme pain and fear my shoulder has been injured.

Minor arm pain in the injection arm. Severe headache about 10-12 hours after the shot lingered for a few days fluctuating in severity after the second day. Body chills night of vaccine. Slight Fever night of vaccine.

Pain and swelling at injection site becoming hot and red at injection site, becoming very swollen in upper arm and some swelling in forearm. Became very hot in upper arm. No fever when taking temperature. Also some mild headache and mild body aches

Pt begin feeling dizzy about 3 minutes after dose. She was sitting down, I encouraged her to drink some water and sat with her. Her dizziness became worse and I got the Epi Pen ready. A few minutes later, she asked to lie down due to her dizziness. I assisted her and had my tech call 911. She had no trouble breathing but did develop tingling in her hands and a blotchy red rash on her chest. The paramedics arrived and checked her vitals which they said were fine. They took her out to the ambulance as a precaution.

Within 6 hours of getting vaccine I had flu symptoms- chills, aches, headache, fever, tiredness. By 9pm I had a fever of 104 degrees and was dropping sweat, shaking, and very weak. Within 24 hours, I developed a rash on my chest ans torso area of little red bumps that were itchy and spreading throughout the day. The fever came and went on the second day. Terrible flu symptoms have lasted over 24 hours now.

Janssen COVID-19 Vaccine EUA. Headache, fever (99.5 degree F), fatigue, sore injection site, sore left arm, forgetfulness,

4-5 hours after vaccine - slight nausea 8-10 hours after vaccine - heavy head/headache/slightly feverish 18-24 + hours after vaccine - headache/feverish/weak body/pain at injection site

The following two days I had a low grade fever, extreme fatigue, dizziness, and light headedness. This was intermittent throughout the two days. By day three it was done. I also have noticed (three weeks later) that there?s still swelling at the injection site, similar to a boil

-Fever over 104 degrees approx. 10 hours after injection, Tylenol successfully lowered fever -Body aches and skin sensitivity for 24 hours following fever, resolved on its own -Multiple canker sore flare ups in mouth approx 3 days after vaccine, has not yet resolved (5 days post vaccine)

Within 5 to 10minutes of receiving vaccine, pt was visibly red, reported feeling hot all over with scratchy throat. Over the next few minutes mouth became numb. Medics evaluated pt, and after 30-40 minutes, pt left pharmacy with a family member. (medics came to pharmacy)

Headache and fatigue one hour after the vaccine. Terrible chills where I could not get warm starting two hours after the Vaccine. Also starting three hours after the vaccine I had extremely painful muscle aches and pains. Bruise at injection site and swollen arm. Excruciating pain in both arms and both knees. When the leg pain started, it started behind my knees. I was in tears for about 14 hours in excruciating pain due to the muscle aches and I am still having random hurts of sharp muscle and joint pain.

Vertigo Lightheadedness Chills Exhaustion Trouble sleeping Slight fever Muscle aches Injection site pain Headaches Nausea Swollen lymph nodes in shoulder, neck, and armpit

Experienced light headedness ( started before time stated but not sure when exactly). Around 6:30pm-7pm I began feeling dizzy, going between dizzy and light headed. I was drinking plenty fluids and did eat. A few people noted that I looked very out of it, and I felt very out of it. I tried staying seated and this did not have any effect on the dizzy feeling. I went to lay down and before going to sleep around 10pm-11pm, laying in bed I felt like the room was spinning. I also had typical symptoms, soreness as injections site and arm (starting immediately the day of vaccine), fever at it's highest was 102 (starting at 100.5 that morning, not peaking until Motrin wore off*see below*), feeling tired and very heavy.. like everywhere was waited down by something (starting early in the morning). I was given Motrin by my coworker in the morning as I was had a headache and was feeling sore and moving sore due to heavy feeling. Wednesday waking up the dizziness and lightheadedness were gone. A slight feeling of being out of it however, fever was about 99-100 throughout the day (99 being my typical temp). As of today only a feeling of sore arm and tiredness which sometimes feels like I and out of it but I feel both from later yesterday and today is due to the tired feeling that comes common.

Ache in injection site, muscle aches in joints throughout body, fever of 102 throughout night, loss of sense of taste, headache, chills

FELLING WARM TO TOUCH AT INJECTION SITE; INJECTION SITE SWOLLEN ARM; INJECTION SITE PAIN; REDNESS OF INJECTION SITE; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced felling warm to touch at injection site, injection site swollen arm, injection site pain, and redness of injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site swollen arm, redness of injection site, felling warm to touch at injection site and injection site pain was not reported. This report was non-serious.

About 12 hours after injection, I started feeling achey 13 hours later, I had a spell where I could not hear anything and felt as if I wasn?t in control of my body- in talking to medical personnel they say what I?m describing is what happens right before one passes out. I came out of it within 10 minutes. 16 hours later I had a 102 fever. Took Tylenol Felt fine 24 hours later 32 hours later I started to get a headache and light sensitivity. Fever back to over 99- low grade for me. 35 hours later I had such a bad headache and light sensitivity. I couldn?t watch tv, be on my phone, or look at a computer screen. I also started to get bouts of nausea. 38 hours later, I vomited for the first time. Same symptoms as what I described last. 42 hours later, I vomited again. 48 hours later - 5 days later, light sensitivity and migraine symptoms continued , but improved slowly each day. 6 days later, all previous symptoms were gone. I woke up with a bump in my inner eye. Slowly went away throughout the day, then developed a itchy, red bump in between my lips and nose, that progressively got bigger throughout the day and made my lip swell. Bump was about 2 inches in diameter at its biggest. Took Claritin, cleaned face with alcohol, and by 24 hours later it was not noticeable. 8 days later, the bump appeared again in between lip and nose on the opposite side of my face. Took Benadryl, bump slowly went down throughout the day. By 24 hours later it was gone

12 hours after vaccine around 3:30am on Saturday I woke up with sever chills, shaking uncontrollably for an hour or 2. I fell back to sleep and woke up about an hour later burning up and sore head to toe. I threw up and had a migraine that lasted the rest of the day. I was able to fall asleep around 6:30am and when I woke up around 9 I was just exhausted, sore all over, nauseous, with a headache. This lasted about a day. On sunday afternoon my toddler lightly hit my right arm where the vaccine was and it became sore, red, and swollen. By the late evening that day the soreness and redness increased. Monday-Thursday the redness and swelling increased to about 2 inches round and felt very tight with a lump in the swelling and it was warm to the touch. By friday the redness and swelling reduced to about an inch, but there is still an inch small lump at the injection site and hurts when anything touches it. The redness has faded and there is no visual bruising.

Janssen COVID-19 Vaccine EUA Initial pain in injected arm (left) that dissipated after 20 min. Roughly 5hrs. after vaccination: -Fever of 102.5 degrees F, nausea, eye sockets sore, intense throbbing headache, chills, felt like skin was over heating, dizziness, disorientation, intense body aches all over (arms, legs and back felt too sore to move) -Fever broke roughly 24 hours after injection -Treatment involved drinking lots of water, ice compress on forehead, and 1 Tylenol pill

This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anemia, alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and drug abuse illicit allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 09:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced throwing up. On 05-APR-2021, the subject experienced swollen arm. On 05-APR-2021, the subject experienced itchy at the injection site. On 05-APR-2021, the subject experienced arm pain. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021, the subject experienced fatigue/ tired. On 05-APR-2021, the subject experienced red at the injection site. On 05-APR-2021 15:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, fatigue/ tired, arm pain, swollen arm, red at the injection site, and throwing up, and the outcome of itchy at the injection site was not reported. This report was non-serious.

For the entire day of 4/10/2021 I experienced fatigue, nausea, dizziness, sensitive skin, headache and left arm soreness. Now on 4/11/2021 I feel completely fine, except my arm still hurts a little.

Completely covered in hives. Arms, legs, back, neck, face, feet. Allegy medicine doing little to stop break out despite using two claritin 24hour medicine (recommended dose 1).

Intense full body aches, starting 10 hours after shot. Fatigue, weakness. Chills. Fever. Heart racing. Body aches and fatigue lasted 24 hours. Chills and fever lasted 12 hours. Redness, swelling, and itchiness at injection site starting 48 hours after shot.

injection site reaction, swelling and knotting even 6 days after injection. Losing feeling in right hand and tingling.

Immediate pain around injection site, has persisted until now 9:30pm began feeling nauseous/ experiencing stomach pain all night: muscle soreness, joint soreness, body aches, clamminess/feverishness Next day 4/11: weakness, fatigue, body aches, muscle and joint soreness, diarrhea, nausea (no vomiting), clamminess/feverishness intermittent-- confined to bed for 24 hours after side effects began

noticed 99F Fever started at about 5pm day of dose (day 1); fever rose to 103F by 7pm, 101F with 500mg acetaminophen lasting until next morning (day 1-2); chills started at about 1pm and went away with fever (day 1,2); pain during injection (day 1); injection site soreness day of and on (day 1+); headache (pain moving eyes, pain during coughing/sneezing) started a few hours after vaccine, worsened with fever (day 1-3); next day slight raised tender bump at injection site (day 2); quarter-sized raised bump with hardness and tenderness surrounding the raised bump at injection site, minimal redness if at all, slightly warm to touch (day 3,7)* bump is half-dollar size and itchy (day 4-6); pain moving eyes side-to-side and background headache that is obvious when moving quickly (day 1-8); slight dizziness (day 1-4) afterimages (day 3-4) *the pharmacist administering the vaccine was not wearing gloves and did not clean my arm with alcohol prior to vaccination.

started as lethargy, progressed to moderate/ marked body aches- full body joint based aching. also febrile, headache from 10pm until around 8am on 4/9. Injection site pain until 4/11

3 sets of hives over 36 hours - would swell down with Pepcid & Benadryl, also took Zyrtec. Had to go to Urgent Care.

Started out with bad chills and a fever. Whole Body ache. Around 9-10am I broke out in hives all over my body that lasted all day. Now they are coming and going

Uncontrollable itching all over body, fever, bruises all over body. Itching started within hours of receiving the vaccine. Took Claritin, took hot bath and tried sleeping but was difficult. By Sunday, 4/11, rashes and bruises began to go away.

Severe body aches, nausea, dizziness, headaches, rash/skin reaction on back for 3-5 days Pain, hardness and scabbing at injection site. Bump still present 4/14/21

BODY ACHES; JOINT PAIN; HEADACHE; INJECTION SITE PAIN /SEVERE ARM PAIN; PASSED OUT AT INJECTION; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vonn willebrand's disease, non-alcoholic, non-smoker, and needle phobia, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced passed out at injection. On 12-MAR-2021, the subject experienced injection site pain /severe arm pain. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced joint pain. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, joint pain, and headache on 15-MAR-2021, had not recovered from injection site pain /severe arm pain, and the outcome of passed out at injection was not reported. This report was non-serious.

Large briuse on left thigh 1 week after the Johnson Vaccine. Pt did not experience any other symptom. No SOB, Chest pain, ABD pain or leg edema was noted.

Large bruise on left thigh 1 week after the Janssen Vaccine. Pt did not experience any other symptoms Denies SOB, Headache or ABD pain. No swelling or leg edema noted as well.

Illness duration post injection: 30 hrs., High fever of 101.9 began 6.5 hrs post injection, sustained high fever for 24 hrs, treated with Tylenol PO during this time, fever then after 24 hrs converted to a low grade fever for an additional 6 more hours. During this whole time, had a persistent headache, general malaise., 5 hrs after the start of the fever, developed NUMBNESS IN FEET, ANKLES, CALVES, which then, 1.5 hrs later evolved into HOT & SWOLLEN & REDDENED FEET, ANKLES, CALVES, KNEES, HANDS, & FACE, this was treated with 50 mg PO of Benadryl, which did provide relief and was followed up with 10 mg of Zyrtec 20 hrs after the Benadryl was initially given, as a precautionary measure.

developed shingles on eyelid 4 days after vaccine. patient has previous history of shingles, reports that this is 9th outbreak in 2 years

The side effects began the night following my vaccine and lasted the entire next day. It began with fatigue/brain fog, then chills and soreness at the injection site. Once the chills began I was very ill with a fever (100-101), severe aches and pains in my body from head to toe, and experienced occasional shooting pains. Once the fever went away about 30 hours after my vaccine, I still felt pain and heaviness in my body and had a bad headache. The next day (day 3) was much better- I had no fever but still felt some brain fog, drowsiness, and slight muscle soreness (but no pain). Two weeks after my vaccine (4/20/21) I had a very similar experience but am not certain it was related to the vaccine. I developed chills, fatigue, and a headache for the majority of the day. In the evening, it progressed to muscle/joint pain, a severe headache, extreme fatigue, and a 100 degree fever. The next day (today 4/21), the fever has subsided and I feel slightly fatigued. Though I am not sure this was related to the vaccine, it mirrored my initial reaction to the vaccine two weeks prior. It is very unusual for me to get a fever in the 100 degree range and typically only happens every two years or so.

SWOLLEN AT INJECTION SITE; INJECTION SITE GREENISH PURPLE BRUISE COLOR; ABDOMINAL PAIN AND PRESSURE; INJECTION SITE SORE/TENDERNESS AT INJECTION SITE; FEVER; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 test. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced abdominal pain and pressure. On 11-APR-2021, the subject experienced injection site sore/tenderness at injection site. On 12-APR-2021, the subject experienced injection site greenish purple bruise color. On 12-APR-2021, the subject experienced swollen at injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, abdominal pain and pressure, injection site sore/tenderness at injection site, swollen at injection site, injection site greenish purple bruise color, and headache. This report was non-serious.

On Sunday morning i woke up to my left arm being swollen, red, hot to the touch. Over the course of the next few days the swollen part got bigger to the size of a baseball Tuesday I called my doctor and they wanted me to get seen right away at the ER. They did an ultrasound right away and they ruled out a blood clot and an abscess. They figured it would just be an infection. They put me on an antibiotic for 7 days up to 4x a day. Today 4/21 I took my last dose of the 7 days. Called my doctor and they are starting me on another 5 days of antibiotic to get rid of this infection in my arm. It is now down to a quarter size or a little bigger. Hoping that in the next 5 days it will be completely gone. I don't have the redness and heat anymore just a smallish lump.

I first noticed a bruise the day after receiving the shot. I seemed to fade and then the area became red. It was a circle around the area of the shot and it was three and a half inches. It was a little painful. I went to the doctor and she prescribed antibiotics. The area stayed red and became better over the course of a week. I got the second dose and my arm did not get red or sore.

VOMITING; DECREASED APPETITE; 106 DEGREE FAHRENHEIT (F) FEVER; FATIGUE; STOOL ODOUR ABNORMAL; REDNESS OF LEGS; BRUISING OF LEG; PYLORIC SPHINCTER INSUFFICIENCY; PSORIASIS; This spontaneous report received from a consumer concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1139170) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported. On APR-2021, the subject experienced stool odour abnormal. On APR-2021, the subject experienced redness of legs. On APR-2021, the subject experienced bruising of leg. On APR-2021, the subject experienced pyloric sphincter insufficiency. On APR-2021, the subject experienced psoriasis. On APR-2021, the subject experienced 106 degree fahrenheit (f) fever. On APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 106 F. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced decreased appetite. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, had not recovered from stool odour abnormal, redness of legs, bruising of leg, pyloric sphincter insufficiency, and psoriasis, and the outcome of 106 degree fever, vomiting and decreased appetite was not reported. This report was non-serious.

HEADACHE; FEVER; NAUSEA; TONGUE TINGLING; SKIN SENSITIVITY; BODY ACHES; This spontaneous report received from a consumer concerned a 26 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 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced tongue tingling. On MAR-2021, the subject experienced skin sensitivity. On MAR-2021, the subject experienced body aches. Laboratory data included: Body temperature (NR: not provided) 99.6. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, nausea, tongue tingling, skin sensitivity and body aches was not reported. This report was non-serious.

Reaction after Janssen vaccine (1805031), in right arm, at 1:20pm 3-16-2021: - Within 15 minutes: nothing - Within an hour or two after: itchy right hand, pulsing in right side of head behind eye, dizziness - About 8pm, onset like a wall: severe anxiety/impending feeling of doom, shortness of breath slightly, increased heart rate, tiredness, muscle aches, sore skin, feeling of sharp pains in ?blood stream?, chills, nausea - 12pm after sleeping for about half an hour: flushing of face, slight shortness of breath, facial swelling and blotchiness, swollen lips, fast heart rate, feeling of impending doom, nausea, tongue swelling, slight difficulty swallowing, nasal congestion, groggy voice, sinuses full of moving fluid, ear pressure, hot with chills, eye redness, achy body and sore skin, feeling of sharp pains ?in blood stream? - 1am, in addition to previous symptoms (peak of symptoms): Fever 101.4 F, puffy feet that hurt, dizziness - 1:30am, after eating a little: temp 100.8 F, puffiness went down slightly and severe symptoms improved a bit. Still chills - 2:45am woke up drenched in sweat and hot, 100.7 F. Chills mostly gone. Nose very stuffy. Eye pressure/pain. Feel improved. Chest feels exhausted. Still body aches but improved. Ear pressure. - 8am: 99.4 F. Feel better mostly overall. Head feels like a cinder block. Eyes and ears hurt. Body aches mostly gone. Pain at injection site. Chills gone. Sweats gone. Skin still sore. - 1pm: 98.3 F. - Only remaining symptom for next couple days is tenderness at the injection site. -Following a few days: completely recovered. no symptoms, back to 100%

The first 2 days had awful headache and muscle aches, could not leave the bed. Then a week later, I got a horrible rash all of my body, worse at my hands and feet. The rash included many blisters. Loss of appetite and cannot sleep. I still have the rash now, and it is even getting worse in some parts, while other parts are better due to a steroid cream prescribed by my dermatologist. On April 26, I felt very dizzy and weak and went to urgent care. I have since recovered from those symptoms.

She was patient at the COVID imz event today. She suddenly got very cold after her COVID imz and her fingers turned blue. This happened while she was waiting the 15 minutes. She did tell me she has Raynaud?s , however the room was very warm. There was a nurse on site who evaluated her, checked BP, listened to lungs, HR. The nurse stayed with her and I checked on her periodically. After about 30 minutes she felt fine and returned to work. She did tell me she was a little skittish about getting shots when I gave her the vaccine.

Rash on chest/arms/back w/HA x 3 days with itchiness; denies any SOB/N/V/Photophobia/vision changes; reports taking Tylenol 1000mg at 0530 with some relief; J&J rec'd 5May21

So the 28th, early in the morning, I started getting a fever until 06:00 pm that day. Then I felt fine. Monday, the 29th, I had a small rash on my jaw area. It was pretty small but it kept spreading - face, ears , neck and then on to my chest, arms - it was very itchy. Thursday, I went to Immediate Care. I was prescribed prednisone. On Friday, my face was swollen to double the size. They gave me five days worth of doses which I got from the pharmacy on Friday, the 2nd.. I started April 2 with the prescription. It didn't offer immediate relief. I was still taking Benadryl in addition to prednisone. My rash still lasted for another week and a half to two weeks. I think there are still sometimes traces of it - it appears in small patches - I still get a rash on my neck. It has not fully gone away.

My primary care doctor describes what I am experiencing as dermatographia. I started off having an itchy spot on the back of my neck, lightly rubbed the spot, and then my skin became immediately inflamed causing swelling and redness. I continue to experience this all over my body, it is not localized to one area. This has never happened to me before, I am not allergic to anything that I am aware of, and have never had a reaction from a vaccine previously.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: Pt told us she tends to faint when she gets shots. gave her the janssen shot and in 5 mins she told us she was about to faint. she became confused and started walking. technican went after her and she layed on the ground. called 911. took her bp. told them she did not eat today and most likely why she fainted. pt rested for additional 30mins. had some water and food. Felt better and left for home. called her back at 5pm to follow up. states she is feeling better just a sore arm.

BOTH EYES ARE SWOLLEN/PUFFY/LEFT EYE MORE SWOLLEN; FACE WAS SWOLLEN (SWOLLEN CHEEKS); DARK RED COLOR AROUND EYES; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced both eyes are swollen/puffy/left eye more swollen. On 19-MAY-2021, the subject experienced face was swollen (swollen cheeks). On 19-MAY-2021, the subject experienced dark red color around eyes. On 19-MAY-2021, the subject experienced chest tightness. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient was recovering from chest tightness, and had not recovered from both eyes are swollen/puffy/left eye more swollen, face was swollen (swollen cheeks), and dark red color around eyes. This report was non-serious.

Received shot on 4/7. Felt fine three days after on 4/10 and went for a standard run. Morning of 4/11, woke up with three massive bruises on my knees. On left knee, bruises were located on the inside and outside of my knee. On the right knee, bruises were located on the inside of my knee. These bruises were at least 3-4 inches in diameter. News of blood clotting from J&J vaccine was released on 4/13. Days after 4/11, knees and ankles started to swell. By 4/14, the swelling in my knees and ankles continued and I became fearful of blood clots that would become life-threatening. Evening of 4/14, admitted myself to the ER.

During injection, felt pins and needles from injection site to fingertips which faded to tingling and stopped entirely after about 7 minutes. Intense nausea and sweating beginning 1-2 minutes post injection; unable to sit up. Lasted approximately 7-10 minutes before clearing up 2 hours later (7:10 pm), arm at and above injection site felt hot to the touch and had mild dull pain at every movement. Slightly dizzy and nauseous. Arm periodically ached without movement. By 7:26 pm, arm pain from movement was a sharp pain, though still pretty mild. Around 9:30 pm, gently pressed at site of injection and a jolt of pain went all the way down to my fingers Nausea increased at 10:13, still mild. Decided to go to sleep. Woke up at least 5 times before 12:30 am in various states of pain and discomfort, including nausea when attempting to sit up; dry throat/mouth; pins and needles throughout my glutes and thighs accompanied by pain in my left hip, knee, ankle, and jaw; and mild to moderate arm pain at the injection site. Took about 15 minutes to be able to get up due to nausea and got some water. Was cold so wrapped myself in a blanket. Nausea and arm pain with movement remained but I was able to go back to sleep around 1:15 am. Woke up at 2:53 am - arm pain minimal and nausea gone, blanket felt nice but unnecessary, went back to sleep Woke up at 5:34 am with pins and needles in glutes and thighs and pain in my right jaw, knee, hip, and ankle (all sites of previous moderate injuries) along with a low grade headache. Went back to sleep. Woke up after an hour or so feeling relatively normal, arm pain and headache returned after sitting up. Got out of bed but ended up taking another nap. Woke up after another hour with just a headache and brain feeling fuzzy, but strong tingles began returning to my glutes and thighs like they had fallen asleep (referred after this point as tingles). Arm hurt. Drank some more water and took another nap. Woke up around 9:15 am with a low grade headache and slight tingles; fuzzy brain feeling was gone. Legs wobbly when I walked. Realized that tingling got worse anytime I was sitting down or lying on my back. Around 10:20 am started crying - no known cause. Couldn't stop for a few minutes. This is not normal for me. Around 1 pm realized I had a pretty high fever; unsure how high it was or how long I'd had it. Took another nap at 1:30 pm and woke up at 2:20 pm feeling much less hot so I thought it had broken, but I was told by my friend who dropped by that I was still feverish just much lower. Slept from about 2:45-3:55 pm; headache was much better when I awoke; tingles and sore arm remained. Realized at 4:13 pm that I'd had no appetite the whole day. I'd also barely been able to force myself to drink water; too cold and it hurt, room temperature didn't feel right. No times, but felt periodic stabbing pain in my left ear until about 6:30 pm. Much else also recovered by 6:30 pm: felt well enough to drink cold stuff, tingles were low grade, fever was present but low. Arm was still sore. 7:08 pm headache was gone. 8:49 pm felt much better and able to do things and take care of myself with minimal discomfort, but felt a little lousy overall - low grade headache, head felt like there was some pressure in it, periodic tingles, achy arm. 9:29 pm felt exhausted and slightly achy but otherwise mostly normal. Felt some hunger twinges for the first time that day but nothing felt appealing (realized I had only eaten about 5 spoonfuls of soup the whole day). Fell asleep getting ready for bed; woke up at 10:49 pm and finished getting ready for bed then went back to sleep. Summary: Friday: Symptoms: mild to moderate nausea, mild dizziness, mild to moderate injection site pain, pins and needles in glutes and thighs, joint pain Treatment: drinking water Saturday: Symptoms: mild to moderate pain at injection site, headache, fever, nausea, tiredness, glute and thigh tingles, lack of appetite, periodic stabbing pain in left ear Treatments: ice/cold pack on arm (helped with arm pain while on), drinking water, sleeping

Severe chills within 5 hours of shot. Awoke at 2:30 AM (about 9 hours after shot) with fever of 101.5 that climbed as high as 101.8 by morning. Accompanied by body aches, mild headache. Took Acetaminophen occasionally over 24 hours, but lower fever (100.8) persisted each time after medicine wore off. Limbs are sore. Slight soreness at injection site but more soreness in ankles/lower limbs. About 24 hours in, I noticed 2 faint red splotches on my stomach and chest.

My shot hurt very bad, and my IMMEDIATE reaction was ?wow she shot me really high on my shoulder?. Thought that was strange, but didn?t think anything of it. Pain increased daily, and 3 weeks after my vaccine (after taking advil/tylenol daily) I was in such excruciating level 10 pain that I was losing sleep at night. I then found out about SIRVA from a friend, and after doing some reading, I was sure that?s what it was. I went to urgent care, and they knew nothing about it. They gave me muscle relaxers that didn?t do anything. I woke up a few days later with such intense throbbing/sharp pain that I was unable to move my arm/shoulder above my elbow. I went to the emergency room with a friend because I couldn?t even drive, and they also didn?t know what SIRVA was. They gave me oral steroid medication & an orthopedic referral for it it got worse. The meds helped a little, brought my pain down to a 6/7. Once the meds were complete, my pain increased, so I went to the ortho, who KNEW WHAT I WAS TALKING ABOUT, and diagnosed me with SIRVA after doing an x-ray. He told me to let him know how it was feeling a week later, since the steroids did help a bit. Unfortunately, the pain only got worse, so I went back in for a cortisone shot. That helped more than anything, and my pain is now down to a 2/3. I have been trying out some PT, but am honestly reading some crazy stories about chronic pain online that are scaring me and am afraid I will never have my arm at 100% again. The reason I am bothering with this form, is because I would love to be considered for any compensation for the nearly 3 grand in medical bills sitting on my desk. Of course on top of it, my last day at my last job was 3/31 (few days before getting vaccinated) and I just got a new job this week. These past few months have been a really really stressful time period, and I?m super angry that it?s just because I got vaccinated. Sorry for the rambling, but I really hope they raise awareness of this and alert untrained health care workers of the possibility, so that no one has to go through this again.

I woke up at three AM feeling like I had a fever. I had body aches. The next morning when I woke up I felt like I had a tourniquet on my arms and legs. I was also short of breath. I went to the ER and they checked for blood clots. I started to get lower extremity cramps and muscle spasms. Two days after I started to have some shortness of breath and I was out of breath if I walked any length. One week after the vaccine I ended up wit an ear infection in my right ear. The muscle spasms continued especially in my right lower legs with twitching which lasted for five weeks. Two weeks after the shot my Asthma, which is normally controlled got very severe. My inhalers didn't seem to work. Three weeks after the vaccine my Asthma got worse and I was having trouble breathing. I went to the ER again and there were more tests done. I was prescribed Prednisone, and I took one week off work. After multiple treatments I was prescribed antibiotics and switched my inhaler which helped. I have been trying to do some Cardio activity this weeks and I feel better after six weeks. I don't have to use my Nebulizer as much as I had been.

Unusually heavy menstrual bleeding with thinner consistency that started a few days earlier than expected and just two days after receiving the vaccination. Injection site still painful and swollen today. If it is relevant, I also experienced more common effects like severe body body pain and hot flashes beginning several hours after receiving the vaccine, lasting 48 hrs.

Pt developed sore arm, Tmax to 102, fatigue and headache ~5 hours post vax, but these symptoms mostly improved within 24 hours. Vax site swelling (Left arm) increased to size of palm of hand and developed pain shooting down legs (R>L) over the next few days. Today is 5 days post vax.

6/28/21 A 26y/o female client 10:25 A client was given the following vaccines; Hepatitis A- Lot #G99R expiration date in the right deltoid; Hepislav B- Lot # 934599 expiration date in the right deltoid: and Johnson & Johnson Janssen COVID vaccine Lot # 202A21 expiration date 08/07/2021 in the left deltoid. 10:30A During routine observation noted client color was pale, skin warm and dry. Client initially states she is ?okay?. After questioning client again this time Client admits she feels ?dizzy?. Client denies any difficulty breathing and B/P 112/70 with a heart rate 76; pulse was strong and regular. 10:35A Client now c/o a ?dry mouth and dry throat?. Client given a minute sip of water was able to swallow without difficulty. Client continue to deny any difficulty breathing or swallowing so couple of minutes later client tried another minute sip of water, but this time had some difficulty swallow. Now client admits she is having ?pain in my throat? and ?chest pains? in the left side. Epi pen -Lot #G201104X expiration date 02/2022 was given in client?s upper left thigh without problems; repeat B/P 118/68 and 911 was summoned by nurse 10:40AM Paramedics arrived ? reported to Paramedics epi pen was given. 10:47AM Client B/P per Paramedics 107/73, heart rate 72; Paramedics report client will be transported to the Hospital ED for evaluation. 3:50PM Noted client was back. Client reports she is feeling ?okay?. Client states she was ?discharged from ED at 13:22? (1:22PM) with the diagnosis of ?allergic reaction?. Client resumed her routine scheduled chores and continue to report she feels ?okay?. RN CCM

Racing heart, highest recorded beat was 108, lasted from 7:45 to 8:45 pm Face/throat swelling, I treated with benedryl , lasted from about 8:15 PM to 8:45 PM Vomiting and nausea , I treated with anti-nausea med lasted from 7:15 pm to 9 pm Migraine-like headache , I treated with ibuprofen, started around 9 pm and finally decreased around 4:30 am. I still have a slight headache. Chills - started around 3 pm and lasted until around 6am this morning. Site pain - 10 Am until 3:30 am.

Symptoms: Significant bruising on bilateral legs and Left arm, dark red/purple spots on Left knee present 2 months after receiving vaccine. No physical activity, unexplainable bruising

FEELING NUMBNESS IN THE PALM OF HER RIGHT HAND AND IN RIGHT LEG AND FOOT; DIFFICULT TO MOVE FOR ABOUT 4 DAYS; FELT SEVERE PAIN IN BOTH THE HANDS, LEGS, AND ARMS; ABNORMAL HEART BEAT; HIGH BLOOD PRESSURE; FELT WEAK; SLIGHT HEADACHE; PAIN ON INJECTION SITE; LOSS OF APPETITE; SLIGHT CHILLS; This spontaneous report received from a patient concerned a 26 year old , female. The patient's height, and weight were not reported. The patient's concurrent conditions included nonsmoker, non alcohol use, and blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced loss of appetite, slight chills, weakness, slight headache and pain on injection site. After 2-3 weeks after receiving vaccine, on 01-MAY-2021, the patient experienced sever pain in hands, legs and arms and it was very difficult to move for about 4 days. Patient went to the clinic in May to seek help for her pain and new heart side effects. Patient noticed that her heart was beating abnormally, It would beat hard 10 minutes and then stop. On MAY-2021, Laboratory data included: Scan (NR: not provided) No abnormalities with heart. In clinic they also checked blood pressure and Laboratory data included: Blood pressure (NR: not provided) Abnormally high, Heart rate (NR: not provided) normal, Patient did an Magnetic resonance imaging (MRI) 3 days after the clinic appointment and had No abnormalities, results came normal. On 11-JUL-2021, the patient experienced feeling numbness in the palm of right hand and in right leg and foot and Patient said it's not serious but had been dealing with the symptoms continuously. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficult to move for about 4 days, and loss of appetite, slight chills, weakness, slight headache, and pain on injection site on 11-APR-2021, had not recovered from felt severe pain in both the hands, legs, and arms, abnormal heart beat, and feeling numbness in the palm of right hand and in right leg and foot, and the outcome of high blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210730598-covid-19 vaccine ad26.cov2.s -Abnormal heart beat. 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).

Later in the evening after receiving the vaccine, I experienced a very strong and pounding headache. I took some Ibuprofens and went to sleep around 9pm and the headache was resolved around 11:30pm. However, later during the night the headache came back. Also, my body aches all over and just generally uncomfortable feelings. The injection site felt warm to the touch and sore.

Itching all over the body, random red patches, hives around injection site that are persistent, pain at injection site, consistent nausea over the past 4 days.

Starting at 8 pm on 3/11 I had flu symptoms; fever, aches, headache neck ache. Had fever through night chills and sweats. This morning I noticed around 9 am I started to develop hives on my shoulders/back/neck/face and my ears are red. I took 400 mg Aleve at 1:30 am 3/12, Tylenol 500 mg at 9 am and Benedryl at 11 am all on 3/12. My arms/shoulders/chest/neck feel itchy.

High fever (102), extreme headache, severe body chills, body aches, swollen lymph nodes in neck and groin. Onset at 2:00 pm, kept developing rapidly until I took 800 mg of ibuprofen around 6 pm and symptoms lessened within an hour. Symptoms still present but mild with the pain meds. Injection site pain as well.

flu symptoms. Pt received Covid J&J 1100 10MAR2021. Pt started having HA, fever, chills started midnight. Pt denies coughs, nausea, chest pain, respiratory problems, abd pain. History: pt received J&J COVID-19 vaccine around 10am and woke up around midnight with shakes/chills and mild non-thunderclap frontal headache with mild body ache, here for eval. Had work-out earlier and not sure if body ache is from work-out, per pt. denies any recent illness/injury or symptoms prior to the COVID-19 vaccine this morning. No visual deterioration, sore throat, cough, SOB, vomit/diarrhea, rash, sick contact, recent COVID-19 hotspot visit, co-morbidities, use of any meds, or chance of pregnancy, per pt.

After several hours of injection, started to feel chills and headache during the whole night. Second day had fever 100-102F throughout the day and headache and tiredness. Third day the fever is gone, injection site still experienced mild soreness.

Fever, muscle aches, tender skin, started the night of and passed by the next evening. Nausea lasted about an hour. Facial rash, bumpy and itchy started the 2nd day and is ongoing.

-fatigue, fever, shortness of breath, vomiting, chills, headache Began at 6:00pm (about 9 and a half hours after vaccination, and lasted for about 6-8 hours). -soreness in arm, lump at injection site Continuous (3 days later and still sore).

I noticed a very mild headache and slight coldness within 2 hours of my vaccine. Onset of my severe symptoms began around 10PM on 03/12/2021 with a stabbing headache (Felt like someone took an air pump and kept 'blowing up' my head. My eyes felt achy and heavy and every time I looked in a different direction I would get a zapping/electric feeling throughout my head that would cause my head and neck to spasm (longer duration) or twitch (quick jolt). This also caused dizziness). I got really cold and had intense shivering and shaking. Around midnight, my skin started feeling bruised all over my body (very sensitive to touch, including my bed sheets against my spine felt like rubbing up against a wound). At the same time, my joints (especially my neck, hips, and knees) got hot to the touch and were incredibly painful (induced tears). My muscles developed a deep ache that also caused significant pain. I felt very weak and confused. I didn't take my temperature until the early morning, and it was 102.9 at that time. I alternated taking Tylenol and Ibuprofen throughout the day, but my temperature stayed between 102 and 103.1 for about 24 hours, as did the previously noted symptoms. I noticed a gradual improvement of my symptoms over the next two days. On the evening of 03/14/2021, my headache worsened some, and I had an unexpected episode where I nearly passed out (dropped to the floor but stayed conscious). I also had intermittent foot tingling (very noticeable, not mild) over the course of a few hours. For 3 full days (but by far the most severe within the first 24 hours), I experienced some strange sound processing. Things like the sound of a car driving by or the ceiling fan felt like it echoed throughout my whole body and gave me an uncomfortable shivering feeling. As of today (03/16/2021), I am mostly recovered. I am still experiencing fatigue, a very mild headache, and some mild pain. My nausea has completely resolved, though that was never a chief complaint of mine. I realize that some of my symptoms are to be expected with this vaccine. But especially the level of pain I experienced throughout my entire body was very concerning and not something that I was aware could happen as a result of the vaccine.

Loss of circulation/feeling in vaccinated arm, onset within 40 minutes, lasting two and a half hours. Nausea, onset within one hour, lasting 30 hours. Severe headache, onset within 18 hours, lasting 54 hours. Body aches, onset within three hours, lasting 60 hours. Fever of 99.7F, onset within two hours, lasting 48 hours. Rash on vaccinated arm, lasting 60 hours.

high fever, chills and sweats throughout the night; extreme fatigue and weakness the next day in addition to sore injection site

Approximately 1 to2 hours post 2 hives on top of each foot, treated with benadryl topical. Relief 5 hours post- chills, restlessness, and body aches, treated with Tylenol no improvement, clonazepam taken to help sleep, slept 3 hours. 9 hours post- low grade fever, restless, body aches, treated with Tylenol no improvement. 14 hours post- swelling of both lips and around the mouth, body aches, tried Tylenol again still no improvement. 20 hours post- lip and around the mouth still swollen still body aches low grade fever with PCP approval took benadryl and ibuprofen body aches improved fell asleep 26 hours post- body aches mild, no fever, lips and around mouth decreased a small amount, ibuprofen helped with body aches again. 27 hours 30minutes post- swelling still present took benadryl again and went to bed. Slept through the night. 37 hours post- feeling much better, very small amount of swelling with lips and around mouth, slight injection site soreness

In addition to the effects I submitted earlier this week I have now developed a full body rash. I am covered in a mixture of hives, painful red splotches, and it a mixture of itchy and painful. The rash covers both arms, my stomach and chest, my back, my thighs, my neck, and is spreading rather quickly since I discovered it.

11:00 Feverish, headache 3:30 Headache 4:00 Extreme fatigue, back pain, extreme headache in front of head, chills 4:30 Chills, hard to focus, shoulder pain 5:00 Chills 9:30 Extreme chills, fever, back soreness Symptoms continued to March 11 with extreme headache, fatigue, fever, and chills March 12 symptoms included fatigue, congestion, headache March 13 symptoms mild fatigue and congestion March 14 symptoms included lip swelling around 2:00 as if allergic reaction, used Benadryl and it stopped swelling March 15-16, lip dryness and chapping, lips are numb and skin feeling tight

Headache, muscle pain, pain in the arm of the injection, chills, internal fever, nasal congestion, eyes pain.

person reported itching on her arms. Person moved to observation area and was there at the same time as another person with n/v. Person then progressed to n/v as well. While EMS assessed the other person they also assessed her. She was hypertensive. Benadryl was given. She also reported only 4 hours of sleep and not having anything to eat before getting vaccine.

Patient reports urticaria rash onset 22 hours after vaccine. No angioedema. Experienced fever (Tmax 101.6), bodyaches hours before that improved with tylenol. Did not take benadryl, any other antihistamine, rash persistently itchy 4 days after onset.

4 hours after injection: Nausea, slight fever, fatigue, inflammation in joints, headache, dizziness 24 hours after injection: Hives on skin on arms, legs, and torso 48 hours after injection: Hives remained, larger rash spread 72 hours after injection: Hives and rash had spread on entire torso and up the neck

lt thigh pain. Lt thigh pain x 4 days; became raised and tender yesterday, reports some drainage yesterday, increased pain today Reports fevers at home. 23 yo F w/ no known chronic medical conditions, p/w several days gradually worsening "boil" to L inner thigh. Initially thought it was an ingrown hair, so she pulled the hair out. A boil formed yesterday, which she attempted to "pop." The area drained a little bit of pus at the time, but since then area has grown since. Woke up and the lesion had doubled in size; now raised, red, warm, very tender. Hurts to walk; couldn't even put on her underwear this morning because it hurts so much to touch the area. Denies fevers/chills, n/v/d, lesions/rash elsewhere. No h/o si23 yo F w/ no known chronic medical conditions, p/w several days gradually worsening "boil" to L inner thigh. Initially thought it was an ingrown hair, so she pulled the hair out. A boil formed yesterday, which she attempted to "pop." The area drained a little bit of pus at the time, but since then area has grown since. Woke up and the lesion had doubled in size; now raised, red, warm, very tender. Hurts to walk; couldn't even put on her underwear this morning because it hurts so much to touch the area. Denies fevers/chills, n/v/d, lesions/rash elsewhere. No h/o similar sx.

Lips and tongue tingly/numb. Fever 101.4, body ache, muscle pain, headache, chills, pain at injection site, fatigue.

Pain at injection site immediately, swelling around site, after about an hour, cold chills and a headache, body aches about 2 hours after

About five hours after the vaccine injection, at around 11 PM, I began to feel cold and achy, which soon led to body chills all over. It felt like I could not get warm no matter how many extra blankets I added. This soon led to a fever. I was in an out of sleep for the next few hours and woke up around 2:30 AM. At that point the fever had broken and I was sweating. I still had body aches, which I think was due to my body being tensed up for some many hours, and I had a splitting headache, as well. At around 4:30 AM, I woke up again, with a very sore arm a terrible headache still. I got up and took 400 mg of Ibuprofen and went back to sleep. At 7 AM my alarm went off and all adverse effects seemed to be gone other than a sore arm. The sore arm last for about 6 days.

Two hours after the COVID-19 Jansen shot I started to see a rash of my neck ,chest, back and know going down to my stomach and legs.

Severe body and joint aches, fever, headache, cough, runny nose, injection site swelling and redness, sore arm.

I started having chills, light fever, and muscle discomfort starting about 10 hours following my vaccination. For the next 24 hours after that, I experienced chills, muscle discomfort, and injection site discomfort.

Headache & difficulty moving my eyes without pain (felt like migraine), injection site pain, pain in lower and upper back (very sensitive to touch too), extreme shivers and skin cold and hot to the touch, dizziness Drank water, used a lot of pain medication, heat pad for lower back

Vaccine received by 9am. Start having fever at 4-5pm, 38.3 for 6-8 hours, chills, fatigue, pain at injection site, took 325mg Tylenol once , fever broke. Next day, temp 37.6, took another Tylenol 325 once. Symptoms resolved in the next 24 hours

At about 12:45AM on 4/2/21 I noticed I had a fever, a headache, chills, and injection site pain. My fever broke about 5 hours later and my headache and chills went with it. The injection site pain continues even now on 4/6/21.

