Johnson & Johnson

Saturday night: bad headache which started around 7pm and lasted the wholel night Sunday: headache persisted, then ended around noon. Around noon became bloated and then by 5pm I had the runs and was using the bathroom for about 6 hours

Janssen COVID-19 Vaccine EUA Side Effects: - Nausea - Head ache - Body aches - Chills - Very sore arm

Pt reported that approximately five hours after vaccination, she experienced uncontrollable tremors, fainting, vomiting, chest pain and tightness. Today, extremely fatigued and has some chest tightness. She has a history of chest tightness. Did not seek emergency care last night, but called physician this morning who was not in office and referred to local health dept. Advised that it would be best to consult with local emergency facility and if anything worsens she needs emergency care.

Fever, aches, chills, sweats, racing pulse, swollen ears, vomiting. Fever and aches continuing to the next day. Unable to sleep due to pain and getting up several times at night to vomit.

Janssen COVID-19 Vaccine EUA Six hours after I received the vaccine I began to feel full body muscle aches and shivers. I took 2 Advil. I went to bed at 9:30 p.m. and woke up at 11:30 p.m. feeling as though I had slept 8 hours because I had a 102 fever. My face was burning from the heat and I was shaking. I took two more Advil. About 30 minutes later I threw up. I waited 30 more minutes and threw up again. As a result, of having Addison's disease, I have an emergency steroid injection that I use during crises such as this. I took my shot and immediately began feeling slightly better. I was able to go back to bed and at some point the fever went down overnight. I am currently feeling weak and with no fever. I also have a slight headache.

5 hours after being given the shot, uncontrollable tremors began. Muscles began tensing up, tunnel vision started, extreme dizziness, vomiting, severe weakness in muscles, and fainting. These lasted for about 2 hours before decreasing in severity but continued to be present until about 10:30pm, 13 and a half hours after receiving the shot. Nothing was done to treat the symptoms. As of 12:30pm on 3/10, some minor symptoms are still present, such as muscle weakness and pain, severe migraine, and dizziness.

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

I felt dizzy, nauseous, massive headache, it felt like my brain was swelling. hips and joints where so sore. dehydrated. i was exhausted all day and night. these symptoms lasted up untill today.

After vaccination patient developed fever and chills lasting though today as well as severe GI issues.

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.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: a few minutes after vaccination, pt expressed nausea and dizziness and was unable to stand due to dizziness. pharmacist assisted patient to the ground to lay down. she said she felt much better after laying down but symptoms returned after she sat back up. symptoms were on and off for about 30 minutes. pt recovered with no issues after about 30 minutes of rest

Around 1:00 am I started having chills and body aches. At 5:00 am I woke up with a headache and cold like symptoms, sore throat, headache, waves of nausea, soreness.

My symptoms started at 4:30pm on Friday, March 12 and lasted until about 5:30pm on Saturday, March 13. My symptoms included headache, pressure in the ears, body chills, fever of 100.3, fatigue, loss of appetite, and body sweats.

Hi, I received the Johnson and Johnson vaccine one week ago, Thurs March 11. On friday, I experienced the typical flu like symptoms - chills aches pains and fever. These have slowly gone away, but a week later I still have chills and constantly shake, and diarrhea. The most significant side effect I want to report is extreme vertigo and dizziness and headaches. These have been present for a week now and have prevented me from working and doing daily activities. I constantly feel like Im going to fall over and cannot see clearly. I previously had vestibular migraines, but these have been mostly gone due to going to the chiropractor and taking my supplements. The vaccine brought them back now in full force. I read that this is becoming a commonality among other people and need answers on this. I want to make sure its not permanent or that I will have this as a serious side effect.

- 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

102 degree fever, severe chills, severe muscle / body aches, severe headache exacerbation, severe diarrhea for 36 hours and hypovolemia, severe exacerbation in chronic abdominal pain, severe exacerbation in chronic joint pain, severe fatigue, insomnia, exacerbation in nausea and food intolerance

Janssen COVID-19 Vaccine EUA: patient received vaccine in the morning then later that afternoon developed fever, chill, backache, upper abdominal pain, malaise. Presents to emergency department (ED) with vital signs within normal ranges. Temperature 37.7 degrees Celsius. Patient received ondansetron and intravenous fluids. Discharged home medically stable with symptom improvement.

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

before vaccination person reported that she had n/v everytime she had recived a flu vaccine. It was discussed with her and she insisted on taking the vaccine so she could keep working. 10 min after taking vaccination she had headache. Brought to observation area and progressed to n/v. Monitored for 30 min and then called for EMS. She was given Benadryl. She reported only 4 hours of sleep and not eating anything after waking up. transported via EMS for on site observation

Started to experience nausea and chills about 8 hours after the shot. A few hours later I had a low grade fever of 100.7 and a headache. My body became very sore and weak and my heart was racing. Woke up around 4am with a headache, fever, and racing heart. My chest feels heavy and I?m very tired and weak. The shot was given to me at a local clinic.

stomach pain. pt presents to the ED for severe abdominal pain x 8-10 hours, pt states she has left flank pain that radiates to her upper back, chills, denies N/V/D, denies any recent stools and endorses frequent eructation. 26 yo f w/spouse at bedside c/o ongoing intermittent episodes of diffuse abd pain/cramping (hypogastric > epigastric) w/additional nausea w/o vomiting x 2wks, worsening over past 24-48hrs, states latest onset largely R-sided in nature x8hrs; Pt denies any fevers/ns/chills, urinary sx's, vaginal bleeding/discharge, prior hx of abd trauma/surg/procedure

HA, vertigo dizziness started ~10am 3/21 with nausea - dizziness worse with walking - though also every 30min and lasts for seconds at a time - vomiting last night; + cold chills - also worsened reflux with epigastric pain with nausea; no cp or sob - no fever - + h/o vertigo in past - 3mo after delivery (suspected migraine/ anxiety - better with topamax and lexparo) -Denies dyspnea, no painful respirations, no loss of taste or smell

Patient began with nausea and walked to the restroom because she felt she may throw up. She returned to the post-vaccine administration monitoring area after about two minutes to sit down again. At that time, I asked more questions about symptoms. She was also feeling weak and like she may pass out. I gave her a cold compress to place on her neck which improved her symptoms very rapidly. She remained in the area with the cold compress for about 10 more minutes before she felt well and she then left with her husband.

At approximately 3:30 am on 4/2 I began experiencing moderately-severe muscle aches and muscle cramping throughout my body including hips, knees, fingers, thighs, and back. Accompanied with fever, cold sweats, and hot flashes. These symptoms lasted through 10 PM 4/2. Headache present from 7 am to 12 pm 4/5. Arm soreness and fatigue present from 4/2-present. Poor appetite from 4/1-4/5.

Janssen COVID-19 Vaccine EUA - Muscle aches starting within 3 hours of vaccination, growing worse for 24 hours before receding after 36 hours - Headache starting within 5 hours of vaccination, ending by 20 hours post-vaccine (upon waking next morning) - Fever of up to 100.6 F starting 7 hours after vaccination, gone by 20 hours post-vaccine (upon waking next morning) - Fatigue starting within 3 hours of vaccination, lasting ~48 hours - Nausea off and on between 7 and 10 hours post-vaccine

Admitted 4/3 with a cerebral sinus venous thrombosis, portal vein thrombosis and pulmonary embolus. Pt received covid vaccine 3/18. Symptoms began 3/26 which started with chills and body aches. Then on 3/27- developed a severe headache in the back of her head with associated nausea. On 3/28 she had the most severe headache on the right side of her head. She was vomiting from 3/28-3/30. On 3/30 she went to the ER for evaluation of her severe headache. She was given a "migraine cocktail", no imaging was completed and she was sent home. Appetite improved on 3/31 and she had a small headache relieved with Excedrin. Then on 4/1-4/2 she had severe bloating , abdominal pain and fever of 100.4. She had been visiting her mom for the holidays and came to the ER. Imaging revealed cerebral sinus venous thrombosis, portal vein thrombosis and pulmonary embolus. She was started on a heparin drip and brought to ICU for monitoring.. She is not on any oral contraceptives and does not have any family history of clotting disorders.

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

I started to feel weird around 7pm, like the feeling of being "off" right before you get sick. By 9pm, I had the chills and a fever. For the next hour, I experienced nausea, headache, and worsening fever. I was shaking, had body aches and intense chills. I went to sleep at 10:30pm with a fever of 101.4 and had a fever until 8am the next morning. I experienced a terrible headache throughout the next day and felt extremely exhausted.

3/30/21- Chills, inability to sleep, nausea 3/31/21 - Chills, Headache, severe Muscle/body aches, runny nose, fatigue 4/1/21- chills, headache, muscle/body aches

A few minutes after being vaccinated patient was sitting for her 15 minute observation period and walked over to the pharmacy counter stating "I just got my vaccine and I really don't feel well" the pharmacist approached the patient and caught her under both arms from behind her back as the patient fainted. Patient did not hit the ground or injure herself-she did not lose consciousness she was flushed and sweating. Pharmacist sat on floor with patient for 2-3 minutes and gave her water, patient was then able to stand up with little assistance and brought to sit down. Patient stated she felt nauseous and may vomit she was given a trash can but did not vomit she was able to drink a bottle of water and was given a soft pretzel. After about 10 minutes she stated she was feeling much better was no longer flushed or sweating she called her boyfriend for a ride home.

J&J COVID-19 Vaccine EUA Fever around 100 F (about 6 hours) Muscle aches (about 12 hours) Headache (about 12 hours) Diarrhea (about 6 times over the course of 8 hours) Vomiting (about 4 times over the course of 1 hour)

Fever, chills, nausea, fatigue, blinding headache, body aches. Took 2 ibuprophin because the headache was unbearable.

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

Vaccine at 9 am. By 1 pm getting mild headache and nausea and fever symptoms including chills. By 6:30 pm, severe headache and nausea. Felt extremely hot and chills at the same time. May have had fever. Slight stomach ache. Would not have been able to work and notified work that may have to stay home next morning if felt the same way. Headache improved after Advil. Took hours to fall asleep and woke up several times throughout night. Woke up with slight but improved chills in the morning and back to mild headache and nausea. Very minor nausea and headache rest of day but back to mild headache and nausea the next day at 8 pm.

4/8/2021 3:00pm, 1 hour after vaccine stomach ache, drowsiness, and dizziness/lightheaded 4/8/2021 8:00pm, 6 hours after vaccine numb tongue, swollen face - allergic reaction -- took 1 25mg Benadryl 4/8/2021 10:00pm, 8hours after vaccine swollen face, throat tightness, swollen face, sore throat- allergic reaction -- went to ER given Pepcid, Benadryl, and steroid -- also prescribed these items for next 3 days. 4/9/2021 6:20am - following morning lips swelling - took 1 25mg benadryl

Woke up at midnight with chills, fatigue and nausea. I took 3 Advil (generic version) and after one hour symptoms subsided.

VOMITING; FEVER; POUNDING IN HEAD; NAUSEA; 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 irritable bowel syndrome, and concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included patient do not have known allergies, patient do 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 13:30 for prophylactic vaccination on right arm. Concomitant medications included cannabis sativa for irritable bowel syndrome. On 02-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101 degree F. On 02-APR-2021 14:30, the subject experienced pounding in head. On 02-APR-2021 15:30, the subject experienced fever. On 02-APR-2021 17:30, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 02-APR-2021 17:30, and pounding in head, was recovering from nausea, and had not recovered from vomiting. 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

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

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.

Within 7 hours had chills, muscle and body aches, fever, severe headache, abdominal and kidney pain, nausea. Within 27 hours of dose got my menstrual period 2 weeks early with a very heavy flow, despite being on birth control.

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.

Nearly immediate after administration of vaccine- stood up to move to a waiting chair & experienced dizziness to the point of near syncope, heart pounding, nausea, sweating- pharmacy brought juice and watched me. Drank juice but was disoriented enough to spill a bit- sat for about 30 minutes until symptoms cleared up enough to walk around and got a ride home.

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.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild

Tingling in left hand and left side of face starting aprox 20 min. after injection and subsiding ~1 hr later with no treatment fever and chills starting 2-3 hrs after injection & subsiding 4 days later treated with ibuprofen severe body spasms starting ~7hrs after injection & subsided 2 days later treated with ibuprofen, heat and rest Nausea starting ~7 hrs after injection and subsiding 4 days later with no treatment Migraine starting ~4 hrs after injection, treated with ibuprofen and rest, subsided 2 days later

Had the vaccine 11:30am. Beginning around 5pm, I began to feel nauseous and have extreme chills. I took Tylenol and felt better until about 8pm. I then began to feel nauseous again and get extreme chills. I vomited multiple times, and was curled up in a fetal position crying from the nausea, headache, and a feeling of pressure in my chest. I ended up going to bed to sleep it off, waking up in a pool of sweat. I felt better the next day.

Within 2 hours of getting the vaccine, I developed a severe migraine, fever(100.1-100.4), chills, dizziness, extreme body aches, nausea and was very weak. Once the bulk of the symptoms subsided, a little under 48 hours after the vaccine was administered, I was able to resume to my daily life. I still have a lingering migraine, arm pain, body aches and a low grade fever of 99.9 now almost 72 hours later, but it is bearable unlike the immediate 48 hours following the vaccine. Over-the-counter medications usually take the edge off of my migraines, though they didn?t even come close to helping the one I currently have. I have been rotating Tylenol and ibuprofen since developing the side effects.

Fever of 101.1+ lasting 10 hours, on-and-off low-grade fever for 48 hours Headache, including eye and jaw pain, lasting 3+ days Dizziness; inability to stand or walk due to head pain and fear of fainting (dizziness lasted ~24 hours) Nausea and loss of appetite (ongoing) Body aches, including spinal pain and hip pain lasting 48 hours

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

Around 11 PM on April 8th after receiving the Janssen vaccine around 4:50, I woke up with intense chills, nausea and a fever. I also experienced an intense stomach pain that came and went that would make it difficult to move without severe pain. I felt extremely disoriented and confused and had a strong headache throughout the intense period of symptoms. Around 7 AM on April 9th the next day, the symptom's severity decreased and I experienced all of the symptoms mildly along with drowsiness. On april 10th I did not experience any stomach pain, body aches, or chills but, still experienced drowsiness, intermittent headaches and a mild fever. On april 11th, drowsiness and a headache continued. Today, april 12th, I am still experiencing a mild headache and slight drowsiness.

Lost vision like 3 mins after vax at the drive through shot center, paramedics were with me for about 20 mins to make sure blood pressure was okay and vision was 100% better. Besides the body aches and diarrhea on 4/3 and 4/4, On 4/6 I had the worst migraine ever where I lost 1/3 of my vision for about an hour and my right side of my body went numb for about 15 mins. I've been having migraines more frequently than I ever have and unsure if it is vaccine related or just extra stress. I have been trying to reduce screen time as much as I can but hard when I work full-time and in grad school and use the computer all the time. I also have been taking motrin/tylenol for the pain and lay down to let the pain pass.

Within 20mins of injection: Right arm tremors and twitching resembling dystonia, brain fog, nausea, extreme thirst, difficult swallowing, jaw pain, increased heart rate, and fatigue. Drank water and rested. Resolved within 120mins. After 12 hours if injection: nigh sweats, chills, fatigue, headache, and fatigue. Resolved with 600mg ibuprofen. After 48 hours of injection: Muscle tightness and twitching, limping, tachycardia, extreme fatigue and loss of strength. (Resembled POTS flare) Drank water, laid down, and rested. Resolved within 120minutes.

The next day after I got the shot, I was very sick. I just felt very out of it. Then about three weeks after the shot I puked up blood. It was a lot of blood.

Received shot at 4:00 PM, 2 AM that night symptoms started: fever, chills, nausea, vomiting, headache, body aches. Took Tylenol and all symptoms were gone in 48 hours

Headache X 24 hours. Rigors, low grade fever, nausea X 1 hour 12 hours after injection. Improved with tylenol. Fever of 101 at hour 36.

I had the common symptoms within 24hrs of receiving the vaccine, including headache, body aches, body chills, fever, and tiredness, which lasted approximately 24hrs. I had taken both Adderall and Allegra that day. 4 days after receiving the vaccine, I took Adderall and Allegra and had an adverse reaction (I hadn't taken Adderall the prior 3 days). I experienced palpitations and vertigo/dizziness plus slight nausea. The next day, I took a much lower dose of Adderall and decided to continue taking approximately 1/3rd of my typical dose after an E-visit with my primary care Dr. During the week of 4/5, I was able to increase the dose by a little bit without any adverse reactions. Starting on 4/11, I was able to take 2/3rds of the typical dose without adverse reaction. However, I am still experiencing vertigo/dizziness, which may or may not be sinus-related due to seasonal allergies.

Shot was at 1:50. At 8:00PM I started getting chills and body continues to shiver. Was able to fall asleep and got up to use the restroom around 2:00AM and had dizziness, headache, Nausea and felt faint. Same occurrence happened around 4:00AM as I got up to use the restroom again. By 8:00AM I could slowly get up and move around with out feeling faint or nauseous. Left with fatigue

20 mins after injection felt dizzy and face numbness. 12 hours after injection felt nausea, chills, fever, fatigue. Fatigue persisted for 36 hours. 48 hours after injection, face numbness returned and persisted for about 3 hours. Localization around the eyes and nose.

Vomiting, Blurred Vision, Hard time catching my breath, numbness in arms, chest pressure, ear pain, headache, muscle aches, fever, dizziness for about 3 hours starting at 11:00 p.m. Ambulance was called around 2:00 a.m. taken to Hospital Seen by MD tests: Imaging XR CHEST AP PORTABLE MD Apr 12, 2021 The result is abnormalLab CBC WITH PLATELET AND DIFFERENTIAL MD Apr 12, 2021 The result is abnormalLab COMPREHENSIVE METABOLIC PANEL MD Apr 12, 2021 Lab PT-PTT MD Apr 12, 2021 Lab TROPONIN MD Apr 12, 2021 Lab CKMB W/TOTAL CPK MD Apr 12, 2021 Lab P-NATRIURETIC PEPTIDE, MD Apr 12, 2021 The result is abnormalLab MAGNESIUM MD Apr 12, 2021 Lab ESTIMATED GLOMERULAR FILTRATION RA MD Apr 12, 2021 Lab SARS-CoV-2 RNA RT-HDA MD Apr 12, 2021 Lab POCT PERFORM URINE PREGNANCY MD Apr 12, 2021 Pt seen and examined. Workup ordered. IVB, zofran, pepcid, toradol 15mg iv ordered. Reassess. Magnesium 1.4. repletion ordered. covid19 -ve. Upon reevaluation, pt feels better. VSS. Pt is clinically stable for d\c from ER. D\c to home per d\c instructions Strict d\c instructions and parameters when to RTER d\w pt, all of which pt verbalized understanding and agreement.

*Fever above 102 degrees and as high as 103.2 - utilized acetominophen, ice packs and could get it down to 100 degrees *Sweating *Intense spells of extreme cold with shivers *Extreme fatigue *Sleepiness *Muscle aches *Generalized pain *Vomiting TREATMENT: Acetominophen; Heating pad for aches and to warm self up; cold cloth for sweating; ice pack for fever; Slept alot; had mother (nurse) taking care of me - pushing fluids, BRAT diet and constant supervision for need to go to ER or PCP. Since mother is a RN we handled my symptoms at home. Symptoms continued for 3 days (I missed 2 days of work). Fever subsided on Day 3; other symptoms were milder day 4-10.

Patient's mother called on 4/14/21 to report that her daughter have been having severe headaches, severe abdominal and leg pain since getting vaccine on Monday night

Sudden onset back pain on 04/09/2021, localized to the center of my spine, so bad i thought i was going to vomit. Tylenol was unhelpful but I had also taken my anxiety medication and 25mg of Benedryl, so the fact that it lasted roughly 4 hours is an estimation because i did eventually fall asleep. Chest pain on 04/10/2021, ongoing but only sometimes excruciatingly painful. Had costochondritis about a year ago, it eventually went away. This pain is the same as that. I was told that people who get costochondritis are likely to get it again, so may be unrelated to the vaccine, but thought i would list it anyways. General unwell feeling lasted until 04/13/2021 Unrelenting nausea lasted until 04/13/2021 Diarrhea started today 04/14/2021

Felt okay until around 6:30pm that evening when I began to feel achy, fatigued, as well as pins and needles all over my limbs. I was extremely tired and the aches had significantly increased so I went to bed at about 8:00pm. When I couldn?t sleep around 9:30pm I took 1000 mg of acetaminophen. I woke up at around 11:00pm and felt extremely feverish (shivering, entire body extremely soar. My joints hurt so badly that I couldn?t get comfortable) and nauseous. I then had 4 or 5 episodes of violent vomiting throughout the night every 2 or so hours. After, I would be drenched in sweat. When I got up *crawled to trash can next to my bed* at around 2:30/3:00AM I took 200mg ibprofin. Felt fatigued and no appetite the next day then was fine

Had typical post vaccine symptoms right after - nausea, muscle aches, chills, fatigue. 5 days after vaccine those appeared to have dissipated. Went for a light walk in the morning. Completely lost vision in both eyes extremely blurry. Stumbled my way home running into trees, cars. Vision came back, thought it was migraine (had them before but nowhere NEAR as bad, never had vision completely blocked) Excurtating headache behind eyes and nausea, feels like pressure in head. Worst headache of my life, went to ER. Gave morphine (did not help pain at all which was horrifying) got a head CT scan which came out clear and discharged because clotting ruled out. It is now day 6 and my headache is persistent and still excruciatingly painful. I?m also extremely nauseous. I?m terrified because I know something is very wrong. ER doc said might be lingering side effect from vaccine but those effects felt very different.

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

Obtained J&J vaccine on 4/4/21 Signs/symptoms started 4/12 and continue today Has intermittent severe headache that ranges in pain from 2-7/10 Current pain is 2/10 Intermittent abdominal pain that radiates to back Pain is mainly in shoulder blades just under her bra line Hurts when she takes a deep breath in Pain rated at 2/10 current but can range as high as 7/10 at times Denies Shortness of breath or difficulty breathing or speaking, states pain only when taking in deep breathing Sometimes the pain will shoot down her back to her hips Intermittent pain across the front of her upper chest States she does not know how to describe it but it is not severe Sore all over Fatigued Afebrile

SYNCOPE; MIGRAINE; WHOLE BODY TREMORS; VOMITING; NUMBNESS IN HAND AND FEET; WHOLE BODY ACHES; 105.0 F TEMPERATURE; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight was 120 pounds, and height was 60 inches. Obstetrics history included gravida 1 para 1 (gave birth to a daughter 8 weeks ago). Concurrent conditions included penicillin allergy, non-alcohol user and non-smoker. The patient was not pregnant at the time of vaccination and had no history of drug abuse/illicit drug use. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on left arm on 03-APR-2021 for prophylactic vaccination. The product was stored properly from receipt to administration. No concomitant medications were reported. On 03-APR-2021, the patient experienced migraine, whole body tremors, vomiting, had a temperature of 105.0 F (required emergency room visit/urgent care), numbness in hand and feet, and whole body aches. On the same day, she recovered from whole body tremors. On 04-APR-2021, the patient experienced syncope. On the same day, she recovered from syncope, vomiting, and numbness in hand and feet. On 05-APR-2021, she recovered from whole body aches and 'temperature 105.0 F'. The patient was breastfeeding her child at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope, vomiting, numbness in hand and feet, 105.0 F temperature, whole body aches and whole body tremors, and was recovering from migraine. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210412341.; Sender's Comments: V0:20210411086-covid-19 vaccine ad26.cov2.s-Syncope. 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).

LOST VOICE; VOMIT; HARD TO FOCUS; HEADACHE; LITTLE FEVER; FEELING UNCOMFORTABLE; DIZZY; SWEATING; WEAKNESS; 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, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 09-APR-2021, the subject experienced feeling uncomfortable. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced weakness. On 09-APR-2021, the subject experienced little fever. On 11-APR-2021, the subject experienced lost voice. On 11-APR-2021, the subject experienced vomit. On 11-APR-2021, the subject experienced hard to focus. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever on APR-2021, had not recovered from dizzy, lost voice, hard to focus, and feeling uncomfortable, and the outcome of sweating, weakness, headache and vomit was not reported. This report was non-serious.

Night of shot Friday 4/9I got chills for 2+ hours, then was over heating body aches nausea. Saturday 4/10 body aches continued headache, exhaustion and the chills hot flashes continue but not as intense as the day before. Sunday 4/12 I was exhausted but I also noticed a lump in my vagina. I called my Mom who is a nurse who told me to go see a doctor. On Monday 4/13 it was worse I went the the doctor they thought it was a barcilan abcess. It was sore all week I was soaking it. On Friday I went back to the doctor and they diagnosed it as Lipshultz Ulcer, like I had when I was 12 from Zithromax

5 Blood clots coming from right nostril, headache, fatigue, stomach pains Nose bleed with clots lasted 15-20 minutes. Headache, fatigue, stomach pains lasted throughout the day.

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.

4/8-4/9: arm pain, chills, chattering teeth, fever, sweating, dehydration, insomnia 4/9: fatigue, brain fog/confusion 4/8-4/22: random muscle pains mostly in legs, ankles, feet 4/17: insomnia, sweating, neck pain, nausea, dizziness, fainting, muscle pains, dehydration, anxiety/elevated heart rate -> went to ER at 4am on 4/18, tests found no abnormalities 4/17-4/22: neck pain and upper back, fatigue, muscle pains, anxiety/elevated heart rate (intermittent chest pain/sensitivity), insomnia, general discomfort overall and thus depression from not feeling normal for so long

VOMITING; SEVERED LEFT LEG PAIN; HEADACHE; CHILLS; DIZZINESS; 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 asthma. 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced dizziness. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced severed left leg pain. On 15-APR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 06-APR-2021, was recovering from severed left leg pain, and vomiting, and had not recovered from dizziness. This report was non-serious.

