Johnson & Johnson

Patient received a vaccine not indicated for 16 years of age. Patient felt a little tired on 3/22 and then this morning she was ok, per mom.

Patient reported fever. Also this shot was given to a patient outside of the approved use. Patient was only 16 years old, this vaccine was approved use for 18+.

PATIENT REPORTED: IMMEDIATELY AFTER VACCINATION SHE FELT WOOZY. AROUND MIDNIGHT PATIENT REPORTS FEVER AND CHILLS THAT LASTED UNTIL 1-2AM (3/16/21). PATIENT ALSO REPORTS HEADACHES FOR THE NEXT 2 DAYS.

There was not an unusual reaction other than temp around 101 and body ache. However, she was not 18 at the time of administration. Due to temp Patient consulted MD for note for a excuse from work leave

Vaccine SHOULD NOT have been administered. When I took patient I did not know that the Janssen HAS NOT been approved for under 18 year olds. Nausea, tiredness, weakness, sweating, headache, shakes

Inadvertently was given Janssen vaccine at age 16. Patient's mother reports that Avery had fever of 101, fatigue, and 'flu like' symptoms which fully resolved by April 3. Avery has been feeling well since.

Patient received an incorrect vaccine Janssen instead of Pfizer. Patient is 16 years of age. Mother of patient wanted me to know that her 16 year old daughter is 5'10" and 230 pounds. Patient experence nausea and fever and chills. Happen 6 hour after receiving vaccines and lasted one day. Mother states both of her daughters had the exact same symptoms and received the same vaccine at the same time . Her other daughter is 26 years of age .

DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; FLU LIKE SYMPTOMS; OFF LABEL USE; This spontaneous report received from a physician concerned a 16 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21/JUN/2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced drug administered to subject of inappropriate age. On 03-APR-2021, the subject experienced flu like symptoms. On 03-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 04-APR-2021, and the outcome of drug administered to patient of inappropriate age and off label use was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.

ADMINISTRATION ERROR: vaccine dose administered to a person too young to meet EUA requirements. 16yo female received Janssen COVID19 vaccine, but the vaccine is currently only approved for patients age 18+. Error identified by patient's parents. Currently patient has not reported any serious ADEs, but is self-reporting fever, chills, and body ache.

SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; SORENESS IN THE ARM; TIRED AT NIGHT; This spontaneous report received from a parent concerned a 16 year old female. The patient's height, and weight were not reported. The patient was diagnosed with Lyme disease when she was 10 or 11 years old but no after effects and she is fine now. The patient have just seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total, administered to the left arm on 12-MAY-2021 (coded as inappropriate age at vaccine administration) for prophylactic vaccination. No concomitant medications were reported. After vaccination, the patient had soreness in the arm for a couple of days and felt tired at night which cleared in 24-48 hours. The patient work at a camp, where somebody came down with Covid and there have been couple of cases of Covid-19. The patient exhibited symptoms of Covid and was tested by rapid test on 13-JUN-2021, which was negative. Laboratory data included: SARS-CoV-2 test (NR: not provided) negative. The patient was subsequently tested twice on 14-JUN-2021, both positive (suspected clinical vaccination failure and suspected covid-19 infection). The patient's father did not know the specifics of the tests that were done. The patient was quarantined in the camp and was till under quarantine in the camp. The patient also presented with Covid symptoms such as Covid cough and pain in the chest for coughing. The patient felt fine now (as reported). The patient's father mentioned that the camp had to make a report to the health authorities but did not think that the patient visited a physician. Laboratory data included SARS-CoV-2 test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in the arm, and tired at night on 14-MAY-2021, and the outcome of suspected covid-19 infection, suspected clinical vaccination failure and inappropriate age at vaccine administration was not reported. This report was serious (Other Medically Important Condition). This case is associated with the Product quality complaint (PQC): 90000184104.; Sender's Comments: V0 - 20210660267- COVID-19 VACCINE AD26.COV2.S -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Discovered that patient was 17 years and 9 months of age later in the day after vaccine was administered. No adverse reaction reported from patient, however when I reached out to mother on 3/12/21 (the next day) to discuss age guidelines the mother reported that patient did have a fever of 104F and a headache. The mother states she is/will give OTC fever reducers and monitor her for further adverse reaction.

nausea, headache, shakes, high fever 103+, 104+ for Thursday - Saturday, Health Department dispatched the nurse to inject the vaccine at the facility. My daughter?s COVID-19 vaccine card clearly states her birthday / age. Why did the nurse administer the unapproved COVID-19 vaccine, Janssen, to a minor? According to CDC, only Phfizer vaccine is approved to be administered to someone of age of 17?

Patient is 17 years of age and vaccine inadvertently administered. The error was noted on entry of the vaccination later at the clinic. Follow up on 4/1/21 with the father reports that although did not feel well in the AM of 3/31/21, is not having any complaints at this time.

Vaccine was given outside of recommended age group (patient was 17 years old at time of vaccination). Patient had symptoms in line with clinical trials (body aches, fatigue, flu) for 1.5 days after which they were feeling

I was notified by IRIS that the individual was 17 years of age and not the 18 years of age per vaccine guidelines. She did come in with a company. I did talk with client and notified her and parent. Client said she has a little fever and that is all today. Feelling well she reports.

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

Client was 17 years old when she received J&J vaccination. Client and parent note fatigue and mild dizziness, but no other concerns. Educated that parent/child may be contacted by the State for further follow up.

Client was 17 years old when she receieved Janssen vaccine. Notes fever and body aches that resolved within 3 days. Denies any other concerns. Guardian and client aware state may contact further

REALLY SICK; FEVER; HEADACHE; VACCINE ADMINISTERED TO PERSON WHOSE AGE IS 17; This spontaneous report received from a parent concerned a 17 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: Unknown) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 28-JUL-2021, the subject experienced vaccine administered to person whose age is 17. On 29-JUL-2021, the subject experienced really sick. On 29-JUL-2021, the subject experienced fever. On 29-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and really sick, and the outcome of vaccine administered to person whose age is 17 was not reported. This report was non-serious.

5 hours after injection I came down with intense chills and a high fever (between 102 and 105) which lasted all night and all day the following day. Fever did not break all through the night, despite taking multiple ibuprofen.

Mother reports same evening patient had 102 fever and body aches. off work/school following day 3/9/21

Complaint for headache, sore back, chills - not severe, but did not eat supper, and went to bed with extra blankets, in bed resting

Bad headache, fatigue. Started about 15 hours after vaccination. Fever 100.1. Normal ?shot hurt? pain in arm. Took Advil. Slight improvement. Submitting this form 17 hours after injection.

severe body, muscle and joint pain/ache, fever, fatigue, weak, dizzy, fuzzy, nausea, headache, loss of appetite, unable to go to school Tylenol every 4-6 hours

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

about 10-15 minutes after receiving vaccine pt complaine of dizziness, loss of vision, sweating, loss of consciousness, vomiting and of her left hand getting cold.

Really sore throat, headache, dry cough, puffy eyes, knees, and and hands. I received my vaccine this past Saturday and felt better, but now it is tuesday and i am feeling worse.

03/16/2021: At around 8:00 am my head and stomach began to hurt. A wave of drowsiness overcame me and I slept from 8:30 am- 1:30 pm. I then experienced body aches and extreme body weakness, thoughts were difficult to articulate and process, and I began to feel nauseated. This continued until 03/17/2021 in which I felt only nauseated, bloated. My headache was kept at bay with acetaminophen.

Minutes after I got the vaccine I started to lose hearing in my left ear (it sounded like I was under water) which slowly spread to my right ear as well. My hands and feet went numb and I started sweating all over. I felt sick to my stomach and I felt like I was above the whole situation-- I could hear the people talking but I felt like I was somewhere else. After resting my head on the table for about 10 minutes I felt better and was able to move to a cot where I rested for another 20 minutes or so until I felt pretty much back to normal. I was treated by the medical team at the site who cleared me to go home.

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

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

Chills and full-body shaking starting about 2:30pm, going away for a few hours, and returning about 6:00pm?resolved by 7pm (this may have been anxiety, since I was working myself up, and this symptom was markedly similar to how I sometimes get during panic attacks). Fever (max temp 101.7F) starting around 8:30pm?broke by 2:30am 4/3/21 after taking ibuprofen 9pm on 4/2/21 (last checked temp 98.4F). Mild headache from 2:30pm to 8pm.

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

Syncope about 5 minutes after shot. Fell out of chair, immediately awake. Sweating, no trouble breathing. Paramedics checked her out, said she was ok. Mom picked her up.

Patient had seizure-like activity about 10 minutes after receiving the Johnson & Johnson Covid Vaccine. Nurse saw her eyes rolling back and struggling to breath. She was placed on her side until wheelchair was brought to her side and then transferred to wheelchair and taken to the ER. While in transit she regained consciousness and was lethargic but was responding appropriately to questions. Patient was checked by Dr. and his review was tachycardic and mild dyspnea. Skin was pink and warm. She was taken to the ER for further evaluation.

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

Muscle aches and pains and a fever of 103.3 that only went down to 99 degrees after taking two aleve.

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

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

Headache 4/2 after going for a run (got vaccine 4/1) . On morning of 4/6, she called EMS for persistent and very severe headache unresponsive to APAP. Vitals stable, EMS evaluated her and transferred to ED where she was treated with ibu and APAP and was discharged after a few hours with no further issues.

Patient awake at 2:50AM shaking and sweating. She began stuggling to breathe around 3:00AM. Mother took her to the ED where she received the medications listed in #19 & felt relief about an hour later.

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

I felt completely normal after getting the vaccine. Then at 8 pm (5 hours after getting it) I felt heat rushing to my head and face. I became very weak in my legs and I had to lay down. I took ibuprofen at 9 pm because my body aching was very intense. I woke up at 11:30 pm with such terrible body aches I could not sleep and I was crying from the pain. I had freezing chills and a throbbing headache. When I tried to stand up, I almost fell over because I felt so light-headed. I thought I was going to faint. I was so concerned about the amount of pain I was in that I called my doctor and public safety came and checked on me. I couldn't get out of bed for 3 hours. I drank Gatorade and took more ibuprofen. I was able to check my temperature. I had a 101-103 degree fever. The entire next day (Tuesday) I took ibuprofen every six hours. My body was still very weak and aching everywhere as well as a headache. I stayed in bed the entire day. Today (Wednesday) I feel much better??both of my arms still ache a lot and my body feels exhausted.

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

night chills, fever, headache, body aches, loss of taste, swollen discolored (whiteish) tongue with bumps along the perimeter

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

Immediate ringing and loss of hearing in ears, blurred/starry vision, excessive sweating, nausea, and faintness.

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

Headache and dizziness hours after shot. Body aches / muscle pain next morning at 6am. Headache all day the day after shot. Fatigued since shot was administered.

RIGHT AFTER THE SHOT, THE PATIENT SAID THAT SHE FELT LIGHT HEADED AND TIRED. SHE STARTED TO SHAKE AND SLUMPED OVER AGAINST HER FATHER THAT WAS NEXT TO HER. SHE STARTED TO SNORE, WOKE UP AND THEN PASSED OUT AGAIN. HER FATHER SAID THAT SHE REACTS TO SHOTS THIS WAY. SHE DID NOT RECEIVE ANY TREATMENT. SHE WAS IN THE PHARMACY FOR A TOTAL OF 25 MINUTES.

Moderately severe body aches all over the body, headache, sore throat, wooziness, feeling feverish, chills

Fever of 103, chills, body aches. Still undergoing, fever down to 100, she is sleeping and I am monitoring her temperature. It has been 12 hours of fever and body aches. Fever went from 103 to 100 and is maintaining 100 so far. This is approx. 17-18 hours from the time of the vaccination.

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

CHILLS; HEADACHE; MUSCLE ACHE; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's 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: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, muscle ache, and chills. This report was non-serious.

Side effects of the Johnson & Johnson shot I?ve had...weakness , fever, muscle pain, body aches, headache, cold sweats, dizziness, chills.

Janssen COVID-19 Vaccine Chills, muscle aches, mild headache, a sudden reduced ability to hear and see, cold sweat, lightheadedness, disorientation Starting at approximately 1:00 am on 4/08/21 I woke up with a throbbing left arm, muscle aches, a very mild headache, and chills accompanied by bouts of uncontrollable shivering. I experienced these cold like symptoms throughout the night. At around 6:00 am, I woke up with a very mild headache and muscle aches. I took my temperature, and had a 101 degree Fahrenheit fever. I rested, and took my temperature multiple times that morning-- which had been gradually decreasing. At around 11:30/12:00 I experienced a sudden onset of extreme fatigue followed closely by a greatly reduced ability to hear and see, along with extreme lightheadedness and the feeling like I was going to pass out. I suddenly became cold, and my body was drenched in sweat in a matter of seconds. I think the whole experience lasted around 10 minutes, before it eventually began to pass. I could see clearly again and began to regain my hearing, however I still experienced some lingering auditory complications for an additional three- five minutes ( it sounded like a throbbing white noise). After that, I felt a little disoriented and tired. My aunt had taken me to Urgent Care, but they turned me away, saying I needed to go to the ER. However, by that time my symptoms had passed and I was feeling ok. So I went home and rested. By the next morning, I felt I had completely recovered

J and j COVID vaccine EUA Light headed and shaky - within 10 minutes Nausea - within 10 minutes Headache - within half an hour Fatigue - 2 hours post Fever - reached peak of 101.5 - 6 hours post, lowered to 100 steady by 20 hours and has not subsided Advil taken - 7 hours post Dizziness - cannot walk for more than 100 ft without rest - 6 hours post, worsened with fever, has not subsided Muscle aches - 8 hours post, strongest in both shoulders, has not subsided Abdominal cramps - 20 hours post, has not subsided Overall confusion - extremely ?out of it?, processing time is slow and focus is nonexistent, cannot answer simple questions easily or do basic tasks like reading or typing for extended periods - 4 hours post, worsened with fever and catatonic by 8 hours post, comes in fits and has not subsided

Woke up approximately 12 hours after receiving the vaccination with a horrible headache where she was seeing stars, dizziness, fever of 101.8, exhaustion. Tylenol helped the fever and headache. She slept most of the day following the shot. By the next morning, she was feeling better, slight fever of 100.2.

Patient had blank stares, nonverbal, loss of vision, cold/clammy hands, stomach tightness, and headache. BP fell to 55/26, 83/48, and 79/42, HR 57 and 62. Patient stabilized and released with father, advised to follow up with provider

Initially: Severe arm pain at the site immediately and then within minutes of vaccine: hearing loss and then tunnel vision to vision loss to feeling that could pass out: Hearing and vision came back in about 5-10 min and with taking off sweatshirt at that time 12 hours later: 101 fever and chills

BODY ACHES; CHILLS; FEVER; This spontaneous report received from a health care professional concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid muscle on 03-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021 18:00, the patient experienced body aches, chills and fever. On 03/Apr/2021 at 18:00; the patient had fever of 100.1 (unit not specified) and was treated with 2 extra strength Tylenol. At 22:00 the patient had fever of 101.0 (unit not specified) and patient was treated with 2 Ibuprofen 200 milligram. On 04-Apr-2021, at 14:30, the patient had fever of 102.9 (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and body aches. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210407171-covid-19 vaccine ad26.cov2.s-Body ache, Chills. 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). 20210407171-covid-19 vaccine ad26.cov2.s-Fever. This event(s) is labeled per agency and is therefore considered potentially related.

Pins and Needles Sensation in fingers- Pt suspects it might be due to anxiety that was exacerbated by the stress of getting an injection - Pt also stated cold feeling in localized to left arm similar to tickling - Continued medical elevation by Doctor and EMT. Pt Parent stated that Pins and Needles Sensation disappeared after the pt arrived at home - As per mom Pt also presented with fever and "pretty bad body aches"

Patient immediately complained of shoulder pain and not feeling well. Within a few hours patient had a fever of a 102+, chills, body aches, nausea, dizziness, feeling faint,shortness of breath, severe headache, severe shoulder pain in both shoulders, severe back pain, loss of sensation in right hand.

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

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

Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Additional Details: The patient has had issues with other vaccines. She felt light headed and sweaty. She had a head ache onthe onset. She left here feeling fine after we monitored her for a while.

Flu-like symptoms of Fever that progressed into severe chills and headache. Fatigue and general muscle / joint soreness, along with dizziness.

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

Patient felt faint, saw black spots, couldn't hear and was sweaty, She told the pharmacy that she didn't feel well and asked if we had a place for her to lay down. The pharmacist brought her into the immunization room and had her sit with her feet up on a 2nd chair. Gave her a bottle of water and sat with her until she felt better.

While at recovery after 3 minutes pt complained of dizziness, became pale diaphoretic. put pt on cot to lie down feet elevated with ice pack to back of neck. no LOC no SOB no NV VS taken 116/78, HR 68 reg strong, resp 12 reg non labored. pt stated she is afraid of needles. Also stated she didn't eat anything all day. Monitored for 30 min. pallor, diaphoresis and dizziness subsided. Provided reassurance sat for 30 minutes. stated I feel fine now. OKd to exit

Janssen COVID-19 Vaccine EUA Cough and wheezing persisting 6 days after vaccination (still present). Fever and chills for one day after vaccination (now gone).

Patient complained immediately of shoulder pain and not feeling well. Within 6 hours, Patient had a fever of 102+, body aches, chills, severe headache, shoulder pain, lower back pain, nausea, dizziness, and loss of sensation in right hand. Symptoms continued for approximately 36 hours.

My whole body got tingly and then I was freezing and had a fever of 105 my head hurt so bad it made me nauseous I was weak I couldn't even keep my balance to walk I couldn't sleep I woke up every 15 minutes because I was so uncomfortable

fever, body aches, muscle cramping, left arm and hand numbness, shaking, loss of bladder control multiple times

Heart palpitations that turned into sinus tachycardia lasting for around 6 hours until intervention. Heart rate peaked around 180. Rapid heart rate was likely a response to a high fever of 103 degrees F.

I got the vaccine at 3:45 arm was sore but I wasn?t worried Later that night around 6 I started feeling disgusting from vaccine so I took an Advil. Around 8-10pm my body started getting chills, I started shaking, I had a headache my muscles were sore, and I started getting a fever. Around 12am all of the previous symptoms got worse my fever was at about 101 and rising and I was extremely tired. At 1am I felt the worst I have ever felt in my entire life. I could barely walk because my muscles and joints hurt and my fever was over 102.5 and I felt like my veins were on fire. At 2 am I moved to my bathroom because the floor was cold and I didn?t want my roommate seeing me cry from how much pain I was in. I have a high pain tolerance but this was the worst pain I?ve ever been in. In the bathroom I was at the peak of the pain of the vaccine. My fever was over 103 all of my previous side effects were worse than ever I felt weak and a little dizzy. I also was having a hard time breathing, my breathing was weak and I felt like I wasn?t getting enough air. I tried looking up on my phone if I should go to the hospital but I could barely pick up my phone to type or look. I dropped my phone and fell asleep in the floor for 20 minutes before I woke up. I walked slowly over to my bed and took a Tylenol and then had a sip of water and felt like I was going to puke. I tried to use my inhaler and I couldn?t hold my breath to use it. I crawled into bed and slept until 11 the next day and was too sore to walk to class all of my joints still hurt and I had a fever of 101 and a headache . I took a Tylenol and around 6pm my fever broke and I was feeling better. The next day I was still too sore to walk to class and had a headache. Today I am still sore but better my lungs still feel a little tight, I feel unfocused , and I still feel dizzy occasionally. I have no appetite and I feel nauseous when I eat so I?ve been eating in smaller portions . Every single day since the shot I?ve felt very tired. I hope these symptoms get better and Looking back on the night of vaccine I should have gone to the hospital.

Vomiting starting at 9:15 pm on/off through 11:30 pm. Attempted to take pepto at 10:00 pm and promptly threw that up too, had chills during this period, used layers and a heating pad to warm up, was dizzy at 2:40 am on 04/10, lasted into 04/10. Had body aches on 4/10 as well as a mild headache. Felt nauseous throughout the 4/10-4/11 weekend, and experienced odd stool during this time as well.

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

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

high fever, whole body pain, chills, nausea, headache, treated with tylenol, lasting for 2+ days and counting

Around 5:00 PM the day I got the shot I started to get a slight headache. Shortly after the headache appeared I started to get the chills, I was wrapped up in multiple blankets and started shaking uncontrollably. I then checked my temperature and at this time it was 100.3. I then ate dinner and decided to try and fall asleep. When I lied down my heart began to beat very fast. I tracked my heart rate via a watch and my resting heart rate was around 140 bpm. My fever had also increased to 102. My head ache continued to get worse and I began to have bad neck and lower back pains. I was also having muscle spasm in my calfs. The entire night I could barely sleep because of my high heart rate, body aches, shakes, and the constant change from freezing cold to hot and sweating.

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

Approximately 5 minutes post vaccine, patient reported feeling dizzy, warm and was sweating profusely. Patient was given cold compress for back of neck and wrists. Patient did not lose consciousness but did report dizziness and nausea. Patient was able to hold conversation and reported feeling better after about 5 minutes. Patient was monitored for an additional 15 minutes and reported feeling normal before she left.

chills, vomiting, nausea, intense muscle aches, fever, dizziness. started suddenly around 11pm to midnight, lasted through the night. in am of 4/13, still felt ill

Day 1: Fatigue, headache, feeling hot and then cold, fever, fast and shallow respirations, muscle pain, cold extremities, difficulty sleeping for more than a few hours. Day 2: nausea, fatigue, fever

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

Beginning at 4:00 pm she started having a severe headache, and stomach ach., within an hour she was vomiting. She vomited twice and was in severe pain with head ach. She also had body aches. By 4/10 in the am symptoms were still there but less severe. She has had a mild headache and some stomach pain and diarrhea since Sunday

Severe headache this morning and all today. We went to the pediatrician and they performed neurological tests because of the blood clots that were reported. She was sent home and alerted to go to ER if any other symptoms develop

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

Around 10:00pm, I developed a fever and chills. The chills lasted for about two hours until I was just left with the fever until I fell asleep around 2:00am. The next day, I woke up with neck and head pain which disappeared after a couple more hours of rest until 11:00am. Afterward, that day, I had a slight headache which eventually disappeared sometime late in the evening around 9pm. The following day after the shot (second day later), I felt completely normal.

Evening after shot had fever of 102.3, chills, body aches bad enough to make it hard to walk. Those ended by next day. Developed very sore left hip/buttocks. Pain up to level 8. Now about 3-4. Saw pediatrician today to see if there was concern for blood clot. Was told to watch for sudden changes and sharp pain.

Fainted and hit head, ,fever, threw up, bad headache, nausea, body aches so bad that it hurt her to touch her anywhere, chest heavy, mouth felt like something in it Lasted for about 36 hours and then weak for another 12 hours Took Tylenol and Motrin after calling Doctor

joint aches initially and then severe headache with a slight fever that lasted at lest 4 hours. Patient took an ibuprofen around 10 pm and finally fell asleep around 1 am. During the next day she had intermittent headaches and had sore joints.

got a fever of 106 degrees about seven-eight hours after the shot. it got up to 107.2 degrees. started throwing up about 10 hours after the shot. went to the hospital. was given an iv bag and some anti nausea medicine. after about a day and a half i felt better.

4:30- chills, headache 5:00- chills worsened, headache, pressure in my head when I moved 6:00- hurt to breath when laying down 6:30- 101 degree fever 7:30- pain in my head worsened when I moved 8:00- bed *woke up every 10 min* *next day* 6:00- 100 degree fever, still hurt to stand, nauseous, really really weak, chills 7:00- chills and hot flashes (with same symptoms as before) 12:00- started to feel a little better- still cold and headache 8pm- feeling okay *next day* Clammy but good

HEADACHE; PAIN IN ARM; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and pain in arm. This report was non-serious.

AROUND 11PM STARTED GETING THE CHILLS, LEGS SHAKING AND HAD FEVER OF 104. AT 1:30AM, EYES HURT TO THE TOUCH. MOM ENDED TAKING TO ER AROUND 3AM. THEY GAVE HER TYLENOL AND IBUPROFEN. SHE GOT HOME AT 6AM AND SLEPT AND TOOK TYLENOL AND IBUPROFEN ON AND OFF. FEVER FLUCTUATED FROM 101 TO 104 AND BACK, TYLENOL TOOK FEVER DOWN TO 99.7. BUT UPTO TODAY, SHE STILL HAS BODY ACHES.

Chills, shortly followed by shivering and chattering. The shivering is so intense it essentially renders the patient in a state of involuntary writhing; muscles across the body, even if not in movement, may be tensed to the point of pain. Muscles affected lie in the legs, arms, and torso. An observer might mistake the event for a seizure, though the patient is fully conscious for the duration. The episode lasts only a few minutes; such an episode has only occurred once.

Around 9pm on date of vaccine severe chills, teeth chattering, nausea, headache. Saw HCP. Next day PT felt no better. Went to two urgent care that would not see her. Went to Med center. She had severe back pain and ringing in her ears at this point. They left her in a room for 30 minutes to go consult with a doctor after she told them she had the J&J vaccine. They came back and told her she had fluid in ear from pollen and back pain was caused from the chills and shaking. She still has a sharp pain in her ear and ringing in ears is still present.

Systemic: Body Aches Generalized-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Additional Details: patient was taken to er after having a seizure. patient has been feeling sick ever since injection and has missed her period. The physicians at the Emergency room said they could not find anything wrong with her. But mother is convinced something is not right. she is seeking a second opinion from different hospital

10 pm 3/6 fever chills body aches nausea headache 7 am 3/7 nausea headache and syncope x 2 mins low blood pressure 90/60 x 48 hours thereafter

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

severe chills, shaking throughout the day. Severe right arm pain and lethargy ongoing at time of report.

She got her J & J vaccine around 4:30 on April 7th ,2021. She was feeling fine up until around 10:00 that night when she began to have some of the regular side effects in addition to some unusual ones that were more concerning. She had chills was feverish and nauseous with flu like symptoms of her body aching. However, at around 10:30 that night she reported having difficulty breathing and having chest pains with pain when she would take breaths. She noticeably was taking very small but frequent breaths due to the pain. She described a pressure on her chest as if there was a bowling ball sitting on top of her chest. She was crying from the pain and her difficulty breathing. She also reported that her throat felt like it was smaller/ constricted. At that time, she was given Acetaminophen and later around 12:00 she was given Benadryl. When she went to bed that night, she was in pain but she also reported that her heart was racing and her resting pulse at the time was 110 bpm. She had the flu like symptoms into Thursday evening but by Friday she looked a lot better except for her difficulty breathing with complaints of chest pain when she breaths with continued pressure on her chest. She rested in bed for most of Friday and on Saturday she got dressed in the afternoon and took a walk around half a mile at which time she was exhausted and felt out of breath. When she walked back from her destination about a half mile, she needed to rest in bed to recuperate. The pain while breathing lasted into Sunday. Monday morning, she attempted to run and became winded from running a short distance of ¼ of the block and could not catch her breath having difficulty breathing and throwing up with a lot of subsequent chest pain that day. She was taken to the doctor by 10:00 that morning to run lab tests and get an examination. She is slowly getting better and taking it easy but Tuesday she still had some pain and by Thursday she is reporting that while the chest pain is still there it is more of a discomfort that she feels when breathing as compared to pain. She continues to report the discomfort when breathing till today 4/16/21 and is still limiting her physical activity but going about her daily routine.