Injection technique seemed poor as it was the most painful vaccination I've ever received, and upper arm became tight and achy immediately. Soreness lingered but the sharper pain went away shortly after. About 8-10 hours later I began feeling nauseous and lightheaded. 12 hours after vaccine I had trouble falling asleep, overcome with nausea and chills. This turns into sweating and insomnia the rest of the night. The following day I felt better, but the next night (and following one) I continued feeling a bit sick. Currently (3 days later) my upper arm is still very sore and I have lots of muscle/joint aches throughout my whole body.

15 hours after I was vaccinated I woke up with a severe headache and also felt very hot/feverish. When I got up at 3:30 am to get some water/Advil I also felt light stomach pain and dizziness. It took me about an hour to go back to sleep. Currently the time is 11:00 AM on 07APR2021 and I am experiencing a light headache, but am no longer experiencing dizziness or stomach pain. Arm is still sore from the site of injection.

Increased heart rate, dry throat, anxious, itchy skin. Pt was given 2 tabs Benadryl PO, monitored for an extra 30 minutes and cleared.

I had a high fever - for me a high fever is above 98.4 or 98.6. I was running a fever of 99.1-100.2 for three days. I didn't take anything for awhile for it. Thursday morning, on the first, my arm - at the injection site - was swollen to size of nickel. Over the next few days it grew to a size of a paper dollar bill - red, hot and swollen and very itchy. Saturday - 4/3/2021 - I went to a pharmacy where I get my meds and the pharmacist suggested I take anti-inflammatories and Benadryl. I did put ice pack on before taking those. I do still have a lump on my arm at the injection site - it's probably the size of a quarter now.

RASH ON TORSO; HIVES; A SLIGHT RAISE IN BODY TEMPERATURE; NAUSEA; MILD FEVER; LETHARGY; TIREDNESS; CHILLS; MUSCLE FATIGUE; INFLAMMED JOINTS; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, and other pre-existing medical conditions included the patient ha no known drug allergies. The patient was previously treated with omeprazole for acid reflux. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 20-MAR-2021, the subject experienced muscle fatigue. On 20-MAR-2021, the subject experienced inflamed joints. On 20-MAR-2021, the subject experienced lethargy. On 20-MAR-2021, the subject experienced tiredness. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced a slight raise in body temperature. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced mild fever. On 21-MAR-2021, the subject experienced rash on torso. On 21-MAR-2021, the subject experienced hives. On 22-MAR-2021, Laboratory data included: Body temperature (NR: not provided) a slight raise in temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle fatigue, inflamed joints, and tiredness on MAR-2021, and nausea, and mild fever on 20-MAR-2021, had not recovered from rash on torso, and hives, and the outcome of chills, lethargy and a slight raise in body temperature was not reported. This report was non-serious. Version created to amend previously reported information on 23-Mar-2021. Upon review the following information was amended: Event Lethargy Labeled Muscle fatigue labeled Hives labeled.

Day 1 (4/5/2021): extreme exhaustion and nausea Day 2 (4/6/2021): extreme exhaustion, nausea, fever (101), chills, sweating, whole body and muscle aches, vomiting, disoriented, unbalanced, light headed, head ache Day 3 (4/7/2021): extreme exhaustion, nausea, fever (101), chills, sweating, whole body and muscle aches, vomiting, disoriented, unbalanced, light headed, head ache, vertigo, injection site is a hard, swollen, and red Day 4 (4/8/2021): extreme exhaustion, nausea, vomiting, whole body and muscle aches, disoriented, unbalanced, lightheaded, head ache, vertigo, injection site is a hard, swollen, and red Day 5 (4/9/2021): extreme exhaustion, nausea, whole body and muscle aches, disoriented, unbalanced, lightheaded, head ache, vertigo, injection site is a hard, swollen, and red

Janssen COVID-19 Vaccine EUA little bumps all over her forearm and it spread to her neck and face. doesn't appear to be like a rash and no open sores.

Starting on 4/8/21 around 9:00 PM my body started to feel slightly sore and I had a low grade temperature of 99.6. Throughout the night my body became extremely sensitive and sore especially in my lower back and neck. My temperature also continued to rise to 103.0. Throughout the day of 4/9/21 I was taking Tylenol and ibuprofen on a rotating schedule. My temperature went up and down throughout the day spiking at 105.7 and dropping down to 101.2. Around 10:00 PM it was around 102.9 and my body was becoming even weaker. This morning, now 36 hours after my symptoms started, I can barely lift my arm, my headache has worsened, my total soreness and weakness is no better and my temperature is 102.3. I have also had trouble with staying hydrated because my skin hurts if it is not covered from the air and I get heavy chills, but when I cover up I am profusely sweating constantly. The sweat is so bad, I constantly have to lay on a towel and change my clothes.

Was administered covid vaccine J&J on left arm felt a burning sensation just after it which i knew it normal you just got a vaccine. Walked to the observatory area where we are supposed to wait 15min until you are released to go. Well less than 10 min in the observation area that?s when i started to feel un well my body started sweating excessively and thats when i felt numbness on my right side of my head with a tingling sensation couldn?t hear with my right ear and i freaked out when i started to get blurred vision thats when i knew something was wrong i got up to ask for water once i got up i felt like i was going to faint and felt really dizzy. Once i got to the lady that was there in the observation area she was shocked at how i looked she told me to go sit down and brought me water as she called the ambulance. Once i was sitting down and was brought water i drank like more than half of the water and the numbness was going down from my right side of my head but still had blurred vision and just felt disoriented and not my self. The ambulance took me to the ER once i got there i felt a little better but still disoriented and dizzy. So disoriented that i left the hospital with me actually realizing i had to stay there to get checked because they kept saying i was fine.

Vaccine at 12:50 20 minutes after shot: fuzzy, drugged 35 minutes after: face and neck was red and blotchy and itchy. Tongue was itchy. Pain at injection site Drive home was bad. Slurring my words. Eyes were so heavy, hard to keep open. I felt weight on me. Pressure on my chest, heart was tight. Fatigue. Started hysterically crying. Got home, couldn?t walk normally. Sweating. Chills started at 8 Body aches at 9 Woke up with TERRIBLE body aches at 11:40. Skin was so hot, I was shivering cold. My legs hurt so bad. My knees mostly. My ankles. My inner thigh muscles. My lower back couldn?t handle any pressure. It hurt to lay. My left shoulder blade and upper arm hurt bad. Then my head hurt. My hips couldn?t move. My elbow felt weak and painful, like they would break. 12:40 headache got worse. I was shaking. I was nauseous. Chills were awful. Ears were ringing. No appetite for days. Sore joints, muscle pain and fatigue still 4/13

In the evening while making dinner I noticed mild pain at injection site and began to notice increasing chills, and unusually intense tiredness, which were followed that night by a low grade fever, headache, and nausea which led to vomiting. Was unable to sleep that night and unable to eat most of the following day due to these symptoms, primarily the nausea. Symptoms began to resolve during the later afternoon of April 11th. No medical treatment sought as these were side effects listed on the fact sheet and expected to go away which they did. Still experiencing mild arm pain in injection arm but expecting that to resolve soon on its own.

Rash (resembling a hundred mosquito bites) appearing around elbows and back of the knee, around midriff, and then neck and back. Disappeared when I took Benadryl but came back once it wore off.

cold chills, low back pain, trouble sleeping, injection site pain, migraine, fever starting at 99.8 in pm and 101.7 in the AM.

Janssen COVID-19 Vaccine EUA Fatigue and chills, but no fever. These symptoms started about 6 hours post-vaccine and lastest for about 36 hours on and off. Arm at injection site is still sore to the touch, but manageable. Around 3 PM on Sunday, April 11th a small rash/hives broke out on the inside of my left arm opposite of my elbow. My vaccine was given in the right arm, but the right arm did not have any reaction. This rash lasted for about 12-24 hours and then was gone. It was never itchy.

Fever and chills for 24 hours, hives for about 12 hours, body aches for 8 hours until Tylenol was taken. Fatigue and mental fogginess for 36 hours.

I had sparkles in my vision 5 min. after getting my shot. They went away quickly, so I wasn't concerned. I had a little bit of hotness up my neck and a little itchy, but both also were quick to go away. I went home and went to bed without issue. I woke up at 4am crying and in a lot of pain all over my body. I had a crushing headache, my back, arms and legs ached down to the bone. I had a fever of 100.7, and had to call in sick from work. I took 3 ibuprofen and it didn't help stop the pain or fever. I cried myself back to sleep after wreathing in pain for 3 hours. Woke up again crying again and the pain and fever continued on. I drank 2 beers to see if that would help relax my muscles and back around 3pm and by 4pm I finally felt somewhat better, but still couldn't get up out of bed. I had to call my brother over to help me and considered asking him to take me to the hospital several times because the pain was so intense. The spot where I got my shot wasn't inflamed, or if it was I didn't notice. It did seem a little stiff. I managed to fall back asleep and by the time I woke up again the next day around 5am, I felt completely fine. Fever disappeared and the body pain was gone. It was like nothing had ever happened.

big round swelling and tenderness below where shot was. warm to touch, slightly raised. happened 2 days after vaccine was given.

Pt sts that shortly after her vaccine she became lightheaded and dizzy. She had a similar issue when she gave plasma in the past (she passed out completely). She did not tell staff ahead of time that she passes out with vaccines and was sitting in her chair at the time of administration. Pt sts she immediately got lightheaded and dizzy and she passed out before she even knew what happened. Pt did fall out of her chair and hit her head on the floor. She was responsive within 10 seconds per bystanders and was AOX4. She does have a small amount of swelling to an approximate 1" hematoma to the R side of her head just into her hairline. She was treated and released by EMSA. She refused transport to the hospital. She did have pain at the site of the hematoma. PMS was intact X4 and her neuro function was intact per EMSA during exam. Pt left POV.

3/26-vaccine 3/29- pain, swelling, redness, hot to touch, hard lump at injection site. Was mostly gone by 4/9. As of 4/15 hard lump remains at injection site. 4/6- 12:15pm hives, redness, itching, burning on sides of upper thighs, buttocks, within 2 hours hives spread to backs of arms, all the way down legs. Went to quick care facility at 2:30pm. Waited in waiting room until 3:50pm checked legs with doctor at 4:00pm and little red dots appeared in random clusters down both legs. Doctor assumed folliculitis, prescribed Cephalexin. 5:00pm took 50mg Benadryl while waiting for prescription. Picked up antibiotic around 6:30pm. When I got home around 7:00pm both legs were burning. Discovered huge painful red patches all over both legs. 10:00pm took 50mg Benadryl again. Went to bed 4/7- 9:00am red patches still painful, burning. Took 50mg more Benadryl. Spent most of the day sleeping 4/8- hives gone due to benadryl. Red patches slightly less painful. New red patches/dots appeared on ankles and tops of feet 4/9- red dots spread over tops of feet/toes, new itchy bumps with red dots appeared trailing down the backs of calf area on both legs. 8:30am went back to quick care facility. Saw new doctor who instructed to stop taking antibiotic and switch to cream form of "triamcinolone 0.1%" twice daily. Also referred to dermatology specialist. 3:30pm first application of steroid cream made legs burn and feet/ankles swell. Determined too much was used 4/10-4/13 smaller amount of cream applied twice daily as directed. Burning stopped but feet/ankles still swollen each day 4/13-original large red patches mostly cleared. New red dots on backs of calves and tops of feet still prevalent. 4:00pm saw dermatology specialist who determined red dots were a form of vasculitis. Ordered blood and urine analysis to determine if other organs have been affected. Scheduled appointment with laboratory for 4/17 at 11:00am Other symptoms: dizziness, abdominal pain/pressure, diarrhea at various points throughout the day from 4/9-current

On 03/18/2021 at 03:30AM I had a lot of arm pain from my shoulder to my elbow in my left arm. This lasted until 03/31/2021. On 03/18/2021 I woke up with a headache that would not go away. Next, at about 03:15PM I was not able to walk for about 10 minutes. Then, at about 05:00PM I started menstruating. At 07:00PM I had severe pain in my pelvic area for an hour and a half. At approximately 08:30PM I passed a softball sized blood clot vaginally. I bled heavily through the night. On 03/19/2021 I still had a headache and no energy at all. I continued to bleed heavily all day as well. 03/20/2021 was the exact same as the days prior. 03/21/2021 I was still bleeding heavily throughout the day with no energy. I still had the headache as well. I started feeling dizzy while walking on this day. 03/22/2021 I went to work like normal. I was cold all day. I was still bleeding, headache and dizziness. It was hard to stand for 30 minutes. While climbing the stairs I got very light headed and dizzy. I could not go up the stairs at a normal pace. 03/23/2021 I had the same symptoms all day but I was getting short of breath walking short distances. I still had very little energy and a headache. I also lost all color in my face and hands. I was still cold all day. I noticed some slight swelling in my ankles. 03/24/2021 The symptoms were getting more intense. I was still cold. I finally took some aspirin for the headache because it was very severe. The medication didn't help with it. This routine went on for the next week and the symptoms intensified with each day. Throughout this time I was still passing clots that ranged in size from golf/ping pong ball to baseballs. They were very painful when they passed. The days from 03/25/2021 to 04/01/2021 were all the same as far as how I felt. On 04/02/2021 I woke up with the same symptoms but now I could not stay awake for anything. I slept on and off all day. I only ate one meal a day because I was so tired and I had no appetite. The headache was getting worse as the days went on. The bleeding was still happening. It was not as heavy as the weeks before, but enough to be painful still. I also started having abdominal pain. On 04/03/2021 I was seeing stars when I moved too quickly. My heart rate was elevated with shortness of breath along with the rest of the previous symptoms. My headache however was very intense. 04/04/2021 I still couldn't stay awake on top of all the other symptoms. The dizziness and stars were more frequent. I couldn't move my head without seeing stars. 04/05/2021 I couldn't get warm and I still felt the same way. I called and made a doctor?s appointment for Wednesday the 7th. I had all the same symptoms still and they were getting worse. I had to move in slow motion so I could try to function. 04/06/2021 I woke up drained of all my energy and color. I couldn't shower because of the pain in my body. I couldn't stand because I felt like I was going to fall down. I could barely stand up straight let alone walk very far. I was shaking from being so cold. I had all the same symptoms from the days prior. I was in severe pain. I couldn't sit because of the pain in my abdomen I couldn't stand because of the weakness in my legs. I could barely see anything because of the stars I was seeing. At this point I had no color and I was barely conscious. That is when my family took me to the emergency room.

BACK PAIN; PAIN IN BILATERAL ARM; PAIN AT RIGHT KNEE; CHILLS; HEADACHE; PAIN AT INJECTION SITE; FEVERISH FEELING; FATIGUE; This spontaneous report received from a parent concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included premature at birth, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced back pain. On 09-APR-2021, the subject experienced pain in bilateral arm. On 09-APR-2021, the subject experienced pain at right knee. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced pain at injection site. On 09-APR-2021, the subject experienced feverish feeling. On 09-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at right knee, chills, and feverish feeling on 10-APR-2021, was recovering from pain in bilateral arm, back pain, and fatigue, and had not recovered from headache, and pain at injection site. This report was non-serious.

RED FLAT LINE ON LEFT SIDE; ACHY; This spontaneous report received from a parent concerned a 27 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 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced red flat line on left side. On 10-APR-2021, the subject experienced achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red flat line on left side, and achy. This report was non-serious.

Rash on neck, chest, under breast, abdomen, groin - treated with hydrocortisone 1% - not yet resolved

Red & swollen arm, fever, chills, headache, body tremors, weak, muscle fatigue; started 5 hours after shot, got worse over night, was very painful in the morning to the point of sobbing and having to call into work sick, ended within 30 hours of getting vaccine; arm still a little soar 1 week after shot (felt like a bruise)

4/13- itching began in perineal area. 4/14- blisters appeared. Burning and itching. 4/15- more blisters, more burning and itching. 4/16- ER trip. Tested for herpes and other STIs. Given Valtrex and Lidocaine. - set f/up appointment with OB/GYN ()on Wed 4/21/21 4/17- area slightly improved. 4/18- Negative results on tests. Area slightly improved.

6-48h: joint pain, fever, chills, headache, nausea, sore arm and pain around injection site, extreme pain below knees 48h+: original symptoms subsided but developed numbness and weakness left leg and left arm 56 hours: left face partially paralyzed and/or swollen to the point where couldn?t move week. Prickly feeling left skull. Weakness and numbness in leg and arm persisting (decreased feeling on skin on left side of the body) 1 week: saw GP, neurologist, and sought emergent care at hospital for symptoms as doctors feared potential small stroke. MRI, chest X-ray, and blood works all clear. Discharged same day. 1 week+: partial facial paralysis gone, numbness and weakness in left side located to below the knee, but not present in both legs. Pain and uncomfortable feeling in both calves when lying down .

nausea, back pain possible uti foul odor, blood in urine ongoing for 2 weeks, urine urgency, abdominal pain unsure if related to period (Period doesn't typically last two weeks), chills, janssen vaccine small bump on arm where vaccine is, arm is warm to touch with redness around the area, headache comes ago did not have a h/a last week, chest pain

INCREASING CHILLS; MILD PAIN AT INJECTION SITE; UNUSUALLY INTENSE TIREDNESS; LOW GRADE FEVER; HEADACHE; NAUSEA; UNABLE TO SLEEP; UNABLE TO EAT; VOMITING; This spontaneous report received from a patient concerned a 27 year old. 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: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unable to sleep. On APR-2021, the subject experienced unable to eat. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced low grade fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced increasing chills. On 10-APR-2021, the subject experienced mild pain at injection site. On 10-APR-2021, the subject experienced unusually intense tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increasing chills, unusually intense tiredness, low grade fever, headache, nausea, vomiting, unable to sleep, and unable to eat, and had not recovered from mild pain at injection site. This report was non-serious.

Itching at injection site, pain at injection site, hard lump about the size of a quarter at injection almost 2 weeks after injection, slight discoloration like a bruise

On the 13th, I had a low grade fever and it never actually broke past 100. I spent most of the day in bed. Fatigued - and general was exhausted and tired .After that day, everything was pretty good. I had minor discomfort in my arm (that first day.) On the Friday, the 16th- my left arm - a third of my upper arm was bright red, swollen and hot to the touch and it was very painful. I reached out to a doctor for a chat with a doctor. The dr had me take 600 mg of Motrin and a Claritin and I took those based on the dosages allowed on the box, consistently for about 24 hours and after that it started getting a lot better. I'd say by Sunday the 18th, I was pretty much back to normal and everything resolved. Doctor chat but not a regular doctor visit.

Patient presented on 4/17 to urgent care afer significant vaginal bleeding (soaking through a pad every 1 hour to 1.5 hours) and petechia on multiple extremeties. She also had a nose bleed and bleeding in mouth earlier in the day that resolved spontaneously. After obtaining CBC, platelets were <1000. She was on oral contraceptives. She is a non smoker. She received work up for thrombosis, not indication of thrombosis. She did have some muscle aches and fever and fatigue the day after vaccine. Histroy notable for mild diffuse petechiae on all 4 extremeties. As inpatient received solumedrol 125 mg (then switched to prednisone 80 mg daily), IVIG 1 g/kg x 2 doses. she was discharged on 4/19 d/t rising platelets, Vaginal bleeding slowing and Petechia much fainter.

SKIN SENSITIVITY; LIGHT SENSITIVE; BODY ACHE; CHILLS; NAUSEA; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 27 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 24-MAR-2021 09:30 at left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced skin sensitivity. On MAR-2021, the subject experienced light sensitive. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the skin sensitivity, nausea, chills, headache, light sensitive and tiredness was not reported. This report was non-serious.

Fatigue almost immediately, lasting 36 hours Intermittent headaches, treated with ibuprofen lasting 36 hours Whole body aches starting 12 hours after injection, lasting 24 hours Injection site bruising and soreness

Broke out in hives once a week since 04/09/21 that varies: around my stomach, on both sides of my torso from armpit to waist, inner thighs, around the clavicles, and/or below my knees. Worsens at night. Since 04/23/21, it happened almost everyday and it comes and goes. As of now, on 04/30/21, it hasn't appeared. I take generic Benadryl around the evening time, but it doesn't really help.

Patient experienced hives/rash within first half-hour of receiving the vaccine. She took Benadryl and rash subsided. Pt woke up the next day (4/4/21) feeling ill with heart racing, hypertension, and headache. She was scheduled to have an infusion appointment 4/5/21, which was canceled when she was found to have elevated liver enzymes and very high blood pressure. Patient went to ED on 4/6/21 for high blood pressure, lightheadedness, and headache.

APPENDICITIS; CHEST PAIN; WEAKNESS; BODY ACHES; SKIN BLOTCHES; BRUISES; HEADACHE; This spontaneous report received from a consumer concerned a 27 year old white, hispanic or latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to aspirin (unknown reaction), no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no relevant medical history. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. It was reported that, the patient experienced side effects that developed after receiving covid-19 vaccine ad26.cov2.s. On 03-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced skin blotches and bruises. On 07-APR-2021, the patient experienced body aches. On 14-APR-2021, the patient experienced weakness. On 19-APR-2021, the patient experienced chest pain. On 27-APR-2021, the patient experienced appendicitis and had a hospitalization that resulted in surgery for appendectomy. The patient had visited emergency room/department or urgent care and doctor/healthcare professional office. The patient was hospitalized for 1 day and was discharged on 28-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin blotches, bruises, and appendicitis, and had not recovered from headache, chest pain, body aches, and weakness. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210456304- COVID-19 VACCINE AD26.COV2.S-Appendicitis. 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).

Within 15 mins of receiving vaccine client informed EMTs she was feeling itchiness around face. First vitals at 1630: blood pressure 138/89, pulse 129, oxygen 98%. PHN joined shortly after. Per client had anaphalaxis reaction to 1st dose Pfizer vaccine and was recommended to receive Janssen. Client with flushed face, rash on chest, neck and left arm. Client denied shortness of breath, chest pain, or trouble swallowing. PHN offered client Benadryl. Per client had pre-medicated with Benadryl 1.5hrs ago. Client informed she would we kept an additional 30 mins in observation. 1635 vitals: blood pressure 134/81, pulse 118, oxygen 98%. Client stated symptoms same, denied shortness of breath. Rash on chest, neck and left arm same, not spreading. PHN asked client if she had followed up with provider after first reaction. Per client did speak with provider and was given steroids afterwards. Medical history: Ehlers-Danlos Syndrome and mass cell activation. Current medications: Cromolyn Sodium, Clonidine, Corlanor, Klonopin, Hydrocodone, Flexeril, Metropolol, Microgestin, Singulair, Vitamin B, Vitamin B12, Claritin, Iron, Magnesium, Famotidone, Zyrtec, and Probiotic. Per client no past history of allergies to vaccines. 1640 vitals: blood pressure 123/93, pulse 108, oxygen 97%. Per client itchiness resolved, rash to chest, neck improving. Vitals at 1650: blood pressure 121/79, pulse 100, oxygen 98%. Per client throat felt "weird", denied shortness of breath, closing of throat, no swelling of tongue. Client able to answer all questions and breathing normal. Per client itchiness was resolved. Rash to chest and neck resolved, left arm with improved rash. 1655 vitals: blood pressure 110/80, pulse 95, oxygen 98%. Per client feeling much better. Denied shortness of breath, no itchiness, rash resolved. Client given ER precautions. Per client not driving, was getting picked up. Client left facility with steady gait at 1705.

So the first night, I had a fever, achy, near the injection site was warm and it hurt; stiffness there at the site and headache- a lot of flu-like symptoms - it was about 36 hours that they lasted. Thursday evening, 8th, I got hives - all over my body and that started on my left arm and then it didn't go in my mouth but otherwise all over. I went to my doctor - the ER at my doctor's site - on Saturday, 10th. He prescribed me some medicine - don't remember what plus I took Benadryl . I had to take a week and a half off of work because the medication was so strong. My hives lasted another week. It stopped growing after that week and then it started healing.

Patient is a 27 year old female who presents to ED with left arm redness and swelling at the injection site of her J&J COVAX from last Tuesday. No fever, no chills, no other symptoms.

Headache, fever, tooth pain, restlessness, chills, nausea, joint pain, sore/heavy feeling arm, swelling at the injection site, loss of appetite, reoccurring dreams

Patient felt lightheaded immediately after vaccine. Patient bleed a lot straight away. Patient was feeling nervous before vaccine. I have elevated patients legs and instructed her to stay for 30 minutes to ensure systems don't get worse. Patient is fine and coherent and able to talk. Patient was able to walk and had no dizziness no sweating or feeling hot. Patient was getting picked up by partner

4/3/21 - Noticed Skin eruptions on arms and legs 4/11/21 Skin eruptions were getting worse 4/19/21 - began heavy vaginal bleeding 4/20/21 - began feeling dizzy, light headed, hard to breath 4/22/21 - admitted into hospital with Cellulitis, Sepsis, Sever Anemia - discharged 8 days later Red blood count was 5

I started to feel a little intoxicated 20 minutes after the vaccine. After about 30 minutes I had rashes on my face. I was unable to walk in a straight line. I was also very emotional. I took a nap and woke up with a headache, chills and sweating, I had body aches and pain in my back. My skin was hot to the touch. I was nauseous and weak with no fever. The next day I was having shortness of breath and I thought I had blood clots.

Immediately after receiving the vaccine, my left arm and left side of my neck and back became very sore and I felt very light headed and dizzy. 7 hours later, the back pain worsened and I started sweating a lot. Soon after my skin all over my body began to tingle as if I had bugs crawling all over my body and it was very uncomfortable. During the night I couldn't sleep because I was sweating so much, the back pain was getting worse and worse, and the tingly skin feeling turned into very intense skin sensitivity and hurt any time my body touched something or rubbed against my clothing. At some points I would be extremely hot and sweating a lot and then some points I was freezing cold and shaking uncontrollably. These signs all lasted 24 hours and slowly started going away after 48 hours. After 48 hours, I felt much better and back to "normal" but couldn't help but notice some strange reactions that I still have today, 3 weeks later... I have had acne which is uncommon for me. I have had period cramps and mood swings but am not on my period. I also have had crazy bloating in my stomach and all over my body... swollen legs, feet, hands, etc. I also have been experiencing brain fog where I loose my train of thought in conversation, I can't remember where I put things, I can't remember if I took my eye contacts out or not, or fed the dog... very strange and uncharacteristic of me to be so aloof and forgetful but to the point where I have zero recollection of doing such activities.

Immediate sharp pain at the vaccine site radiating to the forearm and hand associated with tingling dysesthesias into the forearm. Pain and tingling lasted three days then lessened with rest and ibuprofen only to recur at 7-10 days with increasing pain with arm movement and then at two weeks after injection to near constant throbbing pain in the shoulder, sharp deltoid region pain with abuduction and elevation . Pain wakes her from sleep at hight.

Client called the Health Department as directed by provider. Client reports she received J&J COVID-19 vaccination on 04/05/2021 and then 2 days later developed hives on 70% of her body. Hives have continued for 6-7 weeks, was prescribed steriods for 10 days which resolved hives, but hives then returned after steriods completed and are currently present on 15% of client's body. Advised client to continue to follow-up with provider regarding this and report would be submitted by this RN. Also advised client to call administering facility to inform of her reaction. Of Note, state immunization database shows vaccination given on 04/07/2021, unable to reach client by phone to verify.

BRUISE ON TOP OF RT KNEE; TINGLING ON HAND AND LEGS; FEELS LIKE LEGS ARE SWELLING; ARM FROM INJECTION SITE FEELS LIKE A HEAVINESS AND PAIN; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808986, and batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced bruise on top of rt knee. On 17-JUN-2021, the subject experienced tingling on hand and legs. On 17-JUN-2021, the subject experienced feels like legs are swelling. On 17-JUN-2021, the subject experienced arm from injection site feels like a heaviness and pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise on top of rt knee, tingling on hand and legs, feels like legs are swelling, and arm from injection site feels like a heaviness and pain. This report was non-serious.

Patient experienced formation of grape-sized subcutaneous nodule in location of vaccine receipt soon after vaccine receipt. Clinically consistent with a post-injection Granuloma.

The initial reaction started as an injection site reaction about three weeks post-vaccine. It was painful and itchy. About two months after , on or around May 13, the initial injection, the rash from the arm spread to my chest, which then spread to my stomach. Near the end of June the rash from my stomach and chest spread to my back. At the beginning of July, it spread to my left arm. As of July 15, it spread to my nose and up my neck.

TWO LITTLE BLISTERS ON LOWER LIP; TINGLING SENSATION ON LOWER LIP; MILD DIARRHEA; PAIN ON THE INJECTION SITE LEFT ARM; TIREDNESS; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight was 190 pounds, and height was 195.58 centimeters. The patient's pre-existing medical conditions included the patient at the time of reporting was not pregnant .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced pain on the injection site left arm. On 26-JUN-2021, the subject experienced tiredness. On 27-JUN-2021, the subject experienced mild diarrhea. On 10-JUL-2021, the subject experienced tingling sensation on lower lip. On 13-JUL-2021, the subject experienced two little blisters on lower lip. The patient visited to the Doctor/healthcare professional office for the blisters in lower lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild diarrhea on 27-JUN-2021, tingling sensation on lower lip on 11-JUL-2021, pain on the injection site left arm on 29-JUN-2021, and tiredness on 26-JUN-2021, and had not recovered from two little blisters on lower lip. This report was non-serious.

Patient reported mild swelling and itchiness in his hands and feet starting approximately two days after vaccination. He was advised to take diphenhydramine as directed per over-the-counter packaging. He was instructed to contact his primary care physician/urgent care if the condition were to worsen or if he were to have any difficulty breathing.

At 1035 patient complained of feeling light headed and weak immediately following the injection of the vaccine. Lead RN and EMTs made contact with client who stated she felt very weak, dizzy and light headed. Client began to slide out of her chair while fully conscious. EMTs helped client sit up in chair and a first set of vitals were taken while seated at 1035: BP 110/58, HR: 66, RR: 12 skins cool, dry and pale for ethnicity. Client was A&Ox4. Client stated she had the same feeling when having blood drawn. Client was assisted to a wheelchair and to the zero gravity chair without incidence. Client stated she was feeling "incredibly nervous" about getting the shot and explained she was scared to get "myocarditis". Lead RN provided education on the different vaccines and potential side effects and client stated that made her feel better. Client denied any pertinent medical history, denied allergies to any medications/foods/environment. Client stated she had depression and she takes a weekly anti-depressant which she couldn't remember the name of, last dose was Saturday August 17th. Client denied any other medication use. Client stated last oral intake was a pastry just before arrival to the vaccination site. Client was given a bottle of water which she sipped and a granola bar which she ate slowly. At 1040 a second set of vitals taken while seated: BP 100/56, HR: 58, RR 12, skins warm, dry and normal for ethnicity. . Client instructed to rest and relax in the chair for an additional 30 minutes for monitoring. Client stated symptoms of dizziness, weakness and lightheadedness resolved. At 1055 RN took another BP reading: BP 98/60. At 1110 client stood up and walked around the observation area stating she felt much better. At 1125 a third set of vitals taken while seated: BP 98/60, HR: 66, RR 12. At 1128 EMT took another BP reading with the automatic BP reader while client was seated: BP 96/61, HR: 68. Client stated dizziness, weakness and lightheaded feeling had resolved. At 1145 a final set of vitals taken while seated with automatic cuff: BP 101/67, HR: 68 RR 12. Lead RN educated client on ER precautions. Client stated she felt much better and left the observation site on her own accord with a normal gait.

Extreme muscle aches and joint pain to the point of barely being able to move Chills Sweats Burning/Irritated Skin Nausea Thirst

Sore at injection site. 5 hours after injection, i had an Increased heart rate, 101 fever, convulsing from the chills, body aches, poor sleep. splitting headache, fatigue, and fever continued to next day. Most symptoms were gone by 48 hours after injection, except soreness around arm. Took ibuprofen to help with symptoms.

Janssen COVID-19 Vaccine EUA. Injection site on arm hurt immediately after injection and upper arm is still sore today (3 days later). Approx 7 hours after receiving vaccine I experienced a sudden onset of overall body aches and joint pain specifically in my knees. It was kind of severe- even my skin was hurting when I got goosebumps. A fever came on after that and I was shivering, cold, sweaty. Approx 11 hours after injection I began to experience a severe headache and sleepiness. Symptoms continued overnight and disturbed my sleep, but were relieved somewhat by taking ibuprofen. By the next morning (after sleeping 14 hours) I was only feeling tired, arm soreness, and headache (no more fever, chills, body aches). All symptoms except arm soreness cleared up rather suddenly, approx 24 hours after they came on (which was approx 31 hours after injection).

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient was extremely anxious when she came in for vaccine informing vaccinator that this was her second appointment because she had cancelled the first appointment due to anxiety of side effects (was worried she \"was going to die\"). She stated that her mouth was slightly numb/itchy and that for a moment it was her whole body. Then stated that her mouth had become dry from being anxious about the vaccine. After giving a dose of diphenhydramine & getting the patient to calm down the rxn subsided

Pain at injection site, headache, fever, fatigue, extreme pain all over body , skin is painful to the touch, nauseous, dizzy and difficulty walking, extreme perspiration while sleeping

Janssen COVID-19 Vaccine EUA - had numbness and tingling in pinky and ring finger on left hand. Woke up at 1:40AM with skin hurting, fever was 100.9. Really bad headache, lightheaded

By 930 that evening, i was experiencing arm pain at injection site and nausea then went to sleep. i woke up at 830 the following day 3/14, with the same symptoms as the day prior along with a migraine, light sensitivity, a fever of 100.6. i took 1000mg of tylenol and went back to sleep until 1pm. i awoke with a migraine and nausea still but fever had subsided to 99. went to sleep at 10:30, awoke today, 3/15 with headache, nausea but temperature at 98 flat. arm pain has persisted entire time and still continues.

Fever and chills occurred 9 hours after injection and lasted for 4 hours. Mild fever the next morning with body aches and fatigue and moderate pain at injection site. Following day slight headache and remaining pain at injection site. Today very mild pain at injection site (3 days later)

I had some slight arm pain the day of the shot, but the morning after my arm that received the injection was in so much pain that I could barely even move it. Very little mobility, slight bruising and a red circle around the injection site about 1.5 inches. However, I felt fine most of the entire day besides that. Around hour 28 of getting vaccinated I started to get very bad chills that lasted for about 3 hours. Took my temperature, which stayed around 100 degrees the entire night, 100.5 at its highest point that I checked. The next day it was standing in around 99.9. Felt slight muscle soreness the last couple days, but no fever since then. My arm gained a little mobility on Sunday, 2 days since vaccination so I thought it was getting better. but Monday and today (Tuesday) my knot/lump in my arm at the vaccination site is back to hurting extremely bad and the swelling and size of the lump and red circle is actually growing and pain is starting to increase again. The red circle is around 4.5 inches now and the pain is sharper where the injection happened. I am starting to get worried something is wrong, but will give it another day or so before checking in with a doctor.

Around 12:00 a.m. on Monday, March 15, 2021 (which was 12 hours after receiving the vaccination) I started to experience cold chills so severe I thought I was having a seizure. My husband stacked 10+ blankets on top of me trying to get me to warm up. I was running a fever of 103, and my heart rate was at 104 all night long. My fever didn't break until shortly before 8:00 a.m. on Monday, March 15, 2021 but my heart rate stayed between 95 - 102 most of the day. The body aches weren't too terrible, but I did have those. I have bruising, puffiness, and swelling at the injection site.

Immediately after vaccination, pt was sitting in chair in clinic lobby, she states she felt like she was having a panic attack and that is the last thing she remembers. She fell out of chair and hit her head on the clinic floor. Staff responded to pt lying in the lobby floor with a quarter sized red knot on left side of forehead. Pt complained of a headache, was found to be diaphoretic and had nausea and small amount of emesis but had moderate nausea for 30 minutes after event. Vitals were obtained and WNL. EMS was called and pt agreed to be transported to ER for evaluation.

Approximately 48 hours after receiving the vaccine, i developed what may be described as "Covid Arm": A warm, red large circle surrounding the injection site that was tender to the touch and itchy at times. Additionally, I developed a hard mass under the skin at the injection site. The redness and itchiness lasted about a week. The redness increased with touch and after showers. The itchiness slighlt subsided with topical cortisone. The pain/tenderness surrounding the hard mass lasted about 12 days. I'm currently 13 days out from receipt of vaccination and continue to have the hard mass under the injection site.

I had immediate soreness at the injection site. Later that evening around 9:30 I felt very weak and shakey. I had a bad headache, fever, chills, muscle aches, and nausea. I couldn't hold down water of food. At 10am the following day (3/21) I was able to take aTylenol and the fever came down. So far, I have taken Tylenol throughout the day and kept the fever down, however I still get bad night sweats and muscle aches. Today (3/23) I feel a little off, but much better.

Around 6 pm after receiving the vaccine, I had a massive headache (felt like my head was being compressed severely), chills and body aches all over, pain and swelling at the injection site, nausea, a fever of 100 F, and my bones feeling brittle/weak. I had blankets piled on me, an ice pack on my head, and two ibuprofen. The fever broke over night and the headache reduced over night as well. The oter symptoms became less severe over the course of the 28th and are only remnant on the 29th. The arm pain and swelling are still present and I have muscle tension and pain pulsing up the left upper back/ neck area.

Pain immediately at injection site. Tiredness, chills to the point I was shaking, using hand warmers and comforters with heat turned way up, pain in my arm that goes to my fingers and into my neck, head pain, then getting so hot I felt like I was burning, then freezing again, nausea and multiple trips to the bathroom.

Low grade fever for 24hrs? still active: Full body muscle aches(primarily lower back, neck, and shoulders), pain at injection site, fatigue...

Yesterday (3/31/21) after the shot (4:00pm) my arm at the injection site was sore. This has continued into today. No swelling or redness but my arm hurts to touch or move. Beginning this morning (4/1/21) around 7:30 am I started having a headache. I took an ibuprofen which slightly lessened the pain but it has not gone away all day. It worsens with activity. Starting around 8:30-9:00 am I started to feel nauseous and lightheaded. I didn't take any medication for these symptoms. They've stuck with me all day. Starting around 11:30am I started to feel cold chills and body/muscle aches. This has continued throughout the day. Starting around 2:45 pm I've felt feverish, with severe cold chills.

Currently pregnant and due June 19, 2021. Experiencing: pain at injection site, body aches, lethargy, low-grade fever

About an hour after injection (~9:15am), I felt mild fatigue and a very mild headache. The fatigue progressed throughout the day and made me very exhausted. About 8 hours after the injection, I had chills, still fatigued, mild headache, and about an hour later I ran a low grade fever (about 99*). Took Tylenol to keep my fever down. Temp shot back up to 101* a few hours later (still having body aches, fatigue and chills, and some mild nausea at this point.) My fever broke about 19 hours after the injection. 24 hours after the injection, the injection site was sore and I had a moderate headache with mild nausea. This continued throughout the day so I rested. 48 hours after the injection, still soreness in my upper left arm from the injection with mild headache, mild nausea and small lack of appetite. 72 hours after injection, completely back to normal with some soreness in my upper left arm at injection site.

Fever, fatigue, headache, body aches, weakness the day after injection. Fever lasted for two days. Arm soreness and fatigue was present for three days following injection.

pt states that her arm was very sore after getting the vax. Her arm is still sore today but was severely sore for a week and half. She gets a chronic migraine every day since taking this vax. She says the headache comes on about 10 AM everyday and it may last about 30 minutes or it may last a couple of hours. She has bouts of vomiting that comes and goes. she says the vomit contains blood. When she vomits her face breaks out into a rash. Pt says she is not feeling well, has chills and very fatigued. These symptoms have been going on for almost 2 weeks. Pt will see her PCP next week for symptoms on 4/14 @ 10AM.

Patient felt dizzy right after vaccine administration and fainted and collapsed into vaccinating pharmacists arms. Patient immediately regained consciousness but still hot, dizzy, sweaty. 911 called immediately and paramedics arrived to assess vitals in the ambulance, patient walked out of the store to the ambulance with assistance.

4/5 8:30am -Pain at injection site immediately, sore left arm 1pm -Fatigure 2pm -Body aches and chills 6pm -100.4 degree fever (lasted 4 hours) 4/6 Sore left arm, fatigue, nausea, right armpit swollen lymph node 4/7 nausea and fatigue 4/8 nausea and fatigue

Beginning on 04/06/21 I had pain at injection site, joint, and muscle pain, aches all over my body, chills, mild fever, and headache. Beginning on 04/07/21 I began having severe shoulder, and neck pain, unable to turn my head to the left (side of injection) and unable to lift my head upwards, pain at base of my head, mild fever, body aches, joint, and muscle pain, headache, pain at injection site. 04/08/21 fever has subsided, headache, pain at the base of the head, still experiencing pain in my shoulder and neck on the left side, and mobility is still limited. Still feeling achey, and sluggish.

After receiving the shot, I was required to sit down for 15 minutes. About 5 minutes in, I started to become dizzy, my vision started blacking out, my hearing was muffled, I became clammy, sweaty, and experienced mental disorientation. It became harder for me to breathe, but I never struggled to take a breath. I drank some water and waited for the symptoms to subside. I remained seated and these symptoms went away within 5 minutes. After feeling better for about 5 minutes, I felt cold and was shivering. The woman sitting next to me was completely fine after her shot. I've since felt a slight burning sensation on my skin in areas that I have scratched lightly. I'm also experiencing strange feelings throughout my body- specifically my head, leg, and hand. It feels like I can feel something in each area for a bit and then it subsides after several minutes.

I had the Janssen covid shot yesterday. The shot stung a little and made my arm sore. Later on in the evening I became tired (so far nothing I didn't assume would happen) so I took a nap. When I woke up, my arm stung worse than when I had the shot and the pain kept shooting up my shoulder into my neck. I went back to sleep, thinking it was just normal vaccine stuff. When I woke up this morning, I had chills, a fever of 101.7, and muscle aches. My body feels like I have a sunburn all over it. My right arm feels like it was stung by a scorpion. I feel dizzy and nauseous, and I have head fog. I feel the exact same way I did when I had COVID19, but with my arm hurting so bad, anything that barely touches it (such as clothes) shoots a stinging pain up my neck

Day of Vaccine: Slightly blurry distance vision, mild fever, chills, mild headache, injection site pain/soreness, One day after Vaccine: Mild fever, chills, injection site pain/soreness, red/raw tongue. Two days after Vaccine: Mild injection site soreness, red/raw tongue.