Twenty four hours after the shot I had a high fever ,body aches and nausea which lasted 48 hours. I felt better for a few days and five or six days after the shot I started to get headaches again. The headaches got progressively worse and more frequent. I don't normally get headaches. It was pain at the lower back side of my head which was dull but got worse and throbbing in periods. My pain level was an eight or nine. They lasted most of the day. I am still getting a few headaches after three weeks. I have been taking Tylenol and Ibuprofen and it is starting to get better. It is still every day and the mornings are worse before I take a pain reliever. My pain level with the headaches is more like a 3-5 range level of pain.

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.

Nausea/vomiting/diarrhea, abdominal cramping and pain, headache, body aches (specifically pelvis and shoulders), fever of 101.2, chills

Lightheaded with mild nausea. Cardiac monitor showed occasional PAC followed by a sinus pause and junctional escape beat. resolved with PO fluids and rest.

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.

Immediately agter receiving the shot I broke out into a sweat and began to feel lightheaded. My eyes started to blur like I could pass out. The pharmacist/doctors at CVS gave me some water and told me to elevate ny legs. After 10 minutes they checked my termperature and blood pressure. I stabized somewhat and when home. I was sure it it was my nerves but something did feel right. I had a slight burning in my chest and felt queezy on/off throughout the day. Chills and hot flashes followed. I was anxious and paranoid about the possibility something serious coukd be wrong with me. I felt shooting pains in my lower left abdomen that nught and the next day. The following day I still felt very weak. My arm hurt. My muscles felt like jello and I?m unhappy. I wish I never got the shot and I?m worried about my body?s reaction to it.

Around 4 pm I had flu like symptoms. Headache, back pain, fatigue, chills, sweats. Around 5:30 I started feeling light-headed. I got out of bed and fainted on the floor. Laid there for a few moments. Got water. Laid back into bed and my body completely locked up. It felt like there were pins and needles coursing through my entire body. I couldn?t bend or move my legs. My wrists were bent down and my fingers all locked together. I could not move them at all. I was screaming out in pain. It was the worst pain I?ve ever felt. My roommate called 911. Paramedics arrived and took my temperature and blood pressure. They tried calming me down. eventually I did. And my fingers and legs unlocked but I continued having a severe headache, back pain, muscle aches and nausea. I woke up every hour of the night and threw up several times. It?s been 24 hours after the shot and I am still having headaches fatigue and muscle spasms.

Extremely painful period. Never had painful periods before, now my back hurts so bad. My stomach. Worst period I?ve had. And came early. In April and now happening again in May

Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Additional Details: Patient receieved vaccine. After about 5-10 minutes the patient stated she was very nauseous. I went to grab a trash can for her and within the 20 seconds or so it took to grab she had what seemed like a single muscle spasm or convulsion then she slid out of her chair onto the floor. She was breathing and coherent right away however she did not remember getting on the floor. Called 911 and EMS came out and took her vitals. She stated she felt fine afterward and did not go with them.

BACK ACHE; MUSCLE SPASM; HEAVY DARK CLOTTY PERIOD; PARALYSIS; PINS AND NEEDLES SENSATION; NUMBING; SWEATS; SORENESS; NAUSEA; 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 birth control implanted in arm that is old and needs to be taken out, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug allergies nor illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-MAY-2021 at 09:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 3-May-2021 at 09:00, the patient was vaccinated. At 17:00, the patient had pain, nausea, sweats, and soreness. At 18:00, she had pins and needles sensation, numbing, and paralysis. Later, she had sweats. Paramedics had checked the patient blood pressure and heart rate and they were within normal limits. The patient was still experiencing backache, muscle spasm, pain and heavy dark clotty period which was unusual. The patient had birth control implanted in arm that was old and needed to be taken out. Laboratory data included: Blood pressure and Heart rate was found normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness, back ache, muscle spasm, and heavy dark clotty period, and the outcome of nausea, sweats, pins and needles sensation, numbing and paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210511206-COVID-19 VACCINE AD26.COV2.S- Paralysis. 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).

Pt sat down after vaccine. Became dizzy with in 10 minutes. She briefly fainted where she was unresponsive. When she started responding she was very nauseous and vomitted. She stayed sitting and we provided gatorade. She was feeling better 30 minutes later and left the vaccine location

Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Tachycardia-Mild

My symptoms starting the night I got the vaccine and lasted for 2 weeks after. I had a fever, chills, severe headache, nausea, shortness of breath, muscle aches, fatigue, and pain in my left leg. We ended up going to the emergency room the week after because of fear of blood clots.

Pt became very hot, light headed, nauseous, and almost passed out. We sat her on the floor and checked pt's BP and monitored her until she felt better. She refused emergency services and left on her own choice after she felt better.

Bodyache, headache, vomiting x2times and fever after J&J shot 2days ago. Denies abdominal pain, difficult breathing or chest pain.

VOMITING; DIARRHEA; SLEEPINESS; NAUSEA; LOW GRADE FEVER; SORENESS, ACHY KIND OF LIKE WHEN HAVE THE FLU; A LITTLE BIT OF SWELLING; 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 (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced soreness, achy kind of like when have the flu. On MAY-2021, the subject experienced a little bit of swelling. On MAY-2021, the subject experienced low grade fever. On 12-MAY-2021, the subject experienced vomiting. On 12-MAY-2021, the subject experienced diarrhea. On 12-MAY-2021, the subject experienced sleepiness. On 12-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from soreness, achy kind of like when have the flu, a little bit of swelling, vomiting, and low grade fever on MAY-2021, and had not recovered from nausea, diarrhea, and sleepiness. This report was non-serious.

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

I experience respiratory issues, coughing, running nose, sinus pressure, coughing up film. I treated with Mucinex, cough syrup, throat spray. Pretty much over the counter medications. And a migraine that caused me to throw up. Getting more frequent headaches. And also feeling fatigue.

3 hours after vaccine started throwing up for the next 16 hours on and on for two hours. Next two days after she had diarrhea. First day she had a fever.

Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Vomiting-Mild, Additional Details: After Janssen vaccine shot given to patient.Patient lowered her face and body to our blood machine monitor and appear to experienced partial seizure with mild symptoms. Called 911. Patient was assessed her side effects and she told them that she had history of epilepsy and haven't had an episode for at least a year. Provide water to her and also garbage bin next to her due to Patient being nausea. Paramedics arrived about 3 minutes after they were called.

The day after my vaccine I woke up with a very bad headache stomach ache diarrhea fever and chills and all of my symptoms besides a severe headache have subsided I am on week eight of a constant headache I have had to ER visits one of which was because of my headache and elevated blood clotting factors

05/19/2021 Nosebleed and 20 to 30 to stop. Abdominal pain. 05/27/2021 Infection, hospitalized to prevent infection to shunt. 06/01/2021 Pneumonia

patient was afraid of needles to begin with, she warned me that she has passed out before, I gave her the injection, she did with the shot but after 5 mintues , she started feeling dizzinees, and fainting, so I asked to call 911 , she wouldn't let me, I gave her bottle of water , she told me to check bp so I checked bp and it was 80/50, then she said she felt good, few minutes later, i told her your bp is really low so gave her some crackers from the store, she ate, ,but then she felt like throwing up so I called 911, and attended her, emergency came they checked her bp , it was 80/50, they told her they needed to take her to hospital, but she refused, and said she will be ok, she left with her boyfirend, and was ok

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

MINUTES AFTER RECEIVING VACCINE PT STARTED TO FEEL DIZZING, BLURRED VISION (SEEING DOTS), FEELING CLAMY, COLD, TONGUE TINGLING, NAUSEA. PT WAS ABLE TO VERBALLY COMMUNICATE WHAT SHE WAS FEELING. RPH ON DUTY CALLED 911

FEVER; FELT NAUSEATED; FELT REALLY HOT; COLD; COUGH; BILATERAL EAR ACHE; FELT BURNING PAIN ON STOMACH MOSTLY ON THE MIDDLE AREA; SEVERE HEADACHE; BODY ACHE; 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 blood clot, non alcoholic, occasional smoker, penicillin allergy, allergic to amoxicillin, and bee sting allergy, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. Patient's concomitant medication included: cemoxazine100 mg twice a day for anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. Concomitant medications included hydroxyzine for anxiety. On 02-JUL-2021, the subject experienced body ache. On 02-JUL-2021, the subject experienced cold. On 02-JUL-2021, the subject experienced cough. On 02-JUL-2021, the subject experienced bilateral ear ache. On 02-JUL-2021, the subject experienced felt burning pain on stomach mostly on the middle area. On 02-JUL-2021, the subject experienced severe headache. On 03-JUL-2021, the subject experienced felt really hot. On 03-JUL-2021, the subject experienced felt nauseated. On an unspecified date, the subject experienced fever. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) Headache, Body ache and Bilateral ear ache had pain scale of 10/10. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, body ache, felt really hot, cold, cough, bilateral ear ache, felt burning pain on stomach mostly on the middle area, and felt nauseated, and the outcome of fever was not reported. This report was non-serious.

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.

R10.11 - Right upper quadrant pain R74.01 - Transaminitis R93.5 - Abnormal CT of the abdomen R17 - Elevated bilirubin K80.66 - Calculus of gallbladder and bile duct with acute and chronic cholecystitis without obstruction

Approximately 2-5 minutes after administration, she became sweaty, loss of color in her face, nausea and dry heaving, dizziness, tingling and numbness in all extremities, stiffness in lower extremities, difficulty talking and ability to catch her breath.

I developed dysautonomia (elevated heart rate, chest pain, and shortness of breath upon standing. also GI distress) on June 12, 2021. I ended up in the emergency room and being admitted to the hospital twice over the next week and a half. I have been trialing medications, wearing compression socks, and drinking a lot of water and eating a lot of salt. My symptoms have improved a little but my doctors believe I will be managing this for life (or at least a while). Prior to this episode, I got the Janssen vaccine which caused me to have tachycardia for about 12 hours within the first 24 hours. I felt fine for a week but the second week I felt very fatigued and couldn't do much other than sit on the couch for the week.

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).

Coughing when not exercising, and that coughing prompting a gag reflex. Essentially, I feel like I'm going to vomit when I cough, and unlike in the past the coughing is not tied to exertion. This started sometime in June (I regrettably didn't record when I first noticed it). I have been tested by Dr., who is a respiratory specialist, as I originally believed this to be an odd development in my asthma. He currently theorizes that I have in fact outgrown my asthma (which first presented in 2005, at age 9), and this is some new, unknown issue. Our first move was to stop my asthma medications, positing that if this was asthma, my symptoms would worsen. They have not. Additionally, his first guess was that this may be related to acid reflux (which I have experienced mildly in the past), and he prescribed me Omeprazole 40mg/daily. However, around the sane time that I started the omeprazole (roughly a week ago), I began experiencing debilitating nausea, a worsening of the gagging sensation when coughing, and horrible stomach pain. As of today, at Dr.'s recommendation, I have reduced the omeprazole to 20mg to try to determine if it is the cause of my worsening symptoms, but it is too early to tell. I have also contacted the physician I see for Hormone Replacement Therapy, which I began about a month prior to my vaccination. Nausea is a noted side effect of estrodial, so I was advised to take that medicine at night instead of the morning. This advice also came mere days ago, so it is too early to tell if it will affect anything.

Patient stated she received her vaccine around 9:50 am and started having symptoms of fever, body aches, HA, chills and nausea around 3:50 pm that afternoon. States fever went as high as 106 degrees. She took tylenol initially for symptoms. As fever continued to increase she called her PCP who told her to take tylenol and motrin at the same time and if temperature did not drop below 103 to report to her local hospital. States her temperature decreased to 102 the next morning on 3/6/21 and then all symptoms resided by afternoon on the 6th.

Nausea, cramping, soreness all over my body, headache, chills and fever. These have lasted so far for 10 hours.

Severe joint and muscle pain to the point of being unable to get out of bed alone. Difficulty taking deep breaths. Deep breaths cause coughing. Severe headache and nausea to the point of having trouble standing without feeling sick. Started with a few hours of getting that vaccine and is still present. Have missed two days of work so far as a result with no symptom improvement so far.

On 3/10/2021 at approximately 2035, a female patient notified vaccine observation staff that she was feeling light headed, queasy and anxious. As staff began to assess the patient she began to pass out loosing consciousness. Staff were able to hold patient before any falls and lower her to the floor. The paramedic on scene began her emergency assessment of the patient. Staff paramedic was able to arouse the patient with a sternal rub. The patient was not fully aware of the event that had occurred. The paramedic place the patient on oxygen via nasal cannula. The patient?s level of consciousness began to improve. The patient stated she has a history of syncopal episode after any immunizations. The patient also relayed that she has a history of anxiety and is complaint with her medication. After secondary assessment of the patient, it was noted that the patient had an extended recovery time from the sycopal episode. She was unable to stand on her own and she still felt nauseous after vomiting. The staff at the clinic notified county EMS at 2055 and care of the patient was transferred.

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.

Extreme chills/shivering. Subsided after 1 hour with extra clothing for warmth, tylenol, and ibuprofen Headache neausea

Patient was found unconscious laying back in her chair shortly after receiving her Covid-19 vaccine. Patient was awoken with a light shake on the shoulder, but not to noise. The patient stated they had difficulty hearing, along with nausea and light headedness. The patient denied any other symptoms, including difficulty breathing, abdominal pain, and body soreness. Nothing was administered on the pharmacy's end. The paramedics arrived shortly after and took the patient as she was going in and out of consciousness. Patient was contacted after the incident, in which she said that she was told she had vasovagal syncope. The patient is fine now.

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.

After receiving the vaccine, I slept okay, the next morning about an hour after I woke up I had severe chills, body aches, and nausea. I had to go home from work due to these feelings. Eventually, developed into a fever. I went home and the chills and aches worsened. I could not get warm not matter how many layers or blankets I had. I took tylenol and fell asleep after several hours. When I woke up, I was profusely sweaty, my fever broke. I was able to eat a small lunch and continued to lie down the whole day. My symptoms lessened and were more minimal 24 hours after. After going to sleep the second night, I felt back to normal upon wake up.

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.

-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).

Within 8 hours of receiving the vaccine, I started to feel weak and began to develop a fever. By that night I had a 102f fever. My muscles were very achey, and my heart was racing. I was slightly nauseous but still able to eat a little. By 24 hours after the shot my fever was down to 99f. I started to get diarrhea beginning the second day and has lasted until now the third day after vaccination day.

Severe chills starting at 1:30 am 17Mar21 followed by fever/sweats at approximately 3:00 am 17Mar21, Headache and body aches 8 am 17Mar21, vomiting 10 am 17Mar21. Headache and body aches present until 10:30 pm 17Mar21.

Nausea , fatigue, weakness, headache , back and Neck pain, pressure behind eyes, headache, fever, intermittent hot then chills, rapid heart rate 110s, and shortness of breath at rest & w/ exertion. Vaccine @ 9:00am 3/13 ?> symptoms progressing at 4:00pm and lasting until next day 3/14 3:00pm

Fever, chills, whole body aches, nausea onset 6 hours after injection. Fever reached 102 degrees overnight, came down to 100 by next morning at 9am. Body aches and nausea continue so far, 18h after injection (time of reporting is 18h post injection)

Patient reports receiving the Janssen vaccine on 3/16/2021. She developed symptoms the same day of subjective fever, body aches, chills, diarrhea, nausea, and abdominal pain. Patient was prescribed loperamide HCL and Ondansetron HCl to treat her symptoms. Outcome unknown as of right now as treatment was initiated today.

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

Extreme body pain, vomiting, chills, migraine. Considered going to hospital as I could not keep any fluids down, including water.

Woke in the middle of the night to nausea and a low grade fever with chills. Took ibuprofen, fever broke around two hours later.

3:30pm - shot given 7:00pm- fatigue and nausea 9:00pm- fatigue, nausea and fever 12:00am-3pm next day- fatigue, nausea, fever, chills, body ache, muscle pain, headache 3:00pm next day - fatigue, fever, body ache, headache 5:00pm- start to get energy back, slowly feeling better

Chills started at 4:30am the next day - then I had nausea, then I had a fever of 101, then I had a headache

Patient was/is breastfeeding and child developed digestive issues. No other changes in diet, habits or environment for occurance other than the vaccine.

PT JUST HAD SOME LIGHTHEADNESS AND NAUSEA FOR ABOPUT 1 MINUTE. SHE WAITED FOR 30 MINUTES POSTS VACCINATION AND FELT FINE

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.

Fever, nausea, dizziness, migraine, chills beginning at 10 pm. Fever and migraine significantly reduced with Naproxen sodium. Continuing dizziness, fatigue for next 24 hours

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.

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.

Vaccination appointment was at 1:30 pm on Monday, April 5. I received the shot at around 2:00pm in my left arm. It hurt going in, but quickly dissipated as I moved my arm. I felt fine for the rest of the day. I felt normal the following morning (April 6), but started to feel tired in the early afternoon. I took a nap around 3:00-4:30pm, and woke up feeling slightly hungry. I went to bed around 11:00pm. I woke up the next day (April 7) with a headache. I called in sick to work and stayed in bed as my headache grew worse and nausea began to appear. I threw up for the first time at 11:00am, then again around 11:30am. I emptied my bowels in between these bouts of vomiting, and my stomach was very obviously empty after the second bout. I took a nap from 12:00-2:00pm, after which I threw up at 2:30pm and then again at 3:00pm and again at 3:30pm. I took another nap from 4:00-5:00pm, then threw up again around 5:30pm. I threw up a seventh time around 6:00pm and saw a couple flecks of blood in my vomit. Each bout was sudden in onset and violent but quick. I think I burst some of the blood vessels in my throat, because it was sore. I called a friend to take me to the ER, and threw up once or twice more while waiting. On the way to the ER, I threw up for the last time. The ER gave me Toradol, Zofran, and two bags of IV fluids. This improved all my symptoms. The next morning, April 8, I felt much better until 12:00pm, when I laid down for a nap and couldn't get out of bed until 4:30. My headache had returned so I took Advil, then ate some rice. I felt better from 6:00pm onwards.

103.5 fever for 8 hours; violently throwing up for 4 hours; migraine, dizziness, and body aches for 24 hours after shot.

Chest pain, disorientation, dizziness, nausea, brain fog, muscle spasms, inflammatory response in prior surgical sites (from 6 months to 2 years old), and fatigue

Severe body aches began at 11pm on 4/8. Then, a high fever - the worst fever I?ve ever had in my life. That lasted until 8am on 4/9. Now, I have chills and nausea - still ongoing.

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

At 3pm on 4/7 (the day of the vaccine), I started to feel ?out of it? with chills. At around 4pm, a mild headache started, and I was experiencing cramping from my chest down to my stomach. I had no appetite that evening. By 8pm, I had a 101.0 fever, and by 9:30pm the cramps were severe in my lower stomach. I was sweating profusely and shaking until I vomited, which helped to relieve some of the stomach pain. Before I vomited, I was in intense pain- possibly some of the worst pain that I have experienced in my life. The sweats and chills alternated throughout the night, and the headache was intense. The next day, the chills, sweats and headache persisted until mid-afternoon, in addition to the occasional stomach pain and diarrhea. The side effects slowly subsided, and I was feeling better by 4/9. The sweating was the longest lasting side effect.

Started with a slight headache that worsened to a crushing headache that felt like my head was in a vice. Lower back started hurting, followed by all joints and eventually every part of my body was in pain. 103 fever, severe chills. Sweating, nausea, shakes.

15 mins after Injection I had pain in my jaw 5pm I had a fever of 100.5 by 6:30 I had a fever of 101.5 which lasted for 15 hours. Starting at 5 I had a pounding f headache and pain in my teeth and jaw By 7pm I had my period which was not supposed to be coming until next month. The next morning I woke up with VOmmiting and stomach pain 10am the morning after the shot I was still in paid around my back neck and head. Still with a fever Fever subsided by 4pm the day after injection

Around 4/4:30pm I started to feel dizzy and by 5pm I grew worried I might faint (I?ve never previously fainted). Around approximately 8pm I was feeling very feverish, experiencing body aches, mental fog, intense shaking and chills, and within the next few hours threw up multiple times. I eventually fell asleep and sweated profusely, waking up multiple times (unusual for me). The next day I had low appetite, fatigue, and body aches, but other symptoms were reduced.

Dizziness, nausea, vomiting, diarrhea, arm pain, body aches, joint pain, headache, my period which is otherwise regular started two weeks early the day after the vaccine

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

Approx 5 mins after vaccination patient reported feeling dizzy, lightheaded and nauseous (dry heaving), pt looked pale and diaphoretic - symptoms lasted approx 5-10 minutes. Left on her own, no EMS needed

Fever, dizziness, weakness, trouble walking, full body aches, headache, wheezing, difficulty breathing, rapid heartbeat, high fever, cough, shortness of breath, vomiting, heartburn, earaches (pressure in the ear), chills, extreme night sweats

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.

Fever 102 degrees for 6 hours Sore Arm 1 week Ibuprofen taken to lessen fever Extreme exhaustion 18 hours Pancreas pain day 2 and day 3 No medical care sought as symptoms went away on there own.

reports she had dizziness, warm sensation, tongue numbness, decreased appetite, decreased sense of taste, vomiting x1, sore throat, myalgias, and intermittent shortness of breath and chest pain. of note had Covid in December 2020

Diarrhea (March 23rd-present, treated with pepto-bismol and imodium) Nausea (March 23rd-present, treated with zofran and phenergan) Vomiting (March 23rd-March 31st, treated with zofran and phenergan) Kidney Infection (March 24th, treated with 7 days of Ciprofloxacin) Blood in stool (March 24th-April 9th) Body aches (March 23rd-26th, treated with acetaminophen)

4:30pm hot flashes and chills begin 5:45pm sleepiness, fever, sweating, headache and abdominal pain begin 6pm nausea begins and laying down doesn't help Unknown time between 6 and 7:45 Advil is taken 7:45 - 9:45pm sleep 9:45pm headache pain has centralized to one spot, no more nausea, still sweating with fever 11:30pm all symptoms except fever, nausea, and headache are gone. Remaining symptoms are less than they were. Day after vaccine fever, nausea, and headache persist but are decreased by Advil and drinking pedialyte and sports drinks with electrolytes. Day 3, only headache and fever occasionally return. No need for medicine, just taking constant electrolytes.

Fever, chills, nausea, headache, body aches. Started around 10pm on 4/10 (day I received vaccine). Fever broke around 2pm on 4/11. The headache, nausea and body aches went away around 5-6pm on 4/11.

I got the J&J vaccine around 2:30pm on a Saturday and by 6 or 7pm I was experiencing a really bad headache. This headache extended down my back and around the back and top of my skull. By 8pm I had began experiencing chills, body aches, and nausea. By 9pm I had a fever and could not stand up without feeling like I was going to vomit. Walking to even get water in the other room gave me motion sickness. I was shaking and sweating with a fever all night, was unable to sleep, and experienced hallucinations due to the high fever. The next morning I still had a fever but could finally sleep. I still had a bad headache, body aches, and nausea. I slept most of the day and my fever went down but was still >100 degrees all day. On Monday, I had a mild fever in the morning which went away by afternoon. I felt weak all day Monday and still experienced body aches and a headache. By Tuesday, I was only experiencing fatigue and brain fog. This lasted about a week.

About seven hours post-injection, I started feeling short of breath and chest tightness. I also had extreme nausea, headache, and fatigue. Fatigue continued for about one week. Nausea spells continued for about 2 days.

patient received vaccine @ 6pm. waited the 15 minutes and was walking to her car with mom. Mom notified RN that patient was c/o nausea, vomiting, tremors, phlegm build up in throat. Nursing staff evaluated patient and per protocol gave 50mg IM Benadryl. Patient unable to have PO due to vomiting. Patient was aox4, lungs clear. 911 was called at 627. Benadryl given at 629. pt tolerated IM Benadryl. 911 arrived at 632 and assessed the patient and transported to medical center for further evaluation

Woke up the following morning with severe headache and vomiting. Recommended follow-up immediately with MD.

Vomited two hours after vaccine Aches and fatigue 4-24 hours after vaccine Ocular migraine two days after vaccine Ocular migraine three days after vaccine

Received vaccination 2 days prior to expected menstrual period start date. After a week of the vaccination, I started experiencing menstrual symptoms...extreme bloating, very swollen breasts, and stomach cramps, but I have not gotten my cycle. I am now 3 weeks late and have had very consistent periods prior to my vaccination. I took three negative at-home pregnancy tests.

After feeling better from the expected symptoms of the vaccine I experienced intermittent nausea and a few instances of dizziness. These events would happen about 3 times per day lasting from an hour to two hours for about 3 weeks after my vaccine. The bouts were the worst the first 2 weeks after vaccination and have finally now begun to subside about 5 weeks after. I have never experienced nausea without any other symptoms before in my life. I honestly thought I could be pregnant but I have had 2 periods since vaccination so it definitely was not that.

Approximately 10:00pm, I started having mild body aches, general malaise, and mild fever/chills. Around 1:00am (4/11/21), my fever and chills escalated, my body was shaking until I wrapped up in several blankets. At 2:30am, I woke up with nausea. At 3:00am, I vomited. I continued to have fever and chills and body aches. At 9:30am, I had body aches and felt only slightly feverish. I took acetaminophen for the rest of the day and had no problems.

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

Friday evening I had what I thought was normal reaction: chills, aches, headache, nausea. Saturday it was mostly aches. Sunday was dizziness, aches, nausea and cramping in left leg. Monday was nausea, aches, tingling in hands and feet, headache, brain fog. Tuesday I woke up with major imbalance and needed to use walls to walk without falling over. Dizziness subsided after some time to only rapid movements. I had a warm burning sensation in left leg with tingling hands and feet. Moderate headache. Reports came out of stopping the Janssen vaccine so I contacted my doctor with my symptoms and they ordered blood tests for clots.

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.

My temp gradually rose over the course of the day/night after getting the vaccine. By the 12 hour mark I had a 103.9 fever, chills, severe body aches, nausea, weakness, fatigue, and dizziness. Treated with Tylenol and Advil over the next 24 hours. Fever, aches and chills subsided within 48 hours. Weakness and fatigue lasted for 7 days after vaccination, then went away. General dizziness (constantly feels like when you have a cold/ear infection and get up and are dizzy) persists through date of this report (day 12 after vaccination). I feel completely better except for the dizziness.