In the observation area for 5 minutes and started to feel light headache and hot. transported to observation with medics. In observation for 30 minutes. 12:50 PM sitting and eating a granola bar. 1:00pm went home on her own.

Janssen COVID-19 Vaccine EUA 10Pm Night of Vaccine: Extreme chills - shivering and teeth chattering , fever of 101.7 degrees, weakness, lower back and body muscle aches, headache, dizziness and spinning sensation Morning After Vaccine: Fatigue, nausea, loss of appetite, headache, fever of 100.3 degrees

HEAD ACHE; CHILLS; FEVER; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced head ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and head ache on APR-2021. This report was non-serious.

Horrific headache the night she received the shot. Headache continue to next day then eased. Slight fever 101. Mild body aches

CHILLS; MUSCLE ACHES; This spontaneous report received from a consumer concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 an unspecified date, the subject experienced chills, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches and chills was not reported. This report was non-serious.

Patient was nervous and shortly after injection reported that she had vision changes and got diaphoretic. While assisting the pt into a reclining position she briefly lost consciousness; total duration 3-5 seconds. She regained consciousness immediately once she was flat and her feet were elevated. I monitored her blood several times and it was normal. Over the course of 30-40 minutes she recovered and left the pharmacy.

SPASMS ON LEGS, ARMS AND HEAD; SLIGHT HEADACHE; EXTREME TIREDNESS; SLIGHT FEVER; NAUSEA; BODY ACHES; PROFUSE SWEATING; POSSIBLE SEIZURE; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: unknown) dose was not reported, 1 total administered on 11-APR-2021 around 11:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, after vaccination patient had done lower body workout. On 11-APR-2021, the patient experienced nausea, extreme tiredness, slight fever, slight headache, body aches, and profuse sweating by evening. She took some children's liquid paracetamol (Tylenol). On 12-APR-2021 about 02:00, she also had spasms of her arms, legs, and head that lasted about 20 minutes. She took paracetamol (Tylenol) at about 03:00 and was pretty out of it. The patient's mother was concerned that it could had been a seizure (possible seizure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spasms on legs, arms and head on 12-APR-2021, and the outcome of nausea, extreme tiredness, slight fever, slight headache, body aches, profuse sweating and possible seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210423951-Covid-19 vaccine ad26.cov2.s-seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

FELLING TOO HOT OR TOO COLD; STOMACH PAIN; BODY SORENESS; CHILLS; HEADACHE; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's past medical history included birth control, and concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient have allergies. but no allergies detail provided. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025,expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body soreness. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced severe headache. On 02-APR-2021, the subject experienced stomach pain. On an unspecified date, the subject experienced felling too hot or too cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body soreness, stomach pain, and severe headache on 13-APR-2021, felling too hot or too cold, and chills on 02-APR-2021. This report was non-serious.

GENERAL MALAISE; FEVER; INJECTION SITE SWELLING; INJECTION SITE REDNESS; INJECTION SITE VERY WARM TO TOUCH; INJECTION SITE HIVES; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight was 230 pounds, and height was 170.18 centimeters. The patient's concurrent conditions included asthma, low thyroid, pollen allergy, sesame allergy, abstain from alcohol and and non smoker. The patient was not pregnant at the time of reporting. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included levothyroxine for low thyroid. On 12-APR-2021, the subject experienced injection site very warm to touch. On 12-APR-2021, the subject experienced injection site hives. On 12-APR-2021, the subject experienced injection site swelling. On 12-APR-2021, the subject experienced injection site redness. On 13-APR-2021, the subject experienced general malaise. On 13-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) ranging from 99 to 100 degree Fahrenheit. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, injection site swelling, injection site redness, injection site hives, general malaise, and injection site very warm to touch. This report was non-serious.

DIZZINESS; SEVERE HEADACHE; NAUSEA; TEMPERATURE OF 100; This spontaneous report received from a health care professional concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included covid-19. 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 13:00 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) POSITIVE. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced severe headache. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced temperature of 100. Laboratory data included: Body temperature (NR: not provided) 100 F. On 07-APR-2021 05:30, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headache, dizziness, nausea and temperature of 100 was not reported. This report was non-serious.

Got vaccine at 7:30 PM. On 4/6/2021 woke up at 2:20 AM with RIGORS. No fever. Difficulty walking. Wheezing and trouble breathing. In ER initial pulsox was 88% but reduced to 42% and difficult to obtain BP. Given oxygen, epinephrine, magnesium, steroids and albuterol. Discharged but continues with coughing and wheezing.

After getting the vaccine patient didnt feel well which was expected, but shortly after she begin to complain about feeling dizzy, fatigue. and heart palpitations

SEVER SHAKING; COLD; DIZZINESS; FEVER; NAUSEA; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient was previously treated with amoxicillin/clavulanic acid for covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sever shaking. On APR-2021, the subject experienced cold. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103 F, 102 F, 101 F, 99.8 F. Treatment medications (dates unspecified) included: ibuprofen, dimenhydrinate, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever shaking, dizziness, fever, and nausea on APR-2021, and the outcome of cold was not reported. This report was non-serious.

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

I vomited multiple times over the course of a couple days and I had a fever of 101 with lots of sore muscles

Chills that night until the next morning, head cold and tiredness the next day, Treated with acetaminophen

About 5 days post vaccination, patient developed headache, nausea, photosensitivity. These symptoms were still lingering when I saw her on April 28th. I am unsure if they are related to vaccination.

April 7th Adverse reactions to vaccine 5 hours after taking it including, feeling like a bowling ball was sitting on my chest, throat felt like it was closing, racing heart, resting pulse at 110, headache, chills, nausea April 8th flue like symptoms with chest pains April 9th chest pains, headache and fatigue was in bed entire day April 10th rested at home on Saturday but was very fatigued when I took a slow paced walk April 11th rested at home on Sunday continued chest pain April 12th Was part of a game where there was running involved after a ¼ of a block of running I threw up and felt like I could not breath, the rest of the day I had chest pain and went to

The patient was sitting in the waiting area following her vaccination when shortly after receiving the vaccine, her mother flagged us down and said that she lost her vision. She was describing feeling unwell. I had her lay down on the floor in the immunization booth and her mother elevated her legs. I asked her to describe her symptoms and she said that she just saw all white. I asked if she wanted me to check her blood pressure and I had her sit up on the floor and it was low around 75/53 with a pulse of 53 but not sure how accurate it was since she was sitting on the floor. She fluctuated from starting to feel better and feeling unwell again and her vision going out again. I asked if they wanted me to call 911 and her mother said she wasn't sure what to do, if she should take her to an urgent care. I said that it would be best if she was seen in an emergency room where they can better respond to this kind of situation. The patient was able to get up and walk with her mother's assistance. I was going to help walk her out but she said that she was okay walking out with her mother's help. About 10 minutes later, I called the patient to see how she was doing. Her mother said that she was doing okay and that they were on their way to the hospital just to make sure that she was checked and everything was okay.

Was was pain in calf area and having a hard time breathing and very tired.. went to doctor on 4/20/2021 Doctors Diagnosed with Pulmonary Embolism

ARM HURT; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned an 18 year old female. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 01-JUN-2021) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced arm hurt. On 02-MAY-2021, the subject experienced fever. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, fever, headache and fatigue on 03-MAY-2021. This report was non-serious.

About 10-15 hours after injection - Came down with headache, fever, body aches, fatigue, and night sweats. Recovered fully 24 hours after injection. May 5th, 2021 ~7:30 am (4 days post-vaccination) I stood up from a seated position and then collapsed moments later and had, what my brother described as, a seizure which was followed by confusion, nausea, and fatigue.

pt presents to the ED for fever/HA and body aches after receiving J&J COVID vaccine, states she is no longer febrile but is still experiencing body aches.

Systemic: Dizziness / Lightheadness-Mild, Systemic: patient stated that she couldn't see-Mild, Systemic: Nausea-Mild, Additional Details: Patient stated that she was feeling dizzy and lightheaded. She was sweaty and clammy. She stated that she couldn't see, but now she can see and seems to be fine. I gave her a bottle of water as well.

PAIN IN ARM; ELEVATED HEART RATE; FEVER; BODY ACHES; DIFFICULTY SLEEPING; This spontaneous report received from a pharmacist concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non-alcoholic, and drug allergy, and other pre-existing medical conditions included patient had no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced difficulty sleeping. On 03-MAY-2021, the subject experienced fever. On 04-MAY-2021, Laboratory data included: Heart rate (NR: not provided) 105-120 bpm, 110 bpm. On 04-MAY-2021 02:00, the subject experienced elevated heart rate. On 04-MAY-2021 02:30, treatment medications included: paracetamol. On an unspecified date, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping on MAY-2021, was recovering from body aches, had not recovered from elevated heart rate, and the outcome of fever and pain in arm was not reported. This report was non-serious.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: resolved after about 10 minutes (reaction developed within 5 minutes of vaccine administration)

Severely bad headache (she has been in tears and didn't want to play video games she felt so bad. She is complaining of feeling like she was going to throw up but that has been for over a month now and has 100% to do with her anxiety. The headache however is related I believe.

LOSS OF APPETITE; VOMITING; SLEEPING; CHILLS; LOW FEVER; SEVERE HEADACHE; STOMACH PAIN ON RIGHT SIDE; BACK ACHE; BODY ACHES; HOT/COLD SENSATIONS; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included birth control. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included etonogestrel for birth control. On 03-MAY-2021, the subject experienced stomach pain on right side. On 03-MAY-2021, the subject experienced back ache. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced hot/cold sensations. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced sleeping. On 03-MAY-2021, the subject experienced low fever. On 03-MAY-2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 97 F. Treatment medications included: ibuprofen. On 03-MAY-2021 05:00, the subject experienced vomiting. On 04-MAY-2021, the subject experienced loss of appetite. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach pain on right side, severe headache, back ache, body aches, hot/cold sensations, chills, and vomiting, and the outcome of sleeping, low fever and loss of appetite was not reported. This report was non-serious.

Within 5 minutes of receiving vaccine, patient was hot and covered in a full body sweat, seeing spots, kept losing consciousness, nauseous. I couldn't get a reading on the BP monitor at that time as it was too low to read and she couldn't move her limbs. While waiting for EMS she could breathe fine, I could feel a faint pulse, but I had to keep taping her leg and talking to her to keep her awake. She was able to tell us her name and how many fingers I was holding up. I kept trying to get her to squeeze my hand, but I could only feel the tips of her fingers twitching and the whole time she was unable to move her feet/toes. I was able to look at her HR on her watch right before EMS arrived and it was at 62 and by that time her body temp seemed to be back to normal as her Mom said she felt cool and clammy. The BP reading by EMS was 100/60 and they tried to get her to stand but she couldn't and she still kept wanting to roll her head back and sleep.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe

HEART RATE WAS 130/ RAPID HEART RATE; FEEL DIZZY/ FEEL VERY LIGHTHEADED; WHOLE BODY FEVER/ BURNING UP REAL BAD; NAUSEA; FELT WEAK WHEN WALK; HEADACHE / MIGRAINE; This spontaneous report received from a patient concerned an 18 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced headache / migraine. On MAY-2021, the subject experienced felt weak when walk. On 04-MAY-2021, the subject experienced heart rate was 130/ rapid heart rate. On 04-MAY-2021, the subject experienced feel dizzy/ feel very lightheaded. On 04-MAY-2021, the subject experienced whole body fever/ burning up real bad. On 04-MAY-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 130. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel dizzy/ feel very lightheaded, nausea, whole body fever/ burning up real bad, and heart rate was 130/ rapid heart rate, and the outcome of headache / migraine and felt weak when walk was not reported. This report was non-serious.

Friday night, at 04:00, I got a fever and it was low grade until 10:00 pm and it spiked to 103 and it lasted to 01:00 am. I took Tylenol for it. The next morning, at 08:00 am, I woke up to abdominal pain right under my sternum - and it lasted until 08:00 pm that night - it came and went throughout the day but was pretty much over by that night.. I went to Urgent Care. I took Tylenol for the abdominal pain as they did not know the cause of it. I was very tired until Thursday of that next week.

Staff member received the first dose of the Moderna vaccine on 4-15-21 and was scheduled to receive the second dose on 5-13-21. The nurse administering the vaccine on 5-13-21 administered the Janseen vaccine instead of the second Moderna vaccine by mistake. She reports that she had a fever, stomach ache/cramping, muscle cramps, lightheadedness and fatigue X 3 days following administration of Janseen vaccine.

At first once I received the vaccine I felt completely fine. Later that evening I started to lose my breath and had a fever. By 9:00pm I was unable to move the left side of my body, had sharp pains throughout my body, and involuntarily urinated and vomited. This continues until 12:00pm Friday, the vomiting and urinating involuntarily stopped but the high fever, body pains, and numbness continued until Sunday evening. Now I still am experiencing random sharp pains and numbness on the left side of my body to the point where I cannot move it at all. I am throwing up occasionally (which has never happened before), and I have had a headache and insomnia since I got the vaccine. Pains behind my eye, loss of appetite and weight loss have occurred since.

The night of the vaccine: body aches, intense chills, fever, night sweats, headache, insomnia The morning after: Passing out/fainting (loss of consciousness for a couple seconds), body aches, chills, headache. *Symptoms improved with sleep throughout the afternoon of the the day after. Body aches and weakness continued for about 4 days.

Patient felt dizzy less than 5 minutes after vaccine, patient became light headed and pale, had difficulty opening eyes. She remained sitting, but was on the verge of passing out. Our technician then called 911 and they advised not to give patient any water. Paramedics arrived and took her to the hospital for observation. Appears to be a vasovagal response to the vaccine.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Patient has vasovagal and experiences syncope somewhat regularly. 911 was called when she did not immediately regain consciousness, however she came to within 1-2 minutes. After 45 minutes of rest, reporting she felt normal again and being evaluated by EMTs she was cleared to leave on her own.

The next day, I had headache, fever, and felt like throwing up. I felt fine afterwards. I went to the doctor because I had an ear infection and it was really bad - 4/28/2021 - gave me some ear drops. The ear drops helped with it. I had the ear infection for about five or six days before I went to the doctor and it lasted three or four more days after I saw the doctor.

I started having chills and a fever and went to bed. I woke up the next morning brushed my teeth and i passed out and hit my head and was dehydrated. I stayed in the ER for about 5 hours.

I had a severe cold, with a harsh cough for over a week, extreme shortness of breath, and exhaustion. Slight fevers. I tried mucinex, but had to go to the hospital for an inability to void, with resulted in a catheter. We couldn't figure out what was wrong, so I stopped the mucinex. Then, I took doxycycline, and that seemed to help significantly. After four or five days on the doxycycline, the symptoms were almost gone.

LOW GRADE FEVER; TIREDNESS; BODY ACHE; This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included patient had no known allergies. patient had no use of drug and drug illicit usage. 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 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: ibuprofen. On 24-MAY-2021, the subject experienced body ache. On 24-MAY-2021, the subject experienced tiredness. On 25-MAY-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever on 25-MAY-2021, had not recovered from body ache, and the outcome of tiredness was not reported. This report was non-serious.

About 10 minutes after the vaccine, pt's father signaled he needed help. Pt was cold and had chills. She did not speak English well, and she said she couldn't hear. Then she stated that her throat was closing up. Then she stated she couldn't see.

2 days a/f vaccine administration, HA (general HA 6/10; occular pain 7-8/10). 6 days a/f vaccination abdominal pain; R side sub costal, 6/10; stabbing; intermittent; associated dizziness). sleeping and analgesics help to relief s/s. Denies: V, diarrhea, hematuria, melena. RN Scheduled visit w/ Provider.

Patient received vaccination seemed okay went to get a drink of water. Sat down in waiting room and said she was going to pass out. I ran out she passed out for 30 seconds. She was completely out I shook her arm called her name several times. She came to and was very clammy and sweating. Her skin went pale. She vomited. I laid her down on the floor.

DIZZINESS (WHEN WALKING); FEVER; SORE ARM; SEVERE HEADACHES; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced sore arm. On 07-JUN-2021, the subject experienced severe headaches. On 08-JUN-2021, the subject experienced dizziness (when walking). On 08-JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from sore arm, and had not recovered from severe headaches, dizziness (when walking), and fever. This report was non-serious.

Alert and talkative prior and during vaccine. Appeared warm, pink and well perfused. After sitting for 3-4 minutes in recovery area had episode of syncope and fell off chair onto hard floor. Fall was observed by another patient in recovery as well as pharmacy staff. Continued 1:1 observation from pharmacy staff for and additional 45 minutes. Food and fluids were offered. Patient was alert and talkative as pharmacy staff approached her on floor. Mild pallor and sweating were noted. Continued to observe patient the full 45 minutes after event. At time of discharge had eaten, taken fluids, was alert, talkative and pink.

sweating and limp, Still responsive but slow. Treated her with cool packs and laying her down. BP 60/48 HR 38 SpO2 99% at first. After 30 mins BP 90/48, HR 40 - which is normal for her. SpO2 99%. Gave her 2 chewable diphenhydramine. Was able to stand on her own with out any dizziness or feeling light headed. Both parents here when she was dismissed to their care.

Patient experienced fatigue, nausea and 105 degree fever approximately 10 hours after the vaccine shot. The next morning at the breakfast table she began crying and shouting that she had lost her vision and everything went dark. Within minutes she stopped breathing and her eyes rolled back in her head. Her body went rigid and her mother caught her as she was falling backward in her chair. Her skin was white and her lips blue. I administered CPR and after approximately 4 mouth to mouth breathes she began breathing again. When she regained conciousness she said she could not hear. The paramedics arrived and tended to her.

Around 8pm on the day on my vaccination, started having chills and a fever. These were the worst chills I have ever had. My whole body was shaking. I think that the chills ended around midnight. I lost my appetite the evening that I got my vaccination, haven?t regained my appetite yet, and I became somewhat nauseous. I haven?t thrown up yet. The morning the day after my vaccination I woke up and my abdomen was hurting a little bit. I was hot most of the night into the next day.

TINY BLOOD SPOTS ON THE LEFT THIGH, LEFT SIDE OF FOREHEAD AND NEAR BOTH EYES; CHEST PAIN; SHORTNESS OF BREATH; PERSISTENT ABDOMINAL PAIN; BLURRED VISION; LEG PAIN; MUSCLE ACHE; FEVER; FATIGUE; HEADACHE; SORENESS IN RIGHT ARM; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and allergic to pineapples. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced soreness in right arm. On 16-JUN-2021, the subject experienced tiny blood spots on the left thigh, left side of forehead and near both eyes. On 16-JUN-2021, the subject experienced chest pain. On 16-JUN-2021, the subject experienced shortness of breath. On 16-JUN-2021, the subject experienced persistent abdominal pain. On 16-JUN-2021, the subject experienced blurred vision. On 16-JUN-2021, the subject experienced leg pain. On 16-JUN-2021, the subject experienced muscle ache. On 16-JUN-2021, the subject experienced fever. On 16-JUN-2021, the subject experienced fatigue. On 16-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.8 to 100.2. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in right arm, headache, fatigue, muscle ache, fever, chest pain, shortness of breath, blurred vision, persistent abdominal pain, leg pain, and tiny blood spots on the left thigh, left side of forehead and near both eyes. This report was non-serious.

Developed sore throat and cough. became positive for Covid - 19 after Johnson and Johnson Vaccine was received-

SHOOTING PAIN DOWN THE ARM; HEADACHE; FEVER; This spontaneous report received from a consumer concerned an 18 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: Unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced shooting pain down the arm. On JUN-2021, the subject experienced headache. On JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shooting pain down the arm, headache, and fever on JUN-2021. This report was non-serious.

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

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

Chills, beginning at 9 PM and ending at 12 AM, not treated with medicine but went away after lying under a thick blanket for a few hours Pounding headache, beginning at 12 AM and ending sometime after 4:30 AM, ibuprofen was taken at 4:30 AM and the headache was gone upon waking up the next morning Nausea, beginning at 11 PM and ending at 4:30 AM, very minimal at first but became severe around 4:30 AM, went away after throwing up once Vomiting, 4:30 AM, very minimal and only happened once Insomnia, 9 PM to 4:30 PM, may have been a result of the pounding headache, went away shortly after taking ibuprofen

SHORTNESS OF BREATH; CHEST PRESSURE; STOMACH PAIN; BACK PAIN; NECK PAIN; NUMBNESS IN CALVES; TINGLING IN FEET/SKIN FEELS STRANGE; SORE THROAT; BUBBLED EARS/RINGING IN EARS; PALE HANDS AND LEGS; RESTING HEART RATE WAS 99-110; SHOULDER PAIN; RIGHT LEG PAIN; HEAVINESS IN LEGS; CHILLS; PAIN AT INJECTION SITE (DURING ADMINISTRATION OF VACCINE); FEVER; HEADACHE; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight was 153 pounds, and height was 65 inches. The patient's concurrent conditions included positive for lupus anticoagulant factor (anti-phospholipid factor), non smoker, non-alcohol user, latex allergy, rubber allergy, allergic to silicone, and resting heart rate runs high. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 05-JUL-2021 11:15 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, Laboratory data included: Heart rate (NR: not provided) 99-110, and Oxygen saturation (NR: not provided) 96-99%. On 05-JUL-2021, the subject experienced shortness of breath. On 05-JUL-2021, the subject experienced chest pressure. On 05-JUL-2021, the subject experienced stomach pain. On 05-JUL-2021, the subject experienced back pain. On 05-JUL-2021, the subject experienced neck pain. On 05-JUL-2021, the subject experienced numbness in calves. On 05-JUL-2021, the subject experienced tingling in feet/skin feels strange. On 05-JUL-2021, the subject experienced sore throat. On 05-JUL-2021, the subject experienced bubbled ears/ringing in ears. On 05-JUL-2021, the subject experienced pale hands and legs. On 05-JUL-2021, the subject experienced resting heart rate was 99-110. On 05-JUL-2021, the subject experienced shoulder pain. On 05-JUL-2021, the subject experienced right leg pain. On 05-JUL-2021, the subject experienced heaviness in legs. On 05-JUL-2021, the subject experienced chills. On 05-JUL-2021, the subject experienced pain at injection site (during administration of vaccine). On 05-JUL-2021, the subject experienced fever. On 05-JUL-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 06-JUL-2021, Laboratory data included: Body temperature (NR: not provided) 101.1 F, Heart rate (NR: not provided) 117, and Oxygen saturation (NR: not provided) 97 %. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) high, and Lupus anticoagulant (NR: not provided) positive, slightly high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pale hands and legs, had not recovered from neck pain, and the outcome of fever, pain at injection site (during administration of vaccine), headache, sore throat, chills, heaviness in legs, tingling in feet/skin feels strange, shortness of breath, bubbled ears/ringing in ears, stomach pain, back pain, numbness in calves, chest pressure, right leg pain, shoulder pain and resting heart rate was 99-110 was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.

VOMITING (NOTHING CAME OUT); DIZZINESS; HAND SORENESS; WEAKNESS; FEVER OF 104; NAUSEA; HEADACHE (FELT SHE COULD SCREAM); This spontaneous report received from a parent concerned an 18 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced vomiting (nothing came out). On 09-JUL-2021, the subject experienced dizziness. On 09-JUL-2021, the subject experienced hand soreness. On 09-JUL-2021, the subject experienced weakness. On 09-JUL-2021, the subject experienced fever of 104. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced headache (felt she could scream). Laboratory data included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 104, nausea, vomiting (nothing came out), weakness, headache (felt she could scream), hand soreness and dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210724637.

Patient walked to waiting area and sat down and then appeared to lose consciousness, and slump over on the table beside her. Patient appeared pale and was perspiring from her face. After about a minute she regained consciousness and was responding vocally.

I began feeling weak and fluey around 8:30 or 9:00 pm. I decided to go to sleep around 10, noticed my fingers had turned yellow and lost all circulation. I went downstairs to ask my dad what to do, and immediately felt like I was going to faint. Sat down on a chair and put my head between my legs, but passed out as I was doing so, and fell on the floor. According to onlookers (brother and sister, who is an EMT) I was convulsing and stopped breathing for about thirty seconds, and my eyes were glassy and rolling. I woke up to my sister telling me to breathe. There was blood on the floor (I had hit my face on the way down) and I was trembling uncontrollably and had wet myself. I was awake and aware of my surroundings, and remembered everything up to and including sitting sitting on the chair before I passed out. My brother had called 911 while I was out and an ambulance came within five minutes. The paramedics put me in the ambulance and took me to the hospital (they would have taken me to local except there was risk that it was a seizure, which I guess local isn't equipped to handle). They measured my vital signs, made IV ports in my arms and drew some blood. My blood pressure was super low and my heart rate was super high, and I had a temperature of 102. When I got to the hospital they put two liters of saline drip into me to rehydrate me, did a CAT scan, and some bloodwork. They discharged me around 3:30 AM on Monday morning, told me to stay hydrated and get a lot of rest. I slept all day yesterday (Monday) and was feverish and weak. By today (Tuesday) I think I have mostly recovered.

BLURRED VISION; FEELING GENERALLY UNWELL; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned an 18 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: Unknown) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUL-2021, treatment medications included: paracetamol. On 14-JUL-2021, the subject experienced blurred vision. On 14-JUL-2021, the subject experienced feeling generally unwell. On 14-JUL-2021, the subject experienced low grade fever. On 14-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision, low grade fever, headache, and feeling generally unwell. This report was non-serious.

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

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

Janssen COVID-19 Vaccine EUA Symptoms started yesterday, March 9th, with muscle aches in my lower back a couple hours after receiving the shot. The muscle aches spread throughout my body as time went on, and joint pain and headaches came as the muscle aches worsened. I took two ibuprofens, though they had no effect. A bit later in the day, I developed a fever and felt very nauseous. When I went to sleep, I had a hard time staying asleep and ended up vomiting when I woke up at around 1:00AM. Today, March 10th, I continue to have muscle aches, joint pain, a headache, and slight nausea.

Covid-19 Vaccine EUA -drowsiness (begin at 545) -101+ fever (7pm, got first fever, continually on and off every 45 mins since then) -uncontrollable vomiting (3:02 am- 3:34 am) -extreme muscle aches (all night) -dizziness (all night)

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

patient experienced tiredness and fainted for a few seconds after injection, a few seconds of twitching occurred before waking up. Paramedics were called, once arrived, patient was evaluated and denied transport.

Swollen/redness of the Uvula in throat. Started 6am 3/10/21 and still going as of now 3/11/21 at 10pm.

9 hours after the vaccine, the patient was extremely fatigued, experiencing hot flashes, muscle aches, and a fever. Treated with 1000 mg Tylenol. The patient felt relief at hour 26 after vaccination

Nose bleed started day after vaccination along with nausea which makes it hard to eat. Had flu like symptoms day of vaccination with head ache and body aches persisting.