I received the vaccine on 4/8/2021 around 8:35am. I felt fine all day, only soreness at injection site. Later that day (around 6:00pm) I started feeling lightheaded, chills and a headache. My hands, feet, nose and hands were freezing but other areas of my body were warm. I also felt body aches- my lower back started with the aches and it spread up to my upper neck. Around 9:00pm I started feeling very hot and this hot/cold changes continued throughout the night. This morning of 4/9/2021 I have less of a headache however, my body is still very sore and I continue to experience the hot/cold changes.

Immediate arm pain at injection site and overall arm heaviness. Aches throughout body and exhaustion about 2 hours after. Headache and nausea about four hours after shot. Fever of 102.6 about 7 hours after shot accompanied by chills/shaking worse than any fever I?ve had. Tylenol was taken around time of headache which may have delayed the fever and chills. Tylenol and ibuprofen were taken simultaneously every 5 hours starting that evening and throughout the night and all the next day. Food consumption was minimal due to nausea but hydration was maintained.

Typical side effects of fever, chills, injection site pain began 12 hours after the shot. 24 hours after the shot, my breathing got gradually worse. It was like an asthma attack, but normally my asthma attacks are caused by a sinus infection. This was just shortness of breath and gasping for air. I used my rescue inhaler with increasing frequency over the course of the following week. By March 12, I had to use my nebulizer. I used the nebulizer once on March 12, twice on March 13, twice on March 14, and I finally went to urgent care on March 15 when the nebulizer stopped helping. Urgent care was unable to help due to covid protocols, so they put me on oxygen for 5 minutes and transferred me to the ER. At the ER, by the time I got to the ER, my breathing had normalized. I was given prednisone on site, as well as a prescription for 5 days. I had a chest xray done that returned completely normal.

Racing heart, mild fever, body aches - 12-24 hours after shot Nausea - 12-36 hours after shot Hives outbreak - 36 hours after shot

Left arm injection. Read and white (left arm) Sore (left arm) Bruised injection site Diarrhea Fatigue

About 14 hrs after injection, I got really bad chills for a couple of hours, then got very hot and had a 3 timepoints of chest pains (I assume I had a fever at this time but didn?t verify). By 7am when I got out of bed, it felt like a truck hit me. I had a major headache, very fatigue, fever (checked at this point and it was 101), nausea, hotness/chills. By 12pm, I had an 100 degree fever, chills/hotness, and headache. By 6pm, I was only tired. Next day, I was back to normal with a little soreness in my injection arm.

vaccine taken on right arm on Wednesday 4/7/21 at 12:30 pm -symptoms began at 3am in the morning with a swelling 5cm by 3.5 cm at the site that was painful firm and hot to the touch, I was also febrile (temp not taken) with chills, sweating and body aches. The swelling has persisted until Sunday 4/11/21 and I went to urgent care and was prescribed cephalexin. The fever lasted until the Saturday morning and was self treated with over the counter Tylenol.

I experienced a low-grade fever (100), muscle and joint pain, pain at the injection site, and fatigue during the first 24 hours after receiving the vaccine. A little less than 24 hours after the vaccine, my fever broke, and I began to develop a rash on my legs, which consisted of small, itchy, bug-bite like red bumps. I consulted my primary care physician, who recommended I take Benadryl. The rash worsened and spread to my torso - stomach, chest, underarms, and forearms - but was never present at the injection site. The rash on my chest was significantly different than the rest of my body, and when I saw an urgent care provider (5 days after being vaccinated), she diagnosed the chest rash as a separate issue (Folliculitis) and prescribed oral antibiotics. I saw no improvement in any symptoms. A week after being vaccinated and symptoms not improving, I saw my Allergist, who prescribed a 10-day course of oral steroids (Prednisone). My symptoms gradually improved, but the rash did not fully disappear for approximately 3 weeks after the first symptoms appeared.

VOMITING; FEVER; ARM SORENESS AT INJECTION SITE; FAST HEART BEAT; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included patient had series of rabies vaccines last year., and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:00 in left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced fast heart beat. On 05-APR-2021, the subject experienced arm soreness at injection site. On 05-APR-2021 21:00, the subject experienced fever. On 06-APR-2021 02:00, the subject experienced vomiting. On 06-APR-2021 03:10, Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, vomiting, arm soreness at injection site, and fast heart beat. This report was non-serious.

About 12 hrs later, strong headache, chills, sweating, vomiting, body ache. Next day mild headache and tiredness. Sore arm around injection site

Severe body aches and pain, chills, headache, 102 degree fever, fatigue. Severe symptoms lasted about 16 hours, mild symptoms after 24 hours. Feeling almost back to normal after 48 hours except for a maintained arm soreness where injection was taken.

Dose at 1:32 pm, low fever 99.5 at 8 pm high fever 102 at 9 pm. Dizziness, confusion, numbness, muscle aches, entire body skin pain, lower back pain, neck stiffness.

Fever, throat closing, red hives all over body, swollen eyes, swollen jaw, swollen cheeks, muscle aches

Fever, extreme chills, extreme body aches, muscle weakness, headache, sore injection site; ibuprofen every 6 hours; symptoms set in within 5 hours of injection

Janssen COVID-19 Vaccine EUA Felt light headed at 8pm. I laid down and then started to get terrible chills. Around 10pm the chills turned to muscle aches all over and a terrible headache. Had a fever of 99.9 at 3am. The headache and mild muscle aches have continued into the next day as of 9:30am. The site of injection has been sore to the touch ever since I got the shot as well.

left arm has bump on Injection site it?s also very warm and tender to the touch headaches left side very tired fevers nausea lost of appetite

Arm very sore and itchy starting 2 days after injection. Rash appeared later in the 2nd day. Injunction site red, swollen to size of golf ball, and hot. Reaction gone 5 days after injection.

Om March 26th I recieved the vaccine and then had a fever later that night. I recovered from the fever. On April 1st I was exposed to someone who had Covid 19 and contracted it myself. I became symptomatic with congestion, cough, fatigue which all last until the 9th of April. On April 12th a rash began to breakout on my skin and I began to experience nausea. Today, April 13th, the nausea has worsen and the rash spread to my whole body. I am unsure of whether it is related to Covid or the vaccine.

8pm - Severe body aches began and skin sensitive to touch 10pm - Temperature begins to climb and chills start 12am - Tylenol taken 1am - Temperature reaches 103.1 3am - Temperature begins to decline Next day: extreme fatigue, chills continue, low grade fever (99.5-100.4), pain at injection site, and vomiting (3 episodes)

I was fine for the most part after the vaccine. The only thing that hurt was my arm at the injection site. I started feeling nauseous about an hour later. Then at about 9:00 pm, I started to feel really sick. I felt very tired and my whole body hurt. I had a low body temperature, 95 degrees. Chills, fever, shaking, nausea. Very SEVERE symptoms. Felt very disoriented. I thought I was going to pass out and faint. Vision blurry and seen white. Pounding headache. Ears ringing. I could hardly walk that night, I was crawling on the floor. I felt out of breath. My heart was beating very fast. My left side of my chest hurt by my ribs. When I did wake up from sleep, I woke up with blood in my mouth and dried blood on my lips.

redness and swelling at injection site, large lump on arm at injection site, burning sensation down arm 6 days post vaccination. Still not feeling 100% myself 6 days after vaccination.

On Sunday, 4/11 my eyelids were tingling, it then went to my forehead, entire face and both of my arms. My muscles stiffened and my hands/thumbs were cramping inward. My hands were also red and blotchy during this time. My face was tight and hard to move or talk. This entire incident lasted in total around 20 minutes or so. I seem to be okay since that incident, I have had a headache off and on. Not sure if it?s related to the vaccine but I haven?t experienced anything like this before.

Lightheadedness and dizziness spell about an hour after injection. Nausea all night of first evening. Day after shot, felt tired and achey. This lasted for about 48 hours. On the second day, my arm began swelling near the injection site and turned red. It?s now been 7 days since my injection and my arm still has a large knot under the skin and is sore.

Fever set in the next evening, on Saturday the 3rd. Lasted until Sunday the 4th. Injection site swelled up starting that Sunday, and lasted a week. Grew to be about grapefruit sized in diameter, raised out of the skin like a large lump. Was red, and painful to the touch. Shrunk slowly over the course of the week, while still remaining painful and red. Tomorrow will be 2 weeks from vaccination, a lump still remains in the arm. Redness is gone, and slight pain remains when touched.

Immediate injection site soreness, dissipated after a few hours by moving arm after injection Fever (100.5 degrees F), chills, body aches, headache began about 8 hours after receiving the vaccine and lasted for 12 hours after that Lethargy and headache remained for additional 12-24 hours Symptoms managed with 2 Tylenol rapid release gels, 500mg each; taken first night before bed and the following morning

Got J&J vaccine on Friday at 3pm (April 9) and felt Body aches, Muscles hurt, Stomach hurt, Dizzy, Nauseous , Heart rate fast, Clammy Chills, Didnt sleep, Chest tightness, Upset stomach, Fever, Head hurt, Arm hurts and chest tightness feels in-line with where I got the shot, by Sunday (April 11) Flu like symptoms went away, but still have chest tightness uncomfortable and Feels like i have to cough When I take a deep breathe it it feels tight. Have diarrhea everyday since vaccine Still feel weak and dizzy Most of the flu like symptoms have gone away but chest tightness still concerning When I bend over or lay on my right side feels constricted and tight and uncomfortable. Bilirueben associated with liver is elevated and white blood cell count is low. On Wednesday, April 14th I started to get super congestion, runny nose and sneezing and Eyes a little red. Rashes and Hives that were red, blotchy and bumpy started Wednesday April 14 at 6pm and worse at 9pm. Continues to get worse and hurt throughout Wednesday and Thursday night. Developed all over body, legs felt hot. The hives and blotches would disappear and would then reappear at different areas of my body. Called Nurse Triage line and suggested I treat at home with Benadryl since hospitals had 6 hour wait and were full of COVID positive patients. Unable to sleep Wednesday and Thursday due to hives, very comfortable feeling. Diarrhea on Thursday morning , cough and felt shakey. Noticed on Thursday April 15th, some skin on right foot looked like it was pealing. Thursday night noticed some blotching and hives but not as bad as they were the night before. Friday April 16, No redness on legs at 1130am, but Lips feel dried out and Feel a little dehydrated . Bilirueben associated with liver is elevated still and will need to follow up with Doctore in two weeks. However, when laying on right side or bending down feels like something is stuck un chest and need to cough still, with chest tightness. Still had diarrhea until Saturday, April 17th. Chest is still tight and feels like something is stuck. Sunday, April 18th, went for short walk and felt uncomfortable breathing and not normal. This has not resolved still and does not feel breathing is normal.

I was tired the night of the shot and my arm was painful near the injection site, hard to move arm and touch caused great pain. My neck also started to lock up from my shoulder across to my spine and up my neck. This lasted about three days with occasional tension in the neck area coming back. Next morning I was very achy and my entire body felt like my muscles had a buildup of lactic acid. I did not have a fever but felt feverish that night. I felt the fever broke Saturday night/early Sunday morning (4/4) while I was asleep. I developed a slight cough for a few days and the muscle aches decreased by half each day. I felt mostly better after a week but occasionally felt tired and the cough lasted about a week. My arm developed a bolus at the injection site in the muscle that took about two weeks to go away, with occasional ice. The arm pain only lasted about 4 days before full range of motion was restored.

INJECTION SITE ARM SORENESS; This spontaneous report received from a patient concerned a 28 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 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site arm soreness. This report was non-serious. This case, from the same reporter is linked to 20210424282.

I had back pain two days after I got Johnson & Johnson shot. Then, 5 days later, my skin started to peel off from my hands...I'm checking my hands everyday and they are getting worse.

Day 1: Extreme fatigue / muscle ache / headache / dizzy. Day 4: Lost sense of taste Day 6: Took covid test, negative Day 8 + : Painful mouth ulcers forming all over tongue and roof of mouth. Currently on day 14 and the mouth ulcers are getting worse, not better. Tongue is extremely inflamed and red spots all over the roof of my mouth.

I received the shot on Saturday, March 6th. Flu-like symptoms developed 12 hours after (aches, chills, extreme fatigue) and lasted about 12 hours -- pain in left arm lasted a full five days. On Thursday March 11th I started to develop a cold sore on my chin which was followed by malaise and swollen glands. I treated it with Zovirax. On Wednesday March 17th I developed what looked to be a pimple in the middle of my left eyelid. There was a small white/ fluid filled head about the size of a pin head. Over the next three days, three more fluid-like blisters the size of a pin-head began to develop on upper eyelid. By Tuesday March 23rd, I had over half a dozen fluid filled blisters that were painful and began to crust. The blisters extended from upper eyelid to below the brow (only on left side of face). On Tuesday March 23rd I went to the eye doctor. The eye doctor had asked if I ever had shingles (I have had the chicken pox vaccine, but never had chicken pox nor shingles). I have had HSV-1 since childhood and get the yearly cold-sore when stressed or immunity is low, but I never have had cold sores appear anywhere else other than lip/chin area. The doctor had suspected the eye blisters were a form of herpes and prescribed me 14 days of Valacyclovir. The blisters only affected the skin-- not the cornea or inside eye. Within a day and a half of the antivirals medication, the blisters were fully crusted over and started to clear up.

Minor fever 48 hours post injection; acne-like rash across upper back and shoulders 11 days post-injection. Rash almost gone 14 days post-injection.

DIZZY; LIGHTHEADEDNESS; PAIN UNDER THE LEFT ARM; CHILLS; SORENESS AT INJECTION SITE; FEVER; GENERALIZED ACHING; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient does not have any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 01:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced generalized aching. On 10-APR-2021, the subject experienced soreness at injection site. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced dizzy. On 13-APR-2021, the subject experienced lightheadedness. On 13-APR-2021, the subject experienced pain under the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized aching on 12-APR-2021, chills on 11-APR-2021, soreness at injection site on 10-APR-2021, and fever on 13-APR-2021, and was recovering from dizzy, lightheadedness, and pain under the left arm. This report was non-serious.

FLU-LIKE SYMPTOMS CHILLS, MUSCLE SORENESS, HEADACHE AND ACHY SKIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included clotting disorder (unknown cause, with two episodes of clot prior), chronic migraine, celiac disease, penicillin allergy, cephalosporin allergy, sulfa drugs allergy, and social drinker (once every few months). The patient experienced drug allergy when treated with tetracycline, and vancomycin non-company 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 14:15 in left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced injection site pain. On 15-MAR-2021 22:00, the subject experienced flu-like symptoms chills, muscle soreness, headache and achy skin. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient was recovering from flu-like symptoms chills, muscle soreness, headache and achy skin, and injection site pain. This report was non-serious.

I have severe, random, and unprovoked bruising covering both legs. I have abdominal pain that has persistent since being vaccinated. I?m dizzy. I?m bleeding in my urine, stool, and vaginally. Period came early (unrelated to previous vaginal bleeding) and is not clotting. Just significant amounts of red blood, soaking through one ultra absorbency tampon an hour. I have a headache. Went to the ER and my platelets were (345) and my blood sugar low. My bp was 145/90 which is high for me, from the bleeding. They said I have a ?higher chance of being bitten by a shark? than having a side effect. They diagnosed me with a single contusion and sent me home. Have been feeling worse since leaving the hospital.

I was seen on April 10th for the lump in my arm at the injection site. I was told I had ?covid arm? and that it should resolve over time. It?s gotten much better, but I still have a very small lump there. I was seen on April 19th for constant pounding in my left ear that started around April 12th. I was told I had pulsatile tinnitus, and I will be having a MRA scan on May 8th. I have felt some pressure in my head since then, and was told it may be related, but to just wait for the scan.

Woken in the middle of the night to njection site pain, headache, profuse sweating for 8 hours+, nausea, projectile vomiting.

Adverse event: Rash on upper-left arm. Rash was itchy, red, and hot to the touch. Rash spread to right arm, then to right calf, then left calf. Treatment: During the time it was spreading, I made an online doctor?s appointment to get it checked out. Doctor told me to take Claritin and prescribed steroids for if the rash didn?t go away with the Claritin. Outcome: Claritin turned out to be enough, rash went completely away within 2-3 hours of taking it. Steroids were not needed.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient regained consciousness within one minute. Her blood pressure was 107/78 mmHg and heart rate was 62 bpm. She was fully recovered and left the pharmacy after 30 minutes. I follow-up with the patient on 05/08/2021. Patient said she was fine after she left the pharmacy and only had soreness at the right arm.

Developed hives on arms, legs, and feet within 24 hours. Was able to suppress hives for the first week and a half with Benadryl. Switched to Zyrtec and Pepcid with some break through hives. It has been 7 weeks since the vaccine and hives continue. Sometimes they will be mild or completely suppressed by the medicine. Other weeks there will be bad outbreaks despite continued medication (40 mg Zyrtec, 40 mg Pepcid as prescribed by the doctor and occasionally an additional Benadryl). This includes hives covering feet, legs, butt, back, chest, arms, and hands. Sometimes the hives are small and distinct and other times they merge together to large red swollen areas. Hives are red and swollen often surrounded by a thin white area. Sometimes they are not at all itchy and other times they are highly itchy.

R facial edema and pruritus, headache, chest pressure, dizziness, cough. Treated with diphenhydramine 50mg IM in clinic, Benadryl at home.

I developed a rash under my right breast and on my right back. It was itchy and I went to the doctor (on a regular OB appt) and they diagnosed as shingles. And I was prescribed Valtrex for two weeks. I took it the full course and the rash went away. I still had the rash when baby was born but it went away after that. While I was in the hospital for delivery, a few different people came and looked at the rash with a concern it might be contagious to my new daughter. Pregnancy - first pregnancy; due date was May 9 and I delivered on May 3. Birth weight of baby - 8 lbs and 13 ounces.

The patient developed a pustular rash on arms, legs, stomach, inside the mouth, tongue and inside nose.

Review of ED notes show she received IV infusion of normal saline, and IV push of benadryl and compazine after going to the ER for severe headache on 04/17/2021. She first noticed pain when streching the arm shortly after the IV infusion but didn't pay attention to it, then 5 day later she noticed localized swelling and redness. Patient was sent for US doppler which left cephalic vein thrombus detected on duplex US. Was treated with aspirin and had follow up doppler of UE for follow up on LUE cephalic vein thrombosis-negative 5/13/21.

Patient reported basically immediately feeling a ringing of the ears, muscle pain at injection site and nausea.

Fever, chills, tingling in the lips, throat swelling, hives, high blood pressure, coughing, asthma attack. The lip tingling was within 30 minutes of my vaccine, and continued for 2 weeks. Throat swelling lasted the first week. Hives lasted 1 week 4 days. Coughing started on day 3 and lasted 3 days. Asthma attack happened one time, during the coughing phase. High blood pressure started the evening of the vaccine and has continued. Doctor has prescribed a low dose of blood pressure medication to help combat it. Fever and chills started on the first day and lasted through the second day.

ITCHING; GOLF BALL SIZE SWELLING AT INJECTION SITE ABOUT 6 HOURS AFTER THE VACCINATION; PAIN; ABOUT 3 HOURS AFTER THE VACCINATION LOW GRADE FEVER AND TEMPERATURE; REDNESS; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy, and other pre-existing medical conditions included no illness or surgery to report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 12:00 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride for drug used for unknown indication. On 08-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 12-MAR-2021, the subject experienced itching. On 12-MAR-2021, the subject experienced golf ball size swelling at injection site about 6 hours after the vaccination. On 12-MAR-2021, the subject experienced pain. On 12-MAR-2021, the subject experienced about 3 hours after the vaccination low grade fever and temperature. On 12-MAR-2021, the subject experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching, and redness, and had not recovered from golf ball size swelling at injection site about 6 hours after the vaccination, pain, and about 3 hours after the vaccination low grade fever and temperature. This report was non-serious.

Swollen itchy Rash on Left arm elbow has had for 3 days When bitten by mosquito. When scrated by my cat Large red rash appeared on both hands and wrist. Rash was there for less than a day

4 inch in diameter red circle, raised slightly in areas with a few bumps around affected area. Hard and darker at center with purplish hue. No fever/chill/ body aches reported. Symptoms persisted since day after vaccination.

WHITE PATCHES ON THE BODY/PATCHES WORSENING; BODY ACHES; FEVER; PAIN IN INJECTION SITE; INJECTION GIVEN TWICE BY VACCINE FACILITY; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included vertilligo in childhood.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and batch number: 043A21A expiry: 21-AUG-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced injection given twice by vaccine facility. On 05-APR-2021, the subject experienced body aches. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced pain in injection site. On 10-MAY-2021, the subject experienced white patches on the body/patches worsening. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 08-APR-2021, fever on 07-APR-2021, and pain in injection site on 19-APR-2021, was recovering from white patches on the body/patches worsening, and the outcome of injection given twice by vaccine facility was not reported. This report was non-serious.

Same day on the vaccine I noticed swelling on the vaccine site. Two days later I started feeling my throat swollen I had my lymph node swollen on my neck & under the jaw line everything was on the left side as the vaccine. It started to become very painful 6 days later I went to the urgent care and they gave me antibiotics to treat it. It was a 2 week treatment once I finished it about 5 days later I had to go again because it started to happen again I went in to get more. Now a couple a weeks ago its starting again but I have not gone to the urgent care anymore I'm just watching it and hoping it goes away. If it does get worst then I will be going again.

Hives, breaking out, flush, chills, faintness/dizziness Treatment was an injection of Benadryl and ice packs

Was good for first 18 days. Then big bruise on my arm. Doctors confirmed not a blood clot and said I was good. Keep having lots of pain in the arm at the injection site 4-5 months later

I had side effects starting one hour after the vaccine - headache and nausea. Muscle pain started 12 hours after and it spread to my other arm - my entire upper body ached. I was nauseous and peeing a lot for 2 days. I did have a few hives, 2 on my arm and 1 on my face and I had not eaten anything high in histamine. The weather that week was stormy and lousy. On Friday-Saturday, I had an intense bought of allergies (plugged dripping nose) and that is very rare for me, regardless of the weather. By Sunday, I had shortness of breath, nausea, and shaking. I tried eating and playing a game to get my mind off it and that didn't help. Usually with my anxiety, I can just tell myself I'll be okay. I told myself I would be okay and if I got a blood clot I would be perfectly fine. It did not work at all. This kind of anxiety was unlike anything I've ever experienced. Nothing I did helped and it felt like everything was going a mile a minute. I decided to take a benadryl, telling myself that this was just the "impending sense of doom" that happens with food allergies. I slept for 12 hours and felt exhausted when I woke up, like I had just been through something tough. I tried to just move past it, but the anxiety got worse and worse. I saw a doctor 06/23/2021 and have started taking Prozac.

Pain in left shoulder, hurts to move or lay on. No relief from cold compresses; some relief from Tylenol. Seeing physician next week for evaluation

Patient was given 1 dose of the Jansen Covid Vaccine in the left deltoid by the administering intern. Within 30 seconds the patient became light headed, dizzy and upon standing up, then fainted. Intern notified the pharmacist on duty immediately. The RPh attempted to communicate with the patient of which she was unresponsive. RPh then informed technician to call 911. Patient was red in the face, arms and very hot upon touch. Patients eyes were open but was not lucid of responsive to questions. RPh then administered 1 dose of an Epi-pen. Patient immediately became responsive upon first Epi-Pen administration and was able to sit-up and communicate with pharmacy staff. Patient declined 911 services upon being informed of 911 being called. Patient was able to sit-up and talk stated that she was fine. Patient called her mother to come and get her from the pharmacy after resting for roughly 20min in the immunization room. Pharmacist on duty followed-up with patient about 4 hours later to check-in with how patient was doing. Patient stated she was a little jittery from the epi-pen but otherwise feeling fine. Due to the holiday, RPh told patient she would follow up with the patient and the patients primary care the following day (07/06/21), along with informing patient to also follow up with her Primary Care.

I?ve always had eczema, but after the vaccine it became MUCH MUCH worse. It?s so bad. Both of my eyes look like someone punched them. My neck and chin are red as well and some on my arms. It?s so painful, it keeps me awake at night. It?s the worst it?s ever been in my life.

Three day fever, extreme fatigue, swollen left arm (hot to touch, itchy, painful, fluid build up), rash down left arm. Received botox shot for migraines within ten days of shot, had extreme swelling in forehead for a few days. This has never occurred in prior botox shots.

Small petechiae/purpura like (not professionally diagnosed) lesions on upper thigh below buttocks. The small purple/red dots are clustered together in an area roughly 2" by 2" in the same spot on each leg.

At the time of injection, it was pretty painful and thus sent my body into a shock less than 5 mins after receiving my dose. My vision went white and I was very light-headed and hot/sweaty. A nurse came with me outside to monitor and I was feeling back to normal in 15 minutes. This is something that happens when I experience a high amount of pain, so just reporting for others who maybe have low blood pressure issues. At about 8pm, other side effects started to set in. I first experienced a headache, then experienced soreness/ache-y-ness in my back. Around 8:30, I started to feel light headed again and soon my whole body felt ache-y. I quickly developed chills where I felt so cold that I was uncontrollably shaking and felt very sore/stiff. I have been laying under a heated blanket for the last hour and a half and am finally feeling better with no more shaking or chills. I still have soreness throughout my body and a headache, but I took ibuprofen around 8:30pm.

Around 3:15 in the afternoon, I began experiencing severe aches and muscle pains, combined with a growing migraine. Not realizing what it may be related to, I took two ibuprofen and I've acetaminophen. By the time I around home around 6:30, I could barely hold myself up. I ate dinner, which only helped minimally, and by 8 pm felt like death. My husband notice I looked red and felt my forehead, immediately going for the thermometer. I had a fever of 100.5. We eventually got me into bed after downing a lot of water, but the pain would not ease up. The pain was too excruciating. At 10:30 my husband came to bed and we took my temp again which was 101.6. To help me sleep I took another Tylenol. At 5:45 my work alarm went off and I checked my temp again; still 101.6. I got a cold pack for my migraine and went back to sleep. Slowly throughout the day my fever dwindled, until it finally broke in the early afternoon. By 4:15, as I am writing this, all that's left is done tiredness, thirst, and a small bit of achiness.

Vasovagal syncope a few minutes after vaccination. Fever of 101.8F 24h after vaccination (3/10/2021). Fever is continuing today (3/11/2021), but is lower at 100.4F. Tingling fingers on hand from vaccination arm (left), swelling from vaccination injection site, headache, and neck pain all developed on 3/10/2021. Headache and neck pain could be due to head trauma from vasovagal syncope. Tingling fingers were not observed on 3/11/2021. *I have had vasovagal syncope in the past, but never with vaccines. It always occurs when I see my own blood.

A rash with swelling on the left arm around the injection site. The rash first spread Friday morning, small in size and has grown daily since. The rash is red and hot around 10 x 10 cm in size. Starting antibiotics. Cephalexin (KEFLEX) 500 mg Oral Cap and Mupirocin (CENTANY) 2 % Top Oint

Headache and eyes aching around 10:30pm on 3/12/21 I went to bed and started aching around 4:00am on 3/13/21 by 6:00am 3/13/21 I had a fever of 101.5 and my body aches. I took two pills of extra strength Tylenol and water and laid back down to break the fever and help with the aches and pains. I woke up around 9:30am on 3/13/21 and did not have and appetite all day. I was extremely fatigued all day and had no energy to get out of bed or do much. On 3/14/21 I began to develop an appetite again around noon. I was still fatigued. My arm was very tender and itchy at the injection site and hurt to the touch. My 5:00pm on 3/14/21 I had more energy and the aches were gone but my arm was still hurting and sore.

Vaccinated at 3 pm on 3/14/21. At 12:30 am (3/15, 9 hours post) woke with chills. At 2:30 am, woke again overheated and with a bad headache. Could not sleep well. Some muscle aches in my upper legs. Checked temp at 6 am. No fever. Hot/chills resolved. Tired all day 3/15. Headache and muscle aches resolved by noon 3/15. Fatigue resolved when awoke on 3/16/21. Bruising and soreness at injection site. Still present.

I started feeling subtle flu-like symptoms about 6 hours after receiving shot. At first I thought it was in my head but by the early evening I felt like I had a full blown fever even though I never actually had a fever at any point. I had chills, muscles aches, head aches, and extreme fatigue. My back hurt especially and overall I felt very weak. I also had pain at the injection site that got worse the following day. I had trouble even lifting my arm to reach a drink just a few feet away from me. The arm soreness lasted through the Monday following my vaccination (I received it on a Friday). All my symptoms were at their worst on Saturday. I felt much better on Sunday but still had the arm pain through Monday. Motrin did help relieve the worst my symptoms. I thought that was the end of my symptoms but that last week I have noticed what I believe to be a lingering fatigue from the vaccination. While it's not usual for me to feel tired at points throughout the day, I have been feeling a heavier and more full body fatigue than I usually experience. I have had to take naps more often, sometimes multiple times in a day. During these bouts of fatigue, my whole body feels heavy and somewhat weak. It's similar to the exhausted feeling someone might have after they've been crying for a while but I haven't been crying or emotionally taxed in anyway. Normally when I wake up in the morning, I might feel tired for the first 30 minutes to an hour but once I get moving, I feel better and more alter. I have been having a harder time feeling rested or awake in the mornings and even if I get more sleep than normal, I still feel exhausted. I did not change my routine or diet which I why I think this is related to the vaccine.

Immediately after getting the shot, I experienced dizziness, nausea, a wierd taste in my mouth,, and my tongue felt numb. The day after I recieved the covid vaccine Janssen, I started noticing the injection site getting red and swollen. By the next day it had grown in size and was itching rather badly. I could sleep from how badly it was itching and burning. It has been 6 days since I got the vaccine and it's still large and swollen and really itchy. I have been taking ibuprofen for the pain and using benadryl for the itching.

About 30 min after the vaccine, I started to feel symptoms. I had a fever, chills, vomiting, diarrhea. The next day, my arm swelled up at the injection site and was extremely tender, hot, and my whole arm was swollen as well.

Around 8 hours after the shot I started to experience fatigue, body aches, uncontrollable body shakes, blueish lips and sweating (which to me indicated I had a fever). After taking some Advil my lips returned to normal and the body shakes stopped although it was hard to regulate my body temperature. I was sweating but felt cold. The worst of the symptoms seemed to last around 13 hours after they had started (so about 7pm on 3/25 to about 8am on 3/26). It's now been around 30 hours and I'm feeling better but still fatigued and have soreness in my left arm where I received the injection.

I received the vaccine at 1:30 pm in the afternoon on 3/22/21 and immediately afterwards I felt fine. I waited my 15 minutes and had no signs of a reaction and was free to go. Later in the afternoon, around 3:15 pm, I began to feel a little fatigued and my arm was sore. Around 6:00 pm that same night, I developed a low grade temp of 99.8, I was very fatigued, had achiness all over, as well as my arm was very warm and tender. I was unable to sleep through the night of 3/22/21 into 3/23/21 and got out of bed around 4: 30 am on 3/23/21 and had to call into work due to the pain. The pain was not an achiness but sharp throughout my whole body. Around 9:00 am, I took a pain reliever and was able to sleep for a few hours. Upon waking up around 1:30-2:00 pm, I was still hurting and was then nauseated as well. I tried to drink water and ate a few crackers to settle my stomach with no relief. At 5:15 pm on 3/23/21, I went to the bathroom and got in the shower to try to help with the pain. After a few minutes in the shower, I became extremely lightheaded and felt like I was going to be sick. I sat down in the bathtub and hollered for my mother to come help me because at this point, I felt like I needed to go to the hospital. Upon sitting down in the bathtub, I began to profusely vomit and started to lose feeling in my legs. My mother entered the bathroom and I explained what was happening and soon after my hands contracted and were stuck in an abnormal position. The pain was unbearable and I was unable to move them from that position. I was unable to get myself out of the bathtub so my mom then called for an ambulance. These symptoms occurred somewhere around 5:20-5:21 pm and EMS was called at 5:22 pm. After a few minutes, I was able to regain movement of my legs but my hands and fingers were still contracted and unmovable. I was able to help my mother enough to put my clothes on and to make my way outside to the front porch to get fresh air. After getting outside, I was accompanied by my mother and my neighbor whom is a nurse. My neighbor looked at my hands and noticed they were discolored and she attempted to straighten out my fingers to no avail. The pain in my fingers was sharp and excruciating but there was also a pins and needle type pain as well. I remained outside until EMS arrived. I was then transported to Hospital where I was seen in the ER for this. Upon arrival to the ER, the physician ordered labs and fluids and stated that apparently he had seen at least 2 other cases that day with a similar reaction to the vaccine. He explained that I was having an adverse reaction to the vaccine and that my hands should return to normal within 24-48 hours. I was then discharged home. As of 3/24/21, I was able to straighten my left hand out and my right hand, my fingers would straighten out, but they would return to a curled resting position. As of 3/25/21, I returned to work and I have some weakness in both hands with a slight discoloration of each hand as well. I am a nurse and work in an office and the physicians in my office commented on the color of skin upon seeing them. I was still very achy and fatigued. My arm was still sore and tender as well. As of today, 3/26/21, I am still achy as well as tired. My right hand has improved some but still returns to a curled resting position. The color of my hands has improved as well. I am a nurse and have seen many things throughout my career. This experience has been absolutely terrifying and I still have no answers as to why this happened to my body. I did my part by being vaccinated and was terrified that I was going to lose my life to it. I pray this does not happen to anyone else.

Flu-like symptoms beginning at 1:30 am with no fever, and vomiting at 4:30 am. Both arms were hot and anything that touched them felt like sandpaper, and a fever begins at 5:30 am and goes up past 100° at 9 am. Fever finally reduced and feeling back to normal by 7 pm that same day.

Injection site pain, weakness, fever, chills, disrupted sleep, body aches, joint pain, dizziness, headache, stiff neck, back pain

Pain at injection site, severe fatigue, feeling of passing out, drowsiness on the first day. Treated by sleeping and taking Tylenol. Second day: headache, muscle weakness and body aches on side of body injection was given. Facial weakness, weakness in right arm, headache persistent on third day as well as redness and swelling at injection site. Difficulty swallowing.

On Monday 3/15 or Tuesday 3/16 I started developing a rash on the knuckles of my right hand and fingers. It first looked like small burns, and then started swelling to look more like spider bites. The rash spread over the course of the next two weeks, and also showed up on my left hand. Eventually, the one on my right hand looked like a blood blister. The rashes itched at first, and then started hurting to the touch. They were especially sensitive to sunlight. Now, as of 3/30, they seem to be clearing up.

Patient went to COVID vaccine clinic and was administered Janssen COVID 19 vaccination lot# 1802068 at 0800. About 14 minutes following vaccination developed a diffuse erythematous blotchy rash across her chest and arms. Did complain of burning to her skin. Patient did not have any shortness of breath or difficutly in breathing. She was given 50mg of PO benadryl and transferred to the ER for further care. While in the ER the patient was given 20mg of IV famotidine and 125mg of IV solumedrol. Patient was discharged from ER about an hour later - her symptoms had completely resolved - she was advised to continue Benadryl 50mg every 6 hours for the next 24 hours by the ER provider.

fever, chills, body aches, interrupted sleep, loss of appetite, fatigue, soreness at site of injection

Tiredness: started from 4pm 4/1; sore at the injection site, fever about 100 F: started from 10pm 4/1 till 2pm 4/2; sore in lower back and finger joints: 4/2 No treatment.

Patient began itching this am. She went to a urgent care where they gave her oral Benadryl tablets then was transported to ER. There she received IV steroid. The provider thought she had an allergic reaction to the Covid vaccine. She was not given any additional meds for home use.

At 1024, RRT was called to the post-vaccine recovery area for a 29 y/o F that c/o feeling ?hot? after receiving the vaccine. She also complains of pain to her left arm radiating to her neck. She was initially light-headed, cool, and clammy. Head-to-toe assessment completed. Vitals ? BP: 100/56, RR: 18, HR: 100. No PMH, NKA, did not take any medications. Not pregnant. Throughout monitoring period, client?s status improved. Client given a cool compress to improve condition which client states, helped. Pain to left arm decreased, client?s skin warm, and she had no complaints of dizziness before she left home. The feeling of feeling hot went away. Client opted to go home after monitoring/evaluation period. Client left facility at 1100, accompanied by her girlfriend. Girlfriend stated she will be driving home. Client left in stable condition, AA0x4, in no acute distress, breathing even and unlabored.

I began to feel bad 6 hours after the application of the vaccine with chills, stiffness, muscle and body pain. I already imagined that the fever was starting. 3 hours later I got home and took my temperature, it was 101 F. the fever lasted more than 15 hours. I didn?t take any medication. I put cold cloths on my head, bathed and rested. the headache was very intense. So far I have discomfort from that but the fever has already stopped. The most striking thing was the allergic reaction that I began to have around midnight and it continued until today. they were hives all over the body. swelling and itching and redness. Finally after 24hs after vaccine I took an anti allergy called levocetirizine cause itching won?t stop.

Symptoms started around 7:00 PM and gradually increased. The first symptoms were chills and body aches which gradually increased and also led to a fever of 103 F, confusion and lower back pain level 10/10. The fever and chills subsided the next day however fatigue and soreness followed the next couple of days. I still have lower back pain that comes and goes.

Pain and swelling at injection site immediately after and through the time of this report. Full body muscle aches overnight. Nausea, fever, fatigue, and muscle aches through time of this report (ongoing).

Janssen COVID-19 Vaccine EUA 4/5 - (from time of waking up in the AM) persistent migraine, joint pain, heart palpatations, soreness at injection site, nausea, dizziness, persistent lethargy and lack of appetite 4/6 - persistent headache, joint pain, light-headedness, lack of appetite. Noticed a red welt at injection site (bright red, hot to the touch, swollen) 4/7 - red welt inflamed, still hot, sore, became incredibly itchy, whole arm uncomfortable and hurting. All other symptoms gone 4/8 - Inflammation of welt partially faded but red irritation spread out like it was dispersing. Later became darker red, still itching, began to hurt so much that even light fabric brushing across the skin caused pain. Still very warm to the touch. Doctor diagnosed the welt as Cellulitis and immediately issued an antibiotic.

Fever, chills, body aches, sore throat, diarrhea, fatigue, continued swelling, redness, and pain at injection site

Within an hour of receiving the vaccine I had lightheadedness and dizziness. I had mild bouts of nausea with this episode. The dizziness subsided close to 1 pm. At approximately 4 pm I was lethargic, and starting to run a fever with arm pain at the injection site. By 7pm I had no energy, small cough, fever (unknown), chills, and headache. This lasted until 10 AM the next day. Headache lasted until 5 pm the next day.

8 hours afters after receiving my Janssen vaccine, I woke up in the middle of the night with a 103 fever that was not well managed by taking Tylenol. I also suffered from extreme body aches, fatigue, nausea, upset stomach, diarrhea. This lasted a full 24 hours before my fever went away. The following day I still had an upset stomach. I also developed a red welt at the injection site which lasted for about a week, was red, swollen, bruised and itchy. 11 days later I tested positive for COVID19 and had full fledged symptoms of COVID19 as well.

Fever and body aches beginning around 5pm, 7 hours after the vaccine. Nausea hit at 10pm and lasted until the next morning. I threw up 4 times throughout the night. I have red splotches all over my face from broken blood vessels I think. They are all around my eyes, but also on the rest of my face and neck. Fever of 100.4. Had a headache and was shaky all night. The next two days I have been fatigued.

Janssen COVID-19 Vaccine EUA. Day after vaccination I had a slight fever and severe fatigue. I was only able to stay awake for an hour at a time. I also had a severe headache and pain and swelling at the injection site. The next day, the fever broke (about halfway through the day) and my fatigue lightened. I was still experiencing a minor headache and continued pain and swelling at the injection site. The third day, I woke up feeling normal, until I engaged in physical activity. The fatigue returned, however I am no longer experiencing a headache and the pain in my arm has lessened considerably. The swelling hasn?t reduced.

Dizzy, lightheaded, headache, chills, muscle and joint pain, weakness, extremely tired. Well I laid in the bed with two blankets and took tylenol. Once I was done freezing and with the fever it felt like my skin was on fire. I was in so much pain that night that I couldn't move without crying. After I slept that night and about 7 hours the next day I finally started to feel better.

Starting around 8:00pm started to experience muscle and joint pain in lower back and hips and headache. Left arm became warm to touch and felt slightly swollen. Chills and fever started to set in. Chills lasted for about 3 hours. Fever with a high of 101.7 degrees F noted around 2am. Took tylenol, which brought fever down, and reduced headache and muscle aaches. Fever remained between 99 and 100 degrees F for most of the following day. Took another tylenol in the late afternoon. Fever finally broke by the evening on 4/10/2021. Still fatigued for all of 4/10/2021. Woke up on 4/11/2021 with out any other adverse effects. Fever, headache, and muscle aches passed. Still a little tired, but felt more energized.

I had immediate soreness after the vaccine does. Then at 7pm of the evening after getting my vaccine, I began to feel weak, get chills, and run a low grade fever. At midnight, my fever had increased to 101 and I began taking Tylenol (recommended by Pharmacy). I had sever body aches, muscle fatigue, joint paint, chills and nausea through the night and the next day. In the morning, I had excruciating pain in my abdomen and began vomitting. Later that day, my fever increased to 102.7 (with Tylenol) and I called my regular doctor. She told me to continue to monitor and if my fever did not decrease by 7pm to go the hospital. Finally, my fever decreased to 101, muscle aches, chills and joint pain continued. I began vomitting uncontrollably for a short period of time. I was very dizzy and weak the remainder of the day. Saturday, my fever finally broke (I sweated all day) but my body was still weak and sore. I also had dizzy spells on and off. Sunday, I felt much better but was still very tired compared to my normal self. I had abdomen pain and burning on and off. I also got hive on my hands Sunday afternoon. After Benadryl, the hives went away but I still felt itchy all over. Today (Monday), I still don't feel like myself, but it is the best I have felt since receiving the vaccine. I have never experienced anything like this and was miserable Thursday night, Friday and some of Saturday. It truly was a terrible experience.

I'm still experiencing heaviness on my left arm, almost like a "bump" on the injection site, pain on injection site and some itchiness. On the day following the injection I experienced high fevers, chills, body aches and nausea.