Hypothermic episodes (95.5) during periods of fever Extreme and persistent nausea Highly elevated neutrophil count (12.18 10*3/uL)

After the shot I had a pasta lunch and then took a nap for about one hour. When I woke up ( 3-4 hours after the shot) I had a fever. I could tell because I was very hot and sweaty even though my room was air conditioned. I drank water and immediately was nauseous and vomited. I continued to have sweats, chills, and after about another hour body aches set in. My whole body was cramping up and my hands were shaky. I was very short of breath over short movements like to get to the bathroom, I would be out of breath and dizzy. Around 1700 (6 hours post shot) I took Tylenol and continued to take it every six hours. I was able to keep ginger ale and crackers down but didn't eat much else until the next morning. I think the fever broke in the night. The next morning I was just really tired and sore, but much less achy than the day prior. I was able to eat light meals and I stopped taking Tylenol sometime that mid-morning. I felt fine the next day (about 48 hours after the shot).

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

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 .

about 12 hours after I received the Janssen Covid Vaccine I woke up and had a really bad fever. I was nauseas, was drenched in sweat, and couldn't stop shaking. I went to the bathroom and began violently puking for 30 minutes and then I continued to shake continuously for 3 hours. I was also in a lot of pain and couldn't sleep.

NUMBNESS IN CHEEKS; TINGLING PINS AND NEEDLES; GROGGY; FELT GROSS; SWEATY; NAUSEA; VERY TIRED; HEADACHE; CHILLS AND FEVERS; 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: 205A264, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 22:00, the subject experienced chills and fevers. On 10-APR-2021, the subject experienced sweaty. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced very tired. On 10-APR-2021, the subject experienced headache. On 10-APR-2021 10:00, the subject experienced groggy. On 10-APR-2021 10:00, the subject experienced felt gross. On 11-APR-2021 22:00, the subject experienced tingling pins and needles. On 12-APR-2021, the subject experienced numbness in cheeks. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty, groggy, felt gross, nausea, and headache, and chills and fevers on 10-APR-2021, had not recovered from tingling pins and needles, and very tired, and the outcome of numbness in cheeks was not reported. This report was non-serious.

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.

Client received Jansen Covid 19 vaccine and on her way out she was seen passing out on the floor, she was caught and lowered to the ground. Client did not lose consciousness and reports feeling nauseous, she states that she usually passes out when her blood is drawn. Her lying BP was 106/68 p54, sitting BP is 116/81 p 74, standing BP 116/76. She started to vomit and 911 was called. Medic 203 responded and arrived at 12:30, IV line was stablished and client was transported to the hospital.

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.

Severe Headache. Pain from nose up throughout that half of the head from front, sides, and back of head. Excederin did not help. Nausea and eventually threw up everything in stomach. Went to ER, recieved fluids, toradol, Reglan by IV, and tylonal by mouth. After the ER visit, the pain went away.

The first night, around 06:00-07:00 pm, I had pretty intense muscle pain/myalgia. Joint pain; 101 degrees, chills and headache - these lessened but still continued into unspecified day- Fatigue and Muscle pain lasted the whole 12 days. (. Unspecified date in the night into the next day - I had stomach pain ,nausea, diarrhea, dizziness and I decided to go to unspecified hospital - symptoms were getting worse. They gave me an IV treatment. They provided my the IV because I was dehydrated and then told me to wait it out.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Visual Changes/Disturbances-Medium

On Friday 4/23 I began experiencing a severe headache, chills, and body aches. I had trouble falling asleep because of these symptoms. I had bloody stool. On Saturday 4/24 I was still experiencing body and head pains and continued having bloody stool and by around midnight I had abdominal pains and went to the ER. My appetite was poor the prior week, and since this incident I have hardly been able to eat. I am constantly nauseous and dizzy. After days of not being able to eat, I ate some soup and vomited it back up. I still have abdominal pain, nausea, and am fatigued with a less intense headache.

Immediately after the injection I felt light headed. Soon I could not see (very blurry vision) and I could not hear (like drowning in water). I then started to sweat profusely from every inch of my skin. I couldn?t catch my breath. I was handed water and told to sip on it, which proved difficult when my throat started to feel like it was swelling up. After about a 15 minute ordeal, it was like nothing ever happened. The only symptom that remained, was sweat soaked clothes

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).

Around seven hours after receiving the vaccination I was very fatigued. Nine hours post vaccine I had chills and a fever. Upon waking up the next morning I was nauseas, had a mild headache, a fever and chills, and very sore and stiff joints. Tylenol has been helping with the fever and the joint pain.

NAUSEA; HEADACHE; 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 penicillin allergy, alcohol user, and non smoker, and other pre-existing medical conditions included no illicit drug usage or drug abuse.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and headache. This report was non-serious.

Patient administered Janssen vaccine on 5/5/21 at 1011AM by pharmacist on duty. Patient did not admit any anxiety surrounding vaccine during counseling prior to receiving the vaccine. After administration patient mentioned she has can get anxious sometimes and has tendency to create symptoms in her head. She asked what to be on the look out for for signs of syncope and described starting to feel nauseous, clamy, and tunnel vision. Within seconds she briefly lost consciousness and started to slump in chair within immunization room. Pharmacist prevented her from falling out of chair while opening door to waiting room and asked for assistance from patients boyfriend. Together we held patient in place on chair and propped feet up on another chair. Immediately patient regained consciousness enough to explain what she was feeling but then quickly lost consciousness again and started snoring as if she immediately fell asleep. Boyfriend said no history of sleep issues/narcolepsy, together we laid patient on floor of immunization room with feet slightly elevated and boyfriend at her head and again she immediately regained consciousness. Patient explained that she was immediately starting to feel better and felt dizzy and described having very odd dream like scenarios. She laid on floor for 10 min, Alert and orientedx4, moved to seated position for another 10 min, accepted offer for apple juice, moved to waiting area to sit for another 10min before OK leaving. MOD/PDM aware....Called patient at 6pm that same evening and patient reported feeling great.

Initially presented with 5 out of 10 chest pain (substernal, no radiation, no exacerbating or relieving factors), nausea, vomiting, diarrhea, dyspnea on exertion, and fatigue. Further history obtained included decreased exercise tolerance since four weeks prior to presentation (noticeable during runs). She was found to have an abnormal EKG at an urgent care and was sent to an outside hospital emergency department. She ultimately was found to have heart failure with preserved ejection fraction (56%), Stage C, Class III, and myocarditis. The highest suspicion for the etiology of her myocarditis is viral vs. autoimmune (given response to steroids) vs. genetically-mediated myocarditis. She was discharged on aspirin, a prednisone taper, colchicine, metoprolol, and Entresto with cardiology follow-up. Patient discharged with 4 week monitor to monitor for arrhythmia as per EP service. Infiltrative cardiomyopathy evaluation pending as well- plan for SPEP/UPEP, serum/urine protein electrophoresis, immunofixation, and alpha-galactosidase (not sent due to specific tube not available).

ABDOMINAL CRAMPING; BACK PAIN; DIZZY; HEADACHE; FATIGUE; NAUSEA; 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 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced abdominal cramping. On 07-MAY-2021, the subject experienced back pain. On 07-MAY-2021, the subject experienced dizzy. On 07-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced fatigue. On 07-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal cramping, headache, back pain, fatigue, dizzy, and nausea. This report was non-serious.

On March 22 2021, I had leg cramps that felt like Charlie horses, I had a fever of 102 and I missed work. On March 24 I went to my doctor because my legs were still bothering me. That same night I ended up experiencing extreme dizzy spells, I fainted. On March 25 called my doctor I told them my symptoms were getting worse, the office made me a follow up appointment for April 2 for dizzy spells and fatigue. My symptoms continued to get worse, I had a tele visit April 5. Then, I started developing a dry cough. I called again that same day 4/5 for shortness of breath and went in to my doctors office 1:10pm. They did a chest xray. April 6th I had another tele appointment for anxiety Because I started developing anxiety from all my symptoms. April 7th I called again I had blood in my urine and back pain, It was very alarming because my last period was & years ago. April 7th I went to an Urgent Care . April 8th it got really bad. I went emergency room, I felt like I had a lump in my throat and experiencing some chest tightness, my pulse was 101 beats per minute, heart 118, BP was 143/106 I presented with unspecified Right Bundle Branch block and I ended up tachycardia, they did a CT scan of my chest. the doctor gave me Valium & Hydroxyzine. At the hospital I started dry heaving and vomiting. April 9th saw a new doctor still very nauseated and I was experienced nausea and heart palpitations, and rapid heart.

5/9/21: woke up disoriented and with a headache, fatigued and slept all day - took three ibuprofen 5/10/21: less severe headache on and off morning to afternoon, body aches all over, still fatigued and slept all day, felt queasy towards evening 5/11/21: no headache but body aches continued, couldn?t hold down water or food, drank half a glass of water around 5ish and threw it up a minute or so later; I stayed home and slept 5/12/21: body aches less intense but still felt weak all over, continued to struggle holding down liquids, fatigued; I slept it out 5/13/21: finally able to eat, body aches and fatigue continued, some queasiness on and off 5/14/21: felt weak and sore but not fatigued, some queasiness 5/15/21: felt better, but a little weak - would describe it as an ?in recovery? feeling 5/16/21: a little queasy in the morning, but otherwise on the mend 5/17/21: felt better in the morning and afternoon but drowsy in evening - not sure if it was vaccine related though 5/18/21: felt slightly queasy in the evening but puked around 11:45 pm - not a large amount

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

Day after vaccine I had extreme nausea and head ache. Following day my lips went numb. Woke up the next day to Bell?s palsy (ER diagnosed) steroids seem to be helping. Currently still taking them.

I first noticed a sore throat on 4/16 that I attributed to the start of allergy symptoms. On Saturday, I began to get a headache and felt very lethargic. On Sunday, I was extremely lethargic and unable to leave my bed. I had no appetite, a headache, a sore throat, and a dry cough. My fever reached 101 degrees F. Monday morning I went to urgent care; I no longer had a fever but was still tired with a sore throat. As the week went on, my symptoms dissipated

Patient was seated for 5 minutes after injection and then fell on floor. She immediately sat up. She experienced nausea and dry heaving but no vomiting. She walked out of the store under her own power about 20 minutes after the event.

HEAVY MENSTRUATION; IRREGULAR SPOTTING; NAUSEA; 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: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced heavy menstruation. On 19-MAY-2021, the subject experienced irregular spotting. On 19-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 20-MAY-2021, had not recovered from heavy menstruation, and the outcome of irregular spotting was not reported. This report was non-serious.

Patient fainted after sitting down in observation. Disoriented and scared once alert. Complained of nausea and headache. EMS called. Patient alert and agreed to go to hospital. Vitals @ 12:11p: 110/80 BP, 84 Pulse, 98% O2.

Started with shivers. Then appeared the fever 102F at 7pm. Treated with Tylenol 400mg but then I threw it up. I tried again and tolerated it. At 11pm the fever started to go down. At 00am, I took Tylenol again and at 8am the fever was 99F. In the course, I had joint pain, tiredness and a little headache.

I started with headaches. Then I went to the ER. I had leg and abdominal pain also. Back pain that won't go away either. The doctors are not finding anything and It is stressful.

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.

I have had gastrointestinal issues since the day after relieving the shot, I spent the night in the ER because of it 2 days ago. For 3 weeks I have not been able to eat without being in excruciating pain.

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.

Pt had headache, lightheadedness, shaky and was hot about 25 minutes after receiving vaccine. Her blood pressure and pulse were normal. About an hour after the vaccine, she was still lightheaded. She because nauseous after her initial reaction and threw up.

MATERNAL EXPOSURE DURING PREGNANCY; STUFFY EARS; VOMITING; FEELING UNWELL; CHILLS; FEVER; HEADACHE; NAUSEA; This solicited pregnancy report received from a patient concerned a 27 year old female. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines International Pregnancy Exposure Registry number: C00243). The patient's weight was 77.1 kilograms, and height was not reported. The patient's pre-existing medical conditions included the patient had multigravida. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ascorbic acid/calcium pantothenate/cyanocobalamin/ergocalciferol/nicotinamide/pyridoxine hydrochloride/retinol palmitate/riboflavin/thiamine mononitrate. On 09-APR-2021, the patient experienced maternal exposure during pregnancy. On 09-APR-2021, the patient experienced stuffy ears. On 09-APR-2021, the patient experienced vomiting. On 09-APR-2021, the patient experienced feeling unwell. On 09-APR-2021, the patient experienced chills. On 09-APR-2021, the patient experienced fever. On 09-APR-2021, the patient experienced headache. On 09-APR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stuffy ears, vomiting, feeling unwell, fever, headache, nausea, chills and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and stuffy ears, vomiting, feeling unwell, chills, fever, headache, and nausea was related. This report was non-serious.

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.

It started about a week after getting the vaccine. I had tingling in my feet and my hands, more prominent on my left side. Like pins and needles. Really hard to remain laying on my back. I cannot breathe. A couple of days back I got really dizzy, I have been really bad nauseous. A couple of days ago my middle finger in my left hand was like a little numb. Yesterday with the doctor they tested my sensitivity and I definitely have less sensitivity in my left side. I have more migraines now. They referred me to a neurologist but I have not seen him yet. The day before yesterday I had really bad pain on my left shoulder, I could not move it so I went to urgent care at 9 am yesterday.

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

Patient fainted about 2 minutes after receiving vaccine. She experience nausea, dizziness , and a moment of confusion. Patient stated at pharmacy for 1 hour after episode. She was given water and crackers but refused other medical attention. Patient denied shortness of breath: difficulty breathing. Checked patients blood pressure. It was 144/74. Patient left pharmacy after 1 hour. She called when she make it home. She said she was still a little dizzy and nauseous. She had vomited. I asked patient if she was alone or if someone was there with her. She stated her sister is a nurse and was with her. Will follow up with patient on 3/10/21

Client begin to experience weakness, dizziness and nausea shortly after receiving the Covid 19 Janssen vaccine. She was assisted to triage area. EMT was present at facility and assessed client. She remained alert, awake and oriented to self, person, place and time. She was cleared per EMT, educated on vaccine side effects and care by this nurse. Client was able to ambulate out of facility and drive self home.

3/6 3:30pm received vaccine. 6pm felt foggy, extreme exhaustion, irritable, nauseated, arm pain. Headache 3/7 12:30am restless in bed with muscle pain in thighs with burning sensation down into calves and up into lower back. 4:30am fever of 102 degrees Fever all day till about 8pm when temperature dropped below 100 degrees. Chills throughout day Extreme fatigue throughout day Headache 3/8 No fever in AM 8pm felt queasy & nauseated continued overnight. Extreme fatigue continued Slight cough Headache 3/9 Temperature over 100 Chills Queasiness and nausea continued throughout remainder of day. 6:30pm lesser sense of taste Headache

Fever, shakes, severe body aches and sharp pains throughout my body. Nausea and vomiting and constant use of the bathroom. Dizziness, and severe migraine, fatigue and trouble breathing that lasted 2+ hours.

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

Immediately experienced pain and soreness in arm upon administration of vaccine. Started experiencing additional side effects 9-10 hours after vaccine administration: at night I developed a severe migraine, nausea and chills. When I woke up the next morning, I still had a migraine, my nausea was less apparent, but I did begin to experience fatigue/exhaustion and muscle aches. I've experienced chills and hot flashes in waves throughout March 11th. I took my temperature for the first time at 4PM on March 11th and I have a low grade fever of 99.6. degrees Fahrenheit.

Vomiting began at 10am, continued all day. No food was consumed, and small sips of water not tolerated until 7:00pm

Fatigue, 12+ hours after vaccination Tachycardia, heart rate 130-140 resting,, onset 12+ hours after vaccination Nausea, onset 1 hour after vaccination Headache, onset 1 hour after vaccination

Immediately after the vaccine I had extreme sleepiness and some dizziness. After taking a nap I felt better for a few hours. I did notice my Raynaud?s symptoms became way worse. At about 5:30pm I started to feel extremely cold. By 6pm I was having horrible pains and spasms in my lower back and hips. My muscles and joints became very stiff. This moved to my neck/shoulders, and down my thighs. I lost feeling in my feet and started struggling to be able to take in a full breath. I felt like my whole body was locked up. I started feeling nauseous, but part of that may have been from the nerves. The next morning I felt a bit more mobile but still nauseous and stiff. I have slowly gotten better throughout the day, but am still stiff and exhausted

bodyache. PT receive J/J vaccine yesterday approx 0930 reports onset of bodyaches, chills, HA and nausea since last night. denies feeling ill prior to vaccination. 28 yo F, no known chronic medical conditions, got the COVAX (J&J) at 0930 yesterday; at about 1900 she started to experience severe fatigue, chills, frontal HA, body aches, and nausea. No fever, neck pain, vomiting, diarrhea, urinary urgency/frequency, hematuria. No CP, cough, SOB, abd pain. Felt well prior to receiving the vaccine.

9 hours after the shot I became nausea and had the chills. About 11 hours after the shot I had a fever of 101 and then vomited. 18 hours after the shot my fever has gone down but I still have a headache and bodyaches. I?ve been taking Tylenol to treat the symptoms.

Within a few minutes after Jannsen vaccination, in the observation area, patient called attention to staff. A few nurses arrived immediately including this RN. She became dizzy, nauseated. Emesis bag but no vomiting occurred. Vital Signs taken with Systolic BP in the 60's, mild bradycardia, significant clamminess. Patient endorses usally HR higher than this. Patient then developed a period of absence x 2, similar to absent seizure. Patient was laid on a stretcher with slow improvement in S-BP to 111 and clamminess. Given the significant hypotension and suspected absence seizures, staff had already call 911. Patient reported only having some popcorn and coffee all day with no meaningful intake of food or fluids once patient became more alert. This RN provided 2 bags of chips with salt and 2-16 oz. bottles of water. This RN encouraged intake. Fire, EMS, and Police arrived. Patient refused transport to hospital. Patient agreed to wait until significant other arrived to drive patient home. Patient stayed for about an hour extra to eat and drink with moderate effect. Patient stood up and felt moderately dizzy but patient was able to ambulate to her significant other's vehicle. The team encourage patient to contact and see PCP regarding the absent seizure and encourage rest with hydration and intake at home. Incident report was filed with facility.

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.

AMI onsite Paramedics were approached by a 28 y/o female stating she was about to ?pass? out as she was kneeling approx. 10 mins after receiving the vaccination which was administered at 16:54. Pt was caught prior to losing consciousness for approx. 30 seconds post vaccination and presenting with sz like activity consisting of decorticate posturing and pupils dilated @6mm. Pt was carried onto available cot via two man carry where pt regained consciousness, coax4 of 4 GCS 15. Pt stated she felt lethargic and was diaphoretic and feeling nauseated, no emesis. Pt was placed left lateral and was placed on oxygen via N/C @2lpm while EMS responded. Pt denies allergies but states being hypersensitive to Augmentin, no meds taken, no prior medical hx but states she?s had similar episodes since the age of 17 being reported as sz like but never diagnosed and denies having a neurologist. Pt also stated that this was the worst episode. While awaiting EMS, pts nausea and diaphoresis had subsided but stated feeling ?heavy?. HEENT-unremarkable, Pupils now equal and reactive, neck-supple ,equal chest rise with clear equal lung sounds ,abd non tender, FROM to extremities x4 with equal weak strength. Upon EMS arrival, report was provided, EOR.

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.

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.

Patient was administered the Janssen vaccine at approximately 10:00 a.m. At approximately 10:10 a.m., she complained of difficulty swallowing and was sent to the healthcare unit for assessment. She was assessed by Dr and administered Benedryl. Patient was transferred to hospital emergency room for further care.

March 31, 2021: 12:30pm: Headache and sore arm 3:30pm: Nausea and severe headache 4:30pm: Pain in joints and swelling in hands + headache continuing 7pm: Severe chills with temperature at 100.3 F + headache continuing 8:30pm: Abdominal pain and continuation of chills + headache. Quite a bit of abdominal gas April 1, 2021: 12:30am: Chills subsided and temp raised to 100.5F. Joints still still and sore. 6:30am: Sore joints but body temp back down to 98.3F and body aches not as bad 8am: Minor traces of blood in stool 10am: Took 2 advil for headache and other body pains 12pm: No more traces of blood in stool 11am: Headache minimized and body aches greatly reduced

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.

Janssen COVID-19 Vaccine EUA Received the shot at 11 am and started feeling tired with some muscle aches at 2:45 pm. I slept from 3:45 to 4:30 pm but was still tired and felt weak. I did feel hungry and made dinner over 30 minutes. However, this wore me out. I was even more tired and started getting dizzy. I almost fainted as I made my way to a chair to sit down. I couldn't eat because of slight nausea and cold chills. I was shaking for about 20 minutes. Eventually, I made it to my bed to lay down, but my legs were shaking as I walked up the stairs. At 6:00 pm, my temperature was 98.8 F. I was freezing a shivering for the next hour in bed under 3 blankets. My hands and feet felt like ice. At 8:00 pm, I had a fever of 100.2 F that lasted all night. My body ached all over, especially at the hips. I couldn't sit still and couldn't sleep until 4:00 am. I woke at 8:30 am with some milder aches and fatigue with a temperature of 97.6 F.

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.

Started with muscle aches, then got a headache. Several hours later I had a low fever (99 degrees) and chills. I also experienced nausea. A few hours later my fever broke and the chills went away. The muscle aches are still there but are gradually subsiding.

Patient reported having a brief wave of nausea after waiting 10 minutes in observation. When she got up to leave when her observation period was over, she reported tinging in her lips. 13:18 138/80, pulse 70, resp 20...tingling in lips 13:50 Pulse 72, Resp 12. Feeling better. Drank some water. Lip tingling present but faint. Reports she has to "focus to know it is there". Pulse reg, lungs clear, mentation clear, no stridor, no rash, no lip or tongue swelling. Call placed/Voice message left for follow up on 3/26. No return call received.

4/02/21-body aches dizzyness, nausea 4/03/21-body aches, nausea, dizzyness, fever, chills, chest pain 4/04/21- dizzyness, nausea,worsening chest pain

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.

I awoke at 6:45 a.m. feeling a bit sore in my arm, but relatively okay. I was up for approximately ten minutes and then extended my arms over my head to stretch out some of the achiness and immediately regretted the action. I began to feel dizzy and nauseous and saw black spots encroaching on my peripheral vision. I washed my face to relieve some discomfort with no change. I walked toward the bedroom to grab my glass of water when the black spots increased, clouded my entire vision, and I collapsed on the bed. I then began to hyper-salivate and after waking my husband and catching my breath, I returned to bathroom, experienced diarrhea, and simultaneously vomited into the trash can. The vomit tasted chemical and extremely acidic. My body was also shaking uncontrollably during this time and I kept switching between chills and being too hot. After I felt comfortable leaving the bathroom, I crawled back in bed but was shaking so much that I couldn't stop my teeth from chattering and could not get warm no matter that my husband placed an extra blanket over me. I had taken my temperature before while I was in the bathroom and it read 94.6 degrees Fahrenheit. I took it again in bed about twenty minutes later and it read 99.4 degrees Fahrenheit. My head was splitting and my arm ached, but I was eventually able to go back to sleep. I felt better after sleeping for a few hours and drinking more fluids.

Shot administrated at 11:45am 2:30pm Neck and Back became tense 4pm pain started spreading from neck and back into the rest of the body Bones began locking up and I couldn?t move my joints, Headache, Nauseous set in, pain was so intense over entire body I was just shaking and couldn?t walk without assistance. I wasn?t able to rotate my hips or spine, couldn?t not sit, lay down, or stand on my own. Pain continued like this until 8am April 6th when it then started receding into my back again. I am still very tensed up in my back and neck with pain in my spine. Headache is still present, and my jaw and ears hurt when moved.

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.

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

Pt received vaccine and then began to feel nauseated and fatigue. Pt laid down on a cot, with small sips of water and less than 15 minutes later patient said the symptoms resolved.

Fever around102F for 3 hours, petered out slowly over the next 8 hours Headache Nausea/vomiting Chills Slight shortness of breath All symptoms resolved within 24 hours of onset

2:00 am woke up with teeth chattering, cold chills, body aches continued to wake up through the night almost hourly in extreme body pain 6:00 am woke up in severe pain, stomach cramping, lower back pain, nauseous, attempted to get myself water and had to sit down in the kitchen in fear of passing out, barely made it back to bedroom before almost passing out again and immediately broke out in a profuse sweat. Body pain and aches continue for rest of day and into the next.

CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patiennt 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:30am in left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, chills and nausea was not reported. This report was non-serious.

patient reported muscle cramping and shaking,, sharp headaches, fever 101.9 unresponsive to tylenol and ibuprofen for 8 hours, nausea, and back pain

Approximately 15 minutes after vaccination, stated she felt hot and flush. Given 20mg of Benadryl and given juice. Moved to an area she was able to take her mask off and take deep breaths. Denied any SOB or throat concerns. 5 minutes later stated she still felt hot and flush and felt as if she were going to throw up. Given another dose of Benadryl 20mg at this time. Approximately 8 minutes later stated she was doing okay, but still a little warm but felt the room was warm. Opened window and she sat by the window for approximately 4 minutes. At this time stated she felt better and wanted to return to work.

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

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

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.

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.

Patient experienced anxiety, SOB, clammy hands, vomiting, sweating, arm numbness. BP 108/77 HR98 R16, then 10 minutes later 103/67 HR82, RR18. Patient stable, released with instructions to f/u with healthcare provider

Fever, headache, nausea, fatigue, shivering. Adverse effects: Throat and ears soar. Aligns timeline wise with the other reactions and is lasting longer. I haven?t been sick in a long long time so I believe it?s from the vaccine.

Patient felt nauseus approximately 10 minutes after the imz, then proceeded to vomit, She then stated that she felt better. She stated she gets herself worked up

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

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.

MOM STATES THAT ABOUT 2 HOURS AFTER DAUGHTER RECEIVED THE VACCINE, SHE REPORTED A SPLITTING HEADACHE. DIARRHEA AND VOMITING SOON STARTED BETWEN 4/10/21 AND 4/12/21.