Around 7 hours after receiving the vaccine I started to get a fever. It was 99.6 at 11:30pm, 102.2 at 2:15am, 102.7 at 3:25am. It started going down at 4:00am after taking 1000 mg naproxen and Tylenol. Fever came back around 1:15pm today at 100.7 and has been up to 101.7 as of 5:30pm. The fever has come along with relentless shaking due to the chills. A migraine has also persisted despite taking NSAIDs to help with that as well.

Body Aches, extreme fatigue, increased heart rate, fever (101°F) starting at 7:15 pm 03/13/2021. Taken 1000mg acetaminophen 10:00 pm - fever increased from 99 to 101

extreme headache and dizziness about 4 hours after the shot at around 4:00 PM. migraine continued to get worse and i was seeing spots, vertigo and loosing balance and that lasted until 7 pm on 3/13

Dose given at 1415. At approximately 2030 on the same day, patient began experiencing upper extremity myalgias, then generalized myalgias, fevers to 104.3 F and chills. Her oral intake decreased and she vomited multiple times. She subsequently presented to the emergency department where she continued to spike fevers. Her vomiting has subsequently subsided.

I received the Janssen COVID-19 Vaccine EAU at 1:45 PM. I was very tired around 8:30 PM, so I went to bed. I never fell fully asleep and began feeling worse at 11:00 PM. I had a fever of 101.5 F, chills, muscle spasms, anxiety, shortness of breath, and could not stop crying. This lasted until approx. 4 AM when I finally fell asleep. The next morning I woke up feeling much better. But, for the next 5 days, I have had on-and-off low-grade fevers between 99F and 100F.

fever, chills, muscle aches recommended tylenol or ibuprofen to relieve symptoms. If symptoms worsen referred her to see primary provider.

8am: woke up with a moderate headache and it subsided after taking 2 advil 6pm: blurry vision, hard to focus on computer screen, lasted for about an hour 7pm: fatigue, lightheaded 8pm: very sensitive to light, wanted to lie down 8:30pm: chills, mild fever, slight cough 11pm: some sweating while sleeping, felt very dehydrated *didn't take any other medicine throughout the day, slept it off and felt much better the next morning besides tolerable headache

National Guard Nurse Note: "1323: approx 10 minutes after Janssen covid 19 vaccine was administered patient c/o feeling 'lightheaded, hot, dizzy, sweaty and shakey'. Pt vitals were taken b/p 100/60, ox/ra 97%, p 70, r13. Assisted to stretcher in a seated position. Pt denies headache, vistion changes, or sob. shis is aox3. Communication is appropriate, no slurred speech. Pt able to smile w/o facial drooping. Given water to drink and ice pack placed behind her neck. 1338 vitals takend b/p 110/60, ox/ra 96%, p 73, r13. Pt states she does have a history of anxiety and 'afraid of needles and coming to the clinic today'. 1345: Pt states 'I feel better'. offered pt a snack but declined. pt denies sob or difficulty breathing. 1400: pt states she feels well enough to leave. Pt denies dizziness, lightheadedness, shortness of breath, headache or feeling of being hot. 1401 Pt assisted to her vehicle, her friend will be driving. Pt adn her friend advised if symptoms return, difficulty breathing or sob, hives, rash or any other unusual symptoms occur to call 911 immedicately." RA BSN 3/15/21 @ 1412

Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: she fainted shortly after administration. when i went back to her..she was conscience and breathing ok. She felt like it was typical to what she experiences with vaccines and did not blame the vaccine at all. She was responsive and did not seek additional help. she refused an ambulance. she had a friend pick her up so she didnt have to drive home.

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

Extreme chills starting around 9:00 PM, no fever Around 11:00 PM, extreme vomiting Around 11:45 PM vomiting again

Violent uncontrollable full-body shaking for an hour with a high fever, shooting pain throughout the body for a day or so.

Roughly six hours after receiving the vaccine, I began to get the chills, and I couldn't stop shaking. Roughly an hour to an hour and a half later, the chills/shaking stopped, only to be replaced by a fever. My temperature shot up, my ears began to ring, and my head began to pound. When I tried to eat, I felt sick to my stomach. My fever lasted for the entire evening, and I spent most of the night alternating between chills and heat flashes. My head continued to pound, and whenever I tried to sit up, I felt dizzy. At around 4am, I awoke with an upset stomach, diarrhea, and further dizziness. By around 8-9am, my fever had subsided, and I was beginning to feel a bit better. However, I have been feeling physically drained and a little achy today (03/26).

I received the vaccine at 9:00am. At 4:00pm I started to experience brain fog and cloudy judgement. Around 8pm I felt the beginning of a fever. By 10:00pm I started vomiting. Checked my fever at 104 degrees. Had severe Fatigue for the next 24 hours.

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

SEIZURE; DEHYDRATION; This spontaneous report received from a pharmacist concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dehydrated, anxious, non alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient did not had history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient had an seizures with in 1 minute after vaccine administration which was lasted for 10 second. The patient did not had history of seizure. The patient was taken to hospital via ambulance and they found that she was dehydrated and was given fluids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure on 16-MAR-2021, and the outcome of dehydration was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210332197 -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Seizure, Dehydration. 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).

The patient reported that beginning around 6 pm on the day of the vaccination (3/30/21) she began to feel achey, with body aches and headache that was a 4 on a 1-10 scale with chills, fever, and a temperature of 99.1. She stated that at 8 pm her symptoms worsened and she took Ibuprofen 600 mg without effect. She was able to sleep, however. This morning (3/31/21) @ approximately 8:30 AM she was standing in the bathroom and became lightheaded and thought she was going to pass out, sat down for a few minutes, felt better, began to walk into her bedroom holding onto the walls and then collapsed against the wall and "passed out". She recoved later on her own and sought help. She denied any head injury or tenderness of the scalp. Upon arrival at the clinic her vital signs: BP 80/46, P 88, R 16, O2sat 98%, T97.5 (she had just come in from outside where it was cold). Her vitals signs after 10 min: BP 80/50, P 104, R 16, O2sat 98%, T 99.1 She remained lightheaded for the remainder of her visit. She was instructed she would need to be evaluated in the local ED where she was then sent.

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

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

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

3 min after vaccine given patient felt light headed and got vertigo, became green, fainted and was sweating.

At 0830, RRT was called for a 19 y/o F with c/o dizziness, lightheadedness, pain in neck area, and difficulty with vision. At initial meeting, client was pale and stated she had difficulty breathing and had blurry vision, per client, like in ?hyperspace?. Head-to-toe assessment completed. Client was diaphoretic and cool and clammy. Pulse was thready. AA0x4 and tachypneic but has clear breath sounds. PERRLA. Vitals: BP: 100/60, HR: 55, 02: 95% on RA. Mother and father present during this time. No PMH, NKA. Did not take any medications today, only ate a small breakfast. Not pregnant. Client states she had a similar reaction like this with the HPV vaccine 1 year ago. During monitoring/observation time, client?s status improved. Client insisted for EMT/ambulance assistance. 911 called. EMT arrived at 0845. During EMT evaluation, client vomited about 70 ml of clearish/yellow emesis. After paramedic explained options of going home or transportation to the hospital, client opted to be transported to the hospital. Client left facility with paramedics (AMR 332), accompanied by mother and father. Patient transported to Hospital via ambulance.

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

I began to have a high heart rate about hours after getting the shot then a fever came along and I had chills, and my lips were dry and I also had a headache. My heart rate would barely stay below 100 BPM, even when laying down in bed. I developed a 102 F fever last night and took motrin, which helped lower it but I?ve also been having lingering throbbing headaches. My heart rate went to about 100-105 when while I took a nap but as soon as I got up and moved it jumped to 117, in the morning I went to use the bathroom and did nothing else and just that made it jump to 160. I have no trouble breathing. I was sitting in bed eating and my heart rate was around 123-130

extremely high fever, runny nose, chills, full-body aches, hard-time breathing, joint aches, swollen lymph nodes, headache

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

Patient became dizzy and lightheaded shortly following vaccination. Other symptoms included paleness, partial loss of consciousness, momentary loss of vision, diaphoresis and slurred speech. Patient was given a cold compress for the back of her neck, some peanut butter crackers to eat and water to drink. She had not eaten anything today with the exception of candy and coffee. Feet and legs were elevated and patient began to regain some color in her face and started feeling better after a few minutes.

Immediately after the vaccine, my left arm was shooting pain and cramped up. That faded after a couple minutes and I felt fine afterwards. Starting at 7:00PM (April 6/same day), I suddenly felt extremely dizzy, nauseous, and my entire body is aching to the point of tears. My lower abdomen and spine/hips are also in terrible pain. I?m in too much pain to sleep even though I?m exhausted and for a little while, I was struggling to catch my breath. I also have chills and feel that a fever is not far off.

I?ve been fevering and shaking since 4am on 04/6/2021 and it is now 8:51 on 04/6/2021. I have dizzy spells, a runny nose, aching joints, a pounding headache, my eyes ache and burn, I constantly feel like throwing up, and I haven?t been able to sleep at all.

She had no history of anaphylaxis from any cause, she had no history of reactions to vaccines or components. After about 5 minutes I checked on her and she said she was feeling very dizzy. I called management for assistance and got her ice packs for neck and forehead. I took her blood pressure and it was 150/90, HR 73. We laid her down and elevated her legs. She said that she felt some pressure in her chest but she had pulled a muscle there the day before and wasn't sure if it was related. She said the room was spinning as she continued to lay on the ground and it was not improving. Her blood pressure was taken about 5 minutes later and it was 143/85 HR 73. She said it is usually low. She had no signs of local reaction, hives, or swelling. She complained of nausea. After a few more minutes she said she was not feeling any better and was having pain in her throat and difficulty breathing. I asked her to try to take a deep breath and she was gasping for air, unable to breathe deeply. I administered epinephrine (one dose) and called 911. I rechecked blood pressure while waiting for paramedics and it was 125/80. She was taken to hospital when they arrived. Her mom arrived shortly before the ambulance and went with her. Pt never lost consciousness. Management followed up with patient this evening and patient is home and well, but the ER did classify the event as an allergic reaction.

101.3 fever by 6 pm, 101.1 fever the next morning (6 am) intense shivering and aches in afternoon of 4-06 and intense heat evening of 4-06 and morning of 4-07. I took Tylenol and ibuprofen throughout it which definitely helped and my fever would break but then once the medicine wore off the fever would come back. Symptoms ended around noon today (4/07).

HEART RATE OF 120; FEVER; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's 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: Unknown) once a total dose was not reported, administered on 26-MAR-2021 08:40 at right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced heart rate of 120. On 26-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2, and Heart rate (NR: not provided) 120. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and heart rate of 120. This report was non-serious.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure as the case is assessed as non-serious.

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

The day after i felt tired and weak, headache and body/joint pain, i started to feel better but then i woke up today feeling very dizzy and lightheaded

Within the hour after receiving shot, migraine formed along with fatigue. Both progressively got worse through out that day(4/7/21). On 4/8/21 I woke up many times through out the night with a migraine that felt as though my brain was burning and sinus pressure, causing immense eye sensitivity. Throughout the night I became increasingly more sweaty, but didn?t have the proper thermometer to take my temperature. I took ibuprofen (at 6:45 AM on 4/8/21) which helped those two side effects subside (around 8 AM). Fatigue has been constant throughout both days. Around 5:00 PM on 4/8/21 I ate broccoli and rice for dinner, small amounts, and encountered bad diarrhea. It lasted for about half an hour. Migraine is reduced significantly (at 6:41 PM), but there is slight nausea, weakness, and fatigue.

I?m not sure if it?s too important but I had Covid previously and got extreme aches and chills. I couldn?t get up without feeling like my whole body was attacking me and I was attempting to brush my teeth and my legs wouldn?t stay up straight.

Chills / sweating : 4/7 all night into 4/8 Fatigue : 4/7-4/9 Nausea: 4/8-4/9 Muscle / body ache: 4/7-4/9

Janssen COVID-19 Vaccine EUA About 8 hours after the vaccine, I developed a fever and chills. Then when I went to bed at 9:30 pm I had extreme thirst. I tried falling asleep but my fever got worse, chills worsened, I developed body aches, and I got a massive headache. I ended up not being able to get any sleep at all during the entire night because I was in so much pain. I felt tightness in my chest, stomach pains, super sore joints, and my body aches and headache kept getting worse and worse. When I got up to go use the bathroom I could barely walk because I felt so weak and was super dizzy. Later into the night my legs felt like pins and needles as if they were starting to go numb. I still have a fever, body aches, and a headache.

Janssen COVID-19 Vaccine EUA Immediately after getting the vaccine, I experienced severe nausea for 10-20 minutes. I experienced no symptoms for 3-4 hours afterward, but then began to develop a low-grade fever, muscle aches, a headache, and became nauseous again. Around 12 hours after getting the vaccine, I developed a fever of 102 F, I began to experience severe muscle aches and cramps in my calves and abdomen. I also began to develop a much worse headache and lost partial vision in my right eye for a few hours. This is when I became violently nauseous, but I was unable to throw up, or defecate. I was unable to sleep during this time, and at 2 am, my nausea peaked, and I threw up incredibly violently and incredibly suddenly. It was so violent, it caused me to pop a blood vessel in my eye, and gave me a sore throat. However, after throwing up, most of nausea subsided. At this point, the vision began to return to my eye. 20-40 minutes after throwing up, I began to experience chills that lasted for up to an hour. Eventually, I slept at 4 am, but slept fitfully, and woke every 40 minutes to 2 hours. At 7 am on the 9th, the nausea was completely gone the day after my vaccination, but the muscle aches and headaches were back. My fever was down to 101, and I took some Tylenol and slept fitfully until 2 pm when I woke up feeling significantly better.

Symptoms started around 9:15pm on 4/8 ??Mild Arm Soreness initially ??Fever of 100.0 at 10pm. 101.4 at 11:30pm, 99.6 at 4am ??Chills/Tremors: Stop and Start after a couple minutes. Did not stop until 2am ??Hot Breath; Felt like fire after cold water ??Extra Discomfort on lower back/sides ??Jaw Pain after chills stopped around 11:50pm. Took Advil to help Symptoms for 4/9 ??Sharp pain in chest when breathe in too hard at 4:50pm ??Fatigue all day. Only got out of bed to pick up mail and use the bathroom ??Diarrhea at 6pm. Couldn't keep anything solid down except oranges and bone broth ??Chest Pain after 8:30pm: Put ice pack on chest and it relieved pressure. It feels like something is stuck down my esophagus, even though I have not been able to eat anything solid.

My school, hosted a clinic and pressured students to receive the vaccine, threatening them with an email saying we may not be able to return to school the next semester if we did not receive the vaccine in the next day and a half. I felt extremely dizzy after recieving the vaccine, and I've never felt like that after any shot before, sho I was concerned. Within five hours, I started feeling really weak, and I developed a fever. In an hour, my fever rose to 104, my hands and feet were blue, and I felt so cold my fingers and feet were numb. I couldn't breathe, and I started coughing every time I took a deep breath. My entire body ached and I had stabbing pains in my abdomen. This was the worst pain I had ever felt in my life.

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

Within 5 hours started with a fever of 101.8, and 9 hours after shot started vomiting (more than 10 times) and fever reached 104.6, headache and chills

Janssen COVID-19 Vaccine EUA: uncontrolled muscle contractions causing full body shivers as if cold including teeth chattering; body shivers lasting over 30 minutes causing muscle ache and joint ache

CHILLS; NAUSEA; This spontaneous report received from a parent concerned a 19 year old female. The patient's height, and weight were not reported. The patient's past medical history included asthma, 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) dose was not reported, administered on 04-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea on 05-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210412007.

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

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

I woke up with a headache at 7:30 am and a dry mouth. I got out of bed to get my water bottle, which exacerbated the headache. I tried to go back to sleep but kept waking up to drink water every half hour or so, until 10:18 am. I got out of bed to fill my now-empty waterbottle. The headache rotated and became more intense as I got up. I could only walk very slowly and tried to keep my eyes closed. Around 12:00 pm I took one tylenol. The headache is still present. It is not located in any specific part of the brain but moves around depending on if I'm sitting, standing, or laying down. During that time I also felt nauseous, but I no longer do.

The patient called the pharmacy today reporting that she has muscle aches and headache following her Janssen vaccine on 4/8/21. She states she developed numbness in the left cheek starting on 4/9/21. For reference she says the vaccine was given in the left arm. The numbness comes and goes. I encouraged her to register for VSAFE and report her symptoms and to notify us if anything else develops.

Patient became diaphoretic, vomited clear liquids, Patient placed in wheelchair and moved to room and placed on cot. VS remained normal throughout event. patient observed for 35 minutes. patient left after stating she feels normal and will drive myself home. Patient advised to call PCP or 9/11 if need arises.

Headaches, muscle aches, chills, fatigue, fever, nausea, vomiting. Felt chills and fatigue first, followed by headaches and muscle aches. Fever was treated with Tylenol, vomited twice

At around 4 pm the day I got the vaccine, I started feeling drowsy. I didn't think anything of it. However, about an hour later I was experiencing full body aches. This was eventually followed by chills, aches and pains, a cough, and a fever. These symptoms went away around 1 am that night of April 10, 2021. Then they returned around 3 pm the following day. Then went away again around 8 pm.

had delayed reaction. Threw up 2 hrs later. 7 hrs later aches, low grade fever increased to 103.5 overnight. Given Advil didn?t respond, switched to 2 extra strength Tylenol, slowly reduced fever. General feeling of aches, pain everywhere. Took 2 more Extra Strength Tylenol and reduced the fever to 100.2 mid next day. Felt better by end of second day. Left fatigued by 3rd day.

Mild symptoms began around 4:30pm (nausea, chills, headache, fever of 101). I took a nap around 7:00pm and when I got up around 8:30 my fever was 102. It continued to go up until it hit 104.6 around 9:00. My chills were gone, I was a little achy and had a headache, and was unconsciously crying even though I was experiencing very little pain. I took some Tylenol, and it went down to about 101 at 10:00pm. It stayed around 101 for most of the night and was back to normal by morning. We had called the hospital and they said there's nothing they can do for vaccine symptoms, but I thought I should report the high temperature.

By 9:15 pm I developed a splitting headache, I could not look at any light. I tried wearing sunglasses but that didn't help. I was dizzy. I had taken Advil at 8:30 and my temperature was still 100.5. (I kept taking Advil and my temp remained at 100.5.) The pain in my head was the worst I had ever felt and was intense and stabbing .I had waves of nausea, and had extreme chills. I had severe hot and cold flashes. I also had a stomach ache. I tried to watch TV but it was too painful. I was really scared and I did not think the night would end.

While in observation area, patient started to feel dizzy/lightheaded, sweaty/numbness to hands/feet, "static" vision. BP after laying supine: 107/68, Pulse 58, repeat BP 10 minutes later after rest/hydration/snack: 120/83, Pulse 84. last meal/snack/drink: 2.5 hours prior to vaccine- fruit smoothie Prior history of syncope from tooth extraction/flu illness Patient gradually recovered after rest/hydration/food.

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

Woke up about 1am the morning after getting my vaccine with chills, body aches, and a strong, consistent headache. Woke up every half hour to an hour after that until about 8am. Experienced chills until about 10am. The body aches lasted until about 10pm of the same day, getting less and less severe as the day went on. The headache lasted until about 11:30pm. I took two Aleve to help with the headache around 12pm and it helped fairly well, although it still lingered. I felt nauseous for periods of 5-30 minutes about throughout the day, about 5 or 6 times total. I went to sleep that night and woke up this morning feeling normal besides being slightly tired.

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

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

Patient passed out/syncopal episode with head injury approximately 16 hours after getting vaccine per patient. Patient states she had a headache, fever, body aches, chills approximately 7 hours the vaccine. Patient sustained a head injury/possible concussion with nausea, head pain, irritability after syncopal episode.

101.8 fever Muscle pain in neck Shooting pains in spine, hips, and legs, focused on the joints Lasting headache Brief sore throat

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

Patient received her vaccine and was being observed in the observation area upon becoming diaphoretic, pale, clammy and not looking well. RN approached asked if she was having difficulty breathing and pt reported yes. initially unable to obtain pulse or 02 reading. BP 58/38 and Epi injection was administered to the right outer thigh. Patient color and vitals started to improve and breathing was better. patient also was placed on cot in supine position initially. Last set of vitals prior to EMS arriving was BP 84/72, p-71, 02-99% and respirations are 22.

Patient has felt Blurred vision, extreme nausea. Numbness in hands and legs. sweaty and most imp. Felt CHEAST PAIN from it.

Syncope 1 minute witnessed by clinic staff in monitoring area approximately 10 minutes after vaccine administered. Patient denied chest pain, shortness of breath, abdominal pain and dizziness. Patient's skin assessment: pale, cool, diaphoretic. Vital signs obtained: BP 110/60, HR 84, Pulse Ox: 99%, RR 18. Patient remained in medical monitoring area for 30 minutes with no further reaction. Patient given fruit snacks and juice. Patient's skin color returned to normal, stated she felt better after lying down and eating.

About 4 hours after the injection I began to feel extremely tired and took a nap for a couple of hours. When I woke up at 5 pm I noticed body aches and chills, and a migraine that would get substantially worse and became throbbing when I would sit up or stand. After taking some Tylenol (300 mg) I thought I was able to walk for small periods or time (aka walk to the bathroom) but I fainted on the way back

4/11/21 fatigue weakness slept 5 hours 4/12/21 chefs pain, clammy dizzy, fainted Headache 4/13/21 trouble tracking, time. Clammy, dizzy, fainted, headache, vomit, body aches, fatigue, tingling, shaking, cheats pain

Patient developed complaint of headache and dizziness , "whoozy", post vaccination nearly immediately after injection. Stated prone to dizziness when gets shots. Not SOB no rash. Monitored over 30 minutes, given juice, blood sugar 89 BP 129/78, EMS on scene and assessing along with NP. Pt felt better and discharged from vaccination clinic but about an hour later patient called to report dizziness and persistent headache and returned to vaccination clinic for re-evaluation. EMS on scene administered 2L o2 via NC for comfort as pt highly anxious and tearful reporting feeling dizzy and frontal HA. Is not with Shortness of breath or chest pain. Advised transport to ED for further evaluation and management

Extreme back aches, extreme nausea, slight headaches, and fatigue. Took Advil which helped side effects but was still in pain for three days after vaccine.

SWEATING; NAUSEA; EXTREME FATIGUE; This spontaneous report received from a parent concerned a 19 year old female. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced extreme fatigue. On 08-APR-2021, the subject experienced sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, extreme fatigue, and sweating. This report was non-serious.

Weakness/Fatigue starting the evening of the injection and persisting for about 48 hours. Chills/fever, nausea, and lightheadedness starting the next morning. Loss of consciousness (Uncertain if it was vasovagal syncope or seizure) 10:30 pm the next day.

Fever, chills, severe headache (between eyes). Severe pain with moving eyes. Symptoms lasted approximately 8 hours. Symptoms returned 10 hours after they diminished for another 8 hours.

Received the vaccine at around 7:15pm. Left the vaccination site and about 2 hours later experienced extreme tiredness and extreme head pain. Head pain progressed and got worse and worse. A fever was present by 3am (99.0) and went up every hour reaching the highest of 102.7. I experienced violent chills and shaking, extreme nausea, extreme muscle aches and pains, extreme light sensitivity, dizziness, lethargy, and extreme weakness. I took extra strength Tylenol every 6 hours to control fever and other symptoms. All symptoms subsided within 24 hours, except for headache, tiredness and aches and pains. All symptoms went away by 8pm on 4/13/2021.

At about 6PM the same day, I began violently shaking and experiencing severe pain in my hips, back, neck, and all of my leg muscles felt like they were about to cramp. I started having a very severe headache. Today, the next day, I still feel severe joint pain but my headache has been lessened by tylenol. I feel nauseous, am experiencing diarrhea, and am very cold and sweaty.

Nausea Vomiting, Dizziness Sever headache, Server sweating so much she had to change her cloths multiple times and left wet marks on chairs, had to change sheets.

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

Nausea onset the evening vaccine was received - 03/08/2021. Severe headache the following day 03/09/2021. Symptoms persisted and continued to progress/worsen. Patient presented with neck stiffness, chest tightness, difficulty breathing, severe migraine. Admitted to hospital where she was tested for viral meningitis and had lumbar puncture and CT Scan. Treated with steroids.

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

Fever, headache, body aches, chills, nausea. Took Advil. As at 4/13/2021 still have headache and body aches.

High fever, entire body sore in all joints, extreme nausea, diarrhea, dry heaving, vomiting. I took no medication in efforts to prevent change in effectiveness to vaccine. Severe symptoms were between 11PM and 4AM. Afterward continued to have a fever and slight soreness until later in the night.

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

Cold chills, sweat, nausea, vomiting, horrible headaches, dizziness, and lightheaded, burning sensation around abdominal area, difficulty breathing.

Started with chills then led to a fever, gave me a headache, and body ache. Took 2 Advils for it and put some cold cloths around my body to bring down the fever. Fever was gone by 5am so it only lasted approximately 6-7 hours. All symptoms were gone by the next day.

On 4/8/2021 I developed a headache after receiving the Johnson and Johnson vaccine. I took the next few days easy, and laid in bed for the majority of the weekend. On 4/10/2021 I left my residence to get dinner and noticed I was short of breath just walking from the building to my car. The shortness of breath worsened over the next few days. On 4/13/2021 I called a clinic and told them I had been short of breath and they directed me to the ER. I arrived to the ER around 2:30 in the afternoon. They ordered a chest x-ray and ran a test to determine if I could have a blood clot. The test came back with results indicating I could have a blood clot, so they did a chest CT and an MRI. The chest CT showed a blood clot in my left pulmonary artery. They prescribed a blood thinner, told me to stop taking oral birth control, and discharged me.

Daily headaches of varying severity without any accompanying neurological symptoms since the day after vaccination. Headaches described by patient as " worse than usual".

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

Patient presents headache, lower backache, chills, N/V, photophobia, weakness x 7 hours. Patient reports symptoms have been worsening after being sent home from work at 1430. Received J&J COVID vaccine at 0800.

Extreme fatigue lasting over a week, inability to workout without abnormal extreme soreness, poor digestion and nausea for over a week, looking pale and gaunt to the degree of notice by others, overall feeling bad consistently over a week.

Fever, HA and body aches x 2 days after receiving J&J vaccine on 13 Apr 21. Pt report taking tylenol and ibuprofen with minimal relief; last dose meds yesterday at 1800.

Insomnia first night, fever lasting a few hours beginning 12 hours after the shot. Body aches and exhausted muscles the next day. Night sweats lasting four days (ongoing), swollen lymph nodes in neck. Left lymph node is the size of an egg, right node the size of a grape. Nodes are getting so swollen it is affecting ability to eat, drink, swallow and talk. Feels as if it is restricting throat. Taken single acetaminophen dose night of the vaccination (4/11/21), and one 4/15/21.

VOMITING; CHILLS; This spontaneous report received from a parent concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, 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 chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, and chills. This report was non-serious.

19 year old, female patient received the J&J vaccine on 4/12/21. Today, 4/16/21 she reported chills (the night of), headache and abdominal pain since then, and also that she cannot feel the right side of her face. Went over the EUA information for J&J such as side effects, etc and recommended for patient to contact her health care provider/seek medical attention as a precautionary measure.