Woke up between 10:30 and 11pm night of vaccine administration with full body shaking and shortness of breath. It?s unclear if shortness of breath was a direct result of the severity or the shaking or something else underlying the shakes. Walking or standing for any period of time was nearly impossible. I felt too warm and too cold at the same time and felt myself sweating but also shivering. My temperature was 99.6 (high for me - I?m usually low, around 96-97 on average) which persisted until around 5:30-6am the following morning. A severely painful, throbbing headache was present until well into the next evening. The symptoms of the headache did subside with use of OTC extra strength Tylenol (2 oral every 6 hours, taken twice totally 4 over the course of 24 hrs) but the headache was still felt somewhat even with use of Tylenol. Moderate fatigue was present all of 4/9 and until around mid morning of 4/10. Pain at the injection site was present but only noticed if laying on the affected arm (left) or if the site was accidentally touched. Dull aching at the site was felt on occasion until the following Monday, 4/12. All other symptoms had fully subsided by 4/10. As of today, 4/13, I am symptom free but I have noticed that I am taking deep breaths every once in a while (maybe several times an hour) as if I?m trying to catch my breath/I can?t catch a full satisfying breath. It feels somewhat like breathing through a straw for a few moments and I breath in until a full breath ?catchs?.

?? SUN Apr 11 3:50 is when we received the Johnson & Johnson vaccine for COVID19 Arm of injection was sore for a few hours ?? MON Apr 12 6am, woke up not feeling good. Was really hot but then really cold.. Had trouble with sleep throughout the night 8:30am had chills, throat really dry/sore, head and body aches 11:30am Lower back in quite a bit of pain. Same symptoms from the morning. Brain fog. Full body chills 11pm started to feel not as bad, chills ended, body less achy. Arm still sore ?? TUES Apr 13 8p woke up with Throat still sore, but not as bad as last time and dryness in nose wasn't as bad either. Muscles sore but not weak. Injection site still sore.

Chills, fatigue, nausea, injection site pain, body aches lasting for 24 hours. Late period, menstrual type cramps, spotting and bloating. Been going on for a week now.

I started getting a body aches, a headache and chills around 6 p.m. the night that I got the vaccine. I ended up having a 102 degree fever later in the night with continued body aches, nausea, headache and chills. The morning after I got the vaccine I woke up feeling disoriented and nauseous. I had several spells of dry heaving that morning and a headache and body aches most of the day . I had soreness at the injection site for about a week.

Pt complained of burning when vaccine injected. Within 2 minutes pt put her head down; stated she was dizzy and then her eyes rolled back and she started to slump over in her chair and then fainted. Moved pt to the floor. She was unconscious for only 1 minute. Vitals: BP: 110/62, Pulse 48, R: 12, T: 98.1, Pulse ox: 99%, Finger stick for blood sugar: 92. Pt had not eaten for almost 24 hours and has a fear of needles. Within 10 minutes vitals improved: BP: 125/90, P: 67, R: 18, Pulse ox: 99%. Pt is a smoker and had worked all night.

Per patient: I received the J&J covid vaccine on April 5th. The following day I was dizzy, tired, running a fever, and my injection site was very sore. I could not lift my arm above my head without being in pain. I was not able to eat anything the entire day. I attempted to eat some soup but threw it up. I woke up at 3am on Wednesday morning and drank some water but within 10mins I threw that up along with blood. At one point when I checked my temperature it was 104.8. By Wednesday afternoon I was still not able to eat anything but I was able to drink Gatorade. My fever did not break until Thursday afternoon. I was able to go back to work on Friday but my arm still hurt and was red and swollen. The injection site began to itch on Friday and continued all weekend. On Sunday my hand of the arm that had the injection got swollen for about an hour. It is now Tuesday of the week following my vaccine and I feel fine but my injection site is now purple.

I had a huge rash that started on my right ear, and then came down, but later I had the rash on my neck, arms, and knees. Finally I had a huge red area on my knees since Saturday. Its not painful or anything is just a huge red spot.

3/9/21: fever/chills/body aches/headache. lasted 30 hrs 3/10/21: little red bumps appeared on left arm at the bend of elbow(size of pin head-about 50 of them) lasted for 3 days 3/10/21: swollen eyelid (right eye) that lasted 3 days 3/18/21: bloody nose (I've never gotten a bloody nose before). Only happened that day.

Within 30 minutes client developed rash on chest and upper arms. Client treated self with Benadryl and symptoms resolved during monitoring period.

Swelling of injection site, medium size nodules around vaccine site, left arm shooting pain 7 days post vaccine

Injection site nodule - approximately the size of a ping pong ball, no symptoms (no pain, itching, swelling or tenderness), persisting three weeks post injection.

0-9 hours after injection: slight soreness and feeling of heat in arm of injection. 9 hours after injection: chills. 16 hours after injection: nausea, light headed, fever, headache, soreness and achiness in arm of injection - took Tylenol. 24 hours after injection: symptoms started to get better, headache still present. 40 hours after injection: headache still present- still taking Tylenol and by 48 hours symptoms almost completely gone. (Continuously took Tylenol every 6 hours or so)

Patient with complaints of persistent headache and insomnia the night of the vaccination. Patient developed bruising on her leg, shoulder and abdomen the next day. Patient presented to ER on day 4 post vaccination and is admitted at the hospital with ITP.

Immediately after receiving the vaccine I felt burning at the site and shoulder that went away after a few minutes. My left arm was tingling , this lasted the rest of the night. The next day i experienced numbness/tingling and dull aching pain in my elbow, down my arm to my palm and two fingers (middle and ring). This has been intermittent for a week now, really effecting me while i drive and work as a travel nurse.

Started feeling jittery about 4PM, then dizzy around 8PM, by 10PM I had almost a 101.5 fever, chills that were incontrollable, sweating, my whole body felt sunburnt and was bright red, I was freezing and burning up, and crying, whole body was aching and headache and eye ache that was pounding. Slept four hours and woke up the next day feeling lethargic, sore, achy, bad headache. Then two days later most the symptoms went away but i still got waves of heat flashes

Diarrhea, multiple days Sharp, dull stomach pains Pain at injection site from 4/8-4/15 Muscle weakness, slight Nausea

Body pain, temperature lasted 4 days after the injection, tinnitus in my left ear, Around where they put me the injection it felt hot and I got an allergy red spot that lasted a week or more, headache still hurts.

Tingling and burning in arms, neck, chest, and legs. Fever developed that night and body aches. Fatigue the next day along with headache and body aches. Tingling has continued on and off for the past week.

Hives and swelling around mouth, dizziness and weakness aprox 1 hour after vaccine and still occurring 1 week later.

6 hours after J&J shot, began shivering uncontrollably and immediately went to bed. Was in bed with flu-like symptoms for 24 hours. Took Advil Day 2 and 3 after shot, had a mild headache. Took ibuprofen Day 4 to present, noticed a red, raised, somewhat itchy ?bubble? patch of skin on the side of my nose, which my mom said looks like Hives. I also have red patches of slightly itchy skin under my eyes. Took Benadryl but doesn?t seem to be helping

Headache that night of the shot (within an hour or two of the shot). That lasted until Thursday evening and going into Friday. I didn't wake up with it. I took 600 mg of Ibuprofen at bedtime on Wednesday. Didn't wake up with the headache Thursday. I started getting body aches all over my body on Wednesday and they got worse until about 2:30 and I took a 15 min nap and woke up and felt a little better but I had them all the way to bedtime. And I was cold. That was until 1:00 PM on Wednesday. Wednesday night at 06:00 pm, on my left foot from arch to my toes I had a hot sensation. I thought one of my pets had pied on my foot - hot and wet feeling. But they didn't. That has been happening frequently and intermittently and I am still experiencing them. The level of heat has decreased - it it warm and wet instead of hot and wet feeling. Happens frequently throughout the day. On Friday, I noticed, I had a rash on my left forearm. I noticed it on Friday evening and that went away on Thursday of last week after I was able to be hydrocortisone ointment on it for a few days. The rash was really itchy. Patient portal - messages to doctor: She ruled out deep vein thrombosis - Naturopathic Oncology .

SLIGHT SHORTNESS OF BREATH; BODY ACHES; TINGLING IN INJECTED ARM; FEVER OF 100-102; HEADACHE; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced slight shortness of breath. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced tingling in injected arm. On 13-APR-2021, the subject experienced fever of 100-102. On 13-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100-102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 100-102, body aches, headache, tingling in injected arm, and slight shortness of breath. 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.

** Backache - As of this visit today, April 21, 2021, pt still has c/o continuous back pains all down her spine since receiving the Johnson & Johnson COVID-19 Vaccine on March 31, 2021. patient continues to report pain in her neck (cervical), thoracic, and lumbar spine. She insists that the cervical pain radiates into both shoulders and down to her arms bilaterally. She states these pains started almost immediately after receiving the vaccine and persists as of today. On a scale of 0-10, patient rates her spine and shoulder pains at 3 continuously. -- I've added methocarbamol 750mg tid for muscle relaxant with ibuprofen 400mg q6h. ** Severe headache - As previously noted in my previous findings with patient she reported having moderate headaches for two days after receiving the J&J COVID-19 Vaccine on March 31, 2021 but she states her headaches have now subsided. *** Other: On my first visit with patient on April 6, 2021, she was very concerned about a sudden loss of hair since taking the J&J Vaccine in addition to the spine pains and bruising. ** Leg swelling - patient reported both leg and hand swelling for 2 days after receiving J&J COVID-19 Vaccine with some new neurologic symptoms as noted below: ** New neurologic symptoms -patient continues to report significant weakness and fatigue. -- Her headaches that were present after receiving the vaccine have subsided after the first two days following the vaccine being administered. -- She reported new numbness x 2 days in both fingers and toes bilaterally with both hands and legs swelling immediately after receiving the vaccine. -- She also reported 2 hours of dizziness immediately after receiving the vaccine on March 31, 2021. -- patient reported a new onset of hand tremors that suddenly came on a week ago Sunday, April 11, 2021 while fishing that lasted for a few hours. She stated that the tremors would come and go for a while. -- patient has been and is currently negative for loss of consciousness, seizures, and migraines. ** Severe abdominal pain - patient initially reported episodic sharp shooting pains in abdominal area on multiple occasions after receiving the vaccine but have mostly now subsided. However, today, April 21, 2021 she reports more abdominal shooting "Sharp Pains" in her RUQ this morning that she rated 3/10 pain, and LLQ "Sharp Shooting" pain last Friday, 4/16/21. She states that the shooting pains last approximately 3 minutes in duration. ** Shortness of breath ? patient has continuous episodic shortness of breath complaints that have persisted since receiving the vaccine on March 31, 2021. Her last episode was again this morning, April 21, 2021 and she also states she is feeling like she is having trouble breathing during the exam today. Her SaO2 is 98% on Room Air during triage. She also reported yesterday, the same at the Clinic. She reported being at work on Monday, April 19, 2021 and became short of breath and had to lay down on the floor to breath easier. patient is a Kindergarden teacher. She also became short of breath Monday evening while at home while cleaning her closet. -- Yesterday, April 20, 2021 at Clinic I added a rescue inhaler for her shortness of breath. ** Petechiae (tiny red spots on the skin) - patient reported a new eruption on her upper back and shoulders after receiving J&J Vaccine. While the red spots are not bleeding, there was a significant notable rash to bilateral shoulders and upper back when I last saw her a week ago on April 13, 2021 at the Clinic. Today, the rash has cleared significantly. She was prescribed TRIAMCINOLONE 0.025% (80GM) OINT,TOP in Urgent Care last week, when I referred her to Dr. in the ER. ** New or easy bruising - multiple new bruising noted today on her left bicep arm. Yesterday, April 20, 2021 at the Clinic, I noted new bruising on lower extremities in addition to the bruising noted the week prior. The bruising started after receiving the J&J COVID-19 Vaccine that I noted in my previous findings last week.

HANDS SWOLLEN; RASH ON ARMS, THIGHS, BOTH FEET AND HANDS; JOINTS HURT; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced rash on arms, thighs, both feet and hands. On 13-MAR-2021, the subject experienced joints hurt. On 14-MAR-2021, the subject experienced hands swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on arms, thighs, both feet and hands, hands swollen, and joints hurt. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

On 4/18 woke up with a rash on arms, legs, butt, and back. Went to Urgent care and was given a steroid and benadryll. That evening the rash intensified and went to the emergency room. Was admitted so they could monitor the rash. Was discharged on 4/20 with instruction to start a steroid pack and continue with benadryl cream, benadryl, claratin and pepcid. Rash is still continuning to appear as of 4/27/21. Very itchy and irritating. TRYING TO ENTER HOSPITALIZATION DATES IN PART 21 BUT IT WILL NOT ALLOW ME TO TYPE ANYTHING. , 2 DAYS STAY,

Patient experimented skin hyperpigmentation on vaccine site right after it was administered and the skin still did not return to normal color since.

Upon getting the shot, it was extremely painful, so much so that I cried out in pain. I have gotten many shots in my adult life and have never done this. About a week after the vaccine, the normal shot soreness began to turn into extreme stiffness. I experienced weakness and loss of range of motion as well as pain in my left arm.

24hr reaction Shakes Chills Fever Migraine Soreness at site of injection Irregular menstrual bleeding

Initial injection site felt a lot of pressure and at first there were mild symptoms of ringing in the ears and mind fogginess. Within 5 minutes after receiving injection I got up and walked less than 10 feet when I began experiencing extreme dizziness, ringing in the ears, lightheadedness, felt warm, and began to feel chills/tingling throughout my whole body but especially in my head. I ended up passing out and was unable to sit up in a chair without assistance. For about 10 minutes I was profusely sweating all over my entire body, had continued chills/tingling, difficulty breathing and was semi coherent. The nurse at the pharmacy had me sniff ammonia salt and gave me water to help. I waited for 20 more minutes before finally feeling able to get up and walk around the store. Body chills and cold sweats continued for a while but no further symptoms at this time (2hrs after vaccination).

About 7 hours or so after I was vaccinated I began to feel a pulsing type of headache, but i was tired so I fell asleep. About 3 hours later (around 6am) I woke up with the worst headache I've ever felt. On a pain scale of 0 to 10 it was a solid 10. It was a splitting headache, a pulsing and crippling pain, it was also sensitive to light. Every time I moved or changed the direction in which I was looking the pain would surge through my head and paralyzed me. I took 1000 MG of acetaminophen and then half an hour later I took 800 MG of ibuprofen. The headache calmed down a for a while, but 8 hours later I was already feeling just as bad as when I felt the headache the worst, so I took another dose of acetaminophen and ibuprofen. The entire day went on like that, along with body aches, some nausea and fatigue. Throughout the next four days, all of those symptoms gradually diminished. On the third day after vaccination, the injection site felt very sore; my whole arm would hurt every time I moved it.

I have continued to lose lots of hair since my vaccine. I have not had a period since my vaccine, and am not pregnant.

In first 24 hours, at 03:00 am, I woke up feeling chills and with headache and I got dizzy and feeling weak and tired. My muscles hurt and a body felt very fatigued. Also, a little bit nauseous. I think my fever got to 100 degrees. By noon, I broke my fever. By three pm I was fine again. The following days, I had soreness at injection site. I had a couple of headaches. There was one episode where two weeks later, I did get a panic attack and went to urgent care. I went because it lasted longer than normal. This panic attack lasted for 30 minutes that is why I went to Urgent Care. Usually my panic attacks last for 3 minutes - but I also had personal things going on that could have caused it. No treatment, they just said to relax.

ER- TWO VISITS- 4/10/2021 4/12/2021. I've seen a couple doctors to get follow ups and get stronger allergy medications, I can't recall how many I have seen. I had a rash, difficulty breathing, dizziness, chills, shaking, fast heart rate, throat swelling, extremely fatigue. Still having breathing problems, still getting hives, started allegra and I take it daily, I also have to use my inhaler almost daily, I have never had asthmatic symptoms before this.

In ED on 3/11 0246 with the following Chief complaint - I got the johnson and johnson covid vaccine 3/10 at 4pm and now I can't stop throwing up" c/o emesis, fever, body aches. HR 140s. pt is A/O x3. + nasuea, chills fever 101.2. denies throat swelling or SOB. pt presents with swelling at vaccine site and rash to both shoulder blades She does feel lightheaded and dizzy. Denies any recent illnesses. Denies any prior intolerance to vaccines. Fever 101.7F Patient has low-grade fever but nontoxic-appearing. Blood work shows mild leukocytosis with left shift likely reactive otherwise within normal limits. After 3 L of IV fluids she remains persistently tachycardic in the high 130s to 140s. Additional information for Item 18: She states she was feeling fine prior to her vaccine, denies any recent illness, sick contacts, recent travel, CP, SOB, abd pain, dysuria. After eating and drinking patient states she feels a little nauseous and having some indigestion so was given some more Zofran and Maalox. She continues to be presenting tachycardic in the 130s. Given the rest of the reassuring ED work-up I think this is likely autoimmune response to the vaccine however given her current heart rate I cannot discharge her safely. Will admit her to medicine team for observation. SIRS, likely 2/2 vaccine - hold off on antibiotics for now without clear source of infection, procalcitonin negative - tylenol prn for fever Principal Problem: SIRS (systemic inflammatory response syndrome) Active Problems: Tachycardia Asthma 3/12 discharge summary She was given 3L IVF bolus in the ED -- still tachycardic in the 110s, fever has improved. There was concern for adverse reaction to vaccine and she was given prednisone 60 mg x 1 in the ED. Her symptoms have improved and she is able to tolerate PO without vomiting. Of note, she says her entire family had a respiratory viral illness approx 1 year ago which her PCP suspected was COVID 19, but were unable to be tested at the time. Fever has resolved, has been afebrile x24 hours, leukocytosis has resolved tachycardia has improved although still HR in the 110's with ambulation, ordered an echo however patient did not want to stay wanted to follow-up with PCP and have this done there. Vital signs have been stable, patient states back to her baseline and feeling great. Would like to go home.

Received vaccine Monday. Sore arm immediately. Tuesday morning and afternoon is fine. Tuesday night, high fever, chills & sweating, arm has a huge swollen lump at injection site, body aches (legs) and a headache. Took 500mg Naproxen and went to sleep. Woke up next day with all symptoms gone except the swollen, painful lump in my arm at the injection site, which I still have as of today, June 10th. It's not getting any smaller. If the lump and pain doesn't go away by Monday, I will be visiting my doctor again.

4/8: Immediate injection site numbness and dizziness. As day wore on, I felt fatigued and later developed a fever ranging around 100.5°F. Throughout the night, I had body chills, muscle and joint pain as well as skin sensitivity. 4/9: Fever ranged from 100.5°F to 101.1°F. Dizziness, fatigue, headache, chills, muscle and joint pain, skin sensitivity and nausea. 4/10: Fever ranged from 99.8°F to 100°F. Dizziness, fatigue, headache, muscle and joint pain with mild nausea. 4/11: Fever ended. Mild dizziness, fatigue, muscle and joint pain. Around mid-day, both arms went numb with tingling/prickling pain from shoulders to fingertips. Could not open and close hands well. Could not hold, grasp, text or type/weakness in hands. Pain: 7-8/10. 4/12: Severe numbness. Noticing pain radiating from behind both elbows and going up to the shoulders as well as down to fingertips. Weakness in hands. 4/13: Went to school clinic and referred to ER for testing. Was given ibuprofen and told to take OTC painkillers. 4/19: Issues with insurance/unable to schedule follow-up with neurology in home town due to insurance based in nearby city but I am unable to drive and school is still in session. Telehealth call with PCP to go over options. Left arm is slightly improving but still going numb/tingly/prickly occasionally with pain radiating from behind elbow. Pain: 5-6/10. No improvement in right arm with pain and numbness being constant. Noticing slight pain behind left knee. Pain: 3/10. Purchased hand brace and arm sling for right arm. Taking Advil but noticing little to no relief. Use of warm and cold compresses as well as massage instead to help alleviate pain. 4/29: Attempted performing everyday tasks and school assignments for ceramics. Exasperated both arms. Severe numbness and tingly/prickly pain. Pain: 8-9/10. Left knee pain has not dissipated/becoming more and more noticeable. Pain: 3-4/10. 5/4: Intense pain decreased back to usual pain levels. Noticed swelling behind left knee and pain going down to calf muscle. 5/6: Appt w/ school clinic again. Referred to ortho doctor on 5/13 and prescribed Celecoxib 200 mg. 5/12: Appt w/ school clinic. Saw ortho doc. Diagnosed with potential Baker's Cyst. Sent to ER to double check for blood clots. There was none. Diagnosis is potential Baker's Cyst or Meniscus Tears. Was prescribed Diclofenac Sodium 1% Gel and told to wrap knee. 5/13: MRI of full cervical spine with and without contrast done at Radiology at another city. 5/26: Left arm is almost completely recovered. Pain: 2/10. Still slight pain behind left elbow. If overused, however, more pain and numbness. Right arm is constantly in pain but it is not as severe as previous month. Pain is 6/10 and runs from shoulder to fingertips but more prevalent around shoulders to behind left elbow and wrist. Shoulder pain feels like burning pain instead of usual tingly/prickly pain like the rest of the arm. Left knee gives out randomly and I feel pain from behind knee to calf whenever standing for long periods of time or walking for more than 20-30 minutes. Pain 2-3/10. 6/1: Telehealth appointment with PCP to go over test results. Referred for neuro consult. Was prescribed medication for neuropathy but currently meds are with mother in a city. Unable to drive from city to city to pick it up. 6/8: Telehealth appointment with neuro consult. Waiting on referral for nerve conduction study. Pain has not changed for right arm or behind left knee. Decreased walking due to more frequent moments of knee giving out. Overall, due to constant arm pain in dominant arm (right arm), I am unable to do most activities without assistance such as cooking, cleaning or driving. Right arm/shoulder get exhausted fairly quickly or nerves become inflamed when attempting to use it more. Shoulder feels like it's burning slightly. Sometimes hand/arm will shake and feel a spike of pain when overused. Must do things more with left arm and can not walk far without falling down randomly due to left knee giving out.

Headache for first 24 hours and feeling achy. I felt sluggish around 8:00PM. My mom woke me up in the morning because I was burning up and I took a Tylenol. When I woke up, I had a massive headache and feeling achy all over. Had the headache for about 24 hours and feeling achy. I did go to work later that day, still, I was just a bit sluggish, brain-foggish and achy. I had the brain fog for a few days. I have been having a headache most days - not every day though. Right now she has me taking some magnesium and some Riboflavin to see if that will help. I hydrate quite a bit. June 8th, Rash on my neck - itchy and burning sensation. I applied Cortisone but it wouldn't go away. On the 11th, I called doctor because it was getting bigger and going across my neck. She told me to stop taking that and she prescribed for me some Clotrimazole but I stopped taking it - it seemed to make the rash worse and one day my throat was closing up and I went to the ER and I took Benadryl before I went in. By time that I got there to see the doctor, it wasn't so bad. Diagnosed at ER with Contact dermatitis - is diagnosis - and they prescribed a medicine for it - Prednisone and to continue taking Benadryl until the rash disappeared/healed. After about 3 days of that, it seemed to be going away. Right now, it's healed but there's still marks from it. There is still a small patch of the rash that is on my neck (where it originated) there and my doctor said to leave it alone for right now. Recently, I have been experiencing some leg pain on my left leg. It's been hurting lately. Doctor has prescribed an ultrasound to look at my calf and my foot.

12 hours later I woke up in a cold sweat. I couldn?t sleep, had severe chills but felt very hot, slight fever, very bad inner ear burning, headache in temples + front and back of head. Severe skin sensitivity, light and sound sensitivity. Severe muscle aches and can?t really get out of bed.

Patient presented with unusual bruising to upper leg. Instructed patient to seek urgent medical attention.

Janssen COVID-19 Vaccine EUA. Please note the chronic knee injury previously reported. A day after my shot, I experienced 48 hours of joint pain in my chronically injured knee. I ruled out outlying factors like excessive exercise, overuse, or weather events, and could only conclude the shot was affecting me. Today, around 5 pm until writing this report at 12:30 am, my knee has been experiencing joint pain again, and again, I've ruled out all other reasons other than this potentially being an adverse symptom of the shot. The joint pain is mostly felt in the front of my knee, underneath my patella, and does not move to other areas. The knee is warm to the touch and not swollen like it usually would be when I experience overuse.

Low-grade fever (99.9 F - 100.4 F) Extreme fatigue Muscle aches Headache Neck pain Soreness at injection site

Headache that began shortly after vaccination and has continued into day four. Bruising at the site of injection. On the morning of day four, redness and itchiness appeared.

Janssen COVID-19 Vaccine EUA slight rash (red skin) on back of both hands and slight headache; both faded after a couple of hours

Pain and swelling at the injection site that began 3/12/2021 and remain 3 days later Muscle soreness beginning 3/12/2021 to 3/14/2021 Fatigue beginning 3/13/2021 to 3/14/2021

Injection site soreness and somewhat severe flu-like symptoms starting the evening after the vaccine. Flu-like symptoms included chills, sweats, fever, achy muscles, dry cough. Symptoms persisted all night and most of the next day. Symptoms were treated with Dayquil, which helped a lot. Symptoms seem gone today, approximately 30 hours after symptom onset. Injection site tenderness persists, but is only noticeable if I poke it.

Three days after A raised red painful rash that is spreading and much bigger than the actual injection site. Pain increasing so far each day as is the size of rash/reddened area

12:28pm Splotchy red rash on L deltoid ( shot site) and chest traveling up left neck and ear. Patient given Diphenhydramine 25 mg PO. BP:135/84 p:81 Monitored vital signs: 12:35: 125/86 p:83 12:40: 119/83 p:76 12:46: 133/91 p: 92 Rash fading 12:50: 125/80 p:92 Rash much more diminished and patient denies any shortness of breath, scratchy throat, itchy ness or other symptoms. Ate a granola bar and them dismissed with instructions to call 911 if scratchy throat or difficulty breathing occur.

6.45pm: started with chills and being very cold including blue lips 8pm until 1am: chills got worse and were uncontrollable. Body was shaking heavily. At some point, body was very hot and I developed headaches and some back/neck aches. Chills continued during that time. I was very thirsty but drinking resulted in nausea. I had one thought over and over again which I couldn't break out of. 1am: Vomitted 1:30am: Admission to ER

Received the covid19 vaccine at 11am. Started feeling very cold around 2pm (nail beds were turning purple). By 4pm I had a headache, body aches, upset stomach, tired, fever, and chills. My fever would go up and down, highest was 103.2 reached that temp 3 times. By 2am my mother drove me to the ER. I was diagnosed with a migraine and was given IV fluids and an IV migraine cocktail. After receiving the fluids and meds I felt much better and was released back home. I periodically have pain in the injection site.

I developed Shingles on 3/16 left side of my face. It started off as small cluster blisters contained to that one side of my face spreaded back of my neck accompanied by TJ symptoms. I had a TeleHealth visit was prescribed Antiviral medication and was told vaccine might have triggered my immune system. I have been on the medication for a week now symptoms had subsided.

Janssen COVID-19 Vaccine EUA Pain, swelling, redness, and itchiness at injection site. Pain has decreased since 3/21 (day after vaccination) but is still present; redness, swelling, and itchiness have become more prevalent.

Fever (4+ days), sweating (4+ days), chills (4+ days), nausea (2 days), headache (2 days), sore joints (4+ days), skin hurt (3 days), fatigue (4+ days), stuffy nose (2 days), sneezing (1 day)

Right after I received my vaccine I was told to pull up and wait 15 minutes. After about 2 minutes I started to feel hot and noticed my arm was red. I pulled down my visor and used the mirror to look at my face and chest area and noticed red splotches all over. The rash quickly moved to cover my whole body within minutes of receiving the vaccine. Ochsner had me pull over by the EMT tent and I waited 45 additional minutes to see if I had any other effects. The rash didn't go away but I didn't itch and I wasn't uncomfortable. It was just a surface rash. The rash was completely gone by 10PM that same night. I woke up at 2AM that same night/early the next morning and the whole left side of my body was numb and felt very heavy. I also had a very mild fever and cold like symptoms. These symptoms included chills, dizziness, fatigue, and headaches. All of my symptoms, including the pain and heaviness on my left side, were gone the following morning which was about 36 hours after first receiving the vaccine.

first night- severe headache, body aches and chills. second day - severe reaction to the sun. face, neck, and legs are swollen and red from being outside for about an hour and a half. nothing unusual for me as I normally spend time outside in the sun.

Patient received vaccine while seated and had no problems. She stood up and walked several feet to the observation seating area and had a seat. A few minutes later she fainted and fell out of the chair onto the floor. We helped her up to a sitting position and gave her a bottle of water and an ice pack. The right side of her forehead appeared red from apparent hit on the floor when she fainted. We had her wait on the floor for about 30 minutes to ensure she remained conscious. Patient reported an ache on her forehead at site of hit. She was also sweating and reported feeling hot. Patient had a partner with her who agreed to escort her to an urgent care clinic in the same building as the pharmacy. Store manager in charge took the patient to the urgent care clinic by wheelchair to be examined.

4/1/2021 in the morning: nauseous, dizziness, sore throat. In the afternoon: chills and hot flashes alternating . All day extremely painful arm 4/2/2021 morning nauseous. All day hot flashes. Pain injection site. 4/3/2021 all day hot flashes, loss of smell. Mild pain injection site. No fever any of those days

About 12 hours after vaccine - migraine, nausea, chills, high heart rate, sweating , sore arm At around 24 hours - migraine, sore arm but other symptoms gone. At around 36 hours - all symptoms gone besides slightly sore arm around vaccine site.

Jansen COVID-19 Vaccine EUA ENDED UP IN ER ON 4/4/2021 due to severe allergic reaction at injection sight and unbearable pain. Discovered by doctors that a nerve was hit at injection sight and that the shot was done too low in my arm. Very hot to touch and swelling as well.

Arm hurt very badly immediately during and after vaccine in similar sensation to ulnar nerve being struck in arm, bled only a little but caused swelling and then a large bruise developed over the evening of 4/4/2021 and is still dark today (4/7/2021). Concerned my bone was hit with a too long vaccine needle. Had chills/fever evening of 4/4/2021 into morning of 4/6/2021?had to take off work. Have had neurological symptoms ongoing with ?brain fogginess? since 4/5/2021. On 4/6/2021, began to see flashes/spots of light in vision of left eye, which worsened through today. Took off afternoon from work and went to an eye clinic to have eye dilated and looked at, but the spots in vision continue through reporting time (4/7/2021, 5pm CT).

Patient reported that she had a red, itchy rash on her face and arms. She also reported mild tightness in her throat.

BODY ACHE; DIZZINESS; GETTING COLDER; SWEATING; CAN'T MOVE LEGS AND INJECTED ARM; HEADACHE; NAUSEA; HIGH FEVER; INJECTION SITE ARM SORENESS; This spontaneous report received from a vaccine facility concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAR-2021, the subject experienced body ache. On 29-MAR-2021, the subject experienced dizziness. On 29-MAR-2021, the subject experienced getting colder. On 29-MAR-2021, the subject experienced sweating. On 29-MAR-2021, the subject experienced can't move legs and injected arm. On 29-MAR-2021, the subject experienced headache. On 29-MAR-2021, the subject experienced nausea. On 29-MAR-2021, the subject experienced high fever. On 29-MAR-2021, the subject experienced injection site arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body ache, dizziness, nausea, high fever, getting colder, sweating, injection site arm soreness, and can't move legs and injected arm. This report was non-serious.

After taking the vaccine Janssen 24 hours, injection area appeared a dime size red rash, and it turned into 2 x 3.5 in. Swelling. In the 48 hr, it expanded to downwards towards elbow, around 1/2 upper arm, the 72hrs, it expanded to 2/3 of the upper arm. Feeling sore, swelling, itchy. Took the Advil, Vick?s cold medicine, and benadry, did not relieve the symptoms much.

~30 seconds of bleeding from injection site. About 10 hours after injection, severe flu-like symptoms including nausea, headache, exhaustion, body aches, high fever. Intense flu-like symptoms, including fever, lasted about 12 hours after onset (~24 hours after injection). Severe symptoms treated by OTC ibuprofen ~20 hours after injection -- moderately helpful at abating symptoms. Milder symptoms, including headache, body aches, and tiredness persisted for 36 hours after injection.

Fever at 100.3F Stiff and weak muscles-severe (had trouble walking in home) Fatigue-severe (struggled to stay awake at work) Chills Muscle aches-severe Developed a knot on the arm Itching at injection for 6 days Constant thirst (I was drinking more water than usual and could not seem to feel hydrated no matter how much I drank)

Night of vaccination: Immediate intense pain at injection site - subsided slightly after movement 5:00PM - Chills, tiredness 8:00PM - Low grade fever 99.1 10:00PM - Fever 100.4, extra strength Tylenol taken 11:00PM - fever breaks, immense headache, elevated heart rate 12:00AM - headache begins to subside due to Tylenol, still elevated heartrate 12:30AM - falls asleep Next day: 8:00AM - woke up with slight headache, no fever, slight nausea, arm pain subsided slightly 10:00AM - extra strength Tylenol re-administered 11:00AM - headache breaks for rest of day The rest of the day was waves of tiredness The following day: Tiredness continues, arm pain begins to subside Third day following vaccine: Felt more like myself, occasional sore arm which subsided after the week mark

High fever, body aches, headache - presented roughly 8 hours after injection. General soreness around injection site.

FULL BODY HIVES; HEADACHE; EXTREME FATIGUE; NAUSEA; FEVER; BODYACHE; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight was 110 (unit unspecified), and height was 5.1 (unit unspecified). The patient's concurrent conditions included asthma, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 10:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced bodyache. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced extreme fatigue. On 06-MAR-2021, the subject experienced nausea. On 06-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced full body hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyache, extreme fatigue, nausea, and fever on MAR-2021, recovered with sequelae from headache on MAR-2021, and was recovering from full body hives. This report was non-serious.

DIZZINESS; BODY ACHE; MUSCLE STIFFNESS; JOINT PAIN; CHILLS; HEADACHE; FEVER; VACCINE EXPOSURE DURING PREGNANCY; SORE INJECTION SITE; FATIGUE; This spontaneous pregnancy report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced sore injection site. On 04-APR-2021, the subject experienced fatigue. On 04-APR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. On 05-APR-2021, the subject experienced body ache. On 05-APR-2021, the subject experienced muscle stiffness. On 05-APR-2021, the subject experienced joint pain. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: paracetamol. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 06-APR-2021, was recovering from sore injection site, headache, body ache, joint pain, and muscle stiffness, had not recovered from fatigue, and dizziness, and the outcome of vaccine exposure during pregnancy and fever was not reported. This report was non-serious.

Fever over 100, chills, cold sweats, muscle aches, headache, nausea, injection site pain, whole arm pain. My fiancé had same symptoms as well in the same time frame - he got his at the same time.

First I began to notice generalized itching a few hours post vaccine, similar to allergic reactions I have had to insects. Then I began to notice mild finger swelling. Then swallowing became difficult, then I began to become nauseated.

Body aches, I'm shaking so hard I bit a hole in my tongue, I'm dizzy, freezing cold even with 2 fuzzy blankets and a heating pad. I lost feeling in my hands last night and my fingertips felt like they were buzzing (like neuropathy feeling). Hallucinations. I tried to take a warm bath last night to knock the chill off but it hurts when water touches my skin. I couldn't do anything but cry. Could not sleep because of cold/shaking and body pain

On friday night 4/9, pt started to have swelling and redness on arm with soreness. pt presented today with same symptom with warm to touch. Pt marked arm with sharpie to determine if spreading was occurring. in about 3 hours time, the redness spread about 3/4" out of the sharpie marked area with further discomfort felt by they patient. the pt will see medical evaluation and further care if needed.

Janssen COVID-19 Vaccine EUA Injection site redness, swelling, pain, warm to touch Headache, very tired, body aches

Hot flashes without fever, tiredness, redness and welting at injection site, abdominal cramping, vaginal spotting, menstrual cramping

At around 6:30 p.m on April 9, 2021, I started to feel very cold at home. I had sever chills where I was under 5 heavy blankets unable to get warm. I also had a high fever which was 104.8 degrees Fahrenheit. I also threw up twice and had body aches in my arm where the nurse injected the vaccine, my lower back, and calves of my legs. When my temperature did not go down, I went to Emergency Room at around 12:00 a.m. April 10, 2021. I was placed in isolation. The nurse took my vitals and the doctor ordered covid test for me and a urine analysis. The covid test came back negative and my urine analysis was in the normal range. The nurse gave me Tynenol at around 1 am and ibuprofen at around 2:30 am. I was discharged at approximately 5 am on April 10, 2021 with a 98.4 degree temperature.

10Apr2021 Joint pain (toes, ankles, knees and hips) starting at 6pm - currently ongoing - took two 200mg Advil, no resolution. Mild fever 100.4 at 10pm - took two 500mg Tylenol, fever subsided at 11pm 11Apr2021 Continued joint pain, took two 200mg Advil at 2pm, no resolution. Took two 500mg Tylenol at 10pm, was able to sleep until pain woke me up at 6am. 12Apr2021 New painful, swollen, red, warm to touch bump at injection site, visible after shower at 8am - currently ongoing. Continuing joint pain, took two 500mg Tylenol at 9am, helped for a little bit, pain still ongoing (more like intermittent sharp pain now). New hives appeared on my face at 10am, took 25mg of Benadryl, slept for four hrs, hives subsided.

Dizziness started 1 hr after, shaking/chills started 5 hours after. 103 degree fever for 3 days (even while taking ibuprofen and tylenol), headache, body aches, swollen lymph nodes, rash, extreme nausea and vomiting.

Shortness of breath (still to this day) Headache Body pain Blister in left side of stomach that resulted in wound. Wound on left lower back with skin coming off from light scratch Severe redness on injection site (left arm) that was hot to touch and lasted for 2 weeks post vaccination.

After 3 days in the vaccinated arm I got 2 red dots under the skin, then in the other arm I got a diminutive dot and likewise another 2 dots in my chest on the right side and in my stomach one more dot, lately today I have a little pain in the left side of my leg where I have little veins.... and I noticed that my veins are more visible

102.6 fever by PM of 4/6/2021; chills, elevated heart rate (resting HR at 120-130), oxygen levels at 95-96%; redness, swelling and pain at injection site Fever continued through 4/8/2021 reaching a high of 103.6; chills, elevated heart rate continued but lower to around 110, oxygen levels 96%; redness, swelling and pain at injection site Redness, swelling and pain at injection site still continued through today, 4/13/2021; large border of bruise on upper arm from injection

Day of vaccine- Within hours, site soreness, raised red, approx size of a quarter, mildly painful, with a "lump (that is still palpable) under the surface of the skin". Within 5-6 hours following vaccine administration, she reports she developed fever, chills for approx 2 days with fatigue and hot flashes on and off. ** On 4/7/2021, patient states that in the morning she developed pain in her right calf. She saw her PCP.

INJECTION SITE BLEEDING; This spontaneous report received from a patient concerned a 30 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 was not reported, administered on 07-APR-2021 for prophylactic vaccination. The Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 07-APR-2021, the subject experienced injection site bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site bleeding. This report was non-serious.

Got the vaccine on Thursday 4/8. By Sunday 4/11, injection site swelled to side of bicep diameter, became inflamed, deep aches and pain, severe itching, small blisters. Treating it at home with standard ibuprofen, icing, and topical steroid cream.

-Dibilitating headache came on slowly starting around 4pm day of vaccine (roughly 60-90 minutes following) Built in intensity and the following morning throughout the day after vaccine was causing dizziness to the point of motionsickness and vomiting when moved too much. headache hit peak at 24 hrs post vaccination and slowly decreased in intensity until about 48 hrs post vaccination. Took advil throughout. -Full body shivers despite warm or hot environment and comfort level Beginning about 30 hrs post vaccination vaccination and lasting about 6 hrs. -Large bump at vaccination point started developing 72 hrs post vaccination. By 5 days post it was the diameter of roughly a baseball but only slightly raised, hot to the touch, very painful, restricted arm function and itched. That evening before bed (5 days post) self treated with 20 minute ice pack, hydrocortizone cream and performing deep massage moving outward from vaccination point as long as could tolerate pain. Noticed extreme improvement the next morning: area had cooled to regular body temperature marked improvement in pain, size and fuctionality. Repeated "treatment" that evening (6 days post) and today (a few hours shy of 7 days post) area is still itchy, knot has decreased to the size of a bean, pain gone except when poked like a bruise. I will likely repeat self prescribed treatment more time.

Rash- appeared within 30 minutes- resolved with three doses of benadryl Numbness- appeared within 30 minutes-comes in waves- provider recommended to continue benadryl Itchy- appeared within 30 minutes-comes in waves- provider recommended to continue benadryl pain- generalized pain- appeared within 30 minutes-comes in waves Migraine- 3:00 am day following - able to treat with Aleve

Per participant 04/10/2021 15 to 20 minutes post injection , rash started on neck and chest. By the time patient arrived home +/- 20 min, rash had spread to both legs. Onset lower extremity edema occurred in L/R ankle, L/R leg, L/R feet. Took Benadryl 04/11/2021 swelling and rash no longer present. Slept most of the day, did get up to eat dinner, experienced diarrhea in the evening, notices no change in appetite. Rotating Tylenol/ Ibuprofen 04/12/2021 fatigue, light headiness, dizziness, headache, chills, nausea, diarrhea, jaw/mouth pain, sore throat 04/13/2021 sob, severe fatigue, nausea Rotating Tylenol/Ibuprofen

Thursday the 8th around 1:30pm:Started feeling sick By 5:00pm had chills, headache, very tired, body aches Friday April 9th- Monday April 12th: Chills, arms continues to switch from hot to cold, pins and needles feeling, difficult to hold something in had for a long period of time. The vaccine spot was very sore and red. By Sunday evening it started itching. Tuesday April 13th: Spot is still red however swelling has gone down. Arm still switches from hot too cold with pins and needles. Still cannot grip something in hand for a long period of time.

my daughter, 30 year old, on disability with POTS, MCAS, EDS, dysautonomia, received the JJ COVID vaccine at 1:30 PM on 4/9/2021.. She started vomiting 20 minutes after the vaccine was administered and the pharmacist said it was because she was anxious and has not eaten much. We went home, she was very tired and slept most of the afternoon. At 6 PM she started vomiting again. It continued till 10:30 PM when she could not drink anything. We went to the hospital where she exhibited what looked like a seizure in the waiting room and was admitted to the hospital for observation. Discharged 4/10/2021 evening. 4/11/2021 exhibited restless leg syndrome, could not sit, lay down, whole body aches. 4/12/2021 extremely sore arm, could not move it without pain. Area of injection looks read but not hot and no swelling.

Janssen COVID-19 Vaccine EUA On 4/13/2021, I work up and noticed a rash on both of my hands and wrists consisting of little small red docs about the size of a pencil eraser. That night, my knees where very itchy and I noticed the rash was on my knees, thighs and hips. On 4/14/2021, I woke up and the rash was all over my body from the neck down. My left arm was very red with my right arm not having as much redness. My knees very extremely red with little normal skin color showing. The rash was slightly itchy.

Fever, lightheaded, severe muscle weakness and back pain. Headache. Increasing rash on back of scalp over 24 hours later.