Fever began around 1-2 am on 4/9/2021. At the same time I began having chills & sweats. Fever lasted until 4/10/2021 around 1 pm. Ranging from 99.2-101.4. Aches and pains in my muscles that were felt all the way to my bones. The aches went away by about 10 am on 4/10/2021. I took about 5 or 6 doses of tylenol extra strength and motrin to help. Nausea and dizziness began on 4/10/2021 which I am still experiencing today 4/12/2021. I began my menstrual cycle 4/10/2021 and have noticed more shedding than usual.

Low grade fever, chills, body aches, headache, nausea, diziness/lightheaded. Felt like the full flu for 24 hours about 12 hours after recieving the vaccine.

Nausea within minutes after injection, metallic taste and smell within an hour, slight full body muscle weakness and stronger muscle weakness at injection site within a few hours. All symptoms still present 11 hours after injection.

Chest Pains 24 hours after vaccine. Lasted two days. No Treatment. Went away on its own. Sharp Stomach Cramps 48 hours after vaccine- 04/09-No Treatment. Ended 04/13. Irregular Menstrual Cycle. Period not due for 3 weeks and started in middle of birth control packet (Lo Loestrin Fe (doesn't usually have a normal flow of blood on birth control)- 04/11 coupled with fatigue and headache. It is 04/13 and am currently still bleeding.

few hours after vaccination, I started to have severe headache, dizzy and abdominal pain. The headache and abdominal pain reached to their peak at night on the same day, and I took extra strength tylenol. I felt better after two hours. I still took the tylenol the following day since the severe headache and abdominal pain came back. It was relieved after a couple hours. The following five days, I had minor headache, felt dizzy and very tired. I did not any more medicine. I got recovered a week since vaccination date.

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

Within 3 minutes of getting the Janssen shot I started feeling really sick, lost my vision and all feeling in my hands. I sweated through all of the clothes and soaked the chair I was sitting in. That night around 7 pm I got a migraine and felt really fatigued I couldn't stay awake and I was really sore. My chest hurt and so did my head. I was nauseated to no end The next day was worse. All day I couldn't stay awake. I felt so sore and sick to my stomach and I coint move too much because I was super dizzy. The next day I was still sick and dizzy By day four I felt fine just dizzy.

About 2 minutes after vaccine I became very faint, nauseous and felt very hot. Sweating pretty bad as well. That night I had a fever going up too 103.5. Took Tylenol to get rid of that. Bad headache and body aches all until the next day.

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.

Shot administered at 1:30 pm, onset of symptoms at 8:00pm fever, chills,, body aches, nausea. Severe for 10 hours, then just general soreness and feeling tired.

Extremely high fever, light-headed, fainting, muscle aches, chills, nausea. Symptoms began at about 4 pm. By 8 pm, they were unbearable and fainting began. Fever broke at 11:30 pm after laying under cold towels and taking aspirin at 8 pm. Headache and fatigue lasted until noon Saturday (April 10)

Chills and fever were accompanied by sharp joint pains, severe throbbing and pulsating headaches (primarily on the upper right side) and migraines that developing into throbbing and pulsing in the entire body lasting for 10 hours; three fever cycles and the first lasted 10 hours before the fever broke in a sweat; I could not sleep the entirety of the first night and experienced hourly urination and intense dehydration. After first fever cycle I was alert for an hour before second cycle began; after third cycle symptoms changed to nausea and dizziness that prevented me from being mobile without assistance or upright for more than a few minutes, by Saturday evening symptoms went away and I could resume eating, drinking, and walking again

The week prior to delivery (3/22), I started feeling shortness of breath and a headache. I thought it was just normal pregnancy symptoms. That Friday (3/26), I noticed swelling in my ankles. I am a teacher so I asked my school nurse to check my blood pressure; it was high (for me) around 144/88. She said I should call my OB and let them know. I did, and they said to rest for the weekend and they'd see me on Tuesday for my 29 week appointment. We had a weekend trip planned. We took our son there. The next night, I didn't feel right. My belly felt hard to me and I wasn't feeling my daughter move as much, but soon after, I went to sleep. Our two year old son woke us up crying around midnight, and I noticed that I started bleeding when I went to the bathroom. My husband drove me straight to the emergency room. I was diagnosed with sudden and severe preeclampsia. My fibrinogen levels were 100% indicative of a placental abruption. They called the transport team in from hospital so they could transfer my daughter immediately after birth. At 5:57 am on 3/28, my daughter was born via emergency c-section. She is currently fighting everyday at the NICU in the hospital. On Friday, 4/2 I was readmitted for severe preeclampsia to hospital. My blood pressure was 190/115. I had to receive another round of magnesium sulfate. I was released from the hospital on Sunday, 4/4.

Presented to urgent care with chest pressure, abdominal pain, and low back pain beginning last evening

The day I received the shot, I started to feel severe fatigue, headache, light-headed, and started running a fever about 6 hours after the shot was administered. The next day (4/6) was worse. Severe fatigue, muscle aches, headache, loss of appetite, fever (101.5 was the highest I notice but seemed to be around 101.1-101.3 all day), and general flu like symptoms. However, I also started experiencing abnormal menstrual bleeding. I am on the Depo shot and have been for some time. Due to this, I do not usually experience any menstrual bleeding so I found this to be a little odd. It was not heavy but it was noticeable and contained quite a few clots. Day 3 (4/7) was about the same except my fever came down and ranged from 99.8-101.1. Abnormal menstrual bleeding continued. New side effect this day included diarrhea. Day 4 (4/8) I started to see improvement. No fever (that I could tell). Remaining side effects included mild headache, fatigue, diarrhea, and abnormal menstrual bleeding. Day 5 (4/9), I had one of the worst nose bleeds I've ever had in my life. I apologize for the graphic description but it lasted about 20 minutes and my bathroom looked like a crime scene after. Blood was pouring out of my left nostril and I threw two large clots that were about the size of slug (or slightly larger than a fun size snickers... I wish I had a better way to describe it). I've had some bad nose bleeds, particularly when I was on Accutane, and this was worse! The rest of the day I felt like I was improving. Energy levels were better. No fever. Menstrual bleeding stopped. Only lingering side effect was mild headache and mild diarrhea. Since then I've continued to feel better and the diarrhea seems like it's improving. Mild headache persists. Only new item is an annoying twitch in my left eye that started on Monday (4/12).

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.

Vomiting for 48 hours, nausea, headache, chills, fever 102 for two days; period started and bleeding increases daily. Vaginal bleeding still heavy with dime size clots.

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)

Severe fever (101.7) and abdominal pain began around 12am on March 27th, and persisted throughout the day and into March 28th. Symptoms were unresponsive to Acetaminophen 1000mg. Needed to consistently take 1000mgs every 4 hours to bring fever down to 100.7. I was 18 weeks pregnant at the time of vaccination, due on Aug 28th 2021, and 10 oz

High fever over 102°F, severe fatigue, severe chills and night sweats, severe body aches, lack of appetite for the first 48 hours after receiving the vaccine. Bad taste in mouth and bad smell in nose since recieving the vaccine and currently still experiencing (causing foods to taste or smell spoiled, sour or rotten , unable to enjoy things that I previously liked)- the taste and smell are like that of dirty, old, wet paper towels and are present all the time even when I'm not eating.

Initially had tingling in the lips (7 minutes after injection) The next day I had a fever of 104.5 with severe body aches, chills, lack of appetite, headache, weakness, productive cough and congestion. Have had severe body aches, chills, lack of appetite, headache, weakness, productive cough and congestion since the injection as of 4/15/2021

Friday 4/9/2021- Nausea, Upper Body Pains (arms, chest, upper back, neck, stomach), Dizziness, unable to walk, fatigue, headache. Saturday 4/10- Same symptoms with little to no improvement Sunday 4/11- Same symptoms with minor improvement Monday 4/12- Same symptoms with no improvement, increased pains, dizziness, fatigue with headache and facial pain in eyes, cheeks, jaw, ear, nose, and back of neck, primarily on left side of face. Tuesday 4/13- Same symptoms, No improvements, increased nausea with severe headaches and facial pains Wednesday 4/14- Same symptoms, with diarrhea. Thursday 4/15- Ongoing same symptoms, little improvement with Tylenol. Less upper body pains, and nausea. Off and on facial pain and headaches but with facial numbness when without the pain. Dizziness while standing. Diarrhea has ceased. Still weak/fatigue.

Aches started about 4-5 hours after the shot, and about 6 hours after the shot I had a 102 degree fever that lasted 12 hours. I also felt nauseous and had chills.

Janssen COVID-19 Vaccine EUA So after the shot I felt tired is but nothing big, then I went to bed around 9 p.m and I started getting chills, and I was freezing cold even under two blankets. I was wearing a fitbit and then noticed my heart Rate went up to the 90s and fluctuated between 90-110 bpm all night into the next morning. I woke up every 2 hours to a new symptom on top of what I was feeling already. It started with chills, then sweating, nausea and a headache. I had a fever of 99.5 at the highest. And then the last time I woke up at 5 my heart hurt so bad, my whole chest muscle hurt with a sharp pain and It hurt to breath. The next day I had a little headache and my body hurt, and I had cramping in my legs for a few days, but I also started my menstrual cycle on the 13th. The leg cramping continued for a few days but only when I sat on my legs for too long.

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.

FEELING A LITTLE SHAKY; NAUSEA; HEADACHE; MUSCLE ACHES ON THE LEFT SIDE OF THE BODY; VOMITING; SHAKINESS; HOT FLASHES; DIZZINESS; 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: 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 vomiting. On 08-APR-2021, the subject experienced shakiness. On 08-APR-2021, the subject experienced hot flashes. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced muscle aches on the left side of the body. On 10-APR-2021, the subject experienced feeling a little shaky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, shakiness, hot flashes, dizziness, nausea, and muscle aches on the left side of the body on 09-APR-2021, and had not recovered from headache, and feeling a little shaky. This report was non-serious.

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.

VOMITING; CHILLS; NAUSEA; FEVER; This spontaneous report received from a patient via a company representative concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient's medical history was unknown and 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: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 03:00, the subject experienced vomiting. On 09-APR-2021 03:00, the subject experienced chills. On 09-APR-2021 03:00, the subject experienced nausea. On 09-APR-2021 03:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, nausea, and fever on 10-APR-2021. This report was non-serious.

Pain and soreness in left arm, upper back, and neck as well as nausea day of administration (12:30am). Ongoing on and off nausea since administration. Deep burning sensation on side left side between neck and shoulder. Mild joint pain. Ongoing fatigue (11 days).

Severe headache for two days. Extreme chills, nausea, cold sweats, fatigue for three days. On the third day previous symptoms went away and I got an extreme head cold, congestion, tiredness, lethargic. My varicose veins have been midly painful but it might be from laying all day for a week. On day five I started my menstrual cycle two weeks early, it was completely black and clumpy (not normal). It is now day 10 and I still have a slight cold, very tired, and am still on my period.

WHOLE BODY HURTS; VOMITING; FEVER; HEADACHE; This spontaneous report received from a consumer 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: 1802068, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 09:15 in left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, approximately at 16:00 the subject experienced whole body hurts. On 24-MAR-2021, approximately at 16:00 the subject experienced vomiting. On 24-MAR-2021, approximately at 16:00 the subject experienced fever. On 24-MAR-2021, approximately at 16:00 the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from whole body hurts, fever, headache, and vomiting. 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.

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

4/5 vaccination. By 1pm, I felt fatigue, HA, light headed, feverish, loss of appetitive. 4/6 same symptoms but worsened; 101.5 fever. flu like symptoms. Abnormal menstrual period 4/7 fever was low. Diarrhea, upset stomach 4/8 low grade fever; 99. HA, fatigue, diarrhea. 4/9 really bad nose bleed with 2 really large clots. Continuing of flu like symptoms. 4/14 HA and flu like symptoms persisted till this date. 4/16 fever and HA stopped. 4/5-4/22 menstrual bleeding continued. *clots in nose bleeds and menstrual bleeding. Tele med on 4/14, 4/15 MRI. *still experiencing some intermittent spotting but not as much.

7:00 PM I started feeling tired and a little cold, by 7:30 PM I had horrible body aches and chills and was very tired. I laid down to go to sleep at 8:30 PM and dosed in and out of sleep. Around 10:30 PM I had a fever of 100.7 degree Fahrenheit. Around 12 AM my fever broke and by 1:30 PM I started feeling better. I had a really bad headache all night and into the morning, so bad I could feel throbbing in my teeth. I still have some soreness in my left hip joint and shoulder/neck. I have also had diarrhea once around 12:30 PM today. I did have COVID-19 at the end of December 2020 into January 2020. Not sure if that makes a difference.

Pregnancy: 24 weeks at time of vaccine, estimated due date: 7/27/2021. Second pregnancy but no prior live birth. Adverse effects: Woke at 2:30am the next morning with chills, low grade fever throughout the next 24 hours (99 degrees F), severe muscle and body aches, extreme fatigue, slight nausea. Outcomes: Completely resolved by the following day (4/9/2021). Pregnancy is uncomplicated with baby in 25th %ile for EFW. Baby healthy and active. No issues with cervix or placenta.

Arm pain immediately after injection - sore arm, whole arm felt heavy 4 hours later - headache At about 5:30pm - slight fever, slight chills 6:30pm-7:00pm - high fever, terrible chills, widespread body aches, delirium, nausea, extreme weakness, bed ridden The following day - weak, body aches, loss of taste

Patient had vasovagal episode followed by vomiting. Went to hospital s\p vaccination and help there overnight for observation. Released 3/28/2021- in AM

Half hour after shot numbness and tingling on my face Fever of 101.4 starting about 4 hours after injection along with headache body aches nausea and chills, ringing in the ears and dizziness when laying down or closing my eyes Fever remained high with Tylenol and Motrin for about 24 hours. Around 24 hours the fever broke and for 3 days had a low grade fever of 99-100 the body aches resolved but the dizziness ringing in the ears nausea Continued for 5 day after the shot

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Minutes after receiving the Janssen vaccine, patient described feeling dizzy and light-headed. Pt put her head between her knees for some minutes; during that time she appeared clammy and described nausea, dizziness, and sweatiness. After some minutes she began to feel better. She stayed sitting in the pharmacy observation area for 30 minutes, after which she seemed to have fully recovered and was able to leave.

9 pm post dinner in order of occurance -BAD back ache -Muscle aches all night -Chills -Fever of 102.5 -Vomiting Fever lasted through the night, 101 in morning - finally broke at 11 am next morning

patient was anxious before getting vaccine. When she got her shot, she was panicking about the pain. .15-20 mins after vaccine administration patient complained of nausea. Patient looked pale and nervous .We had her lie down with her legs elevated and alerted Code White. Patient was responsive and talking .We did some cold compress around her neck and face. Patient started feeling better afterwards ,waited in the pharmacy for about 30 mins post episode.

immediately post-vaccination pt experienced flushing/warm sensation L side of arm/neck/face. Patient sat in chair x15min, given water. Pt states continued flushing with dizziness and inability to focus vision/blurry vision. Had patient continue to sit and observed additional 30 min. Pt reported no change in symptoms, moved pt back to vaccination room to reduce noise/traffic. Checked BP 144/100, pulse 77. Pt given more water and observed. No labored breathing or obvious distress noted. Pt reported tingling of tongue/throat. No signs of swelling of tongue/throat with examination but increased flushing of face/throat/ears. Pt offered benadryl, she disclosed anaphylaxis to benadryl and refused antihistamine. discussed concern of reaction and use of epipen/EMS services. Patient declined, asked for continued observation. observed x 15 min, no change in status. observed additional 15min, offered loratadine (pt states taken safely in past) pt declined. observed 15min, pt states continued tingling in mouth/throat with slight difficulty swallowing, no observed labored breathing, pt able to carry conversation without effort. Recommended epipen and EMS, pt refused. Pharmacist advised against driving and recommended seeking emergent care. Patient refused EMS and left with friend with request from pharmacist to go to ER. F/u with pt 2 hrs later, pt was at ER but no updated status. Phone call F/u with pt next day (5/13, 1pm). pt states given 1 medication (unknown) that reduced symptoms of tingling but HR/BP continued to fluctuate. ER discharged pt home evening of 5/12 and pt has f/u with primary care 5/14/21.

patient felt dizzy and pass out for few seconds , 2 minute after receiving the vaccination . Patient felt hot and then vomited .Patient said she felt better after vomited and drank water . No treatment was given .Patient stayed at pharmacy for 30 minute and deiced to go home.

COLIC ABDOMINAL PAIN; LIQUID STOOLS; NUMBNESS SENSATION IN THE LEFT ARM; HEADACHE; DIFFICULTY BREATHING; PAIN IN ARM; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 02-MAY-2021, the subject experienced pain in arm. On 15-MAY-2021, the subject experienced difficulty breathing. On an unspecified date, the subject experienced colic abdominal pain, liquid stools, numbness sensation in the left arm, and headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from difficulty breathing, and the outcome of pain in arm, colic abdominal pain, liquid stools, headache and numbness sensation in the left arm was not reported. This report was non-serious.

Pt c/o nausea 15 mins after receiving vaccine. She denied chest pain, SOB, difficulty breathing, or other complaints. Past med hx as reported by patient is carotid artery disease. Pt assessed and evaluated by NP and paramedic. Pt had mild anxiety, BP - 157/80.

I visited the urgent care the following Tuesday. I felt very flushed and dizzy. 24hrs after I had major migraines which lasted two days. I had a flare up from my lupus. I also had extreme stomach pain which is why I went to the urgent care.

Pt admitted to the ED with chest pain one day following the vaccination. Pt described this as subtle at first that increased to wake pt up in pain. Sharp pleuritic pain localized in the center of her chest and slightly in the epigastric region. No prior symptoms previously. Pt has been diagnosed with bilateral pleural effusion, acute pericardial effusion and acute pulmonary embolism.

Pt given Vax at 11:11am, about 11:23am pt started feeling dizzy and nauseous. Pt laid on the floor and put feet on the chair. Ice pack provided to forehead at 11:28am, BP 11:31am 97/61 P53. Pt is talking, awake. said she moved her arm and was an influx of pain and that's what made her dizzy. 11:40am- BP 107/67 P55. pt more awake and feeling better, 11:43am BP 102/74 P68. Pt sat up on her own, ate a few pieces of chocolate. feeling much better 11:52am BP 109/73 P 66 pt was able to stand up and feeling ok

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

Pt states she felt fatigue and nausea the day after getting vaccine. 3 wks post vaccine, started feeling neck pain- April 27.

It was nausea, vomiting, light sensitivity (migraine symptoms), pounding on the base of my skull. It hurt to open my eyes. I took my rescue medication Ubrelvy 100 mg at onset of migraine, it didn't work. I took another one two hours later. I sat in the shower trying to relieve the pressure. It took about 48 hours for it actually go away. It was lingering though. I could go about my day to day but there was this constant pressure in my head. That went on for about a week. I work with my physicians and he confirmed it was a migraine. Rest was what helped.

Patient was experiencing paleness and trouble swallowing saliva shortly after administration of the vaccine. She was fine a couple minutes later.

I was 13 weeks and 3 days pregnant on my vaccine date, my baby is due 12/26/21. My vaccine symptoms started at 9pm with severe chills, body muscle aches, severe headache, pain everywhere. Then by midnight I was crying in severe pain, everything worsened plus I had severe nausea and diarrhea. My neck and back and every limb was throbbing, I was sweating profusely and had the chills, my headache has still persisted even now. I had to call out of work today. I stayed in bed until 11am and finally was able to shower. I?ve been lethargic, and in pain all day. Today more in my hands and head.

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.

20 hours after vaccine began having copious vomiting, 2 episodes of diarrhea, myalgia, fatigue, and tingling to BUE

Have had no period since being on Nexplanon. Had very strong PMS Symptoms (sensitive nipples for 1 week, then bloating for 1 week, then a period for 1 week). The following month, happened again, but less severe than the first time.

Patient received the J and J vaccine June 20. For the next 4-5 days, patient had vomiting, fevers, chills. After that patient developed full body aches, cramps. Patient states that the initial pain was in the level of her spine and radiating down to her legs. She then states that she has and numbness difficulty with walking. She had walking difficulty especially when climbing up steps and initially later needed having help with ambulation. She also has reports that after initial symptoms 7 days after she started having some abdominal discomfort. Most recently she started having some urinary retention issues and was seen evaluated outlying hospital ER on 5th of July. Patient also states that on July 9 she presented a.m. to ER for facial numbness, right side of the mouth . She also has noticed some left-sided finger tingling because of were deficits patient present to ER. Neurology Consultation Note from 7/10/21. Pt is currently admitted to our facility currently. Right facial weakness new Paresthesias weakness Demyelinating process MRI brain with t2 flair hyperintensity differential ADEM vs CIS vs MS vs NMO spectrum disorder Left side ptosis hearing impairment chronic secondary to acoustic neuroma Low suspicion of GBS good distal strength 5/5 ankle bilaterally and knee except for left knee extension 3/5 intact distal reflexes ankle and patellar -Time of onset of symptoms was: Patient has had a progressive course of multiple neurologic complaints from June 20, 2021 when was reported that she received at a intake COVID vaccine -Had symptoms of: Initially had flu like symptoms, followed by bilateral lower extremity weakness, numbness, progressive to have urinary retention, facial weakness on the right side MRI brain Multifocal abnormal white matter T2 hyperintensities, most pronounced involving the subcortical white matter, left greater than right Abnormal signal within the upper cervical spinal cord. Diffusely low marrow signal on T1 imaging suggesting red marrow hyperplasia. Plan: LP ordered for tomorrow AM Follow up CSF results methylprednisolone 1gm x5 days will check blood sugars q.8 hours q4h neuro checks Message Lab for myelin oligodendrocyte glycoprotein (MOG) IgG autoantibody and the aquaporin-4 (AQP4) IgG serum autoantibody Follow up to see if sent.

Abdominal pain began 7/29 and treatment for BV began 7/12. Thyroid panel on 7/9 showed high out of range T3 with TSH and T4 in healthy range. On 7/13 symptoms of heart palpitations, muscle weakness, vision distortion, and elevated blood pressure began suddenly during work. I have history of stroke caused by thyroid storms. Immediately took atenolol, a beta blocker, and called my endocrinologist to prescribe it for the next 30 days. Switched from armour thyroid back to levothyroxine. Atenolol has caused other side effects, heart palpitations are mild and not gone, menstrual cycle is highly irregular. Waiting 6 weeks from the change to levothyroxine for next thyroid panel, continuing atenolol until thyroid levels are in range.

1:20am: woke up with full body chills and felt feverish. Temperature was 99.1 4:30am: woke up with full body chills. Temperature 101.7. full body aches. headache. 6:30am: took ibuprofen. 8:00am-4pm: fever went away. aches and headache remained. 12:00pm: took ibuprofen 4pm: diarrhea 7pm: achy and lethargic. took ibuprofen 8pm: went to bed. 6:00am: woke up sweaty. Felt 99% back to normal. Left arm still sore.

Arm sore after injection. Loss of appetite for dinner. Woke up around 2:00 AM with chills. Added more clothes and tried to go back to sleep. Felt hot and took temperature and had a temperature of 100. Body aches. Took Tylonel around 3:30 AM. Couldn't sleep. Tylonel helped and I was able to fall back asleep. Woke up at 6:00 AM for my day. Fever gone, aches still a little there, tired from lack of sleep and a little bit of chills. It was a rough night but overall feeling good today.

I got the vaccine around 12 pm went home and fell asleep at 1 woke up around 4 was felling very tired and my body was beginning to feel very sore fell asleep again and got up at 6 with a fever and awful migraine and chills and laid down until 8 when I stood up I started to feel very nauseous and started to vomit uncontrollably all throughout the night maybe 4 or 5 times and vomited twice the next day I?ve had a continuous migraine and fever soreness muscle aches in head, neck and back.

Severe chills, fever of 100.7, vomiting, fatigue, weakness for less than 12 hours Chills, diarrhea, fatigue, weakness for three days

muscle aches, nausea, and fever in lower extremities; was not able to sleep ibuprofen taken within 12 hours of onset

5:50pm to around 8:30pm constant shivering no matter how many layers to heat up body. Fingers and toes tingling and numb from cold. (It was 70 degrees in the house). Fingers under nails discolored bluish. 8:30pm shivering stopped, started getting a fever and headache, vomiting around 9:30pm. Vomiting started and stopped within an hour. 9:30pm to 4:20am (this morning) fever, severe headache. 4:20am to 10:30am severe headache.

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.

Patient received vaccine on 3/13/21 in the morning. Later that evening she stopped by and said she felt tired but was well. I saw her today and asked how she was doing. She stated that by 6pm that evening at home she had body aches, fatigue, fever, nausea and at 2am her fever was at 102.4. Sunday continued with fever, down to 100.8, body aches, and fatigue, nausea, and diarrhea. Her temperature this morning was 99 and was she was feeling much better. Treatment was not needed.

3/14: fatigue and nausea 3/15: severe headache (alleviated with Tylenol) and fatigue/flu like symptoms

Chills/ sweating, fever (103) with Tylenol, muscle and joint pain/ burning, difficulty standing, difficulty walking, difficulty bending limbs, nausea, fatigue, headache, loss of appetite, lower abdominal pain, sensitivity to light, weakness

fever,vomiting. Got J&J vaccine yesterday @1400. Sx started since this morning. C/O cold sweats, headache and n/v. vomit x2 this morning. No blood in vomit. Had L temporal headache but not at this moment. No visual changes or dizziness. Not took medication.History: pt had J&J COVID-19 vaccine yesterday and started feeling sick this morning, with some muscle aches, intermittent headache, vomit x 2 this morning, and slight cough this morning (which stopped afterwards), here for eval. Pt was doing ok before the vaccine and lives off-post and denies recent COVID-19 hotspot visit or sick contact. No neck stiffness, runny nose, ear pain, sore throat, visual deterioration, chest/abdominal pain, diarrhea/constipation, History: pt had J&J COVID-19 vaccine yesterday and started feeling sick this morning, with some muscle aches, intermittent headache, vomit x 2 this morning, and slight cough this morning (which stopped afterwards), here for eval. Pt was doing ok before the vaccine and lives off-post and denies recent COVID-19 hotspot visit or sick contact. No neck stiffness, runny nose, ear pain, sore throat, visual deterioration, chest/abdominal pain, diarrhea/constipation, vaginal bleed/discharge, rash, prior surgery, prior co-morbidities. Has had implanted contraceptive since before 11/2020.