Started a mild headache a few hours after the shot, then progressed to a moderate headache that evening with body aches. Friday morning, woke up with chest tightness. By Friday afternoon, headache was blinding, and can't breathe well. Go to ER around 430pm. Had fever of 100, tachicardia. Given IM Tordol to help with the fever, body pains, and migraine. Sent home withSteroid inhalants through nebulizer prescribed and picked up at 6pm and started at 7pm that evening. Sunday morning at 4am, back at ER for severe can't breathe, migraine back. Tachicardic again. IV Benedryl, Reglan, and Tordol given. Sent home. Body aches remained, headache stayed moderate from Sunday to Thursday at 2am, when headache became blinding again, chest was tight again. Back to ER. Given muscle relaxer and sent home.

Patient claims she felt dizzy after vaccination and lost consciousness near checkout lane approximately 10 minutes after vaccination. She was assisted by asset protection staff and pharmacy staff. She left the store under her own power. She reported that she has had headaches and dizziness after the vaccination and was seen at an urgent care that did not provider her with a diagnosis, but felt her symptoms may have been caused by a concussion. She was advised by clinical team to contact her primary care doctor to follow-up, especially with recent reports of thrombosis linked with the J&J vaccine.

SEVERE PAIN IN TEMPLE; VOMITING; ACHINESS; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 40z1AZ1A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced severe temple pain. On 06-APR-2021 03:00, the subject experienced vomiting. On 06-APR-2021 03:00, the subject experienced achiness. On 06-APR-2021 03:00, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, achiness, chills, fever, and severe temple pain on 06-APR-2021 13:00. This report was non-serious.

CHEST PRESSURE; FEVER; MUSCLE ACHES; HEADACHE; CHILLS; This spontaneous report received from a parent concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced fever. On 07-MAR-2021, the subject experienced muscle aches. On 07-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99-100.5 F. On 08-MAR-2021, the subject experienced chest pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, fever, and muscle aches, had not recovered from chest pressure, and the outcome of headache was not reported. This report was non-serious.

FEVER; CHILLS; FATIGUE; VERY BAD HEADACHE; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight was not reported and height was 67 inches. The patient's concurrent conditions included non alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced very bad headache. On 13-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 12-APR-2021, and had not recovered from fatigue, very bad headache, and fever. This report was non-serious.

Approximately 6hrs after receiving the J&J COVID19 vaccine, patient developed headache, fever, body aches and abdominal pain and bloating. The fever and body aches resolved but abdominal bloating and pain, fatigue/malaise, and headache has persisted. Patient was seen in the ER for abdominal complaints on 4/14/21 and her labs revealed elevated liver enzymes, her abdominal US was unremarkable. patient was discharged home and asked to follow up with PCP. Her repeat CMP in our office on 4/16/21 revealed similarly high liver enzymes. I evaluated patient on 4/19/21- she continues to have abdominal bloating and pain, fatigue/malaise, and headache without improvement. Her additional labs and imaging are pending

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

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

Janssen Covid vaccine was received on 3/15. On April 14th, the female teenager began experiencing symptoms that felt like a severe cold. Out of an abundance of caution she scheduled a Covid test on April 16th. Despite wearing a mask and social distancing where possible, she was exposed for a very short period of time to another student who tested positive. The female teenager received a positive test result on April 19th and continues to experience symptoms that have gotten more severe in nature.

DIZZY; HEADACHES ON RIGHT SIDE BY EARS; GROGGY; FELT OUT OF IT; SOARED AROUND ARM; TIREDNESS; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight was 380 pounds, and height was 71 inches. The patient's concurrent conditions included pre-diabetes, high blood pressure, pollen allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced groggy. On 02-APR-2021, the subject experienced felt out of it. On 02-APR-2021, the subject experienced soared around arm. On 02-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced headaches on right side by ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soared around arm, and tiredness, and had not recovered from groggy, headaches on right side by ears, dizzy, and felt out of it. This report was non-serious.

BODY ACHE; NAUSEA; CHILLS; VOMITING; HOT FLASHES; MIGRAINE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced hot flashes. On 12-APR-2021, the subject experienced migraine. On 12-APR-2021, the subject experienced chills. On 12-APR-2021 18:00, the subject experienced nausea. On 13-APR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and the outcome of vomiting, hot flashes, body ache, chills and migraine was not reported. This report was non-serious.

STOMACH ACHE; FELT HOT INSIDE; THROWING UP; STARTED HAVING RUNS; CHILLS ON AND OFF; HEADACHE; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced stomach ache. On APR-2021, the subject experienced felt hot inside. On APR-2021, the subject experienced throwing up. On APR-2021, the subject experienced started having runs. On APR-2021, the subject experienced chills on and off. On 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 stomach ache, headache, felt hot inside, chills on and off, throwing up, and started having runs. This report was non-serious.

BURNING NEEDLE IN INJECTION SITE; STOMACH ACHE; FEELING HOT INSIDE; THROWING UP; HAVING THE RUNS; CHILLS ON AND OFF; HEADACHE; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced stomach ache. On APR-2021, the subject experienced feeling hot inside. On APR-2021, the subject experienced throwing up. On APR-2021, the subject experienced having the runs. On APR-2021, the subject experienced chills on and off. On APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced burning needle in injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, headache, feeling hot inside, chills on and off, throwing up, and having the runs, and the outcome of burning needle in injection site was not reported. This report was non-serious. This case, involving the same patient is linked to 20210435721.

CHILLS; HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced headache. On 30-MAR-2021, the subject experienced fever. On 30-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, fever and nausea was not reported. This report was non-serious.

BODY ACHES; SHAKING CHILLS; FEVER OF 101.4F; HEADACHE; NAUSEA; PAIN/SORENESS AT INJECTION SITE; This spontaneous report received from a parent concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mild asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced shaking chills. On 12-APR-2021, the subject experienced fever of 101.4f. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced pain/soreness at injection site. Laboratory data included: Body temperature (NR: not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking chills, fever of 101.4f, headache, body aches, nausea, and pain/soreness at injection site. This report was non-serious.

She has a history of Bipolar II, dx about 2 years ago. She has been in counseling for the past 5 years. She just changed from effexor to lexapro about 1 month ago. She has been on abilify 10mg for the past ~6months. On 4/8/21 she went to bed around 11pm and awoke on 4/9 around 8:30am. She had her JJ covid vaccine on 4/9/21. She had 2 handfuls of goldfish crackers on the way to her vaccine appointment around 11am. She had ~6-8oz of water when she awoke. She arrived at the Clinic on campus. She sat down for ~5 minutes and then the staff came to get her. She had the shot administered in left deltoid. When she first felt the pain her vision started to go black and she felt like she was going to pass out. She denies feeling hot or dizzy prior to event. Her vision went completely black, then when she "came to" she was bent over in her chair with arms drawn up to body and fists clenched. Immediately her body relaxed and she felt very confused. She was told she just had a seizure - bend forward and had whole body shaking for ~30 seconds. She felt extremely nauseated and had some dry heaving. Someone helped her to the floor and put up her legs. She was told she looked very pale. She felt much better within 5 minutes. Vitals were checked and were stable. She was given granola bar to eat and drank ~12oz of water. No one sided weakness, no incontinence, no tongue bite. She stayed there for ~45 minutes for monitoring. Someone walked her to her car, asked her if she was ok, and then she drove herself home. Of note, the room she was in was warm and they were going to open doors to get some air. She was not ill or tired at the time. After the event she drove for 5 minutes to her home. Once in her room she felt extremely tired and then slept until 7pm (~6-7 hours). She then called Mom. Mom reports that patient sounded different on the phone. Speech was slow and she seemed "off." Mom drove to her and was at her room by around 7:40pm. At that time, patient looked very pale to Mom. Mom took her home, gave her chicken soup. She did not have an appetite. She just wanted to go to sleep. Mom tried to have her stay up until around 10pm. She had ~8oz of water and then went to bed. She slept through the night. She awoke the next morning and reports that her brain felt like it hurt to work. She had chills, body pain, shakiness during the day on 4/10/21. This was easily managed by tylenol q4. Of note, she did have covid19 in 8/2020. She was ill for ~1 week with lack of smell/taste, febrile, shakiness, headache. She had an odd event on 4/19/21 while giving a presentation at school. She had sudden onset of left pinky numbness/tingling with radiated up the side of her forearm. This lasted ~1-2 minutes. However, her left arm hurt for a few hours afterward. She denies any fatigue after event. She has a Mirena IUD. She smokes nicotine via vape numerous times per day. She smoke weed up to 3X/day but not every day. She drinks beer a few days per week.

SEVERE VAGINAL ULCERS; SEVERE HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid positive, and concurrent conditions included vaginal ulcers not related to sexually transmitted infections, and not sexually active, 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: 1802070 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On AUG-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 15-MAR-2021, the subject experienced severe headache. On 15-MAR-2021, the subject experienced fatigue. On 17-MAR-2021, the subject experienced severe vaginal ulcers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, and had not recovered from severe vaginal ulcers, and fatigue. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

TUNNEL VISION; EXTREME BODY ACHE; DIZZINESS; VOMITING; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a 19 year old female. The patient's weight was 112 pounds and height was 66 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 10-APR-2021 at11:30a.m.in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The parent reported that the patient on 10-APR-2021 experienced tunnel vision, extreme body ache, dizziness, vomiting, chills, headache and nausea for which eight hours later patient went to the emergency room where the patient was given two bags of intravenous fluid and rotated ibuprofen and paracetamol when awake. The patient was also given Benadryl at evenings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tunnel vision on 11-APR-2021, and vomiting, and chills on 10-APR-2021, was recovering from extreme body ache, headache, and dizziness, and had not recovered from nausea. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210428952- covid-19 vaccine ad26.cov2.s-Tunnel vision, extreme body ache, dizziness, vomiting. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210428952- covid-19 vaccine ad26.cov2.s-chills, headache, nausea. These events are labeled per RSI and are therefore considered potentially related.

SICK; FEVERISH; TIRED; This spontaneous report received from a consumer concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 sick. On APR-2021, the subject experienced feverish. On APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, fever, and tired on APR-2021. This report was non-serious.

extreme muscle ache. fever. Excruciating back pain. loss of appetitie. flu like symtoms. Worst pain all over my body

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

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: 5 minutes after vaccine pt felt lightheaded and blurred vision. then passed out. patient advised to sit down then passed out again and started to shake head (seizure like symptoms) for a few seconds. patient was pale, confused and started sweating, fingers were cold to touch. Then her fingers started to get numb and tingly. she was having a hard time seeing colors and she started having ringing in ears. Ambulance was called and they took over.

NUMBNESS AND TINGLING IN ARM; IT STARTED IN HER LEFT PINKY AND RADIATED UP THE LEFT ARM. IT HURT FOR A FEW HOURS; BRAIN HURT; SHAKINESS; BODY PAIN; CHILLS; EXHAUSTION; SEIZURES; This spontaneous report received from a health care professional concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 09-APR-2021 on left deltoid for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 09-APR-2021, the patient experienced seizures, confusion, pale appearance and nausea after forty five minutes patient was okay. The patient was drove back home and slept for 7 hours then experienced exhaustion. The next morning on 10-APR-2021, the patient's brain hurt to work and experienced body pain, shakiness, chills. Ten days later on 19-APR-2021, the patient experienced numbness and tingling in left arm. It was started in left pinky finger and radiated up the left arm. It was hurt for a few hours (just 1 episode). health care professional has ordered tests but they had not been completed yet. The patient was seen by a pediatric neurologist on 22-APR-2021 for evaluation of seizures. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures, exhaustion, chills, body pain, shakiness, brain hurt, numbness and tingling in arm, It started in her left pinky and radiated up the left arm, It hurt for a few hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210450038- JANSSEN COVID-19 VACCINE Ad26.COV2.S-Seizures. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

19y/o AD female w/fever,chills,HA,and cough. Had J&J vaccine yesterday and states she is feeling worse today. PT states she had a sore throat and sinus infection before getting the vaccine x1week. denies N,V,D. Has not taken any meds for pain.

Severe arm pain, headache, swollen cheeks, periorbital rash, lip angioedema, and shortness of breath all within 1 hour of receiving the vaccine

HEADACHE; This spontaneous report received from a parent concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine. 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 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.

After about 6 minutes post-injection, she started feeling really dizzy and briefly passed out. After a couple minutes she was responsive, but still really weak and tired and said she had blurry vision. We called 911 and they came in and monitored blood pressure and heart rate, which was really low when they started, but did come back up into normal range and patient was feeling much better after about 15 minutes, but still tired.

PATIENT IMMEDIATELY FELT DIZZY AND PASSED OUT A FEW SECONDS LATER. THE VACCINATOR WAS NOT ABLE TO CATCH HER FALL AND SHE FELL OUT OF THE CHAIR AND HIT HER FOREHEAD. PT WAS IN AND OUT OF CONSCIOUNESS Q5 MIN, UNRESPONSIVE TO PAINFUL STIMULI, AND MUCOUS MEMBRANES WERE BLUE FOR 30 SECONDS BEFORE JERKING AWAKE AND COLOR RETURNED TO NORMAL. SHE DENIES NECK PAIN, HEADACHE, AND SPINE INTACT. SHE REPORTED DIZZINESS, BLURRED VISION, AND RINGING IN THE EARS FOR Q15 MINUTES UNTIL RESIDED. PT PRESENTED WITH DIAPHORESIS UNTIL HER REPORTED SYMPTOMS RESIDED. VITALS, CLEAR LUNG SOUNDS, AND GLUCOMETER WERE DONE. MEDICS GAVE ORAL GLUCOSE. VITALS MONITORED UNTIL STABLE. PATIENT STAYED WITH FIRE Q1H AND SIGNED AMA WITH FIRE TO GO HOME. SCHOOL SECURITY WALKED HER HOME.

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

c/o fever, chills, lightheadedness, and generalized body aches after receiving J&J COVID vaccine yesterday. Pt states she is currently feeling better than last night with OTC medications.

Pt is a 19 YO female with NKA who received her J&J COVID-19 vaccination on 4/10/2021. On 4/13, she calls this instiution stating she has developed a severe headache, sores on her vagina, shortness of breath, is light-headed and tired. Pt was recommended to call 911 or go to the ER but declined. She had a Ob/Gyn appointment scheduled for the next day (4/14) and says she will discuss her symptoms with them. RN on the phone call reviewed signs and symptoms of blood clot and recommended immediate assessment. Unable to gather any additional information.

shortness of breath, pain in legs specifically hip and knee joints. fever of 103. cold sweats, body aches. extreme headache. hallucinations

Nausea and dizziness and diaphoretic. Past in a couple of minutes. Observed for 30 minutes. VS stable.

BACK OF NECK WARM TO TOUCH; PAIN ON BACK OF NECK; HEADACHE; FEVER; This spontaneous report received from a parent concerned a 19 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: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: acetylsalicylic acid, and ibuprofen. On 06-MAY-2021, the subject experienced back of neck warm to touch. On 06-MAY-2021, the subject experienced pain on back of neck. On 06-MAY-2021, the subject experienced headache. On 06-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on MAY-2021, and had not recovered from headache, back of neck warm to touch, and pain on back of neck. This report was non-serious.

First symptoms were fever of 103.5 at midnight on the 28th. I called the RA on call in my university department and they called PD - to come and make sure I was okay. For 36 hours, I felt terrible - couldn't do anything. About 1 1/2 to 2 weeks later, I started getting really severe back pain that made it hard for me to do things - even sitting in a chair caused so much pain or walking or standing for long periods of time made me light headed because it was intense pain. There was one instance, when I nearly passed out from the pain but I didn't as I called for help for someone to catch me. It kind of moves around - the pain - sometimes it's a along my spine and sometimes it's low below my shoulder blades. I'm still having this pain. It's not on the same pain scale as it was a couple of weeks ago. It's more manageable right now. I do stretches and some medications and there are a couple of patches - Salontas - that my dad uses that he recommended I try to use for backaches. I am calling my doctor today to make an appointment.

19 yo otherwise healthy f c/o ongoing mild diffuse ha w/o visual changes, dizziness and nausea w/o vomiting x24hrs s/p J&J vaccine yesterday; Pt denies any cp, sob, rashes, dyspnea, abd pain/cramping, prior hx of vaccine rxn.

Patient said she had ringing in ear, and was nauseous immediately after immunization. Patient appeared pale, sweaty, and shaky. I told the patient to put her head between her knees. She regained color within minutes. She felt better but we called 911 just to be safe. The patient and the EMT decided the she would be driven home bu her mother to rest.

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

Patient felt lightheadedness and headache after shot. Put pt up for legs elevated, patient felt better instantly,. She was monitored for an extra 10 minutes until symptoms subsided. Patient left with mother

Shivering, cold, sweating, dizziness, stomachaches, nausea, headaches, soreness, loss of appetite, extreme exhaustion, drowsiness.

Chills, fever, nausea, body aches for a week after vaccination. Headache since the vaccination with no relief.

Patient reports receiving Jansen vaccine around 5:30 pm at the pharmacy. The patient then went home and went to bed. She woke up around 1:00 am on 5/27/2021 with numbness/tingling/pain in the left arm and in both legs. She states "it hurts to even stand on my legs". This has persisted all day and is not getting better. She has contacted her PCP and the pharmacy and they informed her to call us. Other symptoms include headache, jaw pain, dizziness body ache (mostly lower back) and cough. None of these symptoms are normal for her.

After administration the patient stated that "it felt weird". She moved her arm around a little and said she was afraid to move it too much. A minute later she said she felt like she was going to pass out. She leaned against the wall and her eyes started to close. I noticed that she was starting to break out into a sweat. I asked it she was having trouble breathing, if her throat felt like it was swelling or if she felt nauseous. She said no, just dizzy and really thirsty and asked for some water. I asked again if she was having trouble breathing or was nauseous and she said no, then passed out. I took her blood pressure, which was normal. After a couple of minutes she started to wake up, although not fully, and asked what happened. I told her I had given her a COVID vaccine and asked if she remembered that. She said yes then seemed to pass out again. I then decided to call 911. A minute later the patient woke up. I asked how she was feeling and she said better. After a minute she asked if she could sit up and I said yes, as long as she felt she could. I took her blood pressure a second time. By the time EMS arrived the patient was fully alert, we were having a conversation and she said she felt fine. EMS checked her over but she refused to go to the hospital. I had her sit a few more minutes while I filled out her immunization card. When she left she said she felt completely fine.

Patient first noticed nausea. Patient then felt like she was going to throw up and was sweating. We provided patient with a bottle of water and garbage can. Patient left after her 15 minutes stating she was feeling better.

BODY ACHES; LOW GRADE FEVER; VERY TIRED; This spontaneous report received from a parent concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A,expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced tiredness. On 25-MAY-2021, the subject experienced low grade fever. On 25-MAY-2021, the subject experienced body aches. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from tiredness on MAY-2021, and low grade fever, and body aches on 25-MAY-2021. This report was non-serious.

Extreme chills, fever, and difficulty breathing from 11:30 pm to 4:00 pm this morning. Considered hospitalization but can't afford it.

Patient recieved vaccine and in appoximately 5 minutes stated she didn't feel right. Momentary loss of conciousness then "I feel sick going to throw up" proceeded to vomit. Staff called 911. She was shaking and upset. EMTs arrived and checked pulse and other vitals. After observation for approximately 30 minutes from time EMTs arrived, patient , her father, EMTs and pharmacist agreed she did not need to go to the ER.

PT presents with back and head pain with abd cramping x 1500. reports fever of 101.9 took tylenol motrin 2030. received JJ vaccine 1055.

Patient says she wasnt feeling well about 3 hours after shot. She went to the ground and reports feeling paralyzed. She says it lasted for about 6 hours and she also started to vomit after 4 hours. When she was able to move again she reported having a headache that lasted for a few days. Patient says she is feeling fine now with no symptoms or issues.

Systemic: Dizziness / Lightheadness-Medium, Systemic: patient said her ears felt like she was under water-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: within 5 minutes of vaccination, pt said she felt like she was going to pass out, her vision was blurry/weird & her ears felt like she was under water. She was sweating & felt clammy and I asked if she ate/drank today and she said she had about 2 hours prior. I helped her to floor % put her in recovery position. after 2 minutes pt stated she was starting to feel better. After 10 minutes patient was able to get off the floor and back into a chair. Had her drink gatorade, her bp was normal.

The night of vaccination I had fever, aches and body chills that lasted for 4 days. On the 6th day after the vaccine the chest pains started. I've been seen in the ER three times now. A stabbing pain under my left breast that is continuous.

Patient felt light headed/dizzy and sweaty after receiving vaccine. Assisted to mat on floor and feet elevated. Symptoms resolved. No loss of consciousness or injury. Initial vitals 121/79, pulse 72-regular, rr 16. Sat up after 10 minutes, BP 112/66, pulse 75. Bottled water provided. Observed and monitored for 30 minutes after incident with no further symptoms. She declined further evaluation and was released. BP prior to leaving 100/76 (patient states this is at baseline), pulse 85 and regular.

Headache and vomiting since she had a Janssen yesterday. Took some tylenol @1700 without relief. Denies chest pain, difficult breathing.

Called health system call center to report chills, difficulty breathing, shortness of breathe and throat hurts when she speaks. She took a tab of 500mg tylenol yesterday after the vaccine and one about 2hours ago.

The patient fainted upon exiting the vaccine room and sitting back in her observation chair approximately two minutes after the vaccine was given. She was in and out of consciousness for about 10 minutes total, was sweating heavily, and eyes dilated and unable to track. We applied a cold compress and ice packs, and then laid patient down flat. Upon laying her down she quickly came back to consciousness and then the paramedics arrived. Paramedics recommended patient go to the hospital for fluids, but patient felt like she was okay. She went out to the ambulance for further observation and testing.

19 yo female reported to her father she was not feeling well after receiving Janssen vaccine at 15:00. Father flagged observation nurse over as patient displayed a syncopal episode. Client reported her vision went black but did not recall if she lost consciousness. Client became alert without assist. BP 72/50; client appeared pale client given gatorade and reported feeling better BP 100/50 client finished observation and was ambulatory upon leave with father

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

This 19 year old female received the J&J vaccine Monday morning. That afternoon, she experienced uncontrollable crying and then extreme fatigue. As the day went on, she developed the worst headache of her life that made her unable to fall asleep due to the extreme throbbing. She also experienced the chills and vomiting. After a restless night, she felt better the next day besides a minor headache.

Within four hours of vaccination, fever began that continued throughout the night and spiked to 103 Fahrenheit with Tylenol to manage it. Nausea began shortly after fever started; vomiting started partway through the night, time unknown. Severe headache began in the afternoon of the shot and lasted through the following afternoon.

Patient was fine receiving vaccine as well as during the 15 minute mandatory waiting period, however later that evening upon going home she complained of headache and leg pain. Patient was instructed to contact PCP as soon as possible.

Mother called to report pt having the following side effects: fever 102.5, whole body muscle aches, headache, anxiety and shortness of breath. She stated she went to bed around 10:30pm on 7/12/21 with not issues and when she awoke about 2am her daughter was on the couch crying and in pain from the body aches and headache. Mother calling to report event and questions about seeking medical treatment. Advised to go for evaluation or call emergency services if pt is having difficulty breathing or is short of breath.

8 hours after receiving vaccine I began to shake and get super cold. A pounding headache began. Legs were crampy. This continued through the night but was better in the morning.

Chills and sweating 8-12 hours after vaccine Abnormally HEAVY menstrual bleeding July 20+ - never in 7 years has it been this heavy. - normally, I only need to use light-normal pads ?? now I might need a diaper.

After the vaccination, patient reacted in a couple of minutes. She had stressed breathing, body started to drop and she started to sweat. Patient seemed to have loss consciousness for about a minute so we helped her lie down on the floor.

104 fever, hands shaking, extreme chills, headache, dizziness, exhaustion, sensitive to light. This came on quickly, less than three hours after receiving the vaccine. Drinking lots of water. I dod not get sick when I got covid. Was not comfortable getting vaccine but had to get it to participate in collegiate sports.

- severe body aches - high fever (102.6 peak before taking Tylenol) - headaches - tingly sensation in skin - muscle soreness

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

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

100.9 fever, horrible migraine (can't touch chin to neck), chills, sweats, stomach hurts, shivering, body aches, brain zaps, bad neck pain, nauseous Took Tylenol

Patient received her vaccine with 2 family members in the room who also got the vaccine. Moments after (less than 2 minutes) giving her the vaccine, I was giving another family member the injection and patient asked if she could take her mask off. I turned around and she was very pale. She took her mask off and started slumping in her seat. She was taking deep breaths and reported no difficulties breathing. She then became ill and began gagging, at which point I gave her the trash receptacle to vomit in. I had a technician grab the patient a water and packet of crackers. After half an hour of resting in the chair, monitoring her breathing, blood pressure, heart rate, and getting some food and water into her system, she appeared and reported to feel back to normal. Patient's family member mentioned she had a similar reaction a few weeks ago when getting blood drawn at her doctor's office.

Body/Joint aches, headache, sinus pain, fever. Started about 6 hours after vaccination, took ibuprofen about 12 hours after vaccination

Flu like symptoms 8 hours after injection, bad headache, body chills and shaking, felt both cold and hot, couldn't untense legs or relax, body aches. Lasted around 4 hours until falling asleep. Mild headache the next day.

felt fine until about 6 hours after (approx 12 am 03/13/2021) and then i got severe chills, felt feverish, had severe muscle and joint aches, a moderate headache. woke up at 4 am with nausea but no vomiting, still had muscle and joint aches. felt like i had the flu. it's about 13 hours since i got the shot, now having headache, muscle and joint pain, and increased heart rate

Upset Stomach. Diarrhea. Left side of nose started to hurt and burn (same side of vaccine) immediately after vaccination for 10 minutes following.

Took the vaccine at 6:00 P.M. the night before, no side effects besides occasional dull throbbing pain Woke up at 7:30 A.M., right arm is sore and hurts to lift, experiencing chills, fever of 101.3

Immediately after receiving vaccine, a cold, tingling, transient sensation was experienced radiating from the site of the injection up into the neck. Roughly 6 hours after injection (1 a.m., 3/9/2021) severe chills were experienced for approximately two and a half hours, preventing sleep. Patient experienced dizziness. spO2 was within normal limits. Temperature was measured w/ oral thermometer to be 101.3 degrees farenheit at 4:55 a.m. in the morning on 3/9/2021. Treatment was a single dose of ibuprofen at roughly 8 a.m. (3/9/21). Pt. continued to experience fatigue and sporadic chills, with gradual abatement of symptoms over the course of the day. Pt. had no symptoms the following Wednesday (3/10/21). Pt. experienced symptoms the following Thursday (3/11/21), with a sudden onset of intense stomach pain (8/10 on NRS) starting at approximately noon. Stomach pain was more similar to muscle cramps (with aching quality) than nausea. Other symptoms included fatigue and some feverish experiences (such as chills). Treatment was conservative (ginger tea, peppermint candies, rest). Temperature taken that evening via oral thermometer (roughly 7pm, 3/11/21) was 101.4 degrees farenheit. Symptoms were significantly reduced the following morning, Friday 3/12/21. Temperature taken approximately 10 a.m. was within normal limits.