Patient experienced a rash, bruising, and swelling several days after the injection. She reported it to her doctor.

Woke up at 11 pm the same night after dose with a 102.5 fever, chills, severe headache, fatigue, body aches, vomiting, dizziness, and pain at injection site. These symptoms including the fever lasted for 2 days.

From the moment I was injected I felt a sharp shooting pain from the injection site down to my elbow. This was constant for about 2 weeks and up until now it is frequent with some intermittent relief. It is a deep pain that still radiates the entire upper portion of my injected arm (left arm).. at this point, I am unsure if this could be permanent and result in testing.

Initial injection site pain lasted for a day or so, went away, and now arm is sore again at injection site.

No adverse reaction immediately following vaccine, but woke up the next morning with hives on arms, feet, chest, lips and tongue were tingling, throat was itchy. Immediately had a phone appointment with primary who advised to take benadryl and go to hospital if it gets any worse. Immediately went to get benadryl and by the time I got to the pharmacy, my lips and tongue were completely numb. Benadryl was effective, hives and scratchy throat persisted for 10 days.

Full-body hives that began on the thighs and spread beginning 5 p.m. April 15 and ending approximately 10 a.m April 18. Did not seek a doctor but instead self-medicated with OTC Benadryl, hydrocortisone cream, and oatmeal baths.

BODY ACHES; EYES HURT AND WERE SENSITIVE TO LIGHT; MUSCLE CRAMPS; EYES HURT; BRUISE AT INJECTION SITE; RASH AT INJECTION SITE; WEAKNESS; TIREDNESS; EXTREME HEADACHE; FEVER; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, once a total administered on 23-MAR-2021 vaccinated at left arm, for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced eyes hurt and were sensitive to light. On 24-MAR-2021, the subject experienced muscle cramps. On 24-MAR-2021, the subject experienced eyes hurt. On 24-MAR-2021, the subject experienced bruise at injection site. On 24-MAR-2021, the subject experienced rash at injection site. On 24-MAR-2021, the subject experienced weakness. On 24-MAR-2021, the subject experienced tiredness. On 24-MAR-2021, the subject experienced extreme headache. On 24-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, extreme headache, muscle cramps, eyes hurt and were sensitive to light, bruise at injection site, rash at injection site, weakness, tiredness, body aches and eyes hurt was not reported. This report was non-serious.

About 24-36 hours after receiving the vaccine I experienced pain/burning on my labia (the outside, not inside). After inspecting it myself I realized I had multiple lesions 2 days post vax. I saw a nurse practitioner and I went on anti virals prescribed by a local woman?s clinic for suspected herpes which cleared things up within the 10 day regimen. They immediately did a swab of the area for suspected herpes simplex which was negative. I have since done 4+ herpes simplex 1 and 2 tests (blood and swab) and all have been negative. I have also done HIV, RPR, chlamydia, gonorrhea, and auto immune blood tests (and more) and all results have been negative. The issue is now cleared but my PCP wanted to find the root cause of the issue and potential underlying condition. I have a history of shingles on my back/shoulder and the pain/lesions appeared similar in nature but presented on both sides of my labia in this situation (though much more on one side than the other). My last major outbreak on my back/shoulder was in 2010-2011. This was the only outbreak in which lesions appeared though I sometimes feel the area tingle/tense up when under stress or sick. In addition to the lesions, I had typical flu like symptoms after the vaccine that began about 8 hours after and lasted for 2-3 days.

Patient had immediate dizziness and nausea after vaccine administration at 1:00 pm. She developed a widespread urticarial rash on chest and neck within 5 minutes of vaccine administration. She was immediately given diphenhydramine suspension, 25 mg (10 mL of 12/5mg/5mL). Rash resolved within 15 min of administration. She continued to have nausea. At 1:45pm symptoms had improved and she was cleared to go home.

Pain at injection site - immediate and went away within a few minutes Dizziness, fuzzy head - started 10 minutes after shot and has continued consistently (now 6 hours later)

Arm pain 3 weeks post vaccine. Initial arm pain faded after 4 days. New pain started after 19 days. Hurts to lift or put pressure on the left arm at all. Getting worse by the day. Pain is directly at vaccination site and slightly below. Was told by doctor to come back in if I develop a fever and take ibuprofen in the meantime.

Broke out in hives consistently, shortness of breath, throat tightening. Hives are not clearing up. D dimer 1450.

Patient is 30 yo G1P0 at approximately 27 weeks gestation. Her pregnancy was complicated by depression on Zoloft. She reported an all-over body rash a week after the vaccine. Approximately 2 weeks later, she presented with neurological symptoms with L facial weakness, now with significant bifacial paresis and bilateral hand paresthesias concerning for Guillain Barre Syndrome which was confirmed on lumbar puncture.

4/8/2021- After shot I had high fever fluctuated between 101-104 and went away next morning 4/12/2021- I saw 3 circular tiny rashes on my left chest, above my brests. It eventually lightened and went away after 2 weeks. 4/24/2021- I noticed inflammation in my left knee and it blew up by 4/26/2021 and I was not able to walk. 4/26/2021 Spoke with my primary physician and was advised to visit the urgent care, the pain was a 9 out 10 . 10 the extreme 4/26/2021 - Visited Urgent Care , Two injection were given Tordal and Decadron. Was prescribed Medrol 25mg for next 6 days 4/27/2021- There was no pain, there was swelling/inflammation present, Continued wearing compression socks and treated with ice pack 3-5 times a day 4/29/2021- Inflammation was gone 5/1/2021- Inflammation on right ankle, took advil 5/3/2021 - I had no issues(inflammation) until this weekend and also completed medrol dose . However, this morning I started seeing inflammation on my right ankle, this has started impacting my normal walk. I am using icepack and the socks to provide some relief. took advil and continued with ice pack and wearing compression socks 5/5/20211. the pain and inflammation has shifted to my top of right upper foot. feeling discomfort, swelling , warmth from my toe to area to the middle top of right foot.My walking is painful, if I put weight on my right foot. I had taken ibuprofen and continued wearing the socks. Also another development on my right hand wrist same thing , I could not brush with wrist movement toward the right side. 5/6/2021- Same pain and had a virtual visit with my primary physician 5/7/2020 - Going in for more lab work for uric acid level

Covid-19 vaccine given to patient @ 4pm on 5/10/21. Patient started to feel hot within the 15 minute observation period. She claimed she felt well and left coming back to the pharmacy immediately explaining "something was not right." She had trouble breathing, hives, facial swelling, throat swelling, itching, flushing, shortness of breath, chest tightness, throat tightness, anxiety and sweating as well as tachycardia. 911 was called. Epi-pen was provided as recommended by 911 dispatch and per pharmacy Immunization protocol. Fire team arrived and gave the patient O2 and monitored stats. Emergency team arrived and took her to the Emergency room,

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Medium

My arm has been swollen for over 4 days and is very itchy and red. It has been very painful to the touch

Almost immediately after the vaccine at the injection site I got a real bad hot sensation. For about 2 days it was swollen and had localized pain for about 9 days. I was very fatigued. And I developed a severe headache the next day that was so bad I could barely stand it. 4/11 I went to the Primary Care and saw a dr who took bloodwork and prescribed some iron because she said I was anemic. But for about the first 3 days after the vaccine the headache pain intensity level was at a 10, then it lowered on its on to about a level 3 but was still there for about 3 more days and after about day 6 the headache intensity returned to a level 10 and on day 8 I went back to the dr because nothing would relieve the pain and the pain was so intense I couldnt bare it. I had an MRI on 4/21 which came back normal with sinus pressure present and finally about 4/23 the headaches finally subsided. I also notice the next 2 menustral cycles after I had severe cramping and my breast got really tender and sore and I bled longer than usual which is abnormal for me and I also noticed I had developed a cyst in my right breast and had a mammogram performed which did show that I had a large cyst in my breast

shortly after vaccine given I noted a rash on patient's chest and she reported that her face was feeling flushed. she stated no rash prior to vaccine. Using an interpreter I monitored patient and at no time did she report tightness of chest, throat or lips. I took her Blood pressure 128/93 pulse 82. Patient drank about 1/2 bottle of water. Continued monitoring her and rash receded. Patient said she felt better. I offered further medical attention. Patient declined. I instructed patient to hydrate and minimize activity for the rest of the day if rash returns take a benadryl. Seek medical attention in the event of any tightness in chest or throat. patient remained in store over 45 minutes and stated she felt fine and departed

HIVES ALL OVER BODY; ITCHY RASHES IN FACE AND NECK AREA; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23/JUN/2021) .5 ml, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced hives all over body. On 26-MAY-2021, the subject experienced itchy rashes in face and neck area. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, loratadine, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy rashes in face and neck area, and had not recovered from hives all over body. This report was non-serious.

Hot Flashes, chills, increase in non-epileptic Seizures, fever 103.7, body aches, rash around injection site, extreme exhaustion, vomiting, chest pain. Symptoms lasted 3 days with exception of rash, fever and chills which lasted 8days.

Beginning day two my face and neck, which are typically completely clear, broke out into bumps resembling heat rash. This breakout has yet to clear following my normal routine. The only change in my normal activities in that time was the vaccine. The breakout may have started earlier, but I had no need to check a mirror while resting from other side effects.

4/25/2021 went to ER with headache that was over 24 hours, CT scan showed nothing was sent home where head still persisted in total over 48 hours. Veritgo the immediate week after was horrible. Shoulder pain at injection site persisited for 8 weeks. Random burning spots of pain began in injected right arm a couple days after, random burning pain spread to both thighs and continued in thighs and arm for 6-8 weeks after. Periods are heavier than ever before.

Pt states she felt dizzy. EMT got behind pt and pt fell into staff. Pt passed out unconscious with eyes wide open, c-spine stabilized. Jaw clenched shut, held her breath, turned blue, sternal rub performed, jaw thrust maneuver performed. Pt in decerebrate posturing, bladder incontinent during episode. Emergency services called. Pt became alert, hyperventilating, began crying. Staff assisted her to cot. States no previous medical history, no allergies, ate two hours prior to vaccination. VSS, pt continuing to hyperventilate and cry. EMS arrived on site and took over. Placed 20g IV in RAC, drew blood, bgl 122.Pt and all belongings taken to Community Hospital by EMS. Pt was AOX4 GCS 15 at time of tx

Fever, mild headache, fatigue approximately ten hours after vaccination, treated with Tylenol and rest. Soreness at injection site occurred the next day, approximately 24 hours after vaccination, and lasted approximately 72 hours before subsiding; treated with massaging the area.

Patient is a 30 y.o. female who presents to the ED with concern of reaction to her second vaccine. She received the vaccine on Wednesday and that evening he developed nausea, vomiting and diarrhea. She states she has mild, intermittent coughing, fevers body aches and fatigue. She she states that she has been having difficulty keeping any food or fluids and as she will have episode of vomiting or diarrhea shortly after eating or drinking. On her left arm area of the injection site she has area of redness that is irregularly shaped approximately 10 cm in length by 6 cm in width. The area is mildly warm to palpation. She has been applying ice packs. She has been taking acetaminophen to control the fever no other medications taken. She states she has been attempting to stay hydrated with sips of fluids.

Injection spot hurt right after injection but became incredibly painful deep inside my shoulder within a few hours. Four weeks later, it still hurts to turn my arm away from my body, lift my arm, pick up any weight away from my body, drink with my left hand holding the cup. I went to my primary care and she prescribed Etodolac 500mg twice a day for 10 days believing the pain to be stemming from inflammation in my shoulder. I believe it's my fault because I dropped my shoulder inside my shirt and kept it dropped while the injection happened. When I put my shoulder back normal, the injection seemed really high.

Fever so far reaching 100.2, headache, neck pain, weakness, skin sensitivity, hair sensitivity, nausea, muscle and joint pain, muscle spasms/cramps with short term weakness.

Arm pain following injection. One day after the injection, I experienced a headache and used otc ibuprofen to treat it. Then a firm red bump appeared at the injection site about 2 days after receiving the vaccine. The bump is roughly 1" by .5" and hurts when touched.

Janssen COVID-19 Vaccine EUA At 7:00am on 3/11/2021 felt light headed as waking up along obvious soreness on the arm where I received the vaccine- left arm. Then later around 10:00am a feeling of tiredness came over my whole body. Around 12:00pm I felt even more tired, lightheaded and my eyeballs felt as if with high pressure in them and are feel sensitive to the sunlight. Also, at 12pm, I had lunch, which was my first meal of this day and felt the necessity to lay in bed and take a nap for 20 minutes before returning to work. While taking the nap I felt tingling on my feet, arms, hands and neck along with certain sudden muscle contractions on the same parts.

From 6pm-5am I experienced a terrible migraine, horrible body aches (every joint and muscle was throbbing), upset stomach, uncontrollable shaking/chills, and light headedness. Could only sleep short spurts after taking 400 mg of Ibuprofen. 24 hours after the vaccination, my body is still achey, sore at injection site, and uneasy stomach.

Developed a fever of 104F at 14 hours after injection. After taking acetaminophen, the fever dropped to around 101 and stayed there for 12 hours before subsiding. Body aches and extreme fatigue were also present. 48 hours after injection (03/08/2021) I woke up with major skin irritation. There were no visible signs like a rash or any redness, but my skin felt sunburned and wearing clothes was extremely uncomfortable. This lasted until 03/10/2021. I used lotions and took cool showers to help with the symptoms.

Tingling/numbness in left arm near injection site and in face and tongue. Began about 20 minutes after vaccine and continued until I took benadryl and the symptoms subsided.

Pain at injection site, Chills and whole body muscle ache, feeling as though I had a fever and had been hit by a car

4 full days after receiving vaccine, red rash started on arm of injection, slightly below injection sight. Red area continued to grow for 24+ hours. Red area hot to touch. Left arm very sore.

after the vaccine arm got swollen was administered Fever and nausea Doctor- follow up with neurologist and at the moment she wasn't expressing any symptoms and if she started experiencing any symptoms call PCP The symptoms began at 5p.m. and hasn't gotten the doctor but will call him tomorrow

Day of/after pain in right arm and slight fever(99.4). On March 11 I broke out in hives on both arms, both thighs, neck/clavicle, and lower right leg this started around 8am. After work I went to Pharmacy to their consultation window (2:15) and they recommended benadryl and to call my PCP. I took my first dose at 2:30pm and followed up with a second one around 9pm. I called and spoke with my PCP over the phone, she had me take benadryl at night for the next 3 days and claritin in the morning for the next 3 days. The hives and redness were gone by the morning of the 12th. My skin was still sensitive throughout the 12th but was back to normal by the time I went to bed on the 12 (10pm ish)

High fever (102), chills, shaking, nausea, extreme stomach cramps, injection site pain, fatigue, headache Symptoms started approximately six hours after vaccine and were extreme for about 8 hours. Temperature dropped to upper 100s on second day. On third day, temperature is still in 99s and other reactions mentioned are still present.

After she waited 15 minutes after having the injection, she was fine. Starting driving home, she had a light headache. She had itching, tenderness, body rash and fever. She went to ER.

About 6 hours after vaccination on 3/8, flu-like symptoms: chills, weakness, fatigue, headache. That lasted into the following ~1.5 days and was relieved with Tylenol and bed rest. Mild nausea on 3/9-3/10. The most concerning possible adverse event started on the evening of 3/12. I noticed my achilles area was itchy after taking a shower that night. I woke up the following morning on 3/13 VERY itchy on my left arm and ankles. I started to break out in hives on my lower legs and bilateral arms into the afternoon. I took Benadryl as directed on the package to try and relieve the hives. In the evening on 3/13 I tried taking a lukewarm bath with 1/2 cup of baking soda and epsom salt. After soaking for about 30 minutes, the hives had worsened and about 65% of my body was covered in hives. I called my primary care's emergency line that night and was prescribed 40mg Pepcid x 7 days and a Methylprednisolone pack to take in addition to the Benadryl. I took the 40mg Pepcid along with Benadryl and was able to relieve most of the hives. I did not take the methylprednisolone at all. I did wake up in the middle of the night with a scratchy throat and took another Benadryl to relieve that. The following morning on 3/14 I woke up and had some hives on my hands that disappeared that early afternoon without having to take Benadryl. In the evening on 3/14 at around 6pm the hives started to reappear on bilateral arms as well as legs. I took the 40mg Pepcid as well as Benadryl and the hives did not completely disappear before bed. The following morning on 3/15 it appears that the hives had disappeared. They did not reappear the following evening but I still took the 40mg Pepcid the evening of 3/15. Today is 3/16 and I have continued to be hive-free. One other detail to note, on 3/15 at around 4 in the afternoon I took an old supplement - Cranberry with Vitamin C. So I am not sure if this reaction was related to the expired supplement, the vaccine, or both.

At 0700, a splotchy red rash appeared in my wrists and feet. It was not raised up and had an irregular border and was very very itchy. By 1000, the rash was splotchy up to my ankles and onto my forearm. By 1400, the entirety of my forearms were solid red rash, and I had large splotches on my calves, thighs, and upper arm. By 1800, the rash was only on my shoulder area, but lower body was still very red. My entire right leg from ankle to hip was red splotchy and my left leg from knee up. I had 2 splotches on my hips. I took 1 benadryl at this time and went to bed. I woke up on 3/18/21 with a few light splotches on my chest but no where else. This faded By 1000 and I do not have any rash now.

Patient had a allergic reaction to Johnson and Johnson. EMS was called. Patient had numbness on left arm, limited mobility, and redness at site of injection. Vaccine given by nurse. She initially couldn't move her arm after the injection. We called 911 afterwards, and stayed with patient. We gave water/Benadryl and stayed with the patient until they arrived. They checked on her vitals. BP 104/60, pulse 72. No SOB, or tightness in chest, no other areas of redness, and patient had more mobility after given Benadryl. EMS said she was fine to leave, and to follow up with PCP. No history of allergic reaction to vaccine.

Joint pain 3-11-2021 9:00pm - 3-13-2021 10:00pm Fever 3-12-2021 6:00pm - 9:00pm (Ibuprofen resolved the issue) Feeling hot but no fever 3-12-2021 12:00am - 3-13-2021 10:00pm Fatigue 3-12-2021 8:00am - 3-13-2021 10:00pm Injection site pain 3-11-201 7:00pm - 3-17-2021 10:00pm

Started at 2:00pm with itching and redness on left arm at the injection site. By 6:30pm rash/hives spread to legs, arms, feet, stomach and back. Severe itching. Took 25mg of Benadryl at 6:30pm. Rash appeared to subside. By 10:30pm rash and severe itching returned on legs, feet, back, stomach and arm. Felt tingling and numbness in tongue. Took additional 25mg of benadryl and called 911. Paramedics arrived and assessed vitals. Rash began to subside. Sunday 3/21 had residual internal itching all over body.

I received the vaccine at 36 weeks pregnant. I am estimated to deliver April 16th. About 8 hours after receiving the vaccine I noticed general bodily discomfort and achiness, as well as a loss of appetite and a headache. About 30 minutes after that I developed chills but no fever, and was fatigued enough to fall asleep an hour before my usual bedtime. I slept terribly in the night due to the achiness and pain at the injection site making it hard to lay on my side, which I have to do for pregnancy. I went to bed with chills but woke up sweating and discovered a fever of 100.2 around 12:45 AM. By 5:30 my temperature was down to 98. The following morning I continue to experience achiness, fatigue, decreased appetite, and a headache. I seem to have felt some pelvic cramping associated with pregnancy but it may be unrelated.

Patient received vaccine on 3/16 @ 1:30 PM. Rash developed 3/21....turn into painful red rash on 3/22 in the morning (pt had hard time putting on shirt). Rash is on left lower arm/left side of body. Patient describes it as pulsating. I informed patient that it may be related to the vaccine, to contact her primary or got to an Urgent care ASAP and recommended OTC products in the mean time (anti-histamine+iburpofen/apap for pain) Patient will report back to me what her physician thinks is causing the rash. I will continue to document and follow up with patient

About 24 hours later, I noticed a rash the size of quarter. On Tuesday, the rash was bigger and it was swollen underneath - the lump underneath it was the size of a golf ball. Wednesday and Thursday - Nurse measured it had rash top was 7 cm and the lump underneath was the size of my palm (much bigger). It was really painful and really itchy. On Thursday, I did a telehealth video chat - and I showed it to the doctor and that's when I went to the clinic where the nurse measured it. Treatment was given: Steroid cream - called Triamcinolone. I used it that night and by the next day the redness had gone down 50% and the lump decrease, also. I have been using it twice a day since Thursday. Today the redness is gone and the lump is maybe the size of a quarter. It's about 90% better but not completely gone.

3:40 pm received shot and felt soreness at injection site. 11 pm: started experiencing chills, goose bumps, headache, body aches, 3/25: all symptoms continued and also experienced sensitivity to light. Eyes hurt when moving them around All symptoms diminished 36 hours after shot. Symptoms were gone 48 hours after shot. Only soreness at injection site remained for 2 more days.

After being administered the vaccine at 7:12 am, when the nurse stood me up and started to walk me to the holding area, I became dizzy, my legs got weak, and there was a loud ringing in my ears. I nearly collapsed as I reached the seat in the holding area they were taking me to. I placed one 0.5MG tablet of my prescription Alprazolam in my mouth and waited for the nurse to bring water. They took me via wheelchair from the holding area to a secluded spot behind a curtain. There, I laid on a cot, received cold water, and a nurse talked to me while I recovered. It felt like I was having an anxiety attack, which has never happened to me after getting a shot before. Fitbit heart rate data shows my heart rate at 105 BPM at 7:00 am (going through the admission process, walking around the facility), 83 BPM at 7:10 am, 79 BPM at 7:15 am, 74 BPM at 7:20 am. Between 8:15 am and 1:25 pm, my heart rate remained between 63 and 89 BPM. My arm was sore and my skin hurt (an issue that I have when I feel very stressed). Additional symptoms arose around 1:35 pm. I began going through cycles of chills, sweating and overheating. My heart rate ranged from 127 BPM and 93 BPM for the remainder of the night. I took Tylenol at 7:07 PM to help with my fever.

Pain at injection site right away that gradually faded, body aches, fatigue and stiffness that started around 7 PM, 99.1 fever taken shortly before 9 PM with NSAIDs on board and just after taking a drink.

Patient was nervous of taking vaccine then after injected patient started c/o of slight headache, then her head started itching. Reports no shortness of breath, no hives seen , patient was anxious. Patient was not able to take a Benadryl due to driving back home.

Fever, chills, body aches, joint aches, exhaustion, dizziness. Giant red knot in arm 4 days later. Still getting bigger.

I received the Janssen (J&J) vaccine at 11:12pm on 3/5/2021. I went to bed with a slightly sore arm. I woke up the following day 3/6/2021 with a slight headache and feeling a little achy. At around 11:00-12:00pm on 3/6/2021 I started having a fever, chills, aches, an increasingly bad headache. For the next 18 hours I had a fever, shaking, aches, bad migraine headache, diarrhea, nausea, and vomiting. I felt increasingly sick and my lowest point was at around 9:00pm on 3/6/2021 when I vomited. Around 5:00-6:00am on 3/7/2021 I felt considerably better and no longer had a fever. I was exhausted and still had a headache. I was very fatigued for the next two weeks. I was menstruating when I received the vaccine. My menstruation stopped when I was having side effects for about 2-3 days and then started again. In addition, I have psoriasis and on 3/7/2021 my skin looked noticeably better than it had looked before I received the vaccine. The psoriasis I had on my hands almost completely disappeared. A few days later, my psoriasis looked worse than I had looked before I received the vaccine. Today 3/29/2021, my psoriasis is back to how it looked right before I received the vaccination.

Severe chills, body aches, low grade fever, slight shortness of breath, mild burning sensation on skin. Lasted for around 3 hours.

about an hour have receiving the injection i experienced a mild rash from armpit to armpit. I do have sensitive skin and was doing yard work earlier in the day so that may be the cause. It only last a few hours.

Tasted metal 15 minutes after injection, 25 minutes after injection left eyelid felt heavy and appeared droopy, could not lift my left eyebrow, forehead and check feel tight. 22hrs later my forehead and left check feel tight and eye still droopy. Eyebrow can move more normally

Small itch bumps that turn into welts 9 days after vaccination. New welts are still forming. Rash on face stomach and legs.

Flushed skin, body heated, hives and tingling in hands. Given 25 mg of Oral Benadryl and drank 16.9 ounces of water. All symptoms went away within 15 minutes of taking Benadryl. No further symptoms occurred.

6:00pm- intense shaking chills lasting 5-6 hrs 7:00pm- body pain, moderate- felt like nerve endings all over my body were on fire- applied topical CBD lotion (maybe 200mg?) 8:30pm- pain at injection site, mild to moderate (ongoing, 12+ hr) 11:00pm- mild fever (100-101F), spiked to 101.7F at 3am but effectively controlled by Tylenol All symptoms mitigated with 1200mg Tylenol per 8 hrs (took 600mg at 11am after vaccination, 1200mg 7pm, 1200mg 3am); chills were barely controllable but fever and body aches showed marked improvement. Pedialyte and topical CBD may also have lessened body aches.

Client had injection site pain at first Client complained for post vaccination syndrome on Monday client complained of chest tightness and pain Clients BP was elevated at the time. Client is now hospitalized

On April 5 2021, Approximately 2 weeks after the J&J Covid vaccine I noticed the area around my left knee had become discolored (dark brown). I feel no pain, pressure, or discomfort from it. It?s not swollen either-just discolored.

Dizzyness, pain at injection site and pain throughout arm that was injected. Very tired and headache the entire day after.

patient right arm with burning and was swollen, warm and redness on the day after receiving injection. seen by PMD on 4/5 and was prescribed Bactrim. per MD note:R arm + redness , warmth with spreading of erythema down and up arm, blotchy red area over chest wall

Left arm swelled slightly a couple hours after injection. Staying swollen, a rash started to appear four days after injection.

Within about 30 mins of the shot I became extremely lethargic. Hard to keep my eyes open. The injection site was extremely hot to touch and very sore. While the rest of my body was of normal temperature. Shortly after, I?d say about 45 minutes after injection, came the cold chills. I was freezing cold and shaking fallowed by a fever. I became very foggy. It was hard to keep a conversation and had extreme waves of nausea. My mouth would salivate like the vomit was coming. I never actually vomited. But that continued for the next 36 hours. I had to call out of work yesterday. Starting 24hrs after injection. I could not get out of bed. My body was very weak. Aches everywhere, I was freezing cold shaking with chills yet waking up in my bed covered in sweat. I was extremely restless and kept waking up to put a cold towel on my head to try to break my fever. At this point my headache was so severe. Any movement felt like my head would explode. It?s now 48 hours after the injection my head is still pounding and my body still full of aches. Left arm is still really sore. I truly regret taking the vaccine. And would recommend others to not take it until further testing goes into this product.

Injection Site pain (beginning at time of injection), Headache (beginning at 5am 4/9/21), fever (100.5-102.0°F, beginning the morning of 4/9/21), muscle pain ( beginning 4/9/21), abdominal pain ( ~8am 4/9/21)

SUPER ITCHY ARM AT INJECTION SITE, ARM IS OBSESSIVELY ITCHY; REDNESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 31 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) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced itchiness at injection site. On 02-APR-2021, the subject experienced redness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchiness at injection site, and redness at injection site. This report was non-serious.

On 4/5/2021(Monday) patient received vaccine approx. 2pm. Patient noted at 11pm their throat was closing and rash. Patient went to ER but did not wait and decided to take benadryl which help her symptoms. Patient called the Pharmacy 4/9/2021 (Friday) at 6pm and informed us of side effects she was experiencing and stated her throat/skin was itching and hard to swallow . I told her to take benadryl immediately and go to the ER.

Lips started tingling, Left side of face felt droopy but did not look droopy to others, Sweating then extreme cold, face was red, dizzy, head pain on the left side and mottling of the hands. When I got home my lymph node in my neck swelled up on the left side and remains swollen today. Teeth also hurt after eating anything. Extreme tiredness and nausea.

My arm was sore after getting the shot. About 2 hours after I received the shot I got a headache. Around 1:30am (about 10 hours after shot) I had body aches, chills, low fever, and my headache continued. I felt this way until about 2:30pm (around 24 hours after shot). I continued to be a little sore and tired the rest of the day but felt normal the next day.

Chills, fever, nauseous, headache, sweating, pain at injection site and whole arm.. Sore muscles, sore joints.

3/8 -6pm: pain in arm moved to shoulders and neck -7pm: starting to feel achy -8pm: chills, took a hot shower and couldn?t get warm -9pm: full body aches and chills, wore an extra blanket to bed, shivering -12am: woke up after shivering for hours, fever, full body aches -3:30am: migraine, fever, body aches, chills 3/9: -5:30am: barely got out of bed, full body aches, nauseous with migraine -10am: fever breaks, still have some body aches, migraine -2pm: migraine and body aches -6pm: migraine -8:30pm: went to bed with migraine 3/10: -5:45am: woke up with no migraine, arm was sore, slightly nauseous -8am: very fatigued, sore arm -10:30pm: went to bed, sore arm 3/11: -6:30am: arm very sore -6:30pm: arm sore 3/12: Pain in shoulder at injection site- difficult to raise or rotate left arm. Shoulder/injection site pain continued until a doctor visit on 3/30. Doctor stated that shoulder was still warm and prescribed Medrol to help with inflammation. Pain subsided and arm was not painful. As soon as the Medrol was completed (4/9), the pain in the shoulder/injection site came back. As of 4/11, it is painful to left and rotate left arm.

Onset 7 hours post-injection; duration approx. 24 hours. fever, body aches, leg pain, chills/shivering, headache, neck soreness; maintained hydration and treated with warm bath, hot herbal tea, and alternating ibuprofen 200mg or Excedrin Migraine every 6-8 hours. 12 hours post-injection: onset of muscle soreness around injection site; duration continues 72-hours post-injection. Treatment with hot-compress, arnica salve, and massage of area.

Arm hot, severely bruised, lump in arm from 3/31/21 at 8pm until 4/13/21 arm still has large lump and bruising that has not gone away the chills and sweats stopped 1 week after injection date also had a large lump raised out of my chest that is on the right side as well the provider contributed to the cellulites that was affecting the right arm that the injection was done and the lump has not gone down either Dermatologist believes that it is a inflamed lymph node in my chest from the shot the lump is hard and painful.

Migraine from hell, lump and redness on arm, feel like I have a cold, fever, and also hard time breathing

Patient described right leg pain and swelling following injection, right side body pain and tingling. Headaches, and pain at the injection site.(right deltoid injection site)

Shot at 5:40 PM. Chills and shaking 6 hours after until the morning. Day 1- loss of appetite, nausea, migraine and light sensitivity. Fever 102. Shaking, sweating and chills. Fatigue. Throwing up at night. Arm soreness Day 2- fever hovering around 103-104 for almost 24 hours. Threw up in morning. Migraine dissipated to a headache. No arm pain. No appetite Day 3 - woke up sweaty - ~100 temp. Arm pain but no headache. Temp down to 98.7 by afternoon-ish. No appetite Day 4- extreme right arm pain beyond soreness at injection site. Inability to move arm laterally. No fever minor chills. Extreme exhaustion (hangover effect from fever probably!) appetite coming back!

BODY ACHES; SHORTNESS OF BREATH; LOSS OF APPETITE; SORE ARM; HEADACHE; FEVER; NAUSEA; FEELS VACCINE WAS ADMINISTERED A LITTLE HIGH ON THE SHOULDER; MORE PAINFUL SHOT THAN EXPECTED; This spontaneous report received from a patient concerned a 31 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, intra muscular and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 11:45 on left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced feels vaccine was administered a little high on the shoulder. On 05-APR-2021, the subject experienced more painful shot than expected. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 05-APR-2021 20:00, the subject experienced body aches. On 05-APR-2021 20:00, the subject experienced shortness of breath. On 05-APR-2021 20:00, the subject experienced loss of appetite. On 05-APR-2021 20:00, the subject experienced sore arm. On 05-APR-2021 20:00, the subject experienced headache. On 05-APR-2021 20:00, the subject experienced fever. On 05-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 body aches, shortness of breath, loss of appetite, headache, fever, and nausea on 07-APR-2021 18:10, and more painful shot than expected on 05-APR-2021, was recovering from sore arm, and the outcome of feels vaccine was administered a little high on the shoulder was not reported. This report was non-serious.

Redness/swelling at injection sight. Soreness at injection sight. Dizzy, migraine, nauseous, fainting spell, and body aches.

Janssen COVID-19 Vaccine EUA I began by feeling stiffness and soreness in my joints and muscles, particularly my back and lower body. The pain and stiffness worsened, and I began to feel ill similar to a common cold. Approximately 12-18 hours after receiving the vaccine, my symptoms worsened so much that I could hardly stand or move around, and began throwing up. This continued and worsened as my entire body felt pain and stiffness, I felt very weak and fatigued, and I was throwing up violently with frequency. I threw up so much and with enough force that I started to see bright red blood in my spittle and vomit. I had a severe headache accompanying these other symptoms. I also had problems with homeostatic temperature regulation and was simultaneously sweating profusely and very warm to the touch while feeling like I was cold. I was shaky and experienced tremors and twitches in my hands, arms, legs, and feet. I kept throwing up and experiencing these symptoms for approximately 72 hours after recieving my vaccine. I was virtually incapacitated for those three days of severe illness-like symptoms.

102 fever, body chills, body aches for 12 hours starting 11pm on Sunday, April 11th (about 8 hours after vaccination). Continued pain in sight of injection and body aches for third day now.

Six hours after injection of vaccine, I experienced nausea, moderate chills, headache, and a low fever which lasted for 6 hours. I also had numb fingertips which lasted for around 20 minutes right after the chills really set in. I'm not positive its related but two nights after my vaccine injection, I woke up at night because my feet were itching and hot. They also had the pins and needles sensation and these symptoms lasted around 20 to 30 minutes. I have never had that happen before so I assume it was vaccine related.

I am about 6 weeks pregnant. No known complications in this pregnancy, or any previous pregnancies. On 4/14, 6 days after receiving the Janssen vaccine, I started to break out in an itchy rash at about 5:30pm. It started on my left calf, and over the course of the next couple hours it spread to my left arm (bicep area), right arm (bicep area), right calf and knee, and left thigh. The areas were red, hot, and itchy, with some larger raised welts scattered through the area. It didn?t seem to respond to Benedryl, but I was able to sleep after liberally applying hydrocortisone cream. It seemed better in the morning, with a few lingering patches by the knees. However, at about 1:30pm it came back, this time mostly covering new places- lower back, shoulders, forearms, stomach.

Burning and itching at injection site; tingling and numbness of entire arms; dizziness; redness and slight swelling around eyes. All symptoms resided within an hour or two then I became very tired for the rest of the day and normal vaccine reactions occurred(low grade fever, chills, body ache, etc).

WARM TO TOUCH AT INJECTION SITE; LUMP AT THE INJECTION SITE; RED RAISED RASH AROUND THE INJECTION SITE THAT WAS VERY ITCHY; PAIN AT INJECTION SITE/TENDERNESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obese, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain at injection site/tenderness at injection site. On 04-APR-2021, the subject experienced red raised rash around the injection site that was very itchy. On 05-APR-2021, the subject experienced warm to touch at injection site. On 05-APR-2021, the subject experienced lump at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from red raised rash around the injection site that was very itchy, and had not recovered from lump at the injection site, warm to touch at injection site, and pain at injection site/tenderness at injection site. This report was non-serious.

knot under skin at injection site with discoloration to skin, this started happing three days after the shot. left leg and foot swollen, tightness April 12,2021

The vaccine administration site is swollen 2 weeks post vaccination. The patient denies pain or fever. The area under the skin is swollen. The area affected is approximately 2.5-3.5 inches wide. Patient advised to follow up with primary care provider.

Bad headache, fever and body aches wouldn't stop then I had my first ever shingles outbreak starting 4/16

CHILLS; BODY ACHE; DIZZINESS/LIGHTHEADEDNESS; INJECTION SITE PAIN; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had topical soaps allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 95.5 Unit not reported, 93.4 Unit not reported. On 08-APR-2021, the subject experienced dizziness/lightheadedness. On 08-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever. On 08-APR-2021 17:30, the subject experienced body ache. On 08-APR-2021 17:30, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, injection site pain, headache, and fever on 09-APR-2021, and had not recovered from dizziness/lightheadedness. This report was non-serious.

About a week after the vaccine I noticed 1 patch of hair loss which procceded to 2 or 3. I visited my Dermatologist who injected steroids into each spot but within the next week more and more patches would fall out. A bedtime oil was prescribed for me to use and I am still experiencing the issue to date which has caused me to have to chop off all my hair yesterday. I have a 4week F/U appt with the dermatologist to see if any changes has occured

On March 6, 2021, I received the Johnson and Johnson Vaccination at about 8:15 am. Around 7:00 pm that evening I started to experience the normal symptoms that they had advertised. Yes, I felt like I COVID again for about 48 hours, but nothing alarming. On March 12, 2021, I went to an appointment with doctor due to extreme abdominal cramping and very heavy period. This is not totally out of the norm due to my infertility, but I felt like something was off. I had random abdominal bruising and ruptured cyst pain; which I am still experiencing. She ordered an ultrasound to rule out a mass in my uterus due to the extreme pain and bruising. On March 22, 2021, I woke up at 3:00 am with extreme stomach pain and extreme diarrhea. As the morning went on I began to feel worse and worse. Other symptoms I experienced were; severe headache, shortness of breath, heartburn (I felt like I was having a heart attack), nausea, back pain, and extremely tired. At 6:30 am took me to the ER due to my worsening symptoms. Everything checked out fine and they thought I could have an ulcer, but I wanted to make you aware of these symptoms that I experienced. I still have days that I experience some of these symptoms, but they have been under control and monitored closely.

CRAMPS ON LEGS; BODY ACHES; LETHARGIC; HEADACHE ON SIDES OF TEMPLES; SORE RIGHT ARM; BUMP AT INJECTION SITE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies, patient had not reported any medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sore right arm. On 12-APR-2021, the subject experienced bump at injection site. On 14-APR-2021, the subject experienced body aches. On 14-APR-2021, the subject experienced lethargic. On 14-APR-2021, the subject experienced headache on sides of temples. On 15-APR-2021, the subject experienced cramps on legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, lethargic, and sore right arm on 15-APR-2021, and had not recovered from bump at injection site, headache on sides of temples, and cramps on legs. This report was non-serious.

I received my shot at approx 5pm in the right arm, at about 630 as I was getting intot he bath, I noticed a large bruise covering my right thigh, which faded while in the tub. Friday 4/2 the bruise appeared again in the same location, and faded after the shower. I went to my doctor who ordered bloodwork which I got the next morning. Came back normal. Saturday 4/10 , monday 4/19 the same occured. I saw a hematologist as I was concerned, pending more bloodwork.

Saturday 4/10: 3:00 pm- first sign of headache -anxious and fatigued, series of falling asleep and waking up confused 10:41pm: First sign of chills and running ?hot and cold? Sleep was disturbed with intense vivid dreams and waking to sweat and running hot and freezing cold Sunday 4/11: 2:15 pm: Headache, sweating, diarrhea 6:51 pm: experienced confusion, brain fog, muscle tightness all over body Monday 4/12: 8:15 am: Woke up to muscle soreness, brain fog, and stuffy nose with green mucus. Left arm from at injection sight still sore. 8:53 am: Experienced disorientation and concern about safety driving to work 10:53 am: Dizziness and overall feeling of being unwell. Series of running hot and ?clammy? Expressed that everything seemed like a dream-like state. Experienced forgetfulness, confusion and uncertainty. 11:59 am: Ran hot and cold going from sweating to shivering cold. 12:02 pm: Questioned ?what?s real and what?s imagined?, hard to grasp reality. Fatigued, confused and trouble at work concentrating. 12:35- 1pm: Shivering cold, difficulty regulating body temp 2:30 pm: Starting feeling a little better, body temp started to go back to somewhat normal Tuesday 4/13 1:13 am: woke up sweating drenched and anxious, confused and achy. Experienced unusual amount of milky discharge not usually present in between menses. Throughout the day experienced less confusion as before, but still sore and not well overall in general Wednesday 4/14 4:15 am: woke up with major feet cramps, toes curling in without release for over an hour. Intense pain that had not been experienced before with the length of the duration of the cramp in both feet. 7:15 am: Feet cramped on and off, noticed left eye swollen (previously has happened before but not sure reason why). Took a Claritin and drank water to help with the cramping. Experienced immense anxiety about driving vehicle to work due to the muscle spasms now mostly on the left foot. 8:07 pm: Left foot was still cramping up sporadically throughout the day with lingering pain when muscle was relaxed Sleep throughout the night was accompanied by vivid intense dreams and waking up with more cramping in feet, more the left foot now Thursday 4/15 7am: Cramps in feet were still present, decided to check in to an urgent care to check it out 9:30 am: MD Now Urgent care visit- ran urine analysis and blood tests. 10:30 am: Discharged from Urgent care with following diagnosis: Acute cystitis without hematuria, abnormal urinalysis adverse effect of vaccine, initial encounter cyanosis of skin, shortness of breath and protein found in urinalysis. Instructed to immediately get CT angiogram to rule out blood clot. 12: pm Admitted to Mount Sinai Emergency Room-blood work, XRay and IV given. details below Discharged with the following diagnosis: Foot cramps - Primary Local reaction to COVID-19 vaccine Friday 4/16 Subtle and lingering muscle spasm on left food. Experienced chills and consistent headache throughout the day Saturday 4/17 10 pm: Began to run a fever however did not check the temperature. Radiated heat and friend took care of me throughout the night as I sweated with confusion Sunday 4/19 Complete fatigue and tiredness, cramping in the foot seemed to have subsided. Still was running hot throughout the day. Monday 4/20 Took off work due to exhaustion and muscle ache and what seemed to be a fever Thursday 4/23 Followed up with General Practitioner Dr. Franco and was advised to report my experience with the Johnson and Johnson vaccine. Feeling better as of Friday 4/24 with slight fatigue but body temperature seems to be ok. No signs of the lingering cramping in the left foot but still slightly achy all over the body.

FEEL SICK; SHIVERS; FEVER; HEADACHE; INJECTION SITE PAIN; BODY ACHE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021, 09:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced shivers. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced injection site pain. On 24-MAR-2021 15:00, the subject experienced feel sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and shivers, had not recovered from fever, headache, and injection site pain, and the outcome of feel sick was not reported. This report was non-serious.