15 mins after receiving the vaccine, I began feeling nauseous. One hour after receiving the vaccine, I began throwing up. I could not keep anything down until 2 PM the next day. I was also extremely tired and slept most of the next day. I was 10 weeks pregnant at the time of receiving the vaccine. Had a terrible headache. I took Tylenol for the headache.

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.

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.

103 temperature, seizures, vomiting, feeling like the bones were broken in my neck. I did not make it into the ER

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.

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.

DEHYDRATION; CANNOT EAT DUE TO BLISTERS AND INFLAMED GUMS; CANNOT DRINK DUE TO BLISTERS AND INFLAMED GUMS; DIZZY/LIGHTHEADED; INFLAMED GUMS; MOUTH BLISTERS; INFLAMED, SWOLLEN AND SORE THROAT; SWEATS; CHILLS; FEVER; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user (Social once in a month), and non smoker, and other pre-existing medical conditions included 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient experienced sweats, chills, fever, muscle aches, nausea. On 12-MAR-2021, the patient experienced mouth blisters, inflamed, swollen and sore throat and the patient was given steroid shot. On 13-MAR-2021, the patient experienced dizzy/lightheaded, inflamed gums. On an unspecified date, the patient experienced dehydration, cannot eat due to blisters and inflamed gums, and cannot drink due to blisters and inflamed gums. The patient was given IV for dehydration. Laboratory data (dates unspecified) included: Streptococcal sore throat (NR: not provided) Negetive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflamed, swollen and sore throat on 13-MAR-2021, and sweats, chills, fever, muscle aches, and nausea on 12-MAR-2021, had not recovered from mouth blisters, dizzy/lightheaded, and inflamed gums, and the outcome of dehydration, cannot eat due to blisters and inflamed gums and cannot drink due to blisters and inflamed gums was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210329079-covid-19 vaccine ad26.cov2.s -Mouth blisters, Inflamed Swollen and sore throat, Cannot eat due to blister, Cannot drink due to blisters, Dizziness, Dehydration, Inflamed gums, Sweats, Chills. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210329079-covid-19 vaccine ad26.cov2.s -Fever, Muscle aches, Nausea. These events are labeled and are therefore considered potentially related.

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

Almost exactly 6 hours later, I vomited, had body aches, ran a 102.3 fever, and had uncontrollable shivering. The fever and body aches lasted approximately 24 hours.

I got my vaccine at 1220pm , and started experiencing side effects around 8pm . I was overly tired , cold sweats , fever , headache , nausea all for about 24 hours after the initial side effects began .

Experiencing headache, nausea, body aches, fever approximately 10 hours after injection of J&J vaccine.

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).

Facial tingling around 1:00 PM followed by drowsiness. Around 6:30 PM chills started followed by a headache. Drowsiness continued and then fever of 102 throughout the night. Headache at temples, in between eyes and eyes continued to get worse along with pressure in those areas. Full body aches also developed. Nausea also occurred along with grassiness. Around 9 AM the next day the fever broke but headache continued. Aches subsided but persisted in neck, shoulders and most notably middle to lower back along with stomach aches. Weakness in the arms and hands still noticeable. Dull headache still exists, aches, and weakness as of 9:00 PM.

The patient lost consciousness briefly post vaccination. She began to fall from a chair and was caught and was able to respond to prompts. She became nauseated as well. After laying down and had a cold compress at her neck she felt much better.

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.

Woke up the morning after getting the vaccine and had these symptoms chills achy body Temperature was around 99.0 Headache no appetite lethargy I usually run about 97. The symptoms got worse in the afternoon. Anytime something touched my skin, I would get goose bumps and go between feeling cold and hot. My temperature is now 99.8.

1:32p shot Less than 8 hours: Minor headache and nausea. Still able to do normal life activities. 12 hours: cold chills 13 hours: body aches 14 hours: random sharp pains, body aches, nausea 15 hours: major headache, nausea, weak 18 hours: took Tylenol 500mg 21 hours: woke up sweaty, but feeling ?better?, no appetite 24 hours: major headache, body aches, random sharp pains (not as bad), weak, nausea, somewhat dizzy. Still, no fever. 25 hours: Took Tylenol again, plus Ibuprofen. 30 hours: Began feeling better, had my appetite back. Light headache. 46 hours: (now) feel back to normal.

Headache began around 12:30 am Unable to sleep rest of night Nausea and vomitting occurred around 2:52 am General body soreness and muscle pain rest of day, plus prolonged headache Recovered next day

Nausea and vomiting within minutes of vaccination; lightheadedness and hypotensive (86/66; 93/70). H20, food and rest provided. Recovered within 30 minutes. States history of anxiety related to "needles".

Janssen COVID-19 Vaccine EUA - headache and muscle aches starting 5 hours after shot - fever starting 7 hours after shot, with headache, chills, nausea, fatigue - maximum temperature of 101 degrees, treated with ibuprofen - 24 hrs after shot: fatigue, muscle aches, no fever.

After 8 hours: headache and fatigue (still experiencing after 24 hours) After 10 hours: Back pain, especially in lower back--unable to get comfortable or sleep (still experiencing after 24 hours) Nausea--couldn't lay on my back because it made me feel like I would throw up. Burping. Elevated heart rate--I felt like my heart was pounding out of my chest. My resting heart rate lying in bed was 90 bpm (I'm a runner and my resting heart rate is usually around 55 bpm). This lasted for 3-4 hours.

Starting 11:45pm on 4/6 woke up with severe chills lasting about 2 hours, severe muscle and bone aches all over body, headache, fever, nausea and dry mouth. All symptoms remained at same intensity for 12 hours and started getting better early afternoon on 4/7. Still had headache and muscle aches until around 6am 4/8.

Immediately and after the next 5 mins for at least 3 hours Arm pain, Nausea, Burst of adrenaline/energy

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

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.

Nausea, vomiting, diarrhea, headache, dizziness, fatigue, low grade fever (100.8?F), body aches, joint pain, abdominal pain, chills, insomnia

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.

J&J COVID-19 Vaccine EUA beginning 5 hours after vaccination, I developed nausea that lasted 2 hours, chills that lasted 12 hours, aches that lasted 16 hours, and a 104-degree fever that lasted throughout the night but was gone by morning. Acetaminophen helped alleviate these symptoms.

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.

3:00pm sudden chills, felt extremely cold and shivering, muscle ache and fatigue 3:30 pm lightheadedness/dizziness to the point of almost fainting 5:00PM continued symptoms with added naesua 9:00PM extremely hot , 101.8 degree fever Following day felt much better except for headache and fatigue. Continued to have some much aches and pains Currently on day 3 and have some aches and lains, arm tenderness still, but no lightheadedness or naseau since the first day Treated with Tylenol, rest, ibuprofen

Burning sensation in arm. Lightheaded. Dizzy. Nausea. Severe headache. Fever. Chills/Sweating. Elevated heart rate / Palpitations.

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.

Patient had a covid vaccine appointment at 11:20a 4/12/21. 5 minutes after administering the Janssen vaccine to patient, she alerted us stating that she was starting to feel lightheaded and nausea. Patient was instructed to lay on her back with her feet elevated. A cold compress was also provided to her. A member of management was also notified. Her blood pressure was monitored at 125/92 at 12:10p and 123/88 at 12:30p. Calling for an ambulance was denied by patient. Patient doesn't have a primary care provider for me to inform. Patient was with her mother who will be driving her home. Patient stayed for at least 30 minutes before leaving pharmacy.

7pm: Uncontrollable chills, nausea, muscle aches 12 am: fever (100.4 F), restlessness, muscle aches, headache, nausea 6 am: muscle aches, headache, lethargy 12 pm: no more symptoms

Body aches and chills (8 hours after) fever, nausea, chills, body aches, dizziness, and chest pain (12 hours after)

BACK PAIN; LEG PAIN; HEADACHE; ELEVATED TEMPERATURE; NAUSEA; This spontaneous report received from a consumer concerned a 29 year old female. The patient's weight was 82 kilograms, and height was 159 centimeters. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient has no known allergies. the patient had no drug abuse or illicit drug usage. the patient was not pregnant at the of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered at left arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced back pain. On 06-APR-2021, the subject experienced leg pain. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced elevated temperature. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain, leg pain, headache, and elevated temperature, and the outcome of nausea was not reported. This report was non-serious.

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.

Headache (turned into a migraine), extremely drained of energy, lack of appetite, and felt off all day (4/9/21). The next morning (4/10/21) felt the same as the day before, however, had several episodes where I would get really light headed, dizzy, and nauseous. Went to Home Depot at 2:15pm (4/10) and while there my vision blurred and started to fade, I had ringing in my ears and couldn?t hear out of the right and barely was able to hear out of the left. I got very nauseous and I couldn?t breath. I managed to sit on something and put my head between my legs that helped. Fortunately my step- dad was with me and helped me outside while I could barely see and hear and he stated I was very pale. I was having a hard time talking or being conherent. Once outside the symptoms slowly cleared over about the next 6-7 hours. At 4:45pm my mom decided to take me to the doctor but the walk in had just closed and I went to the ER. They stated I had elevated d-dime and did a chest CT scan to check for blood clots around 7:30pm (I believe not sure exact time) doctor stated they came back clear but when asked if he suspected that the episode and symptoms were due to a dissipated blood clot he would not directly answer it. I overheard him dictating his notes and he started he beloved as such. I have never experienced anything like this before. I still felt drained, headache (migraine), occasionally dizzy, and lack of appetite (4/11/21, 4/12/21) and still currently feel the same drained, migraine, lack of appetite, and occasionally dizzy.

Symptoms- extreme fatigue, migraine, loss of appetite, low grade fever, shortness of breath. ALl symptoms lasted 24 hours

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.

Left arm numbness and tingling from shoulder to tips of fingers, developed 1-2hr after immunization, constant, unresolved; other symptoms include vomiting, diarrhea, and entire arm soreness (unable to raise arm)

I felt fine until about 12 hours after vaccine. Then i had a headache, body aches, chills, fever, diarrhea, and was tired. About 24 hours qfter i started feeling the effects i felt better. I felt better during those 24 hours when i took a 600mg ibuprofen

Intense leg cramping in both legs, couldn?t sit still or lay down until my Aleve kicked in. Prickly feeling in arms when I tried to lay down. Vomiting Dizzy, nauseous, warm temperature Migraine

At approx 9:30 at night - I received chills and then was hot and cold through out the night. My back began to hurt and that then moved into my neck and muscles as a whole with a little headache. The next morning I took Tylenol which I then started to feel a little better but then at approx 3PM, my muscles began to hurt again, I took another tylenol which did not seem to help and felt nauseated. I then took a shower hoping it would help, but instead thew up after getting out. For the remainder of the night - my overall body felt week and standing up for long periods, I felt dizzy.

Immediate dizziness and nausea Soreness in arm after 12 hours Tongue swelling and tongue has white spots on sides of tongue 48 hours after

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.

CG recieved vaccine on 3/19. CG called 4/13 to report the follow: On the evening of 3/19, CG experienced nausea, body aches, and chills. Next day on 3/20-- CG describes feeling lousy and experienced body aches. On 3/21, CG states feelings of a bad hangover (nausea, headache, chills, fatigue). After 3/23, CG experienced moderate to severe headaches every other day. Severe headache continues to persist. Today (4/13), CG called to report severe headaches. History of migraines. CG will visit PCP tomorrow

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.

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.

4/6: The vaccine burned as it went in. The nurse at the Pharmacy administering the vaccine made the comment: "Oh, that's weird. Everyone who has gotten this batch (Johnson&Johnson) today have complained of burning." 4/7: Experienced severe body aches, chills, nausea, sweat, and vomiting. Headache that lasted all day. 4/8- 4/9: A mild headache that waxed and waned. 4/10: After drinking four alcoholic drinks between 10A to 2P, about an hour apart each, I became violently ill. By the second drink I felt a little sick but passed it off for being outside in the sun. Not being told that we shouldn't drink after the vaccine I didn't consider that I shouldn't. Throughout the day I experienced several blackouts, nausea, chills and a severe headache that lasted until 2A until I was finally able to go to sleep. This was absolutely terrifying as I have never experienced anything like this. I have bits and pieces completely gone of this day. I did not drink enough to black out, nor have I ever experienced blackouts or ever drank enough to cause me to black out. I do believe this is connected directly to the vaccine. 4/11: The headache remained as well as dizziness and nausea. 4/12: The headache waxed and waned along with the nausea. 4/13: I still have a headache and mild nausea.

Extreme fever, vomiting, dehydration, headache, severe chills, intense muscular pain to the point of it affecting motor function, dizziness, and hallucinations.

Around 7 hours after getting the vaccine muscle soreness and extreme headache started Around hour 9 after vaccine a fever spiked, vomiting, and chills that could not stop. I have never been so miserable in my life I thought I was going to die

About 6 hours after receiving the vaccine I felt bad enough to go to the Emergency Room, I did not go because I was hoping it would pass, I felt 100 times worse than I did when I had Covid. I had full body chills, I was shaking back and forth, my head was pounding so hard it felt like someone had a hammer to it, I got in a hot bath and it felt ice cold to me, I was throwing up, couldnt lay down because every part of my body that was touching something was in terrible pain. Could not sleep. The next day I had all of the same symptoms except I was sweating a lot along with everything else. These symptoms lasted three full days. It has now been exactly three week, I still have pain in my arm the shot was is, it hurts to raise it. I also still have an incredibly awful headache that will not go away, I hadn't had a headache is years and years prior to this, I overall have not felt well ever since I got the shot and my reaction was incredibly awful. Now I have concerns about my headache and body aches that still are not subsiding.

6 h after injection: 101.7 fever, chills, severe headache (all went away after 24 h of injection) 48 h after injection: severe abdominal pain below the belly button (went away after 1.5 h) loose stools followed for 12 h 10 h after injection: tooth pain due to grinding from chills, still lingering

4 days after vaccination pt experienced severe abdominal pain the RLQ and diarrhea. Pt was sent from village to emergency room where i evaluated, exam with significant RLQ tenderness but no rebound or guarding, some LLQ tenderness as well. With exception of mild tachycardia and slight hypertension associated with pain, vitals were normal.

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)

Nausea and sweating within five minutes of receiving vaccination. Menstrual cycle began early, the day after vaccine was administered. Usually use a light tampon had to use super extra and went through that in approx an hour or two. Very abnormal. Extreme headache with no relief with Acetaminophen. Most symptoms resolved within 8 days.

It started slowly with feeling extra tired and light arm soreness. Then rapidly became extreme shivering, a fever, headache and full body muscle aches. In the early morning I also got stomachache cramps and felt hungry, but food didn?t help. It actually made me feel nauseous. By 6am the next day I had a serious migraine too - sensitivity to light. My eyes hurt. It actually was so bad I caved and took 2 liquid Advil?s to help with the pain. From there I slowly got better over the day but still had the above mentioned symptoms, just less intense. Around 8pm the fever came back and I called it a night. Next morning I felt better, but still tired. Still had a headache but not a migraine. And occasional stomach aches. It?s now 2 days later and the head aches, arm soreness and occasional stomach aches have not gone away.

Began around 3am (exact time unknown due to it being overnight while sleeping) Extreme chills (shaking, not just shivering) Fever (101.2 after waiting a couple of hours to take temperature) which didn't break for over 8 hours Nausea Dizziness Headache Symptoms didn't completely go away for 24 hours

SOUR TASTE BUDS; BODY ACHES; DIARRHEA; CHILLS; HEADACHES; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 11-APR-2021 03:00, the subject experienced sour taste buds. On 11-APR-2021 03:00, the subject experienced body aches. On 11-APR-2021 03:00, the subject experienced diarrhea. On 11-APR-2021 03:00, the subject experienced chills. On 11-APR-2021 03:00, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, diarrhea, chills, and headaches on 12-APR-2021, and had not recovered from sour taste buds. This report was non-serious.

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

Immediately after the shot, extremely sore arm for approximately 1 day. Roughly 10 minutes after the shot an overwhelming feeling of exhaustion lasting approximately 1 day. Approximately 1 hour after the shot, an extreme sense of nausea onset and proceeded for approximately 20 hours.

April 4 - abdominal pain and some back pain. April 14, left leg pain, chest pain, light pressure on chest, left hip pain. April 16 left leg and foot pain. April 17, pain under rib cage and pelvic, stomach pain. April 18, left forearm and leg pain, left side back pain, slight stomach pain.

WEAKNESS; SEVERE HEADACHE; FEVER; STOMACH ACHE; VOMITING; BODY ACHES; DROWSINESS; CHILLS; DID NOT SLEEP WELL; VERY FATIGUE; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight was 170 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced did not sleep well. On APR-2021, the subject experienced very fatigue. On 08-APR-2021, the subject experienced stomach ache. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced drowsiness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced severe headache. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and fever on 10-APR-2021, and body aches, drowsiness, chills, and weakness on 09-APR-2021, was recovering from stomach ache, had not recovered from severe headache, and the outcome of did not sleep well and very fatigue was not reported. This report was 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.

Extreme muscle pain and weakness, cranial hypertension, vomiting. Symptoms lasted roughly 24 hours, cranial hypertension resolved once vomiting subsided long enough to take pain medication.

Systemic: Abdominal Pain-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium

Fainted 10 minutes after receiving shot. Next day, (starting 12 hours after vaccine) severe muscle aches, nausea, fatigue, slight fever, all for approximately 12 hours. Felt slightly fatigued the next day but back to normal after that.

I was asked to sit for 15 minutes in a chair. Didn't have any reactions till i was being driven home and that's when the fever and headaches and abdominal pain started. I haven't had a chance to visit a hospital because I'm too weak to stand let alone move.

AFTER 5 MINS PT GOT VERY SWEATY AND THEN NAUSEOUS AND NOT FEELING WELL ALSO DIZZY AND WEAK. THEN PT GOT SUPER COLD AND CHILLS AND PT WAS STILL SWEATING PARAMEDICS CAME AND CHECKED HER OUT AND AFTER ABOUT 30 MINS PT STARTING FEELING BETTER

I sat there for 15 min after getting the shot. I felt tired 5 min after. got home about 4:00 p.m. i started feeling really nauseas and end up throwing up part of my tong is swollen. when i couch it feels like glass my arm that the shot was given in keeps going on and off of tangling

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.

After receiving the COVID19 vaccine on Friday, March 19th at 12:30pm, I started feeling the normal side effects around 5pm. I had a low grade fever, chills, muscle aches, nausea and low energy through Saturday night around 7pm. When I woke up on Sunday morning, those side effects I no longer felt but instead I had pain in my vagina. All day, I assumed it was a yeast infection and would go to the store Monday to pick up Monistat. Monday morning, the pain had gotten worse. My labia was very swollen and irritated and hurt when I urinated. At that point, I decided to look and found 10-15 lesions on my labia (both right and left side). I immediately called my primary care physican's office to make a same day appointment. My primary doctor was unavailable so I saw another doctor instead. She swabbed several of the lesions as she seemed to think that it was a herpes outbreak (which would have been my first). She wrote me a prescpription for Valacyclovir (10 days) and submitted my vaginal swab for HSV 1 and HSV 2 testing. Two days later I received negative test results for HSV 1 and HSV 2. I asked her for further testing as I was still in pain. I went back in for blood work: Comprehensive Metabolic Panel, CBC with Differential, Epstein Barr Virus AB Panel, Herpes Simplex Birus Antibody IGM, Herpes Simplex I/II IGG. All came back normal. I didn't have any old or new Herpes antibodies. This lead both her and my gynocologist to question whether or not this was a side effect of the vaccine.

Patient had difficulty breathing, fainted, gasping for breath, given epinephrine injection in thigh, started to become conscious and breath more easily, then started vomiting. Called 911 in meantime. Patient taken to hospital.

STOMACH PAINS; 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: Unknown, expiry date: unknown) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 13-MAY-2021, the subject experienced stomach pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach pains. This report was non-serious.

DIZZINESS, NAUSEA, SWEATING, SLEEPING SENSATION IN A CORNER OF THE TONGUE, BP A LITTLE HIGH AT THE BEGINNING AND THEN LOW. OXYGEN WAS ADMINISTERED AND WAS TAKEN TO THE HOPITAL IN AMBULANCE

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.

Irregular abdominal cramps and menstrual bleeding happening every 2 weeks and lasting for everal days (4/21st, 5/5th, 5/21st). Typical menstrual cycle was regular once per month prior to COVID vaccine.

This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced inflamed joints below legs. On 22-MAY-2021, the subject experienced can't walk. On 22-MAY-2021, the subject experienced chills. On 22-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced fever. On 22-MAY-2021, the subject experienced nausea. On 22-MAY-2021, the subject experienced severe muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and nausea on 24-MAY-2021, was recovering from fever, had not recovered from inflamed joints below legs, and severe muscle soreness, and the outcome of can't walk was not reported. This report was non-serious.; Sender's Comments: V0:MAC not required as per standard procedure as case was assessed as non- serious.

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.

2 to 3 minutes after vaccination patient had chills, sweaty feeling, and nausea. the symptoms resolved completely after 10 minutes per patient. She states she has had this feeling after other procedures so it may be nerves.

The first 24 hours there was a fever (102 degrees) and extreme fatigue. Ever since, I have lost my appetite. My normally large appetite has changed into not wanting to eat meals and when I do feel hungry I can only eat a little bit. Weight loss is happening. The fever and fatigue was only the first 24 hours but the lack of appetite is still happening.

Chills and shaking 05/27/2021 Cough, fatigue, pain in legs 05/27/2021-05/30/21 I slept nearly all day 05/31/21- 06/02/21 Difficulty breathing + coughing 06/05/21-06/07/21 Fever, pounding headache, Shortness of breath, pain in arms 06/08/2021 Shortness of breath, pain in abdomen, headache, nose feels like it?s underwater, nauseous 06/09/2021

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.

patient got nausea and vomiting 10 minutes after getting the vaccine ( she didn't eat anything prior vaccination per patient )

Resident received the vaccine around 1:40PM on 6/23/2021. She waited in the office where vaccine was given with no adverse symptoms reported at end of 15 minute monitoring. She went to work as CNA for her shift and at 2:30PM began to complain of dizziness, double vision, anxiety, weakness and nausea without vomiting. Vital signs where taken. Vital signs at 2:30 were BP=138/48, P=86. T=98.1 and 02 sat=99%. Vitals at 2:45: BP=149/98, P=77, T=98.1, 02sat=99, Vitals at 3:00PM: BP=141/92, P=98, T=97.6, 02sat=94. Resident was encouraged to go the urgent care. Her mother picked her up around 3:15PM.

I felt fine the entire day I got the shot, but after falling asleep for the night I woke up feeling like I had the worst hangover of my life. Throbbing back of the head headache, nausea, vomiting, high fever with cold sweats, body aches, insomnia. It felt as though I drank an entire bottle of red wine to myself after not eating all day and went to bed without drinking any water, but worse. 12/10 would not recommend

On 06/28/2021 i received the vaccine. I was sitting in a chair at the pharmacy, unsupervised. Within 5 minutes of receiving the shot I began to feel light-headed, lost consciousness and fell onto the floor and hit my head (according to a witness). I came to and there were staff members/medical personnel present and talking to me. I spoke with them and was immediately brought to the emergency room for further examination. An EKG was administered and a urine sample was taken. Results were normal. I was given acetaminophen and ibuprofen and discharged. Since being vaccinated on 06/28/2021 to today, 07/01/2021 I have experienced the following symptoms: muscle aches/soreness, headache, joint pain, fatigue, nausea, diarrhea

Around 9:45I started to feel like I was about to puke, then I got the chills, then a fever, then really bad body aches. I felt tired but couldn't sleep because my body hurt so bad. I had also felt numb and tingling in my hands, feels, and face. I also had cramps being to happen. They all ended up fading with 48 hours.

Developed elevated temp, HA, body aches and fatigue the day after receiving the vaccine. On 5/18, she developed increase in respirations and feeling like she could not take a deep breath. Hx of asthma, she used her inhaler with no improvement.Tried Benadryl with no relief. Felt like she had sinus congestion and nasal congestion, but able to breath through her nose fine. Feels SOB, worse on exertion. She also mentioned some difficulty swallowing. Denies cough/wheezing. O2 sat was 98 or above, even on ambulation. Cervical lymphadenopathy, tongue swelling, and flaring of her right TMJ was noted on . Prednisone was started. On May 20th, pt reported to PCP's nurse that she was feeling better.

Before the shot the patient was very nervous. 5 Minutes later she lost consciousness in her chair but quickly recovered, with dizziness, tunnel vision, sweating, shivering, nausea, weakness. She got better with resting her head down by her knees, had some water, then stood up to go to the bathroom due to nausea, but didn't make it and vomited 2 times. After resting on the floor with pharmacist supervision for about 20 minutes she began to feel better. I called her boyfriend who came to pick her up. She did not want the ambulance.

**24 weeks pregnant. Due Date 6/24/21. 1st pregnancy** I got the vaccine at 5pm and was fine through the night. I was fine early in the morning and then stated feeling nausea and I vomited 3 times and was unable to retain fluids or food. Everything I tried to consume something I would throw it up. The vomiting and Dehydration was the worst, I had nausea in my first trimester so not sure if it's linked to my pregnancy. I called my OB and spoke with them on the phone, they were concerned at on point but eventually was able to hold down an Gatorade and Tylenol . The other effect I had were mainly fatigue and headache but Tylenol helped with both of those. I still feel tired but other than that no other symptoms. By Friday evening I was feeling fine, the only thins that carried on was fatigue. I didn't experience site pain, no redness, swelling or hurting.