Around 10PM on the day of the vaccine I had full body chills and the worst headache ever. I woke up at 3AM with a fever and then I took Tylenol. I went to the walk in clinic at CVS on Saturday because I was still feeling fatigue, headache, nose bleeds (I was having them before the vaccine about a week before) and sinus congestion, they antibiotics and I was able to get started on them on the same day. I still feel the fatigue, congestion and the sinus pressure/headache. The fever and chills are gone.

Extreme fatigue, headache, sweating, chills, shaking, nausea, muscle cramping, difficulty breathing, and dizziness beginning approximately 6 hours after the vaccination. It was so bad that it caused me to stay in bed all day the day following the vaccine and I had to stay home from school and work. Today I am still extremely fatigued and have a bad headache and dizziness. This was not relieved by the maximum dose of Tylenol.

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

Started with chills Muscle aches began Woke up with fever Dizziness , headache, muscle aches, fatigue for the entire day Swelling in lymph nodes and pain

Fever reaching a high of 101.7 degrees F, whole body muscle aches and pains, migraine, shivers, fatigue, unable to get comfortable enough to sleep, severe facial pain and headache

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

Patient's housemate, called pharmacy 3/26/21 to report pt patient's sx. 3/25/21 approx. 11:00pm fever up to 100.9 F 3/26/21 approx. 9:00am severe abdominal pain, approx. 12:00pm vomiting x2, approx. 3:45pm pt clammy Pharmacist reviewed literature on FDA website regarding Janssen Vaccine ADE's. There was a very small percentage of pts that had appendicitis following vaccine. Although pt is 19.5 yrs old, here sx were also consistent with those experiencing MIS-C due to the virus. Pharmacist recommended pt to contact doctor immediately and follow his/her advice as to the need of further medical care. At 4:30pm 3/26/21 Pharmacist contacted pt to see how she was doing. Pt admitted feeling a little better and able to keep down soup. Pt stated that her provider told her sx were normal s/e of vaccine and that she received the vaccine too early, following 3/8/21 dx of COVID. Pt stated provider ordered meds for abdominal pain. Names unknown and not sent to our pharmacy.

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

Around 9pm I got very short of breath and got very sick. I was very nauseous and the next day I fainted.

Chills, fever, body aches, muscle/joint aches, headache, extremely elevated heart rate (~140 bpm): emergency room visit

At 4:00pm I got lightheaded, dizzy, and achy. The lightheadedness was such that my heart was pounding, vision was lost for a second (similar to the effect when you stand up too fast), and the sound went out for a second. Around 7:00 I got chills, a 101 degree F fever, and headache. The chills, fever, and headache lasted throughout the night, but they were gone in the morning. The entire day after getting the vaccine, 4/1/2021, I had a metallic taste in my mouth. By the morning of 4/2/2021 the metallic taste was gone.

It started with my teeth chattering and chills, but no fever yet. All of the muscles in my body had a severe tremor, and I had trouble with simple tasks like filling my nasal rinse bottle, because the tremor was so bad. My jaw was smacking the entire time, so hard that the headboard smacked against the blinds. Then I checked my temperature and it had gone from 97.5 to about 99.5. The symptoms got worse, and added in excessive thirst, pain at the base of my head where it meets my neck, pressure under and behind the eyes, severe lower back pain, muscle pain escalating on the right side of my body only, nausea, pain across the top of my forehead, and a weird heat sensation under my fingernails? Maybe and hour or so passed, and my fever rose to above 101, and I tried to go back to sleep. By this point the tremors were over, but slight chills and every other symptoms remained. I took my temp later and it was 102.7, and I again had all symptoms except the initial tremors. I also had tachycardia (super rapid heartbeat) and got dizzy for a second and have a little trouble focusing my vision when I sat up in bed.

Patient experienced swelling of the face, eyes, and lips, and a burning sensation in her throat and chest. We called 9-1-1 to check vitals and they recommended going to her doctor or the hospital in case of additional swelling. We called the doctor and they told us to try Benadryl. This worked a little bit, but she is still in a lot of discomfort today (Saturday after Thursday shot).

6:00 headache, exhaustion 7:30 chills/hot, skin sensitivity, headache, exhaustion Headache and exhaustion have lasted 2 days. Chills/hot and skin sensitivity were only the night of the vaccine.

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

extremely restless sleep, persistent mild nausea, minor headache, generally feeling run down and unwell. It's been a little over 24 hours since I got the injection. Symptoms started about 7 hours after injection. Advil helps a bit for nausea and headache

I have chronic tension headaches and yesterday my headache wouldn't go away even with over the counter medication. I felt overall achy but still able to get up and do what I needed to do. Once I went to bed though, I woke up around 2:00a sweating, achy, and with a fever. I couldn't fall back asleep very easily and once I woke up around 7:00a I confirmed I had a fever. I am currently still bedridden with a fever, complete body aches, and slight feelings of nausea. As of right now it is 8:56a 04/06/21 and the symptoms haven't gotten any better. I haven't taken any medication since 04/05/21 at 6:15p ish, which was to treat my headache from yesterday.

Head started feeling groggy at 3:30 pm. At the time of writing this it is about 6:30 pm and it feels like I have a mild flu?chills, headache, general body aches, pressure when sitting up. Chills in particular started at about 3:45 pm. Around 4:15 I had to lay down because I believe the shivering was exacerbating my aching.

FELT LIGHT HEADED; HOT AND COLD SWINGS; BODY ACHES; CHILLS; WEAK; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-MAR-2021 11:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.5 F. On 31-MAR-2021 17:00, the subject experienced felt light headed. On 31-MAR-2021 17:00, the subject experienced hot and cold swings. On 31-MAR-2021 17:00, the subject experienced body aches. On 31-MAR-2021 17:00, the subject experienced chills. On 31-MAR-2021 17:00, the subject experienced weak. On 31-MAR-2021 17:00, the subject experienced fatigue. On 31-MAR-2021 17:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, felt light headed, fatigue, weak, chills, hot and cold swings, and body aches. This report was non-serious.

At first I had no side effects other than a sore arm. However, later on the same day, I began experiencing severe cold chills. The next morning I experienced hot and cold flashes and had a fever.

Started sweating after I got my shot for about 3 minutes. Felt fine for the next few hours. At 9:00 pm I was shaking I was so cold, I was achy. A few hours after that around 10:30-11:00 I was sweating. My arm has been sore the last 3 days. I have/had a mild headache. And yesterday I felt lethargic and tired.

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

Within 5-6 minutes after receiving vaccine profuse sweating was noted, loss of hearing and impaired vision. Also felt extremely nauseous

Severe chills beginning at midnight, stopped at 1:30am. Developed headache. 3:30 am fever developed of 100.9, took tylenol. 8:00 am developed neck and back aches. Fatigued from not sleeping through the night.

CHEST TIGHTNESS; FEVER OF 101.1 F; This spontaneous report received from a consumer concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 3580333, and expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.1 F. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 28-MAR-2021, the subject experienced chest tightness. On 28-MAR-2021, the subject experienced fever of 101.1 F. The action taken with covid-19 vaccine was not applicable. The outcome of the fever of 101.1 f and chest tightness 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.

Felt pain in left arm immediately followed by difficulty breathing, sweating, nausea, loss of hearing and vision. No treatment given. Suddenly felt ok after a few moments. Went home, got full body aches, chills, tiredness, inability to sleep, and diarrhea

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

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

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

When I got the vaccine, I had almost passed out and felt like I needed to vomit. Later, I started getting really cold and shivering, and there was nothing I could do to make it stop. I started getting a headache, nausea, and weakness around that time too, maybe a bit sooner, like 3:00pm. The chills started at around 5:00pm.

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

Severe headache starting around 2 am that only got worse as the day went on and ending around 6 pm. When I woke up at 7 am I became very faint about 10 minutes after getting up and walking around; it sounded like I was underwater, I had tunnel vision, I could not speak coherently, and I was sweating. This subsided about 15 minutes after laying on the cold floor with a cold towel. The faintness completely disappeared after an hour

Racing heart for about 3 hours post vaccination. Heart stopped racing, but turned into a severe headache, fever, vomitting, nausea, full body aches and dizziness. This has been going on for 24 hours.

I began feeling a migraine at 3pm. I took a nap and woke up at 6pm feeling extremely ill. My temperature was 101.5F and my entire body was in pain. I took two Tylenol as suggested. Over the course of the entire evening, I was vomiting profusely; I vomited approximately 10 times. By around 10pm my extremities became numb and I could not walk without assistance. I could not think or speak straight. I nearly fainted every time I tried to sit up. I tried to take ondansetron for vomiting but proceeded to vomit the medication as well. I wanted to go in to the ER because I felt like I was dying, but I do not feel financially comfortable doing so. All symptoms remained consistent until about 3am when I was able to sleep until 7am. I woke up with several bouts of diarrhea, intense nausea, and head to toe muscle and joint pains, as well as numbness and tingling in my arms and legs still. It is now 5pm the next day and I still can't eat or stand for too long without feeling faint. I still have diarrhea and strong migraine.

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

Last night (around 9:00 pm) I became very nauseous and had a severe headache, chills and nausea. I took 2 Tylenol pills and went to bed. At 11:00pm I became extremely ill with a fever of 103 F and vomited 4 times consecutively. I went back to bed, still with a fever and chills. At 12:30 am (April 9th) I again started vomiting again (around 3 times). I then went back to bed and fell asleep. I woke up around 8am (April 9th) still feeling feverish, with chills and a severe headache. I have no appetite and no energy to get out of bed as of right now (11:00am).

6-7 pm began a fever that lasted until the next morning. Did have a few moments of severe chills. Minimal nausea and dizziness. Sore joints, and entire skull hurt. Inner ears also hurt. Slept or 12 hours Headache was also present most of the day before the fever set in. My period started the day before and usually I have heavy days first. I had a light day after my injection and today it's extremely heavy. So it messed with the flow.

Immediately after receiving the vaccine, I experienced muscle pain which lasted for approximately two hours. At 7:00, three hours after receiving the vaccine, I developed a fever and slight nausea, as well as fatigue. I went to sleep at 9:00 and woke up several times during the night with a fever. At 3:00am, I woke up with severe nausea which lasted for an hour. At 6:30am, I woke up with a fever, headache, and muscle pain in my left arm and legs. I took two Advil at 6:40. At around 10:40 my symptoms were relieved.

pt stated that 4 hours after vaccine on 4/8/21 she fainted while at home and hit her arm. She stated that she believes she did not eat enough. She said that after eating and drinking electrolytes she felt better. AS of 4/9/21 she states she has a headache and feels icky. pt stated she did not receive any medical attention

Night of vaccine: severe chills, fever, severe headache Following Day: fever, chills and hot flashes, headache Symptoms mostly subsided on the 3rd day, only a minor headache remained which was progressively better.

Patient stated that she has a previous history of fainting when receiving vaccination, and was nervous to be vaccinated. Patient was seated but became pale, sweaty, and fainted for approximately 5 seconds after receiving the vaccination. Conversation was maintained with the patient through out the entire transaction. Pt was evaluated by emergency personnel, refused treatment, and went home to rest.

Fever, chills, sore/tender arm. Fever lasted about a day, and went down after taking ibuprofen and did not return. Arm was sore for about a week. Symptoms were overall mild

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

5 hours after my vaccine, I developed a bad headache, chills, a runny nose, muscle aches, and tiredness. Around 6:00 pm (7 hours later) I discovered I had a fever. The symptoms are still present at 11 hours post-vaccination.

On 3/21, 10 hours after shot 101 fever. 11 hours after shot fainted Fever for 24 hours 36 hours after shot developed swollen lymph nodes in neck that lasted 4 days

Began with a head ache and slight dizziness followed by shaking/chills, after a while with those side effects I took ibuprofen. Later that night I had a fever, body aches and I woke up nauseous in the middle of the night. Other than being very tired and sleeping very late the next day all side effects subsided by Sunday March 14th.

Began to feel tired/lethargic and had a headache at around 5:30 pm, got feverish and shivery, took a nap and ibuprofen. Checked temp after waking up and had a fever of 101.3°F at 7pm, down to 99.5 at 10pm.

Jansen COVID-19 Vaccine EUA was given to me on 04/09/21 and later in the evening of 04/09/21 I started to feel sore in my arms and legs and did feel tired but not very tired but I don?t know if it?s from the vaccine because I came back from a walk when it started to happen.

About 3 hours after vaccination, intense headache began. My head felt like it was being pounded with a hammer, and the pain was so intense it traveled down from my forehead to my jaw bone. At around 3:00 pm on April 8, I began to develop a fever which first started at 100 degrees Fahrenheit. By around 5:00 pm, the fever had progressed to 102 degrees Fahrenheit, and the 700mg of Tylenol I had taken was not breaking the fever. I started to get body chills, muscle pain, joint soreness, and cold sweats. Again, Tylenol was not helping. I had no appetite and was having trouble keeping fluids down. Around 11:00 pm on April 8, I took more Tylenol and the fever began to break but did not fully break until 36 hours after the vaccination. It is now April 10 and I am starting to feel like myself again, but for a full 36 hours the pain was so intense that even a light sheet covering my body was painful.

Less than 6 hours after vaccination, patient felt intense body aches all over, profound malaise/fatigue, and fever (Tm 103.7).

Beginning the night following the shot, I experienced extreme fatigue and muscle soreness. I spiked a fever of 100.4 in the middle of the night. This morning I was incredibly nauseous and vomited 5-6 times throughout the day.

Headache, 7pm 4/10/2021, currently happening Severe Dizziness (nearly to fainting), 8:30am 4/11/2021, ended 12:00 pm 4/11/2021 Tiredness, 9pm 4/10/2021, currently happening Chills, 1pm 4/11/2021, currently happening

The night after receiving the vaccine experienced fatigue, dizziness, nausea, vomiting, chills, sweats, and muscle aches. The next day symptoms had improved but hadn't gone away completely.

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

(prior report filed incorrect description of event disregard report 427860) At recovery table pt became dizzy, lightheaded, slightly nauseated, pale, diaphoretic. Brought to recovery cot to lie down with feet elevated. Ice pack to back of neck. VS taken 122/80, HR 67reg strong, rest 12 reg non labored, SpO2 97% no LOC, no SOB, no V. Left deltoid site benign - redness - swelling - bleeding. Changed to monitor 30 minutes. Pt stated he was anxious about getting the vaccine. after 10 min pallor, dizziness, diaphoresis and nausea subsided. Provided reassurance, provided water for hydration . Vasovagal response to vaccine. pt stated "I feel much better" Ok'd to exit after 30 min.

FEVER; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and alcoholic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 at 13:00 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 06-APR-2021 18:45, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and chills. This report was non-serious.

Patient fainted and had seizure like symptoms with eyes rolling back in head, clamminess, sweating, severe stomach cramps, blurred vision, and temporary loss of hearing

Weakness/heaviness of the right side of the body, headache only on the right side of the head - lasted ~30 mins. Flulike symptoms, fever, general headache - lasted 24 hours. Extreme fatigue - lasted 4 days.

Within 1 minute of receiving the vaccine, patient reported not feeling well. Administrating technician called for assistance from the pharmacist. Patient was breathing but was unresponsive. Pharmacist instructed store manager (also on scene) to call 911, and gently laid the patient on the floor. Within one minute the patient became responsive, and remained on the floor per instructions received from 911 over the phone. Shortly thereafter EMS arrived and assessed the patient. Patient refused to go with EMS for further medical assistance. She agreed to stay in a chair in front of the pharmacy for further observation for 30 minutes. After the 30 minutes lapsed, patient left the store under her own volition.

My arm swelled up about 30 minutes after the injection near my shoulder. I started feeling pain in my forearm and the facility nurse gave me an ice pack. I stayed an hour after the shot and the nurse said I should be fine, so I went home. Around 10 pm I started having a really bad reaction, worse than normal flu symptoms. A fever of 102 and body chills that lasted for about an hour. Heart rate also consistently stayed above 130 bpm. I drank a lot of water and took an Advil. I then was advised to take a warm shower, and this helped bring my fever to a 99. After the shower, I became really nauseous and started throwing up. I was debating going to the ER. I also drank chicken broth and a lot of water and did not go to sleep until 4 am. The next two days I had a low fever and bad muscle aches throughout my body, the flu symptoms ended in 4 days.

Fever, fatigue, chills, body aches, headache, nausea, elevated resting pulse rate. Fever has lasted for 3 days to date as well as the elevated heart rate.

At 10PM (8 hours after getting the JnJ vaccine) pt developed chills and pulsate headache. Pt was able to sleep. Next day in the morning by 7:40AM she went downstairs and got dizzy and fall gradually on the floor. Pt got help, but when she was trying to get up she got lightheaded/passed out again bumping her head on the wall. Pt reacted, fluids were given. Pt slept all morning. At 2PM she got up from bed. No pulsate headache, just "mild headache." Today, 48 hours later, pt reported light headache. Denies abdominal pain or pain in extremities. Pt and parents of pt were encouraged to report to patient's PCP.

CHILLS; FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-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, and chills. This report was non-serious.

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

Within 10 minutes of administration, patient reported feeling poorly. Reported lightheadedness and chills. EMS was present and assisted. On exam, elevated BP 180/118. SpO2 98% on RA. Patient was given juice and water and assisted to a quiet area to lay down. EMS stayed with her and continued to monitor. After 30 minutes patient reported feeling better and left vaccine area with her friend. She was feeling better by her report in the afternoon. Received a call at 9:30pm that evening. Reported same symptoms she had initially. She was advised to go to the ER for further evaluation but she declined. She took benadryl 25mg and rested. Reported feeling better the next day. Fatigue and mild headache. I saw her in the office for a BP recheck on 4/12. BP 120/70. She reported feeling much better with just some mild residual fatigue.

SHORTNESS OF BREATH, IRREGULAR HEART BEAT, FEVER, MUSCLE ACHES, WHOLE BODY SWOLLEN, NAUSEA, FATIGUE, NECK AND BACK STIFFNESS

Nausea & vomiting started around midnight on 4/1/2021 thru 4/4/2021 Feeling of confusion around 3:00am on 4/2/2021 Aches 8:00pm 4/1/2021 Tired 5:00pm 4/1/2021

Janssen COVID-19 Vaccine I felt okay until 2:30. I started to get very bad body aches and the chills, later on I developed a headache and I couldn?t move out of bed because I felt so sick. My temp reached 102 at 8:15 even after taking a 500mg tylenol earlier. I had to stay sitting up because I got nauseous when I tried to lay down completely. I also kept getting very hot then very cold. It?s 4/13 and I?m feeling a bit better but still feel kinda weak and get exhausted easily.

At 2:30am on April 13, I woke up with a 101-degree fever. Throughout the rest of the day I have felt chills, a headache, soreness all over my body, dizziness and overall weak. My temperature had fluctuated around 99.5-100 degrees all day.

At 5:30 PM she was feeling nauseous and weak. She passed out, had a headache, chills, and intermittently experienced profuse sweating. She had a fever at 12:30 AM that evening (next day). She was a little nauseous and took it easy the next day and was fine after a day passed.

Extreme pain in left leg all night on 4/8, turned to more gradual coming and going pain since then Headache every night since 4/8, located in back of head between the ears area Dizziness/feeling like I may faint on 4/8, comes and goes since then Shortness of breathe, unsure of exact start date but has been around a week

Dr writes the following " is a 20 y.o. female with a history of leukopenia who is here today for evaluation of lower back pain. Patient states that she got the J&J vaccine yesterday and then over night she had onset of severe lower back pain that is localized to her back, but can occasionally be felt in her buttocks area. She first noticed body aches prior to bed. She woke around 3am to use bathroom and had terrible headache and back pain. Headache had subsided, but the back pain has persisted. The pain is located along her lower back, bilaterally. Sometimes the pain is felt in her buttocks. Pain otherwise is localized. Pain is dull, but intense. She rates the pain as a 8 or 9/10. Pain can not be alleviated. She tried a hot pack, with no relief. Laying down increases the pain, and the pain is so severe that she is unable to move. She feels afraid to move the pain is so intense. She has noticed no other symptoms. All other symptoms from the shot have subsided. Patient also became nauseated while in the exam room. Patient had negative pregnancy test yesterday. "

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

At about 8pm the night of the day I got the vaccination, I began to experience pretty bad muscle & joint pains from my hips down to my ankles. I was also going back and forth between being very cold and very hot. I have not gotten a fever so far. The pain was so bad that I wasn?t able to sleep at all. The following morning, today, I am still experiencing pain in my hips, thighs, and knees, as well as a faint headache every so often.

I was in the passenger seat while my mom was driving me home after vaccination, and I began to feel nauseous a few minutes into the drive. About ten to fifteen minutes after we left (in total, about 25-30 minutes post-vaccination) I felt so sick (nausea, sweating, chills) that I couldn't keep my head up. I briefly fainted, but I woke up about two minutes later. My mom finished driving me home, and my condition improved with rest over the following hours.

ABOUT 10 MINUTES AFTER RECEIVING THE VACCINE, PATIENT WAS SITTING WITH HER MOTHER AND BECAME LIGHT HEADED AND BEGAN SWEATING. SHE NEVER LOST CONSCIOUSNESS AND WAS ABLE TO FOLLOW DIRECTIONS DURING THAT TIME. EMS WAS ALREADY ON SITE ATTENDING TO A PREVIOUS PATIENT WHO HAD FAINTED. THEY RENDERED AID TO PATIENT BY CHECKING HER VITAL SIGNS. SHE WAS HYPOTENSIVE ON A MONITOR. THEY DID NOT CHECK BLOOD SUGAR. UPON GETTING HER HISTORY, IT WAS DISCOVERED SHE HAD DRIVEN 3 HOURS FROM HER HOME TO FIND A LOCATION WITH THE VACCINE AND HAD ONLY EATEN LITTLE DURING THE DAY. AND PRIOR TO HER VACCINE, ANOTHER PATIENT FAINTED.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: patient experienced nervousness.

April 7th 6pm - April 8th 10am: nausea and fever (reached 103.5°), did not go down with acetaminophen and lowered slightly with ibuprofen April 7th - April 11th: sore arm

Extremely high fever, 104° for prolonged hours causing nausea, vomiting, and extreme exhaustion and chills

About 10 hours after receiving my vaccine- I became extremely ill. I had migraines, fever of 101, chills, nausea, tightness of chest, abdominal pain, difficulty with my stool / bowl movements, and body aches. I could not move, and most effects subsided after laying in bed for two/three days straight. However, continuing up to today (three weeks later) I have still had tightness of chest/throat, bowl difficulties, and abdominal pain. I also noticed that for the past 2/3 weeks I have also had blood spotting with clots alongside my abdominal pain. It has not yet subsided.

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

I had Janssen vaccine on 3/10. I had some fatigue after, and was doing well until several hours later, when I developed severe chest pain, shortness of breath, headache, and back pain. I went to ER, fever to 102.2F. EKG w sinus tachycardia, heart rate 153bpm, treated with IV fluids, tylenol and IV ativan with significant symptomatic improvement. Labs and CXR were normal. Since then, I have not had any more symptoms.

Started out with a headache and dizziness within a few minutes of the vaccine, along with nausea. I stayed put laying down with a lollipop and water bottle along with ice packs on me for about an hour until I was well enough they thought for me to drive back to my dorm. Once I started driving the headache was back but I was driving so I couldn?t do much. Almost pulled over because I was getting over whelmed but ended up making it back to my dorm. Once I got back I changed and laid down in bed hoping to fell better. Things started getting worse from there. Throughout the rest of the day my head ache and dizziness got worse to the point where I was pretty unsteady on my feet. Chills and body aches also started and progressed rapidly despite no fever. My nausea was present in waves but eventually dissipated around 8 PM. I tried to go to bed around 11 hoping to sleep off the symptoms. I began tossing and turning. My chills were really bad and it got to the point where my skin was so sensitive that the clothes I was wearing touching and rubbing against my skin were hurting me. I was so dizzy and light headed to the point where it didn?t matter if I was laying down or sitting up, I felt the same, extremely dizzy and lightheaded as if cotton were in my brain or as if it were working too slow. It was like trying to process thoughts through molasses. Then around 1:30 I couldn?t take it anymore and thought maybe a quick shower would help me to at least feel better so I could sleep. When I got in the shower I immediately knew things were worse. My vision started going black at the edges and black spots in the middle to the point where at certain moments I couldn?t see. I was fighting to stay on my feet and conscious and it was hurting to breathe. I knew I needed to get help so I stumbled to my dorm and collapsed when I got in the doorway to my room. My vision was spotty, my chest was hurting and I could barely breathe. My hands and feet went numb as well, I was shivering, and my body temperature was a little down to about 98.1 degrees Fahrenheit. I was transported to a hospital via ambulance my vitals were normal except elevated heart rate and O2 and was admitted at 2:40 in the morning. I received a chest x ray and my heart rate was better. The dizziness was under control by then. I was discharged at 4:50 in the morning.

Headache started Sunday night, but controlled with Tylenol. Monday the headache was intermittent. Tuesday 4/12 the headache and leg craps started in the afternoon. 4/14 She was sent home from work with nausea, headache not letting up after taking Tylenol, numb hands. I called Occupational Health and they suggested having her report to Backus ED today.

Started with B leg achiness and pain the day after vaccination. She was having difficulty walking. the second day began having arm pain L>R to the point she could not lift her left arm. Also has severe headache unable to be treated by otc medicine, chest tightness and some difficulty breathing.

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

LOOKS PALE; FEELING SICK; HEADACHE; TEMPERATURE 102.4C; DIZZINESS AND WHEN TRIED TO SLEEP DIZZY; BODY ACHES; FEELING COLD; SWEATY; PRESSURE IN HEAD; PRESSURE IN EARS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's past medical history included dehydration, 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 08:40 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102.4 C. On 08-APR-2021, the subject experienced dizziness and when tried to sleep dizzy. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced feeling cold. On 08-APR-2021, the subject experienced sweaty. On 08-APR-2021, the subject experienced pressure in head. On 08-APR-2021, the subject experienced pressure in ears. On 08-APR-2021, the subject experienced feeling sick. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced temperature 102.4c. On 09-APR-2021, the subject experienced looks pale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness and when tried to sleep dizzy, feeling sick, body aches, headache, feeling cold, sweaty, pressure in head, temperature 102.4c, looks pale, and pressure in ears. This report was non-serious.

Full body aches and pains, fever, chills, sweats, severe headache, nausea, chest pain/pressure, fatigue but not being able to sleep due to intense pain.