PAINFUL RASH; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight was 155 pounds, and height was 167.64 centimeters. The patient's concurrent conditions included autoimmune celiac, gluten intolerant, and alcohol use, 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced painful rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful rash. This report was non-serious. Additional information received from patient on 25-Mar-2021. The following information was updated and incorporated into the case narrative: patient (weight, height, age at time of vaccination, patient history text), product (frequency time, vaccine military information) and due diligence correction made.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious

TIREDNESS; HIVES A COUPLE ON HER BACK AND ONE ON HER CHEST AND ONE ON HER NECK; HOT - 99 CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 (vaccination at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced hives a couple on her back and one on her chest and one on her neck. On 13-MAR-2021, the subject experienced hot - 99 chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced tiredness. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives a couple on her back and one on her chest and one on her neck, fever, hot - 99 chills, headache, and tiredness. This report was non-serious.

Sore upper arm/muscle, reduced range of motion. Symptoms (re)appeared on day 9-10 after vaccination and have continued through today (day 17), and appear to be getting slightly worse. Pain is mild to moderate but certain movements make it much worse. (This is beyond initial symptoms - fever, headache, muscle aches and sore injection site, which all resolved w/in approximately 36 hours of vaccine administration.)

Began on 3/26/21 with numbness in face. Woke up on 3/27 with numbness in feet. Spread to my feet and up legs and arms through next couple days. Fatigue increased dramatically, though it was present prior. Dizziness, sharp pains in left ear in skull, nerve issues. The following is a log from when the symptoms became most intense, so significant I have not been able to drive myself and been working from home due to balance issues, no feeling in feet, and neurological symptoms. After different a week and a half,, i sought medical care and began logging daily as follows: Fri 4/9: fatigue was high, neuropathy present. Balance was off. Stabbing sharp pains into the left ear but behind the ear in head. Dizzy spells with static feeling rush in forehead lasting a few seconds and passing. Gate while walking feels awkward and difficult. Think walking after sprinting on a treadmill plus's stiffness Sat 4/10: couldn't eat. General malaise. Fatigue. Neuropathy and balance issues present. Gate slightly improved. Noted increase in joint pain and popping in wrists elbows hips and knees. Needed white noise to cover ear ringing to sleep. Sun 4/11: feeling a bit better. Able to eat. Gastric issues after eating. Slightly more energy but neuropathy and balance was frustrating like superglue on my fingers and areas of my feet with no feeling at all surrounded by pins and needles. Aching in wrists and pain shooting down through to heel of my foot. Ear ringing more noticeable. Two instances of ice pick ear pain. Monday 4/12: neuropathy present, balance improved. No digestive issues. Feeling more stable while walking. Still numb in hands and feet and part of my face but less pronounced. Ear ringing unbearably loud and constant. Tuesday 4/13: slightly less energy but neuropathy still seems improved and not losing balance as much. Ears obnoxious, joints popping and cracking constantly. Pain in wrists and hands. One instance of ice pick ear pain Wednesday: same as Tuesday, but no ear pains. Had to take a nap in the middle of the day due to worn out feeling. Laying in bed felt something in my back snap, then a stabbing pain into my lower right side of my back. Aching like the skin was hurting for hours. Thursday: other symptoms same as Tuesday. Ears ringing crazy loud, stiff in the hips more noticeably. Neuropathy present with dizzy waves/vertigo. Low back skin pain right side continue. Also right hip. Gate while walking is starting to feel like it did before after a few days of improvement. Friday: back still hurting. Neuropathy increased. More numbness than previous few days. Very stiff throughout lower back hips and legs. Low back pain. Gate while walking feels awkward and robotic. Ears ringing. Joints throughout cracking/popping. This is not historically common for me. While washing dishes got shooting pain down my left wrist back of hand almost shooting down the veins to in between my pointer finger and thumb. Painful to touch. Immediate strong increase in the pins and needles in my hand concentrated in finger tips but now radiating up forearm too. .numbness in feet and part of my face. Whole body aching. When trying to sleep kept getting head rush static attributed to Benadryl to sleep and staying up too late. Saturday: very tired. Back hurting in morning. Felt better after getting up. Kept feeling head rush like static in forehead continuing on and off throughout the day into the night with dizziness almost like I might pass out. Nausea and low appetite Fatigue higher than normal. Neuropathy still present. Ears ringing insanely loud and constant. Aching and stiffness in hands wrists and legs and feet in heel/sole. Chest pain in sternum. Had a few months ago almost daily for awhile. Went away til now. Sunday- neuropathy the same. Ears ringing the same. Stiffness throughout. Dizzy spells and static in forehead. Nausea and low appetite. Fatigue. Ice pick ear pain starting in evening a few times throughout the night. Monday. Neuropathy the same. Ears ringing the same. Slightly less pain and popping in joints. Fatigue high. No appetite. Ice pick ear pain starting in morning happening several times. PREDNISONE STARTED WEDNESDAY Wed April 21: feeling about the same. Ringing in ears, neuropathy same, fatigue high. Appetite improved. Ice pick ear pain a couple times. Neuropathy seemed to improve towards the end of the day, when it usually is worsening. Felt nauseas and sick to stomach before bed with digestive issues. Dizzy spells all evening with static feeling. Ears ringing constant. Thursday: neuropathy improved, still present and noticeable but I was able to walk normally and had more feeling than previous. Joints still cracking and popping. Not as nauseas or sick feeling throughout the day. No ear pain. Dizziness occasional, less than day before. Ears ringing constant. Friday: neuropathy still improved but present and noticeable, able to walk more normally than previous. Joins still the same. Not as nauseas or sick feeling. Chest pains in sternum and stabbing ice pick ear pains on and off all day. Very painful in the ear. Light headed/easily motionsick, but better than Wednesday worse than thursday. Ears ringing constant. Saturday: Neuropathy still improved, joints are stiff but not in pain. Light headed easily, ears ringing constant. This is the worst day for the ice pick ear pain yet. Repetitive ?attacks? concentrated in the morning enough to make me have to drop and hold my head. It was very painful and higher frequency than ever seen previously. Sunday: Feeling sore in my hip joints. Ears ringing constantly. Ice pick ear pain only happened twice. Neuropathy slightly more than day previous but okay and balance still improved. Chest pains in sternum present. Episodes of blurred vision/double vision towards the end of the day.

On the 28th of April, 18 days from the shot, I went for a walk and came home around 6:30 p.m. to the outside of my right calf bright red and hot. I went to the ER where an ultrasound was performed and they found a DVT blood clot. I am now on an anticoagulant, Xarelto and have an appointment with my doctor on the 5th to schedule more imaging and blood work.

Arm slightly sore at injection site. Right arm, right shoulder, upper back, neck, left shoulder, left arm all extremely stiff sore and weak. Fatigue. Slight headache. Chest feels weak when breathing but not sure if it's due to upper body muscle weakness.

WARM TO TOUCH; TINGLING A LITTLE; RED RASH MEASURING ABOUT 3 INCHES; This spontaneous report received from a pharmacist concerned a 31 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, and batch number: 1816022 expiry: 01-JUL-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced warm to touch. On 03-MAY-2021, the subject experienced tingling a little. On 03-MAY-2021, the subject experienced red rash measuring about 3 inches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the red rash measuring about 3 inches, warm to touch and tingling a little was not reported. This report was non-serious.

Patient has a quarter sized lump that is firm and has pain to the touch at the injection site 11 days after injection.

Got lightheaded intialky. Through out the day I slept b hurt then I woke up short of breath and itchy with a slight rash on my chest. I had but if itchiness in my arms but no sign of rash and she watched me an additional 15 minutes to the original 10. Pharmacist gave me shot in left arm.

Shortness of breath by 12:30am 05/11 2 hours laters chest rash. 12:26pm still some shortness of breath.

FIRST 24-48 HOURS; FEVER, CHILLS, CONVULSIONS, NAUSEA, HEADACHE, BURNING SENSATION IN NECK & SPINAL COLUMN, FATIGUE. FROM 4/9/2021-PRESENT; SPORADIC BODYWIDE SKIN HIVES THAT ARE RED, BUMPY AND ITCHY- SPORADIC BLISTER LIKE SKIN LESIONS ON ANKLES, LEGS AND ARMS.

Fever and chills 10 hours after injection Pain at injection site immediately after Headache, fatigue, muscle soreness 24 hours after

SKIN LESIONS THAT LOOK LIKE BLISTER; HIVES; FEVER; NAUSEA; HEADACHE; CONVULSIONS; BURNING SENSATION IN SPINAL COLUMN AND NECK; SWEATING; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. 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, administered on 07-APR-2021 in Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. On 07-APR-2021, the patient experienced adverse effects of fever, chills, nausea, burning sensation in spinal column and neck, convulsions, sweating and headache after receiving the JANSSEN COVID-19 VACCINE. On an unspecified date, the patient experienced skin lesions that look like blisters appeared on her arms, legs, feet, ankles, thigh, neck and face and also experienced hives which has been ongoing since then. The patient has not taken any medications for these adverse effects, but she takes sertraline as concomitant medication. On 13-May-2021, the patient stated that she visited the HCP who advised her to get OTC Zyrtec and prescribed a steroid cream which she is yet to pick from the pharmacy The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from convulsions, burning sensation in spinal column and neck, sweating, fever, nausea, and headache on 09-APR-2021, and had not recovered from hives, and skin lesions that look like blister. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210532543-COVID-19 VACCINE AD26.COV2.S- Convulsions- This event 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.

Patient developed all over body rash 4 days after receiving vaccine. She took a benadryl and called the pharmacy.

The Tuesday after vaccination, I had physical discomfort and pain inside like period cramps. It felt like there was a tampon inserted weirdly, I tried a yeast infection solution with yogurt on a tampon. Later that week I had pelvic bone pain like I had strained to hard using the bathroom. Friday I got a hyper sensitive spot on upper right thigh, diagnosed as paresthesia, the swelling and discomfort around pelvis was still there. Saturday the swelling and discomfort on the insides started going down, both legs experienced pain, It felt as If I had done a workout and pulled my muscle. I typically have a high threshold for pain, No change on Sunday. Monday the back of right knee stated aching, sensitivity in left thigh. Both muscles on outside of legs felt like I had done a workout and needed stretched, On the 13th the aching traveled from the back of knees to calves I went to the Hospital. Myalgia and paresthesia and acute vaginitis. Shot of Toradol in left arm, which did nothing. Did ultrasound with normal results, no blood clots. The 14th my legs were comfortable as long as I was moving, started having a sharp stinging in left calf. The soles of my felt felt blistered but no visible blisters. Significant headache. I wore compression socks. I got a weird Charlie horse in left foot toes, top of right foot got really sensitive also. Volotoral is a topical pain cream that I had I used it on specific areas, of pain. Thursday the 15th the left outside of my foot was still sore, my calves had gotten better, the outside of the calf still had hypersensitivity. The muscles on the back of my knee's and calves were still sore. While driving my Hip and thighs for aching. Ankles are popping a lot. Fri-Sun following I had leg stiffening and muscle soreness mainly in the left side, went for a walk that weekend and while walking they felt ok, until I stopped walking. Mon-tue after I had a headache that felt like my brain was burning near the left temple area.

The next day/week my entire arm was in pain. Then a week later, I had to go to the hospital because my stomach was in serious pain and I noticed red dots on my skin.

The day after I experienced extreme muscle and joint pain that lasted about a week. And it started to get better but the following Saturday I got a very terrible headache. And over the course of that week I started bruising very easily and all the veins all over my body were very prominent. The headache wouldn't go away and I started to have chest pain by that monday. And at that point all the muscle and joint pain came back and it was very very painful. At that point I called my primary care provider and they scheduled me with someone else in the clinic because i was having the chest pain. And they did a test for covid and urged me to go to the emergency room, which i did. After that I went to the emergency room and sat for 5 hours, they did bloodwork to check clotting factor, basic blood panel and also a CT of my head. According to them, everything was normal and they sent me home with a terrible headache. My biggest complaint was the bruising all over my body but no one ever looked at that.

Rash around neckline, first appeared like a bad sunburn. Not irritated or raised surface, almost hive like. Gave Benadryl and increased fluid intake. Rash improved and is now peeling over the course of 5 days. No pain or itching.

About 7 hours after, I developed a fever of 103 that lasted about 12 hours. On 5/25, I woke up with a rash/hives that covered my chest, stomach and back, which I still have. I went to the urgent care and was given steroids, Benadryl and Pepcid. The meds stopped them from spreading, but they didn't go away. On 5/31, I went back to urgent care due to it spreading more onto my neck, bottom and starting to do down my thighs. It looks like little burns all over my body. They are thinking I got it because my body was trying to fight off the vaccine due to my deficiency. I was put on 12 days of steroids to prevent it from continuing to spread, the inflammation and itching. She diagnosed it as Pityriasis Rosea. She said that I will have this rash for approx 4-8 weeks.

A rash developed on the arm of the injection soon after receiving vaccine, similar to a heat rash. Approximitely 8 days later, my entire body broke out in what looked like measles & hives. It was extremely itchy and sensitive; it was treated with steriod pack via Urgent Care, where the Dr. confirmed that this was an allergic reaction to COVID-19 vax.

Red itchy, warm to the touch, rash 5.5cm in length near injection site. Also tiredness to the level of having mononucleosis. Itching started the day after rash appeared. Rash appeared 6/13 and itching started morning of 6/14. Monitoring the site to see if it gets any bigger, if so then will have to seek medical. I do take a high level oral otc allergy medication everyday ( Allegra 24hr) so I cannot take anymore allergy medication for the day.

I experienced a rash about three weeks after my J&J vaccine. I also experienced a full body rash, not on my palms or soles of my feet or face but I did have the rash everywhere else. It was itchy, on a scale 6-7 out of 10 on VAS scale, persistent, pervasive and my PCP diagnosed me with pyrethrum rosacea. There was a patch on my back examined by my PCP. My PCP told me it would go away on its own, also gave me a prescription Aciclovir, low dose (25mg) for treatment. As far as today, my rash is still present, comes and goes and I have mild itchiness in more areas of my body and also the back of my knees.

6/25/21 Received vaccine. 6/26/21 In the morning pt stated she couldn't move left arm. In the evening redness and blotches started appearing. 6/27/21 In evening, her arm was hot, and redness was spreading, painful. It took 1 week for redness and pain to go down.

Severe hives (that lasted weeks). I have taken Benadryl and Medrol, but they still have not gone away. Waiting on appointment with allergist.

INABILITY TO SLEEP/SLEEPLESSNESS; SHORTNESS OF BREATH ATTACKS; BRUISES ON ARMS AND LEGS THAT SHOW UP OUT OF NOWHERE/ BRUISING BEGAN ON THE LOWER LIMBS AND SPREADING UPWARD; BITTERNESS IN MOUTH; LOSS OF APPETITE; WEIGHT LOSS; DIFFICULTY HOLDING THINGS; FATIGUE/UNABLE TO DO ANY ACTIVITY; CHEST PAIN; NUMBNESS IN ARMS AND LEGS/ NUMBNESS BEGAN ON THE LEFT HAND AND SPREAD TO THE RIGHT SIDE; PAIN IN ARMS AND LEGS; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sjorgen syndrome, familial mediterranean fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and the patient had no known allergies. the patient was not a drug abuse or illicit drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chest pain. On 13-MAR-2021, the subject experienced numbness in arms and legs (numbness began on the left hand and spread to the right side). On 13-MAR-2021, the subject experienced pain in arms and legs. On 17-MAR-2021, the subject experienced inability to sleep/sleeplessness. On 17-MAR-2021, the subject experienced shortness of breath attacks. On 17-MAR-2021, the subject experienced bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward). On 17-MAR-2021, the subject experienced bitterness in mouth. On 17-MAR-2021, the subject experienced loss of appetite. On 17-MAR-2021, the subject experienced weight loss. On 17-MAR-2021, the subject experienced difficulty holding things. On 17-MAR-2021, the subject experienced fatigue/unable to do any activity. On 16-JUN-2021, Laboratory data included: Blood test (NR: not provided) Ruled out clots. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inability to sleep/sleeplessness, fatigue/unable to do any activity, shortness of breath attacks, bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward), difficulty holding things, chest pain, bitterness in mouth, loss of appetite, and weight loss, and the outcome of numbness in arms and legs (numbness began on the left hand and spread to the right side) and pain in arms and legs was not reported. This report was non-serious.

Whole body rash by Wednesday evening OTC antihistamine not working for relief just progressing. Sent in prescription antihistamine Wednesday at 330pm

Patient with history of allergies presented to retail pharmacy for COVID-19 vaccination. Within 3 minutes of receipt of vaccine patient reported injection site pain radiating to hand. Within 6 minutes of administration patient reported dizziness. Help called and patient brought to ED for evaluation and observation. Review of ED visit note shows no evidence of lip or tongue swelling and no respiratory distress. Upon evaluation and observation in ED, patient discharged.

Janssen COVID-19 Vaccine EUA. Mid Saturday night I woke up to chills and was shaking so bad I couldn't fall back asleep even after adding another layer of clothes and blanket. Sunday morning I was still very cold and tired from not sleeping. I developed body aches but they were everywhere not just my arm. I was very fatigued and didn't have an appetite. The worst part was getting a migraine with extreme light sensitivity. I couldn't stand to be around any windows without blinds. I spent the day in my bedroom sleeping with the curtains closed and an eye mask on. By that night, the migraine had subsided but I was adding hot flashes to the problem list. Had a pretty restless night again on Sunday. Woke up Monday to the light sensitivity back but not as severe. I took the day off work because I couldn't handle looking at a computer screen all day. By about 1pm I was feeling mostly back to normal. My arm is still sore near the injection site and I'm a bit fatigued at times but those are the only things remaining.

I?ve never had an allergic reaction to anything before. Received the vaccine at around 9:55am on 03/08/21. Pain while the vaccine was being administered but it healed within a few minutes. I started getting a mild headache at around 3:30pm while at work. When I got home at around 6pm I started having severe chills, the headache became intense, my mouth and eyelids felt hot, my hands and feet felt very cold and when I checked temperature it was 102.4. By 9:00 pm the headache became excruciating like I?ve never had it before, as if my head was being squeezed or pressed. Eyes and the back of my jaw hurt too. Had light and sound sensitivity. Took 200mg of Advil but pain was still almost intolerable until I was finally able to fall asleep at around 4:00 am. Was still in pain the day after but not as bad as the night before. Only mild pain today but started feeling itchy tonight and noticed some rashes on my body.

Injection site pain, with vaccine administration lasting 72 hours Redness at injection site, following injection until post-vaccine day 4 Dull headache, starting 80+ hours after vaccine administered Back pain, starting 48 hours later, still present post-vaccine day 4

Approximately 15 minutes after receiving dose of vaccine, employee states that she began to itch all over. Eyelids and periorbital area began to swell. She did not experience any shortness of breath or difficulty swallowing.

- Flu-like symptoms on Days 2 and 3 after vaccine - On Day 4 after vaccine, developed marked swelling, pain, and redness around injection site; lasted for 3 days before swelling subsided, but redness and firmness of tissue around injection site persisted - On Day 9 after vaccine, developed "Covid Arm"; heavy swelling, itching, and redness over entirety of upper left arm. Swelling did not respond to Benadryl. No other allergy symptoms (hives elsewhere, etc.) - Filing this report on Day 16 after vaccine and, while swelling has improved, itching persists and I still have a walnut-sized mass of firm tissue under skin near injection site and patch of redness/discoloration on deltoid. Have been checked by doctor who ensured that reaction is indeed dermatological allergic reaction (not infection).

Patient started to feel itchy, had "burning" sensation shortly after injection. Patient was given initial dose of Benadryl and walked to the on-site urgent care clinic. In urgent care following IVs were administered: Pepcid, Benadryl, Solumedrol. Patient was monitored for about 2 hours. Symptoms mostly resolved in that time, still had some residual itching but felt comfortable for discharge. Discharged with outpatient medications of prednisone, famotidine, and Benadryl.

High fever (103.1) + Fever reducing medicine (Acetaminophen) Chills, Lethargy, Severe Headache (treated with Ibuprofen), Blurred vision, loss of appetite on Day 2, increased thirst, sore throat, minimal pain to injection site

Most websites said 1-2 days for side effects to kick in but I was rocked pretty hard within the first 12 hours. The biggest symptoms I had were severe body aches, debilitating chills, fluctuating fever, headache, and no appetite. 4/1/21: * 11:15am: Vaccine administered * 12pm-6pm: Arm soreness, feeling cold/experiencing some chills, minor headache and stomach ache (I felt a little off but couldn?t tell if it was real or in my head) * 5:30pm: I walk home from work, which takes about about 35 minutes. Regret the decision about 10 mins from home due to onset body aches and fatigue * 6pm: I go straight to bed freezing with crippling chills, body aches, and a headache * 8pm: Extreme nausea kicks in, I take Advil and cannot stomach more than one bite of food; still experiencing chills and body pain * 9pm: 100.7 fever, the chills subside and I start to get hot * 10:15pm: I finally eat some food, drink more water, body still aches, start to get chilly again * 10:45pm: My fever is down to 99.3, my ears really hurt, like, ear-infection-style pain * 11:15pm: 12ish hours post-vaccine, I have severe body aches, I alternate between really hot and cold, take more Advil and go to bed (finally fall asleep at midnight) 4/2/21: * 6:15am: Wake up; I spent the night tossing and turning with extreme night sweats. At this point I still have a pretty bad headache and painful body aches, specifically in my lower back and legs; fall back asleep * 8am-9am: Wake up and take more Advil. My whole body hurts. Toss and turn for a bit more. Small fever?99 degree temperature. Make coffee but have absolutely no appetite. * 9am-10am: So sweaty, fever is fully breaking * 11am: No more fever, slight headache, and body aches seem to be subsiding * 11:45am: Almost exactly 24 hours later and feeling good, comparatively speaking. Finally eat a bagel * 5:30pm: After lunch, I took a nap. My body aches have completely subsided, no fever. I still have a small headache and my ears still ache. But overall, I feel pretty normal! Just a little tired but probably from lack of sleep last night.

ACHES; CHEST PAIN; FEVER; SORENESS AT INJECTION SITE; STIFFNESS; WEAKNESS ON THE ENTIRE LEFT SIDE OF BODY; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 196 pounds, and height was 63 inches. The patient's concurrent conditions included sulfas allergy, penicillin allergy and alcohol consumption. The patient does not smoke and does not have any drug abuse or illicit drug usage. The patient stated that she has a general good health. The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on left deltoid on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the patient experienced weakness on the entire left side of her body. On the same day, the patient experienced stiffness, fever, and soreness at injection site and also recovered from the left side body weakness. On 23-MAR-2021, the subject experienced aches and chest pain. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from weakness on the entire left side of body on 22-MAR-2021, was recovering from soreness at injection site, aches, stiffness, and chest pain, and had not recovered from fever. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210345029-Covid-19 Vaccine Ad26.Cov2.S - Weakness On The Entire Left Side Of Her Body. 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.

1:42pm - took shot on upper right arm, felt needle and medicine go in, arm hurts and sore 4pm - arm hurts and sore, body starting to feel achy, start of headache 4:26pm - muscle that was injection feels vibratey, center of chest a little heavy and sore 6pm - arm hurting a little more, completely sore, a little itchy near top of right shoulder 6:46pm - bit more itchy all over, headachey, feeling hot 8pm - bad headache, warm to touch but having chills, soreness and aching, arm sore/hurts really badly, inside of nose hurts 10:23pm - woozy, pain and sore all over, burning up/fever, chills/shaking, heart fast, extremely dry mouth 11pm - thinny racing heart that was hurting, every time i tried to calm down then my heart got fast again, every muscle hurts down to feet to my neck 6:15am - still hot but not too hot, headache moderate, woke up covered on sweat possibly fever and tasting vomit a little, right arm sore, walking around weak but not feeling like im gonna fall over, ear pain on left ear, inside of nose hurts 12:42pm - no longer super hot, walking fine, right arm hurts bad and itches a little, moderate headache, body aches and esp in abdomen, vaginal itching

Headache, body aches, skin sensitivity around 8:30pm. Chills and worse headache around 4:00am on 4/2/21.

Red, swollen ring around injection site for 4+ days. Knot underneath skin for 4+ days. Know/swelling is hot to touch for 4+ days.

ITCHING ALL OVER BODY; RASH; SORE ARM; FAST HEART BEAT OF 140 BPM; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vicodin drug allergy, and sulfa drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 23-MAR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced fast heart beat of 140 bpm. On 23-MAR-2021, the subject experienced rash. On 23-MAR-2021, the subject experienced sore arm. Laboratory data included: Heart rate (NR: not provided) 140 pm. On 23-MAR-2021 16:15, the subject experienced itching all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and had not recovered from itching all over body, rash, and fast heart beat of 140 bpm. 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.

Immediate swelling and burning at injection site. 3 hours later a slight headache started and body aches, around 7pm chills started, 10pm i had a fever spike of 99.9 and chills that made my teeth chatter. Sweating and body aches as well. Fever broke around 6am and chills and body aches mostly subsided. Took tylenol for the residual headache and am feeling mostly normal minus a little soreness at injection site at 8am.

Starting 16 hours after injection: body/joint aches, nausea, dehydration, headache, hot and cold flashes, mental slowness/fog and the injection site pain got much worse. These lasted for another 12 hours and then started getting better. 17 hours after symptoms started, all that remains is mild body and joint aches. I have taken ibuprofen for pain control every 4 hours.

There was no reaction on 04-01-2021 when the shot was administered. At 1:00am on 04-02-2021, I awoke to fever, sweating, racing heart rate, headache, and severe body ache. The racing heart, fever, and sweating lasted until 6:00am. The headache and body aches lasted until 04-05-2021. On 04-03-2021, I also experienced an allergic reaction around 8:00pm. My face, neck, and throat were red and itchy and my upper lip began to swell. I took three doses of Benadryl and the allergy symptoms went away.

Fever 102 degrees for 12 or more hours. All over body pain, crippling skin pain all over body that restricted movement. Headache for several days, extreme lethargy, pain at injection site still at 6 days post injection.

4/6: 10 a.m. soreness at injection site, fully subsided by afternoon of 4/8 4/6: 6:00 p.m. moderate pain in knees and hip joints, moderate nausea began 4/6: 10 p.m. fever, moderate pain in knees, lower back, migraine-like headache, extreme pain in hip joints, unable to get comfortable or sleep due to severe pain 4/7: moderate pain in knees, pain in hips continued all day, low grade fever, intermittent headaches, interfered with daily activities, unable to work 4/7 10:00 p.m. able to sleep after 100 mg Tylenol reduced pain/headache, woke up at 2 a.m. with joint pain increasing, moderate intensity but able to sleep through it 4/8 all day mild joint pain continued, but did not interfere with working, headaches subsided and nausea mostly gone

5 hours after injection I got a headache, 101.0 fever, chills, full body aches, sever nausea and vomiting (every 20-30 minutes for 20 hours). Vomiting and Nausea subsided after 20 hours (25 hours after injection). Fever, chills, strong body aches (especially in legs) and headache lasted another 24 hours. It is now 72 hours post injections. Only remaining symptom is mild soreness at injection side but digestive system is still trying to recover from the intense vomiting that lasts 20 hours. I probably should have gone to the hospital but I don't have insurance so I tried to wait it out because I can't afford the bill and luckily I seem to be ok now.

From approximately 5:00 pm on 4/9/21 - 11:00pm on 4/10/21 I experienced chills, fever (101.7 highest recorded) sweats, body aches, and headache. I've also experienced soreness at the injection site that is worse now 4/11/21 compared to the days since the vaccine was administered.

Roughly 10 hours after injection, moderate muscular pain at injection site, and severe pain in old lower back injury - chronic bulging disc. Back pain onset was severe enough to wake me up from sleep and persisted despite use of OTC pain management. Used 2x extra-strength 500mg acetaminophen, only dulled pain, then 600mg ibuprofen approximately 8 hours later to same result. As of 27 hours post injection, pain is still moderate and disruptive. Lack of sleep and pain make it hard to determine if the fatigue is a unique symptom or purely the result of the pain symptoms. In a non-measurable manner, having had this back injury for over 10 years with multiple reoccurrences, it feels like the joint/disk swelled enough for it to press on the spinal nerves despite attempts to mitigate with ice, elevating feet and head to open intervertebral space.

My body is itchy and turns red started the first day on my feet and ankles, after taking benadryl and sleeping it disappeared. Next day same thing but it was my arms and legs. Looked like hives had to take benadryl the next day the rash disappeared. But I still feel itchy everywhere but as long as its not being scratched no rash seems to appear.

INJECTION SITE RASH; INJECTION SITE ITCHING; This spontaneous report received from a health care professional concerned a 32 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 03-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced injection site rash. On APR-2021, the subject experienced injection site itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site rash, and injection site itching. This report was non-serious.

Flare of rash typical of my autoimmune progesterone dermatitis diagnosis. I was diagnosed with APD several years ago and have since treated it effectively with hormonal birth control. This controls my flares/rashes. However tonight, 3 days post-vaccine, the rash is back.

FEELING DIZZY AND FELT LIKE SHE WAS DEHYDRATED AND WAS GOING TO PASS OUT. PT'S FINGERS ON BOTH HANDS WERE RED AND PT STATED THEY WERE DIFFICULT TO BEND. PT KEPT STATING THAT SHE FELT DEHYDRATED. PT ALSO SAID HER HANDS FELT COLD, BUT WAS SWEATING. PT WAS GIVEN ICE FOR HER NECK AND A COLD COMPRESS FOR HER FACE. PT WAS DRINKING HER WATER WITH A LIQUID IV OTC HYDRATION PRODUCT. SYMPTOMS LASTED ABOUT 15 MINUTES. PT RETURNED TO WORK AFTER ISSUES SUBSIDED. TOUCHED BASE WITH PT BEFORE SHE LEFT FOR THE DAY AND SHE STATED THAT SHE FELT ALOT BETTER AND DID NOT FEEL DEHYDRATED

That evening I had a headache and I was achy. After going to bed I developed chills where I couldn't get warm and I was shaking, and then it turned to sweating. The next day I was weak, achy, nauseous. That night I developed a fever too. My injection site it still warm to the touch and a little red and swollen, but is looking better. I also had stomach pains in the evening Friday and Saturday night that happened when I was nauseous too.

7:00 pm Friday started getting left arm: numbness on whole left side of body, left side of face swelling and droopy. Felt a sharp pain in left arm near basilic vein and started swelling like a ball. Felt shortness of breath and dizzy with blurry vision. Almost passed out when stood up. Was rushed to the ER. Had Sharp pains shooting through left leg.

For over 3 weeks following the injection I have had injection site redness, soreness, area was hot to the touch, and a large lump at injection site. I have also been very fatigued, headaches, and body aches

Symptoms - Nausea, headache, sore arm at injection site, body ache. Lasted 48 hours Treatment - ibuprofen, marijuana, sleep

Fever two nights following the vaccination. Sweating and mild nausea the second night following the vaccination. Slowly fading pain at the injection site for three days following the vaccination.

BODY ACHES; CHILLS; NAUSEA; FEVER; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at 14:00 in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-APR-2021 19:00, the subject experienced body aches. On 06-APR-2021 19:00, the subject experienced chills. On 06-APR-2021 19:00, the subject experienced nausea. On 06-APR-2021 19:00, the subject experienced fever. On 06-APR-2021 19:00, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, nausea, and fever on 08-APR-2021, and had not recovered from soreness at injection site. This report was non-serious.

Pt had her vaccine at 1835 and then proceeded to the monitoring area for her 30 minutes of monitoring due to allergy hx. At 1800 pt reported itchiness over her chest and left leg to monitoring RN. RN noted no other symptoms. Pt provided with diphenhydramine 25mg PO. RN continued to monitor. No added complaints and pt discharged home at 1850 feeling better.

On the morning following my vaccination around 8:30am, I woke up to my tongue and mouth swollen with difficulty swallowing. Due to this my body broke out in red splotchy hives around my hands and legs. I immediately injected myself with a Epi pen and after a few hours all of these symptoms went away.

Severe myalgia pain, bone pain, skin pain, organ pain, mental fogginess, inability to work or think, persistent pin for 15 days

Severe fever, drenching night sweats, itchy skin on and around neck all started Sunday night and were unbearable Monday morning. Drenching night sweats and itchy neck continued the night of Monday, April 12. Night sweats subsided Tuesday, April 13, Itching has turned into rash on neck.

I received the vaccine at 3:50 pm and by 9:45 I had the typical side effects --muscle aches, minor pain at the injection site, and chills. Within an hour from that I also had a terrible headache, nausea, and my skin hurt to touch. I slept most of the next day, save for 5 or 6 hours. Starting on 3/30/21 (exactly two weeks from receiving my vaccine) I started having sore skin. No rash, red marks, itching, just hypersensitive to touch, even with clothing. This started on my right arm right above the elbow. The following day the pain had moved to inside both arms right above the elbow. The day after that, the pain was more intense and was straight across my stomach at belly button height, and across my lower back at that same height. It was more intense for two days and hurt whether anything was touching my skin or not. It was very uncomfortable. In the days following it continued to move to different places on my body. Legs, bottom of feet, palms of hands, ankles, hips, groin, lower back. Sometimes it just hurts, sometimes it's like a prickling, sometimes the skin in that area aches -- especially when on my hands. It's also very sensitive to anything cold. Again, if you look at my skin though you can't see anything. There's no visible signs of something being wrong. It also stopped for a day or so, or just lessened so much that it wasn't that noticeable, but then returns. That's happened twice where I thought this was finally over, only to have it return the next day.

Approximately 7 hours after vaccination, I developed a very high fever, 101 after my severe chills subsided. Joint pain, particularly in my knees, toes, and feet. My skin could not stand being touched. I felt as if I had gone to hell and back.

32-year-old otherwise healthy woman presents to the emergency department with increasing fatigue and palpitations with tachycardia. She received her Covid vaccine on March 8, had 3 days of subsequent myalgias with fevers, T-max 101.9 seemed to improve but she began having urticaria symptoms and was seen in this emergency department yesterday, 4/12 progressive recurrent urticaria symptoms unresponsive to antihistamines they were ultimately treated and improved with epinephrine. Today (4/13/21) the patient had fatigue and progressive weakness with palpitations with exertion walking up the stairs. She presented with tachycardia, her heart rate of 130, BP 140/79, she is afebrile with 100% pulse ox on room air. She has no evidence of exudative pharyngitis or oropharyngeal allergic reaction. No signs of meningitis. She has no evidence of pneumonia. No abdominal tenderness. She does have some nausea. She denies any urinary frequency urgency. No abnormal vaginal discharge. No other rashes. COVID test negative. Patient admitted for observation

bruising, shortness of breath fever severe headaches joint paint , bloody noses, left leg pain, body aches

The night I got the shot I got chills a fever body aches and Nausea which lasted for six hours. Three days after the shot I noticed a lump above my collar bone which is still there. It was a lump the size of a large marble. The doctor said my Lymph node is inflamed and it is still a little swollen after ten days but it is going down.

I?m addition to the flu like symptoms (severe cold chills, severe headache, weak/fatigue, fever, body aches and soreness at the injection site). The flu like symptoms were so severe I had to take an ibuprofen to nurse my baby. I, then, experienced tingly, numb legs followed by pain. I got up to try to walk it off and had shortness of breath. Put on compression socks but the restless leg and shortness of breath continued for 3/4 hours.

Cold Chills, Fever (102.5), nausea, headache, muscle aches and pain at injection site lasting for 24 hours after shot. Still feeling fatigue after 2 days. Self-treatment at home with Tylenol.

I received J&J vaccine on 31st March. I?m 32 years old woman. I?m currently out of states, I came to another Country on 9th April. About 2days ago, I observed some tiny spots on my fingers (3 on middle finger, and 1 on ring finger - refer attached image). Also, at the same time I felt little disorientation where I was almost blank for just few seconds. I believe that might be due to empty stomach/low sugar. And then, I?m having a headache today. After the vaccination, I had a fever of 102.7 degrees for about 2days. I?m just concerned that this is nothing to worry about. And, if there are some blood tests or scans that I should get done just to be safe.

On 4/11/2021 I noticed I had a big rash. it was swollen, hot to the touch, & itchy. Had a telehealth appointment he said just to look out for sever side effects but that this was common and not to worry.

Flu like symptoms about 13 hours after shot. Fever, fatigue, chills, headache. Took over the counter pain reliever. Symptoms gone after 24 hours. Second day after shot arm got a knot at the Injection site and started to turn red, get hot, and swollen. Red spot grew in size for 5 days. Took benadryl and the heat and inflammation went away in 2 days. Lump/knot is still the same size as day 2 on day 9. Ice packs didn't help. Dr is having me rub the knot and apply heat as much as possible along with taking over the counter anti-inflammatory. Lymph nodes behind ears have now swollen.

No symptoms until 10pm when I started to experience achey joints, sensitive skin, and sore muscles. 12am is when I started to experience a fever and took my temperature which was 101'F. The fever and muscle aches lasted until the following morning. Around 12pm is when I began expecting some stomach discomfort/sharp pains on the upper left hand side of my stomach. It began to increase in intensity around 4pm when I began to get nauseous. 5-6pm is when I began vomitting, and decided to go to the ER after the pain reached a level 8-9 and my face and limbs felt numb. I was admitted to the emergency room at 11:30pm and was given a CT Scan where it was discovered I had appendicitis. Wednesday evening I underwent surgery, and was discharged Thursday 4/15. I am still experiencing a slight fever and soreness at the injection site on my left arm.

Facial numbness on left side of face including forehead, cheek, jaw, ear, lips, and tongue. I had a slight droop on the l eft side of my face, mostly noticeable around the corner of my mouth. I also experienced itchiness around the injection site. The symptoms started with numbness in the tip of my tongue about 20 minutes after receiving the vaccine and slowly spread to the rest of my face. Approximately 5 hours after receiving the vaccine the entire left side of my face was numb. I called a nurse hotline to find out if I should seek medical care that night or wait until morning. They urged me to go to the ER. I went to the ER, underwent a plethora of tests, received positive results on all of them, and was sent home with instructions to return if my condition worsened. The doctors said I had Bell?s Palsy but had little insight as to why it had occurred. a nurse hotline

Tonight I started to develop pain in my mid-back, where my kidneys are located but only on the left side. I also have headaches that wont stop with electrical zaps in my head. I also have weird digestion noises located near my liver region. I have developed a rash on all of my neck. I also woke up with the left side of my fact frozen, it took a while for it to start working again. Might be Bells Palsy. Non-stop chest pain which has gone from terrible to manageable over the last 10 days.

Immediately felt sore arm after injection. I could almost feel the vaccine going into my arm. It felt very heavy. A few hours after vaccine, felt weird 'brain fog'. This lasted through the following day. Not a typical headache. 6 days later -- experience 'brain fog' experience again... again lasted 24-36 hours. Still able to work as normal , just harder to focus. Also had weird sensations of goosebumps randomly when not cold. 15 days later -- notice that if I rubbed arm near injection site it was sore. Arm not sore at all unless touching it. Then notice a bruise at the site of injection the following day. Also feeling light-headed.

Patient has developed a rash on which started on her hands but gradually on all over her body 2 weeks after receiving the vaccine

The day of vaccination I got chills, body aches, and fever along with tiredness and bruises. The next 2 days also had tiredness. Every day since I got the shot I've had bruises and leg pains. I continue to have the bruises and leg pains.

4/11 vaccination That evening, I had muscle cramping and soreness at injection site and arm. Mild HA, sore arm. 4/13 Evening, I ended up with a bruise on my leg. Was a quarter size. The next day it was very purple. 4/14 PCM ordered blood work, doubled size. PCM ordered blood work and tests to r/out clotting. 4/17 bruise was gone, HA was gone.

"I received the Johnson & Johnson COVID-19 vaccine on April 10. I felt a little bit woozy a few hours after getting the vaccine. About 2 days after the vaccine, my upper lip was swollen for a few hours after I woke up. This week (about 9-10 days after the vaccine), I noticed red spots and very small bumps on my body, specifically on my left breast, below breasts, and lower stomach areas. It does not itch or hurt. I dont seem to have any other symptoms. I have not had any new foods or used any new products on the affected areas. "

4/5/21: Office visit for myalgias, headache, and localized swelling/erythema to injection site (left deltoid). Bactrim DS prescribed for possible infection with symptom management. 4/13/21: Office visit for continued myalgia as well as chills, malaise, abdominal pain, N/V/D and dizziness. Decadron 10 mg IM given in office and prescribed prednisone. 4/14/21: ED visit for headache and shortness of breath. CTA chest, CT head, UA, urine pregnancy, D-dimer, Chem 14, and CBC done. Diagnosed wtih episodic tension headache and abnormal CT chest (6 mm ground glass nodule to upper left lung). 4/15/21: Office visit with c/o fatigue, dyspnea with moderate exertion, allergy symptoms, and headaches - follow up from ED for abnormal CT results - informed inflammation, infection - will repeat CT in 3-6 months. Prescribed Z-Pak, medrol pak, and promethazine.

As soon as I got the shot it felt like something was flowing through my body limb by limb. My chest starts to feel tight and my upper back my arms were tingling. My right calf and right lower abdomen began having a sharp pain. About 25 minutes later I began sweating and felt like my chest was going to rupture. My heart was racing. Broke out in hives. After about 8 hours I was bedridden Ill. I was puking, fevering, headache and could not move my body I was in so much pain. I was afraid to go to sleep cause I thought I was going to die.

Brain fog within 4 hours of injection lasting approx 36 hours, fatigue 10 hours after injection, pain at site of injection off and on for 5 days, muscle ache in injection arm 18 hours after injection for 24 hours, fever of 100° 24 hours after injection lasting 10 hours. Treated with fluids and rest. All symptoms resolved except pain at injection site.

Patient is a 32-year-old female new patient 5 months post partum & currently breastfeeding, with seasonal and perennial allergic rhinitis and history of childhood asthma, referred by the emergency department to discuss anaphylaxis like reaction to the Johnson Johnson COVID-19 vaccination on 4/28/21. She received her vaccine around 2:00 p.m. She began developing itchiness in her palms/soles of feet and scalp that quickly developed into a a welt like rash about 3-1/2 hours after receiving the vaccine while on a walk with her husband; this was shortly followed by facial swelling over her right eye. They made it home and she got in a cold shower to cool down, became dizzy, started seeing spots and had difficulty breathing. Her husband called EMS and she was hypotensive when they arrived. She was given 2 doses of epinephrine (0.2 mg each per ED note) and a dose of Benadryl which helped. Shortly after the 2nd dose, she began having difficulty swallowing, maintaining the ability to breathe through her nose. She was given a 3rd dose of epinephrine and transferred to the ED; during transport an IV was started with an epinephrine drip. She was seen at Emergency Department; she was given IV fluids, solu medrol, tryptase level and had a normal EKG. She was discharged with an epi pen prescription. Tryptase is still pending at the time of her visit. She started a new prenatal vitamin at 11 am 4/28/21. Otherwise, she reports no new foods, medications or topical products. She did eat before going on a walk, pepper jack cheese, wheat thins, and black bean hummus. She is pretty sure she was not stung by a bee prior to onset of symptoms yesterday. Interestingly she reports recent urticarial episodes that occurred in February of 2021. These occurred when she was visiting her in-laws and occurred in the middle of the night, 2 nights in a row during the middle of her visit. She has never had hives previously. She reports no family history of hives or anaphylaxis. She reports no use of new topical products or medications.

Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: She had pain in neck area and tingling down her arm within about 10 minutes of receiving the shot. An hour later she thought pain in neck had intensified and md suggested tylenol and ice. 24 hours later, she says tingling is gone and just mild soreness in neck area.

pain and swelling in arm where injected, high fever, chills, muscle twitching, extreme full body pain. All lasted about 18hrs

When I received the J&J shot I had typical side effects (headache, pain at the injection site, and chills) for the first 5-6 days. The side effects subsided and I felt normal. About 3 weeks later I started to have pain at the injection site again which started very mild and then built up to nearly the same pain level I felt after the injection. The pain has since decreased and the pain is in a different part of the muscle. I feel a strong pinch in the muscle, almost like a pinched nerve, when my arm is at certain angles or doing a motion such as lifting, tugging, throwing, etc. The pain has been persistent for over a month. I am able to do most daily activities with manageable pain, but the pain is persistent and frustrating. There is no noticeable swelling or rash, nothing to visually indicate that there's pain in the muscle. I scheduled a telehealth visit with my PCP who said that delayed reactions had been documented in some cases with Pfizer but there wasn't data on J&J yet. She recommended that I monitor my arm, take Tylenol as needed, and keep her updated with any developments. I took Tylenol twice and it didn't do much. I don't know anyone else who has had this type of reaction and without data on J&J, I don't know how long to expect the pain to continue.

Fever, 48 hours Frontal headache w/ severe pressure, 48 hours Nausea, 24 hours Hot flashes, 24 hours Pain at injection site, 12 hours Body stiffness, 48 hours

Red, dotted rash that covered entire anterior and posterior torso (chest, breasts, neck, shoulders, axilla, entire back), groin, inner thighs, and buttocks, causing significant itching. The rash lasted 3 days, and resolved with daily use of Benadryl , itching continued for 5 days

Pt developed a rash on both forearms. Hydrocortisone cream was applied and the rash went away after approximately 24 hours.

Severe headache constant everyday since, fever up to 101° for up to 48 hours, tiredness for up to 48 hours, body aches for up to 48 hours, nausea everyday since, vomiting, tingling feeling in my face 48 hours after, blurred vision for up to 48 hours, dizziness everyday since, injection site is sore and started swelling after 48 hours up to 3 inches wide and it's still swollen and warm.

Cellulitis of left arm (worsenign redness, swelling and pain with underlying induration; starting >24 hours post vaccine)

Rash that appeared on the right arm, then moved down the patient's back, then to the right arm, and finally across the anterior chest over the course of 3 days. Patient reports taking Benadryl for discomfort/itching, and that rash is improving. However, patient still reports some itching on posterior right arm and lower back towards the hip.

I experienced two months after my J&J vaccine- soreness to my left arm with pain that lasted two weeks. I also experienced SVT, supraventricular tachycardia, my heart rate went up to 103 bpm and my heart rate could not go down. I went to ER where they helped my heart rate go down and I am still being monitored for SVT.

Fever/ chills/ muscle ache/ nausea/ injection site pain, 3 day duration. Toughed it out at home. Symptoms resolved.

I got shingles. Not sure if it was related to the vaccine, I have a lot of stress going on in my life, but I was told to report it.

MIGRAINE; NUMB TO FINGERS; ARM SWOLLEN; PRESSURE IN ARM/ARM TIGHTNESS; CHILLS; HEADACHE; FELT FEVERISH; INJECTION SITE TINGLING (DOWN THE ARMS TO THE FINGERS AND UP TO THE SHOULDER BLADE); FELT HOT; DIZZINESS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 28-JUN-2021, the subject experienced injection site tingling (down the arms to the fingers and up to the shoulder blade). On 28-JUN-2021, the subject experienced felt hot. On 28-JUN-2021, the subject experienced dizziness. On 28-JUN-2021, the subject experienced numb to fingers. On 28-JUN-2021, the subject experienced arm swollen. On 28-JUN-2021, the subject experienced pressure in arm/arm tightness. On 28-JUN-2021, the subject experienced chills. On 28-JUN-2021, the subject experienced headache. On 28-JUN-2021, the subject experienced felt feverish. On 29-JUN-2021, the subject experienced migraine. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, dizziness, chills, and felt feverish on 30-JUN-2021, was recovering from headache, had not recovered from injection site tingling (down the arms to the fingers and up to the shoulder blade), pressure in arm/arm tightness, numb to fingers, and arm swollen, and the outcome of migraine was not reported. This report was non-serious.

The same evening I received my vaccine I started experiencing the normal side effects of the vaccine - sore muscles, chills, nausea, headache, fatigue, and my skin hurt to touch on my thighs. I had a fever and muscle aches the following two days, but then felt pretty normal. I had some fatigue still, but was ok. Two weeks to the day after receiving the Johnson and Johnson vaccine I started having hyper-sensitive skin to the point that it was unbearable to have clothing or anything touching me. It started on my right arm just above the elbow. The next day it was on the inside of my arms and elbows. The next day it was my lower back and across my stomach at that same height, then it affected my hands, bottoms of my feet, and ankles. The hyper sensitivity gradually spread on my body, but lingering the longest on the trunk - stomach and back. However, it did affect skin on my entire body. It would prickle or burn sometimes too. When it's on my hands, my hands will ache too. I saw my primary care physician for that after a month of having the persistent symptoms. It's important to know that there was no visible reaction - no rash, redness, etc. To look at my skin, you wouldn't have known there was anything amiss. On April 19 I noticed in addition to the hypersensitivity I also felt like my hands weren't getting proper circulation. I could feel it from my elbows down to my finger tips. My hands felt cold and like a minor burning feeling. On May 3rd my joints started aching (felt it in butt /hips). I started taking ibuprofen and tylenol to try to ease symptoms and ibuprofen seemed to help a little bit with joint pain, but also helped a little with the skin hypersensitivity. It did not eliminate symptoms, but gave a little bit of a relief. From there I had that hypersensitivity down my legs, feet (also ached), chest, back, knees, stomach. In the middle of May I was having joint pain in my hands too. Around May 25th I started feeling a numbness sort of feeling in my knees, fronts of thighs, and feet. Less so in my hands at this point. Started feeling tingling, prickles, and like my feet were cold from in the inside. Felt like they weren't getting enough circulation either. On June 7, I noticed some balance issues. Since then, the balance issues have much worsened, and in addition, I've lost muscle control, experiencing weakness especially in my legs, having a lot of trouble walking, that stiffness is still there - I have trouble even bringing my knees up while standing. Having issues with going to the bathroom- urinating more often than usual, have had fecal incontinence, and feeling like my feet all the way up to halfway up my stomach are partially numb. My PCP referred me to a rheumatologist. I've had bloodwork done and the rheumatologist is now referring me to a neurologist.

5/24/21: Started with face numbness on left side, eye twitch, below neck full body numbness (pins and needles) lasted over a week, then just went to my legs, feet, fingers. Foot and legs cramps at night, swollen red toes. Around 6/1/21 toes on both feet became extremely red and painful, as well as the pads of my feet (hot to the touch). Walking and driving became painful and difficult. Nothing could be touching my toes/feet because of the severe pain. Random Jots would go from my feet up through my body. Sleeping became impossible because of the pain. 6/7/21 contacted a Dr. prescribed me METHYLPREDNISOLONE 4 MG DOSEPK. This had no affects to the pain swelling went down in toes. I then scheduled an appointment with a podiatrist 6/21/21. She prescribed another METHYLPREDNISOLONE 4 MG DOSEPK. Followed back up and feet were more red. She advised me to get labs done. Later that day I had acupuncture to treat toes. next two appointments for acupuncture 6/24/21, 6/28/21. Pins in needles were gone other than my feet, toes, right fingers. As of now my left foot /toes are not as painful. Numbness/pins&needles. Right toes and pad of foot are still numb with pins&needles.

HIVES INSIDE THE MOUTH WHICH HURTS AND SOMETIMES OPEN UP AND BLEED; FEVER 99.7; HEADACHES; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included psoriasis, and psoriatic arthritis, and concurrent conditions included asthma, and antibiotic allergy, and other pre-existing medical conditions included patient have allergies to lots of outdoor stuff, kind of antibiotic. 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: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced hives inside the mouth which hurts and sometimes open up and bleed. On 06-APR-2021, the subject experienced fever 99.7. On 06-APR-2021, the subject experienced headaches. Laboratory data included: Body temperature (NR: not provided) Fever 99.7. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 99.7 on 27-JUN-2021, and headaches on 12-APR-2021, and had not recovered from hives inside the mouth which hurts and sometimes open up and bleed. This report was non-serious.

The patient's received the injection at 10:00. After 20 minutes the patient experienced bilateral arm hives with redness and pruritus from the site of injection down to the forearm region, the skin was cool to the touch. Appromextily 11:15, the redness and pruritus have improved. The patient declined any medication to relieve the hive. The patient was recommended to take anti-histamine and a cold pad to relieve the reaction and follow up with her primary care physician. She stayed under observation till 11:20.

skin issue's , hot and cold sweats, stomach pains, migraines, nausea, blurred vision, knee swelling, and aching , Pain in the back like a stabbing fan, Dots under skin, in all areas even head. Has thrown up blood once in the beginning and also slight anal bleeding. Swollen tongue, Hand cramps, finger cramps. *diagnosed with ( henoch-schonlein)

Hospitalized with weight loss, thirsty, blurry vision, leg cramps, cuts on arm with skin infection and generally feeling bad. Diagnosis: Type 1 Diabetes

TACHYCARDIA IN 220'S, SHORTNESS OF BREATH, HIVES,DIFFICULTY BREATHING, AIR WAY CLOSURE: occuring approximately 45 minutes after injection. EMS was called and Benadryl was and EPI on hand. Primary care order Epi on hand prior to vaccine appt and Benadryl to be taken.

Pregnant 17 weeks, Due August 14 2021 Adverse effects: Muscle aches, headache, low grade fever, sore injection site

Chills, Injection site soreness, fatigue, (possible fever) did not record temperature, dizziness and headache.

Around 3:00pm on 3/7/21 I began to feel a little tired. But 3:45pm I was experiencing muscle pain through my body at only continued to get worse. At 4:30pm I took 400mg of ibuprofen since sitting, walking, and lying down were all painful. Relief came around 5:30pm and I was able to nap for an hour. At 6:30pm I awoke and attempted to eat, as I was beginning to feel nauseous. At 8:30pm I laid down again, my symptoms returning and worsening. I was now experiencing chills with my muscle pain and a headache. Pain was located throughout my body and my skin was sensitive to the touch. At 10:30pm I began shaking violently and struggled to feel warm, despite my skill feeling hot. My temperature was not taken. Another 400mg of ibuprofen was taken and one 350mg chewable of Tums anti-acid was eaten. It was not until 12:30am that I was able to sleep again. The morning of 3/8/21 I was still fatigued and sore. Moving was difficult and painful and nausea was still present, and my headache returned. I was unable to eat despite trying. At 10:00am I took two tablets of Excedrin Migrain and napped for almost two hours. Currently, my muscle aches are minimal and my headache has improved. This may however be due to the medication.

Adverse events: Severe chills, fever, fatigue, muscle aches, joint pain, dizziness, injection site pain Treatment: Acetaminophen, ice applied to injection site, rest/sleep Duration: chills lasted about 2 hours, fever lasted about 24 hours, muscle/joint pain lasted about 24 hours, injection site pain lasted about 48 hours

Chest pain, shortness of breath, fever, chills, headache, body aches, canker sores, and exhaustion within 12 hours of short. Within 24 hours, spotting, continued fever, body aches, sore throat and sinus congestion. Exhaustion, chills, canker sores and sinus pain have continued. Bruising and sore arm

Mild pain right after the injection lasted for about 30 seconds. About 8 hours later, I started getting some nausea and an upset stomach, along with some mild aches and pains. After taking a short nap, I woke up feeling a little feverish (though no fever).

I am 12 weeks pregnant, due September 19, 2021. This is my first pregnancy and I had my doctor?s approval to get the vaccine. I have had no complications so far in my pregnancy. On the day after receiving the vaccine, I developed a severe headache, congestion, dehydration, and fatigue. I felt feverish and had chills, but I did not have a fever. I was unable to go about my daily activities (I was not working on this day). These symptoms went away about 36 hours after being vaccinated. I also had pain at the injection site.

100.2 fever, chills, soreness in left arm at site, body aches all over. These symptoms started around 2 am and continued throughout the morning

On the first day, I had fever, chills, aches and pains , and a head ache. Second day- swollen lymph nodes under the arm, aches and pains,. Third day - head ache and muscle fatigue 5th day- starting at 4am. I woke up with skin itching. I noticed a rash on my arm where injection was. It then spread to back, other arm, legs, neck , ankles and knees. Took Benadryl and Zyrtec by doctors orders. The rash went away- but then six hours later returned and has grown. I also have to take more Benadryl since the same amount has not helped the rash disappear.

Injection was Thursday and it is now Monday. Injection site is very hot to the touch. Red raised bump at injection site as well. More so concerned over the heat at the injection site.

Chills, fever, body ache, intense injection site pain, eye pain, dizziness, mild skin irritation throughout body, fatique

Day 1: Very mild headache, slight soreness at injection sight - began upon waking and lasted until 3pm that day Day 4: began at 10:30 pm - Chills, Body Aches, Severe Headache, Sweating - ended around 3am

Symptoms started 8 hours after injection--started slowly with overall body fatigue, hazy mind, sore injection site. Then progressed to body aches, severe chills, headache and high fever( 101) and joint pain.

Yesterday I got the Johnson and Johnson vaccine. I was the last appointment, so they observed me for 5 minutes, and I left. After riding in the car for a few minutes, I noticed that I was having a hard time breathing and my throat felt like it was starting to swell. By that time, the clinic was closed, so I went to the emergency room just in case and sat in my car since they didn't allow people to sit in the waiting room because if covid. It started becoming increasingly difficult to breathe, and I was feeling more and more swelling of my throat and tongue. I was having a lot of dizziness, nausea, facial flushing, palpitations, and some mild confusion. I then started getting numbness in the bottom half of my face. Over time, the numbness spread, mostly staying on the left side of my body (face, scalp, lower arms and legs, left side on tongue and inside of mouth). I also started getting a prickling burning pain sensation for brief periods of time where I had numbness. I had decided that if my breathing worsened at all, I would go to the er even though I can't afford it. After about an hour and a half, my breathing started to feel less constricted and like there was less resistance. The swelling in my throat was mostly in the upper throat where I had difficulty swallowing but not as much difficulty breathing. The numbness continued to get worse and was sometimes disappearing and reappearing in the same spot. At 9:30 pm we went to go get some benadryl. I continued feeling less and less swelling and having an easier time breathing. At that point, I went home. Once I was home, my breathing continued to improve and the numbness started to dissipate. In the middle of the night, I started itching and getting widespread hives and getting a sharp burning pricking pain that would last a few seconds in different areas. The numbness also started coming back mostly in my face. I continued to have difficulty swallowing. I am feeling much better today. I still feel some slight swelling in my throat when I swallow, but my breathing is fine. I'm still itchy and occasionally breaking out in hives. Im having mild lower facial numbness. I'm also starting to get the normal side effects of fever, headache, arm soreness, and body aches. I'm taking benadryl every 4 hours.

I had general fatigue and headaches. The after I woke up my left arm was red and puffy. Overnight the area had doubled in size, itchy and painful. The area was circular and 2-3 inches in diameter. I went to Urgent care and they gave me Benadryl and a Steroid to take. The area is still painful and swollen and is starting to improve. It has been seven days and the area is still red swollen, warm and itchy. I have three more days of Steroid medication left. I just had a headache and fatigue for the first couple of days.

A few days after the shot, the injection site became very red, itchy, warm, and swollen. It has lasted 4 days now and is starting to get better.

Vaccine received Thursday evening 5pm; fatigue all day Friday, but back to normal the following day. Sunday morning arm began feeling very sore. It is now the following Friday so 1 week later and arm still sore and there is a hard lump near injection site and bruised. Other than arm soreness for the entire week, I feel fine with no other adverse side effects.

Pt came to office 3/17/21 with reaction -she had received at another facility on 3/13/21. Pt reports received through school district/employer. Received COVID vaccine LA and felt "tingling" all over and told staff who told her it was normal. Later that day her left arm developed hives, with significant edema and erythema and puritis. She was evaluated in our office on 3/17/21- no respiratory distress, or perioral edema. Advised to use antihistamine and hydrocortisone and reviewed red flags. Returned on 3/19/21 with improving symptoms.

Received vaccine at approximately 12:30 pm on 3/15/21 at 13 weeks pregnant (due date of 9/15/21). Weight and height 5'0", approximates 136lbs. During injection there was a pain from the needle insert and immediate soreness. I would describe it as more painful than the flu shot that I received in November of 2021. I was then escorted to a chair for a 15 minute observation period. I did not have any allergic reactions to the shot. I continued to feel slight soreness in my left arm for the rest of the day. At approximately 8 pm I began to feel "aches and pains" similar to those during a cold and flu. I took (1) regular strength Tylenol Acetaminophen 325 mg tablet. I began to feel a little bit warm around 9-10 pm and checked my temperature with an infrared thermometer and it was slightly elevated by a degree (no exact measurement). I went to bed at approximately 11:30 pm. At approximately 12:45 am I woke up and took my temperature. I first used the infrared thermometer and it came back as 99.4 F. I felt very warm so I then switched to an Oral thermometer for accuracy and began to record the following: 101.1 F - 12:45am (was under blankets so got out of bed to cool off) / 100.0 F - 1:05 am / 100.9 F - 1:20 am At 1:10am I used a cold compress (small ice pack wrapped in a kitchen towel) to cool off and then took a luke-warm shower at 1:15 am (did not wet hair). I also drank a big water bottle of water (Tap Water) probably around 500ml. The room temperature was around 74 F. I re-measured my temp at 1:40 am and it decreased to 99.3 F. I took a 2nd Tylenol tablet (same as above) at 2 am. My temperature at 2:05 am was 100.0 F. I then went in and out of sleep and recorded my temps every time I woke up and went to the bathroom / drank more water. 98.5 F at 3:55 am / 98.4 F at 5:55 am / 99.0 at 7:25 am. At 7:30am I took a 3rd & 4th Tylenol. Temp at 7:55am was 99.4F. I went back to sleep and then woke up at 9am to login remotely for work. Temp at 9:25 am was 98.7. I then took a nap from 9:30 am to 12:00 pm (my boss told me to go to sleep after our call) and slept very soundly. When I woke up I felt a lot better. Aches and pains were no longer present and fever appeared to be gone. The worst of the symptoms were over. I then spot checked my temp a few times throughout the day: 98.0F at 12:15pm / 98.3 F at 1:40pm / 98.7 at 2:05 pm. At 2:15 pm I took a 5th Tylenol just in case. I took my last official temp at 2:20pm at 98.3 F. At about 3pm 3/16 I had a telehealth visit with my OBGYN. She said that my symptoms were normal and everything looked ok. My test results from my 12 week sonogram I had 2 weeks prior were all OK as well. To my knowledge the baby is tracking healthy. Note that during the whole time I did not experience any symptoms related to the baby. No cramps or pains in my abdomen. I am happy to share any past or future data about my pregnancy if anyone reading this is interested in contacting me. I then randomly measured my temp until bed but it never came back as higher than normal (didn?t write it down). Slept through the next night normal and woke up normal temp as well. I would say I was more tired than usual on 3/17 but did not have any more flu like symptoms. The only thing that remained was a soreness at the injection site. It was at the spot of injection and also kind of the general area. The pain/feeling completely went away by the end of the week 3/19. This is a very long description of symptoms. I don?t know if it?s helpful or if anyone even read all of it. But I?m just writing it down for record.

Pregnant and EDD is 4/18/21. This is my 2nd pregnancy. By 8pm the night of the vaccine, I had some nausea, headache and muscle aches. I woke at 3am with severe chills and shaking. I had a fever of 101.5. I took Tylenol Extra Stength and that helped. Had trouble sleeping but managed to fall back asleep for a little bit. Upon waking, I had a head, muscle aches, and a fever. I kept taking the Tylonel every 6 hours throughout the entire day. My fever got as high as 102.1. It broke around 7pm on March 18th. My shoulder where the vaccine was injected was sore through Saturday, March 20th. I had muscle aches and weakness through Saturday, March 20th.

Shot 11:42am (left arm hurts) 5pm?extreme fatigue 7pm?threw up once 9:30pm?went to bed 11:00pm?muscles and joints were in terrible pain. I haven?t felt that bad since I had swine flu in 2009. I could not move without terrible pain all over. 1:00am?joints/muscles still hurting, then my skin starts to tingle and is super sensitive like it has a ?strawberry burn? all over. 2:00am?still awake, could not get to sleep. 4:00am?fall asleep. 8:00am?still so sore, skin is no longer sensitive, muscles, and joints are. Massive headache in temples like I am hungover. 10:00am?took ibuprofen to get rid of headache and to help joints. 10:00-1:00pm?napped. 1:00pm?woke up, headache gone, mildly sore. Feeling better.

Vaccinated at 12:00 19Mar2021. Sore arm started a couple hours afterward and is still present. Started experiencing fogginess and feeling cold at 1:00 am 20Mar2021. Went to bed at 1:00 and dreamed of being sick until waking up at 8:30 am 20Mar2021. Woke up and was very weak (could not push toothpaste through toothpaste tube), almost passed out in trying, so I sat on the floor. Tried getting back to bed and was extremely nauseous and started vomiting. After that, I had the sweats/fever/chills for a couple hours (until ~11:00am), and was fatigued until 4:00 pm. Spent most of the day sleeping, unable to do anything. Today, 22Mar2021, feel slight tingling on palm of left hand and fingers. Injection site is still sore and bruised

3/22/2021, 2:00am - Fever of 102.9 that lasted until 7:00am even after taking 400mg Tylenol. Sweats, chills, muscle and body aches continued through the night into the morning. 03/22/2021, 7:00pm - Fever of 101.2. Went away after Tylenol 400mg. Nursing child had temperature of 99.9 3/23/2021, 9:00am - large bruise over injection site

I did get sick that evening - I had a fever and chills. I did throw up. That lasted all night. The fever broke by the morning. But the exhausted next day - I went home from work early that day. Friday, I got a rash - very itchy and sore (it felt very tender when touched)- on my left side (abdomen). It spread around the left side on my back and to my stomach. I say my doctor on this Tuesday (virtual appt) said it was Shingles - Valtrex - to help it heal faster. The rash is starting to scab over and is peeling now. It's getting better.

At 4PM on 3/9/21 I began getting hives all over my body with extreme itching, I took Benadryl around 5PM and they continued to get worse throughout the night. I took 60mg of prednisone and 5mg of levocetirizine the next morning (3/10/21) and the hives subsided until 4pm that night. I went to the Urgent care and received a shot of dexamethasone IM that day as well. I took 40mg of famotidine and 50mg Benadryl that night and woke up the next morning with only a few small patches of hives that went away throughout the day. The next morning (3/11/21) I took 40mg of famotidine and had a few small patches of hives that went away throughout the day. On 3/12/21 I woke up and had no hives and have not had any symptoms since.

Chills, muscle spasms, body aches, pain, throbbing feeling in legs are sharp stabbing pain in neck and back, abdominal cramping, bloating and gas. heavy irregular vaginal bleeding (uncommon for me) bleeding stopped 24 hours later . Skin sensitivity, like having sunburn, persistent headache, joint pain, specifically hands, knees and shin pain.

Patient reported burning sensation on injection into left deltoid and localized painful reaction. Within approximately 10 minutes following injection, patient reported dizziness, weakness, and nausea. Patient tried to stand and reported that she experienced syncope, fell, and struck her head. Patient called out pharmacist's name. Pharmacist arrived to find patient lying on the floor. Patient had visible mark and bump on her forehead. Pharmacist elevated patient's feet. Patient elevated herself under her own power to a seated position. Patient was given water and blood pressure was taken. Blood pressure was 128/86 with a heart rate of 76. Patient requested pharmacist not contact 911. All events occurred within 15 minutes following vaccination. Patient reported she would visit urgent care following departure from pharmacy but unknown if patient will follow-up. Patient left under her own power and was driven home by husband.

In 24 hours had muscle aches, fever and headaches. After a week I broke out in hives that covered my entire body and entered my mouth. Received treatment right away and the hives stopped spreading after a week

Chills, sore arm with a bruise, leg spasms, drop in blood sugar throughout the day, lots of appetite

Initially three days after flu like symptoms, body aches, sweat, chills cough, fever, nausea. On 03-23-2021, when I woke up the entire left side of my face and head was extremely sensitive. My hair was sensitive, left side, and I also had a fever. My left ear hurt, left side of my tongue, nasal cavity hurt. Strep test was performed was negative, Covid test was negative performed at an urgent care. My symptoms have gotten better but my symptoms to my head are still present nut not as severe.

Rash/Dry Scaly Red spot on Right shoulder. About the size of a quarter. Itchy Rash on abdomen and back.

Fever 102.6 Chills Moderate pain at injection site Severe headache Body ache Hot/cold flashes Severe fatigue Began around 10pm day of vaccine. Symptoms became more severe for next 24 hours then began to dissipate. Fever broke at 24 hours. Still showing severe and mild arm pain at injection site

Fever, chills, fatigue, body aches- moderate for 36 hours following injection. Pain at injection site for 10 days following injection. Ringing in ears on 4/7.

About two weeks after receiving the vaccine, the injection site started getting very painful. It hurts to raise my arm and my joints hurt all in my shoulder, neck and hips, only on the right side.

Hives/welps/open wounds about 30 mins after shot. Still today have hives that itch on neck and face with blistering welps (4/8/21). Covid arm very painful still today.

Pt had seizure lasting approx 5 seconds. After seizure pt complained of continued dizziness and pain in the arm that vaccine was given. she remained at vaccine site for an hour or more with her husband , then they left together.

Vomiting 20 minutes after injection, brain fog, migraine headache, 102 degree fever with sweats and chills, injection site was initially red, then purple and now brownish. pt has swollen lymph nodes, a swollen left breast and is not growing hair in her left armpit.

Felt fatigue and low fever 12 hours after shot. Felt ok the next morning, and then low fever and fatigue again 24 hours after the injection. Arm sore at injection site for a week. Fever and most symptoms (other than sore arm) gone within 48 hours.

After vaccination, patient had seizure-like activity lasting approximately 5 seconds. After seizing activity ended, patient complained of dizziness and pain in the vaccinated arm. Patient remained at the fairgrounds with her husband (who was also vaccinated) for approximately 2 hours after episode. Patient was driven home by her husband.

nausea from 1 day after and still on day 4. slight headache 1 day post shot, soreness in arm for 2 days and slight swelling at entry point. no other symptoms.

Painful swollen lymph nodes behind right ear and neck, red swollen bumps/rash on right side of scalp, general feeling of fatigue and illness.

Itching skin, chest tightness, 0 SOB, 0 dizziness, 0 nausea, IM Benadryl (25 mg) given, symptoms - pt felt better. BP was 110/62. 73 HR. Pt felt better - husband will drive home.

HIVES; FATIGUE; FEVER; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021, the subject experienced fever. Treatment medications included: ibuprofen. On 03-APR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 03-APR-2021, was recovering from fatigue, and body aches, and had not recovered from hives. This report was non-serious.

After about an hour after shot, light headed. 12 hours later, dizziness, rapid heartbeat and pain or ache in isolated spot in upper left thigh. Discovered 2 days later, a red spotty area on upper left thigh where the ache was.

Pain in arm, nausea, fatigue, fever, body ache beginning 2-3 hours after shot, peaking around 2am. Day 2, intense body ache all day. Evening of day 2, itchiness, redness, pain and mild swelling at injection site, two possible hives on chest area. Day three, continued itching, redness, pain and mild swelling at injection site. Day 4, same as day 3.

-Mild tenderness in arm after injection -Chills, fever of around 102 lasting for approximately 12 hours -Body aches and fatigue both day of and day following vaccination

4/8/21 12:45pm injection received. injection site is painful 4/8/21 5:30pm-9:30PM: experienced fatigue, muscle soreness, and unusual body temperature. 4/8/21 9:30pm: temperature of 98.8 degrees F (base temperature being 98.4 degrees F) measured with an at home Non Contact Thermometer. At that time patient was experiencing whole body muscle aches, headache, chills, and fatigue. Patient took 2 500mg Acetaminophen caplets and attempted to sleep. 4/9/21 6:30am: temperature was measured (using the same method as above) and was 99.8. Patient was still experiencing muscle aches, chills, fatigue, and headaches. Patient took 2 more 500mg Acetaminophen caplets and went back to sleep. (called into work) 4/9/21 12pm: a little fatigued and some muscle soreness temp normalized 98.4 4/9/21 6:30pm: a little achy and chilled, took 2 500mg Acetaminophen caplets 4/10/21 no symptoms to report except slight soreness at injection site 4/10/21 9AM saw a doctor via virtual visit to report adverse reaction and recovery. received note releasing for work

Swelling and itching in eyes for almost 4 days. Swollen and extremely sore and itching on arm for up to 3 days. After swelling in eyes went down I'm still experiencing itching and same in the location of injection. Day 6 injection site was still red swollen and itchy and the site was hot to the touch for almost 7 days. Today, 04-13-21 site is still sore to touch and seems to have a lump. Warm to the touch. Eyelids still irritating.

Starting around 8 pm began experiencing fatigue, Chills, and nausea. By 10 pm began having headache and went to lay down. Woke up in middle of the night with high fever, cold sweats, and migraine. By morning migraine intensified, could not stand for more than a few minutes without feeling faint and waves of nausea, complete loss of appetite and felt extremely dehydrated and lethargic. Sore arm at injection site started second day and progressively got worse day 3 and 4. 36 hours after vaccine was when I felt more able to eat, walk around, migraine reduced to a dull headache. Fatigue lingered in day to day activities for about 1 week.

Approx 8-10 hours after injection - severe muscle cramping all over body, neck pain, headache, frequent urination, chills, excessive sweating, heartburn, nausea (lasting approx 12 hours), followed by approx 8 hours of no symptoms. Muscle cramping and headache then returned for a duration of approximately 6 hours. 48 hours after vaccination, the injection site has become increasingly red, swollen and painful/itchy. Redness has grown substantially in the past 24 hours.

Itchiness and slight hives for a few hours at injection site Onset of the following symptoms about 12 hours after injection: Tachycardia (HR up t0 148bpm at rest) Heart palpitations Severe headache Fever (100-101) Chills Soreness in arm for one week Treated with tylenol Felt okay after 36 hours

started on 04/09/2021- severe body aches, sweats, chills, severe headaches, pain on left side of face that ran down jaw and into middle of neck, swelling of injection site, sever fatigue. some symptoms are still ongoing.

I started to feel chilled around 7pm friday evening. I laid down and began to feel nauseous and hot; my skin was sensitive. I soon had a 103.7 fever with chills and a terrible splitting headache. My symptoms lasted through the night. I took one 200mg Ibuprofen at 03:30 saturday morning/it didn't seem to help much. Most of the day saturday I had a headache that was manageable and 100.2 degree fever. Saturday evening I was fever free and had a dull headache. Sunday, I was exhausted.

days 1-3 the expected fever (101), headache, dizziness, extremely sore arm and body aches, tiredness, difficulty falling asleep Day 4 swelling in left armpit about half a golf ball size with pain and soreness into left upper chest, called family drs office they said it?s a listed possible effect of the vaccine Day 7 vomiting, diarrhea, stomach pain, dizziness, flu-like symptoms. Urgent care visit - test for covid came back negative, given medication help keep fluids down. Severe symptoms lasted for 3 days. Diarrhea persisted for 8 days. Followed up with family dr. Continuing to feel unwell - tired, occasional dizzy/lightheaded spells, lesser stomach pains, soreness under left arm into chest area, difficulty sleeping, tightness and darkening of veins in arms especially forearms

Pain initially started 24-48 hours after the vaccine injection. Pain is at injection site, and surrounding area. Seems to be worsening since that time. She has tried over-the-counter Tylenol/Ibuprofen and topical Diclofenac gel with little to no relief of her pain. This is made daily living difficult. She also works as a daycare provider. She had some increased headaches 2-3 days after the vaccine, but these have seemed to resolve.

Migraines Light Headed/Dizzy Swollen Gland on right neck Swelling on right side of face Rash on neck and chest Pain on Right side of face Throbbing pain in Ear on right side

Severe bruising that was raised and painful. Still a deep bruise and it has been 10 full days. Tingly hand and arm.

Soreness at shot site for 3 days. Soreness progressed further down upper arm into muscle pain that has been persistent for two weeks. Not getting better. Affecting ability to carry things and keeping me up at night w the pain. Center of upper arm.

Got my vaccine on Saturday 04/10, today 04/14 I start feeling pain in both of my arms this morning, is a weird feeling like I feel my veins, I had a hearth pain, as soon as I wake up I felt a headache, I had it all day, on the left side of my head and after on the back area, it stoped around 6 pm, in the day I had diarrea, fatigue, pain in my joints, shortness of breath, pain in my arms and in my legs, itchy skin .

Due to history of vaccine reaction of hives to flu vaccine, took 25 mg benadryl 1.5 hours prior to receiving covid vaccine. approximately 1 hours after vaccination, experienced sharp, constant retrosternal chest pain that is was non-radiating. on 4/11 experienced fever, and developed hives to right arm that injection was given as well as nausea without vomiting or diarrhea. Fever continued x 4 days with maximum temperature of 102.9 on 4/12. Chest pain continues as of 4/15. On 4/14 at approximately 2am was awoken with worsening chest pain and at that time also noticed development of a metallic taste in mouth, and since that time have been unable to taste anything but metal regardless of what is eaten or drank. Still with chest pain and metallic taste, hives resolved 4/12 evening and fever resolved on 4/14 late evening.

My scalp started to seriously itch, as time went on ( about 10 min) my whole head and face was very itchy. I started to break out in hives and whelps. My ears were slightly swollen and very red and itchy. At this point I took a good dose of benadryl . Before the benadryl kicked in, it had spread down my back, arms, and stomach. After the medicine had time to work my symptoms started going away and I was fine.

I found out about my pregnancy the day I got the vaccine (which was after I got the vaccine). After that I proceeded to get a pregnancy test confirmation (march 26) and it came back positive from the doctors office. On March 28 I began to have bleeding and I passed a blood clot the size of a baseball. I called the nurse line that next day and they told me they could not give me any medical advice because I had not been seen by a doctor for this pregnancy. During that week I began to experience a rash that began in the middle of my chest and proceeded to spread All over my stomach and back. It is now April 19 in the rash has continue to spread all over my limbs. On April 5 I went to the pregnancy clinic and was also getting a ultrasound and they were unable to locate the embryo in the uterus. On April 15 I got an ultrasound transvaginal and they were unable to locate an embryo or in a heartbeat. I then went to the hospital the next day on April 16 the hospital that I received my vaccine at and they did not give me any care and told me that my rash was a possible contact to something I may have come in contact recently. I try to express to the doctor that I?ve been experiencing issues since I received the vaccine and he did not connect any of the dots to my experiences. As of today April 19 I have come across several Different websites that state that red spot is a part of the symptoms an adverse reaction to the vaccine or should be of concern.

The morning after my shot (received around 3-3:30p on Saturday 4/3/21), I woke up to a partially swollen right eye and pressure pain across the sinuses. Vision slightly obscured, but I could still see. Applied a cold compress throughout the day and monitored for additional concerns. By the end of the day, the swelling subsided. By Monday, both eyes still felt pressure pain, but the swelling was significantly improved. Other side effects included the expected muscle soreness/aches, fatigue, and a mild rash around the vaccination spot. No additional adverse effects observed.

about 6 days later I started getting bad headaches, on and off. Leg pain, joint pain, dizzyness on and off and overall tiredness. 9 days later I started noticing odd bruises on my legs and arms. I am overall tired and achy. The headache comes and goes and I need to take tylenol.

LATEX ALLERGY; RASH; TIRED; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included drug abuse, and concurrent conditions included penicillin allergy, hives, sulfa allergy, welts, latex allergy, alcoholic, and nonsmoker. The patient was previously treated with metamfetamine for drug abuse. 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 08-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 latex allergy. On 09-APR-2021, the subject experienced rash. On 09-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash, and tired, and the outcome of latex allergy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425218.

Patient developed unexplained bilateral bruising behind both knees eight days following vaccination. Does not have a history of bruising so visibly nor a history of blood clots. Bruises started off very red, slightly itchy and scattered. Over the next few days, the bruises darkened purple and merged closer together. Bruising was much more severe on the left leg than the right. Bruising has become less apparent over time.

Patient verbalized to clinic nurse that one day after vaccine was given she had tingling in the right arm. Patient verbalized that the tingling has been " coming and going" since the vaccine was given. Patient spoke with provider and also reported redness and swelling to the site. Patient was instruct to come to the urgent care to be further evaluated. Patient agreed and presented to the clinic on 4/20/21. Patient was assessed and had labs draw there are no abnormalities at this time. Patient was educated on signs and symptoms to monitor for and when to seek medical attention.

PERIOD CRAMPS; ABDOMINAL CRAMPS; ACCELERATED HEART RATE; RASH AT INJECTION SITE; HEADACHE; TIRED; ITCHY ON ARMS; This spontaneous report received from a consumer concerned a 33 year old female. The patient's weight was 140 pounds, and height was 61 inches. The patient's concurrent conditions included allergic to polyethylene glycol, allergic to red dye, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not have any 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: 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 APR-2021, the subject experienced itchy on arms. On APR-2021, the subject experienced tired. On 10-APR-2021, the subject experienced period cramps. On 10-APR-2021, the subject experienced abdominal cramps. On 10-APR-2021, the subject experienced accelerated heart rate. On 10-APR-2021, the subject experienced rash at injection site. On 10-APR-2021, the subject experienced headache. Laboratory data included: Heart rate high (NR: not provided) accelerated, and Pain scale (NR: not provided) 8 (unit not reported), 6 (unit not reported). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, abdominal cramps, accelerated heart rate, rash at injection site, itchy on arms, and period cramps, and the outcome of tired was not reported. This report was non-serious.

The day of the injection i broke out in hives. 3/9/21 My period started early and lasted for 8 days. It normally lasts for 3. Then I ended up starting early again and am currently and actively bleeding. It has been 8 days again. This started the weekend after I got the vaccine. Also. In the muscle around the injection site when I lift heavy things it feels like I'm being pinched or hurt. This started April 17th ish.

She has developed a cellulitis to the left arm near the elbow. site is very swollen and painful and warm to touch. She is also developing some pain, warmth and swelling near the right elbow. she has been started on doxycycline. She saw her PCP and was informed that they have seen this in another individual after receipt of the J and J vaccine.

After two weeks, the injection site is still sore, but mostly, my joints including wrists, knee, ankles are still extremely achy and throbbing persistently. I have experienced sinus pressure headaches as well. My legs and arms feel tingly and numb at times - more often my left side which is where I got injection. I feel weakness and fatigue most afternoons. My body didn't feel this way before the vaccine and it seems as though my body hasn't fully recovered from the shot and has flared up these symptoms. I feel all of a sudden that I have arthritis.

THROAT SENSATION LIKE TICKLE; COUGH; SHORTNESS OF BREATH; LIGHT PRESSURE ON CHEST; FELT LIKE HAVING AN ALLERGY; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included anxiety, and endometriosis, and concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced watery eyes when treated with ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced throat sensation like tickle. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced light pressure on chest. On 10-APR-2021, the subject experienced felt like having an allergy. On 12-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. Laboratory data (dates unspecified) included: Laparoscopy (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt like having an allergy, throat sensation like tickle, and injection site pain, and had not recovered from cough, shortness of breath, and light pressure on chest. This report was non-serious.

NECK WAS SWOLLEN IT WAS GIVING UNDER CHIN; DIZZINESS/LIGHTHEADEDNESS; RED ITCHY RASH UNDER THE BELLY BUTTON AND NECK; SHORTNESS OF BREATH; LOSS OF APPETITE; TIREDNESS; FEVER; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced neck was swollen it was giving under chin. On APR-2021, the subject experienced dizziness/lightheadedness. On APR-2021, the subject experienced red itchy rash under the belly button and neck. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-APR-2021, had not recovered from red itchy rash under the belly button and neck, and the outcome of neck was swollen it was giving under chin, dizziness/lightheadedness, shortness of breath, loss of appetite and tiredness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425148.

Rather large rash extended from injection site in deltoid down the arm for a few days but eventually cleared up.

04/07/2021 fatigue, low grade fever. 04/8/2021-04/14/2021 pain in injection site, fatigue, lack of interest, confusion, vision troubles, trouble understanding, nausea, dyslexia, dizziness, lightheaded, feeling of impeding doom, increased anxiety, headaches, body aches, leg pain, numbness, tingling, arm pain and numbness, face numbness. 04/14/2021 Severe headache with other symptoms described. ER visit helped severe headache. Fatigue, leg pain, confusion and oversleeping continues. Unable to wake up in the morning, consistently late to work or unable to work. Unmotivated, careless, lack of interest, unable to concentrate or function for normal daily activities. Constant Fog, repetitive headaches. Memory issues and unable to complete familiar job duties and other activities. I feel as if something broke in my brain, I just want to be me again. So far little improvement and symptoms getting worse i am afraid this will be permanent.

My Adverse event is strong head ache, A weird Rash in my Body. Its been like that for 1 week and doesn't want to go. I'm not allergic to nothing. I put the Vaccine the 03/30/21 and the rash star the 04/19/21. I went to emergency and the prescribe, Medrol 4mg and Benadryl 25mg. I try Benadryl for days but didn't do nothing, and I'm going to make a appt with my Doctor as soon as possible.

Temp dysregulation (few days), headache(on and off), body aches(1day), fatigue(on and off), nausea(on and off), arm swelling/redness/tenderness(several days), stomach discomfort(few days). Rolaids, Tylenol, aleve, rest, water.