Six hours following shot I became very cold and achy. Around 2:00pm that afternoon (9 hours after) I had a 102 degree fever, horrible headache, and body aches. My fever spiked at 104 degrees around 5:00 and stayed steady at 102 until 5am the next morning. Severe body aches, chills, nausea, and headache persisted. I was unable to eat or drink for 36 hours. Once the fever broke, fatigue and headache persisted until 3/10/21.

Janssen Covid-19 vaccine EUA caused me to feel extreme muscle pain, lower back pain specifically, I felt nauseous, had a severe headache, was light sensitive

Patient woke up on 3/12 with headache, body aches, and nauseous. She went to the bathroom thinking she was going to vomit and ending up passing out and then waking up covered in sweat.

Headache, body ache, Fever, chills, vomit, GI pain. Started at 5pm the same day I took Vaccine and latest until 3am. Next day it cleared up. Except for body ache and dull head pain.

woke up at 4:45 am with severe chills and a low fever (100.5). Throughout the next day was extremely tired, fever rose to 101 and chills were on and off throughout the day. GI accidents of inability to control bowel movements for two days after. Fever and chills lasted 24 hours.

Patient collapsed after vaccination, hitting her head. She remained unconscious while vomiting. We administered epi-pen 0.3mg once and contacted 911. Patient was transported to nearest hospital.

Shortly after the vaccine I developed severe body pains in my legs, joints and back area. I had abdominal pain, chills, a massive headache. And my left hand swole which lasted about 5 days. I was 12 weeks gestation at the time of the vaccine and the EDD is 9/18/2021.

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

Started with severe chills around 10:30pm. Proceeded to nausea, sweats, fever of 100.4F, headache, dizziness, and joint pain. Lasted about 16 hours. The headache and dizziness are still present. I?ve had a COVID test performed on 3/19/21 which was negative.

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.

Immediately after the injection and for the next 36 hours, I had soreness in my right arm where the injection was. Around 8:15pm, I started to develop chills. From there, I developed a fever, headache, neck soreness and body aches in my joints (particularly wrists, knees, elbows). I contained the fever with extra strength Tylenol taken according to the box instructions. The fever broke overnight. I had a 99 degree temperature the next day (3:00 pm) after the vaccine, and experienced fatigue and body aches. Those symptoms largely subsided by the morning of 3/21. I still (as of the PM on 3/22) have no appetite and a persistent feeling of "fullness" in my stomach.

Friday 3/19 7:30-8:00 pm feeling hot 8:00 pm-8:15 pm extreme nausea 8:00pm - 10:00 am extreme chills 12 pm-10 am night sweats Saturday 3/20 12 pm-10 am chills 12 pm-10 am night sweats Sunday 3/21 12 pm-10 am night sweats

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)

Nausea, and body shaking started 2 minutes after injection; chills, fever, severe headache, muscle aches started after

8 hours after the vaccine felt fatigue, had 103 fever, body chills and aches, sweats, head pressure. Took Tylenol and fever went down. Woke up Sunday with 101 fever, aches, took Tylenol again and sweat it out. Fever went away completely but had nausea and diarrhea. That lasted 2 days. Tuesday morning started feeling congested, sinus pressure ringing in ears when laying down, Thursday noticed mild smell and taste. Tested positive for Covid via a rapid test. Friend who had vaccine same day same exact symptoms also tested positive, were never near each other and no one else around me is sick.

Unable to sleep due to level of fever, shaking, nausea and dizziness. Fever, SOB, and dizziness continued until around 10:30 am the next day. Caused a migraine.

Slight stomach ache 3 hours after shot. 6.5 hours after shot: sudden onset of acute nausea, dizziness, lightheadedness, ears buzzing/ringing, fatigue, body aches, headache, moderate fever, chills. Took 1000 mg acetaminophen and went to sleep. 5 hours later (12 hours after vaccine), again experienced severe chills, head and body aches, nausea, dizziness, slight fever. Took 600 mg ibuprofen and went back to sleep. The next day (24 hours after vaccine), more fatigue, head and body aches, nausea, some lightheadedness, slight fever, but less dizziness. Took another 600 mg ibuprofen.

soreness in arm, 8 hours after the injection I had a temperature of 100.4, body soreness especially in back and spine, experienced shakes followed by sweating, loss of appetite/nausea, difficulty standing/moving. I used ice packs down spine to ease soreness, took a melatonin around 10pm, woke up at midnight and vomited, took 500 mg of Tylenol (symptoms lessened after Tylenol), continued to take Tylenol every 4-5 hours until symptoms were gone, approximately 24 hours after injection.

At 3 am this morning I felt fever, body ache, and headache, I took 2 tylenol at 5am and went back to sleep, woke up around 7:30. Since 10 am I've been feeling so much pain in my stomach. Haven't taken any medication because I'm afraid it can get worst

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.

Janssen COVID-19 Vaccine EUA received on Saturday around 4pm 2am- convulsing with chills, nasusa then started, 100.3 fever 230am- vomiting for about 2 hours, fever continued 6 am- sweating profusely and fever went down to 99 Fever stayed around 99 for 24 hours Unable to eat/drink water the follow day (Sunday) tried to drink water but couldn't keep it down. Took Zofran to help with nausea and vomiting stop It's now Monday morning and I'm finally able to eat and drink water and I have a feeling I can only relate to as feeling hungover

R shoulder & neck pain started in early morning about 12 hours after vaccination with nausea & vomiting (3 times to date). Denies any fever, chills, SOB, CP, other body aches, headache, rash or diarrhea. She did eat some left-over food last night. She did not take anything except fluids for therapy. After she called to report AE this morning she was asked to go to an ED or urgent care for evaluation.

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.

A few minutes after receiving the shot I began to feel nauseous, almost like being car sick while looking at my phone. I also began to feel tightness in my chest. After my 15 minutes were up I asked the administrator of my shot if it was normal that I felt dizzy/chest tightness. They said it was probably fine and just to monitor my symptoms. I went and sat in my car a few min and I began to feel very strange, it seemed very bright out, I felt weak, and my eyes felt very heavy. I wanted to get home so I started driving but on the highway, my heart beat was very fast and I began to feel like I couldn't swallow. At one point felt as though I might be about to choke so I pulled over because I thought I was going to have to dial 911 as my throat was feeling like it was closing up. I tried swallowing a few times with great effort and after a few minutes the sensation started to lessen. My throat hadn't closed up completely, however it did feel like it had swelled up.

~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.

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

Felt nauseous, dizzy. Fell after standing up, vitals wnl. Given water, apple juice, and graham crackers.

Stomach cramps, very soft stool and diarrhea. 4 instances in 30 hours. Worst instance around 20 hours after vaccination. Symptoms seems to be lessening around 30 hours after vaccination.

I (the patient) experienced severe symptoms about 10 hours after receiving the vaccine. The serious symptoms lasted for 24 hours after receiving the vaccine: Serious Symptoms: -Intense Chills/Hot flashes -Joint and muscle pain -Headache -Nausea/Diarrhea -Dizziness -Difficulty sleeping Moderate symptoms lasted for 48hrs after receiving the vaccine: -headache -Muscle and Joint pain -Chills

-felt extremely fatigued, not able to walk or move for 30 mins after the vaccination -felt a melting sensation -got blood pressure taken and it was normal -extremely faint -tried to slow down breathing with bigger + longer breaths because of the uncomfortable feeling -major nausea after getting up and sitting down again (lasted 2 mins) -nurse said it may be because of low sugar levels, drank coconut water

Janssen COVID-19 Vaccine EUA - almost exactly 6 hours after my vaccine I started feeling sick. All flu-luke symptoms- fever (102), chills, aches, nausea. The intense symptoms lasted for 12 hours and then eased up a little. Fever broke with acetaminophen and dropped to 99/100.

Within ~5 min of vaccine administration, I developed a vasovagal reaction while sitting down. Became sweaty, nauseous, and my blood pressure dropped to 85/57. Took roughly 30 min for pulse and bp to return to normal. Within 8 hours I developed a fever 100.5-101 degrees and body aches.

Around 5PM I started to get chills and body aches. Later that night I had a fever of high 103F, chills, nausea, body aches, could barely move or lift my right arm. I felt worse than I did when I actually had covid back in December.

Bloody diarrhea multiple times since the shot was administered, it?s not an emergency so we haven?t gotten to a doctor yet

Pt reported nausea, sweating and dizzy. I had her come inside the pharmacy. I gave her water, Tylenol and told her to sit down. She did all that and felt better in 15 minutes.

7pm-aches, getting cold 8pm- fever 100F, neck ache, head ache 9pm-chills Midnight-sweats 2am-nausea 6am-symptoms improved 8am-temp 97.7F, neck ache and body ache persistent 2pm-same as 8am, tired, legs a little tingly No Advil/Tylenol taken. Peptobismol was taken for nausea.. I have been sleeping in the interim times.

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.

Extreme nausea, non stop throwing up, was about to pass out. Ended up in the hospital with a 101.5 fever, low blood pressure, elevated heart rate Immediately after getting the vaccine I felt very nauseas and dizzy as well

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.

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.

Janssen COVID-19 Vaccine 10 hours after the shot, chills began, about 10 minutes after that extreme tiredness. Chills continued for over an hour. Fell asleep, woke up at midnight; no more chills, fever of 101.8 and headache and joint pain in both shoulder, elbows and wrists, and lower back. Mild nausea. 10:00 AM 4/10/21 mild fever 99.8, joint pain continued, plus muscle pain across the upper back/neck. Headache continued with light sensitivity, and skin sensitivity. 8:00 PM no fever, headache and body ache continued. 7:30AM 4/11/21 mild headache and body aches. 8:30 PM mild Headache.

I got a massive headache after the shot and it has not went away as of yet. I also feel extremely tired and very sick to my stomach.

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

First 24 hours: Severe chills, migraine, total body aches, fatigue, nausea 1-5 days: Fatigue, slight chills off-on, waves of nausea, headaches

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.

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.

Got the shot at 12pm by 2pm felt weak, achy, started to get a fever of 99.9, extremely tired. Took Tylenol by 1:30-? was throwing up and fever continued to spike to 102.4 and vomiting started. Pounding headache. Could not get fever to break and freezing.

30 year old femail received Janssen vaccine Lot# 1808982 exp: 6/23/21 at approximately 3pm in the left deltoid. Immediately after being vaccinated, pt. requested to remain seated. The nurse noted that the pt. was getting pale so she suggested the pt. take off the surgical mask to get some air. Before pt. had a chance to take off the mask she lost consciousness. Together with another nurse patient was lowered onto the floor. Pt. regained consciousness for 30-45 seconds and then began to have seizure like activity. Her eyes rolled back and her body became stiff and began a jerking motion. 911 was called. This seizure like activity lasted 4-6 seconds at which time pt. regained consciousness and immediately sat up. Pt was pale and diaphoretic. BP 98/64, HR 78, Pulse Ox 99%. Pt vomited multiple times. Ice was applied to the posterior neck and a cold compress to the forehead . EMS arrived and took vitals: BP 78/40. Pt. was aware of person, place and situation. Pt. was taken to Hospital accompanied by her husband. Pt was called by me Friday and she was home. All tests showed no sign of having a seizure.

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

Almost 12 hours after my dose I got a fever of 102.3, chills, nausea, vomiting, and body aches. I sweat through my clothes and could barely keep water down. I was sick until the next evening around 10 or 11 at night when I had a manageable headache and the other symptoms went away.

Patient stated after the vaccine she had a fever and was nauseous but all resolved after 24 hours. She woke up today with chest pain/ tightness and stated it is painful to breathe. She was advised to go to the ER.

-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.

Pt developed headache and nausea three days after vaccine administration. Came to ER for evaluation given concern for adverse effect related to vaccine

Extreme chills and sweats. Body aches severe enough to not be able to move. Headache for 4-5 days. Nausea for about 8 hours. Extreme fatigue

Post vaccination patient reports soreness of Left arm, light headedness, nausea, and feeling cold. Sent for observation 5:15pm vitals: Pulse 90 BP 131/81 RESP 16. At 5:34pm Pulse 81 BP 118/89 RESP 16. Patient improved with no other symptoms., and released from facility.

Patient reports headache beginning on the evening of the vaccination. Headache lasted for 1 week through 4/7. Patient indicates that they began having dizziness on the evening of vaccination and the dizziness has occurred since that point. Patient reports adnominal pain beginning 4/8 and has persisted since symptom began. Patient was referred to their healthcare provider for evaluation.

Beginning the evening of 04/10/2021 i had developed a migraine, chills, and body aches. This continued throughout the day on 04/11/2021 as well as extreme fatigue. The morning of 04/12/2021, i was feeling fine for the most part outside of having the chills. Around 2:00 p.m. on 04/12/2021, i began to get bodyaches again as well as an accompanying migraine and was now experiencing some nausea and had begun to develop a yeast infection. On 04/13/2021, most symptoms had resolved outside of the continuing yeast infection. No symptoms were present on the morning of 04/14/2021, other than the yeast infection. The evening of 04/14/2021 i began to develop symptoms again in the form of a migraine, body aches, and nausea. The morning of 04/15/2021, i woke up with these same symptoms, but also had the chills again and was very fatigued.

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.

Difficulty breathing; Hot flashes; Diarrhea; Dizziness; Unable to sleep; Intense Chills; Joint pain; muscle pain; Headache; Nausea; This spontaneous report received from a consumer 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, and batch number: unknown expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced difficulty breathing. On 2021, the subject experienced hot flashes. On 2021, the subject experienced diarrhea. On 2021, the subject experienced dizziness. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced intense chills. On 2021, the subject experienced joint pain. On 2021, the subject experienced muscle pain. On 2021, the subject experienced headache. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, hot flashes, diarrhea, dizziness, unable to sleep, intense chills, joint pain, muscle pain, headache, and nausea on 2021. This report was non-serious. This case, from the same reporter is linked to 20210420860.

Pt presents with nausea, body shaking, dizziness and L arm tingly beginning today at 1000 today. 3 days post vaccination

Headache onset 2 hours after shot. Roughly 9 hours after shot developed joint pain/tickling/shaking chills in my legs (mostly in the thighs) and nausea. Temperature rose to 102 degrees over the next 3 hours (I usually run around 97.5) along with the above pain. Around midnight/1 am I was able to get the fever down using Tylenol and a cold bath and the sensation in my legs lessened. The following day I was still a bit nauseous with a headache and low grade fever. The same leg sensation (but to a much lower degree) persisted for 2 days.

Severe chills and shivering, extreme sensation of coldness, teeth chattering, intense migraine with nausea, high fever

Shortly after taking the vaccine, I started having some chest tightness, trouble breathing, and was nauseous but thought it was my asthma so I did not report it. It continued to happen and still have more breathing issues than before.

Nausea, vomiting, chills, slight spike in body temperature 99.4, extreme migraine, left arm pain/numbness, slight dry cough, extreme fatigue, and muscle aches. Symptoms lasted 3 days and started 6 days after getting the vaccine. Subsided after rest and asprin.

Around 5:30 pm in the evening following my vaccine I started having chills, headache, nausea, and fever of 101. Chills got worse, whole body was shaking and shivering. Nausea progressed into constant dry heaving. Head was pounding with the worst pain I have ever felt in my life, worse than natural child birth and worse than running marathons. The nausea was so bad and I could feel my fever burning and getting worse. I was about to vomit so got out of bed to go to the toilet to vomit and the whole room started spinning completely out of control. My heart was racing and I could hear it and feel it pounding rapidly through my ears. I couldn?t walk and was so disoriented I crawled to the bathroom to throw up in the toilet. My husband heard me and came and picked me up off the bathroom floor and carried me to our bed. As the night progressed fever got worse, head was in almost unbearable pain, severe body aches over my whole body, heart racing and horrible nausea and dry heaving. I made it through the night. For two days after I had a headache and fever and nausea and body aches and couldn?t get out of bed to care for my children. By the third and fourth day I was able to get out of bed at times and still felt fatigue, nausea, headache and body aches. Anytime I would stand up for 10 days after the vaccine it felt like I was rocking on a boat. I am almost at 2 weeks and still feel fatigue and dizziness at times. On April 15th, 9 days after my vaccination I had symptoms of a blood clot in my leg. I went to the Emergency Room and was diagnosed with a superficial blood clot of the leg as well as swelling in the vein. I am thankful to be alive!

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.

Severe headache, severe body aches/pain, continuous vomiting for 12+ hours, muscle tremors/shaking. Up all night getting sick 12 weeks pregnant- due October 2021

Severe headache that lasted several days, extremely heavy period. Soaking overnight pads every fifteen - twenty minutes for three days while still leaking and dripping blood everywhere. Extreme cramps that I would rate at a 10/10 in pain. Absolutely debilitating. Day four has been soaking overnight pads at a slower rate but still less than an hour per pad. Diarrhea, nausea and vomiting. Unable to keep food down but able to keep water down. No fever.

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.

Approximately 14 hours after the shot I woke up with extreme shivers (2:30am). I had shivers for 45 minutes until I climbed into a warm bath. The shivers stopped and I became extremely tired. I got out of the bath and had to climb back to bed because the room was spinning and I was nauseous. I did not have a fever at this time. I was able to go back to sleep. I woke up about 2 hours later sweating and with a fever of 100.7. I slept for another 3-4 hours and woke up symptom free. My morning went on normal. Ate breakfast and hung out. I was tired in the early afternoon and took a 4 hour nap which is not normal but expected since I didn't get a good night sleep with symptoms mentioned above in the middle of the night. I also missed my period that month. My period was supposed to start March 30th and it never came. Confirmed I am not pregnant. Period returned in April on normal schedule.

In the ED 3/14/21 Patient states yesterday she got the Johnson & Johnson Covid vaccine. She says that today she started having fevers chills generalized body aches generalized malaise and headache. She says she is otherwise healthy denies any sick significant medical history. She endorses some mild shortness of breath associated as well as some nausea and diarrhea but denies vomiting. IV fluid bolus, acetaminophen and ibuprofen

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

First hour, major headache, fuzzy minded, tired First 24-48 , abdominal cramping with menstrual bleeding, body aches, fever, chills, super sleepy, & nausea

Patient has hx of anaphylactic reaction to Amoxicillin ( difficult breathing) arrived at the site with her mother, was informed about the risk of getting vaccinated at non-clinical setting due to her condition. Patient verbalized understanding, agreed to stay 30 minutes in observation area, proceeded with vaccination. After 5 minutes in observation ( 13:35 PM), patient complained of feeling nauseous, dizzy and tingling/ numbness in the upper extremities. Patient vomited x 2, 40 mL of greenish output, noted with pale complex. EMS presented at site was activated. Vital signs initiated, noted with low BP ( 60~/UNK), HR: 70, O2: 99, R:18 in room air. Patient was taken to the ambulance for further assessment by EMT. Patient received an Epinephrine shot to the L thigh by EMT at 13:52 PM. Blood pressure improved to 110/70, HR: 81, R:18, O2: 99%. Patient also received 1 albuterol treatment 6 LPM. Patient was taken to Hospital at 2:04 PM via Bus.

Seven hours after the vaccine I had a fever of 101 with a headache and chills. An hour later I had a fever of 106.5 degrees. Nothing seemed to work to bring the fever down and I had a very sever headache. I was advised to take a combination of Ibuprofen and Acetaminophen which finally brought it down to 102-103 which lasted three days. I threw up on the third night and I experienced nausea. On the fourth day I went to work, and I was exhausted when I came home, and I had a fever of io2 degrees. I had to take off work for the whole week because I had trouble keeping my fever down to normal. I was fever free after seven days and I was able to go back to work on the tenth day. I have been diagnosed post-concussion syndrome at the end of 2019 and I don?t know if that had an influence on the headaches. The headaches that I got after the vaccine caused similar pain to some I have had before but they did not cause the same symptoms of vertigo.

PATIENT RECEIVED JANNSEN COVID VACCINE. TURNED PALE. FAINTED. VOMITED. COUGHED. PATIENT CONDITION RESOLVED AFTER 20 MINUTES. ACTUAL SYNCOPE LASTED MAYBE 1-2 MINUTES

05/18/2021 evening patient devleoped headache and pain 05/20 patient developed nausea 05/23 patient developed sore throat

Nausea (has since subsided, lasted 2 days), stomach upset/cramping, lower abdominal pain, pain near reproductive organs, some urgency with urination

Immediate abdominal cramping. Bleeding, bloating, numb legs, ovarian pain, nausea, diarrhea, vomit, dizziness, chills.

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.

My period started a week early (I've been keeping track on my fit bit for well over a year), which never happens. At most it will come late but never early. Currently I am going through the worst cramping I have ever experienced and the duration is killing me. Starting when I woke up at 6:30a to now, 3:58p I have had non stop debilitating and fairly consistent abdominal cramping. Now I have had bad cramps a few times in my life, but they won't ever last over an hour.

8hr after vaccine, chills, fever, vomiting for 12hr. Then respiratory symptoms (cough runny nose, sore throat) for 14 days (this is possibly from child's daycare). During this te, Intervals of hot and cold sweats for 2 weeks follow vaccination. On day 14, extreme fatigue, vomiting, diarrhea every 30 min for 12 hours. Nausea and diarrhea continues through day 17. Day 18, another vomiting episode. Swollen painful lymph nodes armpit on side of injection. Heightened anxiety since vaccination (potentially from my fear of vomiting). Today is day 18.

-sore stiff neck one month previous with a headache w/ no trauma to head or neck -6/27/2021 woke up with nausea , left sided numbness -Dx: acute right cerebellar infarct, FLAIR and hyperintensity at right occipital lobe, vertebral artery dissection, left sided numbness, right facial droop, dysarthria,

Patient stated beforehand she doesn't do so good with needles. Almost immediately after receiving the vaccination, the patient started looking flushed, and woozy. About a minute after receiving the vaccine she fainted while sitting in the chair, her spouse and myself stabilized her to make sure she didn't fall. She was drifting in and out of consciousness for about a minute. When she came out of it she seemed confused as to where she was. She spit up a little bile in our trash can. after a few minutes she stated she was ok so we got her up and to the floor with her feet raised, an ice pack on her neck, some water, and some gummy bears. She rested for about 20 minutes on the floor. She eventually felt good enough to get up so we helped her up and made sure she wasnt feeling dizzy and was feeling ok. She walked to our observation area on her own and waited another 15 minutes and she was doing good so she left the pharmacy.

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.

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.

Chills hit me suddenly 6hrs after getting the shot. I was freezing. Two hours later, extremely tired and sore. I feel groggy. 3hrs later, I cannot sleep although I am so tired. Chugged water and took a hot bath but was so tired had to get out of bath. Zero appetite.

Mild headache and nausea set in shortly after the injection on Friday, but went away after rest and eating/drinking. My arm was sore for the entire evening. I woke up around 2am Saturday morning and became dizzy. I fell to the floor and passed out for a short period of time. When I woke, I was extremely nauseous to the point of nearly vomiting. I had chills and fever. I could hardly move due to weakness - I needed help getting back into bed. When I woke the next morning, I had 100.3 fever, I had a headache and my entire body was sore. My fever went away late Saturday afternoon, but I still felt mildly nauseous. It is Monday and I still have mild nausea and light-headedness. My arm is only slightly sore.

Mild nausea began at approximately 6:30pm, chills and shivering began at approximately 7:15pm. Shivering subsided by 8:30pm, headache and muscle aches persisted. No treatments administered.

Severe body aches fever w/ chills headache dizziness weakness diarrhea. Motrin for aches and pain water to keep hydrated

Left arm went numb about 4 hours after injection and remained numb for 12 hours. Severe muscle aches began 4 hours after injection. Extreme dizziness and nausea. Fever, chills, vomiting started 10 hours post injection. Fainting upon standing. Severe chest pain started 12 hours post injection. All symptoms are continuing except for the numbness in the left arm.

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.

Patient felt lightheaded, nauseated, hot and sweaty and appeared pale. She states she has a history of fainting with blood draws and vaccines. VS improved over 25 mins, patient left via own car.

Fever and body aches starting at 10:00pm the day of vaccination and lasting for 24 hours. Fever reached 104 degrees Headache and fatigue 4 days Nausea lasting 1 day Stomach pain and headache still happening (today is Monday, March 15th)

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

Severe chills and body aches at midnight. Took 2 CVS extra strength acetaminophen around 12:40 AM. Temperature in normal range (98.6) at this time. Around 3 AM, chill broken, sweated it out. Still body aches. 4:45 AM through 10 PM - nausea, body aches, head aches. Took 2 acetaminophen as suggested on bottle. Most symptoms were gone by 10 pm Friday but still felt tired on Saturday and Sunday.

Nausea and chills that started about 5 hours after vaccination; followed by joint pain. Ran a fever of 100 degrees at certain points in the night. Symptoms gone after 36 hours.

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.

She was immediately nauseus as soon as she stood up from receiving the vaccine. Medics assessed her on scene and administered zofran.

Janssen COVID-19 Vaccine EUA Body aches - pain level 10/10 from 3am - 7am, pain level 7/10 from 7am-12pm, pain level 4/10 from 12pm-7pm Chills/sweating/fever off and on from 3am-7pm Nausea, loss of appetite Took Tylenol and ibuprofen every 4-6 hours

Chills, body aches, fever, nausea, and headache starting roughly five hours after injection on 3/11/2021. Majority of symptoms including the fever lasted three days, ending on Sunday, 3/14/2021. Headache and body ache still occurring a week later on 3/18/2021.

pt stated that she started shaking really bad and her muscles tensed up along w/ fatigue and feeling very hot but no fever. Pt took ibuprofen and that seemed to help. She woke up with another one of these episodes. She feels like she is shaking but her spouse says she was not physically shaking. She also had headache, body aches with pain, nausea, vomiting and can hardly walk. Ibuprofen is not helping with this pain. pt contacted her PCP and was to call us and and take Tylenol or ibuprofen and rest.

Went to work the next day. Felt fatigued by noon, headache all day. Nasaua was mild but prevalent all day. By 3 or 4 pm, 24 hours later, chills had started. Took Advil twice for headache. Got home, went straight to bed. Chills much worse, headache is splitting. Skipped dinner due to nausea, fever started around 8 pm. By 11 pm, fever reached 101.4, average temperature is 97.9. Fever broke early morning, by 10 it was normal. Went to work.

high fever, severe chills, severe headache, severe body aches, sensitivity to light and noise, nausea. Treated with Tylenol with minimal effect.