After receiving J & J Covid vaccine, client stated she felt weak and dizzy. After sitting for a few minutes, assisted client to lie down on couch. Client was diaphoretic. BP 88/68. Legs elevated and given a few sips of juice. BP rechecked at 100/70. Client was well enough to transfer to observation area. Client waited another 15 minutes and left on her own with no further complaints.

patient recieved J& J vaaccine on saturday at 2 pm following am patient woke up walked to bathroom told mom she wasnt feeling well, mom noticed she was going to pass out and assisted patient to ground, syncope lasted < 30 sec. Patient drank water/ginger ale, patient returned to sleep and woke up and reported feeling normal Patient took an adderrall 15 mg saturday night around 6 pm after vaccine to do school work Patient ate and drank normally saturday night patient has period currently- normal bleeding normal cramping patient on tri lo marzia BC and on spirnolactone for acne Of note patient does report hx of syncope in the am 1 year ago- never seeked treatment it was non recurrant Patient also states that a couple times a week she wakes up feeling dizzy- last about < 1 min and goes away.

c/o dizziness, cough, cold/hot, headaches, body sore since J&J vaccine on 13 Apr. denies v/d/, abd pain, chest pain, or sob. last Tylenol 0900. 20 yo f c/o ongoing diffuse nausea, bodyaches, and ha w/o visual changes x24hrs s/p receiving J&J covid vaccine 24hrs pta; Pt denies any sore throat/neck pain, fevers/ns/chills, abd pain, nvd, ear sx's, cp, sob, dyspnea, rashes, prior hx of vaccine rxn

Developed dull headache within 2 hours of vaccine with fatigue. By 6-7 hours later, her headache escalated to a severe migraine and she had chills, nausea, vomiting and a temp of 101. Severe symptoms lasted for 24 hours and she didn't feel better until 4 days later. By 5th day felt fine.

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

sharp Left-sided CP x 2 days with HA after receiving J&J vaccine yesterday; denies any radiation; reports nothing makes worse or better; continuous

Nurse administered vaccine, within 1-2 mins the patient became drowsy, drooping head forward, closing eyes, and slurring speech. Patient lost consciousness and slumped into chair, EMS on site, administered IV fluids and transported to hospital.

Starting less than 12 hours from the injection, the adverse effects started with a bad headache and light sensitivity. Within an hour the adverse effects evolves to severe chills, fever, body aches, fatigue and nausea. A few hours later all symptoms continued and worsened. Fever spiked to 102, nausea turned to vomiting, chills made the skin hurt from any touch/pressure, muscles aches made pain continually radiate all throughout the body, headache turned to a migraine. Symptoms persisted throughout the night and into the next day resulting in no sleep. The following day ibuprofen was able to manage symptoms enough where patient was able to sleep. Fever decreased, but chills, headache, fatigue, and vomiting continued. Patient was forcefully vomiting bile after not being able to keep anything down. Patient broke capillaries across the face. Extreme tiredness pursued, but symptoms dwindled over the course of three days.

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

CHILLS; LITTLE BIT OF NAUSEA; HEADACHE; FEVER; This spontaneous report received from a consumer concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced little bit of nausea. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from little bit of nausea, and had not recovered from chills, headache, and fever. This report was non-serious.

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

Symptoms began evening after receiving vaccine. Patient reports headache which progressed into the next day to fever, fatigue, intense chills, chest pain. Patient had these symptoms over 2-3 days and had began to experience arm tingling in arm where vaccine was administered, which then spread to both arms. Patient reports arm tingling will come and go. Patient reports taking OTC medication (ibuprofen). Patient called a nursing line and was told to go to the ER. Patient went to ER on 4/14 and was admitted for observation. Chest X-ray was done with no remarkable findings. According to patient, additional testing was done. Patient was discharged on 4/15 and was told to return if arm tingling returns and does not go away.

HEADACHE; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine.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 09-APR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.

BODY ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included consumes alcohol occasionally, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 09:30 to Left Arm for prophylactic vaccination. The batch no. was not reported but it has been requested. No concomitant medications were reported. On 08-MAR-2021 17:30, the subject experienced body aches. On 08-MAR-2021 17:30, the subject experienced chills. On 08-MAR-2021 17:30, the subject experienced headache. On 08-MAR-2021 17:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and chills, and had not recovered from headache, and fever. This report was non-serious.

Nausea, vomiting, severe headaches, chest pain, SOB (only occuring at night), slight leg pain, and upper back pain

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

MUCOSAL ULCERS ON VAGINA; CANKER SORES ON LABIA; MUCOSAL ULCER ON LABIA; FEVERISH; JOINT PAIN; ON AND OFF HEADACHE; FEELING BAD; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included headache, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient was previously treated with acetylsalicylic acid/caffeine/paracetamol for on and off headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feeling bad. On APR-2021, the subject experienced on and off headache. On 04-APR-2021, the subject experienced joint pain. On 05-APR-2021, the subject experienced mucosal ulcers on vagina. On 05-APR-2021, the subject experienced canker sores on labia. On 05-APR-2021, the subject experienced mucosal ulcer on labia. On 05-APR-2021, the subject experienced feverish. On 07-APR-2021, treatment medications included: benzocaine. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, feeling bad, on and off headache, and feverish on APR-2021, and had not recovered from mucosal ulcers on vagina, canker sores on labia, and mucosal ulcer on labia. 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.

LIGHTHEADEDNESS; SWEATING; VOMITING; CHILLS; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021; 10:40 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced lightheadedness. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications (dates unspecified) included: mepyramine maleate/pamabrom/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on APR-2021, and had not recovered from nausea, lightheadedness, sweating, and vomiting. This report was non-serious.

HISTORY OF PRESENT ILLNESS: 21 yo F p/w midsternal chest burning since 2200 last night. Acute, sharp/burning, constant, mild. No similar prior pain. Reports associated subjective dyspnea. Denies fever, chills, nausea, vomiting, syncope, palpitations, back pain, abdominal pain, weakness/numbness. Patient states she received the J&J COVID vaccine 3 days ago, and had chills, fatigue and body aches that resolved the following day. She has since been asymptomatic.

BUMP INSIDE LEFT SIDE OF MOUTH; BODY ACHES; SWELLING; FEVER; FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a 20 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included hereditary blood disorder, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 bump inside left side of mouth. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced swelling. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, fatigue, headaches, body aches, bump inside left side of mouth, and swelling. This report was non-serious.; Sender's Comments: v0:Medical assessment comment not required as per standard operating procedures.

Patient called to report her reaction today to the county vaccination effort and ask for a copy of her consent. Patient stated that 4 hours after vaccine administration, she experienced headache, fever, chills, rapid heart rate, and shortness of breath. After 30 minutes of symptom onset, she presented at local emergency room and was admitted with sinus tachycardia. Patient was discharged the following morning. She states she followed up yesterday with her PCP, states she has some lingering hip and back pain, but original symptoms have resolved.

SWELLING BEHIND HER KNEE, CALF AND THIGH; PAIN BEHIND HER KNEE, CALF AND THIGH; CHILLS; NAUSEA; FEVER; INJECTION SITE PAIN; DIZZINESS; DIFFICULT TIME GETTING UP AND MOVING; HEADACHE/COULD NOT MOVE OR TALK; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, non smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced difficult time getting up and moving. On APR-2021, the subject experienced headache/could not move or talk. On 01-APR-2021, the subject experienced dizziness. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced injection site pain. On 11-APR-2021, the subject experienced swelling behind her knee, calf and thigh. On 11-APR-2021, the subject experienced pain behind her knee, calf and thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 04-APR-2021, injection site pain on 03-APR-2021, and headache/could not move or talk on APR-2021, was recovering from nausea, and dizziness, had not recovered from pain behind her knee, calf and thigh, and swelling behind her knee, calf and thigh, and the outcome of difficult time getting up and moving was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

SWEATING; BODY HURT ALL OVER; NO APPETITE; CHILLS; BAD NAUSEA; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced body hurt all over. On 08-APR-2021, the subject experienced no appetite. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced bad nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 09-APR-2021, body hurt all over, and no appetite on 11-APR-2021, chills on 08-APR-2021, and bad nausea on 12-APR-2021. This report was non-serious.

LEG PAIN; SEVERE HEAD PAIN; This spontaneous report received from a consumer via a company representative concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced leg pain, and severe head pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe head pain, and the outcome of leg pain 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.

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

severe fatigue, headache, chills, body aches. low grade fever, hot flashes, sweating, chest pains, shortness of breath, sore throat, stomach pains, congestion

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

Morning after vaccination (on 4/6/21), pt got diffuse intermittent headache which focalized later into the right temporal area daily for 3 weeks, which she calls 8/10 in severity. These headaches have been so severe to the point that it induces nausea and creates abdominal cramping. She has not as photophobic as before during her headaches, and nothing seems to alleviate it but water and tylenol (but that has little lasting effect). Prior to these headaches her migraines came once every 2 weeks and lasted 2-3 hours at a time, with a 5/10 severity that was bitemporal with more pronounced photophobia.

Systemic: Dizziness / Lightheadness-Severe, Systemic: patients feels hot then an hour later feels cold-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Medium, Additional Details: Patient said she felt light headed and feels weak. Pharmacist had patient lay down with two legs slightly elevated. Patient was given water to drink since she said she feels hot and need water. pharmacist check vital signs 3 times.

patient was administered vaccine as per EUA/standin order. Approx 30 seconds after the vaccine was injected, the patient who was seated,stated she didnt feel well, fainted and slumped forward in chair. RPH who administered shot was able to catch her, keep her from further injury. Approx 10 seconds later, she came to and was disoriented. RPH explained where she wasand what had occured. She complained of nausea, feeling hot and sweaty and numbness in fingers. 911 was called, and while waiting for EMTs to arrive she stated that she had had some similar reaction during a previous blood draw. EMT arrived and transported her to local ER

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Tachycardia-Medium, Additional Details: Loss of hearing for a few minutes. EMTs came to store monitored pt and BP for additional 15-20 mins. BP increased to over 100. PT had water, crackers and chocolate. Pt felt fine and refused to be taken by ambulance but had a friend pick her up. I explained situation to friend and pt was told to take it easy for the rest of the day.

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

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

Patient stated that approximately 6 hours after receiving vaccination she became dizzy, developed a high fever, and was sweating. She then proceeded to pass out.

PT presents with generalized weakness, HA and chills x this morning. reports she received JJ vaccine 1845. took 650mg tylenol PTA.

Patient complaints of dizziness. Per pt, last meal was 6 am ( over 9 hours ago) Patient noted to be pale and diaphoretic. Legs elevated. EMS evaluated. Vital signs obtained. HR noted to be in 40-50s. Patient provided powerade. Patient drank powerade. After drinking powerade, patient stated that she is feeling better. Vitals signs within normal limits.

Patient felt faint, headache, arm/throat/tongue became numb, blurry vision, felt cold, feel tired and nausea. Patient BP and HR was initially high, lied patient on ground with legs elevated and cold pack and patient eventually felt better and BP and HR eventually normalized. Patient had already eaten prior to coming in.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient has history of asthma, and had have same reaction with other vaccines before

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: immunization given on 5/12/2021 at pharmacy at approximately 5:25p. about 3 minutes later patienst complained of lightheadedness and black spots covereing her vision. in an attempt to help her lie down, when patienst was reposistioning, she went limp and passed out for a few seconds. vitals were checked by rph. 911 was called. patienst was cleared and went home on her own record. patienst has driver friend

patient described feeling unwell about 30 seconds after administration while reviewing recommendation to stay near the pharmacy for 15 minutes. She lost consciousness and fell out of chair. I caught her and lowered her to the ground, contacted store management and helped monitor her for about 30-45 minutes. The patient felt well, confirmed she felt safe walking, and called a family member to drive her home.

After patient received Vaccine she started immediately to look very pale and stated she was not feeling well. Patient reported feeling numbness in her right arm and radiating to her left arm . Patient given oxygen via nasal canula , vital sign taken and offered orange juice to drink. patient stated has no breathing concerns or chest tighten. She continued to complain of numbness to both arms and now radiating to her face. patient also displayed cramping of both her hands. Ambulance notified and patient transported to local hospital. Patient was orientate, responsive and alert .

Had COVID -19 two weeks after the vaccine. Tired and really bad chills prior to testing positive to COVID 19 after vaccination.

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

Patient received the Janssen vaccine at approximately 11:30 AM and was asked to stay sitting for a 15 minute observation period. After five minutes, the patient reported signs of blurred vision and upset stomach. The patient was also noticeably sweating. The pharmacy called 911 and medics came to assess the patient. Medics decided to take the patient by ambulance to the hospital because of "a risk of fainting".

Syncopal episode within 10 days of receiving vaccine with residual sharp headache. Followed by development of abdominal pain.

I feel inclined to file this report in hopes that someone could study how receiving this vaccine affected my endometriosis. Please understand that I?m a proponent of vaccination and building herd immunity; however, women?s health is important and we have a right to be AWARE of ALL side effects. I?ve done my best to research this topic and was able to find very few sources on how COVID-19 vaccines impact menstruation. Aside from the lack of statistics, I found forums on social media platforms with women explaining how their menstrual cycles became irregular some way or another. I did experience the common side effects of fever, nausea, vomiting, diarrhea, soreness, and fatigue. In addition, I experienced severe cramps, back pain, thigh pain, groin pain, and nerve pain associated with the sciatic and obturator. I?m happy to be vaccinated because my immune system is far from the best, but if I were to have known that I would be unable to walk from the pain radiating from my back, pelvis, and thigh I would?ve opted for Moderna or Pfizer. At this point in time, I would NOT recommend the Janssen vaccine to someone with endometriosis. At that, this vaccine should be nowhere near as political as it is! My healthcare providers should be more willing to validate my symptoms, rather than saving face with the validity of the vaccine. I was told since my menstrual cycle is irregular I must coincidentally be getting my period, BUT I have not experienced any bleeding nor even spotting. I have no idea what the vaccine did to my body, I have no clue why it would induce such severe pain. I?m glad that the ?normal? symptoms have subsided by the second day, but the nerve pain complicates walking long distance or carrying heavy objects. I think I?ll eventually make a full recovery in the upcoming days, but this experience was so frightening. I laid on the floor for hours crying after I vomited up everything I had eaten. I couldn?t sleep because I couldn?t bear to lay down for long durations of time- and by that I mean more than ten minutes. It genuinely felt like I was getting my period, but whatever it was led to no external bleeding. Again, I?m grateful for the scientists who dedicate their lives to such integral work. I just wish I would?ve known about what was internally happening to my body beforehand, I would?ve chosen a different vaccine.

There were no symptoms until much later in the evening. Around 8:30 PM, I felt fatigued. A little later I had chills for about 30 minutes. Then I felt nauseous and went to the restroom down the hall (I was living in a dorm). I did not throw up, but I had a pounding headache which only got worse. I also felt very hot and the cold floor was welcoming. I laid on the floor in the bathroom but felt too awful to sit up. Someone found me in the bathroom around 10:00 PM and called campus safety, which came about 20-30 minutes later. She determined that she could not give me medication on the spot and that she had to take me to the hospital. We arrived at the ER around 10:45 PM. The nurses and doctor took my temperature and found I had a 103-degree fever. Because of my pounding headache, I couldn't hear very well. The doctor gave me a shot of 60mg of Toradol at 10:56 PM. He then gave me instructions to alternate tylenol and ibuprofen every 3 hours, increase my fluids, and only do activity as can be tolerated. I left the hospital around 11:25 PM with a huge headache, but better than when I initially walked in.

I got extremely sick. I was hot and cold. I was nauseas and threw up. I lost feeling in both of my legs. I had shocking pain in both of my legs.

STOMACH PAIN; VOMITING; DIARRHEA; NAUSEA; CHILLS; FEVER; MUSCLE ACHES; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 26-MAY-2021, the subject experienced chills. On 26-MAY-2021, the subject experienced fever. On 26-MAY-2021, the subject experienced muscle aches. Treatment medications included: paracetamol. On 27-MAY-2021, the subject experienced stomach pain. On 27-MAY-2021, the subject experienced vomiting. On 27-MAY-2021, the subject experienced diarrhea. On 27-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and muscle aches on 26-MAY-2021, had not recovered from stomach pain, vomiting, and diarrhea, and the outcome of nausea was not reported. This report was non-serious.

SKIN FELT HOT TO TOUCH; SWELLING OF THROAT; SWEATING; BODY ACHES (UPPER CHEST, BACK AND LEFT HIP AREA); FELT FREEZE COLD; HEADACHE IN OCCIPITAL LOBE; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight was 168 pounds, and height was 60 inches. The patient's concurrent conditions included post traumatic stress disorder, social anxiety, avoidant personality, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 294A21A, expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On 28-MAY-2021, the subject experienced skin felt hot to touch. On 28-MAY-2021, the subject experienced swelling of throat. On 28-MAY-2021, the subject experienced sweating. On 28-MAY-2021, the subject experienced body aches (upper chest, back and left hip area). On 28-MAY-2021, the subject experienced felt freeze cold. On 28-MAY-2021, the subject experienced headache in occipital lobe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, and had not recovered from felt freeze cold, skin felt hot to touch, swelling of throat, headache in occipital lobe, and body aches (upper chest, back and left hip area). This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non serious.

approximately two minutes after administration of vaccination patient had sat down in waiting area and became lethargic/dizzy/blurred vision. She had passed out with face pale and lips turning blue, minimally responsive. Called 911 and while awaiting for ambulance patient had recovered from all symptoms with the exception of "spotted visions." Observed patient for over an hour while a family member came and upon the time of departure there was resolution of all adverse events.

Dizzy, diaphoretic. Transported via wheelchair to medical screening for evaluation by medic. Left in stable condition at 15:44 p.m. 98/60 114/75 Pulse 95 92 97% 98% Recorded RN.

Patient said she felt ill. became unresponsive. Would fallen if we didn't support in chair. It appeared her eyes rolled back. Airway breathing was monitor. and fine. Called 911. She started to come to but was extremely clammy and complained of ring in ears. she was glad EMT's checked out but declined to go to hospital with them. We kept checking he till a friend came to pick her up.

Immediately after the vaccine was administered, the patient stated that she felt sick and light headed. I instructed her to remove her mask, place her head between her legs and take some deep breaths. Before she had completely bent over she lost consciousness and began seizing. She remained in the chair for the duration of the event and until the paramedics took her out of the pharmacy. I made sure she did not injure herself or fall out of the chair and when the event was over I called ED. I continued to monitor the patient until she was taken by paramedics.

6/1 She woke up with a severe headache and vomiting. She went to the urgent care and was treated for migraine headache and nausea. She was giving medication for pain and vomiting. Slept until the next day. Felt somewhat better the next day and continued meds. She went to work on 6/3 and towards the end of her shift she told her boss about the severe headache and sat in her car outside and then became unresponsive. The paramedics were called and she was transferred to the hospital and diagnosed with a brain blood clot and brain bleeding. She was flow by air car to another hospital and admitted to ICU. She was in Neurology ICU until 6/6, and then transferred to a normal neurology bed and released on 6/11. Diagnosis of left venous sinus thrombosis and hemorrhage in the left temporal lobe.

PALE; SWEATS; FEVER; POUNDING HEADACHE; SICK STOMACH; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.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 15-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 16-JUN-2021, the subject experienced pale. On 16-JUN-2021, the subject experienced sweats. On 16-JUN-2021, the subject experienced fever. On 16-JUN-2021, the subject experienced pounding headache. On 16-JUN-2021, the subject experienced sick stomach. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pale, fever, sweats, pounding headache and sick stomach was not reported. This report was non-serious.

Severe chills and shivering that quickly exhausted me. A headache that wrapped around my entire head and did not respond to ibuprofen. both of these happened around 10 hours after the vaccine.

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

Extreme fatigue (rest, lasted 48 hours) Extreme muscle pain (Advil every four hours, lasted 24 hours) Extreme joint pain (Advil every four hours, lasted 18 hours) Fever (started 12 hours after shot and broke 4 hours after it started) Hot/cold flashes (lasted 36 hours)

Approximately 5 hours after the shot, was very fatigued, had a headache, chills/shivering, body aches and a fever of 101.4. Took Aleve. Symptoms lasted about 24 hours.

Patient visited Urgent Care for cough. Antigen test performed and came back positive. Case investigation with client has not been performed as of this note.

RAPID HEARTBEAT; SORE ARM; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 20 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, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced rapid heartbeat. On JUL-2021, the subject experienced sore arm. On JUL-2021, the subject experienced headache. On JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) not reported, and Heart rate (NR: not provided) rapid. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, headache, and fever on JUL-2021, and had not recovered from sore arm. 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.

Patient felt dizzy, was pale, cold, and diaphoretic after the injection. She lost consciousness for about 30 seconds in the vaccination chair. Vitals were taken. BP was 90/55. EMS was called

Midnight - I got a fever - my face was very, very hot. Fingers and toes were very, very cold. Unable to regulate body temperature. So fever and chills. Those lasted for a good four hours before it let up and then it happened again the next day and the day after that. I had about four days straight where I was not well and I don't remember a lot. On the fourth day, I was okay until the evening and I had really painful diarrhea. I couldn't keep anything in my body and I was in the restroom for about four hours. I was scared as to what was going on. I ended up calling telemedicine. The nurse I talked to over the phone and she said wait 7 days and that I should be okay. I was still slow and lethargic for the following week after but I did feel significantly better on the 8th day after the vaccine. In February, (before the vaccine) I had an UTI that I didn't go to doctor for. I drank a bunch of cranberry juice and I was fine afterwards. I do have an IUD- and on July 12th, I noticed the presence of a UTI and I had painful and really constant urinating. I was unable to hold on to anything at all and I went to Urgent care of the 14th. And they told me that I had deteriorated my bladder walls until I had come to a point where I couldn't hold on to anything. I had collapsed for lower back pain on the 16th of July and made an appt to go to doctor. I ended up speaking to someone on the 17th, and I got the medication that day for a kidney infection due to the lower back pain that I was having. And they said that the UTI had gotten so bad it had gone to the left kidney. I was first prescribed (on the 14th) - Cephalexin and had me take something called Uristat - an OTC cranberry aid and then on the 17th - they told me to stop taking the Uristat so it wouldn't be stressful on the kidneys and they gave me a different antibiotic - Ciprofloxacin and Extra Strength Tylenol. That helped with my symptoms. I had to go back in to the doctor today because for the past three days I have been having the same kidney pain again. I will get the lab results back sometimes this week. I either have another UTI or I didn't get rid of the kidney infection yet completely.

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

Heart rate 160+ beats per minute, chest pain, heart palpitations, low blood pressure, dizziness, shortness of breath, dehydration, migraines, hallucinations, COVID-like symptoms, chills, muscle spasms, fever of over 103 degrees Fahrenheit, vomiting, diarrhea, POTS. I have gone to the ER 5 times since the date I received the vaccine on April 6, 2021. Symptoms are ongoing. I have been referred to and seen by a cardiologist, gastroenterologist, and mental health practitioners as a result.

From about 4:00 p.m. until about 10:00 p.m., Patient had a headache, extreme chills, and a fever. From about 11:00 p.m. until 5:00 a.m., with varying intensity where she was able to sleep for an hour or so and then get woken up by the symptoms, she had at least a 103.5 degree fever, intense chills that caused her body to aggressively shake, excruciating pain throughout every part of her body that caused her to cry out in pain (she said it hurt more than anything she has ever felt), an intense migraine that was so bad it felt like her head was splitting open and her eyes torn out, shortness of breath and hyperventilating that caused her to repeatedly black out and weave in and out of consciousness, and extreme weakness to the point she could not move at all. She also said her muscles were aching and cramping and that her heart was pounding so hard it felt like it was hitting her rib cage. She wanted to call 911 because she didn't know how much longer she could hold on to consciousness, but was too weak to grab the phone, and her calls for help were weak and indecipherable. (Also, only her sister was home at the time, and she went to bed with earplugs in and couldn't hear patient.) From 5:00 a.m. to 7:00 a.m. many symptoms subsided, but there was still an agonizing pain in her kidneys (or adrenal glands?) that pulsed through her whole body. At 7:00 a.m. she woke up, and all the symptoms were gone, except for the area around her heart feeling strained. Two days later she called the nurse hotline and took ibuprofen as directed. The area around her heart gradually improved and seemed fine about two weeks later. Patient thinks she may have had Covid over a year ago because she remembers losing smell and having some chest pain that, for a couple of months, prevented her from exercising as she usually did. However, she never got tested because her symptoms were very mild. For her, getting Covid was a much better and less life-threatening experience than getting the Covid vaccine.

Sx onset 7/21 with nasal congestion & HA (thought she was starting with sinus infection). Lost taste and smell on 7/24. Works in a facility. We do not have the lot number.

I got the vaccine at 10:30 am and began to notice side effects at 7:30. My symptoms are fever, malaise, and migraine.

Chills Fever/flush Periods of being cold then being incredibly hot Weakness/soreness of muscles Dizziness Headache/sinus pressure

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

About 12 hours after the vaccine, I experienced excruciating pain in my head and body. My fever rose to 102 and stayed there for 36 hours after being vaccinated. I was also nauseous and was unable to keep food down until 48 hours after being vaccinated. I was taking both Tylenol and Advil, but getting sick almost instantly after taking them.

Janssen COVID-19 Vaccine EUA fever of over 101°F, dry cough, shortness of breath, chills, muscle aches, weakness, headache

4 hours after vaccine I experienced vasovagal (passed out), for the rest of the day after I experienced fever, chills, fatigue, body aches

Had fever and headache but the event that occurred at the indicated time was uncontrollable movements - almost as if the chills except much more exaggerated movements and higher paced. This was very scary and lasted for an hour or two

Janssen COVID-19 Vaccine EUA day after had fever that went to 103, extreme fatigue and nausea, oxygen went down to 91 briefly, and heart rate in the 150s while resting.

On Tuesday at 12:20 PM Johnson & Johnson Vaccine was received in my left arm After Vaccination until bedtime (around 11 PM) was sleepy but no other symptoms presented themselves. On Wednesday at 01:07 AM woke up to a terrible migraine, nausea, and cold sweats. Could not go back to sleep. On a scale of (least)1-10(most) was a pain level of 6 or 7. I also could not stop shaking. At 2:03 AM developed a fever of 101.3 F. Sat in a cold lukewarm shower until the fever broke. Was able to go back to bed. Spent all of Wednesday inside. Migraine and nausea still present. Intensified with bright lights.

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

Fever (99-101 fluctuations), body aches, chills, nausea, headaches Symptoms continued from 6:00pm March 13 into next morning

Severe chills at 11:30pm to 3am. Woke up at 4:30am and vomited several times. Felt weak and dizzy. The next morning, had severe headache and pain from behind my eyes to the back of my head.

Neck swelling, general pain, flu like symptoms, fever, exhaustion, muscle and body aches, swollen glands, headache, injection arm feels like it?s going to fall off

Around 10PM I was on the phone and felt the body aches start. About an hour or so later it started to get pretty painful, my joints. I was trying to go to sleep and I started with chills. I had a heating pad and 2 blankets and was still shivering, I took my temp and it was 102.4F. I took some Tylenol and was able to sleep and woke up in the middle of the night sweating. Next morning I was again with 102.7F fever. I slept most o the day, and when awake I noticed the body aches were still present. Kept taking Tylenol. Next day my left ear started feeling to hurt and it felt like fluid. I decided to go get checked and that is when they told me I had an inner and outer ear infection. After meds were prescribed (oral antibiotics and ear drops) the swelling has been going down a lot and it is not as near as painful.

Menstrual cycle induced (cycle had completed one week previous, full cycle triggered with much worse cramps than usual), bodyache, fever, chills, headache, nausea

9 hours after the vaccine I had a sudden onset of flu-like symptoms. I had a fairly severe pounding headache, muscle aches, and felt very hot and cold. I was warmer than normal but did not have a full fever. I was extremely fatigued. Most of these symptoms subsided in about 24 hours with acetaminophen. I am still having occasional (every other day) mild headaches and shortness of breath, heaviness in the chest, and a couch that have persisted 5 days so far.