Injection was very painful and felt immediately as if it was improperly administered causing my arm to go limp (so to speak) right away. The pain was so intense that I became extremely lightheaded almost to the point of fainting. Within 15 minutes following the vaccination, I started experiencing excruciating arm pain at the injection site . The pain has persisted for the past month with little to no relief, I now have limited range of motion and cannot make certain movements with my arm.

TREMBLING; BOTTOM OF FEET PAINFUL; BAD/SEVERE HEADACHE; EXTREME FATIGUE; SWELLING AROUND MOUTH; SWOLLEN HANDS AND FEET; ITCHY ON THE TOP FEET WITH RED BLOTCHY RASHES; NUMBNESS AND TINGLING SENSATION AT LEFT SIDE OF EXTREMITIES AND BODY; SWOLLEN THROAT; SEVERE SHARP STOMACH PAIN; TINGLING AROUND MOUTH; SEVERE SHARP CHEST PAIN (STERNUM AREA); SORE THROAT; DIFFICULTY IN BREATHING; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight was 130 pounds, and height was 169 centimeters. The patient's past medical history included surgical removal of left ovary and fallopian tube, and cyst in ovary, and concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known 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, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 7/10. On 10-APR-2021, the subject experienced severe sharp chest pain (sternum area). On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced difficulty in breathing. On 10-APR-2021, the subject experienced tingling around mouth. On 10-APR-2021, the subject experienced swollen throat. On 10-APR-2021, the subject experienced severe sharp stomach pain. On 11-APR-2021, the subject experienced swelling around mouth. On 11-APR-2021, the subject experienced swollen hands and feet. On 11-APR-2021, the subject experienced itchy on the top feet with red blotchy rashes. On 11-APR-2021, the subject experienced numbness and tingling sensation at left side of extremities and body. On 11-APR-2021, the subject experienced bottom of feet painful. On 11-APR-2021, the subject experienced bad/severe headache. On 11-APR-2021, the subject experienced extreme fatigue. Treatment medications included: bismuth subsalicylate, diphenhydramine hydrochloride, famotidine, and ibuprofen. On 12-APR-2021, the subject experienced trembling. Laboratory data included: Fibrin D dimer high (NR: not provided) elevated, and Platelet count (NR: not provided) Normal. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal. On 14-APR-2021, Laboratory data included: CAT scan (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe sharp chest pain (sternum area), sore throat, swelling around mouth, tingling around mouth, itchy on the top feet with red blotchy rashes, and severe sharp stomach pain on 13-APR-2021, difficulty in breathing, swollen hands and feet, numbness and tingling sensation at left side of extremities and body, swollen throat, bottom of feet painful, bad/severe headache, and extreme fatigue on 20-APR-2021, and trembling on 16-APR-2021. 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.

MIGRAINE; DIARRHEA; UPSET STOMACH; TIRED; POUNDING HEADACHE; SORE THROAT; INJECTION SITE PAIN; CHILLS; This spontaneous report received from a patient concerned a 33 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 (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced pounding headache. On 04-MAY-2021, the subject experienced diarrhea. On 04-MAY-2021, the subject experienced upset stomach. On 05-MAY-2021, the subject experienced migraine. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore throat, tired, and pounding headache on 10-APR-2021, chills on 09-APR-2021, and injection site pain on 12-APR-2021, and had not recovered from migraine, diarrhea, and upset stomach. This report was non-serious.

Patient experienced sudden dizziness and nausea within 5 minutes of receiving Janssen COVID-19 immunization. Gave her water, crackers and cold/wet rags for her forehead as she felt hot. Took her temperature, returned normal. Gave her a trash can to keep near. Kept an eye on the patient and realized she was getting red in the face and more dizzy than she had been. Went out and stood next to patient, with her mom on her other side. Began to experience light sensitivity, feeling like the room was spinning. Patient almost fell out of the chair while sitting still. Mom used a personal pulse oximeter on patient, all results normal. Asked the patient about other symptoms, such as chest/abdominal/leg pain, headache, shortness of breath. Patient reported a headache, dizziness, nausea and leg numbness roughly 30 minutes following the vaccine. I recommended going to the ER, mom believed it would pass with time, but insisted she never responds this way to immunizations. Patient began to experience stabbing chest and abdominal pain around 45 minutes. Patient's mom was still hesitant to take her to the ER immediately on her own and asked us to call her PCP. He wanted the patient to go to the ER. Patient believed she would fall if she stood, offered to get a motorized cart, wheelchair or call an ambulance to transport her. Both patient and mom requested the ambulance. Asked a technician to check patient medications and allergies for EMTs, retook the patient's temperature which was normal again. Stayed with patient until EMTs arrived, reported all symptoms patient was experiencing.

Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Bloody Stool-Severe, Additional Details: Ptx stated night of or morning after vaccination on 05/06/21, experienced abdominal pain and had a bowel movement that contained blood in stool (blood filled toilet bowl and could not see stool). Ptx stated arm was sore. No reports of bruising, red sports on skin, severe headache nor swelling in arms or legs. Recommended ptx to contact PCP right away.

Notice pain in right arm (injection site) upon waking up in the morning and before bed. Arm occasionally hurts during the day if I am carrying something heavy. Pain is similar to the aches of having gotten a vaccine.

I experienced after my J&J vaccine, pain to my left hip, left wrist pain, felt like I had broken it and I had difficulty lifting a glass of water. On the following day I developed a rash on my face, head and neck which lasted two weeks . I saw a PCP for my rash and gave me pills to take for 5 days. As of today my symptoms have resolved.

It's been over a month since my injection and I still have severe pain at the injection site & upwards towards my shoulder. I have limited range of motion and lifting above 45° angle is very painful. Pain has been increasing in recent days. During my vaccine I had a very strong burning sensation within my arm that I've never experienced with any other shot. My bruising lasted for 2+ weeks.

Severe headache, nausea, dizziness, light headedness, increased blood pressure, pain at injection site, neck pain, abdominal cramps, muscle aches

Reported itching all over body. Reported welts, "hives" over trunk, arms, legs and all over body. "My skin is on fire". Started afternoon of 5/18. Continuing this morning 5/19/2021. No reports of breathing issues. No reports of other symptoms.

Patient developed itching and a rash over the majority of her body including scalp within 5-10 minutes of administration of the vaccine. We administered 25 mg. diphenhydramine liquid by oral route and continued to monitor the patient for 30 minutes. We contacted the patient's primary provider who stated they would see the patient. The patient chose to be seen at a walk-in clinic.

I have been taking Benlysta infusions for 5.5 years and I have never had an allergic reaction until 5/25/21. The only thing different in my body was the Janssen Vaccine. Midway through my IV I started itching, numbness in my fingers, lips, and feet. My face was on fire and my tongue was swelling and I could feel my throat closing. My arms turned red and blotchy and swelled. My nurse stopped the Benlysta and started Benadryl and a saline flush. The symptoms then went away.

I received the Janssen vaccine on 4/8/21 at 12:00 pm. By 5:00 pm that day I began having flu-like symptoms (fatigue, body aches, nausea). These symptoms carried through to the next day (4/9/21). When I woke up at 6:00 am on 4/10/21 I had a rash on the backs of my upper arms and the front of my thighs. As the day went on, the rash progressed to cover my entire body. I went to the ER around 2 pm where I received a steroid injection and was prescribed oral steroids. I was fatigued for the next two days, but was able to return to work on 4/12/21. The rash began subsiding, but overall lasted 2-3 weeks. I completed my seven day prescription of oral steroids on 4/17/21. On 4/18/21 I was very fatigued. On 4/19/21 and 4/20/21 I was extremely fatigued and unable to get out of bed, sit up, or stand up. On 4/23/21 I woke up at 7:00 am with a swollen face, throat, tongue and lips. I returned to the ER where they prescribed me another round of steroids, but a lower dose and a longer duration. I experienced fatigue for 6 weeks after receiving the vaccine.

Pain in upper arm since time of injection. Redness, hard, and warm to the touch around site of injection. Injection received at 5:30PM on 5/25. I had to take off work on 5/26 and 5/27 due to feeling exhausted and sore. Bruise forming at site. Feeling sweaty then chills occasionally over 4 days. Itchy and sore from upper arm to back of neck. Went to urgent care, afternoon of 5/29 and put on steroids and antibiotic for reaction/infection at site.

Right eye lid swelled up within 24 hours of the shot and is still an issue as of this submission. Some days the swelling has been severe some days and less severe, but the swelling has never fully gone away in the last two months. The swelling can include the eyelid, the skin between the lid and the brow, and below the eye . The eyelid and skin near brow will often turn pink/purple. Beyond the swelling pain, no major main. Some pain on outer eye bone for both eyes. The swelling seems to get worse when I sleep longer or lay down horizontal. When I go to sleep propped up, the swelling is less severe. Or, if I sleep for 7 or less hours, sometimes the swelling can be less.

Later the evening of vaccination I had a high fever of a 104.2, chills, cold sweat. I took a Tylenol to bring it down. Two days after the vaccine in my right eye was cloudy and I couldn't see properly. Also, pain at the injection site.

6/7 hours after vaccine- chills, fever (100.8), very weak *Felt miserable and restless, radiating heat in body *Trouble sleeping *Small pinpricks of pain in different parts of body *Muscle soreness *Blood seemed to be throbbing *Nausea in morning, but ate crackers (so did not throw up like after flu vaccine) *Skin more sensitive than normal (when shaving and when bumped foot into wall accidentally) Next day (6/2)- no energy, easily overexerted; had to sit down after standing, like in shower 6/3- light-headedness after eating chocolate products 6/4- light-headedness, blood appeared to be pooling in legs some when standing (legs would turn red) *Blood still feels weird 6/5- Pinprick feeling in parts of body, still feeling weak during the day 6/6- Weak feeling/headache (stamina is bad still), veins look more red than usual (existing spider veins) 6/7- Feel much better, still feeling rough in the morning when I wake up (Monitored own symptoms, but need not need to go to Dr. or hospital)

Immediate reaction, redness on arm, hot to the touch, hard area at site of vaccination; began 5/25/21 5/26 and 5/27 had to take time off work due to fatigue, hot flashes, arm soreness, neck soreness, chills. Symptoms continued and I was seen at Urgent Care on 5/29 where they prescribed an antibiotic and steroid due to cellulitis at the site. 5/30 I began having headaches which have continued non-stop. Hot flashes, chills, and neck soreness have gone away. Fatigue, cellulitis at the site, and arm soreness have continued. I've had symptoms for 13 days. I saw my nurse practitioner due to headaches on 6/2 and was told to use heat and tylenol for headaches.

RASH AND HIVES IN CHEST ABDOMEN BACK AND NECK; INJECTION SITE SORENESS; LOW GRADE FEVER; FATIGUE; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/illicit drug use. 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, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. Concomitant medications included liothyronine for energy booster, ascorbic acid/biotin/calcium carbonate/calcium pantothenate/chromium nicotinate/colecalciferol/cupric oxide/cyanocobalamin/ferrous fumarate/folic acid/magnesium hydroxide/manganese gluconate/nicotinamide/phytomenadione/potassium iodide/pyridoxine hydrochloride/retinol/riboflavin/selenomethionine/sodium molybdate/thiamine hydrochloride/tocopheryl acetate/zinc gluconate, levothyroxine, and spironolactone. On 24-MAY-2021, the subject experienced body aches. On 24-MAY-2021, the subject experienced chills. On 24-MAY-2021, the subject experienced injection site soreness. On 24-MAY-2021, the subject experienced low grade fever. On 24-MAY-2021, the subject experienced fatigue. On 29-MAY-2021, the subject experienced rash and hives in chest abdomen back and neck. On 01-JUN-2021, treatment medications included: prednisone. Additional treatment medications (dates unspecified) included: diphenhydramine, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 26-MAY-2021, and injection site soreness, low grade fever, and fatigue on 25-MAY-2021, and had not recovered from rash and hives in chest abdomen back and neck. This report was non-serious.

At 6 am this morning I started having the chills. I have had them ever since and it is almost 2 pm my time. The second I received the injection I felt pain and soreness in my arm, it?s been sore ever since. Lingering head ache all day and muscle aches, worse in my back than anywhere else, though I feel achy all over. Extreme lethargy, very tired and want to sleep. Increased appetite since receiving the vaccine, increased thirst.

less than 15 minutes had itching and redness at site of vaccine and then progressed to other symptoms transient decreased visual acuity, nausea-vomited later-, within 30 minutes had overall flushing and body itching she maintained normal blood pressure and pulse oximiter and pulse and respirations she denied any throat swelling or breathing

Tennis ball size allergic reaction at site of injection. Warm to touch, itchy, very painful, red. Started day after the receiving the vaccine. Taking ibuprofen and Benadryl to help, but it is continuing to get bigger.

Immediately after vaccine was given patient felt numbness in arm extending from where shot was given to hand. She said her arm was completely numb but had tingling in hand and fingers. Also complained of tightness in chest, shortness of breath. Patient was able to move hand and fingers. Said tightness in chest was like she felt when her back was out of place. Patient reported no swelling in throat. Observed & followed up with patient for 1 hour. Her tightness in chest improved but was still experiencing numbness in arm and tingling in hand & fingers. She was following up with a medical facility.

Immediate post vaccine: injection site soreness (mild), still present at time of event reporting (42hrs post vaccine) Approx 6hrs post vaccine: uncontrollable, full-body muscle tremors and chills. Came in waves lasting 15-45 seconds each, with rest periods of 30 seconds-2min. Overall, this event lasted approximately 1 hour. 9hrs post vaccine: patient was awoken around 3am with an increased resting heart rate of 100 bpm. Patient's normal resting heart rate is approx 76. Increased heart rate persisted until 18hrs post vaccine, at which point heart rate began to gradually return to normal. Normal resting heart rate returned about 26hrs post vaccine 9hrs post vaccine: acute joint discomfort, primarily in hips. Resolved around 17hrs post vaccine after patient took ibuprofen Unknown start time: Fever of 101.4. Patient took temperature 16hrs post vaccine and took ibuprofen at this time. Body temp went down gradually, returning to normal approx 20hrs post vaccine 16hrs post vaccine: general fatigue. Unknown if reason is solely vaccine or combination of vaccine and lack of sleep due to adverse events. Continued until patient slept from 28-40hrs post vaccine.

I received the vaccine at 9am on Saturday, March 6th. My arm was immediately very sore throughout the day. Around 9:30pm that night I began to feel nauseous. As the night progressed my symptoms got worse. I experienced intense chills and by 11pm had a 100 degree fever. Sunday, March 7th my fever had decreased, but I continued to feel nauseous and have chills throughout the day. Additionally I felt extremely fatigued, weak, and had a throbbing headache. Completing simple tasks were difficult and exhausting. Monday, March 8th I continue to experience significant fatigue, headache, and muscle weakness, but at less intensity. Also, my right arm where I received the injection is very sore. I have also been somewhat dizzy today. I have been taking Advil, drinking fluids, using an ice pack, and resting as much as I can as part of the treatment.

Janssen COVID-19 Vaccine EUA. Started feeling very tired two-three hours after the vaccination, got a mild fever approx 9 h after the vaccination and high fever (38.5 C) after 11 h. Strong dehydration feeling, nose numbness, chills, sensible skin feeling and dizziness. Fever and side effects approx 6-8 h and disappeared approx 17h after the vaccination

Developed Fever of 105 at 12:30 am - fever finally to 99.7 at 4:00am; chills, body aches, severe lethargy. Sunday 3/7/2021 devleoped knot on arm that has sever burning sensation, hot to touch. Monday 3/8/2021 a fever blister developed on mouth; Tuesday 3/9/2021 - knot still there- Urgent Care visit diagnosed cellulitis - dr stated a puss pocket could be seen under skin and knot on arm size of two quarters.

Subject woke up to use the bathroom and passed out while on the toilet. She called my name immediately prior to the event. She fell prostrate on the floor resulting in facial bruising/cuts. Subject regained conciousness one minute later. She was able to work the next day and had chills for the next 2 days.

about 8 to 10 hours after the vaccination started with extreme fatigue, then turned into sweating then chills accompanied by severe joint pain and the injection site was very painful, that last until Monday morning once those symptoms cleared I developed a genital ulcer. I do not have a history of having genital issues and I had no clue you could even get an ulcer in that area.

34-year-old woman with no significant past medical history presents with syncope event after receiving a COVID-19 vaccination prior to arrival. Patient describes lightheadedness and eventually falling forward. She did sustain facial abrasions to her forehead, bridge of the nose, and right zygomatic arch region. Complains of mild headache with without any nausea.

Full body rash started at approximately 7am the morning after the shot. Raised bumps from neck to tops of hands and feet. Lines of rashes on back and trunk.

About 6 hours after receiving the Janssen shot, I came down with a fever, muscle aches and chills. My fever peaked at about midnight with a temperature of 101.8. At that point, I took two Tylenol. Had a rough night and didn't sleep well. Continued taking Tylenol the following day to manage the low grade fever. I seem to back mostly back to normal today (two days after receiving the vaccine), however I do still have soreness in my left arm where I got the shot and some residual aches and pains.

2:15 AM- body aches, headache, chills 4:30 AM- nausea, fever 101.1, bodyaches, headache Injection site sore, red, raises until 3/15

Very bad headache, nausea, pain at injection site. (third pregnancy, due August 12th) Headache started at 3 am the next day, nausea started later that day, have been nauseous for five days, headache lasted three days.

Sore injection site 3+ days Fever 24 hours Chills 24 hours Headache 36 hours Higher than typical heart rate while sleeping first 24 hours

Janssen COVID-19 Vaccine EUA Sunday night 3/7/2021 to 3/9/2021: Fever, weakness, dizziness, swelling left upper arm (where I got my shot) 3/9/2021: difficulty breathing, fast heartbeat

After the injection mild symptoms of pain at the injection site began. Then progressive Muscle fatigue and weakness along with a headache occurred within 4 hours of the vaccine. These symptoms were mild. Was awoken 12 hrs after vaccine administration with sever chills and fatigue, fever (peak 101.2 F). Took Tylenol with mild relief. Still with intermittent chills and ongoing fatigue.

On 3/7/2021 pt states she developed a rash and hives on her face, back and stomach. Pt treated it w/ Benadryl, Zyrtec and Pepcid AC. These symptoms lasted about 7 days. On 3/5/2021 pt developed serious dizziness and balance issues. pt says she is very unsteady and cannot balance herself and is still having these issues. she states she lost at least 50% of her balance after taking the vax. pt contacted her PCP and was told to go to physical therapy 2 times per week. pt says this is helping but seems to be working very slowly. pt will continue therapy for about 6 weeks and then will FU w/ PCP.

Hot flash, headache, nausea, dry mouth - 3/21, 5pm Headache, stomach pain, tiredness, dry mouth - 3/22, 10am - 3/24, 10am Stomach pain, chills, hot flashes - 3/21, 9pm Hives breakout - 3/28, 2am Leg tingling - 3/21, 9pm through present day

Received vaccine at 2:10pm, 8:00pm headache, 10:00pm body aches and chills started (took 1000mg of Tylenol), 11:00pm- 6:00am severe body chills- uncontrollable shaking , 3:00am 103.9 fever with hallucinations (took 1000mg of tylenol), 6:00am fever broke, followed by all day exhaustion and sore arm.

Janssen Covid-19 vaccine EUA Extreme aches, chills, sustained fever of 101, fatigue, nausea, headache, weakness and dizziness. Heart palpitations/racing heart. Vaccine site soreness. Onset was 8 hours after receiving vaccine and has continued for 24 hours.

Client received vaccine at approx 530pm. at 551 client complained of itching. Benadryl 50 mg administered. Client then complained of seeing double. Client remained alert and responsive to staff during time. V/s -BP- 110/70 86 18 97% EMS called and arrived. client left facility at approx 615pm accompanied by two EMT technicians

Itchiness at vaccination site 4 hours after injection Fatigue- lasted 4 days Fever- lasted 48 hrs Chills- lasted 48 hrs Joint pain that lasted a week

Fatigue: 5/5 4pm-5/7; Nausea: 5/5 6pm-5/6 am Fever: 5/5 8pm-5/6 am Chills: 5/5 8pm-5/6 am Muscle aches: 5/5 8pm-5/7 am Skin sensitivity: 5/5 8pm-5/7 am Sweating: 5/5 8pm-5/7 am injection arm sore: 5/5-present still

At dawn on Tuesday, the day after the vaccination, I started to feel a sharp pain in my body and joints, accompanied by hives in the back and legs, chills, mild headache. A slight rise in temperature on Tuesday morning. The body pain is constant until this moment ( 11:00 pm on Tuesday, April 7) Excessive weakness

Post vaccination reports tingling @ vaccine site/ left arm, denies any additional symptoms / complaints; denies any respiratory symptoms / none noted. Medical monitoring x 30 min w/ vital assessment: BP 130/84 O2 sat 99% RA. Symptoms resolve, released home w/ self

Fever onset within 4 hours of getting vaccine. Lasted for about 24 hours. Body aches. Severe redness and swelling below injection site. Redness at it's largest point was 4"x5". There is also a large hard lump in my arm that is still present weeks later. Site of vaccine started to itch around day 3 and continues to intermittently itch. Was able to treat at home with benadryl and hydrocortisone cream.

Within about 30 minutes of the shot I started to get the chills, feel nauseous, hard to focus, and very lethargic. Injection site was hot to the touch and did swell a bit. The following day I went through strong waves of feeling very ill and then feeling ok for about an hour, then back to having chills, nauseous, headache, body ache, and extremely lethargic. Half way through second day I broke out in a rash all over my chest, tummy, and back. Entering into day 3 ( today ) I do feel better, but can't shake the brain fog and feelings of being tired. Rash is still present currently.

Shot was administered at 8AM on 4/7, symptoms started around 4PM on 4/7. I am currently 29 weeks pregnant with a due date of June 22nd. I am 5ft1in and currently weighing 130lbs. List of symptoms: -Chills/Shakes -Fever (up to 101 F) -Extreme muscle weakness -Extreme Fatigue -Finger tips turning blue/purple -Nausea At 7:30PM, I took 3 Tylenol (500mg) and went to bed. Woke up at 8AM the next morning, with only feeling a bit of weakness, which was gone after I ate breakfast that morning.

Vaccine administration at 1522, at 1533 patient states not feeling well. Took to Emergency Department. Flushing, hives, shortness of breath, throat swelling, tachycardia, dizziness.

Janssen COVID-19 Vaccine EUA Symptoms started April 7, 2021 (one day following vaccine): -8am body aches, chills and headache started, noticeable pain, swelling and redness of injection site -10am fever of 100, headache, chills and body aches persisted (took ibuprofen, which reduced fever), redness of injection site grew to nearly 2" diameter. -6pm fever of 102.5, nearly unbearable body aches and chills (took more ibuprofen, which brought fever down to 99.4 and took edge off body aches) April 8, 2021: -3:45am fever of 99.8, sweating until clothes were wet, chills and body aches. Pain at injection site worsened. -7am chills, body aches lessened, dizziness started. After the chills, body aches, fever and headache subsided, I did not experience fever, but I still feel "hot flashes" and dizziness occasionally. Itchiness of the injection site. Redness still around 2" diameter.

Red circle around injection site that has begun to blister. Site has remained hot to the touch and feels like it's burning inside

Chills started 12 hours after injection and lasted for 48 hours Intermittent fever for 72 hours. Highest fever 99.8 F Fatigue for 48 hours with body aches Swelling and pain at injection site Injection site rash the size of a quarter started 24 hours after injection and lasted at least 48 hours (as of the time of this report)

Pain at injection site during shot. Soreness for 48 hours. Headache, chills, body aches - onset at 7 hours after and continued until next morning. Headache persisted until 24 hours from injection. Also experienced gastrointestinal discomfort and diarrhea until 48 hours.

Immediately -Dizziness, soon after-mouth itching, Hour later- severe nausea, abdominal pain ,rash,three hours later- facial swelling, tongue swelling, epipen dose 1, trouble breathing on way to hospital and extreme dizziness. Epi dose 2. Arrive at hospital given IV and meds

4/8/21: I receive the injection at 1:50pm on my left arm. 8pm: I begin experiencing normal side effects: soreness, body aches, and headache. 9pm: In addition to the soreness, body aches, and headache, I start having chills, which last on and off throughout the night. 4/9/21: 7am: I feel fatigued, with headache and body aches throughout the morning and afternoon. 3pm: I begin to have some itchiness on my forehead and both ears. My right knee cap feels hot and bruised, but there is no mark. 5pm: Visible hives appear on my forehead and right knee cap, and my ears are red. All of these spots are very itchy and uncomfortable. 9pm: The hives begin to be much more noticeable and itchier. I take one Benadryl before going to bed which helps the itchiness somewhat. 4/10/21 3:30am: I am woken up by pain in my ears and they have gotten incredible swollen, red, and hot. They are very tender to the touch. I take another tablet of Benadryl. 7am: There are more hives on my forehead and cheeks, as well as my knee and now on two of my fingers. A few spots also appear on my feet and on one toe. My ears are less swollen but still not back to normal, and they are still red, hot and tender. 9am: I have a video call with a Physician?s Assistant who determines it is most likely not an anaphylactic reaction (no swelling in my throat or eyes or any of the other red flag symptoms. I also take my blood pressure with a home monitor and it is normal). He prescribes me a steroid pack. 12pm: The hives begin to be less and less itchy and red. 8pm: The hives are almost completely gone, save for a few spots on my feet. As I am breastfeeding my 14-month-old daughter, I had waited to begin the steroid pack until after our last nursing session of the day (around 7:30pm). As the hives seemed to be going away on their own, I decide to not take the medication. I do take one dose of Zyrtec. 4/11/21: 7am: the hives are completely gone

4/10/21 11:30 a.m. Vaccine administered 6 p.m. Dizziness 6:30 p.m. Chills, leading to low-grade fever 10 p.m. 100.5 degree temperature; took 400 mg Motrin 11 p.m. felt very hot 4/11/21 9:30 a.m. Chills, 99 degree temperature 11:15 a.m. 99.5 degree temperature, slight headache, took 400 mg Motrin 12:40 p.m. Felt very hot again, subsided after a while -- In the middle of the night hands were very sweaty, soaked through my shirt 4/12/21 Occasional feelings of dizziness 7 p.m. Red spots on both hands Note: I am breastfeeding. Baby has been sleeping through the night for weeks, but on the second night after my vaccination (4/11/21) she woke up multiple times in the middle of the night and has seemed fussier than usual.

FEVER; SEVERE HEADACHE; VERY ACHY; CHILLS; PAIN IN ARM; This spontaneous report received from a patient concerned a 34 year old female. The patient's weight was 117 pounds, and height was 62 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 12:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain in arm. On 06-APR-2021 19:00, the subject experienced very achy. On 06-APR-2021 19:00, the subject experienced chills. On 06-APR-2021 23:45, the subject experienced fever. On 06-APR-2021 23:45, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, and pain in arm, and the outcome of fever, chills and very achy was not reported. This report was non-serious.

Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: patient experienced hearing loss for 24 hours- hearing has now returned-Severe

I began having a really bad allergic reaction and I was itching all over my body. That same night I began having a horrible headache, and my muscles and joints began aching and hurting. It felt like I was holding a two ton rock over my head when I would try to walk. I took Benadryl and used Sarna lotion for the itching, and took tylenol for the headache and muscle aches. IF symptoms don't subside, then I will visit the clinic at my job to be treated and see what they could recommend.

I received the J&J one-dose vaccine on Thursday, April 8, at approx. 1600. Within an hour I had a mild headache and was nauseous. I went to sleep around 2130. At 0030 (or 30 minutes past midnight) I was awoken to the sudden shock of feeling very cold. My temperature was 91, within 15 minutes I spiked to 100 degrees, and then 15 minutes later I was at 102. I was shivering but felt like I was on fire. I had intense pain throughout my entire body. Internally and topically (skin) my entire body felt like it was on fire -- a burning sensation. Clothes -- even a soft hoodie -- felt like a steel wool scrubber was brushing against my skin and my skin was very hot to touch. I continued to feel nauseous. After 90 minutes of this, I was able to take acetaminophen (2 x 500 mg). After another 90 minutes, my temperature dipped to 99 and the horrible pain mostly subsided. From 0530 to 1830, in three-hour increments, my temperature continued to spike and fall between 99-101 degrees and the pain came in the same waves. Nausea continued. So, I continued an acetaminophen regimen throughout the day to help with the symptoms and took a few tums to help too. After 1830, I felt very weak and tired. My temperature stabilized at normal. Nausea continued. On Saturday, April 10, I was mostly just tired and had minor body aches/soreness. My shoulder bruised where I was vaccinated. Food did not sit well and my stomach was quick to turn. Sunday, April 11, mostly back to normal. Although, still fatigued. No major side effects or symptoms. Monday, April 12, seems to be the same as Sunday. Note: I had COVID the first week of February 2021.

Received vaccine on Thursday, 4/8/21 @ 10:10 am, 1st symptom (fever & chills, pain at the injection site and pain under left underarm begins at 7p). Took 2 Motrin. Day 2, golf size swelling left underarm. Very painful. Scale from 1-10, it was a 9. Lymph Nodes swelling is not listed on the Johnson & Johnson vaccine factsheet. Pain stayed for 5 days. Pain is less when taking Motrin. On Day 4, woke up with slight migraine. Took motrin. Took blood pressure, high diastolic reading at 110/91 and Day 5, 116/95 since vaccinated.

I received the vaccination 4/2/21 at 11am and at about 6pm the same day - I felt a sudden flush and felt like I was going to faint in the middle of Grocery store. Got very clammy and sweaty and weak - immediately left the store and started projectile vomiting outside the store and all night the first night. Had extremely joint/bone pain throughout my entire body for 4 days straight in bed, very weak, chills and night sweats, day 2 I had a little energy and drove about an hour and immediately started vomiting again for day 2-day 5. Day 5 I woke up with swollen eye lids and hands and thought it was an allergic reaction to something in my house so took benedryl, but didn?t help. The swelling went down on day 6. I?ve had no energy and very foggy brain and been very down. My chest has felt like an anxiety attack 24/7 all week. I am on day 10 since the vaccination and my chest pain has increased. I still have foggy brain and been very out of it and weak still. I vomited day 1-day 5. Really bad pain in my hips and arm where I received the shot.

Soreness and swelling at injection site that lasted at least 11 days post injection. Soreness improving slightly at 10 days, but firm area at injection site still exists.

30 mins after shot face felt numb and body felt heavy. Left work and started to feel better till around 10pm. Back started to hurt and couldn't get comfortable. Then the whole body started to ache. Quickly the whole body and skin hurt and food and drink tasted bad. Started becoming cold and had to wrap a blanket around. Went to bed and had to take Tylenol every four hours to sleep. Woke up and body aches and feeling cold continued the rest of the day. There was also nausea and headaches on and of the whole day. Went back to work the following day but felt heavily nauseous for most of the day and couldn't eat or drink much of the day.

8 hours post vaccination Friday 4/9/21 : chills, headache, muscle aches, very tired Saturday 4/10/21:not hungry, headache, nausea, chills, fever, rash on chest, hands feel like they are on fire, body feels heavy and weak, very tired Sunday 4/11/21: dizzy, nausea, not hungry, achey, tired, heart racing Monday 4/12/21: dizzy, tired, not hungry, body feels heavy, heart racing if too much movement Tuesday 4/13/21:DIZZY, tired, heavy feeling body (like moving through mud), heart races if I move too much

Hives on neck, chest, back, arms, abdomen with onset about 40 mins after receiving vaccine. Hives would subside after several hours and then continued to reappear until 4/13/2021. Rash on both arms also noticed near inner elbow, worse on left arm (injection arm). Hives and rashes continue to appear, but are getting less and less.

Severe Headache-- time course -- Treatment: sinus pain & pressure medicine or migraine Itching at site of injection-- time course: 3 days -- Treatment: applied oatmeal lotion to soothe Fatigue -- time course: a week-- Treatment: Rest Pain at site of injection -- time course: a week -- Treatment: pain medicine Swelling at site of injection -- time course: 3 days -- Treatment: Ice Joint pain (in knees) -- time course: off and on for a week--Treatment: pain medicine body aches -- time course: off and on for a week -- Treatment: pain medicine

Nausea beginning around 7:00 p.m. followed by chills, fever of 100 F, and vomiting on and off for several hours. Joint pain in shoulder near injection site and right hip.

Patient noticed a small lump at the injection site almost immediately after vaccine given. That night patient developed 'pins & needles' down her left arm, arm/hand tremors, chills/fever (102.3), nausea, body aches, fatigue and shoulder pain. Patient took ibuprofen at 4 am on 4/9. Saturday (4/10) patient noticed a lump on her left forearm. She went to the doctor and an ultrasound was done on 4/14 which revealed a superficial venous thrombosis in the cephalic vein of the left forearm. Patient was told to start on aspirin 81mg on 4/15. Dr also measured injection site identified by patient as 1.5 cm below acromion process. Physical therapy will also be set up.

Redness and swelling at injection site. Started 48 hours after injection, and is still there 72+ hours later. Contacted medical professional through a telehealth visit, who recommended Benadryl as to not impact the vaccine's effectiveness, but suggested monitoring it incase it increased in severity.

04/02/2021 @ 7:30pm - chills lasting all night 04/02/2021 @ 9:45pm - fever of 104.3. Fever bounced between 103.1 and 104.3. 04/03/2021 @ 8am - extreme fatigue with my head feeling like it is being pumped and blurry vision with each pump. Lasted 2 days. Fatigue lasted 6 days. Would go away if i layed down. It wouls start back up when i sat up. Sore arm at injection site for 1 wk. Left leg pain most of the day. 04/04/2021 @ 7am - woke up with hives covering the inside of my mouth. Weakness and head pulsing all day but no vision issues. 04/05/2021 @ 7am - woke up with swollen mouth(gums and lips) Went to urgent care. Swelling was on and off all day including the hives 04/06/2021 @ 1:15pm - headache back of my head.

developed hives while sleeping, woke up and took a Benadryl. Hives came back twice as bad later in the day. Hives were on every extremity of my body. Multiple Benadryl doses have subdued the hives.

FELT PAINFUL; RED MARK WHICH GOT INCREASED; SWELLING WHICH GOT INCREASED; This spontaneous report received from a patient concerned a 34 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced felt painful. On 07-APR-2021, the subject experienced red mark which got increased. On 07-APR-2021, the subject experienced swelling which got increased. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red mark which got increased, swelling which got increased, and felt painful. This report was non-serious.

Large, red welt at site of injection that showed up 24-48 hours after injection. Lasted for about one week and then turned into a bruise. Dizziness and vertigo that started about 5 days after injection. Lasted for at least 2-3 days so far.

MUSCLE ACHES (LOWER BACK); TENSION HEADACHE; CHILLS; FEVER; PAIN IN THE RIGHT ARM; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced pain in the right arm. Laboratory data included: Body temperature (NR: not provided) 101 F. On 10-APR-2021, the subject experienced muscle aches (lower back). On 10-APR-2021, the subject experienced tension headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, pain in the right arm, muscle aches (lower back), and tension headache on 11-APR-2021. This report was non-serious.

I had the normal flu like symptoms about six hours after the vaccine on 4/01/21. They subsided the next morning 4/02. On Saturday night 4/03, I developed a rash on the creases of my arms. I woke up on Sunday 4/04 itching like crazy on my legs. The rash moved around my body throughout the week: back, torso, legs, arms. Everywhere except for my face and feet. It seemed to be hives, as I would have the urge to itch and then the rash would flare up. This went on from 4/03 to about Friday 4/09 and then it subsided. I was advised by a GP to take Zyrtec twice a day and could use a topical steroid until the rash subsided and to avoid an oral steroid. I have had a handful of rashes throughout my adult life so I could tell this one did not look very serious. Like the standard rash, I was so itchy at night. It felt like my skin was crawling. I suspect it was my body's delayed reaction to the vaccine shot.

Pain, redness, swelling, and bruising at the injection site. 12 hours later I had chills, fever between 99-101, thigh pain, body aches for 12 hours. Fatigue for 3 days following vaccine. Headache and back pain 5 days after vaccine.

Approximately 1 day after receiving the vaccine my arm was sore and red at the injection site. My arm continued to have red discoloration and soreness for about a week after injection. One the redness went down the injection site was hard and continues to feel as though there is a marble under my skin. It's about the size of a Nickle and now bruised. This might be normal but wanted to report it in the event that it's not.

4/10/21 Patient presented to Urgent Care with Arm Pain (left arm painful and tingly since COVID shot 4/8; now pain is different and there is a lump on her forearm she can feel). 4/13/21 Contacted the office to schedule an appointment regarding worsening symptoms. Scheduled appointment. 4/14/21 cont. Seen in office by PA for: 1. Left arm pain - tender nodule L forearm, will get US due to recent birth, Johnson and Johnson vaccine, FH of DVT, to r/o DVT causing the lump, await results. Symptomatic care in the interim, may use warm compresses. - USV VENOUS UPPER EXTREMITY DUPLEX LEFT; Future 2. Paresthesia of left arm - site of reported injection and superficial induration 1.5cm from acromion process, suspect SIRVA due to sit of administration of vaccine, recommend symptomatic care with warm compresses, gentle massage if benefit noted, pt is breastfeeding so recommend local care at this time, consider PT, pt declines at this time as she will be on vacation next week. Discussed possible cortisone injection but deferred due to recent COVID vaccine 6 days ago, pt agrees as there is some recommendation to avoid steroids in close proximity to vaccinations to avoid blunting the immune response 3. Family history of DVT - see #1 4/15/21 After speaking with the DVT clinic Dr contacted the patient and recommended she take an 81mg low dose daily aspirin, until symptoms resolve, around one month. And repeating venus duplex in 7-10 days. Determined she would go prior to her leaving for her trip as she planned to be out-of-town during that time frame. (Per provider result notes.) 4/16/21 Patient was seen in emergency department for: Patient presents for evaluation of multiple concerns. Following the Johnson & Johnson COVID-19 vaccine she was recently diagnosed with superficial thrombophlebitis in the left forearm by ultrasound, has been taking aspirin and symptoms have not worsened. Left upper extremity exam is quite reassuring today, I see no clinical evidence for DVT and she is neurovascular intact. I did not feel that repeat ultrasound was necessary at this time, but she does have this scheduled next week so I advised her to keep that appointment. She has a very slight headache which has been present since the day she received the vaccine, currently 2/10 without vision or other neurologic concerns. No abdominal pain. I have low clinical suspicion for CVST or PVT at this time. Advised return if she develops worsening headache or new neurologic symptoms. Patient complained of new onset left lower lateral breast pain and lump starting today. She is currently breastfeeding and notes decreased milk production today. She does have a tender fullness on exam but no redness or visible swelling, she is nontoxic and well-appearing without fever. She has history of mastitis in the past, but she states her PCP recommended she be evaluated for possible blood clot in the breast. Advised the patient that I have very little concern for that at this time, if anything it would be superficial and not amenable to anticoagulation but I did not feel that imaging was necessary at this time. I will cover her with antibiotics for lactational mastitis, she has cephalosporin allergy but states she had formal testing for penicillin allergy and tolerated this well so I prescribed Augmentin. She will use a warm compress and continue nursing, I did recommend she start on the right side to initiate let down on the left. 4/20/21 patient was seen in the office for: Patient presents for follow up of recent ED visit. She was seen here last week for left arm pain/nodule/paresthesa following her Johnson & Johnson vaccine. She also reported a slight headache that was present since day of vaccine. An US was performed and showed a left cephalic vein thrombus of LUE. She was advised to start ASA 81mg daily for the next month and get repeat US in 7-10 days. She then called in with left breast pain/swelling and was directed to the ED for evaluation of possible blood clot. She does have hx of mastitis several weeks ago. The ED did not pursue additional imagining of breast, they told her it was likely lactational mastitis and they did prescribe augmentin and warm compresses for this. Today, patient presents states he feels "a lot better". Regarding the left breast lump, redness, swelling she states this has completely resolved. She did not start the augmentin as she was worried about this potentially causing thrush for her daughter; she explains she had mastitis 7-8 weeks ago and was on antibiotics and then her and her daughter continually passed thrush back/forth to eachother 3x so she was hoping to avoid this. She did treat with frequent feeding/pupming, and warm compresses and symptoms resolved. She was told to see us for elevated blood pressure in the ER, per review of EMR and her DC papers, her blood pressure in the ED was 130/75. Today her blood pressure is 122/78. Regarding her left arm symptoms, she states the numbness/tingling has nearly resolved; she will occasionally get a very mild tingling in her 4th/5th fingers that resolves after a few seconds. She denies pain or swelling of the arm. She no longer can palpate the clot and thinks that it is gone. She no longer feels swelling or tenderness in her left axilla. She stopped the ASA and started motrin/warm compresses as was advised by the ED. Her mild headache continues since the vaccine but is somewhat improved. She denies worsening or severe headache; denies vision changes, dizziness, lightheadedness, speech difficulty, etc. Phone encounter also from 4/20/21: Phone call placed to DVT clinic to get their guidance as Dr had talked with them last week. Reached RN, who reviewed with Dr. After review of patient's history/chart/growth of superficial clot, Dr recommended that patient not travel as planned and continue on 81mg ASA daily. They would like us to place a referral so they can see her later this week or early next week. They also want us to place order for repeat US either this coming Friday or Monday and they will coordinate to get this done at their office/same time as appointment. I did place phone call to patient to discuss and give their advice. They had just left this morning for another state by car. I reviewed Dr advice to not travel and she will discuss with her husband if they are going to run around or not. She was agreeable to continuing on the 81mg ASA Daily and repeat US/visit with DVT clinic in 5-7 days as recommended.

about 5 days after receiving the vaccines patient experienced fever, tachycardia, rash, body aches, joint aches, muscle aches, headaches , weakness and fatigue. Patient was seen by a provider on 03/22/2021 where a rapid flu and covid tst were ordered to rule out any other illness. At this time due to the muscle aches and weakness provider did order a left LE venous doppler which was negative. All symptoms subsided approximately 3 weeks post vaccine

ABDOMINAL PAIN; ARM SORENESS; FEVER; FATIGUE; NAUSEA; HEADACHE; INJECTION SITE SORENESS (RIGHT DELTOID); This spontaneous report received from a consumer concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. the patient was taking unspecified name of medication for birth control. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced abdominal pain. On 11-APR-2021, the subject experienced arm soreness. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced injection site soreness (right deltoid). Laboratory data included: Body temperature (NR: not provided) 100.7 F. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, fatigue, nausea, headache, arm soreness, abdominal pain, and injection site soreness (right deltoid). This report was non-serious.