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.

Shortly after receiving this vaccine, I had shaking and severe nausea to the point where I couldn't really get out of bed for several days. I missed work for these days. The nausea has persisted and I am on day 19 after the vaccine and am still having severe nausea. No chance of pregnancy

Patient had Covid in OCTOBER 2020. Patient reports same symptoms as active covid. Severe sore throat, chills, fever, joint pains, severe headache, and nauseated.

Hour 2: numbness in right jaw, numbness in right leg, and abdominal cramping Hour 5: continued numbness in right leg, groin pain Hour 8: chills, shakes lasting 45 minutes), followed by fever for several hours, highest recorded temp of 103.8, took ibuprofen to reduce fever, numbness on right side continued Day 2: numbness on right side, low grade fever, patient stayed in bed and continued taking fever reducers Day 3: numbness on right side, now including arm and back, and abdomen pain brought patient to primary care doctor; strength, pinprick, and vibration tests came back normal. Patient was instructed to return home. That evening patient began experiencing numbness on left side in her ankles, and left calf. Numbness is described as electric pulsation, tingling, and dull feeling. Patient can walk, lift limbs, and control muscles. Patient then experienced breathing difficulties, tightness in chest, sharp pains in chest. Abdomen pain intensified. Mouth numbness and difficulty swallowing. Dizziness grew stronger when patient sat or stood. Day 4: breathing issues and chest pains resolved. Numbness throughout body continued and is described as moving in intensity from one area to another. Often intense in the legs, ?feeling like weights?. Day 5: patient goes to ER seeking answers. ER preforms routine lab work and collects a urine sample to test hydration and electrolytes. Patient shows some signs of dehydration. IV is given. Referred to neurologist.

Fever, chills, nausea, body aches, fatigue, swollen/smooth fingertips, swollen face (feels sunburnt)

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.

16 weeks pregnant, received the Janssen vaccine and had typical symptoms (chills fever aches ) but also had vomiting and had intense sharp pain from lower right side of abdomen that shot up to my lung area that caused me to double over and cry (this lasted for 1-2 minutes prior to vomiting. I feel better today minus a headache and did not require an in person visit but my ob recommended that I report since vomiting isn?t as common of a symptom and there isn?t much data on pregnant women

At around 6pm, it started with chills that made the chest lock up. After a dose of tramadol 50mg cut to 25mg, the chills began to subside. During the overnight and all day Sunday, it escalated to severe migraines, fever, sweating, sensory overload, muscle weakness, dizziness, tossing and turning, couldn?t get up, unable to eat due to severe nausea and vomiting, dehydrated. By Monday, the migraine, sweating, muscle weakness, and nausea reduced, dizziness and fever stopped. Could slowly start to get up. It took until Friday for the rest to stop and return to normal.

At 5pm on 4/2/21 I started having extremely bad stomach pain which turned into diarrhea. Lasted until I went to bed about 10pm.

Night of injection: Chills for several hours, extreme joint paint, muscle pain, headache, took 2 500mg Tylenol Next day, 4/1/21: moderate headache, moderate muscle soreness, fatigue, weakness, took 4 500mg Tylenol throughout day 4/2/21: afternoon fatigue and weakness, headache in afternoon that worsened throughout the night, took 2 500mg Tylenol 4/3/21: severe headache, weakness, loss of appetite and nausea (could be due to acid reflux flaring up), took 4 excedrin migraine throughout the day and 1 Nexium 24hr at night

Around 9-10pm the day of our vaccinations, both my husband and I experienced extreme reactions to the j&j vaccine. We had fever, chills, elevated heart rates, nausea, vomiting, splitting headaches, all for approximately 6 hours.

Within 2 hours I was dizzy, nausea an light headed. Within 4 hours I had a fever (uncontrollable), I laid down. I wasn't able to get up and my arm swelled up really bad. I was having streak in my vison and really bad dey eyes and mouth. I had a fever on going for about 3 weeks straight. I called my Doctor the following day and she said it was a normal reaction, if it get's worse to call her again. I called her again because it got worse, my neck got swollen. left arm was trembling, lymph nodes were swollen, leg leg was pulsating. I started having chills and hot flashes ( I still have some till this day). My Doctor recommended seeing a specialist- Neurologist, Infectious Disease Dr. The Neurologist said he can see where I get the trembles but does not want to put me on medication and see if it goes away on it's own. I have a follow up with him regarding trembles, headache, flashing in my eyes. The Infectious Disease Dr. I'm following up her her again regarding my arm swelling, they prescribed me steroids but had not gone down. Since all of this I have been very fatigue, this is everyday.

I felt the vaccination spreading through my body as I got really heavy and lost consciousness. I woke up to my husband holding my head and yelling my name. I had been seizing and had bitten my tongue. I was very white and nauseous and cold and shaky. They gave me water and a cold pack. The seizure probably only lasted for 5 seconds but it's hard to say. I felt very fatigued afterwards. I stayed for 10 more min and drank water and then they sent me on my way.

Patient stated she had a history of fainting with blood draws. Patient stated she did eat before vaccination. Nurse on hand as well as another person to assist if needed. Patient was administered vaccination by medic within 3 min started feeling nauseated and sweating she lost consiouness. Medic and public health nurse able to lie on floor patient safe and did not hit her head. Ambulance staff paremedic on site. B/p taken 90/58, O2 98% 66 Pulse. Cool cloth to head and ice packs to neck. Within a minute Patient regained cauntiousness. Juice given. Patient was able to eat a cookie. Stated she was feeling better. Assisted tranfer to wheelchair to monitoring station for additional 30 min. Patient declined to be taken to local hospital via medics. B/p reassed at 0112 10/98 100% o2 68 pulse. Patient able to talk and drink water without any problems. Patient was present with husband. Patient monitored a aditional 30 min. before leaving. Patient gait steady and no slurring of speech. Patient was advised if any problems arise to seek 911. Patient stated she would not be driving home her Husband would.

dizziness right after receiving vaccine. 12 hours later severe headache, fever, chills, body aches, slightly elevated heart rate, vomiting.

Chills started at 6 pm the day of. Highest fever 102.7 with medication (ibuprofen) around midnight on 04/08. Significant joint pain causing difficulty sleeping but severe fatigue. Around 9:00 am on 04/08/21 vomited stomach acid. Continued low grade fever (100-101) past 5 pm on 04/08. No medical treatment sought.

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)

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.

Fatigue, fever, body aches, chills, loss of appetite, nausea, dizziness Treated with ibuprofen with some success.

Symptoms included fever, nausea, fatigue, headache, chills - confusion, uncontrollable body shaking in legs and arms -

I began feeling lightheaded about 5 minutes after receiving the injection. The feeling continued to get stronger and I began sweating and feeling nauseous. I felt like I was going to throw up and/ or pass out. I was about to go get someone and let them know, but then it started easing back off again. It came and went all within about five minutes. I hung around the site a little longer than instructed to be safe, but felt fine and left. Two hours later, I've had no other symptoms besides soreness in my arm and a slight headache.

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.

Immediate arm pain and muscle cramping around left side of body specifically the diaphragm. Twelve hours past vaccination: Chills, Extreme Body Aches, Muscle Pain, Chest Pain, Shortness of Breath, Headache, Dizziness, Nausea, Extreme Fatigue, Burning Hot but no registered fever.

Patient became extremely nauseous and dizzy 5-10 minutes after administration. After putting her feet up and drinking water her symptoms resolved.

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.

Dizziness / stomach pain during first hour. Woke up in the middle of the night with general malaise. By noon on Saturday (injection on Friday at 5:15pm), steadily rising fever. Peaked at 102.2 around 2pm. Continued in the 101 range until the following morning (Sunday). Additional persistent symptoms: Severe headache. Light sensitivity. Muscle pain. Joint swelling. Kidney pain. Chest heaviness.

Fever, chills, muscle soreness, cold sweats, headache and nausea. All symptoms apart from headache resolved in 24 hours

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

High fever (102.4 F), body aches, chills, night sweats, mild nausea, mild sore throat, very strong headache

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.

Severe chills, uncontrollable shivering, fever about 6 hours after vaccination. Then the next day experienced nausea, headache, mild body aches, mild fever. Aspirin and acetaminophen were taken for the fever. Symptoms has mostly subsided by the morning of April 11th.

pt says she started having pain in her right arm, neck, shoulder pain, and her back. Her entire body ached and she became lightheaded and dizzy. Pt says the right arm is still swollen and sore and she also has slight nausea, lightheaded and dizziness.

At 10pm flu like symptoms started. Symptoms continued through the day on Sunday and At 10am Sunday 4/11, started vomiting and could not hold anything down (water, dry toast, pedialyte) until about 7pm on Sunday. After 7pm symptoms started going away. Vomited about 10 times on Sunday

i have been experiencing chest pain, chills and 101-102fever since april 6. my arm joint are warm to touch. crqamping on my stomach. still experiencing it today April 13th

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.

Numbing in right arm with extreme pain, unable to lift right arm, pain in hips, lowers, knees, and calves, extreme gas, chills, cough, weakness in legs, headache, dizziness, unable to hold urine when standing Treatment: Cold pack, sleep, ibuprofen - healing still ongoing

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.

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

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!

CHest pain radiating to Back and Jaw , nausea , lightheadedness , Admitted for 2 days to hospital for testing Diagnosed with Pericarditis-

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.

Been sleeping for almost 5 days, nauseous, muscle weakness and exhaustion, rapid onset sinus infection, migraine I can't get rid of, hot and cold Migraine startig 4/14 as of 6 pm 4/15 not gone.

VOMITING; STOMACH ACHE; FEVER; This spontaneous report received from a consumer concerned a 31 year old female. The patient's weight was not reported and height was 66 inches. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 11-APR-2021, the subject experienced vomiting. On 11-APR-2021, the subject experienced stomach ache. On 11-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, vomiting, and stomach ache. This report was non-serious.

At 6pm, I started feeling nauseous, crampy and then like a ton of bricks I had to lie down. I was shaking uncontrollably with a very high fever and chills for two hours. I couldn't eat. I fell asleep for an hour and woke up feeling terrible- headache, fever, muscle aches, and sweating. The next four days I had a headache and shortness of breath. I am on day 8 now and still feel extremely tired.

Approximately 10 minutes after injection, I passed out. Witness said that I was unconscious for approximately 1 minute. My body shook, and it appeared that I had a seizure. Immediately upon waking I started vomiting and having uncontrollable bowel movements for about an hour. I felt confused for about 30 minutes and was unable to speak for a few moments upon waking. When I arrived at the hospital I was still vomiting and having uncontrollable bowel movements. I was given fluids and zofran and sent home without further testing.

Tired, muscle aches (especially back pain), fever (101.5), chills, nausea, headache, started at around 8pm, fever broke just after midnight, felt normal by morning. Took ibuprofen at around 11pm.

THREW UP TWICE; BODY ACHES; JOINT PAIN; FELT WEAK; 103 DEGREE FEVER; CHILLS DESCRIBED AS SHE WAS JUMPING THE CHILLS WERE SO STRONG, AND THEY WERE BETTER DURING THE DAYTIME,; This spontaneous report received from a parent concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included social alcohol user, non smoker, and birth control pills, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills which were described as she was jumping the chills were so strong, and they were better during the daytime. On 09-MAR-2021 11:00, the subject experienced 103 degree fever. On 10-MAR-2021, the subject experienced threw up twice. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced joint pain. On 10-MAR-2021, the subject experienced felt weak. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 103 degree fever, and threw up twice on 10-MAR-2021, and had not recovered from chills described as she was jumping the chills were so strong, and they were better during the daytime, body aches, joint pain, and felt weak. This report was non-serious.

The next morning I went to urgent care because I was experiencing really bad chest pains and body aches where an EKG and chest X-Ray were perform and I was released and advised if the symtoms got any worse to come back or got to the ER. For the next week the chest pain persist and got worse. I experienced severe chest pains, struggled with breathing at night, was extremely tired and felt worn out. I had sharp pains throughtout my body so I went to the ER where a EKG and D-Dimer test was perfomed and was advised it was elevated and I left. I went to the ER later that day who checked the D-Dimer who advised it was normal and was I was released from there as well after monitoring. The next day I began having sharp pains in my stomach and diarreah which prompted me to now go to hospital where a CT scan, X-Ray and EKG was perfomed there also which all results came back normal and advised I reach out to a Cardiovascular Specialist for the Chest pains and I have an appointment scheduled for 4/21/21 for further followup on that

D-dimer is mildly elevated - 0.64 lower Abdomen pain - moderate, lightheadedness since 7th day of vaccine (04/16)

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.

LEGS FEEL WEAK; WEAKNESS; NAUSEA; FEELING DIZZY AND DIZZINESS GOT WORSE; MEDICINAL SMELL IN NOSE; BODY ACHE; CHILLS; STANDS AND WALKS AROUND FELT WINDED; LEGS FEELS HEAVY; This spontaneous report received from a parent concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 15:45 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stands and walks around felt winded. On APR-2021, the subject experienced legs feels heavy. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced feeling dizzy and dizziness got worse. On 12-APR-2021, the subject experienced medicinal smell in nose. On 13-APR-2021, the subject experienced legs feel weak. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 11-APR-2021, had not recovered from feeling dizzy and dizziness got worse, medicinal smell in nose, legs feel weak, nausea, body ache, and weakness, and the outcome of stands and walks around felt winded and legs feels heavy was not reported. This report was non-serious.

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.

RAPID HEART BEAT; VERTIGO (CAN'T WALK AROUND); TINGLING IN RIGHT SIDE OF HEAD; NUMBNESS IN RIGHT SIDE OF HEAD/NUMBNESS TO THE RIGHT BODY; SEVERE MIGRAINE; BRAIN FOGGINESS/COULD NOT THINK CLEARLY/COULD NOT SPEAK CLEARLY; FLU LIKE SYMPTOMS/CHILLS/FEVER/NAUSEA; LOSS OF APPETITE; This spontaneous report received from a parent 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, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced loss of appetite. On 12-APR-2021, the subject experienced flu like symptoms/chills/fever/nausea. On 13-APR-2021, the subject experienced brain fogginess/could not think clearly/could not speak clearly. On 14-APR-2021, the subject experienced vertigo (can't walk around). On 14-APR-2021, the subject experienced tingling in right side of head. On 14-APR-2021, the subject experienced numbness in right side of head/numbness to the right body. On 14-APR-2021, the subject experienced severe migraine. On 19-APR-2021, the subject experienced rapid heart beat. Laboratory data (dates unspecified) included: Heartbeats increased (NR: not provided) 70 bpm, and MRI brain (NR: not provided) Normal. Treatment medications (dates unspecified) included: vitamins nos, and metoclopramide hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe migraine, and the outcome of flu like symptoms/chills/fever/nausea, vertigo (can't walk around), brain fogginess/could not think clearly/could not speak clearly, rapid heart beat, numbness in right side of head/numbness to the right body, loss of appetite and tingling in right side of head was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

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.

Soreness in left arm immediately following vaccine; 5 hours later developed a headache; went to bed; a couple hours later woke up with a severe headache, chills, severe body aches, nausea, dizziness, loss of appetite that lasted approximately 24 hours from onset; felt fatigued with headache for 10 days after that;

Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: pt gets nervous during shots

BRONCHITIS; VOMITING; NAUSEA; SORE LEFT ARM; BODY ACHES; POSSIBLE UTI; 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 hidradenitis suppurativa, penicillin allergy, latex allergy, and overweight. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total was administered on 12-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the patient experienced body aches, chest pain, intermittent dyspnea, and sore left arm, which resulted in hospitalization. Patient was hospitalized on 13-APR-2021. The patient was discharged on an unspecified date. Patient went to another hospital as patient's symptoms did not subside. On APR-2021, the patient was diagnosed with bronchitis. Patient was not able to provide admission and discharge date. On 25-APR-2021, the patient experienced vomiting and nausea. Patient was additionally in contact with her health care professional regarding a possible urinary tract infection and/or yeast infection. Patient was not having any problem before the vaccine, even though patient can't say the Janssen Covid-19 vaccine caused her issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and sore left arm on APR-2021, and vomiting, and nausea on 26-APR-2021, had not recovered from intermittent dyspnea, and the outcome of bronchitis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210413562- covid-19 vaccine ad26.cov2.s-Bronchitis,bodyaches. 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).

10 hours after vaccination, began fever, sweating, muscle aches and cramping, chills, and vomiting. 30 hours after vaccine lips swelled and began experiencing angioedema and anaphylaxis.

Severe migraine headaches, dizziness, painful canker sores on roof of mouth, numbness on right side of body from toes to head, brain fog, light sensitivity, intermittent ringing in ears, nausea, vomiting, fatigue, chills/fever, severe body aches. Went to hospital ER on 4/16/21 - had CT scan, ECG. Returned to ER on 4/17/21 - symptoms had escalated. MRI was performed, she was kept over night for observation. 4/20/21 - back to ER - Abdominal pain radiating to every nerve in body, burning in neck, nausea, throat itchy and closing. Released after more testing. 4/21/21 - Appointment with neurologist who ordered Stat Lumbar Puncture, MRV, MRA, stayed overnight again. Was given and/or prescribed varying drugs to combat pain, swelling, etc.

The patient received the Janssen Johnson & Johnson vaccine from a certified immunizing technician. She was asked to wait 15 minutes after receiving the vaccine before leaving the pharmacy and remained seated in the post vaccination waiting area chair. She began feeling dizzy and lightheaded. She was caught by her family members and the pharmacist on duty before she fell. She briefly had a mild seizure and lost consciousness for a minute. When she regained consciousness she stated that she felt nauseous and was seeing double. 911 was called. EMTs arrived and checked her alertness and how she was feeling. The EMTs then took her off in a stretcher to the hospital out of an abundance of caution due to brief loss of consciousness.

BLOATING; CRAMPS; CHILLS; FEVER; HEADACHE; LOSS OF APPETITE; ABDOMINAL PAIN; 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 penicillin allergy, non alcohol, and non smoker, and other pre-existing medical conditions included the patient has no abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07/MAY/2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included vitamins nos. On MAY-2021, the subject experienced abdominal pain. On MAY-2021, the subject experienced loss of appetite. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced fever. On 07-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced cramps. On 08-MAY-2021, the subject experienced bloating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache, and had not recovered from abdominal pain, cramps, loss of appetite, and bloating. This report was non-serious.

The patient visited due to a vaccine reaction with nausea, headaches, limb pain, and abdominal symptoms. No anomalies from the internal med. point of view (clinical and laboratory), so that the patient was referred to a gynecologic examination due to pregnancy. This examination did not show any anomalies. The treatment remained under outpatient conditions.

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.

Within 15 mins I was sweating and nausea, shaking, I passed out for less than 30 secs. I was shaking.

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.

Vertigo within 15 minutes, nausea. Subsided quickly. Within the hour, itchy, swollen throat, flushed, very intense vertigo, shortness of breath. Visited Emergency Room (04/06/2021), treatment was IV fluids, and Benadryl. Told to take Benadryl to within 24 hours, and symptoms did subside. After 24 hours, body aches and chills.

April 12 - stomach pains, came and went April 15 - stomach cramps, dizzy, like was going to faint, heart palpitations, felt really hot, disoriented/brain fog, had to sit April 16 - went to urgent care, checked blood levels, normal Went to doctor on Tuesday, tests normal Pain went away Thursday

I am currently lactating and breastfeeding for 11 months. The afternoon that I got the vaccine I got a fever, lethargy and extreme fatigue. I was nauseous and I had diarrhea. My fever was 102. I started to feel better after three days. I also got aa headache that was similar to the Migraines I used to have. I hadn't had a Migraine for 18 months and I had a Migraine daily for five weeks. I went to the care facility eight days after the vaccine because I thought I had a UTI. The UTI was positive and I was told I had some Streptococcus B at the time. I was also experiencing confusion, and tiredness. One month after the vaccine I went back to the care facility because I was have having cramps in my lower abdomen and circulating to my lower back as well as my legs. All tests were negative but I was given multiple antibiotics. After eight weeks I still have lower abdominal cramping, vaginal discharge and headaches. Some of the symptoms were relieved by the antibiotics but they have returned.

I was tired when I got home after the shot, so I took a nap. When I woke up my teeth were chattering from a fever of 100, I was throwing up and had spasms, back pain, body pain, and I was shaking. It lasted all night, at least 5-6 hours. The next day was similar. I called my doctor a week later because I was hoping the symptoms would go away. My tongue was swollen which made it hard to talk. The doctor advised me to take Tylenol. I feel like I have had the flu everyday since April 10.

On May 4th, I fainted shortly after waking up. Light headed and unable to sit upright, stand, or walk. Had a fever. Called out of work. Headaches, chills, nausea, pain at injection sight, bedridden for most of the day. Around 3/4 in the afternoon I called the doctor's office (phone kept ringing) so I called the nurse through the insurance company. Nurse advised me to stay home for now but to seek medical care if symptoms persisted for more than 3 days. Symptoms continued but were less severe on Wednesday May 5th causing me to miss another day of school. On Friday May 7th at about 12:50 AM I awoke to severe abdominal pain-the kind the pharmacist had warned me of when getting my vaccine. I could not stand or move. I never take aspirin and yelled for a family member to give me Tylenol. I called the nurse from my insurance company and she asked me a series of questions and advised me to seek immediate medical attention. My family called 911 and an ambulance was sent to the house. They checked my vitals and suggested a family member take me to the ER. My family took me to the Emergency Center. I was wheeled into the ER. ER did test but put "Abdominal Pain, Unknown Cause, (Female) on my paperwork. I missed another day of work due to my ER visit. Symptoms lessened but persisted for several days.

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.

In the morning, I started feeling body aches, headaches, nauseated, very tired as well. Due date September 16, 2021

Right after the shot, symptoms lasted for over an hour: Nausea, fatigue, dizziness, difficulty swallowing, numbness and tingling in the hand. Two days after the vaccine: loss of sensation in both legs (from the knees down) , constant nausea, fatigue and dizziness. Almost three weeks after the vaccine (today): constant fatigue and dizziness, nausea

Fever, cold chills, cold sweats, nausea and fatigue. Aches as in like my bones feel like they hurt especially around my joints.

Patient received vaccination and immediately felt nauseous and faint. She was diaphoretic with a bp of 99/36. She was experiencing chills and muscle rigidity. Upon further investigation, she revealed that she had been fasting for 3 days. Patient was instructed to lay down while EMS was called. EMS found her vitals to be stable and she denied hospital admission. After laying down some time and drinking orange juice, she felt better.

Extreme fatigue, fever, nauseousness, and body aches among waking up first morning after vaccine administration. Cloudy/out of sorts feel throughout the day into the evening and then felt quite a bit better but still lethargic. Nauseous feeling continued through day 2 and now day 3 post vaccine, with vomiting on the evening of 7/21

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.

Injection was given at 1215pm. Immediately after vaccine injection patient became clammy and was lowered to the floor. BP 110/60 P 67. Alert and oriented x3. Nausea with small amount of emesis. Patient felt better. Patient left at 1247 pm.

6 hours in: feeling cold, muscle aches 7 hours in: extreme chills and nausea 8 hours in: extreme chills, muscle aches, feverish 13-14 hours: chills subside, muscle aches, hot/feverish 20 hours: muscle aches, fatigue

Severe chills, severe muscle aches, nausea, and headache. Began around 12:15 am. Severe chills got better with Tylenol after 8 hours. Then fluctuated between hot and cold. Nausea/ vomiting comes and goes. The muscle aches got better, then came back.

Foggy/dizzy almost immediately following vaccination, sever chills that lasted for hours overnight, fever of 102.1 (brought down with Tylenol, it remained at or a over 100 for 8 more hours), nausea, headache

Chills, sweating, loss of appetite Slept for about 10-11 hours cold sweats throughout out the night and lingering feeling afterwards

After receiving the vaccine at 9:30pm, I was awoken at approximately 4:30am that night/the next morning with an extremely high heart rate. After about thirty minutes, I was able to calm down and my pulse/heart rate dropped down to a level that still seemed elevated, but no longer caused a great deal of concern. This event was followed by nausea for the remainder of the day.

Immediately after the shot was given on Saturday 3/6/21, I felt very nauseas. The nausea continued for the next two days. Body aches, headache, and chills set in same day, in the afternoon. I took Tylenol every 6-8 hours until Monday 3/8/21. Exhaustion, dizziness, and some shortness of breath occurred on Monday 3/8/21. Nausea, headache, and exhaustion is still ongoing but not as intense.

Fatigue, chills, fever, body aches, nausea. Lasted approximately 12 hours. Treated with advil, fluids, and rest. Onset of body aches and fever for second time about 36 hours after injection. Treated with advil.

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.

"Janseen COVID-19 Vaccine EUA" - experienced following symptoms for 1 day: diarrhea, stomach pain, chills, brain fog/headache, aches throughout my entire body, could barely walk

6 hours after I got the vaccine I started getting a headache, followed quickly by horrible body chills and then horrible body aches. My temperature about an hour later was 105. I took 1000 mg of Tylenol right away and put a cold rag on my head and tried to go to sleep. A couple hours later my fever started breaking, when it was 102.7 I was a sweaty mess and extremely hot and puked a lot. My fever and other symptoms went away within about 7 hours after my fever started breaking.

Felt chills, started shivering/shaking, temperature rose to 100 in 30 minutes. Went to 102 through the night even with aspirin at appropriate intervals. Next morning light headedness and low grade fever and nausea and a partial loss of taste and appetite. Continued into 48 hours. Third day nausea, loss of taste, appetite. Fourth day loss of appetite, nausea. Normal again day five.

nausea, light headedness, chills, fatigue, fever, headache, body aches advil for headache symptoms lasted ~12 hours

4 hours after the vaccine, I started to get body aches and chills and they continued to worsen. I started to develop a low grade fever 8 hours after the shot. 13 hours after the shot, I had a 104.1 fever. Along with the fever, I experienced severe body aches and chills, nausea and a horrible headache. I couldn?t walk as my body was so weak and my vision was blurry. About 15 hours after the vaccine, my fever went down to 102. I was able to get up and walk to my kitchen to take some Advil. My fever broke 20 hours after the vaccine with the medicine. I?m still experiencing severe body aches, headache, nausea and chills and it has been about 30 hours after vaccine. I did have covid 3 months ago, and the symptoms from the vaccine were much worse than the symptoms I had with actual covid.