At around 11 Pm 10 hours after I took the vaccine, I experienced chills, then a fever, and extreme fatigue. The chills lasted for around 4 hours, and eventually my fever went away with it. I shook so hard my back, and my joints started to ache. I couldn't sleep because I was having hallucinations from the fever and the pain would wake me up every hour, I also had a headache. The next day my back still hurts, my head still hurts despite medication, the shaking has subsided. Yet I'm sweating, I'm still very weak, I can't stand up without getting super dizzy or experiencing extreme fatigue. If I think of food I feel as if I'm going to vomit just drinking too much water can make me ill.

Severe muscle pain could not walk, crying from pain, severe fever (103/ went up to 105) headache, nauseous, stiff neck, abdominal pains for hours

Immediately after injection: dizziness, nausea, light headedness, temporary loss of hearing, blurred vision, abdominal cramps, fever. 1+ Hour after injection: severe abdominal cramps, nausea, severe headache (severe pain behind eyes specially when eyes were open), chest pains, upper back pain, pain in all joints (primarily hips), muscle aches over whole body, fatigue, chills, fever, trouble breathing, light headedness Morning After Injection: full body ache, severe fatigue, trouble sleeping, fever, chills, body sweats, slight chest pains, even more severe headache. 24 -36 hours after Injection: reduced muscled aches, fatigue, headache, pain at the sight of injection.

FEVER 101.5, and EXTREME CHILLS, and EXTREME FATIGUE. Was really hot. Started not feel good before bed, then extreme chills, and then fever and was really fatigued. Stayed in bed all day the next day, was thirsty and also felt sick to my stomach in the morning but did not get sick and that went away. I started feeling better 24 hours later and was totally fine.

EXTREME FATIGUE, chills and fever of 101.5, upset stomach and wanting to get sick. Got shot in afternoon and felt bad before bed, then was really hot, had extreme chills, had a fever, and upset stomach the next morning. Stayed in bed for the day, was thirsty and really hot. Within 24 hours I felt completely fine...but just felt hot still and then that went away after 2 days.

I had chills and a fever starting at 5 pm the day of the injection and those broke sometime in the middle of the night. I experienced some stomach discomfort but was not nauseous. However, in the middle of the night, I went to drink water and after the smallest sip I threw up everything in me. When I would use the restroom to poop I would feel a large pressure in my head, but only then and I also experienced muscular pain in my back. I was able to relieve symptoms with Advil. The fever and stomach discomfort was over by 3 am on 3/28. The chills came and went until mid-day on 3/28 and I believe that was with help of the Advil. The occasional pressure in my head only lasted until mid-day 3/28 and the back pain did not go away until the morning of 3/29. Following the vaccine I felt very dehydrated and while I drink lots of water, I had to increase my intake to even more than normal and this feeling was over by the evening of 3/28. As of today, 3/29 I feel back to 100%.

100 degree + fever following injection. Fever continuing until the current time (100.4) at 8:45. Headaches, Body Aches, Chills, & Nausea are still occurring.

Experienced a fever of 100 degrees about 7.5 hours after injection. The fever lasted for about 9.5 hours. Fever fluctuates between 100 degrees and 102 degrees.

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

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

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

Over the last 36 hours: fever of 103.5, extreme chills, body aches, nausea, and severe flu-like symptoms.

SEIZURE/CONVULSION; LOW BLOOD PRESSURE; SORE ARM; FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN)) dose was not reported, administered on 16-MAR-2021 at 17:00 in the right deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 20-MAR-2021,The caller called to report that her daughter developed some rare side effects. The patient reported that she got the shot on 16-MAR-2021 and went home and went to bed at 23:15 PM experienced convulsing/seizure, chills, shaking, low blood pressure, heart rate increased. The police came to take her to the Emergency room. The patient was hospitalized on 16-MAR-2021. On an unspecified date in MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 70/20 mmHg, 80/30 mmHg, and Heart rate (NR: not provided) 110 OR 115 BPM. The patient has no fever then was given an unspecified IV. At 06:00 On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 98/38 mmHg, COVID-19 virus test (NR: not provided) NEGATIVE, CT scan (NR: not provided) NORMAL, Echocardiogram (NR: not provided) FINE, and Echocardiography (NR: not provided) FINE. Overall she took 6 Liters of IV fluid. The patient was discharged on 17-MAR-2021 at 14:00PM. The duration of hospitalization was two days. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 120/90 mmHg, and Heart rate (NR: not provided) 70 BPM. On an unspecified date, the patient experienced dizzy, lethargic, sore arm and fever. The patient gave permission to speak with her doctor who treated her there and was told to follow up with Primary Care Physician which she did on 18-MAR-2021. No medications were given at discharge. According to her, Blood pressure and Heart Rate was normal when she saw her Primary Care Physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking on 19-MAR-2021, low blood pressure and heart rate increased on 18-MAR-2021, was recovering from, chills and the outcome of, convulsing/seizure, dizzy, sore arm, lethargic and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210339790 - COVID-19 VACCINE AD26.COV2.S - Seizure, Blood Pressure Low. 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).

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

Began feeling lethargic and had a bad headache at 6pm on April 1st. I took ibuprofen to tame it. Began having cold chills 10pm. Took more ibuprofen to tame. Went to bed around midnight. Woke up at 10:30am feeling miserable. Very bad cold chills, painful headache, and body aches. I took Dayquil and covered up with lots of blankets and went back to sleep. Did not sleep well and sweated off the blankets. Woke up at 1:30pm feeling slightly better. The rest of the day I experienced mild headaches and slight chills in the evening.

Fever Severe shoulder pain, limited mobility, arm weakness Both started once I woke up on Saturday. Could not sleep from the shoulder pain and it is still extremely painful

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

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

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

Starting about 12 hours later I started feeling off, weak and achy. I wasn't able to sleep all night, sweating, aching. When I got up the next morning I had nausea all day and complete loss of appetite. My head hurt, my body was achy, and I fought throwing up all day on 4/3. When I woke up 4/4 my appetite wasn't fully there but I was feeling better. Now 4/5 and 4/6 I'm feeling normal.

Started with a headache 5 hours after the vaccine. Got worse and worse and got dizziness, weakness, fever (got worse and worse up to 103), and nausea.

A few hours after vaccine, began to experience chills. Continued to progress to flu-like symptoms including headache, muscle aches, fatigue, and nausea in addition to initial chills.

Chills and moderate to severe fatigue throughout the day of 04/07/2021; headache throughout the day escalating into a migraine at night (began at roughly 9:00 pm) that persisted through most of the night

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

Patient felt dizziness, shaking and light headed few minutes after getting the shot, forehead was hot to touch but temperature was 97F, upper lip was sweating and hands were turning blue, and patient reported temporary loss of vison, patient was conscious the entire time called 911 and patient was taken to Emergency Room, Patient was later discharged and 4 hours later patient came to the pharmacy to pickup the car and drove home.

About 12:30 AM on 04/09/2020 patient started shivering and the intensity has increased since then. She started feeling really cold around 12:45 AM and started having pain in both legs and the right side of her torso around that same time. We are currently headed to the ER.

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

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

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

Felt dizzy, nauseated, and started sweating immediately upon receiving the vaccine. These symptoms passed in about 10 minutes.

Pt received her dose of Janssen Cover 19 vaccine administered to left arm intramuscularly by RN given at 06:54 PM. Pt was seated for observation when scribe noticed pt being pale and sweaty. Sribe asked pt how is she, pt stated that she is dizzy , warm and nauseous. Scribe called RN to assess pt. Pt is alert oriented to self, time, date and location. Initial vital signs was taken by RN at 07:00 PM and it was 145/110mmhg, PR 138 ppm, RR20 cpm, Temp 98.1, Oxygen saturation of 99% at room air. RN assisted pt to lay patient down safely. No SOB and chest pain noted. Pt stated feeling better upon laying down for couple of minutes and stated that her dizziness comes and goes. Pt had no allergic reactions to any other vaccination but pt also stated that she has been feeling dizzy couple of times as her history. No history of elevated BP as well was stated by pt. Pt continuous to complain on and off dizziness, NP assess pt and Called 911 for further assistance. Repeat vitals check done by RN BP 135/100 mmhm, PR 81 ppm, RR 20 cpm, oxygen saturation 98% at room air. EMT came at 07:45 PM came assess pt, checked her vitals, pt requested if she could walk and have the EMT assist her to evaluate herself, no complaints of dizziness reported. EMT offered to bring pt to hospital for further evaluation, pt refused to go to hospital. Pt was advised to go to hospital if episode of dizziness happens again. EMT walked the pt to her car and have her sister drive. Pt left facility at 08:00 PM without any complaints. VAERS was filed and education provider RN was reported.

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

Received vaccine 04/09/2021 at 9:13 AM. Experienced light concentrated headaches around 11pm on the same day. Around 12:30AM 04/10/2021 when trying to sleep experienced cold and hot flashes. On 04/10/2021 4:00AM experienced more hot flashes. From 7:00AM till the time of filling this form (9:00AM) experiencing noticeable back pain (uncomfortable) - muscle pain concentrated on the back. As of 9:00AM 04/10/2021 no other side effects.

Headache started around 7 pm and progressively got worse. Took two Aleve which didn?t help in mitigating pain. Chills around the same time, eventually developing a fever around 10. Used ice packs to try and help bring the fever down. Woke up in the middle of the night sweating through my shirt. Dizziness upon standing, leg pain and chest pain.

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

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

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

HIGH HEART RATE; CONGESTION; BODY SHAKES; VOMITING; FEVER OF 102 F; MUSCLE ACHES; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, 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, batch number: 043a21a, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 17:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 01-APR-2021 01:00, the subject experienced high heart rate. On 01-APR-2021 01:00, the subject experienced congestion. On 01-APR-2021 01:00, the subject experienced body shakes. On 01-APR-2021 01:00, the subject experienced vomiting. On 01-APR-2021 01:00, the subject experienced fever of 102 f. On 01-APR-2021 01:00, the subject experienced muscle aches. On 01-APR-2021 01:00, the subject experienced nausea. On 01-APR-2021 01:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 102 f, high heart rate, muscle aches, nausea, vomiting, headache, congestion, and body shakes. This report was non-serious.

Day 1- sore arm within 1 hr....8 hrs-vomiting and fever 9hrs through rest of night-vomiting Day 2-vomiting all day Day 3- fine all day until 11 PM-vomiting continues

Approximately 6 hours following vaccination, patient experienced chills and a high temperature of 99.0F which passed after 36 hours. Approximately 12 hours following vaccination, patient experienced discomfort in external genitalia area upon wiping with toilet paper. Approximately 60 hours following vaccination, patient noticed three yellow-colored lesions on labia with extreme pain. Patient reports no recent sexual risk activity.

Fever of 101.3, bad headache, fatigue, mild cough. I passed out briefly the morning after due to the fever and fatigue.

Started to feel woozy and weak at 5:30pm, headache with sore muscles starting at 6:30pm, went to bed at 7:30 when couldn?t stand up anymore. At 8:00 chills started, along with a feeling of all my muscles contracting , lost the ability for fine motor control and fell asleep at 9.pm. Woke up at 12:45am covered in sweat feeling as if I was burning with a splitting heavy headache, had fever, don?t know temperature new house so no thermometer but it sucked. dunked head in sink. Legs could barely support me so I couldn?t go down the stairs for pain medication, went back to bed. Got cold washcloth at 1:00am pain felt pretty unbearable, couldn?t make it downstairs or move at this point so I spent night in and out of sleep unable to move. Muscles still feel like rocks and my head feels like it?s stuffed with a mixture of Vaseline and nitroglycerin, every time I move it feels like my brains smashing into my skull with little explosions. Recent development within the last 5-6 hours maybe?(3:00-4:00pm) centralized over my breast bone feels incredibly painful, hurts to breath and feels like something heavy is pressing it through my chest into my spine. Not sure what to do or if this is normal but it hurts really really bad. Accurate hours because I was lucidly texting my friends to make sure I wouldn?t pass out, so I have nearly exact hours when each symptom appeared till I could no longer use my fingers.

Dizziness- at 12:59 am on 04/11/21 Fever of 102.7 at 12:50am on 4/11/21 Fast heart beat when getting up at about 12am on 4/11/21 Headache at 5pm on 4/10/21

Fever: I had a temperature around 100 degrees (and higher maybe) for at least 4 hours (1AM to 5 AM). It may have lasted longer but I was sleeping. I was better when I woke up. I took Ibuprofen at around 4 AM. Joint aches periodically that same night and through the day after.

Janssen COVID-19 Vaccine EUA 11 hours after shot I started to experience a fever with extreme chills and uncontrollable shaking. I felt light headed and nauseous and threw up multiple times. The following day (4/10/21) I was back to my normal self.

Minutes after shot: felt slightly faint, tingling in feet and fingers, nauseous, sense of taste was off. Nausea and altered taste lasted about 3 hours. Insomnia beginning 10 hours after shot. 14 hours after shot: headache, fever 101, pain on left side of chest/spleen area, severe left arm pain, pain in left shoulder and forearm, fatigue, loss of appetite.

between 5 and 6 in the evening i started feeling a sharp throbbing pain in my right quad and then gradually my entire leg got tingly/numb feeling. in addition my symptoms of fever, headache, and body aches set in at this time too

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

Started off with sudden chills not even eight hours after receiving the vaccine. Chills slowly processed into a fever. By 7 pm, the fever progressed to 103.7 deg F. By 11 pm, I started to have nausea. Throughout the night I continued to have chills and sweats with episodic vomiting. The next morning I had terrible body aches and restless leg syndrome. I still had a fever and a lack of taste. It wasn't until 48 hours after receiving my vaccine that my symptoms eventually subsided.

VASOVAGAL: The patient stated she wasn't "feeling good," she felt very dizzy and temporarily lost vision, she was sweating as well. I immediately grabbed another chair and raised her feet above her heart level. She immediately stated that she was "feeling better" and started regaining her vision. we then offered her a cold bottle of water. She appeared very stable within a few minutes. We did call 911 as a precaution, they arrived a while later and deemed the patient was stable and their additional services were declined by the patient. I insisted the patient stay and finish the bottle of water. All together I believe the event was about 30 - 35 minutes before leaving. I encouraged the patient to drink plenty of fluids and electrolytes and to take it easy for the rest of the day.

High fever that reached up to 103 degrees Celsius that lasted for 24-30 hours, dizziness that is still occurring almost 48 hours after, severe migraine, difficulty breathing at onset of fever

Patient reports she got the J&J vaccine Friday, had chills/fever/headache the next day. All side effects have resolved without treatment

JANSSEN COVID-19 Vaccine High fever, chills and nausea started 6 hours after the injection and after tempra was taken.

Chills: I had chills when I was trying to fall asleep. I was cold but I felt my body hot at the same time. I took 1 pill of DayQuil Severe + VapoCool (Acetaminophen 325 mg, Dextromethorphan HBr 10 mg , Guaifenesin 200 mg , Phenylephrine HCl 5 mg) It lasted about 40 minutes. Then I fell asleep. Fever, headache and nausea: I woke up an hour later with fever, mild headache and nausea. It lasted about 4 hours. I took 2 pills of tylenol and had a shower. Started feeling better afterwards but I was too tired because I wasn´t able to sleep. I was okay the whole day but too tired. Then, I got a fever and headache again around 6 pm. Fell asleep for around 3 hrs and woke up feeling better.

Fatigue, dizziness, trouble moving, thinking, and functioning for 24 hours after receiving the vaccine. Tylenol has allowed me to function, but the side effects are worrisome.

Nausea, fatigue, shortness of breath, shaking feeling in the body, headache all within the same week of the shot which was 4/5/2021. Shaking feeling still on going as of 4/13/2021

Had the shot at 1 pm and by 9 pm, I started feeling nauseous and achy . Then around midnight I spiked a 102.8 fever. And all night I had extreme chills, stomach ache, headache and diarrhea. These symptoms lasted about 24 hours. I called the nurse hotline because I felt so bad.

Janssen COVID-19 Vaccine EUA approximately 6 hours after injection: fever and chills between 6 and 9 hours after injection: nausea with some vomiting between 9 and 36 hours after injection: headache Mostly resolved after 36 hours.

I had the typical soreness about 12 hours after the injection. No worries there. The next morning, on the 10th, around 11:40 AM, I started feeling extremely dizzy. The room started spinning. I was standing at the time, and I kept standing, but other than that, I had no control. My hearing starting going fuzzy, starting with ringing in my ears until it sounded like I was underwater. My vision started blurring, as well, eventually going completely black. For a solid 5-10 seconds, I could neither hear clearly nor see at all. I was conscious, because I could think relatively clearly, and I could feel my eyes blinking and could wiggle my fingers, but that was it. Once the episode passed, I immediately sat down. About a minute later, I started having excruciating abdominal pain. The pain was wracking my whole body, causing me to go pale (as I later saw once I could hobble to the bathroom) and making me sweat. After about twenty minutes, the whole thing passed and I was left with minor dizziness and slight nausea. Now, three days later, I still have some of the dizziness, but none of the blindness, deafness, or pain has returned. All other side effects, such as soreness, have completely left.

Pt was in the waiting room. Approximately 5 minutes after getting the vaccine, pt's mother called out and said that her daughter is passing out. Pt was found slump on the chair, slow to respond to my questions and diaphoretic. Pt stated she feels hot. Pt did not lose consciousness. Pt assisted to a room where she laid down. Mother stated she's never had this reaction to vaccines in the past. About 40 minutes later, pt sat up. Pt c/o feeling cold and shaky for a little while, but stated she feels better. Pt waited another 5 minutes and then discharged home accompanied by mother, in stable condition

Patient fainted and, upon waking, was hot/sweaty and generally felt unwell with several random spells of nausea for about 45 minutes afterwards.

Several hours after getting the vaccine, my back spasmed out and the pain was continuous and I still have the upper back pain today. That same evening I developed the chills, stomach pain. The next day I began experiencing a fever, headache, nausea, light headedness, dizziness, chills, back pain, lock jaw, some numbness on left side of face, zoning out or spacing out. My period also came two weeks early. I had some throat irritation as well as the feeling of being weak and some neck stiffness. All these symptoms seem to have gone away by Sunday evening, if not Monday morning. Except for the back pain, the nausea, and the throat irritation and some head pain and some numbness in face seem to have persisted.

Nausea, headache, chills, fever, muscle aches, fatigue (all night of 3/31 into 4/1) As of 4/13/21 still have headache, fatigue, and uterine bleeding.

At 6:30PM, I developed a headache and took acetaminophen. It didn?t subside after taking that, and progressively got worse as the night went on. I began feeling chills and feverish before I went to bed. I woke up sweating in the middle of the night multiple times with my headache getting even worse. At 5:30am, I woke up and it was as its worst, with a 101.2° fever, sweating, chills, and an even worse headache that felt like a migraine. The headache lasted until the next morning and lingered throughout the entire next day, although not as intense as it was at 5:30pm. I?m still struggling with some on and off fatigue from the vaccine, and my arm is still sore.

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

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

After about 7 hours of receiving the vaccine I started to shiver. My body felt extremely cold even though I was in 75 degree temperature indoors. I started getting goosebumps. That lasted for about 9 hours throughout the night. I also experienced nausea for about 30 minutes at 8:45 pm. I felt like I was going to pass out within that time period too. My head was also hurting throughout the night. My body was aching through the night as well. The only reason I am not sure if I had a fever is because I did not have a thermometer. My arm was sore for 3 days and I was also sweating throughout the first night.

Patient received the Janssen COVID-19 Vaccine EUA April 12, 2021 and later that evening started developing severe abdominal pain that would not go away. Following day it was still there, so we took her to the Emergency Room where after an abdominal cat scan she was diagnosed with mesenteric adenitis. They gave her total to manage the pain and sent her home to let the symptoms subside hopefully after a few days. Today she is better, but very tired.

Janssen COVID-19 Vaccine EUA The morning after getting the vaccine I woke up feeling very tired and sore/achey all over. I got to work (I lifeguard at the pool on campus) at around 6:15am and helped get the pool set up. When I sat down to try to do homework I started feeling very dizzy and nauseous. The pool deck is very hot, so I decided to try to go into the pool office where it would be cooler. I remember walking through the door and into the office, and then laying down next to the trash can because I thought I might be sick. One of my coworkers brought me some water and Goldfish, and I layed on the office floor for the rest of my 45 minute shift. Afterwards, when I was looking for my laptop, my other coworker said that when I had tried to go through the door into the pool office I had run into the door (I later got a small lump on my head from this) and that I had dropped my latptop. I do not remember either of these happening, so I believe that I blacked out for a moment, and it was likely hitting my head on the door that woke me up. A small scratch and some mild pain in my foot leads me to believe I dropped the laptop partially, but not completely, on my foot. I felt very tired for the rest of the day, and a little dizzy up until about mid-afternoon. I spent most of the day in bed sleeping. Waking up the next morning I felt completely fine, and was able to go about all of my normal activities with no side effects at all.

Chest tightness, dizziness, fatigue, hemoptysis x1, left side head pain, shortness of breath x 7 days.

Pt exhibited s/s vasovagal rxn immediately after COVID vaccination. Stated she felt "hot and sweaty". Had several emesis and then stated she felt better. Was diaphoretic and pale. BP remained WNL. Denied SOB/dspnea. Pt given water and assisted to supine position on cot. Stated this has happened to her in the past with a blood draw. After about 10 minutes, pt assisted to sitting position and reported s/s resolved. Color had returned and pt less diaphoretic. Pt able to stand without difficulty. Was assisted to waiting area and waited for 30 minute period with 10 extra minutes. Discussed s/s to seek emergency care for. States understanding.

Pt rec'd COVID vaccine and presented to the observation area. Sat for about 5 minute sand flagged staff down. Stated she felt "woozy and shaky". Was diaphoretic and pale. Given water. Denied other s/s. State dshe "saw blood after the shot"and became light headed. BP WNL. Drank water and fanned herself. Remained sitting upright and conscious. Denied any other s/s. After about 10 minutes, pt reported s/s resolved. Pt sat for rest of 30 minute observation period without c/o any other s/s. Stated she felt normal. Ambulated from facility without difficulty. Discussed pulling over when driving if feeling return of s/ sand calling emergency services. States understanding.

Strong shivers along with high fever and pain in legs until current day (04/14). Also shortness of breath

2:30 slight-mild symptoms: headache, body aches 4:20pm- 7am SEVERE flu symptoms: body aches, chills, hot flashes, headache, nausea, dizziness, sensitivity to light and sound, tinder, fever Treatment: Tylenol and cold rag

4/10 at night - lightheaded, fever, chills, sweating, headaches -- > took Tylenol 4/11 in morning- fever, headaches, dizziness, severe dehydration, fainting/passing out -- > taken to ER after passing out, treated with saline, other fluids, and rest

101 fever, Extreme Headache with pain to touch hair, left hand pain, and body twitching. VNS implant device for seizures constantly provided autostimulations, which is not a normal occurrence. Provided OTC Iburophen 800mg every 6 hrs and kept hydrated.

SYMPTOMS PRESENTED: SEIZURES, PALPITATIONS, FEVER, PULSE IN 125-130 FOR SEVERAL HOURS EVEN WHEN I WAS RESTING, BLOOD PRESSURE 86/66

ALMOST PASSED OUT BUT SHE DID NOT; LOSS OF TASTE; LOSS OF SMELL; FATIGUE; MUSCLE ACHE; This spontaneous report received from a health care professional concerned an adult female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of taste. On APR-2021, the subject experienced loss of smell. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced almost passed out but she did not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, muscle ache, loss of taste, almost passed out but she did not and loss of smell was not reported. This report was non-serious.

SWEATING; DIZZINESS/LIGHTHEADEDNESS; ACHING; CHILLS; NAUSEA; SLIGHT HEADACHE; This spontaneous report received from a parent concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included intellectual disabilities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced sweating. On 07-APR-2021, the subject experienced dizziness/lightheadedness. On 07-APR-2021, the subject experienced aching. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, dizziness/lightheadedness, and nausea on 07-APR-2021, and aching, chills, and slight headache on 08-APR-2021. This report was non-serious.

BODY ACHE; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, no alcohol use, smoking, and depression, and other pre-existing medical conditions included the patient has no known allergies and no history of drug abuse or illicit drug use. The patient was not pregnant at the time of event reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: unknown) dose was not reported, administered on 06-APR-2021 08:00 for prophylactic vaccination. Concomitant medications included venlafaxine for anxiety, and depression, bupropion hydrochloride for depression, and ethinylestradiol/norgestimate. On 06-APR-2021 17:00, the subject experienced body ache. On 06-APR-2021 17:00, the subject experienced chills. On 06-APR-2021 17:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, headache, and chills. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious

SEVER COLD; FEVER; SHORTNESS OF BREATH; THROW UP; COUGH; SEVERE BODY PAINS; WEAKNESS; CONSTANT HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced throw up. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced severe body pains. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced constant headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021 20:30, the subject experienced sever cold. On 10-APR-2021 20:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever cold, and fever on 11-APR-2021, and had not recovered from constant headache, cough, shortness of breath, nausea, severe body pains, weakness, and throw up. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

pt reported dizziness, mild diaphoresis, pt reported not doing well with shots, needed to elevate feet, drank juice, ate snack

ELEVATED HEART RATE; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 Expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced elevated heart rate. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103.5 (units unspecified), and Pulse rate (NR: not provided) 130 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, elevated heart rate, and headache. This report was non-serious.

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

RPH ADMINISTERED JANSSEN'S COVID-19 VACCINE AT 10 AM AND WITHIN A FEW MINUTES, PATIENT FAINTED AND SLIPPED OFF HER CHAIR TO THE FLOOR. PATIENT CAME TO WITHIN A MINUTE AND RPH HELPED HER TO THE CHAIR, OFFERED HER WATER AND A BANANA, AND THE PATIENT DID NOT SEEM HURT. RPH MONITORED THE PATIENT'S BLLOD PRESSURE AND COLORING/ SWEATING FOR 30 MINUTES BEFORE SHE LEFT THE PHARMACY AND HER FATHER DROVE HER HOME.

Starting by 5:00pm in the evening, I started feeling faint and very exhausted. I had zero appetite and ate some noodles for dinner. I felt like I couldn't stand up. I started feeling the chills and joint/muscle aches by 8:00pm. I fell asleep at 9:30pm because I was so tired and woke up at 11:00pm feeling incredibly feverish, naseauish and weak. I couldn't stand in the shower I felt so weak. Then around 11:30pm I vomited all of the contents of my stomach. I didn't feel nauseous after I finished vomiting. The next day I still felt feverish and like I didn't have an appetite. I spend around 5 hours of the day sleeping. I felt more like myself by 7:00pm the following day.

she hurts in her body, nausea, headache. No cough, no SOB, c/o chest pain on inspiration intermittently, more a sharp pain near the center just above the breastbone, not a squeezing or a pressure substernal Took some APAP and took alleve 20 min ago I adv that the body aches, N, HA all may be consistent with ADR to the vaccine and generally should be limited to a few days, ok to take OTC pain relievers but not in excess to bottle recommendations. Keep hydrated. Consider a hot pack. Watch the chest pain if this persists or worsens, consider HCF evaluation, though given the body pain throughout and location of the pain may be muscular.