Around 7pm I started with chills, body aches, diarrhea, nauseas, I was throwing up & headaches. I took extra strength Tylenol & the symptoms lasted for a little under 24 hrs.

Fever body aches shakes chills muscle cramping and pain headache nausea, awoken from sleep with symptoms.

The patient presents with a complaint of palpitation while in observation area. Began feeling nauseated with lightheadedness and seen black spots no emesis. No chest pain. No respiratory distress. EMS on site. Patient agreeable to transfer to ED. Family on site. Supination PO fluids given and tolerated relaxation and deep breathing encourage throughout.

Felt fantastic until 7 hours after the shot at 5pm on 3/13/21. Then body aches began followed by fever (100.7 taken by ear) and then headache. Headache and body aches became intense by 6:20pm on the day I received the vaccine. I took Tylenol Extra strength which helped the body aches and lowered the fever a bit but did little for the headache. Chills started around 10pm accompanied by vomiting and severe diarrhea at 1am. Blood pressure spiked at 142/101 shortly after third vomiting episode. Called family to take me to ER but didn?t end up going because I was able to get vomiting and blood pressure under control by 3am. Figured doctors would just hook me up to an IV of fluids and send me on my way anyway, not something I can afford. No more fever or chills since 4am on 3/14/21. Headache and diarrhea and slight nausea still persisting 29 hours after the shot. Treating symptoms with Tylenol, water, pedialyte, chicken broth, and toast diet. Unable to care for my children, worst I?ve felt in years. Regularly get the flu shot with no side effects.

The first day about 10 hours later I got flu like symptoms. I had nausea, chills, stiff muscles- it lasted 14-15 hours. I woke up Sunday morning and had shortness of breathe and have been ever since. I seen my PCP and he sent me for testing to rule out Blood clots and that came back ok, but I'm still having the shortness of breathe. If I get worse he advised me to go to the ER and if im not feeling better to call him in three days.

On the night of Monday 15, I started to have a fever over 102.2 degrees. Took Ibuprofen for the fever. At 3:00 AM of the same day started to feel weak. On that moment I lost consciousness and passed out. In my opinion, I experimented a down on sugar, which had never happened before. My husband was able to catch me and sat me on the floor. A minute after I recovered and my husband gave me fruit (Melon) to raise my blood sugar. On that moment I had lots of nauseas and diarrhea. I was feeling weak and dizzy all night and the next day. Today Wednesday March the 17 I have been feeling much better.

Patient woke up in the middle of the night with swelling in the face, tachycardia 125-130 bpm, BP 142/90, achy joints, sore throat, labored breathing, chills, nausea, fever 102.7

Within 7 hours I was violently shaking with chills. I was shaking so bad my body was in pain. This lasted about 6 hours. The highest fever I ever recorded was 100.6 but it felt much higher. I had nausea, body aches, headache, and exhaustion for a full 24 hours. Within 48 hours, my chills and aches were mostly gone, but a sore throat, cough, and congestion developed. As of this morning, Friday 19 March, I?m still exhausted, but all other symptoms have finally resided.

2:30pm chills and nausea 4:30pm body aches 6:30pm took tylenol 9:00pm nausea ended Excessive night sweats, chills, body aches. Symptoms lasted until approximately 3:00pm 3/14/21.

HEADACHE, CHILLS, NAUSEA; PATIENT EXPLAINED SYMPTOMS AS BEING EXACTLY HOW SHE FELT WHEN SHE HAD COVID

4am - muscle aches, dehydration and extreme thirst 8am - severe muscle aches, weakness, dehydration, nausea, fever, hallucinations, chills, cold sweat, too weak to stand up, migraine and severe light sensitivity, sinus pressure and pain.

Severe headache, fever of 101.2°F, chills, fatigue, muscle aches, nausea. Headache and fever were treated with 500mg acetaminophen and 25mg diphenhydramine. Symptoms have lessened but are lingering on date of this form submission (3/26/2021)

Around 1:00 pm felt nauseous went away. 8:30 pm soreness in arm nausea around food. 9-10 pm chills, fever, muscle aches. 2:30-4:45 am on 3/26/2021 headache, chills, muscle aches. 5:15-6:00 am headache

Patient went home asymptomatic 15 minutes after receiving the vaccine. She returned to the vaccination center 30 minutes later with complaints of repeated loose to watery bowel movements. Upon arrival she appeared pale and complained of dizziness and of being nauseated. No vomiting occurred but she was retching and burping loudly. After arriving to the center she had one more episode of diarrhea. She was afebrile, pale, had a strong regular pulse, a regular heart rhythm, clear bilateral breath sounds and complained of feeling dizzy. No abdominal pain.

I was fine from 10am until 3:30pm on the day of injection. I started to feel feverish and chills at 3:30 and it progressed into a 99.2 fever with all over body aches and a headache and chills. I took alkasletzer cold medicine with Tylenol in it to help with the fever. It got the symptoms down where I could move and stood in the hot shower for 30 minutes to help warm me up. I felt slightly better and still had fever symptoms and severe body aches. I started feeling unable to move due to the fever symptoms again around 9pm and took 2 extra strength Tylenol that eventually worked and I had some nausea with that. I hadn?t been able to eat because of the symptoms and the nausea could have been from taking meds on an empty stomach. I finally felt able to eat around 10pm and had some food and went to bed. I could barley sleep all night and was tossing and turning due to fever. My nose started to get runny around 10pm before I went to bed. I woke up the next day and still had the fever symptoms, body aches and the worst headache I have ever had, a 10 on the pain scale. I took another 2 extra strength Tylenol and went to sleep for 2 hours. I woke up and could tell the fever had broken and my head was still in pretty severe pain- about a 7 on the pain scale. I was incredibly fatigued the entire day and felt hot and cold throughout the day. I was incredibly weak and needed a lot of rest. I still didn?t sleep well through the night and woke up friday feeling fatigued. I expended some energy in the am at the dog park and had to sleep for 3 hours during the day which is atypical for me. I woke up Saturday morning (today) still feeling a headache and exhaustion. I will see how the rest of the day goes and am hoping to feel better and don?t know when the symptoms will stop.

I started developing diarrhea a week after the vaccination. Duration of 3 days, 1 day of break and then started again. I have been taking IMODIUM from the beginning and electrolytes. Diarrhea continues consistently.

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.

The next day I had systmos where I had chills headaches fever muscle aches vomiting could not eat very tried had to go to the er

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

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

High fever (101.8 and rising stopped by medication) and chills lasting 12 hours) headache, extreme fatigue lasting several days (5+ And not resolved yet), diarrhea lasting 2 days, sore arm Ibuprofen helped fever

First felt chills around 4 hours after the vaccination. Chills were very intense, could not get warm. Took acetaminophen around 1:30am and the chills subsided. Then had a fever of 101 degrees. Head ache started the same time as the chills. The next day I had full body aches, headache, nausea. Symptoms subsided as the day went on. The following day, still had some nausea.

At approx 23:31 03 Apr 2021 I experienced uncontrollable shaking and muscle rigidity. This lasted approximately 1 hour where upon I began to experience chills and extreme coldness. Approximately 1 hour later at approximately 01:30 I began to experience a spike in temperature around 101/102 degrees. I began experiencing shortness of breath, cough and congestion with rapid onset of nausea . Around 02:30 I had rapid onset increased heart rate, sweating, and severe headache. This lasted until approximately 07:30 on 04 Apr 2021. Upon waking I continue to experience low grade temperature around 100.4, moderate headache, joint and muscle pain, moderate fatigue and nausea. I took 2 Tylenol arthritis beginning at 08:00 on 03 Apr 2021 and repeated every 8 hours to current time of 17:00 on 04 Apr 2021. I have also taken meloxicam QD in addition to my rescue inhaler Xopenex and Zofran ODT for nausea.

Syncopal, did not fall, disoriented, at shot table, got shot then passed out. 0riginal BP 63/34, P 49 BP 96/53, P 65, nausea

Patient started feeling Light headed, nausea, sweating, knombness on both hands, feeling like she will pass out out 5 minutes after given the vaccination. She was allert and oriented through out. she refused Epi-Pen. She was given Benadryl 50mg capsule. EMS was activated after about 10 minutes of the vaccine. The EMS took her vital signs and she was monitor her for a few minutes and was realeased without any medication.

Patient reported feeling anxious, and dry heaving, also appeared diaphoretic Patient provided water and seen by medical team Patient refused medical transport and signed AMA form Patient stated symptoms resolved and will be driven home by spouse

Sudden fever, body aches, uncontrollable shaking (like shivering/chills, but more intense), headache, nausea, shortness of breath about 9 hours after vaccine injection. These symptoms lessened about 4.5 hours after they started, but the headache, fever, and chills lasted into the night. More mild headache, nausea, and sensitivity to light continued the day after the vaccine.

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

patient felt faint and nauseous. Patient felt better after ice packs and lying down. Patient did not vomit or pass out.

patient complained of a headache about 2 minutes after vaccination. She became hot and flushed and soon began vomiting. Patient's mother contacted ems which took her to the local emergency department. Patient was given ondansetron and diphenhydramine and sent home.

Sore arm and tired 2 hours after shot Mild diarrhea/stomach discomfort Saturday after shot continuing until 4/8 when severe diarrhea started 4/9 contacted dr about severe diarrhea and increased stomach pain

Vaccine given on Tuesday 3/30 Wednesday 3/31 - headache, body aches, fatigue Thursday 4/1 - severe headache, body aches, low grade fever, fatigue, diarrhea Friday 4/2 - sinus congestion, headache, body aches, low grade fever, fatigue, diarrhea, dry cough Saturday 4/3 - sinus congestion, headache, body aches, low grade fever, fatigue, dry cough Sunday - 4/4 - sinus congestion, headache, body aches, low grade fever, fatigue, dry cough Monday 4/5 - sinus congestion, headache, body aches, low grade fever, fatigue, dry cough - Covid Test Tuesday 4/6 - headache, body aches, fever of 102, severe diarrhea, fatigue Wednesday 4/7 - headache, body aches, fever of 100, diarrhea, fatigue Thursday 4/8 - headache, body aches, intestinal discomfort, fever broke, fatigue Friday 4/9 - headache, body aches, intestinal discomfort

within 5 minutes of immunization: syncope, nausea later that day: feeling winded, lessened syncope and nausea overnight: fever 103 F, chills, body aches, headache continuing through today: occasional, mild lightheadedness, nausea and feeling winded

Severe headache lasting 36 hours, chills, sweating, swollen glands (still swollen 15 days later), nausea

Whole body aches and fatigue beginning at 7pm day of vaccination lasting til 1pm following day, Severe Chills beginning at 8:30pm lasting til 12pm, Headache starting 12pm relieved with Tylenol, Mild-Moderate Nausea starting at 4am until 5am

fever of 104 lasting 4-5 hours, persistent vomiting lasting 7 hours, rolling chills, headache. Symptoms started 7 hours after vaccine and subsided fully (with exception of sore arm) within 36 hours of receiving vaccine. 25 weeks pregnant at time of vaccine

Serious muscle aches, severe joint pain (shoulders and hips), and headache; nausea and vomiting (probably just because I took a large pill for pain/fever that caught in my throat and seemed to trigger the nausea); insomnia; feverish and chills but didn't take my temperature to confirm a fever. Symptoms started about 7.5 hrs after injection, mild at first but quickly became severe. When I felt well enough the next morning to try to take another pain/fever reducer, I did with no vomiting and was able to eat a small breakfast, and now it is about 27 hrs after injection and I feel almost 100% again. :)

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.

Around 10pm I started feeling dizzy, had body aches and started having the chills. I started vomiting at 11pm. The vomiting kept going until around 4am. It is 9am the next day and I still have a massive headache, slight dizziness, and body aches

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.

Immediate nausea, left arm pain, tingling in left arm, sweating, loss of vision, loss of hearing, stomach pain, tingling in fingers after approx. 10 minutes.

Severe Headache 4/8-ongoing Sore throat 4/9-ongoing Fever 100*+ 4/9-4/11 Chills 4/9- ongoing Nausea 4/8- ongoing Vomiting 4/8-4/11 Diarrhea 4/8- ongoing Pain in arm 4/8- ongoing Unable to use left arm due to muscle issues 4/8-4/11 Debilitating Fatigue 4/8-ongoing

Severe chills, shaking, fever, nausea, vomiting, sweating, dizziness, light headedness, muscle pain, joint pain. Symptoms started approx. 7 hours after injection and were 90% gone approx. 24 after injection.

4/10/21 4:30pm severe migraine, numbness in fingers and toes, fever, nausea 4/11/21 severe migraine, nausea 4/12/21 severe migraine, nausea, vomiting

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.

Fever, chills, sweating, dizziness, swollen lymph nodes in neck making it difficult to eat and swallow, lethargy, pain, muscle aches, vomiting, itchy throat, pain

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.

Around 6 hours after the shot, patient started feeling headaches. Later that evening came muscle pain, chills, high fever, nausea, vomiting, and migraines. The next day, most side effects went away except for the looming headache. Since the vaccine, patient has been experiencing episodes of dizziness and lightheadedness. There was an article that came out today as it relates to blood clots being a possible side effect of the vaccine and to report any feeling of headaches or possible symptoms that may be related to that.

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.

Severe chills, severe joint pain, severe muscle aches, fever, mild headache, mild nausea, fatigue. Symptoms started the afternoon after the vaccine and got worse as the night progressed, becoming very severe around 8pm. I took generic NyQuil tablets and was able to sleep for a few hours, and was woken up after that by joint pain. Joint pain persisted Saturday (moderate, treated by ibuprofen) and Sunday (mild, no ibuprofen needed.)

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

Arm pain and swelling immediately after shot. Nauseous about an hour after shot. Tingle in my lower shot arm about 4 hours after shot. Headache developed over the course of the afternoon and by the evening I had a high fever and chills. Headache and nausea continued. Low fever, headache and brain fog continued the following day. Fatigue and brain fog along with a heavier period occurred on the 3rd day. Over One week out and there?s still slight pain in my shot arm along with fatigue. I?ve had a few headaches that come and go that may also be vaccine related

Felt extremely faint after the vaccine was administered. Muscle weakness and hyperventilation. Within 6 hours of vaccination extreme fever and chills were experienced along with nausea. The next day I experienced the worst headache of my entire life. I could not think or get out of bed. I also had numbness and tingling in my legs. The headache persisted for 5 days, alone with muscle weakness and nausea. Numbness and tingling were intermittent.

Started to feel very cold and muscles started to tense and shake around 10:00pm. As I was laying down trying to sleep my heart rate increase to approximate 151bmp for approximately 9 mins and remained above 110bmp all night. When I woke up the next morning around 7:25am my heart rate was still approximately 110 bmp and I had a severe headache and nausea. After taking an extra strength Tylenol and eating a piece of bread I went back to sleep for 90ish mins and woke up feeling a little better. At that point my heart rate had dropped below 100 bmp.

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.

8 hours after vaccination I had a fever, vomiting, body aches, chills, I fainted, and had extreme leg pains. The symptoms went away after 24 hours. I took acetaminophen when the symptoms started and for the next 48 hours after.

Nausea set in immediately, shortly after fever and chills began. By dinner time that evening the intense migraine was overpowering, the chills/nausea/muscle pain was intense. The chills went away on the third day after the shot. Muscle pain, fatigue, soreness, discomfort with breathing, headache, abdominal pain/swelling are still prominent.

Body chills. Fever (102.6),severe headache, bodyache, stomach ache, loss of stamina and apetite. No medications taken

Received the J&J Shot the morning on 4/9. By dinner time, I was feeling nauseous and my body ached. That night was flu like symptoms (chills, sweating, body aches, food tastes funny, etc.). On 4/12 I got a terrible headache, blurry vision, and stomach pains. On 4/13, started to feel better, but stomach still had pains and food tastes funny. Today is 4/14 and I'm am still more tired than usual and still have some stomach pains.

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

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.

Day of vaccine- headache, dizziness, mild nausea Day 2- headache, body aches Day 3-present- headaches mild

Patient received J&J Janssen vaccine 4/8. She reported nausea, abd pain, fevers, and fatigue since received vaccine. On 4/13/2021 presented with worst headache of life, trouble speaking, and abnormal gait. Exam showed L sided motor weakness and impaired sensation. Initial CT normal, received tPA for presumed stroke. Platelet count normal. Currently admitted to critical care unit at Hospital.

intramuscular left arm. First Day Chills, bodyache,sore arm and leg pain,severe headache,dizziness,nausea,fatigue. Recurring side effects severe headache, leg pain Treatment;Tylenol

About 5 hours after shot, I started feeling weak, tired, and nauseas with a slight headache. I had discomfort trying to fall asleep. I woke up at 12:43AM with a throbbing headache. I was hospitalized at 18 for viral meningitis, and this was a similar, intense pain. It felt like I had a crown on, and that crown on my head caused a very intense, throbbing, debilitating pain. I also had chattering teeth, shaking with a freezing fever. I eventually fell asleep and woke up again at 2-something. My fever and headache still intense, but now I was drenched in sweat and burning up. I wanted to get up and find my thermometer--I remember digging through my drawers and closets around my apartment, I remember speaking but no recollection what I was trying to say (I live alone), and I remember seeing my reflection looking glazed over. I don't remember getting back in bed but woke up again after 5AM. I still had a bad headache, though less severe, and felt my body was alternating very hot sweating and very cold freezing--like it was mix and matching. I eventually fell asleep again and woke up around 7:45AM. I was fatigued with a fever and chills all day. I found my thermometer and went to sleep with a 100.3 fever that night. I was much better next day, just slight fatigue.

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.

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.

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.

The first 24 hours were very difficult for me. I have never been so sick in my life. I got the typical muscle aches, chills, etc. In fact I got every side effect listed plus more. I want to discuss the other side effects. On day 3 I started to develop extreme chest pain and pressure. It is a dull pain as if someone if sitting on my chest that will not go away. I also started to experience sudden bouts of dizziness and vertigo. It will not go away. Today is Day 7 and I spent the night in the emergency room because my chest pains got so strong. However, all the work up came back okay. I also have this strange feeling of electrical shocks running thru my head, those last about .5 seconds and go away, but it is a very weird feeling I have never experienced. I also have a strange desire to constantly burp, when I do my chest pain feels better. If I don't burp my ears start to feel full and sometimes they ring. Its Day 7 and I still feel SO miserable. Why id no one speaking about these chest pains? I know 5 people who have experienced the same.

NAUSEA; FATIGUE; BODY ACHES; TINGLING IN EXTREMITIES; NUMBNESS OF EXTREMITIES; DULL HEADACHE; 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 pre-existing medical conditions included the patient had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced tingling in extremities. On 01-APR-2021, the subject experienced numbness of extremities. On 01-APR-2021, the subject experienced dull headache. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fatigue. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dull headache on 03-APR-2021, and had not recovered from body aches, tingling in extremities, numbness of extremities, nausea, and fatigue. This report was non-serious.

RAPID HEARTBEAT; FEELING ANXIOUS; LOSS OF SLEEP; NAUSEA; SKIN FELT HOT; COLD; ACHYNESS; 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 hypothyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 16:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced rapid heartbeat. On MAR-2021, the subject experienced feeling anxious. On MAR-2021, the subject experienced loss of sleep. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced skin felt hot. On MAR-2021, the subject experienced cold. On MAR-2021, the subject experienced achyness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, feeling anxious, loss of sleep, nausea, skin felt hot, cold, and achyness on MAR-2021. This report was non-serious.

The patient presents to Urgent Care today with complaint of fever and dry cough x7 days. She had the J&J covid vaccine on 4/9 and began not feeling well on Saturday. She developed a fever and chills and tachycardic. She said every day since then her fever has been going up and down. She started to vomit on Sunday, last time she vomited was Monday night. She was having diarrhea as well. She denies rhinorrhea or congestion. She denies throat pain. She went to the ED on Tuesday and she was given fluids. She said she felt a lot better on Tuesday when she left the ED. She said now she feels bloated. She does have an appetite but because she feels full she isn't eating a lot but states she drinks 1 gallon of water a day, her water bottle is with her. She is having some sob. She denies chest pain. She has bilateral lower back pain when she is sleeping. She took anti nausea meds which did help. She has been taking ibuprofen.

Pt states she had weakness that began about 30 minutes after vaccination. This included muscle spasms and muscle pain "all over." She states she had flu-like symptoms for ~1.5 days after vaccination and then felt ok until approximately 3/22/2021, when muscle weakness began and has not stopped. She presented to another hospital on 3/29/2021 to the emergency room and "had a full work-up including EKG, x-rays, and lab work" and was told she had a viral illness. She was given a prescription for azithromycin and ibuprofen, as she was complaining of sore throat. She presented to the emergency room on 3/30/2021 with c/o generalized weakness, back pain, myalgias and chest pain. She also c/o fever and chills. Temp in the ER was 98.5F. Physical exam revealed "diffusely tender abdomen, no rigidity or guarding" and "diffusely tender back all throughout." 3/31/2021-saw family physician w/ c/o cough and myalgias, negative for back pain and chest pain/palpitations. Sore throat and cough were improved. Was diagnosed with an apparent viral illness and supportive care. She was advised this could be a viral illness and discharged to home in stable condition. 4/11/2021-Pt reports she went to urgent care b/c felt she had a bad ear infection and eyes were hurting (mostly right); was diagnosed with sinus infection and that ears looked ok. Was told to stop azithromycin and begin amoxicillin and ibuprofen. 4/16/2021-presented to emergency room. "Patient with 3 weeks of progressive symptoms of headache, blurry vision, nausea, weakness, and poor control of her bowel and bladder. Symptoms are constant with gradual progression with a duration of 3 weeks. Timing is constant. Severity is now severe. Quality is sharp, tight headache." Vision changes got worse when she was on the flight there. "No exacerbating or alleviating factors. Not associated with fevers. Does have some nausea and muscle aches. Diffuse tremors and difficulty walking without assistance. PE revealed mild psychomotor retardation, tremulous and diffuse weakness, and Romberg present. Mild right sided papilledema. 4/17/2021- further HPI recorded-The patient is presenting for evaluation of headaches, paresthesias, numbness. The patient is a fairly good historian and tells me that symptoms began after she received the Johnson & Johnson COVID-19 vaccine. Patiet began to feel fatigued, malaise, numbness and weakness over the legs. Patient had some mild blurriness of vision in the right eye. Symptoms have been persistent and patient began to have some difficulty with walking and feeling off balance. Patient describes the headaches as primarily right-sided. According to nursing staff, the patient has also had some incontinence of urine today. Patient has had some numbness over proximal legs and "private areas". 4/19/2021 ? Assessment as per Infectious Diseases physician; Pt with continued intermittent headaches. Has continued difficulty bearing full weight due to unsteadiness. No loss of sensation at arms/legs. Has action tremor, wide gait, hyperreflexia of arms/legs bilaterally. ADEM Hyperreflexia CSF pleocytosis Fatigue Headache, new onset Patient has nonspecific findings of CSF pleocytosis as well as clinical findings concerning for ADEM. No infectious cause for this problem; temporally associated with receipt of Janssen COVID vaccine. 4/19 Assessment as per Neurologist; Question of transverse myelitis/ADEM: Perhaps induced by the Covid vaccine On steroids MRI scan of the thoracic spine shows demyelination but no contrast enhancement Continue to work with therapy services No signs of CNS infection and antibiotics discontinued. The patient continues on methylprednisolone 500 mg iv q 12 hr at this time (4/19/2021).

Severe headache, nausea, diarrhea, tachycardia, shortness of breath, fluid in lower lobes of lungs, elevated O BNP, high temperature >103. Blood pressure increased

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.

I experienced headaches, prolong and abdominal cramping and fatigue. My symptoms are mild and I had a virtual call with my PCP and told me to take OTC Tylenol or Advil and to monitor my symptoms. I continue with slight headaches that come and go.

BODY ACHES; LOSS OF APPETITE; DYSPEPSIA; UPPER CHEST DISCOMFORT; SORE THROAT; CHILLS; NAUSEA; SHAKING; This spontaneous report received from a health care professional concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy, personality disorder, alcohol dependence, opioid dependence, seizure, and adjustment disorder.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced shaking. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced loss of appetite. On 13-APR-2021, the subject experienced dyspepsia. On 13-APR-2021, the subject experienced upper chest discomfort. On 13-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, loss of appetite, dyspepsia, nausea, chills, shaking, upper chest discomfort, and sore throat. This report was non-serious. This case, from the same reporter.

Headache Abdominal pain Irregular menstrual cycle: usually I never have one (IUD), and I had a period the day after the vaccination and it was heavy. Chest pain

Report fever, chills, abdominal pain 24 hours post vaccination that resolved within two days. Headache- intermittent started before receiving the vaccine, but continued after receiving the vaccine. Outcome: Symptoms has resolved and over all feels much better.

VOMITING; This spontaneous report received from a parent 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting. This report was non-serious.

THROBBING LEG PAIN/LEGS SORE TO TOUCH; STOMACH UPSET; This spontaneous report received from a patient 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, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: naproxen sodium. On 22-MAR-2021, the subject experienced stomach upset. On 10-APR-2021, the subject experienced throbbing leg pain/legs sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach upset on 24-MAR-2021, and had not recovered from throbbing leg pain/legs sore to touch. This report was non-serious.

Night of vaccine had chills, body aches, fever, headache, nausea, bloating in stomach, fatigued. Next day started numbness and tingling in left leg/foot, left arm and hand, pressure/ fullness in left ear and headache on left side. Very Fatigued, weakness, and brain fog, sensitive to scents.

Patient been feeling ver sick, with high ever, muscle ache and abdominal pain lasting over a week after the administration