HEADACHE; ELEVATED HEART RATE; POUNDING HEART; This spontaneous report received from a patient concerned a 21 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 and batch number: 1808982 expiry: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced elevated heart rate. On 13-APR-2021, the subject experienced heart pounding hard. Laboratory data included: Heart rate (NR: not provided) Elevated. On 15-APR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated heart rate, heart pounding hard, and mild headache. This report was non-serious.

MINOR COLD; SORE ARM; FATIGUE; CHILLS; FEELING HOT; This spontaneous report received from a consumer concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced feeling hot. On 10-APR-2021, the subject experienced chills. On an unspecified date, the subject experienced minor cold, sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, and chills on 11-APR-2021, and minor cold, and had not recovered from sore arm, and fatigue. This report was non-serious. This case, from the same reporter is linked to 20210421646.

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

PAIN IN BOTH ARMS; HEADACHE; CHILLS; PAIN IN INJECTION ARM; FEVER; PAIN IN VEINS; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included thrombosis, and concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of report. The patient was previously treated with rivaroxaban for thrombosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pain in veins. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced pain in injection arm. On 18-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced pain in both arms. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, pain in injection arm, fever, and headache on 19-MAR-2021, had not recovered from pain in both arms, and the outcome of pain in veins was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

BODY ACHE-MOSTLY ALONG THE NECK AND BACK; STIFFNESS ALONG SPINE; HEADACHE; FEVER (103F); This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid removal, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body ache-mostly along the neck and back. On 08-APR-2021, the subject experienced stiffness along spine. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache-mostly along the neck and back, stiffness along spine, and headache on 11-APR-2021, and fever on 09-APR-2021. This report was non-serious.

FLU LIKE SYMPTOMS; SHORTNESS OF BREATH PERIODICALLY DURING THE NIGHT; WAKE FROM SLEEP; This spontaneous report received from a consumer concerned a 21 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 vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms, shortness of breath periodically during the night, and wake from sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and shortness of breath periodically during the night on 06-APR-2021, and the outcome of wake from sleep was not reported. This report was non-serious.

BACK SORE; PAIN IN HIPS DOWN BOTH POSTERIOR LEGS; DID NOT FEEL GOOD; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced back sore. On 12-APR-2021, the subject experienced pain in hips down both posterior legs. On 12-APR-2021, the subject experienced did not feel good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not feel good, and was recovering from back sore, and pain in hips down both posterior legs. This report was non-serious.

SHAKY; HEART RACING; STOMACH PAIN; DIARRHEA; BODY ACHES/BODY PAIN; NAUSEA; FEVER 101F; This spontaneous report received from a parent concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose 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 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced body aches/body pain. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever 101f. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021, the subject experienced heart racing. On 12-APR-2021, the subject experienced shaky. Laboratory data included: Blood glucose (NR: not provided) 120, and Heart rate (NR: not provided) 145. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, stomach pain, diarrhea, body aches/body pain, fever 101f, heart racing and shaky was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

Severe Headache, left leg tingling, nausea, nerve pain in left leg and arm. All started on 4/13 in the PM and are currently ongoing.

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

CALF PAIN; ANKLE PAIN; HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced headache. On 17-APR-2021, the subject experienced calf pain. On 17-APR-2021, the subject experienced ankle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms, and headache, and had not recovered from ankle pain, and calf pain. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious

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

Significant fatigue for the past two months. Not able to do her normal day-to-day activities without taking a break or taking a nap.

Hepatitis / Encephalopathy (seizures, ADEM, MISC/A) PRESENTING PROBLEM: Fever and chills [R50.9] Hepatitis [K75.9] Febrile illness, acute [R50.9] Acute nonintractable headache, unspecified headache type [R51.9] Seizure (HCC) [R56.9] MIS-C associated with COVID-19 (HCC) [M35.81] Active Issues Requiring Follow-up MIS-C/A - 2/2 COVID-19 infection vs idiosyncratic reaction to J&J vaccine -prednisone taper over 16 days as above -ID will be arranging follow up serial labs (CBC with diff, CMP, Ferritin level, CRP, LDH) -Bactrim prophylaxis while on steroids -Acyclovir 400 mg BID for prophylaxis (hx of recurrent HSV infection of eyelid) - duration to be clarified by ID at follow up -ASA 81 mg daily -TTE w/ normal coronaries. She will need cardiac MRI, to be arranged by adult congenital cardiology Generalized tonic-clonic seizures - witnessed and captured on EEG 4/9. No further events. Continue Keppra 1500 mg BID. outaptient f/u with neurology Abnormal MRI brain - diffuse T2 white matter hyperintensities - non-specific. She will need follow up MRI brain w/ and w/o contrast in 1 month and follow up with neurology clinic ADHD - given insomnia, Senthuri was recommended to avoid vyvanse for now. She will discuss with her outpatient prescriber Anxiety and depression - zoloft increased to 125 mg daily Insomnia - 2/2 trauma from critical illness. Improved with trazodone HS. Elevated EBV PCR - ID will continue to monitor. Nausea/vomiting - resolved. Likey 2/2 gastritis in setting of steroid use. PPI BID x 4 weeks DISCHARGE DISPOSITION: Home without services

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

The next morning I was awoken by intense full body aches and pains. I had a fever with chills. I suffered from nausea but no vomiting.

My lips were burning and pulsating, my upper lip had gotten a dry bump. I had tried throwing up once but all I could do was gag. The next day my body felt tired and I had slept the majority of the day my arm had also hurted. My seasonal allergies were bothering me so I took Benadryl only one before bed. Today I woke up my arm is still hurting although not as bad. But I'm still tired I felt like I haven't slept enough but I had gotten about 7 or 8 hours of sleep.

102 degree fever, muscle aches, headache and earache lasting about 36 hours after onset of symptoms. Tylenol helped control symptoms

Patient received JJ COVID 19 vaccine and had a syncopal episode 2-3 minutes later that lasted for 2-3 seconds. She complained of pain back of head and was given ice pack. There was no visible or palpable injury. She was brought to medical; observation area, VSS. She was monitored for 35 minutes and left ambulatory and asymptomatic with a friend.

Dizzy, Sweaty, Lost Vision Temporarily, Hearing muffled, Sensation of needing to urinate, Chills, overwhelmed, numbness in hands

Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Additional Details: light headed started to fall sweating called 911 paramedics took to hospital as blood pressure too long could not leave her

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: before vaccination, pt indicated that she doesn't do well in needles. she experiences panic attacks with needles. pt complained of lightheadedness, nausea,flushed, warm feeling. gave pt a trashcan but didnt vomit. gave a cool compress, and pt already had h20 to drink. after sitting over 30 minutes, pt boyfriend came to p/u pt. called pt. pt is doing much better also indicated she had some blurred vision also.

For thirty-six hours after the vaccine. I had body aches and chills and my eye sockets were sore and it hurt to look up. Ten days after the vaccine I was in the shower and a large blood clot came out of my nose. It was a large clot about the size of a quarter and there was no other blood with it. The clot came out of my left nostril but it was not like a nose bleed. I went to the Urgent Care but they did not do tests.

LEG PAIN; FATIGUE; FEVER; DIZZY; This spontaneous report received from a parent concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced leg pain. On 16-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Not had clots. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, fatigue, and fever on 08-APR-2021, and leg pain. This report was non-serious.

VOMITING; BODY ACHES; CHILLS; FEVER; NAUSEA; PAIN IN ARM; WEAKNESS; This spontaneous report received from a patient concerned a 21 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: 1821286, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 11:40 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced pain in arm. On 12-MAY-2021, the subject experienced weakness. On 12-MAY-2021 22:00, the subject experienced vomiting. On 12-MAY-2021 22:00, the subject experienced body aches. On 12-MAY-2021 22:00, the subject experienced chills. On 12-MAY-2021 22:00, the subject experienced fever. On 12-MAY-2021 22:00, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) Pretty high. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fever, and had not recovered from chills, body aches, nausea, vomiting, pain in arm, and weakness. This report was non-serious.

pt received shot at 1107am at 1110am pt started feeling sweaty/claimy an severe headache, pt asked to wait a few before calling 911, we gave pt a wet paper towel and boyfriend purchased a water to possible give benadryl, at 1112am pt started feeling hot, and felt like throat closing, we called 911 at that time and monitored symptoms pt wasnt running a fever and no rash around injection site, ems and fire arrived and checked vitals all checked out ok we advised we could give a benadryl pt said they had some at home and would just take at home, pt refused to be transfered to hospital so we all signed off on ems sheet and pt left with parent and boyfriend.

LEFT SIDE LIPS NUMBNESS; LEFT SIDE OF NECK AREA HURTS; THROAT SWELLING; SWOLLEN LEFT SIDE OF THE NECK; HARD TIME TO SWALLOW; COLD; TIRED; HEADACHES; DIDN'T SLEEP VERY WELL; SWALLOWING HURTS A LOT; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced swallowing hurts a lot. On 12-MAY-2021, the subject experienced didn't sleep very well. On 12-MAY-2021, the subject experienced tired. On 12-MAY-2021, the subject experienced headaches. On 13-MAY-2021, the subject experienced cold. On 14-MAY-2021, the subject experienced throat swelling. On 14-MAY-2021, the subject experienced hard time to swallow. On 14-MAY-2021, the subject experienced left side of neck area hurts. On 14-MAY-2021, the subject experienced swollen left side of the neck. On 15-MAY-2021, the subject experienced left side lips numbness. The action taken with covid-19 vaccine was not applicable. The patient recovered from didn't sleep very well, and cold on MAY-2021, tired on 12-MAY-2021, and headaches on 13-MAY-2021, and had not recovered from throat swelling, hard time to swallow, left side lips numbness, left side of neck area hurts, swallowing hurts a lot, and swollen left side of the neck. This report was non-serious.

Symptoms started roughly five hours after receiving the vaccine. It began with cold sweats, where I was shivering but sweating. Then I began experiencing nausea overnight coupled with a headache.

The first symptom I experienced was a high grade fever that reached 103.5 degrees Fahrenheit. The fever lasted from 2:00pm on May 10th (the day it was administered) until 2:00 am on a May 11th (the early hours of the day after it was administered). Some weakness, as well as muscular soreness in the left arm persisted in the insuring days. The reason why I chose to report my experience is because something that I thought was abnormal happened. On the evening of May 15th, as I was putting on my pajamas, I noticed an irregular mass in my left breast. As I examined it further, I realized that this mass was not there previously and warning shots fired off in my head, immediately. I immediately asked my grandmother to do another examination of my breast, and she confirmed my suspicion that there was a foreign mass located above my nipple in my left breast. It was difficult for me to closely monitor this mass as it was difficult for me to think about it as it triggered emotional distress. I asked my mom to do an examination and she also noted the mass. A little more than a week later, I noticed that the mass shrunk. Since everyone in my family was on edge for nearly a week suspecting that a 21 year old female in their family could possibly have breast cancer, this caused my family to consult my grandmother?s doctor, and have her assistant contact me about what could potentially be happening. Her assistant spoke to me over the phone and communicated that it is important for me to have the mass formally examined and for me to receive a mammogram. She also mentioned that many women who have received the vaccine also noticed irregular lumps in their breasts after receiving the vaccine. I want women in my age range to be aware that they might notice lumps in their breasts after the vaccine and not to experience the same emotional distress of thinking that they have breast cancer when it could be inflammation occurring in their lymph nodes as a result of being administered the Covid vaccine.

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

Night of vaccine for 3 days, extreme chills and cold sweats, fever, cold symptoms. No medication administered. Numbness in left leg 1 week later.

Patient starting feeling dizzy after the administration and also complained of headache. Healthcare professional checked the patient's blood pressure which was normal. After about 20 minutes of observation, patient was not getting better and EMS was called .

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

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

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

Severe fever, muscle pain, headache, and chills. From time is started as mentioned and until now still.

Uncontrollable shivering, high grade fever (103.5 degrees f), while body muscle aches, extreme headache. Over the course of 24 hours, ibuprofen and cold compress used as treatment.

I woke up around 2 in the morning with body aches, chills, and nausea. I started having muscle seizures that made me unable to talk, but I was still somewhat aware of things going on around me. I went to the ER where they observed my pulse and oxygen levels. I was also completed a full blood panel and an EKG was administered. woke up aroound 2 am with body ached, chills nausea i started havieng mucle seizurs, where I couldn't talk .I went to the ER week to get better

SEVERE MIGRAINE; FLU LIKE SYMPTOMS; STOMACH PAIN; ARM SORENESS ON THE SURROUNDING TISSUE AROUND THE INJECTION; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, severe depressive disorder, generalized anxiety, alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included sertraline for antidepressant, ethinylestradiol/norgestimate for birth control, and salbutamol. On 25-MAY-2021, the subject experienced arm soreness on the surrounding tissue around the injection. On 26-MAY-2021, the subject experienced severe migraine. On 26-MAY-2021, the subject experienced flu like symptoms. On 26-MAY-2021, the subject experienced stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe migraine on 26-MAY-2021, and flu like symptoms, stomach pain, and arm soreness on the surrounding tissue around the injection on 27-MAY-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious

Patient states that in the first two days after vaccination, she experienced flu-like symptoms. Her symptoms progressed and became more severe with nausea, vomiting, fever, and "sleeping legs" (numbness, tingling). Pt's mother called pharmacy on 6/3/2021 to express concern and pharmacist advised her to take daughter to emergency department. Follow-up calls to patient have gone unanswered.

Headaches and pain in sinuses Dizziness persisting "Brain fog" trouble concentrating/memory clumsiness, balance problems possible vertigo

On Sunday, the 13th, I started to have scratchy throat; felt like sand in my throat every time I swallow. The following day, I started to have sinus congestion and sore throat and sneezing. Then the following day, the symptoms continued and I had to leave work early. That Tuesday, I lost my sense of taste and smell for a couple of hours but the next day they came back. I started to get better. Thursday I had high pulse and oxygen levels were a little high for the normal down to 95 and 96 and my usual is 100. I had a doctor I work with listen to my lungs and he couldn't hear anything. 15th I had a visit not with Primary care whoever was covering that day, they prescribed me with a nasal spray. ER heart rate was still high and they did blood work; X-ray; EKG; rapid Covid test and PCR negative result; everything came out fine. No treatment. But diagnosis of Upper Respiratory Infection. I had another visit with dr after ER visit for follow up.I still have the cough.

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

Blood Clots, 5:20 PM, 7 hours Abdominal Pain, 5:00 PM, 7 hours Tiredness, 5:00 PM, 7 hours Back Pain, 6:50 PM, 5 hours

SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FEVER; This spontaneous report was received from a 21-year-old female patient. 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 administration was not reported, batch number: 201A21A, and expiry: unknown) dose was not reported,1 total, administered on left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 (12 hours post vaccination), the patient experienced fever and felt fine after 2 days. On 18-JUN-2021, the patient experienced cough and head cold. On 19-JUN-2021, the patient experienced loss of taste, and loss of smell. The patient then realized that it could be coronavirus disease (COVID-19) symptoms and took an 'at-home' covid test which came back positive (suspected clinical vaccination failure, suspected covid-19 infection). At the time of report, the patient still had some lingering cold and her loss of taste and smell did not return. She generally felt better at the time of report and had not consulted a health care provider as her symptoms were mild. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 10-APR-2021, was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000183672 The suspected product quality complaint has been confirmed to be not void, based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210648767-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

PAIN IN LOWER BACK; CHILLS; FEVER; HEADACHE; NAUSEA; OVERALL WEAKNESS; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies, no any history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204a21a, expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced pain in lower back. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever. On 25-JUN-2021, the subject experienced headache. On 25-JUN-2021, the subject experienced nausea. On 25-JUN-2021, the subject experienced overall weakness. Laboratory data included: Body temperature (NR: not provided) 102.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, nausea, chills, pain in lower back, and overall weakness. This report was non-serious.

PATIENT'S MOTHER CALLED THE PHARMACY ON 07/03/21 9:30 AM TO REPORT THAT THE PATIENT HAD A HEADACHE, CHILLS, FEVER (103 F), INCREASED HEART RATE (145 BPM) AND CHEST PAIN THE NIGHT SHE WAS VACCINATED (07/02/2021). ON HER WAY TO THE ER, PATIENT FAINTED.

WITHIN 3 TO 4 MINUTES OF INJECTION PT FELT DIZZINESS, HEADACHE, SWEATING, FEELING TINGLING ALL OVER BODY, AND NAUSEA . THE FIRE DEPARTMENT MEDIC CAME IN. MONITORED HER. TOOK HER OUTSIDE ON A STRETCHER, SHE FELT BETTER, WALKED BACK AND FORTH AND FELT BETTER AND DID NOT GO TO THE HOSPITAL.

EXTREME BODY ACHE; JOINT PAIN; CHILLS; BAD FEVER; EXTREME HEADACHE; TIRED; This spontaneous report received from a consumer concerned a 21 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1821286 and expiry: UNKNOWN) dose was not reported, administered on 04-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUL-2021, the subject experienced extreme headache. On 04-JUL-2021, the subject experienced tired. On 05-JUL-2021, the subject experienced extreme body ache. On 05-JUL-2021, the subject experienced joint pain. On 05-JUL-2021, the subject experienced chills. On 05-JUL-2021, the subject experienced bad fever. Laboratory data included: Body temperature (NR: not provided) 101 F. 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 bad fever, extreme body ache, joint pain, chills, extreme headache, and tired. This report was non-serious.

SINUS PRESSURE; CHEST TIGHTNESS; CAN'T CATCH BREATH; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine with aura. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced sinus pressure. On 14-JUL-2021, the subject experienced chest tightness. On 14-JUL-2021, the subject experienced can't catch breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus pressure, chest tightness, and can't catch breath. This report was non-serious.

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

I felt no affects after I received the shot at 2:30 PM. Woke up with chills, violent shivering, became sick to my stomach at 2 AM. I fell back to sleep an hour later after covering myself with another blanket and throwing up. My Apple Watch shows at 4 AM my heart rate rose to 127 BPM when I was asleep. It is now 6 PM and I am feeling body aches, headache, stuffy nose, still a bit nauseous-- almost like cold symptoms.

8 hours after getting the vaccine I started to get the chills and couldn't get warm. I took my temperature and it was 99.7. I wait a another hour and I still had the chills and started to have terrible body aches. I took my temperature again and it was at 101.3. This stayed the same until the follow day (03/07/2021) My fever finally went down around 2pm. And the body aches stopped around 4pm.

I first noticed that I was extremely cold and could not get warm at about 11 pm on the evening of my vaccine. I then realized it was getting worse, and I was shivering uncontrollably despite sitting in front of a space heater in warm clothing and wrapped in a blanket. I checked for a fever, but my temp was only 99. I fell asleep around 1 am, and woke up at 5 am (3/8/21) to a splitting headache, extreme thirst, slight nasal congestion, muscle soreness, fatigue, and nausea. These symptoms feel almost identical to the symptoms I experienced when I contracted COVID-19 in September 2020 at my university.

Janssen COVID-19 Vaccine EUA about 6 hours after Janssen shot I experienced a fever, body aches, chills and nausea throughout the night and through the next day.

Muscle pain all over body, specifically glutes, lower back back, and arms. Fever above 99° F Chills and sweats at the same time Headache with pulsating nerve pain on sides and ears. Dryness in mouth no matter how much water intaked Treatment: tylenol and bed rest

Received the vaccine at 3 am on March 8 2021. Symptoms began at 10am. Severe flu like symptoms (9 out of 10 on a pain scale, 10 being extremely painful): body aches and pains and low fever. Took both acetaminophen and ibuprofen to counteract the pains (did not help much). These symptoms lasted through March 9, 2021. Today is March 10, 2021 and my symptoms are feeling moderately faint and lethargic.

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

The night of my vaccine date (6 hours after) I was fatigued and started a fever with chills and acheyness which kept me in bed all night. I got up to shower and get some food as I was going upstairs I grew very faint, my vision grew black and my hearing faded. I was able to make it to my bed then ask for some help. After taking Tylenol, my fever began to be very hot instead of chills. I was able to fall asleep until I woke back up to chills again and taking more medicine. The next morning, I was still dizzy when I walked around but the fever was gone. I was still very fatigued which made me unable to go to class or work. Day 3 I was back to my normal self.

Arm felt heavy and sore 1:30pm took Tylenol. Feel very tired. 6pm Shortness of breath. Needed more air. Used an inhaler & it helped. Exhausted 8pm

Began with chills and muscle aches. Got worse over the course of an hour until I was unable to get out of bed. Pain in my muscles all over from hours of full body chills. The chills stopped after two hours at which point an uncontrolled fever set in. Highest temp recorded was 103. Severe full body muscle pain prevented me from getting up or drinking water on my own. Small movements like sitting up or rolling over to relieve muscle pain resulted in sudden and severe nausea. Considered going to a hospital to bring down the fever and hydrate. After two more hours of applying cold compresses, the fever decreased to 100 at which point I slept it off for six hours. Prolonged bouts of dizziness, dehydration and nausea over the following two days.

patient reported feeling of hot flashes and head pounding; patient informed pharmacist about the reaction 2 hours after the vaccination. Pt felt better after taking Tylenol.

Fatigue: 5pm on 3/13/21- current Extreme muscle pain throughout body: 5pm on 3/13/21- current Uncontrollable shivering: 8pm on 3/13/21- 12am on 3/14/21 Swollen lymph nodes on left side of neck: 5pm on 3/13/21-current Nausea caused by pain and shivering: 8pm on 3/13/21- 12am 3/14/21 Chest pain and arrhythmia: 8pm on 3/13/21- 12am 3/14/21 (mother is an RN and checked this with stethoscope) I took Tylenol around the clock, did not make any changes to my symptoms. Called the ER and was transferred to a pre-recorded line. Called PCP and was instructed to increase fluid intake, rest, and take vitamins C and D.

In a few hours after my COVID shot, I had Intense chills that made my entire body ache, then a headache and a rapid heartbeat, with a 101.7 fever.

Client felt faint and dizzy two minutes after receiving the dose of Janssen vaccine. Client reports no allergies. Client was seated in a chair, and EMTs were called. EMTs assessed the client. Client continued to feel poorly: faint, dizzy, sweaty and pale. Left client in the care of the EMTs.

Fever, chilles, tiredness and muscle aches onset 10 hours after vaccination. The fever, chills, and muscle aches lasted for 8-10 hours. The tiredness lasted about 48 hours. After about 48 hours after having the vaccine I had nausea that lasted about 24 more hours.

headache and feeling ?high? about an hour afterwards. fatigue persisting. seven hours later (12 am) fever 100.5, severe chills and shakiness and a migraine type headache. nausea came sometime after 12 am.

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

Janssen COVID-19 Vaccine EUA I received the Janssen COVID-19 Vaccine EUA on 03/09/21 at 6:20AM. My arm started to ache maybe 15 minutes after and lasted throughout the whole day. Around 4:30:PM I started to feel more aches and chills. Then, by 7:00PM I had a fever. My temperature was 100 degrees. By the next day, 03/10/21 my fever and chills were gone, however, I felt very achy all over the body. It was not until the next day, 03/11/21 that I didn't feel achy anymore.

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

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

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

Received vaccine 3/19 and then woke up 3/20 with fatigue, chills, nausea, diarrhea, congestion. Pt's symptoms were improving as far as congestion, but fatigue was so severe that pt did not feel that she was able to drive herself around and has missed work as a result. Sx ongoing as of 3/23 at 9:30 am.

5 minutes following vaccination, patient became pale, sweaty, dizzy, and light headed. Vitals noted to be: Bp 88/60, P 100, R 16 no distress. Patient laid down on cot and given ice pack on neck. Patient also reported having nausea and abdominal cramps. Patient monitored for half hour. Color improved and Bp noted to improve to 110/66. Patient drove home by father.

After receiving vaccine, patient complained of not feeling well and feeling faint. Patient laid on floor with feet elevated. Bp 96/58, P 70, R 18. Color was pale with no signs of respiratory distress or other skin changes noted. Given cool compress and juice. Transferred to cot to monitor for half hour. Before leaving patient noted to have pink color back to skin, was tolerating sitting without feeling dizzy, and vitals: Bp 110/80, P 88, R 16.

about 7 hours after receiving the vaccine I had horrible body aches, chills, and a fever. these persisted overnight and into the nest day. i continued to have body aches and chills for three days. I then developed a horrible headache two days after receiving the vaccine that lasted for 4 days. once the headache was gone, I continued to be fatigued and have body aches for two more days. overall, I had awful side effects for 7 full days post vaccine.

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

It started as chills and body aches at 2 AM then progressed to a fever, borderline migraine, and nausea. I am unsure about whether or not I should take medicine for it so I have remained unmedicated thus far.

muscle pain in the back of the legs, chills, fever, headache, dizziness, tiredness. It started around 12am and went until 1pm when I took tylenol.

Chills, fatigue, soreness, dizziness, and sinus headache overnight after receiving vaccine. Chills, fatigue, soreness, dizziness, chest pain, and difficulty breathing the day after receiving the vaccine.

About 10 hours after vaccine, began to feel tired and fatigued and nauseous. Then I developed a fever and sore muscles. It progressed to the point where I needed assistance walking. I had extreme chills with uncontrollable shivering and muscle spasms. I felt very cold though I was burning up and sweating profusely. I went to sleep and woke up a few hours later with no fever but very sore muscles. When I woke up in the morning, I felt like nothing had happened, I was just a bit groggy.

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

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

101 degree fever about 12 hours after shot, treated with tylenol, subsided; 100 degree fever about 24 hours after shot; Chronic pain flare-Up for about 36 hours after shot which decreased as fever decreased.

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

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

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

Patient experienced fainting approximately one minute following administration of vaccine. Patient reported hearing ringing in ears prior to fainting. Patient did not fall or experience any physical injury during fainting episode. Patient returned to consciousness and reported feeling hot and sweaty. Patient consumed apple juice and was monitored for thirty minutes. Patient denied the need of emergency medical care and reported feeling better throughout the 30 minute monitoring and prior to leaving the facility. Patient was given a ride home with family members. Patient blood pressure prior to leaving the facility was 113/69 with pulse of 61. Patient denied feelings of dizziness, lightheadedness, ringing in ears and difficulty with breathing prior to leaving facility.

Pt passed out, diaphoretic, anxious. Quickly came to. Left with mother to go to urgent care for evaluation.

Diaphoretic, lightheadedness, blurred vision, pallor. H2O, snack, cool rag on neck. Date: 3/22/2021 Problem: J&J Post-Vac Notes: Time: 1555 Pt. Diaphoretic, light headedness, blurred-vision, and pallor. BP 193/89 HR 49, temp 97.0, RR 26. Gave pt H2O, a small snack, and a cool rag for back of patients neck. Monitored pt. No s/s of acute distress. Time: 1629 Pt reported clear vision and "feeling much better. " Pt teaching on s/s of allergic reaction. BP 179/66, HR 60, temp 97.6 F, SpO2 985. Pt ambulated out of facility building independently. No s/s of distress.